Datasets:

eu_regulatory_ir

like 2

32005L0007

2005

COMMISSION DIRECTIVE 2005/7/EC of 27 January 2005 amending Directive 2002/70/EC establishing requirements for the determination of levels of dioxins and dioxin-like PCBs in feedingstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feeding-stuffs (1), and in particular Article 2 thereof, Whereas: (1) Commission Directive 2002/70/EC of 26 July 2002 establishing requirements for the determination of levels of dioxins and dioxin-like PCBs in feedingstuffs (2), lays down specific provisions concerning the methods of analysis to be applied for the official control provided for in Directive 70/373/EEC. (2) The sampling procedure laid down in Commission Directive 76/371/EEC of 1 March 1976 establishing Community methods of sampling for the official control of feedingstuffs (3) has to be applied for the official control of the levels of dioxins and the determination of dioxin-like PCBs in certain feedingstuffs. It is appropriate to specify that the quantitative requirements in relation to the control of substances or products uniformly distributed throughout the feedingstuffs should be applied. (3) It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised implementation approach in all Member States. (4) Directive 2002/70/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annexes to Directive 2002/70/EC are amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 12 months after the entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0008

2005

COMMISSION DIRECTIVE 2005/8/EC of 27 January 2005 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (1), and in particular Article 8(1) thereof, Whereas: (1) Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I thereto is prohibited. (2) When Directive 2002/32/EC was adopted, the Commission stated that the provisions laid down in Annex I to that Directive would be reviewed on the basis of updated scientific risk assessments and taking into account the prohibition of any dilution of contaminated non-complying products intended for animal feed. (3) Before a complete review based on an updated scientific risk assessment can be carried out, it is necessary to provide for certain amendments in the light of developments in scientific and technical knowledge. (4) It is appropriate to clarify the term green fodder. (5) Since the supply of calcium carbonate, an essential and valuable feed material, could be endangered because the level of total mercury due to normal background contamination is close to or exceeds the maximum level laid down in the Annex I to Directive 2002/32/EC, that maximum level should be amended, taking into account that mercury is present in calcium carbonate in its inorganic form and that the Scientific Committee for Animal Nutrition confirms that mercury in inorganic form is significantly less toxic than organic mercury, in particular methyl mercury. (6) The maximum level for fluorine in other complementary feedingstuffs is 125 mg/kg per 1 % phosphorus. For environmental reasons, the level of phosphorus in animal feed is restricted and the digestibility and bioavailability of phosphorus is improved by making use of an enzyme such as phytase. It is therefore no longer appropriate to establish the maximum level as per 1 % of phosphorus but to establish the maximum level for complementary feed relative to a feedingstuff with a moisture content of 12 %. (7) Directive 2002/32/EC should therefore be amended accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 2002/32/EC is amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive twelve months after the entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0009

2005

COMMISSION DIRECTIVE 2005/9/EC of 28 January 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annex VII thereto to technical progress (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof, After consulting the Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers, Whereas: (1) Part 1 of Annex VII to Directive 76/768/EEC establishes a list of UV filters which cosmetic products may contain. (2) The Scientific Committee on Cosmetic Products and Non-food Products intended for consumers is of the opinion that the use of benzoic acid, 2-[4-(diethylamino) -2-hydroxybenzoyl]-, hexylester up to 10 % in sunscreen products, alone or in combination with other UV absorbers, is safe. Consequently, benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester should be included in Part 1 of Annex VII to Directive 76/768/EEC as reference number 28. (3) Directive 76/768/EEC should therefore be amended accordingly. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products, Article 1 Annex VII to Directive 76/768/EEC is amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 July 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of the national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0010

2005

COMMISSION DIRECTIVE 2005/10/EC of 4 February 2005 laying down the sampling methods and the methods of analysis for the official control of the levels of benzo(a)pyrene in foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption (1), and in particular Article 1 thereof, Whereas: (1) Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs (2) fixes maximum levels for benzo(a)pyrene and makes reference to measures laying down the sampling and analysis methods to be used. (2) Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (3) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs. (3) It seems necessary to fix general criteria, which the method of analysis has to comply with in order to ensure that laboratories, in charge of the control, use methods of analysis with comparable levels of performance. It is also of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach. These interpretation rules are of application for the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Member States shall take all measures necessary to ensure that the sampling for the official control of the levels of benzo(a)pyrene in foodstuffs is carried out in accordance with the methods described in the Annex I to this Directive. Article 2 The Member States shall take all measures necessary to ensure that sample preparation and methods of analyses used for the official control of the levels of benzo(a)pyrene in foodstuffs comply with the criteria described in the Annex II to this Directive. Article 3 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within 12 months following its publication. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 4 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Directive is addressed to the Member States.

32005L0019

2005

COUNCIL DIRECTIVE 2005/19/EC of 17 February 2005 amending Directive 90/434/EEC 1990 on the common system of taxation applicable to mergers, divisions, transfers of assets and exchanges of shares concerning companies of different Member States Having regard to the Treaty establishing the European Community, and in particular Article 94 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the European Economic and Social Committee (2), Whereas: (1) Directive 90/434/EEC (3) introduced common rules applicable to business restructuring which are neutral from the point of view of competition. (2) The objective of Directive 90/434/EEC is that taxation of the income, profits and capital gains from business reorganisations should be deferred and Member States taxing rights safeguarded. (3) One of the aims of Directive 90/434/EEC is to eliminate obstacles to the functioning of the internal market, such as double taxation. In so far as this is not fully achieved by the provisions of that Directive, Member States should take the necessary measures to achieve this aim. (4) The experience gained following implementation of Directive 90/434/EEC in January 1992 has demonstrated different ways in which the Directive can be improved and how the beneficial effects of the common rules as adopted in 1990 could be extended. (5) On 8 October 2001 the Council adopted Regulation (EC) No 2157/2001 on the Statute for a European Company (SE) (4) and Directive 2001/86/EC supplementing the Statute for a European company with regard to the involvement of employees (5). Similarly, on 22 July 2003 the Council adopted Regulation (EC) No 1435/2003 on the Statute for a European Cooperative Society (SCE) (6) and Directive 2003/72/EC supplementing the Statute for a European Cooperative Society with regard to the involvement of employees (7). One of the most important features of these instruments is that both the SE and the SCE will be able to transfer their respective registered offices between Member States without being dissolved and going into liquidation. (6) The transfer of the registered office is a means of exercising freedom of establishment as provided for in Articles 43 and 48 of the Treaty. No assets are transferred and the company and its shareholders do not derive any income, profits or capital gains from it. The company decision to reorganise its business by transferring its registered office should not be hampered by discriminatory tax rules or by restrictions, disadvantages or distortions arising from national tax legislation which is contrary to Community Law. The transfer of the registered office of an SE or an SCE from one Member State to another may not always lead to the SE or SCE ceasing to be resident in the first Member State. The tax residence of the SE or SCE continues to be determined by national legislation and tax treaties. (7) The transfer of the registered office of a company, or an event connected with that transfer, that brings about a change in tax residence, may give rise to some form of taxation in the Member State from which the office is transferred. Taxation may also occur in a case where the transfer of the registered office, or an event connected with that transfer, does not lead to a change in tax residence. In order to deal with that eventuality as far as the SE or SCE is concerned, a number of new rules have been introduced into Directive 90/434/EEC. In a case where, following the transfer of the registered office, the assets of the SE or of the SCE remain effectively connected with a permanent establishment belonging to the SE or SCE and situated in the Member State from which the registered office was transferred, that permanent establishment should enjoy benefits similar to those provided for in Articles 4, 5 and 6 of Directive 90/434/EEC. Those articles concern tax-exempted provisions and reserves, and the take-over of losses. Moreover, in accordance with Treaty principles, the taxation of shareholders on the occasion of the transfer of the registered office should be excluded. Having regard to the obligation on Member States under the Treaty to take all necessary measures to abolish double taxation, it is not necessary at this stage to establish common rules governing the tax residence of the SE or SCE. (8) Directive 90/434/EEC does not deal with losses of a permanent establishment in another Member State recognised in the Member State of residence of an SE or SCE. In particular, where the registered office of an SE or SCE is transferred to another Member State, such transfer does not prevent the former Member State of residence from reinstating losses of the permanent establishment in due time. (9) Directive 90/434/EEC does not cover a type of division where the company transferring branches of activity is not dissolved. Article 4 of that Directive should therefore be extended to cover such cases. (10) Article 3 of Directive 90/434/EEC defines the companies falling within its scope and the Annex thereto lists the forms of company to which the Directive applies. However, certain forms of company are not listed in that Annex even though they are resident for tax purposes in a Member State and are subject to corporation tax there. In the light of the experience, this appears to be an unjustifiable lacuna and the scope of the Directive should therefore be extended to cover entities which can carry out cross-border activities in the Community and which meet all the relevant requirements. (11) Since the SE is a public limited liability company and since the SCE is a cooperative society, both similar in nature to other forms of company already covered by Directive 90/434/EEC, the SE and the SCE should be added to the list set out in the Annex to Directive 90/434/EEC. (12) The other new companies included in the list of the Annex to this Directive are corporate taxpayers in their Member State of residence but some of them are considered fiscally transparent by other Member States. In order for the benefits of Directive 90/434/EEC to be effective, Member States treating non-resident corporate taxpayers as fiscally transparent should apply the benefits of the Directive to them. However, given the difference in tax treatment by Member States of these particular corporate taxpayers, Member States should have the option not to apply the relevant provisions in the Directive when taxing a direct or indirect shareholder of those taxpayers. (13) Where shareholders of companies entering into the transactions governed by Directive 90/434/EEC are treated as fiscally transparent, persons having an interest in the shareholder should not suffer taxation on the occasion of restructuring transactions. (14) Some doubts exist as to the application of Directive 90/434/EEC to the conversion of branches into subsidiaries. In these operations, the assets connected to a permanent establishment and constituting a ‘branch of activity’, as defined in Article 2(i) of Directive 90/434/EEC, are transferred to a newly set up company which will be a subsidiary of the transferring company and it should be made clear that this transaction, being the transfer of assets from a company of a Member State of a permanent establishment located in a different Member State to a company of the latter Member State, is covered by the Directive. (15) The current definition of ‘exchange of shares’ in Article 2(d) of Directive 90/434/EEC does not state whether the term encompasses further acquisitions beyond that granting a simple majority of voting rights. It is not uncommon for company statutes and voting rules to be drafted in such a way that further acquisitions are needed before the acquirer can obtain complete control over the target company. The definition of ‘exchange of shares’ should therefore be amended to state that that term covers all such further acquisitions. (16) In the case of mergers and divisions, the receiving company may derive gains from the difference in value between the assets and liabilities received and the shares that it may have held in the transferring company that are annulled following these operations. Article 7 of Directive 90/434/EEC provides for the exemption of these capital gains since these profits may be derived just as easily in the form of distributed profits from the transferring company that would have been exempted under Council Directive 90/435/EEC of 23 July 1990 on the common system of taxation applicable in the case of parent companies and subsidiaries of different Member States (8). The objectives of both Directive 90/434/EEC and Directive 90/435/EEC coincide with regard to this particular issue but the conditions required are not the same. Directive 90/434/EEC should therefore be amended to assimilate its requirements to those of Directive 90/435/EEC and to take into account the lower shareholding threshold included in that Directive. (17) Given the extension of Directive 90/434/EEC to include partial divisions and the transfer of a registered office of an SE or an SCE, the scope of the provision regarding the countering of tax avoidance and tax evasion should be amended accordingly. (18) Directive 90/434/EEC should therefore be amended accordingly, Article 1 Directive 90/434/EEC is hereby amended as follows: 1. the title shall be replaced by the following: 2. Article 1 shall replaced by the following: ‘Article 1 Each Member State shall apply this Directive to the following: (a) mergers, divisions, partial divisions, transfers of assets and exchanges of shares in which companies from two or more Member States are involved, (b) transfers of the registered office from one Member State to another Member State of European companies (Societas Europaea or SE), as established in Council Regulation (EC) No 2157/2001 of 8 October 2001, on the statute for a European Company (SE) (9), and European Cooperative Societies (SCE), as established in Council Regulation (EC) No 1435/2003 of 22 July 2003 on the Statute for a European Cooperative Society (SCE) (10).’; 3. Article 2 shall be amended as follows: (a) The following paragraph shall be added: ‘(b)(a) “partial division” shall mean an operation whereby a company transfers, without being dissolved, one or more branches of activity, to one or more existing or new companies, leaving at least one branch of activity in the transferring company, in exchange for the pro-rata issue to its shareholders of securities representing the capital of the companies receiving the assets and liabilities, and, if applicable, a cash payment not exceeding 10 % of the nominal value or, in the absence of a nominal value, of the accounting par value of those securities;’ (b) Paragraph (d) shall be replaced as follows: ‘(d) “exchange of shares” shall mean an operation whereby a company acquires a holding in the capital of another company such that it obtains a majority of the voting rights in that company, or, holding such a majority, acquires a further holding, in exchange for the issue to the shareholders of the latter company, in exchange for their securities, of securities representing the capital of the former company, and, if applicable, a cash payment not exceeding 10 % of the nominal value, in the absence of a nominal value, of the accounting par value of the securities issued in exchange;’ (c) The following paragraph shall be added: ‘(j) “transfer of the registered office” shall mean an operation whereby an SE or an SCE, without winding up or creating a new legal person, transfers its registered office from one Member State to another Member State’; 4. the eighth indent of Article 3(c) with respect to Italy shall be replaced as follows: ‘ — imposta sul reddito delle società in Italy,’ 5. the heading of Title II shall be replaced by the following: 6. Article 4 shall be replaced by the following: ‘Article 4 1. A merger, division or partial division shall not give rise to any taxation of capital gains calculated by reference to the difference between the real values of the assets and liabilities transferred and their values for tax purposes. For the purpose of this Article the following definitions shall apply: (a) “value for tax purposes”: the value on the basis of which any gain or loss would have been computed for the purposes of tax upon the income, profits or capital gains of the transferring company if such assets or liabilities had been sold at the time of the merger, division or partial division but independently of it; (b) “transferred assets and liabilities”: those assets and liabilities of the transferring company which, in consequence of the merger, division or partial division, are effectively connected with a permanent establishment of the receiving company in the Member State of the transferring company and play a part in generating the profits or losses taken into account for tax purposes. 2. Where paragraph 1 applies and where a Member State considers a non-resident transferring company as fiscally transparent on the basis of that State’s assessment of the legal characteristics of that company arising from the law under which it is constituted and therefore taxes the shareholders on their share of the profits of the transferring company as and when those profits arise, that State shall not tax any income, profits or capital gains calculated by reference to the difference between the real values of the assets and liabilities transferred and their values for tax purposes. 3. Paragraphs 1 and 2 shall apply only if the receiving company computes any new depreciation and any gains or losses in respect of the assets and liabilities transferred according to the rules that would have applied to the transferring company or companies if the merger, division or partial division had not taken place. 4. Where, under the laws of the Member State of the transferring company, the receiving company is entitled to have any new depreciation or any gains or losses in respect of the assets and liabilities transferred computed on a basis different from that set out in paragraph 3, paragraph 1 shall not apply to the assets and liabilities in respect of which that option is exercised.’; 7. Article 6 shall be replaced by the following: ‘Article 6 To the extent that, if the operations referred to in Article 1, paragraph a, were effected between companies from the Member State of the transferring company, the Member State would apply provisions allowing the receiving company to take over the losses of the transferring company which had not yet been exhausted for tax purposes, it shall extend those provisions to cover the take-over of such losses by the receiving company’s permanent establishments situated within its territory.’; 8. in Article 7, paragraph 2 shall be replaced by the following: ‘2. The Member States may derogate from paragraph 1 where the receiving company has a holding of less than 20 % in the capital of the transferring company. From 1 January 2007 the minimum holding percentage shall be 15 %. From 1 January 2009 the minimum holding percentage shall be 10 %.’; 9. Article 8 shall be replaced by the following: ‘Article 8 1. On a merger, division or exchange of shares, the allotment of securities representing the capital of the receiving or acquiring company to a shareholder of the transferring or acquired company in exchange for securities representing the capital of the latter company shall not, of itself, give rise to any taxation of the income, profits or capital gains of that shareholder. 2. On a partial division, the allotment to a shareholder of the transferring company of securities representing the capital of the receiving company shall not, of itself, give rise to any taxation of the income, profits or capital gains of that shareholder. 3. Where a Member State considers a shareholder as fiscally transparent on the basis of that State’s assessment of the legal characteristics of that shareholder arising from the law under which it is constituted and therefore taxes those persons having an interest in the shareholders on their share of the profits of the shareholder as and when those profits arise, that State shall not tax those persons on income, profits or capital gains from the allotment of securities representing the capital of the receiving or acquiring company to the shareholder. 4. Paragraphs 1 and 3 shall apply only if the shareholder does not attribute to the securities received a value for tax purposes higher than the value the securities exchanged had immediately before the merger, division or exchange of shares. 5. Paragraphs 2 and 3 shall apply only if the shareholder does not attribute to the sum of the securities received and those held in the transferring company, a value for tax purposes higher than the value the securities held in the transferring company had immediately before the partial division. 6. The application of paragraphs 1, 2 and 3 shall not prevent the Member States from taxing the gain arising out of the subsequent transfer of securities received in the same way as the gain arising out of the transfer of securities existing before the acquisition. 7. In this Article the expression “value for tax purposes” means the value on the basis of which any gain or loss would be computed for the purposes of tax upon the income, profits or capital gains of a shareholder of the company. 8. Where, under the law of the Member State in which he is resident, a shareholder may opt for tax treatment different from that set out in paragraphs 4 and 5, paragraphs 1, 2 and 3 shall not apply to the securities in respect of which such an option is exercised. 9. Paragraphs 1, 2 and 3 shall not prevent a Member State from taking into account when taxing shareholders any cash payment that may be made on the merger, division, partial division or exchange of shares.’; 10. Article 10 shall be replaced by the following: ‘Article 10 1. Where the assets transferred in a merger, a division, a partial division or a transfer of assets include a permanent establishment of the transferring company which is situated in a Member State other than that of the transferring company, the Member State of the transferring company shall renounce any right to tax that permanent establishment. The Member State of the transferring company may reinstate in the taxable profits of that company such losses of the permanent establishment as may previously have been set off against the taxable profits of the company in that State and which have not been recovered. The Member State in which the permanent establishment is situated and the Member State of the receiving company shall apply the provisions of this Directive to such a transfer as if the Member State where the permanent establishment is situated were the Member State of the transferring company. These provisions shall also apply in the case where the permanent establishment is situated in the same Member State as that in which the receiving company is resident. 2. By way of derogation from paragraph 1, where the Member State of the transferring company applies a system of taxing worldwide profits, that Member State shall have the right to tax any profits or capital gains of the permanent establishment resulting from the merger, division, partial division or transfer of assets, on condition that it gives relief for the tax that, but for the provisions of this Directive, would have been charged on those profits or capital gains in the Member State in which that permanent establishment is situated, in the same way and in the same amount as it would have done if that tax had actually been charged and paid.’; 11. the following Title shall be inserted: ‘TITLE IVa Special case of transparent entities Article 10a 1. Where a Member State considers a non-resident transferring or acquired company to be fiscally transparent on the basis of that State’s assessment of the legal characteristics of that company arising from the law under which it is constituted, it shall have the right not to apply the provisions of this Directive when taxing a direct or indirect shareholder of that company in respect of the income, profits or capital gains of that company. 2. A Member State exercising the right referred to in paragraph 1 shall give relief for the tax which, but for the provisions of this Directive, would have been charged on the fiscally transparent company on its income, profits or capital gains, in the same way and in the same amount as that State would have done if that tax had actually been charged and paid. 3. Where a Member State considers a non-resident receiving or acquiring company to be fiscally transparent on the basis of that State’s assessment of the legal characteristics of that company arising from the law under which it is constituted, it shall have the right not to apply Article 8 paragraphs 1, 2 and 3. 4. Where a Member State considers a non-resident receiving company to be fiscally transparent on the basis of that State’s assessment of the legal characteristics of that company arising from the law under which it is constituted, that Member State may apply to any direct or indirect shareholders the same treatment for tax purposes as it would if the receiving company were resident in that Member State.’; 12. the following Title shall be inserted. ‘TITLE IVb Rules applicable to the transfer of the registered office of an SE or an SCE Article 10b 1. Where, (a) an SE or an SCE transfers its registered office from one Member State to another Member State, or (b) in connection with the transfer of its registered office from one Member State to another Member State, an SE or an SCE, which is resident in the first Member State, ceases to be resident in that Member State and becomes resident in another Member State, that transfer of registered office or the cessation of residence shall not give rise to any taxation of capital gains, calculated in accordance with of Article 4(1), in the Member State from which the registered office has been transferred, derived from those assets and liabilities of the SE or SCE which, in consequence, remain effectively connected with a permanent establishment of the SE or of the SCE in the Member State from which the registered office has been transferred and play a part in generating the profits or losses taken into account for tax purposes. 2. Paragraph 1 shall apply only if the SE or the SCE computes any new depreciation and any gains or losses in respect of the assets and liabilities that remain effectively connected with that permanent establishment, as though the transfer of the registered office had not taken place or the SE or the SCE had not so ceased to be tax resident. 3. Where, under the laws of that Member State, the SE or the SCE is entitled to have any new depreciation or any gains or losses in respect of the assets and liabilities remaining in that Member State computed on a basis different from that set out in paragraph 2, paragraph 1 shall not apply to the assets and liabilities in respect of which that option is exercised. Article 10c 1. Where, (a) an SE or an SCE transfers its registered office from one Member State to another Member State, or (b) in connection with the transfer of its registered office from one Member State to another Member State, an SE or an SCE, which is resident in the first Member State, ceases to be resident in that Member State and becomes resident in another Member State, the Member States shall take the necessary measures to ensure that, where provisions or reserves properly constituted by the SE or the SCE before the transfer of the registered office are partly or wholly exempt from tax and are not derived from permanent establishments abroad, such provisions or reserves may be carried over, with the same tax exemption, by a permanent establishment of the SE or the SCE which is situated within the territory of the Member State from which the registered office was transferred. 2. To the extent that a company transferring its registered office within the territory of a Member State would be allowed to carry forward or carry back losses which had not been exhausted for tax purposes, that Member State shall allow the permanent establishment, situated within its territory, of the SE or of the SCE transferring its registered office, to take over those losses of the SE or SCE which have not been exhausted for tax purposes, provided that the loss carry forward or carry back would have been available in comparable circumstances to a company which continued to have its registered office or which continued to be tax resident in that Member State. Article 10d 1. The transfer of the registered office of an SE or of an SCE shall not, of itself, give rise to any taxation of the income, profits or capital gains of the shareholders. 2. The application of paragraph 1 shall not prevent the Member States from taxing the gain arising out of the subsequent transfer of the securities representing the capital of the SE or of the SCE that transfers its registered office.’ 13. In Article 11, paragraph 1 shall be replaced by the following: ‘1. A Member State may refuse to apply or withdraw the benefit of all or any part of the provisions of Titles II, III, IV and IVb where it appears that the merger, division, partial division, transfer of assets, exchange of shares or transfer of the registered office of an SE or an SCE: (a) has as its principal objective or as one of its principal objectives tax evasion or tax avoidance; the fact that one of the operations referred to in Article 1 is not carried out for valid commercial reasons such as the restructuring or rationalisation of the activities of the companies participating in the operation may constitute a presumption that the operation has tax evasion or tax avoidance as its principal objective or as one of its principal objectives; (b) results in a company, whether participating in the operation or not, no longer fulfilling the necessary conditions for the representation of employees on company organs according to the arrangements which were in force prior to that operation.’ 14. The Annex shall be replaced by the text in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply both with the provisions of this Directive regarding the transfer of the registered office of an SE or of an SCE, and with the entry (a) in the Annex to this Directive by 1 January 2006. Member States shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, as regards the provisions other than those referred to in paragraph 1, by 1 January 2007. Member States shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive is addressed to the Member States.

32005L0013

2005

COMMISSION DIRECTIVE 2005/13/EC of 21 February 2005 amending Directive 2000/25/EC of the European Parliament and of the Council concerning the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors, and amending Annex I to Directive 2003/37/EC of the European Parliament and of the Council concerning the type-approval of agricultural or forestry tractors (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2000/25/EC of the European Parliament and of the Council of 22 May 2000 on action to be taken against the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors and amending Council Directive 74/150/EEC (1), and in particular Articles 6 and 7 thereof, Having regard to Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Council Directive 74/150/EEC (2), and in particular Article 19(1)(a) thereof, Whereas: (1) Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in no-road mobile machinery (3) as amended by Directive 2004/26/EC sets out more stringent emission requirements for engines installed in non-road mobile machinery, and introduces three new stages for emission limits. (2) Directive 2000/25/EC, which is one of the separate Directives in the framework of the type approval procedure under Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (4), should be aligned with Directive 97/68/EC as amended by Directive 2004/26/EC, in particular as regards the introduction of the flexibility scheme provided for in the latter. (3) Annexes I and II to Directive 2000/25/EC need to be adapted, notably to take account of the introduction by Directive 97/68/EC as amended by Directive 2004/26/EC of new emission limits for combined emission of hydrocarbons and oxides of nitrogen. Other changes should be introduced in those annexes to ensure consistency between the provisions on information documents laid down in Directives 2000/25/EC, 97/68/EC and 2003/37/EC. In addition, Annex III to Directive 2000/25/EC needs to be adapted in order to add the alternative type-approvals to be recognised for the new stages III A, III B and IV. (4) It is also necessary to adapt Annex I to Directive 2003/37/EC in order to ensure consistency between the provisions on information documents laid down in Directives 2000/25/EC, 97/68/EC and 2003/37/EC. In particular, discrepancies in terminology should be eliminated in the interests of clarity. (5) Directives 2000/25/EC and 2003/37/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 20(1) of Directive 2003/37/EC, Article 1 Directive 2000/25/EC is amended as follows: 1. In Article 1, the following indent is added: ‘ — “replacement engine” means a newly built engine which replaces an engine in a machine and which has been supplied for this purpose only;’ 2. In Article 3, the following paragraph is added: ‘3. Replacement engines shall comply with the limit values that the engine to be replaced had to meet when originally placed on the market. The text “REPLACEMENT ENGINE” shall be attached to a label on the engine or inserted into the owner’s manual;’ 3. The following Article 3a is inserted: ‘Article 3a Flexibility Scheme By way of derogation from Article 3(1) and (2), Member States shall provide that, at the request of the tractor manufacturer, and subject to permission being granted by the approval authority, the engine manufacturer may, during the period between two successive limit value stages, place on the market a limited number of engines that comply only with the emission limit value stage immediately preceding the currently applicable stage, or tractors with such engines, provided that he complies with the procedure set out in Annex IV.’; 4. Article 4 is amended as follows: (a) In paragraph 2, the following points (c), (d) and (e) are added: ‘(c) in stage III A — after 31 December 2005 for engines of categories H, I and K (power range as defined in Article 9(3a) of Directive 97/68/EC), — after 31 December 2006 for engines of category J (power range as defined in Article 9(3a) of Directive 97/68/EC); (d) in stage III B — after 31 December 2009 for engines of category L (power range as defined in Article 9(3c) of Directive 97/68/EC), — after 31 December 2010 for engines of categories M and N (power range as defined in Article 9(3c) of Directive 97/68/EC), — after 31 December 2011 for engines of category P (power range as defined in Article 9(3c) of Directive 97/68/EC); (e) in stage IV — after 31 December 2012 for engines of category Q (power range as defined in Article 9(3d) of Directive 97/68/EC), — after 30 September 2013 for engines of category R (power range as defined in Article 9(3d) of Directive 97/68/EC).’; (b) in paragraph 3, the following indents are added: ‘ — after 31 December 2005 for engines of category H, — after 31 December 2006 for engines of categories I, — after 31 December 2006 for engines of categories K, — after 31 December 2007 for engines of category J, — after 31 December 2010 for engines of category L, — after 31 December 2011 for engines of categories M, — after 31 December 2011 for engines of categories N, — after 31 December 2012 for engines of category P, — after 31 December 2013 for engines of category Q, — after 30 September 2014 for engines of category R.’; (c) paragraph 5 is replaced by the following: ‘5. For engines of categories A to G Member States may postpone the dates laid down in paragraph 3 for two years with respect to engines with a production date prior to the said date. They may grant other exceptions under the conditions laid down in Article 10 of Directive 97/68/EC.’; (d) the following paragraphs 6, 7 and 8 are added: ‘6. For engines of categories H to R, the dates laid down in paragraph 3 shall be postponed for two years with respect to engines with a production date prior to the said date. 7. For engine types or engine families meeting the limit values set out in the table in section 4.1.2.4, 4.1.2.5 and 4.1.2.6 of Annex I to Directive 97/68/EC before the dates laid down in paragraph 3 of this Article, Member States shall allow special labelling and marking to show that the equipment concerned meets the required limit values before the dates laid down. 8. In accordance with the procedure referred to in Article 20(2) of Directive 2003/37/EC, the Commission shall align the limit values and dates of stages IIIB and IV with the limit values and dates decided following the revision procedure provided for in Article 2(b) of Directive 2004/26/EC, with a view to the needs of agricultural or forestry tractors and, in particular, tractors of categories T2, T4.1 and C2.’; 5. Annexes I, II and III are amended in accordance with Annex I to this Directive. 6. Annex IV, the text of which is set out in Annex II to this Directive, is added. Article 2 Annex I to Directive 2003/37/EC is amended in accordance with Annex III to this Directive. Article 3 1. Member States shall adopt and publish, by 31 December 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 January 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0015

2005

COUNCIL DIRECTIVE 2005/15/EC of 28 February 2005 amending Annex IV to Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular point (d) of the second paragraph of Article 14 thereof, Having regard to the proposal of the Commission, Whereas: (1) Directive 2004/102/EC (2) amends Annexes II, III, IV and V to Directive 2000/29/EC and is to be implemented by the Member States by 1 March 2005. (2) Directive 2004/102/EC contains provisions related to wood and wood products. The measures related to pallets, boxes and dunnage align Community measures with the FAO International Standard for Phytosanitary Measures (ISPM) No 15 on ‘Guidelines for regulating wood packaging material in international trade’ which was adopted in March 2002 by the Fourth Interim Commission on Phytosanitary Measures (ICPM). (3) Standard No 15 describes that wood packaging (including dunnage) made of coniferous and non-coniferous raw wood, should be subjected to approved measures such as heat treatment (56 °C for a minimum of 30 minutes) or fumigation with Methyl Bromide. Moreover the wood should display a specified mark to certify that the wood has been subjected to an approved measure. (4) The Standard also provides that countries may require that imported wood packaging material subjected to an approved measure be made from debarked wood and display a mark subject to ‘technical justification’. (5) Third countries have requested that the Community consider alternative methods of achieving the same goal. To this end, research is under way on technical aspects of debarking wood, in particular the efficiency of ‘pest risk reduction’ of debarking in addition to treatment measures. (6) While awaiting the results of that research, it is appropriate to postpone for debarked wood, the application of the requirement to be used. (7) Directive 2000/29/EC should therefore be amended accordingly. (8) The Standing Committee on Plant Health has not delivered an opinion within the time limit set by its Chairman, Article 1 Directive 2000/29/EC is amended as follows: 1. In Annex IV, Part A, section I, point 2, the following paragraph shall be added at the end of the right hand column: ‘The first indent, requiring wood packaging material to be made from debarked round wood, shall only apply from 1 March 2006.’ 2. In Annex IV, Part A, section I, point 8, the following paragraph shall be added at the end of the right hand column: ‘The first line of point (a), requiring wood packaging material to be made from debarked round wood, shall only apply from 1 March 2006.’ Article 2 1. Member States shall adopt and publish, not later than 28 February 2005, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between these provisions and this Directive. They shall apply these provisions from 1 March 2005. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0018

2005

COMMISSION DIRECTIVE 2005/18/EC of 2 March 2005 amending Directive 2001/32/EC as regards certain protected zones exposed to particular plant health risks in the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular the first subparagraph of Article 2(1)(h) thereof, Having regard to the requests made by the Czech Republic, Denmark, Estonia, Greece, Ireland, Italy, Sweden and the United Kingdom, Whereas: (1) From information supplied by the Czech Republic, Denmark, Greece (as far as Crete and Lesvos are concerned), Ireland, Sweden and the United Kingdom (including the Channel Islands but not the Isle of Man), it appears that Cryphonectria parasitica (Murrill) Barr. is not present in the territory of these countries. Therefore these countries should be recognised as protected zones for Cryphonectria parasitica (Murrill) Barr. (2) From information supplied by Denmark based on updated surveys, Denmark should no longer be recognised as a protected zone in respect of Beet necrotic yellow vein virus as it appears that this harmful organism is now established in Denmark. (3) From information supplied by Estonia based on updated surveys, it appears that Erwinia amylovora (Burr.) Winsl. et al. is not present in the territory of Estonia. Therefore, Estonia should be recognised temporarily as a protected zone for this organism. (4) From information supplied by the United Kingdom based on updated surveys for the presence of Dendroctonus micans Kugelan, it appears that this harmful organism is now established in some parts of the United Kingdom but not in Northern Ireland, nor in the Isle of Man or Jersey. The protected zone should therefore be modified and restricted to Northern Ireland, the Isle of Man and Jersey. (5) From information supplied by Italy based on updated surveys and from additional information collected by the Food and Veterinary Office during a mission in Italy in May 2004, it appears that this harmful organism is now established in this country. Italy should therefore no longer be recognised as a protected zone in respect of Citrus tristeza virus (CTV). (6) From information supplied by Sweden, it appears that some names of counties in Sweden recognised as protected zone for Leptinotarsa decemlineata may need to be corrected typographically. (7) Directive 2001/32/EC (2) should therefore be amended accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 2001/32/EC is amended as follows: 1. at the end of Article 1 the following paragraph is added: ‘In the case of point (b)(2) of the Annex, the said zone in Estonia is recognised until 31 March 2007.’; 2. the Annex is amended in accordance with the Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 14 May 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall apply those provisions from 15 May 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0016

2005

COMMISSION DIRECTIVE 2005/16/EC of 2 March 2005 amending Annexes I to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular points (c) and (d) of the second paragraph of Article 14 thereof, After consulting the Member States concerned, Whereas: (1) Directive 2000/29/EC provides for certain measures against the introduction into the Member States from other Member States or third countries of organisms which are harmful to plants or plant products. It also provides for certain zones to be designed as protection zones. (2) Due to a clerical error in the 2003 Act of Accession, the list of counties in Sweden recognised as a protected zone in respect of Leptinotarsa decemlineata Say was incorrect and needs to be rectified. (3) From information supplied by Denmark, that Member State should no longer be recognised as a protected zone in respect of Beet necrotic yellow vein virus as it appears that that harmful organism is now established in Denmark. (4) From information supplied by the United Kingdom, it appears that Dendroctonus micans Kugelan is now established in some parts of the United Kingdom. Accordingly, the protected zone in respect of Dendroctonus micans Kugelan should be restricted to Northern Ireland. In addition, the protected zone in respect of that organism should also be restricted to the Isle of Man and Jersey. (5) From information supplied by Estonia, it appears that Erwinia amylovora (Burr.) Winsl. et al. is not present in that Member State. Estonia may therefore be recognised as a protected zone for that organism. (6) From information supplied by Italy and from additional information collected by the Food and Veterinary Office during a mission in Italy in May 2004, it appears that Citrus tristeza virus is now established in that Member State. Italy should therefore no longer be recognised as a protected zone in respect of Citrus tristeza virus. (7) From the Swiss legislation on plant protection, it appears that the Canton of Ticino is no longer recognised as a protected zone for Erwinia amylovora (Burr.) Winsl. et al. in Switzerland. The rules on imports to the Community should be adjusted to remove special treatment given to plants originating in Ticino. (8) Due to a clerical error in the preparation of Commission Directive 2004/31/EC (2), the special requirements for the introduction and movement of Vitis plants in Cyprus as laid down in point 21.1 of Part B of Annex IV to Directive 2000/29/EC were erroneously deleted. Accordingly, that Annex should be amended. (9) In order to enhance the phytosanitary protection of the Community seeds of Medicago sativa L. and the Community certified seeds of Helianthus annuus L., Lycopersicon lycopersicum (L.) Karsten ex Farw. and Phaseolus L., those seeds need to be accompanied by a plant passport when moving, other than locally, within the Community. (10) The relevant Annexes to Directive 2000/29/EC should therefore be amended accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annexes I, II, III, IV and V to Directive 2000/29/EC are amended in accordance with the text in the Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 14 May 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 15 May 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0017

2005

COMMISSION DIRECTIVE 2005/17/EC of 2 March 2005 amending certain provisions of Directive 92/105/EEC concerning plant passports Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular the second subparagraph of Article 2(1)(f), and the second subparagraph of Article 10(1) thereof, Whereas: (1) Under Commission Directive 92/105/EEC of 3 December 1992 establishing a degree of standardisation for plant passports to be used for the movement of certain plants, plant products or other objects within the Community, and establishing the detailed procedures related to the issuing of such plant passports and the conditions and detailed procedures for their replacement (2), certain detailed procedures relating to the issuing of plant passports have been established. (2) New provisions should be introduced considering the labels issued in accordance with Community provisions applicable to the marketing of some officially certified seed meeting the relevant requirements of Directive 2000/29/EC, to be plant passports. (3) It appeared that many Member States already use labels without the indication ‘EC-plant passport’ for the coming season 2004 to 2005. It is appropriate to lay down rules for the use of labels during a transitional period. (4) Directive 92/105/EEC provides that the plant passports are to contain certain information including the wording ‘EEC plant passport’. Since the adoption of the Treaty on European Union, the Community is now known as the ‘European Community’, with the corresponding abbreviation ‘EC’, so that wording should be amended to ‘EC plant passport’. (5) Directive 92/105/EEC should therefore be amended accordingly. (6) The system using the above labels should be reviewed by 31 December 2006 to take into account the experiences gained. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 92/105/EEC is amended as follows: 1. Article 1(2) is amended as follows: (a) point (c) is replaced by the following: ‘(c) in the case of tubers of Solanum tuberosum L., intended for planting, as listed in point 18.1 of Section II of Part A of Annex IV to Council Directive 2000/29/EC (3), the official label defined in Annex III to Council Directive 2002/56/EC (4) may be used in place of a plant passport provided that the label provides evidence that the requirements referred to in Article 6(4) of Directive 2000/29/EC are complied with (after 31 December 2005, this label must indicate the words “EC plant passport”); compliance with the provisions governing the introduction of tubers of Solanum tuberosum L., intended for planting into, and their movement within, a protected zone recognised in respect of harmful organisms relating to those tubers, shall be noted either on the label or on any other trade document.’ (3) OJ L 169, 10.7.2000, p. 1." (4) OJ L 193, 20.7.2002, p. 60." (b) the following points (d), (e) and (f) are added: ‘(d) in the case of seeds of Helianthus annuus L., listed in point 26 of Section II of Part A of Annex IV to Directive 2000/29/EC, the official label defined in Annex IV to Council Directive 2002/57/EC (5) may be used in place of a plant passport provided that the label provides evidence that the requirements referred to in Article 6(4) of Directive 2000/29/EC are complied with (after 31 August 2005, this label must indicate the words “EC plant passport”). (e) in the case of seeds of Lycopersicon lycopersicum (L.) Karsten ex Farw. and Phaseolus L., listed in points 27 and 29 of Section II of Part A of Annex IV to Directive 2000/29/EC, the official label defined in Annex IV A to Council Directive 2002/55/EC (6) may be used in place of a plant passport provided that the label provides evidence that the requirements referred to in Article 6(4) of Directive 2000/29/EC are complied with (after 31 August 2005, this label must indicate the words “EC plant passport”). (f) in the case of seeds of Medicago sativa L., listed in points 28.1 and 28.2 of Section II of Part A of Annex IV to Directive 2000/29/EC, the official label defined in Annex IV Part A to Council Directive 66/401/EEC (7) may be used in place of a plant passport provided that the label provides evidence that the requirements referred to in Article 6(4) of Directive 2000/29/EC are complied with (after 31 August 2005, this label must indicate the words “EC plant passport”).’ (5) OJ L 193, 20.7.2002, p. 74." (6) OJ L 193, 20.7.2002, p. 33." (7) OJ 125, 11.7.1966, p. 2298/66." 2. Article 4 is deleted. 3. In the Annex, point 1 is replaced by the following: ‘1. “EC plant passport” (for a transitional period expiring on 1 January 2006, the wording “EEC plant passport” may be used).’ Article 2 The system whereby the labels referred to in Article 1(1) are used shall be reviewed by 31 December 2006. Article 3 1. Member States shall adopt and publish, by 14 May 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall apply these provisions from 15 May 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0024

2005

COUNCIL DIRECTIVE 2005/24/EC of 14 March 2005 with regard to the use of ova and embryos and storage centres for semen from pure-bred breeding animals of the bovine species (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Parliament (1), Having regard to the Opinion of the European Economic and Social Committee (2), Whereas: (1) Article 4 of Council Directive 87/328/EEC of 18 June 1987 on the acceptance for breeding purposes of pure-bred breeding animals of the bovine species (3) requires semen for intra-Community trade to be collected, treated and stored in an officially approved artificial insemination centre. (2) Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in, and imports of, semen of domestic animals of the bovine species (4) allows semen to be stored not only in semen collection centres but also in semen storage centres. (3) In order to ensure consistency in Community legislation, Article 4 of Directive 87/328/EEC should be adapted to the extended scope of, and the newly introduced definitions in, Directive 88/407/EEC. On that occasion, Directive 87/328/EEC should be aligned on the other legislation on pure-breeding animals with regard to ova and embyros, Article 1 Directive 87/328/EEC shall be amended as follows: 1. Article 1 shall be replaced by the following: ‘Article 1 Member States shall ensure that, without prejudice to animal health rules, there is no prohibition, restriction or impediment on: — the acceptance of pure-bred female animals of the bovine species for breeding purposes, — the acceptance of pure-bred bulls for natural service, and — the use of ova and embryos from pure-bred female animals of the bovine species.’; 2. Article 4 shall be replaced by the following: ‘Article 4 Member States shall ensure that, for intra-Community trade, the semen referred to in Article 2 is collected, processed and stored in a collection centre, or, if need be, stored in a storage centre, approved in accordance with Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species (5).’. (5) OJ L 194, 22.7.1988, p. 10. Directive as last amended by Commission Decision 2004/101/EC (OJ L 30, 4.2.2004, p. 15)." Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 24 March 2007. They shall forthwith communicate to the Commission the text of those measures, together with a table showing how the provisions of this Directive correspond to the national measures adopted. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the twentieth day following the date of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0026

2005

COMMISSION DIRECTIVE 2005/26/EC of 21 March 2005 establishing a list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1), and in particular second subparagraph of Article 6(11) thereof, Whereas: (1) Annex IIIa of Directive 2000/13/EC establishes a list of food ingredients to be indicated on the label as they are likely to cause adverse reactions in susceptible individuals. (2) In accordance with Directive 2000/13/EC the Commission may provisionally exclude certain ingredients or products of those ingredients from Annex IIIa to that Directive, while food manufacturers or their associations conduct scientific studies to establish that those ingredients or products comply with the conditions for definite exclusion from that Annex. (3) The Commission received 27 applications regarding 34 ingredients or products thereof, of which 32 fall within the scope of this Directive, and have been submitted to the European Food Safety Authority (EFSA) for a scientific opinion. (4) Based on the information provided by the applicant, and other information available, the EFSA has considered that certain products of ingredients are not likely, or not very likely, to cause adverse reactions in susceptible individuals. In certain cases, EFSA has concluded that it cannot draw a firm conclusion, though no reported cases were mentioned. (5) Those products or ingredients complying with these conditions should therefore provisionally be excluded from Annex IIIa of Directive 2000/13/EC, Article 1 The ingredients or substances listed in the Annex to this Directive shall be excluded from Annex IIIa of Directive 2000/13/EC until 25 November 2007. Article 2 1. Member States shall adopt and publish, by 21 September 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 25 November 2005. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0030

2005

COMMISSION DIRECTIVE 2005/30/EC of 22 April 2005 amending, for the purposes of their adaptation to technical progress, Directives 97/24/EC and 2002/24/EC of the European Parliament and of the Council, relating to the type-approval of two or three-wheel motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 97/24/EC of the European Parliament and of the Council of 17 June 1997 on certain components and characteristics of two or three-wheel motor vehicles (1), and in particular Article 7 thereof, Having regard to Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two and three-wheel motor vehicles and repealing Council Directive 92/61/EEC (2), and in particular Article 17 thereof, Whereas: (1) Directive 97/24/EC is one of the separate Directives for the purposes of the EC type approval procedure laid down by Directive 2002/24/EC. (2) Technical measures for the type-approval, as separate technical units, of replacement catalytic converters should be introduced in order to ensure an appropriate emissions performance. Measures should be introduced in order to aid enforcement in Member States through the marking of replacement catalytic converters and their packaging. (3) The Member State type-approval code for Malta and Cyprus, in Annex V to Directive 2002/24/EC, should be updated. (4) Directives 97/24/EC and 2002/24/EC should be amended accordingly. (5) The measures provided for this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress, Article 1 The text annexed to Directive 97/24/EC is amended in accordance with Annex I to this Directive. Article 2 Annexes II and V to Directive 2002/24/EC are amended in accordance with Annex II to this Directive. Article 3 1. With effect from 18 May 2006 Member States shall not, in respect of new replacement catalytic converters which are intended to be fitted on vehicles that have been type-approved in accordance with Directive 97/24/EC: (a) refuse to grant EC type-approval pursuant to Article 4(1) of Directive 2002/24/EC; (b) prohibit the sale or installation on a vehicle. 2. With effect from 18 May 2006, Member States shall, on grounds relating to the measures to be taken against air pollution, permissible sound level or anti-tampering measures, no longer grant EC type-approval pursuant to Article 4(1) of Directive 2002/24/EC in respect of a new replacement catalytic converter which fails to comply with Directive 97/24/EC, as amended by this Directive. Article 4 1. Member States shall adopt and publish, by 17 May 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 18 May 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32005L0031

2005

COMMISSION DIRECTIVE 2005/31/EC of 29 April 2005 amending Council Directive 84/500/EEC as regards a declaration of compliance and performance criteria of the analytical method for ceramic articles intended to come into contact with foodstuffs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 5(2) thereof, Whereas: (1) Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs (2) is a specific measure within the meaning of Article 5 of Regulation (EC) No 1935/2004. It concerns the possible migration of lead and cadmium from ceramic articles which, in their finished state, are intended to come into contact with foodstuffs, or which are in contact with foodstuffs, and are intended for that purpose. (2) Article 16 of Regulation (EC) No 1935/2004 provides that the specific measures are to require that materials and articles covered by those measures are accompanied by a written declaration stating that they comply with the rules applicable to them. (3) That requirement has not yet been set out in Directive 84/500/EEC. There is a need to lay down that obligation for all ceramic articles which are not yet in contact with foodstuffs to clearly distinguish them from decorative articles. (4) The national competent authorities should have access to documents demonstrating that the ceramic articles comply with the migration limits for lead and cadmium. Therefore, the manufacturer or importer into the Community should make information concerning analysis carried out available to them on request. (5) Directive 84/500/EEC lays down a method for the analysis of lead and cadmium. Technological progress has been made in that area and the analytical method set out in that Directive is only one amongst several possible methods. This Directive should take technological progress into account and establish a set of performance criteria that the analytical method must comply with having regard to Commission Directive 2001/22/EC of 8 March 2001 laying down the sampling methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs (3). (6) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of ensuring the free movement of ceramic articles intended to come into contact with foodstuffs to lay down rules for a correct enforcement of Directive 84/500/EEC. This Directive does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with the third paragraph of Article 5 of the Treaty. (7) Directive 84/500/EEC should therefore be amended accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Directive 84/500/EEC is amended as follows: 1. The following Article 2a is inserted: ‘Article 2a 1. At the marketing stages up to and including the retail stage, ceramic articles which are not yet in contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (4). That declaration shall be issued by the manufacturer or by a seller established within the Community and shall contain the information laid down in Annex III to this Directive. 2. Appropriate documentation to demonstrate that the ceramic articles comply with the migration limits for lead and cadmium set out in Article 2 shall be made available by the manufacturer or the importer into the Community to the national competent authorities on request. That documentation shall contain the results of the analysis carried out, the test conditions and the name and the address of the laboratory that performed the testing. 2. Annex II is replaced by the text in Annex I to this Directive. 3. A new Annex III, the text of which is set out in Annex II to this Directive, is added. Article 2 1. Member States shall adopt and publish, by 20 May 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions in such a way as to: (a) permit the trade in and use of ceramic articles complying with this Directive, from 20 May 2006; (b) prohibit the manufacture and importation into the Community of ceramic articles which do not comply with this Directive, from 20 May 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0014

2005

DIRECTIVE 2005/14/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 May 2005 amending Council Directives 72/166/EEC, 84/5/EEC, 88/357/EEC and 90/232/EEC and Directive 2000/26/EC of the European Parliament and of the Council relating to insurance against civil liability in respect of the use of motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular the first and third sentences of Article 47(2), Article 55 and Article 95(1) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Insurance against civil liability in respect of the use of motor vehicles (motor insurance) is of special importance for European citizens, whether they are policyholders or victims of an accident. It is also a major concern for insurance undertakings as it constitutes an important part of non-life insurance business in the Community. Motor insurance also has an impact on the free movement of persons and vehicles. It should therefore be a key objective of Community action in the field of financial services to reinforce and consolidate the single insurance market in motor insurance. (2) Very significant advances in this direction have already been achieved by Council Directive 72/166/EEC of 24 April 1972 on the approximation of the laws of Member States relating to insurance against civil liability in respect of the use of motor vehicles, and to the enforcement of the obligation to insure against such liability (4), by second Council Directive 84/5/EEC of 30 December 1983 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles (5), by third Council Directive 90/232/EEC of 14 May 1990 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles (6) and by Directive 2000/26/EC of the European Parliament and of the Council of 16 May 2000 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles (fourth motor insurance Directive) (7). (3) The Community system of motor insurance needs to be updated and improved. This need has been confirmed by the consultation conducted with the industry, consumers and victims' associations. (4) In order to exclude any possible misinterpretation of the provisions of Directive 72/166/EEC and to make it easier to obtain insurance cover for vehicles bearing temporary plates, the definition of the territory in which the vehicle is normally based should refer to the territory of the State of which the vehicle bears a registration plate, irrespective of whether such a plate is permanent or temporary. (5) In accordance with Directive 72/166/EEC, vehicles bearing false or illegal plates are considered to be normally based in the territory of the Member State that issued the original plates. This rule often means that national insurers' bureaux are obliged to deal with the economic consequences of accidents which do not have any connection with the Member State where they are established. Without altering the general criterion of the registration plate to determine the territory in which the vehicle is normally based, a special rule should be laid down for accidents caused by vehicles without a registration plate or bearing a registration plate which does not correspond or no longer corresponds to the vehicle. In this case and for the sole purpose of settling the claim, the territory in which the vehicle is normally based should be considered to be the territory in which the accident took place. (6) In order to facilitate the interpretation and application of the term ‘random checks’ in Directive 72/166/EEC, the relevant provision should be clarified. The prohibition of systematic checks on motor insurance should apply to vehicles normally based in the territory of another Member State as well as to vehicles normally based in the territory of a third country but entering from the territory of another Member State. Only non-systematic checks which are not discriminatory and are carried out as part of a control not aimed exclusively at insurance verification may be permitted. (7) Article 4(a) of Directive 72/166/EEC permits a Member State to act in derogation from the general obligation to take out compulsory insurance in respect of vehicles belonging to certain natural or public or private legal persons. For accidents caused by such vehicles, the Member State so derogating must designate an authority or body to compensate for the damage to victims of accidents caused in another Member State. In order to ensure that due compensation is paid not only to the victims of accidents caused by these vehicles abroad but also the victims of accidents occurring in the same Member State in which the vehicle is normally based, whether or not they are resident in its territory, the aforementioned Article should be amended. Furthermore, Member States should ensure that the list of persons exempt from compulsory insurance and the authorities or bodies responsible for compensation of victims of accidents caused by such vehicles is communicated to the Commission for publication. (8) Article 4(b) of Directive 72/166/EEC permits a Member State to act in derogation from the general obligation to take out compulsory insurance in respect of certain types of vehicles or certain vehicles having a special plate. In that case, the other Member States are allowed to require, at the entry into their territory, a valid green card or a frontier insurance contract, in order to ensure the provision of compensation to victims of any accident which may be caused by those vehicles in their territories. However, since the elimination of border controls within the Community means that it is not possible to ensure that vehicles crossing frontiers are covered by insurance, compensation for victims of accidents caused abroad can no longer be guaranteed. Furthermore, it should also be ensured that due compensation is awarded not only to the victims of accidents caused by those vehicles abroad, but also in the same Member State in which the vehicle is normally based. For this purpose, Member States should treat the victims of accidents caused by those vehicles in the same way as victims of accidents caused by non-insured vehicles. Indeed, as provided for in Directive 84/5/EEC, compensation to victims of accidents caused by uninsured vehicles should be paid by the compensation body of the Member State in which the accident took place. Where payments are made to victims of accidents caused by vehicles subject to the derogation, the compensation body should have a claim against the body of the Member State in which the vehicle is normally based. After a period of five years from the date of entry into force of this Directive, the Commission should, if appropriate, in view of the experience with the implementation and application of this derogation, submit proposals for its replacement or repeal. The corresponding provision in Directive 2000/26/EC should also be deleted. (9) In order to clarify the scope of application of the motor insurance directives in accordance with Article 299 of the Treaty, the reference to the non-European territory of the Member States in Articles 6 and 7(1) of Directive 72/166/EEC should be deleted. (10) Member States' obligations to guarantee insurance cover at least in respect of certain minimum amounts constitute an important element in ensuring the protection of victims. The minimum amounts provided for in Directive 84/5/EEC should not only be updated to take account of inflation, but also increased in real terms, to improve the protection of victims. The minimum amount of cover for personal injury should be calculated so as to compensate fully and fairly all victims who have suffered very serious injuries, whilst taking into account the low frequency of accidents involving several victims and the small number of accidents in which several victims suffer very serious injuries in the course of one and the same event. A minimum amount of cover of EUR 1 000 000 per victim or EUR 5 000 000 per claim, regardless of the number of victims, is a reasonable and adequate amount. With a view to facilitating the introduction of these minimum amounts, a transitional period of five years from the date of implementation of this Directive should be established. Member States should increase their amounts to at least a half of those levels within 30 months of the date of implementation. (11) In order to ensure that the minimum amount of cover is not eroded over time, a periodic review clause should be introduced using as a benchmark the European Index of Consumer Prices (EICP) published by Eurostat, as provided for in Council Regulation (EC) No 2494/95 of 23 October 1995 concerning harmonised indices of consumer prices (8). The procedural rules governing such a review need to be established. (12) Directive 84/5/EEC, which allows Member States, in the interest of preventing fraud, to limit or exclude payments by the compensation body in the case of damage to property by an unidentified vehicle, may impede legitimate compensation of victims in some cases. The option of limiting or excluding compensation on the basis that the vehicle is not identified should not apply where the body has paid compensation for significant personal injuries to any victim of the same accident in which the damage to property was caused. Member States may provide for an excess up to the limit set out in the said Directive for which the victim of the damage to property may be responsible. The conditions in which personal injuries are to be considered significant should be determined by the national legislation or administrative provisions of the Member State where the accident takes place. In establishing these conditions, the Member State may take into account, inter alia, whether the injury has required hospital care. (13) At present, an option contained in Directive 84/5/EEC allows Member States to authorise, up to a specified ceiling, excesses for which the victim would be responsible in the event of damage to property caused by uninsured vehicles. That option unjustly reduces the protection of victims and creates discrimination with respect to victims of other accidents. It should therefore no longer be permitted. (14) Second Council Directive 88/357/EEC of 22 June 1988 on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance and laying down provisions to facilitate the effective exercise of freedom to provide services (9) should be amended in order to permit branches of insurance undertakings to become representatives with respect to motor insurance activities, as already happens with respect to insurance services other than motor insurance. (15) The inclusion within the insurance cover of any passenger in the vehicle is a major achievement of the existing legislation. This objective would be placed in jeopardy if national legislation or any contractual clause contained in an insurance contract excluded passengers from insurance cover because they knew or should have known that the driver of the vehicle was under the influence of alcohol or of any other intoxicating agent at the time of the accident. The passenger is not usually in a position to assess properly the intoxication level of the driver. The objective of discouraging persons from driving whilst under the influence of intoxicating agents is not achieved by reducing the insurance cover for passengers who are victims of motor vehicle accidents. Cover of such passengers under the vehicle's compulsory motor insurance does not prejudge any liability they might incur pursuant to the applicable national legislation, nor the level of any award of damages in a specific accident. (16) Personal injuries and damage to property suffered by pedestrians, cyclists and other non-motorised users of the road, who are usually the weakest party in an accident, should be covered by the compulsory insurance of the vehicle involved in the accident where they are entitled to compensation under national civil law. This provision does not prejudge the civil liability or the level of awards for damages in a specific accident, under national legislation. (17) Some insurance undertakings insert into insurance policies clauses to the effect that the contract will be cancelled if the vehicle remains outside the Member State of registration for longer than a specified period. This practice is in conflict with the principle set out in Directive 90/232/EEC, according to which the compulsory motor insurance should cover, on the basis of a single premium, the entire territory of the Community. It should therefore be specified that the insurance cover is to remain valid during the whole term of the contract, irrespective of whether the vehicle remains in another Member State for a particular period, without prejudice to the obligations under Member States' national legislation with respect to the registration of vehicles. (18) Steps should be taken to make it easier to obtain insurance cover for vehicles imported from one Member State into another, even though the vehicle is not yet registered in the Member State of destination. A temporary derogation from the general rule determining the Member State where the risk is situated should be made available. For a period of 30 days from the date when the vehicle is delivered, made available or dispatched to the purchaser, the Member State of destination should be considered to be the Member State where the risk is situated. (19) Any person wishing to take out a new motor insurance contract with another insurer should be in a position to justify his accident and claims record under the old contract. The policyholder should have the right to request at any time a statement concerning the claims, or the absence of claims, involving the vehicle or vehicles covered by the insurance contract at least during the preceding five years of the contractual relationship. The insurance undertaking, or any body which may have been appointed by a Member State to provide compulsory insurance or to supply such statements, should provide this statement to the policyholder within 15 days of the request. (20) In order to ensure due protection of victims of motor vehicle accidents, Member States should not permit insurance undertakings to rely on excesses against an injured party. (21) The right to invoke the insurance contract and to claim against the insurance undertaking directly is of great importance for the protection of victims of motor vehicle accidents. Directive 2000/26/EC already provides victims of accidents occurring in a Member State other than the Member State of residence of the injured party, which are caused by the use of vehicles insured and normally based in a Member State, with a right of direct action against the insurance undertaking covering the person responsible against civil liability. In order to facilitate an efficient and speedy settlement of claims and to avoid as far as possible costly legal proceedings, this right should be extended to victims of any motor vehicle accident. (22) To enhance the protection of victims of motor vehicle accidents, the ‘reasoned offer’ procedure provided for in Directive 2000/26/EC should be extended to any kind of motor vehicle accident. This same procedure should also apply mutatis mutandis where the accident is settled by the system of national insurers' bureaux provided for in Directive 72/166/EEC. (23) In order to make it easier for the injured party to seek compensation, the information centres set up in accordance with Directive 2000/26/EC should not be confined to providing information concerning the accidents covered by that Directive, but should be able to provide the same kind of information for any motor vehicle accident. (24) Under Article 11(2) read in conjunction with Article 9(1)(b) of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (10), injured parties may bring legal proceedings against the civil liability insurance provider in the Member State in which they are domiciled. (25) As Directive 2000/26/EC was adopted before the adoption of Regulation (EC) No 44/2001, which replaced the Brussels Convention of 27 September 1968 on the same matter for a number of Member States, the reference to that Convention in that Directive should be adapted as appropriate. (26) Council Directives 72/166/EEC, 84/5/EEC, 88/357/EEC and 90/232/EEC and Directive 2000/26/EC of the European Parliament and of the Council should therefore be amended accordingly, Article 1 Amendments to Directive 72/166/EEC Directive 72/166/EEC shall be amended as follows: 1. Article 1(4) is amended as follows: (a) the first indent shall be replaced by the following: ‘ — the territory of the State of which the vehicle bears a registration plate, irrespective of whether the plate is permanent or temporary, or’ ; (b) the following indent shall be added: ‘ — in cases where the vehicle does not bear any registration plate or bears a registration plate which does not correspond or no longer corresponds to the vehicle and has been involved in an accident, the territory of the State in which the accident took place, for the purpose of settling the claim as provided for in the first indent of Article 2(2) of this Directive or in Article 1(4) of Second Council Directive 84/5/EEC of 30 December 1983 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles (11); 2. Article 2(1) is replaced by the following: ‘1. Member States shall refrain from making checks on insurance against civil liability in respect of vehicles normally based in the territory of another Member State and in respect of vehicles normally based in the territory of a third country entering their territory from the territory of another Member State. However, they may carry out non-systematic checks on insurance provided that they are not discriminatory and are carried out as part of a control which is not aimed exclusively at insurance verification.’ ; 3. Article 4 is amended as follows: (a) in point (a), second subparagraph: (i) the first sentence shall be replaced by the following: ‘A Member State so derogating shall take the appropriate measures to ensure that compensation is paid in respect of any loss or injury caused in its territory and in the territory of other Member States by vehicles belonging to such persons.’ ; (ii) the last sentence shall be replaced by the following: ‘It shall communicate to the Commission the list of persons exempt from compulsory insurance and the authorities or bodies responsible for compensation. The Commission shall publish the list.’ ; (b) in point (b), the second subparagraph shall be replaced by the following: ‘In that case Member States shall ensure that vehicles as mentioned in the first subparagraph of this point are treated in the same way as vehicles for which the insurance obligation provided for in Article 3(1) has not been satisfied. The compensation body of the Member State in which the accident has taken place shall then have a claim against the guarantee fund provided for in Article 1(4) of Directive 84/5/EEC in the Member State where the vehicle is normally based. After a period of five years from the date of entry into force of Directive 2005/14/EC of the European Parliament and of the Council of 11 May 2005 amending Council Directives 72/166/EEC, 84/5/EEC, 88/357/EEC and 90/232/EEC and Directive 2000/26/EC of the European Parliament and of the Council relating to insurance against civil liability in respect of the use of motor vehicles (12), Member States shall report to the Commission on the implementation and practical application of this point. The Commission, after having examined these reports, shall, if appropriate, submit proposals on the replacement or repeal of this derogation. 4. in Articles 6 and 7(1) ‘or in the non-European territory of a Member State’ shall be deleted. Article 2 Amendments to Directive 84/5/EEC Article 1 of Directive 84/5/EEC is replaced by the following: ‘Article 1 1. The insurance referred to in Article 3(1) of Directive 72/166/EEC shall cover compulsorily both damage to property and personal injuries. 2. Without prejudice to any higher guarantees which Member States may lay down, each Member State shall require insurance to be compulsory at least in respect of the following amounts: (a) in the case of personal injury, a minimum amount of cover of EUR 1 000 000 per victim or EUR 5 000 000 per claim, whatever the number of victims; (b) in the case of damage to property, EUR 1 000 000 per claim, whatever the number of victims. If necessary, Member States may establish a transitional period of up to five years from the date of implementation of Directive 2005/14/EC of the European Parliament and of the Council of 11 May 2005 amending Council Directives 72/166/EEC, 84/5/EEC, 88/357/EEC and 90/232/EEC and Directive 2000/26/EC of the European Parliament and of the Council relating to insurance against civil liability in respect of the use of motor vehicles (13), within which to adapt their minimum amounts of cover to the amounts provided for in this paragraph. Member States establishing such a transitional period shall inform the Commission thereof and indicate the duration of the transitional period. Within 30 months of the date of implementation of Directive 2005/14/EC Member States shall increase guarantees to at least a half of the levels provided for in this paragraph. 3. Every five years after the entry into force of Directive 2005/14/EC or the end of any transitional period as referred to in paragraph 2, the amounts referred to in that paragraph shall be reviewed, in line with the European Index of Consumer Prices (EICP), as set out in Council Regulation (EC) No 2494/95 of 23 October 1995 concerning harmonised indices of consumer prices (14). The amounts shall be adjusted automatically. Such amounts shall be increased by the percentage change indicated by the EICP for the relevant period, that is to say, the five years immediately preceding the review, and rounded up to a multiple of EUR 10 000. The Commission shall communicate the adjusted amounts to the European Parliament and the Council and shall ensure their publication in the Official Journal of the European Union. 4. Each Member State shall set up or authorise a body with the task of providing compensation, at least up to the limits of the insurance obligation for damage to property or personal injuries caused by an unidentified vehicle or a vehicle for which the insurance obligation provided for in paragraph 1 has not been satisfied. The first subparagraph shall be without prejudice to the right of the Member States to regard compensation by the body as subsidiary or non-subsidiary and the right to make provision for the settlement of claims between the body and the person or persons responsible for the accident and other insurers or social security bodies required to compensate the victim in respect of the same accident. However, Member States may not allow the body to make the payment of compensation conditional on the victim establishing in any way that the person liable is unable or refuses to pay. 5. The victim may in any event apply directly to the body which, on the basis of information provided at its request by the victim, shall be obliged to give him a reasoned reply regarding the payment of any compensation. Member States may, however, exclude the payment of compensation by that body in respect of persons who voluntarily entered the vehicle which caused the damage or injury when the body can prove that they knew it was uninsured. 6. Member States may limit or exclude the payment of compensation by the body in the event of damage to property by an unidentified vehicle. However, where the body has paid compensation for significant personal injuries to any victim of the same accident in which damage to property was caused by an unidentified vehicle, Member States may not exclude the payment of compensation for damage to property on the basis that the vehicle is not identified. Nevertheless, Member States may provide for an excess of not more than EUR 500 for which the victim of such damage to property may be responsible. The conditions in which personal injuries are to be considered significant shall be determined in accordance with the legislation or administrative provisions of the Member State in which the accident takes place. In this regard, Member States may take into account, inter alia, whether the injury has required hospital care. 7. Each Member State shall apply its laws, regulations and administrative provisions to the payment of compensation by the body, without prejudice to any other practice which is more favourable to the victim. Article 3 Amendment to Directive 88/357/EEC The second sentence in the fourth subparagraph of Article 12a(4) of Directive 88/357/EEC shall be deleted. Article 4 Amendments to Directive 90/232/EEC Directive 90/232/EEC shall be amended as follows: 1. in Article 1, the following paragraph shall be inserted between the first and second paragraphs: ‘Member States shall take the necessary measures to ensure that any statutory provision or any contractual clause contained in an insurance policy which excludes a passenger from such cover on the basis that he knew or should have known that the driver of the vehicle was under the influence of alcohol or of any other intoxicating agent at the time of an accident, shall be deemed to be void in respect of the claims of such passenger.’ ; 2. the following Article shall be inserted: ‘Article 1a The insurance referred to in Article 3(1) of Directive 72/166/EEC shall cover personal injuries and damage to property suffered by pedestrians, cyclists and other non-motorised users of the roads who, as a consequence of an accident in which a motor vehicle is involved, are entitled to compensation in accordance with national civil law. This Article shall be without prejudice either to civil liability or to the amount of damages.’ ; 3. in Article 2, the first indent shall be replaced by the following: ‘ — cover, on the basis of a single premium and during the whole term of the contract, the entire territory of the Community, including for any period in which the vehicle remains in other Member States during the term of the contract; and’ ; 4. the following Articles shall be inserted: ‘Article 4a 1. By way of derogation from the second indent of Article 2(d) of Directive 88/357/EEC (15), where a vehicle is dispatched from one Member State to another, the Member State where the risk is situated shall be considered to be the Member State of destination, immediately upon acceptance of delivery by the purchaser for a period of thirty days, even though the vehicle has not formally been registered in the Member State of destination. 2. In the event that the vehicle is involved in an accident during the period mentioned in paragraph 1 of this Article while being uninsured, the body referred to in Article 1(4) of Directive 84/5/EEC in the Member State of destination shall be liable for the compensation provided for in Article 1 of the said Directive. Article 4b Member States shall ensure that the policyholder has the right to request at any time a statement relating to the third party liability claims involving the vehicle or vehicles covered by the insurance contract at least during the preceding five years of the contractual relationship, or to the absence of such claims. The insurance undertaking, or a body which may have been appointed by a Member State to provide compulsory insurance or to supply such statements, shall provide this statement to the policyholder within 15 days of the request. Article 4c Insurance undertakings shall not rely on excesses against the injured party to an accident as far as the insurance referred to in Article 3(1) of Directive 72/166/EEC is concerned. Article 4d Member States shall ensure that injured parties to accidents caused by a vehicle covered by insurance as referred to in Article 3(1) of Directive 72/166/EEC enjoy a direct right of action against the insurance undertaking covering the person responsible against civil liability. Article 4e Member States shall establish the procedure provided for in Article 4(6) of Directive 2000/26/EC (16) for the settlement of claims arising from any accident caused by a vehicle covered by insurance as referred to in Article 3(1) of Directive 72/166/EEC. In the case of accidents which may be settled by the system of national insurers' bureaux provided for in Article 2(2) of Directive 72/166/EEC, Member States shall establish the same procedure as in Article 4(6) of Directive 2000/26/EC. For the purpose of applying this procedure, any reference to insurance undertaking shall be understood as a reference to national insurers' bureaux as defined in Article 1, point 3 of Directive 72/166/EEC. 5. Article 5(1) is replaced by the following: ‘1. Member States shall ensure that, without prejudice to their obligations under Directive 2000/26/EC, the information centres established or approved in accordance with Article 5 of that Directive, provide the information specified in that Article to any party involved in any traffic accident caused by a vehicle covered by insurance as referred to in Article 3(1) of Directive 72/166/EEC.’ Article 5 Amendments to Directive 2000/26/EC Directive 2000/26/EC shall be amended as follows: 1. the following recital 16a shall be inserted: ‘(16a) Under Article 11(2) read in conjunction with Article 9(1)(b) of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (17), injured parties may bring legal proceedings against the civil liability insurance provider in the Member State in which they are domiciled. 2. Article 4(8) is replaced by the following: ‘8. The appointment of a claims representative shall not in itself constitute the opening of a branch within the meaning of Article 1(b) of Directive 92/49/EEC and the claims representative shall not be considered an establishment within the meaning of Article 2(c) of Directive 88/357/EEC or: — an establishment within the meaning of the Brussels Convention of 27 September 1968 on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters (18) — as far as Denmark is concerned, — an establishment within the meaning of Regulation (EC) No 44/2001 — as far as the other Member States are concerned. 3. in Article 5(1)(a), point 2(ii) shall be deleted. 4. the following Article is inserted: ‘Article 6a Central body Member States shall take all appropriate measures to facilitate the availability in due time to the victims, their insurers or their legal representatives of the basic data necessary for the settlement of claims. This basic data shall, where appropriate, be made available in electronic form in a central repository in each Member State, and be accessible by parties involved in the case at their express request.’ Article 6 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 11 June 2007 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States may, in accordance with the Treaty, maintain or bring into force provisions which are more favourable to the injured party than the provisions necessary to comply with this Directive. 3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 7 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 8 Addressees This Directive is addressed to the Member States.

32005L0037

2005

COMMISSION DIRECTIVE 2005/37/EC of 3 June 2005 amending Council Directives 86/362/EEC and 90/642/EEC as regards the maximum levels for certain pesticide residues in and on cereals and certain products of plant origin, including fruit and vegetables (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables (2), and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), and in particular Article 4(1)(f) thereof, Whereas: (1) The following existing active substances have been included in Annex I to Directive 91/414/EEC: maleic hydrazide by Commission Directive 2003/31/EC (4); propyzamide by Commission Directive 2003/39/EC (5); and mecoprop and mecoprop-p by Commission Directive 2003/70/EC (6). (2) The new active substances isoxaflutole, trifloxystrobin, carfentrazone-ethyl and fenamidone were included in Annex I to Directive 91/414/EEC by Commission Directive 2003/68/EC (7). (3) The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning the proposed use. Information relating to this use has been submitted by certain Member States in accordance with Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed. (4) Where no Community MRL or provisional MRL exists, Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing these active substances may be authorised. (5) Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a limited number of Codex MRLs for maleic hydrazide. There are already Community MRLs in Directive 90/642/EEC for: maleic hydrazide, (Council Directive 93/58/EC) (8) and in Directives 86/362/EEC and 90/642/EEC for: propyzamide (Council Directives 96/32/EC (9) and 96/33/EC (10)). These have been considered when setting the MRLs concerned by the adaptations made by this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. The MRLs based on Codex MRLs having been evaluated in the light of the risks for the consumers. No risk was established when using the toxicological end points based on the studies available to the Commission. (6) With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, the related technical and scientific evaluations were finalised in the form of Commission review reports. The assessment reports for those substances mentioned were finalised on the dates as mentioned in the Commission Directives cited in Recitals 1 and 2. These reports fixed the acceptable daily intake (ADI) and if necessary, the acute reference dose (ARfD) for the substances concerned. The exposure of consumers of food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation (11) and the opinion of the Scientific Committee for Plants (12) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded. (7) In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, provisional MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination. (8) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances concerned in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRL should then become definitive. (9) It is therefore necessary to add or replace, all of the pesticide residues arising from the use of these plant protection products to the Annexes to Directives 86/362/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. Where MRLs have already been defined in the annexes to those directives it is appropriate to modify them. Where MRLs have not been defined until now, it is appropriate to set them for the first time. (10) Directives 86/362/EEC and 90/642/EEC should therefore be amended accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Directive 86/362/EEC is amended as follows: (a) in Part A of Annex II the maximum pesticide residue levels for isoxaflutole, trifloxystrobin, carfentrazone-ethyl, mecoprop, mecoprop-p, maleic hydrazide and fenamidone as shown in Annex I to this Directive are added; (b) in Part A of Annex II the maximum pesticide residue levels for propyzamide are replaced by those as shown in Annex II to this Directive. Article 2 Directive 90/642/EEC is amended as follows: (a) in Annex II the maximum pesticide residue levels for isoxaflutole, trifloxystrobin, carfentrazone-ethyl, mecoprop, mecoprop-p and fenamidone as shown in Annex III to this Directive are added. (b) in Annex II the maximum pesticide residue levels for propyzamide and maleic hydrazide are replaced by those as shown in Annex IV to this Directive. Article 3 1. Member States shall adopt and publish, by 4 December 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 4 December 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0042

2005

COMMISSION DIRECTIVE 2005/42/EC of 20 June 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II, IV and VI thereto to technical progress (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof, After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, Whereas: (1) On the basis of the assessment of the cutaneous toxicities of costus root oil (Saussurea lappa Clarke), 7-Ethoxy-4-methylcoumarin, hexahydrocoumarin and peru balsam (Myroxylon pereirae), the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) is of the opinion that those substances should not be used as fragrance ingredients in cosmetic products. They should therefore be included in Annex II to Directive 76/768/EEC. (2) Azo-dyes CI 12150, CI 20170 and CI 27290 are included in Part 1 of Annex IV to Directive 76/768/EEC as colouring agents which are allowed for use in cosmetic products. The safety of those colorants has been questioned on the ground that they may form carcinogenic amines during metabolism. The SCCNFP is of the opinion, based on the available information, that the use of the colorants CI 12150, CI 20170 and CI 27290 poses a risk to the health of the consumer as they may release one or more carcinogenic aromatic amines. Those colorants should therefore be excluded from Part 1 of Annex IV to Directive 76/768/EEC. (3) Benzethonium chloride is included as reference number 53 in Part 1 of Annex VI to Directive 76/768/EEC as a preservative which may be employed in rinse-off cosmetic products up to a concentration of 0,1 %. It is the opinion of the SCCNFP that Benzethonium chloride should also be allowed to be employed in leave-on cosmetic products other than for oral care use up to a concentration of 0,1 %. The entry under the reference number 53 in Part 1 of Annex VI to Directive 76/768/EEC should therefore be amended accordingly. (4) The SCCNFP is of the opinion that Methylisothiazolinone does not pose a risk to the health of consumers if employed in finished cosmetic products as a preservative up to a concentration of 0,01 %. Methylisothiazolinone should therefore be included in Part 1 of Annex VI to Directive 76/768/EEC as reference number 57. (5) Directive 76/768/EEC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products, Article 1 Annexes II, IV and VI to Directive 76/768/EEC are amended in accordance with the Annex to this Directive. Article 2 Member States shall take the necessary measures to ensure that from 31 March 2006 cosmetic products which fail to comply with Annexes II and IV of Directive 76/768/EEC as amended by this Directive are not placed on the market by Community manufacturers or by importers established within the Community, nor sold or disposed of to the final consumer. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0032

2005

DIRECTIVE 2005/32/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 2005 establishing a framework for the setting of ecodesign requirements for energy-using products and amending Council Directive 92/42/EEC and Directives 96/57/EC and 2000/55/EC of the European Parliament and of the Council Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The disparities between the laws or administrative measures adopted by the Member States in relation to the ecodesign of energy-using products can create barriers to trade and distort competition in the Community and may thus have a direct impact on the establishment and functioning of the internal market. The harmonisation of national laws is the only means to prevent such barriers to trade and unfair competition. (2) Energy-using products (EuPs) account for a large proportion of the consumption of natural resources and energy in the Community. They also have a number of other important environmental impacts. For the vast majority of product categories available on the Community market, very different degrees of environmental impact can be noted though they provide similar functional performances. In the interest of sustainable development, continuous improvement in the overall environmental impact of those products should be encouraged, notably by identifying the major sources of negative environmental impacts and avoiding transfer of pollution, when this improvement does not entail excessive costs. (3) The ecodesign of products is a crucial factor in the Community strategy on Integrated Product Policy. As a preventive approach, designed to optimise the environmental performance of products, while maintaining their functional qualities, it provides genuine new opportunities for manufacturers, for consumers and for society as a whole. (4) Energy efficiency improvement — with one of the available options being more efficient end use of electricity — is regarded as contributing substantially to the achievement of greenhouse gas emission targets in the Community. Electricity demand is the fastest growing energy end use category and is projected to grow within the next 20 to 30 years, in the absence of any policy action to counteract this trend. A significant reduction in energy consumption as suggested by the Commission in its European Climate Change Programme (ECCP) is possible. Climate change is one of the priorities of the Sixth Community Environment Action Programme, laid down by Decision No 1600/2002/EC of the European Parliament and of the Council (3). Energy saving is the most cost-effective way to increase security of supply and reduce import dependency. Therefore, substantial demand side measures and targets should be adopted. (5) Action should be taken during the design phase of EuPs, since it appears that the pollution caused during a product's life cycle is determined at that stage, and most of the costs involved are committed then. (6) A coherent framework for the application of Community ecodesign requirements for EuPs should be established with the aim of ensuring the free movement of those products which comply and of improving their overall environmental impact. Such Community requirements should respect the principles of fair competition and international trade. (7) Ecodesign requirements should be set bearing in mind the goals and priorities of the Sixth Community Environment Action Programme, including as appropriate applicable goals of the relevant thematic strategies of that Programme. (8) This Directive seeks to achieve a high level of protection for the environment by reducing the potential environmental impact of EuPs, which will ultimately be beneficial to consumers and other end-users. Sustainable development also requires proper consideration of the health, social and economic impact of the measures envisaged. Improving the energy efficiency of products contributes to the security of the energy supply, which is a precondition of sound economic activity and therefore of sustainable development. (9) A Member State deeming it necessary to maintain national provisions on grounds of major needs relating to the protection of the environment, or to introduce new ones based on new scientific evidence relating to the protection of the environment on grounds of a problem specific to that Member State arising after the adoption of the applicable implementing measure, may do so following the conditions laid down in Article 95(4), (5) and (6) of the Treaty, that provides for a prior notification to and approval from the Commission. (10) In order to maximise the environmental benefits from improved design it may be necessary to inform consumers about the environmental characteristics and performance of EuPs and to advise them about how to use products in a manner which is environmentally friendly. (11) The approach set out in the Green Paper on Integrated Product Policy, which is a major innovative element of the Sixth Community Environment Action Programme, aims to reduce the environmental impacts of products across the whole of their life cycle. Considering at the design stage a product's environmental impact throughout its whole life cycle has a high potential to facilitate environmental improvement in a cost-effective way. There should be sufficient flexibility to enable this factor to be integrated in product design whilst taking account of technical, functional and economic considerations. (12) Although a comprehensive approach to environmental performance is desirable, greenhouse gas mitigation through increased energy efficiency should be considered a priority environmental goal pending the adoption of a working plan. (13) It may be necessary and justified to establish specific quantified ecodesign requirements for some products or environmental aspects thereof in order to ensure that their environmental impact is minimised. Given the urgent need to contribute to the achievement of the commitments in the framework of the Kyoto Protocol to the United Nations Framework Convention on Climate Change (UNFCCC), and without prejudice to the integrated approach promoted in this Directive, some priority should be given to those measures with a high potential for reducing greenhouse gas emissions at low cost. Such measures can also contribute to a sustainable use of resources and constitute a major contribution to the 10-year framework of programmes on sustainable production and consumption agreed at the World Summit on Sustainable Development in Johannesburg in September 2002. (14) As a general principle, the energy consumption of EuPs in stand-by or off-mode should be reduced to the minimum necessary for their proper functioning. (15) While the best-performing products or technologies available on the market, including on international markets, should be taken as reference, the level of ecodesign requirements should be established on the basis of technical, economic and environmental analysis. Flexibility in the method for establishing the level of requirements can make swift improvement of environmental performance easier. Interested parties involved should be consulted and cooperate actively in this analysis. The setting of mandatory measures requires proper consultation of the parties involved. Such consultation may highlight the need for a phased introduction or transitional measures. The introduction of interim targets increases the predictability of the policy, allows for accommodating product development cycles and facilitates long term planning for interested parties. (16) Priority should be given to alternative courses of action such as self-regulation by the industry where such action is likely to deliver the policy objectives faster or in a less costly manner than mandatory requirements. Legislative measures may be needed where market forces fail to evolve in the right direction or at an acceptable speed. (17) Self-regulation, including voluntary agreements offered as unilateral commitments by industry, can provide for quick progress due to rapid and cost-effective implementation, and allows for flexible and appropriate adaptation to technological options and market sensitivities. (18) For the assessment of voluntary agreements or other self-regulation measures presented as alternatives to implementing measures, information on at least the following issues should be available: openness of participation, added value, representativeness, quantified and staged objectives, involvement of civil society, monitoring and reporting, cost-effectiveness of administering a self-regulatory initiative, sustainability. (19) Chapter 6 of the Commission's ‘Communication on Environmental Agreements at Community level within the Framework of the Action Plan on the Simplification and Improvement of the Regulatory Environment’ could provide useful guidance when assessing self-regulation by industry in the context of this Directive. (20) This Directive should also encourage the integration of ecodesign in small and medium-sized enterprises (SMEs) and very small firms. Such integration could be facilitated by wide availability of and easy access to information relating to the sustainability of their products. (21) EuPs complying with the ecodesign requirements laid down in implementing measures to this Directive should bear the ‘CE’ marking and associated information, in order to enable them to be placed on the internal market and move freely. The rigorous enforcement of implementing measures is necessary to reduce the environmental impact of regulated EuPs and to ensure fair competition. (22) When preparing implementing measures and its working plan the Commission should consult Member States' representatives as well as interested parties concerned with the product group, such as industry, including SMEs and craft industry, trade unions, traders, retailers, importers, environmental protection groups and consumer organisations. (23) When preparing implementing measures, the Commission should also take due account of existing national environmental legislation, in particular concerning toxic substances, which Member States have indicated that they consider should be preserved, without reducing the existing and justified levels of protection in the Member States. (24) Regard should be given to the modules and rules intended for use in technical harmonisation Directives set out in Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives (4). (25) Surveillance authorities should exchange information on the measures envisaged within the scope of this Directive with a view to improving surveillance of the market. Such cooperation should make the utmost use of electronic means of communication and relevant Community programmes. The exchange of information on environmental life cycle performance and on the achievements of design solutions should be facilitated. The accumulation and dissemination of the body of knowledge generated by the ecodesign efforts of manufacturers is one of the crucial benefits of this Directive. (26) A competent body is usually a public or private body, designated by the public authorities, and presenting the necessary guarantees for impartiality and availability of technical expertise for carrying out verification of the product with regard to its compliance with the applicable implementing measures. (27) Noting the importance of avoiding non-compliance, Member States should ensure that the necessary means are available for effective market surveillance. (28) In respect of training and information on ecodesign for SMEs, it may be appropriate to consider accompanying activities. (29) It is in the interest of the functioning of the internal market to have standards which have been harmonised at Community level. Once the reference to such a standard has been published in the Official Journal of the European Union, compliance with it should raise a presumption of conformity with the corresponding requirements set out in the implementing measure adopted on the basis of this Directive, although other means of demonstrating such conformity should be permitted. (30) One of the main roles of harmonised standards should be to help manufacturers in applying the implementing measures adopted under this Directive. Such standards could be essential in establishing measuring and testing methods. In the case of generic ecodesign requirements harmonised standards could contribute considerably to guiding manufacturers in establishing the ecological profile of their products in accordance with the requirements of the applicable implementing measure. These standards should clearly indicate the relationship between their clauses and the requirements dealt with. The purpose of harmonised standards should not be to fix limits for environmental aspects. (31) For the purpose of definitions used in this Directive it is useful to refer to relevant international standards such as ISO 14040. (32) This Directive is in accordance with certain principles for the implementation of the new approach as set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards (5) and of making reference to harmonised European standards. The Council Resolution of 28 October 1999 on the role of standardisation in Europe (6) recommended that the Commission should examine whether the New Approach principle could be extended to sectors not yet covered as a means of improving and simplifying legislation wherever possible. (33) This Directive is complementary to existing Community instruments such as Council Directive 92/75/EEC of 22 September 1992 on the indication by labelling and standard product information of the consumption of energy and other resources by household appliances (7), Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme (8), Regulation (EC) No 2422/2001 of the European Parliament and of the Council of 6 November 2001 on a Community energy efficiency labelling programme for office equipment (9), Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE) (10), Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (11) and Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (12). Synergies between this Directive and the existing Community instruments should contribute to increasing their respective impacts and building coherent requirements for manufacturers to apply. (34) Since Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (13), Directive 96/57/EC of the European Parliament and of the Council of 3 September 1996 on energy efficiency requirements for household electric refrigerators, freezers and combinations thereof (14) and Directive 2000/55/EC of the European Parliament and of the Council of 18 September 2000 on energy efficiency requirements for ballasts for fluorescent lighting (15) already contain provisions for the revision of the energy efficiency requirements, they should be integrated into the present framework. (35) Directive 92/42/EEC provides for a star rating system intended to ascertain the energy performance of boilers. Since Member States and the industry agree that the star rating system has proved not to deliver the expected result, Directive 92/42/EEC should be amended to open the way for more effective schemes. (36) The requirements laid down in Council Directive 78/170/EEC of 13 February 1978 on the performance of heat generators for space heating and the production of hot water in new or existing non-industrial buildings and on the insulation of heat and domestic hot-water distribution in new non-industrial buildings (16) have been superseded by provisions of Directive 92/42/EEC, Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels (17) and Directive 2002/91/EC of the European Parliament and of the Council of 16 December 2002 on the energy performance of buildings (18). Directive 78/170/EEC should therefore be repealed. (37) Council Directive 86/594/EEC of 1 December 1986 on airborne noise emitted by household appliances (19) lays down the conditions under which publication of information on the noise emitted by such appliances may be required by Member States, and defines a procedure to determine the level of noise. For harmonisation purposes noise emissions should be included in an integrated assessment of environmental performance. Since this Directive provides for such an integrated approach, Directive 86/594/EEC should be repealed. (38) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (20). (39) Member States should determine the penalties to be applied in the event of infringements of the national provisions adopted pursuant to this Directive. Those penalties should be effective, proportionate and dissuasive. (40) It should be remembered that paragraph 34 of the Interinstitutional agreement on better law-making (21) states that the Council ‘will encourage the Member States to draw up, for themselves and in the interests of the Community, their own tables which will, as far as possible, illustrate the correlation between directives and the transposition measures and to make them public.’ (41) Since the objective of the proposed action, namely to ensure the functioning of the internal market by requiring products to reach an adequate level of environmental performance, cannot be sufficiently achieved by Member States acting alone and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective. (42) The Committee of the Regions was consulted but did not deliver an opinion, Article 1 Subject matter and scope 1. This Directive establishes a framework for the setting of Community ecodesign requirements for energy-using products with the aim of ensuring the free movement of those products within the internal market. 2. This Directive provides for the setting of requirements which the energy-using products covered by implementing measures must fulfil in order for them to be placed on the market and/or put into service. It contributes to sustainable development by increasing energy efficiency and the level of protection of the environment, while at the same time increasing the security of the energy supply. 3. This Directive shall not apply to means of transport for persons or goods. 4. This Directive and the implementing measures adopted pursuant to it shall be without prejudice to Community waste management legislation and Community chemicals legislation, including Community legislation on fluorinated greenhouse gases. Article 2 Definitions For the purposes of this Directive the following definitions shall apply: 1. ‘Energy-using product’ or ‘EuP’ means a product which, once placed on the market and/or put into service, is dependent on energy input (electricity, fossil fuels and renewable energy sources) to work as intended, or a product for the generation, transfer and measurement of such energy, including parts dependent on energy input and intended to be incorporated into an EuP covered by this Directive which are placed on the market and/or put into service as individual parts for end-users and of which the environmental performance can be assessed independently; 2. ‘Components and sub-assemblies’ means parts intended to be incorporated into EuPs, and which are not placed on the market and/or put into service as individual parts for end-users or the environmental performance of which cannot be assessed independently; 3. ‘Implementing measures’ means measures adopted pursuant to this Directive laying down ecodesign requirements for defined EuPs or for environmental aspects thereof; 4. ‘Placing on the market’ means making an EuP available for the first time on the Community market with a view to its distribution or use within the Community whether for reward or free of charge and irrespective of the selling technique; 5. ‘Putting into service’ means the first use of an EuP for its intended purpose by an end-user in the Community; 6. ‘Manufacturer’ means the natural or legal person who manufactures EuPs covered by this Directive and is responsible for their conformity with this Directive in view of their being placed on the market and/or put into service under the manufacturer's own name or trademark or for the manufacturer's own use. In the absence of a manufacturer as defined in the first sentence or of an importer as defined in point 8, any natural or legal person who places on the market and/or puts into service EuPs covered by this Directive shall be considered a manufacturer; 7. ‘Authorised representative’ means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this Directive; 8. ‘Importer’ means any natural or legal person established in the Community who places a product from a third country on the Community market in the course of his business; 9. ‘Materials’ means all materials used during the life cycle of an EuP; 10. ‘Product design’ means the set of processes that transform legal, technical, safety, functional, market or other requirements to be met by an EuP into the technical specification for that EuP; 11. ‘Environmental aspect’ means an element or function of an EuP that can interact with the environment during its life cycle; 12. ‘Environmental impact’ means any change to the environment wholly or partially resulting from an EuP during its life cycle; 13. ‘Life cycle’ means the consecutive and interlinked stages of an EuP from raw material use to final disposal; 14. ‘Reuse’ means any operation by which an EuP or its components, having reached the end of their first use, are used for the same purpose for which they were conceived, including the continued use of an EuP which is returned to a collection point, distributor, recycler or manufacturer, as well as reuse of an EuP following refurbishment; 15. ‘Recycling’ means the reprocessing in a production process of waste materials for the original purpose or for other purposes but excluding energy recovery; 16. ‘Energy recovery’ means the use of combustible waste as a means to generate energy through direct incineration with or without other waste but with recovery of the heat; 17. ‘Recovery’ means any of the applicable operations provided for in Annex II B to Council Directive 75/442/EEC of 15 July 1975 on waste (22); 18. ‘Waste’ means any substance or object in the categories set out in Annex I to Directive 75/442/EEC which the holder discards or intends or is required to discard; 19. ‘Hazardous waste’ means any waste which is covered by Article 1(4) of Council Directive 91/689/EEC of 12 December 1991 on hazardous waste (23); 20. ‘Ecological profile’ means a description, in accordance with the implementing measure applicable to the EuP, of the inputs and outputs (such as materials, emissions and waste) associated with an EuP throughout its life cycle which are significant from the point of view of its environmental impact and are expressed in physical quantities that can be measured; 21. ‘Environmental performance’ of an EuP means the results of the manufacturer's management of the environmental aspects of the EuP, as reflected in its technical documentation file; 22. ‘Improvement of the environmental performance’ means the process of enhancing the environmental performance of an EuP over successive generations, although not necessarily in respect of all environmental aspects of the product simultaneously; 23. ‘Ecodesign’ means the integration of environmental aspects into product design with the aim of improving the environmental performance of the EuP throughout its whole life cycle; 24. ‘Ecodesign requirement’ means any requirement in relation to an EuP, or the design of an EuP, intended to improve its environmental performance, or any requirement for the supply of information with regard to the environmental aspects of an EuP; 25. ‘Generic ecodesign requirement’ means any ecodesign requirement based on the ecological profile as a whole of an EuP without set limit values for particular environmental aspects; 26. ‘Specific ecodesign requirement’ means a quantified and measurable ecodesign requirement relating to a particular environmental aspect of an EuP, such as energy consumption during use, calculated for a given unit of output performance; 27. ‘Harmonised standard’ means a technical specification adopted by a recognised standards body under a mandate from the Commission, in accordance with the procedure laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (24), for the purpose of establishing a European requirement, compliance with which is not compulsory. Article 3 Placing on the market and/or putting into service 1. Member States shall take all appropriate measures to ensure that EuPs covered by implementing measures may be placed on the market and/or put into service only if they comply with those measures and bear the CE marking in accordance with Article 5. 2. Member States shall designate the authorities responsible for market surveillance. They shall arrange for such authorities to have and use the necessary powers to take the appropriate measures incumbent upon them under this Directive. Member States shall define the tasks, powers and organisational arrangements of the competent authorities which shall be entitled: (i) to organise appropriate checks on EuP compliance, on an adequate scale, and to oblige the manufacturer or its authorised representative to recall non-compliant EuPs from the market in accordance with Article 7; (ii) to require the provision of all necessary information by the parties concerned, as specified in implementing measures; (iii) to take samples of products and subject them to compliance checks. 3. Member States shall keep the Commission informed about the results of the market surveillance, and where appropriate the Commission shall pass on such information to the other Member States. 4. Member States shall ensure that consumers and other interested parties are given an opportunity to submit observations on product compliance to the competent authorities. Article 4 Responsibilities of the importer Where the manufacturer is not established within the Community and in the absence of an authorised representative, the obligation: — to ensure that the EuP placed on the market or put into service complies with this Directive and the applicable implementing measure, — to keep the declaration of conformity and the technical documentation available, shall lie with the importer. Article 5 Marking and declaration of conformity 1. Before an EuP covered by implementing measures is placed on the market and/or put into service, a CE conformity marking shall be affixed and a declaration of conformity issued whereby the manufacturer or its authorised representative ensures and declares that the EuP complies with all relevant provisions of the applicable implementing measure. 2. The CE conformity marking consists of the initials ‘CE’ as shown in Annex III. 3. The declaration of conformity shall contain the elements specified in Annex VI and shall refer to the appropriate implementing measure. 4. The affixing of markings on an EuP which are likely to mislead users as to the meaning or form of the CE marking shall be prohibited. 5. Member States may require the information to be supplied pursuant to Annex I, Part 2 to be in their official language(s) when the EuP reaches the end-user. Member States shall also authorise the provision of this information in one or more other official Community language(s). When applying the first subparagraph, Member States shall take into account in particular: (a) whether the information can be supplied by harmonised symbols or recognised codes or other measures; (b) the type of user anticipated for the EuP and the nature of the information which is to be provided. Article 6 Free movement 1. Member States shall not prohibit, restrict or impede the placing on the market and/or putting into service, within their territories, on grounds of ecodesign requirements relating to those ecodesign parameters referred to in Annex I, Part 1 which are covered by the applicable implementing measure, of an EuP that complies with all the relevant provisions of the applicable implementing measure and bears the CE marking in accordance with Article 5. 2. Member States shall not prohibit, restrict or impede the placing on the market and/or putting into service, within their territories, of an EuP bearing the CE marking in accordance with Article 5 on grounds of ecodesign requirements relating to those ecodesign parameters referred to in Annex I, Part 1 for which the applicable implementing measure provides that no ecodesign requirement is necessary. 3. Member States shall not prevent the display, for example at trade fairs, exhibitions and demonstrations, of EuPs which are not in conformity with the provisions of the applicable implementing measure, provided that there is a visible indication that they may not be placed on the market and/or put into service until brought into conformity. Article 7 Safeguard clause 1. Where a Member State ascertains that an EuP bearing the CE marking referred to in Article 5 and used in accordance with its intended use does not comply with all the relevant provisions of the applicable implementing measure, the manufacturer or its authorised representative shall be obliged to make the EuP comply with the provisions of the applicable implementing measure and/or with the CE marking and to end the infringement under conditions imposed by the Member State. Where there is sufficient evidence that an EuP might be non-compliant, the Member State shall take the necessary measures which, depending on the gravity of the non-compliance, can go as far as the prohibition of the placing on the market of the EuP until compliance is established. Where non-compliance continues, the Member State shall take a decision restricting or prohibiting the placing on the market and/or putting into service of the EuP in question or ensure that it is withdrawn from the market. In cases of prohibition or withdrawal from the market, the Commission and the other Member States shall be immediately informed. 2. Any decision by a Member State pursuant to this Directive which restricts or prohibits the placing on the market and/or the putting into service of an EuP shall state the grounds on which it is based. Such decision shall be notified forthwith to the party concerned, who shall at the same time be informed of the legal remedies available under the laws in force in the Member State concerned and of the time limits to which such remedies are subject. 3. The Member State shall immediately inform the Commission and the other Member States of any decision taken pursuant to paragraph 1, indicating the reasons therefore, and, in particular, whether non-compliance is due to: (a) failure to satisfy the requirements of the applicable implementing measure; (b) incorrect application of harmonised standards as referred to in Article 10(2); (c) shortcomings in harmonised standards as referred to in Article 10(2). 4. The Commission shall enter into consultation with the parties concerned without delay and may draw upon technical advice from independent external experts. Following that consultation, the Commission shall immediately inform the Member State which took the decision and the other Member States of its views. Where the Commission considers that the decision is unjustified, it shall immediately inform the Member States to that effect. 5. Where the decision referred to in paragraph 1 is based on a shortcoming in a harmonised standard, the Commission shall immediately initiate the procedure set out in Article 10(2), (3) and (4). The Commission shall at the same time inform the Committee referred to in Article 19(1). 6. The Member States and the Commission shall take the necessary measures to guarantee confidentiality with regard to information provided during that procedure, where justified. 7. The decisions taken by Member States pursuant to this Article shall be made public, in a transparent way. 8. The Commission's opinion on those decisions shall be published in the Official Journal of the European Union. Article 8 Conformity assessment 1. Before placing an EuP covered by implementing measures on the market and/or putting such an EuP into service, the manufacturer or its authorised representative shall ensure that an assessment of the EuP's conformity with all the relevant requirements of the applicable implementing measure is carried out. 2. The conformity assessment procedures shall be specified by the implementing measures and shall leave to manufacturers the choice between the internal design control set out in Annex IV and the management system set out in Annex V. When duly justified and proportionate to the risk, the conformity assessment procedure shall be specified among relevant modules as described in Decision 93/465/EEC. If a Member State has strong indications of probable non-compliance of an EuP, that Member State shall as soon as possible publish a substantiated assessment of the EuP's compliance which may be conducted by a competent body in order to allow timely corrective action, if any. If an EuP covered by implementing measures is designed by an organisation registered in accordance with Regulation (EC) No 761/2001 of the European Parliament and of the Council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) (25) and the design function is included within the scope of that registration, the management system of that organisation shall be presumed to comply with the requirements of Annex V to this Directive. If an EuP covered by implementing measures is designed by an organisation having a management system which includes the product design function and which is implemented in accordance with harmonised standards the reference numbers of which have been published in the Official Journal of the European Union, that management system shall be presumed to comply with the corresponding requirements of Annex V. 3. After placing an EuP covered by implementing measures on the market or putting it into service, the manufacturer or its authorised representative shall keep relevant documents relating to the conformity assessment performed and declarations of conformity issued available for inspection by Member States for a period of 10 years after the last of that EuP has been manufactured. The relevant documents shall be made available within 10 days upon receipt of a request by the competent authority of a Member State. 4. Documents relating to the conformity assessment and declaration of conformity referred to in Article 5 shall be drawn up in one of the official languages of the Community. Article 9 Presumption of conformity 1. Member States shall regard an EuP bearing the CE marking referred to in Article 5 as conforming to the relevant provisions of the applicable implementing measure. 2. Member States shall regard an EuP for which harmonised standards have been applied, the reference numbers of which have been published in the Official Journal of the European Union, as conforming to all the relevant requirements of the applicable implementing measure to which such standards relate. 3. EuPs which have been awarded the Community eco-label pursuant to Regulation (EC) No 1980/2000 shall be presumed to comply with the ecodesign requirements of the applicable implementing measure insofar as those requirements are met by the eco-label. 4. For the purposes of the presumption of conformity in the context of this Directive, the Commission, acting in accordance with the procedure referred to in Article 19(2), may decide that other eco-labels fulfil equivalent conditions to the Community eco-label pursuant to Regulation (EC) No 1980/2000. EuPs which have been awarded such other eco-labels shall be presumed to comply with the ecodesign requirements of the applicable implementing measure, insofar as those requirements are met by that eco-label. Article 10 Harmonised standards 1. Member States shall, to the extent possible, ensure that appropriate measures are taken to enable interested parties to be consulted at national level on the process of preparing and monitoring harmonised standards. 2. Where a Member State or the Commission considers that harmonised standards the application of which is presumed to satisfy specific provisions of an applicable implementing measure do not entirely satisfy those provisions, the Member State concerned or the Commission shall inform the Standing Committee set up under Article 5 of Directive 98/34/EC to that effect, giving the reasons. The Committee shall issue an opinion as a matter of urgency. 3. In the light of that Committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain or to withdraw the references to the harmonised standards concerned in the Official Journal of the European Union. 4. The Commission shall inform the European standardisation body concerned and, if necessary, issue a new mandate with a view to revision of the harmonised standards concerned. Article 11 Requirements for components and sub-assemblies Implementing measures may require manufacturers or their authorised representatives placing components and sub-assemblies on the market and/or putting them into service to provide the manufacturer of an EuP covered by implementing measures with relevant information on the material composition and the consumption of energy, materials and/or resources of the components or sub-assemblies. Article 12 Administrative cooperation and exchange of information 1. Member States shall ensure that appropriate measures are taken in order to encourage the authorities responsible for implementing this Directive to cooperate with each other and provide each other and the Commission with information in order to assist the operation of this Directive and in particular, assist in the implementation of Article 7. The administrative cooperation and exchange of information shall take utmost advantage of electronic means of communication and may be supported by relevant Community programmes. Member States shall inform the Commission of the authorities responsible for applying this Directive. 2. The precise nature and structure of the exchange of information between the Commission and Member States shall be decided in accordance with the procedure referred to in Article 19(2). 3. The Commission shall take appropriate measures in order to encourage and contribute to the cooperation between Member States referred to in this Article. Article 13 Small and medium-sized enterprises 1. In the context of programmes from which SMEs and very small firms can benefit, the Commission shall take into account initiatives which help SMEs and very small firms to integrate environmental aspects including energy efficiency when designing their products. 2. Member States shall ensure, in particular by strengthening support networks and structures, that they encourage SMEs and very small firms to adopt an environmentally sound approach as early as at the product design stage and to adapt to future European legislation. Article 14 Consumer information In accordance with the applicable implementing measure, manufacturers shall ensure, in the form they deem appropriate, that consumers of EuPs are provided with: — the requisite information on the role that they can play in the sustainable use of the product; — when required by the implementing measures, the ecological profile of the product and the benefits of ecodesign. Article 15 Implementing measures 1. When an EuP meets the criteria listed under paragraph 2, it shall be covered by an implementing measure or by a self-regulation measure in accordance with paragraph 3(b). When the Commission adopts implementing measures, it shall act in accordance with the procedure referred to in Article 19(2). 2. The criteria referred to in paragraph 1 are as follows: (a) the EuP shall represent a significant volume of sales and trade, indicatively more than 200 000 units a year within the Community according to most recently available figures; (b) the EuP shall, considering the quantities placed on the market and/or put into service, have a significant environmental impact within the Community, as specified in Community strategic priorities as set out in Decision No 1600/2002/EC; (c) the EuP shall present significant potential for improvement in terms of its environmental impact without entailing excessive costs, taking into account in particular: — the absence of other relevant Community legislation or failure of market forces to address the issue properly; — a wide disparity in the environmental performance of EuPs available on the market with equivalent functionality. 3. In preparing a draft implementing measure the Commission shall take into account any views expressed by the Committee referred to in Article 19(1) and shall further take into account: (a) Community environmental priorities, such as those set out in Decision No 1600/2002/EC or in the Commission's European Climate Change Programme (ECCP); (b) relevant Community legislation and self-regulation, such as voluntary agreements, which, following an assessment in accordance with Article 17, are expected to achieve the policy objectives more quickly or at lesser expense than mandatory requirements. 4. In preparing a draft implementing measure the Commission shall: (a) consider the life cycle of the EuP and all its significant environmental aspects, inter alia, energy efficiency. The depth of analysis of the environmental aspects and of the feasibility of their improvement shall be proportionate to their significance. The adoption of ecodesign requirements on the significant environmental aspects of an EuP shall not be unduly delayed by uncertainties regarding the other aspects; (b) carry out an assessment, which will consider the impact on environment, consumers and manufacturers, including SMEs, in terms of competitiveness including on markets outside the Community, innovation, market access and costs and benefits; (c) take into account existing national environmental legislation that Member States consider relevant; (d) carry out appropriate consultation with stakeholders; (e) prepare an explanatory memorandum of the draft implementing measure based on the assessment referred to in point (b); (f) set implementing date(s), any staged or transitional measure or periods, taking into account in particular possible impacts on SMEs or on specific product groups manufactured primarily by SMEs. 5. Implementing measures shall meet all the following criteria: (a) there shall be no significant negative impact on the functionality of the product, from the perspective of the user; (b) health, safety and the environment shall not be adversely affected; (c) there shall be no significant negative impact on consumers in particular as regards the affordability and the life-cycle cost of the product; (d) there shall be no significant negative impact on industry's competitiveness; (e) in principle, the setting of an ecodesign requirement shall not have the consequence of imposing proprietary technology on manufacturers; (f) no excessive administrative burden shall be imposed on manufacturers. 6. Implementing measures shall lay down ecodesign requirements in accordance with Annex I and/or Annex II. Specific ecodesign requirements shall be introduced for selected environmental aspects which have a significant environmental impact. Implementing measures may also provide that no ecodesign requirement is necessary for certain specified ecodesign parameters referred to in Annex I, Part 1. 7. The requirements shall be formulated so as to ensure that market surveillance authorities can verify the conformity of the EuP with the requirements of the implementing measure. The implementing measure shall specify whether verification can be achieved directly on the EuP or on the basis of the technical documentation. 8. Implementing measures shall include the elements listed in Annex VII. 9. Relevant studies and analyses used by the Commission in preparing implementing measures should be made publicly available, taking into account in particular easy access and use by interested SMEs. 10. Where appropriate, an implementing measure laying down ecodesign requirements shall be accompanied by guidelines, to be adopted by the Commission in accordance with Article 19(2), on the balancing of the various environmental aspects; these guidelines will cover specificities of the SMEs active in the product sector affected by the implementing measure. If necessary and in accordance with Article 13(1), further specialised material may be produced by the Commission for facilitating implementation by SMEs. Article 16 Working plan 1. In accordance with the criteria set out in Article 15 and having consulted the Consultation Forum referred to in Article 18, the Commission shall not later than 6 July 2007 establish a working plan which shall be made publicly available. The working plan shall set out for the following three years an indicative list of product groups which will be considered as priorities for the adoption of implementing measures. The working plan shall be amended periodically by the Commission after consultation with the Consultation Forum. 2. However, during the transitional period, while the first working plan referred to in paragraph 1 is being established, and, in accordance with the procedure laid down in Article 19(2) and the criteria set out in Article 15, and after consulting the Consultation Forum, the Commission shall as appropriate introduce by anticipation: — implementing measures starting with those products which have been identified by the ECCP as offering a high potential for cost-effective reduction of greenhouse gas emissions, such as heating and water heating equipment, electric motor systems, lighting in both the domestic and tertiary sectors, domestic appliances, office equipment in both the domestic and tertiary sectors, consumer electronics and HVAC (heating ventilating air conditioning) systems; — a separate implementing measure reducing stand-by losses for a group of products. Article 17 Self-regulation Voluntary agreements or other self-regulation measures presented as alternatives to implementing measures in the context of this Directive shall be assessed at least on the basis of Annex VIII. Article 18 Consultation Forum The Commission shall ensure that in the conduct of its activities it observes, in respect of each implementing measure, a balanced participation of Member States' representatives and all interested parties concerned with the product/product group in question, such as industry, including SMEs and craft industry, trade unions, traders, retailers, importers, environmental protection groups and consumer organisations. These parties shall contribute, in particular, to defining and reviewing implementing measures, to examining the effectiveness of the established market surveillance mechanisms, and to assessing voluntary agreements and other self-regulation measures. These parties shall meet in a Consultation Forum. The rules of procedure of the Forum shall be established by the Commission. Article 19 Committee procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 20 Penalties The Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties shall be effective, proportionate and dissuasive, taking into account the extent of non-compliance and the number of units of non-complying products placed on the Community market. Article 21 Amendments 1. Directive 92/42/EEC is hereby amended as follows: 1. Article 6 shall be deleted; 2. the following Article shall be inserted: ‘Article 10a This Directive constitutes an implementing measure within the meaning of Article 15 of Directive 2005/32/EC of the European Parliament and of the Council of 6 July 2005 establishing a framework for the setting of ecodesign requirements for energy-using products (26), with regard to energy efficiency during use, in accordance with that Directive, and may be amended or repealed in accordance with Article 19(2) of Directive 2005/32/EC. 3. Annex I, point 2, shall be deleted; 4. Annex II shall be deleted. 2. Directive 96/57/EC is hereby amended as follows: The following Article shall be inserted: ‘Article 9a This Directive constitutes an implementing measure within the meaning of Article 15 of Directive 2005/32/EC of the European Parliament and of the Council of 6 July 2005 establishing a framework for the setting of ecodesign requirements for energy-using products (27) , with regard to energy efficiency during use, in accordance with that Directive, and may be amended or repealed in accordance with Article 19(2) of Directive 2005/32/EC. 3. Directive 2000/55/EC is hereby amended as follows: The following Article shall be inserted: ‘Article 9a This Directive constitutes an implementing measure within the meaning of Article 15 of Directive 2005/32/EC of the European Parliament and of the Council of 6 July 2005 establishing a framework for the setting of ecodesign requirements for energy-using products (28), with regard to energy efficiency during use, in accordance with that Directive, and may be amended or repealed in accordance with Article 19(2) of Directive 2005/32/EC. Article 22 Repeals Directives 78/170/EEC and 86/594/EEC are repealed. Member States may continue to apply existing national measures adopted under Directive 86/594/EEC until such time as implementing measures for the products concerned are adopted under this Directive. Article 23 Review Not later than 6 July 2010 the Commission shall review the effectiveness of this Directive and of its implementing measures, the threshold for implementing measures, market surveillance mechanisms and any relevant self-regulation stimulated, after consultation of the Consultation Forum referred to in Article 18, and, as appropriate, present proposals to the European Parliament and the Council for amending this Directive. Article 24 Confidentiality Requirements relating to the supply of information referred to in Article 11 and Annex I, Part 2, by the manufacturer and/or its authorised representative shall be proportionate and shall take into account the legitimate confidentiality of commercially sensitive information. Article 25 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 11 August 2007. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 26 Entry into force This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 27 Addressees This Directive is addressed to the Member States.

32005L0033

2005

DIRECTIVE 2005/33/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 2005 amending Directive 1999/32/EC Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) The Community's environmental policy, as set out in the action programmes on the environment and, in particular, in the Sixth Community Environment Action Programme adopted by Decision No 1600/2002/EC of the European Parliament and of the Council (4), on the basis of Article 174 of the Treaty, aims to achieve levels of air quality that do not give rise to unacceptable impacts on, and risks to, human health and the environment. (2) Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels (5) lays down the maximum permitted sulphur content of heavy fuel oil, gas oil and marine gas oil used in the Community. (3) Directive 1999/32/EC requires the Commission to consider what measures could be taken to reduce the contribution to acidification of the combustion of marine fuels other than marine gas oils and, if appropriate, make a proposal. (4) Emissions from shipping due to the combustion of marine fuels with high sulphur content contribute to air pollution in the form of sulphur dioxide and particulate matter, harming human health, damaging the environment, public and private property and cultural heritage and contributing to acidification. (5) Human beings and the natural environment in coastal areas and in the vicinity of ports are particularly affected by pollution from ships with high sulphur fuels. Specific measures are therefore required in this regard. (6) The measures in this Directive complement Member States' national measures to comply with emission ceilings for atmospheric pollutants set out in Directive 2001/81/EC of the European Parliament and of the Council (6). (7) Reducing the sulphur content of fuels has certain advantages for ships, in terms of operating efficiency and maintenance costs, and facilitates the effective use of certain emission abatement technologies such as selective catalytic reduction. (8) The Treaty requires consideration to be given to the special characteristics of the outermost regions of the Community, namely the French overseas departments, the Azores, Madeira and the Canary Islands. (9) In 1997, a diplomatic conference adopted a Protocol to amend the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto (hereinafter MARPOL). This Protocol adds a new Annex VI to MARPOL, containing regulations for the prevention of air pollution from ships. The 1997 Protocol, and consequently Annex VI to MARPOL, entered into force on 19 May 2005. (10) Annex VI to MARPOL makes provision for certain areas to be designated as Sulphur Oxide Emission Control Areas (hereinafter SOx Emission Control Areas). It already designates the Baltic Sea as such an area. Discussions within the International Maritime Organisation (IMO) have resulted in agreement on the principle of the designation of the North Sea, including the English Channel, as a SOx Emission Control Area following the entry into force of Annex VI. (11) Given the global nature of maritime shipping, every effort should be made to find international solutions. Both the Commission and the Member States should endeavour to secure within the IMO a worldwide reduction in the maximum authorised sulphur content of marine fuels, including by examining the merits of designating new sea areas as SOx Emission Control Areas in accordance with Annex VI to MARPOL. (12) Enforcement of the obligations with regard to the sulphur content of marine fuels is necessary to achieve the aims of this Directive. Effective sampling and dissuasive penalties throughout the Community are necessary to ensure credible implementation of this Directive. Member States should take enforcement action with respect to vessels flying their flag and to vessels of all flags while in their ports. It is also appropriate for Member States to cooperate closely to take additional enforcement action with respect to other vessels in accordance with international maritime law. (13) To allow sufficient time for the maritime industry to bring about technical adaptation to a maximum limit of 0,1 % sulphur by weight for marine fuels used by inland waterway vessels and ships at berth in Community ports, the date on which this requirement is to be applied should be 1 January 2010. Since this deadline might present Greece with technical problems, a temporary derogation is appropriate for some specific vessels operating within the territory of the Hellenic Republic. (14) This Directive should be seen as the first step in an ongoing process to reduce marine emissions, offering prospects for further emission reductions through lower fuel sulphur limits and abatement technologies, and for economic instruments to be developed as an incentive to achieve significant reductions. (15) It is essential to reinforce Member States' positions in IMO negotiations, in particular to promote, in the revision phase of Annex VI to MARPOL, the consideration of more ambitious measures as regards tighter sulphur limits for heavy fuel oils used by ships and the use of equivalent alternative emission abatement measures. (16) In its resolution A.926(22), the IMO Assembly invited Governments, particularly those in regions where SOx Emission Control Areas have been designated, to ensure the availability of low sulphur bunker fuel oil in areas within their jurisdiction and to call on the oil and shipping industries to facilitate the availability and use of low sulphur bunker fuel oil. Member States should take action as appropriate to ensure that local marine fuel suppliers make compliant fuel available, in sufficient quantities to meet demand. (17) The IMO has adopted guidelines for the sampling of fuel oil for determining compliance with Annex VI to MARPOL, and is due to develop guidelines on exhaust gas cleaning systems and other technological methods to limit SOx emissions in SOx Emission Control Areas. (18) Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants (7) recasts Council Directive 88/609/EEC (8) . Directive 1999/32/EC should be revised accordingly, as provided for in Article 3(4) thereof. (19) It is appropriate for the existing Committee on Safe Seas and the Prevention of Pollution from Ships established by Regulation (EC) No 2099/2002 of the European Parliament and of the Council (9) to assist the Commission in the context of the approval of emission abatement technologies. (20) Emission abatement technologies, provided they have no adverse effect on ecosystems and are developed subject to appropriate approval and control mechanisms, can provide emission reductions at least equivalent to, or even greater than, those achievable using low sulphur fuel. It is essential that the correct conditions exist to promote the emergence of new emission abatement technologies. (21) The European Maritime Safety Agency should provide assistance to the Commission and Member States, as appropriate, in monitoring the implementation of this Directive. (22) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (10). (23) Directive 1999/32/EC should therefore be amended accordingly, Article 1 Directive 1999/32/EC is amended as follows: 1. Article 1(2) shall be replaced by the following: ‘2. Reductions in emissions of sulphur dioxide resulting from the combustion of certain petroleum-derived liquid fuels shall be achieved by imposing limits on the sulphur content of such fuels as a condition for their use within Member States' territory, territorial seas and exclusive economic zones or pollution control zones.’ The limitations on the sulphur content of certain petroleum-derived liquid fuels as laid down in this Directive shall not, however, apply to: (a) fuels intended for the purposes of research and testing; (b) fuels intended for processing prior to final combustion; (c) fuels to be processed in the refining industry; (d) fuels used and placed on the market in the outermost regions of the Community provided that the relevant Member States ensure that, in those regions: — air quality standards are respected, — heavy fuel oils are not used if their sulphur content exceeds 3 % by mass; (e) fuels used by warships and other vessels on military service. However, each Member State shall endeavour to ensure, by the adoption of appropriate measures not impairing the operations or operational capability of such ships, that these ships act in a manner consistent, so far as is reasonable and practical, with this Directive; (f) any use of fuels in a vessel necessary for the specific purpose of securing the safety of a ship or saving life at sea; (g) any use of fuels in a ship necessitated by damage sustained to it or its equipment, provided that all reasonable measures are taken after the occurrence of the damage to prevent or minimise excess emissions and that measures are taken as soon as possible to repair the damage. This shall not apply if the owner or master acted either with intent to cause damage, or recklessly; (h) fuels used on board vessels employing approved emission abatement technologies in accordance with Article 4c.'; 2. Article 2 shall be amended as follows: (a) the first indent in point 1 shall be replaced by the following: ‘- any petroleum-derived liquid fuel, excluding marine fuel, falling within CN code 2710 19 51 to 2710 19 69, or’; (b) the first subparagraph of point 2 shall be replaced by the following: ‘gas oil means: — any petroleum-derived liquid fuel, excluding marine fuel, falling within CN code 2710 19 25, 2710 19 29, 2710 19 45 or 2710 19 49, or — any petroleum-derived liquid fuel, excluding marine fuel, of which less than 65 % by volume (including losses) distils at 250 oC and of which at least 85 % by volume (including losses) distils at 350 oC by the ASTM D86 method.’; (c) point 3 shall be replaced by the following: ‘3. marine fuel means any petroleum-derived liquid fuel intended for use or in use on board a vessel, including those fuels defined in ISO 8217;’ (d) the following points shall be inserted: ‘3a. marine diesel oil means any marine fuel which has a viscosity or density falling within the ranges of viscosity or density defined for DMB and DMC grades in Table I of ISO 8217; 3b. marine gas oil means any marine fuel which has a viscosity or density falling within the ranges of viscosity or density defined for DMX and DMA grades in Table I of ISO 8217; 3c. MARPOL means the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto; 3d. Annex VI to MARPOL means the annex, entitled “Regulations for the Prevention of Air Pollution from Ships”, that the Protocol of 1997 adds to MARPOL; 3e. Ox Emission Control Areas means sea areas defined as such by the IMO under Annex VI to MARPOL; 3f. passenger ships means ships that carry more than 12 passengers, where a passenger is every person other than: (i) the master and the members of the crew or other person employed or engaged in any capacity on board a ship on the business of that ship, and (ii) a child under one year of age; 3g. regular services means a series of passenger ship crossings operated so as to serve traffic between the same two or more ports, or a series of voyages from and to the same port without intermediate calls, either: (i) according to a published timetable, or (ii) with crossings so regular or frequent that they constitute a recognisable schedule; 3h. warship means a ship belonging to the armed forces of a State bearing the external marks distinguishing such ships of its nationality, under the command of an officer duly commissioned by the government of the State and whose name appears in the appropriate service list or its equivalent, and manned by a crew which is under regular armed forces discipline; 3i. ships at berth means ships which are securely moored or anchored in a Community port while they are loading, unloading or hotelling, including the time spent when not engaged in cargo operations; 3j. inland waterway vessel means a vessel particularly intended for use on an inland waterway as defined in Council Directive 82/714/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels (11) , including all vessels which carry: (i) a Community inland navigation certificate, as defined in Directive 82/714/EEC, (ii) a certificate issued pursuant to Article 22 of the Revised Convention for the Navigation of the Rhine; 3k. placing on the market means supplying or making available to third persons, against payment or free of charge, anywhere within Member States' jurisdictions, marine fuels for on-board combustion. It excludes supplying or making available marine fuels for export in ships' cargo tanks; 3l. outermost regions means the French overseas departments, the Azores, Madeira and the Canary Islands, as set out in Article 299 of the Treaty; 3m. emission abatement technology means an exhaust gas cleaning system, or any other technological method that is verifiable and enforceable;’ (e) point 6 shall be deleted; 3. Article 3 shall be replaced by the following: ‘Article 3 Maximum sulphur content of heavy fuel oil 1. Member States shall take all necessary steps to ensure that, as from 1 January 2003, heavy fuel oils are not used within their territory if their sulphur content exceeds 1 % by mass. 2. (i) Subject to appropriate monitoring of emissions by competent authorities this requirement shall not apply to heavy fuel oils used: (a) in combustion plants which fall within the scope of Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants (12), which are considered new in accordance with the definition given in Article 2(9) thereof and which comply with the sulphur dioxide emission limits for such plants set out in Annex IV to that Directive and applied in accordance with Article 4 thereof; (b) in combustion plants which fall within the scope of Directive 2001/80/EC, which are considered existing in accordance with the definition given in Article 2(10) thereof, where the sulphur dioxide emissions from these combustion plants are equal to or less than 1 700 mg/Nm3 at an oxygen content in the flue gas of 3 % by volume on a dry basis, and where, from 1 January 2008, the emissions of sulphur dioxide from combustion plants subject to Article 4(3)(a) of Directive 2001/80/EC are equal to or less than those resulting from compliance with the emission limit values for new plants contained in Part A of Annex IV to that Directive and where appropriate applying Articles 5, 7 and 8 thereof; (c) in other combustion plants which do not fall under (a) or (b), where the sulphur dioxide emissions from those combustion plants do not exceed 1 700 mg/Nm3 at an oxygen content in the flue gas of 3 % by volume on a dry basis; (d) for combustion in refineries, where the monthly average of emissions of sulphur dioxide averaged over all plants in the refinery, irrespective of the type of fuel or fuel combination used, is within a limit to be set by each Member State, which shall not exceed 1 700 mg/Nm3. This shall not apply to combustion plants which fall under (a) or, from 1 January 2008, to those which fall under (b). (ii) Member States shall take the necessary measures to ensure that any combustion plant using heavy fuel oil with a sulphur concentration greater than that referred to in paragraph 1 is not operated without a permit issued by a competent authority, which specifies the emission limits. 3. The provisions of paragraph 2 shall be reviewed and, if appropriate, amended in the light of any future amendment of Directive 2001/80/EC.’ 4. Article 4 shall be amended as follows: (a) with effect from 1 January 2010: (i) in paragraph 1, the words ‘including marine gas oils’ shall be deleted; (ii) paragraph 2 shall be deleted; (b) with effect from 11 August 2005, paragraphs 3 and 4 shall be deleted; 5. The following Articles shall be inserted: ‘Article 4a Maximum sulphur content of marine fuels used in SOx Emission Control Areas and by passenger ships operating on regular services to or from Community ports 1. Member States shall take all necessary measures to ensure that marine fuels are not used in the areas of their territorial seas, exclusive economic zones and pollution control zones falling within SOx Emission Control Areas if the sulphur content of those fuels exceeds 1,5 % by mass. This shall apply to all vessels of all flags, including vessels whose journey began outside the Community. 2. The application dates for paragraph 1 shall be as follows: (a) for the Baltic Sea area referred to in regulation 14(3)(a) of Annex VI to MARPOL, 11 August 2006; (b) for the North Sea: — 12 months after entry into force of the IMO designation, according to established procedures, or — 11 August 2007, whichever is the earlier; (c) for any other sea areas, including ports, that the IMO subsequently designates as SOx Emission Control Areas in accordance with regulation 14(3)(b) of Annex VI to MARPOL: 12 months after the date of entry into force of the designation. 3. Member States shall be responsible for the enforcement of paragraph 1 at least in respect of: — vessels flying their flag, and — in the case of Member States bordering SOx Emission Control Areas, vessels of all flags while in their ports. Member States may also take additional enforcement action in respect of other vessels in accordance with international maritime law. 4. From the date referred to in paragraph 2(a), Member States shall take all necessary measures to ensure that marine fuels are not used in their territorial seas, exclusive economic zones and pollution control zones by passenger ships operating on regular services to or from any Community port if the sulphur content of those fuels exceeds 1,5 % by mass. Member States shall be responsible for the enforcement of this requirement at least in respect of vessels flying their flag and vessels of all flags while in their ports. 5. From the date referred to in paragraph 2(a), Member States shall require the correct completion of ships' logbooks, including fuel-changeover operations, as a condition of ships' entry into Community ports. 6. From the date referred to in paragraph 2(a), and in accordance with Regulation 18 of Annex VI to MARPOL, Member States shall: — maintain a register of local suppliers of marine fuel, — ensure that the sulphur content of all marine fuels sold in their territory is documented by the supplier on a bunker delivery note, accompanied by a sealed sample signed by the representative of the receiving ship, — take action as appropriate against marine fuel suppliers that have been found to deliver fuel that does not comply with the specification stated on the bunker delivery note, — ensure that remedial action as appropriate is taken to bring any non-compliant marine fuel discovered into compliance. 7. From the date referred to in paragraph 2(a), Member States shall ensure that marine diesel oils are not placed on the market in their territory if the sulphur content of those marine diesel oils exceeds 1,5 % by mass. 8 The Commission shall notify Member States of the application dates mentioned in paragraph 2(b) and publish them in the Official Journal of the European Union. Article 4b Maximum sulphur content of marine fuels used by inland waterway vessels and ships at berth in Community ports 1. With effect from 1 January 2010, Member States shall take all necessary measures to ensure that the following vessels do not use marine fuels with a sulphur content exceeding 0,1 % by mass: (a) inland waterway vessels; and (b) ships at berth in Community ports, allowing sufficient time for the crew to complete any necessary fuel-changeover operation as soon as possible after arrival at berth and as late as possible before departure. Member States shall require the time of any fuel-changeover operation to be recorded in ships' logbooks. 2. Paragraph 1 shall not apply: (a) whenever, according to published timetables, ships are due to be at berth for less than two hours; (b) to inland waterway vessels that carry a certificate proving conformity with the International Convention for the Safety of Life at Sea, 1974, as amended, while those vessels are at sea; (c) until 1 January 2012 for the vessels listed in the Annex and operating exclusively within the territory of the Hellenic Republic; (d) to ships which switch off all engines and use shore-side electricity while at berth in ports. 3. With effect from 1 January 2010, Member States shall ensure that marine gas oils are not placed on the market in their territory if the sulphur content of those marine gas oils exceeds 0,1 % by mass. Article 4c Trials and use of new emission abatement technologies 1. Member States may, in cooperation with other Member States, as appropriate, approve trials of ship emission abatement technologies on vessels flying their flag, or in sea areas within their jurisdiction. During these trials the use of marine fuels meeting the requirements of Articles 4a and 4b shall not be mandatory, provided that: — the Commission and any port State concerned are notified in writing at least six months before trials begin, — permits for trials do not exceed 18 months in duration, — all ships involved install tamper-proof equipment for the continuous monitoring of funnel gas emissions and use it throughout the trial period, — all ships involved achieve emission reductions which are at least equivalent to those which would be achieved through the limits on sulphur in fuel specified in this Directive, — there are proper waste management systems in place for any waste generated by the emission abatement technologies throughout the trial period, — there is an assessment of impacts on the marine environment, particularly ecosystems in enclosed ports, harbours and estuaries throughout the trial period, and — full results are provided to the Commission, and made publicly available, within six months of the end of the trials. 2. Emission abatement technologies for ships flying the flag of a Member State shall be approved in accordance with the procedure referred to in Article 3(2) of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) (13), taking into account: — guidelines to be developed by the IMO, — results of any trials conducted under paragraph 1, — effects on the environment, including achievable emission reductions, and impacts on ecosystems in enclosed ports, harbours and estuaries, — feasibility of monitoring and verification. 3. Criteria shall be established for the use of emission abatement technologies by ships of all flags in enclosed ports, harbours and estuaries in the Community in accordance with the procedure referred to in Article 9(2). The Commission shall communicate these criteria to the IMO. 4. As an alternative to using low sulphur marine fuels meeting the requirements of Articles 4a and 4b, Member States may allow ships to use an approved emission abatement technology, provided that these ships: — continuously achieve emission reductions which are at least equivalent to those which would be achieved through the limits on sulphur in fuel specified in this Directive, — are fitted with continuous emission monitoring equipment, and — document thoroughly that any waste streams discharged into enclosed ports, harbours and estuaries have no impact on ecosystems, based on criteria communicated by the authorities of port States to the IMO.’ 6. Article 6 shall be amended as follows: (a) the following paragraph shall be inserted: ‘1a. Member States shall take the necessary measures to ensure that the sulphur content of marine fuels complies with the relevant provisions of Articles 4a and 4b. Each of the following means of sampling, analysis and inspection shall be used as appropriate: — sampling of the marine fuel for on-board combustion while being delivered to ships, following IMO guidelines, and analysis of its sulphur content; — sampling and analysis of the sulphur content of marine fuel for on-board combustion contained in tanks, where feasible, and in sealed bunker samples on board ships; — inspection of ships' log books and bunker delivery notes. Sampling shall commence on the date on which the relevant limit for maximum sulphur content in the fuel comes into force. It shall be carried out with sufficient frequency, in sufficient quantities, and in such a way that the samples are representative of the fuel examined, and of the fuel being used by ships while in relevant sea areas, ports and inland waterways. Member States shall also take reasonable measures, as appropriate, to monitor the sulphur content of marine fuels other than those to which Articles 4a and 4b apply.’; (b) in paragraph 2, point (a) shall be replaced by the following: ‘(a) ISO method 8754 (1992) and PrEN ISO 14596 for heavy fuel oil and marine fuels;’ 7. Article 7 shall be replaced by the following: ‘Article 7 Reporting and review 1. On the basis of the results of the sampling, analysis and inspections carried out in accordance with Article 6, Member States shall by 30 June of each year provide the Commission with a short report on the sulphur content of the liquid fuels falling within the scope of this Directive and used within their territory during the preceding calendar year. That report shall include a record of the total number of samples tested by fuel type and shall indicate the corresponding quantity of fuel used, and the calculated average sulphur content. Member States shall also report the number of inspections made on board ships, and record the average sulphur content of marine fuels used in their territory which do not fall within the scope of this Directive on 11 August 2005. 2. On the basis, inter alia, of: (a) annual reports submitted in accordance with paragraph 1; (b) observed trends in air quality, acidification, fuel costs and modal shift; (c) progress in reducing emissions of sulphur oxides from ships through IMO mechanisms following Community initiatives in this regard; (d) a new cost-effectiveness analysis, including direct and indirect environmental benefits, of measures contained in Article 4a(4) and of possible further emission reduction measures; and (e) the implementation of Article 4c, the Commission shall, by 2008, submit a report to the European Parliament and to the Council. The Commission may submit with its report proposals for amending this Directive, in particular as regards: — a second stage of sulphur limit values laid down for each fuel category, and — taking account of work within the IMO, the sea areas where low sulphur marine fuels are to be used. The Commission shall give particular consideration to proposals for: (a) the designation of additional SOx Emission Control Areas; (b) the reduction of sulphur limits for marine fuel used in SOx Emission Control Areas possibly down to 0,5 %; (c) alternative or complementary measures. 3. By 31 December 2005, the Commission shall report to the European Parliament and to the Council on the possible use of economic instruments, including mechanisms such as differentiated dues and kilometre charges, tradable emission permits and offsetting. The Commission may consider submitting proposals on economic instruments as alternative or complementary measures in the context of the 2008 review, provided that environmental and health benefits can be clearly demonstrated. 4. Any amendments necessary to make technical adaptations to Article 2, points 1, 2, 3, 3a, 3b and 4 or Article 6(2) in the light of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 9(2). Such adaptations shall not result in any direct changes to the scope of this Directive or to limits on sulphur in fuel specified in this Directive.’; 8. Article 9 shall be replaced by the following: ‘Article 9 Committee procedure 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC (14) shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure.’ 9. The text set out in the Annex to this Directive shall be added. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 11 August 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0046

2005

COMMISSION DIRECTIVE 2005/46/EC of 8 July 2005 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for amitraz (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1) and in particular Article 10 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2) and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables (3) and in particular Article 7 thereof, Whereas: (1) For the existing active substance amitraz a decision was taken not to include it in Annex I to Council Directive 91/414/EEC (4) by Commission Decision 2004/141/EC (5). This Decision provides that plant protection products containing this active substance shall no longer be authorised for use in the Community except for a limited number of uses, where at the moment no alternatives are available (essential uses). (2) Decision 2004/141/EC allowed a phasing out period, and it is appropriate that maximum residue levels (MRLs) premised on the notion that use of the substance concerned is not authorised in the Community, should not apply until the end of the phasing out period applying to that substance. (3) For amitraz MRLs for residues resulting from veterinary medicinal uses have been set on animal products in the framework of Council Regulation (EC) No 2377/90 (6). It is appropriate to take these into account in this Directive. (4) Community MRLs and the levels recommended by the Codex Alimentarius (7) are fixed and evaluated following similar procedures. There are a limited number of Codex MRLs for amitraz. These have been considered in the setting of the MRLs fixed in this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. The MRLs based on Codex MRLs having been evaluated in the light of the risks for the consumers, no risk was established. (5) In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination. (6) It is therefore necessary to amend several of the pesticide residues arising from use of amitraz in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. (7) The relevant annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 In part A of Annex II to Directive 86/362/EEC the following row is replaced: Pesticide residue Maximum level in mg/kg ‘Amitraz including the metabolites containing the 2,4-dimethylaniline moiety expressed as amitraz 0,05 (8) cereals Article 2 In part B of Annex II to Directive 86/363/EEC the following rows are replaced: Pesticide residue Maximum level (mg/kg) Of meat, including fat, preparations of meat, offals and animal fats as listed in Annex I within CN code Nos 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex02 08, 0209 00, 0210, 1601 00 and 1602 For milk and milk products listed in Annex 1 within CN code Nos 0401, 0402, 0405 00 and 0406 Of shelled fresh eggs, for bird’s eggs and egg yolks listed in Annex 1 within CN code Nos 0407 00 and 0408 ‘Amitraz including the metabolites containing the 2,4-dimethylaniline moiety expressed as amitraz 0,05 (9), Poultry 0,01 (9) Article 3 The maximum pesticide residue levels for amitraz in Annex II to Directive 90/642/EEC are replaced by those in the Annex to this Directive. Article 4 1. Member States shall adopt and publish, by 9 January 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply these provisions from 10 January 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32005L0047

2005

COUNCIL DIRECTIVE 2005/47/EC of 18 July 2005 on the Agreement between the Community of European Railways (CER) and the European Transport Workers’ Federation (ETF) on certain aspects of the working conditions of mobile workers engaged in interoperable cross-border services in the railway sector Having regard to the Treaty establishing the European Community, and in particular Article 139(2) thereof, Having regard to the proposal from the Commission, Whereas: (1) This Directive complies with the fundamental rights and principles set out in the Charter of Fundamental Rights of the European Union and is designed to ensure full compliance with Article 31 thereof, which provides that all workers have the right to healthy, safe and dignified working conditions, to a limit on their maximum working time and to weekly and daily rest periods and an annual period of paid holidays. (2) The social partners may, in accordance with Article 139(2) of the Treaty, jointly request that Agreements concluded at Community level be implemented by a Council Decision on a proposal from the Commission. (3) The Council adopted Directive 93/104/EC of 23 November 1993 concerning certain aspects of the organisation of working time (1). Rail transport was one of the sectors of activity excluded from the scope of that Directive. The European Parliament and the Council adopted Directive 2000/34/EC (2) amending Directive 93/104/EC in order to cover the sectors and activities which had previously been excluded. (4) The European Parliament and the Council adopted Directive 2003/88/EC of 4 November 2003 concerning certain aspects of the organisation of working time (3), which codified and repealed Directive 93/104/EC. (5) Directive 2003/88/EC provides for derogations from Articles 3, 4, 5, 8 and 16 thereof in the case of persons working in the rail transport sector on board trains. (6) The Community of European Railways (CER) and the European Transport Workers’ Federation (ETF) have informed the Commission of their desire to enter into negotiations in accordance with Article 139(1) of the Treaty. (7) On 27 January 2004 those organisations concluded an Agreement on certain aspects of the working conditions of mobile workers engaged in interoperable cross-border services, hereinafter referred to as ‘the Agreement’. (8) The Agreement included a joint request for the Commission to implement the Agreement by a Council Decision on a proposal from the Commission in accordance with Article 139(2) of the Treaty. (9) Directive 2003/88/EC applies to mobile workers engaged in interoperable cross-border services, except where more specific provisions are contained in this Directive and in the Agreement annexed thereto. (10) For the purposes of Article 249 of the Treaty, the appropriate instrument for implementing the Agreement is a Directive. (11) Since, in the light of completion of the internal market in the rail transport sector and the competition in the sector, the objectives of this Directive, which is intended to protect health and safety, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary to achieve those objectives. (12) The development of the European railways sector requires close monitoring of the role of current and new actors, in order to ensure harmonious development throughout the Community. The European social dialogue in this field should be able to reflect this development and to take it into account as far as possible. (13) This Directive leaves the Member States free to define those terms of the Agreement that it does not specify in accordance with national legislation and practice, as is the case for other Directives on social policy matters using similar terms, as long as the definitions used are compatible with the Agreement. (14) The Commission has prepared its proposal for a Directive in accordance with its Communication of 20 May 1998 entitled ‘Adapting and promoting social dialogue at Community level’, taking into account the representative status of the contracting parties and the legality of each clause of the Agreement; the signatories are sufficiently representative of the mobile railway workers assigned to interoperable cross-border services run by the railway companies. (15) The Commission has drawn up its proposal for a Directive in accordance with Article 137(2) of the Treaty, which provides that Directives in the social domain shall avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings. (16) This Directive and the Agreement lay down minimum standards; the Member States and/or the social partners should be able to maintain or introduce more favourable provisions. (17) The Commission has informed the European Parliament, the European Economic and Social Committee and the Committee of the Regions by sending them the proposal for a Directive for implementing the Agreement. (18) The European Parliament adopted a resolution on the Agreement of the social partners on 26 May 2005. (19) Implementing the Agreement will contribute to achieving the aims set out in Article 136 of the Treaty. (20) In accordance with paragraph 34 of the Interinstitutional agreement on better law-making (4), Member States will be encouraged to draw up, for themselves and in the interest of the Community, their own tables, which will, as far as possible, illustrate the correlation between this Directive and the transposition measures and to make them public, Article 1 The purpose of this Directive is to implement the Agreement concluded on 27 January 2004 between the Community of European Railways (CER) and the European Transport Workers’ Federation (ETF) on certain aspects of the working conditions of mobile workers engaged in interoperable cross-border services. The text of the Agreement is annexed to this Directive. Article 2 1. Member States may maintain or introduce more favourable provisions than those laid down by this Directive. 2. The implementation of this Directive shall under no circumstances constitute sufficient grounds for justifying a reduction in the general level of protection of workers in the fields covered by this Directive. This shall be without prejudice to the rights of Member States and/or management and labour to lay down, in the light of changing circumstances, different legislative, regulatory or contractual arrangements to those prevailing at the time of the adoption of this Directive, provided always that the minimum requirements laid down in this Directive are complied with. Article 3 Without prejudice to the provisions of the Agreement on the follow-up and evaluation by the signatories, the Commission shall, after consulting management and labour at European level, report to the European Parliament and the Council on the implementation of this Directive in the context of the development of the railways sector, before 27 July 2011. Article 4 Member States shall determine what penalties are applicable when national provisions enacted pursuant to this Directive are infringed and shall take all necessary measures to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall notify these provisions to the Commission by 27 July 2008 and any subsequent amendments thereto in good time. Article 5 Member States shall, after consultation with the social partners, bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 27 July 2008 or shall ensure that the social partners have adopted the necessary provisions by means of an Agreement by that date. They shall immediately forward the text of the provisions to the Commission. Member States shall take all necessary measures to enable them to guarantee at any time the outcome required by this Directive and shall inform the Commission thereof immediately. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 6 This Directive shall enter into force on the date of its publication in the Official Journal of the European Union. Article 7 This Directive is addressed to the Member States.

32005L0050

2005

COMMISSION DIRECTIVE 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (1), and in particular Article 13(1)(b) thereof, Having regard to the request submitted by France and the United Kingdom, Whereas: (1) On the basis of the classification rules set out in Annex IX to Directive 93/42/EEC, total joint replacements are class IIb medical devices. (2) France and the United Kingdom requested the classification of total joint replacements as class III medical devices by way of derogation from the provisions of Annex IX to Directive 93/42/EEC, in order to ensure an appropriate conformity assessment of total joint replacements before their placing on the market. (3) Conformity assessment is based on a number of elements such as a proper classification, the designation and monitoring of the notified bodies and the proper implementation of the conformity assessment modules as described in Directive 93/42/EEC. (4) Reclassification by derogation to the classification rules set out in Annex IX to Directive 93/42/EEC is indicated where the shortcomings identified due to the specific characteristics of a product will be more properly addressed under the conformity assessment procedures corresponding to the new category. (5) Hip, knee and shoulder replacements should be distinguished from other total joint replacements, due to the particular complexity of the joint function to be restored and the consequent increased risk of failure due to the device itself. (6) In particular, hip and knee replacements are weight-bearing and extremely sophisticated implants, for which the risk of revision surgery is significantly greater than for other joints. (7) Shoulder implants are a more recent technique, which are subject to similar dynamic forces; their possible replacement is in principle connected with serious medical problems. (8) Furthermore, hip, knee and shoulder replacement surgery is increasingly taking place on young people with a high life expectancy; consequently, the need for such implants to function properly over the life expectancy of the patients and to reduce revision surgery and its risks has been increased. (9) Specific clinical data, including long term performance data are not always available for hip, knee and shoulder replacements before they are placed on the market and put into service; consequently, conclusions on clinical data collected by the manufacturer in the framework of the evaluation of the conformity of these products with the requirements concerning their characteristics and performance referred to in Sections 1 and 3 of Annex I to Directive 93/42/EEC should be subject to particular attention and examination in order to verify the appropriateness of the clinical data available. (10) Total joint replacements can be subject to multiple modifications following their introduction into clinical use and placing on the market, as shown by hip and knee replacements on the market. However, experience has shown that what appear at first sight to be minor post-marketing changes to the design of previously trouble-free replacements can lead to serious problems due to unintended consequences, which may lead to early failure and major safety concerns. (11) In order to achieve the optimal level of safety and health protection and to reduce the design related problems to the lowest level, the design dossier of hip, knee and shoulder replacements, including the clinical data used by the manufacturer to support the claimed performance and the subsequent post-marketing design and manufacturing changes should be examined in detail by the notified body before these devices are introduced in general clinical use. (12) Consequently, the notified body should, under the full quality assurance system, effectively carry out an examination of the design dossier and of the changes to the approved design in accordance with point 4 of Annex II to Directive 93/42/EEC. (13) For these reasons, it is necessary to proceed to the reclassification of hip, knee and shoulder total joint replacements as class III medical devices. (14) It is necessary to provide for an adequate transitional period for hip, knee and shoulder total joint replacements already assessed as class IIb medical devices under the full quality assurance system of Annex II to Directive 93/42/EEC, allowing for their complementary assessment under point 4 of Annex II to the Directive. (15) Hip, knee and shoulder total joint replacements already certified following the procedure relating to the EC type examination set out in Annex III to Directive 93/42/EEC, coupled with the procedure relating to the EC verification set out in Annex IV or the procedure relating to the EC declaration of conformity set out in Annex V to that Directive, are not affected by the present Directive as these certification schemes are the same for both class IIb and class III medical devices. (16) It is necessary to provide for an adequate transitional period for hip, knee and shoulder total joint replacements that have already been subject to the procedure relating to the EC type examination under Annex III to Directive 93/42/EEC coupled with the procedure relating to the EC declaration of conformity set out in Annex VI to that Directive, allowing for their assessment under Annex IV or Annex V to Directive 93/42/EEC. (17) The measures provided for in this Directive are in accordance with the opinion of the Committee on Medical Devices set up by Article 6(2) of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (2), Article 1 By way of derogation from the rules set out in Annex IX to Directive 93/42/EEC, hip, knee and shoulder replacements shall be reclassified as medical devices falling within class III. Article 2 For the purpose of this Directive, a hip, knee or shoulder replacement means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint. Ancillary components (screws, wedges, plates and instruments) are excluded from this definition. Article 3 1. Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 11(3)(a) of Directive 93/42/EEC before 1 September 2007 shall be subject to a complementary conformity assessment under point 4 of Annex II to Directive 93/42/EEC leading to an EC design examination certificate before 1 September 2009. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on Article 11(1)(b) of Directive 93/42/EEC. 2. Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 11(3)(b)(iii) of Directive 93/42/EEC before 1 September 2007 may be subject to a conformity assessment as class III medical devices pursuant to Article 11(1)(b)(i) or (ii) before 1 September 2010. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on Article 11(1)(a) of Directive 93/42/EEC. 3. Member States shall accept until 1 September 2009 the placing on the market and the putting into service of hip, knee and shoulder replacements covered by a Decision in accordance with Article 11(3)(a) of Directive 93/42/EEC issued before 1 September 2007. 4. Member States shall accept until 1 September 2010 the placing on the market of hip, knee and shoulder replacements which are covered by a Decision in accordance with Articles 11(3)(b)(iii) of Directive 93/42/EEC issued before 1 September 2007 and permit such total joint replacements to be put into service beyond that date. Article 4 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 March 2007. They shall immediately inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. Member States shall determine how such a reference is to be made. Member States shall apply those provisions from 1 September 2007. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32005L0048

2005

COMMISSION DIRECTIVE 2005/48/EC of 23 August 2005 amending Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for certain pesticides in and on cereals and certain products of animal and plant origin (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 10 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (3), and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (4), and in particular Article 4(1)(f) thereof, Whereas: (1) The following existing active substances have been included in Annex I to Directive 91/414/EEC: iprodione by Commission Directive 2003/31/EC (5); propiconazole by Commission Directive 2003/70/EC (6) and molinate by Commission Directive 2003/81/EC (7). (2) The following new active substances have been included in Annex I to Directive 91/414/EEC: mesotrione by Commission Directive 2003/68/EC (8) and silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium and fosthiazate by Commission Directive 2003/84/EC (9). (3) The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning the proposed use. Information relating to this use has been submitted by certain Member States in accordance with Article 4(1)(f) of that Directive. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed. (4) Where no Community MRL or provisional MRL exists, Member States are to establish a national provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection products containing these active substances may be authorised. (5) Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a limited number of Codex MRLs for iprodione and propiconazole. There are already Community MRLs set out in 86/362/EEC, 86/363/EEC and 90/642/EEC for: iprodione (Council Directive 93/58/EEC) (10) and propiconazole (Council Directive 94/30/EC) (11). These have been taken into account in this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. The MRLs based on Codex MRLs having been evaluated in the light of the risks for the consumers. No risk was established when using the toxicological end points based on the studies available to the Commission. (6) With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned, the related technical and scientific evaluations were finalised in the form of Commission review reports. The assessment reports for those substances mentioned were finalised on the dates as mentioned in the Commission Directives cited in Recitals 1 and 2. These reports fixed the Acceptable Daily Intake (ADI) and if necessary, the Acute Reference Dose (ARfD) for the substances concerned. The exposure of consumers of food products treated with the active substance concerned has been assessed and evaluated in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation (12) and the opinion of the Scientific Committee for Plants (13) on the methodology employed. It has been concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded. (7) In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, provisional MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination. (8) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances concerned in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI to that Directive. It is considered that a period of four years is sufficient to permit the development of further uses of the active substance concerned. The provisional MRL should then become definitive. (9) It is therefore necessary to modify the MRLs set out in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. Where MRLs have already been defined in the Annexes to those Directives, it is appropriate to amend them. Where MRLs have not already been defined, it is appropriate to set them for the first time. (10) Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article1 Directive 86/362/EEC is amended as follows: 1. In Part A of Annex II, maximum residue levels are added for mesotrione, silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium, fosthiazate and molinate, as set out in Annex I to this Directive. 2. In Part A of Annex II, the maximum residue levels for propiconazole and iprodione are replaced by those set out in Annex II to this Directive. Article 2 Directive 86/363/EEC is amended as follows: 1. In Part A of Annex II, maximum residue levels are added for picoxystrobin, as set out in Annex III to this Directive. 2. In Part B of Annex II, the maximum residue levels for propiconazole are replaced by those set out in Annex IV to this Directive. Article 3 Directive 90/642/EEC is amended as follows: 1. In Annex II, maximum residue levels are added for mesotrione, silthiofam, picoxystrobin, flufenacet, iodosulfuron-methyl-sodium, fosthiazate and molinate, as set out in Annex V to this Directive. 2. In Annex II, the maximum residue levels for propiconazole and iprodione, are replaced by those set out in Annex VI to this Directive. Article 4 1. Member States shall adopt and publish, by 24 February 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 24 February 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32005L0036

2005

DIRECTIVE 2005/36/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 on the recognition of professional qualifications (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 40, Article 47(1), the first and third sentences of Article 47(2), and Article 55 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Pursuant to Article 3(1)(c) of the Treaty, the abolition, as between Member States, of obstacles to the free movement of persons and services is one of the objectives of the Community. For nationals of the Member States, this includes, in particular, the right to pursue a profession, in a self-employed or employed capacity, in a Member State other than the one in which they have obtained their professional qualifications. In addition, Article 47(1) of the Treaty lays down that directives shall be issued for the mutual recognition of diplomas, certificates and other evidence of formal qualifications. (2) Following the European Council of Lisbon on 23 and 24 March 2000, the Commission adopted a Communication on ‘An Internal Market Strategy for Services’, aimed in particular at making the free provision of services within the Community as simple as within an individual Member State. Further to the Communication from the Commission entitled ‘New European Labour Markets, Open to All, with Access to All’, the European Council of Stockholm on 23 and 24 March 2001 entrusted the Commission with presenting for the 2002 Spring European Council specific proposals for a more uniform, transparent and flexible regime of recognition of qualifications. (3) The guarantee conferred by this Directive on persons having acquired their professional qualifications in a Member State to have access to the same profession and pursue it in another Member State with the same rights as nationals is without prejudice to compliance by the migrant professional with any non-discriminatory conditions of pursuit which might be laid down by the latter Member State, provided that these are objectively justified and proportionate. (4) In order to facilitate the free provision of services, there should be specific rules aimed at extending the possibility of pursuing professional activities under the original professional title. In the case of information society services provided at a distance, the provisions of Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (4), should also apply. (5) In view of the different systems established for the cross-border provision of services on a temporary and occasional basis on the one hand, and for establishment on the other, the criteria for distinguishing between these two concepts in the event of the movement of the service provider to the territory of the host Member State should be clarified. (6) The facilitation of service provision has to be ensured in the context of strict respect for public health and safety and consumer protection. Therefore, specific provisions should be envisaged for regulated professions having public health or safety implications, which provide cross-frontier services on a temporary or occasional basis. (7) Host Member States may, where necessary and in accordance with Community law, provide for declaration requirements. These requirements should not lead to a disproportionate burden on service providers nor hinder or render less attractive the exercise of the freedom to provide services. The need for such requirements should be reviewed periodically in the light of the progress made in establishing a Community framework for administrative cooperation between Member States. (8) The service provider should be subject to the application of disciplinary rules of the host Member State having a direct and specific link with the professional qualifications, such as the definition of the profession, the scope of activities covered by a profession or reserved to it, the use of titles and serious professional malpractice which is directly and specifically linked to consumer protection and safety. (9) While maintaining, for the freedom of establishment, the principles and safeguards underlying the different systems for recognition in force, the rules of such systems should be improved in the light of experience. Moreover, the relevant directives have been amended on several occasions, and their provisions should be reorganised and rationalised by standardising the principles applicable. It is therefore necessary to replace Council Directives 89/48/EEC (5) and 92/51/EEC (6), as well as Directive 1999/42/EC of the European Parliament and of the Council (7) on the general system for the recognition of professional qualifications, and Council Directives 77/452/EEC (8), 77/453/EEC (9), 78/686/EEC (10), 78/687/EEC (11), 78/1026/EEC (12), 78/1027/EEC (13), 80/154/EEC (14), 80/155/EEC (15), 85/384/EEC (16), 85/432/EEC (17), 85/433/EEC (18) and 93/16/EEC (19) concerning the professions of nurse responsible for general care, dental practitioner, veterinary surgeon, midwife, architect, pharmacist and doctor, by combining them in a single text. (10) This Directive does not create an obstacle to the possibility of Member States recognising, in accordance with their rules, the professional qualifications acquired outside the territory of the European Union by third country nationals. All recognition should respect in any case minimum training conditions for certain professions. (11) In the case of the professions covered by the general system for the recognition of qualifications, hereinafter referred to as ‘the general system’, Member States should retain the right to lay down the minimum level of qualification required to ensure the quality of the services provided on their territory. However, pursuant to Articles 10, 39 and 43 of the Treaty, they should not require a national of a Member State to obtain qualifications, which they generally lay down only in terms of the diplomas awarded under their national educational system, where the person concerned has already obtained all or part of those qualifications in another Member State. As a result, it should be laid down that any host Member State in which a profession is regulated must take account of the qualifications obtained in another Member State and assess whether they correspond to those which it requires. The general system for recognition, however, does not prevent a Member State from making any person pursuing a profession on its territory subject to specific requirements due to the application of professional rules justified by the general public interest. Rules of this kind relate, for example, to organisation of the profession, professional standards, including those concerning ethics, and supervision and liability. Lastly, this Directive is not intended to interfere with Member States' legitimate interest in preventing any of their citizens from evading enforcement of the national law relating to professions. (12) This Directive concerns the recognition by Member States of professional qualifications acquired in other Member States. It does not, however, concern the recognition by Member States of recognition decisions adopted by other Member States pursuant to this Directive. Consequently, individuals holding professional qualifications which have been recognised pursuant to this Directive may not use such recognition to obtain in their Member State of origin rights different from those conferred by the professional qualification obtained in that Member State, unless they provide evidence that they have obtained additional professional qualifications in the host Member State. (13) In order to define the mechanism of recognition under the general system, it is necessary to group the various national education and training schemes into different levels. These levels, which are established only for the purpose of the operation of the general system, have no effect upon the national education and training structures nor upon the competence of Member States in this field. (14) The mechanism of recognition established by Directives 89/48/EEC and 92/51/EEC remains unchanged. As a consequence, the holder of a diploma certifying successful completion of training at post-secondary level of a duration of at least one year should be permitted access to a regulated profession in a Member State where access is contingent upon possession of a diploma certifying successful completion of higher or university education of four years' duration, regardless of the level to which the diploma required in the host Member State belongs. Conversely, where access to a regulated profession is contingent upon successful completion of higher or university education of more than four years, such access should be permitted only to holders of a diploma certifying successful completion of higher or university education of at least three years' duration. (15) In the absence of harmonisation of the minimum training conditions for access to the professions governed by the general system, it should be possible for the host Member State to impose a compensation measure. This measure should be proportionate and, in particular, take account of the applicant's professional experience. Experience shows that requiring the migrant to choose between an aptitude test or an adaptation period offers adequate safeguards as regards the latter's level of qualification, so that any derogation from that choice should in each case be justified by an imperative requirement in the general interest. (16) In order to promote the free movement of professionals, while ensuring an adequate level of qualification, various professional associations and organisations or Member States should be able to propose common platforms at European level. This Directive should take account, under certain conditions, in compliance with the competence of Member States to decide the qualifications required for the pursuit of professions in their territory as well as the contents and the organisation of their systems of education and professional training and in compliance with Community law, and in particular Community law on competition, of those initiatives, while promoting, in this context, a more automatic character of recognition under the general system. Professional associations which are in a position to submit common platforms should be representative at national and European level. A common platform is a set of criteria which make it possible to compensate for the widest range of substantial differences which have been identified between the training requirements in at least two thirds of the Member States including all the Member States which regulate that profession. These criteria could, for example, include requirements such as additional training, an adaptation period under supervised practice, an aptitude test, or a prescribed minimum level of professional practice, or combinations thereof. (17) In order to take into account all situations for which there is still no provision relating to the recognition of professional qualifications, the general system should be extended to those cases which are not covered by a specific system, either where the profession is not covered by one of those systems or where, although the profession is covered by such a specific system, the applicant does not for some particular and exceptional reason meet the conditions to benefit from it. (18) There is a need to simplify the rules allowing access to a number of industrial, commercial and craft activities, in Member States where those professions are regulated, in so far as those activities have been pursued for a reasonable and sufficiently recent period of time in another Member State, while maintaining for those activities a system of automatic recognition based on professional experience. (19) Freedom of movement and the mutual recognition of the evidence of formal qualifications of doctors, nurses responsible for general care, dental practitioners, veterinary surgeons, midwives, pharmacists and architects should be based on the fundamental principle of automatic recognition of the evidence of formal qualifications on the basis of coordinated minimum conditions for training. In addition, access in the Member States to the professions of doctor, nurse responsible for general care, dental practitioner, veterinary surgeon, midwife and pharmacist should be made conditional upon the possession of a given qualification ensuring that the person concerned has undergone training which meets the minimum conditions laid down. This system should be supplemented by a number of acquired rights from which qualified professionals benefit under certain conditions. (20) To allow for the characteristics of the qualification system for doctors and dentists and the related acquis communautaire in the area of mutual recognition, the principle of automatic recognition of medical and dental specialities common to at least two Member States should continue to apply to all specialities recognised on the date of adoption of this Directive. To simplify the system, however, automatic recognition should apply after the date of entry into force of this Directive only to those new medical specialities common to at least two fifths of Member States. Moreover, this Directive does not prevent Member States from agreeing amongst themselves on automatic recognition for certain medical and dental specialities common to them but not automatically recognised within the meaning of this Directive, according to their own rules. (21) Automatic recognition of formal qualifications of doctor with basic training should be without prejudice to the competence of Member States to associate this qualification with professional activities or not. (22) All Member States should recognise the profession of dental practitioner as a specific profession distinct from that of medical practitioner, whether or not specialised in odontostomatology. Member States should ensure that the training given to dental practitioners equips them with the skills needed for prevention, diagnosis and treatment relating to anomalies and illnesses of the teeth, mouth, jaws and associated tissues. The professional activity of the dental practitioner should be carried out by holders of a qualification as dental practitioner set out in this Directive. (23) It did not appear desirable to lay down standardised training for midwives for all the Member States. Rather, the latter should have the greatest possible freedom to organise their training. (24) With a view to simplifying this Directive, reference should be made to the concept of ‘pharmacist’ in order to delimit the scope of the provisions relating to the automatic recognition of the qualifications, without prejudice to the special features of the national regulations governing those activities. (25) Holders of qualifications as a pharmacist are specialists in the field of medicines and should, in principle, have access in all Member States to a minimum range of activities in this field. In defining this minimum range, this Directive should neither have the effect of limiting the activities accessible to pharmacists in the Member States, in particular as regards medical biology analyses, nor create a monopoly for those professionals, as this remains a matter solely for the Member States. The provisions of this Directive are without prejudice to the possibility for the Member States to impose supplementary training conditions for access to activities not included in the coordinated minimum range of activities. This means that the host Member State should be able to impose these conditions on the nationals who hold qualifications which are covered by automatic recognition within the meaning of this Directive. (26) This Directive does not coordinate all the conditions for access to activities in the field of pharmacy and the pursuit of these activities. In particular, the geographical distribution of pharmacies and the monopoly for dispensing medicines should remain a matter for the Member States. This Directive leaves unchanged the legislative, regulatory and administrative provisions of the Member States forbidding companies from pursuing certain pharmacists' activities or subjecting the pursuit of such activities to certain conditions. (27) Architectural design, the quality of buildings, their harmonious incorporation into their surroundings, respect for natural and urban landscapes and for the public and private heritage are a matter of public interest. Mutual recognition of qualifications should therefore be based on qualitative and quantitative criteria which ensure that the holders of recognised qualifications are in a position to understand and translate the needs of individuals, social groups and authorities as regards spatial planning, the design, organisation and realisation of structures, conservation and the exploitation of the architectural heritage, and protection of natural balances. (28) National regulations in the field of architecture and on access to and the pursuit of the professional activities of an architect vary widely in scope. In most Member States, activities in the field of architecture are pursued, de jure or de facto, by persons bearing the title of architect alone or accompanied by another title, without those persons having a monopoly on the pursuit of such activities, unless there are legislative provisions to the contrary. These activities, or some of them, may also be pursued by other professionals, in particular by engineers who have undergone special training in the field of construction or the art of building. With a view to simplifying this Directive, reference should be made to the concept of ‘architect’ in order to delimit the scope of the provisions relating to the automatic recognition of the qualifications in the field of architecture, without prejudice to the special features of the national regulations governing those activities. (29) Where a national and European-level professional organisation or association for a regulated profession makes a reasoned request for specific provisions for the recognition of qualifications on the basis of coordination of minimum training conditions, the Commission shall assess the appropriateness of adopting a proposal for the amendment of this Directive. (30) In order to ensure the effectiveness of the system for the recognition of professional qualifications, uniform formalities and rules of procedure should be defined for its implementation, as well as certain details of the pursuit of the profession. (31) Since collaboration among the Member States and between them and the Commission is likely to facilitate the implementation of this Directive and compliance with the obligations deriving from it, the means of collaboration should be organised. (32) The introduction, at European level, of professional cards by professional associations or organisations could facilitate the mobility of professionals, in particular by speeding up the exchange of information between the host Member State and the Member State of origin. This professional card should make it possible to monitor the career of professionals who establish themselves in various Member States. Such cards could contain information, in full respect of data protection provisions, on the professional's professional qualifications (university or institution attended, qualifications obtained, professional experience), his legal establishment, penalties received relating to his profession and the details of the relevant competent authority. (33) The establishment of a network of contact points with the task of providing the citizens of the Member States with information and assistance will make it possible to ensure that the system of recognition is transparent. These contact points will provide any citizen who so requests and the Commission with all the information and addresses relevant to the recognition procedure. The designation of a single contact point by each Member State within this network does not affect the organisation of competencies at national level. In particular, it does not prevent the designation at national level of several offices, the contact point designated within the aforementioned network being in charge of coordinating with the other offices and informing the citizen, where necessary, of the details of the relevant competent office. (34) Administering the various systems of recognition set up by the sectoral directives and the general system has proved cumbersome and complex. There is therefore a need to simplify the administration and updating of this Directive to take account of scientific and technical progress, in particular where the minimum conditions of training are coordinated with a view to automatic recognition of qualifications. A single committee for the recognition of professional qualifications should be set up for this purpose, and suitable involvement of representatives of the professional organisations, also at European level, should be ensured. (35) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (20). (36) The preparation by the Member States of a periodic report on the implementation of this Directive, containing statistical data, will make it possible to determine the impact of the system for the recognition of professional qualifications. (37) There should be a suitable procedure for adopting temporary measures if the application of any provision of this Directive were to encounter major difficulties in a Member State. (38) The provisions of this Directive do not affect the powers of the Member States as regards the organisation of their national social security system and determining the activities which must be pursued under that system. (39) In view of the speed of technological change and scientific progress, life-long learning is of particular importance for a large number of professions. In this context, it is for the Member States to adopt the detailed arrangements under which, through suitable ongoing training, professionals will keep abreast of technical and scientific progress. (40) Since the objectives of this Directive, namely the rationalisation, simplification and improvement of the rules for the recognition of professional qualifications, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (41) This Directive is without prejudice to the application of Articles 39(4) and 45 of the Treaty concerning notably notaries. (42) This Directive applies, concerning the right of establishment and the provision of services, without prejudice to other specific legal provisions regarding the recognition of professional qualifications, such as those existing in the field of transport, insurance intermediaries and statutory auditors. This Directive does not affect the operation of Council Directive 77/249/EEC of 22 March 1977 to facilitate the effective exercise by lawyers of freedom to provide services (21), or of Directive 98/5/EC of the European Parliament and of the Council of 16 February 1998 to facilitate practice of the profession of lawyer on a permanent basis in a Member State other than that in which the qualification was obtained (22). The recognition of professional qualifications for lawyers for the purpose of immediate establishment under the professional title of the host Member State should be covered by this Directive. (43) To the extent that they are regulated, this Directive includes also liberal professions, which are, according to this Directive, those practised on the basis of relevant professional qualifications in a personal, responsible and professionally independent capacity by those providing intellectual and conceptual services in the interest of the client and the public. The exercise of the profession might be subject in the Member States, in conformity with the Treaty, to specific legal constraints based on national legislation and on the statutory provisions laid down autonomously, within that framework, by the respective professional representative bodies, safeguarding and developing their professionalism and quality of service and the confidentiality of relations with the client. (44) This Directive is without prejudice to measures necessary to ensure a high level of health and consumer protection, TITLE I GENERAL PROVISIONS Article 1 Purpose This Directive establishes rules according to which a Member State which makes access to or pursuit of a regulated profession in its territory contingent upon possession of specific professional qualifications (referred to hereinafter as the host Member State) shall recognise professional qualifications obtained in one or more other Member States (referred to hereinafter as the home Member State) and which allow the holder of the said qualifications to pursue the same profession there, for access to and pursuit of that profession. Article 2 Scope 1. This Directive shall apply to all nationals of a Member State wishing to pursue a regulated profession in a Member State, including those belonging to the liberal professions, other than that in which they obtained their professional qualifications, on either a self-employed or employed basis. 2. Each Member State may permit Member State nationals in possession of evidence of professional qualifications not obtained in a Member State to pursue a regulated profession within the meaning of Article 3(1)(a) on its territory in accordance with its rules. In the case of professions covered by Title III, Chapter III, this initial recognition shall respect the minimum training conditions laid down in that Chapter. 3. Where, for a given regulated profession, other specific arrangements directly related to the recognition of professional qualifications are established in a separate instrument of Community law, the corresponding provisions of this Directive shall not apply. Article 3 Definitions 1. For the purposes of this Directive, the following definitions apply: (a) ‘regulated profession’: a professional activity or group of professional activities, access to which, the pursuit of which, or one of the modes of pursuit of which is subject, directly or indirectly, by virtue of legislative, regulatory or administrative provisions to the possession of specific professional qualifications; in particular, the use of a professional title limited by legislative, regulatory or administrative provisions to holders of a given professional qualification shall constitute a mode of pursuit. Where the first sentence of this definition does not apply, a profession referred to in paragraph 2 shall be treated as a regulated profession; (b) ‘professional qualifications’: qualifications attested by evidence of formal qualifications, an attestation of competence referred to in Article 11, point (a) (i) and/or professional experience; (c) ‘evidence of formal qualifications’: diplomas, certificates and other evidence issued by an authority in a Member State designated pursuant to legislative, regulatory or administrative provisions of that Member State and certifying successful completion of professional training obtained mainly in the Community. Where the first sentence of this definition does not apply, evidence of formal qualifications referred to in paragraph 3 shall be treated as evidence of formal qualifications; (d) ‘competent authority’: any authority or body empowered by a Member State specifically to issue or receive training diplomas and other documents or information and to receive the applications, and take the decisions, referred to in this Directive; (e) ‘regulated education and training’: any training which is specifically geared to the pursuit of a given profession and which comprises a course or courses complemented, where appropriate, by professional training, or probationary or professional practice. The structure and level of the professional training, probationary or professional practice shall be determined by the laws, regulations or administrative provisions of the Member State concerned or monitored or approved by the authority designated for that purpose; (f) ‘professional experience’: the actual and lawful pursuit of the profession concerned in a Member State; (g) ‘adaptation period’: the pursuit of a regulated profession in the host Member State under the responsibility of a qualified member of that profession, such period of supervised practice possibly being accompanied by further training. This period of supervised practice shall be the subject of an assessment. The detailed rules governing the adaptation period and its assessment as well as the status of a migrant under supervision shall be laid down by the competent authority in the host Member State. The status enjoyed in the host Member State by the person undergoing the period of supervised practice, in particular in the matter of right of residence as well as obligations, social rights and benefits, allowances and remuneration, shall be established by the competent authorities in that Member State in accordance with applicable Community law; (h) ‘aptitude test’: a test limited to the professional knowledge of the applicant, made by the competent authorities of the host Member State with the aim of assessing the ability of the applicant to pursue a regulated profession in that Member State. In order to permit this test to be carried out, the competent authorities shall draw up a list of subjects which, on the basis of a comparison of the education and training required in the Member State and that received by the applicant, are not covered by the diploma or other evidence of formal qualifications possessed by the applicant. The aptitude test must take account of the fact that the applicant is a qualified professional in the home Member State or the Member State from which he comes. It shall cover subjects to be selected from those on the list, knowledge of which is essential in order to be able to pursue the profession in the host Member State. The test may also include knowledge of the professional rules applicable to the activities in question in the host Member State. The detailed application of the aptitude test and the status, in the host Member State, of the applicant who wishes to prepare himself for the aptitude test in that State shall be determined by the competent authorities in that Member State; (i) ‘manager of an undertaking’: any person who in an undertaking in the occupational field in question has pursued an activity: (i) as a manager of an undertaking or a manager of a branch of an undertaking; or (ii) as a deputy to the proprietor or the manager of an undertaking where that post involves responsibility equivalent to that of the proprietor or manager represented; or (iii) in a managerial post with duties of a commercial and/or technical nature and with responsibility for one or more departments of the undertaking. 2. A profession practised by the members of an association or organisation listed in Annex I shall be treated as a regulated profession. The purpose of the associations or organisations referred to in the first subparagraph is, in particular, to promote and maintain a high standard in the professional field concerned. To that end they are recognised in a special form by a Member State and award evidence of formal qualifications to their members, ensure that their members respect the rules of professional conduct which they prescribe, and confer on them the right to use a title or designatory letters or to benefit from a status corresponding to those formal qualifications. On each occasion that a Member State grants recognition to an association or organisation referred to in the first subparagraph, it shall inform the Commission, which shall publish an appropriate notification in the Official Journal of the European Union. 3. Evidence of formal qualifications issued by a third country shall be regarded as evidence of formal qualifications if the holder has three years' professional experience in the profession concerned on the territory of the Member State which recognised that evidence of formal qualifications in accordance with Article 2(2), certified by that Member State. Article 4 Effects of recognition 1. The recognition of professional qualifications by the host Member State allows the beneficiary to gain access in that Member State to the same profession as that for which he is qualified in the home Member State and to pursue it in the host Member State under the same conditions as its nationals. 2. For the purposes of this Directive, the profession which the applicant wishes to pursue in the host Member State is the same as that for which he is qualified in his home Member State if the activities covered are comparable. TITLE II FREE PROVISION OF SERVICES Article 5 Principle of the free provision of services 1. Without prejudice to specific provisions of Community law, as well as to Articles 6 and 7 of this Directive, Member States shall not restrict, for any reason relating to professional qualifications, the free provision of services in another Member State: (a) if the service provider is legally established in a Member State for the purpose of pursuing the same profession there (hereinafter referred to as the Member State of establishment), and (b) where the service provider moves, if he has pursued that profession in the Member State of establishment for at least two years during the 10 years preceding the provision of services when the profession is not regulated in that Member State. The condition requiring two years' pursuit shall not apply when either the profession or the education and training leading to the profession is regulated. 2. The provisions of this title shall only apply where the service provider moves to the territory of the host Member State to pursue, on a temporary and occasional basis, the profession referred to in paragraph 1. The temporary and occasional nature of the provision of services shall be assessed case by case, in particular in relation to its duration, its frequency, its regularity and its continuity. 3. Where a service provider moves, he shall be subject to professional rules of a professional, statutory or administrative nature which are directly linked to professional qualifications, such as the definition of the profession, the use of titles and serious professional malpractice which is directly and specifically linked to consumer protection and safety, as well as disciplinary provisions which are applicable in the host Member State to professionals who pursue the same profession in that Member State. Article 6 Exemptions Pursuant to Article 5(1), the host Member State shall exempt service providers established in another Member State from the requirements which it places on professionals established in its territory relating to: (a) authorisation by, registration with or membership of a professional organisation or body. In order to facilitate the application of disciplinary provisions in force on their territory according to Article 5(3), Member States may provide either for automatic temporary registration with or for pro forma membership of such a professional organisation or body, provided that such registration or membership does not delay or complicate in any way the provision of services and does not entail any additional costs for the service provider. A copy of the declaration and, where applicable, of the renewal referred to in Article 7(1), accompanied, for professions which have implications for public health and safety referred to in Article 7(4) or which benefit from automatic recognition under Title III Chapter III, by a copy of the documents referred to in Article 7(2) shall be sent by the competent authority to the relevant professional organisation or body, and this shall constitute automatic temporary registration or pro forma membership for this purpose; (b) registration with a public social security body for the purpose of settling accounts with an insurer relating to activities pursued for the benefit of insured persons. The service provider shall, however, inform in advance or, in an urgent case, afterwards, the body referred to in point (b) of the services which he has provided. Article 7 Declaration to be made in advance, if the service provider moves 1. Member States may require that, where the service provider first moves from one Member State to another in order to provide services, he shall inform the competent authority in the host Member State in a written declaration to be made in advance including the details of any insurance cover or other means of personal or collective protection with regard to professional liability. Such declaration shall be renewed once a year if the service provider intends to provide temporary or occasional services in that Member State during that year. The service provider may supply the declaration by any means. 2. Moreover, for the first provision of services or if there is a material change in the situation substantiated by the documents, Member States may require that the declaration be accompanied by the following documents: (a) proof of the nationality of the service provider; (b) an attestation certifying that the holder is legally established in a Member State for the purpose of pursuing the activities concerned and that he is not prohibited from practising, even temporarily, at the moment of delivering the attestation; (c) evidence of professional qualifications; (d) for cases referred to in Article 5(1)(b), any means of proof that the service provider has pursued the activity concerned for at least two years during the previous ten years; (e) for professions in the security sector, where the Member State so requires for its own nationals, evidence of no criminal convictions. 3. The service shall be provided under the professional title of the Member State of establishment, in so far as such a title exists in that Member State for the professional activity in question. That title shall be indicated in the official language or one of the official languages of the Member State of establishment in such a way as to avoid any confusion with the professional title of the host Member State. Where no such professional title exists in the Member State of establishment, the service provider shall indicate his formal qualification in the official language or one of the official languages of that Member State. By way of exception, the service shall be provided under the professional title of the host Member State for cases referred to in Title III Chapter III. 4. For the first provision of services, in the case of regulated professions having public health or safety implications, which do not benefit from automatic recognition under Title III Chapter III, the competent authority of the host Member State may check the professional qualifications of the service provider prior to the first provision of services. Such a prior check shall be possible only where the purpose of the check is to avoid serious damage to the health or safety of the service recipient due to a lack of professional qualification of the service provider and where this does not go beyond what is necessary for that purpose. Within a maximum of one month of receipt of the declaration and accompanying documents, the competent authority shall endeavour to inform the service provider either of its decision not to check his qualifications or of the outcome of such check. Where there is a difficulty which would result in delay, the competent authority shall notify the service provider within the first month of the reason for the delay and the timescale for a decision, which must be finalised within the second month of receipt of completed documentation. Where there is a substantial difference between the professional qualifications of the service provider and the training required in the host Member State, to the extent that that difference is such as to be harmful to public health or safety, the host Member State shall give the service provider the opportunity to show, in particular by means of an aptitude test, that he has acquired the knowledge or competence lacking. In any case, it must be possible to provide the service within one month of a decision being taken in accordance with the previous subparagraph. In the absence of a reaction of the competent authority within the deadlines set in the previous subparagraphs, the service may be provided. In cases where qualifications have been verified under this paragraph, the service shall be provided under the professional title of the host Member State. Article 8 Administrative cooperation 1. The competent authorities of the host Member State may ask the competent authorities of the Member State of establishment, for each provision of services, to provide any information relevant to the legality of the service provider's establishment and his good conduct, as well as the absence of any disciplinary or criminal sanctions of a professional nature. The competent authorities of the Member State of establishment shall provide this information in accordance with the provisions of Article 56. 2. The competent authorities shall ensure the exchange of all information necessary for complaints by a recipient of a service against a service provider to be correctly pursued. Recipients shall be informed of the outcome of the complaint. Article 9 Information to be given to the recipients of the service In cases where the service is provided under the professional title of the Member State of establishment or under the formal qualification of the service provider, in addition to the other requirements relating to information contained in Community law, the competent authorities of the host Member State may require the service provider to furnish the recipient of the service with any or all of the following information: (a) if the service provider is registered in a commercial register or similar public register, the register in which he is registered, his registration number, or equivalent means of identification contained in that register; (b) if the activity is subject to authorisation in the Member State of establishment, the name and address of the competent supervisory authority; (c) any professional association or similar body with which the service provider is registered; (d) the professional title or, where no such title exists, the formal qualification of the service provider and the Member State in which it was awarded; (e) if the service provider performs an activity which is subject to VAT, the VAT identification number referred to in Article 22(1) of the sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonisation of the laws of the Member States relating to turnover taxes - Common system of value added tax: uniform basis of assessment (23); (f) details of any insurance cover or other means of personal or collective protection with regard to professional liability. TITLE III FREEDOM OF ESTABLISHMENT CHAPTER I General system for the recognition of evidence of training Article 10 Scope This Chapter applies to all professions which are not covered by Chapters II and III of this Title and in the following cases in which the applicant, for specific and exceptional reasons, does not satisfy the conditions laid down in those Chapters: (a) for activities listed in Annex IV, when the migrant does not meet the requirements set out in Articles 17, 18 and 19; (b) for doctors with basic training, specialised doctors, nurses responsible for general care, dental practitioners, specialised dental practitioners, veterinary surgeons, midwives, pharmacists and architects, when the migrant does not meet the requirements of effective and lawful professional practice referred to in Articles 23, 27, 33, 37, 39, 43 and 49; (c) for architects, when the migrant holds evidence of formal qualification not listed in Annex V, point 5.7; (d) without prejudice to Articles 21(1), 23 and 27, for doctors, nurses, dental practitioners, veterinary surgeons, midwives, pharmacists and architects holding evidence of formal qualifications as a specialist, which must follow the training leading to the possession of a title listed in Annex V, points 5.1.1, 5.2.2, 5.3.2, 5.4.2, 5.5.2, 5.6.2 and 5.7.1, and solely for the purpose of the recognition of the relevant specialty; (e) for nurses responsible for general care and specialised nurses holding evidence of formal qualifications as a specialist which follows the training leading to the possession of a title listed in Annex V, point 5.2.2, when the migrant seeks recognition in another Member State where the relevant professional activities are pursued by specialised nurses without training as general care nurse; (f) for specialised nurses without training as general care nurse, when the migrant seeks recognition in another Member State where the relevant professional activities are pursued by nurses responsible for general care, specialised nurses without training as general care nurse or specialised nurses holding evidence of formal qualifications as a specialist which follows the training leading to the possession of the titles listed in Annex V, point 5.2.2; (g) for migrants meeting the requirements set out in Article 3(3). Article 11 Levels of qualification For the purpose of applying Article 13, the professional qualifications are grouped under the following levels as described below: (a) an attestation of competence issued by a competent authority in the home Member State designated pursuant to legislative, regulatory or administrative provisions of that Member State, on the basis of: (i) either a training course not forming part of a certificate or diploma within the meaning of points (b), (c), (d) or (e), or a specific examination without prior training, or full-time pursuit of the profession in a Member State for three consecutive years or for an equivalent duration on a part-time basis during the previous 10 years, (ii) or general primary or secondary education, attesting that the holder has acquired general knowledge; (b) a certificate attesting to a successful completion of a secondary course, (i) either general in character, supplemented by a course of study or professional training other than those referred to in point (c) and/or by the probationary or professional practice required in addition to that course, (ii) or technical or professional in character, supplemented where appropriate by a course of study or professional training as referred to in point (i), and/or by the probationary or professional practice required in addition to that course; (c) a diploma certifying successful completion of (i) either training at post-secondary level other than that referred to in points (d) and (e) of a duration of at least one year or of an equivalent duration on a part-time basis, one of the conditions of entry of which is, as a general rule, the successful completion of the secondary course required to obtain entry to university or higher education or the completion of equivalent school education of the second secondary level, as well as the professional training which may be required in addition to that post-secondary course; or (ii) in the case of a regulated profession, training with a special structure, included in Annex II, equivalent to the level of training provided for under (i), which provides a comparable professional standard and which prepares the trainee for a comparable level of responsibilities and functions. The list in Annex II may be amended in accordance with the procedure referred to in Article 58(2) in order to take account of training which meets the requirements provided for in the previous sentence; (d) a diploma certifying successful completion of training at post-secondary level of at least three and not more than four years' duration, or of an equivalent duration on a part-time basis, at a university or establishment of higher education or another establishment providing the same level of training, as well as the professional training which may be required in addition to that post-secondary course; (e) a diploma certifying that the holder has successfully completed a post-secondary course of at least four years' duration, or of an equivalent duration on a part-time basis, at a university or establishment of higher education or another establishment of equivalent level and, where appropriate, that he has successfully completed the professional training required in addition to the post-secondary course. Article 12 Equal treatment of qualifications Any evidence of formal qualifications or set of evidence of formal qualifications issued by a competent authority in a Member State, certifying successful completion of training in the Community which is recognised by that Member State as being of an equivalent level and which confers on the holder the same rights of access to or pursuit of a profession or prepares for the pursuit of that profession, shall be treated as evidence of formal qualifications of the type covered by Article 11, including the level in question. Any professional qualification which, although not satisfying the requirements contained in the legislative, regulatory or administrative provisions in force in the home Member State for access to or the pursuit of a profession, confers on the holder acquired rights by virtue of these provisions, shall also be treated as such evidence of formal qualifications under the same conditions as set out in the first subparagraph. This applies in particular if the home Member State raises the level of training required for admission to a profession and for its exercise, and if an individual who has undergone former training, which does not meet the requirements of the new qualification, benefits from acquired rights by virtue of national legislative, regulatory or administrative provisions; in such case this former training is considered by the host Member State, for the purposes of the application of Article 13, as corresponding to the level of the new training. Article 13 Conditions for recognition 1. If access to or pursuit of a regulated profession in a host Member State is contingent upon possession of specific professional qualifications, the competent authority of that Member State shall permit access to and pursuit of that profession, under the same conditions as apply to its nationals, to applicants possessing the attestation of competence or evidence of formal qualifications required by another Member State in order to gain access to and pursue that profession on its territory. Attestations of competence or evidence of formal qualifications shall satisfy the following conditions: (a) they shall have been issued by a competent authority in a Member State, designated in accordance with the legislative, regulatory or administrative provisions of that Member State; (b) they shall attest a level of professional qualification at least equivalent to the level immediately prior to that which is required in the host Member State, as described in Article 11. 2. Access to and pursuit of the profession, as described in paragraph 1, shall also be granted to applicants who have pursued the profession referred to in that paragraph on a full-time basis for two years during the previous 10 years in another Member State which does not regulate that profession, providing they possess one or more attestations of competence or documents providing evidence of formal qualifications. Attestations of competence and evidence of formal qualifications shall satisfy the following conditions: (a) they shall have been issued by a competent authority in a Member State, designated in accordance with the legislative, regulatory or administrative provisions of that Member State; (b) they shall attest a level of professional qualification at least equivalent to the level immediately prior to that required in the host Member State, as described in Article 11; (c) they shall attest that the holder has been prepared for the pursuit of the profession in question. The two years' professional experience referred to in the first subparagraph may not, however, be required if the evidence of formal qualifications which the applicant possesses certifies regulated education and training within the meaning of Article 3(1)(e) at the levels of qualifications described in Article 11, points (b), (c), (d) or (e). The regulated education and training listed in Annex III shall be considered as such regulated education and training at the level described in Article 11, point (c). The list in Annex III may be amended in accordance with the procedure referred to in Article 58(2) in order to take account of regulated education and training which provides a comparable professional standard and which prepares the trainee for a comparable level of responsibilities and functions. 3. By way of derogation from paragraph 1, point (b) and to paragraph 2, point (b), the host Member State shall permit access and pursuit of a regulated profession where access to this profession is contingent in its territory upon possession of a qualification certifying successful completion of higher or university education of four years' duration, and where the applicant possesses a qualification referred to in Article 11, point (c). Article 14 Compensation measures 1. Article 13 does not preclude the host Member State from requiring the applicant to complete an adaptation period of up to three years or to take an aptitude test if: (a) the duration of the training of which he provides evidence under the terms of Article 13, paragraph 1 or 2, is at least one year shorter than that required by the host Member State; (b) the training he has received covers substantially different matters than those covered by the evidence of formal qualifications required in the host Member State; (c) the regulated profession in the host Member State comprises one or more regulated professional activities which do not exist in the corresponding profession in the applicant's home Member State within the meaning of Article 4(2), and that difference consists in specific training which is required in the host Member State and which covers substantially different matters from those covered by the applicant's attestation of competence or evidence of formal qualifications. 2. If the host Member State makes use of the option provided for in paragraph 1, it must offer the applicant the choice between an adaptation period and an aptitude test. Where a Member State considers, with respect to a given profession, that it is necessary to derogate from the requirement, set out in the previous subparagraph, that it give the applicant a choice between an adaptation period and an aptitude test, it shall inform the other Member States and the Commission in advance and provide sufficient justification for the derogation. If, after receiving all necessary information, the Commission considers that the derogation referred to in the second subparagraph is inappropriate or that it is not in accordance with Community law, it shall, within three months, ask the Member State in question to refrain from taking the envisaged measure. In the absence of a response from the Commission within the abovementioned deadline, the derogation may be applied. 3. By way of derogation from the principle of the right of the applicant to choose, as laid down in paragraph 2, for professions whose pursuit requires precise knowledge of national law and in respect of which the provision of advice and/or assistance concerning national law is an essential and constant aspect of the professional activity, the host Member State may stipulate either an adaptation period or an aptitude test. This applies also to the cases provided for in Article 10 points (b) and (c), in Article 10 point (d) concerning doctors and dental practitioners, in Article 10 point (f) when the migrant seeks recognition in another Member State where the relevant professional activities are pursued by nurses responsible for general care or specialised nurses holding evidence of formal qualifications as a specialist which follows the training leading to the possession of the titles listed in Annex V, point 5.2.2 and in Article 10 point (g). In the cases covered by Article 10 point (a), the host Member State may require an adaptation period or an aptitude test if the migrant envisages pursuing professional activities in a self-employed capacity or as a manager of an undertaking which require the knowledge and the application of the specific national rules in force, provided that knowledge and application of those rules are required by the competent authorities of the host Member State for access to such activities by its own nationals. 4. For the purpose of applying paragraph 1 points (b) and (c), ‘substantially different matters’ means matters of which knowledge is essential for pursuing the profession and with regard to which the training received by the migrant shows important differences in terms of duration or content from the training required by the host Member State. 5. Paragraph 1 shall be applied with due regard to the principle of proportionality. In particular, if the host Member State intends to require the applicant to complete an adaptation period or take an aptitude test, it must first ascertain whether the knowledge acquired by the applicant in the course of his professional experience in a Member State or in a third country, is of a nature to cover, in full or in part, the substantial difference referred to in paragraph 4. Article 15 Waiving of compensation measures on the basis of common platforms 1. For the purpose of this Article, ‘common platforms’ is defined as a set of criteria of professional qualifications which are suitable for compensating for substantial differences which have been identified between the training requirements existing in the various Member States for a given profession. These substantial differences shall be identified by comparison between the duration and contents of the training in at least two thirds of the Member States, including all Member States which regulate this profession. The differences in the contents of the training may result from substantial differences in the scope of the professional activities. 2. Common platforms as defined in paragraph 1 may be submitted to the Commission by Member States or by professional associations or organisations which are representative at national and European level. If the Commission, after consulting the Member States, is of the opinion that a draft common platform facilitates the mutual recognition of professional qualifications, it may present draft measures with a view to their adoption in accordance with the procedure referred to in Article 58(2). 3. Where the applicant's professional qualifications satisfy the criteria established in the measure adopted in accordance with paragraph 2, the host Member State shall waive the application of compensation measures under Article 14. 4. Paragraphs 1 to 3 shall not affect the competence of Member States to decide the professional qualifications required for the pursuit of professions in their territory as well as the contents and the organisation of their systems of education and professional training. 5. If a Member State considers that the criteria established in a measure adopted in accordance with paragraph 2 no longer offer adequate guarantees with regard to professional qualifications, it shall inform the Commission accordingly, which shall, if appropriate, present a draft measure in accordance with the procedure referred to in Article 58(2). 6. The Commission shall, by 20 October 2010, submit to the European Parliament and the Council a report on the operation of this Article and, if necessary, appropriate proposals for amending this Article. CHAPTER II Recognition of professional experience Article 16 Requirements regarding professional experience If, in a Member State, access to or pursuit of one of the activities listed in Annex IV is contingent upon possession of general, commercial or professional knowledge and aptitudes, that Member State shall recognise previous pursuit of the activity in another Member State as sufficient proof of such knowledge and aptitudes. The activity must have been pursued in accordance with Articles 17, 18 and 19. Article 17 Activities referred to in list I of Annex IV 1. For the activities in list I of Annex IV, the activity in question must have been previously pursued: (a) for six consecutive years on a self-employed basis or as a manager of an undertaking; or (b) for three consecutive years on a self-employed basis or as a manager of an undertaking, where the beneficiary proves that he has received previous training of at least three years for the activity in question, evidenced by a certificate recognised by the Member State or judged by a competent professional body to be fully valid; or (c) for four consecutive years on a self-employed basis or as a manager of an undertaking, where the beneficiary can prove that he has received, for the activity in question, previous training of at least two years' duration, attested by a certificate recognised by the Member State or judged by a competent professional body to be fully valid; or (d) for three consecutive years on a self-employed basis, if the beneficiary can prove that he has pursued the activity in question on an employed basis for at least five years; or (e) for five consecutive years in an executive position, of which at least three years involved technical duties and responsibility for at least one department of the company, if the beneficiary can prove that he has received, for the activity in question, previous training of at least three years' duration, as attested by a certificate recognised by the Member State or judged by a competent professional body to be fully valid. 2. In cases (a) and (d), the activity must not have finished more than 10 years before the date on which the complete application was submitted by the person concerned to the competent authority referred to in Article 56. 3. Paragraph 1(e) shall not apply to activities in Group ex 855, hairdressing establishments, of the ISIC Nomenclature. Article 18 Activities referred to in list II of Annex IV 1. For the activities in list II of Annex IV, the activity in question must have been previously pursued: (a) for five consecutive years on a self-employed basis or as a manager of an undertaking, or (b) for three consecutive years on a self-employed basis or as a manager of an undertaking, where the beneficiary proves that he has received previous training of at least three years for the activity in question, evidenced by a certificate recognised by the Member State or judged by a competent professional body to be fully valid, or (c) for four consecutive years on a self-employed basis or as a manager of an undertaking, where the beneficiary can prove that he has received, for the activity in question, previous training of at least two years' duration, attested by a certificate recognised by the Member State or judged by a competent professional body to be fully valid, or (d) for three consecutive years on a self-employed basis or as a manager of an undertaking, if the beneficiary can prove that he has pursued the activity in question on an employed basis for at least five years, or (e) for five consecutive years on an employed basis, if the beneficiary can prove that he has received, for the activity in question, previous training of at least three years' duration, as attested by a certificate recognised by the Member State or judged by a competent professional body to be fully valid, or (f) for six consecutive years on an employed basis, if the beneficiary can prove that he has received previous training in the activity in question of at least two years' duration, as attested by a certificate recognised by the Member State or judged by a competent professional body to be fully valid. 2. In cases (a) and (d), the activity must not have finished more than 10 years before the date on which the complete application was submitted by the person concerned to the competent authority referred to in Article 56. Article 19 Activities referred to in list III of Annex IV 1. For the activities in list III of Annex IV, the activity in question must have been previously pursued: (a) for three consecutive years, either on a self-employed basis or as a manager of an undertaking, or (b) for two consecutive years, either on a self-employed basis or as a manager of an undertaking, if the beneficiary can prove that he has received previous training for the activity in question, as attested by a certificate recognised by the Member State or judged by a competent professional body to be fully valid, or (c) for two consecutive years, either on a self-employed basis or as a manager of an undertaking, if the beneficiary can prove that he has pursued the activity in question on an employed basis for at least three years, or (d) for three consecutive years, on an employed basis, if the beneficiary can prove that he has received previous training for the activity in question, as attested by a certificate recognised by the Member State or judged by a competent professional body to be fully valid. 2. In cases (a) and (c), the activity must not have finished more than 10 years before the date on which the complete application was submitted by the person concerned to the competent authority referred to in Article 56. Article 20 Amendment of the lists of activities in Annex IV The lists of activities in Annex IV which are the subject of recognition of professional experience pursuant to Article 16 may be amended in accordance with the procedure referred to in Article 58(2) with a view to updating or clarifying the nomenclature, provided that this does not involve any change in the activities related to the individual categories. CHAPTER III Recognition on the basis of coordination of minimum training conditions Section 1 General Provisions Article 21 Principle of automatic recognition 1. Each Member State shall recognise evidence of formal qualifications as doctor giving access to the professional activities of doctor with basic training and specialised doctor, as nurse responsible for general care, as dental practitioner, as specialised dental practitioner, as veterinary surgeon, as pharmacist and as architect, listed in Annex V, points 5.1.1, 5.1.2, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.6.2 and 5.7.1 respectively, which satisfy the minimum training conditions referred to in Articles 24, 25, 31, 34, 35, 38, 44 and 46 respectively, and shall, for the purposes of access to and pursuit of the professional activities, give such evidence the same effect on its territory as the evidence of formal qualifications which it itself issues. Such evidence of formal qualifications must be issued by the competent bodies in the Member States and accompanied, where appropriate, by the certificates listed in Annex V, points 5.1.1, 5.1.2, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.6.2 and 5.7.1 respectively. The provisions of the first and second subparagraphs do not affect the acquired rights referred to in Articles 23, 27, 33, 37, 39 and 49. 2. Each Member State shall recognise, for the purpose of pursuing general medical practice in the framework of its national social security system, evidence of formal qualifications listed in Annex V, point 5.1.4 and issued to nationals of the Member States by the other Member States in accordance with the minimum training conditions laid down in Article 28. The provisions of the previous subparagraph do not affect the acquired rights referred to in Article 30. 3. Each Member State shall recognise evidence of formal qualifications as a midwife, awarded to nationals of Member States by the other Member States, listed in Annex V, point 5.5.2, which complies with the minimum training conditions referred to in Article 40 and satisfies the criteria set out in Article 41, and shall, for the purposes of access to and pursuit of the professional activities, give such evidence the same effect on its territory as the evidence of formal qualifications which it itself issues. This provision does not affect the acquired rights referred to in Articles 23 and 43. 4. Member States shall not be obliged to give effect to evidence of formal qualifications referred to in Annex V, point 5.6.2, for the setting up of new pharmacies open to the public. For the purposes of this paragraph, pharmacies which have been open for less than three years shall also be considered as new pharmacies. 5. Evidence of formal qualifications as an architect referred to in Annex V, point 5.7.1, which is subject to automatic recognition pursuant to paragraph 1, proves completion of a course of training which began not earlier than during the academic reference year referred to in that Annex. 6. Each Member State shall make access to and pursuit of the professional activities of doctors, nurses responsible for general care, dental practitioners, veterinary surgeons, midwives and pharmacists subject to possession of evidence of formal qualifications referred to in Annex V, points 5.1.1, 5.1.2, 5.1.4, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.5.2 and 5.6.2 respectively, attesting that the person concerned has acquired, over the duration of his training, and where appropriate, the knowledge and skills referred to in Articles 24(3), 31(6), 34(3), 38(3), 40(3) and 44(3). The knowledge and skills referred to in Articles 24(3), 31(6), 34(3), 38(3), 40(3) and 44(3) may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting them to scientific and technical progress. Such updates shall not entail, for any Member State, an amendment of its existing legislative principles regarding the structure of professions as regards training and conditions of access by natural persons. 7. Each Member State shall notify the Commission of the legislative, regulatory and administrative provisions which it adopts with regard to the issuing of evidence of formal qualifications in the area covered by this Chapter. In addition, for evidence of formal qualifications in the area referred to in Section 8, this notification shall be addressed to the other Member States. The Commission shall publish an appropriate communication in the Official Journal of the European Union, indicating the titles adopted by the Member States for evidence of formal qualifications and, where appropriate, the body which issues the evidence of formal qualifications, the certificate which accompanies it and the corresponding professional title referred to in Annex V, points 5.1.1, 5.1.2, 5.1.4, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.5.2, 5.6.2 and 5.7.1 respectively. Article 22 Common provisions on training With regard to the training referred to in Articles 24, 25, 28, 31, 34, 35, 38, 40, 44 and 46: (a) Member States may authorise part-time training under conditions laid down by the competent authorities; those authorities shall ensure that the overall duration, level and quality of such training is not lower than that of continuous full-time training; (b) in accordance with the procedures specific to each Member State, continuing education and training shall ensure that persons who have completed their studies are able to keep abreast of professional developments to the extent necessary to maintain safe and effective practice. Article 23 Acquired rights 1. Without prejudice to the acquired rights specific to the professions concerned, in cases where the evidence of formal qualifications as doctor giving access to the professional activities of doctor with basic training and specialised doctor, as nurse responsible for general care, as dental practitioner, as specialised dental practitioner, as veterinary surgeon, as midwife and as pharmacist held by Member States nationals does not satisfy all the training requirements referred to in Articles 24, 25, 31, 34, 35, 38, 40 and 44, each Member State shall recognise as sufficient proof evidence of formal qualifications issued by those Member States insofar as such evidence attests successful completion of training which began before the reference dates laid down in Annex V, points 5.1.1, 5.1.2, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.5.2 and 5.6.2 and is accompanied by a certificate stating that the holders have been effectively and lawfully engaged in the activities in question for at least three consecutive years during the five years preceding the award of the certificate. 2. The same provisions shall apply to evidence of formal qualifications as doctor giving access to the professional activities of doctor with basic training and specialised doctor, as nurse responsible for general care, as dental practitioner, as specialised dental practitioner, as veterinary surgeon, as midwife and as pharmacist, obtained in the territory of the former German Democratic Republic, which does not satisfy all the minimum training requirements laid down in Articles 24, 25, 31, 34, 35, 38, 40 and 44 if such evidence certifies successful completion of training which began before: (a) 3 October 1990 for doctors with basic training, nurses responsible for general care, dental practitioners with basic training, specialised dental practitioners, veterinary surgeons, midwives and pharmacists, and (b) 3 April 1992 for specialised doctors. The evidence of formal qualifications referred to in the first subparagraph confers on the holder the right to pursue professional activities throughout German territory under the same conditions as evidence of formal qualifications issued by the competent German authorities referred to in Annex V, points 5.1.1, 5.1.2, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.5.2 and 5.6.2. 3. Without prejudice to the provisions of Article 37(1), each Member State shall recognise evidence of formal qualifications as doctor giving access to the professional activities of doctor with basic training and specialised doctor, as nurse responsible for general care, as veterinary surgeon, as midwife, as pharmacist and as architect held by Member States nationals and issued by the former Czechoslovakia, or whose training commenced, for the Czech Republic and Slovakia, before 1 January 1993, where the authorities of either of the two aforementioned Member States attest that such evidence of formal qualifications has the same legal validity within their territory as the evidence of formal qualifications which they issue and, with respect to architects, as the evidence of formal qualifications specified for those Member States in Annex VI, point 6, as regards access to the professional activities of doctor with basic training, specialised doctor, nurse responsible for general care, veterinary surgeon, midwife, pharmacist with respect to the activities referred to in Article 45(2), and architect with respect to the activities referred to in Article 48, and the pursuit of such activities. Such an attestation must be accompanied by a certificate issued by those same authorities stating that such persons have effectively and lawfully been engaged in the activities in question within their territory for at least three consecutive years during the five years prior to the date of issue of the certificate. 4. Each Member State shall recognise evidence of formal qualifications as doctor giving access to the professional activities of doctor with basic training and specialised doctor, as nurse responsible for general care, as dental practitioner, as specialised dental practitioner, as veterinary surgeon, as midwife, as pharmacist and as architect held by nationals of the Member States and issued by the former Soviet Union, or whose training commenced (a) for Estonia, before 20 August 1991, (b) for Latvia, before 21 August 1991, (c) for Lithuania, before 11 March 1990, where the authorities of any of the three aforementioned Member States attest that such evidence has the same legal validity within their territory as the evidence which they issue and, with respect to architects, as the evidence of formal qualifications specified for those Member States in Annex VI, point 6, as regards access to the professional activities of doctor with basic training, specialised doctor, nurse responsible for general care, dental practitioner, specialised dental practitioner, veterinary surgeon, midwife, pharmacist with respect to the activities referred to in Article 45(2), and architect with respect to the activities referred to in Article 48, and the pursuit of such activities. Such an attestation must be accompanied by a certificate issued by those same authorities stating that such persons have effectively and lawfully been engaged in the activities in question within their territory for at least three consecutive years during the five years prior to the date of issue of the certificate. With regard to evidence of formal qualifications as veterinary surgeons issued by the former Soviet Union or in respect of which training commenced, for Estonia, before 20 August 1991, the attestation referred to in the preceding subparagraph must be accompanied by a certificate issued by the Estonian authorities stating that such persons have effectively and lawfully been engaged in the activities in question within their territory for at least five consecutive years during the seven years prior to the date of issue of the certificate. 5. Each Member State shall recognise evidence of formal qualifications as doctor giving access to the professional activities of doctor with basic training and specialised doctor, as nurse responsible for general care, as dental practitioner, as specialised dental practitioner, as veterinary surgeon, as midwife, as pharmacist and as architect held by nationals of the Member States and issued by the former Yugoslavia, or whose training commenced, for Slovenia, before 25 June 1991, where the authorities of the aforementioned Member State attest that such evidence has the same legal validity within their territory as the evidence which they issue and, with respect to architects, as the evidence of formal qualifications specified for those Member States in Annex VI, point 6, as regards access to the professional activities of doctor with basic training, specialised doctor, nurse responsible for general care, dental practitioner, specialised dental practitioner, veterinary surgeon, midwife, pharmacist with respect to the activities referred to in Article 45(2), and architect with respect to the activities referred to in Article 48, and the pursuit of such activities. Such an attestation must be accompanied by a certificate issued by those same authorities stating that such persons have effectively and lawfully been engaged in the activities in question within their territory for at least three consecutive years during the five years prior to the date of issue of the certificate. 6. Each Member State shall recognise as sufficient proof for Member State nationals whose evidence of formal qualifications as a doctor, nurse responsible for general care, dental practitioner, veterinary surgeon, midwife and pharmacist does not correspond to the titles given for that Member State in Annex V, points 5.1.1, 5.1.2, 5.1.3, 5.1.4, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.5.2 and 5.6.2, evidence of formal qualifications issued by those Member States accompanied by a certificate issued by the competent authorities or bodies. The certificate referred to in the first subparagraph shall state that the evidence of formal qualifications certifies successful completion of training in accordance with Articles 24, 25, 28, 31, 34, 35, 38, 40 and 44 respectively and is treated by the Member State which issued it in the same way as the qualifications whose titles are listed in Annex V, points 5.1.1, 5.1.2, 5.1.3, 5.1.4, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.5.2 and 5.6.2. Section 2 Doctors of medicine Article 24 Basic medical training 1. Admission to basic medical training shall be contingent upon possession of a diploma or certificate providing access, for the studies in question, to universities. 2. Basic medical training shall comprise a total of at least six years of study or 5 500 hours of theoretical and practical training provided by, or under the supervision of, a university. For persons who began their studies before 1 January 1972, the course of training referred to in the first subparagraph may comprise six months of full-time practical training at university level under the supervision of the competent authorities. 3. Basic medical training shall provide an assurance that the person in question has acquired the following knowledge and skills: (a) adequate knowledge of the sciences on which medicine is based and a good understanding of the scientific methods including the principles of measuring biological functions, the evaluation of scientifically established facts and the analysis of data; (b) sufficient understanding of the structure, functions and behaviour of healthy and sick persons, as well as relations between the state of health and physical and social surroundings of the human being; (c) adequate knowledge of clinical disciplines and practices, providing him with a coherent picture of mental and physical diseases, of medicine from the points of view of prophylaxis, diagnosis and therapy and of human reproduction; (d) suitable clinical experience in hospitals under appropriate supervision. Article 25 Specialist medical training 1. Admission to specialist medical training shall be contingent upon completion and validation of six years of study as part of a training programme referred to in Article 24 in the course of which the trainee has acquired the relevant knowledge of basic medicine. 2. Specialist medical training shall comprise theoretical and practical training at a university or medical teaching hospital or, where appropriate, a medical care establishment approved for that purpose by the competent authorities or bodies. The Member States shall ensure that the minimum duration of specialist medical training courses referred to in Annex V, point 5.1.3 is not less than the duration provided for in that point. Training shall be given under the supervision of the competent authorities or bodies. It shall include personal participation of the trainee specialised doctor in the activity and responsibilities entailed by the services in question. 3. Training shall be given on a full-time basis at specific establishments which are recognised by the competent authorities. It shall entail participation in the full range of medical activities of the department where the training is given, including duty on call, in such a way that the trainee specialist devotes all his professional activity to his practical and theoretical training throughout the entire working week and throughout the year, in accordance with the procedures laid down by the competent authorities. Accordingly, these posts shall be the subject of appropriate remuneration. 4. The Member States shall make the issuance of evidence of specialist medical training contingent upon possession of evidence of basic medical training referred to in Annex V, point 5.1.1. 5. The minimum periods of training referred to in Annex V, point 5.1.3 may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting them to scientific and technical progress. Article 26 Types of specialist medical training Evidence of formal qualifications as a specialised doctor referred to in Article 21 is such evidence awarded by the competent authorities or bodies referred to in Annex V, point 5.1.2 as corresponds, for the specialised training in question, to the titles in use in the various Member States and referred to in Annex V, point 5.1.3. The inclusion in Annex V, point 5.1.3 of new medical specialties common to at least two fifths of the Member States may be decided on in accordance with the procedure referred to in Article 58(2) with a view to updating this Directive in the light of changes in national legislation. Article 27 Acquired rights specific to specialised doctors 1. A host Member State may require of specialised doctors whose part-time specialist medical training was governed by legislative, regulatory and administrative provisions in force as of 20 June 1975 and who began their specialist training no later than 31 December 1983 that their evidence of formal qualifications be accompanied by a certificate stating that they have been effectively and lawfully engaged in the relevant activities for at least three consecutive years during the five years preceding the award of that certificate. 2. Every Member State shall recognise the qualification of specialised doctors awarded in Spain to doctors who completed their specialist training before 1 January 1995, even if that training does not satisfy the minimum training requirements provided for in Article 25, in so far as that qualification is accompanied by a certificate issued by the competent Spanish authorities and attesting that the person concerned has passed the examination in specific professional competence held in the context of exceptional measures concerning recognition laid down in Royal Decree 1497/99, with a view to ascertaining that the person concerned possesses a level of knowledge and skill comparable to that of doctors who possess a qualification as a specialised doctor defined for Spain in Annex V, points 5.1.2 and 5.1.3. 3. Every Member State which has repealed its legislative, regulatory or administrative provisions relating to the award of evidence of formal qualifications as a specialised doctor referred to in Annex V, points 5.1.2 and 5.1.3 and which has adopted measures relating to acquired rights benefiting its nationals, shall grant nationals of other Member States the right to benefit from those measures, in so far as such evidence of formal qualifications was issued before the date on which the host Member State ceased to issue such evidence for the specialty in question. The dates on which these provisions were repealed are set out in Annex V, point 5.1.3. Article 28 Specific training in general medical practice 1. Admission to specific training in general medical practice shall be contingent on the completion and validation of six years of study as part of a training programme referred to in Article 24. 2. The specific training in general medical practice leading to the award of evidence of formal qualifications issued before 1 January 2006 shall be of a duration of at least two years on a full-time basis. In the case of evidence of formal qualifications issued after that date, the training shall be of a duration of at least three years on a full-time basis. Where the training programme referred to in Article 24 comprises practical training given by an approved hospital possessing appropriate general medical equipment and services or as part of an approved general medical practice or an approved centre in which doctors provide primary medical care, the duration of that practical training may, up to a maximum of one year, be included in the duration provided for in the first subparagraph for certificates of training issued on or after 1 January 2006. The option provided for in the second subparagraph shall be available only for Member States in which the specific training in general medical practice lasted two years as of 1 January 2001. 3. The specific training in general medical practice shall be carried out on a full-time basis, under the supervision of the competent authorities or bodies. It shall be more practical than theoretical. The practical training shall be given, on the one hand, for at least six months in an approved hospital possessing appropriate equipment and services and, on the other hand, for at least six months as part of an approved general medical practice or an approved centre at which doctors provide primary health care. The practical training shall take place in conjunction with other health establishments or structures concerned with general medicine. Without prejudice to the minimum periods laid down in the second subparagraph, however, the practical training may be given during a period of not more than six months in other approved establishments or health structures concerned with general medicine. The training shall require the personal participation of the trainee in the professional activity and responsibilities of the persons with whom he is working. 4. Member States shall make the issuance of evidence of formal qualifications in general medical practice subject to possession of evidence of formal qualifications in basic medical training referred to in Annex V, point 5.1.1. 5. Member States may issue evidence of formal qualifications referred to in Annex V, point 5.1.4 to a doctor who has not completed the training provided for in this Article but who has completed a different, supplementary training, as attested by evidence of formal qualifications issued by the competent authorities in a Member State. They may not, however, award evidence of formal qualifications unless it attests knowledge of a level qualitatively equivalent to the knowledge acquired from the training provided for in this Article. Member States shall determine, inter alia, the extent to which the complementary training and professional experience already acquired by the applicant may replace the training provided for in this Article. The Member States may only issue the evidence of formal qualifications referred to in Annex V, point 5.1.4 if the applicant has acquired at least six months' experience of general medicine in a general medical practice or a centre in which doctors provide primary health care of the types referred to in paragraph 3. Article 29 Pursuit of the professional activities of general practitioners Each Member State shall, subject to the provisions relating to acquired rights, make the pursuit of the activities of a general practitioner in the framework of its national social security system contingent upon possession of evidence of formal qualifications referred to in Annex V, point 5.1.4. Member States may exempt persons who are currently undergoing specific training in general medicine from this condition. Article 30 Acquired rights specific to general practitioners 1. Each Member State shall determine the acquired rights. It shall, however, confer as an acquired right the right to pursue the activities of a general practitioner in the framework of its national social security system, without the evidence of formal qualifications referred to in Annex V, point 5.1.4, on all doctors who enjoy this right as of the reference date stated in that point by virtue of provisions applicable to the medical profession giving access to the professional activities of doctor with basic training and who are established as of that date on its territory, having benefited from the provisions of Articles 21 or 23. The competent authorities of each Member State shall, on demand, issue a certificate stating the holder's right to pursue the activities of general practitioner in the framework of their national social security systems, without the evidence of formal qualifications referred to in Annex V, point 5.1.4, to doctors who enjoy acquired rights pursuant to the first subparagraph. 2. Every Member State shall recognise the certificates referred to in paragraph 1, second subparagraph, awarded to nationals of Member States by the other Member States, and shall give such certificates the same effect on its territory as evidence of formal qualifications which it awards and which permit the pursuit of the activities of a general practitioner in the framework of its national social security system. Section 3 Nurses responsible for general care Article 31 Training of nurses responsible for general care 1. Admission to training for nurses responsible for general care shall be contingent upon completion of general education of 10 years, as attested by a diploma, certificate or other evidence issued by the competent authorities or bodies in a Member State or by a certificate attesting success in an examination, of an equivalent level, for admission to a school of nursing. 2. Training of nurses responsible for general care shall be given on a full-time basis and shall include at least the programme described in Annex V, point 5.2.1. The content listed in Annex V, point 5.2.1 may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting it to scientific and technical progress. Such updates may not entail, for any Member State, any amendment of its existing legislative principles relating to the structure of professions as regards training and the conditions of access by natural persons. 3. The training of nurses responsible for general care shall comprise at least three years of study or 4 600 hours of theoretical and clinical training, the duration of the theoretical training representing at least one-third and the duration of the clinical training at least one half of the minimum duration of the training. Member States may grant partial exemptions to persons who have received part of their training on courses which are of at least an equivalent level. The Member States shall ensure that institutions providing nursing training are responsible for the coordination of theoretical and clinical training throughout the entire study programme. 4. Theoretical training is that part of nurse training from which trainee nurses acquire the professional knowledge, insights and skills necessary for organising, dispensing and evaluating overall health care. The training shall be given by teachers of nursing care and by other competent persons, in nursing schools and other training establishments selected by the training institution. 5. Clinical training is that part of nurse training in which trainee nurses learn, as part of a team and in direct contact with a healthy or sick individual and/or community, to organise, dispense and evaluate the required comprehensive nursing care, on the basis of the knowledge and skills which they have acquired. The trainee nurse shall learn not only how to work in a team, but also how to lead a team and organise overall nursing care, including health education for individuals and small groups, within the health institute or in the community. This training shall take place in hospitals and other health institutions and in the community, under the responsibility of nursing teachers, in cooperation with and assisted by other qualified nurses. Other qualified personnel may also take part in the teaching process. Trainee nurses shall participate in the activities of the department in question insofar as those activities are appropriate to their training, enabling them to learn to assume the responsibilities involved in nursing care. 6. Training for nurses responsible for general care shall provide an assurance that the person in question has acquired the following knowledge and skills: (a) adequate knowledge of the sciences on which general nursing is based, including sufficient understanding of the structure, physiological functions and behaviour of healthy and sick persons, and of the relationship between the state of health and the physical and social environment of the human being; (b) sufficient knowledge of the nature and ethics of the profession and of the general principles of health and nursing; (c) adequate clinical experience; such experience, which should be selected for its training value, should be gained under the supervision of qualified nursing staff and in places where the number of qualified staff and equipment are appropriate for the nursing care of the patient; (d) the ability to participate in the practical training of health personnel and experience of working with such personnel; (e) experience of working with members of other professions in the health sector. Article 32 Pursuit of the professional activities of nurses responsible for general care For the purposes of this Directive, the professional activities of nurses responsible for general care are the activities pursued on a professional basis and referred to in Annex V, point 5.2.2. Article 33 Acquired rights specific to nurses responsible for general care 1. Where the general rules of acquired rights apply to nurses responsible for general care, the activities referred to in Article 23 must have included full responsibility for the planning, organisation and administration of nursing care delivered to the patient. 2. As regards the Polish qualification of nurse responsible for general care, only the following acquired rights provisions shall apply. In the case of nationals of the Member States whose evidence of formal qualifications as nurse responsible for general care was awarded by, or whose training started in, Poland before 1 May 2004 and who do not satisfy the minimum training requirements laid down in Article 31, Member States shall recognise the following evidence of formal qualifications as nurse responsible for general care as being sufficient proof if accompanied by a certificate stating that those Member State nationals have effectively and lawfully been engaged in the activities of a nurse responsible for general care in Poland for the period specified below: (a) evidence of formal qualifications as a nurse at degree level (dyplom licencjata pielęgniarstwa) — at least three consecutive years during the five years prior to the date of issue of the certificate, (b) evidence of formal qualifications as a nurse certifying completion of post-secondary education obtained from a medical vocational school (dyplom pielęgniarki albo pielęgniarki dyplomowanej) — at least five consecutive years during the seven years prior to the date of issue of the certificate. The said activities must have included taking full responsibility for the planning, organisation and administration of nursing care delivered to the patient. 3. Member States shall recognise evidence of formal qualifications in nursing awarded in Poland, to nurses who completed training before 1 May 2004, which did not comply with the minimum training requirements laid down in Article 31, attested by the diploma ‘bachelor’ which has been obtained on the basis of a special upgrading programme contained in Article 11 of the Act of 20 April 2004 on the amendment of the Act on professions of nurse and midwife and on some other legal acts (Official Journal of the Republic of Poland of 30 April 2004 No 92, pos. 885), and the Regulation of the Minister of Health of 11 May 2004 on the detailed conditions of delivering studies for nurses and midwives, who hold a certificate of secondary school (final examination — matura) and are graduates of medical lyceum and medical vocational schools teaching in a profession of a nurse and a midwife (Official Journal of the Republic of Poland of 13 May 2004 No 110, pos. 1170), with the aim of verifying that the person concerned has a level of knowledge and competence comparable to that of nurses holding the qualifications which, in the case of Poland, are defined in Annex V, point 5.2.2. Section 4 Dental practitioners Article 34 Basic dental training 1. Admission to basic dental training presupposes possession of a diploma or certificate giving access, for the studies in question, to universities or higher institutes of a level recognised as equivalent, in a Member State. 2. Basic dental training shall comprise a total of at least five years of full-time theoretical and practical study, comprising at least the programme described in Annex V, point 5.3.1 and given in a university, in a higher institute providing training recognised as being of an equivalent level or under the supervision of a university. The content listed in Annex V, point 5.3.1 may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting it to scientific and technical progress. Such updates may not entail, for any Member State, any amendment of its existing legislative principles relating to the system of professions as regards training and the conditions of access by natural persons. 3. Basic dental training shall provide an assurance that the person in question has acquired the following knowledge and skills: (a) adequate knowledge of the sciences on which dentistry is based and a good understanding of scientific methods, including the principles of measuring biological functions, the evaluation of scientifically established facts and the analysis of data; (b) adequate knowledge of the constitution, physiology and behaviour of healthy and sick persons as well as the influence of the natural and social environment on the state of health of the human being, in so far as these factors affect dentistry; (c) adequate knowledge of the structure and function of the teeth, mouth, jaws and associated tissues, both healthy and diseased, and their relationship to the general state of health and to the physical and social well-being of the patient; (d) adequate knowledge of clinical disciplines and methods, providing the dentist with a coherent picture of anomalies, lesions and diseases of the teeth, mouth, jaws and associated tissues and of preventive, diagnostic and therapeutic dentistry; (e) suitable clinical experience under appropriate supervision. This training shall provide him with the skills necessary for carrying out all activities involving the prevention, diagnosis and treatment of anomalies and diseases of the teeth, mouth, jaws and associated tissues. Article 35 Specialist dental training 1. Admission to specialist dental training shall entail the completion and validation of five years of theoretical and practical instruction within the framework of the training referred to in Article 34, or possession of the documents referred to in Articles 23 and 37. 2. Specialist dental training shall comprise theoretical and practical instruction in a university centre, in a treatment teaching and research centre or, where appropriate, in a health establishment approved for that purpose by the competent authorities or bodies. Full-time specialist dental courses shall be of a minimum of three years' duration supervised by the competent authorities or bodies. It shall involve the personal participation of the dental practitioner training to be a specialist in the activity and in the responsibilities of the establishment concerned. The minimum period of training referred to in the second subparagraph may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting it to scientific and technical progress. 3. The Member States shall make the issuance of evidence of specialist dental training contingent upon possession of evidence of basic dental training referred to in Annex V, point 5.3.2. Article 36 Pursuit of the professional activities of dental practitioners 1. For the purposes of this Directive, the professional activities of dental practitioners are the activities defined in paragraph 3 and pursued under the professional qualifications listed in Annex V, point 5.3.2. 2. The profession of dental practitioner shall be based on dental training referred to in Article 34 and shall constitute a specific profession which is distinct from other general or specialised medical professions. Pursuit of the activities of a dental practitioner requires the possession of evidence of formal qualifications referred to in Annex V, point 5.3.2. Holders of such evidence of formal qualifications shall be treated in the same way as those to whom Articles 23 or 37 apply. 3. The Member States shall ensure that dental practitioners are generally able to gain access to and pursue the activities of prevention, diagnosis and treatment of anomalies and diseases affecting the teeth, mouth, jaws and adjoining tissue, having due regard to the regulatory provisions and rules of professional ethics on the reference dates referred to in Annex V, point 5.3.2. Article 37 Acquired rights specific to dental practitioners 1. Every Member State shall, for the purposes of the pursuit of the professional activities of dental practitioners under the qualifications listed in Annex V, point 5.3.2, recognise evidence of formal qualifications as a doctor issued in Italy, Spain, Austria, the Czech Republic and Slovakia to persons who began their medical training on or before the reference date stated in that Annex for the Member State concerned, accompanied by a certificate issued by the competent authorities of that Member State. The certificate must show that the two following conditions are met: (a) that the persons in question have been effectively, lawfully and principally engaged in that Member State in the activities referred to in Article 36 for at least three consecutive years during the five years preceding the award of the certificate; (b) that those persons are authorised to pursue the said activities under the same conditions as holders of evidence of formal qualifications listed for that Member State in Annex V, point 5.3.2. Persons who have successfully completed at least three years of study, certified by the competent authorities in the Member State concerned as being equivalent to the training referred to in Article 34, shall be exempt from the three-year practical work experience referred to in the second subparagraph, point (a). With regard to the Czech Republic and Slovakia, evidence of formal qualifications obtained in the former Czechoslovakia shall be accorded the same level of recognition as Czech and Slovak evidence of formal qualifications and under the same conditions as set out in the preceding subparagraphs. 2. Each Member State shall recognise evidence of formal qualifications as a doctor issued in Italy to persons who began their university medical training after 28 January 1980 and no later than 31 December 1984, accompanied by a certificate issued by the competent Italian authorities. The certificate must show that the three following conditions are met: (a) that the persons in question passed the relevant aptitude test held by the competent Italian authorities with a view to establishing that those persons possess a level of knowledge and skills comparable to that of persons possessing evidence of formal qualifications listed for Italy in Annex V, point 5.3.2; (b) that they have been effectively, lawfully and principally engaged in the activities referred to in Article 36 in Italy for at least three consecutive years during the five years preceding the award of the certificate; (c) that they are authorised to engage in or are effectively, lawfully and principally engaged in the activities referred to in Article 36, under the same conditions as the holders of evidence of formal qualifications listed for Italy in Annex V, point 5.3.2. Persons who have successfully completed at least three years of study certified by the competent authorities as being equivalent to the training referred to in Article 34 shall be exempt from the aptitude test referred to in the second subparagraph, point (a). Persons who began their university medical training after 31 December 1984 shall be treated in the same way as those referred to above, provided that the abovementioned three years of study began before 31 December 1994. Section 5 Veterinary surgeons Article 38 The training of veterinary surgeons 1. The training of veterinary surgeons shall comprise a total of at least five years of full-time theoretical and practical study at a university or at a higher institute providing training recognised as being of an equivalent level, or under the supervision of a university, covering at least the study programme referred to in Annex V, point 5.4.1. The content listed in Annex V, point 5.4.1 may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting it to scientific and technical progress. Such updates may not entail, for any Member State, any amendment of its existing legislative principles relating to the structure of professions as regards training and conditions of access by natural persons. 2. Admission to veterinary training shall be contingent upon possession of a diploma or certificate entitling the holder to enter, for the studies in question, university establishments or institutes of higher education recognised by a Member State to be of an equivalent level for the purpose of the relevant study. 3. Training as a veterinary surgeon shall provide an assurance that the person in question has acquired the following knowledge and skills: (a) adequate knowledge of the sciences on which the activities of the veterinary surgeon are based; (b) adequate knowledge of the structure and functions of healthy animals, of their husbandry, reproduction and hygiene in general, as well as their feeding, including the technology involved in the manufacture and preservation of foods corresponding to their needs; (c) adequate knowledge of the behaviour and protection of animals; (d) adequate knowledge of the causes, nature, course, effects, diagnosis and treatment of the diseases of animals, whether considered individually or in groups, including a special knowledge of the diseases which may be transmitted to humans; (e) adequate knowledge of preventive medicine; (f) adequate knowledge of the hygiene and technology involved in the production, manufacture and putting into circulation of animal foodstuffs or foodstuffs of animal origin intended for human consumption; (g) adequate knowledge of the laws, regulations and administrative provisions relating to the subjects listed above; (h) adequate clinical and other practical experience under appropriate supervision. Article 39 Acquired rights specific to veterinary surgeons Without prejudice to Article 23(4), with regard to nationals of Member States whose evidence of formal qualifications as a veterinary surgeon was issued by, or whose training commenced in, Estonia before 1 May 2004, Member States shall recognise such evidence of formal qualifications as a veterinary surgeon if it is accompanied by a certificate stating that such persons have effectively and lawfully been engaged in the activities in question in Estonia for at least five consecutive years during the seven years prior to the date of issue of the certificate. Section 6 Midwives Article 40 The training of midwives 1. The training of midwives shall comprise a total of at least: (a) specific full-time training as a midwife comprising at least three years of theoretical and practical study (route I) comprising at least the programme described in Annex V, point 5.5.1, or (b) specific full-time training as a midwife of 18 months' duration (route II), comprising at least the study programme described in Annex V, point 5.5.1, which was not the subject of equivalent training of nurses responsible for general care. The Member States shall ensure that institutions providing midwife training are responsible for coordinating theory and practice throughout the programme of study. The content listed in Annex V, point 5.5.1 may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting it to scientific and technical progress. Such updates must not entail, for any Member State, any amendment of existing legislative principles relating to the structure of professions as regards training and the conditions of access by natural persons. 2. Access to training as a midwife shall be contingent upon one of the following conditions: (a) completion of at least the first 10 years of general school education for route I, or (b) possession of evidence of formal qualifications as a nurse responsible for general care referred to in Annex V, point 5.2.2 for route II. 3. Training as a midwife shall provide an assurance that the person in question has acquired the following knowledge and skills: (a) adequate knowledge of the sciences on which the activities of midwives are based, particularly obstetrics and gynaecology; (b) adequate knowledge of the ethics of the profession and the professional legislation; (c) detailed knowledge of biological functions, anatomy and physiology in the field of obstetrics and of the newly born, and also a knowledge of the relationship between the state of health and the physical and social environment of the human being, and of his behaviour; (d) adequate clinical experience gained in approved institutions under the supervision of staff qualified in midwifery and obstetrics; (e) adequate understanding of the training of health personnel and experience of working with such. Article 41 Procedures for the recognition of evidence of formal qualifications as a midwife 1. The evidence of formal qualifications as a midwife referred to in Annex V, point 5.5.2 shall be subject to automatic recognition pursuant to Article 21 in so far as they satisfy one of the following criteria: (a) full-time training of at least three years as a midwife: (i) either made contingent upon possession of a diploma, certificate or other evidence of qualification giving access to universities or higher education institutes, or otherwise guaranteeing an equivalent level of knowledge; or (ii) followed by two years of professional practice for which a certificate has been issued in accordance with paragraph 2; (b) full-time training as a midwife of at least two years or 3 600 hours, contingent upon possession of evidence of formal qualifications as a nurse responsible for general care referred to in Annex V, point 5.2.2; (c) full-time training as a midwife of at least 18 months or 3 000 hours, contingent upon possession of evidence of formal qualifications as a nurse responsible for general care referred to in Annex V, point 5.2.2 and followed by one year's professional practice for which a certificate has been issued in accordance with paragraph 2. 2. The certificate referred to in paragraph 1 shall be issued by the competent authorities in the home Member State. It shall certify that the holder, after obtaining evidence of formal qualifications as a midwife, has satisfactorily pursued all the activities of a midwife for a corresponding period in a hospital or a health care establishment approved for that purpose. Article 42 Pursuit of the professional activities of a midwife 1. The provisions of this section shall apply to the activities of midwives as defined by each Member State, without prejudice to paragraph 2, and pursued under the professional titles set out in Annex V, point 5.5.2. 2. The Member States shall ensure that midwives are able to gain access to and pursue at least the following activities: (a) provision of sound family planning information and advice; (b) diagnosis of pregnancies and monitoring normal pregnancies; carrying out the examinations necessary for the monitoring of the development of normal pregnancies; (c) prescribing or advising on the examinations necessary for the earliest possible diagnosis of pregnancies at risk; (d) provision of programmes of parenthood preparation and complete preparation for childbirth including advice on hygiene and nutrition; (e) caring for and assisting the mother during labour and monitoring the condition of the foetus in utero by the appropriate clinical and technical means; (f) conducting spontaneous deliveries including where required episiotomies and in urgent cases breech deliveries; (g) recognising the warning signs of abnormality in the mother or infant which necessitate referral to a doctor and assisting the latter where appropriate; taking the necessary emergency measures in the doctor's absence, in particular the manual removal of the placenta, possibly followed by manual examination of the uterus; (h) examining and caring for the new-born infant; taking all initiatives which are necessary in case of need and carrying out where necessary immediate resuscitation; (i) caring for and monitoring the progress of the mother in the post-natal period and giving all necessary advice to the mother on infant care to enable her to ensure the optimum progress of the new-born infant; (j) carrying out treatment prescribed by doctors; (k) drawing up the necessary written reports. Article 43 Acquired rights specific to midwives 1. Every Member State shall, in the case of Member State nationals whose evidence of formal qualifications as a midwife satisfies all the minimum training requirements laid down in Article 40 but, by virtue of Article 41, is not recognised unless it is accompanied by a certificate of professional practice referred to in Article 41(2), recognise as sufficient proof evidence of formal qualifications issued by those Member States before the reference date referred to in Annex V, point 5.5.2, accompanied by a certificate stating that those nationals have been effectively and lawfully engaged in the activities in question for at least two consecutive years during the five years preceding the award of the certificate. 2. The conditions laid down in paragraph 1 shall apply to the nationals of Member States whose evidence of formal qualifications as a midwife certifies completion of training received in the territory of the former German Democratic Republic and satisfying all the minimum training requirements laid down in Article 40 but where the evidence of formal qualifications, by virtue of Article 41, is not recognised unless it is accompanied by the certificate of professional experience referred to in Article 41(2), where it attests a course of training which began before 3 October 1990. 3. As regards the Polish evidence of formal qualifications as a midwife, only the following acquired rights provisions shall apply. In the case of Member States nationals whose evidence of formal qualifications as a midwife was awarded by, or whose training commenced in, Poland before 1 May 2004, and who do not satisfy the minimum training requirements as set out in Article 40, Member States shall recognise the following evidence of formal qualifications as a midwife if accompanied by a certificate stating that such persons have effectively and lawfully been engaged in the activities of a midwife for the period specified below: (a) evidence of formal qualifications as a midwife at degree level (dyplom licencjata położnictwa): at least three consecutive years during the five years prior to the date of issue of the certificate, (b) evidence of formal qualifications as a midwife certifying completion of post-secondary education obtained from a medical vocational school (dyplom położnej): at least five consecutive years during the seven years prior to the date of issue of the certificate. 4. Member States shall recognise evidence of formal qualifications in midwifery awarded in Poland, to midwives who completed training before 1 May 2004, which did not comply with the minimum training requirements laid down in Article 40, attested by the diploma ‘bachelor’ which has been obtained on the basis of a special upgrading programme contained in Article 11 of the Act of 20 April 2004 on the amendment of the Act on professions of nurse and midwife and on some other legal acts (Official Journal of the Republic of Poland of 30 April 2004 No 92, pos. 885), and the Regulation of the Minister of Health of 11 May 2004 on the detailed conditions of delivering studies for nurses and midwives, who hold a certificate of secondary school (final examination — matura) and are graduates of medical lyceum and medical vocational schools teaching in a profession of a nurse and a midwife (Official Journal of the Republic of Poland of 13 May 2004 No 110, pos 1170), with the aim of verifying that the person concerned has a level of knowledge and competence comparable to that of midwives holding the qualifications which, in the case of Poland, are defined in Annex V, point 5.5.2. Section 7 Pharmacist Article 44 Training as a pharmacist 1. Admission to a course of training as a pharmacist shall be contingent upon possession of a diploma or certificate giving access, in a Member State, to the studies in question, at universities or higher institutes of a level recognised as equivalent. 2. Evidence of formal qualifications as a pharmacist shall attest to training of at least five years' duration, including at least: (a) four years of full-time theoretical and practical training at a university or at a higher institute of a level recognised as equivalent, or under the supervision of a university; (b) six-month traineeship in a pharmacy which is open to the public or in a hospital, under the supervision of that hospital's pharmaceutical department. That training cycle shall include at least the programme described in Annex V, point 5.6.1. The contents listed in Annex V, point 5.6.1 may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting them to scientific and technical progress. Such updates must not entail, for any Member State, any amendment of existing legislative principles relating to the structure of professions as regards training and the conditions of access by natural persons. 3. Training for pharmacists shall provide an assurance that the person concerned has acquired the following knowledge and skills: (a) adequate knowledge of medicines and the substances used in the manufacture of medicines; (b) adequate knowledge of pharmaceutical technology and the physical, chemical, biological and microbiological testing of medicinal products; (c) adequate knowledge of the metabolism and the effects of medicinal products and of the action of toxic substances, and of the use of medicinal products; (d) adequate knowledge to evaluate scientific data concerning medicines in order to be able to supply appropriate information on the basis of this knowledge; (e) adequate knowledge of the legal and other requirements associated with the pursuit of pharmacy. Article 45 Pursuit of the professional activities of a pharmacist 1. For the purposes of this Directive, the activities of a pharmacist are those, access to which and pursuit of which are contingent, in one or more Member States, upon professional qualifications and which are open to holders of evidence of formal qualifications of the types listed in Annex V, point 5.6.2. 2. The Member States shall ensure that the holders of evidence of formal qualifications in pharmacy at university level or a level deemed to be equivalent, which satisfies the provisions of Article 44, are able to gain access to and pursue at least the following activities, subject to the requirement, where appropriate, of supplementary professional experience: (a) preparation of the pharmaceutical form of medicinal products; (b) manufacture and testing of medicinal products; (c) testing of medicinal products in a laboratory for the testing of medicinal products; (d) storage, preservation and distribution of medicinal products at the wholesale stage; (e) preparation, testing, storage and supply of medicinal products in pharmacies open to the public; (f) preparation, testing, storage and dispensing of medicinal products in hospitals; (g) provision of information and advice on medicinal products. 3. If a Member State makes access to or pursuit of one of the activities of a pharmacist contingent upon supplementary professional experience, in addition to possession of evidence of formal qualifications referred to in Annex V, point 5.6.2, that Member State shall recognise as sufficient proof in this regard a certificate issued by the competent authorities in the home Member State stating that the person concerned has been engaged in those activities in the home Member State for a similar period. 4. The recognition referred to in paragraph 3 shall not apply with regard to the two-year period of professional experience required by the Grand Duchy of Luxembourg for the grant of a State public pharmacy concession. 5. If, on 16 September 1985, a Member State had a competitive examination in place designed to select from among the holders referred to in paragraph 2, those who are to be authorised to become owners of new pharmacies whose creation has been decided on as part of a national system of geographical division, that Member State may, by way of derogation from paragraph 1, proceed with that examination and require nationals of Member States who possess evidence of formal qualifications as a pharmacist referred to in Annex V, point 5.6.2 or who benefit from the provisions of Article 23 to take part in it. Section 8 Architect Article 46 Training of architects 1. Training as an architect shall comprise a total of at least four years of full-time study or six years of study, at least three years of which on a full-time basis, at a university or comparable teaching institution. The training must lead to successful completion of a university-level examination. That training, which must be of university level, and of which architecture is the principal component, must maintain a balance between theoretical and practical aspects of architectural training and guarantee the acquisition of the following knowledge and skills: (a) ability to create architectural designs that satisfy both aesthetic and technical requirements; (b) adequate knowledge of the history and theories of architecture and the related arts, technologies and human sciences; (c) knowledge of the fine arts as an influence on the quality of architectural design; (d) adequate knowledge of urban design, planning and the skills involved in the planning process; (e) understanding of the relationship between people and buildings, and between buildings and their environment, and of the need to relate buildings and the spaces between them to human needs and scale; (f) understanding of the profession of architecture and the role of the architect in society, in particular in preparing briefs that take account of social factors; (g) understanding of the methods of investigation and preparation of the brief for a design project; (h) understanding of the structural design, constructional and engineering problems associated with building design; (i) adequate knowledge of physical problems and technologies and of the function of buildings so as to provide them with internal conditions of comfort and protection against the climate; (j) the necessary design skills to meet building users' requirements within the constraints imposed by cost factors and building regulations; (k) adequate knowledge of the industries, organisations, regulations and procedures involved in translating design concepts into buildings and integrating plans into overall planning. 2. The knowledge and skills listed in paragraph 1 may be amended in accordance with the procedure referred to in Article 58(2) with a view to adapting them to scientific and technical progress. Such updates must not entail, for any Member State, any amendment of existing legislative principles relating to the structure of professions as regards training and the conditions of access by natural persons. Article 47 Derogations from the conditions for the training of architects 1. By way of derogation from Article 46, the following shall also be recognised as satisfying Article 21: training existing as of 5 August 1985, provided by ‘Fachhochschulen’ in the Federal Republic of Germany over a period of three years, satisfying the requirements referred to in Article 46 and giving access to the activities referred to in Article 48 in that Member State under the professional title of ‘architect’, in so far as the training was followed by a four-year period of professional experience in the Federal Republic of Germany, as attested by a certificate issued by the professional association in whose roll the name of the architect wishing to benefit from the provisions of this Directive appears. The professional association must first ascertain that the work performed by the architect concerned in the field of architecture represents convincing application of the full range of knowledge and skills listed in Article 46(1). That certificate shall be awarded in line with the same procedure as that applying to registration in the professional association's roll. 2. By way of derogation from Article 46, the following shall also be recognised as satisfying Article 21: training as part of social betterment schemes or part-time university studies which satisfies the requirements referred to in Article 46, as attested by an examination in architecture passed by a person who has been working for seven years or more in the field of architecture under the supervision of an architect or architectural bureau. The examination must be of university level and be equivalent to the final examination referred to in Article 46(1), first subparagraph. Article 48 Pursuit of the professional activities of architects 1. For the purposes of this Directive, the professional activities of an architect are the activities regularly carried out under the professional title of ‘architect’. 2. Nationals of a Member State who are authorised to use that title pursuant to a law which gives the competent authority of a Member State the power to award that title to Member States nationals who are especially distinguished by the quality of their work in the field of architecture shall be deemed to satisfy the conditions required for the pursuit of the activities of an architect, under the professional title of ‘architect’. The architectural nature of the activities of the persons concerned shall be attested by a certificate awarded by their home Member State. Article 49 Acquired rights specific to architects 1. Each Member State shall accept evidence of formal qualifications as an architect listed in Annex VI, point 6, awarded by the other Member States, and attesting a course of training which began no later than the reference academic year referred to in that Annex, even if they do not satisfy the minimum requirements laid down in Article 46, and shall, for the purposes of access to and pursuit of the professional activities of an architect, give such evidence the same effect on its territory as evidence of formal qualifications as an architect which it itself issues. Under these circumstances, certificates issued by the competent authorities of the Federal Republic of Germany attesting that evidence of formal qualifications issued on or after 8 May 1945 by the competent authorities of the German Democratic Republic is equivalent to such evidence listed in that Annex, shall be recognised. 2. Without prejudice to paragraph 1, every Member State shall recognise the following evidence of formal qualifications and shall, for the purposes of access to and pursuit of the professional activities of an architect performed, give them the same effect on its territory as evidence of formal qualifications which it itself issues: certificates issued to nationals of Member States by the Member States which have enacted rules governing the access to and pursuit of the activities of an architect as of the following dates: (a) 1 January 1995 for Austria, Finland and Sweden; (b) 1 May 2004 for the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia; (c) 5 August 1987 for the other Member States. The certificates referred to in paragraph 1 shall certify that the holder was authorised, no later than the respective date, to use the professional title of architect, and that he has been effectively engaged, in the context of those rules, in the activities in question for at least three consecutive years during the five years preceding the award of the certificate. CHAPTER IV Common provisions on establishment Article 50 Documentation and formalities 1. Where the competent authorities of the host Member State decide on an application for authorisation to pursue the regulated profession in question by virtue of this Title, those authorities may demand the documents and certificates listed in Annex VII. The documents referred to in Annex VII, point 1(d), (e) and (f), shall not be more than three months old by the date on which they are submitted. The Member States, bodies and other legal persons shall guarantee the confidentiality of the information which they receive. 2. In the event of justified doubts, the host Member State may require from the competent authorities of a Member State confirmation of the authenticity of the attestations and evidence of formal qualifications awarded in that other Member State, as well as, where applicable, confirmation of the fact that the beneficiary fulfils, for the professions referred to in Chapter III of this Title, the minimum training conditions set out respectively in Articles 24, 25, 28, 31, 34, 35, 38, 40, 44 and 46. 3. In cases of justified doubt, where evidence of formal qualifications, as defined in Article 3(1)(c), has been issued by a competent authority in a Member State and includes training received in whole or in part in an establishment legally established in the territory of another Member State, the host Member State shall be entitled to verify with the competent body in the Member State of origin of the award: (a) whether the training course at the establishment which gave the training has been formally certified by the educational establishment based in the Member State of origin of the award; (b) whether the evidence of formal qualifications issued is the same as that which would have been awarded if the course had been followed entirely in the Member State of origin of the award; and (c) whether the evidence of formal qualifications confers the same professional rights in the territory of the Member State of origin of the award. 4. Where a host Member State requires its nationals to swear a solemn oath or make a sworn statement in order to gain access to a regulated profession, and where the wording of that oath or statement cannot be used by nationals of the other Member States, the host Member State shall ensure that the persons concerned can use an appropriate equivalent wording. Article 51 Procedure for the mutual recognition of professional qualifications 1. The competent authority of the host Member State shall acknowledge receipt of the application within one month of receipt and inform the applicant of any missing document. 2. The procedure for examining an application for authorisation to practise a regulated profession must be completed as quickly as possible and lead to a duly substantiated decision by the competent authority in the host Member State in any case within three months after the date on which the applicant's complete file was submitted. However, this deadline may be extended by one month in cases falling under Chapters I and II of this Title. 3. The decision, or failure to reach a decision within the deadline, shall be subject to appeal under national law. Article 52 Use of professional titles 1. If, in a host Member State, the use of a professional title relating to one of the activities of the profession in question is regulated, nationals of the other Member States who are authorised to practise a regulated profession on the basis of Title III shall use the professional title of the host Member State, which corresponds to that profession in that Member State, and make use of any associated initials. 2. Where a profession is regulated in the host Member State by an association or organisation within the meaning of Article 3(2), nationals of Member States shall not be authorised to use the professional title issued by that organisation or association, or its abbreviated form, unless they furnish proof that they are members of that association or organisation. If the association or organisation makes membership contingent upon certain qualifications, it may do so, only under the conditions laid down in this Directive, in respect of nationals of other Member States who possess professional qualifications. TITLE IV DETAILED RULES FOR PURSUING THE PROFESSION Article 53 Knowledge of languages Persons benefiting from the recognition of professional qualifications shall have a knowledge of languages necessary for practising the profession in the host Member State. Article 54 Use of academic titles Without prejudice to Articles 7 and 52, the host Member State shall ensure that the right shall be conferred on the persons concerned to use academic titles conferred on them in the home Member State, and possibly an abbreviated form thereof, in the language of the home Member State. The host Member State may require that title to be followed by the name and address of the establishment or examining board which awarded it. Where an academic title of the home Member State is liable to be confused in the host Member State with a title which, in the latter Member State, requires supplementary training not acquired by the beneficiary, the host Member State may require the beneficiary to use the academic title of the home Member State in an appropriate form, to be laid down by the host Member State. Article 55 Approval by health insurance funds Without prejudice to Article 5(1) and Article 6, first subparagraph, point (b), Member States which require persons who acquired their professional qualifications in their territory to complete a preparatory period of in-service training and/or a period of professional experience in order to be approved by a health insurance fund, shall waive this obligation for the holders of evidence of professional qualifications of doctor and dental practitioner acquired in other Member States. TITLE V ADMINISTRATIVE COOPERATION AND RESPONSIBILITY FOR IMPLEMENTATION Article 56 Competent authorities 1. The competent authorities of the host Member State and of the home Member State shall work in close collaboration and shall provide mutual assistance in order to facilitate application of this Directive. They shall ensure the confidentiality of the information which they exchange. 2. The competent authorities of the host and home Member States shall exchange information regarding disciplinary action or criminal sanctions taken or any other serious, specific circumstances which are likely to have consequences for the pursuit of activities under this Directive, respecting personal data protection legislation provided for in Directives 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (24) and 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (25). The home Member State shall examine the veracity of the circumstances and its authorities shall decide on the nature and scope of the investigations which need to be carried out and shall inform the host Member State of the conclusions which it draws from the information available to it. 3. Each Member State shall, no later than 20 October 2007, designate the authorities and bodies competent to award or receive evidence of formal qualifications and other documents or information, and those competent to receive applications and take the decisions referred to in this Directive, and shall forthwith inform the other Member States and the Commission thereof. 4. Each Member State shall designate a coordinator for the activities of the authorities referred to in paragraph 1 and shall inform the other Member States and the Commission thereof. The coordinators' remit shall be: (a) to promote uniform application of this Directive; (b) to collect all the information which is relevant for application of this Directive, such as on the conditions for access to regulated professions in the Member States. For the purpose of fulfilling the remit described in point (b), the coordinators may solicit the help of the contact points referred to in Article 57. Article 57 Contact points Each Member State shall designate, no later than 20 October 2007, a contact point whose remit shall be: (a) to provide the citizens and contact points of the other Member States with such information as is necessary concerning the recognition of professional qualifications provided for in this Directive, such as information on the national legislation governing the professions and the pursuit of those professions, including social legislation, and, where appropriate, the rules of ethics; (b) to assist citizens in realising the rights conferred on them by this Directive, in cooperation, where appropriate, with the other contact points and the competent authorities in the host Member State. At the Commission's request, the contact points shall inform the Commission of the result of enquiries with which they are dealing pursuant to the provisions of point (b) within two months of receiving them. Article 58 Committee on the recognition of professional qualifications 1. The Commission shall be assisted by a Committee on the recognition of professional qualifications, hereinafter referred to as ‘the Committee’, made up of representatives of the Member States and chaired by a representative of the Commission. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having due regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months. 3. The Committee shall adopt its rules of procedure. Article 59 Consultation The Commission shall ensure the consultation of experts from the professional groups concerned in an appropriate manner in particular in the context of the work of the committee referred to in Article 58 and shall provide a reasoned report on these consultations to that committee. TITLE VI OTHER PROVISIONS Article 60 Reports 1. As from 20 October 2007, Member States shall, every two years, send a report to the Commission on the application of the system. In addition to general observations, the report shall contain a statistical summary of decisions taken and a description of the main problems arising from the application of this Directive. 2. As from 20 October 2007, the Commission shall draw up every five years a report on the implementation of this Directive. Article 61 Derogation clause If, for the application of one of the provisions of this Directive, a Member State encounters major difficulties in a particular area, the Commission shall examine those difficulties in collaboration with the Member State concerned. Where appropriate, the Commission shall decide, in accordance with the procedure referred to in Article 58(2), to permit the Member State in question to derogate from the provision in question for a limited period. Article 62 Repeal Directives 77/452/EEC, 77/453/EEC, 78/686/EEC, 78/687/EEC, 78/1026/EEC, 78/1027/EEC, 80/154/EEC, 80/155/EEC, 85/384/EEC, 85/432/EEC, 85/433/EEC, 89/48/EEC, 92/51/EEC, 93/16/EEC and 1999/42/EC are repealed with effect from 20 October 2007. References to the repealed Directives shall be understood as references to this Directive and the acts adopted on the basis of those Directives shall not be affected by the repeal. Article 63 Transposition Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 October 2007 at the latest. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 64 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 65 Addressees This Directive is addressed to the Member States.

32005L0035

2005

DIRECTIVE 2005/35/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 on ship-source pollution and on the introduction of penalties for infringements Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The Community's maritime safety policy is aimed at a high level of safety and environmental protection and is based on the understanding that all parties involved in the transport of goods by sea have a responsibility for ensuring that ships used in Community waters comply with applicable rules and standards. (2) The material standards in all Member States for discharges of polluting substances from ships are based upon the Marpol 73/78 Convention; however these rules are being ignored on a daily basis by a very large number of ships sailing in Community waters, without corrective action being taken. (3) The implementation of Marpol 73/78 shows discrepancies among Member States and there is thus a need to harmonise its implementation at Community level; in particular the practices of Member States relating to the imposition of penalties for discharges of polluting substances from ships differ significantly. (4) Measures of a dissuasive nature form an integral part of the Community's maritime safety policy, as they ensure a link between the responsibility of each of the parties involved in the transport of polluting goods by sea and their exposure to penalties; in order to achieve effective protection of the environment there is therefore a need for effective, dissuasive and proportionate penalties. (5) To that end it is essential to approximate, by way of the proper legal instruments, existing legal provisions, in particular on the precise definition of the infringement in question, the cases of exemption and minimum rules for penalties, and on liability and jurisdiction. (6) This Directive is supplemented by detailed rules on criminal offences and penalties as well as other provisions set out in Council Framework Decision 2005/667/JHA of 12 July 2005 to strengthen the criminal law framework for the enforcement of the law against ship-source pollution (3). (7) Neither the international regime for the civil liability and compensation of oil pollution nor that relating to pollution by other hazardous or noxious substances provides sufficient dissuasive effects to discourage the parties involved in the transport of hazardous cargoes by sea from engaging in substandard practices; the required dissuasive effects can only be achieved through the introduction of penalties applying to any person who causes or contributes to marine pollution; penalties should be applicable not only to the shipowner or the master of the ship, but also the owner of the cargo, the classification society or any other person involved. (8) Ship-source discharges of polluting substances should be regarded as infringements if committed with intent, recklessly or by serious negligence. These infringements are regarded as criminal offences by, and in the circumstances provided for in, Framework Decision 2005/667/JHA supplementing this Directive. (9) Penalties for discharges of polluting substances from ships are not related to the civil liability of the parties concerned and are thus not subject to any rules relating to the limitation or channelling of civil liabilities, nor do they limit the efficient compensation of victims of pollution incidents. (10) There is a need for further effective cooperation among Member States to ensure that discharges of polluting substances from ships are detected in time and that the offenders are identified. For this reason, the European Maritime Safety Agency set up by Regulation (EC) No 1406/2002 of the European Parliament and of the Council of 27 June 2002 (4) has a key role to play in working with the Member States in developing technical solutions and providing technical assistance relating to the implementation of this Directive and in assisting the Commission in the performance of any task assigned to it for the effective implementation of this Directive. (11) In order better to prevent and combat marine pollution, synergies should be created between enforcement authorities such as national coastguard services. In this context, the Commission should undertake a feasibility study on a European coastguard dedicated to pollution prevention and response, making clear the costs and benefits. This study should, if appropriate, be followed by a proposal on a European coastguard. (12) Where there is clear, objective evidence of a discharge causing major damage or a threat of major damage, Member States should submit the matter to their competent authorities with a view to instituting proceedings in accordance with Article 220 of the 1982 United Nations Convention on the Law of the Sea. (13) The enforcement of Directive 2000/59/EC of the European Parliament and of the Council of 27 November 2000 on port reception facilities for ship-generated waste and cargo residues (5) is, together with this Directive, a key instrument in the set of measures to prevent ship-source pollution. (14) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6). (15) Since the objectives of this Directive, namely the incorporation of the international ship-source pollution standards into Community law and the establishment of penalties — criminal or administrative — for violation of them in order to ensure a high level of safety and environmental protection in maritime transport, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (16) This Directive fully respects the Charter of fundamental rights of the European Union; any person suspected of having committed an infringement must be guaranteed a fair and impartial hearing and the penalties must be proportional, Article 1 Purpose 1. The purpose of this Directive is to incorporate international standards for ship-source pollution into Community law and to ensure that persons responsible for discharges are subject to adequate penalties as referred to in Article 8, in order to improve maritime safety and to enhance protection of the marine environment from pollution by ships. 2. This Directive does not prevent Member States from taking more stringent measures against ship-source pollution in conformity with international law. Article 2 Definitions For the purpose of this Directive: 1. ‘Marpol 73/78’ shall mean the International Convention for the Prevention of Pollution from Ships, 1973 and its 1978 Protocol, in its up-to-date version; 2. ‘polluting substances’ shall mean substances covered by Annexes I (oil) and II (noxious liquid substances in bulk) to Marpol 73/78; 3. ‘discharge’ shall mean any release howsoever caused from a ship, as referred to in Article 2 of Marpol 73/78; 4. ‘ship’ shall mean a seagoing vessel, irrespective of its flag, of any type whatsoever operating in the marine environment and shall include hydrofoil boats, air-cushion vehicles, submersibles and floating craft. Article 3 Scope 1. This Directive shall apply, in accordance with international law, to discharges of polluting substances in: (a) the internal waters, including ports, of a Member State, in so far as the Marpol regime is applicable; (b) the territorial sea of a Member State; (c) straits used for international navigation subject to the regime of transit passage, as laid down in Part III, section 2, of the 1982 United Nations Convention on the Law of the Sea, to the extent that a Member State exercises jurisdiction over such straits; (d) the exclusive economic zone or equivalent zone of a Member State, established in accordance with international law; and (e) the high seas. 2. This Directive shall apply to discharges of polluting substances from any ship, irrespective of its flag, with the exception of any warship, naval auxiliary or other ship owned or operated by a State and used, for the time being, only on government non-commercial service. Article 4 Infringements Member States shall ensure that ship-source discharges of polluting substances into any of the areas referred to in Article 3(1) are regarded as infringements if committed with intent, recklessly or by serious negligence. These infringements are regarded as criminal offences by, and in the circumstances provided for in, Framework Decision 2005/667/JHA supplementing this Directive. Article 5 Exceptions 1. A discharge of polluting substances into any of the areas referred to in Article 3(1) shall not be regarded as an infringement if it satisfies the conditions set out in Annex I, Regulations 9, 10, 11(a) or 11(c) or in Annex II, Regulations 5, 6(a) or 6(c) of Marpol 73/78. 2. A discharge of polluting substances into the areas referred to in Article 3(1)(c), (d) and (e) shall not be regarded as an infringement for the owner, the master or the crew when acting under the master's responsibility if it satisfies the conditions set out in Annex I, Regulation 11(b) or in Annex II, Regulation 6(b) of Marpol 73/78. Article 6 Enforcement measures with respect to ships within a port of a Member State 1. If irregularities or information give rise to a suspicion that a ship which is voluntarily within a port or at an off-shore terminal of a Member State has been engaged in or is engaging in a discharge of polluting substances into any of the areas referred to in Article 3(1), that Member State shall ensure that an appropriate inspection, taking into account the relevant guidelines adopted by the International Maritime Organisation (IMO), is undertaken in accordance with its national law. 2. In so far as the inspection referred to in paragraph 1 reveals facts that could indicate an infringement within the meaning of Article 4, the competent authorities of that Member State and of the flag State shall be informed. Article 7 Enforcement measures by coastal States with respect to ships in transit 1. If the suspected discharge of polluting substances takes place in the areas referred to in Article 3(1)(b), (c), (d) or (e) and the ship which is suspected of the discharge does not call at a port of the Member State holding the information relating to the suspected discharge, the following shall apply: (a) If the next port of call of the ship is in another Member State, the Member States concerned shall cooperate closely in the inspection referred to in Article 6(1) and in deciding on the appropriate measures in respect of any such discharge; (b) If the next port of call of the ship is a port of a State outside the Community, the Member State shall take the necessary measures to ensure that the next port of call of the ship is informed about the suspected discharge and shall request the State of the next port of call to take the appropriate measures in respect of any such discharge. 2. Where there is clear, objective evidence that a ship navigating in the areas referred to in Article 3(1)(b) or (d) has, in the area referred to in Article 3(1)(d), committed an infringement resulting in a discharge causing major damage or a threat of major damage to the coastline or related interests of the Member State concerned, or to any resources of the areas referred to in Article 3(1)(b) or (d), that State shall, subject to Part XII, Section 7 of the 1982 United Nations Convention on the Law of the Sea and provided that the evidence so warrants, submit the matter to its competent authorities with a view to instituting proceedings, including detention of the ship, in accordance with its national law. 3. In any event, the authorities of the flag State shall be informed. Article 8 Penalties 1. Member States shall take the necessary measures to ensure that infringements within the meaning of Article 4 are subject to effective, proportionate and dissuasive penalties, which may include criminal or administrative penalties. 2. Each Member State shall take the measures necessary to ensure that the penalties referred to in paragraph 1 apply to any person who is found responsible for an infringement within the meaning of Article 4. Article 9 Compliance with international law Member States shall apply the provisions of this Directive without any discrimination in form or in fact against foreign ships and in accordance with applicable international law, including Section 7 of Part XII of the 1982 United Nations Convention on the Law of the Sea, and they shall promptly notify the flag State of the vessel and any other State concerned of measures taken in accordance with this Directive. Article 10 Accompanying measures 1. For the purposes of this Directive, Member States and the Commission shall cooperate, where appropriate, in close collaboration with the European Maritime Safety Agency and taking account of the action programme to respond to accidental or deliberate marine pollution set up by Decision No 2850/2000/EC (7) and if appropriate, of the implementation of Directive 2000/59/EC in order to: (a) develop the necessary information systems required for the effective implementation of this Directive; (b) establish common practices and guidelines on the basis of those existing at international level, in particular for: — the monitoring and early identification of ships discharging polluting substances in violation of this Directive, including, where appropriate, on-board monitoring equipment, — reliable methods of tracing polluting substances in the sea to a particular ship, and — the effective enforcement of this Directive. 2. In accordance with its tasks as defined in Regulation (EC) No 1406/2002, the European Maritime Safety Agency shall: (a) work with the Member States in developing technical solutions and providing technical assistance in relation to the implementation of this Directive, in actions such as tracing discharges by satellite monitoring and surveillance; (b) assist the Commission in the implementation of this Directive, including, if appropriate, by means of visits to the Member States, in accordance with Article 3 of Regulation (EC) No 1406/2002. Article 11 Feasibility Study The Commission shall, before the end of 2006, submit to the European Parliament and the Council a feasibility study on a European coastguard dedicated to pollution prevention and response, making clear the costs and benefits. Article 12 Reporting Every three years, Member States shall transmit a report to the Commission on the application of this Directive by the competent authorities. On the basis of these reports, the Commission shall submit a Community report to the European Parliament and the Council. In this report, the Commission shall assess, inter alia, the desirability of revising or extending the scope of this Directive. It shall also describe the evolution of relevant case-law in the Member States and shall consider the possibility of creating a public database containing such relevant case-law. Article 13 Committee procedure 1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS), established by Article 3 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council, of 5 November 2002 (8). 2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month. Article 14 Provision of information The Commission shall regularly inform the Committee set up by Article 4 of Decision No 2850/2000/EC of any proposed measures or other relevant activities concerning the response to marine pollution. Article 15 Amendment procedure In accordance with Article 5 of Regulation (EC) No 2099/2002 and following the procedure referred to in Article 13 of this Directive, the COSS may exclude amendments to Marpol 73/78 from the scope of this Directive. Article 16 Implementation Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 March 2007 and forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 17 Entry into force This Directive shall enter into force on the day following its publication in the Official Journal of the European Union. Article 18 Addressees This Directive is addressed to the Member States.

32005L0039

2005

DIRECTIVE 2005/39/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 amending Council Directive 74/408/EEC relating to motor vehicles with regard to the seats, their anchorages and head restraints (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Research has shown that the use of safety belts and restraint systems can substantially reduce the number of fatalities and the severity of injuries in the event of an accident, even one due to rollover. Fitting them in all categories of vehicles will certainly constitute an important step forward in bringing about an increase in road safety and a consequent saving of lives. (2) A substantial benefit to society can be attained if all vehicles are fitted with safety belts. (3) In its Resolution of 18 February 1986 on common measures to reduce road accidents, as part of the Community's programme for road safety (3), the European Parliament stressed the need for making the wearing of safety belts compulsory for all passengers, including children, except in public service vehicles. Therefore, a distinction has to be made between public service buses and other vehicles as regards the compulsory installation of safety belts and/or restraint systems. (4) Pursuant to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4), the Community type-approval system has only been implemented for all new vehicles of category M1 since 1 January 1998. Consequently, only vehicles of category M1 type-approved after that date have to be fitted with seats, seat anchorages and head restraints complying with the provisions of Directive 74/408/EEC (5). (5) Until the Community type-approval system is extended to all categories of vehicles, the installation of seats and seat anchorages compatible with the installation of seat belt anchorages should be required, in the interests of road safety, in vehicles belonging to categories other than M1. (6) Directive 74/408/EEC already provides for all technical and administrative provisions allowing the type-approval of vehicles of categories other than M1. Therefore, the Member States do not need to introduce further provisions. (7) Since the entry into force of Commission Directive 96/37/EC of 17 June 1996 adapting to technical progress Council Directive 74/408/EEC (6), several Member States have already made compulsory the provisions contained therein in respect of certain categories of vehicles other than M1. Manufacturers and their suppliers have thus developed the appropriate technology. (8) Research has shown that it is not possible to provide side-facing seats with safety belts ensuring the same level of safety to the occupants as front-facing seats. For safety reasons, it is necessary to ban those seats in certain categories of vehicles. (9) The provisions allowing side-facing seats with two-point belts in certain classes of vehicle of category M3 should be of a temporary nature, pending the entry into force of Community legislation recasting Directive 70/156/EEC and extending Community type-approval to all vehicles, including vehicles of category M3. (10) Directive 74/408/EEC should be amended accordingly. (11) Since the objective of this Directive, namely the improvement of road safety by making compulsory the fitting of safety belts in certain categories of vehicles, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Amendments to Directive 74/408/EEC Directive 74/408/EEC is hereby amended as follows: 1. Article 1 shall be amended as follows: (a) the following subparagraph shall be added to paragraph 1: ‘Vehicles of category M2 and M3 shall be subdivided into classes as defined in section 2 of Annex I to Directive 2001/85/EC of the European Parliament and of the Council of 20 November 2001 relating to special provisions for vehicles used for the carriage of passengers comprising more than eight seats in addition to the driver's seat (7). (b) paragraph 2 shall be replaced by the following: ‘2. This Directive shall not apply to rearward-facing seats.’ 2. The following Article shall be inserted: ‘Article 3a 1. The installation of side-facing seats shall be prohibited in vehicles of categories M1, N1, M2 (of class III or B) and M3 (of class III or B). 2. Paragraph 1 shall not apply to ambulances or to vehicles listed in the first indent of Article 8(1) of Directive 70/156/EEC. 3. Paragraph 1 shall further not apply to vehicles of category M3 (of class III or B) of a technically permissible maximum laden mass exceeding 10 tonnes in which side-facing seats are grouped together at the rear of the vehicle to form an integrated saloon of up to 10 seats. Such side-facing seats shall be fitted with, at least, a head restraint and a two-point belt with retractor type-approved in accordance with Council Directive 77/541/EEC (8). The anchorages for their safety belts shall comply with Council Directive 76/115/EEC (9). This exemption shall have effect for five years from 20 October 2005. It may be extended if reliable accident statistics are available and there has been further development of restraint systems. 3. Annex II shall be amended as follows: (a) Point 1.1 shall be replaced by the following: ‘1.1. The requirements of this Annex do not apply to rearward-facing seats or to any head restraint fitted to such seats.’ (b) Point 2.3 shall be replaced by the following: ‘2.3. “Seat” means a structure which may or may not be integral with the vehicle structure, complete with trim, intended to seat one adult person. The term covers both an individual seat or part of a bench seat intended to seat one person. Depending on its orientation, a seat is defined as follows: 2.3.1. “Forward-facing seat” means a seat which can be used whilst the vehicle is in motion and which faces towards the front of the vehicle in such a manner that the vertical plane of symmetry of the seat forms an angle of less than + 10o or - 10o with the vertical plane of symmetry of the vehicle; 2.3.2. “Rearward-facing seat” means a seat which can be used whilst the vehicle is in motion and which faces towards the rear of the vehicle in such a manner that the vertical plane of symmetry of the seat forms an angle of less than + 10o or - 10o with the vertical plane of symmetry of the vehicle; 2.3.3. “Side-facing seat” means a seat which, with regard to its alignment with the vertical plane of symmetry of the vehicle, does not meet either of the definitions given in 2.3.1 or 2.3.2 above;’ (c) Point 2.9 shall be deleted; 4. In Annex III, point 2.5 shall be replaced by the following: ‘2.5. “Seat” means a structure likely to be anchored to the vehicle structure, including its trim and attachment fittings, intended to be used in a vehicle and to seat one or more adult persons. Depending on its orientation, a seat is defined as follows: 2.5.1. “Forward-facing seat” means a seat which can be used whilst the vehicle is in motion and which faces towards the front of the vehicle in such a manner that the vertical plane of symmetry of the seat forms an angle of less than + 10o or - 10o with the vertical plane of symmetry of the vehicle; 2.5.2. “Rearward-facing seat” means a seat which can be used whilst the vehicle is in motion and which faces towards the rear of the vehicle in such a manner that the vertical plane of symmetry of the seat forms an angle of less than + 10o or - 10o with the vertical plane of symmetry of the vehicle; 2.5.3. “Side-facing seat” means a seat which, with regard to its alignment with the vertical plane of symmetry of the vehicle, does not meet either of the definitions given in 2.5.1 or 2.5.2 above;’ 5. Annex IV shall be amended as follows: (a) Point 1.1 shall be replaced by the following: ‘1.1. The requirements set out in this Annex apply to vehicles of categories N1, N2 and N3 and to those of categories M2 and M3 not covered by the scope of Annex III. With the exception of the provisions of point 2.5, the requirements also apply to side-facing seats of all categories of vehicles.’ (b) Point 2.4 shall be replaced by the following: ‘2.4. All seats which can be tipped forward or have fold-on backs must lock automatically in the normal position. This requirement does not apply to seats fitted in the wheelchair spaces of vehicles of category M2 or M3 of class I, II or A.’ Article 2 Implementation 1. As from 20 April 2006, with respect to seats, their anchorages and head restraints which comply with the requirements set out in this Directive, Member States shall not: (a) refuse to grant EC type-approval or national type-approval, in respect of a type of vehicle; (b) prohibit the registration, sale or entry into service of new vehicles. 2. As from 20 October 2006, with respect to seats, their anchorages and head restraints which do not comply with the requirements set out in this Directive, Member States shall, in respect of a new type of vehicle: (a) no longer grant EC type-approval; (b) refuse to grant national type-approval. 3. As from 20 October 2007, with respect to seats, their anchorages and head restraints which do not comply with the requirements set out in this Directive, Member States shall: (a) consider certificates of conformity which accompany new vehicles as no longer valid for the purpose of Article 7(1) of Directive 70/156/EEC; (b) refuse the registration, sale and entry into service of new vehicles, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked. Article 3 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 20 April 2006. They shall forthwith inform the Commission thereof. 2. They shall apply these measures from 21 April 2006. 3. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 4. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 5 Addressees This Directive is addressed to the Member States.

32005L0045

2005

DIRECTIVE 2005/45/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 on the mutual recognition of seafarers' certificates issued by the Member States and amending Directive 2001/25/EC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) In its conclusions of 5 June 2003 on improving the image of Community shipping and attracting young people to the seafaring profession, the Council highlighted the necessity of fostering the professional mobility of seafarers within the European Union, with particular emphasis on recognition procedures for seafarers' certificates of competency, while ensuring thorough compliance with the requirements of the International Maritime Organisation (IMO) Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978 (the STCW Convention) in its up to date version. (2) Maritime transport is an intensively and rapidly developing sector of a particularly international character. Accordingly, in view of the increasing shortage of Community seafarers, the balance between supply and demand in personnel can be maintained more efficiently at the Community, rather than the national level. It is therefore essential that the common transport policy in the field of maritime transport be extended to facilitate the movement of seafarers within the Community. (3) As regards seafarers' qualifications, the Community has laid down minimum maritime education, training and certification requirements by way of Directive 2001/25/EC of the European Parliament and of the Council of 4 April 2001 on the minimum level of training of seafarers (3). That Directive incorporates into Community law the international training, certification and watchkeeping standards laid down by the STCW Convention. (4) Directive 2001/25/EC provides that seafarers must hold a certificate of competency issued and endorsed by the competent authority of a Member State in accordance with that Directive and entitling the lawful holder thereof to serve on a ship in the capacity and perform the functions involved at the level of responsibility specified therein. (5) Under Directive 2001/25/EC, mutual recognition among Member States of certificates held by seafarers, whether or not nationals of a Member State, is subject to Directives 89/48/EEC (4) and 92/51/EEC (5) setting up, respectively, a first and a second general system for the recognition of professional education and training. Those Directives do not provide for the automatic recognition of formal qualifications of seafarers, as seafarers may be subject to compensation measures. (6) Each Member State should recognise any certificate and other evidence of formal qualifications issued by another Member State in accordance with Directive 2001/25/EC. Therefore, each Member State should permit a seafarer having acquired his/her certificate of competency in another Member State, satisfying the requirements of that Directive, to take up or to pursue the maritime profession for which he/she is qualified, without any prerequisites other than those imposed on its own nationals. (7) Since this Directive is aimed at facilitating the mutual recognition of certificates, it does not regulate the conditions concerning access to employment. (8) The STCW Convention specifies language requirements for seafarers. These requirements should be introduced into Community law to ensure effective communication on board ships and facilitate the free movement of seafarers within the Community. (9) Today, the proliferation of certificates of competency of seafarers obtained by fraud poses a serious danger to safety at sea and the protection of the marine environment. In most cases, holders of fraudulent certificates of competency do not meet the minimum certification requirements of the STCW Convention. These seafarers could easily be involved in maritime accidents. (10) Member States should therefore take and enforce specific measures to prevent and penalise fraudulent practices associated with certificates of competency as well as pursue their efforts within the IMO to achieve strict and enforceable agreements on the worldwide combating of such practices. The Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) is an appropriate forum for exchanging information, experience and best practices in this respect. (11) Regulation (EC) No 1406/2002 (6), established a European Maritime Safety Agency (the Agency), for the purpose of ensuring a high, uniform and effective level of maritime safety and prevention of pollution from ships. One of the tasks assigned to the Agency is to assist the Commission in the performance of any task assigned to it by Community legislation applicable to the training, certification and watchkeeping of ships' crews. (12) The Agency should therefore assist the Commission in verifying that Member States comply with the requirements laid down in this Directive and Directive 2001/25/EC. (13) The mutual recognition among Member States of certificates held by seafarers, whether or not nationals of a Member State, should no longer be subject to Directives 89/48/EEC and 92/51/EEC, but should be governed by this Directive. (14) Directive 2001/25/EC should therefore be amended accordingly. (15) Since the objective of this Directive, namely the mutual recognition of the seafarers' certificates issued by the Member States, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (16) In accordance with paragraph 34 of the Interinstitutional Agreement on better law-making (7), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables, which will, as far as possible, illustrate the correlation between this Directive and their transposition measures, and to make those tables public, Article 1 Scope This Directive shall apply to seafarers who are: (a) nationals of a Member State; (b) non-nationals who hold a certificate issued by a Member State. Article 2 Definitions For the purposes of this Directive the following definitions shall apply: (a) ‘seafarer’ means a person who is trained and who is certificated by a Member State at least in accordance with the requirements laid down in Annex I to Directive 2001/25/EC; (b) ‘certificate’ means a valid document within the meaning of Article 4 of Directive 2001/25/EC; (c) ‘appropriate certificate’ means a certificate as defined in Article 1(27) of Directive 2001/25/EC; (d) ‘endorsement’ means a valid document issued by the competent authority of a Member State in accordance with Article 5(2) and (6) of Directive 2001/25/EC; (e) ‘recognition’ means the acceptance by the competent authorities of a host Member State of a certificate or appropriate certificate issued by another Member State; (f) ‘host Member State’ means any Member State in which a seafarer seeks recognition of his/her appropriate certificate(s) or other certificate(s); (g) ‘STCW Convention’ means the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, in its up-to-date version; (h) ‘STCW Code’ means the Seafarers' Training, Certification and Watchkeeping Code, as adopted by Resolution 2 of the 1995 STCW Conference of Parties, in its up-to-date version; (i) ‘the Agency’ means the European Maritime Safety Agency, established by Regulation (EC) No 1406/2002. Article 3 Recognition of certificates 1. Every Member State shall recognise appropriate certificates or other certificates issued by another Member State in accordance with the requirements laid down in Directive 2001/25/EC. 2. The recognition of appropriate certificates shall be limited to the capacities, functions and levels of competency prescribed therein and be accompanied by an endorsement attesting such recognition. 3. Member States shall ensure the right to appeal against any refusal to endorse a valid certificate, or the absence of any response, in accordance with national legislation and procedures. 4. Notwithstanding paragraph 2, the competent authorities of a host Member State may impose further limitations on capacities, functions and levels of competence relating to near-coastal voyages, as referred to in Article 7 of Directive 2001/25/EC, or alternative certificates issued under Regulation VII/1 of Annex I to Directive 2001/25/EC. 5. A host Member State shall ensure that seafarers who present for recognition certificates for functions at the management level have an appropriate knowledge of the maritime legislation of that Member State relevant to the functions they are permitted to perform. Article 4 Amendments to Directive 2001/25/EC Directive 2001/25/EC is hereby amended as follows: 1. Article 4 shall be replaced by: ‘Article 4 Certificate A certificate shall be any valid document, by whatever name it may be known, issued by or under the authority of the competent authority of a Member State in accordance with Article 5 and with the requirements laid down in Annex I.’; 2. the following Article shall be inserted: ‘Article 7a Prevention of fraud and other unlawful practices 1. Member States shall take and enforce the appropriate measures to prevent fraud and other unlawful practices involving the certification process or certificates issued and endorsed by their competent authorities, and shall provide for penalties that are effective, proportionate and dissuasive. 2. Member States shall designate the national authorities competent to detect and combat fraud and other unlawful practices and exchange information with the competent authorities of other Member States and of third countries concerning the certification of seafarers. Member States shall forthwith inform the other Member States and the Commission of the details of such competent national authorities. Member States shall also forthwith inform any third countries with which they have entered into an undertaking in accordance with Regulation I/10, paragraph 1.2 of the STCW Convention of the details of such competent national authorities. 3. At the request of a host Member State, the competent authorities of another Member State shall provide written confirmation or denial of the authenticity of seafarers' certificates, corresponding endorsements or any other documentary evidence of training issued in that other Member State.’; 3. Article 18(1) and (2) shall be deleted with effect from 20 October 2007; 4. The following Articles shall be inserted: ‘Article 21a Regular monitoring of compliance Without prejudice to the powers of the Commission under Article 226 of the Treaty, the Commission, assisted by the European Maritime Safety Agency, established by Regulation (EC) No 1406/2002 (8), shall verify on a regular basis and at least every five years that Member States comply with the minimum requirements laid down by this Directive. Article 21b Compliance report No later than 20 October 2010 the Commission shall submit to the European Parliament and the Council an evaluation report drawn up on the basis of the information obtained pursuant to Article 21a. In the report the Commission shall analyse the Member States' compliance with this Directive and, where necessary, make proposals for additional measures. 5. the following paragraph shall be inserted in Annex I, Chapter I: ‘1a. Member States shall ensure that seafarers possess adequate language proficiency, as defined in Sections A-II/1, A-III/1, A-IV/2 and A-II/4 of the STCW Code so as to enable them to perform their specific duties on a vessel flying the flag of a host Member State.’ Article 5 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 October 2007. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Article 6 Entry into force This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Article 7 Addressees This Directive is addressed to the Member States.

32005L0041

2005

DIRECTIVE 2005/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 amending Council Directive 76/115/EEC on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Research has shown that the use of safety belts and restraint systems can contribute to a substantial reduction in the number of fatalities and the severity of injury in the event of an accident, even due to rollover. Their fitting in all categories of vehicles will certainly constitute an important step forward in bringing about an increase in road safety and a consequent saving of lives. (2) A substantial benefit to society can be attained if all vehicles are provided with safety belts. (3) In its Resolution of 18 February 1986 on common measures to reduce road accidents, as part of the Community's programme for road safety (3), the European Parliament stressed the need for making the wearing of safety belts compulsory for all passengers, including children, except in public service vehicles. Therefore, a distinction has to be made between public service buses and other vehicles as regards the compulsory installation of safety belts and/or restraint systems. (4) Pursuant to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4), the Community type-approval system has only been implemented for all new vehicles of category M1 since 1 January 1998. Consequently, only these vehicles have to be fitted with anchorages intended for safety belts and/or restraint systems fulfilling the provisions of Directive 76/115/EEC (5). (5) Until the Community type-approval system is extended to all categories of vehicles, the installation of anchorages intended for safety belts and/or restraint systems should be required, in the interests of road safety, in vehicles belonging to categories other than M1. (6) Directive 76/115/EEC already provides for all technical and administrative provisions allowing the type-approval of vehicles of categories other than M1. Therefore, the Member States do not need to introduce further provisions. (7) Since the entry into force of Commission Directive 96/38/EC of 17 June 1996 adapting to technical progress Council Directive 76/115/EEC relating to anchorages for motor vehicle safety belts, several Member States have already made compulsory the provisions contained therein in respect of certain categories of vehicles other than M1. Manufacturers and their suppliers have thus developed appropriate technology. (8) Directive 76/115/EEC should be amended accordingly. (9) Since the objective of this Directive, namely the improvement of road safety by the introduction of the compulsory fitting of safety belts in certain categories of vehicles, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Amendments to Directive 76/115/EEC Directive 76/115/EEC is hereby amended as follows: (1) In Article 2 the following paragraph shall be added: ‘Vehicles of category M2 and M3 shall be subdivided into classes as defined in section 2 of Annex I to Directive 2001/85/EC of the European Parliament and of the Council of 20 November 2001 relating to special provisions for vehicles used for the carriage of passengers comprising more than eight seats in addition to the driver's seat (6). (2) Annex I shall be amended as follows: (a) point 1.9. shall be deleted; (b) point 4.3.1. shall be replaced by the following: ‘4.3.1. Vehicles belonging to categories M1, M2 (of class III or B), M3 (of class III or B) and N must be equipped with anchorages for safety belts conforming to the requirements of this Directive.’; (c) point 4.3.8. shall be replaced by the following: ‘4.3.8. For seating intended solely for use when the vehicle is stationary, as well as any seats of any vehicle not covered in points 4.3.1. to 4.3.5., no belt anchorages are required. If the vehicle is fitted with anchorages for such seats, these anchorages must comply with the provisions of this Directive. However, any anchorage intended solely for use in conjunction with a disabled person's belt, or any other restraint system mentioned in Article 2a of Council Directive 77/541/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (7), need not conform to the requirements of this Directive provided it is designed and constructed under national legal requirements to provide the maximum practical level of safety. Article 2 Measures envisaged for disabled people No later than 20 April 2008, the Commission shall examine specific procedures to harmonise requirements for anchorages intended solely for use in conjunction with a disabled person's belt, or any other restraint system mentioned in Article 2a of Directive 77/541/EEC, based upon existing international standards and national legal requirements, in order to provide an equivalent level of safety to this Directive. If appropriate, the Commission shall present draft measures. Amendments to this Directive shall be adopted in accordance with Article 13 of Directive 70/156/EEC. Article 3 Implementation 1. As from 20 April 2006, with respect to the anchorages for safety belts which comply with the requirements set out in Directive 76/115/EEC as amended by this Directive, Member States shall not: (a) refuse to grant EC type-approval or national type-approval, in respect of a type of vehicle; (b) prohibit the registration, sale or entry into service of new vehicles. 2. As from 20 October 2006, with respect to the anchorages for safety belts which do not comply with the requirements set out in Directive 76/115/EEC as amended by this Directive, Member States shall, in respect of a new type of vehicle: (a) no longer grant EC type-approval; (b) refuse to grant national type-approval. 3. As from 20 October 2007, with respect to the anchorages for safety belts which do not comply with the requirements set out in Directive 76/115/EEC as amended by this Directive, Member States shall: (a) consider certificates of conformity which accompany new vehicles as no longer valid for the purpose of Article 7(1) of Directive 70/156/EEC; (b) refuse the registration, sale or entry into service of new vehicles, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked. Article 4 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 20 April 2006. They shall forthwith inform the Commission thereof. 2. They shall apply those measures from 21 April 2006. 3. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 4. Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive. Article 5 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 6 Addressees This Directive is addressed to the Member States.

32005L0040

2005

DIRECTIVE 2005/40/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 amending Council Directive 77/541/EEC on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Research has shown that the use of safety belts and restraint systems can contribute to a substantial reduction in the number of fatalities and the severity of injury in the event of an accident, even due to rollover. Their fitting in all categories of vehicles will certainly constitute an important step forward in bringing about an increase in road safety and a consequent saving of lives. (2) A substantial benefit to society can be attained if all vehicles are provided with safety belts. (3) In its Resolution of 18 February 1986 on common measures to reduce road accidents, as part of the Community's programme for road safety (3), the European Parliament stressed the need for making the wearing of safety belts compulsory for all passengers, including children, except in public service vehicles. Therefore, a distinction has to be made between public service buses and other vehicles as regards the compulsory installation of safety belts and/or restraint systems. (4) Pursuant to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4), the Community type-approval system has only been implemented for all new vehicles of category M1 since 1 January 1998. Consequently, only these vehicles have to be fitted with safety belts and/or restraint systems fulfilling the provisions of Directive 77/541/EEC (5). (5) Until the Community type-approval system is extended to all categories of vehicles, the installation of safety belts and/or restraint systems should be required, in the interests of road safety, in vehicles belonging to categories other than M1. (6) Directive 77/541/EEC already provides for all technical and administrative provisions allowing the type-approval of vehicles of categories other than M1. Therefore, the Member States do not need to introduce further provisions. (7) Since the entry into force of Commission Directive 96/36/EC of 17 June 1996 adapting to technical progress Council Directive 77/541/EEC relating to safety belts and restraint systems of motor vehicles (6), several Member States have already made compulsory the provisions contained therein in respect of certain categories of vehicles other than M1. Manufacturers and their suppliers have thus developed the appropriate technology. (8) Directive 2001/85/EC of the European Parliament and of the Council of 20 November 2001 relating to special provisions for vehicles used for the carriage of passengers comprising more than eight seats in addition to the driver's seat (7), makes provision for allowing persons of reduced mobility such as disabled people to access more easily vehicles used for the carriage of passengers comprising more than eight seats. It is necessary to allow Member States to permit the installation of safety belts and/or restraint systems which do not comply with the technical specifications of Directive 77/541/EEC but are specifically designed for the purposes of securing those people in such vehicles. (9) Directive 77/541/EEC should be amended accordingly. (10) Since the objective of this Directive, namely the improvement of road safety by the introduction of the compulsory fitting of safety belts in certain categories of vehicles, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, Article 1 Amendments to Directive 77/541/EEC Directive 77/541/EEC is hereby amended as follows: 1. the following Article shall be inserted: ‘Article 2a 1. Member States may, under national law, allow the installation of safety belts or restraint systems other than those covered by this Directive provided they are intended for disabled people. 2. Member States may also exempt restraint systems designed to comply with the provisions of Annex VII to Directive 2001/85/EC of the European Parliament and of the Council of 20 November 2001 relating to special provisions for vehicles used for the carriage of passengers comprising more than eight seats in addition to the driver's seat (8) from the provisions of this Directive. 3. The requirements of Annex I, point 3.2.1 of this Directive shall not apply to seat belts and restraint systems covered by paragraphs 1 and 2. 2. in Article 9, the following paragraph shall be added: ‘Vehicles of category M2 and M3 shall be subdivided into classes as defined in section 2 of Annex I to Directive 2001/85/EC.’; 3. Annex I shall be amended as follows: (a) the footnote related to point 3.1 shall be deleted; (b) point 3.1.1 shall be replaced by the following: ‘3.1.1. With the exception of seating intended solely for use when the vehicle is stationary, the seats of vehicles belonging to category M1, M2 (of class III or B), M3 (of class III or B) and N shall be equipped with safety belts and/or restraint systems conforming to the requirements of this Directive. Class I, II or A vehicles belonging to category M2 or M3 may be fitted with safety belts and/or restraint systems, provided they conform to the requirements of this Directive.’ Article 2 Measures envisaged for disabled people No later than 20 April 2008, the Commission shall examine specific procedures to harmonise requirements for safety belts intended for disabled people, based upon existing international standards and national legal requirements, in order to provide an equivalent level of safety to this Directive. If appropriate, the Commission shall present draft measures. Amendments to this Directive shall be adopted in accordance with Article 13 of Directive 70/156/EEC. Article 3 Implementation 1. As from 20 April 2006, with respect to the installation of safety belts and/or restraint systems which comply with the requirements set out in Directive 77/541/EEC as amended by this Directive, Member States shall not: (a) refuse to grant EC type-approval or national type-approval, in respect of a type of vehicle; (b) prohibit the registration, sale or entry into service of new vehicles. 2. As from 20 October 2006, with respect to the installation of safety belts and/or restraint systems which do not comply with the requirements set out in Directive 77/541/EEC as amended by this Directive, Member States shall, in respect of a new type of vehicle: (a) no longer grant EC type-approval; (b) refuse to grant national type-approval. 3. As from 20 October 2007, with respect to the installation of safety belts and/or restraint systems which do not comply with the requirements set out in Directive 77/541/EEC as amended by this Directive, Member States shall: (a) consider certificates of conformity which accompany new vehicles as no longer valid for the purpose of Article 7(1) of Directive 70/156/EEC; (b) refuse the registration, sale or entry into service of new vehicles, except where the provisions of Article 8(2) of Directive 70/156/EEC are invoked. Article 4 Transposition 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 20 April 2006. They shall forthwith inform the Commission thereof. 2. They shall apply those measures from 21 April 2006. 3. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 4. Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive. Article 5 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 6 Addressees This Directive is addressed to the Member States.

32005L0052

2005

COMMISSION DIRECTIVE 2005/52/EC of 9 September 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annex III thereto to technical progress (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof, After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, Whereas: (1) Commission Directive 2004/87/EC of 7 September 2004 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress, extended until 31 December 2005 the provisional use of sixty hair dyes listed in Part 2 of the Annex III to Directive 76/768/EEC under the reference numbers 1 to 60 (2). (2) According to the hair dye strategy, published in the internet, it was agreed with the Member States and stakeholders that the date of July 2005 would be appropriate for the presentation to the Scientific Committee on Consumer Products (SCCP) of the additional information on the above hair dyes. (3) Additional information concerning 38 hair dyes listed in Annex III, Part 2 of Directive 76/768/EEC has been submitted by the industry. This information has to be evaluated by the SCCP. Definitive regulation of those hair dyes, on the basis of such evaluations, and its implementation into the laws of Member States will not be possible before 31 December 2006. Therefore, their provisional use in cosmetic products under the restrictions and conditions laid down in Annex III, Part 2 should be prolonged until 31 December 2006. (4) For 22 hair dyes listed in Annex III, Part 2 of Directive 76/768/EEC such additional information has not been submitted. Definitive regulation of those hair dyes will be considered after the appropriate procedures are carried out. Such definitive regulation and its implementation into the laws of Member States will not be possible before 31 August 2006. Therefore, their provisional use in cosmetic products under the restrictions and conditions laid down in Annex III, Part 2 should be prolonged until 31 August 2006. (5) Directive 76/768/EEC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products, Article 1 Part 2, column g of the Annex III to Directive 76/768/EEC is amended as follows: 1. for reference numbers 1, 2, 8, 13, 15, 17, 23, 30, 34, 40, 41, 42, 43, 45, 46, 51, 52, 53, 54, 57, 59 and 60, ‘31.12.2005’ is replaced by ‘31.08.2006’; 2. for reference numbers 3, 4, 5, 6, 7, 9, 10, 11, 12, 14, 16, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 31, 32, 33, 35, 36, 37, 38, 39, 44, 47, 48, 49, 50, 55, 56 and 58, ‘31.12.2005’ is replaced by ‘31.12.2006’. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0053

2005

COMMISSION DIRECTIVE 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (2), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl. (2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Regulation (EEC) No 3600/92 (3), the following rapporteur Member States were designated, which in turn submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. For chlorothalonil the rapporteur Member State was the Netherlands, and all relevant information was submitted on 31 January 2000. For chlorotoluron, the rapporteur Member State was Spain and all relevant information was submitted on 7 May 1999. For cypermethrin the rapporteur Member State was Belgium and all relevant information was submitted on 25 October 1999. For daminozide the rapporteur Member State was the Netherlands and all relevant information was submitted on 30 July 1999. For thiophanate-methyl, the rapporteur Member State was Germany and all relevant information was submitted on 21 November 1997. (3) The assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. (4) The reviews of all active substances were finalised on 15 February 2005 in the format of the Commission review reports for chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl. (5) The review of chlorothalonil, chlorotoluron and cypermethrin did not reveal any open questions to be addressed by the Scientific Committee on Plants or the European Food Safety Authority (EFSA) which has taken over the role of the latter. (6) The review of daminozide revealed a number of open questions which were addressed by the EFSA. The Scientific Panel on Plant Health, Plant Protection Products and their Residues (PPR Panel) of the EFSA was asked to comment on the mechanism of action of the carcinogenic response of rodents to 1,1-dimethylhydrazide (UDMH) and to indicate whether or not a threshold could be derived for this effect. If yes, it was requested to indicate this value. The PPR Panel, having regard to the submitted questions, concluded (4) that, on the basis of the available data, it is not possible to identify the mechanism responsible for the carcinogenic action of UDMH in rodents. There is no in vitro evidence of genotoxicity of pure and oxidation-protected UDMH and in vivo studies are not available. In addition, the PPR Panel noted an apparent discrepancy in that daminozide long-term studies did not give rise to carcinogenicity in rats and mice at doses that should have produced internal doses of metabolically-formed UDMH at least one order of magnitude higher than those proven to be effective on direct testing. In addition, methylation of N7 guanine was found to be 50-fold higher in one study following oral administration of UDMH to rats, when compared to the corresponding data for daminozide. Thus, the PPR Panel considered that any conclusion on the mechanism of carcinogenicity of orally administered UDMH should be regarded to include a degree of uncertainty. The PPR Panel concluded that the weight of evidence is against a genotoxic mechanism. Among possible non-genotoxic mechanisms, altered regulation of cell proliferation or hormonal imbalance are plausible alternatives to genotoxicity, but these mechanisms have not been specifically investigated and thus a more definitive conclusion on the mechanism involved is not possible at the moment. In experimental testing of UDMH for carcinogenicity in rats and mice, no effects were observed at 0,09 mg/kg bw/day and 1,41 mg/kg bw/day, respectively. If the observed UDMH carcinogenicity is due to a non-genotoxic mechanism, the above indicated doses should be considered to be toxicological thresholds. However, taking together the uncertainties associated with the mechanism and the possibility that UDMH in greenhouse conditions may form oxidised derivatives that might be genotoxic, the PPR Panel is of the opinion that any use of these doses as thresholds should be undertaken only with due caution. The opinion was taken into consideration by the Standing Committee that concluded that the use of daminozide is acceptable under the specified conditions. (7) The review of thiophanate-methyl revealed a number of open questions which were addressed by the Scientific Committee on Plants. The Scientific Committee was asked to comment on the advisability of establishing an acceptable daily intake (ADI) and acceptable operator exposure level (AOEL) having regard particularly to the results of mutagenicity, carcinogenicity and reproductive studies for benomyl, carbendazim and thiophanate-methyl. The Committee (5) noted that carbendazim is the biologically active substance common to these three substances. Benomyl in particular, but also thiophanate-methyl, is metabolised to carbendazim and all three substances produce numerical chromosomal aberrations (aneuploidy) in mammalian cells, exposed in vivo. There is no evidence that any other form of damage to genetic material is induced by any of these substances. Carcinogenicity is not a concern. The known effects of these fungicides upon reproduction are explicable by interaction with the microtubules of the spindle apparatus. The mechanism of aneuploidy induction is well understood and consists of inhibition of polymerisation of tubulin, the protein that is essential for the segregation of chromosomes during cell division: it does not involve any interaction with DNA. Since multiple copies of tubulin molecules are present in proliferating cells, in the presence of low concentration of the fungicides a limited number of tubulin molecules will be affected and consequently no toxicological adverse effects will ensue. Consequently, a clear no adverse effect level is recognisable and both an ADI and an AOEL can be established. (8) It has appeared from the various examinations made that plant protection products containing chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include this active substance in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (9) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (10) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (11) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I. (12) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (13) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 August 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 September 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as active substances by 31 August 2006. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl are met, with the exception of those identified in part B of the entries concerning those active substances, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive. 2. By derogation from paragraph 1, for each authorised plant protection product containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 28 February 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entries in Annex I to that Directive concerning chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2010 at the latest; or (b) in the case of a product containing chlorothalonil, chlorotoluron, cypermethrin, daminozide or thiophanate-methyl as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 March 2006. Article 5 This Directive is addressed to the Member States.

32005L0054

2005

COMMISSION DIRECTIVE 2005/54/EC of 19 September 2005 amending Council Directive 91/414/EEC to include tribenuron as active substance (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes tribenuron. (2) For tribenuron the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifiers. Moreover, those regulations designate the Rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For tribenuron (in the form of tribenuron-methyl) the Rapporteur Member State was Sweden and all relevant information was submitted on 19 June 2003. (3) The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 19 October 2004 in the format of the EFSA Scientific Report for tribenuron (4). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 15 February 2005 in the format of the Commission review report for tribenuron. (4) It has appeared from the various examinations made that plant protection products containing tribenuron may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include tribenuron in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (5) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (6) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing tribenuron to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (7) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I. (8) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 August 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 September 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing tribenuron as an active substance by 31 August 2006. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to tribenuron are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive. 2. By derogation from paragraph 1, for each authorised plant protection product containing tribenuron as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 28 February 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning tribenuron. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing tribenuron as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2010 at the latest; or (b) in the case of a product containing tribenuron as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 March 2006. Article 5 This Directive is addressed to the Member States.

32005L0057

2005

COMMISSION DIRECTIVE 2005/57/EC of 21 September 2005 amending Council Directive 91/414/EEC to include MCPA and MCPB as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes MCPA and MCPB. (2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Regulation (EEC) No 3600/92 (3), Italy was designated as rapporteur Member State. On 5 April 2001 and 19 December 2001 Italy submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. (3) The assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The reviews were finalised on 15 April 2005 in the format of the Commission review reports for MCPA and MCPB. (4) The reviews of MCPA and MCPB did not reveal any open question to be addressed by the Scientific Committee on Plants or the European Food Safety Authority (EFSA) which has taken over the role of the latter. (5) It has appeared from the various examinations made that plant protection products containing MCPA or MCPB may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. (6) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (7) Without prejudice to the obligations defined by Directive 91/414 as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing MCPA or MCPB to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (8) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 October 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 November 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing MCPA or MCPB as active substances by 31 October 2006. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to MCPA and MCPB respectively are met, with the exception of those identified in part B of the entry concerning those active substances, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13. 2. By derogation from paragraph 1, for each authorised plant protection product containing MCPA or MCPB as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 April 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning MCPA and MCPB respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing MCPA or MCPB as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2010 at the latest; or (b) in the case of a product containing MCPA or MCPB as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 May 2006. Article 5 This Directive is addressed to the Member States.

32005L0058

2005

COMMISSION DIRECTIVE 2005/58/EC of 21 September 2005 amending Council Directive 91/414/EEC to include bifenazate and milbemectin as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC, the Netherlands received on 3 July 2001 an application from Crompton Europe Ltd. for the inclusion of the active substance bifenazate in Annex I to Directive 91/414/EEC. Commission Decision 2002/268/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) The Netherlands received an application under Article 6(2) of Directive 91/414/EEC on 6 March 2000 from Sankyo Company Ltd. for the inclusion of the active substance milbemectin in Annex I to Directive 91/414/EEC. Commission Decision 2000/540/EC (3) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (3) For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 3 April 2003 (bifenazate) and 16 June 2001 (milbemectin). (4) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 3 June 2005 in the format of the Commission review reports for bifenazate and milbemectin. (5) The review of bifenazate and milbemectin did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee. (6) It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include bifenazate and milbemectin in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive. (7) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing bifenazate or milbemectin to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (8) The inclusion of bifenazate in Annex I is based on a dossier covering the use of this active substance on ornamental plants in greenhouses. Other uses are currently not adequately supported by data from the notifier and not all of the risks from such uses have shown to be adequately addressed under the criteria required by Annex VI. If Member States are to grant authorisations for other uses, they should therefore require the data and information necessary to prove that the uses are compatible with the criteria in Directive 91/414/EEC, in particular concerning the effect on human consumers and the environment. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish by 31 May 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 June 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing bifenazate or milbemectin as active substances by 31 May 2006. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to bifenazate and milbemectin, respectively, are met, with the exception of those identified in part B of the entry concerning those active substances, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13. 2. By way of derogation from paragraph 1, for each authorised plant protection product containing bifenazate or milbemectin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 November 2005 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning bifenazate and milbemectin, respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing bifenazate or milbemectin as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2007 at the latest; or (b) in the case of a product containing bifenazate or milbemectin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2007 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 December 2005. Article 5 This Directive is addressed to the Member States.

32005L0055

2005

DIRECTIVE 2005/55/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 September 2005 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive-ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Council Directive 88/77/EEC of 3 December 1987 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles (3) is one of the separate Directives under the type-approval procedure laid down by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (4). Directive 88/77/EEC has been substantially amended several times to introduce successively more stringent pollutant emission limits. Since further amendments are to be made, it should be recast in the interests of clarity. (2) Council Directive 91/542/EEC (5) amending Directive 88/77/EEC, Directive 1999/96/EC of the European Parliament and of the Council of 13 December 1999 on the approximation of the laws of the Member States relating to measures to be taken against the emission of gaseous and particulate pollutants from compression ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles and amending Council Directive 88/77/EEC (6), and Commission Directive 2001/27/EC (7) adapting to technical progress Council Directive 88/77/EEC have introduced provisions which, while being autonomous, are closely linked to the scheme established under Directive 88/77/EEC. Those autonomous provisions should be fully integrated into the recast of Directive 88/77/EEC in the interests of clarity and legal certainty. (3) It is necessary that all the Member States adopt the same requirements, in order, in particular, to permit the implementation, for each vehicle type, of the EC type-approval system which is the subject of Directive 70/156/EEC. (4) The Commission’s programme on air quality, road transport emissions, fuels and emission abatement technologies, hereinafter ‘the first Auto-Oil programme’, showed that further reductions in pollutant emissions from heavy-duty vehicles were necessary with a view to achieving future air quality standards. (5) Reductions in emission limits applicable from the year 2000, corresponding to abatements of 30 % in emissions of carbon monoxide, total hydrocarbons, oxides of nitrogen and particulate matter were identified by the first Auto-Oil programme as key measures for the achievement of medium-term air quality. A reduction of 30 % in exhaust smoke opacity should additionally contribute to the reduction of particulate matter. Additional reductions in emission limits applicable from the year 2005, corresponding to additional abatements of 30 % in carbon monoxide, total hydrocarbons and oxides of nitrogen and 80 % in particulate matter should greatly contribute to air quality improvement in the medium to longer term. The additional limit for oxides of nitrogen applicable in the year 2008 should result in a further 43 % reduction in the emission limit for this pollutant. (6) Type-approval tests for gaseous and particulate pollutants and smoke opacity are applicable to allow for a more representative evaluation of the emissions performance of engines under test conditions that more closely resemble those encountered by vehicles in-service. Since 2000 conventional compression-ignition engines and those compression-ignition engines fitted with certain types of emission control equipment have been tested over a steady-state test cycle and using a new load response test for smoke opacity. Compression-ignition engines fitted with advanced emission control systems have, in addition, been tested over a new transient test cycle. From 2005, all compression-ignition engines should be tested on all those test cycles. Gas fuelled engines are only tested on the new transient test cycle. (7) Under all randomly selected load conditions within a defined operating range, the limit values may not be exceeded by more than an appropriate percentage. (8) In laying down new standards and test procedures, it is necessary to take account of the impact on air quality of future traffic growth in the Community. The work undertaken by the Commission in this sphere has shown that the motor industry in the Community has made great strides in the perfection of the technology allowing a considerable reduction in emissions of gaseous and particulate pollutants. However, it is still necessary to press for further improvements in emission limits and other technical requirements in the interests of environmental protection and public health. In particular, the results of ongoing research into the characteristics of ultra-fine particulates should be taken into account in any future measures. (9) It is necessary that further improvements be made to the quality of motor fuels to enable the efficient and durable performance of emission control systems in service. (10) New provisions for on-board diagnostics (OBD) should be introduced from 2005 with a view to facilitating the immediate detection of the deterioration or failure of engine emission control equipment. This should enhance diagnostic and repair capability, significantly improving the sustainable emission performance of in-service heavy-duty vehicles. Since, on the worldwide stage, OBD for heavy-duty diesel engines is in its infancy, it should be introduced in the Community in two stages to allow for system development so that the OBD system does not give false indications. In order to assist the Member States in ensuring that the owners and operators of heavy-duty vehicles meet their obligation to repair faults indicated by the OBD system, the distance covered or the time that has elapsed after a fault has been indicated to the driver should be recorded. (11) Compression-ignition engines are inherently durable and have demonstrated that, with proper and effective maintenance, they can retain a high level of emissions performance over the significantly high distances travelled by heavy-duty vehicles in the course of commercial operations. However, future emission standards will push the introduction of emission control systems downstream of the engine, such as deNOx systems, diesel particulate filters and systems that are a combination of both and, perhaps, other systems yet to be defined. It is therefore necessary to establish a useful life requirement on which to base procedures for ensuring the compliance of an engine’s emission control system throughout that reference period. In establishing such a requirement, due account should be taken of the considerable distances covered by heavy-duty vehicles, of the need to incorporate appropriate and timely maintenance and of the possibility of type-approving category N1 vehicles in accordance with either this Directive or Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States on measures to be taken against air pollution by emissions from motor vehicles (8). (12) Member States should be allowed, by means of tax incentives, to expedite the placing on the market of vehicles that satisfy the requirements adopted at Community level, provided that such incentives comply with the provisions of the Treaty and satisfy certain conditions intended to prevent distortion of the internal market. This Directive does not affect the right of the Member States to include emissions of pollutants and other substances in the basis for calculating road traffic taxes on motor vehicles. (13) Since some of those tax incentives are State aids under Article 87(1) of the Treaty, they would have to be notified to the Commission under Article 88(3) of the Treaty for evaluation in accordance with the relevant criteria of compatibility. The notification of such measures in accordance with this Directive should be without prejudice to the obligation to notify under Article 88(3) of the Treaty. (14) With the aim of simplifying and accelerating the procedure, the Commission should be entrusted with the task of adopting measures implementing the fundamental provisions laid down in this Directive as well as the measures for adapting the annexes of this Directive to scientific and technical progress. (15) The measures necessary for the implementation of this Directive and its adaptation to scientific and technical progress should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9). (16) The Commission should keep under review the need to introduce emission limits for pollutants which are as yet unregulated and which arise as a consequence of the wider use of new alternative fuels and new exhaust emission control systems. (17) The Commission should submit proposals it may deem appropriate for a further stage for limit values for NOx and particulate emissions as soon as possible. (18) Since the objective of this Directive, namely the realisation of the internal market through the introduction of common technical requirements concerning gaseous and particulate emissions for all types of vehicles, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective. (19) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive change as compared with the earlier Directives. The obligation to transpose the provisions which are unchanged arises under the earlier Directives. (20) This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex IX, Part B. Article 1 Definitions For the purposes of this Directive the following definitions shall apply: (a) ‘vehicle’ means any vehicle as defined in Article 2 of Directive 70/156/EEC and propelled by a compression-ignition or gas engine, with the exception of vehicles of category M1 with a technically permissible maximum laden mass less than or equal to 3,5 tonnes; (b) ‘compression-ignition or gas engine’ means the motive propulsion source of a vehicle for which type-approval as a separate technical unit, as defined in Article 2 of Directive 70/156/EEC, may be granted; (c) ‘enhanced environment-friendly vehicle (EEV)’ means a vehicle propelled by an engine which complies with the permissive emission limit values set out in row C of the tables in Section 6.2.1 of Annex I. Article 2 Obligations of the Member States 1. For types of compression-ignition or gas engines and types of vehicle propelled by compression-ignition or gas engines, where the requirements set out in Annexes I to VIII are not met and in particular where the emissions of gaseous and particulate pollutants and opacity of smoke from the engine do not comply with the limit values set out in row A of the tables in Section 6.2.1 of Annex I, Member States: (a) shall refuse to grant EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC; and (b) shall refuse national type-approval. 2. Except in the case of vehicles and engines intended for export to third countries or replacement engines for in-service vehicles, Member States shall, where the requirements set out in Annexes I to VIII are not met and in particular where the emissions of gaseous and particulate pollutants and opacity of smoke from the engine do not comply with the limit values set out in row A of the tables in Section 6.2.1 of Annex I: (a) consider certificates of conformity which accompany new vehicles or new engines pursuant to Directive 70/156/EEC as no longer valid for the purposes of Article 7(1) of that Directive; and (b) prohibit the registration, sale, entry into service or use of new vehicles propelled by a compression-ignition or gas engine and the sale or use of new compression-ignition or gas engines. 3. Without prejudice to paragraphs 1 and 2, with effect from 1 October 2003 and except in the case of vehicles and engines intended for export to third countries or replacement engines for in-service vehicles, Member States shall, for types of gas engines and types of vehicles propelled by a gas engine which do not comply with the requirements set out in Annexes I to VIII: (a) consider certificates of conformity which accompany new vehicles or new engines pursuant to Directive 70/156/EEC as no longer valid for the purposes of Article 7(1) of that Directive; and (b) prohibit the registration, sale, entry into service or use of new vehicles and the sale or use of new engines. 4. If the requirements set out in Annexes I to VIII and in Articles 3 and 4 are satisfied, in particular where the emissions of gaseous and particulate pollutants and opacity of smoke from the engine comply with the limit values set out in row B1 or row B2 or with the permissive limit values set out in row C of the tables in Section 6.2.1 of Annex I, no Member State may, on grounds relating to the gaseous and particulate pollutants and opacity of smoke emissions from an engine: (a) refuse to grant EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC or to grant national type-approval for a type of vehicle propelled by a compression-ignition or gas engine; (b) prohibit the registration, sale, entry into service or use of new vehicles propelled by a compression-ignition or gas engine; (c) refuse to grant EC type-approval for a type of compression-ignition or gas engine; (d) prohibit the sale or use of new compression-ignition or gas engines. 5. With effect from 1 October 2005, for types of compression-ignition or gas engines and types of vehicle propelled by compression-ignition or gas engines which do not meet the requirements set out in Annexes I to VIII and in Articles 3 and 4 and in particular where the emissions of gaseous and particulate pollutants and opacity of smoke from the engine do not comply with the limit values set out in row B1 of the tables in Section 6.2.1 of Annex I, Member States: (a) shall refuse to grant EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC; and (b) shall refuse national type-approval. 6. With effect from 1 October 2006 and except in the case of vehicles and engines intended for export to third countries or replacement engines for in-service vehicles, Member States shall, where the requirements set out in Annexes I to VIII and in Articles 3 and 4 are not met and in particular where the emissions of gaseous and particulate pollutants and opacity of smoke from the engine do not comply with the limit values set out in row B1 of the tables in Section 6.2.1 of Annex I: (a) consider certificates of conformity which accompany new vehicles or new engines pursuant to Directive 70/156/EEC as no longer valid for the purposes of Article 7(1) of that Directive; and (b) prohibit the registration, sale, entry into service or use of new vehicles propelled by a compression-ignition or gas engine and the sale or use of new compression-ignition or gas engines. 7. With effect from 1 October 2008, for types of compression-ignition or gas engines and types of vehicle propelled by compression-ignition or gas engines which do not meet the requirements set out in Annexes I to VIII and in Articles 3 and 4 and in particular where the emissions of gaseous and particulate pollutants and opacity of smoke from the engine do not comply with the limit values set out in row B2 of the tables in Section 6.2.1 of Annex I, Member States: (a) shall refuse to grant EC type-approval pursuant to Article 4(1) of Directive 70/156/EEC; and (b) shall refuse national type-approval. 8. With effect from 1 October 2009 and except in the case of vehicles and engines intended for export to third countries or replacement engines for in-service vehicles, Member States shall, where the requirements set out in Annexes I to VIII and in Articles 3 and 4 are not met and in particular where the emissions of gaseous and particulate pollutants and opacity of smoke from the engine do not comply with the limit values set out in row B2 of the tables in Section 6.2.1 of Annex I: (a) consider certificates of conformity which accompany new vehicles or new engines pursuant to Directive 70/156/EEC as no longer valid for the purposes of Article 7(1) of that Directive; and (b) prohibit the registration, sale, entry into service or use of new vehicles propelled by a compression-ignition or gas engine and the sale or use of new compression-ignition or gas engines. 9. In accordance with paragraph 4 an engine that satisfies the requirements set out in Annexes I to VIII, and, in particular, complies with the limit values set out in row C of the tables in Section 6.2.1 of Annex I shall be considered as complying with the requirements set out in paragraphs 1, 2 and 3. In accordance with paragraph 4 an engine that satisfies the requirements set out in Annexes I to VIII and in Articles 3 and 4 and, in particular, complies with the limit values set out in row C of the tables in Section 6.2.1 of Annex I shall be considered as complying with the requirements set out in paragraphs 1 to 3 and 5 to 8. 10. For compression-ignition or gas engines that must comply with the limit values set out in Section 6.2.1 of Annex I under the type-approval system, the following shall apply: under all randomly selected load conditions, belonging to a definite control area and with the exception of specified engine operating conditions which are not subject to such a provision, the emissions sampled during a time duration as small as 30 seconds shall not exceed by more than 100 % the limit values in rows B2 and C of the tables in Section 6.2.1 of Annex I. The control area to which the percentage not to be exceeded shall apply, the excluded engine operating conditions and other appropriate conditions shall be defined in accordance with the procedure referred to in Article 7(1). Article 3 Durability of emission control systems 1. From 1 October 2005 for new type-approvals and from 1 October 2006 for all type-approvals, the manufacturer shall demonstrate that a compression-ignition or gas engine type-approved by reference to the limit values set out in row B1 or row B2 or row C of the tables in Section 6.2.1 of Annex I will comply with those limit values for a useful life of: (a) 100 000 km or five years, whichever is the sooner, in the case of engines to be fitted to vehicles of category N1 and M2; (b) 200 000 km or six years, whichever is the sooner, in the case of engines to be fitted to vehicles of category N2, N3 with a maximum technically permissible mass not exceeding 16 tonnes and M3 Class I, Class II and Class A, and Class B with a maximum technically permissible mass not exceeding 7,5 tonnes; (c) 500 000 km or seven years, whichever is the sooner, in the case of engines to be fitted to vehicles of category N3 with a maximum technically permissible mass exceeding 16 tonnes and M3, Class III and Class B with a maximum technically permissible mass exceeding 7,5 tonnes. From 1 October 2005, for new types, and from 1 October 2006, for all types, type-approvals granted to vehicles shall also require confirmation of the correct operation of the emission control devices during the normal life of the vehicle under normal conditions of use (conformity of in-service vehicles properly maintained and used). 2. The measures for the implementation of paragraph 1 shall be adopted by 28 December 2005 at the latest. Article 4 On-board diagnostic systems 1. From 1 October 2005 for new type-approvals of vehicles and from 1 October 2006 for all type-approvals, a compression-ignition engine type-approved by reference to the emission limit values set out in row B1 or row C of the tables in Section 6.2.1 of Annex I or a vehicle propelled by such an engine shall be fitted with an on-board diagnostic (OBD) system that signals the presence of a fault to the driver if the OBD threshold limits set out in row B1 or row C of the table in paragraph 3 are exceeded. In the case of exhaust after-treatment systems, the OBD system may monitor for major functional failure any of the following: (a) a catalyst, where fitted as a separate unit, whether or not it is part of a deNOx system or a diesel particulate filter; (b) a deNOx system, where fitted; (c) a diesel particulate filter, where fitted; (d) a combined deNOx-diesel particulate filter system. 2. From 1 October 2008 for new type-approvals and from 1 October 2009 for all type-approvals, a compression-ignition or a gas engine type-approved by reference to the emission limit values set out in row B2 or row C of the tables in Section 6.2.1 of Annex I, or a vehicle propelled by such an engine shall be fitted with an OBD system that signals the presence of a fault to the driver if the OBD threshold limits set out in row B2 or row C of the table in paragraph 3 are exceeded. The OBD system shall also include an interface between the engine electronic control unit (EECU) and any other engine or vehicle electrical or electronic systems that provide an input to or receive an output from the EECU and which affect the correct functioning of the emission control system, such as the interface between the EECU and a transmission electronic control unit. 3. The OBD threshold limits shall be as follows: Row Compression-ignition engines Mass of oxides of nitrogen (NOx) g/kWh Mass of particulate (PT) g/kWh B1 (2005) 7,0 0,1 B2 (2008) 7,0 0,1 C (EEV) 7,0 0,1 4. Full and uniform access to OBD information must be provided for the purposes of testing, diagnosis, servicing and repair in keeping with the relevant provisions of Directive 70/220/EEC and provisions regarding replacement components ensuring compatibility with OBD systems. 5. The measures for the implementation of paragraphs 1, 2 and 3 shall be adopted by 28 December 2005 at the latest. Article 5 Emission control systems using consumable reagents In defining the measures necessary to implement Article 4, as provided for by Article 7(1), the Commission shall, if appropriate, include technical measures to minimise the risk of emission control systems using consumable reagents being inadequately maintained in service. In addition, and if appropriate, measures shall be included to ensure that emissions of ammonia due to the use of consumable reagents are minimised. Article 6 Tax incentives 1. Member States may make provision for tax incentives only in respect of vehicles which comply with this Directive. Such incentives shall comply with the provisions of the Treaty, as well as with either paragraph 2 or paragraph 3 of this Article. 2. The incentives shall apply to all new vehicles offered for sale on the market of a Member State which comply in advance with the limit values set out in row B1 or B2 of the tables in Section 6.2.1 of Annex I. They shall be terminated with effect from the mandatory application of the limit values in row B1, as laid down in Article 2(6), or from the mandatory application of the limit values in row B2, as laid down in Article 2(8). 3. The incentives shall apply to all new vehicles offered for sale on the market of a Member State which comply with the permissive limit values set out in row C of the tables in Section 6.2.1 of Annex I. 4. In addition to the conditions referred to in paragraph 1, for each type of vehicle, the incentives shall not exceed the additional cost of the technical solutions introduced to ensure compliance with the limit values set out in row B1 or row B2 or with the permissive limit values set out in row C of the tables in Section 6.2.1 of Annex I, and of their installation on the vehicle. 5. Member States shall inform the Commission in sufficient time of plans to institute or change the tax incentives referred to in this Article, so that it can submit its observations. Article 7 Implementation measures and amendments 1. The measures necessary for the implementation of Articles 2(10), 3 and 4 of this Directive shall be adopted by the Commission, assisted by the Committee established by Article 13(1) of Directive 70/156/EEC, in accordance with the procedure referred to in Article 13(3) of that Directive. 2. Amendments to this Directive which are necessary to adapt it to scientific and technical progress shall be adopted by the Commission, assisted by the committee established by Article 13(1) of Directive 70/156/EEC, in accordance with the procedure referred to in Article 13(3) of that Directive. Article 8 Review and reports 1. The Commission shall review the need to introduce new emission limits applicable to heavy-duty vehicles and engines in respect of pollutants that are as yet unregulated. The review shall be based on the wider market introduction of new alternative fuels and on the introduction of new additive-enabled exhaust emission control systems to meet future standards laid down in this Directive. Where appropriate, the Commission shall submit a proposal to the European Parliament and the Council. 2. The Commission should submit to the European Parliament and the Council legislative proposals on further limits on NOx and particulate emissions for heavy-duty vehicles. If appropriate, it shall investigate whether setting an additional limit for particulate levels and size is necessary, and, if so, include it in the proposals. 3. The Commission shall report to the European Parliament and to the Council on the progress in negotiations for a worldwide harmonised duty cycle (WHDC). 4. The Commission shall submit a report to the European Parliament and to the Council on requirements for the operation of an on-board measurement (OBM) system. On the basis of that report, the Commission shall, where appropriate, submit a proposal for measures to include the technical specifications and corresponding annexes in order to provide for the type-approval of OBM systems which ensure at least equivalent levels of monitoring to OBD systems and which are compatible therewith. Article 9 Transposition 1. Member States shall adopt and publish, before 9 November 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. If the adoption of the implementing measures referred to in Article 7 is delayed beyond 28 December 2005, Member States shall comply with this obligation by the transposition date provided in the Directive containing these implementing measures. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 9 November 2006 or, if the adoption of the implementing measures referred to in Article 7 is delayed beyond 28 December 2005, from the transposition date specified in the Directive containing these implementing measures. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directives repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 10 Repeal The Directives listed in Annex IX, Part A, are repealed with effect from 9 November 2006 without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex IX, Part B. References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex X. Article 11 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 12 Addressees This Directive is addressed to the Member States.

32005L0063

2005

COMMISSION DIRECTIVE 2005/63/EC of 3 October 2005 correcting Directive 2005/26/EC concerning the list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (1) and in particular Article 6 (11), thereof, Whereas: (1) Commission Directive 2005/26/EC (2) established the list of food ingredients or substances provisionally excluded from Annex IIIa of Directive 2000/13/EC, having heard the opinion of the European Food Safety Authority (EFSA). (2) In its opinion of 2 December 2004 on certain uses of fish gelatine, the EFSA concluded that this product, when used as a carrier for vitamin and carotenoid preparations, is not likely to cause severe allergic reactions. (3) Carotenoids were wrongly omitted from the list in annex to Directive 2005/26/EC and must therefore be added to it, Article 1 In the second column of the Annex to Directive 2005/26/EC, the seventh row shall be replaced by the following: ‘ — Fish gelatine used as a carrier for vitamin or carotenoid preparations and flavours.’ Article 2 1. The Member States shall adopt and publish, by 3 December 2005 at the latest, the rules, regulations and administrative provisions necessary to comply with the present Directive. They shall immediately communicate the text of those provisions to the Commission together with a correlation table those provisions and this Directive. They shall apply those provisions from 25 November 2005. When the Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by a reference at the time of their official publication. The Member States shall determine how such reference is to be made. 2. The Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0067

2005

COMMISSION DIRECTIVE 2005/67/EC of 18 October 2005 amending, for the purposes of their adaptation, Annexes I and II to Council Directive 86/298/EEC, Annexes I and II to Council Directive 87/402/EEC and Annexes I, II and III to Directive 2003/37/EC of the European Parliament and of the Council, relating to the type-approval of agricultural or forestry tractors (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/298/EEC of 26 May 1986 on rear-mounted roll-over protection structures of narrow-tracked wheeled agricultural or forestry tractors (1), and in particular Article 12 thereof, Having regard to Council Directive 87/402/EEC of 25 June 1987 on roll-over protection structures mounted in front of the driver's seat in wheeled agricultural or forestry tractors (2), and in particular Article 11 thereof, Having regard to Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Council Directive 74/150/EEC (3), and in particular Article 19(1)(a) and (b) thereof, Whereas: (1) Directive 2003/37/EC introduced the fitting of seat belt anchorages as a new requirement for the agricultural or forestry whole vehicle type-approval in accordance with Council Directive 76/115/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to anchorages for motor vehicle safety belts (4). Since Directive 76/115/EEC concerns the type-approval of different categories of non-agricultural motor vehicles, it is necessary to specify which requirements of that Directive shall apply to certain agricultural or forestry tractors. (2) The requirements in Appendix 1 of Annex I to Directive 76/115/EEC for forward facing centre seats of vehicle category N3 are appropriate for tractors of a maximum design speed of 40 km/h or less. (3) On 29 March 2005, the Council of the OECD approved Decision C(2005) 1, which establishes new versions of the OECD codes for the testing of agricultural and forestry tractors. (4) It is appropriate to adapt the references to the OECD codes in Directives 2003/37/EC, 86/298/EEC and 87/402/EEC in order to take account of Decision C(2005) 1 of the OECD Council. (5) Directives 86/298/EEC, 87/402/EEC and 2003/37/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 20(1) of Directive 2003/37/EC, Article 1 Annexes I, II and III to Directive 2003/37/EC are amended in accordance with Annex I to this Directive. Article 2 Annexes I and II to Directive 86/298/EEC are amended in accordance with Annex II to this Directive. Article 3 Annexes I and II to Directive 87/402/EEC are amended in accordance with Annex III to this Directive. Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 5 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States.

32005L0070

2005

COMMISSION DIRECTIVE 2005/70/EC of 20 October 2005 amending Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for certain pesticides in and on cereals and certain products of animal and plant origin (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), and in particular Article 5 thereof, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (2), and in particular Article 10 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (3), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (4), and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (5) and in particular Article 4(1)(f) thereof, Whereas: (1) The following existing active substances have been included in Annex I to Directive 91/414/EEC: glyphosate by Commission Directive 2001/99/EC (6), chlorpropham by Commission Directive 2004/20/EC (7) and bromoxynil, and ioxinyl by Commission Directive 2004/58/EC (8). (2) The following new active substances have been included in Annex I to Directive 91/414/EEC: dimethenamid-P and flurtamone by Commission Directive 2003/84/EC (9) propoxycarbazone and zoxamide by Commission Directive 2003/119/EC (10), flazasulfuron and pyraclostrobin by Commission Directive 2004/30/EC (11), quinoxyfen by Commission Directive 2004/60/EC (12) and mepanipyrim, by Commission Directive 2004/62/EC (13). (3) The inclusion in Annex I to Directive 91/414/EEC of the active substances concerned was based on the assessment of the information submitted concerning their proposed use. Information relating to that use has been submitted by certain Member States in accordance with Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to allow certain maximum residue levels (MRLs) to be fixed. (4) Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a number of Codex MRLs for chlorpropham, and glyphosate. There are already Community MRLs in Directive 76/895/EEC for chlorpropham (Council Directive 82/528/EEC (14)) and in Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for glyphosate (Council Directive 1998/82/EC (15)). These have been taken into consideration when setting the MRLs concerned by the adaptations made by this Directive. Codex MRLs that will be recommended for withdrawal in the near future were not taken into account. The MRLs based on Codex MRLs have been evaluated in the light of the risks for the consumers. No risk was established when using the toxicological end points based on the studies available to the Commission. (5) The Commission review reports which were prepared for the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned fixed the Acceptable Daily Intake (ADI) and, if necessary, the Acute Reference Dose (ARfD) for those substances. The exposure of consumers of food products treated with the active substances concerned has been assessed in accordance with Community procedures. Account has also been taken of guidelines published by the World Health Organisation (16) and the opinion of the Scientific Committee for Plants (17) on the methodology employed. It is concluded that MRLs proposed will not lead to those ADIs or ARfD being exceeded. (6) In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, provisional MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination. (7) The setting at Community level of such provisional MRLs does not prevent the Member States from establishing provisional MRLs for the substances concerned in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRL should then become definitive. (8) It is therefore necessary to add or replace all of the MRLs arising from the use of these plant protection products to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer. Where MRLs have already been defined in the Annexes to those Directives it is appropriate to modify them. Where MRLs have not been defined until now, it is appropriate to set them for the first time. (9) Glyphosate is used as ester or salt. In case of glyphosate trimesium salt, the residue of trimethylsulfonium cation is also of toxicological relevance. It is therefore necessary to set MRLs for that cation. (10) Provisions of Directive 76/895/EEC which set MRLs for chlorpropham should consequently be deleted. (11) Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 In Annex II to Directive 76/895/EEC, the line for chlorpropham is deleted. Article 2 Directive 86/362/EEC is amended as follows: 1. In Part A of Annex II, the lines for bromoxynil, chlorpropham, dimethenamid-P, flazasulfuron, flurtamone, ioxinyl, mepanipyrim, propoxycarbazone, pyraclostrobin, quinoxyfen, trimethylsulfonium cation and zoxamide as set out in Annex I to this Directive are added. 2. In Part A of Annex II, the line for glyphosate is replaced by the text in Annex II to this Directive. Article 3 Directive 86/363/EEC is amended as follows: 1. In Part A of Annex II, the lines for bromoxynil, chlorpropham, ioxinyl, pyraclostrobin, quinoxyfen and trimethylsulfonium cation, as set out in Annex III to this Directive, are added. 2. In Part B of Annex II, the line for glyphosate is replaced by the text in Annex IV to this Directive. Article 4 Directive 90/642/EEC is amended as follows: 1. In Annex II, the lines for bromoxynil, chlorpropham, dimethenamid-P, flazasulfuron, flurtamone, ioxinyl, mepanipyrim, propoxycarbazone, pyraclostrobin, quinoxyfen, trimethylsulfonium cation and zoxamide, as set out in Annex V to this Directive, are added. 2. In Annex II, the line for glyphosate is replaced by the text in Annex VI to this Directive. Article 5 1. Member States shall adopt and publish, by 21 April 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 21 April 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 6 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. Article 7 This Directive is addressed to the Member States.

32005L0072

2005

COMMISSION DIRECTIVE 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to include chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (2), establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes chlorpyrifos, chlorpyrifos-methyl (under the spelling chlorpyriphos and chlorpyriphos-methyl) mancozeb, maneb and metiram. (2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the Rapporteur Member States for the implementation of Commission Regulation (EEC) No 3600/92 (3), the following Rapporteur Member States were designated, which submitted the relevant assessment reports and recommendations to the Commission in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. For chlorpyrifos and chlorpyrifos-methyl the Rapporteur Member State was Spain, and all relevant information was submitted on 16 September 1997 and 7 May 1999. For mancozeb, maneb and metiram Italy was designated as Rapporteur Member State and all relevant information was submitted on 3 October 2000, 29 November 2000 and 22 August 2000 respectively. (3) The assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The reviews were finalised on 3 June 2005 in the format of the Commission review reports for chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and metiram. (4) The reviews of chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and metiram did not reveal any open question to be addressed by the Scientific Committee on Plants or the European Food Safety Authority (EFSA) which has taken over the role of that Committee. (5) It has appeared from the various examinations made, that plant protection products containing chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and metiram may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include these active substances in Annex I, in order to ensure that, in all Member States, the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. (6) Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and metiram should be subjected to further testing for confirmation of the risk assessment for some non-target organisms and in case of maneb, and mancozeb also for developmental toxicity, and that such studies should be presented by the notifiers. (7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (8) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb or metiram to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (9) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I. (10) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 December 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 January 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb or metiram as active substances by 31 December 2006. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and metiram are met, with the exception of those identified in part B of the entries concerning those active substances, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13. 2. By way of derogation from paragraph 1, for each authorised plant protection product containing chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb or metiram as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 June 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and metiram respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb or metiram as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2010 at the latest; or (b) in the case of a product containing chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb or metiram as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 July 2006. Article 5 This Directive is addressed to the Member States.

32005L0074

2005

COMMISSION DIRECTIVE 2005/74/EC of 25 October 2005 amending Council Directive 90/642/EEC as regards the maximum residue levels of ethofumesate, lambda-cyhalothrin, methomyl, pymetrozine and thiabendazole fixed therein (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables (1), and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2), and in particular Article 4(1)(f) thereof, Whereas: (1) In accordance with Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations are required to be based on the evaluation of effects on human and animal health and influence on the environment. Elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops. (2) Maximum residue levels (MRLs) reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in terms of estimated dietary intake. (3) MRLs for pesticides should be kept under review. They may be changed to take account of new uses, new information and data. (4) MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data. (5) Information on new or changed uses of certain pesticides covered by Directive 90/642/EEC has been notified to the Commission. This concerns ethofumesate, lambda-cyhalothrin, methomyl, pymetrozine and thiabendazole In the case of lambda-cyhalothrin, methomyl and pymetrozine, for which an acute reference (ARfD) dose exists, the acute exposure of consumers via each of the food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the procedures and practices currently used within the European Community, taking account of guidelines published by the World Health Organisation. The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account. The intake assessment of lambda-cyhalothrin, methomyl and pymetrozine shows, that by setting the MRLs concerned, ARfD will not be exceeded. In the case of ethofumesate and thiabendazol, an assessment of the available information has shown that no ARfD is required and that therefore a short-term assessment is not needed. (6) Therefore it is appropriate to fix new maximum levels for residues of those pesticides. (7) In the light of technological and scientific developments, it may be appropriate to set specific MRLs for products which are relatively new in the Community, such as ‘Papaya’ and ‘Cassava.’ The list of examples within the groups specified in Annex I to Directive 90/642/EEC should therefore be amended accordingly. (8) The setting or modification at Community level of provisional MRLs does not prevent the Member States from establishing provisional MRLs for ethofumesate in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of the active substance concerned. The provisional MRL should then become definitive. (9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The item ‘papaya’ is added to Annex I to Directive 90/642/EEC under the category 1(vi) miscellaneous fruit between the items ‘Olives’ and ‘Passion fruit’. The item ‘Cassava’ is added to Annex I to Directive 90/642/EEC under the category 2(i) root and tuber vegetables between the items ‘Carrots’ and ‘Celeriac’. Article 2 Directive 90/642/EEC is amended as follows: 1. In Annex II, the maximum levels for pesticide residues of ethofumesate, lambda-cyhalothrin, methomyl, pymetrozine, and thiabendazole are replaced by those in Annex I to this Directive. 2. In Annex II, maximum levels for pesticide residues of ethofumesate are added as set out in Annex II to this Directive. Article 3 1. Member States shall adopt and publish, by 26 April 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply these provisions from 27 April 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0065

2005

DIRECTIVE 2005/65/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 October 2005 on enhancing port security (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Security incidents resulting from terrorism are among the greatest threats to the ideals of democracy, freedom and peace, which are the very essence of the European Union. (2) People, infrastructure and equipment in ports should be protected against security incidents and their devastating effects. Such protection would benefit transport users, the economy and society as a whole. (3) On 31 March 2004 the European Parliament and the Council of the European Union adopted Regulation (EC) No 725/2004 (4) on enhancing ship and port facility security. The maritime security measures imposed by that Regulation constitute only part of the measures necessary to achieve an adequate level of security throughout maritime-linked transport chains. That Regulation is limited in scope to security measures on board vessels and the immediate ship/port interface. (4) In order to achieve the fullest protection possible for maritime and port industries, port security measures should be introduced, covering each port within the boundaries defined by the Member State concerned, and thereby ensuring that security measures taken pursuant to Regulation (EC) No 725/2004 benefit from enhanced security in the areas of port activity. These measures should apply to all those ports in which one or more port facilities covered by Regulation (EC) No 725/2004 are situated. (5) The security objective of this Directive should be achieved by adopting appropriate measures without prejudice to the rules of the Member States in the field of national security and measures which might be taken on the basis of Title VI of the Treaty on European Union. (6) Member States should rely upon detailed security assessments to identify the exact boundaries of the security-relevant port area, as well as the different measures required to ensure appropriate port security. Such measures should differ according to the security level in place and reflect differences in the risk profile of different sub-areas in the port. (7) Member States should approve port security plans which incorporate the findings of the port security assessment. The effectiveness of security measures also requires the clear division of tasks between all parties involved as well as regular exercises. This clear division of tasks and the recording of exercise procedures in the format of the port security plan is considered to contribute strongly to the effectiveness of both preventive and remedial port security measures. (8) Roll-on roll-off vessels are particularly vulnerable to security incidents, in particular if they carry passengers as well as cargo. Adequate measures should be taken on the basis of risk assessments which ensure that cars and goods vehicles destined for transport on roll-on roll-off vessels on domestic and international routes do not cause a risk to the vessel, its passengers and crew or to the cargo. The measures should be taken in a way which impedes as little as possible the fluidity of the operations. (9) Member States should be able to establish port security committees entrusted with providing practical advice in the ports covered by this Directive. (10) Member States should ensure that responsibilities in port security are clearly recognised by all parties involved. Member States should monitor compliance with security rules and clearly establish a responsible authority for all their ports, approve all security assessments and plans for their ports, set and communicate as appropriate security levels and ensure that measures are well communicated, implemented and coordinated. (11) Member States should approve assessments and plans and monitor their implementation in their ports. In order to keep disruption to ports and the administrative burden on inspection bodies to a minimum, the Commission's monitoring of the implementation of this Directive should be conducted jointly with the inspections provided for in Article 9(4) of Regulation (EC) No 725/2004. (12) Member States should ensure that a focal point for port security takes up the role of contact point between the Commission and Member States. They should inform the Commission which ports are covered by this Directive on the basis of the security assessments carried out. (13) The effective and standard implementation of measures under this security policy raises important questions in relation to its funding. The funding of extra security measures should not generate distortions of competition. By 30 June 2006, the Commission should submit to the European Parliament and the Council the findings of a study on the costs involved in measures taken under this Directive, addressing in particular the way financing is shared between the public authorities, port authorities and operators. (14) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. (15) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5). (16) A procedure should be defined for the adaptation of this Directive to take account of developments in international instruments and, in the light of experience, to adapt or complement the detailed provisions of the Annexes to this Directive, without broadening the scope of this Directive. (17) Since the objectives of this Directive, namely the balanced introduction of appropriate measures in the field of maritime transport and port policy, cannot be sufficiently achieved by the Member States and can therefore, by reason of the European scale of this Directive, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (18) Since this Directive concerns seaports, the obligations herein contained should not be applicable to Austria, the Czech Republic, Hungary, Luxembourg or Slovakia, Article 1 Subject matter 1. The main objective of this Directive is to introduce Community measures to enhance port security in the face of threats of security incidents. This Directive shall also ensure that security measures taken pursuant to Regulation (EC) No 725/2004 benefit from enhanced port security. 2. The measures referred to in paragraph 1 shall consist of: (a) common basic rules on port security measures; (b) an implementation mechanism for these rules; (c) appropriate compliance monitoring mechanisms. Article 2 Scope 1. This Directive lays down security measures which shall be observed in ports. Member States may apply the provisions of this Directive to port-related areas. 2. The measures laid down in this Directive shall apply to every port located in the territory of a Member State in which one or more port facilities covered by an approved port facility security plan pursuant to Regulation (EC) No 725/2004 is or are situated. This Directive shall not apply to military installations in ports. 3. Member States shall define for each port the boundaries of the port for the purposes of this Directive, appropriately taking into account information resulting from the port security assessment. 4. Where the boundaries of a port facility within the meaning of Regulation (EC) No 725/2004 have been defined by a Member State as effectively covering the port, the relevant provisions of Regulation (EC) No 725/2004 shall take precedence over those of this Directive. Article 3 Definitions For the purpose of this Directive: 1. ‘port’ means any specified area of land and water, with boundaries defined by the Member State in which the port is situated, containing works and equipment designed to facilitate commercial maritime transport operations; 2. ‘ship/port interface’ means the interactions that occur when a ship is directly and immediately affected by actions involving the movement of persons or goods or the provision of port services to or from the ship; 3. ‘port facility’ means a location where the ship/port interface takes place; this includes areas such as anchorages, waiting berths and approaches from seaward, as appropriate; 4. ‘focal point for port security’ means the body designated by each Member State to serve as contact point for the Commission and other Member States and to facilitate, follow up and provide information on the application of the port security measures laid down in this Directive; 5. ‘port security authority’ means the authority responsible for security matters in a given port. Article 4 Coordination with measures taken in application of Regulation (EC) No 725/2004 Member States shall ensure that port security measures introduced by this Directive are closely coordinated with measures taken pursuant to Regulation (EC) No 725/2004. Article 5 Port security authority 1. Member States shall designate a port security authority for each port covered by this Directive. A port security authority may be designated for more than one port. 2. The port security authority shall be responsible for the preparation and implementation of port security plans based on the findings of port security assessments. 3. Member States may designate a ‘competent authority for maritime security’ provided for under Regulation (EC) No 725/2004 as port security authority. Article 6 Port security assessment 1. Member States shall ensure that port security assessments are carried out for the ports covered by this Directive. These assessments shall take due account of the specificities of different sections of a port and, where deemed applicable by the relevant authority of the Member State, of its adjacent areas if these have an impact on security in the port and shall take into account the assessments for port facilities within their boundaries as carried out pursuant to Regulation (EC) No 725/2004. 2. Each port security assessment shall be carried out taking into account as a minimum the detailed requirements laid down in Annex I. 3. Port security assessments may be carried out by a recognised security organisation as referred to in Article 11. 4. Port security assessments shall be approved by the Member State concerned. Article 7 Port security plan 1. Subject to the findings of port security assessments, Member States shall ensure that port security plans are developed, maintained and updated. Port security plans shall adequately address the specificities of different sections of a port and shall integrate the security plans for port facilities within their boundaries established pursuant to Regulation (EC) No 725/2004. 2. Port security plans shall identify, for each of the different security levels referred to in Article 8: (a) the procedures to be followed; (b) the measures to be put in place; (c) the actions to be undertaken. 3. Each port security plan shall take into account as a minimum the detailed requirements specified in Annex II. Where, and to the extent appropriate, the port security plan shall in particular include security measures to be applied to passengers and vehicles set for embarkation on seagoing vessels which carry passengers and vehicles. In the case of international maritime transport services, the Member States concerned shall cooperate in the security assessment. 4. Port security plans may be developed by a recognised security organisation as referred to in Article 11. 5. Port security plans shall be approved by the Member State concerned before implementation. 6. Member States shall ensure that the implementation of port security plans is monitored. The monitoring shall be coordinated with other control activities carried out in the port. 7. Member States shall ensure that adequate exercises are performed, taking into account the basic security training exercise requirements listed in Annex III. Article 8 Security levels 1. Member States shall introduce a system of security levels for ports or parts of ports. 2. There shall be three security levels, as defined in Regulation (EC) No 725/2004: — ‘Security level 1’ means the level for which minimum appropriate protective security measures shall be maintained at all times; — ‘Security level 2’ means the level for which appropriate additional protective security measures shall be maintained for a period of time as a result of a heightened risk of a security incident; — ‘Security level 3’ means the level for which further specific protective security measures shall be maintained for a limited period of time when a security incident is probable or imminent, although it may not be possible to identify the specific target. 3. Member States shall determine the security levels in use for each port or part of a port. At each security level, a Member State may determine that different security measures are to be implemented in different parts of the port depending on the findings of the port security assessment. 4. Member States shall communicate to the appropriate person or persons the security level in force for each port or part of a port as well as any changes thereto. Article 9 Port security officer 1. A port security officer shall be approved by the Member State concerned for each port. Each port shall, where practicable, have a different port security officer, but may, if appropriate, share a security officer. 2. Port security officers shall fulfil the role of point of contact for port security related issues. 3. Where the port security officer is not the same as the port facility(ies) security officer(s) under Regulation (EC) No 725/2004, close cooperation between them shall be ensured. Article 10 Reviews 1. Member States shall ensure that port security assessments and port security plans are reviewed as appropriate. They shall be reviewed at least once every five years. 2. The scope of the review shall be that of Articles 6 or 7, as appropriate. Article 11 Recognised security organisation Member States may appoint recognised security organisations for the purposes specified in this Directive. Recognised security organisations shall fulfil the conditions set out in Annex IV. Article 12 Focal point for port security Member States shall appoint for port security aspects a focal point. Member States may designate for port security aspects the focal point appointed under Regulation (EC) No 725/2004. The focal point for port security shall communicate to the Commission the list of ports concerned by this Directive and shall inform it of any changes to that list. Article 13 Implementation and conformity checking 1. Member States shall set up a system ensuring adequate and regular supervision of the port security plans and their implementation. 2. The Commission shall, in cooperation with the focal points referred to in Article 12, monitor the implementation of this Directive by Member States. 3. This monitoring shall be conducted jointly with the inspections provided for in Article 9(4) of Regulation (EC) No 725/2004. Article 14 Adaptations Annexes I to IV may be amended in accordance with the procedure referred to in Article 15(2), without broadening the scope of this Directive. Article 15 Committee procedure 1. The Commission shall be assisted by the committee set up by Regulation (EC) No 725/2004. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month. 3. The Committee shall adopt its Rules of Procedure. Article 16 Confidentiality and dissemination of information 1. In applying this Directive, the Commission shall take, in accordance with Decision 2001/844/EC, ECSC, Euratom (6), appropriate measures to protect information subject to the requirement of confidentiality to which it has access or which is communicated to it by Member States. Member States shall take equivalent measures in accordance with relevant national legislation. 2. Any personnel carrying out security inspections, or handling confidential information related to this Directive, shall have an appropriate level of security vetting by the Member State of which the person concerned is a national. Article 17 Penalties Member States shall ensure that effective, proportionate and dissuasive penalties are introduced for infringements of the national provisions adopted pursuant to this Directive. Article 18 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 June 2007. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 19 Evaluation report By 15 December 2008 and every five years thereafter, the Commission shall submit an evaluation report to the European Parliament and the Council based, among other things, on the information obtained pursuant to Article 13. In the report, the Commission shall analyse compliance with this Directive by Member States and the effectiveness of the measures taken. If necessary, it shall present proposals for additional measures. Article 20 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 21 Addressees This Directive is addressed to the Member States which have ports as referred to in Article 2(2).

32005L0059

2005

DIRECTIVE 2005/59/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 October 2005 amending for the 28th time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (toluene and trichlorobenzene) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The risks presented to man and the environment by toluene and trichlorobenzene (TCB) have been assessed under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (3). The risk evaluation identified a need to limit those risks, and the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) confirmed that conclusion. (2) Commission Recommendation 2004/394/EC of 29 April 2004 on the results of the risk evaluation and the risk reduction strategies for the substances: acetonitrile; acrylamide; acrylonitrile; acrylic acid; butadiene; hydrogen fluoride; hydrogen peroxide; methacrylic acid; methyl methacrylate; toluene; trichlorobenzene (4), adopted within the framework of Regulation (EEC) No 793/93, contains a strategy for limiting risks of toluene and TCB, recommending restrictions to limit the risks from certain uses of these substances. (3) In order to protect human health and the environment, it therefore appears necessary that the placing on the market and the use of toluene and TCB should be restricted. (4) The aim of this Directive is to introduce harmonising measures with regard to toluene and TCB, which have as their object the proper functioning of the internal market whilst ensuring a high level of protection of human health and of the environment, as required by Article 95 of the Treaty. (5) This Directive is to apply without prejudice to Community legislation laying down minimum requirements for the protection of workers, contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5), and individual directives based thereon, in particular Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (14th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (6) and Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (7). (6) Directive 76/769/EEC (8) should be amended accordingly, Article 1 Annex I to Directive 76/769/EEC shall be amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 15 December 2006. They shall forthwith inform the Commission thereof. They shall apply these measures from 15 June 2007. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0056

2005

DIRECTIVE 2005/56/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 October 2005 on cross-border mergers of limited liability companies (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 44 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) There is a need for cooperation and consolidation between limited liability companies from different Member States. However, as regards cross-border mergers of limited liability companies, they encounter many legislative and administrative difficulties in the Community. It is therefore necessary, with a view to the completion and functioning of the single market, to lay down Community provisions to facilitate the carrying-out of cross-border mergers between various types of limited liability company governed by the laws of different Member States. (2) This Directive facilitates the cross-border merger of limited liability companies as defined herein. The laws of the Member States are to allow the cross-border merger of a national limited liability company with a limited liability company from another Member State if the national law of the relevant Member States permits mergers between such types of company. (3) In order to facilitate cross-border merger operations, it should be laid down that, unless this Directive provides otherwise, each company taking part in a cross-border merger, and each third party concerned, remains subject to the provisions and formalities of the national law which would be applicable in the case of a national merger. None of the provisions and formalities of national law, to which reference is made in this Directive, should introduce restrictions on freedom of establishment or on the free movement of capital save where these can be justified in accordance with the case-law of the Court of Justice and in particular by requirements of the general interest and are both necessary for, and proportionate to, the attainment of such overriding requirements. (4) The common draft terms of the cross-border merger are to be drawn up in the same terms for each of the companies concerned in the various Member States. The minimum content of such common draft terms should therefore be specified, while leaving the companies free to agree on other items. (5) In order to protect the interests of members and others, both the common draft terms of cross-border mergers and the completion of the cross-border merger are to be publicised for each merging company via an entry in the appropriate public register. (6) The laws of all the Member States should provide for the drawing-up at national level of a report on the common draft terms of the cross-border merger by one or more experts on behalf of each of the companies that are merging. In order to limit experts’ costs connected with cross-border mergers, provision should be made for the possibility of drawing up a single report intended for all members of companies taking part in a cross-border merger operation. The common draft terms of the cross-border merger are to be approved by the general meeting of each of those companies. (7) In order to facilitate cross-border merger operations, it should be provided that monitoring of the completion and legality of the decision-making process in each merging company should be carried out by the national authority having jurisdiction over each of those companies, whereas monitoring of the completion and legality of the cross-border merger should be carried out by the national authority having jurisdiction over the company resulting from the cross-border merger. The national authority in question may be a court, a notary or any other competent authority appointed by the Member State concerned. The national law determining the date on which the cross-border merger takes effect, this being the law to which the company resulting from the cross-border merger is subject, should also be specified. (8) In order to protect the interests of members and others, the legal effects of the cross-border merger, distinguishing as to whether the company resulting from the cross-border merger is an acquiring company or a new company, should be specified. In the interests of legal certainty, it should no longer be possible, after the date on which a cross-border merger takes effect, to declare the merger null and void. (9) This Directive is without prejudice to the application of the legislation on the control of concentrations between undertakings, both at Community level, by Regulation (EC) No 139/2004 (3), and at the level of Member States. (10) This Directive does not affect Community legislation regulating credit intermediaries and other financial undertakings and national rules made or introduced pursuant to such Community legislation. (11) This Directive is without prejudice to a Member State’s legislation demanding information on the place of central administration or the principal place of business proposed for the company resulting from the cross-border merger. (12) Employees’ rights other than rights of participation should remain subject to the national provisions referred to in Council Directive 98/59/EC of 20 July 1998 on collective redundancies (4), Council Directive 2001/23/EC of 12 March 2001 on the safeguarding of employees’ rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses (5), Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for informing and consulting employees in the European Community (6) and Council Directive 94/45/EC of 22 September 1994 on the establishment of a European Works Council or a procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of informing and consulting employees (7). (13) If employees have participation rights in one of the merging companies under the circumstances set out in this Directive and, if the national law of the Member State in which the company resulting from the cross-border merger has its registered office does not provide for the same level of participation as operated in the relevant merging companies, including in committees of the supervisory board that have decision-making powers, or does not provide for the same entitlement to exercise rights for employees of establishments resulting from the cross-border merger, the participation of employees in the company resulting from the cross-border merger and their involvement in the definition of such rights are to be regulated. To that end, the principles and procedures provided for in Council Regulation (EC) No 2157/2001 of 8 October 2001 on the Statute for a European company (SE) (8) and in Council Directive 2001/86/EC of 8 October 2001 supplementing the Statute for a European company with regard to the involvement of employees (9), are to be taken as a basis, subject, however, to modifications that are deemed necessary because the resulting company will be subject to the national laws of the Member State where it has its registered office. A prompt start to negotiations under Article 16 of this Directive, with a view to not unnecessarily delaying mergers, may be ensured by Member States in accordance with Article 3(2)(b) of Directive 2001/86/EC. (14) For the purpose of determining the level of employee participation operated in the relevant merging companies, account should also be taken of the proportion of employee representatives amongst the members of the management group, which covers the profit units of the companies, subject to employee participation. (15) Since the objective of the proposed action, namely laying down rules with common features applicable at transnational level, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and impact of the proposed action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective. (16) In accordance with paragraph 34 of the Interinstitutional Agreement on better law-making (10), Member States should be encouraged to draw up, for themselves and in the interest of the Community, their own tables which will, as far as possible, illustrate the correlation between this Directive and the transposition measures and to make them public, Article 1 Scope This Directive shall apply to mergers of limited liability companies formed in accordance with the law of a Member State and having their registered office, central administration or principal place of business within the Community, provided at least two of them are governed by the laws of different Member States (hereinafter referred to as cross-border mergers). Article 2 Definitions For the purposes of this Directive: 1) ‘limited liability company’, hereinafter referred to as ‘company’, means: (a) a company as referred to in Article 1 of Directive 68/151/EEC (11), or (b) a company with share capital and having legal personality, possessing separate assets which alone serve to cover its debts and subject under the national law governing it to conditions concerning guarantees such as are provided for by Directive 68/151/EEC for the protection of the interests of members and others; 2. ‘merger’ means an operation whereby: (a) one or more companies, on being dissolved without going into liquidation, transfer all their assets and liabilities to another existing company, the acquiring company, in exchange for the issue to their members of securities or shares representing the capital of that other company and, if applicable, a cash payment not exceeding 10 % of the nominal value, or, in the absence of a nominal value, of the accounting par value of those securities or shares; or (b) two or more companies, on being dissolved without going into liquidation, transfer all their assets and liabilities to a company that they form, the new company, in exchange for the issue to their members of securities or shares representing the capital of that new company and, if applicable, a cash payment not exceeding 10 % of the nominal value, or in the absence of a nominal value, of the accounting par value of those securities or shares; or (c) a company, on being dissolved without going into liquidation, transfers all its assets and liabilities to the company holding all the securities or shares representing its capital. Article 3 Further provisions concerning the scope 1. Notwithstanding Article 2(2), this Directive shall also apply to cross-border mergers where the law of at least one of the Member States concerned allows the cash payment referred to in points (a) and (b) of Article 2(2) to exceed 10 % of the nominal value, or, in the absence of a nominal value, of the accounting par value of the securities or shares representing the capital of the company resulting from the cross-border merger. 2. Member States may decide not to apply this Directive to cross-border mergers involving a cooperative society even in the cases where the latter would fall within the definition of ‘limited liability company’ as laid down in Article 2(1). 3. This Directive shall not apply to cross-border mergers involving a company the object of which is the collective investment of capital provided by the public, which operates on the principle of risk-spreading and the units of which are, at the holders’ request, repurchased or redeemed, directly or indirectly, out of the assets of that company. Action taken by such a company to ensure that the stock exchange value of its units does not vary significantly from its net asset value shall be regarded as equivalent to such repurchase or redemption. Article 4 Conditions relating to cross-border mergers 1. Save as otherwise provided in this Directive, (a) cross-border mergers shall only be possible between types of companies which may merge under the national law of the relevant Member States, and (b) a company taking part in a cross-border merger shall comply with the provisions and formalities of the national law to which it is subject. The laws of a Member State enabling its national authorities to oppose a given internal merger on grounds of public interest shall also be applicable to a cross-border merger where at least one of the merging companies is subject to the law of that Member State. This provision shall not apply to the extent that Article 21 of Regulation (EC) No 139/2004 is applicable. 2. The provisions and formalities referred to in paragraph 1(b) shall, in particular, include those concerning the decision-making process relating to the merger and, taking into account the cross-border nature of the merger, the protection of creditors of the merging companies, debenture holders and the holders of securities or shares, as well as of employees as regards rights other than those governed by Article 16. A Member State may, in the case of companies participating in a cross-border merger and governed by its law, adopt provisions designed to ensure appropriate protection for minority members who have opposed the cross-border merger. Article 5 Common draft terms of cross-border mergers The management or administrative organ of each of the merging companies shall draw up the common draft terms of cross-border merger. The common draft terms of cross-border merger shall include at least the following particulars: (a) the form, name and registered office of the merging companies and those proposed for the company resulting from the cross-border merger; (b) the ratio applicable to the exchange of securities or shares representing the company capital and the amount of any cash payment; (c) the terms for the allotment of securities or shares representing the capital of the company resulting from the cross-border merger; (d) the likely repercussions of the cross-border merger on employment; (e) the date from which the holding of such securities or shares representing the company capital will entitle the holders to share in profits and any special conditions affecting that entitlement; (f) the date from which the transactions of the merging companies will be treated for accounting purposes as being those of the company resulting from the cross-border merger; (g) the rights conferred by the company resulting from the cross-border merger on members enjoying special rights or on holders of securities other than shares representing the company capital, or the measures proposed concerning them; (h) any special advantages granted to the experts who examine the draft terms of the cross-border merger or to members of the administrative, management, supervisory or controlling organs of the merging companies; (i) the statutes of the company resulting from the cross-border merger; (j) where appropriate, information on the procedures by which arrangements for the involvement of employees in the definition of their rights to participation in the company resulting from the cross-border merger are determined pursuant to Article 16; (k) information on the evaluation of the assets and liabilities which are transferred to the company resulting from the cross-border merger; (l) dates of the merging companies’ accounts used to establish the conditions of the cross-border merger. Article 6 Publication 1. The common draft terms of the cross-border merger shall be published in the manner prescribed by the laws of each Member State in accordance with Article 3 of Directive 68/151/EEC for each of the merging companies at least one month before the date of the general meeting which is to decide thereon. 2. For each of the merging companies and subject to the additional requirements imposed by the Member State to which the company concerned is subject, the following particulars shall be published in the national gazette of that Member State: (a) the type, name and registered office of every merging company; (b) the register in which the documents referred to in Article 3(2) of Directive 68/151/EEC are filed in respect of each merging company, and the number of the entry in that register; (c) an indication, for each of the merging companies, of the arrangements made for the exercise of the rights of creditors and of any minority members of the merging companies and the address at which complete information on those arrangements may be obtained free of charge. Article 7 Report of the management or administrative organ The management or administrative organ of each of the merging companies shall draw up a report intended for the members explaining and justifying the legal and economic aspects of the cross-border merger and explaining the implications of the cross-border merger for members, creditors and employees. The report shall be made available to the members and to the representatives of the employees or, where there are no such representatives, to the employees themselves, not less than one month before the date of the general meeting referred to in Article 9. Where the management or administrative organ of any of the merging companies receives, in good time, an opinion from the representatives of their employees, as provided for under national law, that opinion shall be appended to the report. Article 8 Independent expert report 1. An independent expert report intended for members and made available not less than one month before the date of the general meeting referred to in Article 9 shall be drawn up for each merging company. Depending on the law of each Member State, such experts may be natural persons or legal persons. 2. As an alternative to experts operating on behalf of each of the merging companies, one or more independent experts, appointed for that purpose at the joint request of the companies by a judicial or administrative authority in the Member State of one of the merging companies or of the company resulting from the cross-border merger or approved by such an authority, may examine the common draft terms of cross-border merger and draw up a single written report to all the members. 3. The expert report shall include at least the particulars provided for by Article 10(2) of Council Directive 78/855/EEC of 9 October 1978 concerning mergers of public limited liability companies (12). The experts shall be entitled to secure from each of the merging companies all information they consider necessary for the discharge of their duties. 4. Neither an examination of the common draft terms of cross-border merger by independent experts nor an expert report shall be required if all the members of each of the companies involved in the cross-border merger have so agreed. Article 9 Approval by the general meeting 1. After taking note of the reports referred to in Articles 7 and 8, the general meeting of each of the merging companies shall decide on the approval of the common draft terms of cross-border merger. 2. The general meeting of each of the merging companies may reserve the right to make implementation of the cross-border merger conditional on express ratification by it of the arrangements decided on with respect to the participation of employees in the company resulting from the cross-border merger. 3. The laws of a Member State need not require approval of the merger by the general meeting of the acquiring company if the conditions laid down in Article 8 of Directive 78/855/EEC are fulfilled. Article 10 Pre-merger certificate 1. Each Member State shall designate the court, notary or other authority competent to scrutinise the legality of the cross-border merger as regards that part of the procedure which concerns each merging company subject to its national law. 2. In each Member State concerned the authority referred to in paragraph 1 shall issue, without delay to each merging company subject to that State’s national law, a certificate conclusively attesting to the proper completion of the pre-merger acts and formalities. 3. If the law of a Member State to which a merging company is subject provides for a procedure to scrutinise and amend the ratio applicable to the exchange of securities or shares, or a procedure to compensate minority members, without preventing the registration of the cross-border merger, such procedure shall only apply if the other merging companies situated in Member States which do not provide for such procedure explicitly accept, when approving the draft terms of the cross-border merger in accordance with Article 9(1), the possibility for the members of that merging company to have recourse to such procedure, to be initiated before the court having jurisdiction over that merging company. In such cases, the authority referred to in paragraph 1 may issue the certificate referred to in paragraph 2 even if such procedure has commenced. The certificate must, however, indicate that the procedure is pending. The decision in the procedure shall be binding on the company resulting from the cross-border merger and all its members. Article 11 Scrutiny of the legality of the cross-border merger 1. Each Member State shall designate the court, notary or other authority competent to scrutinise the legality of the cross-border merger as regards that part of the procedure which concerns the completion of the cross-border merger and, where appropriate, the formation of a new company resulting from the cross-border merger where the company created by the cross-border merger is subject to its national law. The said authority shall in particular ensure that the merging companies have approved the common draft terms of cross-border merger in the same terms and, where appropriate, that arrangements for employee participation have been determined in accordance with Article 16. 2. To that end each merging company shall submit to the authority referred to in paragraph 1 the certificate referred to in Article 10(2) within six months of its issue together with the common draft terms of cross-border merger approved by the general meeting referred to in Article 9. Article 12 Entry into effect of the cross-border merger The law of the Member State to whose jurisdiction the company resulting from the cross-border merger is subject shall determine the date on which the cross-border merger takes effect. That date must be after the scrutiny referred to in Article 11 has been carried out. Article 13 Registration The law of each of the Member States to whose jurisdiction the merging companies were subject shall determine, with respect to the territory of that State, the arrangements, in accordance with Article 3 of Directive 68/151/EEC, for publicising completion of the cross-border merger in the public register in which each of the companies is required to file documents. The registry for the registration of the company resulting from the cross-border merger shall notify, without delay, the registry in which each of the companies was required to file documents that the cross-border merger has taken effect. Deletion of the old registration, if applicable, shall be effected on receipt of that notification, but not before. Article 14 Consequences of the cross-border merger 1. A cross-border merger carried out as laid down in points (a) and (c) of Article 2(2) shall, from the date referred to in Article 12, have the following consequences: (a) all the assets and liabilities of the company being acquired shall be transferred to the acquiring company; (b) the members of the company being acquired shall become members of the acquiring company; (c) the company being acquired shall cease to exist. 2. A cross-border merger carried out as laid down in point (b) of Article 2(2) shall, from the date referred to in Article 12, have the following consequences: (a) all the assets and liabilities of the merging companies shall be transferred to the new company; (b) the members of the merging companies shall become members of the new company; (c) the merging companies shall cease to exist. 3. Where, in the case of a cross-border merger of companies covered by this Directive, the laws of the Member States require the completion of special formalities before the transfer of certain assets, rights and obligations by the merging companies becomes effective against third parties, those formalities shall be carried out by the company resulting from the cross-border merger. 4. The rights and obligations of the merging companies arising from contracts of employment or from employment relationships and existing at the date on which the cross-border merger takes effect shall, by reason of that cross-border merger taking effect, be transferred to the company resulting from the cross-border merger on the date on which the cross-border merger takes effect. 5. No shares in the acquiring company shall be exchanged for shares in the company being acquired held either: (a) by the acquiring company itself or through a person acting in his or her own name but on its behalf; (b) by the company being acquired itself or through a person acting in his or her own name but on its behalf. Article 15 Simplified formalities 1. Where a cross-border merger by acquisition is carried out by a company which holds all the shares and other securities conferring the right to vote at general meetings of the company or companies being acquired: — Articles 5, points (b), (c) and (e), 8 and 14(1), point (b) shall not apply, — Article 9(1) shall not apply to the company or companies being acquired. 2. Where a cross-border merger by acquisition is carried out by a company which holds 90 % or more but not all of the shares and other securities conferring the right to vote at general meetings of the company or companies being acquired, reports by an independent expert or experts and the documents necessary for scrutiny shall be required only to the extent that the national law governing either the acquiring company or the company being acquired so requires. Article 16 Employee participation 1. Without prejudice to paragraph 2, the company resulting from the cross-border merger shall be subject to the rules in force concerning employee participation, if any, in the Member State where it has its registered office. 2. However, the rules in force concerning employee participation, if any, in the Member State where the company resulting from the cross-border merger has its registered office shall not apply, where at least one of the merging companies has, in the six months before the publication of the draft terms of the cross-border merger as referred to in Article 6, an average number of employees that exceeds 500 and is operating under an employee participation system within the meaning of Article 2(k) of Directive 2001/86/EC, or where the national law applicable to the company resulting from the cross-border merger does not (a) provide for at least the same level of employee participation as operated in the relevant merging companies, measured by reference to the proportion of employee representatives amongst the members of the administrative or supervisory organ or their committees or of the management group which covers the profit units of the company, subject to employee representation, or (b) provide for employees of establishments of the company resulting from the cross-border merger that are situated in other Member States the same entitlement to exercise participation rights as is enjoyed by those employees employed in the Member State where the company resulting from the cross-border merger has its registered office. 3. In the cases referred to in paragraph 2, the participation of employees in the company resulting from the cross-border merger and their involvement in the definition of such rights shall be regulated by the Member States, mutatis mutandis and subject to paragraphs 4 to 7 below, in accordance with the principles and procedures laid down in Article 12(2), (3) and (4) of Regulation (EC) No 2157/2001 and the following provisions of Directive 2001/86/EC: (a) Article 3(1), (2) and (3), (4) first subparagraph, first indent, and second subparagraph, (5) and (7); (b) Article 4(1), (2), points (a), (g) and (h), and (3); (c) Article 5; (d) Article 6; (e) Article 7(1), (2) first subparagraph, point (b), and second subparagraph, and (3). However, for the purposes of this Directive, the percentages required by Article 7(2), first subparagraph, point (b) of Directive 2001/86/EC for the application of the standard rules contained in part 3 of the Annex to that Directive shall be raised from 25 to 33 1/3 %; (f) Articles 8, 10 and 12; (g) Article 13(4); (h) part 3 of the Annex, point (b). 4. When regulating the principles and procedures referred to in paragraph 3, Member States: (a) shall confer on the relevant organs of the merging companies the right to choose without any prior negotiation to be directly subject to the standard rules for participation referred to in paragraph 3(h), as laid down by the legislation of the Member State in which the company resulting from the cross-border merger is to have its registered office, and to abide by those rules from the date of registration; (b) shall confer on the special negotiating body the right to decide, by a majority of two thirds of its members representing at least two thirds of the employees, including the votes of members representing employees in at least two different Member States, not to open negotiations or to terminate negotiations already opened and to rely on the rules on participation in force in the Member State where the registered office of the company resulting from the cross-border merger will be situated; (c) may, in the case where, following prior negotiations, standard rules for participation apply and notwithstanding these rules, determine to limit the proportion of employee representatives in the administrative organ of the company resulting from the cross-border merger. However, if in one of the merging companies employee representatives constituted at least one third of the administrative or supervisory board, the limitation may never result in a lower proportion of employee representatives in the administrative organ than one third. 5. The extension of participation rights to employees of the company resulting from the cross-border merger employed in other Member States, referred to in paragraph 2(b), shall not entail any obligation for Member States which choose to do so to take those employees into account when calculating the size of workforce thresholds giving rise to participation rights under national law. 6. When at least one of the merging companies is operating under an employee participation system and the company resulting from the cross-border merger is to be governed by such a system in accordance with the rules referred to in paragraph 2, that company shall be obliged to take a legal form allowing for the exercise of participation rights. 7. When the company resulting from the cross-border merger is operating under an employee participation system, that company shall be obliged to take measures to ensure that employees’ participation rights are protected in the event of subsequent domestic mergers for a period of three years after the cross-border merger has taken effect, by applying mutatis mutandis the rules laid down in this Article. Article 17 Validity A cross-border merger which has taken effect as provided for in Article 12 may not be declared null and void. Article 18 Review Five years after the date laid down in the first paragraph of Article 19, the Commission shall review this Directive in the light of the experience acquired in applying it and, if necessary, propose its amendment. Article 19 Transposition Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 December 2007. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 20 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 21 Addressees This Directive is addressed to the Member States.

32005L0066

2005

DIRECTIVE 2005/66/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 October 2005 relating to the use of frontal protection systems on motor vehicles and amending Council Directive 70/156/EEC Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Systems providing additional frontal protection for motor vehicles have been increasingly used in recent years. Some of these systems constitute a risk to the safety of pedestrians and other road users in the event of a collision. Measures are therefore required in order to safeguard the public against such risks. (2) Frontal protection systems can be provided as original equipment fitted to a vehicle or marketed as separate technical units. The technical requirements for the type approval of motor vehicles with regard to any frontal protection systems that might be fitted to the vehicle should be harmonised in order to prevent the adoption of requirements that vary from one Member State to another and to ensure the proper functioning of the internal market. For the same reasons, it is necessary to harmonise the technical requirements for the type approval of frontal protection systems as separate technical units within the meaning of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (3). (3) It is necessary to control the use of frontal protection systems and to establish the test, construction and installation requirements to be complied with by any frontal protection system either supplied as original equipment fitted to a vehicle or placed on the market as a separate technical unit. Tests should require that frontal protection systems are designed in a way that improves pedestrian safety and reduces the number of injuries. (4) These requirements should also be regarded in the context of the protection of pedestrians and other vulnerable road users and with reference to Directive 2003/102/EC of the European Parliament and of the Council of 17 November 2003 relating to the protection of pedestrians and other vulnerable road users before and in the event of a collision with a motor vehicle (4). The present Directive should be reviewed in the light of further research and experience gained during the first four years of its application. (5) This Directive is one of the separate Directives within the framework of the EC type-approval procedure established by Directive 70/156/EEC. (6) The Commission should monitor the impact of this Directive and report to the European Parliament and the Council. If it is deemed necessary to achieve further improvements in pedestrian protection, the Commission should make proposals to amend this Directive in accordance with technical progress. (7) It is recognised, however, that certain vehicles included in the scope of this Directive, and to which frontal protection systems may be fitted, will not be subject to Directive 2003/102/EC. For such vehicles it is considered that the upper leg test requirements of this Directive may be technically unfeasible. To facilitate an improvement in pedestrian safety, with respect to head injury, it may be necessary to allow alternative requirements for the upper leg test, for application to those vehicles only, whilst ensuring that the installation of any frontal protection system does not increase the risk of leg injury to pedestrians or other vulnerable road users. (8) The measures necessary for the implementation of this Directive and for its adaptation to scientific and technical progress should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5). (9) Since the objective of this Directive, namely to promote the safety of pedestrians and other vulnerable road users through laying down technical requirements for the type-approval of motor vehicles as regards frontal protection systems, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective. (10) This Directive is part of the European road safety action programme and may be supplemented by national measures to prohibit or restrict the use of frontal protection systems already on the market before its entry into force. (11) Directive 70/156/EEC should therefore be amended accordingly, Article 1 Subject matter The purpose of this Directive is to improve pedestrian and vehicle safety through passive measures. It lays down technical requirements for the type-approval of motor vehicles as regards frontal protection systems supplied as original equipment fitted to vehicles or as separate technical units. Article 2 Definitions For the purposes of this Directive the following definitions and the definitions in Annex I, paragraph 1, shall apply: 1. ‘vehicle’ means any motor vehicle of class M1 as defined in Article 2 of Directive 70/156/EEC and in Annex II thereto, of a total permissible mass not exceeding 3,5 tonnes and any motor vehicle of class N1 as defined in Article 2 of Directive 70/156/EEC and in Annex II thereto; 2. ‘separate technical unit’ means any separate technical unit within the meaning of Article 2 of Directive 70/156/EEC and intended for installation and use on one or more types of vehicles. Article 3 Type-approval provisions 1. With effect from 25 August 2006, in respect of a new type of vehicle fitted with a frontal protection system which complies with the requirements laid down in Annex I and Annex II, Member States shall not, on grounds relating to frontal protection systems: (a) refuse to grant EC type-approval or national type-approval; (b) prohibit registration, sale or entry into service. 2. With effect from 25 August 2006, in respect of a new type of frontal protection system which is made available as a separate technical unit and which complies with the requirements laid down in Annex I and Annex II, Member States shall not: (a) refuse to grant EC type-approval or national type-approval; (b) prohibit sale or entry into service. 3. With effect from 25 November 2006, in respect of a new type of vehicle fitted with a frontal protection system, or a new type of frontal protection system supplied as a separate technical unit, which does not comply with the requirements laid down in Annex I and Annex II, Member States shall refuse to grant EC type-approval or national type-approval. 4. With effect from 25 May 2007, in respect of vehicles which do not comply with the requirements laid down in Annex I and Annex II, Member States shall, on grounds relating to frontal protection systems: (a) consider certificates of conformity which accompany new vehicles in accordance with Directive 70/156/EEC to be no longer valid for the purposes of Article 7(1) of that Directive; (b) prohibit the registration, sale or entry into service of new vehicles which are not accompanied by a certificate of conformity in accordance with Directive 70/156/EEC. 5. With effect from 25 May 2007, the requirements under Annex I and Annex II relating to frontal protection systems made available as separate technical units, shall apply for the purposes of Article 7(2) of Directive 70/156/EEC. Article 4 Implementation measures and amendments 1. Detailed technical requirements for the test provisions laid down in paragraph 3 of Annex I shall be adopted by the Commission in accordance with the procedure referred to in Article 13(3) of Directive 70/156/EEC. 2. Amendments necessary for adapting this Directive shall be adopted by the Commission, in accordance with the procedure referred to in Article 13(3) of Directive 70/156/EEC. Article 5 Review Not later than 25 August 2010, in the light of technical progress and experience, the Commission shall review the technical provisions of this Directive and, in particular, the conditions for requiring the Upper Legform to Frontal Protection System test, the inclusion of an Adult Headform to Frontal Protection System test and the specification of a Child Headform to Frontal Protection System test. The results of this review will be the subject of a report from the Commission to the European Parliament and the Council. If, as a result of this review, it is considered appropriate to adapt the technical provisions of this Directive, such adaptation shall be carried out in accordance with the procedure laid down in Article 13(3) of Directive 70/156/EEC. Article 6 Amendments to Directive 70/156/EEC Annexes I, III, IV and XI to Directive 70/156/EEC are hereby amended in accordance with Annex III to this Directive. Article 7 Transposition 1. Member States shall adopt and publish, by 25 August 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply those provisions from 25 August 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 8 Separate technical units This Directive shall not affect the Member States' competence to prohibit or to restrict the use of frontal protection systems placed on the market as separate technical units before the entry into force of this Directive. Article 9 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 10 Addressees This Directive is addressed to the Member States.

32005L0076

2005

COMMISSION DIRECTIVE 2005/76/EC of 8 November 2005 amending Council Directives 90/642/EEC and 86/362/EEC as regards the maximum residue levels of kresoxim-methyl, cyromazine, bifenthrin, metalaxyl and azoxystrobin fixed therein (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (2), and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), and in particular Article 4(1)(f) thereof, Whereas: (1) In accordance with Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations have to be based on the evaluation of effects on human and animal health and influence on the environment. Elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops. (2) Maximum residue levels (MRLs) reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in terms of estimated dietary intake. (3) MRLs for pesticides should be kept under review. They may be changed to take account of new uses, new information and data. (4) MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residues in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data. (5) Information on new or changed uses of certain pesticides covered by Directive 90/642/EEC and Directive 86/362/EEC has been notified to the Commission. This concerns kresoxim-methyl, cyromazine, bifenthrin, metalaxyl and azoxystrobin. (6) The lifetime exposure of consumers to these pesticides via food products that may contain residues of these pesticides, has been assessed and evaluated in accordance with the procedures and practices used within the Community, taking account of guidelines published by the World Health Organisation (4). It has been calculated that the MRLs concerned will ensure that the acceptable daily intake is not exceeded. (7) An assessment of the available information has shown that no ARfD is required and that therefore a short term assessment is not needed. (8) Therefore it is appropriate to fix new maximum levels for residues of those pesticides. (9) The setting or modification at Community level of provisional MRLs does not prevent the Member States from establishing provisional MRLs for metalaxyl in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of metalaxyl or metalaxyl-M. The provisional Community MRL should then become definitive. (10) Directives 90/642/EEC and 86/362/EEC should therefore be amended accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Part A of Annex II to Directive 86/362/EEC is amended in accordance with Annex I to this Directive. Article 2 Part A of Annex II to Directive 90/642/EEC is amended in accordance with Annex II to this Directive. Article 3 1. Member States shall adopt and publish, by 9 May 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 10 May 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0077

2005

COMMISSION DIRECTIVE 2005/77/EC of 11 November 2005 amending Annex V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular point (d) of the second paragraph of Article 14 thereof, Whereas: (1) Directive 2000/29/EC provides for certain measures against the spread within the Community of organisms which are harmful to plants or plant products. It also provides for the use of plant passports, giving evidence that the plants or plant products have successfully undergone the Community checking system. (2) Plant passports are currently required for moving certified seeds of Helianthus annuus L., Lycopersicon lycopersicum (L.) Karsten ex Farw. and Phaseolus L. within the Community, other than locally. (3) To improve the phytosanitary protection of seeds of Helianthus annuus L., Lycopersicon lycopersicum (L.) Karsten ex Farw. and Phaseolus L., the requirement that seeds have to be accompanied by a plant passport when moved within the Community, other than locally, should be applied to all seeds of those species. (4) Annex V to Directive 2000/29/EC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 In point 2.4 of section I of part A of Annex V to Directive 2000/29/EC the last indent is replaced by the following: ‘ — Seeds of Helianthus annuus L., Lycopersicon lycopersicum (L.) Karsten ex Farw. and Phaseolus L.’ Article 2 1. Member States shall adopt and publish, by 30 April 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 May 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0078

2005

COMMISSION DIRECTIVE 2005/78/EC of 14 November 2005 implementing Directive 2005/55/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles and amending Annexes I, II, III, IV and VI thereto (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), and in particular second indent of Article 13(2) thereof, Having regard to Directive 2005/55/EC of the European Parliament and of the Council of 28 September 2005 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles (2), and in particular Article 7 thereof, Whereas: (1) Directive 2005/55/EC is one of the separate directives under the type-approval procedure laid down by Directive 70/156/EEC. (2) Directive 2005/55/EC requires new heavy-duty engines and engines of new heavy-duty vehicles to comply with new technical requirements covering on-board diagnostic systems, durability and conformity of in-service vehicles which are properly maintained and used, from 1 October 2005. The technical provisions necessary to implement Articles 3 and 4 of that Directive should be adopted. (3) In order to ensure compliance with Article 5 of Directive 2005/55/EC, it is appropriate to introduce requirements encouraging the proper use, as intended by the manufacturer, of new heavy-duty vehicles equipped with engines having an exhaust after-treatment system requiring the use of a consumable reagent to achieve the intended reduction of regulated pollutants. Measures should be introduced to ensure that the driver of such a vehicle is informed in good time if any on-vehicle supply of a consumable reagent is about to run out or if the reagent dosing activity does not take place. If the driver ignores such warnings, the engine performance should be modified until the driver replenishes the supply of the consumable reagent required for the efficient operation of the exhaust after-treatment system. (4) Where engines within the scope of Directive 2005/55/EC require the use of a consumable reagent in order to achieve the emission limits for which those engines were granted type-approval, the Member States should take appropriate steps to ensure that such reagents are available on a geographically balanced basis. Member States should be able to take appropriate steps to encourage the use of such reagents. (5) It is appropriate to introduce requirements that will enable the Member States to monitor and ensure, at the time of the periodic technical inspection, that heavy-duty vehicles equipped with exhaust after-treatment systems requiring the use of a consumable reagent have been properly operated during the period preceding the inspection. (6) Member States should be able to prohibit the use of any heavy-duty vehicle equipped with an exhaust after-treatment system that requires the use of a consumable reagent in order to achieve the emission limits for which such vehicles were granted a type-approval if the exhaust after-treatment system does not actually consume the required reagent or if the vehicle does not carry the required reagent. (7) Manufacturers of heavy-duty vehicles equipped with exhaust after-treatment systems requiring the use of a consumable reagent should inform their customers how such vehicles should properly be operated. (8) The requirements of Directive 2005/55/EC relating to the use of defeat strategies should be adapted to take account of technical progress. Requirements for multi-setting engines and for devices that can limit engine torque under certain operating conditions should also be specified. (9) Annexes III and IV to Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuel and amending Council Directive 93/12/EEC (3) require petrol and diesel motor fuels for sale throughout the Community to have a maximum sulphur content of 50 mg/kg (parts per million, ppm), from 1 January 2005. Motor fuels with a sulphur content of 10 mg/kg or less are increasingly available throughout the Community and Directive 98/70/EC requires such fuels to be available from 1 January 2009. The reference fuels used for the type-approval testing of engines against the emission limits specified in row B1, row B2 and row C of the tables in Annex I to Directive 2005/55/EC should therefore be redefined in order to better reflect, where applicable, the sulphur content of the diesel fuels that are available on the market from 1 January 2005 and that are used by engines with advanced emission control systems. It is also appropriate to redefine the liquefied petroleum gas (LPG) reference fuel to reflect progress in the market since 1 January 2005. (10) Technical adaptations to the sampling and measurement procedures are necessary to enable the reliable and repeatable measurement of particulate mass emissions for compression-ignition engines that are granted a type-approval according to the particulate limits specified either in row B1, row B2 or row C of the tables in section 6.2.1 of Annex I to Directive 2005/55/EC and for gas engines that are granted a type-approval according to the emission limits specified in row C of table 2 in section 6.2.1 of that Annex. (11) Since the provisions concerning the implementation of Articles 3 and 4 of Directive 2005/55/EC are adopted at the same time as those adapting that Directive to technical progress, both types of measures have been included in the same act. (12) In view of the rapid technological progress in this area, this Directive will be reviewed by 31 December 2006, if necessary. (13) Directive 2005/55/EC should therefore be amended accordingly. (14) The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 13(1) of Directive 70/156/EEC, Article 1 Annexes I, II, III, IV and VI to Directive 2005/55/EC are amended in accordance with Annex I to this Directive. Article 2 Measures for the implementation of Articles 3 and 4 of Directive 2005/55/EC are laid down in Annexes II to V to this Directive. Article 3 1. Member States shall adopt and publish, by 8 November 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 9 November 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0069

2005

DIRECTIVE 2005/69/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 November 2005 amending for the 27th time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (polycyclic aromatic hydrocarbons in extender oils and tyres) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Tyres are produced by using extender oils that may contain various levels of polycyclic aromatic hydrocarbons (PAHs) that are not added intentionally. During the production process PAHs can be incorporated into the rubber matrix. Therefore, they can be present in various amounts in the final product. (2) Benzo(a)pyrene (BaP) can be a qualitative and quantitative marker for the presence of PAHs. BaP and other PAHs have been classified as carcinogenic, mutagenic and toxic to reproduction. In addition, due to the presence of these PAHs, several extender oils as such have been classified as carcinogenic, mutagenic and toxic to reproduction. (3) The Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) has confirmed the scientific findings which identify the adverse health effects of PAHs. (4) The emission of BaP and other PAHs into the environment should be reduced as much as possible. In order to provide a high level of protection to human health and the environment and to contribute to the reduction of total annual emissions of PAHs as required in the 1998 Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants, it therefore appears necessary to restrict the placing on the market and the use of PAH-rich extender oils and blends used as extender oils for the production of tyres. (5) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (3) should therefore be amended accordingly. (6) Without prejudice to the requirements of other European provisions, this Directive covers passenger car tyres (4), light and heavy truck tyres (5), agricultural tyres (6) and motorcycle tyres (7). (7) In order to meet the necessary safety requirements and in particular to ensure that tyres have a high degree of wet grip performance, a transitory period is necessary during which tyre producers will develop and test new types of tyres produced without high aromatic extender oils. According to the information at present available, the development and testing work will take a considerable amount of time, as producers will have to perform numerous series of test runs before the necessary high level of wet grip performance of the new tyres can be guaranteed. Therefore, this Directive should be applied to economic operators from 1 January 2010. (8) The adoption of harmonised test methods is necessary for the application of this Directive as regards the content of PAHs in extender oils and tyres. The adoption of such test methods should not delay the entry into force of this Directive. The test method should preferably be developed at European or international level, where appropriate by the European Committee for Standardisation (CEN) or by the International Organisation for Standardization (ISO). The Commission may publish references to the relevant CEN or ISO standards or establish such methods in accordance with Article 2a of Directive 76/769/EEC, where necessary. (9) This Directive does not affect the Community legislation laying down minimum requirements for the protection of workers, such as Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (8), and individual directives based thereon, in particular Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (9) and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (14th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (10). (10) It is not the purpose of this Directive to restrict the placing on the market, as defined in Article 2(1)(e) of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (11), of tyres produced before 1 January 2010 and which can thus be sold off from stocks subsequent to this date. The date of production of tyres can be easily recognised by the existing mandatory marking of the ‘date of manufacture’ on the tyre as stipulated in Directive 92/23/EEC. All tyres retreaded after 1 January 2010 should be retreaded with new tread containing new PAH-low extender oils, Article 1 Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 29 December 2006. They shall forthwith inform the Commission thereof. They shall apply those measures from 1 January 2010. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0079

2005

COMMISSION DIRECTIVE 2005/79/EC of 18 November 2005 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 5(2) thereof, After consulting the European Food Safety Authority, Whereas: (1) Commission Directive 2002/72/EC (2) establishes a list of monomers and other starting substances, which may be used for the manufacture of plastic materials and articles. On the basis of new information related to the risk assessment of such substances, certain monomers provisionally admitted at national level as well as new monomers should be included in the Community list of permitted substances in that Directive. (2) Directive 2002/72/EC also contains an incomplete list of additives which may be used in the manufacture of plastic materials and articles. That list should be amended so as to include other additives evaluated by the European Food Safety Authority (the Authority). (3) For certain substances, the restrictions already established at Community level should be amended on the basis of the new information available. In particular for epoxidised soybean oil (ESBO) the Authority recommended to decrease its specific migration limit (SML) for PVC gaskets containing that substance which are used to seal glass jars containing infant formulae and follow-on formulae or containing processed cereal-based foods and baby foods for infants and young children. In fact the Authority noted that the exposure of infants who regularly eat such foods may exceed the TDI. Therefore the SML for ESBO is decreased for these particular applications from 60 to 30 mg/kg of food or food simulant while it remains unchanged for all other applications. (4) A transitional period should be provided for in respect of PVC gaskets containing epoxidised soybean oil, used to seal glass jars, which are brought into contact with food before the 19 November 2006. (5) Directive 2002/72/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annexes II, III, V and VI of Directive 2002/72/EC are amended in accordance with Annexes I to IV to this Directive. Article 2 PVC gaskets containing epoxidised soybean oil, with reference number 88640 in section A of Annex III to Directive 2002/72/EC, which are used to seal glass jars containing infant formulae and follow-on formulae as defined by Commission Directive 91/321/EEC (3) or containing processed cereal-based foods and baby foods for infants and young children as defined by Commission Directive 96/5/EC (4), filled before 19 November 2006 and which comply with the restrictions and/or specifications provided for in Section A of Annex III to Directive 2002/72/EC as amended by Directive 2004/19/EC, may continue to be placed on the market provided that the date of filling appears on the materials and articles. The date of filling may be replaced by another indication, provided that that indication permits the identification of the date of filling. Upon request the date of filling shall be made available to the competent authorities and any person enforcing the requirements of this Directive. The first and second subparagraphs shall apply without prejudice to Directive 2000/13/EC of the European Parliament and of the Council (5). Article 3 1. Member States shall adopt and publish, by 19 November 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions in such a way as to: (a) permit the trade in and use of plastic materials and articles intended to come into contact with food and complying with this Directive, from 19 November 2006; (b) prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food and which do not comply with this Directive, from 19 November 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0080

2005

COMMISSION DIRECTIVE 2005/80/EC of 21 November 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II and III thereto to technical progress (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 4b and Article 8(2) thereof, After consulting the Scientific Committee on Consumer Products, Whereas: (1) Directive 76/768/EEC, as amended by Directive 2003/15/EC of the European Parliament and of the Council (2), prohibits the use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1, 2 and 3, under Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (3), but allows the use of substances classified in category 3 pursuant to Directive 67/548/EEC subject to evaluation and approval by the Scientific Committee on Cosmetic products and Non-Food Products intended for consumers SCCNFP, replaced by the Scientific Committee on Consumer Products (SCCP) by Commission Decision 2004/210 (4). (2) Directive 67/548/EEC has been amended by Directive 2004/73/EC, and it is therefore necessary to adopt measures so as to bring Directive 76/768/EEC in line with the provisions of Directive 67/548/EEC. (3) In so far as some of the substances classified as CMR of category 1 and 2 under Annex I to Directive 67/548/EEC are not yet listed in Annex II to Directive 76/768/EEC, it is necessary to include them in that Annex. Substances classified as CMR of category 3 under Annex I to Directive 67/548/EEC should also be included in Annex II to Directive 76/768/EEC, except if they have been evaluated by the SCCP and found acceptable for use in cosmetic products. (4) Substances classified as CMR of category 1 and 2 listed in Annex III, Part 1 to Directive 76/768/EEC should be deleted, since these substances are now listed in Annex II to Directive 76/768/EEC and therefore must not form part of the composition of cosmetic products. (5) Commission Directive 2004/93/EC (5) provided for the insertion in Annex II to Directive 76/768/EEC of certain substances which were already listed there. That Annex should therefore be amended for the sake of clarity. (6) Directive 76/768/EEC should therefore be amended accordingly. (7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products, Article 1 Annexes II and III to Directive 76/768/EEC are amended in accordance with the text set out in the Annex to this Directive. Article 2 Member States shall take all necessary measures to ensure that from 22 August 2006 cosmetic products which fail to comply with this Directive are not placed on the market by Community manufacturers or by importers established within the Community. Member States shall take all necessary measures to ensure that those products are not sold or disposed of to the final consumer after 22 November 2006. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 22 May 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0083

2005

COMMISSION DIRECTIVE 2005/83/EC of 23 November 2005 amending, for the purposes of their adaptation to technical progress, Annexes I, VI, VII, VIII, IX and X to Council Directive 72/245/EEC relating to the radio interference (electromagnetic compatibility) of vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), and in particular the second indent of Article 13(2) thereof, Having regard to Council Directive 72/245/EEC of 20 June 1972 relating to the radio interference (electromagnetic compatibility) of vehicles (2), and in particular Article 4 thereof, Whereas: (1) Directive 72/245/EEC is one of the separate directives under the type-approval procedure established by Directive 70/156/EEC. (2) The Electromagnetic Compatibility requirements and test provisions for electrical and electronic equipment have been constantly updated through the standardisation work of the International Special Committee on Radio Interference (CISPR) and the International Organisation for Standardisation (ISO). Therefore Commission Directive 2004/104/EC (3), which amended Directive 72/245/EEC, introduced references to the test procedures outlined in the recent editions of the relevant standards. (3) Since the entry into force of Directive 2004/104/EC, several standards have been replaced by more recent versions adapting them to technical progress. It is therefore necessary to update the references to those standards in Directive 72/245/EEC. (4) In addition, some editorial corrections need to be introduced. (5) Directive 72/245/EEC should therefore be amended accordingly, Article 1 Annexes I, VI, VII, VIII, IX and X to Directive 72/245/EEC are amended in accordance with the Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 30 September 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 October 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0085

2005

COUNCIL DIRECTIVE 2005/85/EC of 1 December 2005 on minimum standards on procedures in Member States for granting and withdrawing refugee status Having regard to the Treaty establishing the European Community, and in particular point (1)(d) of the first paragraph of Article 63 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the European Economic and Social Committee (3), Whereas: (1) A common policy on asylum, including a Common European Asylum System, is a constituent part of the European Union’s objective of establishing progressively an area of freedom, security and justice open to those who, forced by circumstances, legitimately seek protection in the Community. (2) The European Council, at its special meeting in Tampere on 15 and 16 October 1999, agreed to work towards establishing a Common European Asylum System, based on the full and inclusive application of the Geneva Convention of 28 July 1951 relating to the status of refugees, as amended by the New York Protocol of 31 January 1967 (Geneva Convention), thus affirming the principle of non-refoulement and ensuring that nobody is sent back to persecution. (3) The Tampere Conclusions provide that a Common European Asylum System should include, in the short term, common standards for fair and efficient asylum procedures in the Member States and, in the longer term, Community rules leading to a common asylum procedure in the European Community. (4) The minimum standards laid down in this Directive on procedures in Member States for granting or withdrawing refugee status are therefore a first measure on asylum procedures. (5) The main objective of this Directive is to introduce a minimum framework in the Community on procedures for granting and withdrawing refugee status. (6) The approximation of rules on the procedures for granting and withdrawing refugee status should help to limit the secondary movements of applicants for asylum between Member States, where such movement would be caused by differences in legal frameworks. (7) It is in the very nature of minimum standards that Member States should have the power to introduce or maintain more favourable provisions for third country nationals or stateless persons who ask for international protection from a Member State, where such a request is understood to be on the grounds that the person concerned is a refugee within the meaning of Article 1(A) of the Geneva Convention. (8) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. (9) With respect to the treatment of persons falling within the scope of this Directive, Member States are bound by obligations under instruments of international law to which they are party and which prohibit discrimination. (10) It is essential that decisions on all applications for asylum be taken on the basis of the facts and, in the first instance, by authorities whose personnel has the appropriate knowledge or receives the necessary training in the field of asylum and refugee matters. (11) It is in the interest of both Member States and applicants for asylum to decide as soon as possible on applications for asylum. The organisation of the processing of applications for asylum should be left to the discretion of Member States, so that they may, in accordance with their national needs, prioritise or accelerate the processing of any application, taking into account the standards in this Directive. (12) The notion of public order may cover a conviction for committing a serious crime. (13) In the interests of a correct recognition of those persons in need of protection as refugees within the meaning of Article 1 of the Geneva Convention, every applicant should, subject to certain exceptions, have an effective access to procedures, the opportunity to cooperate and properly communicate with the competent authorities so as to present the relevant facts of his/her case and sufficient procedural guarantees to pursue his/her case throughout all stages of the procedure. Moreover, the procedure in which an application for asylum is examined should normally provide an applicant at least with the right to stay pending a decision by the determining authority, access to the services of an interpreter for submitting his/her case if interviewed by the authorities, the opportunity to communicate with a representative of the United Nations High Commissioner for Refugees (UNHCR) or with any organisation working on its behalf, the right to appropriate notification of a decision, a motivation of that decision in fact and in law, the opportunity to consult a legal adviser or other counsellor, and the right to be informed of his/her legal position at decisive moments in the course of the procedure, in a language he/she can reasonably be supposed to understand. (14) In addition, specific procedural guarantees for unaccompanied minors should be laid down on account of their vulnerability. In this context, the best interests of the child should be a primary consideration of Member States. (15) Where an applicant makes a subsequent application without presenting new evidence or arguments, it would be disproportionate to oblige Member States to carry out a new full examination procedure. In these cases, Member States should have a choice of procedure involving exceptions to the guarantees normally enjoyed by the applicant. (16) Many asylum applications are made at the border or in a transit zone of a Member State prior to a decision on the entry of the applicant. Member States should be able to keep existing procedures adapted to the specific situation of these applicants at the border. Common rules should be defined on possible exceptions made in these circumstances to the guarantees normally enjoyed by applicants. Border procedures should mainly apply to those applicants who do not meet the conditions for entry into the territory of the Member States. (17) A key consideration for the well-foundedness of an asylum application is the safety of the applicant in his/her country of origin. Where a third country can be regarded as a safe country of origin, Member States should be able to designate it as safe and presume its safety for a particular applicant, unless he/she presents serious counter-indications. (18) Given the level of harmonisation achieved on the qualification of third country nationals and stateless persons as refugees, common criteria for designating third countries as safe countries of origin should be established. (19) Where the Council has satisfied itself that those criteria are met in relation to a particular country of origin, and has consequently included it in the minimum common list of safe countries of origin to be adopted pursuant to this Directive, Member States should be obliged to consider applications of persons with the nationality of that country, or of stateless persons formerly habitually resident in that country, on the basis of the rebuttable presumption of the safety of that country. In the light of the political importance of the designation of safe countries of origin, in particular in view of the implications of an assessment of the human rights situation in a country of origin and its implications for the policies of the European Union in the field of external relations, the Council should take any decisions on the establishment or amendment of the list, after consultation of the European Parliament. (20) It results from the status of Bulgaria and Romania as candidate countries for accession to the European Union and the progress made by these countries towards membership that they should be regarded as constituting safe countries of origin for the purposes of this Directive until the date of their accession to the European Union. (21) The designation of a third country as a safe country of origin for the purposes of this Directive cannot establish an absolute guarantee of safety for nationals of that country. By its very nature, the assessment underlying the designation can only take into account the general civil, legal and political circumstances in that country and whether actors of persecution, torture or inhuman or degrading treatment or punishment are subject to sanction in practice when found liable in the country concerned. For this reason, it is important that, where an applicant shows that there are serious reasons to consider the country not to be safe in his/her particular circumstances, the designation of the country as safe can no longer be considered relevant for him/her. (22) Member States should examine all applications on the substance, i.e. assess whether the applicant in question qualifies as a refugee in accordance with Council Directive 2004/83/EC of 29 April 2004 on minimum standards for the qualification and status of third country nationals or stateless persons as refugees or as persons who otherwise need international protection and the content of the protection granted (4), except where the present Directive provides otherwise, in particular where it can be reasonably assumed that another country would do the examination or provide sufficient protection. In particular, Member States should not be obliged to assess the substance of an asylum application where a first country of asylum has granted the applicant refugee status or otherwise sufficient protection and the applicant will be readmitted to this country. (23) Member States should also not be obliged to assess the substance of an asylum application where the applicant, due to a connection to a third country as defined by national law, can reasonably be expected to seek protection in that third country. Member States should only proceed on this basis where this particular applicant would be safe in the third country concerned. In order to avoid secondary movements of applicants, common principles for the consideration or designation by Member States of third countries as safe should be established. (24) Furthermore, with respect to certain European third countries, which observe particularly high human rights and refugee protection standards, Member States should be allowed to not carry out, or not to carry out full examination of asylum applications regarding applicants who enter their territory from such European third countries. Given the potential consequences for the applicant of a restricted or omitted examination, this application of the safe third country concept should be restricted to cases involving third countries with respect to which the Council has satisfied itself that the high standards for the safety of the third country concerned, as set out in this Directive, are fulfilled. The Council should take decisions in this matter after consultation of the European Parliament. (25) It follows from the nature of the common standards concerning both safe third country concepts as set out in this Directive, that the practical effect of the concepts depends on whether the third country in question permits the applicant in question to enter its territory. (26) With respect to the withdrawal of refugee status, Member States should ensure that persons benefiting from refugee status are duly informed of a possible reconsideration of their status and have the opportunity to submit their point of view before the authorities can take a motivated decision to withdraw their status. However, dispensing with these guarantees should be allowed where the reasons for the cessation of the refugee status is not related to a change of the conditions on which the recognition was based. (27) It reflects a basic principle of Community law that the decisions taken on an application for asylum and on the withdrawal of refugee status are subject to an effective remedy before a court or tribunal within the meaning of Article 234 of the Treaty. The effectiveness of the remedy, also with regard to the examination of the relevant facts, depends on the administrative and judicial system of each Member State seen as a whole. (28) In accordance with Article 64 of the Treaty, this Directive does not affect the exercise of the responsibilities incumbent upon Member States with regard to the maintenance of law and order and the safeguarding of internal security. (29) This Directive does not deal with procedures governed by Council Regulation (EC) No 343/2003 of 18 February 2003 establishing the criteria and mechanisms for determining the Member State responsible for examining an asylum application lodged in one of the Member States by a third-country national (5). (30) The implementation of this Directive should be evaluated at regular intervals not exceeding two years. (31) Since the objective of this Directive, namely to establish minimum standards on procedures in Member States for granting and withdrawing refugee status cannot be sufficiently attained by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective. (32) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, the United Kingdom has notified, by letter of 24 January 2001, its wish to take part in the adoption and application of this Directive. (33) In accordance with Article 3 of the Protocol on the position of the United Kingdom and Ireland, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Ireland has notified, by letter of 14 February 2001, its wish to take part in the adoption and application of this Directive. (34) In accordance with Articles 1 and 2 of the Protocol on the position of Denmark, annexed to the Treaty on European Union and to the Treaty establishing the European Community, Denmark does not take part in the adoption of this Directive and is not bound by it or subject to its application, CHAPTER I GENERAL PROVISIONS Article 1 Purpose The purpose of this Directive is to establish minimum standards on procedures in Member States for granting and withdrawing refugee status. Article 2 Definitions For the purposes of this Directive: (a) ‘Geneva Convention’ means the Convention of 28 July 1951 relating to the status of refugees, as amended by the New York Protocol of 31 January 1967; (b) ‘application’ or ‘application for asylum’ means an application made by a third country national or stateless person which can be understood as a request for international protection from a Member State under the Geneva Convention. Any application for international protection is presumed to be an application for asylum, unless the person concerned explicitly requests another kind of protection that can be applied for separately; (c) ‘applicant’ or ‘applicant for asylum’ means a third country national or stateless person who has made an application for asylum in respect of which a final decision has not yet been taken; (d) ‘final decision’ means a decision on whether the third country national or stateless person be granted refugee status by virtue of Directive 2004/83/EC and which is no longer subject to a remedy within the framework of Chapter V of this Directive irrespective of whether such remedy has the effect of allowing applicants to remain in the Member States concerned pending its outcome, subject to Annex III to this Directive; (e) ‘determining authority’ means any quasi-judicial or administrative body in a Member State responsible for examining applications for asylum and competent to take decisions at first instance in such cases, subject to Annex I; (f) ‘refugee’ means a third country national or a stateless person who fulfils the requirements of Article 1 of the Geneva Convention as set out in Directive 2004/83/EC; (g) ‘refugee status’ means the recognition by a Member State of a third country national or stateless person as a refugee; (h) ‘unaccompanied minor’ means a person below the age of 18 who arrives in the territory of the Member States unaccompanied by an adult responsible for him/her whether by law or by custom, and for as long as he/she is not effectively taken into the care of such a person; it includes a minor who is left unaccompanied after he/she has entered the territory of the Member States; (i) ‘representative’ means a person acting on behalf of an organisation representing an unaccompanied minor as legal guardian, a person acting on behalf of a national organisation which is responsible for the care and well-being of minors, or any other appropriate representation appointed to ensure his/her best interests; (j) ‘withdrawal of refugee status’ means the decision by a competent authority to revoke, end or refuse to renew the refugee status of a person in accordance with Directive 2004/83/EC; (k) ‘remain in the Member State’ means to remain in the territory, including at the border or in transit zones, of the Member State in which the application for asylum has been made or is being examined. Article 3 Scope 1. This Directive shall apply to all applications for asylum made in the territory, including at the border or in the transit zones of the Member States, and to the withdrawal of refugee status. 2. This Directive shall not apply in cases of requests for diplomatic or territorial asylum submitted to representations of Member States. 3. Where Member States employ or introduce a procedure in which asylum applications are examined both as applications on the basis of the Geneva Convention and as applications for other kinds of international protection given under the circumstances defined by Article 15 of Directive 2004/83/EC, they shall apply this Directive throughout their procedure. 4. Moreover, Member States may decide to apply this Directive in procedures for deciding on applications for any kind of international protection. Article 4 Responsible authorities 1. Member States shall designate for all procedures a determining authority which will be responsible for an appropriate examination of the applications in accordance with this Directive, in particular Articles 8(2) and 9. In accordance with Article 4(4) of Regulation (EC) No 343/2003, applications for asylum made in a Member State to the authorities of another Member State carrying out immigration controls there shall be dealt with by the Member State in whose territory the application is made. 2. However, Member States may provide that another authority is responsible for the purposes of: (a) processing cases in which it is considered to transfer the applicant to another State according to the rules establishing criteria and mechanisms for determining which State is responsible for considering an application for asylum, until the transfer takes place or the requested State has refused to take charge of or take back the applicant; (b) taking a decision on the application in the light of national security provisions, provided the determining authority is consulted prior to this decision as to whether the applicant qualifies as a refugee by virtue of Directive 2004/83/EC; (c) conducting a preliminary examination pursuant to Article 32, provided this authority has access to the applicant’s file regarding the previous application; (d) processing cases in the framework of the procedures provided for in Article 35(1); (e) refusing permission to enter in the framework of the procedure provided for in Article 35(2) to (5), subject to the conditions and as set out therein; (f) establishing that an applicant is seeking to enter or has entered into the Member State from a safe third country pursuant to Article 36, subject to the conditions and as set out in that Article. 3. Where authorities are designated in accordance with paragraph 2, Member States shall ensure that the personnel of such authorities have the appropriate knowledge or receive the necessary training to fulfil their obligations when implementing this Directive. Article 5 More favourable provisions Member States may introduce or maintain more favourable standards on procedures for granting and withdrawing refugee status, insofar as those standards are compatible with this Directive. CHAPTER II BASIC PRINCIPLES AND GUARANTEES Article 6 Access to the procedure 1. Member States may require that applications for asylum be made in person and/or at a designated place. 2. Member States shall ensure that each adult having legal capacity has the right to make an application for asylum on his/her own behalf. 3. Member States may provide that an application may be made by an applicant on behalf of his/her dependants. In such cases Member States shall ensure that dependant adults consent to the lodging of the application on their behalf, failing which they shall have an opportunity to make an application on their own behalf. Consent shall be requested at the time the application is lodged or, at the latest, when the personal interview with the dependant adult is conducted. 4. Member States may determine in national legislation: (a) the cases in which a minor can make an application on his/her own behalf; (b) the cases in which the application of an unaccompanied minor has to be lodged by a representative as provided for in Article 17(1)(a); (c) the cases in which the lodging of an application for asylum is deemed to constitute also the lodging of an application for asylum for any unmarried minor. 5. Member States shall ensure that authorities likely to be addressed by someone who wishes to make an application for asylum are able to advise that person how and where he/she may make such an application and/or may require these authorities to forward the application to the competent authority. Article 7 Right to remain in the Member State pending the examination of the application 1. Applicants shall be allowed to remain in the Member State, for the sole purpose of the procedure, until the determining authority has made a decision in accordance with the procedures at first instance set out in Chapter III. This right to remain shall not constitute an entitlement to a residence permit. 2. Member States can make an exception only where, in accordance with Articles 32 and 34, a subsequent application will not be further examined or where they will surrender or extradite, as appropriate, a person either to another Member State pursuant to obligations in accordance with a European arrest warrant (6) or otherwise, or to a third country, or to international criminal courts or tribunals. Article 8 Requirements for the examination of applications 1. Without prejudice to Article 23(4)(i), Member States shall ensure that applications for asylum are neither rejected nor excluded from examination on the sole ground that they have not been made as soon as possible. 2. Member States shall ensure that decisions by the determining authority on applications for asylum are taken after an appropriate examination. To that end, Member States shall ensure that: (a) applications are examined and decisions are taken individually, objectively and impartially; (b) precise and up-to-date information is obtained from various sources, such as the United Nations High Commissioner for Refugees (UNHCR), as to the general situation prevailing in the countries of origin of applicants for asylum and, where necessary, in countries through which they have transited, and that such information is made available to the personnel responsible for examining applications and taking decisions; (c) the personnel examining applications and taking decisions have the knowledge with respect to relevant standards applicable in the field of asylum and refugee law. 3. The authorities referred to in Chapter V shall, through the determining authority or the applicant or otherwise, have access to the general information referred to in paragraph 2(b), necessary for the fulfilment of their task. 4. Member States may provide for rules concerning the translation of documents relevant for the examination of applications. Article 9 Requirements for a decision by the determining authority 1. Member States shall ensure that decisions on applications for asylum are given in writing. 2. Member States shall also ensure that, where an application is rejected, the reasons in fact and in law are stated in the decision and information on how to challenge a negative decision is given in writing. Member States need not state the reasons for not granting refugee status in a decision where the applicant is granted a status which offers the same rights and benefits under national and Community law as the refugee status by virtue of Directive 2004/83/EC. In these cases, Member States shall ensure that the reasons for not granting refugee status are stated in the applicant’s file and that the applicant has, upon request, access to his/her file. Moreover, Member States need not provide information on how to challenge a negative decision in writing in conjunction with a decision where the applicant has been provided with this information at an earlier stage either in writing or by electronic means accessible to the applicant. 3. For the purposes of Article 6(3), and whenever the application is based on the same grounds, Member States may take one single decision, covering all dependants. Article 10 Guarantees for applicants for asylum 1. With respect to the procedures provided for in Chapter III, Member States shall ensure that all applicants for asylum enjoy the following guarantees: (a) they shall be informed in a language which they may reasonably be supposed to understand of the procedure to be followed and of their rights and obligations during the procedure and the possible consequences of not complying with their obligations and not cooperating with the authorities. They shall be informed of the time-frame, as well as the means at their disposal for fulfilling the obligation to submit the elements as referred to in Article 4 of Directive 2004/83/EC. This information shall be given in time to enable them to exercise the rights guaranteed in this Directive and to comply with the obligations described in Article 11; (b) they shall receive the services of an interpreter for submitting their case to the competent authorities whenever necessary. Member States shall consider it necessary to give these services at least when the determining authority calls upon the applicant to be interviewed as referred to in Articles 12 and 13 and appropriate communication cannot be ensured without such services. In this case and in other cases where the competent authorities call upon the applicant, these services shall be paid for out of public funds; (c) they shall not be denied the opportunity to communicate with the UNHCR or with any other organisation working on behalf of the UNHCR in the territory of the Member State pursuant to an agreement with that Member State; (d) they shall be given notice in reasonable time of the decision by the determining authority on their application for asylum. If a legal adviser or other counsellor is legally representing the applicant, Member States may choose to give notice of the decision to him/her instead of to the applicant for asylum; (e) they shall be informed of the result of the decision by the determining authority in a language that they may reasonably be supposed to understand when they are not assisted or represented by a legal adviser or other counsellor and when free legal assistance is not available. The information provided shall include information on how to challenge a negative decision in accordance with the provisions of Article 9(2). 2. With respect to the procedures provided for in Chapter V, Member States shall ensure that all applicants for asylum enjoy equivalent guarantees to the ones referred to in paragraph 1(b), (c) and (d) of this Article. Article 11 Obligations of the applicants for asylum 1. Member States may impose upon applicants for asylum obligations to cooperate with the competent authorities insofar as these obligations are necessary for the processing of the application. 2. In particular, Member States may provide that: (a) applicants for asylum are required to report to the competent authorities or to appear before them in person, either without delay or at a specified time; (b) applicants for asylum have to hand over documents in their possession relevant to the examination of the application, such as their passports; (c) applicants for asylum are required to inform the competent authorities of their current place of residence or address and of any changes thereof as soon as possible. Member States may provide that the applicant shall have to accept any communication at the most recent place of residence or address which he/she indicated accordingly; (d) the competent authorities may search the applicant and the items he/she carries with him/her; (e) the competent authorities may take a photograph of the applicant; and (f) the competent authorities may record the applicant’s oral statements, provided he/she has previously been informed thereof. Article 12 Personal interview 1. Before a decision is taken by the determining authority, the applicant for asylum shall be given the opportunity of a personal interview on his/her application for asylum with a person competent under national law to conduct such an interview. Member States may also give the opportunity of a personal interview to each dependant adult referred to in Article 6(3). Member States may determine in national legislation the cases in which a minor shall be given the opportunity of a personal interview. 2. The personal interview may be omitted where: (a) the determining authority is able to take a positive decision on the basis of evidence available; or (b) the competent authority has already had a meeting with the applicant for the purpose of assisting him/her with completing his/her application and submitting the essential information regarding the application, in terms of Article 4(2) of Directive 2004/83/EC; or (c) the determining authority, on the basis of a complete examination of information provided by the applicant, considers the application to be unfounded in cases where the circumstances mentioned in Article 23(4)(a), (c), (g), (h) and (j) apply. 3. The personal interview may also be omitted where it is not reasonably practicable, in particular where the competent authority is of the opinion that the applicant is unfit or unable to be interviewed owing to enduring circumstances beyond his/her control. When in doubt, Member States may require a medical or psychological certificate. Where the Member State does not provide the applicant with the opportunity for a personal interview pursuant to this paragraph, or where applicable, to the dependant, reasonable efforts shall be made to allow the applicant or the dependant to submit further information. 4. The absence of a personal interview in accordance with this Article shall not prevent the determining authority from taking a decision on an application for asylum. 5. The absence of a personal interview pursuant to paragraph 2(b) and (c) and paragraph 3 shall not adversely affect the decision of the determining authority. 6. Irrespective of Article 20(1), Member States, when deciding on the application for asylum, may take into account the fact that the applicant failed to appear for the personal interview, unless he/she had good reasons for the failure to appear. Article 13 Requirements for a personal interview 1. A personal interview shall normally take place without the presence of family members unless the determining authority considers it necessary for an appropriate examination to have other family members present. 2. A personal interview shall take place under conditions which ensure appropriate confidentiality. 3. Member States shall take appropriate steps to ensure that personal interviews are conducted under conditions which allow applicants to present the grounds for their applications in a comprehensive manner. To that end, Member States shall: (a) ensure that the person who conducts the interview is sufficiently competent to take account of the personal or general circumstances surrounding the application, including the applicant’s cultural origin or vulnerability, insofar as it is possible to do so; and (b) select an interpreter who is able to ensure appropriate communication between the applicant and the person who conducts the interview. The communication need not necessarily take place in the language preferred by the applicant for asylum if there is another language which he/she may reasonably be supposed to understand and in which he/she is able to communicate. 4. Member States may provide for rules concerning the presence of third parties at a personal interview. 5. This Article is also applicable to the meeting referred to in Article 12(2)(b). Article 14 Status of the report of a personal interview in the procedure 1. Member States shall ensure that a written report is made of every personal interview, containing at least the essential information regarding the application, as presented by the applicant, in terms of Article 4(2) of Directive 2004/83/EC. 2. Member States shall ensure that applicants have timely access to the report of the personal interview. Where access is only granted after the decision of the determining authority, Member States shall ensure that access is possible as soon as necessary for allowing an appeal to be prepared and lodged in due time. 3. Member States may request the applicant’s approval of the contents of the report of the personal interview. Where an applicant refuses to approve the contents of the report, the reasons for this refusal shall be entered into the applicant’s file. The refusal of an applicant to approve the contents of the report shall not prevent the determining authority from taking a decision on his/her application. 4. This Article is also applicable to the meeting referred to in Article 12(2)(b). Article 15 Right to legal assistance and representation 1. Member States shall allow applicants for asylum the opportunity, at their own cost, to consult in an effective manner a legal adviser or other counsellor, admitted or permitted as such under national law, on matters relating to their asylum applications. 2. In the event of a negative decision by a determining authority, Member States shall ensure that free legal assistance and/or representation be granted on request, subject to the provisions of paragraph 3. 3. Member States may provide in their national legislation that free legal assistance and/or representation is granted: (a) only for procedures before a court or tribunal in accordance with Chapter V and not for any onward appeals or reviews provided for under national law, including a rehearing of an appeal following an onward appeal or review; and/or (b) only to those who lack sufficient resources; and/or (c) only to legal advisers or other counsellors specifically designated by national law to assist and/or represent applicants for asylum; and/or (d) only if the appeal or review is likely to succeed. Member States shall ensure that legal assistance and/or representation granted under point (d) is not arbitrarily restricted. 4. Rules concerning the modalities for filing and processing requests for legal assistance and/or representation may be provided by Member States. 5. Member States may also: (a) impose monetary and/or time-limits on the provision of free legal assistance and/or representation, provided that such limits do not arbitrarily restrict access to legal assistance and/or representation; (b) provide that, as regards fees and other costs, the treatment of applicants shall not be more favourable than the treatment generally accorded to their nationals in matters pertaining to legal assistance. 6. Member States may demand to be reimbursed wholly or partially for any expenses granted if and when the applicant’s financial situation has improved considerably or if the decision to grant such benefits was taken on the basis of false information supplied by the applicant. Article 16 Scope of legal assistance and representation 1. Member States shall ensure that a legal adviser or other counsellor admitted or permitted as such under national law, and who assists or represents an applicant for asylum under the terms of national law, shall enjoy access to such information in the applicant’s file as is liable to be examined by the authorities referred to in Chapter V, insofar as the information is relevant to the examination of the application. Member States may make an exception where disclosure of information or sources would jeopardise national security, the security of the organisations or person(s) providing the information or the security of the person(s) to whom the information relates or where the investigative interests relating to the examination of applications of asylum by the competent authorities of the Member States or the international relations of the Member States would be compromised. In these cases, access to the information or sources in question shall be available to the authorities referred to in Chapter V, except where such access is precluded in cases of national security. 2. Member States shall ensure that the legal adviser or other counsellor who assists or represents an applicant for asylum has access to closed areas, such as detention facilities and transit zones, for the purpose of consulting that applicant. Member States may only limit the possibility of visiting applicants in closed areas where such limitation is, by virtue of national legislation, objectively necessary for the security, public order or administrative management of the area, or in order to ensure an efficient examination of the application, provided that access by the legal adviser or other counsellor is not thereby severely limited or rendered impossible. 3. Member States may provide rules covering the presence of legal advisers or other counsellors at all interviews in the procedure, without prejudice to this Article or to Article 17(1)(b). 4. Member States may provide that the applicant is allowed to bring with him/her to the personal interview a legal adviser or other counsellor admitted or permitted as such under national law. Member States may require the presence of the applicant at the personal interview, even if he/she is represented under the terms of national law by such a legal adviser or counsellor, and may require the applicant to respond in person to the questions asked. The absence of a legal adviser or other counsellor shall not prevent the competent authority from conducting the personal interview with the applicant. Article 17 Guarantees for unaccompanied minors 1. With respect to all procedures provided for in this Directive and without prejudice to the provisions of Articles 12 and 14, Member States shall: (a) as soon as possible take measures to ensure that a representative represents and/or assists the unaccompanied minor with respect to the examination of the application. This representative can also be the representative referred to in Article 19 of Directive 2003/9/EC of 27 January 2003 laying down minimum standards for the reception of asylum seekers (7); (b) ensure that the representative is given the opportunity to inform the unaccompanied minor about the meaning and possible consequences of the personal interview and, where appropriate, how to prepare himself/herself for the personal interview. Member States shall allow the representative to be present at that interview and to ask questions or make comments, within the framework set by the person who conducts the interview. Member States may require the presence of the unaccompanied minor at the personal interview, even if the representative is present. 2. Member States may refrain from appointing a representative where the unaccompanied minor: (a) will in all likelihood reach the age of maturity before a decision at first instance is taken; or (b) can avail himself, free of charge, of a legal adviser or other counsellor, admitted as such under national law to fulfil the tasks assigned above to the representative; or (c) is married or has been married. 3. Member States may, in accordance with the laws and regulations in force on 1 December 2005, also refrain from appointing a representative where the unaccompanied minor is 16 years old or older, unless he/she is unable to pursue his/her application without a representative. 4. Member States shall ensure that: (a) if an unaccompanied minor has a personal interview on his/her application for asylum as referred to in Articles 12, 13 and 14, that interview is conducted by a person who has the necessary knowledge of the special needs of minors; (b) an official with the necessary knowledge of the special needs of minors prepares the decision by the determining authority on the application of an unaccompanied minor. 5. Member States may use medical examinations to determine the age of unaccompanied minors within the framework of the examination of an application for asylum. In cases where medical examinations are used, Member States shall ensure that: (a) unaccompanied minors are informed prior to the examination of their application for asylum, and in a language which they may reasonably be supposed to understand, of the possibility that their age may be determined by medical examination. This shall include information on the method of examination and the possible consequences of the result of the medical examination for the examination of the application for asylum, as well as the consequences of refusal on the part of the unaccompanied minor to undergo the medical examination; (b) unaccompanied minors and/or their representatives consent to carry out an examination to determine the age of the minors concerned; and (c) the decision to reject an application for asylum from an unaccompanied minor who refused to undergo this medical examination shall not be based solely on that refusal. The fact that an unaccompanied minor has refused to undergo such a medical examination shall not prevent the determining authority from taking a decision on the application for asylum. 6. The best interests of the child shall be a primary consideration for Member States when implementing this Article. Article 18 Detention 1. Member States shall not hold a person in detention for the sole reason that he/she is an applicant for asylum. 2. Where an applicant for asylum is held in detention, Member States shall ensure that there is a possibility of speedy judicial review. Article 19 Procedure in case of withdrawal of the application 1. Insofar as Member States provide for the possibility of explicit withdrawal of the application under national law, when an applicant for asylum explicitly withdraws his/her application for asylum, Member States shall ensure that the determining authority takes a decision to either discontinue the examination or reject the application. 2. Member States may also decide that the determining authority can decide to discontinue the examination without taking a decision. In this case, Member States shall ensure that the determining authority enters a notice in the applicant’s file. Article 20 Procedure in the case of implicit withdrawal or abandonment of the application 1. When there is reasonable cause to consider that an applicant for asylum has implicitly withdrawn or abandoned his/her application for asylum, Member States shall ensure that the determining authority takes a decision to either discontinue the examination or reject the application on the basis that the applicant has not established an entitlement to refugee status in accordance with Directive 2004/83/EC. Member States may assume that the applicant has implicitly withdrawn or abandoned his/her application for asylum in particular when it is ascertained that: (a) he/she has failed to respond to requests to provide information essential to his/her application in terms of Article 4 of Directive 2004/83/EC or has not appeared for a personal interview as provided for in Articles 12, 13 and 14, unless the applicant demonstrates within a reasonable time that his/her failure was due to circumstances beyond his control; (b) he/she has absconded or left without authorisation the place where he/she lived or was held, without contacting the competent authority within a reasonable time, or he/she has not within a reasonable time complied with reporting duties or other obligations to communicate. For the purposes of implementing these provisions, Member States may lay down time-limits or guidelines. 2. Member States shall ensure that the applicant who reports again to the competent authority after a decision to discontinue as referred to in paragraph 1 of this Article is taken, is entitled to request that his/her case be reopened, unless the request is examined in accordance with Articles 32 and 34. Member States may provide for a time-limit after which the applicant’s case can no longer be re-opened. Member States shall ensure that such a person is not removed contrary to the principle of non-refoulement. Member States may allow the determining authority to take up the examination at the stage where it was discontinued. Article 21 The role of UNHCR 1. Member States shall allow the UNHCR: (a) to have access to applicants for asylum, including those in detention and in airport or port transit zones; (b) to have access to information on individual applications for asylum, on the course of the procedure and on the decisions taken, provided that the applicant for asylum agrees thereto; (c) to present its views, in the exercise of its supervisory responsibilities under Article 35 of the Geneva Convention, to any competent authorities regarding individual applications for asylum at any stage of the procedure. 2. Paragraph 1 shall also apply to an organisation which is working in the territory of the Member State concerned on behalf of the UNHCR pursuant to an agreement with that Member State. Article 22 Collection of information on individual cases For the purposes of examining individual cases, Member States shall not: (a) directly disclose information regarding individual applications for asylum, or the fact that an application has been made, to the alleged actor(s) of persecution of the applicant for asylum; (b) obtain any information from the alleged actor(s) of persecution in a manner that would result in such actor(s) being directly informed of the fact that an application has been made by the applicant in question, and would jeopardise the physical integrity of the applicant and his/her dependants, or the liberty and security of his/her family members still living in the country of origin. CHAPTER III PROCEDURES AT FIRST INSTANCE SECTION I Article 23 Examination procedure 1. Member States shall process applications for asylum in an examination procedure in accordance with the basic principles and guarantees of Chapter II. 2. Member States shall ensure that such a procedure is concluded as soon as possible, without prejudice to an adequate and complete examination. Member States shall ensure that, where a decision cannot be taken within six months, the applicant concerned shall either: (a) be informed of the delay; or (b) receive, upon his/her request, information on the time-frame within which the decision on his/her application is to be expected. Such information shall not constitute an obligation for the Member State towards the applicant concerned to take a decision within that time-frame. 3. Member States may prioritise or accelerate any examination in accordance with the basic principles and guarantees of Chapter II, including where the application is likely to be well-founded or where the applicant has special needs. 4. Member States may also provide that an examination procedure in accordance with the basic principles and guarantees of Chapter II be prioritised or accelerated if: (a) the applicant, in submitting his/her application and presenting the facts, has only raised issues that are not relevant or of minimal relevance to the examination of whether he/she qualifies as a refugee by virtue of Directive 2004/83/EC; or (b) the applicant clearly does not qualify as a refugee or for refugee status in a Member State under Directive 2004/83/EC; or (c) the application for asylum is considered to be unfounded: (i) because the applicant is from a safe country of origin within the meaning of Articles 29, 30 and 31, or (ii) because the country which is not a Member State, is considered to be a safe third country for the applicant, without prejudice to Article 28(1); or (d) the applicant has misled the authorities by presenting false information or documents or by withholding relevant information or documents with respect to his/her identity and/or nationality that could have had a negative impact on the decision; or (e) the applicant has filed another application for asylum stating other personal data; or (f) the applicant has not produced information establishing with a reasonable degree of certainty his/her identity or nationality, or it is likely that, in bad faith, he/she has destroyed or disposed of an identity or travel document that would have helped establish his/her identity or nationality; or (g) the applicant has made inconsistent, contradictory, improbable or insufficient representations which make his/her claim clearly unconvincing in relation to his/her having been the object of persecution referred to in Directive 2004/83/EC; or (h) the applicant has submitted a subsequent application which does not raise any relevant new elements with respect to his/her particular circumstances or to the situation in his/her country of origin; or (i) the applicant has failed without reasonable cause to make his/her application earlier, having had opportunity to do so; or (j) the applicant is making an application merely in order to delay or frustrate the enforcement of an earlier or imminent decision which would result in his/her removal; or (k) the applicant has failed without good reason to comply with obligations referred to in Article 4(1) and (2) of Directive 2004/83/EC or in Articles11(2)(a) and (b) and 20(1) of this Directive; or (l) the applicant entered the territory of the Member State unlawfully or prolonged his/her stay unlawfully and, without good reason, has either not presented himself/herself to the authorities and/or filed an application for asylum as soon as possible, given the circumstances of his/her entry; or (m) the applicant is a danger to the national security or public order of the Member State, or the applicant has been forcibly expelled for serious reasons of public security and public order under national law; or (n) the applicant refuses to comply with an obligation to have his/her fingerprints taken in accordance with relevant Community and/or national legislation; or (o) the application was made by an unmarried minor to whom Article 6(4)(c) applies, after the application of the parents or parent responsible for the minor has been rejected and no relevant new elements were raised with respect to his/her particular circumstances or to the situation in his/her country of origin. Article 24 Specific procedures 1. Member States may provide for the following specific procedures derogating from the basic principles and guarantees of Chapter II: (a) a preliminary examination for the purposes of processing cases considered within the framework set out in Section IV; (b) procedures for the purposes of processing cases considered within the framework set out in Section V. 2. Member States may also provide a derogation in respect of Section VI. SECTION II Article 25 Inadmissible applications 1. In addition to cases in which an application is not examined in accordance with Regulation (EC) No 343/2003, Member States are not required to examine whether the applicant qualifies as a refugee in accordance with Directive 2004/83/EC where an application is considered inadmissible pursuant to this Article. 2. Member States may consider an application for asylum as inadmissible pursuant to this Article if: (a) another Member State has granted refugee status; (b) a country which is not a Member State is considered as a first country of asylum for the applicant, pursuant to Article 26; (c) a country which is not a Member State is considered as a safe third country for the applicant, pursuant to Article 27; (d) the applicant is allowed to remain in the Member State concerned on some other grounds and as result of this he/she has been granted a status equivalent to the rights and benefits of the refugee status by virtue of Directive 2004/83/EC; (e) the applicant is allowed to remain in the territory of the Member State concerned on some other grounds which protect him/her against refoulement pending the outcome of a procedure for the determination of status pursuant to point (d); (f) the applicant has lodged an identical application after a final decision; (g) a dependant of the applicant lodges an application, after he/she has in accordance with Article 6(3) consented to have his/her case be part of an application made on his/her behalf, and there are no facts relating to the dependant’s situation, which justify a separate application. Article 26 The concept of first country of asylum A country can be considered to be a first country of asylum for a particular applicant for asylum if: (a) he/she has been recognised in that country as a refugee and he/she can still avail himself/herself of that protection; or (b) he/she otherwise enjoys sufficient protection in that country, including benefiting from the principle of non-refoulement; provided that he/she will be re-admitted to that country. In applying the concept of first country of asylum to the particular circumstances of an applicant for asylum Member States may take into account Article 27(1). Article 27 The safe third country concept 1. Member States may apply the safe third country concept only where the competent authorities are satisfied that a person seeking asylum will be treated in accordance with the following principles in the third country concerned: (a) life and liberty are not threatened on account of race, religion, nationality, membership of a particular social group or political opinion; (b) the principle of non-refoulement in accordance with the Geneva Convention is respected; (c) the prohibition of removal, in violation of the right to freedom from torture and cruel, inhuman or degrading treatment as laid down in international law, is respected; and (d) the possibility exists to request refugee status and, if found to be a refugee, to receive protection in accordance with the Geneva Convention. 2. The application of the safe third country concept shall be subject to rules laid down in national legislation, including: (a) rules requiring a connection between the person seeking asylum and the third country concerned on the basis of which it would be reasonable for that person to go to that country; (b) rules on the methodology by which the competent authorities satisfy themselves that the safe third country concept may be applied to a particular country or to a particular applicant. Such methodology shall include case-by-case consideration of the safety of the country for a particular applicant and/or national designation of countries considered to be generally safe; (c) rules in accordance with international law, allowing an individual examination of whether the third country concerned is safe for a particular applicant which, as a minimum, shall permit the applicant to challenge the application of the safe third country concept on the grounds that he/she would be subjected to torture, cruel, inhuman or degrading treatment or punishment. 3. When implementing a decision solely based on this Article, Member States shall: (a) inform the applicant accordingly; and (b) provide him/her with a document informing the authorities of the third country, in the language of that country, that the application has not been examined in substance. 4. Where the third country does not permit the applicant for asylum to enter its territory, Member States shall ensure that access to a procedure is given in accordance with the basic principles and guarantees described in Chapter II. 5. Member States shall inform the Commission periodically of the countries to which this concept is applied in accordance with the provisions of this Article. SECTION III Article 28 Unfounded applications 1. Without prejudice to Articles 19 and 20, Member States may only consider an application for asylum as unfounded if the determining authority has established that the applicant does not qualify for refugee status pursuant to Directive 2004/83/EC. 2. In the cases mentioned in Article 23(4)(b) and in cases of unfounded applications for asylum in which any of the circumstances listed in Article 23(4)(a) and (c) to (o) apply, Member States may also consider an application as manifestly unfounded, where it is defined as such in the national legislation. Article 29 Minimum common list of third countries regarded as safe countries of origin 1. The Council shall, acting by a qualified majority on a proposal from the Commission and after consultation of the European Parliament, adopt a minimum common list of third countries which shall be regarded by Member States as safe countries of origin in accordance with Annex II. 2. The Council may, acting by a qualified majority on a proposal from the Commission and after consultation of the European Parliament, amend the minimum common list by adding or removing third countries, in accordance with Annex II. The Commission shall examine any request made by the Council or by a Member State to submit a proposal to amend the minimum common list. 3. When making its proposal under paragraphs 1 or 2, the Commission shall make use of information from the Member States, its own information and, where necessary, information from UNHCR, the Council of Europe and other relevant international organisations. 4. Where the Council requests the Commission to submit a proposal for removing a third country from the minimum common list, the obligation of Member States pursuant to Article 31(2) shall be suspended with regard to this third country as of the day following the Council decision requesting such a submission. 5. Where a Member State requests the Commission to submit a proposal to the Council for removing a third country from the minimum common list, that Member State shall notify the Council in writing of the request made to the Commission. The obligation of this Member State pursuant to Article 31(2) shall be suspended with regard to the third country as of the day following the notification to the Council. 6. The European Parliament shall be informed of the suspensions under paragraphs 4 and 5. 7. The suspensions under paragraphs 4 and 5 shall end after three months, unless the Commission makes a proposal before the end of this period, to withdraw the third country from the minimum common list. The suspensions shall in any case end where the Council rejects a proposal by the Commission to withdraw the third country from the list. 8. Upon request by the Council, the Commission shall report to the European Parliament and the Council on whether the situation of a country on the minimum common list is still in conformity with Annex II. When presenting its report, the Commission may make such recommendations or proposals as it deems appropriate. Article 30 National designation of third countries as safe countries of origin 1. Without prejudice to Article 29, Member States may retain or introduce legislation that allows, in accordance with Annex II, for the national designation of third countries other than those appearing on the minimum common list, as safe countries of origin for the purposes of examining applications for asylum. This may include designation of part of a country as safe where the conditions in Annex II are fulfilled in relation to that part. 2. By derogation from paragraph 1, Member States may retain legislation in force on 1 December 2005 that allows for the national designation of third countries, other than those appearing on the minimum common list, as safe countries of origin for the purposes of examining applications for asylum where they are satisfied that persons in the third countries concerned are generally neither subject to: (a) persecution as defined in Article 9 of Directive 2004/83/EC; nor (b) torture or inhuman or degrading treatment or punishment. 3. Member States may also retain legislation in force on 1 December 2005 that allows for the national designation of part of a country as safe, or a country or part of a country as safe for a specified group of persons in that country, where the conditions in paragraph 2 are fulfilled in relation to that part or group. 4. In assessing whether a country is a safe country of origin in accordance with paragraphs 2 and 3, Member States shall have regard to the legal situation, the application of the law and the general political circumstances in the third country concerned. 5. The assessment of whether a country is a safe country of origin in accordance with this Article shall be based on a range of sources of information, including in particular information from other Member States, the UNHCR, the Council of Europe and other relevant international organisations. 6. Member States shall notify to the Commission the countries that are designated as safe countries of origin in accordance with this Article. Article 31 The safe country of origin concept 1. A third country designated as a safe country of origin in accordance with either Article 29 or 30 may, after an individual examination of the application, be considered as a safe country of origin for a particular applicant for asylum only if: (a) he/she has the nationality of that country; or (b) he/she is a stateless person and was formerly habitually resident in that country; and he/she has not submitted any serious grounds for considering the country not to be a safe country of origin in his/her particular circumstances and in terms of his/her qualification as a refugee in accordance with Directive 2004/83/EC. 2. Member States shall, in accordance with paragraph 1, consider the application for asylum as unfounded where the third country is designated as safe pursuant to Article 29. 3. Member States shall lay down in national legislation further rules and modalities for the application of the safe country of origin concept. SECTION IV Article 32 Subsequent application 1. Where a person who has applied for asylum in a Member State makes further representations or a subsequent application in the same Member State, that Member State may examine these further representations or the elements of the subsequent application in the framework of the examination of the previous application or in the framework of the examination of the decision under review or appeal, insofar as the competent authorities can take into account and consider all the elements underlying the further representations or subsequent application within this framework. 2. Moreover, Member States may apply a specific procedure as referred to in paragraph 3, where a person makes a subsequent application for asylum: (a) after his/her previous application has been withdrawn or abandoned by virtue of Articles 19 or 20; (b) after a decision has been taken on the previous application. Member States may also decide to apply this procedure only after a final decision has been taken. 3. A subsequent application for asylum shall be subject first to a preliminary examination as to whether, after the withdrawal of the previous application or after the decision referred to in paragraph 2(b) of this Article on this application has been reached, new elements or findings relating to the examination of whether he/she qualifies as a refugee by virtue of Directive 2004/83/EC have arisen or have been presented by the applicant. 4. If, following the preliminary examination referred to in paragraph 3 of this Article, new elements or findings arise or are presented by the applicant which significantly add to the likelihood of the applicant qualifying as a refugee by virtue of Directive 2004/83/EC, the application shall be further examined in conformity with Chapter II. 5. Member States may, in accordance with national legislation, further examine a subsequent application where there are other reasons why a procedure has to be re-opened. 6. Member States may decide to further examine the application only if the applicant concerned was, through no fault of his/her own, incapable of asserting the situations set forth in paragraphs 3, 4 and 5 of this Article in the previous procedure, in particular by exercising his/her right to an effective remedy pursuant to Article 39. 7. The procedure referred to in this Article may also be applicable in the case of a dependant who lodges an application after he/she has, in accordance with Article 6(3), consented to have his/her case be part of an application made on his/her behalf. In this case the preliminary examination referred to in paragraph 3 of this Article will consist of examining whether there are facts relating to the dependant’s situation which justify a separate application. Article 33 Failure to appear Member States may retain or adopt the procedure provided for in Article 32 in the case of an application for asylum filed at a later date by an applicant who, either intentionally or owing to gross negligence, fails to go to a reception centre or appear before the competent authorities at a specified time. Article 34 Procedural rules 1. Member States shall ensure that applicants for asylum whose application is subject to a preliminary examination pursuant to Article 32 enjoy the guarantees provided for in Article 10(1). 2. Member States may lay down in national law rules on the preliminary examination pursuant to Article 32. Those rules may, inter alia: (a) oblige the applicant concerned to indicate facts and substantiate evidence which justify a new procedure; (b) require submission of the new information by the applicant concerned within a time-limit after he/she obtained such information; (c) permit the preliminary examination to be conducted on the sole basis of written submissions without a personal interview. The conditions shall not render impossible the access of applicants for asylum to a new procedure or result in the effective annulment or severe curtailment of such access. 3. Member States shall ensure that: (a) the applicant is informed in an appropriate manner of the outcome of the preliminary examination and, in case the application will not be further examined, of the reasons for this and the possibilities for seeking an appeal or review of the decision; (b) if one of the situations referred to in Article 32(2) applies, the determining authority shall further examine the subsequent application in conformity with the provisions of Chapter II as soon as possible. SECTION V Article 35 Border procedures 1. Member States may provide for procedures, in accordance with the basic principles and guarantees of Chapter II, in order to decide at the border or transit zones of the Member State on applications made at such locations. 2. However, when procedures as set out in paragraph 1 do not exist, Member States may maintain, subject to the provisions of this Article and in accordance with the laws or regulations in force on 1 December 2005, procedures derogating from the basic principles and guarantees described in Chapter II, in order to decide at the border or in transit zones as to whether applicants for asylum who have arrived and made an application for asylum at such locations, may enter their territory. 3. The procedures referred to in paragraph 2 shall ensure in particular that the persons concerned: (a) are allowed to remain at the border or transit zones of the Member State, without prejudice to Article 7; (b) are be immediately informed of their rights and obligations, as described in Article 10(1) (a); (c) have access, if necessary, to the services of an interpreter, as described in Article 10(1)(b); (d) are interviewed, before the competent authority takes a decision in such procedures, in relation to their application for asylum by persons with appropriate knowledge of the relevant standards applicable in the field of asylum and refugee law, as described in Articles 12, 13 and 14; (e) can consult a legal adviser or counsellor admitted or permitted as such under national law, as described in Article 15(1); and (f) have a representative appointed in the case of unaccompanied minors, as described in Article 17(1), unless Article 17(2) or (3) applies. Moreover, in case permission to enter is refused by a competent authority, this competent authority shall state the reasons in fact and in law why the application for asylum is considered as unfounded or as inadmissible. 4. Member States shall ensure that a decision in the framework of the procedures provided for in paragraph 2 is taken within a reasonable time. When a decision has not been taken within four weeks, the applicant for asylum shall be granted entry to the territory of the Member State in order for his/her application to be processed in accordance with the other provisions of this Directive. 5. In the event of particular types of arrivals, or arrivals involving a large number of third country nationals or stateless persons lodging applications for asylum at the border or in a transit zone, which makes it practically impossible to apply there the provisions of paragraph 1 or the specific procedure set out in paragraphs 2 and 3, those procedures may also be applied where and for as long as these third country nationals or stateless persons are accommodated normally at locations in proximity to the border or transit zone. SECTION VI Article 36 The European safe third countries concept 1. Member States may provide that no, or no full, examination of the asylum application and of the safety of the applicant in his/her particular circumstances as described in Chapter II, shall take place in cases where a competent authority has established, on the basis of the facts, that the applicant for asylum is seeking to enter or has entered illegally into its territory from a safe third country according to paragraph 2. 2. A third country can only be considered as a safe third country for the purposes of paragraph 1 where: (a) it has ratified and observes the provisions of the Geneva Convention without any geographical limitations; (b) it has in place an asylum procedure prescribed by law; (c) it has ratified the European Convention for the Protection of Human Rights and Fundamental Freedoms and observes its provisions, including the standards relating to effective remedies; and (d) it has been so designated by the Council in accordance with paragraph 3. 3. The Council shall, acting by qualified majority on a proposal from the Commission and after consultation of the European Parliament, adopt or amend a common list of third countries that shall be regarded as safe third countries for the purposes of paragraph 1. 4. The Member States concerned shall lay down in national law the modalities for implementing the provisions of paragraph 1 and the consequences of decisions pursuant to those provisions in accordance with the principle of non-refoulement under the Geneva Convention, including providing for exceptions from the application of this Article for humanitarian or political reasons or for reasons of public international law. 5. When implementing a decision solely based on this Article, the Member States concerned shall: (a) inform the applicant accordingly; and (b) provide him/her with a document informing the authorities of the third country, in the language of that country, that the application has not been examined in substance. 6. Where the safe third country does not re-admit the applicant for asylum, Member States shall ensure that access to a procedure is given in accordance with the basic principles and guarantees described in Chapter II. 7. Member States which have designated third countries as safe countries in accordance with national legislation in force on 1 December 2005 and on the basis of the criteria in paragraph 2(a), (b) and (c), may apply paragraph 1 to these third countries until the Council has adopted the common list pursuant to paragraph 3. CHAPTER IV PROCEDURES FOR THE WITHDRAWAL OF REFUGEE STATUS Article 37 Withdrawal of refugee status Member States shall ensure that an examination to withdraw the refugee status of a particular person may commence when new elements or findings arise indicating that there are reasons to reconsider the validity of his/her refugee status. Article 38 Procedural rules 1. Member States shall ensure that, where the competent authority is considering withdrawing the refugee status of a third country national or stateless person in accordance with Article 14 of Directive 2004/83/EC, the person concerned shall enjoy the following guarantees: (a) to be informed in writing that the competent authority is reconsidering his or her qualification for refugee status and the reasons for such a reconsideration; and (b) to be given the opportunity to submit, in a personal interview in accordance with Article 10(1)(b) and Articles 12, 13 and 14 or in a written statement, reasons as to why his/her refugee status should not be withdrawn. In addition, Member States shall ensure that within the framework of such a procedure: (c) the competent authority is able to obtain precise and up-to-date information from various sources, such as, where appropriate, from the UNHCR, as to the general situation prevailing in the countries of origin of the persons concerned; and (d) where information on an individual case is collected for the purposes of reconsidering the refugee status, it is not obtained from the actor(s) of persecution in a manner that would result in such actor(s) being directly informed of the fact that the person concerned is a refugee whose status is under reconsideration, nor jeopardise the physical integrity of the person and his/her dependants, or the liberty and security of his/her family members still living in the country of origin. 2. Member States shall ensure that the decision of the competent authority to withdraw the refugee status is given in writing. The reasons in fact and in law shall be stated in the decision and information on how to challenge the decision shall be given in writing. 3. Once the competent authority has taken the decision to withdraw the refugee status, Article 15, paragraph 2, Article 16, paragraph 1 and Article 21 are equally applicable. 4. By derogation to paragraphs 1, 2 and 3 of this Article, Member States may decide that the refugee status shall lapse by law in case of cessation in accordance with Article 11(1)(a) to (d) of Directive 2004/83/EC or if the refugee has unequivocally renounced his/her recognition as a refugee. CHAPTER V APPEALS PROCEDURES Article 39 The right to an effective remedy 1. Member States shall ensure that applicants for asylum have the right to an effective remedy before a court or tribunal, against the following: (a) a decision taken on their application for asylum, including a decision: (i) to consider an application inadmissible pursuant to Article 25(2), (ii) taken at the border or in the transit zones of a Member State as described in Article 35(1), (iii) not to conduct an examination pursuant to Article 36; (b) a refusal to re-open the examination of an application after its discontinuation pursuant to Articles 19 and 20; (c) a decision not to further examine the subsequent application pursuant to Articles 32 and 34; (d) a decision refusing entry within the framework of the procedures provided for under Article 35(2); (e) a decision to withdraw of refugee status pursuant to Article 38. 2. Member States shall provide for time-limits and other necessary rules for the applicant to exercise his/her right to an effective remedy pursuant to paragraph 1. 3. Member States shall, where appropriate, provide for rules in accordance with their international obligations dealing with: (a) the question of whether the remedy pursuant to paragraph 1 shall have the effect of allowing applicants to remain in the Member State concerned pending its outcome; (b) the possibility of legal remedy or protective measures where the remedy pursuant to paragraph 1 does not have the effect of allowing applicants to remain in the Member State concerned pending its outcome. Member States may also provide for an ex officio remedy; and (c) the grounds for challenging a decision under Article 25(2)(c) in accordance with the methodology applied under Article 27(2)(b) and (c). 4. Member States may lay down time-limits for the court or tribunal pursuant to paragraph 1 to examine the decision of the determining authority. 5. Where an applicant has been granted a status which offers the same rights and benefits under national and Community law as the refugee status by virtue of Directive 2004/83/EC, the applicant may be considered as having an effective remedy where a court or tribunal decides that the remedy pursuant to paragraph 1 is inadmissible or unlikely to succeed on the basis of insufficient interest on the part of the applicant in maintaining the proceedings. 6. Member States may also lay down in national legislation the conditions under which it can be assumed that an applicant has implicitly withdrawn or abandoned his/her remedy pursuant to paragraph 1, together with the rules on the procedure to be followed. CHAPTER VI GENERAL AND FINAL PROVISIONS Article 40 Challenge by public authorities This Directive does not affect the possibility for public authorities of challenging the administrative and/or judicial decisions as provided for in national legislation. Article 41 Confidentiality Member States shall ensure that authorities implementing this Directive are bound by the confidentiality principle as defined in national law, in relation to any information they obtain in the course of their work. Article 42 Report No later than 1 December 2009, the Commission shall report to the European Parliament and the Council on the application of this Directive in the Member States and shall propose any amendments that are necessary. Member States shall send the Commission all the information that is appropriate for drawing up this report. After presenting the report, the Commission shall report to the European Parliament and the Council on the application of this Directive in the Member States at least every two years. Article 43 Transposition Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 December 2007. Concerning Article 15, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 December 2008. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Article 44 Transition Member States shall apply the laws, regulations and administrative provisions set out in Article 43 to applications for asylum lodged after 1 December 2007 and to procedures for the withdrawal of refugee status started after 1 December 2007. Article 45 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 46 Addressees This Directive is addressed to the Member States in conformity with the Treaty establishing the European Community.

32005L0087

2005

COMMISSION DIRECTIVE 2005/87/EC of 5 December 2005 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed as regards lead, fluorine and cadmium (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (1), and in particular Article 8(1) thereof, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (2), and in particular the third sentence of Article 13(2) thereof, Whereas: (1) Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I thereto is prohibited. (2) When Directive 2002/32/EC was adopted, the Commission stated that the provisions laid down in Annex I to that Directive would be reviewed on the basis of updated scientific risk assessments and taking into account the prohibition of any dilution of contaminated non-complying products intended for animal feed. (3) The Scientific Panel on contaminants in the Food Chain of the European Food Safety Authority (EFSA) adopted an opinion on a request from the Commission related to lead as undesirable substance in animal feed on 2 June 2004. (4) Contamination of food with lead is of public health concern. Lead accumulates to some extent in kidney and liver tissue, muscle tissues contain very low residual amounts of lead and carry-over into milk is limited. Therefore foods of animal origin are not a major source of human exposure to lead. (5) Cattle and sheep seem to be the most sensitive animal species with respect to acute lead toxicity. Individual intoxications have been reported, resulting from ingestion of feed material originating from polluted areas or accidental ingestions of lead sources. However, the levels found in commercial feed materials in the European Union do not induce clinical signs of toxicity. (6) The existing legal provisions as regards lead in products intended for animal feed are generally appropriate to ensure that these products do not represent any danger to human health, animal health or adversely affect the livestock production. (7) Cattle and sheep seem to be the most sensitive animal species and green fodder is a major component of their daily ration, it is important to provide for a review in view of a possible further reduction of the maximum level of lead in green fodder. (8) In addition the establishment of a maximum level of lead for additives belonging to the functional group of trace elements, binders and anti-caking agents and for premixtures is appropriate. The maximum level established for premixtures takes into account the additives with the highest level of lead and not the sensitivity of the different animal species to lead. In order to protect animal and public health, it is therefore the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feedingstuffs. (9) The Scientific Panel on contaminants in the Food Chain of the EFSA adopted an opinion on a request from the Commission related to fluorine as undesirable substance in animal feed on 22 September 2004. (10) Fluoride accumulates particularly in calcifying tissues. In contrast, transmission into edible tissues including milk and eggs is limited. Hence, the fluoride concentrations in foods from animal origin contribute only marginally to human exposure. (11) In the European Union, fluoride levels in pastures, herbages and compound feeds are generally low and subsequently exposure of animals to fluoride is generally below the level causing detrimental effects. However, in certain distinct geographic areas and incidentally in the proximity of industrial sites with high fluoride emission, excessive exposure to fluoride is associated with dental and skeleton abnormalities. (12) The existing legal provisions as regards fluorine in products intended for animal feed are appropriate to ensure that these products do not represent any danger to human health, animal health or adversely affect the livestock production. (13) The extraction procedure used has a large influence on the analytical result and it is therefore appropriate to determine the extraction procedure. Equivalent procedures with demonstrated equal extraction efficiency can be used. (14) The level for fluorine in marine crustaceans such as marine krill has to be amended in order to take into account new processing techniques to improve the nutritional quality and to reduce the biomass loss but which also results in higher levels of fluorine in the final end product. (15) Commission Directive 84/547/EEC of 26 October 1984 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (3) establishes a maximum level for fluorine in vermiculite (E 561). The scope of Directive 2002/32/EC provides for the possibility of the establishment of maximum levels of undesirable substances in feed additives and the rules governing undesirable substances should be collected in a single text for greater clarity. (16) The Scientific Panel on contaminants in the Food Chain of the EFSA adopted an opinion on a request from the Commission related to cadmium as undesirable substance in animal feed on 2 June 2004. (17) Contamination of food with cadmium is of public health concern. Accumulation of cadmium in animal tissue is function of dietary concentration and duration of exposure. The short life span of animals like fattening pigs and poultry minimizes the risk of undesirable cadmium concentrations in edible tissues of these animals Ruminants and horses however may be exposed during their entire lifespan to cadmium present in pastures. In distinct regions this may result in an undesirable cadmium accumulation particularly in kidneys. (18) Cadmium is toxic to all animal species. In most of the domestic animal species, including pigs which are considered the most sensitive species, gross clinical symptoms are unlikely to occur if dietary cadmium concentrations remain below 5 mg/kg feed. (19) The existing legal provisions as regards cadmium in products intended for animal feed are appropriate to ensure that these products do not represent any danger to human health, animal health or adversely affect the livestock production. (20) No maximum level is currently established for pet food and feed materials of mineral origin other than phosphates. It is appropriate to establish a maximum level for these products intended for animal feed. It is appropriate to amend the current maximum level for cadmium for fish feed in order to take into account recent developments in formulating fish feed incorporating higher ratios of fish oil and fishmeal. In addition the establishment of a maximum level of cadmium for additives belonging to the functional group of trace elements, binders and anti-caking agents and for premixtures is appropriate. The maximum level established for premixtures takes into account the additives with the highest level of cadmium and not the sensitivity of the different animal species to cadmium. As provided in Article 16 of Regulation (EC) No 1831/2003, in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feedingstuffs. (21) Directive 2002/32/EC and Directive 84/547/EEC should therefore be amended accordingly. (22) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 2002/32/EC is amended in accordance with the Annex to this Directive. Article 2 Without prejudice to the other conditions for the authorisation of the additive vermiculite, belonging to the group of binders, anti-caking agents and coagulants, laid down in Directive 70/524/EEC, the maximum fluorine content shall be as set out in the Annex to this Directive. Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 12 months after the entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0086

2005

COMMISSION DIRECTIVE 2005/86/EC of 5 December 2005 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed as regards camphechlor (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (1), and in particular Article 8 (1) thereof, Whereas: (1) Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I thereto is prohibited. (2) When Directive 2002/32/EC was adopted, the Commission stated that the provisions laid down in Annex I to that Directive would be reviewed on the basis of updated scientific risk assessments and taking into account the prohibition of any dilution of contaminated non-complying products intended for animal feed. (3) The Scientific Panel on contaminants in the food chain of the European Food Safety Authority (EFSA) adopted an opinion on a request from the Commission related to camphechlor as undesirable substance in animal feed on 2 February 2005. (4) Camphechlor is a non systemic insecticide of which the use is phased out in most of the world. Camphechlor mixtures show a complex composition, with at least 202 different congeners identified. Due to its persistence and chemical properties, camphechlor is still found in the environment. (5) While some congeners, such as CHB 32, which are major constituents in technical mixtures, are subject to relatively fast biotransformation, other congeners such as CHB 26, 50 and 62 are more persistent and bio-accumulate significantly within the food chain. The congeners CHB 26, 50 and 62 can serve as indicators of camphechlor contamination. The presence of CHB 32 is an indicator for a recent contamination and could be included in monitoring programmes to identify possible fraudulent practices. (6) The main sources of camphechlor exposure to animals from feed are fish oil and fish meal. Fish feed (particularly for carnivorous species) can contain significant amounts of fish meal and fish oil. For other animals the use of fish meal is low, hence their exposure via feed is lower. (7) Fish are the most sensitive to camphechlor toxicity. The carry-over of camphechlor into edible tissues of fatty fish is high, while the carry over in other farmed animals is lower. Fish, in particular lipid rich species, are the main source of human exposure while other sources are of less importance. (8) It is appropriate to replace the current general maximum level as regards camphechlor in all feedingstuffs, by a maximum level for camphechlor in fish oil, fish meal and fish feed in order to ensure that these products do not represent any danger to human health and animal health. The feed safety has been improved as the level for fish feed, which is fed directly to fish, has been significantly decreased and enforcement through a targeted control on these products intended for animal feeding identified as being the main source of camphechlor exposure should improve the feed safety. (9) The current general maximum level for camphechlor does not reflect the current normal background contamination levels in fish oil. It is appropriate to establish a maximum level in fish oil taking into account the background levels without endangering animal and public health. This maximum level is to be reviewed in the light of the necessary application on a wider scale of decontamination procedures. (10) Directive 2002/32/EC should therefore be amended accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 2002/32/EC is amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 12 months after the entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0084

2005

DIRECTIVE 2005/84/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 December 2005 amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Article 14 of the Treaty establishes an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured. (2) Work on the internal market should improve the quality of life, health protection and consumer safety. This Directive complies with the requirements of ensuring a high level of health protection and of consumer protection in the definition and implementation of all Community policies and activities. (3) The use of certain phthalates in toys and childcare articles made of plasticised material or including parts made of plasticised material should be prohibited as the presence of certain phthalates presents or could potentially present risks related to the health of children. Toys and childcare articles which, although not intended for that purpose, can be put in the mouth, may under certain circumstances present a risk to the health of small children if they are made of plasticised material, or include parts made of plasticised material, which contains certain phthalates. (4) The Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE), after being consulted by the Commission, has delivered opinions on the health risks raised by these phthalates. (5) Commission Recommendation 98/485/EC of 1 July 1998 on childcare articles and toys intended to be placed in the mouth by children of less than three years of age, made of soft PVC containing certain phthalates (4), invited Member States to take measures to ensure a high level of child health protection with regard to these products. (6) Since 1999, the use of six phthalates in toys and childcare articles intended to be placed in the mouth by children under the age of three is subject to a temporary ban at European Union level following the adoption of Commission Decision 1999/815/EC (5) in the framework of Council Directive 92/59/EEC of 29 June 1992 on general product safety (6). This Decision is being renewed regularly. (7) Limitations already adopted by certain Member States on the placing on the market of toys and childcare articles because of their phthalate content directly affect the completion and functioning of the internal market. It is therefore necessary to approximate the laws of the Member States in this field and consequently to amend Annex I to Directive 76/769/EEC (7). (8) The precautionary principle should be applied where scientific evaluation does not allow the risk to be determined with sufficient certainty in order to ensure a high level of protection of health, in particular for children. (9) Children as developing organisms are particularly vulnerable to reprotoxic substances. Therefore, the exposure of children to all practically avoidable sources of emissions of these substances, especially from articles which are put into the mouth by children, should be reduced as far as possible. (10) During risk assessments and/or within the framework of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (8), di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP) have been identified as reprotoxic substances and have therefore been classified as reprotoxic, category 2. (11) Scientific information regarding di-isononyl phthalate (DINP), di-isodecyl phthalate (DIDP) and di-n-octyl phthalate (DNOP) is either lacking or conflictual, but it cannot be excluded that they pose a potential risk if used in toys and childcare articles, which are by definition produced for children. (12) The uncertainties in the evaluation of exposure to these phthalates, such as mouthing times and exposure to emissions from other sources, require that precautionary considerations be taken into account. Therefore, restrictions on the use of these phthalates for toys and childcare articles and on the placing on the market of such articles should be introduced. However, the restrictions for DINP, DIDP and DNOP should be less severe than the ones proposed for DEHP, DBP and BBP for reasons of proportionality. (13) The Commission should review other applications of articles made from plasticised material or including parts made from plasticised material which may expose people to risks, especially those used in medical devices. (14) In line with the Commission Communication on the Precautionary Principle, the measures based on this principle should be subject to review in the light of new scientific information. (15) The Commission, in cooperation with the Member State authorities responsible for market surveillance and enforcement for toys and childcare articles, and in consultation with the relevant organisations of producers and importers, should monitor the use of phthalates and other substances as plasticisers in toys and childcare articles. (16) For the purpose of Directive 76/769/EEC, the term ‘childcare article’ should be defined. (17) In accordance with paragraph 34 of the Interinstitutional Agreement on Better Law-making (9), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public. (18) The Commission will review the use of the phthalates listed in Annex I to Directive 76/769/EEC in other products when the risk evaluation under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (10) will have been concluded. (19) This Directive applies without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (11) and in individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (12) and Council Directive 98/24/EC of 7 April 1998 on protection of health and safety of workers from the risk related to chemical agents at work (13), Article 1 Directive 76/769/EEC is amended as follows: 1. the following point shall be added to Article 1(3): ‘(c) “childcare article” means any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.’ ; 2. Annex I shall be amended as set out in the Annex to this Directive. Article 2 The Commission shall re-evaluate, by 16 January 2010 at the latest, the measures provided for in Directive 76/769/EEC as amended by this Directive in the light of new scientific information on substances described in the Annex to this Directive and their substitutes, and if justified, these measures shall be modified accordingly. Article 3 1. By 16 July 2006 Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these measures from 16 January 2007. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32005L0088

2005

DIRECTIVE 2005/88/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 December 2005 amending Directive 2000/14/EC on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Directive 2000/14/EC of the European Parliament and of the Council (3) has been the subject of a review by the Working Group on Outdoor Equipment, set up by the Commission. (2) In its report dated 8 July 2004, this Working Group concluded that a number of the stage II limits due to be mandatorily applied as from 3 January 2006 were not technically feasible. However, the intention was never to restrict the placing on the market or putting into service of equipment solely based on technical feasibility. (3) It is therefore necessary to provide that certain types of equipment listed in Article 12 of Directive 2000/14/EC, which would not be able to meet the stage II limits by 3 January 2006 solely for technical reasons, can still be placed on the market and/or put into service as from that date. (4) The experience of the first five years of application of Directive 2000/14/EC has demonstrated that more time is needed to fulfil the provisions under Articles 16 and 20 thereof and highlighted the need to review that Directive with a view to its possible amendment, in particular with respect to the stage II limits referred to therein. It is therefore necessary to extend by two years the deadline for submission of the report to the European Parliament and to the Council on the Commission’s experience in implementing and administering Directive 2000/14/EC as referred to in Article 20(1) of that Directive. (5) Article 20(3) of Directive 2000/14/EC provides for the submission, by the Commission, of a report to the European Parliament and to the Council on whether, and to what extent, technical progress allows a reduction of limit values for lawnmowers and lawn trimmers/lawn-edge trimmers. In view of the fact that the obligations contained in Article 20(1) of that Directive are more prescriptive than those in Article 20(3), and in order to avoid duplication of effort, it is appropriate to include these types of equipment in the general report provided for in Article 20(1) of that Directive. Consequently, the separate reporting obligation in Article 20(3) of that Directive should be deleted. (6) Since the objective of this Directive, namely, to ensure the ongoing functioning of the internal market by requiring equipment used outdoors to comply with harmonised environmental noise provisions, cannot be sufficiently achieved by Member States and can therefore, by reason of the scale and effects of the proposed action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective, in that its scope is confined to those types of equipment for which compliance with the stage II limits is presently impossible for technical reasons. (7) In accordance with point 34 of the Interinstitutional agreement on better law making (4), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public. (8) Directive 2000/14/EC should therefore be amended accordingly, Article 1 Directive 2000/14/EC is hereby amended as follows: 1. The table in Article 12 shall be replaced by the following: ‘Type of equipment Net installed power P (in kW) Electric power P el (5) in kW Mass of appliance m in kg Cutting width L in cm Permissible sound power level in dB/1 pW Stage I as from 3 January 2002 Stage II as from 3 January 2006 Compaction machines (vibrating rollers, vibratory plates, vibratory rammers) P ≤ 8 108 105 (6) 8 < P ≤ 70 109 106 (6) P > 70 89 + 11 lg P 86 + 11 lg P (6) Tracked dozers, tracked loaders, tracked excavator-loaders P ≤ 55 106 103 (6) P > 55 87 + 11 lg P 84 + 11 lg P (6) Wheeled dozers, wheeled loaders, wheeled excavator-loaders, dumpers, graders, loader-type landfill compactors, combustion-engine driven counterbalanced lift trucks, mobile cranes, compaction machines (non-vibrating rollers), paver-finishers, hydraulic power packs P ≤ 55 104 101 (6) (7) P > 55 85 + 11 lg P 82 + 11 lg P (6) (7) Excavators, builders’ hoists for the transport of goods, construction winches, motor hoes P ≤ 15 96 93 P > 15 83 + 11 lg P 80 + 11 lg P Hand-held concrete-breakers and picks m ≤ 15 107 105 15 < m < 30 94 + 11 lg m 92 + 11 lg m (6) m ≥ 30 96 + 11 lg m 94 + 11 lg m Tower cranes 98 + lg P 96 + lg P Welding and power generators P el ≤ 2 97 + lg P el 95 + lg P el 2 < P el ≤ 10 98 + lg P el 96 + lg P el 10 > P el 97 + lg P el 95 + lg P el Compressors P ≤ 15 99 97 P > 15 97 + 2 lg P 95 + 2 lg P Lawnmowers, lawn trimmers/lawn-edge trimmers L ≤50 96 94 (6) 50 < L ≤ 70 100 98 70 < L ≤ 120 100 98 (6) L > 120 105 103 (6) The permissible sound power level shall be rounded up or down to the nearest integer number (less than 0,5, use lower number; greater than or equal to 0,5, use higher number)’ 2. Article 20 shall be amended as follows: (a) In the first sentence of paragraph 1, the words ‘Not later than 3 January 2005’ shall be replaced by ‘Not later than 3 January 2007’; (b) Paragraph 3 shall be deleted. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2005 at the latest. They shall forthwith inform the Commission thereof. They shall apply those measures from 3 January 2006. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32005L0094

2005

COUNCIL DIRECTIVE 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Parliament (1), Having regard to the Opinion of the European Economic and Social Committee (2), After consulting the Committee of the Regions, Whereas: (1) Avian influenza is a serious, highly contagious disease of poultry and other captive birds caused by different types of influenza viruses. Those viruses may also spread to mammals, in particular pigs, and humans. (2) Since poultry is covered by live animals listed in Annex I to the Treaty, one of the Community's tasks in the veterinary field is to improve the health status of poultry, thereby facilitating trade in poultry and poultry products and ensuring the development of this sector. Furthermore, a high level of human health protection is to be ensured when defining and implementing Community policies and activities. (3) Influenza viruses include a large number of different virus strains. The level of risks posed by the different strains of influenza viruses for animal and public health is very variable and to some extent unpredictable, due to rapid virus mutation and possible re-assortment of the genetic material between different strains. (4) The infection with certain strains of influenza viruses of avian origin may trigger outbreaks in domestic birds of epizootic proportions, causing mortality and disturbances of poultry on a scale, which can threaten in particular the profitability of poultry farming as a whole. (5) Community measures for the control of avian influenza were established by Council Directive 92/40/EEC of 19 May 1992 introducing Community measures for the control of avian influenza (3), in order to ensure the protection of animal health and contribute to the development of the poultry sector. (6) The measures laid down in Directive 92/40/EEC should be fundamentally reviewed in the light of recent scientific knowledge on the risks of avian influenza for animal and public health, development of new laboratory tests and vaccines and the lessons learnt during recent outbreaks of this disease in the Community as well as in third countries. (7) The new Community measures should also take account of the most recent opinions delivered by the Scientific Committee on Animal Health and Animal Welfare and by the European Food Safety Authority (EFSA) and the changes in the Terrestrial Animal Health Code and the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the International Office of Epizootics (O.I.E.) on avian influenza. (8) Certain influenza viruses of avian origin may in some circumstances affect humans and may then pose a serious risk to public health. The provisions of this Directive, which aim at fighting the disease in farmed animals, could indirectly contribute to preventing public health problems. However, it is, at this stage, chiefly for the Member States to tackle such problems. (9) At Community level, the human health risks posed by influenza viruses are primarily dealt with by other actions and legal acts. These concern in particular the European Centre for Disease Prevention and Control (hereinafter referred to as ‘ECDC’), established by Regulation (EC) No 851/2004 of the European Parliament and of the Council (4), the recommendations issued by the Commission on Community Influenza pandemic preparedness and response planning, the European Union Early Warning and Response System and the establishment of the European Influenza Surveillance Scheme. (10) It is appropriate, however, for the Commission to assess together with ECDC whether further public health or workers' health and safety measures, complementing the animal health provisions of this Directive are needed at Community level to address the risks posed by certain influenza viruses of avian origin to humans and in particular for workers in contact with infected animals and to present any necessary legislative proposals. (11) Current knowledge indicates that the health risks posed by the so-called low pathogenic avian influenza viruses are inferior to the risks posed by highly pathogenic avian influenza viruses, which originate from a mutation of certain low pathogenic viruses. (12) Community legislation for the control of avian influenza should enable Member States to adopt disease control measures in a proportionate and flexible manner, taking into account the various levels of risk posed by different virus strains, the likely social and economic impact of the measures in question on the agriculture sector and other sectors involved while at the same time ensuring that the measures taken for each specific disease scenario are the most appropriate. (13) In view of the potential of low pathogenic avian influenza viruses to mutate into highly pathogenic avian influenza viruses, provision should be made for the early detection of infection in poultry aimed at a quick reaction and the adoption of appropriate and proportionate control and eradication measures which should include a system of active surveillance to be carried out by Member States. Such surveillance should follow general guidelines to be adapted in the light of further knowledge and developments in this field. (14) Any suspicion of avian influenza infection which may arise from clinical or laboratory investigations or any other reason that leads to the suspicion of the presence of infection should set in motion immediate official investigations so that prompt and effective action can be taken, as appropriate. Such action should be reinforced as soon as the presence of infection is confirmed to include depopulation of the holdings infected and of those which are at risk of infection. (15) In the case of detection of infection with low pathogenic avian influenza virus, control measures may differ from those which should apply in the case of detection of highly pathogenic avian influenza virus, taking into account the different levels of risk posed by these two conditions. (16) Disease control measures and in particular the establishment of restriction zones should also be modulated taking into account the density of the poultry population as well as other risk factors in the area in which the infection has been detected. (17) If an outbreak occurs, it is also necessary to prevent any further spread of infection by carefully monitoring and restricting movements of poultry and the use of products liable to be contaminated, by tightening biosecurity measures at all levels of poultry production, by cleansing and disinfecting the infected holding, by establishing protection and surveillance zones around the outbreak and, if necessary, by vaccination. (18) Community measures for the control of highly pathogenic avian influenza should be based first on the depopulation of the infected flocks, in accordance with Community legislation on animal welfare. (19) Council Directive 93/119/EC of 22 December 1993 on the protection of animals at the time of slaughter or killing (5) sets out the minimum standards for the protection of animals at the time of slaughter or killing including for the purpose of disease control. Such rules apply fully to slaughter or killing pursuant to this Directive. (20) Vaccination against avian influenza can be an effective tool to supplement disease control measures and to avoid massive killing and destruction of poultry or other captive birds. Current knowledge suggests that vaccination may be useful not only as a short-term measure in emergencies but also as a long-term measure to prevent disease in situations of higher risk of introduction of avian influenza viruses from wild life or other sources. Provisions should therefore be established for both emergency and preventive vaccination. (21) Vaccinated poultry, although protected against the clinical signs of disease, may become infected and thus contribute to the further spread of the infection. Vaccination must therefore be accompanied by appropriate surveillance and restriction measures established at Community level. Therefore, the vaccination strategy should allow differentiation between infected and vaccinated animals. Products of vaccinated poultry, such as meat and table eggs, should be then placed on the market in accordance with the relevant Community legislation, including this Directive. (22) It should also be made possible for the Community and the Member States to establish reserves of vaccine against avian influenza to be used in poultry or other captive birds in the case of an emergency. (23) Provisions should be adopted to ensure that harmonised procedures and methods are used for the diagnosis of avian influenza, including the functioning of a Community reference laboratory as well as reference laboratories in Member States. (24) Provisions should be adopted to ensure the necessary level of preparation by Member States effectively to tackle emergency situations caused by one or more outbreaks of avian influenza, in particular by drawing up contingency plans and setting up control centres. (25) If avian influenza is detected during importation in a quarantine facility or centre, as provided for in Commission Decision 2000/666/EC of 16 October 2000 laying down the animal health requirements and the veterinary certification for the import of birds, other than poultry and the conditions for quarantine (6), this should be reported to the Commission. However, reporting as provided for by Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (7), in cases of outbreaks in Member States would not be appropriate. (26) Cleansing and disinfection should be an integral part of the Community control policy for avian influenza. Disinfectants should be used in compliance with Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (8). (27) Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (9) lays down the rules on the collection, transport, storage, handling, processing and use or disposal of animal by-products including animals killed to eradicate epizootic diseases, to prevent them from presenting a risk to animal and public health. That Regulation and its implementing measures provide for a general framework for the disposal of dead animals. Provision should be made for the adoption, by the committee procedure, of specific, additional or different measures where necessary to enhance further avian influenza control measures. (28) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (10) and Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (11) may be applied under certain conditions to eggs originating from holdings where poultry suspected of being infected with avian influenza is kept. (29) Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive. (30) Provision should be made for the possibility for amendments to be made to the Annexes to this Directive when necessary without delay in order to take account of developments in scientific and technical knowledge. (31) Taking into account the unpredictability of influenza viruses, it is appropriate to ensure that a swift procedure is also in place for a rapid adoption at Community level of additional or more specific measures to control any infection of poultry and other animal species whenever such measures are necessary. (32) This Directive should set out the minimum control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds. However, Member States are free to take more stringent administrative and sanitary action in the field covered by this Directive. In addition, this Directive should provide for Member States' authorities to apply measures proportionate to the health risk posed by different disease situations. (33) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objectives of ensuring the development of the poultry sector and contributing to the protection of animal health, to lay down rules on specific measures and minimum measures aimed at the prevention and control of avian influenza. This Directive does not go beyond what is necessary in order to achieve the objectives pursued, in accordance with the third paragraph of Article 5 of the Treaty. (34) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12). (35) In the interests of clarity and rationality of Community legislation, Directive 92/40/EEC should be repealed and replaced by this Directive. (36) The Council, in accordance with point 34 of the Inter-Institutional Agreement on better law making (13), encourages Member States to draw up, for themselves and in the interest of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures and to make them public, CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter and scope 1. This Directive sets out: (a) certain preventive measures relating to the surveillance and the early detection of avian influenza and increasing the level of the competent authorities' and the farming community's awareness of, and preparation for, the risks of that disease; (b) the minimum control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds and the early detection of possible spread of avian influenza viruses to mammals; (c) other subsidiary measures to avoid the spread of influenza viruses of avian origin to other species. 2. Member States shall remain free to take more stringent measures in the field covered by this Directive. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: 1. ‘avian influenza’ means any of the influenza infections so described in Annex I(1); 2. ‘highly pathogenic avian influenza (HPAI)’ means any of the avian influenza infections so described in Annex I(2); 3. ‘low pathogenic avian influenza (LPAI)’ means any of the avian influenza infections so described in Annex I(3); 4. ‘poultry’ means all birds that are reared or kept in captivity for the production of meat or eggs for consumption, the production of other products, for restocking supplies of game birds or for the purposes of any breeding programme for the production of these categories of birds; 5. ‘wild bird’ means a free-living bird which is not kept on any holding as defined in point 8; 6. ‘other captive bird’ means any bird other than poultry that is kept in captivity for any reason other than those referred to in point 4 including those that are kept for shows, races, exhibitions, competitions, breeding or selling; 7. ‘officially registered rare breeds of poultry or other captive birds’ means any poultry or other captive birds that the competent authority has officially recognised as a rare breed within their contingency plan provided for in Article 62; 8. ‘holding’ means any agricultural or other premises, including hatcheries, circuses, zoos, pet bird shops, bird markets, and aviaries, where poultry or other captive birds are being bred or kept . However, this definition does not include slaughterhouses, means of transport, quarantine facilities and centres, border inspection posts and laboratories authorised by the competent authority to hold avian influenza virus; 9. ‘commercial poultry holding’ means a holding where poultry are kept for commercial purposes; 10. ‘non-commercial holding’ means a holding where poultry or other captive birds are kept by their owners: (a) for their own consumption or use; or (b) as pets; 11. ‘poultry compartment’ or ‘other captive birds compartment’ means a holding or holdings under a common biosecurity management system containing a poultry or other captive birds sub-population with a distinct health status with respect to avian influenza subjected to appropriate surveillance, control and biosecurity measures; 12. ‘flock’ means all poultry or other captive birds within a single production unit; 13. ‘production unit’ means a unit on a holding which the official veterinarian is satisfied is completely independent of any other unit in the same holding in terms of its location and day-to-day management of the poultry or other captive birds kept there; 14. ‘day-old chicks’ means all poultry less than 72 hours old, not yet fed, and muscovy ducks (Cairina moschata) or their crosses, less than 72 hours old, whether or not fed; 15. ‘diagnostic manual’ means the diagnostic manual provided for in Article 50(1); 16. ‘poultry or other captive birds suspected of being infected’ means any poultry or other captive birds exhibiting clinical signs or showing post-mortem lesions or reactions to laboratory tests which are such that the presence of avian influenza cannot be excluded; 17. ‘owner’ means any person or persons, either natural or legal having ownership of poultry or other captive birds, or charged with keeping such, whether or not for commercial purposes; 18. ‘competent authority’ means the authority of a Member State competent to carry out physical checks or administrative formalities in accordance with this Directive or any authority to which such competencies are delegated; 19. ‘official veterinarian’ means the veterinarian designated by the competent authority; 20. ‘official surveillance’ means the action of careful monitoring by the competent authority of the health status of poultry or other captive birds or mammals on a holding in relation to avian influenza; 21. ‘official supervision’ means the actions taken by the competent authority to verify that the requirements of this Directive and of any instructions from that authority as to how those requirements should be met are being, or have been, complied with; 22. ‘killing’ means any process other than slaughter causing the death of a mammal, poultry or other captive birds; 23. ‘slaughter’ means any process causing the death of a mammal or poultry by bleeding, for the purpose of human consumption; 24. ‘disposing of’ means the act of collecting, transporting, storing, handling, processing and using or disposing of animal by-products in accordance with: (a) Regulation (EC) No 1774/2002; or (b) rules to be adopted under the procedure referred to in Article 64(2); 25. ‘Community vaccine bank’ means appropriate premises designated in accordance with Article 58(1) for the storage of Community reserves of avian influenza vaccines; 26. ‘contact holding’ means a holding where avian influenza could have come from or have been introduced to as a result of its location, the movement of persons, poultry or other captive birds, vehicles or in any other way; 27. ‘suspected outbreak’ means a holding where the competent authority suspects the presence of avian influenza; 28. ‘outbreak’ means a holding where avian influenza has been confirmed by the competent authority; 29. ‘primary outbreak’ means an outbreak not epidemiologically linked with a previous outbreak in the same region of a Member State as defined in Article 2(2), point (p), of Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (14) or the first outbreak in a different region of the same Member State; 30. ‘Differentiating Infected from Vaccinated Animal (DIVA) strategy’ means a vaccination strategy which enables a differentiation to be made between vaccinated/infected and vaccinated/non-infected animals through the application of a diagnostic test designed to detect antibodies against the field virus and the use of non-vaccinated sentinel birds; 31. ‘mammal’ means an animal of the class Mammalia, except humans; 32. ‘carcase’ means poultry or other captive birds which have died or have been killed and are unfit for human consumption, or parts thereof. CHAPTER II PREVENTIVE BIOSECURITY, SURVEILLANCE, NOTIFICATIONS AND EPIDEMIOLOGICAL INQUIRIES Article 3 Preventive biosecurity measures Specific provisions concerning preventive biosecurity measures may be established in accordance with the procedure referred to in Article 64(2). Article 4 Surveillance programmes 1. Member States shall carry out surveillance programmes in order to: (a) detect the prevalence of infections with avian influenza virus subtypes H5 and H7 in different species of poultry; (b) contribute, on the basis of a regularly updated risk assessment, to the knowledge on the threats posed by wild birds in relation to any influenza virus of avian origin in birds. 2. The surveillance programmes referred to in paragraph 1(a) shall comply with guidelines to be drawn up by the Commission in accordance with the procedure referred to in Article 64(2). Article 5 Notification 1. Member States shall ensure that the suspected presence and presence of avian influenza are compulsorily and immediately notified to the competent authority. 2. In addition to the requirements provided for in Community legislation on notification of outbreaks of animal diseases, Member States shall notify the Commission in accordance with Annex II of any avian influenza confirmed by the competent authority in slaughterhouses, means of transport, border inspection posts and other places at Community borders and quarantine facilities or centres operating in accordance with Community legislation on imports of poultry or other captive birds. 3. Member States shall notify the results of any surveillance for avian influenza virus carried out in mammals. Article 6 Epidemiological inquiry 1. Member States shall ensure that epidemiological inquiries are started on the basis of questionnaires, established within the framework of the contingency plans provided for in Article 62. 2. The epidemiological inquiry shall include the following at least: (a) the length of time during which avian influenza may have been present on the holding or other premises or means of transport; (b) the possible origin of avian influenza; (c) the identification of any contact holding; (d) the movements of poultry, other captive birds, persons, mammals, vehicles or any material or other means by which the avian influenza virus could have spread. 3. The competent authority shall take account of the epidemiological inquiry when: (a) deciding whether additional disease control measures, as provided for in this Directive need to be applied; and (b) granting derogations as provided for in this Directive. 4. If the epidemiological inquiry suggests that avian influenza may have spread from or to other Member States, the Commission and the other Member States concerned shall be immediately informed of the results of all findings of the inquiry. CHAPTER III SUSPECTED OUTBREAKS Article 7 Measures to be applied on holdings where outbreaks are suspected 1. In the case of a suspected outbreak, the competent authority shall immediately set in motion an investigation to confirm or exclude the presence of avian influenza in accordance with the diagnostic manual and place the holding under official surveillance. The competent authority shall also ensure that the measures provided for in paragraphs 2 and 3 are complied with. 2. The competent authority shall ensure that the following measures are applied on the holding: (a) poultry, other captive birds and all mammals of domestic species are counted or, if appropriate, their numbers estimated by the type of poultry or species of other captive bird; (b) a list is compiled of the approximate number of poultry, other captive birds and all mammals of domestic species already sick, dead or likely to be infected in each category on the holding; that list shall be updated daily to take account of hatchings, births and deaths throughout the period of the suspected outbreak and shall be produced on request to the competent authority; (c) all poultry and other captive birds are brought inside a building on their holding and kept there. Where this is impractical or if their welfare is compromised they are confined in some other place on the same holding such that they do not have contact with other poultry or other captive birds on other holdings. All reasonable steps are taken to minimise their contact with wild birds; (d) no poultry or other captive birds may enter or leave the holding; (e) no carcases of poultry or other captive birds, meat of poultry including offal (‘poultry meat’), poultry feed (‘feed’), utensils, materials, waste, droppings, poultry or other captive birds manure (‘manure’), slurry, used litter or anything likely to transmit avian influenza may leave the holding without an authorisation from the competent authority, observing appropriate biosecurity measures such as to minimise any risk of the spread of avian influenza; (f) no eggs may leave the holding; (g) the movement of persons, mammals of domestic species, vehicles and equipment to or from the holding is subject to the conditions and authorisation of the competent authority; (h) appropriate means of disinfection are used at the entrances and exits of buildings housing poultry or other captive birds and of the holding itself in accordance with the instructions of the competent authority. 3. The competent authority shall ensure that an epidemiological inquiry is carried out in accordance with Article 6 (‘the epidemiological inquiry’). 4. Notwithstanding paragraph 1, the competent authority may provide for the submission of samples in other cases. In such circumstances the competent authority may proceed without adopting some or all of the measures referred in paragraph 2. Article 8 Derogations from certain measures to be applied on holdings where outbreaks are suspected 1. The competent authority may grant derogations from the measures provided for in Article 7(2) points (c) to (e) on the basis of a risk assessment and taking into account the precautions taken and the destination of the birds and products to be moved. 2. The competent authority may also grant derogations from the measures provided for in Article 7(2), point (h) in the case of other captive birds kept on non-commercial holdings. 3. With reference to Article 7(2) point (f), the competent authority may authorise the sending of eggs: (a) directly to an establishment for the manufacture of egg products, as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004, to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004; where the competent authority issues such an authorisation, the latter shall be subject to the conditions set out in Annex III to this Directive; or (b) for disposal. Article 9 Duration of the measures to be applied on holdings where outbreaks are suspected The measures to be applied on holdings in cases of suspected outbreaks, as provided for in Article 7, shall continue to be applied until the competent authority is satisfied that the suspicion of avian influenza on the holding has been ruled out. Article 10 Additional measures based on an epidemiological inquiry 1. Based on the preliminary results of an epidemiological inquiry, the competent authority may apply the measures provided for in paragraphs 2, 3 and 4 in particular if the holding is located in an area with a high density of poultry. 2. Temporary restrictions may be introduced on the movements of poultry, other captive birds and eggs and the movement of vehicles used by the poultry sector in a defined area or in the whole of the Member State. Such restrictions may be extended to movements of mammals of domestic species, but in that case shall not exceed 72 hours, unless justified. 3. The measures provided for in Article 11 may be applied to the holding. However, if conditions permit, application of those measures may be limited to the poultry or other captive birds suspected of being infected and their production units. Samples shall be taken from the poultry or other captive birds if they are killed in order for the risk of a suspected outbreak to be confirmed or excluded, in accordance with the diagnostic manual. 4. A temporary control zone around the holding may be established and some or all of the measures provided for in Article 7(2) shall be applied as necessary to the holdings within that zone. CHAPTER IV HIGHLY PATHOGENIC AVIAN INFLUENZA (HPAI) SECTION 1 Holdings, separate production units and contact holdings Article 11 Measures to be applied on holdings where outbreaks are confirmed 1. In case of an outbreak of HPAI, the competent authority shall ensure that the measures provided for in Article 7(2) and (3) and paragraphs 2 to 10 of this Article are applied. 2. All poultry and other captive birds on the holding shall be killed without delay under official supervision. The killing shall be carried out in such a way as to avoid the risk of spread of avian influenza, in particular during transport. However, Member States may grant derogations for certain species of poultry or other captive birds not to be killed, on the basis of an assessment of the risk of further spread of avian influenza. The competent authority may take appropriate measures to limit any possible spread of avian influenza to any wild birds on the holding. 3. All carcases and eggs on the holding shall be disposed of under official supervision. 4. Poultry already hatched from eggs collected from the holding during the period between the probable date of introduction of HPAI on the holding and the application of the measures provided for in Article 7(2), shall be placed under official supervision and investigations shall be carried out in accordance with the diagnostic manual. 5. Meat of poultry slaughtered and eggs collected from the holding during the period between the probable date of introduction of HPAI on the holding and the application of the measures provided for in Article 7(2) shall, wherever possible, be traced and disposed of under official supervision. 6. All substances and waste likely to be contaminated, such as feed, shall be destroyed or undergo a treatment ensuring the destruction of the avian influenza virus, in accordance with the instructions of the official veterinarian. 7. However, manure, slurry and bedding likely to be contaminated shall undergo one or more of the procedures provided for in Article 48. 8. Following the disposal of carcases, the buildings used for housing them, pastures or land, the equipment likely to be contaminated and the vehicles used for transporting the poultry or other captive birds, carcases, meat, feed, manure, slurry, bedding and any other material or substance likely to be contaminated shall undergo one or more of the procedures provided for in Article 48. 9. Other captive birds or mammals of domestic species shall not enter or leave the holding without the authorisation of the competent authority. That restriction shall not apply to mammals of domestic species which have access only to the living areas for humans. 10. In the case of a primary outbreak, the virus isolate shall be subjected to the laboratory procedure in accordance with the diagnostic manual to identify the genetic subtype. That virus isolate shall be submitted to the Community reference laboratory, as provided for in Article 51(1) as soon as possible. Article 12 Derogations 1. Member States shall draw up detailed rules for granting derogations, as provided for in Articles 11(2), 13 and 14, including alternative appropriate measures and conditions. Such derogations shall be based on a risk assessment carried out by the competent authority. 2. Member States shall immediately notify the Commission of any derogation granted in accordance with Article 13(1) and Article 14. 3. Where a derogation has been granted, as provided for in Article 13(1) and Article 14, the Commission shall immediately review the situation with the Member State concerned and in the Standing Committee on the Food Chain and Animal Health (‘the Committee’) as soon as possible. 4. Taking account of any derogation granted, as provided for in Article 13(1) and Article 14, measures to prevent the spread of avian influenza may be adopted in accordance with the procedure referred to in Article 64(3). Article 13 Derogations concerning certain holdings 1. The competent authority may grant derogations from the measures provided for in the first subparagraph of Article 11(2) in cases of an outbreak of HPAI in a non-commercial holding, a circus, a zoo, a pet bird shop, a wild life park, a fenced area where poultry or other captive birds are kept for scientific purposes or purposes related to the conservation of endangered species or officially registered rare breeds of poultry or other captive birds, provided that such derogations do not endanger disease control. 2. The competent authority shall ensure that where a derogation is granted, as provided for in paragraph 1, the poultry and other captive birds concerned by the derogation: (a) are brought inside a building on their holding and kept there. Where this is impractical or if their welfare is compromised they are confined in some other place on the same holding such that they do not have contact with other poultry or other captive birds on other holdings. All reasonable steps are taken to minimise their contact with wild birds; (b) are subjected to further surveillance and testing in accordance with the diagnostic manual and are not moved until the laboratory tests have indicated that they no longer pose a significant risk of further spread of HPAI; and (c) are not moved from their holding of origin, except for slaughter or to another holding: (i) located in the same Member State, in accordance with the instructions of the competent authority; or (ii) in another Member State, subject to the agreement of the Member State of destination. 3. The competent authority may grant derogations from the measures provided for in Article 11(5), for eggs to be sent directly to an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004. Any such authorisations shall be subject to the conditions set out in Annex III to this Directive. Article 14 Measures to be applied in cases of outbreaks of HPAI in separate production units In cases of an outbreak of HPAI in a holding which consists of two or more separate production units, the competent authority may grant derogations from the measures provided for in the first subparagraph of Article 11(2) for production units containing poultry or other captive birds where no HPAI is suspected, provided that such derogations do not endanger disease control. Such derogations shall only be granted in respect of two or more separate production units where the official veterinarian, taking account of the structure, size, operation, type of housing, feeding, water source, equipment, staff and visitors to the holding, is satisfied that they are completely independent of other production units in terms of location and day-to-day management of the poultry or other captive birds kept there. Article 15 Measures to be applied in contact holdings 1. Based on the epidemiological inquiry, the competent authority shall decide if a holding is to be considered as a contact holding. The competent authority shall ensure that the measures provided for in Article 7(2) are applied to contact holdings until the presence of HPAI has been excluded in accordance with the diagnostic manual. 2. Based on the epidemiological inquiry, the competent authority may apply the measures provided for in Article 11 to contact holdings and in particular if the contact holding is located in an area with a high density of poultry. The main criteria to be considered for the application of the measures provided for in Article 11 in contact holdings are set out in Annex IV. 3. The competent authority shall ensure that samples are taken from poultry and other captive birds when they are killed in order to confirm or exclude the presence of HPAI virus in those contact holdings in accordance with the diagnostic manual. 4. The competent authority shall ensure that, on any holding where poultry or other captive birds are killed and disposed of and avian influenza is subsequently confirmed, the buildings and any equipment likely to be contaminated and the vehicles used for transporting the poultry, other captive birds, carcases, meat, feed, manure, slurry, bedding and any other material or substance likely to be contaminated undergo one or more of the procedures provided for in Article 48. SECTION 2 Protection, surveillance and further restricted zones Article 16 Establishment of protection, surveillance and further restricted zones in cases of outbreaks of HPAI 1. Immediately following an outbreak of HPAI, the competent authority shall establish: (a) a protection zone with a radius of at least three kilometres around the holding; (b) a surveillance zone with a radius of at least 10 kilometres around the holding, including the protection zone. 2. If the outbreak of HPAI is confirmed in other captive birds in a non-commercial holding, circus, zoo, pet bird shop, wildlife park, a fenced area where other captive birds are kept for scientific purposes or purposes related to the conservation of endangered species or officially registered rare breeds of other captive birds that do not contain poultry, the competent authority may, following a risk assessment, derogate to the extent necessary from the provisions of Sections 2 to 4 concerning the establishment of the protection and surveillance zones and the measures to be applied therein, provided that such derogations do not endanger disease control. 3. When establishing protection and surveillance zones, as provided for in paragraph 1, the competent authority shall take account of the following criteria at least: (a) the epidemiological inquiry; (b) the geographical situation, particularly natural boundaries; (c) the location and proximity of holdings and the estimated number of poultry; (d) patterns of movements and trade in poultry, other captive birds; (e) the facilities and personnel available to control any movement within the protection and surveillance zones of poultry or other captive birds, their carcases, manure, bedding or used litter, in particular if the poultry or other captive birds to be killed and disposed of have to be moved from their holding of origin. 4. The competent authority may establish further restricted zones around or adjacent to the protection and surveillance zones, taking account of the criteria provided for in paragraph 3. 5. If a protection, surveillance or further restricted zone covers the territories of different Member States, the competent authorities of the Member States concerned shall collaborate to establish the zone. Article 17 Measures to be applied both in the protection and in the surveillance zones 1. The competent authority shall ensure that the following measures are applied within the protection and surveillance zones: (a) arrangements are put in place which permit the tracing of anything likely to spread the avian influenza virus including poultry, other captive birds, meat, eggs, carcases, feed, litter, people who have been in contact with the infected poultry or other captive birds or vehicles with a link to the poultry industry; (b) owners are to provide the competent authority, on request, with any relevant information concerning the poultry or other captive birds and eggs entering or leaving the holding. 2. The competent authority shall take all reasonable steps to ensure that all persons in the protection and surveillance zones affected by the restrictions concerned are fully aware of the restrictions in place. That information may be conveyed through warning notices, media resources such as the press and television or any other appropriate means. 3. The competent authority may, where epidemiological information or other evidence indicates, implement a preventive eradication programme, including preventive slaughtering or killing of poultry or other captive birds, in holdings and areas at risk. 4. Member States applying the measures provided for in paragraph 3 shall immediately inform the Commission thereof, and the Commission shall review the situation with the Member States concerned and in the Committee as soon as possible. SECTION 3 Measures to be applied in protection zones Article 18 Census and visits by the official veterinarian and surveillance The competent authority shall ensure that the following measures are applied in protection zones: (a) a census of all the holdings is made as soon as possible; (b) all commercial holdings are visited by an official veterinarian as soon as possible for a clinical examination of the poultry and other captive birds and, if necessary, the collection of samples for laboratory tests in accordance with the diagnostic manual; a record of such visits and the findings thereof shall be kept; non-commercial holdings are visited by an official veterinarian before the lifting of the protection zone; (c) additional surveillance is immediately implemented in accordance with the diagnostic manual in order to identify any further spread of avian influenza in the holdings located in the protection zone. Article 19 Measures to be applied on holdings in protection zones The competent authority shall ensure that the following measures are applied on holdings in protection zones: (a) all poultry and other captive birds are brought inside a building on their holding and kept there. Where this is impractical or if their welfare is compromised, they are confined in some other place on the same holding such that they do not have contact with other poultry or other captive birds on other holdings. All reasonable steps are taken to minimise their contact with wild birds; (b) carcases are disposed of as soon as possible; (c) vehicles and equipment used for transporting live poultry or other captive birds, meat, feed, manure, slurry and bedding and any other material or substances likely to be contaminated, undergo without delay one or more of the procedures provided for in Article 48; (d) all parts of vehicles used by staff or other persons which enter or leave holdings and are likely to have become contaminated undergo without delay one or more of the procedures provided for in Article 48; (e) no poultry, other captive birds or domestic mammals may enter or leave a holding without authorisation of the competent authority. This restriction shall not apply to mammals which have access only to the living areas for humans in which they: (i) have no contact with resident poultry or other captive birds, and (ii) have no access to any cages or areas where such resident poultry or other captive birds are kept; (f) any increased morbidity or mortality or significant drop in production data in holdings is immediately reported to the competent authority, which shall carry out appropriate investigations in accordance with the diagnostic manual; (g) any person entering or leaving holdings observes appropriate biosecurity measures aimed at preventing the spread of avian influenza; (h) records of all persons visiting holdings, except dwellings, are kept by the owner in order to facilitate disease surveillance and control and must be made available upon request by the competent authority. Such records do not have to be kept where the visitors are to holdings such as zoos and wildlife parks where they have no access to the areas where the birds are kept. Article 20 Prohibition on the removal or spreading of used litter, manure or slurry from holdings The competent authority shall ensure that the removal or spreading of used litter, manure or slurry from holdings in protection zones are prohibited, unless authorised by it. However, the movement of manure or slurry may be authorised from holdings under biosecurity measures to a designated plant for treatment or for intermediate storage for subsequent treatment to destroy the possible presence of avian influenza viruses in accordance with Regulation (EC) No 1774/2002 or with specific rules which may be adopted in accordance with the procedure referred to in Article 64(2). Article 21 Fairs, markets or other gatherings and restocking of game The competent authority shall ensure that fairs, markets, shows or other gatherings of poultry or other captive birds are prohibited in protection zones. The competent authority shall ensure that poultry or other captive birds for restocking of game are not released in protection zones. Article 22 Prohibition on the movement and transport of birds, eggs, poultry meat and carcases 1. The competent authority shall ensure that within protection zones, the movement and transport from holdings on to roads, excluding private service roads of holdings, or by rail, of poultry, other captive birds, ready-to-lay poultry, day-old chicks, eggs and carcases are prohibited. 2. The competent authority shall ensure that the transport of poultry meat from slaughterhouses, cutting plants and cold stores is prohibited unless it has been produced: (a) from poultry which has originated from outside the protection zones and has been stored and transported separately from the meat of poultry from within the protection zones; or (b) on a date at least 21 days before the estimated date of earliest infection on a holding in the protection zone and which since production has been stored and transported separately from such meat produced after that date. 3. However, the prohibitions in paragraphs 1 and 2 shall not apply to transit through the protection zone on roads or rail without unloading or stopping. Article 23 Derogations for the direct transport of poultry for immediate slaughter and the movement or treatment of poultry meat 1. By way of derogation from Article 22, the competent authority may authorise the direct transport of poultry originating from a holding in the protection zone for immediate slaughter to a designated slaughterhouse subject to the following conditions: (a) a clinical examination of the poultry on the holding of origin is carried out by the official veterinarian within 24 hours of being sent for slaughter; (b) where appropriate, laboratory tests have been carried out on poultry on the holding of origin in accordance with the diagnostic manual, with favourable results; (c) the poultry are transported in vehicles sealed by the competent authority or under its supervision; (d) the competent authority responsible for the designated slaughterhouse is informed and agrees to receive the poultry and then confirms the slaughter to the competent authority of dispatch; (e) the poultry from the protection zone are kept separately from other poultry and are slaughtered separately or at different times from other poultry, preferably at the end of a working day; subsequent cleansing and disinfection shall be completed before other poultry are slaughtered; (f) the official veterinarian shall ensure that a detailed examination of the poultry is carried out at the designated slaughterhouse when the poultry arrive and after they are slaughtered; (g) the meat does not enter into intra-Community or international trade and bears the health mark for fresh meat provided for in Annex II to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (15), unless otherwise decided in accordance with the procedure referred to in Article 64(3) of this Directive; (h) the meat is obtained, cut, transported and stored separately from meat intended for intra-Community and international trade and is used in such a way as to avoid it being introduced into meat products intended for intra-Community or international trade, unless: (i) it has undergone a treatment set out in Annex III to Directive 2002/99/EC; or (ii) it is otherwise decided in accordance with the procedure referred to in Article 64(3). 2. By way of derogation from Article 22, the competent authority may authorise the direct transport of poultry from outside the protection zone for immediate slaughter to a designated slaughterhouse within the protection zone and subsequent movement of the meat derived from such poultry providing that: (a) the competent authority responsible for the designated slaughterhouse is informed and agrees to receive the poultry and then confirms the slaughter to the competent authority of dispatch; (b) the poultry are kept separate from other poultry originating within the protection zone and are slaughtered separately or at different times from other poultry; (c) the poultry meat produced is cut, transported and stored separately from poultry meat obtained from other poultry originating in the protection zone; (d) the by-products are disposed of. Article 24 Derogations for the direct transport of day-old chicks 1. By way of derogation from Article 22, the competent authority may authorise the direct transport of day-old chicks, originating from holdings within the protection zone to a holding or shed of that holding in the same Member State, preferably located outside the protection and the surveillance zones, subject to the following conditions: (a) they are transported in vehicles sealed by the competent authority or under its supervision; (b) appropriate biosecurity measures are applied during transport and at the holding of destination; (c) the holding of destination is placed under official surveillance following the arrival of the day-old-chicks; (d) if moved outside the protection or surveillance zone, the poultry shall remain on the holding of destination for at least 21 days. 2. By way of derogation from Article 22, the competent authority may authorise the direct transport of day-old chicks, hatched from eggs originating from holdings located outside the protection and surveillance zones, to any other holding in the same Member State, preferably located outside the protection and the surveillance zones, provided that the hatchery of dispatch can ensure by its logistics and by its hygienic working conditions that no contact has occurred between those eggs and any other hatching eggs or day-old chicks originating from poultry flocks within such zones and which are therefore of a different health status. Article 25 Derogations for the direct transport of ready to lay poultry By way of derogation from Article 22, the competent authority may authorise the direct transport of ready-to-lay poultry to a holding or shed of that holding preferably within the protection or the surveillance zone in which there is no other poultry, subject to the following conditions: (a) a clinical examination of the poultry and other captive birds in the holding of origin and in particular of those to be moved is carried out by the official veterinarian; (b) where appropriate, laboratory tests have been carried out on poultry in the holding of origin in accordance with the diagnostic manual with favourable results; (c) the ready-to-lay poultry is transported in vehicles sealed by the competent authority or under its supervision; (d) the holding or shed of destination is placed under official surveillance following the arrival of the ready-to-lay poultry; (e) if moved outside the protection or surveillance zone, the poultry shall remain on the holding of destination for at least 21 days. Article 26 Derogation for the direct transport of hatching and table eggs 1. By way of derogation from Article 22, the competent authority may authorise the direct transport of hatching eggs either from any holding to a hatchery located, in the protection zone and designated by the competent authority (‘the designated hatchery’) or, subject to the following conditions, from a holding located in the protection zone to any designated hatchery: (a) the parent flocks from which the hatching eggs are derived have been examined in accordance with the diagnostic manual and avian influenza is not suspected on these holdings; (b) the hatching eggs and their packaging are disinfected before dispatch and the tracing back of these eggs can be ensured; (c) the hatching eggs are transported in vehicles sealed by the competent authority or under its supervision; (d) biosecurity measures are applied in the designated hatchery in accordance with the instructions of the competent authority. 2. By way of derogation from Article 22, the competent authority may authorise the direct transport of eggs: (a) to a packing centre designated by the competent authority (‘the designated packing centre’), provided that they are packed in disposable packaging and that all biosecurity measures required by the competent authority are applied; (b) to an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004; or (c) for disposal. Article 27 Derogation for the direct transport of carcases By way of derogation from Article 22, the competent authority may authorise the direct transport of carcases provided that they are transported to be disposed of. Article 28 Cleansing and disinfecting of means of transport The competent authority shall ensure that the vehicles and equipment used for the transport as provided for in Articles 23 to 27 are cleansed and disinfected without delay by one or more of the procedures set down in Article 48 following the transport. Article 29 Duration of measures 1. The measures provided for in this Section shall be maintained for at least 21 days following the date of completion of preliminary cleansing and disinfection on the infected holding by one or more of the procedures set down in Article 48 and until holdings located in the protection zone have been tested in accordance with the diagnostic manual. 2. When the measures referred to in this Section are no longer to be maintained, as provided for in paragraph 1 of this Article, the measures laid down in Article 30 shall apply in the former protection zone, until they are no longer to be applied as provided for in Article 31. SECTION 4 Measures to be applied in the surveillance zones Article 30 Measures to be applied in the surveillance zones The competent authority shall ensure that the following measures are applied in surveillance zones: (a) a census of all commercial poultry holdings is made as soon as possible; (b) the movement of poultry, ready-to-lay poultry, day-old chicks, eggs within the surveillance zone is prohibited unless authorisation is granted by the competent authority, which ensures that appropriate biosecurity measures are applied to prevent the spread of avian influenza; this prohibition shall not apply to transit thorough the surveillance zone on road or rail without unloading or stopping; (c) the movement of poultry, ready-to-lay poultry, day-old chicks and eggs to holdings, slaughterhouses, packing centres or an establishment for the manufacture of egg products located outside the surveillance zone is prohibited; however, the competent authority may authorise the direct transport of: (i) poultry for slaughter to a designated slaughterhouse, for the purpose of immediate slaughter subject to Article 23(1), points (a), (b) and (d); The competent authority may authorise the direct transport of poultry from outside the protection and surveillance zones for immediate slaughter to a designated slaughterhouse within the surveillance zone and the subsequent movement of the meat derived from such poultry; (ii) ready-to-lay poultry to a holding in which there is no other poultry in the same Member State; that holding shall be placed under official surveillance following the arrival of the ready-to-lay poultry and the ready-to-lay poultry shall remain on the holding of destination for at least 21 days; (iii) day-old chicks: to a holding or shed of such holding in the same Member State provided that appropriate biosecurity measures are applied and the holding is placed under official surveillance following the transport and day-old chicks shall remain on the holding of destination for at least 21 days, or if hatched from hatching eggs originating from poultry holdings located outside the protection and surveillance zones, to any other holding, provided that the hatchery of dispatch can ensure by its logistics and biosecurity working conditions that no contact has occurred between these eggs and any other hatching eggs or day-old-chicks originating from poultry flocks within those zones and which are therefore of a different health status; (iv) hatching eggs to a designated hatchery located inside or outside the surveillance zone; the eggs and their packaging shall be disinfected before dispatch and the tracing back of these eggs must be ensured; (v) table eggs to a designated packing centre, provided that they are packed in disposable packaging and that all biosecurity measures required by the competent authority are applied; (vi) eggs to an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004 located inside or outside the surveillance zone; (vii) eggs for disposal; (d) any person entering or leaving holdings in the surveillance zone observes appropriate biosecurity measures aimed at preventing the spread of avian influenza; (e) vehicles and equipment used for transporting live poultry or other captive birds, carcases, feed, manure, slurry and bedding and any other material or substances likely to be contaminated, are cleansed and disinfected without delay after contamination by one or more of the procedures provided for in Article 48; (f) no poultry, other captive birds or mammals of domestic species may enter or leave a holding where poultry is kept without authorisation of the competent authority. This restriction shall not apply to mammals which have access only to the living areas for humans in which they: (i) have no contact with resident poultry or other captive birds, and (ii) have no access to any cages or areas where such resident poultry or other captive birds are kept; (g) any increased morbidity or mortality or significant drop in production data in holdings is immediately reported to the competent authority, which shall carry out appropriate investigations in accordance with the diagnostic manual; (h) the removal or spreading of used litter, manure or slurry is prohibited unless authorised by the competent authority; the movement of manure may be authorised from a holding situated in the surveillance zone under biosecurity measures to a designated plant for treatment or for intermediate storage for subsequent treatment to destroy the possible presence of avian influenza viruses, in accordance with Regulation (EC) No 1774/2002 or with specific rules which may be adopted in accordance with the procedure referred to in Article 64(2); (i) fairs, markets, shows or other gatherings of poultry or other captive birds are prohibited; (j) poultry for restocking of game are not released. Article 31 Duration of measures The measures provided for in this Section shall be maintained for at least 30 days following the date of completion of preliminary cleansing and disinfection on the infected holding in accordance with Article 48. SECTION 5 Measures to be applied in further restricted zones Article 32 Measures to be applied in further restricted zones 1. The competent authority may provide that some or all the measures provided for in Sections 3 and 4 shall apply inside the further restricted zones provided for in Article 16(4) (‘the further restricted zones’). 2. The competent authority may, where epidemiological information or other evidence indicates, implement a preventive eradication programme, including preventive slaughtering or killing of poultry or other captive birds, in holdings and areas at risk, according to the criteria of Annex IV, located in further restricted zones. The restocking of those holdings shall take place in accordance with the instructions of the competent authority. 3. Member States applying the measures provided for in paragraphs 1 and 2 shall immediately inform the Commission thereof. 4. The Commission shall review the situation with the Member States concerned and in the Committee as soon as possible. 5. Without prejudice to decisions to be adopted pursuant to Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (16), further surveillance, biosecurity and control measures to prevent the spreading of avian influenza may be adopted in accordance with the procedure referred to in Article 64(3). SECTION 6 Derogations and additional biosecurity measures Article 33 Derogations 1. Member States shall define the detailed arrangements under which they may grant derogations provided for in Articles 16 and 23 to 27, including alternative appropriate measures and conditions. Such derogations shall be based on a risk assessment carried out by the competent authority. 2. The competent authority may, based on a risk assessment, grant derogations from the measures provided in Sections 3 and 4 in cases of confirmation of HPAI in a hatchery. 3. The competent authority may grant derogations from the measures provided for in Article 18, points (b) and (c), Article 22, and in Article 30, points (b), (c) and (f), in cases of an outbreak of HPAI in a non-commercial holding, a circus, a zoo, a wild life park, a fenced area where poultry or other captive birds are kept for scientific purposes or purposes related to the conservation of endangered species or officially registered rare breeds of poultry or other captive birds. 4. By way of derogation from Sections 3 and 4, in cases of outbreaks of HPAI Member States may, based on a risk assessment, introduce specific measures on movements of racing pigeons into, from and within the protection and surveillance zones. 5. The derogations provided for in paragraphs 1 to 4 shall only be granted provided that such derogations do not endanger disease control. 6. Member States granting derogations provided for in paragraphs 1 to 4 shall immediately inform the Commission thereof. 7. The Commission shall in all cases review the situation with the Member State concerned and in the Committee as soon as possible. Taking account of any derogation granted, as provided for in paragraphs 1 to 4, measures to prevent the spread of avian influenza may be adopted in accordance with the procedure referred to in Article 64(3). 8. Any poultry (including day-old-chicks), other captive birds, hatching eggs, used litter, manure or slurry which come from a holding that has been granted a derogation under this Article, cannot be marketed outside the Member State concerned unless otherwise decided in accordance with the procedure referred in Article 64(3). Article 34 Additional biosecurity measures 1. In order to prevent the spread of avian influenza, the competent authority may, in addition to the measures provided for in Sections 3, 4 and 5, order the implementation of additional biosecurity measures in holdings in the protection and surveillance zones and in the further restricted zones, as well as in poultry compartments and other captive birds compartments in the Member State concerned. Those measures may include restrictions on movements of vehicles or persons for feed supply, egg collection, the transport to slaughterhouses of poultry, the collection for disposal of carcases and other movements of personnel, veterinarians or persons supplying farm equipment. 2. Member States which adopt measures, as provided for in paragraph 1, shall immediately inform the Commission thereof. 3. The Commission shall review the situation with the Member State concerned and in the Committee as soon as possible. 4. Without prejudice to decisions to be adopted pursuant to Decision 90/424/EEC, further surveillance, biosecurity and control measures to prevent the spread of avian influenza maybe adopted in accordance with the procedure referred to in Article 64(3). SECTION 7 Measures to be applied in cases of suspicion and confirmation of highly pathogenic Avian Influenza (HPAI) in certain premises other than holdings and in means of transport Article 35 Investigation of suspected presence of HPAI in slaughterhouses and in means of transport Where there is suspicion or confirmation of the presence of HPAI in slaughterhouses or means of transport, the competent authority shall immediately set in motion an investigation in the holding of origin of the poultry or other captive birds to confirm or exclude its presence in accordance with the diagnostic manual. Article 36 Measures to be applied in slaughterhouses 1. Where HPAI is suspected or confirmed in a slaughterhouse, the competent authority shall ensure that, on the basis of a risk assessment, all poultry present in the slaughterhouse is either killed or slaughtered as soon as possible under official supervision. Where such poultry is slaughtered, the poultry meat and any by-products derived from the poultry and poultry meat and by-products of any other poultry which may have been contaminated during the slaughter and production process, shall be kept separate and under official supervision until investigations in accordance with the diagnostic manual have been completed. 2. If HPAI is confirmed, the poultry meat and any by-products derived from the poultry and poultry meat and by-products of any other poultry which may have been contaminated during the slaughter and production process shall be disposed of as soon as possible under official supervision. Article 37 Measures to be applied in border inspection posts or means of transport 1. Where HPAI is suspected or confirmed in border inspection posts or means of transport, the competent authority shall ensure that, on the basis of a risk assessment, all poultry and other captive birds present in the border inspection post or in the means of transport are killed, slaughtered or placed in isolation away from poultry or other captive birds and kept under official supervision until the investigation is completed in accordance with the diagnostic manual. The competent authority shall apply the measures provided for in Article 7 as appropriate. The competent authority may authorise the movement of the poultry or other captive birds to another place where they are killed, slaughtered or placed into isolation. The competent authority may decide not to kill or slaughter those poultry or other captive birds present in the border inspection post that have not been in contact with the poultry or other captive birds suspected of being infected. 2. Where poultry referred to in paragraph 1 is slaughtered, the poultry meat and any by products derived from those poultry and poultry meat and by-products of any other poultry which may have been contaminated during the slaughter and production process, shall be kept separate and under official supervision until investigations in accordance with the diagnostic manual have been completed. 3. If HPAI is confirmed, the poultry meat and any by-products derived from those poultry and poultry meat and by-products of any other poultry which may have been contaminated during the slaughter and production process shall be disposed of as soon as possible under official supervision. Article 38 Additional measures to be applied to slaughterhouses, border inspection posts or means of transport The competent authority shall ensure that the following additional measures are applied where HPAI is suspected or confirmed in a slaughterhouse, border inspection post or means of transport: (a) no poultry or other captive birds are introduced into the slaughterhouse, the border inspection post or the means of transport until at least 24 hours after the cleansing and disinfection as provided for in point (b) are completed by one or more of the procedures set down in Article 48; in the case of border inspection posts, the prohibition on introduction may be extended to other animals; (b) the cleansing and disinfection of contaminated buildings, equipment and vehicles takes place in accordance with one or more of the procedures set down in Article 48 and under the official supervision of the official veterinarian; (c) an epidemiological inquiry is carried out; (d) the measures provided for in Article 7(2) are applied in the holding of origin of the infected poultry or carcases and in contact holdings; (e) unless otherwise indicated by the epidemiological inquiry and the further investigations, as provided for in Article 35, the measures provided for in Article 11 are applied in the holding of origin; (f) the avian influenza virus isolate is subjected to the laboratory procedure in order to identify the subtype of the virus, in accordance with the diagnostic manual. CHAPTER V LOW PATHOGENIC AVIAN INFLUENZA (LPAI) SECTION 1 Measures to be applied on holdings where outbreaks are confirmed Article 39 Measures to be applied 1. In case of an outbreak of LPAI, the competent authority shall ensure that the measures provided for in points (a), (b), (c), (e), (g) and (h) of Article 7(2), Article 7(3) and paragraphs 2 to 5 of this Article are applied on the basis of a risk assessment and taking account of at least the criteria set out in Annex V. 2. The competent authority shall ensure that all poultry on the holding and all other captive birds of the species in which LPAI has been confirmed are depopulated under official supervision in such a way as to prevent the spread of avian influenza. The depopulation may be extended to other captive birds on the holding based on the assessment of the risk that they pose as regards further spread of avian influenza and to other holdings that may be considered as contact holdings, based on the epidemiological inquiry. Before depopulation, no poultry or other captive birds shall enter or leave the holding, unless authorised by the competent authority. 3. For the purpose of paragraph 2, the depopulation shall be carried out in accordance with Directive 93/119/EC and the competent authority shall decide that the poultry or other captive birds are: (a) killed as soon as possible, or (b) slaughtered in a designated slaughterhouse in accordance with paragraph 4. When depopulation is by slaughter in a designated slaughterhouse, the poultry shall be subjected to further surveillance and testing. The poultry shall not be moved from the holding to the designated slaughterhouse until the competent authority, taking account, in particular, of the investigations and the laboratory tests directed at determining the extent of any excretion of the virus by the poultry carried out in accordance with the diagnostic manual and a risk assessment, is satisfied that the risk of further spread of LPAI is minimal. 4. Slaughter in a designated slaughterhouse in accordance with paragraph 3 may take place only provided that: (a) the poultry is sent directly from the holding to the designated slaughterhouse; (b) each consignment is sealed before dispatch by the official veterinarian responsible for the holding or under his supervision; (c) each consignment remains sealed throughout transport to the designated slaughterhouse; (d) further biosecurity measures prescribed by the competent authority are complied with; (e) the competent authority responsible for the designated slaughterhouse is informed and agrees to receive the poultry; (f) vehicles and equipment used for transporting live poultry and any other material or substances likely to be contaminated are cleansed and disinfected without delay after contamination, by one or more of the procedures set down in Article 48, and (g) the by-products of such poultry at the slaughterhouse are disposed of. 5. The competent authority shall ensure that the following are disposed of under official supervision: (a) carcases, and (b) hatching eggs on the holding. 6. The competent authority shall ensure that the following measures are taken: (a) hatching eggs collected from the holding during the period between the probable introduction of LPAI into the holding and the taking of the measures provided for in this Directive, are whenever possible traced and hatched under official surveillance; (b) poultry already hatched from eggs collected from the holding during the period between the probable introduction of LPAI into the holding and the taking of the measures provided for in this Directive, are whenever possible placed under official surveillance and investigations are carried out in accordance with the diagnostic manual; (c) eggs present on the holding and further produced on the holding before depopulation as provided for in paragraph 2, are transported provided that the risk of spread of LPAI is minimised: (i) to a packing centre designated by the competent authority (‘the designated packing centre’), provided that they are packed in disposable packaging and that all biosecurity measures required by the competent authority are applied; (ii) to an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004; or (iii) for disposal. (d) any material or substance likely to be contaminated are either treated in accordance with the instructions of the official veterinarian or disposed of; (e) manure, slurry and bedding likely to be contaminated undergo one or more of the procedures provided for in Article 48; (f) after depopulation, the buildings used for housing the poultry or other captive birds, the equipment likely to be contaminated and the vehicles used for transporting carcases, feed, manure, slurry, and bedding or any other material or substance likely to be contaminated undergoes without delay one or more of the procedures provided for in Article 48; (g) mammals of domestic species do not enter or leave the holding without the authorisation of the competent authority. This restriction shall not apply to mammals which have access only to the living areas for humans in which they: (i) have no contact with resident poultry or other captive birds, and (ii) have no access to any cages or areas where such resident poultry or other captive birds are kept. (h) in the case of a primary outbreak of LPAI, the virus isolate is subjected to the laboratory tests to identify the subtype of virus in accordance with the diagnostic manual; the virus isolate shall be submitted to the Community reference laboratory, as provided for in Article 51(1), as soon as possible. 7. Member States applying the measures provided for in paragraphs 2, 4 and 5 shall inform the Commission thereof. Article 40 Derogations for certain holdings 1. The competent authority may grant derogations from the measures provided for in Article 39(2) and point (b) of Article 39(5) in cases of an outbreak of LPAI in a non commercial holding, a circus, a zoo, a pet bird shop, a wild life park, a fenced area where poultry or other captive birds are kept for scientific purposes or purposes related to the conservation of endangered species or officially registered rare breeds of poultry or other captive birds, provided that such derogations do not endanger disease control. 2. The competent authority shall ensure that where a derogation is granted, as provided for in paragraph 1, the poultry or other captive birds concerned by the derogation: (a) are brought inside a building on their holding and kept there. Where this is impractical or if their welfare is compromised they are confined in some other place on the same holding such that they do not have contact with other poultry or other captive birds on other holdings. All reasonable steps are taken to minimise their contact with wild birds; (b) are subjected to further surveillance and testing in accordance with the diagnostic manual and are not moved until the laboratory tests have indicated that they no longer pose a significant risk of further spread of LPAI; and (c) are not moved from their holding of origin, except for slaughter or to another holding: (i) located in the same Member State, in accordance with the instructions of the competent authority; or (ii) in another Member State, subject to the agreement of the Member State of destination. 3. The competent authority may in cases of outbreaks of LPAI in hatcheries, based on a risk assessment, grant derogations from some or all of the measures provided for in Article 39. 4. Member States shall draw up detailed rules for applying the derogations provided for in paragraphs 1 and 3. 5. Member States shall immediately inform the Commission of any derogation granted in accordance with paragraphs 1 and 3. 6. The Commission shall review the situation with the Member State concerned and in the Committee as soon as possible. 7. Taking account of any derogation granted, as provided for in paragraph 1, measures to prevent the spread of avian influenza may be adopted in accordance with the procedure referred to in Article 64(3). SECTION 2 Separate production units and contact holdings Article 41 Measures to be applied in cases of outbreaks of LPAI in separate production units 1. In cases of an outbreak of LPAI in a holding which consists of two or more separate production units, the competent authority may grant derogations from the measures provided for in Article 39(2), for production units containing healthy poultry provided that such derogations do not endanger disease control. 2. Member States shall draw up detailed rules for applying the derogations provided for in paragraph 1, taking account of the animal health guarantees which may be obtained and shall provide for alternative appropriate measures. 3. Member States shall immediately inform the Commission of any derogations granted in accordance with paragraph 1. 4. The Commission shall review the situation with the Member State concerned and in the Committee as soon as possible. 5. Taking account of any derogation granted, as provided for in paragraph 1, measures to prevent the spread of avian influenza may be adopted in accordance with the procedure referred to in Article 64(3). Article 42 Measures to be applied in contact holdings 1. Based on the epidemiological inquiry, the competent authority shall decide if a holding is to be considered as a contact holding. The competent authority shall ensure that the measures provided for in Article 7(2) are applied to contact holdings until the presence of LPAI has been excluded in accordance with the diagnostic manual. 2. Based on the epidemiological inquiry, the competent authority may apply the measures provided for in Article 39 to contact holdings and in particular if the contact holding is located in an area with a high density of poultry. The main criteria to be considered for the application of the measures provided for in Article 39 in contact holdings are set out in Annex IV. 3. The competent authority shall ensure that samples are taken from the poultry when they are killed in order to confirm or exclude the presence of the LPAI virus in those contact holdings in accordance with the diagnostic manual. 4. The competent authority shall ensure that, on any holding where poultry or other captive birds are slaughtered or killed and disposed of, and LPAI is subsequently confirmed, the buildings and any pastures used for housing them, farm yards and any equipment likely to be contaminated and the vehicles used for transporting the poultry, other captive birds, carcases, meat, feed, manure, slurry, bedding and any other material or substance likely to be contaminated undergo one or more of the procedures provided for in Article 48. SECTION 3 Establishment of restricted zones Article 43 Establishment of restricted zones in cases of outbreaks of LPAI Immediately following an outbreak of LPAI, the competent authority shall establish a restricted zone with a radius of at least one kilometre around the holding. Article 44 Measures to be applied in the restricted zone 1. The competent authority shall ensure that the following measures are applied in the restricted zone: (a) a census of all commercial holdings is made as soon as possible; (b) laboratory tests are carried out on commercial poultry holdings within a radius of at least one kilometre around the holding in accordance with the diagnostic manual; (c) all movements of poultry, other captive birds, ready-to-lay poultry, day old chicks and eggs within or into the restricted zone are subject to authorisation and to other control measures deemed appropriate by the competent authority; this restriction shall not apply to the transit through the restricted zone on road or rail without unloading or stopping; (d) the movement of poultry, other captive birds, ready-to-lay poultry, day-old chicks and eggs from the restricted zone are prohibited unless the competent authority authorises the direct transport of: (i) poultry for slaughter to a slaughterhouse in the same Member State; (ii) live poultry to a holding or shed in the same Member State in which there is no other poultry. The live poultry shall remain there for 21 days and the holding shall be placed under official surveillance following their arrival; (iii) day-old chicks: to a holding or shed of such holding in the same Member State; the day old chicks shall remain there for 21 days and the holding shall be placed under official surveillance following their arrival; or if hatched from eggs originating from poultry holdings located outside of the restricted zone to any other holding provided that the hatchery can ensure by its logistics and biosecurity working conditions that any contact is excluded with hatching eggs or day-old chicks originating from poultry flocks within the restricted zone and which are therefore of a different health status; (iv) hatching eggs to a designated hatchery; the eggs and their packaging shall be disinfected before dispatch and the tracing back of these eggs must be ensured; (v) table eggs to a packing centre provided that they are packed in disposable packaging and that all biosecurity measures required by the competent authority are applied; (vi) eggs to an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004 located inside or outside the restricted zone; (vii) eggs for disposal; (e) carcases shall be disposed of; (f) any person entering or leaving holdings in the restricted zone observes appropriate biosecurity measures aimed at preventing the spread of avian influenza; (g) vehicles and equipment used for transporting live poultry or other captive birds, feed, manure, slurry and bedding and any other material or substances likely to be contaminated are cleansed and disinfected without delay after contamination, by one or more of the procedures set down in Article 48; (h) no poultry, other captive birds or mammals of domestic species may enter or leave a holding without authorisation of the competent authority. This restriction shall not apply to mammals which have access only to the living areas for humans in which they: (i) have no contact with resident poultry or other captive birds, and (ii) have no access to any cages or areas where such resident poultry or other captive birds are kept; (i) the removal or spreading of used litter, manure or slurry is prohibited, unless authorised by the competent authority; the movement of manure or slurry may be authorised from a holding situated in the restricted zone under biosecurity measures to a designated plant for treatment or for intermediate storage for subsequent treatment to destroy the possible presence of avian influenza viruses in accordance with Regulation (EC) No 1774/2002 or with specific rules which may be adopted in accordance with the procedure referred to in Article 64(2); (j) fairs, markets, shows or other gatherings of poultry or other captive birds are prohibited, unless authorised by the competent authority; (k) poultry or other captive birds for restocking of game are not released. 2. The competent authority may, based on a risk assessment, introduce further measures in addition to the measures provided for in this Section and shall inform the Commission thereof. 3. Further measures may be adopted to prevent the spread of avian influenza in accordance with the procedure referred to in Article 64(3). Article 45 Duration of measures The measures provided for in this Section shall be maintained: (a) at least 21 days following the date of completion of preliminary cleansing and disinfection of the infected holding by one or more of the procedures set down in Article 48, and until the competent authorities, based on the investigations and laboratory tests carried out in the restricted zone in accordance with the diagnostic manual and a risk assessment, consider that the risk of spread of LPAI is negligible; (b) at least 42 days following the date of confirmation of the outbreak and until the competent authorities, based on the investigations and laboratory tests carried out in the restricted zone in accordance with the diagnostic manual and a risk assessment, consider that the risk of spread of LPAI is negligible; or (c) for any other duration and under conditions to be established in accordance with the procedure referred to in Article 64(3). Article 46 Derogations 1. Where LPAI is confirmed in a hatchery, the competent authority may, based on a risk assessment, derogate from some or all of the measures provided for in Articles 43 and 44. 2. The competent authority may grant derogations from the measures provided for in this Section in cases of an outbreak of LPAI in a non-commercial holding, a circus, a zoo, a pet bird shop, a wild life park, a fenced area where poultry or other captive birds are kept for scientific purposes or purposes related to the conservation of endangered species or officially registered rare breeds of poultry or other captive birds, provided that such derogations do not endanger disease control. 3. Member States granting the derogation provided for in paragraphs 1 and 2 shall immediately inform the Commission thereof. 4. The Commission shall review the situation with the Member State concerned and in the Committee as soon as possible. 5. Taking account of any derogation granted, as provided for in paragraphs 1 and 2, measures to prevent the spread of avian influenza may be adopted in accordance with the procedure referred to in Article 64(3). CHAPTER VI MEASURES AIMED AT AVOIDING THE SPREAD OF INFLUENZA VIRUSES OF AVIAN ORIGIN TO OTHER SPECIES Article 47 Laboratory tests and other measures concerning pigs and other species 1. The competent authority shall ensure that following confirmation of avian influenza on any holding, appropriate laboratory tests, in accordance with the diagnostic manual, are carried out on any pigs present on the holding to confirm or exclude that those pigs are, or have been, infected with the avian influenza virus. No pigs shall be moved from the holding pending the results of those tests. 2. Where laboratory tests provided for in paragraph 1 confirm positive findings for avian influenza viruses in pigs, the competent authority may authorise the movement of those pigs to other pig holdings or to designated slaughterhouses, provided that subsequent appropriate tests have shown that the risk of spread of avian influenza is negligible. 3. The competent authority shall ensure that where laboratory tests provided for in paragraph 1 confirm a serious health threat, the pigs are killed as soon as possible under official supervision and in such a way as to prevent the spread of avian influenza virus, in particular during transport, and in accordance with Directive 93/119/EC. 4. The competent authority may, following confirmation of avian influenza on any holding, and based on a risk assessment, apply the measures provided for in paragraphs 1, 2 and 3 to any other mammals present on the holding and may extend those measures to contact holdings. 5. Member States shall inform the Commission within the framework of the Committee of the results of the tests and measures applied pursuant to paragraphs 1 to 4. 6. The competent authority may, following confirmation of avian influenza virus in pigs or any other mammals on any holding, undertake surveillance in accordance with the diagnostic manual to identify any further spread of avian influenza virus. 7. Additional measures to prevent the spread of influenza viruses of avian origin to other species, may be adopted in accordance with the procedure referred to in Article 64(3). CHAPTER VII CLEANSING, DISINFECTION AND RE-POPULATION Article 48 Cleansing, disinfection and procedures for eliminating avian influenza virus Member States shall ensure that: (a) the cleansing, disinfection and treatment of holdings and any materials or substances therein which are contaminated or likely to be contaminated with avian influenza viruses are carried out under official supervision in accordance with: (i) the instructions of the official veterinarian; and (ii) the principles and procedures for cleansing, disinfecting and treatment set out in Annex VI; (b) any land or pastures used by poultry or other captive birds on a holding where avian influenza has been confirmed are not used by poultry or other captive birds until the competent authority is satisfied that any avian influenza virus present has been eliminated or inactivated; (c) the cleansing, disinfection and treatment of slaughterhouses, vehicles, trailers or any other means of transport, border inspection posts and any materials or substances therein which are contaminated or likely to be contaminated with avian influenza viruses are carried out under official supervision in accordance with the instructions of the official veterinarian; (d) any equipment, materials or substances therein which are contaminated or likely to be contaminated with avian influenza viruses and which cannot be effectively cleansed and disinfected or treated are destroyed; (e) the disinfectants to be used and their concentrations are authorised by the competent authority. Article 49 Re-population of holdings 1. Member States shall ensure that paragraphs 2 to 6 of this Article are complied with, following the application of the measures provided for in Articles 11 and 39. 2. The re-population of commercial poultry holdings shall not take place for a period of 21 days following the date of completion of the final cleansing and disinfection as provided for in Article 48. 3. The following measures shall be performed during a period of 21 days following the date of the re-population of the commercial poultry holdings: (a) the poultry undergo at least one clinical examination carried out by the official veterinarian. That clinical examination, or if more than one is carried out, the final clinical examination, is undertaken as near as possible to the end of the 21 day period referred to above; (b) laboratory tests are carried out in accordance with the diagnostic manual; (c) poultry that die during the re-population phase are tested in accordance with the diagnostic manual; (d) any person entering or leaving the commercial poultry holding complies with appropriate biosecurity measures aimed at preventing the spread of avian influenza; (e) during the re-population phase no poultry leaves the commercial poultry holding without the authorisation of the competent authority; (f) the owner keeps a record on the production data, including morbidity and mortality data, which must be updated regularly; (g) any significant change in production data, as referred to in point (f), and other abnormalities are immediately reported to the competent authority. 4. Based on a risk assessment, the competent authority may order that the procedures provided for in paragraph 3 be applied to holdings other than commercial poultry holdings or other species on a commercial poultry holding. 5. The re-repopulation of poultry in contact holdings shall take place in accordance with the instructions of the competent authority based on a risk assessment. CHAPTER VIII DIAGNOSTIC PROCEDURES, DIAGNOSTIC MANUAL AND REFERENCE LABORATORIES Article 50 Diagnostic procedures and diagnostic manual 1. The Member States shall ensure that diagnostic procedures, sampling and laboratory testing to detect the presence of avian influenza in poultry or other captive birds or avian influenza virus in mammals are carried out in accordance with the diagnostic manual in order to ensure uniform procedures for its diagnosis. That manual shall be adopted in accordance with the procedure referred to in Article 64(2) by 3 August 2006. Any subsequent amendment to the manual shall be adopted in accordance with the same procedure. 2. The diagnostic manual provided for in paragraph 1 shall establish at least the following: (a) minimum biosecurity requirements and quality standards to be observed by approved laboratories carrying out tests for the diagnosis of avian influenza; (b) criteria and procedures to be followed when clinical or post-mortem examinations are carried out to confirm or exclude the presence of avian influenza; (c) criteria and procedures to be followed for the collection of samples from poultry or other captive birds for laboratory tests to confirm or exclude the presence of avian influenza; including sampling methods for serological or virological screenings carried out in accordance with this Directive; (d) laboratory tests to be used for the diagnosis of avian influenza, including: (i) tests for the differential diagnosis; (ii) tests to distinguish HPAI and LPAI viruses; (iii) suitable tests to distinguish between birds vaccinated and those infected with the field strain of avian influenza; (iv) criteria for the evaluation of the results of the laboratory tests; (e) laboratory techniques for the typing of avian influenza virus isolates. 3. Member States shall ensure that avian influenza viruses, their genome and antigens, and vaccines for research, diagnosis or manufacture of vaccine shall be manipulated or used only in places, establishments or laboratories approved by the competent authority where the appropriate biosecurity requirements are guaranteed. The list of approved places, establishments or laboratories shall be transmitted to the Commission by 30 September 2007 and kept up-to-date. Article 51 Reference laboratories 1. The laboratory named in Annex VII(1) shall be the Community reference laboratory for avian influenza (hereinafter referred to as ‘the Community reference laboratory’). Without prejudice to Decision 90/424/EEC, the Community reference laboratory shall carry out the functions and duties listed in Annex VII(2). 2. Member States shall designate national reference laboratories and communicate to the Commission and other Member States the details thereof and any subsequent changes. The Commission shall publish and update the list of such national reference laboratories. 3. Member States shall ensure that the national reference laboratories: (a) carry out the functions and duties set out in Annex VIII; (b) are responsible for co-ordinating standards and methods of diagnosis in each Member State in accordance with Annex VIII and liasing with the Community reference laboratory. 4. The Community reference laboratory shall maintain close cooperation and contact with the OIE and FAO reference laboratory for avian influenza and, as appropriate, with other internationally recognised laboratories within the Community in order to ensure training, excellence and support to national reference laboratories in Member States and Third Countries. CHAPTER IX VACCINATION SECTION 1 General prohibition of vaccination Article 52 Manufacture, sale and use of avian influenza vaccines 1. Member States shall ensure that: (a) vaccination against avian influenza is prohibited on their territory, except as provided for in Sections 2 and 3; (b) the handling, manufacture, storage, supply, distribution and sale of avian influenza vaccines on their territory are carried out under official supervision; (c) only vaccines authorised in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (17) or Regulation No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (18) are used. 2. Rules relating to the conditions of supply and storage of stocks of avian influenza vaccines in the Community may be adopted in accordance with the procedure referred to in Article 64(2). SECTION 2 Emergency vaccination Article 53 Emergency vaccination in poultry or other captive birds 1. A Member state may introduce emergency vaccination in poultry or other captive birds as a short term measure to contain an outbreak when a risk assessment indicates there is a significant and immediate threat of avian influenza spreading within or into the Member State concerned in accordance with this Section where there is one or more of the following: (a) an outbreak within that Member State; (b) an outbreak in a nearby Member State; or (c) where avian influenza has been confirmed in poultry or other captive birds in a nearby third country. 2. Where a Member State intends to introduce emergency vaccination, as provided for in paragraph 1, it shall submit an emergency vaccination plan to the Commission for its approval. That plan shall be in accordance with a DIVA strategy and contain at least the following information: (a) the disease situation which has led to the application for emergency vaccination; (b) the geographical area in which emergency vaccination is to be carried out and the number of holdings in that area and the number of holdings to be vaccinated if different; (c) the species and categories of poultry or other captive birds or, if appropriate, the poultry or other captive birds compartment to be vaccinated; (d) the approximate number of poultry or other captive birds to be vaccinated; (e) the summary of the vaccine characteristics; (f) the envisaged duration of the emergency vaccination campaign; (g) the specific provisions on the movements of vaccinated poultry or other captive birds which shall be without prejudice to the measures provided for in Sections 3, 4 and 5 of Chapter IV and Section 3 of Chapter V; (h) the criteria for deciding if emergency vaccination is to be applied in contact holdings; (i) the record keeping and registration of the vaccinated poultry or other captive birds; (j) clinical and laboratory tests to be carried out in the holdings where emergency vaccination is to be carried out and in other holdings located in the emergency vaccination area in order to monitor the epidemiological situation, the effectiveness of the emergency vaccination campaign and the control of movements of vaccinated poultry or other captive birds. 3. Detailed rules for emergency vaccination may be established in accordance with the procedure referred to in Article 64(2). Article 54 Approval of emergency vaccination plans 1. The Commission shall immediately examine the emergency vaccination plan, as provided for in Article 53(2), together with the Member State concerned and shall review the situation in the Committee as soon as possible. 2. The emergency vaccination plan shall be approved in accordance with the procedure referred to in Article 64(3). The approval of the emergency vaccination plan may include measures restricting the movements of poultry or other captive birds and their products. Those measures may include restrictions concerning specific poultry compartments and other captive birds compartments and the establishment of restricted zones. Article 55 Derogations 1. By way of derogation from Article 54, Member States may apply emergency vaccination before approval of the emergency vaccination plan, subject to the following conditions: (a) the Commission is notified of the emergency vaccination plan and the decision to apply emergency vaccination before the commencement of the emergency vaccination; (b) the Member State concerned prohibits the movement of poultry or other captive birds and their products except under the conditions provided for in Annex IX; (c) the decision to apply emergency vaccination does not endanger disease control. 2. When a Member State applies the derogation provided for in paragraph 1, the disease situation and the emergency vaccination plan shall be reviewed in the Committee as soon as possible. 3. The measures applied may be approved or changed in accordance with the procedure referred to in Article 64(3). SECTION 3 Preventive vaccination Article 56 Preventive vaccination in poultry or other captive birds 1. Member States may introduce preventive vaccination in poultry or other captive birds as a long term measure in accordance with this Section where they deem that on the basis of a risk assessment certain areas of their territory, type of poultry husbandry or certain categories of poultry or other captive birds or the poultry or other captive birds compartments are exposed to the risk of avian influenza. 2. Where a Member State intends to introduce preventive vaccination, as provided for in paragraph 1, it shall submit a preventive vaccination plan to the Commission for its approval. That plan shall be in accordance with a DIVA strategy and contain at least the following information: (a) a clear description of the reasons for the preventive vaccination, including the disease history; (b) the area, type of poultry husbandry or certain categories of poultry or other captive birds or the poultry or other captive birds compartments in which the preventive vaccination is to be carried out and the number of holdings in that area and the number and type of holdings to be vaccinated if different; (c) the species and categories of poultry or other captive birds or, if appropriate, the poultry or other captive birds compartment to be vaccinated; (d) the approximate number of poultry or other captive birds to be vaccinated; (e) a summary of the vaccine characteristics; (f) the envisaged duration of the preventive vaccination campaign; (g) the specific provisions on the movements of vaccinated poultry or other captive birds which shall be without prejudice to the measures provided for in Sections 3, 4 and 5 of Chapter IV and Section 3 of Chapter V; (h) the record keeping and registration of the vaccinated poultry or other captive birds; (i) the laboratory tests to be carried out in accordance with the Diagnostic Manual in the holdings where preventive vaccination is to be carried out at the same time as surveillance and testing in an appropriate number of other holdings located in the vaccination area or the poultry or other captive birds compartments in order to monitor the epidemiological situation, the effectiveness of the preventive vaccination campaign and the control of movements of vaccinated poultry or other captive birds. 3. Detailed rules for preventive vaccination may be established in accordance with the procedure referred to in Article 64(2). Article 57 Approval of preventive vaccination plan 1. The Commission shall immediately examine the preventive vaccination plan provided for in Article 56(2), together with the Member State concerned and shall review the situation in the Committee as soon as possible. 2. The preventive vaccination plan shall be approved in accordance with the procedure referred to in Article 64(3). The approval of the preventive vaccination plan may include measures restricting the movements of poultry or other captive birds and their products. Those measures may include restrictions concerning specific poultry compartments and other captive birds compartments and the establishment of restricted zones. SECTION 4 Vaccine banks Article 58 Community vaccine bank 1. A Community vaccine bank for the storage of Community reserves of avian influenza vaccines authorised in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 may be established in accordance with the procedure referred to in Article 64(2). 2. Member States shall have access to the Community vaccine bank on request to the Commission. 3. Where it is in the interest of the Community, the Commission may supply vaccines to third countries. Without prejudice to agreements concluded between the Community and third countries, the access of third countries to the Community vaccine bank shall be authorised in accordance with the procedure referred to in Article 64(3), subject to detailed arrangements between the Commission and the third country concerned on the financial and technical cooperation to be adopted in accordance with that procedure. Article 59 National vaccine banks 1. Member States may, within the framework of the contingency plan provided for in Article 62, establish or maintain a national vaccine bank for storage of reserves of avian influenza vaccines authorised in accordance with Article 5 to Article 15 of Directive 2001/82/EC, to be used for emergency or preventive vaccination. 2. Member States maintaining a national vaccine bank shall inform the Commission of the quantities and types of the stored vaccines. CHAPTER X COMMUNITY CONTROLS, PENALTIES AND CONTINGENCY PLANS Article 60 Community controls Commission experts may make on-the-spot checks in cooperation with the competent authority, in so far as it is necessary to ensure uniform application of this Directive in accordance with Commission Decision 98/139/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in the Member States (19) and Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (20). Article 61 Penalties Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those provisions by the date specified in the first subparagraph of Article 67(1) and shall notify it without delay of any subsequent amendment affecting them. Article 62 Contingency plan 1. Member States shall draw up a contingency plan in accordance with Annex X specifying the national measures to be implemented in the event of an outbreak and submit that plan to the Commission for approval. 2. The contingency plan shall allow access to facilities, equipment, personnel and all other appropriate materials necessary for the rapid and efficient eradication of the outbreak. It shall give an indication of the number and location of all commercial poultry holdings. The contingency plan should give an indication of the maximum number of poultry, by species, that could be present on these commercial holdings. Member States should also estimate the amount of vaccine that would be needed in the event of emergency vaccination. 3. Provisions shall be in place for close cooperation between the competent authorities responsible for the different sectors, particularly those in charge of animal health, public health, environmental matters and health and safety of workers, in particular to ensure proper risk communication to farmers, workers in the poultry sector and the public. 4. The Commission shall examine the contingency plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required, in particular to ensure that they are compatible with those of the other Member States. The contingency plans shall be approved in accordance with the procedure referred to in Article 64(2). Any subsequent amendments to that plan shall be adopted in accordance with the same procedure. 5. Member State shall update the contingency plan at least every five years and submit it to the Commission for approval in accordance with the procedure referred to in Article 64(2). 6. In addition to the measures provided for paragraphs 1 to 4, further rules to ensure a rapid and efficient eradication of avian influenza, including provisions on disease control centres, expert groups and real-time alert exercises, may be adopted in accordance with the procedure referred to in Article 64(2). CHAPTER XI IMPLEMENTING POWERS AND COMMITTEE PROCEDURE Article 63 Implementing powers 1. Detailed rules necessary for the implementation of this Directive shall be adopted in accordance with the procedure referred to in Article 64(2) and may include in particular specific rules concerning: (a) the disposal of carcases, and (b) the movement and treatment of feed, bedding, used litter, manure and slurry contaminated or suspected to be contaminated. 2. Any amendments to the annexes to take account of scientific and technical progress shall be decided in accordance with the procedure referred to in Article 64(2). 3. Detailed rules required by the epidemiological situation to supplement the minimum control measures provided for in this Directive shall be adopted in accordance with the procedure referred to in Article 64(3). 4. Without prejudice to the safeguard measures provided for in Article 9 of Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (21) or Article 10 of Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (22), temporary emergency measures required due to a serious health threat caused by influenza viruses of avian origin other than those referred to in point 1 of Article 2, shall be adopted in accordance with the procedure referred to in Article 64(3). Article 64 Committee procedure 1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (23). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 5(6) of that Decision shall be set at 15 days. 4. The Committee shall adopt its Rules of Procedure. CHAPTER XII TRANSITIONAL AND FINAL PROVISIONS Article 65 Repeal Directive 92/40/EEC shall be repealed as from 1 July 2007. References to Directive 92/40/EEC shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex XI. Article 66 Transitional provisions 1. Contingency plans for the control of avian influenza approved in accordance with Article 17(4) of Directive 92/40/EEC and in force at 1 July 2007 shall continue to apply for the purpose of this Directive. However, by 30 September 2007 Member States shall submit to the Commission amendments to those contingency plans, to bring them in line with this Directive. Those amended plans shall be approved in accordance with the procedure referred to in Article 64(2). 2. Pending the transposition of this Directive, further transitional provisions on the control of avian influenza may be adopted in accordance with the procedure referred to in Article 64(2). Article 67 Transposition 1. Member States shall bring into force by 1 July 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. When they are adopted by Member States, these measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 68 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 69 Addressees This Directive is addressed to the Member States.

32006L0002

2006

COMMISSION DIRECTIVE 2006/2/EC of 6 January 2006 amending, for the purposes of its adaptation to technical progress, Annexe II to Directive 96/73/EC of the European Parliament and of the Council on certain methods for quantitative analysis of binary textile fibre mixtures (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 96/73/EC of the European Parliament and of the Council of 16 December 1996 on certain methods for quantitative analysis of binary textile fibre mixtures (1), and in particular Article 5(2) thereof, Whereas: (1) Directive 96/74/EC of the European Parliament and the Council of 16 December 1996 on textile names (2) requires labelling to indicate the fibre composition of textile products, with checks being carried out by analysis on the conformity of these products with indications given on the label. (2) Uniform methods for quantitative analysis of binary textile fibre mixtures are provided in Directive 96/73/EC. (3) On the basis of recent findings by a technical working group, Directive 96/74/EC was adapted to technical progress, by adding the fibres polylactide and elastomultiester to the list of fibres set out in the Annexes I and II to that Directive. (4) It is therefore necessary to define uniform test methods for polylactide and elastomultiester. (5) Directive 96/73/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Committee for Directives relating to Textile Names and Labelling, Article 1 Annex II to Directive 96/73/EC is amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 6 January 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Members States.

32006L0003

2006

COMMISSION DIRECTIVE 2006/3/EC of 9 January 2006 amending, for the purposes of their adaptation to technical progress, Annexes I and II to Directive 96/74/EC of the European Parliament and of the Council on textile names (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 96/74/EC of the European Parliament and of the Council of 16 December 1996 on textile names (1), and in particular Article 16(1) thereof, Whereas: (1) Directive 96/74/EC lays down rules governing the labelling or marking of products as regards their textile fibre content, in order to ensure that consumer interests are thereby protected. Textile products may be placed on the market within the Community only if they comply with the provisions of that Directive. (2) In view of recent findings by a technical working group, it is necessary, for the purposes of adapting Directive 96/74/EC to technical progress, to add the fibre elastomultiester to the list of fibres set out in the Annexes I and II to that Directive. (3) Directive 96/74/EC should therefore be amended accordingly. (4) The measures provided for in this Directive are in accordance with the opinion of the Committee for Directives relating to Textile Names and Labelling, Article 1 Directive 96/74/EC is amended as follows: 1. in Annex I the following row 45 is added: ‘45 elastomultiester fibre formed by interaction of two or more chemically distinct linear macromolecules in two or more distinct phases (of which none exceeds 85 % by mass) which contains ester groups as dominant functional unit (at least 85 %) and which, after suitable treatment when stretched to one and half times its original length and released, recovers rapidly and substantially to its initial length’ 2. in Annex II the following entry 45 is added: ‘45 Elastomultiester 1,50’ Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 9 January 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0006

2006

COMMISSION DIRECTIVE 2006/6/EC of 17 January 2006 amending Council Directive 91/414/EEC to include tolylfluanid as active substance (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes tolylfluanid. (2) For tolylfluanid the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifiers. Moreover, those regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For tolylfluanid the rapporteur Member State was Finland and all relevant information was submitted on 13 June 2003. (3) The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 14 March 2005 in the format of the EFSA Scientific Report for tolylfluanid (4). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 23 September 2005 in the format of the Commission review report for tolylfluanid. (4) It has appeared from the various examinations made that plant protection products containing tolylfluanid may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include tolylfluanid in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (5) Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that tolylfluanid should be subjected to further testing for confirmation of the long term risk assessment for herbivorous mammals and that such studies should be presented by the notifier. (6) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (7) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing tolylfluanid to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (8) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 March 2007 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 April 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing tolylfluanid as an active substance by 31 March 2007. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to tolylfluanid are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive. 2. By derogation from paragraph 1, for each authorised plant protection product containing tolylfluanid as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning tolylfluanid. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing tolylfluanid as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2010 at the latest; or (b) in the case of a product containing tolylfluanid as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 October 2006. Article 5 This Directive is addressed to the Member States.

32006L0005

2006

COMMISSION DIRECTIVE 2006/5/EC of 17 January 2006 amending Council Directive 91/414/EEC to include warfarin as active substance (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1) and in particular Article 6(1) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes warfarin. (2) For warfarin the effects on human health and the environment has been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a range of uses proposed by the notifiers. By Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Commission Regulation (EEC) No 3600/92 (3), Ireland was designated as Rapporteur Member State. Ireland submitted the relevant assessment report and recommendations to the Commission on 8 May 1996 in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92. (3) The assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 23 September 2005 in the format of the Commission review report for warfarin. (4) The report on warfarin and further information were also submitted to the Scientific Committee for Plants. The Committee was asked to comment on the acceptability of using clinical data generated following repeated warfarin use as an anti-coagulant in human medicine for establishing an acceptable daily intake (ADI) and an acceptable operator exposure level (AOEL). In its opinion (4), the Scientific Committee concluded that it is not necessary to allocate an ADI for warfarin. Furthermore, data available from the extensive clinical use of warfarin as an anticoagulant may confidently be expected to support the establishment of an ADI, should this be considered necessary. An AOEL can likewise be established based on human data, taking into account that in rats about 15 % of the applied dose is absorbed through the skin. (5) It has appeared from the various examinations made, that plant protection products containing warfarin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include warfarin in Annex I, in order to ensure that in all Member States authorisation of plant protection products containing warfarin can be granted in accordance with the provisions of that Directive. (6) Warfarin is used as a rodenticide. All other active substances used as rodenticides are covered by Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (5). Furthermore, the substance is currently subject to evaluation in the framework of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (6). As with all substances included in Annex I to Directive 91/414/EEC, the status of warfarin could be reviewed under Article 5(5) of that Directive in the light of any new data becoming available, in particular from the assessment of similar substances or from the assessment of warfarin itself under Directive 98/8/EC. (7) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties, it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I. (8) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (9) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing warfarin to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (10) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 March 2007, at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 April 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing warfarin as an active substance by 31 March 2007. By that date, they shall in particular verify that the conditions in Annex I to that Directive, relating to warfarin, are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13. 2. By derogation from paragraph 1, for each authorised plant protection product containing warfarin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning warfarin. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing warfarin as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2010 at the latest; or (b) in the case of a product containing warfarin as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 October 2006. Article 5 This Directive is addressed to the Member States.

32005L0090

2006

DIRECTIVE 2005/90/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 January 2006 amending, for the 29th time, Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogenic, mutagenic or toxic to reproduction — c/m/r) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) The measures provided for in this Directive fall within the framework of the action plan adopted in Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003 to 2008) (3). According to that Decision the Community is committed to promoting and improving health, preventing disease, and countering potential threats to health, with a view to reducing avoidable morbidity and premature mortality and activity-impairing disability. (2) The substances which appear in Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (4) and are classified as carcinogens category 1 or 2 may cause cancer. The substances which appear in Annex I to Directive 67/548/EEC and are classified as mutagens category 1 or 2 may cause heritable genetic damage. The substances which appear in Annex I to Directive 67/548/EEC and are classified as toxic to reproduction category 1 or 2 may cause birth defects or may impair fertility. (3) In order to improve human health protection and consumer safety, the use of substances newly-classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2 should be regulated and the placing on the market of substances and preparations containing them should be subject to restriction for sale to the general public. (4) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (5) lays down restrictions on the marketing and use of certain dangerous substances and preparations, with the objective, among others, to improve human health protection and consumer safety. (5) Directive 94/60/EC of the European Parliament and of the Council (6) amending for the 14th time Directive 76/769/EEC, establishes, in the form of an Appendix to Annex I to Directive 76/769/EEC, a list containing substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2. Such substances and preparations containing them should be subject to restriction for sale to the general public. (6) Directive 94/60/EC provides that, no later than six months after publication in the Official Journal of the European Union of an adaptation to technical progress of Annex I to Directive 67/548/EEC, which contains substances classified as carcinogenic, mutagenic or toxic to reproduction in category 1 or 2, the Commission will submit to the European Parliament and Council a proposal for a directive regulating these newly-classified substances, so as to update the Appendix of Annex I to Directive 76/769/EEC. The proposal from the Commission will take account of the risks and advantages of the newly-classified substances, as well as of the Community legislative provisions on risk analysis. (7) Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the 29th time Council Directive 67/548/EEC, and more particularly Annex I thereto, includes 146 entries containing substances newly-classified as carcinogenic category 1, 21 entries containing substances newly-classified as carcinogenic category 2, 152 entries containing substances newly-classified as mutagenic category 2 and 24 entries containing substances newly-classified as toxic to reproduction category 2. (8) Directive 2004/73/EC also amends the notes relating to the identification, classification and labelling ascribed to four substances classified as carcinogenic category 1, thirty-six entries containing substances classified as carcinogenic category 2, six entries containing substances classified as mutagenic category 2, two entries containing substances classified as toxic to reproduction category 1 and three entries containing substances classified as toxic to reproduction category 2. The lists in the Appendix of Annex I to Directive 76/769/EEC should be amended accordingly. (9) The risks and advantages of the substances newly-classified by Directive 2004/73/EC as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2 have been taken into account, in particular those relating to the substances which were not yet subject to a restriction for use in substances and preparations placed on the market for sale to the general public (due to an earlier classification). This analysis concluded that these newly-classified substances could be inserted in the Appendix of Annex I to Directive 76/769/EEC. (10) This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (7), and individual directives based thereon, in particular Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (8), Article 1 The Appendix of Annex I to Directive 76/769/EEC shall be amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 24 February 2007. They shall forthwith communicate to the Commission the text of those measures and a correlation table between those measures and this Directive. They shall apply those measures from 24 August 2007. When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be determined by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0009

2006

COMMISSION DIRECTIVE 2006/9/EC of 23 January 2006 amending Council Directives 90/642/EEC as regards the maximum residue levels of diquat, fixed therein (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables (1), and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2), and in particular Article 4(1)(f) thereof, Whereas: (1) In accordance with Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations have to be based on the evaluation of effects on human and animal health and influence on the environment. Elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops. (2) Maximum residue levels (MRLs) reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in terms of estimated dietary intake. (3) MRLs for pesticides should be kept under review. They may be changed to take account of new uses, new information and data. (4) MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residues in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data. (5) Information on new or changed uses of diquat covered by Directive 90/642/EEC has been notified to the Commission. (6) The lifetime exposure of consumers to these pesticides via food products that may contain residues of these pesticides, has been assessed and evaluated in accordance with the procedures and practices used within the Community, taking account of guidelines published by the World Health Organisation (3). It has been calculated that the MRLs concerned will ensure that the acceptable daily intake is not exceeded. (7) An assessment of the available information has shown that no ARfD is required and that therefore a short term assessment is not needed. (8) Therefore it is appropriate to fix new maximum levels for residues of diquat. (9) The setting or modification at Community level of provisional MRLs does not prevent the Member States from establishing provisional MRLs for diquat in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of diquat. The provisional Community MRL should then become definitive. (10) Directive 90/642/EEC should therefore be amended accordingly. (11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 90/642/EEC is amended as follows. In group ‘4. OILSEEDS’, the entry ‘Hemp seed’ is inserted between the entries ‘Cotton seed’ and ‘Others’. Article 2 Part A of Annex II to Directive 90/642/EEC is amended in accordance with the Annex to this Directive. Article 3 1. Member States shall adopt and publish, by 26 July 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 27 July 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32006L0008

2006

COMMISSION DIRECTIVE 2006/8/EC of 23 January 2006 amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (1), and in particular the first paragraph of Article 20 thereof, Whereas: (1) Preparations composed of more than one substance being classified in Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (2) as carcinogenic, mutagenic and/or toxic for reproduction must currently be labelled with risk phrases (R-phrases) to indicate both category 1 or 2 and category 3 classification. However, providing both R-phrases sends a conflicting message. Preparations should therefore only be classified and labelled with the higher category. (2) For substances very toxic to the aquatic environment (classified as N) and assigned the R-phrases R50 or R50/53, specific concentration limits (SCLs) are currently applied to substances listed in Annex I to Directive 67/548/EEC in order to avoid an underestimation of the hazard. This measure creates distortions between preparations containing substances listed in Annex I to Directive 67/548/EEC, to which SCLs are applied, and those preparations containing substances not yet included in Annex I, but classified and labelled provisionally in accordance with Article 6 of Directive 67/548/EEC and to which no SCLs are applicable. It is therefore necessary to ensure that SCLs are applied in the same way to all preparations containing substances very toxic to the aquatic environment. (3) On 6 August 2001, the Commission adopted Directive 2001/59/EC (3) adapting to technical progress Directive 67/548/EEC. Directive 2001/59/EC revised the criteria in Annex VI to Directive 67/548/EEC for the classification and labelling of ozone depleting substances. The revised Annex III now only provides for the assignment of the symbol N in addition to R-phrase R59. (4) The terminology used to describe the packaging and the labelling requirements in Annex V to Directive 1999/45/EC has raised concerns due to the lack of consistency. It is therefore appropriate to modify the wording in Annex V to Directive 1999/45/EC to make it more accurate. (5) Annexes II, III and V to Directive 1999/45/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations established under Article 20 of Directive 1999/45/EC, Article 1 Annexes II, III and V to Directive 1999/45/EC are amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 March 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0004

2006

COMMISSION DIRECTIVE 2006/4/EC of 26 January 2006 amending the Annexes to Council Directives 86/362/EEC and 90/642/EEC as regards maximum residue levels for carbofuran (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (2), and in particular Article 7 thereof, Whereas: (1) In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected. (2) MRLs for pesticides are kept under review and changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data. (3) Several Member States informed the Commission of their desire to revise national MRLs in accordance with Article 8 of Directive 90/642/EEC in the light of concerns about consumer intake. Proposals for the review of Community MRLs were submitted to the Commission. (4) The lifetime and short-term exposure of consumers to the pesticides referred to in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation (3). On that basis, it is appropriate to fix new MRLs, which will ensure that there is no unacceptable consumer exposure. (5) Where relevant, the acute exposure of consumers to those pesticides via each of the food products that may contain residues has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the new MRLs will not cause acute toxic effects. (6) Through the World Trade Organisation, the Community’s trading partners have been consulted about the new MRLs and their comments on these levels have been taken into account. (7) The Annexes to Directives 86/362/EEC and 90/642/EEC should therefore be amended accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Part A of Annex II to Directive 86/362/EEC is amended in accordance with Annex I to this Directive. Article 2 Part A of Annex II to Directive 90/642/EEC is amended in accordance with Annex II to this Directive. Article 3 Member States shall adopt and publish, by 27 July 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 27 July 2006 at the latest. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32006L0010

2006

COMMISSION DIRECTIVE 2006/10/EC of 27 January 2006 amending Council Directive 91/414/EEC to include forchlorfenuron and indoxacarb as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC Spain received on 7 December 1998 an application from SKW Trostberg AG (on behalf of the Taskforce SKW Trosberg AG (Degussa AG) and Kyowa Hakko Kogyo Co.Ltd.) for the inclusion of the active substance forchlorfenuron in Annex I to Directive 91/414/EEC. Commission Decision 2000/181/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) The Netherlands received an application under Article 6(2) of Directive 91/414/EEC on 6 October 1997 from DuPont de Nemours for the inclusion of the active substance indoxacarb in Annex I to Directive 91/414/EEC. Commission Decision 1998/398/EC (3) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (3) For those active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 2 March 2001 (forchlorfenuron) and 7 February 2000 (indoxacarb). (4) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 23 September 2005 in the format of the Commission review reports for forchlorfenuron and indoxacarb. (5) The review of forchlorfenuron did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee. (6) For indoxacarb, two questions were submitted to the Scientific Committee on Plants (SCP). The SCP was asked to comment on the NOEL (No observed effect level) for effects on red blood cells in rats and on the adequate basis for the derivation of an Acute Reference Dose (ARfD) for indoxacarb. In its opinion (4) the SCP stated that the changes observed in some Red Blood Cells parameters were generally slight and not accompanied by significant reticulocytosis, giving the overall picture of a mild haemolytic effect. While a clear NOEL could not be established, the SCP concluded on a dose up to which the effects observed are not adverse. The SCP furthermore replied that the general and non-specific signs of toxicity observed in the acute neurotoxicity study in rats can be used as a basis for the derivation of the ARfD. (7) The recommendations of the SCP were taken into account during the further review by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health, in this Directive and in the Review Report. This evaluation established the relevant endpoints (ARfD and Acceptable daily intake = ADI) on the basis of the exposure levels identified by the SCP. (8) It has appeared from the various examinations made that plant protection products containing the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include forchlorfenuron and indoxacarb in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive. (9) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing forchlorfenuron or indoxacarb to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (10) The inclusion of forchlorfenuron in Annex I to Directive 91/414/EEC is based on a dossier covering the use of this active substance on kiwi fruits. Other uses are currently not adequately supported by data from the notifier and not all of the risks from such uses have shown to be adequately addressed under the criteria required by Annex VI to that Directive. If Member States are to grant authorisations for other uses, they should therefore require the data and information necessary to prove that the uses are compatible with the criteria in Directive 91/414/EEC, in particular concerning the effect on human consumers and the environment. (11) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish by 30 September 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 October 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing forchlorfenuron or indoxacarb as active substances by 30 September 2006. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to forchlorfenuron and indoxacarb, respectively, are met, with the exception of those identified in part B of the entry concerning those active substances, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13. 2. By way of derogation from paragraph 1, for each authorised plant protection product containing forchlorfenuron or indoxacarb as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 March 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning forchlorfenuron and indoxacarb, respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing forchlorfenuron or indoxacarb as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2007 at the latest; or (b) in the case of a product containing forchlorfenuron or indoxacarb as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2007 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 April 2006. Article 5 This Directive is addressed to the Member States.

32006L0013

2006

COMMISSION DIRECTIVE 2006/13/EC of 3 February 2006 amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed as regards dioxins and dioxin-like PCBs (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (1), and in particular Article 8(1) thereof, Whereas: (1) Directive 2002/32/EC provides that the putting into circulation and the use of products intended for animal feed that contain levels of undesirable substances exceeding the maximum levels laid down in Annex I thereto is prohibited. (2) The term ‘dioxins’ as referred to in this Directive covers a group of 75 polychlorinated dibenzo-p-dioxin congeners (PCDD) and 135 polychlorinated dibenzofuran (PCDF) congeners, of which 17 are of toxicological concern. Polychlorinated biphenyls (PCBs) are a group of 209 different congeners which can be divided into two groups according to their toxicological properties: 12 congeners exhibit similar toxicological properties to dioxins and are therefore often termed ‘dioxin-like PCBs’. The other PCBs do not exhibit dioxin-like toxicity but they have a different toxicological profile. (3) Each congener of dioxins or dioxin-like PCBs exhibits a different level of toxicity. In order to be able to sum up the toxicity of these different congeners, the concept of toxic equivalency factors (TEFs) has been introduced to facilitate risk assessment and regulatory control. This means that the analytical results relating to all 17 individual dioxin congeners and to the 12 dioxin-like PCB congeners are expressed in terms of a quantifiable unit, namely the ‘TCDD toxic equivalent concentration’ (TEQ). (4) On 30 May 2001 the Scientific Committee for Food (SCF) adopted an opinion on the Risk Assessment of Dioxins and Dioxin-like PCBs in Food, updating its opinion of 22 November 2000 on this subject on the basis of new scientific information that had become available since the latter’s adoption (2). The SCF fixed a tolerable weekly intake (TWI) of 14 pg WHO-TEQ/kg body weight for dioxins and dioxin-like PCBs. Exposure estimates indicate that a considerable proportion of the Community population have a dietary intake in excess of the TWI. Certain population groups in some countries could be at higher risk owing to particular dietary habits. (5) More than 90 % of human dioxin and dioxin-like PCB exposure derives from foodstuffs. Foodstuffs of animal origin normally contribute approximately 80 % of overall exposure. The dioxin and dioxin-like PCB burden in animals stems mainly from feedingstuffs. Therefore feedingstuffs, and in some cases soil, are of concern as potential sources of dioxins and dioxin-like PCBs. (6) The Scientific Committee for Animal Nutrition (SCAN) has been asked to advise on the sources of contamination of feedingstuffs with dioxins and PCBs, including dioxin-like PCBs, the exposure of food-producing animals to dioxins and PCBs, the carry-over of these compounds to food products of animal origin, and any impact on animal health of dioxins and PCBs present in feedingstuffs. The SCAN adopted an opinion on 6 November 2000. It identified fish meal and fish oil as the most heavily contaminated feed materials. Animal fat was identified as the next most seriously contaminated material. All other feed materials of animal and plant origin had relatively low levels of dioxin contamination. Roughages presented a wide range of dioxin contamination depending on location, degree of contamination with soil and exposure to sources of aerial pollution. The SCAN recommended, inter alia, that emphasis should be placed on reducing the impact of the most contaminated feed materials on overall diet contamination. (7) Although, from a toxicological point of view, the maximum level should apply to dioxins and dioxin-like PCBs, maximum levels were set for dioxins only and not for dioxin-like PCBs, given the very limited data available at that time on the prevalence of dioxin-like PCBs. However, in the meantime more data on the presence of dioxin-like PCBs have become available. (8) According to Directive 2002/32/EC, the Commission should review the provisions as regards dioxins by the end of 2004 for the first time, in the light of new data on the presence of dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs in the levels to be set. (9) All operators in the food and feed chain must continue to make all possible efforts to do all that is necessary to limit the presence of dioxins and PCBs present in feed and food. Directive 2002/32/EC accordingly provides that the maximum levels applicable should be further reviewed by 31 December 2006 at the latest with the aim of significantly reducing the maximum levels. Given the time necessary to obtain sufficient monitoring data to determine such significantly lower levels, that time-limit should be extended. (10) It is proposed to set maximum levels for the sum of dioxins and dioxin-like PCBs expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs as this is the most appropriate approach from a toxicological point of view. In order to ensure a smooth switchover, for a transitional period the existing levels for dioxins should continue to apply, in addition to the newly set levels for the sum of dioxins and dioxin-like PCBs. The separate maximum level for dioxins (PCDD/F) remains applicable for a temporary period. The products intended for animal feed mentioned in point 27a have to comply during that period with the maximum levels for dioxins and with the maximum levels for the sum of dioxins and dioxin-like PCBs. Consideration will be given by 31 December 2008 to dispensing with the separate maximum level for dioxins. (11) It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach throughout the Community. Commission Directive 2002/70/EC of 26 July 2002 establishing requirements for the determination of levels of dioxins and dioxin-like PCBs in feedingstuffs (3) provides that a product intended for animal feeding shall be considered as non-compliant with the established maximum level if the analytical result confirmed by duplicate analysis and calculated as the mean of at least two separate determinations exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty. There are different possibilities to estimate the expanded uncertainty (4). (12) The scope of Directive 2002/32/EC covers the possibility of establishing maximum levels of undesirable substances in feed additives. Since high levels of dioxins have been found in trace elements, a maximum level should be established for dioxins and the sum of dioxins and dioxin-like PCBs for all additives belonging to the functional group of compounds of trace elements and the maximum levels should be extended to all additives belonging to the functional group of binders and anti-caking agents and to premixtures. (13) In order to encourage a proactive approach to reducing the dioxins and dioxin-like PCBs present in food and feed, action levels were set by Commission Recommendation 2002/201/EC of 4 March 2002 on the reduction of the presence of dioxins, furans and PCBs in feedingstuffs and foodstuffs (5). Those action levels are a tool for competent authorities and operators to highlight those cases where it is appropriate to identify a source of contamination and to take measures to reduce or eliminate it. Since the sources of dioxins and dioxin-like PCBs are different, separate action levels should be determined for dioxins on the one hand and for dioxin-like PCBs on the other hand. (14) Directive 2002/32/EC provides for the possibility of setting action levels. The action levels should therefore be transferred from Recommendation 2002/201/EC to Annex II to Directive 2002/32/EC. (15) The reduction of human exposure to dioxins and dioxin-like PCBs through food consumption is important and necessary to ensure consumer protection. As food contamination is directly related to feed contamination, an integrated approach must be adopted to reduce dioxin and dioxin-like PCB incidence throughout the food chain, i.e. from products intended for animal feed through food-producing animals to humans. A proactive approach is followed to actively reduce the dioxins and dioxin-like PCBs in feed and food and consequently the maximum levels applicable should be reviewed within a defined period of time with the objective to set lower levels. Therefore consideration will be given by 31 December 2008 at the latest to significantly reducing the maximum levels for the sum of dioxins and dioxin-like PCBs. (16) Operators need to make efforts to step up their decontamination capacity to remove effectively dioxins and dioxin-like PCBs from fish oil. Further efforts have to done by the operators to investigate the different possibilities to remove dioxins and dioxin-like PCBs from fish meal and fish protein-hydrolysates. Once the decontamination technology is also available for fish meal and fish protein hydrolysates, operators will have to do efforts to provide for sufficient decontamination capacity. The significant lower maximum level for the sum of dioxins and dioxin-like PCBs, to which consideration shall be given by 31 December 2008, shall be for fish oil, fish meal and fish protein hydrolysates based on the technical possibilities of the most effective, economically viable, decontamination procedure. As regards fish feed, this significant lower level shall be determined based on the technical possibilities of the most effective, economically viable, decontamination procedure for fish oil and fish meal. (17) The extraction procedure used for the analysis of dioxins and dioxin-like PCBs has a large influence on the analytical result in particular on products intended for animal feed of mineral origin and it is therefore appropriate to determine before the date of application the extraction procedure to be used for the analysis of dioxins and dioxin-like PCBs. (18) Directive 2002/32/EC should therefore be amended accordingly. (19) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annexes I and II to Directive 2002/32/EC are amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 4 November 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0014

2006

COMMISSION DIRECTIVE 2006/14/EC of 6 February 2006 amending Annex IV to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular point (d) of the second paragraph of Article 14 thereof, Whereas: (1) The FAO International Standard for Phytosanitary Measures (ISPM) No 15 on ‘Guidelines for regulating wood packaging material in international trade’ was adopted in March 2002 by the Fourth Interim Commission on Phytosanitary Measures (ICPM). The relevant provisions of Directive 2000/29/EC were brought in line with those Guidelines by Commission Directive 2004/102/EC of 5 October 2004 amending Annexes II, III, IV and V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (2). (2) In addition to the measures approved under ISPM 15, Directive 2004/102/EC includes a requirement that imported wood packaging material be made from debarked round wood. ISPM No 15 made this an option subject to technical justification. The application of that requirement was postponed until 1 March 2006 by Council Directive 2005/15/EC of 28 February 2005 amending Annex IV to Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (3). (3) The Community has requested that ISPM No 15 be reviewed at international level to include a requirement addressing the Community’s concern about the presence of bark on such wood packaging material in international trade. (4) While the procedure for the review of ISPM No 15 is under way and pending the results of that review, the application of the Community requirement that wood packaging material imported from third countries be made from debarked round wood should be postponed temporarily. (5) Directive 2000/29/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 2000/29/EC is amended as follows: 1. In Annex IV, Part A, section I, point 2, the last paragraph at the end of the right hand column is replaced by the following: ‘The first indent, requiring wood packaging material to be made from debarked round wood, shall only apply from 1 January 2009. This paragraph shall be reviewed by 1 September 2007.’ 2. In Annex IV, Part A, section I, point 8, the last paragraph at the end of the right hand column is replaced by the following: ‘The first line of point (a), requiring wood packaging material to be made from debarked round wood, shall only apply from 1 January 2009. This paragraph shall be reviewed by 1 September 2007.’ Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2006 at the latest. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0016

2006

COMMISSION DIRECTIVE 2006/16/EC of 7 February 2006 amending Council Directive 91/414/EEC to include oxamyl as active substance (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes oxamyl. (2) For oxamyl, the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations designate the Rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For oxamyl the Rapporteur Member State was Ireland and all relevant information was submitted on 25 August 2003. (3) The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 14 January 2005 in the format of the EFSA Scientific Report for oxamyl (4). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 15 July 2005 in the format of the Commission review report for oxamyl. (4) It has appeared from the various examinations made that plant protection products containing oxamyl may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include oxamyl in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive. (5) Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that oxamyl should be subjected to further testing for confirmation of the risk assessment for some issues and that such studies should be presented by the notifier. (6) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I. (7) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (8) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing oxamyl to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (9) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish, by 31 January 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 February 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing oxamyl as an active substance by 31 January 2007. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to oxamyl are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive. 2. By derogation from paragraph 1, for each authorised plant protection product containing oxamyl as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 July 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning oxamyl. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing oxamyl as the only active substance, where necessary, amend or withdraw the authorisation by 30 July 2010 at the latest; or (b) in the case of a product containing oxamyl as one of several active substances, where necessary, amend or withdraw the authorisation by 30 July 2010 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 August 2006. Article 5 This Directive is addressed to the Member States.

32006L0019

2006

COMMISSION DIRECTIVE 2006/19/EC of 14 February 2006 amending Council Directive 91/414/EEC to include 1-methylcyclopropene as active substance (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 28 February 2002 an application from Rohm and Haas France S.A. for the inclusion of the active substance 1-methylcyclopropene in Annex I to Directive 91/414/EEC. Commission Decision 2003/35/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. (2) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member States submitted a draft assessment report concerning the substance to the European Food Safety Authority (EFSA) on 22 March 2003. (3) The assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 14 January 2005 in the format of the EFSA Scientific Report for 1-methylcyclopropene (3). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 23 September 2005 in the format of the Commission review report for 1-methylcyclopropene. (4) The review of 1-methylcyclopropene did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee. (5) It has appeared from the various examinations made that plant protection products containing the active substance concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include 1-methylcyclopropene in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive. (6) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing 1-methylcyclopropene to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (7) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall adopt and publish by 30 September 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 October 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing 1-methylcyclopropene as active substance by 30 September 2006. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to 1-methylcyclopropene are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.2. 2. By way of derogation from paragraph 1, for each authorised plant protection product containing 1-methylcyclopropene as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 March 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning 1-methylcyclopropene. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing 1-methylcyclopropene as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2007 at the latest; or (b) in the case of a product containing 1-methylcyclopropene as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2007 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 April 2006. Article 5 This Directive is addressed to the Member States.

32006L0007

2006

DIRECTIVE 2006/7/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 February 2006 concerning the management of bathing water quality and repealing Directive 76/160/EEC Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Having regard to the opinion of the Committee of the Regions (3), Acting in accordance with the procedure laid down in Article 251 of the Treaty (4), in the light of the joint text approved by the Conciliation Committee on 8 December 2005, Whereas: (1) Building on the Commission's Communication on sustainable development, the European Council has singled out objectives as general guidance for future development in priority areas such as natural resources and public health. (2) Water is a scarce natural resource, the quality of which should be protected, defended, managed and treated as such. Surface waters in particular are renewable resources with a limited capacity to recover from adverse impacts from human activities. (3) Community policy on the environment should aim at a high level of protection, and contribute to pursuing the objectives of preserving, protecting and improving the quality of the environment and of protecting human health. (4) In December 2000, the Commission adopted a Communication to the European Parliament and the Council on the development of a new bathing water policy and initiated a large‐scale consultation of all interested and involved parties. The main outcome of this consultation was general support for the development of a new Directive based on the latest scientific evidence and paying particular attention to wider public participation. (5) Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (5) contains a commitment to ensuring a high level of protection of bathing water, including by revising Council Directive 76/160/EEC of 8 December 1975 concerning the quality of bathing water (6). (6) Pursuant to the Treaty, in preparing policy on the environment the Community is, inter alia, to take account of available scientific and technical data. This Directive should use scientific evidence in implementing the most reliable indicator parameters for predicting microbiological health risk and to achieve a high level of protection. Further epidemiological studies should be undertaken urgently concerning the health risks associated with bathing, particularly in fresh water. (7) In order to increase efficiency and wise use of resources, this Directive needs to be closely coordinated with other Community legislation on water, such as Council Directives 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (7), 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (8) and Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (9). (8) Appropriate information on planned measures and progress on implementation should be disseminated to stakeholders. The public should receive appropriate and timely information on the results of the monitoring of bathing water quality and risk management measures in order to prevent health hazards, especially in the context of predictable short-term pollution or abnormal situations. New technology that allows the public to be informed in an efficient and comparable way on bathing waters across the Community should be applied. (9) For the purpose of monitoring, harmonised methods and practices of analysis need to be applied. Observation and quality assessment over an extended period are necessary in order to achieve a realistic bathing water classification. (10) Compliance should be a matter of appropriate management measures and quality assurance, not merely of measuring and calculation. A system of bathing water profiles is therefore appropriate to provide a better understanding of risks as a basis for management measures. In parallel, particular attention should be attached to adherence to quality standards and coherent transition from Directive 76/160/EEC. (11) On 17 February 2005 the Community ratified the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the Århus Convention). It is therefore appropriate for this Directive to include provisions on public access to information and to provide for public participation in its implementation to supplement Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (10) and Directive 2003/35/EC of the European Parliament and of the Council of 26 May 2003 providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment (11). (12) Since the objectives of this Directive, namely the attainment by the Member States, on the basis of common standards, of a good bathing water quality and a high level of protection throughout the Community, cannot be sufficiently achieved by the Member States and can be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (13) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12). (14) The continued importance of a Community bathing water policy is evident each bathing season as it protects the public from accidental and chronic pollution discharged in or near Community bathing areas. The overall quality of bathing waters has improved considerably since Directive 76/160/EEC came into force. However, that Directive reflects the state of knowledge and experience of the early 1970. Patterns of bathing water use have since changed, as has the state of scientific and technical knowledge. Therefore, that Directive should be repealed, CHAPTER I GENERAL PROVISIONS Article 1 Purpose and scope 1. This Directive lays down provisions for: (a) the monitoring and classification of bathing water quality; (b) the management of bathing water quality; and (c) the provision of information to the public on bathing water quality. 2. The purpose of this Directive is to preserve, protect and improve the quality of the environment and to protect human health by complementing Directive 2000/60/EC. 3. This Directive shall apply to any element of surface water where the competent authority expects a large number of people to bathe and has not imposed a permanent bathing prohibition, or issued permanent advice against bathing (hereinafter bathing water). It shall not apply to: (a) swimming pools and spa pools; (b) confined waters subject to treatment or used for therapeutic purposes; (c) artificially created confined waters separated from surface water and groundwater. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: 1. the terms ‘surface water’, ‘groundwater’, ‘inland water’, ‘transitional waters’, ‘coastal water’ and ‘river basin’ have the same meaning as in Directive 2000/60/EC; 2. ‘competent authority’ means the authority or authorities that a Member State has designated to ensure compliance with the requirements of this Directive or any other authority or body to which that role has been delegated; 3. ‘permanent’ means, in relation to a bathing prohibition or advice against bathing, lasting for at least one whole bathing season; 4. ‘large number’ means, in relation to bathers, a number that the competent authority considers to be large having regard, in particular, to past trends or to any infrastructure or facilities provided, or other measures taken, to promote bathing; 5. ‘pollution’ means the presence of microbiological contamination or other organisms or waste affecting bathing water quality and presenting a risk to bathers' health as referred to in Articles 8 and 9 and Annex I, column A; 6. ‘bathing season’ means the period during which large numbers of bathers can be expected. 7. ‘management measures’ means the following measures undertaken with respect to bathing water: (a) establishing and maintaining a bathing water profile; (b) establishing a monitoring calendar; (c) monitoring bathing water; (d) assessing bathing water quality; (e) classifying bathing water; (f) identifying and assessing causes of pollution that might affect bathing waters and impair bathers' health; (g) giving information to the public; (h) taking action to prevent bathers' exposure to pollution; (i) taking action to reduce the risk of pollution; 8. ‘short-term pollution’ means microbiological contamination as referred to in Annex I, column A, that has clearly identifiable causes, is not normally expected to affect bathing water quality for more than approximately 72 hours after the bathing water quality is first affected and for which the competent authority has established procedures to predict and deal with as set out in Annex II; 9. ‘abnormal situation’ means an event or combination of events impacting on bathing water quality at the location concerned and not expected to occur on average more than once every four years; 10. ‘set of bathing water quality data’ means data obtained in accordance with Article 3; 11. ‘bathing water quality assessment’ means the process of evaluating bathing water quality, using the assessment method defined in Annex II; 12. ‘cyanobacterial proliferation’ means an accumulation of cyanobacteria in the form of a bloom, mat or scum; 13. the term ‘public concerned’ has the same meaning as in Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment (13). CHAPTER II QUALITY AND MANAGEMENT OF BATHING WATER Article 3 Monitoring 1. Member States shall annually identify all bathing waters and define the length of the bathing season. They shall do so for the first time before the start of the first bathing season after 24 March 2008. 2. Member States shall ensure that monitoring of the parameters set out in Annex I, column A, takes place in accordance with Annex IV. 3. The monitoring point shall be the location within the bathing water where: (a) most bathers are expected; or (b) the greatest risk of pollution is expected, according to the bathing water profile. 4. A monitoring calendar for each bathing water shall be established before the start of each bathing season and for the first time before the start of the third full bathing season after the entry into force of this Directive. Monitoring shall take place no later than four days after the date specified in the monitoring calendar. 5. Member States may introduce monitoring of the parameters set out in Annex I, column A, during the first full bathing season following the entry into force of this Directive. In that case, monitoring shall take place with the frequency specified in Annex IV. The results of such monitoring may be used to build up the sets of bathing water quality data referred to in Article 4. As soon as Member States introduce monitoring under this Directive, monitoring of the parameters set out in the Annex to Directive 76/160/EEC may cease. 6. Samples taken during short-term pollution may be disregarded. They shall be replaced by samples taken in accordance with Annex IV. 7. During abnormal situations, the monitoring calendar referred to in paragraph 4 may be suspended. It shall be resumed as soon as possible after the end of the abnormal situation. New samples shall be taken as soon as possible after the end of the abnormal situation to replace samples that are missing due to the abnormal situation. 8. Member States shall report any suspension of the monitoring calendar to the Commission, giving the reasons for the suspension. They shall provide such reports on the occasion of the next annual report provided for in Article 13 at the latest. 9. Member States shall ensure that the analysis of bathing water quality takes place in accordance with the reference methods specified in Annex I and the rules set out in Annex V. However, Member States may permit the use of other methods or rules if they can demonstrate that the results obtained are equivalent to those obtained using the methods specified in Annex I and the rules set out in Annex V. Member States that permit the use of such equivalent methods or rules shall provide the Commission with all relevant information about the methods or rules used and their equivalence. Article 4 Bathing water quality assessment 1. Member States shall ensure that sets of bathing water quality data are compiled through the monitoring of the parameters set out in Annex I, column A. 2. Bathing water quality assessments shall be carried out: (a) in relation to each bathing water; (b) after the end of each bathing season; (c) on the basis of the set of bathing water quality data compiled in relation to that bathing season and the three preceding bathing seasons; and (d) in accordance with the procedure set out in Annex II. However, a Member State may decide to carry out bathing water quality assessments on the basis of the set of bathing water quality data compiled in relation to the preceding three bathing seasons only. If it so decides, it shall notify the Commission beforehand. It shall also notify the Commission if it subsequently decides to revert to carrying out assessments on the basis of four bathing seasons. Member States may not change the applicable assessment period more than once every five years. 3. Sets of bathing water data used to carry out bathing water quality assessments shall always comprise at least 16 samples or, in the special circumstances referred to in Annex IV, paragraph 2, 12 samples. 4. However, provided that either: — the requirement of paragraph 3 is satisfied, or — the set of bathing water data used to carry out the assessment comprises at least eight samples, in the case of bathing waters with a bathing season not exceeding eight weeks, a bathing water quality assessment may be carried out on the basis of a set of bathing water quality data relating to fewer than four bathing seasons if: (a) the bathing water is newly identified; (b) any changes have occurred that are likely to affect the classification of the bathing water in accordance with Article 5, in which case the assessment shall be carried out on the basis of a set of bathing water quality data consisting solely of the results for samples collected since the changes occurred; or (c) the bathing water had already been assessed in accordance with Directive 76/160/EEC, in which case equivalent data gathered under that Directive shall be used and, for this purpose, parameters 2 and 3 of the Annex to Directive 76/160/EEC shall be deemed to be equivalent to parameters 2 and 1 of column A of Annex I to this Directive. 5. Member States may subdivide or group together existing bathing waters in the light of bathing water quality assessments. They may group existing bathing waters together only if these waters: (a) are contiguous; (b) received similar assessments for the preceding four years in accordance with paragraphs 2, 3 and 4(c); and (c) have bathing water profiles all of which identify common risk factors or the absence thereof. Article 5 Classification and quality status of bathing waters 1. As a result of the bathing water quality assessment carried out in accordance with Article 4, Member States shall, in accordance with the criteria set out in Annex II, classify bathing water as: (a) ‘poor’; (b) ‘sufficient’; (c) ‘good’; or (d) ‘excellent’. 2. The first classification according to the requirements of this Directive shall be completed by the end of the 2015 bathing season. 3. Member States shall ensure that, by the end of the 2015 bathing season, all bathing waters are at least ‘sufficient’. They shall take such realistic and proportionate measures as they consider appropriate with a view to increasing the number of bathing waters classified as ‘excellent’ or ‘good’. 4. However, notwithstanding the general requirement of paragraph 3, bathing waters may temporarily be classified as ‘poor’ and still remain in compliance with this Directive. In such cases, Member States shall ensure that the following conditions are satisfied: (a) in respect of each bathing water classified as ‘poor’, the following measures shall be taken with effect from the bathing season that follows its classification: (i) adequate management measures, including a bathing prohibition or advice against bathing, with a view to preventing bathers' exposure to pollution; (ii) identification of the causes and reasons for the failure to achieve ‘sufficient’ quality status; (iii) adequate measures to prevent, reduce or eliminate the causes of pollution; and (iv) in accordance with Article 12, alerting the public by a clear and simple warning sign and informing them of the causes of the pollution and measures taken, on the basis of the bathing water profile. (b) If a bathing water is classified as ‘poor’ for five consecutive years, a permanent bathing prohibition or permanent advice against bathing shall be introduced. However, a Member State may introduce a permanent bathing prohibition or permanent advice against bathing before the end of the five‐year period if it considers that the achievement of ‘sufficient’ quality would be infeasible or disproportionately expensive. Article 6 Bathing water profiles 1. Member States shall ensure that bathing water profiles are established in accordance with Annex III. Each bathing water profile may cover a single bathing water or more than one contiguous bathing waters. Bathing water profiles shall be established for the first time by 24 March 2011. 2. Bathing water profiles shall be reviewed and updated as provided for in Annex III. 3. When establishing, reviewing and updating bathing water profiles, adequate use shall be made of data obtained from monitoring and assessments carried out pursuant to Directive 2000/60/EC that are relevant for this Directive. Article 7 Management measures in exceptional circumstances Member States shall ensure that timely and adequate management measures are taken when they are aware of unexpected situations that have, or could reasonably be expected to have, an adverse impact on bathing water quality and on bathers' health. Such measures shall include information to the public and, if necessary, a temporary bathing prohibition. Article 8 Cyanobacterial risks 1. When the bathing water profile indicates a potential for cyanobacterial proliferation, appropriate monitoring shall be carried out to enable timely identification of health risks. 2. When cyanobacterial proliferation occurs and a health risk has been identified or presumed, adequate management measures shall be taken immediately to prevent exposure, including information to the public. Article 9 Other parameters 1. When the bathing water profile indicates a tendency for proliferation of macro-algae and/or marine phytoplankton, investigations shall be undertaken to determine their acceptability and health risks and adequate management measures shall be taken, including information to the public. 2. Bathing waters shall be inspected visually for pollution such as tarry residues, glass, plastic, rubber or any other waste. When such pollution is found, adequate management measures shall be taken, including, if necessary, information to the public. Article 10 Cooperation on transboundary waters Wherever a river basin gives rise to transboundary impacts on bathing water quality, the Member States involved shall cooperate as appropriate in implementing this Directive, including through the appropriate exchange of information and joint action to control those impacts. CHAPTER III EXCHANGE OF INFORMATION Article 11 Public participation Member States shall encourage public participation in the implementation of this Directive and shall ensure the provision of opportunities for the public concerned: — to find out how to participate, and — to formulate suggestions, remarks or complaints. This shall relate, in particular, to the establishment, review and updating of lists of bathing waters in accordance with Article 3(1). Competent authorities shall take due account of any information obtained. Article 12 Information to the public 1. Member States shall ensure that the following information is actively disseminated and promptly made available during the bathing season in an easily accessible place in the near vicinity of each bathing water: (a) the current bathing water classification and any bathing prohibition or advice against bathing referred to in this Article by means of a clear and simple sign or symbol; (b) a general description of the bathing water, in non-technical language, based on the bathing water profile established in accordance with Annex III; (c) in the case of bathing waters subject to short-term pollution: — notification that the bathing water is subject to short-term pollution, — an indication of the number of days on which bathing was prohibited or advised against during the preceding bathing season because of such pollution, and — a warning whenever such pollution is predicted or present, (d) information on the nature and expected duration of abnormal situations during such events; (e) whenever bathing is prohibited or advised against, a notice advising the public and giving reasons; (f) whenever a permanent bathing prohibition or permanent advice against bathing is introduced, the fact that the area concerned is no longer a bathing water and the reasons for its declassification; and (g) an indication of sources of more complete information in accordance with paragraph 2. 2. Member States shall use appropriate media and technologies, including the Internet, to disseminate actively and promptly the information concerning bathing waters referred to in paragraph 1 and also the following information in several languages, when appropriate: (a) a list of bathing waters; (b) the classification of each bathing water over the last three years and its bathing water profile, including the results of monitoring carried out in accordance with this Directive since the last classification; (c) in the case of bathing waters classified as being ‘poor’, information on the causes of pollution and measures taken with a view to preventing bathers' exposure to pollution and to tackle its causes as referred to in Article 5(4); and (d) in the case of bathing waters subject to short-term pollution, general information on: — conditions likely to lead to short-term pollution, — the likelihood of such pollution and its likely duration, — the causes of the pollution and measures taken with a view to preventing bathers' exposure to pollution and to tackle its causes. The list referred to in point (a) shall be available each year before the start of the bathing season. The results of the monitoring referred to in point (b) shall be made available on the Internet upon completion of the analysis. 3. The information referred to in paragraphs 1 and 2 shall be disseminated as soon as it is available and with effect from the start of the fifth bathing season after 24 March 2008. 4. Member States and the Commission shall, wherever possible, provide information to the public using geo-referenced technology and present it in a clear and coherent manner, in particular through the use of signs and symbols. Article 13 Reports 1. Member States shall provide the Commission with the results of the monitoring and with the bathing water quality assessment for each bathing water, as well as with a description of significant management measures taken. Member States shall provide this information annually by 31 December in relation to the preceding bathing season. They shall begin providing it once the first bathing water quality assessment has been carried out in accordance with Article 4. 2. Member States shall notify the Commission annually before the start of the bathing season of all waters identified as bathing waters, including the reason for any change compared to the preceding year. They shall do so for the first time before the start of the first bathing season after 24 March 2008. 3. When monitoring of bathing water has started under this Directive, annual reporting to the Commission in accordance with paragraph 1 shall continue to take place pursuant to Directive 76/160/EEC until a first assessment can be made under this Directive. During that period, parameter 1 of the Annex to Directive 76/160/EEC shall not be taken into account in the annual report, and parameters 2 and 3 of the Annex to Directive 76/160/EEC shall be assumed to be equivalent to parameters 2 and 1 of column A of Annex I to this Directive. 4. The Commission shall publish an annual summary report on bathing water quality in the Community, including bathing water classifications, conformity with this Directive and significant management measures undertaken. The Commission shall publish this report by 30 April every year, including via the Internet. When establishing the report the Commission shall, wherever possible, make best use of data collection, assessment and presentation systems under related Community legislation, in particular Directive 2000/60/EC. CHAPTER IV FINAL PROVISIONS Article 14 Report and review 1. The Commission shall, by 2008, submit a report to the European Parliament and to the Council. The report shall have particular regard to: (a) the results of an appropriate European epidemiological study conducted by the Commission in collaboration with Member States; (b) other scientific, analytical and epidemiological developments relevant to the parameters for bathing water quality, including in relation to viruses; and (c) World Health Organisation recommendations. 2. Member States shall, by the end of 2014, submit written observations to the Commission on that report including on the need for any further research or assessments which may be required to assist the Commission in its review of this Directive under paragraph 3. 3. In the light of the report, the Member States' written observations and an extended impact assessment and bearing in mind experience gained from implementing this Directive, the Commission shall, no later than 2020, review this Directive with particular regard to the parameters for bathing water quality, including whether it would be appropriate to phase out the ‘sufficient’ classification or modify the applicable standards, and shall present if necessary appropriate legislative proposals in accordance with Article 251 of the Treaty. Article 15 Technical adaptations and implementing measures 1. It shall be decided in accordance with the procedure referred to in Article 16(2): (a) to specify the EN/ISO standard on the equivalence of microbiological methods for the purposes of Article 3(9); (b) to lay down detailed rules for the implementation of Articles 8(1), 12(1)(a) and 12(4); (c) to adapt the methods of analysis for the parameters set out in Annex I in the light of scientific and technical progress; (d) to adapt Annex V in the light of scientific and technical progress; (e) to lay down guidelines for a common method for the assessment of single samples. 2. The Commission shall present a draft of the measures to be taken in accordance with paragraph 1(b) with respect to Article 12(1)(a) by 24 March 2010. Before doing so, it shall consult representatives of Member States, regional and local authorities, relevant tourist and consumer organisations and other interested parties. After the adoption of relevant rules, it shall publicise them via the Internet. Article 16 Committee procedure 1. The Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 17 Repeal 1. Directive 76/160/EEC is hereby repealed with effect from 31 December 2014. Subject to paragraph 2, this repeal shall be without prejudice to Member States' obligations concerning the time limits for transposition and application set out in the repealed Directive. 2. As soon as a Member State has taken all necessary legal, administrative and practical measures to comply with this Directive, this Directive will be applicable, replacing Directive 76/160/EEC. 3. References to the repealed Directive 76/160/EEC shall be construed as being made to this Directive. Article 18 Implementation 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 24 March 2008. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the texts of the main provisions of national law that they adopt in the field covered by this Directive. Article 19 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 20 Addressees This Directive is addressed to Member States.

32006L0020

2006

COMMISSION DIRECTIVE 2006/20/EC of 17 February 2006 amending, for the purposes of its adaptation to technical progress, Council Directive 70/221/EEC concerning fuel tanks and rear underrun protection of motor vehicles and their trailers (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), and in particular the second indent of Article 13(2) thereof, Having regard to Council Directive 70/221/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection of motor vehicles and their trailers (2), and in particular Article 3 thereof, Whereas: (1) Directive 70/221/EEC is one of the separate Directives in the context of the Community type-approval procedure laid down in Directive 70/156/EEC. The provisions of Directive 70/156/EEC relating to systems, components and separate technical units for vehicles therefore apply to Directive 70/221/EEC. (2) In order to increase the level of protection, rear underrun protection devices should be required to withstand increased force levels, and account should be taken of vehicles using air suspension units. (3) In view of technical progress, and the advances made in vehicle use with regard to the installation of vehicle platform lifts, it is appropriate that account be taken of platform lifts in the context of the installation of rear underrun protection devices. (4) Directive 70/221/EEC should therefore be amended accordingly. (5) The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress set up under Article 13(1) of Directive 70/156/EEC, Article 1 Annex II to Directive 70/221/EEC is amended in accordance with the Annex to this Directive. Article 2 1. With effect from 11 September 2007, if the requirements laid down in Directive 70/221/EEC, as amended by this Directive, are not complied with, a Member State, on grounds related to rear underrun protection: (a) shall refuse to grant EC type-approval or national type-approval of a type of vehicle; (b) shall refuse to grant EC type-approval or national type-approval of a rear underrun protection device, as a separate technical unit, 2. With effect from 11 March 2010, if the requirements laid down in Directive 70/221/EEC, as amended by this Directive, are not complied with, a Member State, on grounds related to rear underrun protection: (a) shall refuse the registration or prohibit the sale or entry into service of new vehicles; (b) shall prohibit the sale or entry into service of a rear underrun protection device, as a separate technical unit. Article 3 1. Member States shall adopt and publish, before 11 March 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 11 March 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32006L0026

2006

COMMISSION DIRECTIVE 2006/26/EC of 2 March 2006 amending, for the purposes of their adaptation to technical progress, Council Directives 74/151/EEC, 77/311/EEC, 78/933/EEC and 89/173/EEC relating to wheeled agricultural or forestry tractors (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC (1), and in particular Article 19(1) thereof, Having regard to Council Directive 74/151/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to certain parts and characteristics of wheeled agricultural or forestry tractors (2), and in particular Article 4 thereof, Having regard to Council Directive 77/311/EEC of 29 March 1977 on the approximation of the laws of the Member States relating to the driver-perceived noise level of wheeled agricultural or forestry tractors (3), and in particular Article 5 thereof, Having regard to Council Directive 78/933/EEC of 17 October 1978 on the approximation of the laws of the Member States relating to the installation of lighting and lighting-signalling devices on wheeled agricultural or forestry tractors (4), and in particular Article 5 thereof, Having regard to Council Directive 89/173/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to certain components and characteristics of wheeled agricultural or forestry tractors (5), and in particular Article 9 thereof, Whereas: (1) The requirements introduced by Directive 74/151/EEC for the maximum permissible laden mass and axle load for wheeled agricultural or forestry tractors need to be adapted for modern tractors, taking into account the enhancements in tractor technology with regard to the increase of productivity as well as occupational safety. (2) In order to facilitate the global operation of Community industry, it is necessary to align Community technical regulations and standards with the corresponding global technical regulations and standards. In relation to the maximum limits laid down in Directive 77/311/EEC for the driver-perceived noise level of wheeled agricultural or forestry tractors, the test speed established in Annexes I and II to that Directive should therefore be harmonised with the test speed required in global technical regulations or standards such as OECD Code 5 and ISO 5131:1996 (6). (3) It is appropriate to adapt the requirements introduced by Directive 78/933/EEC relating to the installation of lighting and light-signalling devices on wheeled agricultural and forestry tractors, so as to meet present needs for simpler design and better illumination. (4) The requirements laid down in Directive 89/173/EEC relating to glazing and coupling of wheeled agricultural or forestry tractors should be brought into line with recent technological developments. In particular, polycarbonate/plastic glazing should be permitted for non-windscreen applications to enhance the protection of the occupants in the event of objects penetrating the driver cab area. The requirements concerning mechanical couplings should be aligned with the standard ISO 6489-1. Furthermore, with a view to reducing the number and severity of accidents and to enhancing occupational safety, it is appropriate not only to make additional provision as regards hot surfaces, but also to lay down measures concerning battery terminal covers, as well as measures designed to prevent unintentional uncoupling. (5) Directives 74/151/EEC, 77/311/EEC, 78/933/EEC and 89/173/EEC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 20(1) of Directive 2003/37/EC, Article 1 Amendment to Directive 74/151/EEC Directive 74/151/EEC is amended in accordance with Annex I to this Directive. Article 2 Amendment to Directive 77/311/EEC Directive 77/311/EEC is amended in accordance with Annex II to this Directive. Article 3 Amendment to Directive 78/933/EEC Directive 78/933/EEC is amended in accordance with Annex III to this Directive. Article 4 Amendment to Directive 89/173/EEC Directive 89/173/EEC is amended in accordance with Annex IV to this Directive. Article 5 Transitional provisions 1. With effect from 1 January 2007, with respect to vehicles which comply with the requirements laid down respectively in Directives 74/151/EEC, 78/933/EEC, 77/311/EEC and 89/173/EEC as amended by this Directive, Member States shall not, on grounds relating to the subject-matter of the Directive concerned: (a) refuse to grant EC type-approval or to grant national type-approval; (b) prohibit the registration, sale or entry into service of such a vehicle. 2. With effect from 1 July 2007, with respect to vehicles which do not comply with the requirements laid down respectively in Directives 74/151/EEC, 78/933/EEC, 77/311/EEC and 89/173/EEC as amended by this Directive, and on grounds relating to the subject-matter of the Directive concerned, Member States: (a) shall no longer grant EC type-approval; (b) may refuse to grant national type-approval. 3. With effect from 1 July 2009, with respect to vehicles which do not comply with the requirements laid down respectively in Directives 74/151/EEC, 78/933/EEC, 77/311/EEC and 89/173/EEC as amended by this Directive, and on grounds relating to the subject-matter of the Directive concerned, Member States: (a) shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 2003/37/EC to be no longer valid for the purposes of Article 7(1); (b) may refuse the registration, sale or entry into service of those new vehicles. Article 6 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 7 Entry into force This Directive shall enter into force on 20th day following its publication in the Official Journal of the European Union. Article 8 Addressees This Directive is addressed to the Member States.

32006L0027

2006

COMMISSION DIRECTIVE 2006/27/EC of 3 March 2006 amending for the purposes of adapting to technical progress Council Directives 93/14/EEC on the braking of two- or three-wheel motor vehicles and 93/34/EEC on statutory markings for two- or three-wheel motor vehicles, Directives of the European Parliament and of the Council 95/1/EC on the maximum design speed, maximum torque and maximum net engine power of two- or three-wheel motor vehicles and 97/24/EC on certain components and characteristics of two- or three-wheel motor vehicles (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two- and three-wheel motor vehicles and repealing Council Directive 92/61/EEC (1), and in particular Article 17 thereof, Having regard to Council Directive 93/14/EEC of 5 April 1993 on the braking of two- or three-wheel motor vehicles (2), and in particular Article 4 thereof, Having regard to Council Directive 93/34/EEC of 14 June 1993 on statutory markings for two- or three-wheel motor vehicles (3), and in particular Article 3 thereof, Having regard to Directive 95/1/EC of the European Parliament and of the Council of 2 February 1995 on the maximum design speed, maximum torque and maximum net engine power of two- or three-wheel motor vehicles (4), and in particular Article 4 thereof, Having regard to Directive 97/24/EC of the European Parliament and of the Council of 17 June 1997 on certain components and characteristics of two- or three-wheel motor vehicles (5), and in particular Article 7 thereof, Whereas: (1) Directives 93/14/EEC, 93/34/EEC, 95/1/EC and 97/24/EC are separate Directives for the purposes of the EC type-approval procedure laid down by Directive 2002/24/EC. (2) It is necessary to introduce the last amendment to United Nations ECE Regulation No 78 into the European type approval requirements in order to maintain equivalence between the requirements laid down in Directive 93/14/EEC and those laid down in United Nations ECE Regulation No 78. (3) The requirements on statutory markings and maximum speed for two- and three-wheel motor vehicles as laid down in Directives 93/34/EEC and 95/1/EC can be simplified for reasons of better regulation. (4) In order to ensure the proper functioning of the type-approval system as a whole, it is necessary to clarify which provisions concerning external projections, safety belt anchorages and safety belts shall apply to bodied vehicles and to unbodied vehicles. (5) In Directive 97/24/EC, the requirements for marking of original catalytic converters and original silencers need to be clarified and completed. (6) Directives 93/14/EEC, 93/34/EEC, 95/1/EC and 97/24/EC should therefore be amended accordingly. (7) The measures provided for this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress, Article 1 The Annex to Directive 93/14/EEC is amended in accordance with the text set out in Annex I to this Directive. Article 2 The Annex to Directive 93/34/EEC is amended in accordance with the text set out in Annex II to this Directive. Article 3 Annex I to Directive 95/1/EC is amended in accordance with the text set out in Annex III to this Directive. Article 4 Annex III to Chapter 1, Annexes I and II to Chapter 3, Annex I to Chapter 4, Annexes I, II, VI, and VII to Chapter 5, the Annex to Chapter 7, Annexes II, III and IV to Chapter 9, the title and Annex I to Chapter 11, and Annexes I and II to Chapter 12 of Directive 97/24/EC are amended in accordance with the text set out in Annex IV to this Directive. Article 5 1. With effect from 1 January 2007, with respect to two- or three- wheel vehicles which comply with the provisions laid down in Directives 93/14/EEC, 93/34/EC, 95/1/EC, and 97/24/EC respectively, as amended by this Directive, Member States shall not, on grounds relating to the subject matter of the Directive concerned, refuse to grant EC type-approval or prohibit the registration, sale or entry into service of such a vehicle. 2. With effect from 1 July 2007, Member States shall refuse, on grounds relating to the subject matter of the Directive concerned, to grant EC type-approval to any new type of two- or three-wheel motor vehicle which does not comply with the provisions laid down in Directives 93/14/EEC, 93/34/EC, 95/1/EC and 97/24/EC respectively, as amended by this Directive. Article 6 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 7 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 8 This Directive is addressed to the Member States.

32006L0028

2006

COMMISSION DIRECTIVE 2006/28/EC of 6 March 2006 amending, for the purposes of their adaptation to technical progress, Council Directive 72/245/EEC of 20 June 1972 relating to the radio interference (electromagnetic compatibility) of vehicles and Council Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), and in particular Article 13(2) thereof, Having regard to Council Directive 72/245/EEC of 20 June 1972 relating to the radio interference (electromagnetic compatibility) of vehicles (2), and in particular Article 4 thereof, Whereas: (1) Directive 72/245/EEC is one of the separate directives under the type-approval procedure established by Directive 70/156/EEC. (2) In order to improve safety of vehicles by encouraging development and deployment of technologies utilising automotive short-range radar equipment, the Commission has harmonised the use of two radio spectrum frequency bands by Commission Decision 2004/545/EC of 8 July 2004 on the harmonisation of radio spectrum in the 79 GHz range for the use of automotive short-range radar equipment in the Community (3) and by Commission Decision 2005/50/EC of 17 January 2005 on the harmonisation of the 24 GHz range radio spectrum band for the time-limited use by automotive short-range radar equipment in the Community (4). (3) In accordance with Decision 2005/50/EC, the use of 24 GHz automotive short-range radar equipment is time-limited and Member States have to set up a monitoring system aiming to quantify the number of vehicles equipped with 24 GHz short-range radar equipment registered in their territory. (4) Directive 72/245/EEC, as amended by Commission Directive 2005/49/EC (5), provided Member States with the appropriate means to carry out this monitoring. Directive 70/156/EEC was amended accordingly by that Directive. (5) Since then it has become obvious that the way to provide these data can be simplified for 24 GHz short-range radar equipment and that it is unnecessary for monitoring purposes to require information about the use of 79 GHz short-radar equipment in the Certificate of Conformity (CoC) in addition to the information about the 24 GHz short range radar equipment, since the 79 GHz band does not interfere with other applications and its use is not restricted. It is therefore appropriate to modify requirements related to the use of 24 GHz short-range radar equipment and delete requirements related to the use of 79 GHz short-range radar equipment in Directive 72/245/EEC. This Directive does not affect the validity of existing approvals for vehicles not fitted with 24 GHz short range radars. (6) Only Technical Services issue attestations according to the model given in Annex III C of Directive 72/245/EEC. No further authority or administration is involved in this process. Therefore, the additional stamping of the attestation presently required is dispensable and shall be removed. (7) Directive 72/245/EEC should therefore be amended accordingly. (8) The amendments to Directive 72/245/EEC have an impact on Directive 70/156/EEC. It is therefore necessary to amend Directive 70/156/EEC accordingly. (9) The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 13 of Directive 70/156/EEC, Article 1 Amendment to Directive 72/245/EEC Directive 72/245/EEC is amended as follows: 1. In Annex I, point 2.1.14 is deleted. 2. Annex II A is amended as follows: (a) Point 12.7.1 is replaced by the following: ‘12.7.1. vehicle equipped with 24 GHz short-range radar equipment: Yes/No/Optional (strike out which is not applicable)’; (b) Point 12.7.2 is deleted. 3. The appendix to Annex III A is amended as follows: (a) Point 1.3.1 is replaced by the following: ‘1.3.1. vehicle equipped with 24 GHz short-range radar equipment: Yes/No/Optional (strike out which is not applicable)’; (b) Point 1.3.2 is deleted. 4. In Annex III C, the words ‘Stamp of administration’ including the surrounding box are deleted. Article 2 Amendment to Directive 70/156/EEC Directive 70/156/EEC is amended as follows: 1. Annex I is amended as follows: (a) Point 12.7.1 is replaced by the following: ‘12.7.1. vehicle equipped with 24 GHz short-range radar equipment: Yes/No/Optional (strike out which is not applicable)’; (b) Point 12.7.2 is deleted. 2. Annex III, Part I, Section A is amended as follows: (a) Point 12.7.1 is replaced by the following: ‘12.7.1. vehicle equipped with 24 GHz short-range radar equipment: Yes/No/Optional (strike out which is not applicable)’; (b) Point 12.7.2 is deleted. 3. Annex IX, on side two of all models of the Certificate of Conformity (COC), is amended as follows: (a) Point 50 is replaced by the following and a footnote is added as follows: ‘50. Remarks (6): (b) Points 50.1, 50.2 and 50.3 are deleted. Article 3 Transposition 1. Member States shall adopt and publish, by 30 June 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 July 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field governed by this Directive. Article 4 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 Addressees This Directive is addressed to the Member States.

32006L0030

2006

COMMISSION DIRECTIVE 2006/30/EC of 13 March 2006 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for the benomyl group (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 10 thereof, Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2), and in particular Article 10 thereof, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (3), and in particular Article 7 thereof, Whereas: (1) In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels reflect the consumption by animals of cereals and products of plant origin treated with pesticides, and where relevant, the direct consequences of the use of veterinary medicines. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected. (2) MRLs for pesticides are kept under review and changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data. (3) Several Member States informed the Commission of their desire to revise national MRLs in accordance with Article 8 of Directive 90/642/EEC, in the light of concerns about consumer intake. Proposals for the review of Community MRLs were submitted to the Commission. (4) The lifetime and short-term exposure of consumers to the pesticides referred to in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation (4). On that basis, it is appropriate to fix new MRLs, which will ensure that there is no unacceptable consumer exposure. (5) The acute exposure of consumers to those pesticides via each of the food products that may contain residues has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the new MRLs will not cause acute toxic effects. (6) Through the World Trade Organisation, the Community’s trading partners have been consulted about the new MRLs and their comments on these levels have been taken into account. (7) The Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 In Annex I to Directive 90/642/EEC in category ‘2. Vegetables, fresh or uncooked, frozen or dry, (iii) Fruiting vegetables, (a) Solanacea’, the entry ‘okra’ is added between the entries ‘aubergine’ and ‘others’. Article 2 Part A of Annex II to Directive 86/362/EEC is amended in accordance with Annex I to this Directive. Article 3 Part B of Annex II to Directive 86/363/EEC is amended in accordance with Annex II to this Directive. Article 4 Part A of Annex II to Directive 90/642/EEC is amended in accordance with Annex III to this Directive. Article 5 1. Member States shall adopt and publish, by 14 September 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 15 September 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 6 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 7 This Directive is addressed to the Member States.

32006L0021

2006

DIRECTIVE 2006/21/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2006 on the management of waste from extractive industries and amending Directive 2004/35/EC Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 8 December 2005, Whereas: (1) The Communication of the Commission entitled ‘Safe operation of mining activities: a follow-up to recent mining accidents’ sets out as one of its priority actions an initiative to regulate the management of waste from the extractive industries. This action is designed to complement initiatives pursuant to Directive 2003/105/EC of the European Parliament and of the Council of 16 December 2003 amending Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances (4) as well as the production of a best available technique document covering the management of waste rock and tailings from mining activities under the auspices of Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (5). (2) In its Resolution (6) of 5 July 2001 concerning that Communication, the European Parliament strongly supported the need for a Directive on waste from the extractive industries. (3) Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (7) sets as the objective for wastes that are still generated that the level of their hazardousness should be reduced and that they should present as little risk as possible, that preference should be given to recovery and especially to recycling, that the quantity of waste for disposal should be minimised and should be safely disposed of, and that waste intended for disposal should be treated as closely as possible to the place of its generation to the extent that this does not lead to a decrease in the efficiency of waste treatment operations. Decision No 1600/2002/EC also prescribes as a priority action, with reference to accidents and disasters, the development of measures to help prevent major accident hazards, with special regard to those arising from mining, and the development of measures on mining waste. Decision No 1600/2002/EC also sets as a priority action the promotion of sustainable management of extractive industries with a view to reducing their environmental impact. (4) In accordance with the objectives of Community policy on the environment, it is necessary to lay down minimum requirements in order to prevent or reduce as far as possible any adverse effects on the environment or on human health which are brought about as a result of the management of waste from the extractive industries, such as tailings (i.e. the waste solids or slurries that remain after the treatment of minerals by a number of techniques), waste rock and overburden (i.e. the material that extractive operations move during the process of accessing an ore or mineral body, including during the pre-production development stage), and topsoil (i.e. the upper layer of the ground) provided that they constitute waste as defined in Council Directive 75/442/EEC of 15 July 1975 on waste (8). (5) In accordance with paragraph 24 of the Johannesburg Plan of Implementation on Sustainable Development adopted within the framework of the United Nations at the 2002 World Summit on Sustainable Development, it is necessary to protect the natural resource base of economic and social development and reverse the current trend in natural resource degradation by managing the natural resource base in a sustainable and integrated manner. (6) Accordingly, this Directive should cover the management of waste from land-based extractive industries, that is to say, the waste arising from the prospecting, extraction (including the pre‐production development stage), treatment and storage of mineral resources and from the working of quarries. However, such management should reflect the principles and priorities identified in Directive 75/442/EEC, which, in accordance with Article 2(1)(b)(ii) thereof, continues to apply to any aspects of the management of waste from the extractive industries which are not covered by this Directive. (7) In order to avoid duplication and disproportionate administrative requirements, the scope of this Directive should be limited to those particular operations considered to be a priority for the purposes of meeting its objectives. (8) Accordingly, the provisions of this Directive should not apply to those waste streams which, albeit generated in the course of mineral extraction or treatment operations, are not directly linked to the extraction or treatment process, e.g. food waste, waste oil, end-of-life vehicles, spent batteries and accumulators. The management of such waste should be subject to the provisions of Directive 75/442/EEC or of Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (9) or any other relevant Community legislation, as is the case for waste generated at a prospecting, extraction or treatment site and transported to a location that is not a waste facility according to this Directive. (9) Nor should this Directive apply to waste resulting from the offshore prospecting, extraction and treatment of mineral resources or to the injection of water and re‐injection of pumped groundwater, while inert waste, non-hazardous prospecting waste, unpolluted soil and waste resulting from the extraction, treatment and storage of peat should be covered only by a limited set of requirements due to their lower environmental risks. For non‐hazardous non‐inert waste, Member States may reduce or waive certain requirements. However, these exemptions should not apply to Category A waste facilities. (10) Moreover, while covering the management of waste from the extractive industries which may be radioactive, this Directive should not cover such aspects as are specific to radioactivity, which are a matter dealt with under the Treaty establishing the European Atomic Energy Community (Euratom). (11) In order to remain true to the principles and priorities identified in Directive 75/442/EEC and, in particular, Articles 3 and 4 thereof, Member States should ensure that operators engaged in the extractive industry take all necessary measures to prevent or reduce as far as possible any negative effects, actual or potential, on the environment or on human health which are brought about as a result of the management of waste from the extractive industries. (12) These measures should be based, inter alia, on the concept of best available techniques as defined in Directive 96/61/EC and, when such techniques are applied, it is for the Member States to determine how the technical characteristics of the waste facility, its geographical location and local environmental conditions can, where appropriate, be taken into consideration. (13) Member States should ensure that operators in the extractive industry draw up appropriate waste management plans for the prevention or minimisation, treatment, recovery and disposal of extractive waste. Such plans should be structured in such a way as to ensure appropriate planning of waste management options with a view to minimising waste generation and its harmfulness, and encouraging waste recovery. Moreover, waste from the extractive industries should be characterised with respect to its composition in order to ensure that, as far as possible, such waste reacts only in predictable ways. (14) In order to minimise the risk of accidents and to guarantee a high level of protection for the environment and human health, Member States should ensure that each operator of a Category A waste facility adopts and applies a major-accident prevention policy for waste. In terms of preventive measures, this should entail the delivery of a safety management system, emergency plans to be used in the event of accidents and the dissemination of safety information to persons likely to be affected by a major accident. In the event of an accident, operators should be required to provide the competent authorities with all the relevant information necessary to mitigate actual or potential environmental damage. These particular requirements should not apply to those waste facilities from the extractive industries falling within the scope of Directive 96/82/EC. (15) A waste facility should not be classified in Category A solely on the basis of risks to the safety and health protection of workers in the extractive industries covered by other Community legislation, in particular Directives 92/91/EEC (10) and 92/104/EEC (11). (16) Because of the special nature of the management of waste from the extractive industries, it is necessary to introduce specific application and permit procedures in respect of waste facilities used to receive such waste. In addition, Member States should take the necessary measures to ensure that the competent authorities periodically reconsider and, where necessary, update permit conditions. (17) Member States should be required to ensure that, in accordance with the UNECE Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters of 25 June 1998 (Aarhus Convention), the public are informed of the application for a waste management permit and the public concerned are consulted prior to the granting of a waste management permit. (18) It is necessary to indicate clearly the requirements with which waste facilities servicing the extractive industries should comply as regards location, management, control, closure and preventive and protective measures to be taken against any threat to the environment in the short and long-term perspectives, and more especially against the pollution of groundwater by leachate infiltration into the soil. (19) It is necessary to define clearly Category A waste facilities used to service waste from the extractive industries, taking into account the likely effects of any pollution resulting from the operation of such a facility or from an accident in which waste escapes from such a facility. (20) Waste placed back into the excavation voids either for their rehabilitation or for construction purposes related to the mineral extraction process, such as the building or maintenance within voids of means of access for machinery, haulage ramps, bulkheads, safety barricades or berms, needs also to be subject to certain requirements in order to protect surface water and/or groundwater, secure the stability of such waste, and ensure appropriate monitoring upon cessation of such activities. Accordingly, such waste should not be subject to the requirements of this Directive which relate exclusively to ‘waste facilities’, except for the requirements mentioned in the specific provision on excavation voids. (21) With a view to ensuring the proper construction and maintenance of waste facilities servicing waste from the extractive industries, Member States should take appropriate measures to ensure that the design, location and management of such facilities is carried out by technically competent persons. It is necessary to ensure that the training and knowledge acquired by operators and staff afford them the necessary skills. In addition, competent authorities should satisfy themselves that operators ensure suitable arrangements with respect to the construction and maintenance of a new waste facility or to any extension or modification of an existing waste facility, including in the after-closure phase. (22) It is necessary to establish monitoring procedures during the operation and after‐closure of waste facilities. An after‐closure period for monitoring and control of Category A waste facilities should be laid down proportionate to the risk posed by the individual waste facility, in a way similar to that required by Directive 1999/31/EC. (23) It is necessary to define when and how a waste facility servicing the extractive industries should be closed and to set out the obligations and responsibilities to be met by the operator during the after-closure period. (24) Member States should require operators of the extractive industries to apply monitoring and management controls in order to prevent water and soil pollution and to identify any adverse effect that their waste facilities may have on the environment or on human health. In addition, for the purposes of minimising water pollution, the discharge of waste into any receiving body of water should comply with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (12). Furthermore, concentrations in tailings ponds of cyanide and cyanide compounds from certain extractive industries should, in view of their harmful and toxic effects, be reduced to the lowest possible levels, using best available techniques. Maximum concentration thresholds should be set accordingly and, in any case, in line with the specific requirements of this Directive to prevent such effects. (25) The operator of a waste facility servicing the extractive industries should be required to lodge a financial guarantee or equivalent in accordance with procedures to be decided by the Member States ensuring that all the obligations flowing from the permit will be fulfilled, including those relating to the closure and after-closure of the waste facility. The financial guarantee should be sufficient to cover the cost of rehabilitation of the land affected by the waste facility, which includes the waste facility itself, as described in the waste management plan prepared pursuant to Article 5 and required by the Article 7 permit, by a suitably qualified and independent third party. It is also necessary for such a guarantee to be provided prior to the commencement of deposition operations in the waste facility and to be periodically adjusted. In addition, in accordance with the polluter pays principle and with Directive 2004/35/EC of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage (13), it is important to clarify that an operator of a waste facility servicing the extractive industries is subject to appropriate liability in respect of environmental damage caused by its operations or the imminent threat of such damage. (26) In the case of the operation of waste facilities servicing the extractive industries that are likely to have significant adverse transboundary effects on the environment and any resultant risks to human health, in the territory of another Member State, there should be a common procedure in place to facilitate consultation among neighbouring countries. This should be done with a view to ensuring that there is an adequate exchange of information between authorities and that the public are duly informed of any such waste facilities that could have adverse effects for the environment of that other Member State. (27) It is necessary for Member States to ensure that competent authorities organise an effective system of inspections or equivalent control measures in respect of waste facilities servicing the extractive industries. Without prejudice to the obligations of the operator under the permit, prior to the commencement of deposition operations there should be an inspection to check that the permit conditions have been complied with. In addition, Member States should ensure that operators and their successors maintain up-to-date records relating to such waste facilities and that operators transfer to their successors information concerning the state of the waste facility and its operations. (28) Member States should send regular reports to the Commission on the implementation of this Directive, including information on accidents or near-accidents. On the basis of those reports, the Commission should report to the European Parliament and the Council. (29) Member States should lay down rules on penalties for infringement of this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive. (30) It is necessary for Member States to ensure that an inventory of closed, including abandoned, waste facilities located on their territory is drawn up in order to identify those which cause serious negative environmental impacts or have the potential of becoming in the medium or short term a serious threat to human health or the environment. These inventories should provide a basis for an appropriate programme of measures. (31) The Commission should ensure an appropriate exchange of scientific and technical information on how to carry out an inventory of closed waste facilities at Member State level and on the development of methodologies to assist Member States in complying with this Directive when rehabilitating closed waste facilities. Moreover, an exchange of information should be ensured within and between Member States on the best available techniques. (32) With a view to the consistent application of Article 6 of the Treaty, environmental protection requirements must be integrated into the implementation of Community policies and activities with a view to promoting sustainable development. (33) This Directive could be a useful instrument to be taken into account when verifying that projects receiving Community funding in the context of development aid include the necessary measures to prevent or reduce as far as possible negative effects on the environment. Such an approach is consistent with Article 6 of the Treaty, particularly with regard to integrating environmental protection requirements into the Community's policy in the sphere of development cooperation. (34) The objective of this Directive, that is to say, improving the management of waste from the extractive industries, cannot be sufficiently achieved by the Member States acting alone because the mismanagement of such waste may cause pollution of a transboundary nature. Under the polluter pays principle it is necessary, inter alia, to take into account any damage to the environment caused by waste from the extractive industries, and different national applications of that principle may lead to substantial disparities in the financial burden on economic operators. Moreover, the existence of different national policies on the management of waste from the extractive industries hampers the aim of ensuring a minimum level of safe and responsible management of such waste and maximising its recovery throughout the Community. Therefore, since by reason of the scale and effects of this Directive, its objective can be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective. (35) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (14). (36) The operation of waste facilities existing at the moment of transposition of this Directive should be regulated in order to take the necessary measures, within a specified period of time, for their adaptation to the requirements of this Directive. (37) In accordance with paragraph 34 of the Interinstitutional agreement on better law‐making (15), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables, which will, as far as possible, illustrate the correlation between this Directive and the transposition measures and to make them public, Article 1 Subject matter This Directive provides for measures, procedures and guidance to prevent or reduce as far as possible any adverse effects on the environment, in particular water, air, soil, fauna and flora and landscape, and any resultant risks to human health, brought about as a result of the management of waste from the extractive industries. Article 2 Scope 1. Subject to paragraphs 2 and 3, this Directive covers the management of waste resulting from the prospecting, extraction, treatment and storage of mineral resources and the working of quarries, hereinafter ‘extractive waste’. 2. The following shall be excluded from the scope of this Directive: (a) waste which is generated by the prospecting, extraction and treatment of mineral resources and the working of quarries, but which does not directly result from those operations; (b) waste resulting from the offshore prospecting, extraction and treatment of mineral resources; (c) injection of water and re-injection of pumped groundwater as defined in the first and second indents of Article 11(3)(j) of Directive 2000/60/EC, to the extent authorised by that Article. 3. Inert waste and unpolluted soil resulting from the prospecting, extraction, treatment and storage of mineral resources and the working of quarries and waste resulting from the extraction, treatment and storage of peat shall not be subject to Articles 7, 8, 11(1) and (3), 12, 13(6), 14 and 16, unless deposited in a Category A waste facility. The competent authority may reduce or waive the requirements for the deposit of non-hazardous waste generated from the prospecting of mineral resources, except oil and evaporites other than gypsum and anhydrite, as well as for the deposit of unpolluted soil and of waste resulting from the extraction, treatment and storage of peat as long as it is satisfied that the requirements of Article 4 are met. Member States may reduce or waive the requirements of Articles 11(3), 12(5) and (6), 13(6), 14 and 16 for non-hazardous non-inert waste, unless deposited in a Category A waste facility. 4. Without prejudice to other Community legislation, waste which falls within the scope of this Directive shall not be subject to Directive 1999/31/EC. Article 3 Definitions For the purposes of this Directive: (1) ‘waste’ is as defined in Article 1(a) of Directive 75/442/EEC; (2) ‘hazardous waste’ is as defined in Article 1(4) of Council Directive 91/689/EEC of 12 December 1991 on hazardous waste (16); (3) ‘inert waste’ means waste that does not undergo any significant physical, chemical or biological transformations. Inert waste will not dissolve, burn or otherwise physically or chemically react, biodegrade or adversely affect other matter with which it comes into contact in a way likely to give rise to environmental pollution or harm human health. The total leachability and pollutant content of the waste and the ecotoxicity of the leachate must be insignificant, and in particular not endanger the quality of surface water and/or groundwater; (4) ‘unpolluted soil’ means soil that is removed from the upper layer of the ground during extractive activities and that is not deemed to be polluted under the national law of the Member State where the site is located or under Community law; (5) ‘mineral resource’ or ‘mineral’ means a naturally occurring deposit in the earth's crust of an organic or inorganic substance, such as energy fuels, metal ores, industrial minerals and construction minerals, but excluding water; (6) ‘extractive industries’ means all establishments and undertakings engaged in surface or underground extraction of mineral resources for commercial purposes, including extraction by drilling boreholes, or treatment of the extracted material; (7) ‘off-shore’ means that area of the sea and seabed extending from the low water mark of ordinary or medium tides outwards; (8) ‘treatment’ means the mechanical, physical , biological, thermal or chemical process or combination of processes carried out on mineral resources, including from the working of quarries, with a view to extracting the mineral, including size change, classification, separation and leaching, and the re-processing of previously discarded waste, but excluding smelting, thermal manufacturing processes (other than the burning of limestone) and metallurgical processes; (9) ‘tailings’ means the waste solids or slurries that remain after the treatment of minerals by separation processes (e.g. crushing, grinding, size-sorting, flotation and other physico‐chemical techniques) to remove the valuable minerals from the less valuable rock; (10) ‘heap’ means an engineered facility for the deposit of solid waste on the surface; (11) ‘dam’ means an engineered structure designed to retain or confine water and/or waste within a pond; (12) ‘pond’ means a natural or engineered facility for disposing of fine-grained waste, normally tailings, along with varying amounts of free water, resulting from the treatment of mineral resources and from the clearing and recycling of process water; (13) ‘weak acid dissociable cyanide’ means cyanide and cyanide compounds that are dissociated with a weak acid at a defined pH; (14) ‘leachate’ means any liquid percolating through the deposited waste and emitted from or contained within a waste facility, including polluted drainage, which may adversely affect the environment if not appropriately treated; (15) ‘waste facility’ means any area designated for the accumulation or deposit of extractive waste, whether in a solid or liquid state or in solution or suspension, for the following time-periods: — no time-period for Category A waste facilities and facilities for waste characterised as hazardous in the waste management plan; — a period of more than six months for facilities for hazardous waste generated unexpectedly; — a period of more than one year for facilities for non-hazardous non-inert waste; — a period of more than three years for facilities for unpolluted soil, non-hazardous prospecting waste, waste resulting from the extraction, treatment and storage of peat and inert waste. Such facilities are deemed to include any dam or other structure serving to contain, retain, confine or otherwise support such a facility, and also to include, but not be limited to, heaps and ponds, but excluding excavation voids into which waste is replaced, after extraction of the mineral, for rehabilitation and construction purposes; (16) ‘major accident’ means an occurrence on site in the course of an operation involving the management of extractive waste in any establishment covered by this Directive, leading to a serious danger to human health and/or the environment, whether immediately or over time, on-site or off-site; (17) ‘dangerous substance’ means a substance, mixture or preparation which is dangerous within the meaning of Directive 67/548/EEC (17) or Directive 1999/45/EC (18); (18) ‘best available techniques’ is as defined in Article 2(11) of Directive 96/61/EC; (19) ‘receiving body of water’ means surface waters, groundwater, transitional waters and coastal water as defined in Article 2(1), (2), (6) and (7) of Directive 2000/60/EC, respectively; (20) ‘rehabilitation’ means the treatment of the land affected by a waste facility in such a way as to restore the land to a satisfactory state, with particular regard to soil quality, wild life, natural habitats, freshwater systems, landscape and appropriate beneficial uses; (21) ‘prospecting’ means the search for mineral deposits of economic value, including sampling, bulk sampling, drilling and trenching, but excluding any works required for the development of such deposits, and any activities directly associated with an existing extractive operation; (22) ‘the public’ means one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups; (23) ‘the public concerned’ means the public affected or likely to be affected by, or having an interest in, the environmental decision-making under Articles 6 and 7 of this Directive; for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any requirement under national law shall be deemed to have such an interest; (24) ‘operator’ means the natural or legal person responsible for the management of extractive waste, in accordance with the national law of the Member State in which waste management takes place, including in respect of temporary storage of extractive waste as well as the operational and the after-closure phases; (25) ‘waste holder’ means the producer of the extractive waste or the natural or legal person who is in possession of it; (26) ‘competent person’ means a natural person who has the technical knowledge and experience, as defined by the national law of the Member State in which the person operates, to perform the duties arising from this Directive; (27) ‘competent authority’ means the authority or authorities which a Member State designates as responsible for performing the duties arising from this Directive; (28) ‘site’ means all land at a distinct geographic location under the management control of an operator; (29) ‘substantial change’ means a change in the structure or operation of a waste facility that, in the opinion of the competent authority, may have significant negative effects on human health or the environment. Article 4 General requirements 1. Member States shall take the necessary measures to ensure that extractive waste is managed without endangering human health and without using processes or methods which could harm the environment, and in particular without risk to water, air, soil and fauna and flora, without causing a nuisance through noise or odours and without adversely affecting the landscape or places of special interest. Member States shall also take the necessary measures to prohibit the abandonment, dumping or uncontrolled depositing of extractive waste. 2. Member States shall ensure that the operator takes all measures necessary to prevent or reduce as far as possible any adverse effects on the environment and human health brought about as a result of the management of extractive waste. This includes the management of any waste facility, also after its closure, and the prevention of major accidents involving that facility and the limiting of their consequences for the environment and human health. 3. The measures referred to in paragraph 2 shall be based, inter alia, on the best available techniques, without prescribing the use of any technique or specific technology, but taking into account the technical characteristics of the waste facility, its geographical location and the local environmental conditions. Article 5 Waste management plan 1. Member States shall ensure that the operator draws up a waste management plan for the minimisation, treatment, recovery and disposal of extractive waste, taking account of the principle of sustainable development. 2. The objectives of the waste management plan shall be: (a) to prevent or reduce waste production and its harmfulness, in particular by considering: (i) waste management in the design phase and in the choice of the method used for mineral extraction and treatment; (ii) the changes that the extractive waste may undergo in relation to an increase in surface area and exposure to conditions above ground; (iii) placing extractive waste back into the excavation void after extraction of the mineral, as far as is technically and economically feasible and environmentally sound in accordance with existing environmental standards at Community level and with the requirements of this Directive where relevant; (iv) putting topsoil back in place after the closure of the waste facility or, if this is not practically feasible, reusing topsoil elsewhere; (v) using less dangerous substances for the treatment of mineral resources; (b) to encourage the recovery of extractive waste by means of recycling, reusing or reclaiming such waste, where this is environmentally sound in accordance with existing environmental standards at Community level and with the requirements of this Directive where relevant; (c) to ensure short and long-term safe disposal of the extractive waste, in particular by considering, during the design phase, management during the operation and after‐closure of a waste facility and by choosing a design which: (i) requires minimal and, if possible, ultimately no monitoring, control and management of the closed waste facility; (ii) prevents or at least minimises any long-term negative effects, for example attributable to migration of airborne or aquatic pollutants from the waste facility; and (iii) ensures the long-term geotechnical stability of any dams or heaps rising above the pre-existing ground surface. 3. The waste management plan shall contain at least the following elements: (a) where applicable, the proposed classification for the waste facility in accordance with the criteria laid down in Annex III: — where a Category A waste facility is required, a document demonstrating that a major-accident prevention policy, a safety management system for implementing it and an internal emergency plan will be put into effect in accordance with Article 6(3); — when the operator considers that a Category A waste facility is not required, sufficient information justifying this, including an identification of possible accident hazards; (b) waste characterisation in accordance with Annex II and a statement of the estimated total quantities of extractive waste to be produced during the operational phase; (c) a description of the operation generating such waste and of any subsequent treatment to which it is subject; (d) a description of how the environment and human health may be adversely affected by the deposit of such waste and the preventive measures to be taken in order to minimise environmental impact during operation and after closure, including the aspects referred to in Article 11(2) (a), (b), (d) and (e); (e) the proposed control and monitoring procedures pursuant to Articles 10, when applicable, and 11(2)(c); (f) the proposed plan for closure, including rehabilitation, after-closure procedures and monitoring as provided for in Article 12; (g) measures for the prevention of water status deterioration in accordance with Directive 2000/60/EC and for the prevention or minimisation of air and soil pollution pursuant to Article 13; (h) a survey of the condition of the land to be affected by the waste facility. The waste management plan shall provide sufficient information to enable the competent authority to evaluate the operator's ability to meet the objectives of the waste management plan as set out in paragraph 2 and his obligations under this Directive. The plan shall explain, in particular, how the option and method chosen as mentioned in paragraph 2(a)(i) will fulfil the objectives of the waste management plan as laid down in paragraph 2(a). 4. The waste management plan shall be reviewed every five years and/or amended, as appropriate, in the event of substantial changes to the operation of the waste facility or to the waste deposited. Any amendments shall be notified to the competent authority. 5. Plans produced pursuant to other national or Community legislation and containing the information specified in paragraph 3 may be used where this obviates the unnecessary duplication of information and the repetition of work by the operator, on condition that all requirements under paragraphs 1 to 4 are met. 6. The competent authority shall approve the waste management plan on the basis of procedures to be decided by the Member States and shall monitor its implementation. Article 6 Major-accident prevention and information 1. This Article shall apply to Category A waste facilities, save for those waste facilities falling within the scope of Directive 96/82/EC. 2. Without prejudice to other Community legislation, and in particular Directives 92/91/EEC and 92/104/EEC, Member States shall ensure that major-accident hazards are identified and that the necessary features are incorporated into the design, construction, operation and maintenance, closure and after-closure of the waste facility in order to prevent such accidents and to limit their adverse consequences for human health and/or the environment, including any transboundary impacts. 3. For the purposes of the requirements under paragraph 2, each operator shall, before the start of operations, draw up a major-accident prevention policy for the management of extractive waste and put into effect a safety management system implementing it, in accordance with the elements set out in Section 1 of Annex I, and shall also put into effect an internal emergency plan specifying the measures to be taken on site in the event of an accident. As part of that policy, the operator shall appoint a safety manager responsible for the implementation and periodic supervision of the major-accident prevention policy. The competent authority shall draw up an external emergency plan specifying the measures to be taken off‐site in the event of an accident. As part of the application for a permit the operator shall provide the competent authority with the information necessary to enable the latter to draw up that plan. 4. The emergency plans referred to in paragraph 3 shall have the following objectives: (a) to contain and control major accidents and other incidents so as to minimise their effects, and in particular to limit damage to human health and the environment; (b) to implement the measures necessary to protect human health and the environment from the effects of major accidents and other incidents; (c) to communicate the necessary information to the public and to the relevant services or authorities in the area; (d) to provide for the rehabilitation, restoration and clean-up of the environment following a major accident. Member States shall ensure that, in the event of a major accident, the operator immediately provides the competent authority with all the information required to help minimise its consequences for human health and to assess and minimise the extent, actual or potential, of the environmental damage. 5. Member States shall ensure that the public concerned are given early and effective opportunities to participate in the preparation or review of the external emergency plan to be drawn up in accordance with paragraph 3. To that end, the public concerned shall be informed about any such proposal and relevant information shall be made available, including, inter alia, information about the right to participate in the decision-making process and about the competent authority to which comments and questions may be submitted. Member States shall ensure that the public concerned is entitled to express comments within reasonable time frames and that, in the decision on the external emergency plan, due account is taken of these comments. 6. Member States shall ensure that information on safety measures and on the action required in the event of an accident, containing at least the elements listed in Section 2 of Annex I, is provided, free of charge and as a matter of course, to the public concerned. That information shall be reviewed every three years and, where necessary, updated. Article 7 Application and permit 1. No waste facility shall be allowed to operate without a permit granted by the competent authority. The permit shall contain the elements specified in paragraph 2 of this Article and shall clearly indicate the category of the waste facility in accordance with the criteria referred to in Article 9. Subject to compliance with all requirements under this Article, any permit produced pursuant to other national or Community legislation may be combined to form a single permit, where such a format obviates the unnecessary duplication of information and the repetition of work by the operator or competent authority. The details specified in paragraph 2 can be covered by one single permit or several permits, provided that all requirements under this Article are complied with. 2. The application for a permit shall contain at least the following details: (a) the identity of the operator; (b) the proposed location of the waste facility, including any possible alternative locations; (c) the waste management plan pursuant to Article 5; (d) adequate arrangements by way of a financial guarantee or equivalent, as required under Article 14; (e) the information provided by the operator in accordance with Article 5 of Directive 85/337/EEC (19) if an environmental impact assessment is required under that Directive. 3. The competent authority shall only grant a permit if it is satisfied that: (a) the operator complies with the relevant requirements under this Directive; (b) the management of waste does not conflict directly or otherwise interfere with the implementation of the relevant waste management plan or plans referred to in Article 7 of Directive 75/442/EEC. 4. Member States shall take the necessary measures to ensure that competent authorities periodically reconsider and, where necessary, update permit conditions: — where there are substantial changes in the operation of the waste facility or the waste deposited; — on the basis of monitoring results reported by the operator pursuant to Article 11(3) or inspections carried out pursuant to Article 17; — in the light of information exchange on substantial changes in best available techniques under Article 21(3). 5. The information contained in a permit granted under this Article shall be made available to the competent national and Community statistical authorities where requested for statistical purposes. Sensitive information of a purely commercial nature, such as information concerning business relations and cost components and the volume of economic mineral reserves, shall not be made public. Article 8 Public participation 1. The public shall be informed, by public notices or other appropriate means, such as electronic media where available, of the following matters early in the procedure for granting a permit or, at the latest, as soon as the information can reasonably be provided: (a) the application for a permit; (b) where applicable, the fact that a decision concerning an application for a permit is subject to consultation between the Member States in accordance with Article 16; (c) details of the competent authorities responsible for taking the decision, those from which relevant information can be obtained, those to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions; (d) the nature of possible decisions; (e) where applicable, the details relating to a proposal for the updating of a permit or of permit conditions; (f) an indication of the times and places where, or the means by which, the relevant information will be made available; (g) details of the arrangements for public participation made pursuant to paragraph 7. 2. Member States shall ensure that, within appropriate time frames, the following are made available to the public concerned: (a) in accordance with national legislation, the main reports and advice transmitted to the competent authority at the time when the public were informed in accordance with paragraph 1; (b) in accordance with the provisions of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (20), any information in addition to that referred to in paragraph 1 of this Article which is relevant for the decision in accordance with Article 7 of this Directive and which only becomes available after the time the public have been informed in accordance with paragraph 1 of this Article. 3. Member States shall take appropriate measures to ensure that the public are informed, in accordance with paragraph 1 of this Article, of an update of permit conditions in accordance with Article 7(4). 4. The public concerned shall be entitled to express comments and opinions to the competent authority before a decision is taken. 5. The results of the consultations held pursuant to this Article shall be duly taken into account in the taking of a decision. 6. When a decision has been taken the competent authority shall, in accordance with the appropriate procedures, inform the public concerned and shall make the following information available to the public concerned: (a) the content of the decision, including a copy of the permit; (b) the reasons and considerations on which the decision is based. 7. The detailed arrangements for public participation under this Article shall be determined by the Member States so as to enable the public concerned to prepare and participate effectively. Article 9 Classification system for waste facilities For the purposes of this Directive, the competent authorities shall classify a waste facility as Category A in accordance with the criteria set out in Annex III. Article 10 Excavation voids 1. Member States shall ensure that the operator, when placing extractive waste back into the excavation voids for rehabilitation and construction purposes, whether created through surface or underground extraction, takes appropriate measures in order to: (1) secure the stability of the extractive waste in accordance, mutatis mutandis, with Article 11(2); (2) prevent the pollution of soil, surface water and groundwater in accordance, mutatis mutandis, with Article 13(1), (3) and (5); (3) ensure the monitoring of the extractive waste and the excavation void in accordance, mutatis mutandis, with Article 12(4) and (5). 2. Directive 1999/31/EC shall continue to apply to the waste other than extractive waste used for filling in excavation voids as appropriate. Article 11 Construction and management of waste facilities 1. Member States shall take appropriate measures to ensure that the management of a waste facility is in the hands of a competent person and that technical development and training of staff are provided. 2. The competent authority shall satisfy itself that, in constructing a new waste facility or modifying an existing waste facility, the operator ensures that: (a) the waste facility is suitably located, taking into account in particular Community or national obligations relating to protected areas, and geological, hydrological, hydrogeological, seismic and geotechnical factors, and is designed so as to meet the necessary conditions for, in the short and long‐term perspectives, preventing pollution of the soil, air, groundwater or surface water, taking into account especially Directives 76/464/EEC (21), 80/68/EEC (22) and 2000/60/EC, and ensuring efficient collection of contaminated water and leachate as and when required under the permit, and reducing erosion caused by water or wind as far as it is technically possible and economically viable; (b) the waste facility is suitably constructed, managed and maintained to ensure its physical stability and to prevent pollution or contamination of soil, air, surface water or groundwater in the short and long-term perspectives as well as to minimise as far as possible damage to landscape; (c) there are suitable plans and arrangements for regular monitoring and inspection of the waste facility by competent persons and for taking action in the event of results indicating instability or water or soil contamination; (d) suitable arrangements are made for the rehabilitation of the land and the closure of the waste facility; (e) suitable arrangements are made for the after-closure phase of the waste facility. Records of the monitoring and inspections referred to in point (c) shall be kept, together with permit documentation, in order to ensure the appropriate hand-over of information, particularly in the event of a change of operator. 3. The operator shall, without undue delay and in any event not later than 48 hours thereafter, notify the competent authority of any events likely to affect the stability of the waste facility and any significant adverse environmental effects revealed by the control and monitoring procedures of the waste facility. The operator shall implement the internal emergency plan, where applicable, and follow any other instruction from the competent authority as to the corrective measures to be taken. The operator shall bear the costs of the measures to be undertaken. At a frequency to be determined by the competent authority, and in any event at least once a year, the operator shall report, on the basis of aggregated data, all monitoring results to the competent authorities for the purposes of demonstrating compliance with permit conditions and increasing knowledge of waste and waste facility behaviour. On the basis of this report the competent authority may decide that validation by an independent expert is necessary. Article 12 Closure and after-closure procedures for waste facilities 1. Member States shall take measures to ensure compliance with paragraphs 2 to 5. 2. A waste facility shall only start the closure procedure if one of the following conditions is satisfied: (a) the relevant conditions stated in the permit are met; (b) authorisation is granted by the competent authority, at the request of the operator; (c) the competent authority issues a reasoned decision to that effect. 3. A waste facility may be considered as finally closed only after the competent authority has, without undue delay, carried out a final on-site inspection, assessed all the reports submitted by the operator, certified that the land affected by a waste facility has been rehabilitated and communicated to the operator its approval of the closure. That approval shall not in any way reduce the operator's obligations under the conditions of the permit or otherwise in law. 4. The operator shall be responsible for the maintenance, monitoring, control and corrective measures in the after-closure phase for as long as may be required by the competent authority, taking into account the nature and duration of the hazard, save where the competent authority decides to take over such tasks from the operator, after a waste facility has been finally closed and without prejudice to any national or Community legislation governing the liability of the waste holder. 5. When considered necessary by the competent authority, in order to fulfil relevant environmental requirements set out in Community legislation, in particular those in Directives 76/464/EEC, 80/68/EEC and 2000/60/EC, following closure of a waste facility, the operator shall, inter alia, control the physical and chemical stability of the facility and minimise any negative environmental effect, in particular with respect to surface and groundwater, by ensuring that: (a) all the structures pertaining to the facility are monitored and conserved, with control and measuring apparatus always ready for use; (b) where applicable, overflow channels and spillways are kept clean and free. 6. Following closure of a waste facility, the operator shall, without delay, notify the competent authority of any events or developments likely to affect the stability of the waste facility, and any significant adverse environmental effects revealed by the relevant control and monitoring procedures. The operator shall implement the internal emergency plan, where applicable, and follow any other instruction from the competent authority as to the corrective measures to be taken. The operator shall bear the costs of the measures to be undertaken. In cases and at a frequency to be determined by the competent authority, the operator shall report, on the basis of aggregated data, all monitoring results to the competent authorities for the purposes of demonstrating compliance with permit conditions and increasing knowledge of waste and waste facility behaviour. Article 13 Prevention of water status deterioration, air and soil pollution 1. The competent authority shall satisfy itself that the operator has taken the necessary measures in order to meet Community environmental standards, in particular to prevent, in accordance with Directive 2000/60/EC, the deterioration of current water status, inter alia, by: (a) evaluating the leachate generation potential, including contaminant content of the leachate, of the deposited waste during both the operational and after‐closure phase of the waste facility, and determining the water balance of the waste facility; (b) preventing or minimising leachate generation and surface water or groundwater and soil from being contaminated by the waste; (c) collecting and treating contaminated water and leachate from the waste facility to the appropriate standard required for their discharge. 2. The competent authority shall ensure that the operator has taken adequate measures to prevent or reduce dust and gas emissions. 3. Where, on the basis of an assessment of environmental risks, taking into account, in particular, Directives 76/464/EEC, 80/68/EEC or 2000/60/EC, as applicable, the competent authority has decided that collection and treatment of leachate is not necessary or it has been established that the waste facility poses no potential hazard to soil, groundwater or surface water, the requirements set out in points (b) and (c) of paragraph 1 may be reduced or waived accordingly. 4. Member States shall make the disposal of extractive waste, whether in solid, slurry or liquid form, into any receiving body of water other than one constructed for the purpose of disposing of extractive waste conditional upon compliance by the operator with the relevant requirements of Directives 76/464/EEC, 80/68/EEC and 2000/60/EC. 5. When placing extractive waste back into excavation voids, whether created through surface or underground extraction, which will be allowed to flood after closure, the operator shall take the necessary measures to prevent or minimise water status deterioration and soil pollution in accordance, mutatis mutandis, with paragraphs (1) and (3).The operator shall provide the competent authority with the information necessary to ensure compliance with Community obligations, in particular those in Directive 2000/60/EC. 6. In the case of a pond involving the presence of cyanide, the operator shall ensure that the concentration of weak acid dissociable cyanide in the pond is reduced to the lowest possible level using best available techniques and, in any case, at waste facilities which have previously been granted a permit or have already been in operation on 1 May 2008 that the concentration of weak acid dissociable cyanide at the point of discharge of the tailings from the processing plant into the pond does not exceed 50 ppm as from 1 May 2008, 25 ppm as from 1 May 2013, 10 ppm as from 1 May 2018 and 10 ppm at waste facilities which are granted a permit after 1 May 2008. If the competent authority so requests, the operator shall demonstrate, through a risk assessment that takes site-specific conditions into account, that those concentration limits need not be further lowered. Article 14 Financial guarantee 1. The competent authority shall, prior to the commencement of any operations involving the accumulation or deposit of extractive waste in a waste facility, require a financial guarantee (e.g. in the form of a financial deposit, including industry-sponsored mutual guarantee funds) or equivalent, in accordance with procedures to be decided by the Member States, so that: (a) all obligations under the permit issued pursuant to this Directive, including after-closure provisions, are discharged; (b) there are funds readily available at any given time for the rehabilitation of the land affected by the waste facility, as described in the waste management plan prepared pursuant to Article 5 and required by the Article 7 permit. 2. The calculation of the guarantee referred to in paragraph 1 shall be made on the basis of: (a) the likely environmental impact of the waste facility, taking into account in particular the category of the waste facility, the characteristics of the waste and the future use of the rehabilitated land; (b) the assumption that independent and suitably qualified third parties will assess and perform any rehabilitation work needed. 3. The size of the guarantee shall be periodically adjusted in accordance with any rehabilitation work needed to be carried out on the land affected by the waste facility, as described in the waste management plan prepared pursuant to Article 5 and required by the Article 7 permit. 4. Where the competent authority approves closure in accordance with Article 12(3), it shall provide the operator with a written statement releasing him from the guarantee obligation referred to in paragraph 1 of this Article with the exception of after-closure obligations as referred to in Article 12(4). Article 15 Environmental liability The following point shall be added to Annex III of Directive 2004/35/EC as follows: ‘13. The management of extractive waste pursuant to Directive 2006/21/EC of the European Parliament and of the Council of 15 March 2006 on the management of waste from extractive industries (23). Article 16 Transboundary effects 1. Where a Member State in which a waste facility is situated is aware that the operation of a Category A waste facility is likely to have significant adverse effects on the environment of, and any resultant risks to human health in, another Member State, or where a Member State likely to be thus affected so requests, the Member State in whose territory the application for a permit pursuant to Article 7 was submitted shall forward the information provided pursuant to that Article to the other Member State at the same time as it makes it available to its own nationals. Such information shall serve as a basis for any consultation necessary within the context of bilateral relations between the two Member States on a reciprocal and equivalent basis. 2. Within the framework of their bilateral relations, Member States shall ensure that in the cases referred to in paragraph 1 the applications are also made available for an appropriate period of time to the public concerned of the Member State likely to be affected so that they will have the right to comment on them before the competent authority reaches its decision. 3. Member States shall ensure that, in the event of an accident involving a waste facility as referred to in paragraph 1 of this Article, information provided by the operator to the competent authority pursuant to Article 6(4) is immediately forwarded to the other Member State in order to help minimise the consequences of the accident for human health and to assess and minimise the extent of the actual or potential environmental damage. Article 17 Inspections by the competent authority 1. Prior to the commencement of deposit operations and at regular intervals thereafter, including the after-closure phase, to be decided by the Member State concerned, the competent authority shall inspect any waste facility covered by Article 7 in order to ensure that it complies with the relevant conditions of the permit. An affirmative finding shall in no way reduce the responsibility of the operator under the conditions of the permit. 2. Member States shall require the operator to keep up-to-date records of all waste management operations and make them available for inspection by the competent authority and to ensure that, in the event of a change of operator during the management of a waste facility, there is an appropriate transfer of relevant up-to-date information and records relating to the waste facility. Article 18 Obligation to report 1. At intervals of three years Member States shall transmit to the Commission a report on the implementation of this Directive. The report shall be drawn up on the basis of a questionnaire or outline to be adopted by the Commission in accordance with the procedure referred to in Article 23(2). The report shall be transmitted to the Commission within nine months of the end of the three-year period covered by it. The Commission shall publish a report on the implementation of this Directive within nine months of receiving the reports from the Member States. 2. Every year Member States shall transmit to the Commission information on events notified by the operators in accordance with Articles 11(3) and 12(6). The Commission shall make this information available to the Member States upon request. Without prejudice to Community law on public access to environmental information, Member States shall in their turn make the information available to members of the public concerned on request. Article 19 Penalties The Member States shall lay down rules on penalties for infringement of the provisions of national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Article 20 Inventory of closed waste facilities Member States shall ensure that an inventory of closed waste facilities, including abandoned waste facilities, located on their territory which cause serious negative environmental impacts or have the potential of becoming in the medium or short term a serious threat to human health or the environment is drawn up and periodically updated. Such an inventory, to be made available to the public, shall be carried out by 1 May 2012, taking into account the methodologies as referred to in Article 21, if available. Article 21 Exchange of information 1. The Commission, assisted by the Committee referred to in Article 23, shall ensure that there is an appropriate exchange of technical and scientific information between Member States, with a view to developing methodologies relating to: (a) the implementation of Article 20; (b) the rehabilitation of those closed waste facilities identified under Article 20 in order to satisfy the requirements of Article 4. Such methodologies shall allow for the establishment of the most appropriate risk assessment procedures and remedial actions having regard to the variation of geological, hydrogeological and climatological characteristics across Europe. 2. Member States shall ensure that the competent authority follows or is informed of developments in best available techniques. 3. The Commission shall organise an exchange of information between Member States and the organisations concerned on best available techniques, associated monitoring and developments in them. The Commission shall publish the results of the exchange of information. Article 22 Implementing and amending measures 1. By 1 May 2008, the Commission shall adopt, in accordance with the procedure referred to in Article 23(2), the provisions necessary for the following, prioritising (e), (f) and (g): (a) the harmonisation and regular transmission of the information referred to in Articles 7(5) and 12(6); (b) the implementation of Article 13(6), including technical requirements relating to the definition of weak acid dissociable cyanide and its measurement method; (c) technical guidelines for the establishment of the financial guarantee in accordance with the requirements of Article 14(2); (d) technical guidelines for inspections in accordance with Article 17; (e) completion of the technical requirements for waste characterisation contained in Annex II; (f) interpretation of the definition contained in point 3 of Article 3; (g) definition of the criteria for the classification of waste facilities in accordance with Annex III; (h) determination of any harmonised standards for sampling and analysis methods needed for the technical implementation of this Directive. 2. Any subsequent amendments necessary for adapting the Annexes to scientific and technical progress shall be adopted by the Commission in accordance with the procedure referred to in Article 23(2). Those amendments shall be made with a view to achieving a high level of environmental protection. Article 23 Committee 1. The Commission shall be assisted by the Committee established by Article 18 of Directive 75/442/EEC, hereinafter ‘the Committee’. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. Article 24 Transitional provision 1. Member States shall ensure that any waste facility which has been granted a permit or which is already in operation on 1 May 2008 complies with the provisions of this Directive by 1 May 2012, except for those set out in Article 14(1) for which compliance must be ensured by 1 May 2014 and for those set out in Article 13(6) for which compliance must be ensured in accordance with the timetable laid down therein. 2. Paragraph 1 shall not apply to waste facilities closed by 1 May 2008. 3. Member States shall ensure that, from 1 May 2006 and notwithstanding any closure of a waste facility after that date and before 1 May 2008, extractive waste is managed in a way that does not prejudice the fulfilment of Article 4(1) of this Directive, and other applicable environmental requirements set out in Community legislation, including Directive 2000/60/EC. 4. Articles 5, 6(3) to (5), 7, 8, 12(1) and (2) and 14(1) to (3) shall not apply to those waste facilities that: — stopped accepting waste before 1 May 2006, — are completing the closure procedures in accordance with the applicable Community or national legislation or programmes approved by the competent authority, and — will be effectively closed by 31 December 2010. Member States shall notify such cases to the Commission by 1 August 2008 and ensure that these facilities are managed in a way that does not prejudice the achievement of the objectives of this Directive, in particular the objectives of Article 4(1), and those of any other Community legislation, including Directive 2000/60/EC. Article 25 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 May 2008. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. Article 26 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 27 Addressees This Directive is addressed to the Member States.

32006L0024

2006

DIRECTIVE 2006/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2006 on the retention of data generated or processed in connection with the provision of publicly available electronic communications services or of public communications networks and amending Directive 2002/58/EC Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (3) requires Member States to protect the rights and freedoms of natural persons with regard to the processing of personal data, and in particular their right to privacy, in order to ensure the free flow of personal data in the Community. (2) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (4) translates the principles set out in Directive 95/46/EC into specific rules for the electronic communications sector. (3) Articles 5, 6 and 9 of Directive 2002/58/EC lay down the rules applicable to the processing by network and service providers of traffic and location data generated by using electronic communications services. Such data must be erased or made anonymous when no longer needed for the purpose of the transmission of a communication, except for the data necessary for billing or interconnection payments. Subject to consent, certain data may also be processed for marketing purposes and the provision of value-added services. (4) Article 15(1) of Directive 2002/58/EC sets out the conditions under which Member States may restrict the scope of the rights and obligations provided for in Article 5, Article 6, Article 8(1), (2), (3) and (4), and Article 9 of that Directive. Any such restrictions must be necessary, appropriate and proportionate within a democratic society for specific public order purposes, i.e. to safeguard national security (i.e. State security), defence, public security or the prevention, investigation, detection and prosecution of criminal offences or of unauthorised use of the electronic communications systems. (5) Several Member States have adopted legislation providing for the retention of data by service providers for the prevention, investigation, detection, and prosecution of criminal offences. Those national provisions vary considerably. (6) The legal and technical differences between national provisions concerning the retention of data for the purpose of prevention, investigation, detection and prosecution of criminal offences present obstacles to the internal market for electronic communications, since service providers are faced with different requirements regarding the types of traffic and location data to be retained and the conditions and periods of retention. (7) The Conclusions of the Justice and Home Affairs Council of 19 December 2002 underline that, because of the significant growth in the possibilities afforded by electronic communications, data relating to the use of electronic communications are particularly important and therefore a valuable tool in the prevention, investigation, detection and prosecution of criminal offences, in particular organised crime. (8) The Declaration on Combating Terrorism adopted by the European Council on 25 March 2004 instructed the Council to examine measures for establishing rules on the retention of communications traffic data by service providers. (9) Under Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR), everyone has the right to respect for his private life and his correspondence. Public authorities may interfere with the exercise of that right only in accordance with the law and where necessary in a democratic society, inter alia, in the interests of national security or public safety, for the prevention of disorder or crime, or for the protection of the rights and freedoms of others. Because retention of data has proved to be such a necessary and effective investigative tool for law enforcement in several Member States, and in particular concerning serious matters such as organised crime and terrorism, it is necessary to ensure that retained data are made available to law enforcement authorities for a certain period, subject to the conditions provided for in this Directive. The adoption of an instrument on data retention that complies with the requirements of Article 8 of the ECHR is therefore a necessary measure. (10) On 13 July 2005, the Council reaffirmed in its declaration condemning the terrorist attacks on London the need to adopt common measures on the retention of telecommunications data as soon as possible. (11) Given the importance of traffic and location data for the investigation, detection, and prosecution of criminal offences, as demonstrated by research and the practical experience of several Member States, there is a need to ensure at European level that data that are generated or processed, in the course of the supply of communications services, by providers of publicly available electronic communications services or of a public communications network are retained for a certain period, subject to the conditions provided for in this Directive. (12) Article 15(1) of Directive 2002/58/EC continues to apply to data, including data relating to unsuccessful call attempts, the retention of which is not specifically required under this Directive and which therefore fall outside the scope thereof, and to retention for purposes, including judicial purposes, other than those covered by this Directive. (13) This Directive relates only to data generated or processed as a consequence of a communication or a communication service and does not relate to data that are the content of the information communicated. Data should be retained in such a way as to avoid their being retained more than once. Data generated or processed when supplying the communications services concerned refers to data which are accessible. In particular, as regards the retention of data relating to Internet e-mail and Internet telephony, the obligation to retain data may apply only in respect of data from the providers' or the network providers' own services. (14) Technologies relating to electronic communications are changing rapidly and the legitimate requirements of the competent authorities may evolve. In order to obtain advice and encourage the sharing of experience of best practice in these matters, the Commission intends to establish a group composed of Member States' law enforcement authorities, associations of the electronic communications industry, representatives of the European Parliament and data protection authorities, including the European Data Protection Supervisor. (15) Directive 95/46/EC and Directive 2002/58/EC are fully applicable to the data retained in accordance with this Directive. Article 30(1)(c) of Directive 95/46/EC requires the consultation of the Working Party on the Protection of Individuals with regard to the Processing of Personal Data established under Article 29 of that Directive. (16) The obligations incumbent on service providers concerning measures to ensure data quality, which derive from Article 6 of Directive 95/46/EC, and their obligations concerning measures to ensure confidentiality and security of processing of data, which derive from Articles 16 and 17 of that Directive, apply in full to data being retained within the meaning of this Directive. (17) It is essential that Member States adopt legislative measures to ensure that data retained under this Directive are provided to the competent national authorities only in accordance with national legislation in full respect of the fundamental rights of the persons concerned. (18) In this context, Article 24 of Directive 95/46/EC imposes an obligation on Member States to lay down sanctions for infringements of the provisions adopted pursuant to that Directive. Article 15(2) of Directive 2002/58/EC imposes the same requirement in relation to national provisions adopted pursuant to Directive 2002/58/EC. Council Framework Decision 2005/222/JHA of 24 February 2005 on attacks against information systems (5) provides that the intentional illegal access to information systems, including to data retained therein, is to be made punishable as a criminal offence. (19) The right of any person who has suffered damage as a result of an unlawful processing operation or of any act incompatible with national provisions adopted pursuant to Directive 95/46/EC to receive compensation, which derives from Article 23 of that Directive, applies also in relation to the unlawful processing of any personal data pursuant to this Directive. (20) The 2001 Council of Europe Convention on Cybercrime and the 1981 Council of Europe Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data also cover data being retained within the meaning of this Directive. (21) Since the objectives of this Directive, namely to harmonise the obligations on providers to retain certain data and to ensure that those data are available for the purpose of the investigation, detection and prosecution of serious crime, as defined by each Member State in its national law, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Directive, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (22) This Directive respects the fundamental rights and observes the principles recognised, in particular, by the Charter of Fundamental Rights of the European Union. In particular, this Directive, together with Directive 2002/58/EC, seeks to ensure full compliance with citizens' fundamental rights to respect for private life and communications and to the protection of their personal data, as enshrined in Articles 7 and 8 of the Charter. (23) Given that the obligations on providers of electronic communications services should be proportionate, this Directive requires that they retain only such data as are generated or processed in the process of supplying their communications services. To the extent that such data are not generated or processed by those providers, there is no obligation to retain them. This Directive is not intended to harmonise the technology for retaining data, the choice of which is a matter to be resolved at national level. (24) In accordance with paragraph 34 of the Interinstitutional agreement on better law-making (6), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public. (25) This Directive is without prejudice to the power of Member States to adopt legislative measures concerning the right of access to, and use of, data by national authorities, as designated by them. Issues of access to data retained pursuant to this Directive by national authorities for such activities as are referred to in the first indent of Article 3(2) of Directive 95/46/EC fall outside the scope of Community law. However, they may be subject to national law or action pursuant to Title VI of the Treaty on European Union. Such laws or action must fully respect fundamental rights as they result from the common constitutional traditions of the Member States and as guaranteed by the ECHR. Under Article 8 of the ECHR, as interpreted by the European Court of Human Rights, interference by public authorities with privacy rights must meet the requirements of necessity and proportionality and must therefore serve specified, explicit and legitimate purposes and be exercised in a manner that is adequate, relevant and not excessive in relation to the purpose of the interference, Article 1 Subject matter and scope 1. This Directive aims to harmonise Member States' provisions concerning the obligations of the providers of publicly available electronic communications services or of public communications networks with respect to the retention of certain data which are generated or processed by them, in order to ensure that the data are available for the purpose of the investigation, detection and prosecution of serious crime, as defined by each Member State in its national law. 2. This Directive shall apply to traffic and location data on both legal entities and natural persons and to the related data necessary to identify the subscriber or registered user. It shall not apply to the content of electronic communications, including information consulted using an electronic communications network. Article 2 Definitions 1. For the purpose of this Directive, the definitions in Directive 95/46/EC, in Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (7), and in Directive 2002/58/EC shall apply. 2. For the purpose of this Directive: (a) ‘data’ means traffic data and location data and the related data necessary to identify the subscriber or user; (b) ‘user’ means any legal entity or natural person using a publicly available electronic communications service, for private or business purposes, without necessarily having subscribed to that service; (c) ‘telephone service’ means calls (including voice, voicemail and conference and data calls), supplementary services (including call forwarding and call transfer) and messaging and multi-media services (including short message services, enhanced media services and multi-media services); (d) ‘user ID’ means a unique identifier allocated to persons when they subscribe to or register with an Internet access service or Internet communications service; (e) ‘cell ID’ means the identity of the cell from which a mobile telephony call originated or in which it terminated; (f) ‘unsuccessful call attempt’ means a communication where a telephone call has been successfully connected but not answered or there has been a network management intervention. Article 3 Obligation to retain data 1. By way of derogation from Articles 5, 6 and 9 of Directive 2002/58/EC, Member States shall adopt measures to ensure that the data specified in Article 5 of this Directive are retained in accordance with the provisions thereof, to the extent that those data are generated or processed by providers of publicly available electronic communications services or of a public communications network within their jurisdiction in the process of supplying the communications services concerned. 2. The obligation to retain data provided for in paragraph 1 shall include the retention of the data specified in Article 5 relating to unsuccessful call attempts where those data are generated or processed, and stored (as regards telephony data) or logged (as regards Internet data), by providers of publicly available electronic communications services or of a public communications network within the jurisdiction of the Member State concerned in the process of supplying the communication services concerned. This Directive shall not require data relating to unconnected calls to be retained. Article 4 Access to data Member States shall adopt measures to ensure that data retained in accordance with this Directive are provided only to the competent national authorities in specific cases and in accordance with national law. The procedures to be followed and the conditions to be fulfilled in order to gain access to retained data in accordance with necessity and proportionality requirements shall be defined by each Member State in its national law, subject to the relevant provisions of European Union law or public international law, and in particular the ECHR as interpreted by the European Court of Human Rights. Article 5 Categories of data to be retained 1. Member States shall ensure that the following categories of data are retained under this Directive: (a) data necessary to trace and identify the source of a communication: (1) concerning fixed network telephony and mobile telephony: (i) the calling telephone number; (ii) the name and address of the subscriber or registered user; (2) concerning Internet access, Internet e-mail and Internet telephony: (i) the user ID(s) allocated; (ii) the user ID and telephone number allocated to any communication entering the public telephone network; (iii) the name and address of the subscriber or registered user to whom an Internet Protocol (IP) address, user ID or telephone number was allocated at the time of the communication; (b) data necessary to identify the destination of a communication: (1) concerning fixed network telephony and mobile telephony: (i) the number(s) dialled (the telephone number(s) called), and, in cases involving supplementary services such as call forwarding or call transfer, the number or numbers to which the call is routed; (ii) the name(s) and address(es) of the subscriber(s) or registered user(s); (2) concerning Internet e-mail and Internet telephony: (i) the user ID or telephone number of the intended recipient(s) of an Internet telephony call; (ii) the name(s) and address(es) of the subscriber(s) or registered user(s) and user ID of the intended recipient of the communication; (c) data necessary to identify the date, time and duration of a communication: (1) concerning fixed network telephony and mobile telephony, the date and time of the start and end of the communication; (2) concerning Internet access, Internet e-mail and Internet telephony: (i) the date and time of the log-in and log-off of the Internet access service, based on a certain time zone, together with the IP address, whether dynamic or static, allocated by the Internet access service provider to a communication, and the user ID of the subscriber or registered user; (ii) the date and time of the log-in and log-off of the Internet e-mail service or Internet telephony service, based on a certain time zone; (d) data necessary to identify the type of communication: (1) concerning fixed network telephony and mobile telephony: the telephone service used; (2) concerning Internet e-mail and Internet telephony: the Internet service used; (e) data necessary to identify users' communication equipment or what purports to be their equipment: (1) concerning fixed network telephony, the calling and called telephone numbers; (2) concerning mobile telephony: (i) the calling and called telephone numbers; (ii) the International Mobile Subscriber Identity (IMSI) of the calling party; (iii) the International Mobile Equipment Identity (IMEI) of the calling party; (iv) the IMSI of the called party; (v) the IMEI of the called party; (vi) in the case of pre-paid anonymous services, the date and time of the initial activation of the service and the location label (Cell ID) from which the service was activated; (3) concerning Internet access, Internet e-mail and Internet telephony: (i) the calling telephone number for dial-up access; (ii) the digital subscriber line (DSL) or other end point of the originator of the communication; (f) data necessary to identify the location of mobile communication equipment: (1) the location label (Cell ID) at the start of the communication; (2) data identifying the geographic location of cells by reference to their location labels (Cell ID) during the period for which communications data are retained. 2. No data revealing the content of the communication may be retained pursuant to this Directive. Article 6 Periods of retention Member States shall ensure that the categories of data specified in Article 5 are retained for periods of not less than six months and not more than two years from the date of the communication. Article 7 Data protection and data security Without prejudice to the provisions adopted pursuant to Directive 95/46/EC and Directive 2002/58/EC, each Member State shall ensure that providers of publicly available electronic communications services or of a public communications network respect, as a minimum, the following data security principles with respect to data retained in accordance with this Directive: (a) the retained data shall be of the same quality and subject to the same security and protection as those data on the network; (b) the data shall be subject to appropriate technical and organisational measures to protect the data against accidental or unlawful destruction, accidental loss or alteration, or unauthorised or unlawful storage, processing, access or disclosure; (c) the data shall be subject to appropriate technical and organisational measures to ensure that they can be accessed by specially authorised personnel only; and (d) the data, except those that have been accessed and preserved, shall be destroyed at the end of the period of retention. Article 8 Storage requirements for retained data Member States shall ensure that the data specified in Article 5 are retained in accordance with this Directive in such a way that the data retained and any other necessary information relating to such data can be transmitted upon request to the competent authorities without undue delay. Article 9 Supervisory authority 1. Each Member State shall designate one or more public authorities to be responsible for monitoring the application within its territory of the provisions adopted by the Member States pursuant to Article 7 regarding the security of the stored data. Those authorities may be the same authorities as those referred to in Article 28 of Directive 95/46/EC. 2. The authorities referred to in paragraph 1 shall act with complete independence in carrying out the monitoring referred to in that paragraph. Article 10 Statistics 1. Member States shall ensure that the Commission is provided on a yearly basis with statistics on the retention of data generated or processed in connection with the provision of publicly available electronic communications services or a public communications network. Such statistics shall include: — the cases in which information was provided to the competent authorities in accordance with applicable national law, — the time elapsed between the date on which the data were retained and the date on which the competent authority requested the transmission of the data, — the cases where requests for data could not be met. 2. Such statistics shall not contain personal data. Article 11 Amendment of Directive 2002/58/EC The following paragraph shall be inserted in Article 15 of Directive 2002/58/EC: ‘1a. Paragraph 1 shall not apply to data specifically required by Directive 2006/24/EC of the European Parliament and of the Council of 15 March 2006 on the retention of data generated or processed in connection with the provision of publicly available electronic communications services or of public communications networks (8) to be retained for the purposes referred to in Article 1(1) of that Directive. Aricle 12 Future measures 1. A Member State facing particular circumstances that warrant an extension for a limited period of the maximum retention period referred to in Article 6 may take the necessary measures. That Member State shall immediately notify the Commission and inform the other Member States of the measures taken under this Article and shall state the grounds for introducing them. 2. The Commission shall, within a period of six months after the notification referred to in paragraph 1, approve or reject the national measures concerned, after having examined whether they are a means of arbitrary discrimination or a disguised restriction of trade between Member States and whether they constitute an obstacle to the functioning of the internal market. In the absence of a decision by the Commission within that period the national measures shall be deemed to have been approved. 3. Where, pursuant to paragraph 2, the national measures of a Member State derogating from the provisions of this Directive are approved, the Commission may consider whether to propose an amendment to this Directive. Article 13 Remedies, liability and penalties 1. Each Member State shall take the necessary measures to ensure that the national measures implementing Chapter III of Directive 95/46/EC providing for judicial remedies, liability and sanctions are fully implemented with respect to the processing of data under this Directive. 2. Each Member State shall, in particular, take the necessary measures to ensure that any intentional access to, or transfer of, data retained in accordance with this Directive that is not permitted under national law adopted pursuant to this Directive is punishable by penalties, including administrative or criminal penalties, that are effective, proportionate and dissuasive. Article 14 Evaluation 1. No later than 15 September 2010, the Commission shall submit to the European Parliament and the Council an evaluation of the application of this Directive and its impact on economic operators and consumers, taking into account further developments in electronic communications technology and the statistics provided to the Commission pursuant to Article 10 with a view to determining whether it is necessary to amend the provisions of this Directive, in particular with regard to the list of data in Article 5 and the periods of retention provided for in Article 6. The results of the evaluation shall be made public. 2. To that end, the Commission shall examine all observations communicated to it by the Member States or by the Working Party established under Article 29 of Directive 95/46/EC. Article 15 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by no later than 15 September 2007. They shall forthwith inform the Commission thereof. When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. 3. Until 15 March 2009, each Member State may postpone application of this Directive to the retention of communications data relating to Internet Access, Internet telephony and Internet e-mail. Any Member State that intends to make use of this paragraph shall, upon adoption of this Directive, notify the Council and the Commission to that effect by way of a declaration. The declaration shall be published in the Official Journal of the European Union. Article 16 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 17 Addressees This Directive is addressed to the Member States.

32006L0033

2006

COMMISSION DIRECTIVE 2006/33/EC of 20 March 2006 amending Directive 95/45/EC as regards sunset yellow FCF (E 110) and titanium dioxide (E 171) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof, After consulting the European Food Safety Authority, Whereas: (1) Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs (2), sets out the purity criteria for the colours mentioned in Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (3). (2) Sunset yellow FCF (E 110) is authorised under Directive 94/36/EC as a colour for use in certain foodstuffs. There is scientific evidence that under certain circumstances, Sudan I (1-(phenylazo)-2-naphthalenol) may be formed as an impurity during the production of sunset yellow. Sudan I is an unauthorised colour and an undesired substance in food. Its presence in sunset yellow should therefore be restricted to an amount below the limit of detection, i.e. 0,5 mg/kg. The purity criteria for sunset yellow FCF (E 110) should therefore be amended accordingly. (3) Account should be taken of the specifications and analytical techniques for additives set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). JECFA began the implementation of a systematic programme to replace the test for heavy metals (as lead) in all existing food additive specifications with appropriate limits for individual metals of concern. These limits for sunset yellow FCF (E 110) should therefore be amended accordingly. (4) Titanium dioxide (E 171) is authorised under Directive 94/36/EC as a colour for use in certain foodstuffs. Titanium dioxide can be manufactured to obtain crystals in the anatase or in the rutile form. The platelet form of rutile titanium dioxide differs from the anatase form in structure and optical properties (pearlescence). There is a technological need for the use of the platelet form of rutile titanium dioxide as a colour in foodstuffs and in film coatings for food supplement tablets. On 7 December 2004 the European Food Safety Authority stated that the use of rutile titanium dioxide in the platelet or amorphous forms would not pose any safety concerns. The purity criteria for titanium dioxide (E 171) should therefore be amended in order to include both the anatase and the rutile form of the substance. (5) Directive 95/45/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 95/45/EC is amended in accordance with the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 10 April 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0034

2006

COMMISSION DIRECTIVE 2006/34/EC of 21 March 2006 amending the Annex to Directive 2001/15/EC as regards the inclusion of certain substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (1), and in particular Article 4(2) thereof, After consulting the European Food Safety Authority, Whereas: (1) Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (2) specifies certain categories of substances and mentions for each of them the chemical substances that may be used in the manufacture of foodstuffs for particular nutritional uses. (2) Those chemical substances that have been evaluated by the European Food Safety Authority (hereafter ‘the Authority’) and have received a favourable scientific evaluation should be included in the Annex to Directive 2001/15/EC. (3) Favourable scientific evaluation for some vitamins and mineral substances has been recently given and made public by the Authority. (4) It is appropriate to replace the category heading ‘folic acid’ in order to take account of the inclusion of other forms of folate in the Annex to Directive 2001/15/EC. (5) Directive 2001/15/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 The Annex to Directive 2001/15/EC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0036

2006

COMMISSION DIRECTIVE 2006/36/EC of 24 March 2006 amending Directive 2001/32/EC recognising protected zones exposed to particular plant health risks in the Community and repealing Directive 92/76/EEC Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular the first subparagraph of Article 2(1)(h) thereof, Whereas: (1) By Commission Directive 2001/32/EC (2), certain Member States or certain areas in Member States were recognised as protected zones in respect of certain harmful organisms. In some cases recognition was granted provisionally, because the information necessary to show that the harmful organism in question was not present in the Member State or area concerned had not been provided. (2) Where the Member States concerned have now provided the necessary information, the zones in question should be recognised as permanent protected zones. (3) Certain regions of Portugal were recognised as protected zones with respect to Bemisia tabaci Genn. (European populations). (4) Portugal has submitted information showing that Bemisia tabaci Genn. (European populations) is now established in some parts of its territory. Those parts of the Portuguese territory should therefore no longer be recognised as a protected zone in respect of that harmful organism. (5) Various regions or parts of regions in Austria and Italy, and the whole territory of Ireland, Lithuania, Slovenia and Slovakia, were provisionally recognised as protected zones with respect to Erwinia amylovora (Burr.) Winsl. et al. until 31 March 2006. (6) From information supplied by Austria, Italy, Ireland, Lithuania, Slovenia and Slovakia, it appears that the provisional recognition of the protected zones for those countries in respect of Erwinia amylovora (Burr.) Winsl. et al. should exceptionally be extended for two years to give those countries the necessary time to submit information showing that Erwinia amylovora (Burr.) Winsl. et al. is not present or, where necessary, to complete their efforts to eradicate that organism. (7) In addition, as Erwinia amylovora (Burr.) Winsl. et al. is now established in some parts of Italy, in the Gorenjska and Maribor regions of Slovenia and in some communes of the Dunajská Streda, Levice, Topoľčany, Poltár, Rožňava and Trebišov Counties in Slovakia, these respective parts of the Italian, Slovenian and Slovakian territory should no longer be recognised as a protected zone for Erwinia amylovora (Burr.) Winsl. et al. (8) Lithuania was provisionally recognised as a protected zone for beet necrotic yellow vein virus until 31 March 2006. (9) Lithuania has submitted information showing that beet necrotic yellow vein virus is now established in that country. Lithuania should therefore no longer be recognised as a protected zone in respect of that harmful organism. (10) Malta was provisionally recognised as a protected zone with respect to Citrus tristeza virus (European strains) until 31 March 2006. (11) From information supplied by Malta, it appears that the provisional recognition of the protected zone for that country in respect of Citrus tristeza virus (European strains) should exceptionally be extended for two years to give that country the necessary time to submit information showing that Citrus tristeza virus (European strains) is not present or, where necessary, to complete its efforts to eradicate that organism. (12) Cyprus was provisionally recognised as a protected zone with respect to Daktulosphaira vitifoliae (Fitch), Ips sexdentatus Börner and Leptinotarsa decemlineata Say until 31 March 2006. (13) From information supplied by Cyprus, it appears that the provisional recognition of the protected zone for that country in respect of Daktulosphaira vitifoliae (Fitch), Ips sexdentatus Börner and Leptinotarsa decemlineata Say should be extended for two years to give that country the necessary time to submit information showing that those harmful organisms, are not present or, where necessary, to complete its efforts to eradicate them. (14) Directive 2001/32/EC should therefore be amended accordingly. (15) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Directive 2001/32/EC is amended as follows: 1) Article 1 is replaced by the following: ‘Article 1 The zones in the Community listed in the Annex are recognised as protected zones within the meaning of the first subparagraph of Article 2(1)(h) of Directive 2000/29/EC, in respect of the harmful organism(s) listed against their names in the Annex to this Directive.’ 2) Article 2 is deleted. 3) The Annex is amended as follows: (a) In point 2 of heading (a), the words in brackets after ‘Portugal’ are replaced by the following words ‘Azores, Beira Interior, Beira Litoral, Entre Douro e Minho, Madeira, Ribatejo e Oeste (communes of Alcobaça, Alenquer, Bombarral, Cadaval, Caldas da Rainha, Lourinhã, Nazaré, Obidos, Peniche and Torres Vedras) and Trás-os-Montes’. (b) In points 3.1, 11 and 13 of heading (a), the words ‘(until 31 March 2008)’ are inserted after the word ‘Cyprus’. (c) Point 2 of heading (b) is replaced by the following: ‘ — Spain, Estonia, France (Corsica), Italy (Abruzzi; Basilicata; Calabria; Campania; Friuli-Venezia Giulia; Lazio; Liguria; Marche; Molise; Piedmont; Sardinia; Sicily; Tuscany; Umbria; Valle d’Aosta), Latvia, Portugal, Finland, United Kingdom (Northern Ireland, Isle of Man and Channel Islands), — and, until 31 March 2008, Ireland, Italy (Apúlia, Emilia-Romagna: provinces of Forlí-Cesena (excluding the provincial area situated to the North of the State road n.9 — Via Emilia), Parma, Piacenza, Rimini (excluding the provincial area situated to the North of the State road n.9 — Via Emilia), Lombardy, Veneto (except in the province of Rovigo the communes Rovigo, Polesella, Villamarzana, Fratta Polesine, San Bellino, Badia Polesine, Trecenta, Ceneselli, Pontecchio Polesine, Arquà Polesine, Costa di Rovigo, Occhiobello, Lendinara, Canda, Ficarolo, Guarda Veneta, Frassinelle Polesine, Villanova del Ghebbo, Fiesso Umbertiano, Castelguglielmo, Bagnolo di Po, Giacciano con Baruchella, Bosaro, Canaro, Lusia, Pincara, Stienta, Gaiba, Salara, and in the province of Padova the communes Castelbaldo, Barbona, Piacenza d’Adige, Vescovana, S. Urbano, Boara Pisani, Masi, and in the province of Verona the communes Palù, Roverchiara, Legnago, Castagnaro, Ronco all’Adige, Villa Bartolomea, Oppeano, Terrazzo, Isola Rizza, Angiari), Lithuania, Austria (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria, Vienna), Slovenia (except the Gorenjska and Maribor regions), Slovakia (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Veľké Ripňany (Topoľčany County), Málinec (Poltár County), Hrhov (Rožňava County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County))’. (d) In point 1 of heading (d), the word ‘Lithuania’ is deleted. (e) In point 3 of heading (d), the words ‘(until 31 March 2008)’ are inserted after the word ‘Malta’. Article 2 1. Member States shall adopt and publish, by 30 April 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and the Directive. They shall apply those provisions from 1 May 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0035

2006

COMMISSION DIRECTIVE 2006/35/EC of 24 March 2006 amending Annexes I to IV to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Having regard to the Treaty establishing the European Community, Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular point (c) of the second paragraph of Article 14 thereof, After consulting the Member States concerned, Whereas: (1) Directive 2000/29/EC provides for certain measures against the introduction into the Member States from other Member States or third countries of organisms which are harmful to plants or plant products. It also provides for certain zones to be recognised as protected zones. (2) From information supplied by Portugal, it appears that Bemisia tabaci Genn. (European populations) is now established in the Alentejo region and in some communes of the Ribatejo e Oeste region. These parts of the Portuguese territory should therefore no longer be recognised as a protected zone in respect of that harmful organism. (3) From information supplied by Slovenia, it appears that Erwinia amylovora (Burr.) Winsl. et al. is now established in the Gorenjska and Maribor regions. These regions should no longer be recognised as a protected zone in respect of Erwinia amylovora (Burr.) Winsl. et al. (4) From information supplied by Slovakia, it appears that Erwinia amylovora (Burr.) Winsl. et al. is now established in certain communes of the Dunajská Streda, Levice, Topoľčany, Poltár, Rožňava and Trebišov Counties. These communes should no longer be recognised as a protected zone in respect of Erwinia amylovora (Burr.) Winsl. et al. (5) Italy has submitted information showing that Erwinia amylovora (Burr.) Winsl. et al. is now established in some parts of its territory. Those parts of the Italian territory should therefore no longer be recognised as a protected zone in respect of Erwinia amylovora (Burr.) Winsl. et al. (6) Lithuania has submitted information showing that Beet necrotic yellow vein virus is now established in its territory. Lithuania should therefore no longer be recognised as a protected zone in respect of Beet necrotic yellow vein virus. (7) The relevant Annexes to Directive 2000/29/EC should therefore be amended accordingly. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 Annexes I to IV to Directive 2000/29/EC are amended in accordance with the text in the Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 30 April 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 May 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such a reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0037

2006

COMMISSION DIRECTIVE 2006/37/EC of 30 March 2006 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (1), and in particular Article 4(5) thereof, After consulting the European Food Safety Authority, Whereas: (1) Directive 2002/46/EC specifies the vitamins and minerals, and for each of them the forms, that may be used for the manufacture of food supplements. (2) Those vitamin and mineral substances that have been evaluated by the European Food Safety Authority (hereafter ‘the Authority’) and have received a favourable scientific evaluation should be included in the Annexes to Directive 2002/46/EC. (3) Favourable scientific evaluation for some vitamins and mineral substances has been recently given and made public by the Authority. (4) It is appropriate to replace the category heading ‘folic acid’ in order to take account of the inclusion of other forms of folate in Annex II to Directive 2002/46/EC. (5) Directive 2002/46/EC should therefore be amended accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex II to Directive 2002/46/EC is amended as set out in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0023

2006

DIRECTIVE 2006/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2006 on a Community air traffic controller licence (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Implementation of the Single European Sky legislation requires the establishment of more detailed legislation, in particular concerning the licensing of air traffic controllers, in order to ensure the highest standards of responsibility and competence, to improve the availability of air traffic controllers and to promote the mutual recognition of licences, as envisaged in Article 5 of Regulation (EC) No 550/2004 of the European Parliament and of the Council of 10 March 2004 on the provision of air navigation services in the single European sky (3), while pursuing the objective of an overall improvement in air traffic safety and competence of personnel. (2) The introduction of a Community licence is a means of recognising the specific role which air traffic controllers play in the safe provision of air traffic control. The establishment of Community competence standards will also reduce fragmentation in this field, making for more efficient organisation of work in the framework of growing regional collaboration between air navigation service providers. This Directive is therefore an essential part of the Single European Sky legislation. (3) A Directive is the most suitable instrument to set competence standards, thus leaving to the Member States to decide on the ways to achieve such standards. (4) This Directive should build on existing international standards. The International Civil Aviation Organisation (ICAO) has adopted provisions on air traffic controller licensing, including linguistic requirements. The European Organisation for the Safety of Air Navigation (Eurocontrol) set up by the International Convention of 13 December 1960 relating to Cooperation for the Safety of Air Navigation has adopted Eurocontrol Safety Regulatory Requirements. In accordance with Article 4 of Regulation (EC) No 550/2004 this Directive transposes the requirements laid down in Eurocontrol Safety Regulatory Requirement No 5 (ESARR 5) relevant to air traffic controllers. (5) The particular characteristics of Community air traffic call for the introduction and effective application of Community competence standards for air traffic controllers employed by air navigation service providers primarily involved in general air traffic. Member States may also apply the national provisions taken pursuant to this Directive to student air traffic controllers and air traffic controllers exercising their functions under the responsibility of air navigation service providers offering their services primarily to aircraft movements other than general air traffic. (6) Where Member States take action to ensure compliance with Community requirements, the authorities performing supervision and verification of compliance should be sufficiently independent of air navigation service providers and training providers. The authorities must also remain capable of performing their tasks efficiently. The national supervisory authority nominated or established under this Directive may be the same body or bodies nominated or established in accordance with Article 4 of Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (4). (7) The provision of air navigation services requires highly skilled personnel whose competence can be demonstrated by several means. For air traffic control the appropriate means is the introduction of a Community licence, to be seen as a kind of diploma, for each individual air traffic controller. The rating on a licence indicates the type of air traffic service an air traffic controller is competent to provide. At the same time, the endorsements included on the licence reflect both the specific skills of the controller and the authorisation of the supervisory authorities to provide services for a particular sector or group of sectors. That is why the authorities must be in a position to evaluate the competence of air traffic controllers when issuing licences or extending the validity of the endorsements. The authorities must also be in a position to suspend a licence, ratings or endorsements when competence is in doubt. In an effort to promote the reporting of incidents (just culture), this Directive should not establish an automatic link between an incident and the suspension of a licence, rating or endorsement. Revocation of a licence should be considered as the last resort for extreme cases. (8) In order to build the confidence of Member States in each other's licensing systems, Community rules on obtaining and maintaining licences are indispensable. It is therefore important, with a view to ensuring the highest level of safety, to harmonise the requirements as regards qualifications, competence and access to the profession of air traffic controller. This should lead to the provision of safe, high-quality air traffic control services and the recognition of licences throughout the Community, thereby increasing freedom of movement and improving the availability of air traffic controllers. (9) Member States should ensure that implementation of this Directive does not lead to circumvention of existing national provisions governing the rights and obligations applicable to the employment relationship between an employer and applicant air traffic controllers. (10) In order to make skills comparable throughout the Community, they need to become structured in a clear and generally accepted way. This will help to guarantee safety not only within the airspace under the control of one air navigation service provider, but especially at the interface between different service providers. (11) In many incidents and accidents, communication plays a significant role. ICAO has therefore adopted language knowledge requirements. This Directive develops these requirements and provides a means of enforcing these internationally accepted standards. There is a need for observance of the principles of non-discrimination, transparency and proportionality in language requirements, so as to encourage free movement while ensuring safety. (12) The objectives of initial training are described in the guidance material developed at the request of the members of Eurocontrol and are considered the appropriate standards. For unit training the lack of generally accepted standards needs to be offset by a range of measures, including the approval of examiners, which should guarantee high standards of competence. This is all the more important as unit training is very costly and decisive in terms of safety. (13) Medical requirements have been developed at the request of Eurocontrol Member States and are considered an acceptable means of compliance with this Directive. (14) The certification of training provision should be regarded, in terms of safety, as one of the decisive factors contributing to the quality of training. Training should be seen as a service similar to air navigation services, also subject to a certification process. This Directive should make it possible to certify training by type of training, by package of training services or by package of training and air navigation services, without losing sight of the particular characteristics of training. (15) This Directive confirms long-standing case-law of the Court of Justice of the European Communities in the field of mutual recognition of diplomas and freedom of movement of workers. The principle of proportionality, reasoned justifications for the imposition of compensation measures and the provision of appropriate appeal procedures constitute basic principles which need to become applicable to the air traffic management sector in a more visible manner. Member States should be entitled to refuse to recognise licences not issued in accordance with this Directive; Member States should also be entitled to recognise such licences after undertaking the appropriate equivalence assessment. Since this Directive is aimed at facilitating the mutual recognition of licences, it does not regulate the conditions concerning access to employment. (16) The profession of air traffic controller is subject to technical innovations which call for such controllers' skills to be regularly updated. This Directive should allow such adaptations to technical developments and scientific progress through the use of the committee procedure. (17) This Directive may have an impact on the daily working practices of air traffic controllers. The social partners should be informed and consulted in an appropriate way on all measures having significant social implications. Therefore, the Sectoral Dialogue Committee set up under Commission Decision 98/500/EC of 20 May 1998 on the establishment of Sectoral Dialogue Committees promoting the Dialogue between the social partners at European level (5) has been consulted and should be consulted on further implementing measures taken by the Commission. (18) Member States should lay down rules on the penalties applicable to infringements of the national provisions adopted pursuant to this Directive and take all measures necessary to ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive. (19) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6). (20) A two-year transposition period is considered sufficient for establishing a Community licensing framework and assimilating within that framework the licences of current licence holders, in accordance with the provisions concerning the conditions for maintaining ratings and keeping endorsements valid, as the requirements laid down in those provisions are in line with existing international obligations. Furthermore, an additional transposition period of two years should be granted for the application of the linguistic requirements. (21) The general conditions for obtaining a licence, insofar as they relate to age, educational requirements and initial training, should not affect the holders of existing licences. (22) In accordance with point 34 of the Interinstitutional agreement on better law-making (7), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public, Article 1 Objective and scope 1. The objective of this Directive is to increase safety standards and to improve the operation of the Community air traffic control system through the issuing of a Community air traffic controller licence. 2. This Directive shall apply to: — student air traffic controllers, and — air traffic controllers exercising their functions under the responsibility of air navigation service providers which offer their services primarily to aircraft movements of general air traffic. 3. Subject to Articles 1(2) and 13 of Regulation (EC) No 549/2004, in cases where regular and planned air traffic control services are provided to general air traffic under the responsibility of air navigation service providers which offer their services primarily to aircraft movements other than general air traffic, Member States shall ensure that the level of safety and quality of the services to general air traffic is at least equivalent to the level resulting from the application of the provisions of this Directive. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: 1. ‘air traffic control service’ means a service provided for the purpose of preventing collisions between aircraft, and, on the manoeuvring area, between aircraft and obstructions, and expediting and maintaining an orderly flow of air traffic; 2. ‘air navigation service providers’ means any public or private entity providing air navigation services for general air traffic; 3. ‘general air traffic’ means all movements of civil aircraft, as well as all movements of State aircraft (including military, customs and police aircraft) when these movements are carried out in conformity with the procedures of the ICAO; 4. ‘licence’ means a certificate, by whatever name it may be known, issued and endorsed in accordance with this Directive and entitling its lawful holder to provide air traffic control services in accordance with the ratings and endorsements contained therein; 5. ‘rating’ means the authorisation entered on or associated with a licence and forming part thereof, stating specific conditions, privileges or limitations pertaining to such licence; the ratings on a licence are at least one of the following: (a) aerodrome control visual; (b) aerodrome control instrument; (c) approach control procedural; (d) approach control surveillance; (e) area control procedural; (f) area control surveillance; 6. ‘rating endorsement’ means the authorisation entered on and forming part of a licence, indicating the specific conditions, privileges or limitations pertaining to the relevant rating; 7. ‘unit endorsement’ means the authorisation entered on and forming part of a licence, indicating the ICAO location indicator and the sectors and/or working positions where the holder of the licence is competent to work; 8. ‘language endorsement’ means the authorisation entered on and forming part of a licence, indicating the language proficiency of the holder; 9. ‘instructor endorsement’ means the authorisation entered on and forming part of a licence, indicating the competence of the holder to give on-the-job training instruction; 10. ‘ICAO location indicator’ means the four-letter code group formulated in accordance with rules prescribed by ICAO in its manual DOC 7910 and assigned to the location of an aeronautical fixed station; 11. ‘sector’ means a part of a control area and/or part of a flight information region/upper region; 12. ‘training’ is the entirety of theoretical courses, practical exercises, including simulation, and on-the-job training required in order to acquire and maintain the skills to deliver safe, high quality air traffic control services; it consists of: (a) initial training, providing basic and rating training, leading to the grant of a student licence; (b) unit training, including transitional training prior to on-the-job training and on-the-job training, leading to the grant of an air traffic controller licence; (c) continuation training, keeping the endorsements of the licence valid; (d) training of on-the-job training instructors, leading to the grant of the instructor endorsement; (e) training of examiners and/or assessors; 13. ‘training provider’ is an organisation which has been certified by the relevant national supervisory authority to provide one or more types of training; 14. ‘Unit Competence Scheme’ is an approved scheme indicating the method by which the unit maintains the competence of its licence holders; 15. ‘Unit Training Plan’ is an approved plan detailing the processes and timing required to allow the unit procedures to be applied to the local area under the supervision of an on-the-job-training instructor. Article 3 National supervisory authorities 1. Member States shall nominate or establish a body or bodies as their national supervisory authority in order to assume the tasks assigned to such authority under this Directive. 2. The national supervisory authorities shall be independent of air navigation service providers and training providers. This independence shall be achieved through adequate separation, at the functional level at least, between the national supervisory authorities and such providers. Member States shall ensure that national supervisory authorities exercise their powers impartially and transparently. 3. Member States shall notify the Commission of the names and addresses of the national supervisory authorities, as well as any changes thereof, and of the measures taken to ensure compliance with paragraph 2. Article 4 Licensing principles 1. Without prejudice to Article 1(3), Member States shall ensure that air traffic control services within the scope of Article 1(2) are only provided by air traffic controllers licensed in accordance with this Directive. 2. Applicants for a licence shall prove that they are competent to act as air traffic controllers or as student air traffic controllers. The evidence demonstrating their competence shall relate to knowledge, experience, skills and linguistic proficiency. 3. The licence shall remain the property of the person to whom it is granted and who shall sign it. 4. In accordance with Article 14(1): (a) a licence, ratings or endorsements may be suspended when the competence of the air traffic controller is in doubt or in cases of misconduct; (b) a licence may be revoked in cases of gross negligence or abuse. 5. The student air traffic controller licence shall authorise the holder to provide air traffic control services under the supervision of an on-the-job-training instructor. 6. The licence shall include the items set out in Annex I. 7. When a licence is issued in a language other than English, it shall include an English translation of the items set out in Annex I. 8. Member States shall ensure that air traffic controllers are sufficiently trained in safety, security and crisis management. Article 5 Conditions for obtaining a licence 1. Student air traffic controller licences shall be granted to applicants who: (a) are at least 18 years old and are holders of at least a secondary education diploma or a diploma granting access to university or equivalent. Member States may provide that the national supervisory authority evaluate the educational standard of applicants who do not fulfil this educational requirement. If this evaluation demonstrates that an applicant has experience and education which gives him/her a reasonable prospect of completing air traffic controller training, this shall be regarded as sufficient; (b) have successfully completed approved initial training relevant to the rating, and rating endorsement if applicable, as set out in Part A of Annex II; (c) hold a valid medical certificate; and (d) have demonstrated an adequate level of linguistic proficiency in accordance with the requirements set out in Annex III. The licence shall contain at least one rating and one rating endorsement, if applicable. 2. Air traffic controller licences shall be granted to applicants who: (a) are at least 21 years old. However, Member States may provide for a lower age limit in duly justified cases; (b) are holders of a student licence and have completed an approved unit training plan and successfully passed the appropriate examinations or assessments in accordance with the requirements set out in Part B of Annex II; (c) hold a valid medical certificate; and (d) have demonstrated an adequate level of linguistic proficiency in accordance with the requirements set out in Annex III. The licence shall be validated by the inclusion of one or more ratings and the relevant rating, unit and language endorsements for which training was successfully completed. 3. The instructor endorsement shall be granted to holders of an air traffic controller licence who: (a) have provided air traffic control services for an immediately preceding period of at least one year, or such longer duration as is fixed by the national supervisory authority having regard to the ratings and endorsements for which instruction is given; and (b) have successfully completed an approved on-the-job training instructor course during which the required knowledge and pedagogical skills were assessed through appropriate examinations. Article 6 Air traffic controller ratings Licences shall contain one or more of the following ratings in order to indicate the type of service which the licence holder may provide: (a) the Aerodrome Control Visual rating (ADV), which shall indicate that the holder of the licence is competent to provide an air traffic control service to aerodrome traffic at an aerodrome that has no published instrument approach or departure procedures; (b) the Aerodrome Control Instrument rating (ADI), which shall indicate that the holder of the licence is competent to provide an air traffic control service to aerodrome traffic at an aerodrome that has published instrument approach or departure procedures and shall be accompanied by at least one of the rating endorsements described in Article 7(1); (c) the Approach Control Procedural rating (APP), which shall indicate that the holder of the licence is competent to provide an air traffic control service to arriving, departing or transiting aircraft without the use of surveillance equipment; (d) the Approach Control Surveillance rating (APS), which shall indicate that the holder of the licence is competent to provide an air traffic control service to arriving, departing or transiting aircraft with the use of surveillance equipment and shall be accompanied by at least one of the rating endorsements described in Article 7(2); (e) the Area Control Procedural rating (ACP), which shall indicate that the holder of the licence is competent to provide an air traffic control service to aircraft without the use of surveillance equipment; (f) the Area Control Surveillance rating (ACS), which shall indicate that the holder of the licence is competent to provide an air traffic control service to aircraft with the use of surveillance equipment and shall be accompanied by at least one of the rating endorsements described in Article 7(3). Article 7 Rating endorsements 1. The Aerodrome Control Instrument rating (ADI) shall bear at least one of the following endorsements: (a) the Tower Control endorsement (TWR), which shall indicate that the holder is competent to provide control services where aerodrome control is provided from one working position; (b) the Ground Movement Control endorsement (GMC), which shall indicate that the holder of the licence is competent to provide ground movement control; (c) the Ground Movement Surveillance endorsement (GMS), granted in addition to the Ground Movement Control endorsement or Tower Control endorsement, which shall indicate that the holder is competent to provide ground movement control with the help of aerodrome surface movement guidance systems; (d) The Air Control endorsement (AIR), which shall indicate that the holder of the licence is competent to provide air control; (e) The Aerodrome Radar Control endorsement (RAD), granted in addition to the Air Control endorsement or Tower Control endorsement, which shall indicate that the holder of the licence is competent to provide aerodrome control with the help of surveillance radar equipment. 2. The Approach Control Surveillance rating (APS) shall bear at least one of the following endorsements: (a) the Radar endorsement (RAD), which shall indicate that the holder of the licence is competent to provide an approach control service with the use of primary and/or secondary radar equipment; (b) the Precision Approach Radar endorsement (PAR), granted in addition to the Radar endorsement, which shall indicate that the holder of the licence is competent to provide ground-controlled precision approaches with the use of precision approach radar equipment to aircraft on the final approach to the runway; (c) the Surveillance Radar Approach endorsement (SRA), granted in addition to the Radar endorsement, which shall indicate that the holder is competent to provide ground-controlled non-precision approaches with the use of surveillance equipment to aircraft on the final approach to the runway; (d) the Automatic Dependent Surveillance endorsement (ADS), which shall indicate that the holder is competent to provide an approach control service with the use of automatic dependent surveillance; (e) the Terminal Control endorsement (TCL), granted in addition to the Radar or Automatic Dependent Surveillance endorsements, which shall indicate that the holder is competent to provide air traffic control services with the use of any surveillance equipment to aircraft operating in a specified terminal area and/or adjacent sectors. 3. The Area Control Surveillance rating (ACS) shall bear at least one of the following endorsements: (a) the Radar endorsement (RAD), which shall indicate that the holder is competent to provide area control services with the use of surveillance radar equipment; (b) the Automatic Dependent Surveillance endorsement (ADS), which shall indicate that the holder is competent to provide area control services with the use of automatic dependent surveillance; (c) the Terminal Control endorsement (TCL), granted in addition to the Radar or Automatic Dependent Surveillance endorsements, which shall indicate that the holder is competent to provide air traffic control services with the use of any surveillance equipment to aircraft operating in a specified terminal area and/or adjacent sectors; (d) the Oceanic Control (OCN) endorsement, which shall indicate that the holder is competent to provide air traffic control services to aircraft operating in an Oceanic Control Area. 4. Without prejudice to paragraphs 1, 2 and 3, Member States may, in exceptional cases which only arise due to particular characteristics of the air traffic in the airspace under their responsibility, develop national endorsements. Such endorsements shall not affect the overall freedom of movement of air traffic controllers. Article 8 Language endorsements 1. Member States shall ensure that air traffic controllers can demonstrate the ability to speak and understand English to a satisfactory standard. Their proficiency shall be determined in accordance with the language proficiency rating scale set out in Annex III. 2. Member States may impose local language requirements when deemed necessary for reasons of safety. 3. The level required in application of paragraphs 1 and 2 shall be level 4 of the language proficiency rating scale set out in Annex III. 4. Notwithstanding paragraph 3, Member States may require level five of the language proficiency rating scale set out in Annex III in application of paragraphs 1 and/or 2 where the operational circumstances of the particular rating or endorsement warrant a higher level for imperative reasons of safety. Such a requirement shall be objectively justified, non-discriminatory, proportionate and transparent. 5. Proficiency shall be demonstrated by a certificate issued after a transparent and objective assessment procedure approved by the national supervisory authority. Article 9 Instructor endorsements The instructor endorsement shall indicate that the holder of the licence is competent to provide training and supervision at a working position for areas covered by a valid rating. Article 10 Unit endorsements The unit endorsement shall indicate that the licence holder is competent to provide air traffic control services for a particular sector, group of sectors or working positions under the responsibility of an air traffic services unit. Member States may, when deemed necessary for reasons of safety, provide that the privileges of a unit endorsement are only exercised by licence holders below a given age. Article 11 Conditions for maintaining ratings and keeping endorsements valid 1. Unit endorsements shall be valid for an initial period of 12 months. The validity of such endorsements shall be extended for the following 12 months if the air navigation service provider demonstrates that: (a) the applicant has been exercising the privileges of the licence for a minimum number of hours, as indicated in the approved unit competence scheme, throughout the previous 12 months; (b) the applicant's competence has been assessed in accordance with Part C of Annex II; and (c) the applicant holds a valid medical certificate. The minimum number of working hours, leaving aside instruction tasks, required to maintain the validity of the unit endorsement may be reduced for on-the-job training instructors in proportion to the time spent instructing trainees on the working positions for which the extension is applied. 2. Where unit endorsements cease to be valid, a unit training plan must be successfully completed so as to revalidate the endorsement. 3. The holder of a rating or rating endorsement who has not been providing air traffic control services associated with that rating or rating endorsement for any period of four consecutive years may only commence unit training in that rating or rating endorsement after appropriate assessment as to whether he/she continues to satisfy the conditions of that rating or rating endorsement, and after satisfying any training requirements that result from this assessment. 4. The language proficiency of the applicant shall be formally evaluated at regular intervals, except in the case of applicants who have demonstrated proficiency level six. This interval shall be no longer than three years for applicants who demonstrate proficiency level four and no longer than six years for applicants who demonstrate proficiency level five. 5. The instructor endorsement shall be valid for a renewable period of 36 months. Article 12 Medical certificates 1. Medical certificates shall be issued by a competent medical body of the national supervisory authority or by medical examiners approved by the national supervisory authority. 2. The issuing of medical certificates shall be consistent with the provisions of Annex I to the Chicago Convention on International Civil Aviation and the Requirements for European Class 3 Medical Certification of Air Traffic Controllers laid down by Eurocontrol. 3. Medical certificates shall be valid from the date of the medical examination and for 24 months thereafter for air traffic controllers up to the age of 40 years and for 12 months above that age. The medical certificate may be revoked at any time if the medical condition of the holder so requires. 4. Member States shall ensure that effective review or appeal procedures are put in place with the appropriate involvement of independent medical advisors. 5. Member States shall ensure that procedures are established to deal with cases of reduced medical fitness and to enable licence holders to notify their employers that they are becoming aware of any decrease in medical fitness or are under the influence of any psychoactive substance or medicines which might render them unable to exercise the privileges of the licence safely and properly. Article 13 Certification of Training Providers 1. The provision of training to air traffic controllers, including related assessment procedures, shall be subject to certification by the national supervisory authorities. 2. The requirements for certification shall relate to technical and operational competence and suitability to organise training courses as set out in point 1 of Annex IV. 3. Applications for certification shall be submitted to the national supervisory authorities of the Member State where the applicant has its principal place of operation and, if any, its registered office. National supervisory authorities shall issue certificates when the applicant training provider fulfils the requirements laid down in point 1 of Annex IV. Certificates may be issued for each type of training or in combination with other air navigation services, whereby the type of training and the type of air navigation service shall be certified as a package of services. 4. Certificates shall specify the information referred to in point 2 of Annex IV. 5. National supervisory authorities shall monitor compliance with the requirements and conditions attached to the certificates. If a national supervisory authority finds that the holder of a certificate no longer satisfies such requirements or conditions, it shall take appropriate measures, which may include withdrawal of the certificate. 6. A Member State shall recognise certificates issued in another Member State. Article 14 Guarantee of compliance with competence standards 1. In order to ensure the levels of competence indispensable for air traffic controllers in order for them to perform their work to high safety standards, the Member States shall ensure that national supervisory authorities supervise and monitor their training. Their tasks shall include: (a) the issuing and revocation of licences, ratings and endorsements for which the relevant training and assessment was completed under the area of responsibility of the national supervisory authority; (b) the maintenance and suspension of ratings and endorsements, the privileges of which are exercised under the responsibility of the national supervisory authority; (c) the certification of training providers; (d) the approval of training courses, unit training plans and unit competence schemes; (e) the approval of competence examiners or competence assessors; (f) the monitoring and auditing of training systems; (g) the establishment of appropriate appeal and notification mechanisms. 2. National supervisory authorities shall provide appropriate information and mutual assistance to the national supervisory authorities of other Member States so as to ensure the effective application of this Directive, particularly in cases involving the free movement of air traffic controllers within the Community. 3. The national supervisory authorities shall ensure that a data base is maintained listing the competencies of all licence holders under their responsibility and the validity dates of their endorsements. To this end, operational units within air navigation service providers shall keep records of the hours effectively worked in the sectors, group of sectors or in the working positions for every licence holder working in the unit and shall provide this data to the national supervisory authorities on request. 4. The national supervisory authorities shall approve the licence holders who are entitled to act as competence examiners or competence assessors for unit and continuation training. Approval shall be valid for a renewable period of three years. 5. The national supervisory authorities shall audit the training providers on a regular basis with a view to guaranteeing effective compliance with the standards laid down in this Directive. In addition to the regular audit, the national supervisory authorities may make on-the-spot visits to check the effective implementation of this Directive and compliance with the standards contained therein. 6. National supervisory authorities may decide to delegate in full or in part the auditing functions and inspections mentioned in paragraph 5 of this Article to recognised organisations in accordance with Article 3 of Regulation (EC) No 550/2004. 7. Member States shall submit to the Commission a report on the application of this Directive by 17 May 2011 May and at three-yearly intervals thereafter. Article 15 Mutual recognition of air traffic controller licences 1. Subject to Article 8, each Member State shall recognise licences and their associated ratings, rating endorsements and language endorsements issued by the national supervisory authority of another Member State in accordance with the provisions of this Directive, as well as the accompanying medical certificates. However, a Member State may decide only to recognise licences of holders who have reached the minimum age limit of 21 as envisaged in Article 5(2)(a). 2. In cases where a licence holder exercises the privileges of the licence in a Member State other than that in which the licence was issued, the licence holder shall have the right to exchange his or her licence for a licence issued in the Member State where the privileges are exercised, without additional conditions being imposed. 3. In order to grant a unit endorsement, the national supervisory authorities shall require the applicant to fulfil the particular conditions associated with this endorsement, specifying the unit, sector or working position. When establishing the unit training plan, the training provider shall take due account of the acquired competencies and the experience of the applicant. 4. The national supervisory authorities shall approve and give a reasoned decision on the unit training plan containing the proposed training for the applicant not later than six weeks after presentation of the evidence, without prejudice to the delay resulting from any appeal that may be made. In their decisions, the national supervisory authorities shall ensure that the principles of non-discrimination and proportionality are respected. Article 16 Adaptation to technical or scientific progress In the light of technical or scientific progress, the Commission may adopt, in accordance with the procedure referred to in Article 17(2), amendments to the ratings in Article 6, the rating endorsements in Article 7, the provisions on medical certificates in Article 12(3) and the Annexes. Article 17 Committee 1. The Commission shall be assisted by the Single Sky Committee instituted by Article 5 of Regulation (EC) No 549/2004. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month. 3. The Committee shall adopt its rules of procedure. Article 18 Penalties The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 17 May 2008 and shall notify it without delay of any subsequent amendment affecting them. Article 19 Transitional arrangements Article 5(2)(a) and (b) shall not apply to holders of air traffic controller licences issued by Member States before 17 May 2008. Article 20 Transposition Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 May 2008 at the latest, with the exception of Article 8, for which the deadline shall be 17 May 2010. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Article 21 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 22 Addressees This Directive is addressed to the Member States.

32006L0025

2006

DIRECTIVE 2006/25/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2006 on the minimum health and safety requirements regarding the exposure of workers to risks arising from physical agents (artificial optical radiation) (19th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof, Having regard to the proposal from the Commission (1), presented after consultation with the Advisory Committee on Safety and Health at Work, Having regard to the opinion of the European Economic and Social Committee (2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 31 January 2006, Whereas: (1) Under the Treaty the Council may, by means of directives, adopt minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the health and safety of workers. Such directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized enterprises (SMEs). (2) The communication from the Commission concerning its action programme relating to the implementation of the Community Charter of the Fundamental Social Rights of Workers provides for the introduction of minimum health and safety requirements regarding the exposure of workers to the risks caused by physical agents. In September 1990 the European Parliament adopted a Resolution concerning this action programme (4), inviting the Commission in particular to draw up a specific directive on the risks caused by noise, vibration and any other physical agents at the workplace. (3) As a first step, the European Parliament and the Council adopted Directive 2002/44/EC of 25 June 2002 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (vibration) (16th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (5). Next, on 6 February 2003 the European Parliament and the Council adopted Directive 2003/10/EC on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (noise) (17th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (6). Thereafter, on 29 April 2004, the European Parliament and the Council adopted Directive 2004/40/EC on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (7). (4) It is now considered necessary to introduce measures protecting workers from the risks associated with optical radiation, owing to its effects on the health and safety of workers, in particular damage to the eyes and to the skin. These measures are intended not only to ensure the health and safety of each worker on an individual basis, but also to create a minimum basis of protection for all Community workers, in order to avoid possible distortions of competition. (5) One of the aims of this Directive is the timely detection of adverse health effects resulting from exposure to optical radiation. (6) This Directive lays down minimum requirements, thus giving Member States the option of maintaining or adopting more stringent provisions for the protection of workers, in particular the fixing of lower exposure limit values. The implementation of this Directive must not serve to justify any deterioration in the situation which already prevails in each Member State. (7) A system of protection against the hazards of optical radiation should limit itself to a definition, free of excessive detail, of the objectives to be attained, the principles to be observed and the basic values to be applied, in order to enable Member States to apply the minimum requirements in an equivalent manner. (8) The level of exposure to optical radiation can be more effectively reduced by incorporating preventive measures into the design of workstations and by selecting work equipment, procedures and methods so as to give priority to reducing the risks at source. Provisions relating to work equipment and methods thus contribute to the protection of the workers involved. In accordance with the general principles of prevention as laid down in Article 6(2) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (8), collective protection measures have priority over individual protection measures. (9) Employers should make adjustments in the light of technical progress and scientific knowledge regarding risks related to exposure to optical radiation, with a view to improving the safety and health protection of workers. (10) Since this Directive is an individual directive within the meaning of Article 16(1) of Directive 89/391/EEC, that Directive applies to the exposure of workers to optical radiation, without prejudice to more stringent and/or specific provisions contained in this Directive. (11) This Directive constitutes a practical step towards creating the social dimension of the internal market. (12) A complementary approach that both promotes the principle of better regulation and ensures a high level of protection can be achieved where the products made by the manufacturers of optical radiation sources and associated equipment comply with harmonised standards devised to protect the health and safety of users from the hazards inherent in such products; accordingly, it is not necessary for employers to repeat the measurements or calculations already undertaken by the manufacturer to determine compliance with the essential safety requirements of such equipment as specified in the applicable Community Directives, provided that the equipment has been properly and regularly maintained. (13) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (9). (14) Adherence to the exposure limit values should provide a high level of protection as regards the health effects that may result from exposure to optical radiation. (15) The Commission should draw up a practical guide to help employers, in particular managers of SMEs, better to understand the technical provisions of this Directive. The Commission should strive to complete this guide as quickly as possible so as to facilitate adoption by the Member States of the measures necessary to implement this Directive. (16) In accordance with paragraph 34 of the Interinstitutional Agreement on better law-making (10), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public, SECTION I GENERAL PROVISIONS Article 1 Aim and scope 1. This Directive, which is the 19th individual Directive within the meaning of Article 16(l) of Directive 89/391/EEC, lays down minimum requirements for the protection of workers from risks to their health and safety arising or likely to arise from exposure to artificial optical radiation during their work. 2. This Directive refers to the risk to the health and safety of workers due to adverse effects caused by exposure to artificial optical radiation to the eyes and to the skin. 3. Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or more specific provisions contained in this Directive. Article 2 Definitions For the purposes of this Directive, the following definitions shall apply: (a) optical radiation: any electromagnetic radiation in the wavelength range between 100 nm and 1 mm. The spectrum of optical radiation is divided into ultraviolet radiation, visible radiation and infrared radiation: (i) ultraviolet radiation: optical radiation of wavelength range between 100 nm and 400 nm. The ultraviolet region is divided into UVA (315-400 nm), UVB (280-315 nm) and UVC (100-280 nm); (ii) visible radiation: optical radiation of wavelength range between 380 nm and 780 nm; (iii) infrared radiation: optical radiation of wavelength range between 780 nm and 1 mm. The infrared region is divided into IRA (780-1 400 nm), IRB (1 400-3 000 nm) and IRC (3 000 nm-1 mm); (b) laser (light amplification by stimulated emission of radiation): any device which can be made to produce or amplify electromagnetic radiation in the optical radiation wavelength range primarily by the process of controlled stimulated emission; (c) laser radiation: optical radiation from a laser; (d) non-coherent radiation: any optical radiation other than laser radiation; (e) exposure limit values: limits on exposure to optical radiation which are based directly on established health effects and biological considerations. Compliance with these limits will ensure that workers exposed to artificial sources of optical radiation are protected against all known adverse health effects; (f) irradiance (E) or power density: the radiant power incident per unit area upon a surface expressed in watts per square metre (W m-2); (g) radiant exposure (H): the time integral of the irradiance, expressed in joules per square metre (J m-2); (h) radiance (L): the radiant flux or power output per unit solid angle per unit area, expressed in watts per square metre per steradian (W m — 2 sr-1); (i) level: the combination of irradiance, radiant exposure and radiance to which a worker is exposed. Article 3 Exposure limit values 1. The exposure limit values for non-coherent radiation, other than that emitted by natural sources of optical radiation, are as set out in Annex I. 2. The exposure limit values for laser radiation are as set out in Annex II. SECTION II OBLIGATIONS OF EMPLOYERS Article 4 Determination of exposure and assessment of risks 1. In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC, the employer, in the case of workers exposed to artificial sources of optical radiation, shall assess and, if necessary, measure and/or calculate the levels of exposure to optical radiation to which workers are likely to be exposed so that the measures needed to restrict exposure to the applicable limits can be identified and put into effect. The methodology applied in assessment, measurement and/or calculations shall follow the standards of the International Electrotechnical Commission (IEC) in respect of laser radiation and the recommendations of the International Commission on Illumination (CIE) and the European Committee for Standardisation (CEN) in respect of non-coherent radiation. In exposure situations which are not covered by these standards and recommendations, and until appropriate EU standards or recommendations become available, assessment, measurement and/or calculations shall be carried out using available national or international science-based guidelines. In both exposure situations, the assessment may take account of data provided by the manufacturers of the equipment when it is covered by relevant Community Directives. 2. The assessment, measurement and/or calculations referred to in paragraph 1 shall be planned and carried out by competent services or persons at suitable intervals, taking particular account of the provisions of Articles 7 and 11 of Directive 89/391/EEC concerning the necessary competent services or persons and the consultation and participation of workers. The data obtained from the assessment, including those obtained from the measurement and/or calculation of the level of exposure referred to in paragraph 1 shall be preserved in a suitable form so as to permit their consultation at a later stage. 3. Pursuant to Article 6(3) of Directive 89/391/EEC, the employer shall give particular attention, when carrying out the risk assessment, to the following: (a) the level, wavelength range and duration of exposure to artificial sources of optical radiation; (b) the exposure limit values referred to in Article 3 of this Directive; (c) any effects concerning the health and safety of workers belonging to particularly sensitive risk groups; (d) any possible effects on workers’ health and safety resulting from workplace interactions between optical radiation and photosensitising chemical substances; (e) any indirect effects such as temporary blinding, explosion or fire; (f) the existence of replacement equipment designed to reduce the levels of exposure to artificial optical radiation; (g) appropriate information obtained from health surveillance, including published information, as far as possible; (h) multiple sources of exposure to artificial optical radiation; (i) a classification applied to a laser as defined in accordance with the relevant IEC standard and, in relation to any artificial source likely to cause damage similar to that of a laser of class 3B or 4, any similar classification; (j) information provided by the manufacturers of optical radiation sources and associated work equipment in accordance with the relevant Community Directives. 4. The employer shall be in possession of an assessment of the risk in accordance with Article 9(1)(a) of Directive 89/391/EEC and shall identify which measures must be taken in accordance with Articles 5 and 6 of this Directive. The risk assessment shall be recorded on a suitable medium, according to national law and practice; it may include a justification by the employer that the nature and extent of the risks related to optical radiation make a further, detailed risk assessment unnecessary. The risk assessment shall be updated on a regular basis, particularly if there have been significant changes which could render it out of date, or if the results of health surveillance show it to be necessary. Article 5 Provisions aimed at avoiding or reducing risks 1. Taking account of technical progress and of the availability of measures to control the risk at source, the risks arising from exposure to artificial optical radiation shall be eliminated or reduced to a minimum. The reduction of risks arising from exposure to artificial optical radiation shall be based on the general principles of prevention set out in Directive 89/391/EEC. 2. Where the risk assessment carried out in accordance with Article 4(1) for workers exposed to artificial sources of optical radiation indicates any possibility that the exposure limit values may be exceeded, the employer shall devise and implement an action plan comprising technical and/or organisational measures designed to prevent the exposure exceeding the limit values, taking into account in particular: (a) other working methods that reduce the risk from optical radiation; (b) the choice of equipment emitting less optical radiation, taking account of the work to be done; (c) technical measures to reduce the emission of optical radiation including, where necessary, the use of interlocks, shielding or similar health protection mechanisms; (d) appropriate maintenance programmes for work equipment, workplaces and workstation systems; (e) the design and layout of workplaces and workstations; (f) limitation of the duration and level of the exposure; (g) the availability of appropriate personal protective equipment; (h) the instructions of the manufacturer of the equipment where it is covered by relevant Community Directives. 3. On the basis of the risk assessment carried out in accordance with Article 4, workplaces where workers could be exposed to levels of optical radiation from artificial sources exceeding the exposure limit values shall be indicated by appropriate signs in accordance with Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (9th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (11). The areas in question shall be identified, and access to them limited where this is technically possible and where there is a risk that the exposure limit values could be exceeded. 4. Workers shall not be exposed above the exposure limit values. In any event, if, despite the measures taken by the employer to comply with this Directive in respect of artificial sources of optical radiation, the exposure limit values are exceeded, the employer shall take immediate action to reduce exposure below the exposure limit values. The employer shall identify the reasons why the exposure limit values have been exceeded and shall adapt the protection and prevention measures accordingly in order to prevent them being exceeded again. 5. Pursuant to Article 15 of Directive 89/391/EEC, the employer shall adapt the measures referred to in this Article to the requirements of workers belonging to particularly sensitive risk groups. Article 6 Worker information and training Without prejudice to Articles 10 and 12 of Directive 89/391/EEC, the employer shall ensure that workers who are exposed to risks from artificial optical radiation at work and/or their representatives receive any necessary information and training relating to the outcome of the risk assessment provided for in Article 4 of this Directive, concerning in particular: (a) measures taken to implement this Directive; (b) the exposure limit values and the associated potential risks; (c) the results of the assessment, measurement and/or calculations of the levels of exposure to artificial optical radiation carried out in accordance with Article 4 of this Directive together with an explanation of their significance and potential risks; (d) how to detect adverse health effects of exposure and how to report them; (e) the circumstances in which workers are entitled to health surveillance; (f) safe working practices to minimise risks from exposure; (g) proper use of appropriate personal protective equipment. Article 7 Consultation and participation of workers Consultation and participation of workers and/or of their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC on the matters covered by this Directive. SECTION III MISCELLANEOUS PROVISIONS Article 8 Health surveillance 1. With the objectives of the prevention and timely detection of any adverse health effects, as well as the prevention of any long-term health risks and any risk of chronic diseases, resulting from exposure to optical radiation, Member States shall adopt provisions to ensure appropriate health surveillance of workers pursuant to Article 14 of Directive 89/391/EEC. 2. Member States shall ensure that health surveillance is carried out by a doctor, an occupational health professional or a medical authority responsible for health surveillance in accordance with national law and practice. 3. Member States shall establish arrangements to ensure that, for each worker who undergoes health surveillance in accordance with paragraph 1, individual health records are made and kept up to date. Health records shall contain a summary of the results of the health surveillance carried out. They shall be kept in a suitable form so as to permit consultation at a later date, taking into account any confidentiality. Copies of the appropriate records shall be supplied to the competent authority on request, taking into account any confidentiality. The employer shall take appropriate measures to ensure that the doctor, the occupational health professional or the medical authority responsible for the health surveillance, as determined by Member States as appropriate, has access to the results of the risk assessment referred to in Article 4 where such results may be relevant to the health surveillance. Individual workers shall, at their request, have access to their own personal health records. 4. In any event, where exposure above the limit values is detected, a medical examination shall be made available to the worker(s) concerned in accordance with national law and practice. This medical examination shall also be carried out where, as a result of health surveillance, a worker is found to have an identifiable disease or adverse health effect which is considered by a doctor or occupational health professional to be the result of exposure to artificial optical radiation at work. In both cases, when limit values are exceeded or adverse health effects (including diseases) are identified: (a) the worker shall be informed by the doctor or other suitably qualified person of the result which relates to him personally. He shall, in particular, receive information and advice regarding any health surveillance which he should undergo following the end of exposure; (b) the employer shall be informed of any significant findings of the health surveillance, taking into account any medical confidentiality; (c) the employer shall: — review the risk assessment carried out pursuant to Article 4, — review the measures provided for to eliminate or reduce risks pursuant to Article 5, — take into account the advice of the occupational health professional or other suitably qualified person or the competent authority in implementing any measure required to eliminate or reduce risk in accordance with Article 5, and — arrange continued health surveillance and provide for a review of the health status of any other worker who has been similarly exposed. In such cases, the competent doctor or occupational health professional or the competent authority may propose that the exposed persons undergo a medical examination. Article 9 Penalties Member States shall provide for adequate penalties to be applicable in the event of infringement of the national legislation adopted pursuant to this Directive. These penalties must be effective, proportionate and dissuasive. Article 10 Technical amendments 1. Any modification of the exposure limit values set out in the Annexes shall be adopted by the European Parliament and the Council in accordance with the procedure laid down in Article 137(2) of the Treaty. 2. Amendments to the Annexes of a strictly technical nature in line with: (a) the adoption of Directives in the field of technical harmonisation and standardisation with regard to the design, building, manufacture or construction of work equipment and/or workplaces; (b) technical progress, changes in the most relevant harmonised European standards or international specifications, and new scientific findings concerning occupational exposure to optical radiation, shall be adopted in accordance with the procedure laid down in Article 11(2). Article 11 Committee 1. The Commission shall be assisted by the Committee referred to in Article 17 of Directive 89/391/EEC. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. SECTION IV FINAL PROVISIONS Article 12 Reports Every five years Member States shall provide the Commission with a report on the practical implementation of this Directive, indicating the points of view of the social partners. Every five years the Commission shall inform the European Parliament, the Council, the European Economic and Social Committee and the Advisory Committee on Safety and Health at Work of the content of these reports, of its assessment of these reports, of developments in the field in question and of any action that may be warranted in the light of new scientific knowledge. Article 13 Practical guide In order to facilitate implementation of this Directive the Commission shall draw up a practical guide to the provisions of Articles 4 and 5 and Annexes I and II. Article 14 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 27 April 2010. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt or have already adopted in the field covered by this Directive. Article 15 Entry into force This Directive shall enter into force on the day of its publication in the Official Journal of the European Union. Article 16 Addressees This Directive is addressed to the Member States.

32006L0032

2006

DIRECTIVE 2006/32/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2006 on energy end-use efficiency and energy services and repealing Council Directive 93/76/EEC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) In the Community there is a need for improved energy end-use efficiency, managed demand for energy and promotion of the production of renewable energy, as there is relatively limited scope for any other influence on energy supply and distribution conditions in the short to medium term, either through the building of new capacity or through the improvement of transmission and distribution. This Directive thus contributes to improved security of supply. (2) Improved energy end-use efficiency will also contribute to the reduction of primary energy consumption, to the mitigation of CO2 and other greenhouse gas emissions and thereby to the prevention of dangerous climate change. These emissions continue to increase, making it more and more difficult to meet the Kyoto commitments. Human activities attributed to the energy sector cause as much as 78 % of the Community greenhouse gas emissions. The Sixth Community Environment Action Programme, laid down by Decision No 1600/2002/EC of the European Parliament and of the Council (4), envisages that further reductions are required to achieve the United Nations Framework Convention on Climate Change long-term objective of stabilising greenhouse gas concentrations in the atmosphere at a level that would prevent dangerous anthropogenic interference with the climate system. Therefore, concrete policies and measures are necessary. (3) Improved energy end-use efficiency will make it possible to exploit potential cost-effective energy savings in an economically efficient way. Energy efficiency improvement measures could realise these energy savings and thus help the Community reduce its dependence on energy imports. Furthermore, a move towards more energy-efficient technologies can boost the Community's innovativeness and competitiveness as underlined in the Lisbon strategy. (4) The Communication from the Commission on the implementation of the first phase of the European Climate Change Programme listed a directive on energy demand management as one of the priority climate change measures to be taken at Community level. (5) This Directive is consistent with Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity (5) and with Directive 2003/55/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in natural gas (6), which provide for the possibility of using energy efficiency and demand-side management as alternatives to new supply and for environmental protection, allowing Member State authorities, inter alia, to tender for new capacity or to opt for energy efficiency and demand-side measures, including systems for white certificates. (6) This Directive is without prejudice to Article 3 of Directive 2003/54/EC, which requires that Member States ensure that all household customers and, where Member States deem it appropriate, small enterprises, enjoy universal service, that is the right to be supplied with electricity of a specified quality within their territory at reasonable, easily and clearly comparable, and transparent prices. (7) The aim of this Directive is not only to continue to promote the supply side of energy services, but also to create stronger incentives for the demand side. The public sector in each Member State should thus set a good example regarding investments, maintenance and other expenditure on energy-using equipment, energy services and other energy efficiency improvement measures. Therefore, the public sector should be encouraged to integrate energy efficiency improvement considerations into its investments, depreciation allowances and operating budgets. Furthermore, the public sector should endeavour to use energy efficiency criteria in tendering procedures for public procurement, a practice allowed under Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors (7) , and Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (8), the principle of which was confirmed by the judgment of 17 September 2002 of the Court of Justice in Case C-513/99 (9). In view of the fact that administrative structures vary widely between Member States, the different types of measures which the public sector may take should be taken at the appropriate national, regional and/or local level. (8) There is a large variety of ways in which the public sector can fulfil its exemplary role: besides the applicable measures listed in Annex III and VI, the public sector may, for example, initiate energy-efficiency pilot projects and stimulate energy-efficient behaviour of employees. In order to achieve the desired multiplier effect, a number of such actions should be communicated in an effective way to individual citizens and/or to companies, whilst emphasising the cost benefits. (9) The liberalisation of the retail markets for final customers for electricity, natural gas, coal and lignite, heating, and in some cases even district heating and cooling, has almost exclusively led to improved efficiency and lower costs on the energy generation, transformation and distribution side. This liberalisation has not led to significant competition in products and services which could have resulted in improved energy efficiency on the demand side. (10) In its Resolution of 7 December 1998 on energy efficiency in the European Community (10), the Council endorsed a target for the Community as a whole to improve energy intensity of final consumption by an additional one percentage point per annum up to the year 2010. (11) Member States should therefore adopt national indicative targets to promote energy end‐use efficiency and to ensure the continued growth and viability of the market for energy services, and thus contribute to the implementation of the Lisbon strategy. The adoption of national indicative targets to promote energy end-use efficiency provides effective synergy with other Community legislation that will, when applied, contribute to the achievement of those national targets. (12) This Directive requires action to be undertaken by the Member States, with the fulfilment of its objectives depending on the effects that such action has on the final consumers of energy. The end result of Member States’ action is dependent on many external factors which influence the behaviour of consumers as regards their energy use and their willingness to implement energy saving methods and use energy saving devices. Therefore, even though Member States commit themselves to making efforts to achieve the target figure of 9 %, the national energy savings target is indicative in nature and entails no legally enforceable obligation for Member States to achieve it. (13) In aiming to achieve their national indicative target, Member States may set themselves a target higher than 9 %. (14) The improvement of energy efficiency will benefit from an exchange of information, experience and best practice at all levels, including, in particular, the public sector. Therefore, Member States should list measures undertaken in the context of this Directive, and review their effect as far as possible, in energy efficiency action plans. (15) When striving for energy efficiency on the basis of technological, behavioural and/or economic changes, substantial negative environmental impact should be avoided, and social priorities should be respected. (16) The funding of supply and the costs of the demand side have an important role to play in energy services. The creation of funds to subsidise the implementation of energy efficiency programmes and other energy efficiency improvement measures and to promote the development of a market for energy services can constitute an appropriate tool for the provision of non-discriminatory start-up funding in such a market. (17) Improved energy end-use efficiency can be achieved by increasing the availability of and demand for energy services or by other energy efficiency improvement measures. (18) In order to realise the energy savings potential in certain market segments where energy audits are generally not sold commercially, such as households, Member States should ensure the availability of energy audits. (19) The Council Conclusions of 5 December 2000 list the promotion of energy services through the development of a Community strategy as a priority area for action to improve energy efficiency. (20) Energy distributors, distribution system operators and retail energy sales companies can improve energy efficiency in the Community if the energy services they market include efficient end-use, such as indoor thermal comfort, domestic hot water, refrigeration, product manufacturing, illumination and motive power. Profit maximisation for energy distributors, distribution system operators and retail energy sales companies thus becomes more closely related to selling energy services to as many customers as possible than to selling as much energy as possible to each customer. Member States should endeavour to avoid any distortion of competition in this area, in order to guarantee a level playing field between all energy service providers; they can, however, delegate this task to the national regulator. (21) Taking full account of the national organisation of market actors in the energy sector and in order to favour the implementation of energy services and of the measures to improve energy efficiency provided for in this Directive, Member States should have the option of making it compulsory for energy distributors, distribution system operators or retail energy sales companies or, where appropriate, for two or all of these market actors, to provide such services and to participate in such measures. (22) The use of third-party financing arrangements is an innovate practice that should be stimulated. In these, the beneficiary avoids investment costs by using part of the financial value of energy savings that result from the third party's investment to repay the third party's investment and interest costs. (23) With a view to making tariffs and other regulations for net-bound energy more conducive to efficient energy end-use, unjustifiable volume-driving incentives should be removed. (24) The promotion of the market for energy services can be achieved by a variety of means, including non-financial ones. (25) The energy services, energy efficiency improvement programmes and other energy efficiency improvement measures put into effect to reach the energy savings target may be supported and/or implemented through voluntary agreements between stakeholders and public sector bodies appointed by the Member States. (26) The voluntary agreements which are covered by this Directive should be transparent and contain, where applicable, information on at least the following issues: quantified and staged objectives, monitoring and reporting. (27) The motor fuel and transport sectors have an important role to play regarding energy efficiency and energy savings. (28) In defining energy efficiency improvement measures, account should be taken of efficiency gains obtained through the widespread use of cost-effective technological innovations, for instance electronic metering. In the context of this Directive, competitively priced individual meters include accurate calorimeters. (29) In order to enable final consumers to make better-informed decisions as regards their individual energy consumption, they should be provided with a reasonable amount of information thereon and with other relevant information, such as information on available energy efficiency improvement measures, comparative final consumer profiles or objective technical specifications for energy-using equipment, which may include ‘Factor Four’ or similar equipment. It is recalled that some such valuable information should already be made available to final customers under Article 3(6) of Directive 2003/54/EC. In addition, consumers should be actively encouraged to check their own meter readings regularly. (30) All types of information relating to energy-efficiency should be widely disseminated in an appropriate form, including through billing, to relevant target audiences. This can include information on financial and legal frameworks, communication and promotion campaigns, and the widespread exchange of best practice at all levels. (31) With the adoption of this Directive, all substantive provisions of Council Directive 93/76/EEC of 13 September 1993 to limit carbon dioxide emissions by improving energy efficiency (SAVE) (11) are covered by other Community legislation and therefore Directive 93/76/EEC should be repealed. (32) Since the objectives of this Directive, namely to promote energy end-use efficiency and to develop a market for energy services, cannot be sufficiently achieved by the Member States and can be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (33) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12), CHAPTER I SUBJECT MATTER AND SCOPE Article 1 Purpose The purpose of this Directive is to enhance the cost-effective improvement of energy end-use efficiency in the Member States by: (a) providing the necessary indicative targets as well as mechanisms, incentives and institutional, financial and legal frameworks to remove existing market barriers and imperfections that impede the efficient end use of energy; (b) creating the conditions for the development and promotion of a market for energy services and for the delivery of other energy efficiency improvement measures to final consumers. Article 2 Scope This Directive shall apply to: (a) providers of energy efficiency improvement measures, energy distributors, distribution system operators and retail energy sales companies. However, Member States may exclude small distributors, small distribution system operators and small retail energy sales companies from the application of Articles 6 and 13; (b) final customers. However, this Directive shall not apply to those undertakings involved in categories of activities listed in Annex I to Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community (13); (c) the armed forces, only to the extent that its application does not cause any conflict with the nature and primary aim of the activities of the armed forces and with the exception of material used exclusively for military purposes. Article 3 Definitions For the purposes of this Directive, the following definitions shall apply: (a) ‘energy’: all forms of commercially available energy, including electricity, natural gas (including liquefied natural gas), liquefied petroleum gas, any fuel for heating and cooling (including district heating and cooling), coal and lignite, peat, transport fuels (excluding aviation and maritime bunker fuels) and biomass as defined in Directive 2001/77/EC of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market (14); (b) ‘energy efficiency’: a ratio between an output of performance, service, goods or energy, and an input of energy; (c) ‘energy efficiency improvement’: an increase in energy end-use efficiency as a result of technological, behavioural and/or economic changes; (d) ‘energy savings’: an amount of saved energy determined by measuring and/or estimating consumption before and after implementation of one or more energy efficiency improvement measures, whilst ensuring normalisation for external conditions that affect energy consumption; (e) ‘energy service’: the physical benefit, utility or good derived from a combination of energy with energy efficient technology and/or with action, which may include the operations, maintenance and control necessary to deliver the service, which is delivered on the basis of a contract and in normal circumstances has proven to lead to verifiable and measurable or estimable energy efficiency improvement and/or primary energy savings; (f) ‘energy efficiency mechanisms’: general instruments used by governments or government bodies to create a supportive framework or incentives for market actors to provide and purchase energy services and other energy efficiency improvement measures; (g) ‘energy efficiency improvement programmes’: activities that focus on groups of final customers and that normally lead to verifiable and measurable or estimable energy efficiency improvement; (h) ‘energy efficiency improvement measures’: all actions that normally lead to verifiable and measurable or estimable energy efficiency improvement; (i) ‘energy service company’ (ESCO): a natural or legal person that delivers energy services and/or other energy efficiency improvement measures in a user's facility or premises, and accepts some degree of financial risk in so doing. The payment for the services delivered is based (either wholly or in part) on the achievement of energy efficiency improvements and on the meeting of the other agreed performance criteria; (j) ‘energy performance contracting’: a contractual arrangement between the beneficiary and the provider (normally an ESCO) of an energy efficiency improvement measure, where investments in that measure are paid for in relation to a contractually agreed level of energy efficiency improvement; (k) ‘third-party financing’: a contractual arrangement involving a third party — in addition to the energy supplier and the beneficiary of the energy efficiency improvement measure — that provides the capital for that measure and charges the beneficiary a fee equivalent to a part of the energy savings achieved as a result of the energy efficiency improvement measure. That third party may or may not be an ESCO; (l) ‘energy audit’: a systematic procedure to obtain adequate knowledge of the existing energy consumption profile of a building or group of buildings, of an industrial operation and/or installation or of a private or public service, identify and quantify cost‐effective energy savings opportunities, and report the findings; (m) ‘financial instruments for energy savings’: all financial instruments such as funds, subsidies, tax rebates, loans, third-party financing, energy performance contracting, guarantee of energy savings contracts, energy outsourcing and other related contracts that are made available to the market place by public or private bodies in order to cover partly or totally the initial project cost for implementing energy efficiency improvement measures; (n) ‘final customer’: a natural or legal person that purchases energy for his own end use; (o) ‘energy distributor’: a natural or legal person responsible for transporting energy with a view to its delivery to final customers and to distribution stations that sell energy to final customers. This definition excludes electricity and natural gas distribution system operators, covered in point (p); (p) ‘distribution system operator’: a natural or legal person responsible for operating, ensuring the maintenance of and, if necessary, developing the distribution system of electricity or natural gas in a given area and, where applicable, its interconnections with other systems, and for ensuring the long term ability of the system to meet reasonable demands for the distribution of electricity or natural gas; (q) ‘retail energy sales company’: a natural or legal person that sells energy to final customers; (r) ‘small distributor, small distribution system operator and small retail energy sales company’: a natural or legal person that distributes or sells energy to final customers, and that distributes or sells less than the equivalent of 75 GWh energy per year or employs fewer than 10 persons or whose annual turnover and/or annual balance sheet total does not exceed EUR 2 000 000; (s) ‘white certificates’: certificates issued by independent certifying bodies confirming the energy savings claims of market actors as a consequence of energy efficiency improvement measures. CHAPTER II ENERGY SAVINGS TARGETS Article 4 General target 1. Member States shall adopt and aim to achieve an overall national indicative energy savings target of 9 % for the ninth year of application of this Directive, to be reached by way of energy services and other energy efficiency improvement measures. Member States shall take cost-effective, practicable and reasonable measures designed to contribute towards achieving this target. This national indicative energy savings target shall be set and calculated in accordance with the provisions and methodology set out in Annex I. For purposes of comparison of energy savings and for conversion to a comparable unit, the conversion factors set out in Annex II shall apply unless the use of other conversion factors can be justified. Examples of eligible energy efficiency improvement measures are given in Annex III. A general framework for the measurement and verification of energy savings is given in Annex IV. The national energy savings in relation to the national indicative energy savings target shall be measured as from 1 January 2008. 2. For the purpose of the first Energy Efficiency Action Plan (EEAP) to be submitted in accordance with Article 14, each Member State shall establish an intermediate national indicative energy savings target for the third year of application of this Directive, and provide an overview of its strategy for the achievement of the intermediate and overall targets. This intermediate target shall be realistic and consistent with the overall national indicative energy savings target referred to in paragraph 1. The Commission shall give an opinion on whether the intermediate national indicative target appears realistic and consistent with the overall target. 3. Each Member State shall draw up programmes and measures to improve energy efficiency. 4. Member States shall assign to one or more new or existing authorities or agencies the overall control and responsibility for overseeing the framework set up in relation to the target mentioned in paragraph 1. These bodies shall thereafter verify the energy savings as a result of energy services and other energy efficiency improvement measures, including existing national energy efficiency improvement measures, and report the results. 5. After having reviewed and reported on the first three years of application of this Directive, the Commission shall examine whether it is appropriate to come forward with a proposal for a directive to further develop the market approach in energy efficiency improvement by means of white certificates. Article 5 Energy end-use efficiency in the public sector 1. Member States shall ensure that the public sector fulfils an exemplary role in the context of this Directive. To this end, they shall communicate effectively the exemplary role and actions of the public sector to citizens and/or companies, as appropriate. Member States shall ensure that energy efficiency improvement measures are taken by the public sector, focussing on cost-effective measures which generate the largest energy savings in the shortest span of time. Such measures shall be taken at the appropriate national, regional and/or local level, and may consist of legislative initiatives and/or voluntary agreements, as referred to in Article 6(2)(b), or other schemes with an equivalent effect. Without prejudice to national and Community public procurement legislation: — at least two measures shall be used from the list set out in Annex VI; — Member States shall facilitate this process by publishing guidelines on energy efficiency and energy savings as a possible assessment criterion in competitive tendering for public contracts. Member States shall facilitate and enable the exchange of best practices between public sector bodies, for example on energy-efficient public procurement practices, both at the national and international level; to this end, the organisation referred to in paragraph 2 shall cooperate with the Commission with regard to the exchange of best practice as referred to in Article 7(3). 2. Member States shall assign to a new or existing organisation or organisations the administrative, management and implementing responsibility for the integration of energy efficiency improvement requirements as set out in paragraph 1. These may be the same authorities or agencies as those referred to in Article 4(4). CHAPTER III PROMOTION OF ENERGY END-USE EFFICIENCY AND ENERGY SERVICES Article 6 Energy distributors, distribution system operators and retail energy sales companies 1. Member States shall ensure that energy distributors, distribution system operators and/or retail energy sales companies: (a) provide on request, but not more than once a year, aggregated statistical information on their final customers to the authorities or agencies referred to in Article 4(4) or to another designated body, provided that the latter in turn transmits to the former the information received. This information must be sufficient to properly design and implement energy efficiency improvement programmes, and to promote and monitor energy services and other energy efficiency improvement measures. It may include historical information and must include current information on end-user consumption, including, where applicable, load profiles, customer segmentation and geographical location of customers, while preserving the integrity and confidentiality of information that is either of private character or commercially sensitive, in compliance with applicable Community legislation; (b) refrain from any activities that might impede the demand for and delivery of energy services and other energy efficiency improvement measures, or hinder the development of markets for energy services and other energy efficiency improvement measures. The Member State concerned shall take the necessary measures to bring such activities to an end where they occur. 2. Member States shall: (a) choose one or more of the following requirements to be complied with by energy distributors, distribution system operators and/or retail energy sales companies, directly and/or indirectly through other providers of energy services or energy efficiency improvement measures: (i) ensure the offer to their final customers, and the promotion, of competitively priced energy services; or (ii) ensure the availability to their final customers, and the promotion, of competitively-priced energy audits conducted in an independent manner and/or energy efficiency improvement measures, in accordance with Article 9(2) and Article 12; or (iii) contribute to the funds and funding mechanisms referred to in Article 11. The level of such contributions shall as a minimum correspond to the estimated costs of offering any of the activities referred to in this paragraph and shall be agreed with the authorities or agencies referred to in Article 4(4); and/or (b) ensure that voluntary agreements and/or other market-oriented schemes, such as white certificates, with an effect equivalent to one or more of the requirements referred to in point (a) exist or are set up. Voluntary agreements shall be assessed, supervised and followed up by the Member State in order to ensure that they have in practice an effect equivalent to one or more of the requirements referred to in point (a). To that end, the voluntary agreements shall have clear and unambiguous objectives, and monitoring and reporting requirements linked to procedures that can lead to revised and/or additional measures when the objectives are not achieved or are not likely to be achieved. With a view to ensuring transparency, the voluntary agreements shall be made available to the public and published prior to application to the extent that applicable confidentiality provisions allow, and contain an invitation for stakeholders to comment. 3. Member States shall ensure that there are sufficient incentives, equal competition and level playing fields for market actors other than energy distributors, distribution system operators and retail energy sales companies, such as ESCOs, installers, energy advisors and energy consultants, to independently offer and implement the energy services, energy audits and energy efficiency improvement measures described in paragraph 2(a)(i) and (ii). 4. Under paragraphs 2 and 3, Member States may place responsibilities on distribution system operators only if this is consistent with the requirements relating to the unbundling of accounts laid down in Article 19(3) of Directive 2003/54/EC and in Article 17(3) of Directive 2003/55/EC. 5. The implementation of this Article shall be without prejudice to derogations or exemptions granted under Directives 2003/54/EC and 2003/55/EC. Article 7 Availability of information 1. Member States shall ensure that information on energy efficiency mechanisms and financial and legal frameworks adopted with the aim of reaching the national indicative energy savings target is transparent and widely disseminated to the relevant market actors. 2. Member States shall ensure that greater efforts are made to promote energy end-use efficiency. They shall establish appropriate conditions and incentives for market operators to provide more information and advice to final customers on energy end-use efficiency. 3. The Commission shall ensure that information on best energy-saving practices in Member States is exchanged and widely disseminated. Article 8 Availability of qualification, accreditation and certification schemes With a view to achieving a high level of technical competence, objectivity and reliability, Member States shall ensure, where they deem it necessary, the availability of appropriate qualification, accreditation and/or certification schemes for providers of energy services, energy audits and energy efficiency improvement measures as referred to in Article 6(2)(a) (i) and (ii). Article 9 Financial instruments for energy savings 1. Member States shall repeal or amend national legislation and regulations, other than those of a clearly fiscal nature, that unnecessarily or disproportionately impede or restrict the use of financial instruments for energy savings in the market for energy services or other energy efficiency improvement measures. 2. Member States shall make model contracts for those financial instruments available to existing and potential purchasers of energy services and other energy efficiency improvement measures in the public and private sectors. These may be issued by the authority or agency referred to in Article 4(4). Article 10 Energy efficient tariffs and other regulations for net-bound energy 1. Member States shall ensure the removal of those incentives in transmission and distribution tariffs that unnecessarily increase the volume of distributed or transmitted energy. In this respect, in accordance with Article 3(2) of Directive 2003/54/EC and with Article 3(2) of Directive 2003/55/EC, Member States may impose public service obligations relating to energy efficiency on undertakings operating in the electricity and gas sectors respectively. 2. Member States may permit components of schemes and tariff structures with a social aim, provided that any disruptive effects on the transmission and distribution system are kept to the minimum necessary and are not disproportionate to the social aim. Article 11 Funds and funding mechanisms 1. Without prejudice to Articles 87 and 88 of the Treaty, Member States may establish a fund or funds to subsidise the delivery of energy efficiency improvement programmes and other energy efficiency improvement measures and to promote the development of a market for energy efficiency improvement measures. Such measures shall include the promotion of energy auditing, financial instruments for energy savings and, where appropriate, improved metering and informative billing. The funds shall also target end-use sectors with higher transaction costs and higher risks. 2. If established, the funds may provide for grants, loans, financial guarantees and/or other types of financing that guarantee results. 3. The funds shall be open to all providers of energy efficiency improvement measures, such as ESCOs, independent energy advisors, energy distributors, distribution system operators, retail energy sales companies and installers. Member States may decide to open the funds to all final customers. Tendering or equivalent methods which ensure complete transparency shall be carried out in full compliance with applicable public procurement regulations. Member States shall ensure that such funds complement, and do not compete with, commercially-financed energy efficiency improvement measures. Article 12 Energy audits 1. Member States shall ensure the availability of efficient, high-quality energy audit schemes which are designed to identify potential energy efficiency improvement measures and which are carried out in an independent manner, to all final consumers, including smaller domestic, commercial and small and medium-sized industrial customers. 2. Market segments that have higher transaction costs and non-complex facilities may be reached by other measures such as questionnaires and computer programmes made available on the Internet and/or sent to customers by mail. Member States shall ensure the availability of energy audits for market segments where they are not sold commercially, taking into account Article 11(1). 3. Certification in accordance with Article 7 of Directive 2002/91/EC of the European Parliament and of the Council of 16 December 2002 on the energy performance of buildings (15) shall be regarded as equivalent to an energy audit meeting the requirements set out in paragraphs 1 and 2 of this Article and as equivalent to an energy audit as referred to in Annex VI(e) to this Directive. Furthermore, audits resulting from schemes based on voluntary agreements between organisations of stakeholders and an appointed body, supervised and followed up by the Member State concerned in accordance with Article 6(2)(b) of this Directive, shall likewise be considered as having fulfilled the requirements set out in paragraphs 1 and 2 of this Article. Article 13 Metering and informative billing of energy consumption 1. Member States shall ensure that, in so far as it is technically possible, financially reasonable and proportionate in relation to the potential energy savings, final customers for electricity, natural gas, district heating and/or cooling and domestic hot water are provided with competitively priced individual meters that accurately reflect the final customer's actual energy consumption and that provide information on actual time of use. When an existing meter is replaced, such competitively priced individual meters shall always be provided, unless this is technically impossible or not cost-effective in relation to the estimated potential savings in the long term. When a new connection is made in a new building or a building undergoes major renovations, as set out in Directive 2002/91/EC, such competitively priced individual meters shall always be provided. 2. Member States shall ensure that, where appropriate, billing performed by energy distributors, distribution system operators and retail energy sales companies is based on actual energy consumption, and is presented in clear and understandable terms. Appropriate information shall be made available with the bill to provide final customers with a comprehensive account of current energy costs. Billing on the basis of actual consumption shall be performed frequently enough to enable customers to regulate their own energy consumption. 3. Member States shall ensure that, where appropriate, the following information is made available to final customers in clear and understandable terms by energy distributors, distribution system operators or retail energy sales companies in or with their bills, contracts, transactions, and/or receipts at distribution stations: (a) current actual prices and actual consumption of energy; (b) comparisons of the final customer's current energy consumption with consumption for the same period in the previous year, preferably in graphic form; (c) wherever possible and useful, comparisons with an average normalised or benchmarked user of energy in the same user category; (d) contact information for consumers’ organisations, energy agencies or similar bodies, including website addresses, from which information may be obtained on available energy efficiency improvement measures, comparative end-user profiles and/or objective technical specifications for energy-using equipment. CHAPTER IV FINAL PROVISIONS Article 14 Reports 1. Member States that already use, for whatever purpose, calculation methods for measuring energy savings similar to those described in Annex IV at the time of the entry into force of this Directive may submit information at the appropriate level of detail to the Commission. Such submissions shall take place as soon as possible, preferably not later than 17 November 2006. This information will enable the Commission to take due account of existing practices. 2. Member States shall submit to the Commission the following EEAPs: — a first EEAP not later than 30 June 2007; — a second EEAP not later than 30 June 2011; — a third EEAP not later than 30 June 2014. All EEAPs shall describe the energy efficiency improvement measures planned to reach the targets set out in Article 4(1) and (2), as well as to comply with the provisions on the exemplary role of the public sector and provision of information and advice to final customers set out in Articles 5(1) and 7(2) respectively. The second and third EEAPs shall: — include a thorough analysis and evaluation of the preceding EEAP; — include the final results with regard to the fulfilment of the energy savings targets set out in Article 4(1) and (2); — include plans for — and information on the anticipated effects of — additional measures which address any existing or expected shortfall vis-à-vis the target; — in accordance with Article 15(4), use and gradually increase the use of harmonised efficiency indicators and benchmarks, both for the evaluation of past measures and estimated effects of planned future measures; — be based on available data, supplemented with estimates. 3. Not later than 17 May 2008, the Commission shall publish a cost/benefit impact assessment examining the linkages between EU standards, regulations, policies and measures on end‐use energy efficiency. 4. The EEAPs shall be assessed in accordance with the procedure referred to in Article 16(2): — the first EEAPs shall be reviewed before 1 January 2008; — the second EEAPs shall be reviewed before 1 January 2012; — the third EEAPs shall be reviewed before 1 January 2015. 5. On the basis of the EEAPs, the Commission shall assess the extent to which Member States have made progress towards achieving their national indicative energy savings targets. The Commission shall publish reports with its conclusions: — on the first EEAPs before 1 January 2008; — on the second EEAPs before 1 January 2012; — on the third EEAPs before 1 January 2015. These reports shall include information on related action at Community level, including legislation currently in force and future legislation. The reports shall take into account the benchmarking system referred to in Article 15(4), identify best practices, identify cases where Member States and/or the Commission are not making enough progress, and may contain recommendations. The second report shall be followed, as appropriate and where necessary, by proposals to the European Parliament and to the Council for additional measures including a possible extension of the period of application of targets. If the report concludes that insufficient progress has been made towards achieving the national indicative targets, these proposals shall address the level and nature of the targets. Article 15 Review and adaptation of the framework 1. The values and calculation methods referred to in Annexes II, III, IV and V shall be adapted to technical progress in accordance with the procedure referred to in Article 16(2). 2. Before 1 January 2008, the Commission, in accordance with the procedure referred to in Article 16(2), shall further refine and complement as required points 2 to 6 of Annex IV, whilst respecting the general framework set out in Annex IV. 3. Before 1 January 2012, the Commission, in accordance with the procedure referred to in Article 16(2), shall raise the percentage of harmonised bottom-up calculations used in the harmonised calculation model referred to in point 1 of Annex IV, without prejudice to those Member State schemes that already use a higher percentage. The new harmonised calculation model with a significantly higher percentage of bottom-up calculations shall first be used as from 1 January 2012. Wherever practicable and possible, the measurement of total savings over the total period of application of the Directive shall use this harmonised calculation model, without prejudice to those Member State schemes that use a higher percentage of bottom-up calculations. 4. Not later than 30 June 2008, the Commission, in accordance with the procedure set out in Article 16(2), shall develop a set of harmonised energy efficiency indicators and benchmarks based upon them, taking into account available data or data that can be collected in a cost-effective manner for each Member State. For the development of these harmonised energy efficiency indicators and benchmarks the Commission shall use as a reference guide the indicative list set out in Annex V. Member States shall gradually integrate these indicators and benchmarks into the statistical data included in their EEAPs as referred to in Article 14, and use them as one of the tools at their disposal to decide on future priority areas in the EEAPs. Not later than 17 May 2011, the Commission shall present to the European Parliament and the Council a report on the progress in setting indicators and benchmarks. Article 16 Committee 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its rules of procedure. Article 17 Repeal Directive 93/76/EEC is hereby repealed. Article 18 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 17 May 2008, with the exception of the provisions of Article 14(1), (2) and (4), for which the date of transposition shall be, at the latest 17 May 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 19 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 20 Addressees This Directive is addressed to the Member States.

32006L0039

2006

COMMISSION DIRECTIVE 2006/39/EC of 12 April 2006 amending Council Directive 91/414/EEC to include clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole as active substances (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof, Whereas: (1) Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole. (2) For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For clodinafop the rapporteur Member State was The Netherlands and all relevant information was submitted on 7 November 2003. For pirimicarb the rapporteur Member State was United Kingdom and all relevant information was submitted on 4 November 2003. For rimsulfuron the rapporteur Member State was Germany and all relevant information was submitted on 6 August 2003. For tolclofos-methyl the rapporteur Member State was Sweden and all relevant information was submitted on 3 November 2003. For triticonazole the rapporteur Member State was Austria and all relevant information was submitted on 29 September 2003. (3) The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 14 March and 10 August 2005 in the format of the EFSA Scientific Reports for clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 January 2006 in the format of the Commission review reports for clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole. (4) The review of pirimicarb revealed a number of open questions which were addressed by the Scientific Panel on Plant Health, Plant Protection Products and their residues (PPR) of the European Food Safety Authority (EFSA). The Scientific Panel was asked to give an opinion on the use of a ‘time quotient approach’ in the acute risk assessment for birds and on the assessment of the acute risk for birds which had been carried out. In its opinion to the first question the PPR Panel concluded that the ‘time quotient approach’ suggested by OECD is equivalent to the current European first tier acute avian risk assessment except that Annex VI of Directive 91/414/EEC stipulates a specific safety factor of 10. Therefore, a detailed scientific analysis would be required to assess whether the current safety factor takes appropriate account of all relevant issues. Since this would require substantial further work that is beyond the scope of the opinion, the PPR Panel suggests that a case by case approach should be used. As result, on the second question, the PPR Panel carried out a refined risk assessment and concluded that even at the upper limit of credible exposures birds feeding on insects in the field are unlikely to achieve a lethal dose of pirimicarb (5). (5) The reviews of clodinafop, rimsulfuron, tolclofos-methyl and triticonazole did not reveal any open question to be addressed by the Scientific Panel on Plant Health, Plant Protection Products and their residues (PPR) of the European Food Safety Authority (EFSA). (6) It has appeared from the various examinations made that plant protection products containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. (7) Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points concerning pirimicarb and triticonazole. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that pirimicarb and triticonazole should be subjected to further testing for confirmation of the risk assessment for some issues and that such studies should be presented by the notifiers. (8) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. (9) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or triticonazole to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (10) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I. (11) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 31 July 2007 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 August 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or triticonazole as active substances by 31 July 2007. By that date they shall in particular verify that the conditions in Annex I to that Directive relating to clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive. 2. By way of derogation from paragraph 1, for each authorised plant protection product containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or triticonazole as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 January 2007 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Following that determination Member States shall: (a) in the case of a product containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or triticonazole as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2011 at the latest; or (b) in the case of a product containing clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl or triticonazole as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. Article 4 This Directive shall enter into force on 1 February 2007. Article 5 This Directive is addressed to the Member States.

32006L0045

2006

COMMISSION DIRECTIVE 2006/45/EC of 16 May 2006 amending Council Directive 91/414/EEC as regards the specification of the active substance propoxycarbazone (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the second indent of the second subparagraph of Article 6(1) thereof, Whereas: (1) By Commission Directive 2003/119/EC (2) propoxycarbazone was included as active substance in Annex I to Directive 91/414/EEC. (2) When applying for the inclusion of propoxycarbazone its manufacturer Bayer CropScience gave a specification based on small-scale production. For large-scale production, that company now intends to modify the specification as regards purity. It has submitted data to show that the modified specification fulfils the requirements for inclusion. (3) Germany evaluated the information and data submitted by the company. It informed the Commission in July 2005 that it concludes that the modified specification does not cause any risks in addition to those already taken into account in the entry for propoxycarbazone in Annex I to Directive 91/414/EEC and in the Commission review report for that substance. (4) Therefore it is justified to modify the specification of propoxycarbazone. (5) It is therefore appropriate to amend Directive 91/414/EEC accordingly. (6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive. Article 2 Member States shall adopt and publish by 18 September 2006 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 19 September 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0043

2006

DIRECTIVE 2006/43/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 44(2)(g) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Currently, the Fourth Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies (3), the Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts (4), Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (5) and Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings (6) require that the annual accounts or consolidated accounts be audited by one or more persons entitled to carry out such audits. (2) The conditions for the approval of persons responsible for carrying out the statutory audit were laid down in the Eighth Council Directive 84/253/EEC of 10 April 1984 on the approval of persons responsible for carrying out the statutory audits of accounting documents (7). (3) The lack of a harmonised approach to statutory auditing in the Community was the reason why the Commission proposed, in its 1998 Communication on the statutory audit in the European Union: the way forward (8), the creation of a Committee on Auditing which could develop further action in close cooperation with the accounting profession and Member States. (4) On the basis of the work of that Committee, on 15 November 2000 the Commission issued a Recommendation on quality assurance for the statutory audit in the European Union: minimum requirements (9) and on 16 May 2002 a Recommendation on Statutory Auditors' Independence in the EU: A Set of Fundamental Principles (10). (5) This Directive aims at high-level — though not full — harmonisation of statutory audit requirements. A Member State requiring statutory audit may impose more stringent requirements, unless otherwise provided for by this Directive. (6) Audit qualifications obtained by statutory auditors on the basis of this Directive should be considered equivalent. It should therefore no longer be possible for Member States to insist that a majority of the voting rights in an audit firm must be held by locally approved auditors or that a majority of the members of the administrative or management body of an audit firm must be locally approved. (7) The statutory audit requires adequate knowledge of matters such as company law, fiscal law and social law. Such knowledge should be tested before a statutory auditor from another Member State can be approved. (8) In order to protect third parties, all approved auditors and audit firms should be entered in a register which is accessible to the public and which contains basic information concerning statutory auditors and audit firms. (9) Statutory auditors should adhere to the highest ethical standards. They should therefore be subject to professional ethics, covering at least their public-interest function, their integrity and objectivity and their professional competence and due care. The public-interest function of statutory auditors means that a broader community of people and institutions rely on the quality of a statutory auditor's work. Good audit quality contributes to the orderly functioning of markets by enhancing the integrity and efficiency of financial statements. The Commission may adopt implementing measures on professional ethics as minimum standards. When doing so, it might consider the principles contained in the International Federation of Accountants (IFAC) Code of Ethics. (10) It is important that statutory auditors and audit firms respect the privacy of their clients. They should therefore be bound by strict rules on confidentiality and professional secrecy which, however, should not impede proper enforcement of this Directive. Those confidentiality rules should also apply to any statutory auditor or audit firm which has ceased to be involved in a specific audit task. (11) Statutory auditors and audit firms should be independent when carrying out statutory audits. They may inform the audited entity of matters arising from the audit, but should abstain from the internal decision processes of the audited entity. If they find themselves in a situation where the significance of the threats to their independence, even after application of safeguards to mitigate those threats, is too high, they should resign or abstain from the audit engagement. The conclusion that there is a relationship which compromises the auditor's independence may be different as regards the relationship between the auditor and the audited entity from that in respect of the relationship between the network and the audited entity. Where a cooperative within the meaning of Article 2(14), or a similar entity as referred to in Article 45 of Directive 86/635/EEC, is required or permitted under national provisions to be a member of a non-profit-making auditing entity, an objective, reasonable and informed party would not conclude that the membership-based relationship compromises the statutory auditor's independence, provided that when such an auditing entity is conducting a statutory audit of one of its members, the principles of independence are applied to the auditors carrying out the audit and those persons who may be in a position to exert influence on the statutory audit. Examples of threats to the independence of a statutory auditor or audit firm are a direct or indirect financial interest in the audited entity and the provision of additional non-audit services. Also, the level of fees received from one audited entity and/or the structure of the fees can threaten the independence of a statutory auditor or audit firm. Types of safeguards to be applied to mitigate or eliminate those threats include prohibitions, restrictions, other policies and procedures, and disclosure. Statutory auditors and audit firms should refuse to undertake any additional non-audit service that compromises their independence. The Commission may adopt implementing measures on independence as minimum standards. In doing so, the Commission might take into consideration the principles contained in the abovementioned Recommendation of 16 May 2002. In order to determine the independence of auditors, the concept of a ‘network’ in which auditors operate needs to be clear. In this regard, various circumstances have to be taken into account, such as instances where a structure could be defined as a network because it is aimed at profit- or cost-sharing. The criteria for demonstrating that there is a network should be judged and weighed on the basis of all factual circumstances available, such as whether there are common usual clients. (12) In cases of self-review or self-interest, where appropriate to safeguard the statutory auditor's or audit firm's independence, it should be for the Member State rather than the statutory auditor or the audit firm to decide whether the statutory auditor or audit firm should resign or abstain from an audit engagement with regard to its audit clients. However, this should not lead to a situation where Member States have a general duty to prevent statutory auditors or audit firms from providing non-audit services to their audit clients. For the purposes of determining whether it is appropriate, in cases of self-interest or self-review, that a statutory auditor or audit firm should not carry out statutory audits, so as to safeguard the statutory auditor's or audit firm's independence, the factors to be taken into account should include the question whether or not the audited public-interest entity has issued transferable securities admitted to trading on a regulated market within the meaning of point 14 of Article 4(1) of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (11). (13) It is important to ensure consistently high quality in all statutory audits required by Community law. All statutory audits should therefore be carried out on the basis of international auditing standards. Measures implementing those standards in the Community should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12). A technical committee or group on auditing should assist the Commission in the assessment of the technical soundness of all the international auditing standards, and should also involve the system of public oversight bodies of the Member States. In order to achieve a maximum degree of harmonisation, Member States should be allowed to impose additional national audit procedures or requirements only if these stem from specific national legal requirements relating to the scope of the statutory audit of annual or consolidated accounts, meaning that those requirements have not been covered by the adopted international auditing standards. Member States could maintain those additional audit procedures until the audit procedures or requirements have been covered by subsequently adopted international auditing standards. If, however, the adopted international auditing standards contain audit procedures the performance of which would create a specific legal conflict with national law stemming from specific national requirements related to the scope of the statutory audit, Member States may carve out the conflicting part of the international auditing standard as long as those conflicts exist, provided the measures referred to in Article 26(3) are applied. Any addition or carving out by Member States should add a high level of credibility to the annual accounts of companies and be conducive to the public good. The above implies that Member States may, for example, require an additional auditor's report to the supervisory board or prescribe other reporting and audit requirements based on national corporate governance rules. (14) For the Commission to adopt an international auditing standard for application in the Community, it must be generally accepted internationally and have been developed with full participation of all interested parties following an open and transparent procedure, add to the credibility and quality of annual accounts and consolidated accounts and be conducive to the European public good. The need for the adoption of an International Auditing Practice Statement as part of a standard should be assessed in accordance with Decision 1999/468/EC on a case-by-case basis. The Commission should ensure that before the start of the adoption process a review is conducted in order to verify whether those requirements have been met and report to members of the Committee set up under this Directive on the outcome of the review. (15) In the case of consolidated accounts, it is important that there be a clear definition of responsibilities as between the statutory auditors who audit components of the group. For this purpose, the group auditor should bear full responsibility for the audit report. (16) In order to increase comparability between companies applying the same accounting standards, and to enhance public confidence in the audit function, the Commission may adopt a common audit report for the audit of annual accounts or consolidated accounts prepared on the basis of approved international accounting standards, unless an appropriate standard for such a report has been adopted at Community level. (17) Regular inspections are a good means of achieving a consistently high quality in statutory audits. Statutory auditors and audit firms should therefore be subject to a system of quality assurance that is organised in a manner which is independent from the reviewed statutory auditors and audit firms. For the application of Article 29 on quality assurance systems, Member States may decide that if individual auditors have a common quality assurance policy, only the requirements for audit firms need to be considered. Member States may organise the system of quality assurance in such a manner that each individual auditor is to be subject to a quality assurance review at least every six years. In this respect, the funding for the quality assurance system should be free from undue influence. The Commission should have the competence to adopt implementing measures in matters relevant to the organisation of quality assurance systems, and in respect of its funding, in cases where public confidence in the quality assurance system is seriously compromised. The public oversight systems of Member States should be encouraged to find a coordinated approach to the carrying-out of quality assurance reviews with a view to avoiding the imposition of unnecessary burdens on the parties concerned. (18) Investigations and appropriate penalties help to prevent and correct inadequate execution of a statutory audit. (19) Statutory auditors and audit firms are responsible for carrying out their work with due care and thus should be liable for the financial damage caused by a lack of the care owed. However, the auditors' and audit firms' ability to obtain professional indemnity insurance cover may be affected by whether they are subject to unlimited financial liability. For its part, the Commission intends examining these issues, taking into account the fact that liability regimes of the Member States may vary considerably. (20) Member States should organise an effective system of public oversight for statutory auditors and audit firms on the basis of home country control. The regulatory arrangements for public oversight should make possible effective cooperation at Community level in respect of the Member States' oversight activities. The public oversight system should be governed by non-practitioners who are knowledgeable in the areas relevant to statutory audit. These non-practitioners may be specialists who have never been linked with the audit profession or former practitioners who have left the profession. Member States may, however, allow a minority of practitioners to be involved in the governance of the public oversight system. Competent authorities of Member States should cooperate with each other whenever necessary for the purpose of carrying out their oversight duties on statutory auditors or audit firms approved by them. Such cooperation can make an important contribution to ensuring consistently high quality in the statutory audit in the Community. Since it is necessary to ensure effective cooperation and coordination at European level among competent authorities designated by Member States, the designation of one entity, responsible for ensuring cooperation, should be without prejudice to the ability of each single authority to cooperate directly with the other competent authorities of the Member States. (21) In order to ensure compliance with Article 32(3) on principles of public oversight, a non-practitioner is deemed to be knowledgeable in the areas relevant to the statutory audit either because of his or her past professional skill or, alternatively, because he or she has knowledge of at least one of the subjects listed in Article 8. (22) The statutory auditor or audit firm should be appointed by the general meeting of shareholders or members of the audited entity. In order to protect the independence of the auditor it is important that dismissal should be possible only where there are proper grounds and if those grounds are communicated to the authority or authorities responsible for public oversight. (23) Since public-interest entities have a higher visibility and are economically more important, stricter requirements should apply in the case of a statutory audit of their annual or consolidated accounts. (24) Audit committees and an effective internal control system help to minimise financial, operational and compliance risks, and enhance the quality of financial reporting. Member States might have regard to the Commission Recommendation of 15 February 2005 on the role of non-executive or supervisory directors of listed companies and on the committees of the (supervisory) board (13), which sets out how audit committees should be established and function. Member States may determine that the functions assigned to the audit committee or a body performing equivalent functions may be performed by the administrative or supervisory body as a whole. With regard to the duties of the audit committee under Article 41, the statutory auditor or audit firm should in no way be subordinated to the committee. (25) Member States may also decide to exempt public-interest entities which are collective investment undertakings whose transferable securities are admitted to trading on a regulated market from the requirement to have an audit committee. This option takes into account the fact that where a collective investment undertaking functions merely for the purpose of pooling assets, the employment of an audit committee will not always be appropriate. The financial reporting and related risks are not comparable to those of other public-interest entities. In addition, undertakings for collective investment in transferable securities (UCITS) and their management companies operate in a strictly defined regulatory environment and are subject to specific governance mechanisms such as controls exercised by their depositary. For those collective investment undertakings which are not harmonised by Directive 85/611/EEC (14) but are subject to equivalent safeguards as provided for by that Directive, Member States should, in this particular case, be allowed to provide for equal treatment with Community-harmonised collective investment undertakings. (26) In order to reinforce the independence of auditors of public-interest entities, the key audit partner(s) auditing such entities should rotate. To organise such rotation, Member States should require a change of key audit partner(s) dealing with an audited entity, while allowing the audit firm with which the key audit partner(s) is/are associated to continue being the statutory auditor of such entity. Where a Member State considers it appropriate in order to attain the objectives pursued, that Member State might, alternatively, require a change of audit firm, without prejudice to Article 42(2). (27) The interrelation of capital markets underlines the need also to ensure high-quality work performed by auditors from third countries in relation to the Community capital market. The auditors concerned should therefore be registered so as to make them subject to quality assurance reviews and to the system of investigations and penalties. Derogations on the basis of reciprocity should be possible subject to an equivalence testing to be performed by the Commission in cooperation with Member States. In any case, an entity which has issued transferable securities on a regulated market within the meaning of point 14 of Article 4(1) of Directive 2004/39/EC should always be audited by an auditor either registered in a Member State or overseen by competent authorities of the third country from which the auditor comes from, provided that the said third country is acknowledged by the Commission or a Member State as meeting the requirements equivalent to Community requirements in the field of principles of oversight, quality assurance systems and systems of investigations and penalties, and that the basis of this arrangement is reciprocity. While one Member State may consider a third country's quality assurance system equivalent, other Member States should not be bound to accept that assessment, nor should the Commission's decision be pre-empted thereby. (28) The complexity of international group audits requires good cooperation between the competent authorities of Member States and those of third countries. Member States should therefore ensure that competent authorities of third countries can have access to audit working papers and other documents through the national competent authorities. In order to protect the rights of the parties concerned and at the same time facilitate access to those papers and documents, Member States should be allowed to grant direct access to the competent authorities of third countries, subject to the agreement of the national competent authority. One of the relevant criteria for the granting of access is whether the competent authorities in third countries meet requirements which the Commission has declared adequate. Pending such a decision by the Commission, and without prejudice thereto, Member States may assess whether the requirements are adequate. (29) Disclosure of information as referred to in Articles 36 and 47 should be in accordance with the rules on the transfer of personal data to third countries as laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (15). (30) The measures necessary for the implementation of this Directive should be adopted in accordance with Decision 1999/468/EC and with due regard to the declaration made by the Commission in the European Parliament on 5 February 2002 concerning the implementation of financial services legislation. (31) The European Parliament should be given a period of three months from the first transmission of draft amendments and implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, it should be possible to shorten that period. If, within that period, a resolution is adopted by the European Parliament, the Commission should re-examine the draft amendments or measures. (32) Since the objectives of this Directive — namely requiring the application of a single set of international auditing standards, the updating of the educational requirements, the definition of professional ethics and the technical implementation of the cooperation between competent authorities of Member States and between those authorities and the authorities of third countries, in order further to enhance and harmonise the quality of statutory audit in the Community and to facilitate cooperation between Member States and with third countries so as to strengthen confidence in the statutory audit — cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Directive, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (33) With a view to rendering the relationship between the statutory auditor or audit firm and the audited entity more transparent, Directives 78/660/EEC and 83/349/EEC should be amended so as to require disclosure of the audit fee and the fee paid for non-audit services in the notes to the annual accounts and the consolidated accounts. (34) Directive 84/253/EEC should be repealed because it lacks a comprehensive set of rules to ensure an appropriate audit infrastructure, such as public oversight, disciplinary systems and systems of quality assurance, and because it does not provide specifically for regulatory cooperation between Member States and third countries. In order to ensure legal certainty, there is a clear need to indicate that statutory auditors and audit firms that have been approved under Directive 84/253/EEC are considered as approved under this Directive, CHAPTER I SUBJECT MATTER AND DEFINITIONS Article 1 Subject matter This Directive establishes rules concerning the statutory audit of annual and consolidated accounts. Article 2 Definitions For the purpose of this Directive, the following definitions shall apply: 1. ‘statutory audit’ means an audit of annual accounts or consolidated accounts insofar as required by Community law; 2. ‘statutory auditor’ means a natural person who is approved in accordance with this Directive by the competent authorities of a Member State to carry out statutory audits; 3. ‘audit firm’ means a legal person or any other entity, regardless of its legal form, that is approved in accordance with this Directive by the competent authorities of a Member State to carry out statutory audits; 4. ‘third-country audit entity’ means an entity, regardless of its legal form, which carries out audits of the annual or consolidated accounts of a company incorporated in a third country; 5. ‘third-country auditor’ means a natural person who carries out audits of the annual or consolidated accounts of a company incorporated in a third country; 6. ‘group auditor’ means the statutory auditor(s) or audit firm(s) carrying out the statutory audit of consolidated accounts; 7. ‘network’ means the larger structure: — which is aimed at cooperation and to which a statutory auditor or an audit firm belongs, and — which is clearly aimed at profit- or cost-sharing or shares common ownership, control or management, common quality-control policies and procedures, a common business strategy, the use of a common brand-name or a significant part of professional resources; 8. ‘affiliate of an audit firm’ means any undertaking, regardless of its legal form, which is connected to an audit firm by means of common ownership, control or management; 9. ‘audit report’ means the report referred to in Article 51a of Directive 78/660/EEC and Article 37 of Directive 83/349/EEC issued by the statutory auditor or audit firm; 10. ‘competent authorities’ means the authorities or bodies designated by law that are in charge of the regulation and/or oversight of statutory auditors and audit firms or of specific aspects thereof; the reference to ‘competent authority’ in a specific article means a reference to the authority or body(ies) responsible for the functions referred to in that Article; 11. ‘international auditing standards’ means International Standards on Auditing (ISA) and related Statements and Standards, insofar as relevant to the statutory audit; 12. ‘international accounting standards’ means International Accounting Standards (IAS), International Financial Reporting Standards (IFRS) and related Interpretations (SIC-IFRIC interpretations), subsequent amendments to those standards and related interpretations, and future standards and related interpretations issued or adopted by the International Accounting Standards Board (IASB); 13. ‘public-interest entities’ means entities governed by the law of a Member State whose transferable securities are admitted to trading on a regulated market of any Member State within the meaning of point 14 of Article 4(1) of Directive 2004/39/EC, credit institutions as defined in point 1 of Article 1of Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking up and pursuit of the business of credit institutions (16) and insurance undertakings within the meaning of Article 2(1) of Directive 91/674/EEC. Member States may also designate other entities as public-interest entities, for instance entities that are of significant public relevance because of the nature of their business, their size or the number of their employees; 14. ‘cooperative’ means a European Cooperative Society as defined in Article 1 of Council Regulation (EC) No 1435/2003 of 22 July 2003 on the Statute for a European Cooperative Society (SCE) (17), or any other cooperative for which a statutory audit is required under Community law, such as credit institutions as defined in point 1 of Article 1 of Directive 2000/12/EC and insurance undertakings within the meaning of Article 2(1) of Directive 91/674/EEC; 15. ‘non-practitioner’ means any natural person who, for at least three years before his or her involvement in the governance of the public oversight system, has not carried out statutory audits, has not held voting rights in an audit firm, has not been a member of the administrative or management body of an audit firm and has not been employed by, or otherwise associated with, an audit firm; 16. ‘key audit partner(s)’ mean(s): (a) the statutory auditor(s) designated by an audit firm for a particular audit engagement as being primarily responsible for carrying out the statutory audit on behalf of the audit firm; or (b) in the case of a group audit, at least the statutory auditor(s) designated by an audit firm as being primarily responsible for carrying out the statutory audit at the level of the group and the statutory auditor(s) designated as being primarily responsible at the level of material subsidiaries; or (c) the statutory auditor(s) who sign(s) the audit report. CHAPTER II APPROVAL, CONTINUING EDUCATION AND MUTUAL RECOGNITION Article 3 Approval of statutory auditors and audit firms 1. A statutory audit shall be carried out only by statutory auditors or audit firms which are approved by the Member State requiring the statutory audit. 2. Each Member State shall designate competent authorities which shall be responsible for approving statutory auditors and audit firms. The competent authorities may be professional associations, provided that they are subject to a system of public oversight as provided for in Chapter VIII. 3. Without prejudice to Article 11, the competent authorities of the Member States may approve as statutory auditors only natural persons who satisfy at least the conditions laid down in Articles 4 and 6 to 10. 4. The competent authorities of the Member States may approve as audit firms only those entities which satisfy the following conditions: (a) the natural persons who carry out statutory audits on behalf of an audit firm must satisfy at least the conditions imposed by Articles 4 and 6 to 12 and must be approved as statutory auditors in the Member State concerned; (b) a majority of the voting rights in an entity must be held by audit firms which are approved in any Member State or by natural persons who satisfy at least the conditions imposed by Articles 4 and 6 to 12. Member States may provide that such natural persons must also have been approved in another Member State. For the purpose of the statutory audit of cooperatives and similar entities as referred to in Article 45 of Directive 86/635/EEC, Member States may establish other specific provisions in relation to voting rights; (c) a majority — up to a maximum of 75 % — of the members of the administrative or management body of the entity must be audit firms which are approved in any Member State or natural persons who satisfy at least the conditions imposed by Articles 4 and 6 to 12. Member States may provide that such natural persons must also have been approved in another Member State. Where such a body has no more than two members, one of those members must satisfy at least the conditions in this point; (d) the firm must satisfy the condition imposed by Article 4. Member States may set additional conditions only in relation to point (c). Such conditions shall be proportionate to the objectives pursued and shall not go beyond what is strictly necessary. Article 4 Good repute The competent authorities of a Member State may grant approval only to natural persons or firms of good repute. Article 5 Withdrawal of approval 1. Approval of a statutory auditor or an audit firm shall be withdrawn if the good repute of that person or firm has been seriously compromised. Member States may, however, provide for a reasonable period of time for the purpose of meeting the requirements of good repute. 2. Approval of an audit firm shall be withdrawn if any of the conditions imposed in Article 3(4), points (b) and (c) is no longer fulfilled. Member States may, however, provide for a reasonable period of time for the purpose of fulfilling those conditions. 3. Where the approval of a statutory auditor or of an audit firm is withdrawn for any reason, the competent authority of the Member State where the approval is withdrawn shall communicate that fact and the reasons for the withdrawal to the relevant competent authorities of Member States where the statutory auditor or audit firm is also approved which are entered in the first-named Member State's register in accordance with Article 16(1), point (c). Article 6 Educational qualifications Without prejudice to Article 11, a natural person may be approved to carry out a statutory audit only after having attained university entrance or equivalent level, then completed a course of theoretical instruction, undergone practical training and passed an examination of professional competence of university final or equivalent examination level, organised or recognised by the Member State concerned. Article 7 Examination of professional competence The examination of professional competence referred to in Article 6 shall guarantee the necessary level of theoretical knowledge of subjects relevant to statutory audit and the ability to apply such knowledge in practice. Part at least of that examination shall be written. Article 8 Test of theoretical knowledge 1. The test of theoretical knowledge included in the examination shall cover the following subjects in particular: (a) general accounting theory and principles; (b) legal requirements and standards relating to the preparation of annual and consolidated accounts; (c) international accounting standards; (d) financial analysis; (e) cost and management accounting; (f) risk management and internal control; (g) auditing and professional skills; (h) legal requirements and professional standards relating to statutory audit and statutory auditors; (i) international auditing standards; (j) professional ethics and independence. 2. It shall also cover at least the following subjects insofar as they are relevant to auditing: (a) company law and corporate governance; (b) the law of insolvency and similar procedures; (c) tax law; (d) civil and commercial law; (e) social security law and employment law; (f) information technology and computer systems; (g) business, general and financial economics; (h) mathematics and statistics; (i) basic principles of the financial management of undertakings. 3. The Commission may, in accordance with the procedure referred to in Article 48(2), adapt the list of subjects to be included in the test of theoretical knowledge referred to in paragraph 1. When adopting those implementing measures the Commission shall take into account developments in auditing and the audit profession. Article 9 Exemptions 1. By way of derogation from Articles 7 and 8, a Member State may provide that a person who has passed a university or equivalent examination or holds a university degree or equivalent qualification in one or more of the subjects referred to in Article 8 may be exempted from the test of theoretical knowledge in the subjects covered by that examination or degree. 2. By way of derogation from Article 7, a Member State may provide that a holder of a university degree or equivalent qualification in one or more of the subjects referred to in Article 8 may be exempted from the test of the ability to apply in practice his or her theoretical knowledge of such subjects if he or she has received practical training in those subjects attested by an examination or diploma recognised by the State. Article 10 Practical training 1. In order to ensure the ability to apply theoretical knowledge in practice, a test of which is included in the examination, a trainee shall complete a minimum of three years' practical training in, inter alia, the auditing of annual accounts, consolidated accounts or similar financial statements. At least two thirds of such practical training shall be completed with a statutory auditor or audit firm approved in any Member State. 2. Member States shall ensure that all training is carried out with persons providing adequate guarantees regarding their ability to provide practical training. Article 11 Qualification through long-term practical experience A Member State may approve a person who does not satisfy the conditions laid down in Article 6 as a statutory auditor, if he or she can show either: (a) that he or she has, for 15 years, engaged in professional activities which have enabled him or her to acquire sufficient experience in the fields of finance, law and accountancy, and has passed the examination of professional competence referred to in Article 7, or (b) that he or she has, for seven years, engaged in professional activities in those fields and has, in addition, undergone the practical training referred to in Article 10 and passed the examination of professional competence referred to in Article 7. Article 12 Combination of practical training and theoretical instruction 1. Member States may provide that periods of theoretical instruction in the fields referred to in Article 8 shall count towards the periods of professional activity referred to in Article 11, provided that such instruction is attested by an examination recognised by the State. Such instruction shall not last less than one year, nor may it reduce the period of professional activity by more than four years. 2. The period of professional activity and practical training shall not be shorter than the course of theoretical instruction together with the practical training required in Article 10. Article 13 Continuing education Member States shall ensure that statutory auditors are required to take part in appropriate programmes of continuing education in order to maintain their theoretical knowledge, professional skills and values at a sufficiently high level, and that failure to respect the continuing education requirements is subject to appropriate penalties as referred to in Article 30. Article 14 Approval of statutory auditors from other Member States The competent authorities of the Member States shall establish procedures for the approval of statutory auditors who have been approved in other Member States. Those procedures shall not go beyond a requirement to pass an aptitude test in accordance with Article 4 of Council Directive 89/48/EEC of 21 December 1988 on a general system for the recognition of higher-education diplomas awarded on completion of professional education and training of at least three years' duration (18). The aptitude test, which shall be conducted in one of the languages permitted by the language rules applicable in the Member State concerned, shall cover only the statutory auditor's adequate knowledge of the laws and regulations of that Member State in so far as relevant to statutory audits. CHAPTER III REGISTRATION Article 15 Public register 1. Each Member State shall ensure that statutory auditors and audit firms are entered in a public register in accordance with Articles 16 and 17. In exceptional circumstances, Member States may disapply the requirements laid down in this Article and Article 16 regarding disclosure only to the extent necessary to mitigate an imminent and significant threat to the personal security of any person. 2. Member States shall ensure that each statutory auditor and audit firm is identified in the public register by an individual number. Registration information shall be stored in the register in electronic form and shall be electronically accessible to the public. 3. The public register shall also contain the name and address of the competent authorities responsible for approval as referred to in Article 3, for quality assurance as referred to in Article 29, for investigations and penalties on statutory auditors and audit firms as referred to in Article 30, and for public oversight as referred to in Article 32. 4. Member States shall ensure that the public register is fully operational by 29 June 2009. Article 16 Registration of statutory auditors 1. As regards statutory auditors, the public register shall contain at least the following information: (a) name, address and registration number; (b) if applicable, the name, address, website address and registration number of the audit firm(s) by which the statutory auditor is employed, or with whom he or she is associated as a partner or otherwise; (c) all other registration(s) as statutory auditor with the competent authorities of other Member States and as auditor with third countries, including the name(s) of the registration authority(ies), and, if applicable, the registration number(s). 2. Third-country auditors registered in accordance with Article 45 shall be clearly indicated in the register as such and not as statutory auditors. Article 17 Registration of audit firms 1. As regards audit firms, the public register shall contain at least the following information: (a) name, address and registration number; (b) legal form; (c) contact information, the primary contact person and, where applicable, the website address; (d) address of each office in the Member State; (e) name and registration number of all statutory auditors employed by or associated as partners or otherwise with the audit firm; (f) names and business addresses of all owners and shareholders; (g) names and business addresses of all members of the administrative or management body; (h) if applicable, the membership of a network and a list of the names and addresses of member firms and affiliates or an indication of the place where such information is publicly available; (i) all other registration(s) as audit firm with the competent authorities of other Member States and as audit entity with third countries, including the name(s) of the registration authority(ies), and, if applicable, the registration number(s). 2. Third-country audit entities registered in accordance with Article 45 shall be clearly indicated in the register as such and not as audit firms. Article 18 Updating of registration information Member States shall ensure that statutory auditors and audit firms notify the competent authorities in charge of the public register without undue delay of any change of information contained in the public register. The register shall be updated without undue delay after notification. Article 19 Responsibility for registration information The information provided to the relevant competent authorities in accordance with Articles 16, 17 and 18 shall be signed by the statutory auditor or audit firm. Where the competent authority provides for the information to be made available electronically, that can, for example, be done by means of an electronic signature as defined in point 1 of Article 2 of Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures (19). Article 20 Language 1. The information entered in the public register shall be drawn up in one of the languages permitted by the language rules applicable in the Member State concerned. 2. Member States may additionally allow the information to be entered in the public register in any other official language(s) of the Community. Member States may require the translation of the information to be certified. In all cases, the Member State concerned shall ensure that the register indicates whether or not the translation is certified. CHAPTER IV PROFESSIONAL ETHICS, INDEPENDENCE, OBJECTIVITY, CONFIDENTIALITY AND PROFESSIONAL SECRECY Article 21 Professional ethics 1. Member States shall ensure that all statutory auditors and audit firms are subject to principles of professional ethics, covering at least their public-interest function, their integrity and objectivity and their professional competence and due care. 2. In order to ensure confidence in the audit function and to ensure uniform application of paragraph 1 of this Article, the Commission may, in accordance with the procedure referred to in Article 48(2), adopt principle-based implementing measures governing professional ethics. Article 22 Independence and objectivity 1. Member States shall ensure that when carrying out a statutory audit, the statutory auditor and/or the audit firm is independent of the audited entity and is not involved in the decision-taking of the audited entity. 2. Member States shall ensure that a statutory auditor or an audit firm shall not carry out a statutory audit if there is any direct or indirect financial, business, employment or other relationship — including the provision of additional non-audit services — between the statutory auditor, audit firm or network and the audited entity from which an objective, reasonable and informed third party would conclude that the statutory auditor's or audit firm's independence is compromised. If the statutory auditor's or audit firm's independence is affected by threats, such as self-review, self-interest, advocacy, familiarity or trust or intimidation, the statutory auditor or audit firm must apply safeguards in order to mitigate those threats. If the significance of the threats compared to the safeguards applied is such that his, her or its independence is compromised, the statutory auditor or audit firm shall not carry out the statutory audit. Member States shall in addition ensure that, where statutory audits of public-interest entities are concerned and where appropriate to safeguard the statutory auditor's or audit firm's independence, a statutory auditor or an audit firm shall not carry out a statutory audit in cases of self-review or self-interest. 3. Member States shall ensure that a statutory auditor or audit firm documents in the audit working papers all significant threats to his, her or its independence as well as the safeguards applied to mitigate those threats. 4. In order to ensure confidence in the audit function and to ensure uniform application of paragraphs 1 and 2 of this Article, the Commission may, in accordance with the procedure referred to in Article 48(2), adopt principle-based implementing measures concerning: (a) the threats and safeguards referred to in paragraph 2; (b) the situations in which the significance of the threats, as referred to in paragraph 2, is such that the independence of the statutory auditor or audit firm is compromised; (c) the cases of self-review and self-interest referred to in the second subparagraph of paragraph 2, in which statutory audits may or may not be carried out. Article 23 Confidentiality and professional secrecy 1. Member States shall ensure that all information and documents to which a statutory auditor or audit firm has access when carrying out a statutory audit are protected by adequate rules on confidentiality and professional secrecy. 2. Confidentiality and professional secrecy rules relating to statutory auditors or audit firms shall not impede enforcement of the provisions of this Directive. 3. Where a statutory auditor or audit firm is replaced by another statutory auditor or audit firm, the former statutory auditor or audit firm shall provide the incoming statutory auditor or audit firm with access to all relevant information concerning the audited entity. 4. A statutory auditor or audit firm who has ceased to be engaged in a particular audit assignment and a former statutory auditor or audit firm shall remain subject to the provisions of paragraphs 1 and 2 with respect to that audit assignment. Article 24 Independence and objectivity of the statutory auditors carrying out the statutory audit on behalf of audit firms Member States shall ensure that the owners or shareholders of an audit firm as well as the members of the administrative, management and supervisory bodies of such a firm, or of an affiliated firm, do not intervene in the execution of a statutory audit in any way which jeopardises the independence and objectivity of the statutory auditor who carries out the statutory audit on behalf of the audit firm. Article 25 Audit fees Member States shall ensure that adequate rules are in place which provide that fees for statutory audits: (a) are not influenced or determined by the provision of additional services to the audited entity; (b) cannot be based on any form of contingency. CHAPTER V AUDITING STANDARDS AND AUDIT REPORTING Article 26 Auditing standards 1. Member States shall require statutory auditors and audit firms to carry out statutory audits in compliance with international auditing standards adopted by the Commission in accordance with the procedure referred to in Article 48(2). Member States may apply a national auditing standard as long as the Commission has not adopted an international auditing standard covering the same subject-matter. Adopted international auditing standards shall be published in full in each of the official languages of the Community in the Official Journal of the European Union. 2. The Commission may decide, in accordance with the procedure referred to in Article 48(2), on the applicability of international auditing standards within the Community. The Commission shall adopt international auditing standards for application in the Community only if they: (a) have been developed with proper due process, public oversight and transparency, and are generally accepted internationally; (b) contribute a high level of credibility and quality to the annual or consolidated accounts in conformity with the principles set out in Article 2(3) of Directive 78/660/EEC and in Article 16(3) of Directive 83/349/EEC; and (c) are conducive to the European public good. 3. Member States may impose audit procedures or requirements in addition to — or, in exceptional cases, by carving out parts of — the international auditing standards only if these stem from specific national legal requirements relating to the scope of statutory audits. Member States shall ensure that these audit procedures or requirements comply with the provisions laid down in points (b) and (c) of paragraph 2 and shall communicate them to the Commission and Member States before their adoption. In the exceptional case of the carving out of parts of an international auditing standard, Member States shall communicate their specific national legal requirements, as well as the grounds for maintaining them, to the Commission and the other Member States at least six months before their national adoption or, in the case of requirements already existing at the time of adoption of an international auditing standard, at the latest within three months of the adoption of the relevant international auditing standard. 4. Member States may impose additional requirements relating to the statutory audits of annual and consolidated accounts for a period expiring on 29 June 2010. Article 27 Statutory audits of consolidated accounts Member States shall ensure that in the case of a statutory audit of the consolidated accounts of a group of undertakings: (a) the group auditor bears the full responsibility for the audit report in relation with the consolidated accounts; (b) the group auditor carries out a review and maintains documentation of his or her review of the audit work performed by third-country auditor(s), statutory auditor(s), third-country audit entity(ies) or audit firm(s) for the purpose of the group audit. The documentation retained by the group auditor shall be such as enables the relevant competent authority to review the work of the group auditor properly; (c) when a component of a group of undertakings is audited by auditor(s) or audit entity(ies) from a third country that has no working arrangement as referred to in Article 47, the group auditor is responsible for ensuring proper delivery, when requested, to the public oversight authorities of the documentation of the audit work performed by the third-country auditor(s) or audit entity(ies), including the working papers relevant to the group audit. To ensure such delivery, the group auditor shall retain a copy of such documentation, or alternatively agree with the third-country auditor(s) or audit entity(ies) his proper and unrestricted access upon request, or take any other appropriate action. If legal or other impediments prevent audit working papers from being passed from a third country to the group auditor, the documentation retained by the group auditor shall include evidence that he or she has undertaken the appropriate procedures in order to gain access to the audit documentation, and in the case of impediments other than legal ones arising from country legislation, evidence supporting such an impediment. Article 28 Audit reporting 1. Where an audit firm carries out the statutory audit, the audit report shall be signed by at least the statutory auditor(s) carrying out the statutory audit on behalf of the audit firm. In exceptional circumstances Member States may provide that this signature need not be disclosed to the public if such disclosure could lead to an imminent and significant threat to the personal security of any person. In any case the name(s) of the person(s) involved shall be known to the relevant competent authorities. 2. Notwithstanding Article 51a(1) of Directive 78/660/EEC, if the Commission has not adopted a common standard for audit reports in accordance with Article 26(1) of this Directive, it may, in accordance with the procedure referred to in Article 48(2) of this Directive, adopt a common standard for audit reports for annual or consolidated accounts which have been prepared in accordance with approved international accounting standards, in order to enhance public confidence in the audit function. CHAPTER VI QUALITY ASSURANCE Article 29 Quality assurance systems 1. Each Member State shall ensure that all statutory auditors and audit firms are subject to a system of quality assurance which meets at least the following criteria: (a) the quality assurance system shall be organised in such a manner that it is independent of the reviewed statutory auditors and audit firms and subject to public oversight as provided for in Chapter VIII; (b) the funding for the quality assurance system shall be secure and free from any possible undue influence by statutory auditors or audit firms; (c) the quality assurance system shall have adequate resources; (d) the persons who carry out quality assurance reviews shall have appropriate professional education and relevant experience in statutory audit and financial reporting combined with specific training on quality assurance reviews; (e) the selection of reviewers for specific quality assurance review assignments shall be effected in accordance with an objective procedure designed to ensure that there are no conflicts of interest between the reviewers and the statutory auditor or audit firm under review; (f) the scope of the quality assurance review, supported by adequate testing of selected audit files, shall include an assessment of compliance with applicable auditing standards and independence requirements, of the quantity and quality of resources spent, of the audit fees charged and of the internal quality control system of the audit firm; (g) the quality assurance review shall be the subject of a report which shall contain the main conclusions of the quality assurance review; (h) quality assurance reviews shall take place at least every six years; (i) the overall results of the quality assurance system shall be published annually; (j) recommendations of quality reviews shall be followed up by the statutory auditor or audit firm within a reasonable period. If the recommendations referred to in point (j) are not followed up, the statutory auditor or audit firm shall, if applicable, be subject to the system of disciplinary actions or penalties referred to in Article 30. 2. The Commission may, in accordance with the procedure referred to in Article 48(2), adopt implementing measures in order to enhance public confidence in the audit function and to ensure uniform application of points (a), (b) and (e) to (j) of paragraph 1. CHAPTER VII INVESTIGATIONS AND PENALTIES Article 30 Systems of investigations and penalties 1. Member States shall ensure that there are effective systems of investigations and penalties to detect, correct and prevent inadequate execution of the statutory audit. 2. Without prejudice to Member States' civil liability regimes, Member States shall provide for effective, proportionate and dissuasive penalties in respect of statutory auditors and audit firms, where statutory audits are not carried out in conformity with the provisions adopted in the implementation of this Directive. 3. Member States shall provide that measures taken and penalties imposed on statutory auditors and audit firms are appropriately disclosed to the public. Penalties shall include the possibility of the withdrawal of approval. Article 31 Auditors' liability Before 1 January 2007 the Commission shall present a report on the impact of the current national liability rules for the carrying out of statutory audits on European capital markets and on the insurance conditions for statutory auditors and audit firms, including an objective analysis of the limitations of financial liability. The Commission shall, where appropriate, carry out a public consultation. In the light of that report, the Commission shall, if it considers it appropriate, submit recommendations to the Member States. CHAPTER VIII PUBLIC OVERSIGHT AND REGULATORY ARRANGEMENTS BETWEEN MEMBER STATES Article 32 Principles of public oversight 1. Member States shall organise an effective system of public oversight for statutory auditors and audit firms based on the principles set out in paragraphs 2 to 7. 2. All statutory auditors and audit firms shall be subject to public oversight. 3. The system of public oversight shall be governed by non-practitioners who are knowledgeable in the areas relevant to statutory audit. Member States may, however, allow a minority of practitioners to be involved in the governance of the public oversight system. Persons involved in the governance of the public oversight system shall be selected in accordance with an independent and transparent nomination procedure. 4. The system of public oversight shall have the ultimate responsibility for the oversight of: (a) the approval and registration of statutory auditors and audit firms; (b) the adoption of standards on professional ethics, internal quality control of audit firms and auditing, and (c) continuing education, quality assurance and investigative and disciplinary systems. 5. The system of public oversight shall have the right, where necessary, to conduct investigations in relation to statutory auditors and audit firms and the right to take appropriate action. 6. The system of public oversight shall be transparent. This shall include the publication of annual work programmes and activity reports. 7. The system of public oversight shall be adequately funded. The funding for the public oversight system shall be secure and free from any undue influence by statutory auditors or audit firms. Article 33 Cooperation between public oversight systems at Community level Member States shall ensure that regulatory arrangements for public oversight systems permit effective cooperation at Community level in respect of Member States' oversight activities. To that end, each Member State shall make one entity specifically responsible for ensuring that cooperation. Article 34 Mutual recognition of regulatory arrangements between Member States 1. Regulatory arrangements of Member States shall respect the principle of home-country regulation and oversight by the Member State in which the statutory auditor or audit firm is approved and the audited entity has its registered office. 2. In the case of a statutory audit of consolidated accounts, the Member State requiring the statutory audit of the consolidated accounts may not impose additional requirements in relation to the statutory audit concerning registration, quality assurance review, auditing standards, professional ethics and independence on a statutory auditor or audit firm carrying out a statutory audit of a subsidiary established in another Member State. 3. In the case of a company whose securities are traded on a regulated market in a Member State other than that in which that company has its registered office, the Member State in which the securities are traded may not impose any additional requirements in relation to the statutory audit concerning registration, quality assurance review, auditing standards, professional ethics and independence on a statutory auditor or audit firm carrying out the statutory audit of the annual or consolidated accounts of that company. Article 35 Designation of competent authorities 1. Member States shall designate one or more competent authorities for the purposes of the tasks provided for in this Directive. Member States shall inform the Commission of their designation. 2. The competent authorities shall be organised in such a manner that conflicts of interests are avoided. Article 36 Professional secrecy and regulatory cooperation between Member States 1. The competent authorities of Member States responsible for approval, registration, quality assurance, inspection and discipline shall cooperate with each other whenever necessary for the purpose of carrying out their respective responsibilities under this Directive. The competent authorities in a Member State responsible for approval, registration, quality assurance, inspection and discipline shall render assistance to competent authorities in other Member States. In particular, competent authorities shall exchange information and cooperate in investigations related to the carrying-out of statutory audits. 2. The obligation of professional secrecy shall apply to all persons who are employed or who have been employed by competent authorities. Information covered by professional secrecy may not be disclosed to any other person or authority except by virtue of the laws, regulations or administrative procedures of a Member State. 3. Paragraph 2 shall not prevent competent authorities from exchanging confidential information. Information thus exchanged shall be covered by the obligation of professional secrecy, to which persons employed or formerly employed by competent authorities are subject. 4. Competent authorities shall, on request, and without undue delay, supply any information required for the purpose referred to in paragraph 1. Where necessary, the competent authorities receiving any such request shall, without undue delay, take the necessary measures to gather the required information. Information thus supplied shall be covered by the obligation of professional secrecy to which the persons employed or formerly employed by the competent authorities that received the information are subject. If the requested competent authority is not able to supply the required information without undue delay, it shall notify the requesting competent authority of the reasons therefor. The competent authorities may refuse to act on a request for information where: (a) supplying information might adversely affect the sovereignty, security or public order of the requested Member State or breach national security rules; or (b) judicial proceedings have already been initiated in respect of the same actions and against the same statutory auditors or audit firms before the authorities of the requested Member State; or (c) final judgment has already been passed in respect of the same actions and on the same statutory auditors or audit firms by the competent authorities of the requested Member State. Without prejudice to the obligations to which they are subject in judicial proceedings, competent authorities which receive information pursuant to paragraph 1 may use it only for the exercise of their functions within the scope of this Directive and in the context of administrative or judicial proceedings specifically related to the exercise of those functions. 5. Where a competent authority concludes that activities contrary to the provisions of this Directive are being or have been carried out on the territory of another Member State, it shall notify the competent authority of the other Member State of that conclusion in as specific a manner as possible. The competent authority of the other Member State shall take appropriate action. It shall inform the notifying competent authority of the outcome and, to the extent possible, of significant interim developments. 6. A competent authority of one Member State may also request that an investigation be carried out by the competent authority of another Member State on the latter's territory. It may further request that some of its own personnel be allowed to accompany the personnel of the competent authority of that other Member State in the course of the investigation. The investigation shall be subject throughout to the overall control of the Member State on whose territory it is conducted. The competent authorities may refuse to act on a request for an investigation to be carried out as provided for in the first subparagraph, or on a request for its personnel to be accompanied by personnel of a competent authority of another Member State as provided for in the second subparagraph, where: (a) such an investigation might adversely affect the sovereignty, security or public order of the requested Member State; or (b) judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the requested Member State; or (c) final judgment has already been passed in respect of the same actions on such persons by the competent authorities of the requested Member State. 7. In accordance with the procedure referred to in Article 48(2) the Commission may adopt implementing measures in order to facilitate cooperation between competent authorities on the procedures for the exchange of information and modalities for cross-border investigations provided for in paragraphs 2 to 4 of this Article. CHAPTER IX APPOINTMENT AND DISMISSAL Article 37 Appointment of statutory auditors or audit firms 1. The statutory auditor or audit firm shall be appointed by the general meeting of shareholders or members of the audited entity. 2. Member States may allow alternative systems or modalities for the appointment of the statutory auditor or audit firm, provided that those systems or modalities are designed to ensure the independence of the statutory auditor or audit firm from the executive members of the administrative body or from the managerial body of the audited entity. Article 38 Dismissal and resignation of statutory auditors or audit firms 1. Member States shall ensure that statutory auditors or audit firms may be dismissed only where there are proper grounds. Divergence of opinions on accounting treatments or audit procedures shall not be proper grounds for dismissal. 2. Member States shall ensure that the audited entity and the statutory auditor or audit firm inform the authority or authorities responsible for public oversight concerning the dismissal or resignation of the statutory auditor or audit firm during the term of appointment and give an adequate explanation of the reasons therefor. CHAPTER X SPECIAL PROVISIONS FOR THE STATUTORY AUDITS OF PUBLIC-INTEREST ENTITIES Article 39 Application to non-listed public-interest entities Member States may exempt public-interest entities which have not issued transferable securities admitted to trading on a regulated market within the meaning of point 14 of Article 4(1) of Directive 2004/39/EC and their statutory auditor(s) or audit firm(s) from one or more of the requirements in this Chapter. Article 40 Transparency report 1. Member States shall ensure that statutory auditors and audit firms that carry out statutory audit(s) of public-interest entities publish on their websites, within three months of the end of each financial year, annual transparency reports that include at least the following: (a) a description of the legal structure and ownership; (b) where the audit firm belongs to a network, a description of the network and the legal and structural arrangements in the network; (c) a description of the governance structure of the audit firm; (d) a description of the internal quality control system of the audit firm and a statement by the administrative or management body on the effectiveness of its functioning; (e) an indication of when the last quality assurance review referred to in Article 29 took place; (f) a list of public-interest entities for which the audit firm has carried out statutory audits during the preceding financial year; (g) a statement concerning the audit firm's independence practices which also confirms that an internal review of independence compliance has been conducted; (h) a statement on the policy followed by the audit firm concerning the continuing education of statutory auditors referred to in Article 13; (i) financial information showing the importance of the audit firm, such as the total turnover divided into fees from the statutory audit of annual and consolidated accounts, and fees charged for other assurance services, tax advisory services and other non-audit services; (j) information concerning the basis for the partners' remuneration. Member States may in exceptional circumstances disapply the requirement in point (f) to the extent necessary to mitigate an imminent and significant threat to the personal security of any person. 2. The transparency report shall be signed by the statutory auditor or audit firm, as the case may be. This can be done, for example, by means of an electronic signature as defined in Article 2(1) of Directive 1999/93/EC. Article 41 Audit committee 1. Each public-interest entity shall have an audit committee. The Member State shall determine whether audit committees are to be composed of non-executive members of the administrative body and/or members of the supervisory body of the audited entity and/or members appointed by the general meeting of shareholders of the audited entity. At least one member of the audit committee shall be independent and shall have competence in accounting and/or auditing. In public-interest entities which meet the criteria of Article 2(1), point (f) of Directive 2003/71/EC (20), Member States may permit the functions assigned to the audit committee to be performed by the administrative or supervisory body as a whole, provided at least that when the chairman of such a body is an executive member, he or she is not the chairman of the audit committee. 2. Without prejudice to the responsibility of the members of the administrative, management or supervisory bodies, or of other members who are appointed by the general meeting of shareholders of the audited entity, the audit committee shall, inter alia: (a) monitor the financial reporting process; (b) monitor the effectiveness of the company's internal control, internal audit where applicable, and risk management systems; (c) monitor the statutory audit of the annual and consolidated accounts; (d) review and monitor the independence of the statutory auditor or audit firm, and in particular the provision of additional services to the audited entity. 3. In a public-interest entity, the proposal of the administrative or supervisory body for the appointment of a statutory auditor or audit firm shall be based on a recommendation made by the audit committee. 4. The statutory auditor or audit firm shall report to the audit committee on key matters arising from the statutory audit, and in particular on material weaknesses in internal control in relation to the financial reporting process. 5. Member States may allow or decide that the provisions laid down in paragraphs 1 to 4 shall not apply to any public-interest entity that has a body performing equivalent functions to an audit committee, established and functioning according to provisions in place in the Member State in which the entity to be audited is registered. In such a case the entity shall disclose which body carries out these functions and how it is composed. 6. Member States may exempt from the obligation to have an audit committee: (a) any public-interest entity which is a subsidiary undertaking within the meaning of Article 1 of Directive 83/349/EEC if the entity complies with the requirements in paragraphs 1 to 4 of this Article at group level; (b) any public-interest entity which is a collective investment undertaking as defined in Article 1(2) of Directive 85/611/EEC. Member States may also exempt public-interest entities the sole object of which is the collective investment of capital provided by the public, which operate on the principle of risk spreading and which do not seek to take legal or management control over any of the issuers of its underlying investments, provided that those collective investment undertakings are authorised and subject to supervision by competent authorities and that they have a depositary exercising functions equivalent to those under Directive 85/611/EEC; (c) any public-interest entity the sole business of which is to act as issuer of asset-backed securities as defined in Article 2(5) of Commission Regulation (EC) No 809/2004 (21). In such instances, the Member State shall require the entity to explain to the public the reasons for which it considers it not appropriate to have either an audit committee or an administrative or supervisory body entrusted to carry out the functions of an audit committee; (d) any credit institution within the meaning of Article 1(1) of Directive 2000/12/EC whose shares are not admitted to trading on a regulated market of any Member State within the meaning of point 14 of Article 4(1) of Directive 2004/39/EC and which has, in a continuous or repeated manner, issued only debt securities, provided that the total nominal amount of all such debt securities remains below EUR 100 000 000 and that it has not published a prospectus under Directive 2003/71/EC. Article 42 Independence 1. In addition to the provisions laid down in Articles 22 and 24, Member States shall ensure that statutory auditors or audit firms that carry out the statutory audit of a public-interest entity: (a) confirm annually in writing to the audit committee their independence from the audited public-interest entity; (b) disclose annually to the audit committee any additional services provided to the audited entity; and (c) discuss with the audit committee the threats to their independence and the safeguards applied to mitigate those threats as documented by them pursuant to Article 22(3). 2. Member States shall ensure that the key audit partner(s) responsible for carrying out a statutory audit rotate(s) from the audit engagement within a maximum period of seven years from the date of appointment and is/are allowed to participate in the audit of the audited entity again after a period of at least two years. 3. The statutory auditor or the key audit partner who carries out a statutory audit on behalf of an audit firm shall not be allowed to take up a key management position in the audited entity before a period of at least two years has elapsed since he or she resigned as a statutory auditor or key audit partner from the audit engagement. Article 43 Quality assurance The quality assurance review referred to in Article 29 shall be carried out at least every three years for statutory auditors or audit firms that carry out statutory audits of public-interest entities. CHAPTER XI INTERNATIONAL ASPECTS Article 44 Approval of auditors from third countries 1. Subject to reciprocity, the competent authorities of a Member State may approve a third-country auditor as statutory auditor if that person has furnished proof that he or she complies with requirements equivalent to those laid down in Articles 4 and 6 to 13. 2. The competent authorities of a Member State shall, before granting approval to a third-country auditor who meets the requirements of paragraph 1, apply the requirements laid down in Article 14. Article 45 Registration and oversight of third-country auditors and audit entities 1. The competent authorities of a Member State shall, in accordance with Articles 15 to 17, register every third-country auditor and audit entity that provides an audit report concerning the annual or consolidated accounts of a company incorporated outwith the Community whose transferable securities are admitted to trading on a regulated market of that Member State within the meaning of point 14 of Article 4(1) of Directive 2004/39/EC, except when the company is an issuer exclusively of debt securities admitted to trading on a regulated market in a Member State within the meaning of Article 2(1)(b) of Directive 2004/109/EC (22), the denomination per unit of which is at least EUR 50 000 or, in case of debt securities denominated in another currency, equivalent, at the date of issue, to at least EUR 50 000. 2. Articles 18 and 19 shall apply. 3. Member States shall subject registered third-country auditors and audit entities to their systems of oversight, their quality assurance systems and their systems of investigation and penalties. A Member State may exempt a registered third-country auditor or audit entity from being subject to its quality assurance system if another Member State's or third country's system of quality assurance that has been assessed as equivalent in accordance with Article 46 has carried out a quality review of the third-country auditor or audit entity concerned during the previous three years. 4. Without prejudice to Article 46, audit reports concerning annual accounts or consolidated accounts referred to in paragraph 1 of this Article issued by third-country auditors or audit entities that are not registered in the Member State shall have no legal effect in that Member State. 5. A Member State may register a third-country audit entity only if: (a) it meets requirements which are equivalent to those laid down in Article 3(3); (b) the majority of the members of the administrative or management body of the third-country audit entity meet requirements which are equivalent to those laid down in Articles 4 to 10; (c) the third-country auditor carrying out the audit on behalf of the third-country audit entity meets requirements which are equivalent to those laid down in Articles 4 to 10; (d) the audits of the annual or consolidated accounts referred to in paragraph 1 are carried out in accordance with international auditing standards as referred to in Article 26, as well as the requirements laid down in Articles 22, 24 and 25, or with equivalent standards and requirements; (e) it publishes on its website an annual transparency report which includes the information referred to in Article 40 or it complies with equivalent disclosure requirements. 6. In order to ensure uniform application of paragraph 5(d) the equivalence referred to therein shall be assessed by the Commission in cooperation with Member States and shall be decided upon by the Commission in accordance with the procedure referred to in Article 48(2). Pending such a decision by the Commission, Member States may assess the equivalence referred to in paragraph 5(d) as long as the Commission has not taken any decision. Article 46 Derogation in the case of equivalence 1. Member States may disapply or modify the requirements in Article 45(1) and (3) on the basis of reciprocity only if the third-country auditors or audit entities are subject to systems of public oversight, quality assurance and investigations and penalties in the third country that meet requirements equivalent to those of Articles 29, 30 and 32. 2. In order to ensure uniform application of paragraph 1 of this Article, the equivalence referred to therein shall be assessed by the Commission in cooperation with Member States and shall be decided upon by the Commission in accordance with the procedure referred to in Article 48(2). Member States may assess the equivalence referred to in paragraph 1 of this Article or rely on the assessments carried out by other Member States as long as the Commission has not taken any decision. If the Commission decides that the requirement of equivalence referred to in paragraph 1 of this Article is not complied with, it may allow the auditors and audit entities concerned to continue their audit activities in accordance with the relevant Member State's requirements during an appropriate transitional period. 3. Member States shall communicate to the Commission: (a) their assessments of the equivalence referred to in paragraph 2; and (b) the main elements of their cooperative arrangements with third-country systems of public oversight, quality assurance and investigations and penalties, on the basis of paragraph 1. Article 47 Cooperation with competent authorities from third countries 1. Member States may allow the transfer to the competent authorities of a third country of audit working papers or other documents held by statutory auditors or audit firms approved by them, provided that: (a) those audit working papers or other documents relate to audits of companies which have issued securities in that third country or which form part of a group issuing statutory consolidated accounts in that third country; (b) the transfer takes place via the home competent authorities to the competent authorities of that third country and at their request; (c) the competent authorities of the third country concerned meet requirements which have been declared adequate in accordance with paragraph 3; (d) there are working arrangements on the basis of reciprocity agreed between the competent authorities concerned; (e) the transfer of personal data to the third country is in accordance with Chapter IV of Directive 95/46/EC. 2. The working arrangements referred to in paragraph 1(d) shall ensure that: (a) justification as to the purpose of the request for audit working papers and other documents is provided by the competent authorities; (b) the persons employed or formerly employed by the competent authorities of the third country that receive the information are subject to obligations of professional secrecy; (c) the competent authorities of the third country may use audit working papers and other documents only for the exercise of their functions of public oversight, quality assurance and investigations that meet requirements equivalent to those of Articles 29, 30 and 32; (d) the request from a competent authority of a third country for audit working papers or other documents held by a statutory auditor or audit firm can be refused: — where the provision of those working papers or documents would adversely affect the sovereignty, security or public order of the Community or of the requested Member State, or — where judicial proceedings have already been initiated in respect of the same actions and against the same persons before the authorities of the requested Member State. 3. The adequacy referred to in paragraph 1(c) shall be decided upon by the Commission in accordance with the procedure referred to in Article 48(2) in order to facilitate cooperation between competent authorities. The assessment of adequacy shall be carried out in cooperation with Member States and be based on the requirements of Article 36 or essentially equivalent functional results. Member States shall take the measures necessary to comply with the Commission's decision. 4. In exceptional cases and by way of derogation from paragraph 1, Member States may allow statutory auditors and audit firms approved by them to transfer audit working papers and other documents directly to the competent authorities of a third country, provided that: (a) investigations have been initiated by the competent authorities in that third country; (b) the transfer does not conflict with the obligations with which statutory auditors and audit firms are required to comply in relation to the transfer of audit working papers and other documents to their home competent authority; (c) there are working arrangements with the competent authorities of that third country that allow the competent authorities in the Member State reciprocal direct access to audit working papers and other documents of that third-country's audit entities; (d) the requesting competent authority of the third country informs in advance the home competent authority of the statutory auditor or audit firm of each direct request for information, indicating the reasons therefor; (e) the conditions referred to in paragraph 2 are respected. 5. The Commission may, in accordance with the procedure referred to in Article 48(2), specify the exceptional cases referred to in paragraph 4 of this Article in order to facilitate cooperation between competent authorities and to ensure the uniform application of paragraph 4 of this Article. 6. Member States shall communicate to the Commission the working arrangements referred to in paragraphs 1 and 4. CHAPTER XII TRANSITIONAL AND FINAL PROVISIONS Article 48 Committee procedure 1. The Commission shall be assisted by a committee (hereinafter referred to as the Committee). 2. Where reference is made to this paragraph Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. The Committee shall adopt its Rules of Procedure. 4. Without prejudice to the implementing measures already adopted, and except for the provisions laid down in Article 26, upon expiry of a two-year period following the adoption of this Directive and on 1 April 2008 at the latest, the application of its provisions requiring the adoption of technical rules, amendments and decisions in accordance with paragraph 2 shall be suspended. Acting on a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and to that end they shall review them prior to the expiry of the period or date referred to above. Article 49 Amendment of Directive 78/660/EEC and Directive 83/349/EEC 1. Directive 78/660/EEC is hereby amended as follows: (a) in Article 43(1) the following point shall be added: (15) ‘separately, the total fees for the financial year charged by the statutory auditor or audit firm for the statutory audit of annual accounts, the total fees charged for other assurance services, the total fees charged for tax advisory services and the total fees charged for other non-audit services. Member States may provide that this requirement shall not apply where the company is included within the consolidated accounts required to be drawn up under Article 1 of Directive 83/349/EEC, provided that such information is given in the notes to the consolidated accounts.’; (b) paragraph 1 of Article 44 shall be replaced by the following: 1. ‘Member States may permit the companies referred to in Article 11 to draw up abridged notes on their accounts without the information required in Article 43(1)(5) to (12), (14)(a) and (15). However, the notes must disclose the information specified in Article 43(1)(6) in total for all the items concerned.’; (c) paragraph 2 of Article 45 shall be replaced by the following: 2. ‘Paragraph 1(b) shall also apply to the information specified in Article 43(1)(8). The Member States may permit the companies referred to in Article 27 to omit disclosure of the information specified in Article 43(1)(8). The Member States may also permit the companies referred to in Article 27 to omit disclosure of the information specified in Article 43(1)(15), provided that such information is delivered to the public oversight system referred to in Article 32 of Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audit of annual accounts and consolidated accounts (23) when requested by such a public oversight system.’ 2. In Article 34 of Directive 83/349/EEC the following point shall be added: (16) ‘Separately, the total fees for the financial year charged by the statutory auditor or audit firm for the statutory audit of the consolidated accounts, the total fees charged for other assurance services, the total fees charged for tax advisory services and the total fees charged for other non-audit services.’ Article 50 Repeal of Directive 84/253/EEC Directive 84/253/EEC shall be repealed with effect from 29 June 2006. References to the repealed Directive shall be construed as references to this Directive. Article 51 Transitional provision Statutory auditors or audit firms that are approved by the competent authorities of the Member States in accordance with Directive 84/253/EEC before the entry into force of the provisions referred to in Article 53(1) shall be considered as having been approved in accordance with this Directive. Article 52 Minimum harmonisation Member States requiring statutory audit may impose more stringent requirements, unless otherwise provided for by this Directive. Article 53 Transposition 1. Before 29 June 2008 Member States shall adopt and publish the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. 2. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. Article 54 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 55 Addressees This Directive is addressed to the Member States.

32006L0042

2006

DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery (4) codified Directive 89/392/EEC (5). Now that new substantial amendments are being made to Directive 98/37/EC, it is desirable, in order to clarify matters, that that Directive should be recast. (2) The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Community economy. The social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installation and maintenance. (3) Member States are responsible for ensuring the health and safety on their territory of persons, in particular of workers and consumers and, where appropriate, of domestic animals and goods, notably in relation to the risks arising out of the use of machinery. (4) In order to ensure legal certainty for users, the scope of this Directive and the concepts relating to its application should be defined as precisely as possible. (5) The Member States' mandatory provisions governing construction site hoists intended for lifting persons or persons and goods, which are often supplemented by de facto compulsory technical specifications and/or by voluntary standards, do not necessarily lead to different levels of health and safety but, because of their disparities, do nevertheless constitute barriers to trade within the Community. Moreover, the national systems for the conformity assessment and certification of these machines diverge considerably. It is therefore desirable not to exclude from the scope of this Directive construction site hoists intended for lifting persons or persons and goods. (6) It is appropriate to exclude from the scope of this Directive weapons, including firearms, that are subject to Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons (6); the exclusion of firearms should not apply to portable cartridge-operated fixing and other impact machinery designed for industrial or technical purposes only. It is necessary to provide for transitional arrangements enabling Member States to authorise the placing on the market and putting into service of such machinery manufactured in accordance with national provisions in force upon adoption of this Directive, including those implementing the Convention of 1 July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms. Such transitional arrangements will also enable the European standardisation organisations to draft standards ensuring the safety level based on the state of the art. (7) This Directive does not apply to the lifting of persons by means of machines not designed for the lifting of persons. However, this does not affect the right of Member States to take national measures, in accordance with the Treaty, with respect to such machines, with a view to implementing Council Directive 89/655/EEC of 30 November 1989 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (7). (8) In relation to agricultural and forestry tractors, the provisions of this Directive concerning the risks currently not covered by Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (8) should no longer apply when such risks are covered by Directive 2003/37/EC. (9) Market surveillance is an essential instrument inasmuch as it ensures the proper and uniform application of Directives. It is therefore appropriate to put in place the legal framework within which market surveillance can proceed harmoniously. (10) Member States are responsible for ensuring that this Directive is effectively enforced on their territory and that the safety of the machinery concerned is, as far as possible, improved in accordance with its provisions. Member States should ensure their capacity to carry out effective market surveillance, taking account of guidelines developed by the Commission, in order to achieve the proper and uniform application of this Directive. (11) In the context of market surveillance, a clear distinction should be established between the disputing of a harmonised standard conferring a presumption of conformity on machinery and the safeguard clause relating to machinery. (12) The putting into service of machinery within the meaning of this Directive can relate only to the use of the machinery itself for its intended purpose or for a purpose which can reasonably be foreseen. This does not preclude the laying down of conditions of use external to the machinery, provided that it is not thereby modified in a way not specified in this Directive. (13) It is also necessary to provide for an adequate mechanism allowing for the adoption of specific measures at Community level requiring Member States to prohibit or restrict the placing on the market of certain types of machinery presenting the same risks to the health and safety of persons either due to shortcomings in the relevant harmonised standard(s) or by virtue of their technical characteristics, or to make such machinery subject to special conditions. In order to ensure the appropriate assessment of the need for such measures, they should be taken by the Commission, assisted by a committee, in the light of consultations with the Member States and other interested parties. Since such measures are not directly applicable to economic operators, Member States should take all necessary measures for their implementation. (14) The essential health and safety requirements should be satisfied in order to ensure that machinery is safe; these requirements should be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements. (15) Where the machinery may be used by a consumer, that is to say, a non-professional operator, the manufacturer should take account of this in the design and construction. The same applies where a machine is normally used to provide a service to a consumer. (16) Although the requirements of this Directive do not apply to partly completed machinery in their entirety, it is nevertheless important that the free movement of such machinery be guaranteed by means of a specific procedure. (17) For trade fairs, exhibitions and such like, it should be possible to exhibit machinery which does not satisfy the requirements of this Directive. However, interested parties should be properly informed that the machinery does not conform and cannot be purchased in that condition. (18) This Directive defines only the essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery. In order to help manufacturers to prove conformity to these essential requirements, and to allow inspection of conformity to the essential requirements, it is desirable to have standards that are harmonised at Community level for the prevention of risks arising out of the design and construction of machinery. These standards are drawn up by private-law bodies and should retain their non-binding status. (19) In view of the nature of the risks involved in the use of machinery covered by this Directive, procedures for assessing conformity to the essential health and safety requirements should be established. These procedures should be devised in the light of the extent of the danger inherent in such machinery. Consequently, each category of machinery should have its appropriate procedure in conformity with Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives (9), taking account of the nature of the verification required for such machinery. (20) Manufacturers should retain full responsibility for certifying the conformity of their machinery to the provisions of this Directive. Nevertheless, for certain types of machinery having a higher risk factor, a stricter certification procedure is desirable. (21) The CE marking should be fully recognised as being the only marking which guarantees that machinery conforms to the requirements of this Directive. All other markings which are likely to mislead third parties as to the meaning or the form of the CE marking, or both, should be prohibited. (22) In order to ensure the same quality for the CE marking and the manufacturer's mark, it is important that they be affixed according to the same techniques. In order to avoid confusion between any CE markings which might appear on certain components and the CE marking corresponding to the machinery, it is important that the latter marking be affixed alongside the name of the person who has taken responsibility for it, namely the manufacturer or his authorised representative. (23) The manufacturer or his authorised representative should also ensure that a risk assessment is carried out for the machinery which he wishes to place on the market. For this purpose, he should determine which are the essential health and safety requirements applicable to his machinery and in respect of which he must take measures. (24) It is essential that, before drawing up the EC declaration of conformity, the manufacturer or his authorised representative established in the Community should prepare a technical construction file. However, it is not essential that all documentation should be permanently available in material form, but it must be possible to make it available on request. It need not include detailed plans of subassemblies used for the manufacture of machinery, unless knowledge of such plans is essential in order to ascertain conformity with the essential health and safety requirements. (25) The addressees of any decision taken under this Directive should be informed of the reasons for such a decision and of the legal remedies open to them. (26) Member States should provide for penalties applicable to infringements of the provisions of this Directive. Those penalties should be effective, proportionate and dissuasive. (27) The application of this Directive to a number of machines intended for lifting persons requires a better delimitation of the products covered by this Directive with respect to those covered by Directive 95/16/EC of the European Parliament and of the Council of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (10). A redefinition of the scope of the latter Directive is thus deemed necessary. Directive 95/16/EC should therefore be amended accordingly. (28) Since the objective of this Directive, namely, to lay down the essential health and safety requirements in relation to design and manufacture in order to improve the safety of machinery placed on the market, cannot be sufficiently achieved by the Member States and can be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (29) In accordance with point 34 of the Interinstitutional Agreement on better law-making (11), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public. (30) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12), Article 1 Scope 1. This Directive applies to the following products: (a) machinery; (b) interchangeable equipment; (c) safety components; (d) lifting accessories; (e) chains, ropes and webbing; (f) removable mechanical transmission devices; (g) partly completed machinery. 2. The following are excluded from the scope of this Directive: (a) safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery; (b) specific equipment for use in fairgrounds and/or amusement parks; (c) machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity; (d) weapons, including firearms; (e) the following means of transport: — agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles, — motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (13), with the exclusion of machinery mounted on these vehicles, — vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (14), with the exclusion of machinery mounted on these vehicles, — motor vehicles exclusively intended for competition, and — means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport; (f) seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units; (g) machinery specially designed and constructed for military or police purposes; (h) machinery specially designed and constructed for research purposes for temporary use in laboratories; (i) mine winding gear; (j) machinery intended to move performers during artistic performances; (k) electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (15): — household appliances intended for domestic use, — audio and video equipment, — information technology equipment, — ordinary office machinery, — low-voltage switchgear and control gear, — electric motors; (l) the following types of high-voltage electrical equipment: — switch gear and control gear, — transformers. Article 2 Definitions For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1(1)(a) to (f). The following definitions shall apply: (a) ‘machinery’ means: — an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application, — an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion, — an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure, — assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole, — an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort; (b) ‘interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool; (c) ‘safety component’ means a component: — which serves to fulfil a safety function, — which is independently placed on the market, — the failure and/or malfunction of which endangers the safety of persons, and — which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function. An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8(1)(a); (d) ‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories; (e) ‘chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories; (f) ‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product; (g) ‘partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies; (h) ‘placing on the market’ means making available for the first time in the Community machinery or partly completed machinery with a view to distribution or use, whether for reward or free of charge; (i) ‘manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer; (j) ‘authorised representative’ means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this Directive; (k) ‘putting into service’ means the first use, for its intended purpose, in the Community, of machinery covered by this Directive; (l) ‘harmonised standard’ means a non-binding technical specification adopted by a standardisation body, namely the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), on the basis of a remit issued by the Commission in accordance with the procedures laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (16). Article 3 Specific Directives Where, for machinery, the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply, or shall cease to apply, to that machinery in respect of such hazards from the date of implementation of those other Directives. Article 4 Market surveillance 1. Member States shall take all appropriate measures to ensure that machinery may be placed on the market and/or put into service only if it satisfies the relevant provisions of this Directive and does not endanger the health and safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen. 2. Member States shall take all appropriate measures to ensure that partly completed machinery can be placed on the market only if it satisfies the relevant provisions of this Directive. 3. Member States shall institute or appoint the competent authorities to monitor the conformity of machinery and partly completed machinery with the provisions set out in paragraphs 1 and 2. 4. Member States shall define the tasks, organisation and powers of the competent authorities referred to in paragraph 3 and shall notify the Commission and other Member States thereof and also of any subsequent amendment. Article 5 Placing on the market and putting into service 1. Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall: (a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I; (b) ensure that the technical file referred to in Annex VII, part A is available; (c) provide, in particular, the necessary information, such as instructions; (d) carry out the appropriate procedures for assessing conformity in accordance with Article 12; (e) draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery; (f) affix the CE marking in accordance with Article 16. 2. Before placing partly completed machinery on the market, the manufacturer or his authorised representative shall ensure that the procedure referred to in Article 13 has been completed. 3. For the purposes of the procedures referred to in Article 12, the manufacturer or his authorised representative shall have, or shall have access to, the necessary means of ensuring that the machinery satisfies the essential health and safety requirements set out in Annex I. 4. Where machinery is also the subject of other Directives relating to other aspects and providing for the affixing of the CE marking, the marking shall indicate that the machinery also conforms to the provisions of those other Directives. However, where one or more of those Directives allow the manufacturer or his authorised representative to choose, during a transitional period, the system to be applied, the CE marking shall indicate conformity only to the provisions of those Directives applied by the manufacturer or his authorised representative. Particulars of the Directives applied, as published in the Official Journal of the European Union, shall be given on the EC declaration of conformity. Article 6 Freedom of movement 1. Member States shall not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of machinery which complies with this Directive. 2. Member States shall not prohibit, restrict or impede the placing on the market of partly completed machinery where the manufacturer or his authorised representative makes a declaration of incorporation, referred to in Annex II, part 1, Section B, stating that it is to be incorporated into machinery or assembled with other partly completed machinery to form machinery. 3. At trade fairs, exhibitions, demonstrations, and such like, Member States shall not prevent the showing of machinery or partly completed machinery which does not conform to this Directive, provided that a visible sign clearly indicates that it does not conform and that it will not be made available until it has been brought into conformity. Furthermore, during demonstrations of such non-conforming machinery or partly completed machinery, adequate safety measures shall be taken to ensure the protection of persons. Article 7 Presumption of conformity and harmonised standards 1. Member States shall regard machinery bearing the CE marking and accompanied by the EC declaration of conformity, the content of which is set out in Annex II, part 1, Section A, as complying with the provisions of this Directive. 2. Machinery manufactured in conformity with a harmonised standard, the references to which have been published in the Official Journal of the European Union, shall be presumed to comply with the essential health and safety requirements covered by such a harmonised standard. 3. The Commission shall publish in the Official Journal of the European Union the references of the harmonised standards. 4. Member States shall take the appropriate measures to enable the social partners to have an influence at national level on the process of preparing and monitoring the harmonised standards. Article 8 Specific measures 1. The Commission, acting in accordance with the procedure referred to in Article 22(3), may take any appropriate measure to implement the provisions relating to the following points: (a) updating of the indicative list of safety components in Annex V referred to in point (c) in Article 2; (b) restriction of the placing on the market of machinery referred to in Article 9. 2. The Commission, acting in accordance with the procedure referred to in Article 22(2), may take any appropriate measure connected with the implementation and practical application of this Directive, including measures necessary to ensure cooperation of Member States with each other and with the Commission, as provided for in Article 19(1). Article 9 Specific measures to deal with potentially hazardous machinery 1. When, in accordance with the procedure referred to in Article 10, the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery with technical characteristics presenting risks due to the shortcomings in the standard or to make such machinery subject to special conditions. When, in accordance with the procedure referred to in Article 11, the Commission considers that a measure taken by a Member State is justified, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery presenting the same risk by virtue of its technical characteristics or to make such machinery subject to special conditions. 2. Any Member State may request the Commission to examine the need for the adoption of the measures referred to in paragraph 1. 3. In the cases referred to in paragraph 1, the Commission shall consult the Member States and other interested parties indicating the measures it intends to take, in order to ensure, at Community level, a high level of protection of the health and safety of persons. Taking due account of the results of this consultation, it shall adopt the necessary measures in accordance with the procedure referred to in Article 22(3). Article 10 Procedure for disputing a harmonised standard Where a Member State or the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission or the Member State shall bring the matter before the committee set up by Directive 98/34/EC, setting out the reasons therefor. The committee shall deliver an opinion without delay. In the light of the committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union. Article 11 Safeguard clause 1. Where a Member State ascertains that machinery covered by this Directive, bearing the CE marking, accompanied by the EC declaration of conformity and used in accordance with its intended purpose or under conditions which can reasonably be foreseen, is liable to compromise the health and safety of persons and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery from the market, to prohibit the placing on the market and/or putting into service of such machinery or to restrict free movement thereof. 2. The Member State shall immediately inform the Commission and the other Member States of any such measure, indicating the reasons for its decision and, in particular, whether the non-conformity is due to: (a) failure to satisfy the essential requirements referred to in Article 5(1)(a); (b) incorrect application of the harmonised standards referred to in Article 7(2); (c) shortcomings in the harmonised standards themselves referred to in Article 7(2). 3. The Commission shall enter into consultation with the parties concerned without delay. The Commission shall consider, after this consultation, whether or not the measures taken by the Member State are justified, and it shall communicate its decision to the Member State which took the initiative, the other Member States, and the manufacturer or his authorised representative. 4. Where the measures referred to in paragraph 1 are based on a shortcoming in the harmonised standards and if the Member State which instigated the measures maintains its position, the Commission or the Member State shall initiate the procedure referred to in Article 10. 5. Where machinery does not conform and bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking and shall so inform the Commission. The Commission shall inform the other Member States. 6. The Commission shall ensure that Member States are kept informed of the progress and outcome of the procedure. Article 12 Procedures for assessing the conformity of machinery 1. The manufacturer or his authorised representative shall, in order to certify the conformity of machinery with the provisions of this Directive, apply one of the procedures for assessment of conformity described in paragraphs 2, 3 and 4. 2. Where the machinery is not referred to in Annex IV, the manufacturer or his authorised representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII. 3. Where the machinery is referred to in Annex IV and manufactured in accordance with the harmonised standards referred to in Article 7(2), and provided that those standards cover all of the relevant essential health and safety requirements, the manufacturer or his authorised representative shall apply one of the following procedures: (a) the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII; (b) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3; (c) the full quality assurance procedure provided for in Annex X. 4. Where the machinery is referred to in Annex IV and has not been manufactured in accordance with the harmonised standards referred to in Article 7(2), or only partly in accordance with such standards, or if the harmonised standards do not cover all the relevant essential health and safety requirements or if no harmonised standards exist for the machinery in question, the manufacturer or his authorised representative shall apply one of the following procedures: (a) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3; (b) the full quality assurance procedure provided for in Annex X. Article 13 Procedure for partly completed machinery 1. The manufacturer of partly completed machinery or his authorised representative shall, before placing it on the market, ensure that: (a) the relevant technical documentation described in Annex VII, part B is prepared; (b) assembly instructions described in Annex VI are prepared; (c) a declaration of incorporation described in Annex II, part 1, Section B has been drawn up. 2. The assembly instructions and the declaration of incorporation shall accompany the partly completed machinery until it is incorporated into the final machinery and shall then form part of the technical file for that machinery. Article 14 Notified bodies 1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the assessment of conformity for placing on the market referred to in Article 12(3) and (4), together with the specific conformity assessment procedures and categories of machinery for which these bodies have been appointed and the identification numbers assigned to them beforehand by the Commission. Member States shall notify the Commission and other Member States of any subsequent amendment. 2. The Member States shall ensure that the notified bodies are monitored regularly to check that they comply at all times with the criteria set out in Annex XI. The notified body shall provide all relevant information on request, including budgetary documents, to enable the Member States to ensure that the requirements of Annex XI are met. 3. Member States shall apply the criteria set out in Annex XI in assessing the bodies to be notified and the bodies already notified. 4. The Commission shall publish in the Official Journal of the European Union, for information, a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date. 5. Bodies meeting the assessment criteria laid down in the relevant harmonised standards, the references of which shall be published in the Official Journal of the European Union, shall be presumed to fulfil the relevant criteria. 6. If a notified body finds that relevant requirements of this Directive have not been met or are no longer met by the manufacturer or that an EC type-examination certificate or the approval of a quality assurance system should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate or the approval issued or place restrictions on it, giving detailed reasons, unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the event of suspension or withdrawal of the certificate or the approval or of any restriction placed on it, or in cases where intervention by the competent authority may prove necessary, the notified body shall inform the competent authority pursuant to Article 4. The Member State shall inform the other Member States and the Commission without delay. An appeal procedure shall be available. 7. The Commission shall provide for the organisation of an exchange of experience between the authorities responsible for appointment, notification and monitoring of notified bodies in the Member States, and the notified bodies, in order to coordinate the uniform application of this Directive. 8. A Member State which has notified a body shall immediately withdraw its notification if it finds: (a) that the body no longer meets the criteria set out in Annex XI; or (b) that the body seriously fails to fulfil its responsibilities. The Member State shall immediately inform the Commission and the other Member States accordingly. Article 15 Installation and use of machinery This Directive shall not affect Member States' entitlement to lay down, in due observance of Community law, such requirements as they may deem necessary to ensure that persons, and in particular workers, are protected when using machinery, provided that this does not mean that such machinery is modified in a way not specified in this Directive. Article 16 CE marking 1. The CE conformity marking shall consist of the initials ‘CE’ as shown in Annex III. 2. The CE marking shall be affixed to the machinery visibly, legibly and indelibly in accordance with Annex III. 3. The affixing on machinery of markings, signs and inscriptions which are likely to mislead third parties as to the meaning or form of the CE marking, or both, shall be prohibited. Any other marking may be affixed to the machinery provided that the visibility, legibility and meaning of the CE marking is not thereby impaired. Article 17 Non-conformity of marking 1. Member States shall consider the following marking not to conform: (a) the affixing of the CE marking pursuant to this Directive on products not covered by this Directive; (b) the absence of the CE marking and/or the absence of the EC declaration of conformity for machinery; (c) the affixing on machinery of a marking, other than the CE marking, which is prohibited under Article 16(3). 2. Where a Member State ascertains that marking does not conform to the relevant provisions of this Directive, the manufacturer or his authorised representative shall be obliged to make the product conform and to put an end to the infringement under conditions fixed by that Member State. 3. Where non-conformity persists, the Member State shall take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedure laid down in Article 11. Article 18 Confidentiality 1. Without prejudice to existing national provisions and practices in the area of confidentiality, Members States shall ensure that all parties and persons concerned by the application of this Directive are required to treat as confidential information obtained in the execution of their tasks. More particularly business, professional and trade secrets shall be treated as confidential, unless the divulging of such information is necessary in order to protect the health and safety of persons. 2. The provisions of paragraph 1 shall not affect the obligations of the Member States and the notified bodies with regard to mutual exchange of information and the issuing of warnings. 3. Any decisions taken by the Member States and by the Commission in accordance with Articles 9 and 11 shall be published. Article 19 Cooperation between Member States 1. Member States shall take the appropriate measures to ensure that the competent authorities referred to in Article 4(3) cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly. 2. The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive. Article 20 Legal remedies Any measure taken pursuant to this Directive which restricts the placing on the market and/or putting into service of any machinery covered by this Directive shall state the exact grounds on which it is based. Such a measure shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject. Article 21 Dissemination of information The Commission shall take the necessary measures for appropriate information concerning the implementation of this Directive to be made available. Article 22 Committee 1. The Commission shall be assisted by a committee, hereinafter referred to as the ‘Committee’. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 4. The Committee shall adopt its rules of procedure. Article 23 Penalties Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 29 June 2008 and shall notify it without delay of any subsequent amendment affecting them. Article 24 Amendment of Directive 95/16/EC Directive 95/16/EC is hereby amended as follows: 1. in Article 1, paragraphs 2 and 3 shall be replaced by the following: 2. ‘For the purposes of this Directive, “lift” shall mean a lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, intended for the transport of: — persons, — persons and goods, — goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier. Lifting appliances moving along a fixed course even where they do not move along guides which are rigid shall be considered as lifts falling within the scope of this Directive. A “carrier” means a part of the lift by which persons and/or goods are supported in order to be lifted or lowered. 3. This Directive shall not apply to: — lifting appliances whose speed is not greater than 0,15 m/s, — construction site hoists, — cableways, including funicular railways, — lifts specially designed and constructed for military or police purposes, — lifting appliances from which work can be carried out, — mine winding gear, — lifting appliances intended for lifting performers during artistic performances, — lifting appliances fitted in means of transport, — lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery, — rack and pinion trains, — escalators and mechanical walkways.’; 2. in Annex I, point 1.2 shall be replaced by the following: 1.2. ‘Carrier The carrier of each lift must be a car. This car must be designed and constructed to offer the space and strength corresponding to the maximum number of persons and the rated load of the lift set by the installer. Where the lift is intended for the transport of persons, and where its dimensions permit, the car must be designed and constructed in such a way that its structural features do not obstruct or impede access and use by disabled persons and so as to allow any appropriate adjustments intended to facilitate its use by them.’ Article 25 Repeal Directive 98/37/EC is hereby repealed. References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex XII. Article 26 Transposition 1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 29 June 2008 at the latest. They shall forthwith inform the Commission thereof. They shall apply those provisions with effect from 29 December 2009. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted. Article 27 Derogation Until 29 June 2011 Member States may allow the placing on the market and the putting into service of portable cartridge-operated fixing and other impact machinery which are in conformity with the national provisions in force upon adoption of this Directive. Article 28 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 29 Addressees This Directive is addressed to the Member States.

32006L0038

2006

DIRECTIVE 2006/38/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 amending Directive 1999/62/EC on the charging of heavy goods vehicles for the use of certain infrastructures Having regard to the Treaty establishing the European Community, and in particular Article 71(1) thereof, Having regard to Directive 1999/62/EC (1), and in particular Article 7 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (2), Having regard to the opinion of the Committee of the Regions (3), Acting in accordance with the procedure laid down in Article 251 of the Treaty (4), Whereas: (1) Eliminating distortions of competition between transport undertakings in the Member States, the proper functioning of the internal market and improved competitiveness all depend on fair mechanisms being established to charge hauliers for the cost of infrastructure use. A degree of harmonisation has already been achieved through Directive 1999/62/EC. (2) A fairer system of charging for the use of road infrastructure, based on the ‘user pays’ principle and the ability to apply the ‘polluter pays’ principle, for instance through the variation of tolls to take account of the environmental performance of vehicles, is crucial in order to encourage sustainable transport in the Community. The objective of making optimum use of the existing road network and achieving a significant reduction in its negative impact should be achieved in such a way as to avoid double taxation and without imposing additional burdens on operators, in the interests of sound economic growth and the proper functioning of the internal market, including outlying regions. (3) The Commission announced its intention of proposing a directive on charging for the use of road infrastructure in the White Paper ‘European transport policy for 2010: time to decide’. The European Parliament confirmed the need for infrastructure charging when it adopted its resolution (5) on the conclusions of the White Paper on 12 February 2003. Following the Göteborg European Council of 15 and 16 June 2001, which drew particular attention to the issue of sustainable transport, the Copenhagen European Council of 12 and 13 December 2002 and the Brussels European Council of 20 and 21 March 2003 also welcomed the Commission's intention of presenting a new ‘Eurovignette’ Directive. (4) In paragraph 29 of the Presidency conclusions of its meeting in Göteborg, the European Council stated that a sustainable transport policy should tackle rising volumes of traffic and levels of congestion, noise and pollution and encourage the use of environment-friendly modes of transport as well as the full internalisation of social and environmental costs. (5) For the purposes of setting tolls, Directive 1999/62/EC takes account of infrastructure construction, operating, maintenance and development costs. A specific provision is needed to ensure clarity regarding the construction costs that may be taken into account. (6) International road transport operations are concentrated on the trans-European road transport network. Furthermore, the proper functioning of the internal market is vital to commercial transport. Consequently, the Community framework should apply to commercial transport on the trans-European road network as defined in Decision No 1692/96/EC of the European Parliament and of the Council of 23 July 1996 on Community guidelines for the development of the trans-European transport network (6). Member States should, in accordance with the principle of subsidiarity, be free to apply tolls and/or user charges on roads other than those on the trans-European road network, in compliance with the Treaty. Where Member States choose to maintain or introduce tolls and/or user charges only on parts of the trans-European road network in their territory and not on others, for reasons such as their isolation or low levels of congestion or pollution or where essential for the introduction of a new tolling arrangement, the choice of the parts of the network subject to tolls or charges should not discriminate against international traffic and should not result in distortions of competition between operators. The same requirements should apply to cases where a Member State maintains or introduces tolls and/or user charges on roads not forming part of the trans-European road network, for example on parallel roads, with a view to managing traffic flows. (7) Where a Member State chooses to extend tolls and/or user charges beyond the trans-European road network, for example to include parallel roads to which traffic may be diverted from the trans-European road network and/or which are in direct competition with certain parts of that network, it should ensure coordination with the authorities responsible for these roads. (8) For reasons of cost efficiency in the implementation of tolling systems, the entire infrastructure to which a toll relates may not necessarily be subject to access restrictions controlling tolls charged. Member States may choose to implement this Directive through the use of tolls at only a particular point on the infrastructure to which the toll relates. This should not discriminate against non-local traffic. (9) Tolls should be based on the principle of recovery of infrastructure costs. In cases where such infrastructures have been co-financed through the general budget of the European Union, the contribution made from Community funds should not be recovered through tolls, unless there are specific provisions in the relevant Community instruments which take into account future toll receipts in establishing the amount of Community co-financing. (10) The fact that the user is able to take decisions which will influence the burden of tolls by choosing the least polluting vehicles and less congested periods or itineraries is an important component of a charging system. Member States should therefore be able to differentiate tolls according to a vehicle's emission category (‘EURO’ classification) and the level of damage it causes to roads, the place, the time and the amount of congestion. Such differentiation in the level of tolls should be proportionate to the objective pursued. (11) Aspects of commercial pricing for road infrastructure use not covered by this Directive should respect the rules of the Treaty. (12) This Directive does not affect the freedom of Member States which introduce a system of tolls and/or user charges for infrastructure to provide, without prejudice to Articles 87 and 88 of the Treaty, appropriate compensation for these charges. Such compensation should not lead to distortions of competition within the internal market and should be subject to the relevant provisions of Community law, in particular the minimum rates of vehicle taxes set out in Annex I to Directive 1999/62/EC and the provisions of Council Directive 2003/96/EC of 27 October 2003 restructuring the Community framework for the taxation of energy products and electricity (7). (13) Where Member States levy tolls or user charges for use of roads in the trans-European road network, the roads subject to charging should be given appropriate priority in the maintenance schedules of Member States. Revenues from tolls or user charges should be used for the maintenance of the infrastructure concerned and for the transport sector as a whole, in the interest of the balanced and sustainable development of transport networks. (14) Particular attention should be devoted to mountain regions such as the Alps or the Pyrenees. The launch of major new infrastructure projects has often failed because the substantial financial resources they would require were not available. In such regions, users may therefore be required to pay a mark-up to finance essential projects of very high European value, including those involving another mode of transport in the same corridor. This amount should be linked to the financial needs of the project. It should also be linked to the basic level of the tolls in order to avoid artificially high charges in any one corridor, which could lead to traffic being diverted to other corridors, thereby causing local congestion problems and inefficient use of networks. (15) Fees should be non-discriminatory and their collection should not involve excessive formalities or create barriers at internal borders. Appropriate measures should therefore be taken to facilitate payment by occasional users, in particular where tolls and/or user charges are collected exclusively by means of a system that requires use of an electronic payment tool (on-board unit). (16) In order to prevent traffic being diverted because of different regimes between Member States and third countries, the Commission should try to ensure that, when negotiating international agreements, no measures are taken by third countries, such as a transit right trading system, that might have a discriminatory effect on transit traffic. (17) In order to ensure consistent, harmonised application of the infrastructure charging system, new tolling arrangements should calculate costs in accordance with the set of core principles set out in Annex II or be set at a level which does not go beyond that which would result from the application of these principles. These requirements should not apply to existing arrangements unless they are substantially modified in the future. Such substantial modifications would include any significant change to the original terms and conditions of the tolling scheme through modification of a contract with the tolling system operator but would exclude changes provided for in the original scheme. In the case of concession contracts, substantial modification could be implemented pursuant to a public procurement process. In order to achieve transparency without creating obstacles to the functioning of the market economy and public private partnerships, Member States must also communicate to the Commission, so that the Commission is in a position to give an opinion, the unit values and other parameters they intend to apply to calculate the various cost elements of the charges or, in the case of concession contracts, the relevant contract and base case. Opinions adopted by the Commission before the introduction of new tolling arrangements in Member States are entirely without prejudice to the Commission's obligation under the Treaty to ensure that Community law is applied. (18) So as to enable an informed and objective decision to be taken in the future regarding the possible application of the ‘polluters pays’ principle for all modes of transport, by means of the internalisation of external costs, uniform calculation principles should be developed, based on scientifically recognised data. Any future decision on this question should take full account of the tax burden already borne by road haulage companies, including vehicle taxes and fuel excise duties. (19) The Commission should begin work on developing a generally applicable, transparent and comprehensible model for the assessment of external costs for all modes of transport to serve as the basis for future calculations of infrastructure charges. In carrying out this work, the Commission should examine all possible options regarding the composition of the external costs to be taken into account, having regard to the elements listed in its 2001 White Paper ‘European Transport Policy for 2010’, carefully assessing the impact that internalisation of the various cost options would have. The European Parliament and the Council will examine diligently any such proposal of the Commission for further revision of Directive 1999/62/EC. (20) Further technical progress is still needed to develop the system of charging for the use of road infrastructure. There should be a procedure allowing the Commission to adapt the requirements of Directive 1999/62/EC to technical progress following consultation with Member States for this purpose. (21) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8). (22) Since the objective of this Directive, namely to harmonise the conditions applicable to tolls and user charges for the use of road infrastructure, cannot be satisfactorily achieved by the Member States acting alone and can therefore, by reason of its European dimension and with a view to safeguarding the internal market for transport, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity enshrined in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective. (23) Directive 1999/62/EC should be amended accordingly, Article 1 1. Article 2 of Directive 1999/62/EC shall be amended as follows: (a) point (a) shall be replaced by the following: (a) ‘“trans-European road network” means the road network defined in Section 2 of Annex I to Decision No 1692/96/EC of the European Parliament and of the Council of 23 July 1996 on Community guidelines for the development of the trans-European transport network (9) as illustrated by maps. The maps refer to the corresponding sections mentioned in the operative part of and/or in Annex II to that Decision;’ (b) the following points shall be inserted: (aa) ‘“construction costs” means the costs related to construction, including, where appropriate, the financing costs, of: — new infrastructure or new infrastructure improvements (including significant structural repairs), or — infrastructure or infrastructure improvements (including significant structural repairs) completed no more than 30 years before 10 June 2008, where tolling arrangements are already in place on 10 June 2008, or completed no more than 30 years before the establishment of any new tolling arrangements introduced after 10 June 2008; costs regarding infrastructure or infrastructure improvements completed before these time limits may also be considered as construction costs where: (i) a Member State has established a tolling system which provides for the recovery of these costs by means of a contract with a tolling system operator, or other legal acts having equivalent effect, which enter into force before 10 June 2008, or (ii) a Member State can demonstrate that the case for building the infrastructure in question depended on its having a design lifetime in excess of 30 years. In any event, the proportion of the construction costs to be taken into account shall not exceed the proportion of the current design lifetime period of infrastructure components still to run on 10 June 2008 or on the date when the new tolling arrangements are introduced, where this is a later date. Costs of infrastructure or infrastructure improvements may include any specific expenditure on infrastructure designed to reduce nuisance related to noise or to improve road safety and actual payments made by the infrastructure operator corresponding to objective environmental elements such as protection against soil contamination; (ab) “financing costs” means interest on borrowings and/or return on any equity funding contributed by shareholders; (ac) “significant structural repairs” means structural repairs excluding those repairs no longer of any current benefit to road users, e.g. where the repair work has been replaced by further road resurfacing or other construction work;’; (c) point (b) shall be replaced by the following: (b) ‘toll’ means a specified amount payable for a vehicle travelling a given distance on the infrastructures referred to in Article 7(1); the amount shall be based on the distance travelled and the type of vehicle, (d) the following point shall be inserted: (ba) ‘“weighted average toll” means the total revenue raised through tolls over a given period divided by the number of vehicle kilometres travelled on a given network subject to tolling during that period, both the revenue and the vehicle kilometres being calculated for the vehicles to which tolls apply;’; (e) points (c), (d), (e) and (f) shall be replaced by the following: (c) ‘“user charge” means a specified amount payment of which confers the right for a vehicle to use for a given period the infrastructures referred to in Article 7(1); (d) “vehicle” means a motor vehicle or articulated vehicle combination intended or used exclusively for the carriage by road of goods and having a maximum permissible laden weight of over 3,5 tonnes; (e) vehicle of the “EURO 0”, “EURO I”, “EURO II”, “EURO III”, “EURO IV”, “EURO V”, “EEV” category means a vehicle that complies with the emission limits set out in Annex 0; (f) “type of vehicle” means a category into which a vehicle falls according to the number of its axles, its dimensions or weight, or other vehicle classification factors reflecting road damage, e.g. the road damage classification system set out in Annex IV, provided that the classification system used is based on vehicle characteristics which either appear in the vehicle documentation used in all Member States or are visually apparent.’; (f) the following points shall be added: (g) ‘“concession contract” means a “public works concession” or a “service concession” as defined in Article 1 of Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (10); (h) “concession toll” means a toll levied by a concessionaire under a concession contract.’ 2. Article 7 is hereby amended as follows: (a) paragraphs 1, 2, 3 and 4 shall be replaced by the following: 1. ‘Member States may maintain or introduce tolls and/or user charges on the trans-European road network, or on parts of that network, only under the conditions set out in paragraphs 2 to 12. This shall be without prejudice to the right of Member States, in compliance with the Treaty, to apply tolls and/or user charges on roads not included in the trans-European road network, inter alia on parallel roads to which traffic may be diverted from the trans-European road network and/or which are in direct competition with certain parts of that network, or to other types of motor vehicle not covered by the definition of “vehicle” on the trans-European road network, provided that the imposition of tolls and/or user charges on such roads does not discriminate against international traffic and does not result in distortions of competition between operators. 1a. Where a Member State decides to maintain or introduce tolls and/or user charges on only parts of the trans-European road network, the resulting exemptions for the other parts (for reasons such as their isolation or low levels of congestion or pollution or where essential for the introduction of a new tolling arrangement) shall not result in any discrimination against international traffic. 2. (a) A Member State may choose to maintain or introduce tolls and/or user charges applicable only to vehicles having a maximum permissible laden weight of not less than 12 tonnes. Where a Member State chooses to apply tolls and/or user charges to vehicles below this weight limit, the provisions of this Directive shall apply. (b) Tolls and/or user charges shall be applied to all vehicles from 2012. (c) A Member State may derogate from the requirement set out in point (b) where it considers that the extension of tolling to vehicles of less than 12 tonnes would: — create significant adverse effects on the free flow of traffic, the environment, noise levels, congestion or health, or — involve administrative costs which would be more than 30 % of additional revenue generated. 3. Tolls and user charges may not both be imposed at the same time on any given category of vehicle for the use of a single road section. However, Member States may also impose tolls on networks where user charges are levied for the use of bridges, tunnels and mountain passes. 4. Tolls and user charges may not discriminate, directly or indirectly, on the grounds of nationality of the haulier, the country or place of establishment of the haulier or of registration of the vehicle, or the origin or destination of the transport operation.’; (b) the following paragraphs shall be inserted: ‘4a. Member States may provide for reduced toll rates or user charges or exemptions from the obligation to pay tolls or user charges for vehicles exempted from the requirement to install and use recording equipment under Council Regulation (EEC) No 3821/85 of 20 December 1985 on recording equipment in road transport (11), and in the cases covered by, and subject to the conditions contained in, Article 6(2)(a) and (b) of this Directive. 4b. As charging structures involving discounts or reductions in tolls for frequent users may lead to actual savings in administrative costs for the infrastructure operator, Member States may provide for such discounts or reductions on condition that: — they fulfil the conditions set out in paragraph 10(a), — they comply with the Treaty, in particular Articles 12, 49, 86 and 87 thereof, — they do not distort competition in the internal market, — the resulting charging structure is linear, proportionate, available to all users on equal terms and does not lead to additional costs being passed on to other users in the form of higher tolls. Such discounts or reductions shall in no case exceed 13 % of the toll paid by equivalent vehicles not eligible for the discount or reduction. 4c. All discount and reduction schemes shall be communicated to the Commission, which shall verify compliance with the conditions set out in paragraphs 4a and 4b and shall approve them in accordance with the procedure referred to in Article 9c(2).’ (c) paragraph 6 shall be replaced by the following: 6. ‘The arrangements for the collection of tolls and/or user charges shall not, financially or otherwise, place non-regular users of the road network at an unjustified disadvantage. In particular, where a Member State collects tolls and/or user charges exclusively by means of a system that requires the use of a vehicle on-board unit, it shall make available the appropriate on-board units under reasonable administrative and economic arrangements.’; (d) the second and third subparagraphs of paragraph 7 shall be deleted; (e) paragraphs 9 and 10 shall be replaced by the following: 9. ‘Tolls shall be based on the principle of the recovery of infrastructure costs only. Specifically the weighted average tolls shall be related to the construction costs and the costs of operating, maintaining and developing the infrastructure network concerned. The weighted average tolls may also include a return on capital or profit margin based on market conditions. 10. (a) Without prejudice to the weighted average tolls referred to in paragraph 9, Member States may vary the toll rates for purposes such as combating environmental damage, tackling congestion, minimising infrastructure damage, optimising the use of the infrastructure concerned or promoting road safety, provided that such variation: — is proportionate to the objective pursued; — is transparent and non-discriminatory particularly regarding the nationality of the haulier, the country or place of establishment of the haulier or of registration of the vehicle, and the origin or destination of the transport operation; — is not designed to generate additional tolling revenue, any unintended increase in revenue (leading to weighted average tolls which are not in accordance with paragraph 9) being counterbalanced through changes to the structure of the variation which must be implemented within two years of the end of the accounting year in which the additional revenue is generated; — respects the maximum flexibility thresholds set out in point (b). (b) Subject to the conditions of point (a), toll rates may be varied according to: — EURO emission class as set out in Annex 0, including the level of PM and NOx, provided that no toll is more than 100 % above the toll charged for equivalent vehicles meeting the strictest emission standards; and/or — the time of day, type of day or season, provided that: (i) no toll is more than 100 % above the toll charged during the cheapest period of the day, type of day or season; or (ii) where the cheapest period is zero-rated, the penalty for the most expensive time of day, type of day or season is no more than 50 % of the level of toll that would otherwise be applicable to the vehicle in question. Member States shall be required to vary the rates at which tolls are charged in conformity with the first indent no later than 2010, or in the case of concession contracts, when that concession contract is renewed. A Member State may nevertheless derogate from this requirement if: (i) this would seriously undermine the coherence of the tolling systems in its territory; (ii) for the tolling system concerned, it would not be technically practicable to introduce such differentiation; or (iii) this would lead to diversion of the most polluting vehicles away from the trans-European road network with consequential impacts on road safety and public health. Any such derogations shall be notified to the Commission. (c) Subject to the conditions of point (a), toll rates may in exceptional cases for specific projects of high European interest be subject to other forms of variation in order to secure the commercial viability of such projects, when they are exposed to direct competition with other modes of transport for vehicles. The resulting charging structure shall be linear, proportionate, openly published, available to all users on equal terms and shall not lead to additional costs being passed on to other users in the form of higher tolls. The Commission shall verify compliance with the conditions of this point prior to the implementation of the charging structure in question.’; (f) the following paragraphs shall be added: 11. ‘Without prejudice to Article 9(1) and (1a), in exceptional cases concerning infrastructure in mountainous regions and after informing the Commission, a mark-up may be added to the tolls of specific road sections: (a) which are the subject of acute congestion affecting the free movement of vehicles; or (b) the use of which by vehicles is the cause of significant environmental damage, on condition that: — the revenue generated from the mark-up is invested in priority projects of European interest identified in Annex III to Decision No 884/2004/EC, which contribute directly to the alleviation of the congestion or environmental damage in question and which are located in the same corridor as the road section on which the mark-up is applied, — the mark-up, which may be applied to tolls varied in accordance with paragraph 10, does not exceed 15 % of the weighted average toll calculated in accordance with paragraph 9 except where the revenue generated is invested in cross-border sections of priority projects of European interest involving infrastructure in mountainous regions, in which case the mark-up may not exceed 25 %, — the application of the mark-up does not result in unfair treatment of commercial traffic compared to other road users, — financial plans for the infrastructure on which the mark-up is applied and a cost/benefit analysis for the new infrastructure project are submitted to the Commission in advance of the mark-up's application, — the period for which the mark-up is to apply is defined and limited in advance and is consistent in terms of the expected revenue to be raised with the financial plans and cost/benefit analysis submitted. Application of this provision to new cross-border projects shall be subject to the agreement of the Member States concerned. When the Commission receives the financial plans from a Member State intending to apply a mark-up, it shall make this information available to the members of the Committee referred to in Article 9c(1). Should the Commission consider that the planned mark-up does not meet the conditions set out in this paragraph, or if it considers that the planned mark-up will have significant adverse effects on the economic development of peripheral regions, it may reject or request modification of the plans for charges submitted by the Member State concerned, in accordance with the procedure referred to in Article 9c(2). 12. Where a driver is unable to produce the vehicle documents necessary to ascertain the information referred to in the first indent of paragraph 10(b), and the type of vehicle in the event of a check, Member States may apply tolls up to the highest level chargeable.’; 3. the following Article shall be inserted: ‘Article 7a 1. In determining the levels of weighted average tolls to be charged on the infrastructure network concerned or a clearly defined part of such a network, Member States shall take into account the various costs set out in Article 7(9). The costs taken into account shall relate to the network or part of the network on which tolls are levied and to the vehicles that are subject to the tolling. Member States may choose not to recover these costs through toll revenue or to recover only a percentage of the costs. 2. Tolls shall be determined in accordance with Article 7 and paragraph 1 of this Article. 3. For new tolling arrangements other than those involving concession tolls put in place by Member States after 10 June 2008, Member States shall calculate costs using a methodology based on the core calculation principles set out in Annex III. For new concession tolls put in place after 10 June 2008, the maximum level of tolls shall be equivalent to, or less than, the level that would have resulted from the use of a methodology based on the core calculation principles set out in Annex III. The assessment of such equivalence shall be made on the basis of a reasonably long reference period appropriate to the nature of a concession contract. Tolling arrangements already in place on 10 June 2008 or for which tenders or responses to invitations to negotiate under the negotiated procedure have been received pursuant to a public procurement process before 10 June 2008 shall not be subject to the obligations set out in this paragraph, for as long as these arrangements remain in force and provided that they are not substantially modified. 4. Member States shall communicate to the Commission at least four months before the implementation of a new tolling arrangement: (a) for tolling arrangements other than those involving concession tolls: — the unit values and other parameters they use in calculating the various cost elements, and — clear information on the vehicles covered by their tolling regime and the geographic extent of the network, or part of the network, used for each cost calculation and the percentage of costs that they are seeking to recover; (b) for tolling arrangements involving concession tolls: — the concession contracts or significant changes to such contracts, — the base case on which the grantor has founded the notice of concession, as referred to in Annex VII B to Directive 2004/18/EC; this base case shall include the estimated costs as defined in Article 7(9) envisaged under the concession, the forecasted traffic divided into types of vehicle, the levels of tolls envisaged and the geographic extent of the network covered by the concession contract. 5. Member States shall also inform the Commission at least four months before their implementation of new tolling arrangements applicable to parallel roads to which traffic may be diverted from the trans-European road network and/or which are in direct competition with certain parts of that network on which tolls are levied. This information shall include at least an explanation of the geographic extent of the network covered by the toll, the vehicles covered and the levels of toll envisaged, together with an explanation of how the level of toll was determined. 6. For the cases subject to the obligations in paragraph 3 the Commission shall, within four months of receiving the information in accordance with paragraph 4, give an opinion as to whether these obligations appear to have been fulfilled. For the tolling arrangements referred to in paragraph 5, the Commission may also give an opinion, in particular regarding the proportionality and the transparency of the proposed arrangements and their likely impact on competition in the context of the internal market and the free movement of goods. The opinions of the Commission shall be made available to the Committee referred to in Article 9c(1). 7. Where a Member State wishes to apply the provisions contained in Article 7(11) in respect of tolling arrangements already in place on 10 June 2008, it shall provide information that demonstrates that the weighted average toll being applied to the infrastructure concerned complies with Articles 2(aa), 7(9) and 7(10).’; 4. the following Article shall be inserted: ‘Article 7b This Directive does not affect the freedom of Member States which introduce a system of tolls and/or user charges for infrastructure to provide, without prejudice to Articles 87 and 88 of the Treaty, appropriate compensation for these charges.’; 5. Article 8(2)(b) shall be replaced by the following: (b) ‘payment of the common user charge shall give access to the network as defined by the participating Member States in accordance with Article 7(1);’; 6. the following Article shall be inserted: ‘Article 8a Each Member State shall monitor the system of tolls and/or user charges to ensure that it functions in a transparent and non-discriminatory manner.’; 7. Article 9 shall be amended as follows: (a) paragraph 1 shall be replaced by the following: 1. ‘This Directive shall not prevent the non-discriminatory application by Member States of: (a) specific taxes or charges: — levied upon registration of the vehicle, or — imposed on vehicles or loads of abnormal weights or dimensions; (b) parking fees and specific urban traffic charges. 1a. This Directive shall not prevent the non-discriminatory application by Member States of: (a) regulatory charges specifically designed to combat time and place-related traffic congestion; (b) regulatory charges designed to combat environmental impacts, including poor air quality on any road, notably in urban areas, including trans-European road network roads crossing an urban area.’; (b) paragraph 2 shall be replaced by the following: 2. ‘Member States shall determine the use to be made of revenue from charges for the use of road infrastructure. To enable the transport network to be developed as a whole, revenue from charges should be used to benefit the transport sector and optimise the entire transport system.’; 8. the following Articles shall be inserted: ‘Article 9a Member States shall establish appropriate controls and determine the system of penalties applicable to infringements of the national provisions adopted under this Directive. They shall take all necessary measures to ensure that they are implemented. The penalties established shall be effective, proportionate and dissuasive. Article 9b The Commission shall facilitate dialogue and the exchange of technical know-how between Member States in relation to the implementation of this Directive and in particular Annex III. The Commission shall update and clarify Annexes 0, III and IV in the light of technical progress and Annexes I and II in the light of inflation, in accordance with the procedure referred to in Article 9c(3). Article 9c 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Article 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 4. The Committee shall adopt its rules of procedure.’; 9. Article 11 shall be replaced by the following: ‘Article 11 No later than 10 June 2011, the Commission shall present a report to the European Parliament and the Council on the implementation and effects of this Directive, taking account of developments in technology and the trend in traffic density, including the use of vehicles of more than 3,5 and less than 12 tonnes, and evaluating its impact on the internal market, including on island, landlocked and peripheral regions of the Community, levels of investment in the sector and its contribution to the objectives of a sustainable transport policy. Member States shall forward the necessary information for the report to the Commission no later than 10 December 2010. No later than 10 June 2008, the Commission shall present, after examining all options including environment, noise, congestion and health-related costs, a generally applicable, transparent and comprehensible model for the assessment of all external costs to serve as the basis for future calculations of infrastructure charges. This model shall be accompanied by an impact analysis of the internalisation of external costs for all modes of transport and a strategy for a stepwise implementation of the model for all modes of transport. The report and the model shall be accompanied, if appropriate, by proposals to the European Parliament and the Council for further revision of this Directive.’; 10. the table in Annex II indicating the amount of annual charges shall be replaced by the following: maximum three axles minimum four axles EURO 0 1 332 2 233 EURO I 1 158 1 933 EURO II 1 008 1 681 EURO III 876 1 461 EURO IV and less polluting 797 1 329 11. the last sentence of Annex II shall be replaced by the following: ‘The daily user charge is equal for all vehicle categories and amounts to EUR 11.’; 12. Annex 0, the text of which appears in Annex I to this Directive, shall be inserted; 13. Annex III, the text of which appears in Annex II to this Directive, shall be added; 14. Annex IV, the text of which appears in Annex III to this Directive, shall be added. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 10 June 2008. They shall forthwith inform the Commission thereof. When Member States adopt such measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the provisions of domestic law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted. Article 3 This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0040

2006

DIRECTIVE 2006/40/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 relating to emissions from air-conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), in the light of the joint text approved by the Conciliation Committee on 14 March 2006, Whereas: (1) The internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital must be ensured, and to that end a Community type-approval system for motor vehicles is in place. The technical requirements for the type-approval of motor vehicles with regard to air-conditioning systems should be harmonised to avoid the adoption of requirements that differ from one Member State to another and to ensure the proper functioning of the internal market. (2) A growing number of Member States intend to regulate the use of air-conditioning systems in motor vehicles as a consequence of Council Decision 2002/358/EC of 25 April 2002 concerning the approval, on behalf of the European Community, of the Kyoto Protocol to the United Nations Framework Convention on Climate Change and the joint fulfilment of commitments thereunder (3). The Decision commits the Community and its Member States to reduce their aggregate anthropogenic emissions of greenhouse gases listed in Annex A to the Kyoto Protocol by 8 % compared to 1990 levels in the period from 2008 to 2012. The uncoordinated implementation of these commitments carries the risk of creating barriers to the free movement of motor vehicles in the Community. Therefore it is appropriate to lay down the requirements to be fulfilled by air conditioning systems fitted to vehicles in order to be allowed on the market and to prohibit from a certain date air conditioning systems designed to contain fluorinated greenhouse gases with a global warming potential higher than 150. (3) Emissions of hydrofluorocarbon-134a (HFC-134a), which has a global warming potential of 1 300, from air-conditioning systems in motor vehicles are of growing concern because of their impact on climate change. Cost-effective and safe alternatives to hydrofluorocarbon‐134a (HFC-134a) are expected to be available in the near future. A review should be carried out to establish, in the light of progress in potential containment of emissions from, or replacement of, fluorinated greenhouse gases in such systems, whether this Directive should be extended to other categories of motor vehicle and whether the provisions concerning the global warming potential of these gases should be amended, taking account of technological and scientific developments and the need to respect industrial product planning timescales. (4) In order to ensure that the prohibition of certain fluorinated greenhouse gases is effective, there is a need to limit the possibility of retrofitting motor vehicles with air-conditioning systems designed to contain fluorinated greenhouse gases with a global warming potential higher than 150 and to prohibit filling air-conditioning systems with such gases. (5) In order to limit the emissions of certain fluorinated greenhouse gases from air conditioning systems in motor vehicles it is necessary to establish limit values for leakage rates and the test procedure for the assessment of leakage in air conditioning systems designed to contain fluorinated greenhouse gases with a global warming potential higher than 150 which are fitted to motor vehicles. (6) In order to contribute to the fulfilment of the commitments of the Community and its Member States under the UN Framework Convention on Climate Change, the Kyoto Protocol and Decision 2002/358/EC, Regulation (EC) No 842/2006 of the European Parliament and of the Council of 17 May 2006 on certain fluorinated greenhouse gases (4) and this Directive, which both contribute to the reduction of emissions of fluorinated greenhouse gases, should be adopted and published in the Official Journal of the European Union simultaneously. (7) Any manufacturer of vehicles should make available to the approval authority all relevant technical information regarding the installed air-conditioning systems and the gases used in them. In the case of air conditioning systems designed to contain fluorinated greenhouse gases with a global warming potential higher than 150, the manufacturer should also make available the leakage rate of these systems. (8) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5). (9) This Directive is one of the separate directives of the EC type-approval procedure which was established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (6). Consequently, Directive 70/156/EEC should be amended accordingly. (10) Since the objectives of this Directive, namely to control the leakage of the specific fluorinated greenhouse gases in the air-conditioning systems fitted to vehicles and to prohibit from a certain date air-conditioning systems designed to contain fluorinated greenhouse gases with a global warming potential higher than 150, cannot be sufficiently achieved by the Member States acting alone and can therefore, by reason of the scale and effects of this Directive, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (11) In accordance with paragraph 34 of the Interinstitutional Agreement on better law-making (7), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables which will, as far as possible, illustrate the correlation between this Directive and the transposition measures, and to make them public, Article 1 Subject matter This Directive lays down the requirements for the EC type-approval or national type-approval of vehicles as regards emissions from, and the safe functioning of, air-conditioning systems fitted to vehicles. It also lays down provisions on retrofitting and refilling of such systems. Article 2 Scope The Directive shall apply to motor vehicles of categories M1 and N1 as defined in Annex II of Directive 70/156/EEC. For the purpose of this Directive, vehicles of category N1 are limited to those of class I as described in the first table in point 5.3.1.4 of Annex I to Council Directive 70/220/EEC of 20 March 1970 on the approximation of the laws of the Member States on measures to be taken against air pollution by emissions from motor vehicles (8), as inserted by Directive 98/69/EC of the European Parliament and of the Council (9). Article 3 Definitions For the purposes of this Directive the following definitions shall apply: 1. ‘vehicle’ means any motor vehicle falling within the scope of this Directive; 2. ‘vehicle type’ means a type as defined in section B of Annex II of Directive 70/156/EEC; 3. ‘air-conditioning system’ means any system whose main purpose is to decrease the air temperature and humidity of the passenger compartment of a vehicle; 4. ‘dual evaporator system’ means a system where one evaporator is mounted in the engine compartment and the other in a different compartment of the vehicle; all other systems shall be considered ‘single evaporator systems’; 5. ‘fluorinated greenhouse gases’ means hydrofluorocarbons (HFCs), perfluorocarbons (PFCs) and sulphur hexafluoride (SF6) as referred to in Annex A of the Kyoto Protocol and preparations containing these substances, but excludes substances controlled under Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer (10); 6. ‘hydrofluorocarbon’ means an organic compound consisting of carbon, hydrogen and fluorine, and where no more than six carbon atoms are contained in the molecule; 7. ‘perfluorocarbon’ means an organic compound consisting of carbon and fluorine only, and where no more than six carbon atoms are contained in the molecule; 8. ‘global warming potential’ means the climatic warming potential of a fluorinated greenhouse gas relative to that of carbon dioxide. The global warming potential (GWP) is calculated in terms of the 100 year warming potential of one kilogram of a gas relative to one kilogram of CO2. The relevant GWP figures are those published in the third assessment report adopted by the Intergovernmental Panel on Climate Change (2001 IPCC GWP values) (11); 9. ‘preparation’ means a mixture composed of two or more substances at least one of which is a fluorinated greenhouse gas. The total global warming potential (12) of the preparation shall be determined in accordance with Part 2 of the Annex; 10. ‘retrofitting’ means installing an air-conditioning system in a vehicle after it has been registered. Article 4 Obligations of the Member States 1. Member States shall grant, as appropriate, EC type-approval or national type-approval, with regard to emissions from air conditioning systems, only to vehicle types that satisfy the requirements of this Directive. 2. For the purpose of granting whole vehicle type-approval pursuant to Article 4(1)(a) of Directive 70/156/EEC, Member States shall ensure that manufacturers supply information on the type of refrigerant used in air-conditioning systems fitted to new motor vehicles. 3. For the purpose of type-approval of vehicles fitted with air-conditioning systems designed to contain a fluorinated greenhouse gas with a global warming potential higher than 150, Member States shall ensure that, in accordance with the harmonised leakage detection test referred to in Article 7(1), the leakage rate of such gases shall not exceed the maximum permissible limits laid down in Article 5. Article 5 Type-approval 1. With effect from six months from the date of adoption of a harmonised leakage detection test, Member States may not, on grounds relating to emissions from air conditioning systems: (a) refuse, in respect of a new type of vehicle, to grant EC type-approval, or national type approval; or (b) prohibit registration, sale or entry into service of new vehicles, if the vehicle fitted with an air-conditioning system designed to contain fluorinated greenhouse gases with a global warming potential higher than 150 complies with the requirements of this Directive. 2. With effect from 12 months from the date of adoption of a harmonised leakage detection test or 1 January 2007, whichever is later, Member States shall no longer grant EC type-approval or national type-approval for a type of vehicle fitted with an air-conditioning system designed to contain fluorinated greenhouse gases with a global warming potential higher than 150, unless the rate of leakage from that system does not exceed 40 grams of fluorinated greenhouse gases per year for a single evaporator system, or 60 grams of fluorinated greenhouse gases per year for a dual evaporator system. 3. With effect from 24 months from the date of adoption of a harmonised leakage detection test or 1 January 2008, whichever is later, in respect of new vehicles fitted with air-conditioning systems designed to contain fluorinated greenhouse gases with a global warming potential higher than 150, unless the rate of leakage from that system does not exceed 40 grams of fluorinated greenhouse gases per year for a single evaporator system or 60 grams of fluorinated greenhouse gases per year for a dual evaporator system, Member States shall: (a) consider certificates of conformity to be no longer valid for the purposes of Article 7(1) of Directive 70/156/EEC; and (b) refuse registration and prohibit sale and entry into service. 4. With effect from 1 January 2011 Member States shall no longer grant EC type-approval or national type-approval for a type of vehicle fitted with an air conditioning system designed to contain fluorinated greenhouse gases with a global warming potential higher than 150. 5. With effect from 1 January 2017, in respect of new vehicles which are fitted with an air-conditioning system designed to contain fluorinated greenhouse gases with a global warming potential higher than 150, Member States shall: (a) consider certificates of conformity to be no longer valid for the purposes of Article 7(1) of Directive 70/156/EEC; and (b) refuse registration and prohibit sale and entry into service. 6. Without prejudice to relevant Community law, in particular Community rules on State aid and Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (13), Member States may promote the installation of air-conditioning systems which are efficient, innovative and further reduce the climate impact. Article 6 Retrofitting and refilling 1. With effect from 1 January 2011, air-conditioning systems designed to contain fluorinated greenhouse gases with a global warming potential higher than 150 shall not be retrofitted to vehicles type-approved from that date. With effect from 1 January 2017, such air-conditioning systems shall not be retrofitted to any vehicles. 2. Air-conditioning systems fitted to vehicles type-approved on or after 1 January 2011 shall not be filled with fluorinated greenhouse gases with a global warming potential higher than 150. With effect from 1 January 2017 air conditioning systems in all vehicles shall not be filled with fluorinated greenhouse gases with a global warming potential higher than 150, with the exception of refilling of air-conditioning systems containing those gases, which have been fitted to vehicles before that date. 3. Service providers offering service and repair for air-conditioning systems shall not fill such equipment with fluorinated greenhouse gases if an abnormal amount of the refrigerant has leaked from the system, until the necessary repair has been completed. Article 7 Implementing measures 1. By 4 July 2007, the Commission shall adopt the measures for the implementation of Article 4 and Article 5, and in particular: (a) the administrative provisions for the EC type-approval of vehicles; and (b) a harmonised leakage detection test for measuring the leakage rate of fluorinated greenhouse gases with a global warming potential higher than 150 from air-conditioning systems. 2. The Commission shall adopt the measures in accordance with the procedure referred to in Article 13 of Directive 70/156/EEC. 3. The Commission shall publish these measures in the Official Journal of the European Union. 4. The procedure referred to in paragraph 2 shall apply to the adoption, where appropriate, of: (a) measures needed to ensure the safe functioning and proper servicing of refrigerants in mobile air-conditioning systems; (b) measures relating to the retrofitting of in-use vehicles with air-conditioning systems and the refilling of in-use air-conditioning systems to the extent not covered by Article 6; (c) the adaptation of the method for determining the relevant global warming potential of preparations. Article 8 Review 1. On the basis of progress in potential containment of emissions from, or replacement of, fluorinated greenhouse gases in air-conditioning systems fitted to motor vehicles, the Commission shall examine whether: — the present legislation should be extended to other categories of vehicles, in particular categories M2 and M3 as well as classes II and III of category N1 and — Community provisions concerning the global warming potential of fluorinated greenhouse gases should be amended; any changes should take account of technological and scientific developments and the need to respect industrial product planning timescales, and shall publish a report by 4 July 2011. Where necessary, it shall present appropriate legislative proposals. 2. Where a fluorinated greenhouse gas with a global warming potential higher than 150, which is not yet covered by the IPCC report referred to in Article 3(8), is included in a future report of the IPCC, the Commission shall assess whether it is appropriate to amend this Directive in order to include that gas. If the Commission considers it necessary, it shall, in accordance with the procedure referred to in Article 13 of Directive 70/156/EEC: — adopt the necessary measures and — define transition periods for the application of these measures. In doing so the Commission shall strike a balance between the need for an appropriate lead-time and the risk that the fluorinated greenhouse gas poses to the environment. Article 9 Amendments to Directive 70/156/EEC Directive 70/156/EEC is hereby amended in accordance with Part 1 of the Annex to this Directive. Article 10 Transposition 1. Member States shall adopt and publish by 4 January 2008 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall apply those measures from 5 January 2008. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 11 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 12 Addressees This Directive is addressed to the Member States.

32006L0050

2006

COMMISSION DIRECTIVE 2006/50/EC of 29 May 2006 amending Annexes IVA and IVB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular Article 29 thereof, Whereas: (1) Annexes IVA and IVB to Directive 98/8/EC set out the requirements for the dossiers to be submitted by applicants for, respectively, inclusion of an active substance consisting of micro-organisms including viruses and fungi in Annex I or IA to that Directive, and authorisation of a biocidal product based on preparations of such micro-organisms including viruses and fungi. (2) It is necessary to adapt Annexes IVA and IVB to Directive 98/8/EC to technical progress and to developments in related legislation, in particular Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2) and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (3), in order to provide a better basis for carrying out the risk assessments for micro-organisms and the biocidal products containing them. In addition, there have been scientific and technical developments within the field of microbiology and biotechnology. Providing for a similar structure of the data requirements in the framework of Directive 98/8/EC with those of Directive 91/414/EEC will facilitate the work of applicants submitting dossiers within both legal frameworks and the work of the Member States authorities evaluating such dossiers. It is therefore appropriate to update the data requirements for micro-organisms including viruses and fungi currently contained in Directive 98/8/EC and to align them as far as possible with those established in the framework of Directive 91/414/EEC. (3) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products. Article 1 Annexes IVA and IVB to Directive 98/8/EC are replaced by the text set out in the Annex to this Directive. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2008 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0051

2006

COMMISSION DIRECTIVE 2006/51/EC of 6 June 2006 amending for the purposes of adapting to technical progress Annex I to Directive 2005/55/EC of the European Parliament and of the Council and Annexes IV and V to Directive 2005/78/EC as regards requirements for the emission control monitoring system for use in vehicles and exemptions for gas engines (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers (1), and in particular the second indent of Article 13(2) thereof, Having regard to Directive 2005/55/EC of the European Parliament and of the Council of 28 September 2005, on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles (2), and in particular Article 7 thereof, Whereas: (1) Directive 2005/55/EC is one of the separate directives in the context of the Community type approval procedure laid down by Directive 70/156/EEC. (2) Commission Directive 2005/78/EC of 14 November 2005 implementing Directive 2005/55/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous and particulate pollutants from compression-ignition engines for use in vehicles, and the emission of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for use in vehicles and amending Annexes I, II, III, IV and VI thereto introduced amending and implementing measures in relation to the durability of emission control systems, in-use conformity over a defined useful period and on-board diagnostic (OBD) systems for new heavy duty vehicles and engines. (3) In view of the technical progress it is now appropriate to introduce improved requirements relating to the verification of the operational conditions, failures and demonstration of the emission control monitoring system at the moment of the type approval. (4) It is necessary to ensure that the functioning of the emission control monitoring system is not impaired by a defeat strategy. (5) Gas engines do not use the exhaust gas recirculation or selective catalytic reduction technologies in order to fulfil the current standards for NOx emissions. Therefore, it is considered that, at this stage, gas engines and vehicles fuelled with gas should be exempted from the requirements to ensure correct operation of NOx control measures. The exemption might be revoked when taking into consideration further emission stages. (6) It is appropriate to adjust the date of application of sections 6.5.3, 6.5.4 and 6.5.5 of Annex I to Directive 2005/55/EC in case of new type approvals. (7) The Commission intends to review the OBD threshold limit values in order to adapt them to the technological progress. (8) Directives 2005/55/EC and 2005/78/EC should therefore be amended accordingly. (9) The measures provided for in this Regulation are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 13(1) of Directive 70/156/EEC, Article 1 Annex I to Directive 2005/55/EC is amended in accordance with Annex I to this Directive. Article 2 Annex IV to Directive 2005/78/EC is amended in accordance with Annex II to this Directive. Article 3 1. Member States shall adopt and publish, by 8 November 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 9 November 2006. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32006L0053

2006

COMMISSION DIRECTIVE 2006/53/EC of 7 June 2006 amending Council Directive 90/642/EEC as regards the maximum residue levels of fenbutatin-oxide, fenhexamid, cyazofamid, linuron, triadimephon/triadimenol, pymetrozine, and pyraclostrobin (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables (1), and in particular Article 7 thereof, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2), and in particular Article 4(1)(f) thereof, Whereas: (1) In accordance with Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations have to be based on the evaluation of effects on human and animal health and influence on the environment. Elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops. (2) Maximum residue levels (MRLs) reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in terms of estimated dietary intake. (3) Maximum residue levels (MRLs) for pesticides covered by Directive 90/642/EEC are to be kept under review and may be modified to take account of new or changed uses. Information about new or changed uses has been communicated to the Commission with respect to fenbutatin oxide, fenhexamid, cyazofamid, linuron, triadimephon/triadimenol, pymetrozine, and pyraclostrobin. (4) The lifetime exposure of consumers to these pesticides via food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the procedures and practices used within the Community, taking account of guidelines published by the World Health Organisation (3). Based on those assessment and evaluations, the MRLs for those pesticides should be set so as to ensure that the acceptable daily intake is not exceeded. (5) In the case of pymetrozine, linuron, triadimenol, pyraclostrobine and fenbutatin oxide for which an acute reference dose (ARfD) exists, the acute exposure of consumers via each of the food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the procedures and practices currently used within the Community, taking account of guidelines published by the World Health Organisation. The opinions of the Scientific Committee on Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides (4), have been taken into account. Based on the intake assessment of pymetrozine, linuron, triadimenol, pyraclostrobine and fenbutatin oxide, the MRLs for those five pesticides should be fixed so as to ensure that the ARfD will not be exceeded. In the case of the other substances, an assessment of the available information has shown that no ARfD is required and that therefore a short term assessment is not needed. (6) Where authorised uses of plant protection products do not result in detectable levels of pesticide residues in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data, MRLs should be fixed at the lower limit of analytical determination. (7) Therefore it is appropriate to fix new MRLs for those pesticides. (8) The setting or modification at Community level of provisional MRLs does not prevent the Member States from establishing provisional MRLs for fenhexamid, cyazofamid, linuron, pymetrozine, and pyraclostrobin in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit further uses of these substances. The provisional Community MRL should then become definitive. (9) Directive 90/642/EEC should therefore be amended accordingly. (10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Article 1 In Annex I to Directive 90/642/EEC in the category ‘2. Vegetables, fresh or uncooked, frozen or dry, (v) Leaf vegetables and fresh herbs, (a) Lettuce and similar’, the entries ‘leaves and stems of brassica’ and ‘ruccola’ are added between the entries ‘Scarole’ and ‘others’. Article 2 Part A of Annex II to Directive 90/642/EEC is amended in accordance with the Annex to this Directive. Article 3 1. Member States shall adopt and publish, by 8 December 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 9 December 2006 except for pyraclostrobine where they shall apply the provisions from 21 April 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 5 This Directive is addressed to the Member States.

32006L0056

2006

COMMISSION DIRECTIVE 2006/56/EC of 12 June 2006 amending the Annexes to Council Directive 93/85/EEC on the control of potato ring rot Having regard to the Treaty establishing the European Community, Having regard to Council Directive 93/85/EEC of 4 October 1993 (1) on the control of potato ring rot, and in particular Article 12 thereof, Whereas: (1) One of the important organisms harmful to potatoes is Clavibacter michiganensis (Smith) Davis et al. ssp. sepedonicus (Spieckermann et Kotthoff) Davis et al., the pathogenic agent of the potato ring rot disease (hereinafter referred to as ‘the organism’). (2) The organism still occurs in some parts of the Community. (3) Council Directive 93/85/EEC has laid down detailed measures to be taken within the Member States against the organism in order to locate it and determine its distribution; prevent its occurrence and spread; and if found, to prevent its spread and to control it with the aim of eradication. (4) Since then, there have been significant developments in the understanding of the biology, the detection and identification procedures of the organism; moreover practical experiences gained in controlling the organism calls for review of several technical provisions related to control measures. (5) As a result of such developments, it appears necessary to review and update the measures included in the Annexes to Directive 93/85/EEC. (6) As regards the detection and identification procedures, recently developed procedures like fluorescent in situ hybridization (FISH) and polymerase chain reaction (PCR) are incorporated as well as improvements of various technical elements of the current detection and identification procedure. (7) As regards the technical elements of the control measures, improved provisions are made for: the way of conservation of tested samples in order to ensure trace back of the organism, the elements needed to determine the extent of the probable contamination, the details of the notification of any confirmed presence of the organism and of the relevant contaminated zone, measures to implement in places of production designated as contaminated and within the demarcated zones. (8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, Article 1 The Annexes to Directive 93/85/EEC are hereby replaced by the corresponding texts in Annex to this Directive. Article 2 1. Member States shall adopt and publish, by 31 March 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and the Directive. They shall apply those provisions from 1 April 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall immediately communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0055

2006

COMMISSION DIRECTIVE 2006/55/EC of 12 June 2006 amending Annex III to Council Directive 66/402/EEC as regards the maximum weight of seed lots (Text with EEA relevance) Having regard to the Treaty establishing the European Community, Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), and in particular Article 21a thereof, Whereas: (1) The international rules in respect of the maximum weights for seed lots of certain cereal species, in particular Triticum aestivum, Triticum durum, Triticum spelta, Secale cereale, Triticosecale and Oryza sativa, Avena sativa and Hordeum vulgare, have recently been revised. (2) It is appropriate to adapt the maximum weights for seed lots of those species laid down in Community law. (3) Directive 66/402/EEC should therefore be amended accordingly. (4) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, Article 1 In column 2 of the table in Annex III to Directive 66/402/EEC, ‘25’ is replaced by ‘30’. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive. Article 3 This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Union. Article 4 This Directive is addressed to the Member States.

32006L0048

2006

DIRECTIVE 2006/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions (recast) (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular the first and third sentences of Article 47(2) thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Economic and Social Committee (1), Having regard to the Opinion of the European Central Bank (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking up and pursuit of the business of credit institutions (4) has been significantly amended on several occasions. Now that new amendments are being made to the said Directive, it is desirable, in order to clarify matters, that it should be recast. (2) In order to make it easier to take up and pursue the business of credit institutions, it is necessary to eliminate the most obstructive differences between the laws of the Member States as regards the rules to which these institutions are subject. (3) This Directive constitutes the essential instrument for the achievement of the internal market from the point of view of both the freedom of establishment and the freedom to provide financial services, in the field of credit institutions. (4) The Commission Communication of 11 May 1999 entitled ‘Implementing the framework for financial markets: Action plan’, listed a number of goals that need to be achieved in order to complete the internal market in financial services. The Lisbon European Council of 23 and 24 March 2000 set the goal of implementing the action plan by 2005. Recasting of the provisions on own funds is a key element of the action plan. (5) Measures to coordinate credit institutions should, both in order to protect savings and to create equal conditions of competition between these institutions, apply to all of them. Due regard should however be had to the objective differences in their statutes and their proper aims as laid down by national laws. (6) The scope of those measures should therefore be as broad as possible, covering all institutions whose business is to receive repayable funds from the public, whether in the form of deposits or in other forms such as the continuing issue of bonds and other comparable securities and to grant credits for their own account. Exceptions should be provided for in the case of certain credit institutions to which this Directive cannot apply. The provisions of this Directive should not prejudice the application of national laws which provide for special supplementary authorisations permitting credit institutions to carry on specific activities or undertake specific kinds of operations. (7) It is appropriate to effect only the essential harmonisation necessary and sufficient to secure the mutual recognition of authorisation and of prudential supervision systems, making possible the granting of a single licence recognised throughout the Community and the application of the principle of home Member State prudential supervision. Therefore, the requirement that a programme of operations be produced should be seen merely as a factor enabling the competent authorities to decide on the basis of more precise information using objective criteria. A measure of flexibility should nonetheless be possible as regards the requirements on the legal form of credit institutions concerning the protection of banking names. (8) Since the objectives of this Directive, namely the introduction of rules concerning the taking up and pursuit of the business of credit institutions, and their prudential supervision, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and the effects of the proposed action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (9) Equivalent financial requirements for credit institutions are necessary to ensure similar safeguards for savers and fair conditions of competition between comparable groups of credit institutions. Pending further coordination, appropriate structural ratios should be formulated making it possible within the framework of cooperation between national authorities to observe, in accordance with standard methods, the position of comparable types of credit institutions. This procedure should help to bring about the gradual approximation of the systems of coefficients established and applied by the Member States. It is necessary, however to make a distinction between coefficients intended to ensure the sound management of credit institutions and those established for the purposes of economic and monetary policy. (10) The principles of mutual recognition and home Member State supervision require that Member States' competent authorities should not grant or should withdraw an authorisation where factors such as the content of the activities programmes, the geographical distribution of activities or the activities actually carried on indicate clearly that a credit institution has opted for the legal system of one Member State for the purpose of evading the stricter standards in force in another Member State within whose territory it carries on or intends to carry on the greater Part of its activities. Where there is no such clear indication, but the majority of the total assets of the entities in a banking group are located in another Member State the competent authorities of which are responsible for exercising supervision on a consolidated basis, in the context of Articles 125 and 126 responsibility for exercising supervision on a consolidated basis should be changed only with the agreement of those competent authorities. A credit institution which is a legal person should be authorised in the Member State in which it has its registered office. A credit institution which is not a legal person should have its head office in the Member State in which it has been authorised. In addition, Member States should require that a credit institution's head office always be situated in its home Member State and that it actually operates there. (11) The competent authorities should not authorise or continue the authorisation of a credit institution where they are liable to be prevented from effectively exercising their supervisory functions by the close links between that institution and other natural or legal persons. Credit institutions already authorised should also satisfy the competent authorities in that respect. (12) The reference to the supervisory authorities' effective exercise of their supervisory functions covers supervision on a consolidated basis which should be exercised over a credit institution where the provisions of Community law so provide. In such cases, the authorities applied to for authorisation should be able to identify the authorities competent to exercise supervision on a consolidated basis over that credit institution. (13) This Directive enables Member States and/or competent authorities to apply capital requirements on a solo and consolidated basis, and to disapply solo where they deem this appropriate. Solo, consolidated and cross-border consolidated supervision are useful tools in overseeing credit institutions. This Directive enables competent authorities to support cross border institutions by facilitating cooperation between them. In particular, the competent authorities should continue to make use of Articles 42, 131 and 141 to coordinate their activities and information requests. (14) Credit institutions authorised in their home Member States should be allowed to carry on, throughout the Community, any or all of the activities listed in Annex I by establishing branches or by providing services. (15) The Member States may also establish stricter rules than those laid down in Article 9(1), first subparagraph, Article 9(2) and Articles 12, 19 to 21, 44 to 52, 75 and 120 to 122 for credit institutions authorised by their competent authorities. The Member States may also require that Article 123 be complied with on an individual or other basis, and that the sub‐consolidation described in Article 73(2) be applied to other levels within a group. (16) It is appropriate to extend mutual recognition to the activities listed in Annex I when they are carried on by financial institutions which are subsidiaries of credit institutions, provided that such subsidiaries are covered by the consolidated supervision of their parent undertakings and meet certain strict conditions. (17) The host Member State should be able, in connection with the exercise of the right of establishment and the freedom to provide services, to require compliance with specific provisions of its own national laws or regulations on the Part of institutions not authorised as credit institutions in their home Member States and with regard to activities not listed in Annex I provided that, on the one hand, such provisions are compatible with Community law and are intended to protect the general good and that, on the other hand, such institutions or such activities are not subject to equivalent rules under this legislation or regulations of their home Member States. (18) The Member States should ensure that there are no obstacles to carrying on activities receiving mutual recognition in the same manner as in the home Member State, as long as the latter do not conflict with legal provisions protecting the general good in the host Member State. (19) The rules governing branches of credit institutions having their head office outside the Community should be analogous in all Member States. It is important to provide that such rules may not be more favourable than those for branches of institutions from another Member State. The Community should be able to conclude agreements with third countries providing for the application of rules which accord such branches the same treatment throughout its territory. The branches of credit institutions authorised in third countries should not enjoy the freedom to provide services under the second paragraph of Article 49 of the Treaty or the freedom of establishment in Member States other than those in which they are established. (20) Agreement should be reached, on the basis of reciprocity, between the Community and third countries with a view to allowing the practical exercise of consolidated supervision over the largest possible geographical area. (21) Responsibility for supervising the financial soundness of a credit institution, and in particular its solvency, should lay with its home Member State. The host Member State's competent authorities should be responsible for the supervision of the liquidity of the branches and monetary policies. The supervision of market risk should be the subject of close cooperation between the competent authorities of the home and host Member States. (22) The smooth operation of the internal banking market requires not only legal rules but also close and regular cooperation and significantly enhanced convergence of regulatory and supervisory practices between the competent authorities of the Member States. To this end, in particular, consideration of problems concerning individual credit institutions and the mutual exchange of information should take place in the Committee of European Banking Supervisors set up by Commission Decision 2004/5/EC (5). That mutual information procedure should not in any case replace bilateral cooperation. Without prejudice to their own powers of control, the competent authorities of the host Member States should be able, in an emergency, on their own initiative or following the initiative of the competent authorities of home Member State, to verify that the activities of a credit institution established within their territories comply with the relevant laws and with the principles of sound administrative and accounting procedures and adequate internal control. (23) It is appropriate to allow the exchange of information between the competent authorities and authorities or bodies which, by virtue of their function, help to strengthen the stability of the financial system. In order to preserve the confidential nature of the information forwarded, the list of addressees should remain within strict limits. (24) Certain behaviour, such as fraud and insider offences, is liable to affect the stability, including the integrity, of the financial system, even when involving institutions other than credit institutions. It is necessary to specify the conditions under which exchange of information in such cases is authorised. (25) Where it is stipulated that information may be disclosed only with the express agreement of the competent authorities, these should be able, where appropriate, to make their agreement subject to compliance with strict conditions. (26) Exchanges of information between, on the one hand, the competent authorities and, on the other, central banks and other bodies with a similar function in their capacity as monetary authorities and, where appropriate, other public authorities responsible for supervising payment systems should also be authorised. (27) For the purpose of strengthening the prudential supervision of credit institutions and the protection of clients of credit institutions, auditors should have a duty to report promptly to the competent authorities, wherever, during the performance of their tasks, they become aware of certain facts which are liable to have a serious effect on the financial situation or the administrative and accounting organisation of a credit institution. For the same reason Member States should also provide that such a duty applies in all circumstances where such facts are discovered by an auditor during the performance of his tasks in an undertaking which has close links with a credit institution. The duty of auditors to communicate, where appropriate, to the competent authorities certain facts and decisions concerning a credit institution which they discover during the performance of their tasks in a non-financial undertaking should not in itself change the nature of their tasks in that undertaking nor the manner in which they should perform those tasks in that undertaking. (28) This Directive specifies that for certain own funds items qualifying criteria should be specified, without prejudice to the possibility of Member States to apply more stringent provisions. (29) According to the nature of the items constituting own funds, this Directive distinguishes between on the one hand, items constituting original own funds and, on the other, those constituting additional own funds. (30) To reflect the fact that items constituting additional own funds are not of the same nature as those constituting original own funds, the amount of the former included in own funds should not exceed the original own funds. Moreover, the amount of certain items of additional own funds included should not exceed one half of the original own funds. (31) In order to avoid distortions of competition, public credit institutions should not include in their own funds guarantees granted them by the Member States or local authorities. (32) Whenever in the course of supervision it is necessary to determine the amount of the consolidated own funds of a group of credit institutions, the calculation should be effected in accordance with this Directive. (33) The precise accounting technique to be used for the calculation of own funds, their adequacy for the risk to which a credit institution is exposed, and for the assessment of the concentration of exposures should take account of the provisions of Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (6), which incorporates certain adaptations of the provisions of Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts (7) or of Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (8), whichever governs the accounting of the credit institutions under national law. (34) Minimum capital requirements play a central role in the supervision of credit institutions and in the mutual recognition of supervisory techniques. In that respect, the provisions on minimum capital requirements should be considered in conjunction with other specific instruments also harmonising the fundamental techniques for the supervision of credit institutions. (35) In order to prevent distortions of competition and to strengthen the banking system in the internal market, it is appropriate to lay down common minimum capital requirements. (36) For the purposes of ensuring adequate solvency it is important to lay down minimum capital requirements which weight assets and off-balance-sheet items according to the degree of risk. (37) On this point, on 26 June 2004 the Basel Committee on Banking Supervision adopted a framework agreement on the international convergence of capital measurement and capital requirements. The provisions in this Directive on the minimum capital requirements of credit institutions, and the minimum capital provisions in Directive 2006/49/EC of the European Parliament and of the Council of 14 June 2006 on the capital adequacy of investment firms and credit institutions (9), form an equivalent to the provisions of the Basel framework agreement. (38) It is essential to take account of the diversity of credit institutions in the Community by providing alternative approaches to the calculation of minimum capital requirements for credit risk incorporating different levels of risk‐sensitivity and requiring different degrees of sophistication. Use of external ratings and credit institutions' own estimates of individual credit risk parameters represents a significant enhancement in the risk‐sensitivity and prudential soundness of the credit risk rules. There should be appropriate incentives for credit institutions to move towards the more risk-sensitive approaches. In producing the estimates needed to apply the approaches to credit risk of this Directive, credit institutions will have to adjust their data processing needs to their clients' legitimate data protection interests as governed by the existing Community legislation on data protection, while enhancing credit risk measurement and management processes of credit institutions to make methods for determining credit institutions' regulatory own funds requirements available that reflect the sophistication of individual credit institutions' processes. The processing of data should be in accordance with the rules on transfer of personal data laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (10). In this regard, the processing of data in connection with the incurring and management of exposures to customers should be considered to include the development and validation of credit risk management and measurement systems. That serves not only to fulfil the legitimate interest of credit institutions but also the purpose of this Directive, to use better methods for risk measurement and management and also use them for regulatory own funds purposes. (39) With regard to the use of both external and an institution's own estimates or internal ratings, account should be taken of the fact that, at present, only the latter are drawn up by an entity — the financial institution itself — which is subject to a Community authorisation process. In the case of external ratings use is made of the products of what are known as recognised rating agencies, which in the Community are not currently subject to an authorisation process. In view of the importance of external ratings in connection with the calculation of capital requirements under this Directive, appropriate future authorisation and supervisory process for rating agencies need to be kept under review. (40) The minimum capital requirements should be proportionate to the risks addressed. In particular the reduction in risk levels deriving from having a large number of relatively small exposures should be reflected in the requirements. (41) The provisions of this Directive respect the principle of proportionality, having regard in particular to the diversity in size and scale of operations and to the range of activities of credit institutions. Respect of the principle of proportionality also means that the simplest possible rating procedures, even in the Internal Ratings Based Approach (‘IRB Approach’), are recognised for retail exposures. (42) The ‘evolutionary’ nature of this Directive enables credit institutions to choose amongst three approaches of varying complexity. In order to allow especially small credit institutions to opt for the more risk-sensitive IRB Approach, the competent authorities should implement the provisions of Article 89(1)(a) and (b) whenever appropriate. Those provisions should be read as such that exposure classes referred to in Article 86(1)(a) and (b) include all exposures that are, directly or indirectly, put on a par with them throughout this Directive. As a general rule, the competent authorities should not discriminate between the three approaches with regard to the Supervisory Review Process, i.e. credit institutions operating according to the provisions of the Standardised Approach should not for that reason alone be supervised on a stricter basis. (43) Increased recognition should be given to techniques of credit risk mitigation within a framework of rules designed to ensure that solvency is not undermined by undue recognition. The relevant Member States' current customary banking collateral for mitigating credit risks should wherever possible be recognised in the Standardised Approach, but also in the other approaches. (44) In order to ensure that the risks and risk reductions arising from credit institutions' securitisation activities and investments are appropriately reflected in the minimum capital requirements of credit institutions it is necessary to include rules providing for a risk‐sensitive and prudentially sound treatment of such activities and investments. (45) Operational risk is a significant risk faced by credit institutions requiring coverage by own funds. It is essential to take account of the diversity of credit institutions in the Community by providing alternative approaches to the calculation of operational risk requirements incorporating different levels of risk-sensitivity and requiring different degrees of sophistication. There should be appropriate incentives for credit institutions to move towards the more risk-sensitive approaches. In view of the emerging state of the art for the measurement and management of operational risk the rules should be kept under review and updated as appropriate including in relation to the charges for different business lines and the recognition of risk mitigation techniques. Particular attention should be paid in this regard to taking insurance into account in the simple approaches to calculating capital requirements for operational risk. (46) In order to ensure adequate solvency of credit institutions within a group it is essential that the minimum capital requirements apply on the basis of the consolidated financial situation of the group. In order to ensure that own funds are appropriately distributed within the group and available to protect savings where needed, the minimum capital requirements should apply to individual credit institutions within a group, unless this objective can be effectively otherwise achieved. (47) The essential rules for monitoring large exposures of credit institutions should be harmonised. Member States should still be able to adopt provisions more stringent than those provided for by this Directive. (48) The monitoring and control of a credit institution's exposures should be an integral Part of its supervision. Therefore, excessive concentration of exposures to a single client or group of connected clients may result in an unacceptable risk of loss. Such a situation can be considered prejudicial to the solvency of a credit institution. (49) Since credit institutions in the internal market are engaged in direct competition, monitoring requirements should be equivalent throughout the Community. (50) While it is appropriate to base the definition of exposures for the purposes of limits to large exposures on that provided for the purposes of minimum own funds requirements for credit risk, it is not appropriate to refer on principle to the weightings or degrees of risk. Those weightings and degrees of risk were devised for the purpose of establishing a general solvency requirement to cover the credit risk of credit institutions. In order to limit the maximum loss that a credit institution may incur through any single client or group of connected clients it is appropriate to adopt rules for the determination of large exposures which take account of the nominal value of the exposure without applying weightings or degrees of risk. (51) While it is desirable, pending further review of the large exposures provisions, to permit the recognition of the effects of credit risk mitigation in a manner similar to that permitted for minimum capital requirement purposes in order to limit the calculation requirements, the rules on credit risk mitigation were designed in the context of the general diversified credit risk arising from exposures to a large number of counterparties. Accordingly, recognition of the effects of such techniques for the purposes of limits to large exposures designed to limit the maximum loss that may be incurred through any single client or group of connected clients should be subject to prudential safeguards. (52) When a credit institution incurs an exposure to its own parent undertaking or to other subsidiaries of its parent undertaking, particular prudence is necessary. The management of exposures incurred by credit institutions should be carried out in a fully autonomous manner, in accordance with the principles of sound banking management, without regard to any other considerations. Where the influence exercised by persons directly or indirectly holding a qualifying participation in a credit institution is likely to operate to the detriment of the sound and prudent management of that institution, the competent authorities should take appropriate measures to put an end to that situation. In the field of large exposures, specific standards, including more stringent restrictions, should be laid down for exposures incurred by a credit institution to its own group. Such standards need not, however be applied where the parent undertaking is a financial holding company or a credit institution or where the other subsidiaries are either credit or financial institutions or undertakings offering ancillary services, provided that all such undertakings are covered by the supervision of the credit institution on a consolidated basis. (53) Credit institutions should ensure that they have internal capital that, having regard to the risks to which they are or may be exposed, is adequate in quantity, quality and distribution. Accordingly, credit institutions should have strategies and processes in place for assessing and maintaining the adequacy of their internal capital. (54) Competent authorities have responsibility to be satisfied that credit institutions have good organisation and adequate own funds, having regard to the risks to which the credit institutions are or might be exposed. (55) In order for the internal banking market to operate effectively the Committee of European Banking Supervisors should contribute to the consistent application of this Directive and to the convergence of supervisory practices throughout the Community, and should report on a yearly basis to the Community institutions on progress made. (56) For the same reason, and to ensure that Community credit institutions which are active in several Member States are not disproportionately burdened as a result of the continued responsibilities of individual Member State competent authorities for authorisation and supervision, it is essential to significantly enhance the cooperation between competent authorities. In this context, the role of the consolidating supervisor should be strengthened. The Committee of European Banking Supervisors should support and enhance such cooperation. (57) Supervision of credit institutions on a consolidated basis aims at, in particular, protecting the interests of the depositors of credit institutions and at ensuring the stability of the financial system. (58) In order to be effective, supervision on a consolidated basis should therefore be applied to all banking groups, including those the parent undertakings of which are not credit institutions. The competent authorities should hold the necessary legal instruments to be able to exercise such supervision. (59) In the case of groups with diversified activities where parent undertakings control at least one credit institution subsidiary, the competent authorities should be able to assess the financial situation of a credit institution in such a group. The competent authorities should at least have the means of obtaining from all undertakings within a group the information necessary for the performance of their function. Cooperation between the authorities responsible for the supervision of different financial sectors should be established in the case of groups of undertakings carrying on a range of financial activities. Pending subsequent coordination, the Member States should be able to lay down appropriate methods of consolidation for the achievement of the objective of this Directive. (60) The Member States should be able to refuse or withdraw banking authorisation in the case of certain group structures considered inappropriate for carrying on banking activities, in particular because such structures could not be supervised effectively. In this respect the competent authorities should have the necessary powers to ensure the sound and prudent management of credit institutions. (61) In order for the internal banking market to operate with increasing effectiveness and for citizens of the Community to be afforded adequate levels of transparency, it is necessary that competent authorities disclose publicly and in a way which allows for meaningful comparison the manner in which this Directive is implemented. (62) In order to strengthen market discipline and stimulate credit institutions to improve their market strategy, risk control and internal management organization, appropriate public disclosure by credit institutions should be provided for. (63) The examination of problems connected with matters covered by this Directive, as well as by other Directives on the business of credit institutions, requires cooperation between the competent authorities and the Commission, particularly when conducted with a view to closer coordination. (64) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (11). (65) In its resolution of 5 February 2002 on the implementation of financial services legislation (12) the Parliament requested that it and the Council should have an equal role in supervising the way in which the Commission exercises its executive role in order to reflect the legislative powers of Parliament under Article 251 of the Treaty. In the solemn declaration made before the Parliament the same day by its President, the Commission supported this request. On 11 December 2002 the Commission proposed amendments to Decision 1999/468/EC, and then submitted an amended proposal on 22 April 2004. The Parliament does not consider that this proposal preserves its legislative prerogatives. In the view of the Parliament, it and the Council should have the opportunity of evaluating the conferral of implementing powers on the Commission within a determined period. It is therefore appropriate to limit the period during which the Commission may adopt implementing measures. (66) The Parliament should be given a period of three months from the first transmission of draft amendments and implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, it should be possible to shorten this period. If, within that period, a resolution is adopted by the Parliament, the Commission should re‐examine the draft amendments or measures. (67) In order to avoid disruption to markets and to ensure continuity in overall levels of own funds it is appropriate to provide for specific transitional arrangements. (68) In view of the risk-sensitivity of the rules relating to minimum capital requirements, it is desirable to keep under review whether these have significant effects on the economic cycle. The Commission, taking into account the contribution of the European Central Bank should report on these aspects to the European Parliament and to the Council. (69) The arrangements necessary for the supervision of liquidity risks should also be harmonised. (70) This Directive respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union as general principles of Community law. (71) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive change as compared with earlier directives. The obligation to transpose the provisions which are unchanged exists under the earlier directives. (72) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex XIII, Part B, CONTENTS TITLE I SUBJECT MATTER, SCOPE AND DEFINITIONS TITLE II REQUIREMENTS FOR ACCESS TO THE TAKING UP AND PURSUIT OF THE BUSINESS OF CREDIT INSTITUTIONS TITLE III PROVISIONS CONCERNING THE FREEDOM OF ESTABLISHMENT AND THE FREEDOM TO PROVIDE SERVICES Section 1 Credit institutions Section 2 Financial institutions Section 3 Exercise of the right of establishment Section 4 Exercise of the freedom to provide services Section 5 Powers of the competent authorities of the host Member State TITLE IV RELATIONS WITH THIRD COUNTRIES Section 1 Notification in relation to third countries' undertakings and conditions of access to the markets of these countries Section 2 Cooperation with third countries' competent authorities regarding supervision on a consolidated basis TITLE V PRINCIPLES AND TECHNICAL INSTRUMENTS FOR PRUDENTIAL SUPERVISION AND DISCLOSURE CHAPTER 1 PRINCIPLES OF PRUDENTIAL SUPERVISION Section 1 Competence of home and host Member State Section 2 Exchange of information and professional secrecy Section 3 Duty of persons responsible for the legal control of annual and consolidated accounts Section 4 Power of sanction and right to apply to the courts CHAPTER 2 TECHNICAL INSTRUMENTS OF PRUDENTIAL SUPERVISION Section 1 Own funds Section 2 Provision against risks Subsection 1 Level of application Subsection 2 Calculation of requirements Subsection 3 Minimum Level of Own Funds Section 3 Minimum own funds requirements for credit risk Subsection 1 Standardised Approach Subsection 2 Internal Ratings based Approach Subsection 3 Credit risk mitigation Subsection 4 Securitisation Section 4 Minimum own funds requirements for operational risk Section 5 Large exposures Section 6 Qualifying holdings outside the financial sector CHAPTER 3 CREDIT INSTITUTIONS' ASSESSMENT PROCESS CHAPTER 4 SUPERVISION AND DISCLOSURE BY COMPETENT AUTHORITIES Section 1 Supervision Section 2 Disclosure by competent authorities CHAPTER 5 DISCLOSURE BY CREDIT INSTITUTIONS TITLE VI POWERS OF EXECUTION TITLE VII TRANSITIONAL AND FINAL PROVISIONS CHAPTER 1 TRANSITIONAL PROVISIONS CHAPTER 2 FINAL PROVISIONS ANNEX I LIST OF ACTIVITIES SUBJECT TO MUTUAL RECOGNITION ANNEX II CLASSIFICATION OF OFF-BALANCE-SHEET ITEMS ANNEX III THE TREATMENT OF COUNTERPARTY CREDIT RISK OF DERIVATIVE INSTRUMENTS, REPURCHASE TRANSACTIONS, SECURITIES OR COMMODITIES LENDING OR BORROWING TRANSACTIONS, LONG SETTLEMENT TRANSACTIONS AND MARGIN LENDING TRANSACTIONS Part 1 Definitions Part 2 Choice of the Method Part 3 Mark‐to-Market Method Part 4 Original Exposure Method Part 5 Standardised Method Part 6 Internal Model Method Part 7 Contractual netting ANNEX IV TYPES OF DERIVATIVES ANNEX V TECHNICAL CRITERIA CONCERNING THE ORGANISATION AND TREATMENT OF RISKS ANNEX VI STANDARDISED APPROACH Part 1 Risk weights Part 2 Recognition of ECAIs and mapping of their credit assessments Part 3 Use of ECAIs' credit assessments for the determination of risk weights ANNEX VII INTERNAL RATINGS BASED APPROACH Part 1 Risk weighted exposure amounts and expected loss amounts Part 2 PD, LGD, and Maturity Part 3 Exposure value Part 4 Minimum Requirements for IRB Approach ANNEX VIII CREDIT RISK MITIGATION Part 1 Eligibility Part 2 Minimum Requirements Part 3 Calculating the effects of credit risk mitigation Part 4 Maturity mismatches Part 5 Combinations of credit risk mitigation in the Standardised Approach Part 6 Basket CRM techniques ANNEX IX SECURITISATION Part 1 Definitions for the purposes of Annex IX Part 2 Minimum requirements for recognition of significant credit risk transfer and calculation of risk-weighted exposure amounts and expected loss amounts for securitised exposures Part 3 External credit assessments Part 4 Calculation ANNEX X OPERATIONAL RISK Part 1 Basic Indicator Approach Part 2 Standardised Approach Part 3 Advanced Measurement Approaches Part 4 Combined use of different methodologies Part 5 Loss event type classification ANNEX XI TECHNICAL CRITERIA ON REVIEW AND EVALUATION BY THE COMPETENT AUTHORITIES ANNEX XII TECHNICAL CRITERIA ON DISCLOSURE Part 1 General criteria Part 2 General requirements Part 3 Qualifying requirements for the use of particular instruments or methodologies ANNEX XIII Part A REPEALED DIRECTIVES, TOGETHER WITH THEIR SUCCESSIVE AMENDMENTS (referred to in Article 158) ANNEX XIII Part B DEADLINES FOR IMPLEMENTATION (referred to in Article 158) ANNEX XIV CORRELATION TABLE TITLE I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 1. This Directive lays down rules concerning the taking up and pursuit of the business of credit institutions, and their prudential supervision. 2. Article 39 and Title V, Chapter 4, Section 1 shall apply to financial holding companies and mixed-activity holding companies which have their head offices in the Community. 3. The institutions permanently excluded pursuant to Article 2, with the exception, however, of the central banks of the Member States, shall be treated as financial institutions for the purposes of Article 39 and Title V, Chapter 4, Section 1. Article 2 This Directive shall not apply to the following: — the central banks of Member States, — post office giro institutions, — in Belgium, the ‘Institut de Réescompte et de Garantie/Herdiscontering- en Waarborginstituut’, — in Denmark, the ‘Dansk Eksportfinansieringsfond’, the ‘Danmarks Skibskreditfond’, the ‘Dansk Landbrugs Realkreditfond’, and the ‘KommuneKredit’, — in Germany, the ‘Kreditanstalt für Wiederaufbau’, undertakings which are recognised under the ‘Wohnungsgemeinnützigkeitsgesetz’ as bodies of State housing policy and are not mainly engaged in banking transactions, and undertakings recognised under that law as non-profit housing undertakings, — in Greece, the ‘Ταμείο Παρακαταθηκών και Δανείων’ (Tamio Parakatathikon kai Danion), — in Spain, the ‘Instituto de Crédito Oficial’, — in France, the ‘Caisse des dépôts et consignations’, — in Ireland, credit unions and the friendly societies, — in Italy, the ‘Cassa depositi e prestiti’, — in Latvia, the ‘krājaizdevu sabiedrības’, undertakings that are recognised under the ‘krājaizdevu sabiedrību likums’ as cooperative undertakings rendering financial services solely to their members, — in Lithuania, the ‘kredito unijos’ other than the ‘Centrinė kredito unija’, — in Hungary, the ‘Magyar Fejlesztési Bank Rt.’ and the ‘Magyar Export-Import Bank Rt.’, — in the Netherlands, the ‘Nederlandse Investeringsbank voor Ontwikkelingslanden NV’, the ‘NV Noordelijke Ontwikkelingsmaatschappij’, the ‘NV Industriebank Limburgs Instituut voor Ontwikkeling en Financiering’ and the ‘Overijsselse Ontwikkelingsmaatschappij NV’, — in Austria, undertakings recognised as housing associations in the public interest and the ‘Österreichische Kontrollbank AG’, — in Poland, the ‘Spółdzielcze Kasy Oszczędnościowo — Kreditowe’ and the ‘Bank Gospodarstwa Krajowego’, — in Portugal, ‘Caixas Económicas’ existing on 1 January 1986 with the exception of those incorporated as limited companies and of the ‘Caixa Económica Montepio Geral’, — in Finland, the ‘Teollisen yhteistyön rahasto Oy/Fonden för industriellt samarbete AB’, and the ‘Finnvera Oyj/Finnvera Abp’, — in Sweden, the ‘Svenska Skeppshypotekskassan’, — in the United Kingdom, the National Savings Bank, the Commonwealth Development Finance Company Ltd, the Agricultural Mortgage Corporation Ltd, the Scottish Agricultural Securities Corporation Ltd, the Crown Agents for overseas governments and administrations, credit unions and municipal banks. Article 3 1. One or more credit institutions situated in the same Member State and which are permanently affiliated, on 15 December 1977, to a central body which supervises them and which is established in the same Member State, may be exempted from the requirements of Articles 7 and 11(1) if, no later than 15 December 1979, national law provides that: (a) the commitments of the central body and affiliated institutions are joint and several liabilities or the commitments of its affiliated institutions are entirely guaranteed by the central body; (b) the solvency and liquidity of the central body and of all the affiliated institutions are monitored as a whole on the basis of consolidated accounts; and (c) the management of the central body is empowered to issue instructions to the management of the affiliated institutions. Credit institutions operating locally which are permanently affiliated, subsequent to 15 December 1977, to a central body within the meaning of the first subparagraph, may benefit from the conditions laid down therein if they constitute normal additions to the network belonging to that central body. In the case of credit institutions other than those which are set up in areas newly reclaimed from the sea or have resulted from scission or mergers of existing institutions dependent or answerable to the central body, the Commission, pursuant to the procedure referred to in Article 151(2) may lay down additional rules for the application of the second subparagraph including the repeal of exemptions provided for in the first subparagraph, where it is of the opinion that the affiliation of new institutions benefiting from the arrangements laid down in the second subparagraph might have an adverse effect on competition. 2. A credit institution referred to in the first subparagraph of paragraph 1, may also be exempted from the provisions of Articles 9 and 10, and also Title V, Chapter 2, Sections 2, 3, 4, 5 and 6 and Chapter 3 provided that, without prejudice to the application of those provisions to the central body, the whole as constituted by the central body together with its affiliated institutions is subject to those provisions on a consolidated basis. In case of exemption, Articles 16, 23, 24, 25, 26(1) to (3) and 28 to 37 shall apply to the whole as constituted by the central body together with its affiliated institutions. Article 4 For the purposes of this Directive, the following definitions shall apply: (1) ‘credit institution’ means: (a) an undertaking whose business is to receive deposits or other repayable funds from the public and to grant credits for its own account; or (b) an electronic money institution within the meaning of Directive 2000/46/EC (13); (2) ‘authorisation’ means an instrument issued in any form by the authorities by which the right to carry on the business of a credit institution is granted; (3) ‘branch’ means a place of business which forms a legally dependent Part of a credit institution and which carries out directly all or some of the transactions inherent in the business of credit institutions; (4) ‘competent authorities’ means the national authorities which are empowered by law or regulation to supervise credit institutions; (5) ‘financial institution’ means an undertaking other than a credit institution, the principal activity of which is to acquire holdings or to carry on one or more of the activities listed in points 2 to 12 of Annex I; (6) ‘institutions’, for the purposes of Sections 2 and 3 of Title V, Chapter 2, means institutions as defined in Article 3(1)(c) of Directive 2006/49/EC; (7) ‘home Member State’ means the Member State in which a credit institution has been authorised in accordance with Articles 6 to 9 and 11 to 14; (8) ‘host Member State’ means the Member State in which a credit institution has a branch or in which it provides services; (9) ‘control’ means the relationship between a parent undertaking and a subsidiary, as defined in Article 1 of Directive 83/349/EEC, or a similar relationship between any natural or legal person and an undertaking; (10) ‘participation’ for the purposes of points (o) and (p) of Article 57, Articles 71 to 73 and Title V, Chapter 4 means participation within the meaning of the first sentence of Article 17 of Fourth Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies (14), or the ownership, direct or indirect, of 20 % or more of the voting rights or capital of an undertaking; (11) ‘qualifying holding’ means a direct or indirect holding in an undertaking which represents 10 % or more of the capital or of the voting rights or which makes it possible to exercise a significant influence over the management of that undertaking; (12) ‘parent undertaking’ means: (a) a parent undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC; or (b) for the purposes of Articles 71 to 73, Title V, Chapter 2, Section 5 and Chapter 4, a parent undertaking within the meaning of Article 1(1) of Directive 83/349/EEC and any undertaking which, in the opinion of the competent authorities, effectively exercises a dominant influence over another undertaking; (13) ‘subsidiary’ means: (a) a subsidiary undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC; or (b) for the purposes of Articles 71 to 73, Title V, Chapter 2, Section 5, and Chapter 4 a subsidiary undertaking within the meaning of Article 1(1) of Directive 83/349/EEC and any undertaking over which, in the opinion of the competent authorities, a parent undertaking effectively exercises a dominant influence. All subsidiaries of subsidiary undertakings shall also be considered subsidiaries of the undertaking that is their original parent; (14) ‘parent credit institution in a Member State’ means a credit institution which has a credit institution or a financial institution as a subsidiary or which holds a participation in such an institution, and which is not itself a subsidiary of another credit institution authorised in the same Member State, or of a financial holding company set up in the same Member State; (15) ‘parent financial holding company in a Member State’ means a financial holding company which is not itself a subsidiary of a credit institution authorised in the same Member State, or of a financial holding company set up in the same Member State; (16) ‘EU parent credit institution’ means a parent credit institution in a Member State which is not a subsidiary of another credit institution authorised in any Member State, or of a financial holding company set up in any Member State; (17) ‘EU parent financial holding company’ means a parent financial holding company in a Member State which is not a subsidiary of a credit institution authorised in any Member State or of another financial holding company set up in any Member State; (18) ‘public sector entities’ means non-commercial administrative bodies responsible to central governments, regional governments or local authorities, or authorities that in the view of the competent authorities exercise the same responsibilities as regional and local authorities, or non‐commercial undertakings owned by central governments that have explicit guarantee arrangements, and may include self administered bodies governed by law that are under public supervision; (19) ‘financial holding company’ means a financial institution, the subsidiary undertakings of which are either exclusively or mainly credit institutions or financial institutions, at least one of such subsidiaries being a credit institution, and which is not a mixed financial holding company within the meaning of Article 2(15) of Directive 2002/87/EC (15); (20) ‘mixed-activity holding company’ means a parent undertaking, other than a financial holding company or a credit institution or a mixed financial holding company within the meaning of Article 2(15) of Directive 2002/87/EC, the subsidiaries of which include at least one credit institution; (21) ‘ancillary services undertaking’ means an undertaking the principal activity of which consists in owning or managing property, managing data-processing services, or any other similar activity which is ancillary to the principal activity of one or more credit institutions; (22) ‘operational risk’ means the risk of loss resulting from inadequate or failed internal processes, people and systems or from external events, and includes legal risk; (23) ‘central banks’ include the European Central Bank unless otherwise indicated; (24) ‘dilution risk’ means the risk that an amount receivable is reduced through cash or non‐cash credits to the obligor; (25) ‘probability of default’ means the probability of default of a counterparty over a one year period; (26) ‘loss’, for the purposes of Title V, Chapter 2, Section 3, means economic loss, including material discount effects, and material direct and indirect costs associated with collecting on the instrument; (27) ‘loss given default (LGD)’ means the ratio of the loss on an exposure due to the default of a counterparty to the amount outstanding at default; (28) ‘conversion factor’ means the ratio of the currently undrawn amount of a commitment that will be drawn and outstanding at default to the currently undrawn amount of the commitment, the extent of the commitment shall be determined by the advised limit, unless the unadvised limit is higher; (29) ‘expected loss (EL)’, for the purposes of Title V, Chapter 2, Section 3, shall mean the ratio of the amount expected to be lost on an exposure from a potential default of a counterparty or dilution over a one year period to the amount outstanding at default; (30) ‘credit risk mitigation’ means a technique used by a credit institution to reduce the credit risk associated with an exposure or exposures which the credit institution continues to hold; (31) ‘funded credit protection’ means a technique of credit risk mitigation where the reduction of the credit risk on the exposure of a credit institution derives from the right of the credit institution — in the event of the default of the counterparty or on the occurrence of other specified credit events relating to the counterparty — to liquidate, or to obtain transfer or appropriation of, or to retain certain assets or amounts, or to reduce the amount of the exposure to, or to replace it with, the amount of the difference between the amount of the exposure and the amount of a claim on the credit institution; (32) ‘unfunded credit protection’ means a technique of credit risk mitigation where the reduction of the credit risk on the exposure of a credit institution derives from the undertaking of a third party to pay an amount in the event of the default of the borrower or on the occurrence of other specified credit events; (33) ‘repurchase transaction’ means any transaction governed by an agreement falling within the definition of ‘repurchase agreement’ or ‘reverse repurchase agreement’ as defined in Article 3(1)(m) of Directive 2006/49/EC; (34) ‘securities or commodities lending or borrowing transaction’ means any transaction falling within the definition of ‘securities or commodities lending’ or ‘securities or commodities borrowing’ as defined in Article 3(1)(n) of Directive 2006/49/EC; (35) ‘cash assimilated instrument’ means a certificate of deposit or other similar instrument issued by the lending credit institution; (36) ‘securitisation’ means a transaction or scheme, whereby the credit risk associated with an exposure or pool of exposures is tranched, having the following characteristics: (a) payments in the transaction or scheme are dependent upon the performance of the exposure or pool of exposures; and (b) the subordination of tranches determines the distribution of losses during the ongoing life of the transaction or scheme; (37) ‘traditional securitisation’ means a securitisation involving the economic transfer of the exposures being securitised to a securitisation special purpose entity which issues securities. This shall be accomplished by the transfer of ownership of the securitised exposures from the originator credit institution or through sub-participation. The securities issued do not represent payment obligations of the originator credit institution; (38) ‘synthetic securitisation’ means a securitisation where the tranching is achieved by the use of credit derivatives or guarantees, and the pool of exposures is not removed from the balance sheet of the originator credit institution; (39) ‘tranche’ means a contractually established segment of the credit risk associated with an exposure or number of exposures, where a position in the segment entails a risk of credit loss greater than or less than a position of the same amount in each other such segment, without taking account of credit protection provided by third parties directly to the holders of positions in the segment or in other segments; (40) ‘securitisation position’ shall mean an exposure to a securitisation; (41) ‘originator’ means either of the following: (a) an entity which, either itself or through related entities, directly or indirectly, was involved in the original agreement which created the obligations or potential obligations of the debtor or potential debtor giving rise to the exposure being securitised; or (b) an entity which purchases a third party's exposures onto its balance sheet and then securitises them; (42) ‘sponsor’ means a credit institution other than an originator credit institution that establishes and manages an asset-backed commercial paper programme or other securitisation scheme that purchases exposures from third party entities; (43) ‘credit enhancement’ means a contractual arrangement whereby the credit quality of a position in a securitisation is improved in relation to what it would have been if the enhancement had not been provided, including the enhancement provided by more junior tranches in the securitisation and other types of credit protection; (44) ‘securitisation special purpose entity (SSPE)’ means a corporation trust or other entity, other than a credit institution, organised for carrying on a securitisation or securitisations, the activities of which are limited to those appropriate to accomplishing that objective, the structure of which is intended to isolate the obligations of the SSPE from those of the originator credit institution, and the holders of the beneficial interests in which have the right to pledge or exchange those interests without restriction; (45) ‘group of connected clients’ means: (a) two or more natural or legal persons who, unless it is shown otherwise, constitute a single risk because one of them, directly or indirectly, has control over the other or others; or (b) two or more natural or legal persons between whom there is no relationship of control as set out in point (a) but who are to be regarded as constituting a single risk because they are so interconnected that, if one of them were to experience financial problems, the other or all of the others would be likely to encounter repayment difficulties; (46) ‘close links’ means a situation in which two or more natural or legal persons are linked in any of the following ways: (a) participation in the form of ownership, direct or by way of control, of 20 % or more of the voting rights or capital of an undertaking; (b) control; or (c) the fact that both or all are permanently linked to one and the same third person by a control relationship; (47) ‘recognised exchanges’ means exchanges which are recognised as such by the competent authorities and which meet the following conditions: (a) they function regularly; (b) they have rules, issued or approved by the appropriate authorities of the home country of the exchange, defining the conditions for the operation of the exchange, the conditions of access to the exchange as well as the conditions that shall be satisfied by a contract before it can effectively be dealt on the exchange; and (c) they have a clearing mechanism whereby contracts listed in Annex IV are subject to daily margin requirements which, in the opinion of the competent authorities, provide appropriate protection. Article 5 Member States shall prohibit persons or undertakings that are not credit institutions from carrying on the business of taking deposits or other repayable funds from the public. The first paragraph shall not apply to the taking of deposits or other funds repayable by a Member State or by a Member State's regional or local authorities or by public international bodies of which one or more Member States are members or to cases expressly covered by national or Community legislation, provided that those activities are subject to regulations and controls intended to protect depositors and investors and applicable to those cases. TITLE II REQUIREMENTS FOR ACCESS TO THE TAKING UP AND PURSUIT OF THE BUSINESS OF CREDIT INSTITUTIONS Article 6 Member States shall require credit institutions to obtain authorisation before commencing their activities. Without prejudice to Articles 7 to 12, they shall lay down the requirements for such authorisation and notify them to the Commission. Article 7 Member States shall require applications for authorisation to be accompanied by a programme of operations setting out, inter alia, the types of business envisaged and the structural organisation of the credit institution. Article 8 Member States may not require the application for authorisation to be examined in terms of the economic needs of the market. Article 9 1. Without prejudice to other general conditions laid down by national law, the competent authorities shall not grant authorisation when the credit institution does not possess separate own funds or in cases where initial capital is less than EUR 5 million. ‘Initial capital’ shall comprise capital and reserves as referred to in Article 57(a) and (b). Member States may decide that credit institutions which do not fulfil the requirement of separate own funds and which were in existence on 15 December 1979 may continue to carry on their business. They may exempt such credit institutions from complying with the requirement contained in the first subparagraph of Article 11(1). 2. Member States may, subject to the following conditions, grant authorisation to particular categories of credit institutions the initial capital of which is less than that specified in paragraph 1: (a) the initial capital shall be no less than EUR 1 million; (b) the Member States concerned shall notify the Commission of their reasons for exercising this option; and (c) the name of each credit institution that does not have the minimum capital specified in paragraph 1 shall be annotated to that effect in the list referred to in Article 14. Article 10 1. A credit institution's own funds may not fall below the amount of initial capital required under Article 9 at the time of its authorisation. 2. Member States may decide that credit institutions already in existence on 1 January 1993, the own funds of which do not attain the levels specified for initial capital in Article 9, may continue to carry on their activities. In that event, their own funds may not fall below the highest level reached with effect from 22 December 1989. 3. If control of a credit institution falling within the category referred to in paragraph 2 is taken by a natural or legal person other than the person who controlled the institution previously, the own funds of that credit institution shall attain at least the level specified for initial capital in Article 9. 4. In certain specific circumstances and with the consent of the competent authorities, where there is a merger of two or more credit institutions falling within the category referred to in paragraph 2, the own funds of the credit institution resulting from the merger may not fall below the total own funds of the merged credit institutions at the time of the merger, as long as the appropriate levels specified in Article 9 have not been attained. 5. If, in the cases referred to in paragraphs 1, 2 and 4, the own funds should be reduced, the competent authorities may, where the circumstances justify it, allow a credit institution a limited period in which to rectify its situation or cease its activities. Article 11 1. The competent authorities shall grant an authorisation to the credit institution only when there are at least two persons who effectively direct the business of the credit institution. They shall not grant authorisation if these persons are not of sufficiently good repute or lack sufficient experience to perform such duties. 2. Each Member State shall require that: (a) any credit institution which is a legal person and which, under its national law, has a registered office shall have its head office in the same Member State as its registered office; and (b) any other credit institution shall have its head office in the Member State which granted its authorisation and in which it actually carries on its business. Article 12 1. The competent authorities shall not grant authorisation for the taking-up of the business of credit institutions unless they have been informed of the identities of the shareholders or members, whether direct or indirect, natural or legal persons, that have qualifying holdings, and of the amounts of those holdings. In determining a qualifying holding in the context of this Article, the voting rights referred to in Article 92 of Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities (16) shall be taken into consideration. 2. The competent authorities shall not grant authorisation if, taking into account the need to ensure the sound and prudent management of a credit institution, they are not satisfied as to the suitability of the shareholders or members. 3. Where close links exist between the credit institution and other natural or legal persons, the competent authorities shall grant authorisation only if those links do not prevent the effective exercise of their supervisory functions. The competent authorities shall also not grant authorisation if the laws, regulations or administrative provisions of a third country governing one or more natural or legal persons with which the credit institution has close links, or difficulties involved in the enforcement of those laws, regulations or administrative provisions, prevent the effective exercise of their supervisory functions. The competent authorities shall require credit institutions to provide them with the information they require to monitor compliance with the conditions referred to in this paragraph on a continuous basis. Article 13 Reasons shall be given whenever a decision not to grant an authorisation is taken and the applicant shall be notified thereof within six months of receipt of the application or, should the latter be incomplete, within six months of the applicant's sending the information required for the decision. A decision shall, in any case, be taken within 12 months of the receipt of the application. Article 14 Every authorisation shall be notified to the Commission. The name of each credit institution to which authorisation has been granted shall be entered in a list. The Commission shall publish that list in the Official Journal of the European Union and shall keep it up to date. Article 15 1. The competent authority shall, before granting authorisation to a credit institution, consult the competent authorities of the other Member State involved in the following cases: (a) the credit institution concerned is a subsidiary of a credit institution authorised in another Member State; (b) the credit institution concerned is a subsidiary of the parent undertaking of a credit institution authorised in another Member State; or (c) the credit institution concerned is controlled by the same persons, whether natural or legal, as control a credit institution authorised in another Member State. 2. The competent authority shall, before granting authorisation to a credit institution, consult the competent authority of a Member State involved, responsible for the supervision of insurance undertakings or investment firms in the following cases: (a) the credit institution concerned is a subsidiary of an insurance undertaking or investment firm authorised in the Community; (b) the credit institution concerned is a subsidiary of the parent undertaking of an insurance undertaking or investment firm authorised in the Community; or (c) the credit institution concerned is controlled by the same person, whether natural or legal, as controls an insurance undertaking or investment firm authorised in the Community. 3. The relevant competent authorities referred to in paragraphs 1 and 2 shall in particular consult each other when assessing the suitability of the shareholders and the reputation and experience of directors involved in the management of another entity of the same group. They shall exchange any information regarding the suitability of shareholders and the reputation and experience of directors which is of relevance for the granting of an authorisation as well as for the ongoing assessment of compliance with operating conditions. Article 16 Host Member States may not require authorisation or endowment capital for branches of credit institutions authorised in other Member States. The establishment and supervision of such branches shall be effected in accordance with Articles 22, 25, 26(1) to (3), 29 to 37 and 40. Article 17 1. The competent authorities may withdraw the authorisation granted to a credit institution only where such an institution: (a) does not make use of the authorisation within 12 months, expressly renounces the authorisation or has ceased to engage in business for more than six months, if the Member State concerned has made no provision for the authorisation to lapse in such cases; (b) has obtained the authorisation through false statements or any other irregular means; (c) no longer fulfils the conditions under which authorisation was granted; (d) no longer possesses sufficient own funds or can no longer be relied on to fulfil its obligations towards its creditors, and in particular no longer provides security for the assets entrusted to it; or (e) falls within one of the other cases where national law provides for withdrawal of authorisation. 2. Reasons shall be given for any withdrawal of authorisation and those concerned informed thereof. Such withdrawal shall be notified to the Commission. Article 18 For the purposes of exercising their activities, credit institutions may, notwithstanding any provisions in the host Member State concerning the use of the words ‘bank’, ‘savings bank’ or other banking names, use throughout the territory of the Community the same name as they use in the Member State in which their head office is situated. In the event of there being any danger of confusion, the host Member State may, for the purposes of clarification, require that the name be accompanied by certain explanatory particulars. Article 19 1. The Member States shall require any natural or legal person who proposes to hold, directly or indirectly, a qualifying holding in a credit institution first to inform the competent authorities, telling them of the size of the intended holding. Such a person shall likewise inform the competent authorities if he proposes to increase his qualifying holding so that the proportion of the voting rights or of the capital held by him would reach or exceed 20 %, 33 % or 50 % or so that the credit institution would become his subsidiary. Without prejudice to paragraph 2, the competent authorities shall have a maximum of three months from the date of the notification provided for in the first and second subparagraphs to oppose such a plan if, in view of the need to ensure sound and prudent management of the credit institution, they are not satisfied as to the suitability of the person concerned. If they do not oppose the plan, they may fix a maximum period for its implementation. 2. If the person proposing to acquire the holdings referred to in paragraph 1 is a credit institution, insurance undertaking or investment firm authorised in another Member State or the parent undertaking of a credit institution, insurance undertaking or investment firm authorised in another Member State or a natural or legal person controlling a credit institution, insurance undertaking or investment firm authorised in another Member State, and if, as a result of that acquisition, the credit institution in which the acquirer proposes to hold a holding would become a subsidiary or subject to the control of the acquirer, the assessment of the acquisition shall be subject to the prior consultation provided for in Article 15. Article 20 The Member States shall require any natural or legal person who proposes to dispose, directly or indirectly, of a qualifying holding in a credit institution first to inform the competent authorities, telling them of the size of his intended holding. Such a person shall likewise inform the competent authorities if he proposes to reduce his qualifying holding so that the proportion of the voting rights or of the capital held by him would fall below 20 %, 33 % or 50 % or so that the credit institution would cease to be his subsidiary. Article 21 1. Credit institutions shall, on becoming aware of any acquisitions or disposals of holdings in their capital that cause holdings to exceed or fall below one of the thresholds referred to in Article 19(1) and Article 20, inform the competent authorities of those acquisitions or disposals. They shall also, at least once a year, inform the competent authorities of the names of shareholders and members possessing qualifying holdings and the sizes of such holdings as shown, for example, by the information received at the annual general meetings of shareholders and members or as a result of compliance with the regulations relating to companies listed on stock exchanges. 2. The Member States shall require that, where the influence exercised by the persons referred to in Article 19(1) is likely to operate to the detriment of the prudent and sound management of the institution, the competent authorities shall take appropriate measures to put an end to that situation. Such measures may consist in injunctions, sanctions against directors and managers, or the suspension of the exercise of the voting rights attaching to the shares held by the shareholders or members in question. Similar measures shall apply to natural or legal persons who fail to comply with the obligation to provide prior information, as laid down in Article 19(1). If a holding is acquired despite the opposition of the competent authorities, the Member States shall, regardless of any other sanctions to be adopted, provide either for exercise of the corresponding voting rights to be suspended, or for the nullity of votes cast or for the possibility of their annulment. 3. In determining a qualifying holding and other levels of holding referred to in this Article, the voting rights referred to in Article 92 of Directive 2001/34/EC shall be taken into consideration. Article 22 1. Home Member State competent authorities shall require that every credit institution have robust governance arrangements, which include a clear organisational structure with well defined, transparent and consistent lines of responsibility, effective processes to identify, manage, monitor and report the risks it is or might be exposed to, and adequate internal control mechanisms, including sound administrative and accounting procedures. 2. The arrangements, processes and mechanisms referred to in paragraph 1 shall be comprehensive and proportionate to the nature, scale and complexity of the credit institution's activities. The technical criteria laid down in Annex V shall be taken into account. TITLE III PROVISIONS CONCERNING THE FREEDOM OF ESTABLISHMENT AND THE FREEDOM TO PROVIDE SERVICES Section 1 Credit institutions Article 23 The Member States shall provide that the activities listed in Annex I may be carried on within their territories, in accordance with Articles 25, 26(1) to (3), 28(1) and (2) and 29 to 37 either by the establishment of a branch or by way of the provision of services, by any credit institution authorised and supervised by the competent authorities of another Member State, provided that such activities are covered by the authorisation. Section 2 Financial institutions Article 24 1. (a) the parent undertaking or undertakings shall be authorised as credit institutions in the Member State by the law of which the financial institution is governed; (b) the activities in question shall actually be carried on within the territory of the same Member State; (c) the parent undertaking or undertakings shall hold 90 % or more of the voting rights attaching to shares in the capital of the financial institution; (d) the parent undertaking or undertakings shall satisfy the competent authorities regarding the prudent management of the financial institution and shall have declared, with the consent of the relevant home Member State competent authorities, that they jointly and severally guarantee the commitments entered into by the financial institution; and (e) the financial institution shall be effectively included, for the activities in question in particular, in the consolidated supervision of the parent undertaking, or of each of the parent undertakings, in accordance with Title V, Chapter 4, Section 1, in particular for the purposes of the minimum own funds requirements set out in Article 75 for the control of large exposures and for purposes of the limitation of holdings provided for in Articles 120 to 122. Compliance with these conditions shall be verified by the competent authorities of the home Member State and the latter shall supply the financial institution with a certificate of compliance which shall form Part of the notification referred to in Articles 25 and 28. The competent authorities of the home Member State shall ensure the supervision of the financial institution in accordance with Articles 10(1), 19 to 22, 40, 42 to 52 and 54. 2. If a financial institution as referred to in the first subparagraph of paragraph 1 ceases to fulfil any of the conditions imposed, the home Member State shall notify the competent authorities of the host Member State and the activities carried on by that financial institution in the host Member State shall become subject to the legislation of the host Member State. 3. Paragraphs 1 and 2 shall apply mutatis mutandis to subsidiaries of a financial institution as referred to in the first subparagraph of paragraph 1. Section 3 Exercise of the right of establishment Article 25 1. A credit institution wishing to establish a branch within the territory of another Member State shall notify the competent authorities of its home Member State. 2. Member States shall require every credit institution wishing to establish a branch in another Member State to provide the following information when effecting the notification referred to in paragraph 1: (a) the Member State within the territory of which it plans to establish a branch; (b) a programme of operations setting out, inter alia, the types of business envisaged and the structural organisation of the branch; (c) the address in the host Member State from which documents may be obtained; and (d) the names of those to be responsible for the management of the branch. 3. Unless the competent authorities of the home Member State have reason to doubt the adequacy of the administrative structure or the financial situation of the credit institution, taking into account the activities envisaged, they shall within three months of receipt of the information referred to in paragraph 2 communicate that information to the competent authorities of the host Member State and shall inform the credit institution accordingly. The home Member State's competent authorities shall also communicate the amount of own funds and the sum of the capital requirements under Article 75 of the credit institution. By way of derogation from the second subparagraph, in the case referred to in Article 24, the home Member State's competent authorities shall communicate the amount of own funds of the financial institution and the sum of the consolidated own funds and consolidated capital requirements under Article 75 of the credit institution which is its parent undertaking. 4. Where the competent authorities of the home Member State refuse to communicate the information referred to in paragraph 2 to the competent authorities of the host Member State, they shall give reasons for their refusal to the credit institution concerned within three months of receipt of all the information. That refusal or a failure to reply, shall be subject to a right to apply to the courts in the home Member State. Article 26 1. Before the branch of a credit institution commences its activities the competent authorities of the host Member State shall, within two months of receiving the information referred to in Article 25, prepare for the supervision of the credit institution in accordance with Section 5 and if necessary indicate the conditions under which, in the interest of the general good, those activities shall be carried on in the host Member State. 2. On receipt of a communication from the competent authorities of the host Member State, or in the event of the expiry of the period provided for in paragraph 1 without receipt of any communication from the latter, the branch may be established and may commence its activities. 3. In the event of a change in any of the particulars communicated pursuant to points (b), (c) or (d) of Article 25(2), a credit institution shall give written notice of the change in question to the competent authorities of the home and host Member States at least one month before making the change so as to enable the competent authorities of the home Member State to take a decision pursuant to Article 25 and the competent authorities of the host Member State to take a decision on the change pursuant to paragraph 1 of this Article. 4. Branches which have commenced their activities, in accordance with the provisions in force in their host Member States, before 1 January 1993, shall be presumed to have been subject to the procedure laid down in Article 25 and in paragraphs 1 and 2 of this Article. They shall be governed, from 1 January 1993, by paragraph 3 of this Article and by Articles 23 and 43 as well as Sections 2 and 5. Article 27 Any number of places of business set up in the same Member State by a credit institution with headquarters in another Member State shall be regarded as a single branch. Section 4 Exercise of the freedom to provide services Article 28 1. Any credit institution wishing to exercise the freedom to provide services by carrying on its activities within the territory of another Member State for the first time shall notify the competent authorities of the home Member State, of the activities on the list in Annex I which it intends to carry on. 2. The competent authorities of the home Member State shall, within one month of receipt of the notification provided for in paragraph 1, send that notification to the competent authorities of the host Member State. 3. This Article shall not affect rights acquired by credit institutions providing services before 1 January 1993. Section 5 Powers of the competent authorities of the host Member State Article 29 Host Member States may, for statistical purposes, require that all credit institutions having branches within their territories shall report periodically on their activities in those host Member States to the competent authorities of those host Member States. In discharging the responsibilities imposed on them in Article 41, host Member States may require that branches of credit institutions from other Member States provide the same information as they require from national credit institutions for that purpose. Article 30 1. Where the competent authorities of a host Member State ascertain that a credit institution having a branch or providing services within its territory is not complying with the legal provisions adopted in that State pursuant to the provisions of this Directive involving powers of the host Member State's competent authorities, those authorities shall require the credit institution concerned to put an end to that irregular situation. 2. If the credit institution concerned fails to take the necessary steps, the competent authorities of the host Member State shall inform the competent authorities of the home Member State accordingly. The competent authorities of the home Member State shall, at the earliest opportunity, take all appropriate measures to ensure that the credit institution concerned puts an end to that irregular situation. The nature of those measures shall be communicated to the competent authorities of the host Member State. 3. If, despite the measures taken by the home Member State or because such measures prove inadequate or are not available in the Member State in question, the credit institution persists in violating the legal rules referred to in paragraph 1 in force in the host Member State, the latter State may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or to punish further irregularities and, in so far as is necessary, to prevent that credit institution from initiating further transactions within its territory. The Member States shall ensure that within their territories it is possible to serve the legal documents necessary for these measures on credit institutions. Article 31 Articles 29 and 30 shall not affect the power of host Member States to take appropriate measures to prevent or to punish irregularities committed within their territories which are contrary to the legal rules they have adopted in the interests of the general good. This shall include the possibility of preventing offending credit institutions from initiating further transactions within their territories. Article 32 Any measure taken pursuant to Article 30(2) and (3), or Article 31 involving penalties or restrictions on the exercise of the freedom to provide services shall be properly justified and communicated to the credit institution concerned. Every such measure shall be subject to a right of appeal to the courts in the Member State in which it was taken. Article 33 Before following the procedure provided for in Article 30, the competent authorities of the host Member State may, in emergencies, take any precautionary measures necessary to protect the interests of depositors, investors and others to whom services are provided. The Commission and the competent authorities of the other Member States concerned shall be informed of such measures at the earliest opportunity. The Commission may, after consulting the competent authorities of the Member States concerned, decide that the Member State in question shall amend or abolish those measures. Article 34 Host Member States may exercise the powers conferred on them under this Directive by taking appropriate measures to prevent or to punish irregularities committed within their territories. This shall include the possibility of preventing offending credit institutions from initiating further transactions within their territories. Article 35 In the event of the withdrawal of authorisation, the competent authorities of the host Member State shall be informed and shall take appropriate measures to prevent the credit institution concerned from initiating further transactions within its territory and to safeguard the interests of depositors. Article 36 The Member States shall inform the Commission of the number and type of cases in which there has been a refusal pursuant to Articles 25 and 26(1) to (3) or in which measures have been taken in accordance with Article 30(3). Article 37 This Section shall not prevent credit institutions with head offices in other Member States from advertising their services through all available means of communication in the host Member State, subject to any rules governing the form and the content of such advertising adopted in the interests of the general good. TITLE IV RELATIONS WITH THIRD COUNTRIES Section 1 Notification in relation to third countries' undertakings and conditions of access to the markets of these countries Article 38 1. Member States shall not apply to branches of credit institutions having their head office outside the Community, when commencing or carrying on their business, provisions which result in more favourable treatment than that accorded to branches of credit institutions having their head office in the Community. 2. The competent authorities shall notify the Commission and the European Banking Committee of all authorisations for branches granted to credit institutions having their head office outside the Community. 3. Without prejudice to paragraph 1, the Community may, through agreements concluded with one or more third countries, agree to apply provisions which accord to branches of a credit institution having its head office outside the Community identical treatment throughout the territory of the Community. Section 2 Cooperation with third countries' competent authorities regarding supervision on a consolidated basis Article 39 1. The Commission may submit proposals to the Council, either at the request of a Member State or on its own initiative, for the negotiation of agreements with one or more third countries regarding the means of exercising supervision on a consolidated basis over the following: (a) credit institutions the parent undertakings of which have their head offices in a third country; or (b) credit institutions situated in third countries the parent undertakings of which, whether credit institutions or financial holding companies, have their head offices in the Community. 2. The agreements referred to in paragraph 1 shall, in particular, seek to ensure the following: (a) that the competent authorities of the Member States are able to obtain the information necessary for the supervision, on the basis of their consolidated financial situations, of credit institutions or financial holding companies situated in the Community and which have as subsidiaries credit institutions or financial institutions situated outside the Community, or holding participation in such institutions; and (b) that the competent authorities of third countries are able to obtain the information necessary for the supervision of parent undertakings the head offices of which are situated within their territories and which have as subsidiaries credit institutions or financial institutions situated in one or more Member States or holding participation in such institutions. 3. Without prejudice to Article 300(1) and (2) of the Treaty, the Commission shall, with the assistance of the European Banking Committee, examine the outcome of the negotiations referred to in paragraph 1 and the resulting situation. TITLE V PRINCIPLES AND TECHNICAL INSTRUMENTS FOR PRUDENTIAL SUPERVISION AND DISCLOSURE CHAPTER 1 Principles of prudential supervision Section 1 Competence of home and host Member State Article 40 1. The prudential supervision of a credit institution, including that of the activities it carries on accordance with Articles 23 and 24, shall be the responsibility of the competent authorities of the home Member State, without prejudice to those provisions of this Directive which give responsibility to the competent authorities of the host Member State. 2. Paragraph 1 shall not prevent supervision on a consolidated basis pursuant to this Directive. Article 41 Host Member States shall, pending further coordination, retain responsibility in cooperation with the competent authorities of the home Member State for the supervision of the liquidity of the branches of credit institutions. Without prejudice to the measures necessary for the reinforcement of the European Monetary System, host Member States shall retain complete responsibility for the measures resulting from the implementation of their monetary policies. Such measures may not provide for discriminatory or restrictive treatment based on the fact that a credit institution is authorised in another Member State. Article 42 The competent authorities of the Member States concerned shall collaborate closely in order to supervise the activities of credit institutions operating, in particular through a branch, in one or more Member States other than that in which their head offices are situated. They shall supply one another with all information concerning the management and ownership of such credit institutions that is likely to facilitate their supervision and the examination of the conditions for their authorisation, and all information likely to facilitate the monitoring of such institutions, in particular with regard to liquidity, solvency, deposit guarantees, the limiting of large exposures, administrative and accounting procedures and internal control mechanisms. Article 43 1. Host Member States shall provide that, where a credit institution authorised in another Member State carries on its activities through a branch, the competent authorities of the home Member State may, after having first informed the competent authorities of the host Member State, carry out themselves or through the intermediary of persons they appoint for that purpose on-the-spot verification of the information referred to in Article 42. 2. The competent authorities of the home Member State may also, for purposes of the verification of branches, have recourse to one of the other procedures laid down in Article 141. 3. Paragraphs 1 and 2 shall not affect the right of the competent authorities of the host Member State to carry out, in the discharge of their responsibilities under this Directive, on-the-spot verifications of branches established within their territory. Section 2 Exchange of information and professional secrecy Article 44 1. Member States shall provide that all persons working for or who have worked for the competent authorities, as well as auditors or experts acting on behalf of the competent authorities, shall be bound by the obligation of professional secrecy. No confidential information which they may receive in the course of their duties may be divulged to any person or authority whatsoever, except in summary or collective form, such that individual credit institutions cannot be identified, without prejudice to cases covered by criminal law. Nevertheless, where a credit institution has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties involved in attempts to rescue that credit institution may be divulged in civil or commercial proceedings. 2. Paragraph 1 shall not prevent the competent authorities of the various Member States from exchanging information in accordance with this Directive and with other Directives applicable to credit institutions. That information shall be subject to the conditions of professional secrecy indicated in paragraph 1. Article 45 Competent authorities receiving confidential information under Article 44 may use it only in the course of their duties and only for the following purposes: (a) to check that the conditions governing the taking-up of the business of credit institutions are met and to facilitate monitoring, on a non-consolidated or consolidated basis, of the conduct of such business, especially with regard to the monitoring of liquidity, solvency, large exposures, and administrative and accounting procedures and internal control mechanisms; (b) to impose penalties; (c) in an administrative appeal against a decision of the competent authority; or (d) in court proceedings initiated pursuant to Article 55 or to special provisions provided for in this in other Directives adopted in the field of credit institutions. Article 46 Member States may conclude cooperation agreements, providing for exchanges of information, with the competent authorities of third countries or with authorities or bodies of third countries as defined in Articles 47 and 48(1) only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those referred to in Article 44(1). Such exchange of information shall be for the purpose of performing the supervisory task of the authorities or bodies mentioned. Where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Article 47 Articles 44(1) and 45 shall not preclude the exchange of information within a Member State, where there are two or more competent authorities in the same Member State, or between Member States, between competent authorities and the following: (a) authorities entrusted with the public duty of supervising other financial organisations and insurance companies and the authorities responsible for the supervision of financial markets; (b) bodies involved in the liquidation and bankruptcy of credit institutions and in other similar procedures; and (c) persons responsible for carrying out statutory audits of the accounts of credit institutions and other financial institutions; in the discharge of their supervisory functions. Articles 44(1) and 45 shall not preclude the disclosure to bodies which administer deposit-guarantee schemes of information necessary to the exercise of their functions. In both cases, the information received shall be subject to the conditions of professional secrecy specified in Article 44(1). Article 48 1. Notwithstanding Articles 44 to 46, Member States may authorise exchange of information between the competent authorities and the following: (a) the authorities responsible for overseeing the bodies involved in the liquidation and bankruptcy of credit institutions and in other similar procedures; and (b) the authorities responsible for overseeing persons charged with carrying out statutory audits of the accounts of insurance undertakings, credit institutions, investment firms and other financial institutions. In such cases, Member States shall require fulfilment of at least the following conditions: (a) the information shall be for the purpose of performing the supervisory task referred to in the first subparagraph; (b) information received in this context shall be subject to the conditions of professional secrecy specified in Article 44(1); and (c) where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Member States shall communicate to the Commission and to the other Member States the names of the authorities which may receive information pursuant to this paragraph. 2. Notwithstanding Articles 44 to 46, Member States may, with the aim of strengthening the stability, including integrity, of the financial system, authorise the exchange of information between the competent authorities and the authorities or bodies responsible under law for the detection and investigation of breaches of company law. In such cases Member States shall require fulfilment of at least the following conditions: (a) the information is for the purpose of performing the task referred to in the first subparagraph; (b) information received in this context is subject to the conditions of professional secrecy specified in Article 44(1); and (c) where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement. Where, in a Member State, the authorities or bodies referred to in the first subparagraph perform their task of detection or investigation with the aid, in view of their specific competence, of persons appointed for that purpose and not employed in the public sector, the possibility of exchanging information provided for in the first subparagraph may be extended to such persons under the conditions specified in the second subparagraph. In order to implement the third subparagraph, the authorities or bodies referred to in the first subparagraph shall communicate to the competent authorities which have disclosed the information, the names and precise responsibilities of the persons to whom it is to be sent. Member States shall communicate to the Commission and to the other Member States the names of the authorities or bodies which may receive information pursuant to this Article. The Commission shall draw up a report on the application of the provisions of this Article. Article 49 This Section shall not prevent a competent authority from transmitting information to the following for the purposes of their tasks: (a) central banks and other bodies with a similar function in their capacity as monetary authorities; and (b) where appropriate, to other public authorities responsible for overseeing payment systems. This Section shall not prevent such authorities or bodies from communicating to the competent authorities such information as they may need for the purposes of Article 45. Information received in this context shall be subject to the conditions of professional secrecy specified in Article 44(1). Article 50 Notwithstanding Articles 44(1) and 45, the Member States may, by virtue of provisions laid down by law, authorise the disclosure of certain information to other departments of their central government administrations responsible for legislation on the supervision of credit institutions, financial institutions, investment services and insurance companies and to inspectors acting on behalf of those departments. However, such disclosures may be made only where necessary for reasons of prudential control. Article 51 The Member States shall provide that information received under Articles 44(2) and 47 and information obtained by means of the on-the-spot verification referred to in Article 43(1) and (2) may never be disclosed in the cases referred to in Article 50 except with the express consent of the competent authorities which disclosed the information or of the competent authorities of the Member State in which on-the-spot verification was carried out. Article 52 This Section shall not prevent the competent authorities of a Member State from communicating the information referred to in Articles 44 to 46 to a clearing house or other similar body recognised under national law for the provision of clearing or settlement services for one of their national markets if they consider that it is necessary to communicate the information in order to ensure the proper functioning of those bodies in relation to defaults or potential defaults by market participants. The information received in this context shall be subject to the conditions of professional secrecy specified in Article 44(1). The Member States shall, however, ensure that information received under Article 44(2) may not be disclosed in the circumstances referred to in this Article without the express consent of the competent authorities which disclosed it. Section 3 Duty of persons responsible for the legal control of annual and consolidated accounts Article 53 1. Member States shall provide at least that any person authorised within the meaning of Directive 84/253/EEC (17) performing in a credit institution the task described in Article 51 of Directive 78/660/EEC, Article 37 of Directive 83/349/EEC or Article 31 of Directive 85/611/EEC (18), or any other statutory task, shall have a duty to report promptly to the competent authorities any fact or decision concerning that credit institution of which he has become aware while carrying out that task which is liable to: (a) constitute a material breach of the laws, regulations or administrative provisions which lay down the conditions governing authorisation or which specifically govern pursuit of the activities of credit institutions; (b) affect the continuous functioning of the credit institution; or (c) lead to refusal to certify the accounts or to the expression of reservations. Member States shall provide at least that that person shall likewise have a duty to report any fact or decision of which he becomes aware in the course of carrying out a task as described in the first sub-paragraph in an undertaking having close links resulting from a control relationship with the credit institution within which he is carrying out that task. 2. The disclosure in good faith to the competent authorities, by persons authorised within the meaning of Directive 84/253/EEC, of any fact or decision referred to in paragraph 1 shall not constitute a breach of any restriction on disclosure of information imposed by contract or by any legislative, regulatory or administrative provision and shall not involve such persons in liability of any kind. Section 4 Power of sanction and right to apply to the courts Article 54 Without prejudice to the procedures for the withdrawal of authorisations and the provisions of criminal law, the Member States shall provide that their respective competent authorities may, as against credit institutions, or those who effectively control the business of credit institutions, which breach laws, regulations or administrative provisions concerning the supervision or pursuit of their activities, adopt or impose penalties or measures aimed specifically at ending the observed breaches or the causes of such breaches. Article 55 Member States shall ensure that decisions taken in respect of a credit institution in pursuance of laws, regulations and administrative provisions adopted in accordance with this Directive may be subject to the right to apply to the courts. The same shall apply where no decision is taken, within six months of its submission, in respect of an application for authorisation which contains all the information required under the provisions in force. CHAPTER 2 Technical instruments of prudential supervision Section 1 Own funds Article 56 Wherever a Member State lays down by law, regulation or administrative action a provision in implementation of Community legislation concerning the prudential supervision of an operative credit institution which uses the term or refers to the concept of own funds, it shall bring this term or concept into line with the definition given in Articles 57 to 61 and Articles 63 to 66. Article 57 Subject to the limits imposed in Article 66, the unconsolidated own funds of credit institutions shall consist of the following items: (a) capital within the meaning of Article 22 of Directive 86/635/EEC, in so far as it has been paid up, plus share premium accounts but excluding cumulative preferential shares; (b) reserves within the meaning of Article 23 of Directive 86/635/EEC and profits and losses brought forward as a result of the application of the final profit or loss; (c) funds for general banking risks within the meaning of Article 38 of Directive 86/635/EEC; (d) revaluation reserves within the meaning of Article 33 of Directive 78/660/EEC; (e) value adjustments within the meaning of Article 37(2) of Directive 86/635/EEC; (f) other items within the meaning of Article 63; (g) the commitments of the members of credit institutions set up as cooperative societies and the joint and several commitments of the borrowers of certain institutions organised as funds, as referred to in Article 64(1); and (h) fixed-term cumulative preferential shares and subordinated loan capital as referred to in Article 64(3). The following items shall be deducted in accordance with Article 66: (i) own shares at book value held by a credit institution; (j) intangible assets within the meaning of Article 4(9) (‘Assets’) of Directive 86/635/EEC; (k) material losses of the current financial year; (l) holdings in other credit and financial institutions amounting to more than 10 % of their capital; (m) subordinated claims and instruments referred to in Article 63 and Article 64(3) which a credit institution holds in respect of credit and financial institutions in which it has holdings exceeding 10 % of the capital in each case; (n) holdings in other credit and financial institutions of up to 10 % of their capital, the subordinated claims and the instruments referred to in Article 63 and Article 64(3) which a credit institution holds in respect of credit and financial institutions other than those referred to in points (l) and (m) in respect of the amount of the total of such holdings, subordinated claims and instruments which exceed 10 % of that credit institution's own funds calculated before the deduction of items in points (l) to (p); (o) participations within the meaning of Article 4(10) which a credit institution holds in: (i) insurance undertakings within the meaning of Article 6 of Directive 73/239/EEC (19), Article 4 of Directive 2002/83/EC (20) or Article 1(b) of Directive 98/78/EC (21), (ii) reinsurance undertakings within the meaning of Article 1(c) of Directive 98/78/EC, or (iii) insurance holding companies within the meaning of Article 1(i) of Directive 98/78/EC; (p) each of the following items which the credit institution holds in respect of the entities defined in point (o) in which it holds a participation: (i) instruments referred to in Article 16(3) of Directive 73/239/EEC, and (ii) instruments referred to in Article 27(3) of Directive 2002/83/EC; (q) for credit institutions calculating risk-weighted exposure amounts under Section 3, Subsection 2, negative amounts resulting from the calculation in Annex VII, Part 1, point 36 and expected loss amounts calculated in accordance with Annex VII, Part 1 points 32 and 33; and (r) the exposure amount of securitisation positions which receive a risk weight of 1 250 % under Annex IX, Part 4, calculated in the manner there specified. For the purposes of point (b), the Member States may permit inclusion of interim profits before a formal decision has been taken only if these profits have been verified by persons responsible for the auditing of the accounts and if it is proved to the satisfaction of the competent authorities that the amount thereof has been evaluated in accordance with the principles set out in Directive 86/635/EEC and is net of any foreseeable charge or dividend. In the case of a credit institution which is the originator of a securitisation, net gains arising from the capitalisation of future income from the securitised assets and providing credit enhancement to positions in the securitisation shall be excluded from the item specified in point (b). Article 58 Where shares in another credit institution, financial institution, insurance or reinsurance undertaking or insurance holding company are held temporarily for the purposes of a financial assistance operation designed to reorganise and save that entity, the competent authority may waive the provisions on deduction referred to in points (l) to (p) of Article 57. Article 59 As an alternative to the deduction of the items referred to in points (o) and (p) of Article 57, Member States may allow their credit institutions to apply mutatis mutandis methods 1, 2 or 3 of Annex I to Directive 2002/87/EC. Method 1 (accounting consolidation) may be applied only if the competent authority is confident about the level of integrated management and internal control regarding the entities which would be included in the scope of consolidation. The method chosen shall be applied in a consistent manner over time. Article 60 Member States may provide that for the calculation of own funds on a stand-alone basis, credit institutions subject to supervision on a consolidated basis in accordance with Chapter 4, Section 1, or to supplementary supervision in accordance with Directive 2002/87/EC, need not deduct the items referred to in points (l) to (p) of Article 57 which are held in credit institutions, financial institutions, insurance or reinsurance undertakings or insurance holding companies, which are included in the scope of consolidated or supplementary supervision. This provision shall apply to all the prudential rules harmonised by Community acts. Article 61 The concept of own funds as defined in points (a) to (h) of Article 57 embodies a maximum number of items and amounts. The use of those items and the fixing of lower ceilings, and the deduction of items other than those listed in points (i) to (r) of Article 57 shall be left to the discretion of the Member States. The items listed in points (a) to (e) of Article 57 shall be available to a credit institution for unrestricted and immediate use to cover risks or losses as soon as these occur. The amount shall be net of any foreseeable tax charge at the moment of its calculation or be suitably adjusted in so far as such tax charges reduce the amount up to which these items may be applied to cover risks or losses. Article 62 Member States may report to the Commission on the progress achieved in convergence with a view to a common definition of own funds. On the basis of these reports the Commission shall, if appropriate, by 1 January 2009, submit a proposal to the European Parliament and to the Council for amendment of this Section. Article 63 1. The concept of own funds used by a Member State may include other items provided that, whatever their legal or accounting designations might be, they have the following characteristics: (a) they are freely available to the credit institution to cover normal banking risks where revenue or capital losses have not yet been identified; (b) their existence is disclosed in internal accounting records; and (c) their amount is determined by the management of the credit institution, verified by independent auditors, made known to the competent authorities and placed under the supervision of the latter. 2. Securities of indeterminate duration and other instruments that fulfil the following conditions may also be accepted as other items: (a) they may not be reimbursed on the bearer's initiative or without the prior agreement of the competent authority; (b) the debt agreement shall provide for the credit institution to have the option of deferring the payment of interest on the debt; (c) the lender's claims on the credit institution shall be wholly subordinated to those of all non-subordinated creditors; (d) the documents governing the issue of the securities shall provide for debt and unpaid interest to be such as to absorb losses, whilst leaving the credit institution in a position to continue trading; and (e) only fully paid-up amounts shall be taken into account. To these securities and other instruments may be added cumulative preferential shares other than those referred to in point (h) of Article 57. 3. For credit institutions calculating risk-weighted exposure amounts under Section 3, Subsection 2, positive amounts resulting from the calculation in Annex VII, Part 1, point 36, may, up to 0,6 % of risk weighted exposure amounts calculated under Subsection 2, be accepted as other items. For these credit institutions value adjustments and provisions included in the calculation referred to in Annex VII, Part 1, point 36 and value adjustments and provisions for exposures referred to in point (e) of Article 57 shall not be included in own funds other than in accordance with this paragraph. For these purposes, risk-weighted exposure amounts shall not include those calculated in respect of securitisation positions which have a risk weight of 1 250 %. Article 64 1. The commitments of the members of credit institutions set up as cooperative societies referred to in point (g) of Article 57, shall comprise those societies' uncalled capital, together with the legal commitments of the members of those cooperative societies to make additional non-refundable payments should the credit institution incur a loss, in which case it shall be possible to demand those payments without delay. The joint and several commitments of borrowers in the case of credit institutions organised as funds shall be treated in the same way as the preceding items. All such items may be included in own funds in so far as they are counted as the own funds of institutions of this category under national law. 2. Member States shall not include in the own funds of public credit institutions guarantees which they or their local authorities extend to such entities. 3. Member States or the competent authorities may include fixed-term cumulative preferential shares referred to in point (h) of Article 57 and subordinated loan capital referred to in that provision in own funds, if binding agreements exist under which, in the event of the bankruptcy or liquidation of the credit institution, they rank after the claims of all other creditors and are not to be repaid until all other debts outstanding at the time have been settled. Subordinated loan capital shall fulfil the following additional criteria: (a) only fully paid-up funds may be taken into account; (b) the loans involved shall have an original maturity of at least five years, after which they may be repaid; (c) the extent to which they may rank as own funds shall be gradually reduced during at least the last five years before the repayment date; and (d) the loan agreement shall not include any clause providing that in specified circumstances, other than the winding-up of the credit institution, the debt shall become repayable before the agreed repayment date. For the purposes of point (b) of the second subparagraph, if the maturity of the debt is not fixed, the loans involved shall be repayable only subject to five years' notice unless the loans are no longer considered as own funds or unless the prior consent of the competent authorities is specifically required for early repayment. The competent authorities may grant permission for the early repayment of such loans provided the request is made at the initiative of the issuer and the solvency of the credit institution in question is not affected. 4. Credit institutions shall not include in own funds either the fair value reserves related to gains or losses on cash flow hedges of financial instruments measured at amortised cost, or any gains or losses on their liabilities valued at fair value that are due to changes in the credit institutions' own credit standing. Article 65 1. Where the calculation is to be made on a consolidated basis, the consolidated amounts relating to the items listed under Article 57 shall be used in accordance with the rules laid down in Chapter 4, Section 1. Moreover, the following may, when they are credit (‘negative’) items, be regarded as consolidated reserves for the calculation of own funds: (a) any minority interests within the meaning of Article 21 of Directive 83/349/EEC, where the global integration method is used; (b) the first consolidation difference within the meaning of Articles 19, 30 and 31 of Directive 83/349/EEC; (c) the translation differences included in consolidated reserves in accordance with Article 39(6) of Directive 86/635/EEC; and (d) any difference resulting from the inclusion of certain participating interests in accordance with the method prescribed in Article 33 of Directive 83/349/EEC. 2. Where the items referred to in points (a) to (d) of paragraph 1 are debit (‘positive’) items, they shall be deducted in the calculation of consolidated own funds. Article 66 1. The items referred to in points (d) to (h) of Article 57, shall be subject to the following limits: (a) the total of the items in points (d) to (h) may not exceed a maximum of 100 % of the items in points (a) plus (b) and (c) minus (i) to (k); and (b) the total of the items in points (g) to (h) may not exceed a maximum of 50 % of the items in points (a) plus (b) and (c) minus (i) to (k). 2. The total of the items in points (l) to (r) of Article 57 shall be deducted half from the total of the items (a) to (c) minus (i) to (k), and half from the total of the items (d) to (h) of Article 57, after application of the limits laid down in paragraph 1 of this Article. To the extent that half of the total of the items (l) to (r) exceeds the total of the items (d) to (h) of Article 57, the excess shall be deducted from the total of the items (a) to (c) minus (i) to (k) of Article 57. Items in point (r) of Article 57 shall not be deducted if they have been included in the calculation of risk-weighted exposure amounts for the purposes of Article 75 as specified in Annex IX, Part 4. 3. For the purposes of Sections 5 and 6, the provisions laid down in this Section shall be read without taking into account the items referred to in points (q) and (r) of Article 57 and Article 63(3). 4. The competent authorities may authorise credit institutions to exceed the limits laid down in paragraph 1 in temporary and exceptional circumstances. Article 67 Compliance with the conditions laid down in this Section shall be proved to the satisfaction of the competent authorities. Section 2 Provision against risks Subsection 1 Level of application Article 68 1. Credit institutions shall comply with the obligations laid down in Articles 22 and 75 and Section 5 on an individual basis. 2. Every credit institution which is neither a subsidiary in the Member State where it is authorised and supervised, nor a parent undertaking, and every credit institution not included in the consolidation pursuant to Article 73, shall comply with the obligations laid down in Articles 120 and 123 on an individual basis. 3. Every credit institution which is neither a parent undertaking, nor a subsidiary, and every credit institution not included in the consolidation pursuant to Article 73, shall comply with the obligations laid down in Chapter 5 on an individual basis. Article 69 1. The Member States may choose not to apply Article 68(1) to any subsidiary of a credit institution, where both the subsidiary and the credit institution are subject to authorisation and supervision by the Member State concerned, and the subsidiary is included in the supervision on a consolidated basis of the credit institution which is the parent undertaking, and all of the following conditions are satisfied, in order to ensure that own funds are distributed adequately among the parent undertaking and the subsidiaries: (a) there is no current or foreseen material practical or legal impediment to the prompt transfer of own funds or repayment of liabilities by its parent undertaking; (b) either the parent undertaking satisfies the competent authority regarding the prudent management of the subsidiary and has declared, with the consent of the competent authority, that it guarantees the commitments entered into by the subsidiary, or the risks in the subsidiary are of negligible interest; (c) the risk evaluation, measurement and control procedures of the parent undertaking cover the subsidiary; and (d) the parent undertaking holds more than 50 % of the voting rights attaching to shares in the capital of the subsidiary and/or has the right to appoint or remove a majority of the members of the management body of the subsidiary described in Article 11. 2. The Member States may exercise the option provided for in paragraph 1 where the parent undertaking is a financial holding company set up in the same Member State as the credit institution, provided that it is subject to the same supervision as that exercised over credit institutions, and in particular to the standards laid down in Article 71(1). 3. The Member States may choose not to apply Article 68(1) to a parent credit institution in a Member State where that credit institution is subject to authorisation and supervision by the Member State concerned, and it is included in the supervision on a consolidated basis, and all the following conditions are satisfied, in order to ensure that own funds are distributed adequately among the parent undertaking and the subsidiaries: (a) there is no current or foreseen material practical or legal impediment to the prompt transfer of own funds or repayment of liabilities to the parent credit institution in a Member State; and (b) the risk evaluation, measurement and control procedures relevant for consolidated supervision cover the parent credit institution in a Member State. The competent authority which makes use of this paragraph shall inform the competent authorities of all other Member States. 4. Without prejudice to the generality of Article 144, the competent authority of the Member States exercising the discretion laid down in paragraph 3 shall publicly disclose, in the manner indicated in Article 144: (a) criteria it applies to determine that there is no current or foreseen material practical or legal impediment to the prompt transfer of own funds or repayment of liabilities; (b) the number of parent credit institutions which benefit from the exercise of the discretion laid down in paragraph 3 and the number of these which incorporate subsidiaries in a third country; and (c) on an aggregate basis for the Member State: (i) the total amount of own funds on the consolidated basis of the parent credit institution in a Member State, which benefits from the exercise of the discretion laid down in paragraph 3, which are held in subsidiaries in a third country; (ii) the percentage of total own funds on the consolidated basis of parent credit institutions in a Member State which benefits from the exercise of the discretion laid down in paragraph 3, represented by own funds which are held in subsidiaries in a third country; and (iii) the percentage of total minimum own funds required under Article 75 on the consolidated basis of parent credit institutions in a Member State, which benefits from the exercise of the discretion laid down in paragraph 3, represented by own funds which are held in subsidiaries in a third country. Article 70 1. Subject to paragraphs 2 to 4 of this Article, the competent authorities may allow on a case by case basis parent credit institutions to incorporate in the calculation of their requirement under Article 68(1) subsidiaries which meet the conditions laid down in points (c) and (d) of Article 69(1), and whose material exposures or material liabilities are to that parent credit institution. 2. The treatment in paragraph 1 shall be allowed only where the parent credit institution demonstrates fully to the competent authorities the circumstances and arrangements, including legal arrangements, by virtue of which there is no material practical or legal impediment, and none are foreseen, to the prompt transfer of own funds, or repayment of liabilities when due by the subsidiary to its parent undertaking. 3. Where a competent authority exercises the discretion laid down in paragraph 1, it shall on a regular basis and not less than once a year inform the competent authorities of all the other Member States of the use made of paragraph 1 and of the circumstances and arrangements referred to in paragraph 2. Where the subsidiary is in a third country, the competent authorities shall provide the same information to the competent authorities of that third country as well. 4. Without prejudice to the generality of Article 144, a competent authority which exercises the discretion laid down in paragraph 1 shall publicly disclose, in the manner indicated in Article 144: (a) the criteria it applies to determine that there is no current or foreseen material practical or legal impediment to the prompt transfer of own funds or repayment of liabilities; (b) the number of parent credit institutions which benefit from the exercise of the discretion laid down in paragraph 1 and the number of these which incorporate subsidiaries in a third country; and (c) on an aggregate basis for the Member State: (i) the total amount of own funds of parent credit institutions which benefit from the exercise of the discretion laid down in paragraph 1 which are held in subsidiaries in a third country; (ii) the percentage of total own funds of parent credit institutions which benefit from the exercise of the discretion laid down in paragraph 1 represented by own funds which are held in subsidiaries in a third country; and (iii) the percentage of total minimum own funds required under Article 75 of parent credit institutions which benefit from the exercise of the discretion laid down in paragraph 1 represented by own funds which are held in subsidiaries in a third country. Article 71 1. Without prejudice to Articles 68 to 70, parent credit institutions in a Member State shall comply, to the extent and in the manner prescribed in Article 133, with the obligations laid down in Articles 75, 120, 123 and Section 5 on the basis of their consolidated financial situation. 2. Without prejudice to Articles 68 to 70, credit institutions controlled by a parent financial holding company in a Member State shall comply, to the extent and in the manner prescribed in Article 133, with the obligations laid down in Articles 75, 120, 123 and Section 5 on the basis of the consolidated financial situation of that financial holding company. Where more than one credit institution is controlled by a parent financial holding company in a Member State, the first subparagraph shall apply only to the credit institution to which supervision on a consolidated basis applies in accordance with Articles 125 and 126. Article 72 1. EU parent credit institutions shall comply with the obligations laid down in Chapter 5 on the basis of their consolidated financial situation. Significant subsidiaries of EU parent credit institutions shall disclose the information specified in Annex XII, Part 1, point 5, on an individual or sub-consolidated basis. 2. Credit institutions controlled by an EU parent financial holding company shall comply with the obligations laid down in Chapter 5 on the basis of the consolidated financial situation of that financial holding company. Significant subsidiaries of EU parent financial holding companies shall disclose the information specified in Annex XII, Part 1, point 5, on an individual or sub‐consolidated basis. 3. The competent authorities responsible for exercising supervision on a consolidated basis pursuant to Articles 125 and 126 may decide not to apply in full or in part paragraphs 1 and 2 to the credit institutions which are included within comparable disclosures provided on a consolidated basis by a parent undertaking established in a third country. Article 73 1. The Member States or the competent authorities responsible for exercising supervision on a consolidated basis pursuant to Articles 125 and 126 may decide in the following cases that a credit institution, financial institution or ancillary services undertaking which is a subsidiary or in which a participation is held need not be included in the consolidation: (a) where the undertaking concerned is situated in a third country where there are legal impediments to the transfer of the necessary information; (b) where, in the opinion of the competent authorities, the undertaking concerned is of negligible interest only with respect to the objectives of monitoring credit institutions and in any event where the balance-sheet total of the undertaking concerned is less than the smaller of the following two amounts: (i) EUR 10 million, or (ii) 1 % of the balance-sheet total of the parent undertaking or the undertaking that holds the participation, (c) where, in the opinion of the competent authorities responsible for exercising supervision on a consolidated basis, the consolidation of the financial situation of the undertaking concerned would be inappropriate or misleading as far as the objectives of the supervision of credit institutions are concerned. If, in the cases referred to in point (b) of the first subparagraph, several undertakings meet the above criteria set out therein, they shall nevertheless be included in the consolidation where collectively they are of non-negligible interest with respect to the specified objectives. 2. Competent authorities shall require subsidiary credit institutions to apply the requirements laid down in Articles 75, 120 and 123 and Section 5 on a sub-consolidated basis if those credit institutions, or the parent undertaking where it is a financial holding company, have a credit institution or a financial institution or an asset management company as defined in Article 2(5) of Directive 2002/87/EC as a subsidiary in a third country, or hold a participation in such an undertaking. 3. Competent authorities shall require the parent undertakings and subsidiaries subject to this Directive to meet the obligations laid down in Article 22 on a consolidated or sub‐consolidated basis, to ensure that their arrangements, processes and mechanisms are consistent and well-integrated and that any data and information relevant to the purpose of supervision can be produced. Subsection 2 Calculation of requirements Article 74 1. Save where otherwise provided, the valuation of assets and off-balance-sheet items shall be effected in accordance with the accounting framework to which the credit institution is subject under Regulation (EC) No 1606/2002 and Directive 86/635/EEC. 2. Notwithstanding the requirements laid down in Articles 68 to 72, the calculations to verify the compliance of credit institutions with the obligations laid down in Article 75 shall be carried out not less than twice each year. The credit institutions shall communicate the results and any component data required to the competent authorities. Subsection 3 Minimum level of own funds Article 75 Without prejudice to Article 136, Member States shall require credit institutions to provide own funds which are at all times more than or equal to the sum of the following capital requirements: (a) for credit risk and dilution risk in respect of all of their business activities with the exception of their trading book business and illiquid assets if deducted from own funds under Article 13(2)(d) of Directive 2006/49/EC, 8 % of the total of their risk-weighted exposure amounts calculated in accordance with Section 3; (b) in respect of their trading-book business, for position risk, settlement and counter‐party risk and, in so far as the limits laid down in Articles 111 to 117 are authorised to be exceeded, for large exposures exceeding such limits, the capital requirements determined in accordance with Article 18 and Chapter V, Section 4 of Directive 2006/49/EC; (c) in respect of all of their business activities, for foreign-exchange risk and for commodities risk, the capital requirements determined according to Article 18 of Directive 2006/49/EC; and (d) in respect of all of their business activities, for operational risk, the capital requirements determined in accordance with Section 4. Section 3 Minimum own funds requirements for credit risk Article 76 Credit institutions shall apply either the Standardised Approach provided for in Articles 78 to 83 or, if permitted by the competent authorities in accordance with Article 84, the Internal Ratings Based Approach provided for in Articles 84 to 89 to calculate their risk-weighted exposure amounts for the purposes of Article 75(a). Article 77 ‘Exposure’ for the purposes of this Section means an asset or off-balance sheet item. Subsection 1 Standardised approach Article 78 1. Subject to paragraph 2, the exposure value of an asset item shall be its balance-sheet value and the exposure value of an off‐balance sheet item listed in Annex II shall be the following percentage of its value: 100 % if it is a full-risk item, 50 % if it is a medium-risk item, 20 % if it is a medium/low-risk item, 0 % if it is a low-risk item. The off-balance sheet items referred to in the first sentence of this paragraph shall be assigned to risk categories as indicated in Annex II. In the case of a credit institution using the Financial Collateral Comprehensive Method under Annex VIII, Part 3, where an exposure takes the form of securities or commodities sold, posted or lent under a repurchase transaction or under a securities or commodities lending or borrowing transaction, and margin lending transactions the exposure value shall be increased by the volatility adjustment appropriate to such securities or commodities as prescribed in Annex VIII, Part 3, points 34 to 59. 2. The exposure value of a derivative instrument listed in Annex IV shall be determined in accordance with Annex III with the effects of contracts of novation and other netting agreements taken into account for the purposes of those methods in accordance with Annex III. The exposure value of repurchase transactions, securities or commodities lending or borrowing transactions, long settlement transactions and margin lending transactions may be determined either in accordance with Annex III or Annex VIII. 3. Where an exposure is subject to funded credit protection, the exposure value applicable to that item may be modified in accordance with Subsection 3. 4. Notwithstanding paragraph 2, the exposure value of credit risk exposures outstanding, as determined by the competent authorities, with a central counterparty shall be determined in accordance with Annex III, Part 2, point 6, provided that the central counterparty's counterparty credit risk exposures with all participants in its arrangements are fully collateralised on a daily basis. Article 79 1. Each exposure shall be assigned to one of the following exposure classes: (a) claims or contingent claims on central governments or central banks; (b) claims or contingent claims on regional governments or local authorities; (c) claims or contingent claims on administrative bodies and non-commercial undertakings; (d) claims or contingent claims on multilateral development banks; (e) claims or contingent claims on international organisations; (f) claims or contingent claims on institutions; (g) claims or contingent claims on corporates; (h) retail claims or contingent retail claims; (i) claims or contingent claims secured on real estate property; (j) past due items; (k) items belonging to regulatory high-risk categories; (l) claims in the form of covered bonds; (m) securitisation positions; (n) short-term claims on institutions and corporate; (o) claims in the form of collective investment undertakings (‘CIU’); or (p) other items. 2. To be eligible for the retail exposure class referred to in point (h) of paragraph 1, an exposure shall meet the following conditions: (a) the exposure shall be either to an individual person or persons, or to a small or medium sized entity; (b) the exposure shall be one of a significant number of exposures with similar characteristics such that the risks associated with such lending are substantially reduced; and (c) the total amount owed to the credit institution and parent undertakings and its subsidiaries, including any past due exposure, by the obligor client or group of connected clients, but excluding claims or contingent claims secured on residential real estate collateral, shall not, to the knowledge of the credit institution, exceed EUR 1 million. The credit institution shall take reasonable steps to acquire this knowledge. Securities shall not be eligible for the retail exposure class. (3) The present value of retail minimum lease payments is eligible for the retail exposure class. Article 80 1. To calculate risk-weighted exposure amounts, risk weights shall be applied to all exposures, unless deducted from own funds, in accordance with the provisions of Annex VI, Part 1. The application of risk weights shall be based on the exposure class to which the exposure is assigned and, to the extent specified in Annex VI, Part 1, its credit quality. Credit quality may be determined by reference to the credit assessments of External Credit Assessment Institutions (‘ECAIs’) in accordance with the provisions of Articles 81 to 83 or the credit assessments of Export Credit Agencies as described in Annex VI, Part 1. 2. For the purposes of applying a risk weight, as referred to in paragraph 1, the exposure value shall be multiplied by the risk weight specified or determined in accordance with this Subsection. 3. For the purposes of calculating risk-weighted exposure amounts for exposures to institutions, Member States shall decide whether to adopt the method based on the credit quality of the central government of the jurisdiction in which the institution is incorporated or the method based on the credit quality of the counterparty institution in accordance with Annex VI. 4. Notwithstanding paragraph 1, where an exposure is subject to credit protection the risk weight applicable to that item may be modified in accordance with Subsection 3. 5. Risk-weighted exposure amounts for securitised exposures shall be calculated in accordance with Subsection 4. 6. Exposures the calculation of risk-weighted exposure amounts for which is not otherwise provided for under this Subsection shall be assigned a risk-weight of 100 %. 7. With the exception of exposures giving rise to liabilities in the form of the items referred to in paragraphs (a) to (h) of Article 57, competent authorities may exempt from the requirements of paragraph 1 of this Article the exposures of a credit institution to a counterparty which is its parent undertaking, its subsidiary, a subsidiary of its parent undertaking or an undertaking linked by a relationship within the meaning of Article 12(1) of Directive 83/349/EEC, provided that the following conditions are met: (a) the counterparty is an institution or a financial holding company, financial institution, asset management company or ancillary services undertaking subject to appropriate prudential requirements; (b) the counterparty is included in the same consolidation as the credit institution on a full basis; (c) the counterparty is subject to the same risk evaluation, measurement and control procedures as the credit institution; (d) the counterparty is established in the same Member State as the credit institution; and (e) there is no current or foreseen material practical or legal impediment to the prompt transfer of own funds or repayment of liabilities from the counterparty to the credit institution. In such a case, a risk weight of 0 % shall be assigned. 8. With the exception of exposures giving rise to liabilities in the form of the items referred to in points (a) to (h) of Article 57, competent authorities may exempt from the requirements of paragraph 1 of this Article the exposures to counterparties which are members of the same institutional protection scheme as the lending credit institution, provided that the following conditions are met: (a) the requirements set out in points (a), (d) and (e) of paragraph 7; (b) the credit institution and the counterparty have entered into a contractual or statutory liability arrangement which protects those institutions and in particular ensures their liquidity and solvency to avoid bankruptcy in case it becomes necessary (referred to below as an institutional protection scheme); (c) the arrangements ensure that the institutional protection scheme will be able to grant support necessary under its commitment from funds readily available to it; (d) the institutional protection scheme disposes of suitable and uniformly stipulated systems for the monitoring and classification of risk (which gives a complete overview of the risk situations of all the individual members and the institutional protection scheme as a whole) with corresponding possibilities to take influence; those systems shall suitably monitor defaulted exposures in accordance with Annex VII, Part 4, point 44; (e) the institutional protection scheme conducts its own risk review which is communicated to the individual members; (f) the institutional protection scheme draws up and publishes once in a year either, a consolidated report comprising the balance sheet, the profit-and-loss account, the situation report and the risk report, concerning the institutional protection scheme as a whole, or a report comprising the aggregated balance sheet, the aggregated profit‐and‐loss account, the situation report and the risk report, concerning the institutional protection scheme as a whole; (g) members of the institutional protection scheme are obliged to give advance notice of at least 24 months if they wish to end the arrangements; (h) the multiple use of elements eligible for the calculation of own funds (‘multiple gearing’) as well as any inappropriate creation of own funds between the members of the institutional protection scheme shall be eliminated; (i) the institutional protection scheme shall be based on a broad membership of credit institutions of a predominantly homogeneous business profile; and (j) the adequacy of the systems referred to in point (d) is approved and monitored at regular intervals by the relevant competent authorities. In such a case, a risk weight of 0 % shall be assigned. Article 81 1. An external credit assessment may be used to determine the risk weight of an exposure in accordance with Article 80 only if the ECAI which provides it has been recognised as eligible for those purposes by the competent authorities (‘an eligible ECAI’ for the purposes of this Subsection). 2. Competent authorities shall recognise an ECAI as eligible for the purposes of Article 80 only if they are satisfied that its assessment methodology complies with the requirements of objectivity, independence, ongoing review and transparency, and that the resulting credit assessments meet the requirements of credibility and transparency. For those purposes, the competent authorities shall take into account the technical criteria set out in Annex VI, Part 2. 3. If an ECAI has been recognised as eligible by the competent authorities of a Member State, the competent authorities of other Member States may recognise that ECAI as eligible without carrying out their own evaluation process. 4. Competent authorities shall make publicly available an explanation of the recognition process, and a list of eligible ECAIs. Article 82 1. The competent authorities shall determine, taking into account the technical criteria set out in Annex VI, Part 2, with which of the credit quality steps set out in Part 1 of that Annex the relevant credit assessments of an eligible ECAI are to be associated. Those determinations shall be objective and consistent. 2. When the competent authorities of a Member State have made a determination under paragraph 1, the competent authorities of other Member States may recognise that determination without carrying out their own determination process. Article 83 1. The use of ECAI credit assessments for the calculation of a credit institution's risk‐weighted exposure amounts shall be consistent and in accordance with Annex VI, Part 3. Credit assessments shall not be used selectively. 2. Credit institutions shall use solicited credit assessments. However, with the permission of the relevant competent authority, they may use unsolicited assessments. Subsection 2 Internal Ratings Based Approach Article 84 1. In accordance with this Subsection, the competent authorities may permit credit institutions to calculate their risk-weighted exposure amounts using the Internal Ratings Based Approach (‘IRB Approach’). Explicit permission shall be required in the case of each credit institution. 2. Permission shall be given only if the competent authority is satisfied that the credit institution's systems for the management and rating of credit risk exposures are sound and implemented with integrity and, in particular, that they meet the following standards in accordance with Annex VII, Part 4: (a) the credit institution's rating systems provide for a meaningful assessment of obligor and transaction characteristics, a meaningful differentiation of risk and accurate and consistent quantitative estimates of risk; (b) internal ratings and default and loss estimates used in the calculation of capital requirements and associated systems and processes play an essential role in the risk management and decision-making process, and in the credit approval, internal capital allocation and corporate governance functions of the credit institution; (c) the credit institution has a credit risk control unit responsible for its rating systems that is appropriately independent and free from undue influence; (d) the credit institution collects and stores all relevant data to provide effective support to its credit risk measurement and management process; and (e) the credit institution documents its rating systems and the rationale for their design and validates its rating systems. Where an EU parent credit institution and its subsidiaries or an EU parent financial holding company and its subsidiaries use the IRB Approach on a unified basis, the competent authorities may allow minimum requirements of Annex VII, Part 4 to be met by the parent and its subsidiaries considered together. 3. A credit institution applying for the use of the IRB Approach shall demonstrate that it has been using for the IRB exposure classes in question rating systems that were broadly in line with the minimum requirements set out in Annex VII, Part 4 for internal risk measurement and management purposes for at least three years prior to its qualification to use the IRB Approach. 4. A credit institution applying for the use of own estimates of LGDs and/or conversion factors shall demonstrate that it has been estimating and employing own estimates of LGDs and/or conversion factors in a manner that was broadly consistent with the minimum requirements for use of own estimates of those parameters set out in Annex VII, Part 4 for at least three years prior to qualification to use own estimates of LGDs and/or conversion factors. 5. If a credit institution ceases to comply with the requirements set out in this Subsection, it shall either present to the competent authority a plan for a timely return to compliance or demonstrate that the effect of non-compliance is immaterial. 6. When the IRB Approach is intended to be used by the EU parent credit institution and its subsidiaries, or by the EU parent financial holding company and its subsidiaries, the competent authorities of the different legal entities shall cooperate closely as provided for in Articles 129 to 132. Article 85 1. Without prejudice to Article 89, credit institutions and any parent undertaking and its subsidiaries shall implement the IRB Approach for all exposures. Subject to the approval of the competent authorities, implementation may be carried out sequentially across the different exposure classes, referred to in Article 86, within the same business unit, across different business units in the same group or for the use of own estimates of LGDs or conversion factors for the calculation of risk weights for exposures to corporates, institutions, and central governments and central banks. In the case of the retail exposure class referred to in Article 86, implementation may be carried out sequentially across the categories of exposures to which the different correlations in Annex VII, Part 1, points 10 to 13 correspond. 2. Implementation as referred to in paragraph 1 shall be carried out within a reasonable period of time to be agreed with the competent authorities. The implementation shall be carried out subject to strict conditions determined by the competent authorities. Those conditions shall be designed to ensure that the flexibility under paragraph 1 is not used selectively with the purpose of achieving reduced minimum capital requirements in respect of those exposure classes or business units that are yet to be included in the IRB Approach or in the use of own estimates of LGDs and/or conversion factors. 3. Credit institutions using the IRB Approach for any exposure class shall at the same time use the IRB Approach for the equity exposure class. 4. Subject to paragraphs 1 to 3 of this Article and Article 89, credit institutions which have obtained permission under Article 84 to use the IRB Approach shall not revert to the use of Subsection 1 for the calculation of risk-weighted exposure amounts except for demonstrated good cause and subject to the approval of the competent authorities. 5. Subject to paragraphs 1 and 2 of this Article and Article 89, credit institutions which have obtained permission under Article 87(9) to use own estimates of LGDs and conversion factors, shall not revert to the use of LGD values and conversion factors referred to in Article 87(8) except for demonstrated good cause and subject to the approval of the competent authorities. Article 86 1. Each exposure shall be assigned to one of the following exposure classes: (a) claims or contingent claims on central governments and central banks; (b) claims or contingent claims on institutions; (c) claims or contingent claims on corporates; (d) retail claims or contingent retail claims; (e) equity claims; (f) securitisation positions; or (g) other non credit-obligation assets. 2. The following exposures shall be treated as exposures to central governments and central banks: (a) exposures to regional governments, local authorities or public sector entities which are treated as exposures to central governments under Subsection 1; and (b) exposures to Multilateral Development Banks and International Organisations which attract a risk weight of 0 % under Subsection 1. 3. The following exposures shall be treated as exposures to institutions: (a) exposures to regional governments and local authorities which are not treated as exposures to central governments under Subsection 1; (b) exposures to Public Sector Entities which are treated as exposures to institutions under the Subsection 1; and (c) exposures to Multilateral Development Banks which do not attract a 0 % risk weight under Subsection 1. 4. To be eligible for the retail exposure class referred to in point (d) of paragraph 1, exposures shall meet the following criteria: (a) they shall be either to an individual person or persons, or to a small or medium sized entity, provided in the latter case that the total amount owed to the credit institution and parent undertakings and its subsidiaries, including any past due exposure, by the obligor client or group of connected clients, but excluding claims or contingent claims secured on residential real estate collateral, shall not, to the knowledge of the credit institution, which shall have taken reasonable steps to confirm the situation, exceed EUR 1 million; (b) they are treated by the credit institution in its risk management consistently over time and in a similar manner; (c) they are not managed just as individually as exposures in the corporate exposure class; and (d) they each represent one of a significant number of similarly managed exposures. The present value of retail minimum lease payments is eligible for the retail exposure class. 5. The following exposures shall be classed as equity exposures: (a) non-debt exposures conveying a subordinated, residual claim on the assets or income of the issuer; and (b) debt exposures the economic substance of which is similar to the exposures specified in point (a). 6. Within the corporate exposure class, credit institutions shall separately identify as specialised lending exposures, exposures which possess the following characteristics: (a) the exposure is to an entity which was created specifically to finance and/or operate physical assets; (b) the contractual arrangements give the lender a substantial degree of control over the assets and the income that they generate; and (c) the primary source of repayment of the obligation is the income generated by the assets being financed, rather than the independent capacity of a broader commercial enterprise. 7. Any credit obligation not assigned to the exposure classes referred to in points (a), (b) and (d) to (f) of paragraph 1 shall be assigned to the exposure class referred to in point (c) of that paragraph. 8. The exposure class referred to in point (g) of paragraph 1 shall include the residual value of leased properties if not included in the lease exposure as defined in Annex VII, Part 3, paragraph 4. 9. The methodology used by the credit institution for assigning exposures to different exposure classes shall be appropriate and consistent over time. Article 87 1. The risk-weighted exposure amounts for credit risk for exposures belonging to one of the exposure classes referred to in points (a) to (e) or (g) of Article 86(1) shall, unless deducted from own funds, be calculated in accordance with Annex VII, Part 1, points 1 to 27. 2. The risk-weighted exposure amounts for dilution risk for purchased receivables shall be calculated according to Annex VII, Part 1, point 28. Where a credit institution has full recourse in respect of purchased receivables for default risk and for dilution risk, to the seller of the purchased receivables, the provisions of Articles 87 and 88 in relation to purchased receivables need not be applied. The exposure may instead be treated as a collateralised exposure. 3. The calculation of risk-weighted exposure amounts for credit risk and dilution risk shall be based on the relevant parameters associated with the exposure in question. These shall include probability of default (PD), LGD, maturity (M) and exposure value of the exposure. PD and LGD may be considered separately or jointly, in accordance with Annex VII, Part 2. 4. Notwithstanding paragraph 3, the calculation of risk-weighted exposure amounts for credit risk for all exposures belonging to the exposure class referred to in point (e) of Article 86(1) shall be calculated in accordance with Annex VII, Part 1, points 17 to 26 subject to approval of the competent authorities. Competent authorities shall only allow a credit institution to use the approach set out in Annex VII, Part 1, points 25 and 26 if the credit institution meets the minimum requirements set out in Annex VII, Part 4, points 115 to 123. 5. Notwithstanding paragraph 3, the calculation of risk weighted exposure amounts for credit risk for specialised lending exposures may be calculated in accordance with Annex VII, Part 1, point 6. Competent authorities shall publish guidance on how credit institutions should assign risk weights to specialised lending exposures under Annex VII, Part 1, point 6 and shall approve credit institution assignment methodologies. 6. For exposures belonging to the exposure classes referred to in points (a) to (d) of Article 86(1), credit institutions shall provide their own estimates of PDs in accordance with Article 84 and Annex VII, Part 4. 7. For exposures belonging to the exposure class referred to in point (d) of Article 86(1), credit institutions shall provide own estimates of LGDs and conversion factors in accordance with Article 84 and Annex VII, Part 4. 8. For exposures belonging to the exposure classes referred to in points (a) to (c) of Article 86(1), credit institutions shall apply the LGD values set out in Annex VII, Part 2, point 8, and the conversion factors set out in Annex VII, Part 3, point 9(a) to (d). 9. Notwithstanding paragraph 8, for all exposures belonging to the exposure classes referred to in points (a) to (c) of Article 86(1), competent authorities may permit credit institutions to use own estimates of LGDs and conversion factors in accordance with Article 84 and Annex VII, Part 4. 10. The risk-weighted exposure amounts for securitised exposures and for exposures belonging to the exposure class referred to in point (f) of Article 86(1) shall be calculated in accordance with Subsection 4. 11. Where exposures in the form of a collective investment undertaking (CIU) meet the criteria set out in Annex VI, Part 1, points 77 and 78 and the credit institution is aware of all of the underlying exposures of the CIU, the credit institution shall look through to those underlying exposures in order to calculate risk-weighted exposure amounts and expected loss amounts in accordance with the methods set out in this Subsection. Where the credit institution does not meet the conditions for using the methods set out in this Subsection, risk weighted exposure amounts and expected loss amounts shall be calculated in accordance with the following approaches: (a) for exposures belonging to the exposure class referred to in point (e) of Article 86(1), the approach set out in Annex VII, Part 1, points 19 to 21. If, for those purposes, the credit institution is unable to differentiate between private equity, exchange-traded and other equity exposures, it shall treat the exposures concerned as other equity exposures; (b) for all other underlying exposures, the approach set out in Subsection 1, subject to the following modifications: (i) the exposures are assigned to the appropriate exposure class and attributed the risk weight of the credit quality step immediately above the credit quality step that would normally be assigned to the exposure, and (ii) exposures assigned to the higher credit quality steps, to which a risk weight of 150 % would normally be attributed, are assigned a risk weight of 200 %. 12. Where exposures in the form of a CIU do not meet the criteria set out in Annex VI, Part 1, points 77 and 78, or the credit institution is not aware of all of the underlying exposures of the CIU, the credit institution shall look through to the underlying exposures and calculate risk-weighted exposure amounts and expected loss amounts in accordance with the approach set out in Annex VII, Part 1, points 19 to 21. If, for those purposes, the credit institution is unable to differentiate between private equity, exchange-traded and other equity exposures, it shall treat the exposures concerned as other equity exposures. For these purposes, non equity exposures are assigned to one of the classes (private equity, exchange traded equity or other equity) set out in Annex VII, Part 1, point 19 and unknown exposures are assigned to other equity class. Alternatively to the method described above, credit institutions may calculate themselves or may rely on a third party to calculate and report the average risk weighted exposure amounts based on the CIU's underlying exposures in accordance with the following approaches, provided that the correctness of the calculation and the report is adequately ensured: (a) for exposures belonging to the exposure class referred to in point (e) of Article 86(1), the approach set out in Annex VII, Part 1, points 19 to 21. If, for those purposes, the credit institution is unable to differentiate between private equity, exchange‐traded and other equity exposures, it shall treat the exposures concerned as other equity exposures; or (b) for all other underlying exposures, the approach set out in Subsection 1, subject to the following modifications: (i) the exposures are assigned to the appropriate exposure class and attributed the risk weight of the credit quality step immediately above the credit quality step that would normally be assigned to the exposure, and (ii) exposures assigned to the higher credit quality steps, to which a risk weight of 150 % would normally be attributed, are assigned a risk weight of 200 %. Article 88 1. The expected loss amounts for exposures belonging to one of the exposure classes referred to in points (a) to (e) of Article 86(1) shall be calculated in accordance with the methods set out in Annex VII, Part 1, points 29 to 35. 2. The calculation of expected loss amounts in accordance with Annex VII, Part 1, points 29 to 35 shall be based on the same input figures of PD, LGD and the exposure value for each exposure as being used for the calculation of risk-weighted exposure amounts in accordance with Article 87. For defaulted exposures, where credit institutions use own estimates of LGDs, expected loss (‘EL’) shall be the credit institution's best estimate of EL (‘ELBE,’) for the defaulted exposure, in accordance with Annex VII, Part 4, point 80. 3. The expected loss amounts for securitised exposures shall be calculated in accordance with Subsection 4. 4. The expected loss amount for exposures belonging to the exposure class referred to in point (g) of Article 86(1) shall be zero. 5. The expected loss amounts for dilution risk of purchased receivables shall be calculated in accordance with the methods set out in Annex VII, Part 1, point 35. 6. The expected loss amounts for exposures referred to in Article 87(11) and (12) shall be calculated in accordance with the methods set out in Annex VII, Part 1, points 29 to 35. Article 89 1. Subject to the approval of the competent authorities, credit institutions permitted to use the IRB Approach in the calculation of risk-weighted exposure amounts and expected loss amounts for one or more exposure classes may apply Subsection 1 for the following: (a) the exposure class referred to in point (a) of Article 86(1), where the number of material counterparties is limited and it would be unduly burdensome for the credit institution to implement a rating system for these counterparties; (b) the exposure class referred to in point (b) of Article 86(1), where the number of material counterparties is limited and it would be unduly burdensome for the credit institution to implement a rating system for these counterparties; (c) exposures in non-significant business units as well as exposure classes that are immaterial in terms of size and perceived risk profile; (d) exposures to central governments of the home Member State and to their regional governments, local authorities and administrative bodies, provided that: (i) there is no difference in risk between the exposures to that central government and those other exposures because of specific public arrangements, and (ii) exposures to the central government are assigned a 0 % risk weight under Subsection 1; (e) exposures of a credit institution to a counterparty which is its parent undertaking, its subsidiary or a subsidiary of its parent undertaking provided that the counterparty is an institution or a financial holding company, financial institution, asset management company or ancillary services undertaking subject to appropriate prudential requirements or an undertaking linked by a relationship within the meaning of Article 12(1) of Directive 83/349/EEC and exposures between credit institutions which meet the requirements set out in Article 80(8); (f) equity exposures to entities whose credit obligations qualify for a 0 % risk weight under Subsection 1 (including those publicly sponsored entities where a zero risk weight can be applied); (g) equity exposures incurred under legislative programmes to promote specified sectors of the economy that provide significant subsidies for the investment to the credit institution and involve some form of government oversight and restrictions on the equity investments. This exclusion is limited to an aggregate of 10 % of original own funds plus additional own funds; (h) the exposures identified in Annex VI, Part 1, point 40 meeting the conditions specified therein; or (i) State and State-reinsured guarantees pursuant to Annex VIII, Part 2, point 19. This paragraph shall not prevent the competent authorities of other Member States to allow the application of the rules of Subsection 1 for equity exposures which have been allowed for this treatment in other Member States. 2. For the purposes of paragraph 1, the equity exposure class of a credit institution shall be considered material if their aggregate value, excluding equity exposures incurred under legislative programmes as referred to in paragraph 1, point (g), exceeds, on average over the preceding year, 10 % of the credit institution's own funds. If the number of those equity exposures is less than 10 individual holdings, that threshold shall be 5 % of the credit institution's own funds. Subsection 3 Credit risk mitigation Article 90 For the purposes of this Subsection, ‘lending credit institution’ shall mean the credit institution which has the exposure in question, whether or not deriving from a loan. Article 91 Credit institutions using the Standardised Approach under Articles 78 to 83 or using the IRB Approach under Articles 84 to 89, but not using their own estimates of LGD and conversion factors under Articles 87 and 88, may recognise credit risk mitigation in accordance with this Subsection in the calculation of risk-weighted exposure amounts for the purposes of Article 75 point (a) or as relevant expected loss amounts for the purposes of the calculation referred to in point (q) of Article 57, and Article 63(3). Article 92 1. The technique used to provide the credit protection together with the actions and steps taken and procedures and policies implemented by the lending credit institution shall be such as to result in credit protection arrangements which are legally effective and enforceable in all relevant jurisdictions. 2. The lending credit institution shall take all appropriate steps to ensure the effectiveness of the credit protection arrangement and to address related risks. 3. In the case of funded credit protection, to be eligible for recognition the assets relied upon shall be sufficiently liquid and their value over time sufficiently stable to provide appropriate certainty as to the credit protection achieved having regard to the approach used to calculate risk-weighted exposure amounts and to the degree of recognition allowed. Eligibility shall be limited to the assets set out in Annex VIII, Part 1. 4. In the case of funded credit protection, the lending credit institution shall have the right to liquidate or retain, in a timely manner, the assets from which the protection derives in the event of the default, insolvency or bankruptcy of the obligor — or other credit event set out in the transaction documentation — and, where applicable, of the custodian holding the collateral. The degree of correlation between the value of the assets relied upon for protection and the credit quality of the obligor shall not be undue. 5. In the case of unfunded credit protection, to be eligible for recognition the party giving the undertaking shall be sufficiently reliable, and the protection agreement legally effective and enforceable in the relevant jurisdictions, to provide appropriate certainty as to the credit protection achieved having regard to the approach used to calculate risk‐weighted exposure amounts and to the degree of recognition allowed. Eligibility shall be limited to the protection providers and types of protection agreement set out in Annex VIII, Part 1. 6. The minimum requirements set out in Annex VIII, Part 2 shall be complied with. Article 93 1. Where the requirements of Article 92 are met the calculation of risk-weighted exposure amounts, and, as relevant, expected loss amounts, may be modified in accordance with Annex VIII, Parts 3 to 6. 2. No exposure in respect of which credit risk mitigation is obtained shall produce a higher risk-weighted exposure amount or expected loss amount than an otherwise identical exposure in respect of which there is no credit risk mitigation. 3. Where the risk-weighted exposure amount already takes account of credit protection under Articles 78 to 83 or Articles 84 to 89, as relevant, the calculation of the credit protection shall not be further recognised under this Subsection. Subsection 4 Securitisation Article 94 Where a credit institution uses the Standardised Approach set out in Articles 78 to 83 for the calculation of risk-weighted exposure amounts for the exposure class to which the securitised exposures would be assigned under Article 79, it shall calculate the risk-weighted exposure amount for a securitisation position in accordance with Annex IX, Part 4, points 1 to 36. In all other cases, it shall calculate the risk-weighted exposure amount in accordance with Annex IX, Part 4, points 1 to 5 and 37 to 76. Article 95 1. Where significant credit risk associated with securitised exposures has been transferred from the originator credit institution in accordance with the terms of Annex IX, Part 2, that credit institution may: (a) in the case of a traditional securitisation, exclude from its calculation of risk‐weighted exposure amounts, and, as relevant, expected loss amounts, the exposures which it has securitised; and (b) in the case of a synthetic securitisation, calculate risk-weighted exposure amounts, and, as relevant, expected loss amounts, in respect of the securitised exposures in accordance with Annex IX, Part 2. 2. Where paragraph 1 applies, the originator credit institution shall calculate the risk‐weighted exposure amounts prescribed in Annex IX for the positions that it may hold in the securitisation. Where the originator credit institution fails to transfer significant credit risk in accordance with paragraph 1, it need not calculate risk-weighted exposure amounts for any positions it may have in the securitisation in question. Article 96 1. To calculate the risk-weighted exposure amount of a securitisation position, risk weights shall be assigned to the exposure value of the position in accordance with Annex IX, based on the credit quality of the position, which may be determined by reference to an ECAI credit assessment or otherwise, as set out in Annex IX. 2. Where there is an exposure to different tranches in a securitisation, the exposure to each tranche shall be considered a separate securitisation position. The providers of credit protection to securitisation positions shall be considered to hold positions in the securitisation. Securitisation positions shall include exposures to a securitisation arising from interest rate or currency derivative contracts. 3. Where a securitisation position is subject to funded or unfunded credit protection the risk‐weight to be applied to that position may be modified in accordance with Articles 90 to 93, read in conjunction with Annex IX. 4. Subject to point (r) of Article 57 and Article 66(2), the risk-weighted exposure amount shall be included in the credit institution's total of risk-weighted exposure amounts for the purposes of Article 75(a). Article 97 1. An ECAI credit assessment may be used to determine the risk weight of a securitisation position in accordance with Article 96 only if the ECAI has been recognised as eligible by the competent authorities for this purpose (hereinafter ‘an eligible ECAI’). 2. The competent authorities shall recognise an ECAI as eligible for the purposes of paragraph 1 only if they are satisfied as to its compliance with the requirements laid down in Article 81, taking into account the technical criteria in Annex VI, Part 2, and that it has a demonstrated ability in the area of securitisation, which may be evidenced by a strong market acceptance. 3. If an ECAI has been recognised as eligible by the competent authorities of a Member State for the purposes of paragraph 1, the competent authorities of other Member States may recognise that ECAI as eligible for those purposes without carrying out their own evaluation process. 4. The competent authorities shall make publicly available an explanation of the recognition process and a list of eligible ECAIs. 5. To be used for the purposes of paragraph 1, a credit assessment of an eligible ECAI shall comply with the principles of credibility and transparency as elaborated in Annex IX, Part 3. Article 98 1. For the purposes of applying risk weights to securitisation positions, the competent authorities shall determine with which of the credit quality steps set out in Annex IX the relevant credit assessments of an eligible ECAI are to be associated. Those determinations shall be objective and consistent. 2. When the competent authorities of a Member State have made a determination under paragraph 1, the competent authorities of other Member States may recognise that determination without carrying out their own determination process. Article 99 The use of ECAI credit assessments for the calculation of a credit institution's risk-weighted exposure amounts under Article 96 shall be consistent and in accordance with Annex IX, Part 3. Credit assessments shall not be used selectively. Article 100 1. Where there is a securitisation of revolving exposures subject to an early amortisation provision, the originator credit institution shall calculate, in accordance with Annex IX, an additional risk-weighted exposure amount in respect of the risk that the levels of credit risk to which it is exposed may increase following the operation of the early amortisation provision. 2. For those purposes, a ‘revolving exposure’ shall be an exposure whereby customers' outstanding balances are permitted to fluctuate based on their decisions to borrow and repay, up to an agreed limit, and an early amortisation provision shall be a contractual clause which requires, on the occurrence of defined events, investors' positions to be redeemed before the originally stated maturity of the securities issued. Article 101 1. An originator credit institution which, in respect of a securitisation, has made use of Article 95 in the calculation of risk-weighted exposure amounts or a sponsor credit institution shall not, with a view to reducing potential or actual losses to investors, provide support to the securitisation beyond its contractual obligations. 2. If an originator credit institution or a sponsor credit institution fails to comply with paragraph 1 in respect of a securitisation, the competent authority shall require it at a minimum, to hold capital against all of the securitised exposures as if they had not been securitised. The credit institution shall disclose publicly that it has provided non‐contractual support and the regulatory capital impact of having done so. Section 4 Minimum own funds requirements for operational risk Article 102 1. Competent authorities shall require credit institutions to hold own funds against operational risk in accordance with the approaches set out in Articles 103, 104 and 105. 2. Without prejudice to paragraph 4, credit institutions that use the approach set out in Article 104 shall not revert to the use of the approach set out in Article 103, except for demonstrated good cause and subject to approval by the competent authorities. 3. Without prejudice to paragraph 4, credit institutions that use the approach set out in Article 105 shall not revert to the use of the approaches set out in Articles 103 or 104 except for demonstrated good cause and subject to approval by the competent authorities. 4. Competent authorities may allow credit institutions to use a combination of approaches in accordance with Annex X, Part 4. Article 103 The capital requirement for operational risk under the Basic Indicator Approach shall be a certain percentage of a relevant indicator, in accordance with the parameters set out in Annex X, Part 1. Article 104 1. Under the Standardised Approach, credit institutions shall divide their activities into a number of business lines as set out in Annex X, Part 2. 2. For each business line, credit institutions shall calculate a capital requirement for operational risk as a certain percentage of a relevant indicator, in accordance with the parameters set out in Annex X, Part 2. 3. For certain business lines, the competent authorities may under certain conditions authorise a credit institution to use an alternative relevant indicator for determining its capital requirement for operational risk as set out in Annex X, Part 2, points 5 to 11. 4. The capital requirement for operational risk under the Standardised Approach shall be the sum of the capital requirements for operational risk across all individual business lines. 5. The parameters for the Standardised Approach are set out in Annex X, Part 2. 6. To qualify for use of the Standardised Approach, credit institutions shall meet the criteria set out in Annex X, Part 2. Article 105 1. Credit institutions may use Advanced Measurement Approaches based on their own operational risk measurement systems, provided that the competent authority expressly approves the use of the models concerned for calculating the own funds requirement. 2. Credit institutions shall satisfy their competent authorities that they meet the qualifying criteria set out in Annex X, Part 3. 3. When an Advanced Measurement Approach is intended to be used by an EU parent credit institution and its subsidiaries or by the subsidiaries of an EU parent financial holding company, the competent authorities of the different legal entities shall cooperate closely as provided for in Articles 129 to 132. The application shall include the elements listed in Annex X, Part 3. 4. Where an EU parent credit institution and its subsidiaries or the subsidiaries of an EU parent financial holding company use an Advanced Measurement Approach on a unified basis, the competent authorities may allow the qualifying criteria set out in Annex X, Part 3 to be met by the parent and its subsidiaries considered together. Section 5 Large exposures Article 106 1. ‘Exposures’, for the purposes of this Section, shall mean any asset or off‐balance‐sheet item referred to in Section 3, Subsection 1, without application of the risk weights or degrees of risk there provided for. Exposures arising from the items referred to in Annex IV shall be calculated in accordance with one of the methods set out in Annex III. For the purposes of this Section, Annex III, Part 2, point 2 shall also apply. All elements entirely covered by own funds may, with the agreement of the competent authorities, be excluded from the determination of exposures, provided that such own funds are not included in the credit institution's own funds for the purposes of Article 75 or in the calculation of other monitoring ratios provided for in this Directive and in other Community acts. 2. Exposures shall not include either of the following: (a) in the case of foreign exchange transactions, exposures incurred in the ordinary course of settlement during the 48 hours following payment; or (b) in the case of transactions for the purchase or sale of securities, exposures incurred in the ordinary course of settlement during the five working days following payment or delivery of the securities, whichever is the earlier. Article 107 For the purposes of applying this Section, the term ‘credit institution’ shall cover the following: (a) a credit institution, including its branches in third countries; and (b) any private or public undertaking, including its branches, which meets the definition of ‘credit institution’ and has been authorised in a third country. Article 108 A credit institution's exposure to a client or group of connected clients shall be considered a large exposure where its value is equal to or exceeds 10 % of its own funds. Article 109 The competent authorities shall require that every credit institution have sound administrative and accounting procedures and adequate internal control mechanisms for the purposes of identifying and recording all large exposures and subsequent changes to them, in accordance with this Directive, and for that of monitoring those exposures in the light of each credit institution's own exposure policies. Article 110 1. A credit institution shall report every large exposure to the competent authorities. Member States shall provide that reporting is to be carried out, at their discretion, in accordance with one of the following two methods: (a) reporting of all large exposures at least once a year, combined with reporting during the year of all new large exposures and any increases in existing large exposures of at least 20 % with respect to the previous communication; or (b) reporting of all large exposures at least four times a year. 2. Except in the case of credit institutions relying on Article 114 for the recognition of collateral in calculating the value of exposures for the purposes of paragraphs 1, 2 and 3 of Article 111, exposures exempted under Article 113(3)(a) to (d) and (f) to (h) need not be reported as laid down in paragraph 1 and the reporting frequency laid down in point (b) of paragraph 1 of this Article may be reduced to twice a year for the exposures referred to in Article 113(3)(e) and (i), and in Articles 115 and 116. Where a credit institution invokes this paragraph, it shall keep a record of the grounds advanced for at least one year after the event giving rise to the dispensation, so that the competent authorities may establish whether it is justified. 3. Member States may require credit institutions to analyse their exposures to collateral issuers for possible concentrations and where appropriate take action or report any significant findings to their competent authority. Article 111 1. A credit institution may not incur an exposure to a client or group of connected clients the value of which exceed 25 % of its own funds. 2. Where that client or group of connected clients is the parent undertaking or subsidiary of the credit institution and/or one or more subsidiaries of that parent undertaking, the percentage laid down in paragraph 1 shall be reduced to 20 %. Member States may, however, exempt the exposures incurred to such clients from the 20 % limit if they provide for specific monitoring of such exposures by other measures or procedures. They shall inform the Commission and the European Banking Committee of the content of such measures or procedures. 3. A credit institution may not incur large exposures which in total exceed 800 % of its own funds. 4. A credit institution shall at all times comply with the limits laid down in paragraphs 1, 2 and 3 in respect of its exposures. If in an exceptional case exposures exceed those limits, that fact shall be reported without delay to the competent authorities which may, where the circumstances warrant it, allow the credit institution a limited period of time in which to comply with the limits. Article 112 1. For the purposes of Articles 113 to 117, the term ‘guarantee’ shall include credit derivatives recognised under Articles 90 to 93 other than credit linked notes. 2. Subject to paragraph 3, where, under Articles 113 to 117, the recognition of funded or unfunded credit protection may be permitted, this shall be subject to compliance with the eligibility requirements and other minimum requirements, set out under Articles 90 to 93 for the purposes of calculating risk-weighted exposure amounts under Articles 78 to 83. 3. Where a credit institution relies upon Article 114(2), the recognition of funded credit protection shall be subject to the relevant requirements under Articles 84 to 89. Article 113 1. Member States may impose limits more stringent than those laid down in Article 111. 2. Member States may fully or partially exempt from the application of Article 111(1), (2) and (3) exposures incurred by a credit institution to its parent undertaking, to other subsidiaries of that parent undertaking or to its own subsidiaries, in so far as those undertakings are covered by the supervision on a consolidated basis to which the credit institution itself is subject, in accordance with this Directive or with equivalent standards in force in a third country. 3. Member States may fully or partially exempt the following exposures from the application of Article 111: (a) asset items constituting claims on central governments or central banks which, unsecured, would be assigned a 0 % risk weight under Articles 78 to 83; (b) asset items constituting claims on international organisations or multilateral development banks which, unsecured, would be assigned a 0 % risk weight under Articles 78 to 83; (c) asset items constituting claims carrying the explicit guarantees of central governments, central banks, international organisations, multilateral development banks or public sector entities, where unsecured claims on the entity providing the guarantee would be assigned a 0 % risk weight under Articles 78 to 83; (d) other exposures attributable to, or guaranteed by, central governments, central banks, international organisations, multilateral development banks or public sector entities, where unsecured claims on the entity to which the exposure is attributable or by which it is guaranteed would be assigned a 0 % risk weight under Articles 78 to 83; (e) asset items constituting claims on and other exposures to central governments or central banks not mentioned in point (a) which are denominated and, where applicable, funded in the national currencies of the borrowers; (f) asset items and other exposures secured, to the satisfaction of the competent authorities, by collateral in the form of debt securities issued by central governments or central banks, international organisations, multilateral development banks, Member States' regional governments, local authorities or public sector entities, which securities constitute claims on their issuer which would be assigned a 0 % risk weighting under Articles 78 to 83; (g) asset items and other exposures secured, to the satisfaction of the competent authorities, by collateral in the form of cash deposits placed with the lending credit institution or with a credit institution which is the parent undertaking or a subsidiary of the lending institution; (h) asset items and other exposures secured, to the satisfaction of the competent authorities, by collateral in the form of certificates of deposit issued by the lending credit institution or by a credit institution which is the parent undertaking or a subsidiary of the lending credit institution and lodged with either of them; (i) asset items constituting claims on and other exposures to institutions, with a maturity of one year or less, but not constituting such institutions" own funds; (j) asset items constituting claims on and other exposures to those institutions which are not credit institutions but which fulfil the conditions referred to in Annex VI, Part 1, point 85, with a maturity of one year or less, and secured in accordance with the same point; (k) bills of trade and other similar bills, with a maturity of one year or less, bearing the signatures of other credit institutions; (l) covered bonds falling within the terms of Annex VI, Part 1, points 68 to 70; (m) pending subsequent coordination, holdings in the insurance companies referred to in Article 122(1) up to 40 % of the own funds of the credit institution acquiring such a holding; (n) asset items constituting claims on regional or central credit institutions with which the lending credit institution is associated in a network in accordance with legal or statutory provisions and which are responsible, under those provisions, for cash‐clearing operations within the network; (o) exposures secured, to the satisfaction of the competent authorities, by collateral in the form of securities other than those referred to in point (f); (p) loans secured, to the satisfaction of the competent authorities, by mortgages on residential property or by shares in Finnish residential housing companies, operating in accordance with the Finnish Housing Company Act of 1991 or subsequent equivalent legislation and leasing transactions under which the lessor retains full ownership of the residential property leased for as long as the lessee has not exercised his option to purchase, in all cases up to 50 % of the value of the residential property concerned; (q) the following, where they would receive a 50 % risk weight under Articles 78 to 83, and only up to 50 % of the value of the property concerned: (i) exposures secured by mortgages on offices or other commercial premises, or by shares in Finnish housing companies, operating in accordance with the Finnish Housing Company Act of 1991 or subsequent equivalent legislation, in respect of offices or other commercial premises; and (ii) exposures related to property leasing transactions concerning offices or other commercial premises; for the purposes of point (ii), until 31 December 2011, the competent authorities of each Member State may allow credit institutions to recognise 100 % of the value of the property concerned. At the end of this period, this treatment shall be reviewed. Member States shall inform the Commission of the use they make of this preferential treatment; (r) 50 % of the medium/low‐risk off‐balance‐sheet items referred to in Annex II; (s) subject to the competent authorities' agreement, guarantees other than loan guarantees which have a legal or regulatory basis and are given for their members by mutual guarantee schemes possessing the status of credit institutions, subject to a weighting of 20 % of their amount; and (t) the low‐risk off‐balance‐sheet items referred to in Annex II, to the extent that an agreement has been concluded with the client or group of connected clients under which the exposure may be incurred only if it has been ascertained that it will not cause the limits applicable under Article 111(1) to (3) to be exceeded. Cash received under a credit linked note issued by the credit institution and loans and deposits of a counterparty to or with the credit institution which are subject to an on‐balance sheet netting agreement recognised under Articles 90 to 93 shall be deemed to fall under point (g). For the purposes of point (o), the securities used as collateral shall be valued at market price, have a value that exceeds the exposures guaranteed and be either traded on a stock exchange or effectively negotiable and regularly quoted on a market operated under the auspices of recognised professional operators and allowing, to the satisfaction of the competent authorities of the Member State of origin of the credit institution, for the establishment of an objective price such that the excess value of the securities may be verified at any time. The excess value required shall be 100 %. It shall, however, be 150 % in the case of shares and 50 % in the case of debt securities issued by institutions, Member State regional governments or local authorities other than those referred to in sub‐point (f), and in the case of debt securities issued by multilateral development banks other than those assigned a 0 % risk weight under Articles 78 to 83. Where there is a mismatch between the maturity of the exposure and the maturity of the credit protection, the collateral shall not be recognised. Securities used as collateral may not constitute credit institutions' own funds. For the purposes of point (p), the value of the property shall be calculated, to the satisfaction of the competent authorities, on the basis of strict valuation standards laid down by law, regulation or administrative provisions. Valuation shall be carried out at least once a year. For the purposes of point (p), residential property shall mean a residence to be occupied or let by the borrower. Member States shall inform the Commission of any exemption granted under point (s) in order to ensure that it does not result in a distortion of competition. Article 114 1. Subject to paragraph 3, for the purposes of calculating the value of exposures for the purposes of Article 111(1) to (3) Member States may, in respect of credit institutions using the Financial Collateral Comprehensive Method under Articles 90 to 93, in the alternative to availing of the full or partial exemptions permitted under points (f), (g), (h), and (o) of Article 113(3), permit such credit institutions to use a value lower than the value of the exposure, but no lower than the total of the fully‐adjusted exposure values of their exposures to the client or group of connected clients. For these purposes, ‘fully adjusted exposure value’ means that calculated under Articles 90 to 93 taking into account the credit risk mitigation, volatility adjustments, and any maturity mismatch (E*). Where this paragraph is applied to a credit institution, points (f), (g), (h), and (o) of Article 113(3) shall not apply to the credit institution in question. 2. Subject to paragraph 3, a credit institution permitted to use own estimates of LGDs and conversion factors for an exposure class under Articles 84 to 89 may be permitted, where it is able to the satisfaction of the competent authorities to estimate the effects of financial collateral on their exposures separately from other LGD‐relevant aspects, to recognise such effects in calculating the value of exposures for the purposes of Article 111(1) to (3). Competent authorities shall be satisfied as to the suitability of the estimates produced by the credit institution for use for the reduction of the exposure value for the purposes of compliance with the provisions of Article 111. Where a credit institution is permitted to use its own estimates of the effects of financial collateral, it shall do so on a basis consistent with the approach adopted in the calculation of capital requirements. Credit institutions permitted to use own estimates of LGDs and conversion factors for an exposure class under Articles 84 to 89 which do not calculate the value of their exposures using the method referred to in the first subparagraph may be permitted to use the approach set out in paragraph 1 or the exemption set out in Article 113(3)(o) for calculating the value of exposures. A credit institution shall use only one of these two methods. 3. A credit institution that is permitted to use the methods described in paragraphs 1 and 2 in calculating the value of exposures for the purposes of Article 111(1) to (3), shall conduct periodic stress tests of their credit-risk concentrations, including in relation to the realisable value of any collateral taken. These periodic stress tests shall address risks arising from potential changes in market conditions that could adversely impact the credit institutions' adequacy of own funds and risks arising from the realisation of collateral in stressed situations. The credit institution shall satisfy the competent authorities that the stress tests carried out are adequate and appropriate for the assessment of such risks. In the event that such a stress test indicates a lower realisable value of collateral taken than would be permitted to be taken into account under paragraphs 1 and 2 as appropriate, the value of collateral permitted to be recognised in calculating the value of exposures for the purposes of Article 111(1) to (3) shall be reduced accordingly. Such credit institutions shall include the following in their strategies to address concentration risk: (a) policies and procedures to address risks arising from maturity mismatches between exposures and any credit protection on those exposures; (b) policies and procedures in the event that a stress test indicates a lower realisable value of collateral than taken into account under paragraphs 1 and 2; and (c) policies and procedures relating to concentration risk arising from the application of credit risk mitigation techniques, and in particular large indirect credit exposures, for example to a single issuer of securities taken as collateral. 4. Where the effects of collateral are recognised under the terms of paragraphs 1 or 2, Member States may treat any covered Part of the exposure as having been incurred to the collateral issuer rather than to the client. Article 115 1. For the purposes of Article 111(1) to (3), Member States may assign a weighting of 20 % to asset items constituting claims on Member States' regional governments and local authorities where those claims would be assigned a 20 % risk weight under Articles 78 to 83 and to other exposures to or guaranteed by such governments and authorities claims on which are assigned a 20 % risk weight under Articles 78 to 83. However, Member States may reduce that rate to 0 % in respect of asset items constituting claims on Member States' regional governments and local authorities where those claims would be assigned a 0 % risk weight under Article 78 to 83 and to other exposures to or guaranteed by such governments and authorities claims on which are assigned a 0 % risk weight under Articles 78 to 83. 2. For the purposes of Article 111(1) to (3), Member States may assign a weighting of 20 % to asset items constituting claims on and other exposures to institutions with a maturity of more than one but not more than three years and a weighting of 50 % to asset items constituting claims on institutions with a maturity of more than three years, provided that the latter are represented by debt instruments that were issued by a institution and that those debt instruments are, in the opinion of the competent authorities, effectively negotiable on a market made up of professional operators and are subject to daily quotation on that market, or the issue of which was authorised by the competent authorities of the Member State of origin of the issuing institutions. In no case may any of these items constitute own funds. Article 116 By way of derogation from Article 113(3)(i) and Article 115(2), Member States may assign a weighting of 20 % to asset items constituting claims on and other exposures to institutions, regardless of their maturity. Article 117 1. Where an exposure to a client is guaranteed by a third party, or by collateral in the form of securities issued by a third party under the conditions laid down in Article 113(3)(o), Member States may: (a) treat the exposure as having been incurred to the guarantor rather than to the client; or (b) treat the exposure as having been incurred to the third party rather than to the client, if the exposure defined in Article 113(3)(o) is guaranteed by collateral under the conditions there laid down. 2. Where Member States apply the treatment provided for in point (a) of paragraph 1: (a) where the guarantee is denominated in a currency different from that in which the exposure is denominated the amount of the exposure deemed to be covered will be calculated in accordance with the provisions on the treatment of currency mismatch for unfunded credit protection in Annex VIII; (b) a mismatch between the maturity of the exposure and the maturity of the protection will be treated in accordance with the provisions on the treatment of maturity mismatch in Annex VIII; and (c) partial coverage may be recognised in accordance with the treatment set out in Annex VIII. Article 118 Where compliance by a credit institution on an individual or sub‐consolidated basis with the obligations imposed in this Section is disapplied under Article 69(1), or the provisions of Article 70 are applied in the case of parent credit institutions in a Member State, measures must be taken to ensure the satisfactory allocation of risks within the group. Article 119 By 31 December 2007, the Commission shall submit to the European Parliament and to the Council a report on the functioning of this Section, together with any appropriate proposals. Section 6 Qualifying holdings outside the financial sector Article 120 1. No credit institution may have a qualifying holding the amount of which exceeds 15 % of its own funds in an undertaking which is neither a credit institution, nor a financial institution, nor an undertaking carrying on activities which are a direct extension of banking or concern services ancillary to banking, such as leasing, factoring, the management of unit trusts, the management of data processing services or any other similar activity. 2. The total amount of a credit institution's qualifying holdings in undertakings other than credit institutions, financial institutions or undertakings carrying on activities which are a direct extension of banking or concern services ancillary to banking, such as leasing, factoring, the management of unit trusts, the management of data processing services, or any other similar activity may not exceed 60 % of its own funds. 3. The limits laid down in paragraphs 1 and 2 may be exceeded only in exceptional circumstances. In such cases, however, the competent authorities shall require a credit institution either to increase its own funds or to take other equivalent measures. Article 121 Shares held temporarily during a financial reconstruction or rescue operation or during the normal course of underwriting or in an institution's own name on behalf of others shall not be counted as qualifying holdings for the purpose of calculating the limits laid down in Articles 120(1) and (2). Shares which are not financial fixed assets as defined in Article 35(2) of Directive 86/635/EEC shall not be included in the calculation. Article 122 1. The Member States need not apply the limits laid down in Articles 120(1) and (2) to holdings in insurance companies as defined in Directives 73/239/EEC and 2002/83/EC, or in reinsurance companies as defined in Directive 98/78/EC. 2. The Member States may provide that the competent authorities are not to apply the limits laid down in Article 120(1) and (2) if they provide that 100 % of the amounts by which a credit institution's qualifying holdings exceed those limits shall be covered by own funds and that the latter shall not be included in the calculation required under Article 75. If both the limits laid down in Article 120(1) and (2) are exceeded, the amount to be covered by own funds shall be the greater of the excess amounts. CHAPTER 3 Credit institutions' assessment process Article 123 Credit institutions shall have in place sound, effective and complete strategies and processes to assess and maintain on an ongoing basis the amounts, types and distribution of internal capital that they consider adequate to cover the nature and level of the risks to which they are or might be exposed. These strategies and processes shall be subject to regular internal review to ensure that they remain comprehensive and proportionate to the nature, scale and complexity of the activities of the credit institution concerned. CHAPTER 4 Supervision and disclosure by competent authorities Section 1 Supervision Article 124 1. Taking into account the technical criteria set out in Annex XI, the competent authorities shall review the arrangements, strategies, processes and mechanisms implemented by the credit institutions to comply with this Directive and evaluate the risks to which the credit institutions are or might be exposed. 2. The scope of the review and evaluation referred to in paragraph 1 shall be that of the requirements of this Directive. 3. On the basis of the review and evaluation referred to in paragraph 1, the competent authorities shall determine whether the arrangements, strategies, processes and mechanisms implemented by the credit institutions and the own funds held by these ensure a sound management and coverage of their risks. 4. Competent authorities shall establish the frequency and intensity of the review and evaluation referred to in paragraph 1 having regard to the size, systemic importance, nature, scale and complexity of the activities of the credit institution concerned and taking into account the principle of proportionality. The review and evaluation shall be updated at least on an annual basis. 5. The review and evaluation performed by competent authorities shall include the exposure of credit institutions to the interest rate risk arising from non‐trading activities. Measures shall be required in the case of institutions whose economic value declines by more than 20 % of their own funds as a result of a sudden and unexpected change in interest rates the size of which shall be prescribed by the competent authorities and shall not differ between credit institutions. Article 125 1. Where a parent undertaking is a parent credit institution in a Member State or an EU parent credit institution, supervision on a consolidated basis shall be exercised by the competent authorities that authorised it under Article 6. 2. Where the parent of a credit institution is a parent financial holding company in a Member State or an EU parent financial holding company, supervision on a consolidated basis shall be exercised by the competent authorities that authorised that credit institution under Article 6. Article 126 1. Where credit institutions authorised in two or more Member States have as their parent the same parent financial holding company in a Member State or the same EU parent financial holding company, supervision on a consolidated basis shall be exercised by the competent authorities of the credit institution authorised in the Member State in which the financial holding company was set up. Where the parents of credit institutions authorised in two or more Member States comprise more than one financial holding company with head offices in different Member States and there is a credit institution in each of these States, supervision on a consolidated basis shall be exercised by the competent authority of the credit institution with the largest balance sheet total. 2. Where more than one credit institution authorised in the Community has as its parent the same financial holding company and none of these credit institutions has been authorised in the Member State in which the financial holding company was set up, supervision on a consolidated basis shall be exercised by the competent authority that authorised the credit institution with the largest balance sheet total, which shall be considered, for the purposes of this Directive, as the credit institution controlled by an EU parent financial holding company. 3. In particular cases, the competent authorities may by common agreement waive the criteria referred to in paragraphs 1 and 2 if their application would be inappropriate, taking into account the credit institutions and the relative importance of their activities in different countries, and appoint a different competent authority to exercise supervision on a consolidated basis. In these cases, before taking their decision, the competent authorities shall give the EU parent credit institution, or EU parent financial holding company, or credit institution with the largest balance sheet total, as appropriate, an opportunity to state its opinion on that decision. 4. The competent authorities shall notify the Commission of any agreement falling within paragraph 3. Article 127 1. Member States shall adopt any measures necessary, where appropriate, to include financial holding companies in consolidated supervision. Without prejudice to Article 135, the consolidation of the financial situation of the financial holding company shall not in any way imply that the competent authorities are required to play a supervisory role in relation to the financial holding company on a stand‐alone basis. 2. When the competent authorities of a Member State do not include a credit institution subsidiary in supervision on a consolidated basis under one of the cases provided for in points (b) and (c) of Article 73(1), the competent authorities of the Member State in which that credit institution subsidiary is situated may ask the parent undertaking for information which may facilitate their supervision of that credit institution. 3. Member States shall provide that their competent authorities responsible for exercising supervision on a consolidated basis may ask the subsidiaries of a credit institution or a financial holding company, which are not included within the scope of supervision on a consolidated basis for the information referred to in Article 137. In such a case, the procedures for transmitting and verifying the information laid down in that Article shall apply. Article 128 Where Member States have more than one competent authority for the prudential supervision of credit institutions and financial institutions, Member States shall take the requisite measures to organise coordination between such authorities. Article 129 1. In addition to the obligations imposed by the provisions of this Directive, the competent authority responsible for the exercise of supervision on a consolidated basis of EU parent credit institutions and credit institutions controlled by EU parent financial holding companies shall carry out the following tasks: (a) coordination of the gathering and dissemination of relevant or essential information in going concern and emergency situations; and (b) planning and coordination of supervisory activities in going concern as well as in emergency situations, including in relation to the activities in Article 124, in cooperation with the competent authorities involved. 2. In the case of applications for the permissions referred to in Articles 84(1), 87(9) and 105 and in Annex III, Part 6, respectively, submitted by an EU parent credit institution and its subsidiaries, or jointly by the subsidiaries of an EU parent financial holding company, the competent authorities shall work together, in full consultation, to decide whether or not to grant the permission sought and to determine the terms and conditions, if any, to which such permission should be subject. An application as referred to in the first subparagraph shall be submitted only to the competent authority referred to in paragraph 1. The competent authorities shall do everything within their power to reach a joint decision on the application within six months. This joint decision shall be set out in a document containing the fully reasoned decision which shall be provided to the applicant by the competent authority referred to in paragraph 1. The period referred to in subparagraph 3 shall begin on the date of receipt of the complete application by the competent authority referred to in paragraph 1. The competent authority referred to in paragraph 1 shall forward the complete application to the other competent authorities without delay. In the absence of a joint decision between the competent authorities within six months, the competent authority referred to in paragraph 1 shall make its own decision on the application. The decision shall be set out in a document containing the fully reasoned decision and shall take into account the views and reservations of the other competent authorities expressed during the six months period. The decision shall be provided to the applicant and the other competent authorities by the competent authority referred to in paragraph 1. The decisions referred to in the third and fifth subparagraphs shall be recognised as determinative and applied by the competent authorities in the Member States concerned. Article 130 1. Where an emergency situation arises within a banking group which potentially jeopardises the stability of the financial system in any of the Member States where entities of a group have been authorised, the competent authority responsible for the exercise of supervision on a consolidated basis shall alert as soon as is practicable, subject to Chapter 1, Section 2, the authorities referred to in Article 49(a) and Article 50. This obligation shall apply to all competent authorities identified under Articles 125 and 126 in relation to a particular group, and to the competent authority identified under Article 129(1). Where possible, the competent authority shall use existing defined channels of communication. 2. The competent authority responsible for supervision on a consolidated basis shall, when it needs information which has already been given to another competent authority, contact this authority whenever possible in order to prevent duplication of reporting to the various authorities involved in supervision. Article 131 In order to facilitate and establish effective supervision, the competent authority responsible for supervision on a consolidated basis and the other competent authorities shall have written coordination and cooperation arrangements in place. Under these arrangements additional tasks may be entrusted to the competent authority responsible for supervision on a consolidated basis and procedures for the decision‐making process and for cooperation with other competent authorities, may be specified. The competent authorities responsible for authorising the subsidiary of a parent undertaking which is a credit institution may, by bilateral agreement, delegate their responsibility for supervision to the competent authorities which authorised and supervise the parent undertaking so that they assume responsibility for supervising the subsidiary in accordance with this Directive. The Commission shall be kept informed of the existence and content of such agreements. It shall forward such information to the competent authorities of the other Member States and to the European Banking Committee. Article 132 1. The competent authorities shall cooperate closely with each other. They shall provide one another with any information which is essential or relevant for the exercise of the other authorities' supervisory tasks under this Directive. In this regard, the competent authorities shall communicate on request all relevant information and shall communicate on their own initiative all essential information. Information referred to in the first subparagraph shall be regarded as essential if it could materially influence the assessment of the financial soundness of a credit institution or financial institution in another Member State. In particular, competent authorities responsible for consolidated supervision of EU parent credit institutions and credit institutions controlled by EU parent financial holding companies shall provide the competent authorities in other Member States who supervise subsidiaries of these parents with all relevant information. In determining the extent of relevant information, the importance of these subsidiaries within the financial system in those Member States shall be taken into account. The essential information referred to in the first subparagraph shall include, in particular, the following items: (a) identification of the group structure of all major credit institutions in a group, as well as of the competent authorities of the credit institutions in the group; (b) procedures for the collection of information from the credit institutions in a group, and the verification of that information; (c) adverse developments in credit institutions or in other entities of a group, which could seriously affect the credit institutions; and (d) major sanctions and exceptional measures taken by competent authorities in accordance with this Directive, including the imposition of an additional capital charge under Article 136 and the imposition of any limitation on the use of the Advanced Measurement Approach for the calculation of the own funds requirements under Article 105. 2. The competent authorities responsible for the supervision of credit institutions controlled by an EU parent credit institution shall whenever possible contact the competent authority referred to in Article 129(1) when they need information regarding the implementation of approaches and methodologies set out in this Directive that may already be available to that competent authority. 3. The competent authorities concerned shall, prior to their decision, consult each other with regard to the following items, where these decisions are of importance for other competent authorities' supervisory tasks: (a) changes in the shareholder, organisational or management structure of credit institutions in a group, which require the approval or authorisation of competent authorities; and (b) major sanctions or exceptional measures taken by competent authorities, including the imposition of an additional capital charge under Article 136 and the imposition of any limitation on the use of the Advances Measurement Approaches for the calculation of the own funds requirements under Article 105. For the purposes of point (b), the competent authority responsible for supervision on a consolidated basis shall always be consulted. However, a competent authority may decide not to consult in cases of urgency or where such consultation may jeopardise the effectiveness of the decisions. In this case, the competent authority shall, without delay, inform the other competent authorities. Article 133 1. The competent authorities responsible for supervision on a consolidated basis shall, for the purposes of supervision, require full consolidation of all the credit institutions and financial institutions which are subsidiaries of a parent undertaking. However, the competent authorities may require only proportional consolidation where, in their opinion, the liability of a parent undertaking holding a share of the capital is limited to that share of the capital in view of the liability of the other shareholders or members whose solvency is satisfactory. The liability of the other shareholders and members shall be clearly established, if necessary by means of formal signed commitments. In the case where undertakings are linked by a relationship within the meaning of Article 12(1) of Directive 83/349/EEC, the competent authorities shall determine how consolidation is to be carried out. 2. The competent authorities responsible for supervision on a consolidated basis shall require the proportional consolidation of participations in credit institutions and financial institutions managed by an undertaking included in the consolidation together with one or more undertakings not included in the consolidation, where those undertakings' liability is limited to the share of the capital they hold. 3. In the case of participations or capital ties other than those referred to in paragraphs 1 and 2, the competent authorities shall determine whether and how consolidation is to be carried out. In particular, they may permit or require use of the equity method. That method shall not, however, constitute inclusion of the undertakings concerned in supervision on a consolidated basis. Article 134 1. Without prejudice to Article 133, the competent authorities shall determine whether and how consolidation is to be carried out in the following cases: (a) where, in the opinion of the competent authorities, a credit institution exercises a significant influence over one or more credit institutions or financial institutions, but without holding a participation or other capital ties in these institutions; and (b) where two or more credit institutions or financial institutions are placed under single management other than pursuant to a contract or clauses of their memoranda or Articles of association. In particular, the competent authorities may permit, or require use of, the method provided for in Article 12 of Directive 83/349/EEC. That method shall not, however, constitute inclusion of the undertakings concerned in consolidated supervision. 2. Where consolidated supervision is required pursuant to Articles 125 and 126, ancillary services undertakings and asset management companies as defined in Directive 2002/87/EC shall be included in consolidations in the cases, and in accordance with the methods, laid down in Article 133 and paragraph 1 of this Article. Article 135 The Member States shall require that persons who effectively direct the business of a financial holding company be of sufficiently good repute and have sufficient experience to perform those duties. Article 136 1. Competent authorities shall require any credit institution that does not meet the requirements of this Directive to take the necessary actions or steps at an early stage to address the situation. For those purposes, the measures available to the competent authorities shall include the following: (a) obliging credit institutions to hold own funds in excess of the minimum level laid down in Article 75; (b) requiring the reinforcement of the arrangements, processes, mechanisms and strategies implemented to comply with Articles 22 and 123; (c) requiring credit institutions to apply a specific provisioning policy or treatment of assets in terms of own funds requirements; (d) restricting or limiting the business, operations or network of credit institutions; and (e) requiring the reduction of the risk inherent in the activities, products and systems of credit institutions. The adoption of these measures shall be subject to Chapter 1, Section 2. 2. A specific own funds requirement in excess of the minimum level laid down in Article 75 shall be imposed by the competent authorities at least on the credit institutions which do not meet the requirements laid down in Articles 22, 109 and 123, or in respect of which a negative determination has been made on the issue described in Article 124, paragraph 3, if the sole application of other measures is unlikely to improve the arrangements, processes, mechanisms and strategies sufficiently within an appropriate timeframe. Article 137 1. Pending further coordination of consolidation methods, Member States shall provide that, where the parent undertaking of one or more credit institutions is a mixed‐activity holding company, the competent authorities responsible for the authorisation and supervision of those credit institutions shall, by approaching the mixed‐activity holding company and its subsidiaries either directly or via credit institution subsidiaries, require them to supply any information which would be relevant for the purpose of supervising the credit institution subsidiaries. 2. Member States shall provide that their competent authorities may carry out, or have carried out by external inspectors, on‐the‐spot inspections to verify information received from mixed‐activity holding companies and their subsidiaries. If the mixed‐activity holding company or one of its subsidiaries is an insurance undertaking, the procedure laid down in Article 140(1) may also be used. If a mixed‐activity holding company or one of its subsidiaries is situated in a Member State other than that in which the credit institution subsidiary is situated, on‐the‐spot verification of information shall be carried out in accordance with the procedure laid down in Article 141. Article 138 1. Without prejudice to Chapter 2, Section 5, Member States shall provide that, where the parent undertaking of one or more credit institutions is a mixed‐activity holding company, the competent authorities responsible for the supervision of these credit institutions shall exercise general supervision over transactions between the credit institution and the mixed‐activity holding company and its subsidiaries. 2. Competent authorities shall require credit institutions to have in place adequate risk management processes and internal control mechanisms, including sound reporting and accounting procedures, in order to identify, measure, monitor and control transactions with their parent mixed‐activity holding company and its subsidiaries appropriately. Competent authorities shall require the reporting by the credit institution of any significant transaction with these entities other than the one referred to in Article 110. These procedures and significant transactions shall be subject to overview by the competent authorities. Where these intra‐group transactions are a threat to a credit institution's financial position, the competent authority responsible for the supervision of the institution shall take appropriate measures. Article 139 1. Member States shall take the necessary steps to ensure that there are no legal impediments preventing the exchange, as between undertakings included within the scope of supervision on a consolidated basis, mixed‐activity holding companies and their subsidiaries, or subsidiaries of the kind covered in Article 127(3), of any information which would be relevant for the purposes of supervision in accordance with Articles 124 to 138 and this Article. 2. Where a parent undertaking and any of its subsidiaries that are credit institutions are situated in different Member States, the competent authorities of each Member State shall communicate to each other all relevant information which may allow or aid the exercise of supervision on a consolidated basis. Where the competent authorities of the Member State in which a parent undertaking is situated do not themselves exercise supervision on a consolidated basis pursuant to Articles 125 and 126, they may be invited by the competent authorities responsible for exercising such supervision to ask the parent undertaking for any information which would be relevant for the purposes of supervision on a consolidated basis and to transmit it to these authorities. 3. Member States shall authorise the exchange between their competent authorities of the information referred to in paragraph 2, on the understanding that, in the case of financial holding companies, financial institutions or ancillary services undertakings, the collection or possession of information shall not in any way imply that the competent authorities are required to play a supervisory role in relation to those institutions or undertakings standing alone. Similarly, Member States shall authorise their competent authorities to exchange the information referred to in Article 137 on the understanding that the collection or possession of information does not in any way imply that the competent authorities play a supervisory role in relation to the mixed‐activity holding company and those of its subsidiaries which are not credit institutions, or to subsidiaries of the kind covered in Article 127(3). Article 140 1. Where a credit institution, financial holding company or a mixed‐activity holding company controls one or more subsidiaries which are insurance companies or other undertakings providing investment services which are subject to authorisation, the competent authorities and the authorities entrusted with the public task of supervising insurance undertakings or those other undertakings providing investment services shall cooperate closely. Without prejudice to their respective responsibilities, those authorities shall provide one another with any information likely to simplify their task and to allow supervision of the activity and overall financial situation of the undertakings they supervise. 2. Information received, in the framework of supervision on a consolidated basis, and in particular any exchange of information between competent authorities which is provided for in this Directive, shall be subject to the obligation of professional secrecy defined in Chapter 1, Section 2. 3. The competent authorities responsible for supervision on a consolidated basis shall establish lists of the financial holding companies referred to in Article 71(2) . Those lists shall be communicated to the competent authorities of the other Member States and to the Commission. Article 141 Where, in applying this Directive, the competent authorities of one Member State wish in specific cases to verify the information concerning a credit institution, a financial holding company, a financial institution, an ancillary services undertaking, a mixed‐activity holding company, a subsidiary of the kind covered in Article 137 or a subsidiary of the kind covered in Article 127(3), situated in another Member State, they shall ask the competent authorities of that other Member State to have that verification carried out. The authorities which receive such a request shall, within the framework of their competence, act upon it either by carrying out the verification themselves, by allowing the authorities who made the request to carry it out, or by allowing an auditor or expert to carry it out.1 The competent authority which made the request may, if it so wishes, participate in the verification when it does not carry out the verification itself. Article 142 Without prejudice to their criminal law provisions, Member States shall ensure that penalties or measures aimed at ending observed breaches or the causes of such breaches may be imposed on financial holding companies and mixed‐activity holding companies, or their effective managers, that infringe laws, regulation or administrative provisions enacted to implement Articles 124 to 141 and this Article. The competent authorities shall cooperate closely to ensure that those penalties or measures produce the desired results, especially when the central administration or main establishment of a financial holding company or of a mixed‐activity holding company is not located at its head office. Article 143 1. Where a credit institution, the parent undertaking of which is a credit institution or a financial holding company, the head office of which is in a third country, is not subject to consolidated supervision under Articles 125 and 126, the competent authorities shall verify whether the credit institution is subject to consolidated supervision by a third‐country competent authority which is equivalent to that governed by the principles laid down in this Directive. The verification shall be carried out by the competent authority which would be responsible for consolidated supervision if paragraph 3 were to apply, at the request of the parent undertaking or of any of the regulated entities authorised in the Community or on its own initiative. That competent authority shall consult the other competent authorities involved. 2. The Commission may request the European Banking Committee to give general guidance as to whether the consolidated supervision arrangements of competent authorities in third countries are likely to achieve the objectives of consolidated supervision as defined in this Chapter, in relation to credit institutions, the parent undertaking of which has its head office in a third country . The Committee shall keep any such guidance under review and take into account any changes to the consolidated supervision arrangements applied by such competent authorities. The competent authority carrying out the verification specified in the first subparagraph of paragraph 1 shall take into account any such guidance. For this purpose the competent authority shall consult the Committee before taking a decision. 3. In the absence of such equivalent supervision, Member States shall apply the provisions of this Directive to the credit institution by analogy or shall allow their competent authorities to apply other appropriate supervisory techniques which achieve the objectives of supervision on a consolidated basis of credit institutions. Those supervisory techniques shall, after consultation with the other competent authorities involved, be agreed upon by the competent authority which would be responsible for consolidated supervision. Competent authorities may in particular require the establishment of a financial holding company which has its head office in the Community, and apply the provisions on consolidated supervision to the consolidated position of that financial holding company. The supervisory techniques shall be designed to achieve the objectives of consolidated supervision as defined in this Chapter and shall be notified to the other competent authorities involved and the Commission. Section 2 Disclosure by competent authorities Article 144 Competent authorities shall disclose the following information: (a) the texts of laws, regulations, administrative rules and general guidance adopted in their Member State in the field of prudential regulation; (b) the manner of exercise of the options and discretions available in Community legislation; (c) the general criteria and methodologies they use in the review and evaluation referred to in Article 124; and (d) without prejudice to the provisions laid down in Chapter 1, Section 2, aggregate statistical data on key aspects of the implementation of the prudential framework in each Member State. The disclosures provided for in the first subparagraph shall be sufficient to enable a meaningful comparison of the approaches adopted by the competent authorities of the different Member States. The disclosures shall be published with a common format, and updated regularly. The disclosures shall be accessible at a single electronic location. CHAPTER 5 Disclosure by credit institutions Article 145 1. For the purposes of this Directive, credit institutions shall publicly disclose the information laid down in Annex XII, Part 2, subject to the provisions laid down in Article 146. 2. Recognition by the competent authorities under Chapter 2, Section 3, Subsections 2 and 3 and Article 105 of the instruments and methodologies referred to in Annex XII, Part 3 shall be subject to the public disclosure by credit institutions of the information laid down therein. 3. Credit institutions shall adopt a formal policy to comply with the disclosure requirements laid down in paragraphs 1 and 2, and have policies for assessing the appropriateness of their disclosures, including their verification and frequency. 4. Credit institutions should, if requested, explain their rating decisions to SMEs and other corporate applicants for loans, providing an explanation in writing when asked. Should a voluntary undertaking by the sector in this regard prove inadequate, national measures shall be adopted. The administrative costs of the explanation have to be at an appropriate rate to the size of the loan. Article 146 1. Notwithstanding Article 145, credit institutions may omit one or more of the disclosures listed in Annex XII, Part 2 if the information provided by such disclosures is not, in the light of the criterion specified in Annex XII, Part 1, point 1, regarded as material. 2. Notwithstanding Article 145, credit institutions may omit one or more items of information included in the disclosures listed in Annex XII, Parts 2 and 3 if those items include information which, in the light of the criteria specified in Annex XII, Part 1, points 2 and 3, is regarded as proprietary or confidential. 3. In the exceptional cases referred to in paragraph 2, the credit institution concerned shall state in its disclosures the fact that the specific items of information are not disclosed, the reason for non‐disclosure, and publish more general information about the subject matter of the disclosure requirement, except where these are to be classified as proprietary or confidential under the criteria set out in Annex XII, Part 1, points 2 and 3. Article 147 1. Credit institutions shall publish the disclosures required under Article 145 on an annual basis at a minimum. Disclosures shall be published as soon as practicable. 2. Credit institutions shall also determine whether more frequent publication than is provided for in paragraph 1 is necessary in the light of the criteria set out in Annex XII, Part 1, point 4. Article 148 1. Credit institutions may determine the appropriate medium, location and means of verification to comply effectively with the disclosure requirements laid down in Article 145. To the degree feasible, all disclosures shall be provided in one medium or location. 2. Equivalent disclosures made by credit institutions under accounting, listing or other requirements may be deemed to constitute compliance with Article 145. If disclosures are not included in the financial statements, credit institutions shall indicate where they can be found. Article 149 Notwithstanding Articles 146 to 148, Member States shall empower the competent authorities to require credit institutions: (a) to make one or more of the disclosures referred to in Annex XII, Parts 2 and 3; (b) to publish one or more disclosures more frequently than annually, and to set deadlines for publication; (c) to use specific media and locations for disclosures other than the financial statements; and (d) to use specific means of verification for the disclosures not covered by statutory audit. TITLE VI POWERS OF EXECUTION Article 150 1. Without prejudice, regarding own funds, to the proposal that the Commission is to submit pursuant to Article 62, the technical adjustments in the following areas shall be adopted in accordance with the procedure referred to in Article 151(2): (a) clarification of the definitions in order to take account, in the application of this Directive, of developments on financial markets; (b) clarification of the definitions to ensure uniform application of this Directive; (c) the alignment of terminology on, and the framing of definitions in accordance with, subsequent acts on credit institutions and related matters; (d) technical adjustments to the list in Article 2; (e) alteration of the amount of initial capital prescribed in Article 9 to take account of developments in the economic and monetary field; (f) expansion of the content of the list referred to in Articles 23 and 24 and set out in Annex I or adaptation of the terminology used in that list to take account of developments on financial markets; (g) the areas in which the competent authorities shall exchange information as listed in Article 42; (h) technical adjustments in Articles 56 to 67 and in Article 74 as a result of developments in accounting standards or requirements which take account of Community legislation or with regard to convergence of supervisory practices; (i) amendment of the list of exposure classes in Articles 79 and 86 in order to take account of developments on financial markets; (j) the amount specified in Article 79(2)(c), Article 86(4)(a), Annex VII, Part 1, point 5 and Annex VII, Part 2, point 15 to take into account the effects of inflation; (k) the list and classification of off‐balance‐sheet items in Annexes II and IV and their treatment in the determination of exposure values for the purposes of Title V, Chapter 2, Section 3; or (l) adjustment of the provisions in Annexes V to XII in order to take account of developments on financial markets (in particular new financial products) or in accounting standards or requirements which take account of Community legislation, or with regard to convergence of supervisory practice. 2. The Commission may adopt the following implementing measures in accordance with the procedure referred to in Article 151(2): (a) specification of the size of sudden and unexpected changes in the interest rates referred to in Article 124(5); (b) a temporary reduction in the minimum level of own funds laid down in Article 75 and/or the risk weights laid down in Title V, Chapter 2, Section 3 in order to take account of specific circumstances; (c) without prejudice to the report referred to in Article 119, clarification of exemptions provided for in Articles 111(4), 113, 115 and 116; (d) specification of the key aspects on which aggregate statistical data are to be disclosed under Article 144(1)(d); or (e) specification of the format, structure, contents list and annual publication date of the disclosures provided for in Article 144. 3. None of the implementing measures enacted may change the essential provisions of this Directive. 4. Without prejudice to the implementing measures already adopted, upon expiry of a two‐year period following the adoption of this Directive, and by 1 April 2008 at the latest, the application of the provisions of this Directive requiring the adoption of technical rules, amendments and decisions in accordance with paragraph 2 shall be suspended. Acting on a proposal from the Commission and in accordance with the procedure laid down in Article 251 of the Treaty, the Parliament and the Council may renew those provisions and, to that end, shall review them prior to the expiry of the period or by the date referred to in this paragraph, whichever the earlier. Article 151 1. The Commission shall be assisted by the European Banking Committee established by Commission Decision 2004/10/EC (22). 2. Where reference is made to this paragraph, the procedure laid down in Article 5 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 7(3) and Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months. 3. The Committee shall adopt its Rules of Procedure. TITLE VII TRANSITIONAL AND FINAL PROVISIONS CHAPTER 1 Transitional provisions Article 152 1. Credit institutions calculating risk‐weighted exposure amounts in accordance with Articles 84 to 89 shall during the first, second and third twelve‐month periods after 31 December 2006 provide own funds which are at all times more than or equal to the amounts indicated in paragraphs 3, 4 and 5. 2. Credit institutions using the Advanced Measurement Approaches as specified in Article 105 for the calculation of their capital requirements for operational risk shall, during the second and third twelve‐month periods after 31 December 2006, provide own funds which are at all times more than or equal to the amounts indicated in paragraphs 4 and 5. 3. For the first twelve‐month period referred to in paragraph 1, the amount of own funds shall be 95 % of the total minimum amount of own funds that would be required to be held during that period by the credit institution under Article 4 of Council Directive 93/6/EEC of 15 March 1993 on the capital adequacy of investment firms and credit institutions (23) as that Directive and Directive 2000/12/EC stood prior to 1 January 2007. 4. For the second twelve‐month period referred to in paragraph 1, the amount of own funds shall be 90 % of the total minimum amount of own funds that would be required to be held during that period by the credit institution under Article 4 of Directive 93/6/EEC as that Directive and Directive 2000/12/EC stood prior to 1 January 2007. 5. For the third twelve‐month period referred to in paragraph 1, the amount of own funds shall be 80 % of the total minimum amount of own funds that would be required to be held during that period by the credit institution under Article 4 of Directive 93/6/EEC as that Directive and Directive 2000/12/EC stood prior .to 1 January 2007. 6. Compliance with the requirements of paragraphs 1 to 5 shall be on the basis of amounts of own funds fully adjusted to reflect differences in the calculation of own funds under Directive 2000/12/EC and Directive 93/6/EEC as those Directives stood prior to 1 January 2007 and the calculation of own funds under this Directive deriving from the separate treatments of expected loss and unexpected loss under Articles 84 to 89 of this Directive. 7. For the purposes of paragraphs 1 to 6 of this Article, Articles 68 to 73 shall apply. 8. Until 1 January 2008 credit institutions may treat the Articles constituting the Standardised Approach set out in Title V, Chapter 2, Section 3, Subsection 1 as being replaced by Articles 42 to 46 of Directive 2000/12/EC as those Articles stood prior to 1 January 2007. 9. Where the discretion referred to in paragraph 8 is exercised, the following shall apply concerning the provisions of Directive 2000/12/EC: (a) the provisions of that Directive referred to in Articles 42 to 46 shall apply as they stood prior to 1 January 2007; (b) ‘risk‐adjusted value’ as referred to in Article 42(1) of that Directive shall mean ‘risk‐weighted exposure amount’; (c) the figures produced by Article 42(2) of that Directive shall be considered risk‐weighted exposure amounts; (d) ‘credit derivatives’ shall be included in the list of ‘Full risk’ items in Annex II of that Directive; and (e) the treatment set out in Article 43(3) of that Directive shall apply to derivative instruments listed in Annex IV of that Directive whether on‐ or off‐balance sheet and the figures produced by the treatment set out in Annex III shall be considered risk‐weighted exposure amounts. 10. Where the discretion referred to in paragraph 8 is exercised, the following shall apply in relation to the treatment of exposures for which the Standardised Approach is used: (a) Title V, Chapter 2, Section 3, Subsection 3 relating to the recognition of credit risk mitigation shall not apply; (b) Title V, Chapter 2, Section 3, Subsection 4 concerning the treatment of securitisation may be disapplied by competent authorities. 11. Where the discretion referred to in paragraph 8 is exercised, the capital requirement for operational risk under Article 75(d) shall be reduced by the percentage representing the ratio of the value of the credit institution's exposures for which risk‐weighted exposure amounts are calculated in accordance with the discretion referred to in paragraph 8 to the total value of its exposures. 12. Where a credit institution calculates risk‐weighted exposure amounts for all of its exposures in accordance with the discretion referred to in paragraph 8, Articles 48 to 50 of Directive 2000/12/EC relating to large exposures may apply as they stood prior to 1 January 2007. 13. Where the discretion referred to in paragraph 8 is exercised, references to Articles 78 to 83 of this Directive shall be read as references to Articles 42 to 46 of Directive 2000/12/EC as those Articles stood prior to 1 January 2007. 14. If the discretion referred to in paragraph 8 is exercised, Articles 123, 124, 145 and 149 shall not apply before the date referred to therein. Article 153 In the calculation of risk‐weighted exposure amounts for exposures arising from property leasing transactions concerning offices or other commercial premises situated in their territory and meeting the criteria set out in Annex VI, Part 1, point 54, the competent authorities may, until 31 December 2012 allow a 50 % risk weight to be assigned without the application of Annex VI, Part 1, points 55 and 56. Until 31 December 2010, competent authorities may, for the purpose of defining the secured portion of a past due loan for the purposes of Annex VI, recognise collateral other than eligible collateral as set out under Articles 90 to 93. In the calculation of risk weighted exposure amounts for the purposes of Annex VI, Part 1, point 4, until 31 December 2012 the same risk weight shall be assigned in relation to exposures to Member States' central governments or central banks denominated and funded in the domestic currency of any Member State as would be applied to such exposures denominated and funded in their domestic currency. Article 154 1. Until 31 December 2011, the competent authorities of each Member State may, for the purposes of Annex VI, Part 1, point 61, set the number of days past due up to a figure of 180 for exposures indicated in Annex VI, Part 1, points 12 to 17 and 41 to 43, to counterparties situated in their territory, if local conditions make it appropriate. The specific number may differ across product lines. Competent authorities which do not exercise the discretion provided for in the first subparagraph in relation to exposures to counterparties situated in their territory may set a higher number of days for exposures to counterparties situated in the territories of other Member States, the competent authorities of which have exercised that discretion. The specific number shall fall within 90 days and such figures as the other competent authorities have set for exposures to such counterparties within their territory. 2. For credit institutions applying for the use of the IRB Approach before 2010, subject to the approval of the competent authorities, the three‐years' use requirement prescribed in Article 84(3) may be reduced to a period no shorter than one year until 31 December 2009. 3. For credit institutions applying for the use of own estimates of LGDs and/or conversion factors, the three year use requirement prescribed in Article 84(4) may be reduced to two years until 31 December 2008. 4. Until 31 December 2012, the competent authorities of each Member State may allow credit institutions to continue to apply to participations of the type set out in Article 57(o) acquired before 20 July 2006 the treatment set out in Article 38 of Directive 2000/12/EC as that article stood prior to 1 January 2007. 5. Until 31 December 2010 the exposure weighted average LGD for all retail exposures secured by residential properties and not benefiting from guarantees from central governments shall not be lower than 10 %. 6. Until 31 December 2017, the competent authorities of the Member States may exempt from the IRB treatment certain equity exposures held by credit institutions and EU subsidiaries of credit institutions in that Member State at 31 December 2007. The exempted position shall be measured as the number of shares as of 31 December 2007 and any additional share arising directly as a result of owning those holdings, as long as they do not increase the proportional share of ownership in a portfolio company. If an acquisition increases the proportional share of ownership in a specific holding the exceeding Part of the holding shall not be subject to the exemption. Nor shall the exemption apply to holdings that were originally subject to the exemption, but have been sold and then bought back. Equity exposures covered by this transitional provision shall be subject to the capital requirements calculated in accordance with Title V, Chapter 2, Section 3, Subsection 1. 7. Until 31 December 2011, for corporate exposures, the competent authorities of each Member State may set the number of days past due that all credit institutions in its jurisdiction shall abide by under the definition of ‘default’ set out in Annex VII, Part 4, point 44 for exposures to such counterparts situated within this Member State. The specific number shall fall within 90‐ up to a figure of 180 days if local conditions make it appropriate. For exposures to such counterparts situated in the territories of other Member States, the competent authorities shall set a number of days past due which is not higher than the number set by the competent authority of the respective Member State. Article 155 Until 31 December 2012, for credit institutions the relevant indicator for the trading and sales business line of which represents at least 50 % of the total of the relevant indicators for all of its business lines accordance with Annex X, Part 2, points 1 to 4, Member States may apply a percentage of 15 % to the business line ‘trading and sales’. CHAPTER 2 Final provisions Article 156 The Commission, in cooperation with Member States, and taking into account the contribution of the European Central Bank, shall periodically monitor whether this Directive taken as a whole, together with Directive 2006/49/EC, has significant effects on the economic cycle and, in the light of that examination, shall consider whether any remedial measures are justified. Based on that analysis and taking into account the contribution of the European Central Bank, the Commission shall draw up a biennial report and submit it to the European Parliament and to the Council, together with any appropriate proposals. Contributions from credit taking and credit lending parties shall be adequately acknowledged when the report is drawn up. By 1 January 2012 the Commission shall, review and report on the application of this Directive with particular attention to all aspects of Articles 68 to 73, 80(7), 80(8) and 129, and shall submit this report to the Parliament and the Council together with any appropriate proposals. Article 157 1. By 31 December 2006 Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with Articles 4, 22, 57, 61 to 64, 66, 68 to 106, 108, 110 to 115, 117 to 119, 123 to 127, 129 to 132, 133, 136, 144 to 149 and 152 to 155, and Annexes II, III and V to XII. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. Notwithstanding paragraph 3, Member States shall apply those provisions from 1 January 2007. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the directives repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. 3. Member States shall apply, from 1 January 2008, and no earlier, the laws regulations and administrative provisions necessary to comply with Articles 87(9) and 105. Article 158 1. Directive 2000/12/EC as amended by the Directives set out in Annex XIII, Part A, is hereby repealed without prejudice to the obligations of the Member States concerning the deadlines for transposition of the said Directives listed in Annex XIII, Part B. 2. References to the repealed Directives shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex XIV. Article 159 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 160 This Directive is addressed to the Member States.

32006L0046

2006

DIRECTIVE 2006/46/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 June 2006 amending Council Directives 78/660/EEC on the annual accounts of certain types of companies, 83/349/EEC on consolidated accounts, 86/635/EEC on the annual accounts and consolidated accounts of banks and other financial institutions and 91/674/EEC on the annual accounts and consolidated accounts of insurance undertakings (Text with EEA relevance) Having regard to the Treaty establishing the European Community, and in particular Article 44(1) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) On 21 May 2003, the Commission adopted an Action Plan announcing measures to modernise company law and enhance corporate governance in the Community. As a short-term priority, the Community was to confirm the collective responsibility of board members, increase transparency in transactions with related parties and off-balance-sheet arrangements and improve disclosure about corporate governance practices applied in a company. (2) Pursuant to that Action Plan, members of the administrative, management and supervisory bodies of a company were, as a minimum requirement, to be collectively responsible towards the company for drawing up and publishing annual accounts and annual reports. The same approach was also to apply to members of the administrative, management and supervisory bodies of undertakings drawing up consolidated accounts. Those bodies act within the competences assigned to them by national law. This should not prevent Member States from going further and providing for direct responsibility towards shareholders or even other stakeholders. On the other hand, Member States were to refrain from opting for a system of responsibility limited to individual board members. However, this should not preclude the ability of courts or other enforcement bodies in the Member States to impose penalties on an individual board member. (3) Liability for drawing up and publishing annual accounts and consolidated accounts as well as annual reports and consolidated annual reports is based on national law. Appropriate liability rules, as laid down by each Member State under its national law or regulations, should be applicable to members of the administrative, management and supervisory bodies. Member States should remain free to determine the extent of the liability. (4) In order to promote credible financial reporting processes across the European Union, members of the company body that is responsible for the preparation of the company's financial reports should have the duty to ensure that the financial information included in a company's annual accounts and annual reports gives a true and fair view. (5) On 27 September 2004 the Commission adopted a Communication on preventing and combating financial and corporate malpractice outlining ‘inter alia’ the Commission policy initiatives regarding internal control in companies and responsibility of board members. (6) At present Fourth Council Directive 78/660/EEC (3) and Seventh Council Directive 83/349/EEC (4) only provide for disclosure of transactions between a company and the company's affiliated undertakings. With the objective of bringing companies whose securities are not admitted to trading on a regulated market closer to companies applying the international accounting standards for their consolidated accounts, disclosure should be extended to cover other types of related parties, such as key management members and spouses of board members, but only where such transactions are material and not carried out at arm's length. Disclosure of material transactions with related parties that are not carried out under normal market conditions can assist users of annual accounts to assess the financial position of the company as well as, when the company belongs to a group, the financial situation of the group as a whole. Intra-group related party transactions should be eliminated in the preparation of consolidated financial statements. (7) Definitions of a related party as set out in the international accounting standards adopted by the Commission in accordance with Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (5) should apply to Directives 78/660/EEC and 83/349/EEC. (8) Off-balance-sheet arrangements may expose a company to risks and benefits which are material for an assessment of the financial position of the company and, when the company belongs to a group, the financial position of the group as a whole. (9) Such off-balance-sheet arrangements could be any transactions or agreements which companies may have with entities, even unincorporated ones, that are not included in the balance sheet. Such off-balance-sheet arrangements may be associated with the creation or use of one or more Special Purpose Entities (SPEs) and offshore activities designed to address, inter alia, economic, legal, tax or accounting objectives. Examples of such off-balance-sheet arrangements include risk and benefit-sharing arrangements or obligations arising from a contract such as debt factoring, combined sale and repurchase agreements, consignment stock arrangements, take or pay arrangements, securitisation arranged through separate companies and unincorporated entities, pledged assets, operating leasing arrangements, outsourcing and the like. Appropriate disclosure of the material risks and benefits of such arrangements that are not included in the balance sheet should be set out in the notes to the accounts or the consolidated accounts. (10) Companies whose securities are admitted to trading on a regulated market and which have their registered office in the Community should be obliged to disclose an annual corporate governance statement as a specific and clearly identifiable section of the annual report. That statement should at least provide shareholders with easily accessible key information about the corporate governance practices actually applied, including a description of the main features of any existing risk management systems and internal controls in relation to the financial reporting process. The corporate governance statement should make clear whether the company applies any provisions on corporate governance other than those provided for in national law, regardless of whether those provisions are directly laid down in a corporate governance code to which the company is subject or in any corporate governance code which the company may have decided to apply. Furthermore, where relevant, companies may also provide an analysis of environmental and social aspects necessary for an understanding of the company's development, performance and position. There is no need to impose the requirement of a separate corporate governance statement on undertakings drawing up a consolidated annual report. However, the information concerning the group's risk management system and internal control system should be presented. (11) The various measures adopted under this Directive should not necessarily apply to the same types of companies or undertakings. Member States should be able to exempt small companies, as described in Article 11 of Directive 78/660/EEC, from the requirements concerning related parties and off-balance-sheet arrangements under this Directive. Companies which already disclose information about transactions with related parties in their accounts pursuant to international accounting standards as adopted in the European Union should not be required to disclose further information under this Directive, as the application of the international accounting standards already results in a true and fair view of such a company. The provisions of this Directive concerning the corporate governance statement should apply to all companies, including banks, insurance and reinsurance undertakings and companies which have issued securities other than shares admitted to trading on a regulated market insofar as they are not exempted by Member States. The provisions of this Directive concerning duties and liabilities of board members as well as penalties should apply to all companies to which Council Directives 78/660/EEC, 86/635/EEC (6) and 91/674/EEC (7) apply and to all undertakings which draw up consolidated accounts in accordance with Directive 83/349/EEC. (12) At present Directive 78/660/EEC makes provision for examination every five years of, inter alia, the maximum thresholds for balance sheet and net turnover which Member States may apply in determining which companies may be exempted from certain disclosure requirements. In addition to those five-yearly examinations, an additional one-off increase in those balance sheet and net turnover thresholds may also be appropriate. There is no obligation on Member States to make use of those increased thresholds. (13) Since the objectives of this Directive, namely facilitating cross-border investments and improving EU-wide comparability and public confidence in financial statements and reports through enhanced and consistent specific disclosures, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and the effects of this Directive, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives. (14) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of the Fundamental Rights of the European Union. (15) In accordance with paragraph 34 of the Interinstitutional agreement on better law-making (8), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public. (16) Directives 78/660/EEC, 83/349/EEC, 86/635/EEC and 91/674/EEC should therefore be amended accordingly, Article 1 Amendments to Directive 78/660/EEC Directive 78/660/EEC is hereby amended as follows: 1. in Article 11, the first paragraph shall be amended as follows: (a) in the first indent the words ‘balance sheet total: EUR 3 650 000’ shall be replaced by the words ‘balance sheet total: EUR 4 400 000’; (b) in the second indent the words ‘net turnover: EUR 7 300 000’ shall be replaced by the words ‘net turnover: EUR 8 800 000’; 2. in Article 11, third paragraph, the words ‘the Directive setting those amounts in consequence of the review provided for in Article 53(2)’ shall be replaced by ‘any Directive setting those amounts’; 3. in Article 27, the first paragraph shall be amended as follows: (a) in the first indent the words ‘balance sheet total: EUR 14 600 000’ shall be replaced by the words ‘balance sheet total: EUR 17 500 000’; (b) in the second indent the words ‘net turnover: EUR 29 200 000’ shall be replaced by the words ‘net turnover: EUR 35 000 000’; 4. in Article 27, third paragraph, the words ‘the Directive setting those amounts in consequence of the review provided for in Article 53(2)’ shall be replaced by ‘any Directive setting those amounts’; 5. in Article 42a, the following paragraph shall be added: ‘(5a) By way of derogation from the provisions of paragraphs 3 and 4, Member States may, in accordance with international accounting standards as adopted by Commission Regulation (EC) No 1725/2003 of 29 September 2003 adopting certain international accounting standards in accordance with Regulation (EC) No 1606/2002 of the European Parliament and of the Council (9), as amended until 5 September 2006, permit or require valuation of financial instruments, together with the associated disclosure requirements which are provided for in international accounting standards adopted in accordance with Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (10). 6. in Article 43(1), the following points shall be inserted: ‘(7a) the nature and business purpose of the company's arrangements that are not included in the balance sheet and the financial impact on the company of those arrangements, provided that the risks or benefits arising from such arrangements are material and in so far as the disclosure of such risks or benefits is necessary for assessing the financial position of the company. Member States may permit the companies referred to in Article 27 to limit the information required to be disclosed by this point to the nature and business purpose of such arrangements; (7b) transactions which have been entered into with related parties by the company, including the amount of such transactions, the nature of the related party relationship and other information about the transactions necessary for an understanding of the financial position of the company, if such transactions are material and have not been concluded under normal market conditions. Information about individual transactions may be aggregated according to their nature except where separate information is necessary for an understanding of the effects of related party transactions on the financial position of the company. Member States may permit the companies referred to in Article 27 to omit the disclosures prescribed in this point unless those companies are of a type referred to in Article 1(1) of Directive 77/91/EEC, in which case Member States may limit disclosure to, as a minimum, transactions entered into directly or indirectly between: (i) the company and its major shareholders, and (ii) the company and the members of the administrative, management and supervisory bodies. Member States may exempt transactions entered into between two or more members of a group provided that subsidiaries which are party to the transaction are wholly owned by such a member. “Related party” has the same meaning as in international accounting standards adopted in accordance with Regulation (EC) No 1606/2002.’ 7. the following Article shall be inserted: ‘Article 46a 1. A company whose securities are admitted to trading on a regulated market within the meaning of Article 4(1), point (14) of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (11) shall include a corporate governance statement in its annual report. That statement shall be included as a specific section of the annual report and shall contain at least the following information: (a) a reference to: (i) the corporate governance code to which the company is subject, and/or (ii) the corporate governance code which the company may have voluntarily decided to apply, and/or (iii) all relevant information about the corporate governance practices applied beyond the requirements under national law. Where points (i) and (ii) apply, the company shall also indicate where the relevant texts are publicly available; where point (iii) applies, the company shall make its corporate governance practices publicly available; (b) to the extent to which a company, in accordance with national law, departs from a corporate governance code referred to under points (a)(i) or (ii), an explanation by the company as to which parts of the corporate governance code it departs from and the reasons for doing so. Where the company has decided not to apply any provisions of a corporate governance code referred to under points (a)(i) or (ii), it shall explain its reasons for doing so; (c) a description of the main features of the company's internal control and risk management systems in relation to the financial reporting process; (d) the information required by Article 10(1), points (c), (d), (f), (h) and (i) of Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids (12), where the company is subject to that Directive; (e) unless the information is already fully provided for in national laws or regulations, the operation of the shareholder meeting and its key powers, and a description of shareholders’ rights and how they can be exercised; (f) the composition and operation of the administrative, management and supervisory bodies and their committees. 2. Member States may permit the information required by this Article to be set out in a separate report published together with the annual report in the manner set out in Article 47 or by means of a reference in the annual report where such document is publicly available on the company's website. In the event of a separate report, the corporate governance statement may contain a reference to the annual report where the information required in paragraph 1, point (d) is made available. Article 51(1), second subparagraph shall apply to the provisions of paragraph 1, points (c) and (d) of this Article. For the remaining information, the statutory auditor shall check that the corporate governance statement has been produced. 3. Member States may exempt companies which have only issued securities other than shares admitted to trading on a regulated market, within the meaning of Article 4(1), point (14) of Directive 2004/39/EC, from the application of the provisions of paragraph 1, points (a), (b), (e) and (f), unless such companies have issued shares which are traded in a multilateral trading facility, within the meaning of Article 4(1), point (15) of Directive 2004/39/EC. 8. the following Section shall be inserted: ‘SECTION 10A Duty and liability for drawing up and publishing the annual accounts and the annual report Article 50b Member States shall ensure that the members of the administrative, management and supervisory bodies of the company have collectively the duty to ensure that the annual accounts, the annual report and, when provided separately, the corporate governance statement to be provided pursuant to Article 46a are drawn up and published in accordance with the requirements of this Directive and, where applicable, in accordance with the international accounting standards adopted in accordance with Regulation (EC) No 1606/2002. Such bodies shall act within the competences assigned to them by national law. Article 50c Member States shall ensure that their laws, regulations and administrative provisions on liability apply to the members of the administrative, management and supervisory bodies referred to in Article 50b, at least towards the company, for breach of the duty referred to in Article 50b.’ 9. Article 53a shall be replaced by the following: ‘Article 53a Member States shall not make available the exemptions set out in Articles 11, 27, 43(1), points (7a) and (7b), 46, 47 and 51 in the case of companies whose securities are admitted to trading on a regulated market within the meaning of Article 4(1), point (14) of Directive 2004/39/EC.’ 10. the following Article shall be inserted: ‘Article 60a Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.’ 11. Article 61a shall be replaced by the following: ‘Article 61a Not later than 1 July 2007, the Commission shall review the provisions in Articles 42a to 42f, Article 43(1)(10) and (14), Article 44(1), Article 46(2)(f) and Article 59(2)(a) and (b) in the light of the experience acquired in applying provisions on fair value accounting, with particular regard to IAS 39 as endorsed in accordance with Regulation (EC) No 1606/2002, and taking account of international developments in the field of accounting and, if appropriate, submit a proposal to the European Parliament and the Council with a view to amending the abovementioned Articles.’ Article 2 Amendments to Directive 83/349/EEC Directive 83/349/EEC is hereby amended as follows: 1. In Article 34, the following points shall be inserted: ‘(7a) The nature and business purpose of any arrangements that are not included in the consolidated balance sheet, and the financial impact of those arrangements, provided that the risks or benefits arising from such arrangements are material and in so far as the disclosure of such risks or benefits is necessary for assessing the financial position of the undertakings included in the consolidation taken as a whole. (7b) The transactions, save for intra-group transactions, entered into by the parent undertaking, or by other undertakings included in the consolidation, with related parties, including the amounts of such transactions, the nature of the related party relationship as well as other information about the transactions necessary for an understanding of the financial position of the undertakings included in the consolidation taken as a whole, if such transactions are material and have not been concluded under normal market conditions. Information about individual transactions may be aggregated according to their nature except where separate information is necessary for an understanding of the effects of the related party transactions on the financial position of the undertakings included in the consolidation taken as a whole.’ 2. In Article 36(2), the following point shall be added: ‘(f) a description of the main features of the group's internal control and risk management systems in relation to the process for preparing consolidated accounts, where an undertaking has its securities admitted to trading on a regulated market within the meaning of Article 4(1), point (14) of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (13). In the event that the consolidated annual report and the annual report are presented as a single report, this information must be included in the section of the report containing the corporate governance statement as provided for by Article 46a of Directive 78/660/EEC. If a Member State permits the information required by paragraph 1 of Article 46a of Directive 78/660/EEC to be set out in a separate report published together with the annual report in the manner prescribed by Article 47 of that Directive, the information provided under the first subparagraph shall also form part of that separate report. Article 37(1), second subparagraph of this Directive shall apply. 3. The following Section shall be inserted: ‘SECTION 3A Duty and liability for drawing up and publishing the consolidated accounts and the consolidated annual report Article 36a Member States shall ensure that the members of the administrative, management and supervisory bodies of undertakings drawing up the consolidated accounts and the consolidated annual report have collectively the duty to ensure that the consolidated accounts, the consolidated annual report and, when provided separately, the corporate governance statement to be provided pursuant to Article 46a of Directive 78/660/EEC are drawn up and published in accordance with the requirements of this Directive and, where applicable, in accordance with the international accounting standards adopted in accordance with Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (14). Such bodies shall act within the competences assigned to them by national law. Article 36b Member States shall ensure that their laws, regulations and administrative provisions on liability apply to the members of the administrative, management and supervisory bodies referred to in Article 36a, at least towards the undertaking drawing up the consolidated accounts, for breach of the duty referred to in Article 36a. 4. In Article 41, the following paragraph shall be inserted: ‘1a. “Related party” has the same meaning as in international accounting standards adopted in accordance with Regulation (EC) No 1606/2002.’ 5. the following Article shall be inserted: ‘Article 48 Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.’ Article 3 Amendment to Directive 86/635/EEC The first sentence of Article 1(1) of Directive 86/635/EEC shall be replaced by the following: ‘Articles 2, 3, 4(1), (3) to (6), Articles 6, 7, 13, 14, 15(3) and (4), Articles 16 to 21, 29 to 35, 37 to 41, 42 first sentence, 42a to 42f, 45(1), 46(1) and (2), 46a, Articles 48 to 50, 50a, 50b, 50c, 51(1) and 51a, 56 to 59, 60a, 61 and 61a of Directive 78/660/EEC shall apply to the institutions mentioned in Article 2 of this Directive, except where this Directive provides otherwise.’ Article 4 Amendment to Directive 91/674/EEC The first sentence of Article 1(1) of Directive 91/674/EEC shall be replaced by the following: ‘Articles 2, 3, 4(1), (3) to (6), Articles 6, 7, 13, 14, 15(3) and (4), Articles 16 to 21, 29 to 35, 37 to 41, 42, 42a to 42f, 43 (1), points 1 to 7b and 9 to 14, 45(1), 46(1) and (2), 46a, 48 to 50, 50a, 50b, 50c, 51(1), 51a, 56 to 59, 60a, 61 and 61a of Directive 78/660/EEC shall apply to the undertakings mentioned in Article 2 of this Directive, except where this Directive provides otherwise.’ Article 5 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 5 September 2008 at the latest. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 6 Entry into force This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 7 Addressees This Directive is addressed to the Member States.

32006L0049

2006

DIRECTIVE 2006/49/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 June 2006 on the capital adequacy of investment firms and credit institutions (recast) Having regard to the Treaty establishing the European Community, and in particular Article 47(2) thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Economic and Social Committee (1), Having regard to the Opinion of the European Central Bank (2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) Council Directive 93/6/EEC of 15 March 1993 on the capital adequacy of investment firms and credit institutions (4) has been significantly amended on several occasions. Now that new amendments are being made to the said Directive, it is desirable, in order to clarify matters, that it should be recast. (2) One of the objectives of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (5) is to allow investment firms authorised by the competent authorities of their home Member State and supervised by the same authorities to establish branches and provide services freely in other Member States. That Directive accordingly provides for the coordination of the rules governing the authorisation and pursuit of the business of investment firms. (3) Directive 2004/39/EC does not, however, establish common standards for the own funds of investment firms nor indeed does it establish the amounts of the initial capital of such firms or a common framework for monitoring the risks incurred by them. (4) It is appropriate to effect only the essential harmonisation that is necessary and sufficient to secure the mutual recognition of authorisation and of prudential supervision systems; in order to achieve mutual recognition within the framework of the internal financial market, measures should be laid down to coordinate the definition of the own funds of investment firms, the establishment of the amounts of their initial capital and the establishment of a common framework for monitoring the risks incurred by investment firms. (5) Since the objectives of this Directive, namely the establishment of the capital adequacy requirements applying to investment firms and credit institutions, the rules for their calculation and the rules for their prudential supervision, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and the effects of the proposed action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve its objectives. (6) It is appropriate to establish different amounts of initial capital depending on the range of activities that investment firms are authorised to undertake. (7) Existing investment firms should be permitted, under certain conditions, to continue their business even if they do not comply with the minimum amount of initial capital fixed for new investment firms. (8) Member States should be able to establish rules stricter than those provided for in this Directive. (9) The smooth operation of the internal market requires not only legal rules but also close and regular cooperation and significantly enhanced convergence of regulatory and supervisory practices between the competent authorities of the Member States. (10) The Commission Communication of 11 May 1999 entitled ‘Implementing the framework for financial markets: Action Plan’ listed a number of goals that need to be achieved in order to complete the internal market in financial services. The Lisbon European Council of 23 and 24 March 2000 set the goal of implementing the action plan by 2005. Recasting of the provisions on own funds is a key element of the action plan. (11) Since investment firms face in respect of their trading book business the same risks as credit institutions, it is appropriate for the pertinent provisions of Directive 2006/48/EC of the European Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the business of credit institutions (6) to apply equally to investment firms. (12) The own funds of investment firms or credit institutions (hereinafter referred to collectively as ‘institutions’) can serve to absorb losses which are not matched by a sufficient volume of profits, to ensure the continuity of institutions and to protect investors. The own funds also serve as an important yardstick for the competent authorities, in particular for the assessment of the solvency of institutions and for other prudential purposes. Furthermore, institutions, engage in direct competition with each other in the internal market. Therefore, in order to strengthen the Community financial system and to prevent distortions of competition, it is appropriate to lay down common basic standards for own funds. (13) For the purposes of recital (12), it is appropriate for the definition of own funds as laid down in Directive 2006/48/EC to serve as a basis, and to provide for supplementary specific rules which take into account the different scope of market risk related capital requirements. (14) As regards credit institutions, common standards have already been established for the supervision and monitoring of different types of risks by Directive 2000/12/EC. (15) In that respect, the provisions on minimum capital requirements should be considered in conjunction with other specific instruments which also harmonise the fundamental techniques of the supervision of institutions. (16) It is necessary to develop common standards for market risks incurred by credit institutions and provide a complementary framework for the supervision of the risks incurred by institutions, in particular market risks, and more especially position risks, counterparty/settlement risks and foreign-exchange risks. (17) It is necessary to provide for the concept of a ‘trading book’ comprising positions in securities and other financial instruments which are held for trading purposes and which are subject mainly to market risks and exposures relating to certain financial services provided to customers. (18) With a view to reducing the administrative burden for institutions with negligible trading-book business in both absolute and relative terms, such institutions should be able to apply Directive 2006/48/EC, rather than the requirements laid down in Annexes I and II to this Directive. (19) It is important that monitoring of settlement/delivery risks should take account of the existence of systems offering adequate protection reducing those risks. (20) In any case, institutions should comply with this Directive as regards the coverage of the foreign-exchange risks on their overall business. Lower capital requirements should be imposed for positions in closely correlated currencies, whether statistically confirmed or arising out of binding intergovernmental agreements. (21) The capital requirements for commodity dealers, including those dealers currently exempt from the requirements of Directive 2004/39/EC, will be reviewed as appropriate in conjunction with the review of that exemption as set out in Article 65(3) of that Directive. (22) The goal of liberalisation of gas and electricity markets is both economically and politically important for the Community. With this in mind, the capital requirements and other prudential rules to be applied to firms active in those markets should be proportionate and should not unduly interfere with achievement of the goal of liberalisation. This goal should, in particular, be kept in mind when the reviews referred to in recital 21 are carried out. (23) The existence of internal systems for monitoring and controlling interest-rate risks on all business of institutions is a particularly important way of minimising such risks. Consequently, such systems should be supervised by the competent authorities. (24) Since Directive 2006/48/EC does not establish common rules for the monitoring and control of large exposures in activities which are principally subject to market risks, it is therefore appropriate to provide for such rules. (25) Operational risk is a significant risk faced by institutions and requires coverage by own funds. It is essential to take account of the diversity of institutions in the EU by providing alternative approaches. (26) Directive 2006/48/EC states the principle of consolidation. It does not establish common rules for the consolidation of financial institutions which are involved in activities principally subject to market risks. (27) In order to ensure adequate solvency of institutions within a group, it is essential that the minimum capital requirements apply on the basis of the consolidated financial situation of the group. In order to ensure that own funds are appropriately distributed within the group and are available to protect investments where needed, the minimum capital requirements should apply to individual institutions within a group, unless this objective can be effectively achieved by other means. (28) Directive 2006/48/EC does not apply to groups which include one or more investment firms but no credit institutions. A common framework for the introduction of the supervision of investment firms on a consolidated basis should therefore be provided for. (29) Institutions should ensure that they have internal capital which, having regard to the risks to which they are or might be exposed, is adequate in quantity, quality and distribution. Accordingly, institutions should have strategies and processes in place for assessing and maintaining the adequacy of their internal capital. (30) Competent authorities should evaluate the adequacy of own funds of institutions, having regard to the risks to which the latter are exposed. (31) In order for the internal banking market to operate effectively, the Committee of European Banking Supervisors should contribute to the consistent application of this Directive and to the convergence of supervisory practices throughout the Community, and should report on a yearly basis to the Community Institutions on progress made. (32) In order for the internal market to operate with increasing effectiveness it is essential that there should be significantly enhanced convergence in the implementation and application of the provisions of harmonising Community legislation. (33) For the same reason, and to ensure that Community institutions which are active in several Member States are not disproportionately burdened as a result of the continued responsibilities of individual Member State competent authorities for authorisation and supervision, it is essential significantly to enhance the cooperation between competent authorities. In this context the role of the consolidating supervisor should be strengthened. (34) In order for the internal market to operate with increasing effectiveness and for citizens of the Union to be afforded adequate levels of transparency, it is necessary that competent authorities disclose publicly and in a way which allows for meaningful comparison the manner in which the requirements of this Directive are implemented. (35) In order to strengthen market discipline and stimulate institutions to improve their market strategy, risk control and internal management organisation, appropriate public disclosures by institutions should be provided for. (36) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7). (37) In its Resolution of 5 February 2002 on the implementation of financial services legislation (8), the Parliament requested that the Parliament and the Council should have an equal role in supervising the way in which the Commission exercises its executive role in order to reflect the legislative powers of Parliament under Article 251 of the Treaty. In the solemn declaration made before the Parliament the same day, by its President, the Commission supported this request. On 11 December 2002, the Commission proposed amendments to Decision 1999/468/EC and then submitted an amended proposal on 22 April 2004. The Parliament considers that this proposal does not preserve its legislative prerogatives. In the Parliament's view, the Parliament and the Council should have the opportunity of evaluating the conferral of implementing powers on the Commission within a determined period. It is therefore appropriate to limit the period during which the Commission may adopt implementing measures. (38) The Parliament should be given a period of three months from the first transmission of draft amendments and implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, it should be possible to shorten this period. If, within that period, a resolution is adopted by the Parliament, the Commission should re-examine the draft amendments or measures. (39) In order to avoid disruption to markets and to ensure continuity in overall levels of own funds, it is appropriate to provide for specific transitional arrangements. (40) This Directive respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union as general principles of Community law. (41) The obligation to transpose this Directive into national law should be confined to those provisions that represent a substantive change compared to earlier directives. The obligation to transpose the provisions that remain unchanged exists under the earlier directives. (42) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex VIII, CHAPTER I Subject matter, scope and definitions Section 1 Subject matter and scope Article 1 1. This Directive lays down the capital adequacy requirements applying to investment firms and credit institutions, the rules for their calculation and the rules for their prudential supervision. Member States shall apply the requirements of this Directive to investment firms and credit institutions as defined in Article 3. 2. A Member State may impose additional or more stringent requirements on those investment firms and credit institutions that it has authorised. Article 2 1. Subject to Articles 18, 20, 22 to 32, 34 and 39 of this Directive, Articles 68 to 73 of Directive 2006/48/EC shall apply mutatis mutandis to investment firms. In applying Articles 70 to 72 of Directive 2006/48/EC to investment firms, every reference to a parent credit institution in a Member State shall be construed as a reference to a parent investment firm in a Member State and every reference to an EU parent credit institution shall be construed as a reference to an EU parent investment firm. Where a credit institution has as a parent undertaking a parent investment firm in a Member State, only that parent investment firm shall be subject to requirements on a consolidated basis in accordance with Articles 71 to 73 of Directive 2006/48/EC. Where an investment firm has as a parent undertaking a parent credit institution in a Member State, only that parent credit institution shall be subject to requirements on a consolidated basis in accordance with Articles 71 to 73 of Directive 2006/48/EC. Where a financial holding company has as a subsidiary both a credit institution and an investment firm, requirements on the basis of the consolidated financial situation of the financial holding company shall apply to the credit institution. 2. When a group covered by paragraph 1 does not include a credit institution, Directive 2006/48/EC shall apply, subject to the following: (a) every reference to credit institutions shall be construed as a reference to investment firms; (b) in Articles 125 and 140(2) of Directive 2006/48/EC, each reference to other articles of that Directive shall be construed as a reference to Directive 2004/39/EC; (c) for the purposes of Article 39(3) of Directive 2006/48/EC, references to the European Banking Committee shall be construed as references to the Council and the Commission; and (d) by way of derogation from Article 140(1) of Directive 2006/48/EC, where a group does not include a credit institution, the first sentence of that Article shall be replaced by the following: ‘Where an investment firm, a financial holding company or a mixed-activity holding company controls one or more subsidiaries which are insurance companies, the competent authorities and the authorities entrusted with the public task of supervising insurance undertakings shall cooperate closely’. Section 2 Definitions Article 3 1. For the purposes of this Directive the following definitions shall apply: (a) ‘credit institutions’ means credit institutions as defined in Article 4(1) of Directive 2006/48/EC; (b) ‘investment firms’ means institutions as defined in Article 4(1)(1) of Directive 2004/39/EC, which are subject to the requirements imposed by that Directive, excluding: (i) credit institutions; (ii) local firms as defined in point (p); and (iii) firms which are only authorised to provide the service of investment advice and/or receive and transmit orders from investors without holding money or securities belonging to their clients and which for that reason may not at any time place themselves in debt with those clients; (c) ‘institutions’ means credit institutions and investment firms; (d) ‘recognised third-country investment firms’ means firms meeting the following conditions: (i) firms which, if they were established within the Community, would be covered by the definition of investment firm; (ii) firms which are authorised in a third country; and (iii) firms which are subject to and comply with prudential rules considered by the competent authorities as at least as stringent as those laid down by this Directive; (e) ‘financial instruments’ means any contract that gives rise to both a financial asset of one party and a financial liability or equity instrument of another party; (f) ‘parent investment firm in a Member State’ means an investment firm which has an institution or financial institution as a subsidiary or which holds a participation in one or both such entities, and which is not itself a subsidiary of another institution authorised in the same Member State or of a financial holding company set up in the same Member State; (g) ‘EU parent investment firm’ means a parent investment firm in a Member State which is not a subsidiary of another institution authorised in any Member State or of a financial holding company set up in any Member State; (h) ‘over-the-counter (OTC) derivative instruments’ means the items falling within the list in Annex IV to Directive 2006/48/EC other than those items to which an exposure value of zero is attributed under point 6 of Part 2 of Annex III to that Directive; (i) ‘regulated market’ means a market as defined in Article 4(1)(14) of Directive 2004/39/EC; (j) ‘convertible’ means a security which, at the option of the holder, may be exchanged for another security; (k) ‘warrant’ means a security which gives the holder the right to purchase an underlying asset at a stipulated price until or at the expiry date of the warrant and which may be settled by the delivery of the underlying itself or by cash settlement; (l) ‘stock financing’ means positions where physical stock has been sold forward and the cost of funding has been locked in until the date of the forward sale; (m) ‘repurchase agreement’ and ‘reverse repurchase agreement’ mean any agreement in which an institution or its counterparty transfers securities or commodities or guaranteed rights relating to title — to securities or commodities where that guarantee is issued by a recognised exchange which holds the rights to the securities or commodities and the agreement does not allow an institution to transfer or pledge a particular security or commodity to more than one counterparty at one time, subject to a commitment to repurchase them — or substituted securities or commodities of the same description — at a specified price on a future date specified, or to be specified, by the transferor, being a repurchase agreement for the institution selling the securities or commodities and a reverse repurchase agreement for the institution buying them; (n) ‘securities or commodities lending’ and ‘securities or commodities borrowing’ mean any transaction in which an institution or its counterparty transfers securities or commodities against appropriate collateral, subject to a commitment that the borrower will return equivalent securities or commodities at some future date or when requested to do so by the transferor, that transaction being securities or commodities lending for the institution transferring the securities or commodities and being securities or commodities borrowing for the institution to which they are transferred; (o) ‘clearing member’ means a member of the exchange or the clearing house which has a direct contractual relationship with the central counterparty (market guarantor); (p) ‘local firm’ means a firm dealing for its own account on markets in financial futures or options or other derivatives and on cash markets for the sole purpose of hedging positions on derivatives markets, or dealing for the accounts of other members of those markets and being guaranteed by clearing members of the same markets, where responsibility for ensuring the performance of contracts entered into by such a firm is assumed by clearing members of the same markets; (q) ‘delta’ means the expected change in an option price as a proportion of a small change in the price of the instrument underlying the option; (r) ‘own funds’ means own funds as defined in Directive 2006/48/EC; and (s) ‘capital’ means own funds. For the purposes of applying supervision on a consolidated basis, the term ‘investment firm’ shall include third-country investment firms. For the purposes of point (e), financial instruments shall include both primary financial instruments or cash instruments and derivative financial instruments the value of which is derived from the price of an underlying financial instrument, a rate, an index or the price of another underlying item, and include as a minimum the instruments specified in Section C of Annex I to Directive 2004/39/EC. 2. The terms ‘parent undertaking’, ‘subsidiary undertaking’, ‘asset management company’ and ‘financial institution’ shall cover undertakings defined in Article 4 of Directive 2006/48/EC. The terms ‘financial holding company’, ‘parent financial holding company in a Member State’, ‘EU parent financial holding company’ and ‘ancillary services undertaking’ shall cover undertakings defined in Article 4 of Directive 2006/48/EC, save that every reference to credit institutions shall be read as a reference to institutions. 3. For the purposes of applying Directive 2006/48/EC to groups covered by Article 2(1) which do not include a credit institution, the following definitions shall apply: (a) ‘financial holding company’ means a financial institution the subsidiary undertakings of which are either exclusively or mainly investment firms or other financial institutions, at least one of which is an investment firm, and which is not a mixed financial holding company within the meaning of Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate (9); (b) ‘mixed-activity holding company’ means a parent undertaking, other than a financial holding company or an investment firm or a mixed financial holding company within the meaning of Directive 2002/87/EC, the subsidiaries of which include at least one investment firm; and (c) ‘competent authorities’ means the national authorities which are empowered by law or regulation to supervise investment firms. CHAPTER II Initial capital Article 4 For the purposes of this Directive, ‘initial capital’ shall be comprised of the items referred to in Article 57(a) and (b) of Directive 2006/48/EC. Article 5 1. An investment firm that does not deal in any financial instruments for its own account or underwrite issues of financial instruments on a firm commitment basis, but which holds clients' money and/or securities and which offers one or more of the following services, shall have initial capital of EUR 125 000: (a) the reception and transmission of investors' orders for financial instruments; (b) the execution of investors' orders for financial instruments; or (c) the management of individual portfolios of investments in financial instruments. 2. The competent authorities may allow an investment firm which executes investors' orders for financial instruments to hold such instruments for its own account if the following conditions are met: (a) such positions arise only as a result of the firm's failure to match investors' orders precisely; (b) the total market value of all such positions is subject to a ceiling of 15 % of the firm's initial capital; (c) the firm meets the requirements laid down in Articles 18, 20 and 28; and (d) such positions are incidental and provisional in nature and strictly limited to the time required to carry out the transaction in question. The holding of non-trading-book positions in financial instruments in order to invest own funds shall not be considered as dealing in relation to the services set out in paragraph 1 or for the purposes of paragraph 3. 3. Member States may reduce the amount referred to in paragraph 1 to EUR 50 000 where a firm is not authorised to hold clients' money or securities, to deal for its own account, or to underwrite issues on a firm commitment basis. Article 6 Local firms shall have initial capital of EUR 50 000 insofar as they benefit from the freedom of establishment or to provide services specified in Articles 31 and 32 of Directive 2004/39/EC. Article 7 Coverage for the firms referred to in Article 3(1)(b)(iii) shall take one of the following forms: (a) initial capital of EUR 50 000; (b) professional indemnity insurance covering the whole territory of the Community or some other comparable guarantee against liability arising from professional negligence, representing at least EUR 1 000 000 applying to each claim and in aggregate EUR 1 500 000 per year for all claims; or (c) a combination of initial capital and professional indemnity insurance in a form resulting in a level of coverage equivalent to that referred to in points (a) or (b). The amounts referred to in the first sub-paragraph shall be periodically reviewed by the Commission in order to take account of changes in the European Index of Consumer Prices as published by Eurostat, in line with and at the same time as the adjustments made under Article 4(7) of Directive 2002/92/EC of the European Parliament and of the Council of 9 December 2002 on insurance mediation (10). Article 8 If a firm as referred to in Article 3(1)(b)(iii) is also registered under Directive 2002/92/EC, it shall comply with Article 4(3) of that Directive and have coverage in one of the following forms: (a) initial capital of EUR 25 000; (b) professional indemnity insurance covering the whole territory of the Community or some other comparable guarantee against liability arising from professional negligence, representing at least EUR 500 000 applying to each claim and in aggregate EUR 750 000 per year for all claims; or (c) a combination of initial capital and professional indemnity insurance in a form resulting in a level of coverage equivalent to that referred to in points (a) or (b). Article 9 All investment firms other than those referred to in Articles 5 to 8 shall have initial capital of EUR 730 000. Article 10 1. By way of derogation from Articles 5(1), 5(3), 6 and 9, Member States may continue an authorisation of investment firms and firms covered by Article 6 which was in existence before 31 December 1995, the own funds of which firms or investment firms are less than the initial capital levels specified for them in Articles 5(1), 5(3), 6 and 9. The own funds of such firms or investment firms shall not fall below the highest reference level calculated after the date of notification contained in Directive 93/6/EEC. That reference level shall be the average daily level of own funds calculated over a six-month period preceding the date of calculation. It shall be calculated every six months in respect of the corresponding preceding period. 2. If control of a firm covered by paragraph 1 is taken by a natural or legal person other than the person who controlled it previously, the own funds of that firm shall attain at least the level specified for them in Articles 5(1), 5(3), 6 and 9, except in the case of a first transfer by inheritance made after 31 December 1995, subject to the competent authorities' approval and for a period of not more than 10 years from the date of that transfer. 3. In certain specific circumstances, and with the approval of the competent authorities, in the event of a merger of two or more investment firms and/or firms covered by Article 6, the own funds of the firm produced by the merger need not attain the level specified in Articles 5(1), 5(3), 6 and 9. Nevertheless, during any period when the level specified in Articles 5(1), 5(3), 6 and 9 has not been attained, the own funds of the new firm may not fall below the merged firms' total own funds at the time of the merger. 4. The own funds of investment firms and firms covered by Article 6 may not fall below the level specified in Articles 5(1), 5(3), 6 and 9 and paragraphs 1 and 3 of this Article. In the event that the own funds of such firms and investment firms fall below that level, the competent authorities may, where the circumstances justify it, allow such firms a limited period in which to rectify their situations or cease their activities. CHAPTER III Trading book Article 11 1. The trading book of an institution shall consist of all positions in financial instruments and commodities held either with trading intent or in order to hedge other elements of the trading book and which are either free of any restrictive covenants on their tradability or able to be hedged. 2. Positions held with trading intent are those held intentionally for short-term resale and/or with the intention of benefiting from actual or expected short-term price differences between buying and selling prices or from other price or interest rate variations. The term ‘positions’ shall include proprietary positions and positions arising from client servicing and market making. 3. Trading intent shall be evidenced on the basis of the strategies, policies and procedures set up by the institution to manage the position or portfolio in accordance with Part A of Annex VII. 4. Institutions shall establish and maintain systems and controls to manage their trading book in accordance with Parts B and D of Annex VII. 5. Internal hedges may be included in the trading book, in which case Part C of Annex VII shall apply. CHAPTER IV Own funds Article 12 ‘Original own funds’ means the sum of points (a) to (c), less the sum of points (i) to (k) of Article 57 of Directive 2006/48/EC. The Commission shall, by 1 January 2009,,submit an appropriate proposal to the European Parliament and to the Council for amendment of this Chapter. Article 13 1. Subject to paragraphs 2 to 5 of this Article and Articles 14 to 17, the own funds of investment firms and credit institutions shall be determined in accordance with Directive 2006/48/EC. In addition, the first subparagraph applies to investment firms which do not have one of the legal forms referred to in Article 1(1) of the Fourth Council Directive 78/660/EEC of 25 July 1978 based on Article 54(3) of the Treaty on the annual accounts of certain types of companies (11). 2. By way of derogation from paragraph 1, the competent authorities may permit those institutions which are obliged to meet the capital requirements calculated in accordance with Articles 21 and 28 to 32 and Annexes I and III to VI to use, for that purpose only, an alternative determination of own funds. No part of the own funds used for that purpose may be used simultaneously to meet other capital requirements. Such an alternative determination shall be the sum of the items set out in points (a) to (c) of this subparagraph, minus the item set out in point (d), with the deduction of that last item being left to the discretion of the competent authorities: (a) own funds as defined in Directive 2006/48/EC, excluding only points (l) to (p) of Article 57 of that Directive for those investment firms which are required to deduct item (d) of this paragraph from the total of items (a) to (c); (b) an institution's net trading-book profits net of any foreseeable charges or dividends, less net losses on its other business, provided that none of those amounts has already been included in item (a) of this paragraph as one of the items set out in points (b) or (k) of Article 57 of Directive 2006/48/EC; (c) subordinated loan capital and/or the items referred to in paragraph 5 of this Article, subject to the conditions set out in paragraphs 3 and 4 of this Article and in Article 14; and (d) illiquid assets as specified in Article 15. 3. The subordinated loan capital referred to in point (c) of the second subparagraph of paragraph 2 shall have an initial maturity of at least two years. It shall be fully paid up and the loan agreement shall not include any clause providing that in specified circumstances, other than the winding up of the institution, the debt will become repayable before the agreed repayment date, unless the competent authorities approve the repayment. Neither the principal nor the interest on such subordinated loan capital may be repaid if such repayment would mean that the own funds of the institution in question would then amount to less than 100 % of that institution's overall capital requirements. In addition, an institution shall notify the competent authorities of all repayments on such subordinated loan capital as soon as its own funds fall below 120 % of its overall capital requirements. 4. The subordinated loan capital referred to in point (c) of the second subparagraph of paragraph 2 may not exceed a maximum of 150 % of the original own funds left to meet the requirements calculated in accordance with Articles 21 and 28 to 32 and Annexes I to VI and may approach that maximum only in particular circumstances acceptable to the competent authorities. 5. The competent authorities may permit institutions to replace the subordinated loan capital referred to in point (c) of the second subparagraph of paragraph 2 with points (d) to (h) of Article 57 of Directive 2006/48/EC. Article 14 1. The competent authorities may permit investment firms to exceed the ceiling for subordinated loan capital set out in Article 13(4) if they judge it prudentially adequate and provided that the total of such subordinated loan capital and the items referred to in Article 13(5) does not exceed 200 % of the original own funds left to meet the requirements calculated in accordance with Articles 21 and 28 to 32 and Annexes I and III to VI, or 250 % of the same amount where investment firms deduct the item set out in Article 13(2)(d) when calculating own funds. 2. The competent authorities may permit the ceiling for subordinated loan capital set out in Article 13(4) to be exceeded by a credit institution if they judge it prudentially adequate and provided that the total of such subordinated loan capital and points (d) to (h) of Article 57 of Directive 2006/48/EC does not exceed 250 % of the original own funds left to meet the requirements calculated in accordance with Articles 28 to 32 and Annexes I and III to VI to this Directive. Article 15 Illiquid assets as referred to in point (d) of the second subparagraph of Article 13(2) shall include the following: (a) tangible fixed assets, except to the extent that land and buildings may be allowed to count against the loans which they are securing; (b) holdings in, including subordinated claims on, credit or financial institutions which may be included in the own funds of those institutions, unless they have been deducted under points (l) to (p) of Article 57 of Directive 2006/48/EC or under Article 16(d) of this Directive; (c) holdings and other investments in undertakings other than credit or financial institutions, which are not readily marketable; (d) deficiencies in subsidiaries; (e) deposits made, other than those which are available for repayment within 90 days, and also excluding payments in connection with margined futures or options contracts; (f) loans and other amounts due, other than those due to be repaid within 90 days; and (g) physical stocks, unless they are already subject to capital requirements at least as stringent as those set out in Articles 18 and 20. For the purposes of point (b), where shares in a credit or financial institution are held temporarily for the purpose of a financial assistance operation designed to reorganise and save that institution, the competent authorities may waive the application of this Article. They may also waive it in respect of those shares which are included in an investment firm's trading book. Article 16 Investment firms included in a group which has been granted the waiver provided for in Article 22 shall calculate their own funds in accordance with Articles 13 to 15, subject to the following: (a) the illiquid assets referred to in Article 13(2)(d) shall be deducted; (b) the exclusion referred to in point (a) of Article 13(2) shall not cover those components of points (l) to (p) of Article 57 of Directive 2006/48/EC which an investment firm holds in respect of undertakings included in the scope of consolidation as defined in Article 2(1) of this Directive; (c) the limits referred to in points (a) and (b) of Article 66(1) of Directive 2006/48/EC shall be calculated with reference to the original own funds less the components of points (l) to (p) of Article 57 of that Directive as referred to in point (b) of this Article which are elements of the original own funds of those undertakings; and (d) the components of points (l) to (p) of Article 57 of Directive 2006/48/EC referred to in point (c) of this Article shall be deducted from the original own funds rather than from the total of all items as laid down in Article 66(2) of that Directive for the purposes in particular of Articles 13(4), 13(5) and 14 of this Directive. Article 17 1. Where an institution calculates risk-weighted exposure amounts for the purposes of Annex II to this Directive in accordance with Articles 84 to 89 of Directive 2006/48/EC, then for the purposes of the calculation provided for in point 4 of Part 1 of Annex VII to Directive 2006/48/EC, the following shall apply: (a) value adjustments made to take account of the credit quality of the counterparty may be included in the sum of value adjustments and provisions made for the exposures indicated in Annex II; and (b) subject to the approval of the competent authorities, if the credit risk of the counterparty is adequately taken into account in the valuation of a position included in the trading book, the expected loss amount for the counterparty risk exposure shall be zero. For the purposes of point (a), for such institutions, such value adjustments shall not be included in own funds other than in accordance with the provisions of this paragraph. 2. For the purposes of this Article, Article 153 and 154 of Directive 2006/48/EC shall apply. CHAPTER V Section 1 Provisions against risks Article 18 1. Institutions shall have own funds which are always more than or equal to the sum of the following: (a) the capital requirements, calculated in accordance with the methods and options laid down in Articles 28 to 32 and Annexes I, II and VI and, as appropriate, Annex V, for their trading-book business; and (b) the capital requirements, calculated in accordance with the methods and options laid down in Annexes III and IV and, as appropriate, Annex V, for all of their business activities. 2. By way of derogation from paragraph 1, the competent authorities may allow institutions to calculate the capital requirements for their trading book business in accordance with Article 75(a) of Directive 2006/48/EC and points 6, 7, and 9 of Annex II to this Directive, where the size of the trading book business meets the following requirements: (a) the trading-book business of such institutions does not normally exceed 5 % of their total business; (b) their total trading-book positions do not normally exceed EUR 15 million; and (c) the trading-book business of such institutions never exceeds 6 % of their total business and their total trading-book positions never exceed EUR 20 million. 3. In order to calculate the proportion that trading-book business bears to total business for the purposes of points (a) and (c) of paragraph 2, the competent authorities may refer either to the size of the combined on- and off-balance-sheet business, to the profit and loss account or to the own funds of the institutions in question, or to a combination of those measures. When the size of on- and off-balance-sheet business is assessed, debt instruments shall be valued at their market prices or their principal values, equities at their market prices and derivatives according to the nominal or market values of the instruments underlying them. Long positions and short positions shall be summed regardless of their signs. 4. If an institution should happen for more than a short period to exceed either or both of the limits imposed in paragraph 2(a) and (b) or either or both of the limits imposed in paragraph 2(c), it shall be required to meet the requirements imposed in paragraph 1(a) in respect of its trading-book business and to notify the competent authority thereof. Article 19 1. For the purposes of point 14 of Annex I, subject to the discretion of the national authorities, a 0 % weighting can be assigned to debt securities issued by the entities listed in Table 1 of Annex I, where these debt securities are denominated and funded in domestic currency. 2. By way of derogation from points 13 and 14 of Annex I, Member States may set a specific risk requirement for any bonds falling within points 68 to 70 of Part 1 of Annex VI to Directive 2006/48/EC which shall be equal to the specific risk requirement for a qualifying item with the same residual maturity as such bonds and reduced in accordance with the percentages given in point 71 of Part 1 to Annex VI to that Directive. 3. If, as set out in point 52 of Annex I, a competent authority approves a third country's collective investment undertaking (CIU) as eligible, a competent authority in another Member State may make use of this approval without conducting its own assessment. Article 20 1. Subject to paragraphs 2, 3 and 4 of this Article, and Article 34 of this Directive, the requirements in Article 75 of Directive 2006/48/EC shall apply to investment firms. 2. By way of derogation from paragraph 1, competent authorities may allow investment firms that are not authorised to provide the investment services listed in points 3 and 6 of Section A of Annex I to Directive 2004/39/EC to provide own funds which are always more than or equal to the higher of the following: (a) the sum of the capital requirements contained in points (a) to (c) of Article 75 of Directive 2006/48/EC; and (b) the amount laid down in Article 21 of this Directive. 3. By way of derogation from paragraph 1, competent authorities may allow investment firms which hold initial capital as set out in Article 9, but which fall within the following categories, to provide own funds which are always more than or equal to the sum of the capital requirements calculated in accordance with the requirements contained in points (a) to (c) of Article 75 of Directive 2006/48/EC and the amount laid down in Article 21 of this Directive: (a) investment firms that deal on own account only for the purpose of fulfilling or executing a client order or for the purpose of gaining entrance to a clearing and settlement system or a recognised exchange when acting in an agency capacity or executing a client order; and b) investment firms: (i) that do not hold client money or securities; (ii) that undertake only dealing on own account; (iii) that have no external customers; (iv) the execution and settlement of whose transactions takes place under the responsibility of a clearing institution and are guaranteed by that clearing institution. 4. Investment firms referred to in paragraphs 2 and 3 shall remain subject to all other provisions regarding operational risk set out in Annex V of Directive 2006/48/EC. 5. Article 21 shall apply only to investment firms to which paragraphs (2) or (3) or Article 46 apply and in the manner specified therein. Article 21 Investment firms shall be required to hold own funds equivalent to one quarter of their preceding year's fixed overheads. The competent authorities may adjust that requirement in the event of a material change in a firm's business since the preceding year. Where a firm has not completed a year's business, starting from the day it starts up, the requirement shall be a quarter of the fixed overheads projected in its business plan, unless an adjustment to that plan is required by the competent authorities. Section 2 Application of requirements on a consolidated basis Article 22 1. The competent authorities required or mandated to exercise supervision of groups covered by Article 2 on a consolidated basis may waive, on a case-by-case basis, the application of capital requirements on a consolidated basis provided that: (a) each EU investment firm in such a group uses the calculation of own funds set out in Article 16; (b) all investment firms in such a group fall within the categories in Article 20(2) and (3); (c) each EU investment firm in such a group meets the requirements imposed in Articles 18 and 20 on an individual basis and at the same time deducts from its own funds any contingent liability in favour of investment firms, financial institutions, asset management companies and ancillary services undertakings, which would otherwise be consolidated and; (d) any financial holding company which is the parent financial holding company in a Member State of any investment firm in such a group holds at least as much capital, defined here as the sum of points (a) to (h) of Article 57 of Directive 2006/48/EC, as the sum of the full book value of any holdings, subordinated claims and instruments as referred to in Article 57 of that Directive in investment firms, financial institutions, asset management companies and ancillary services undertakings which would otherwise be consolidated, and the total amount of any contingent liability in favour of investment firms, financial institutions, asset management companies and ancillary services undertakings which would otherwise be consolidated. Where the criteria in the first subparagraph are met, each EU investment firm shall have in place systems to monitor and control the sources of capital and funding of all financial holding companies, investment firms, financial institutions, asset management companies and ancillary services undertakings within the group. 2. By way of derogation from paragraph 1, competent authorities may permit financial holding companies which are the parent financial holding company in a Member State of an investment firm in such a group to use a value lower than the value calculated under paragraph 1(d), but no lower than the sum of the requirements imposed in Articles 18 and 20 on an individual basis to investment firms, financial institutions, asset management companies and ancillary services undertakings which would otherwise be consolidated and the total amount of any contingent liability in favour of investment firms, financial institutions, asset management companies and ancillary services undertakings which would otherwise be consolidated. For the purposes of this paragraph, the capital requirement for investment undertakings of third countries, financial institutions, asset management companies and ancillary services undertakings is a notional capital requirement. Article 23 The competent authorities shall require investment firms in a group which has been granted the waiver provided for in Article 22 to notify them of the risks which could undermine their financial positions, including those associated with the composition and sources of their capital and funding. If the competent authorities then consider that the financial positions of those investment firms is not adequately protected, they shall require them to take measures including, if necessary, limitations on the transfer of capital from such firms to group entities. Where the competent authorities waive the obligation of supervision on a consolidated basis provided for in Article 22, they shall take other appropriate measures to monitor the risks, namely large exposures, of the whole group, including any undertakings not located in a Member State. Where the competent authorities waive the application of capital requirements on a consolidated basis provided for in Article 22, the requirements of Article 123 and Chapter 5 of Title V of Directive 2006/48/EC shall apply on an individual basis, and the requirements of Article 124 of that Directive shall apply to the supervision of investment firms on an individual basis. Article 24 1. By way of derogation from Article 2(2), competent authorities may exempt investment firms from the consolidated capital requirement established in that Article, provided that all the investment firms in the group are covered by Article 20(2) and the group does not include credit institutions. 2. Where the requirements of paragraph 1 are met, a parent investment firm in a Member State shall be required to provide own funds at a consolidated level which are always more than or equal to the higher of the following two amounts, calculated on the basis of the parent investment firm's consolidated financial position and in compliance with Section 3 of this Chapter: (a) the sum of the capital requirements contained in points (a) to (c) of Article 75 of Directive 2006/48/EC; and (b) the amount prescribed in Article 21 of this Directive. 3. Where the requirements of paragraph 1 are met, an investment firm controlled by a financial holding company shall be required to provide own funds at a consolidated level which are always more than or equal to the higher of the following two amounts, calculated on the basis of the financial holding company's consolidated financial position and in compliance with Section 3 of this Chapter: (a) the sum of the capital requirements contained in points (a) to (c) of Article 75 of Directive 2006/48/EC; and (b) the amount prescribed in Article 21 of this Directive. Article 25 By way of derogation from Article 2(2), competent authorities may exempt investment firms from the consolidated capital requirement established in that Article, provided that all the investment firms in the group fall within the investment firms referred to in Article 20(2) and (3), and the group does not include credit institutions. Where the requirements of the first paragraph are met, a parent investment firm in a Member State shall be required to provide own funds at a consolidated level which are always more than or equal to the sum of the requirements contained in points (a) to (c) of Article 75 of Directive 2006/48/EC and the amount prescribed in Article 21 of this Directive, calculated on the basis of the parent investment firm's consolidated financial position and in compliance with Section 3 of this Chapter. Where the requirements of the first paragraph are met, an investment firm controlled by a financial holding company shall be required to provide own funds at a consolidated level which are always more than or equal to the sum of the requirements contained in points (a) to (c) of Article 75 of Directive 2006/48/EC and the amount prescribed in Article 21 of this Directive, calculated on the basis of the financial holding company's consolidated financial position and in compliance with Section 3 of this Chapter. Section 3 Calculation of consolidated requirements Article 26 1. Where the waiver provided for in Article 22 is not exercised, the competent authorities may, for the purpose of calculating the capital requirements set out in Annexes I and V and the exposures to clients set out in Articles 28 to 32 and Annex VI on a consolidated basis, permit positions in the trading book of one institution to offset positions in the trading book of another institution according to the rules set out in Articles 28 to 32 Annexes I, V and VI. In addition, the competent authorities may allow foreign-exchange positions in one institution to offset foreign-exchange positions in another institution in accordance with the rules set out in Annex III and/or Annex V. They may also allow commodities positions in one institution to offset commodities positions in another institution in accordance with the rules set out in Annex IV and/or Annex V. 2. The competent authorities may permit offsetting of the trading book and of the foreign-exchange and commodities positions, respectively, of undertakings located in third countries, subject to the simultaneous fulfilment of the following conditions: (a) such undertakings have been authorised in a third country and either satisfy the definition of credit institution set out in Article 4(1) of Directive 2006/48/EC or are recognised third-country investment firms; (b) such undertakings comply, on an individual basis, with capital adequacy rules equivalent to those laid down in this Directive; and (c) no regulations exist in the third countries in question which might significantly affect the transfer of funds within the group. 3. The competent authorities may also allow the offsetting provided for in paragraph 1 between institutions within a group that have been authorised in the Member State in question, provided that: (a) there is a satisfactory allocation of capital within the group; and (b) the regulatory, legal or contractual framework in which the institutions operate is such as to guarantee mutual financial support within the group. 4. Furthermore, the competent authorities may allow the offsetting provided for in paragraph 1 between institutions within a group that fulfil the conditions imposed in paragraph 3 and any institution included in the same group which has been authorised in another Member State provided that that institution is obliged to fulfil the capital requirements imposed in Articles 18, 20 and 28 on an individual basis. Article 27 1. In the calculation of own funds on a consolidated basis Article 65 of Directive 2006/48/EC shall apply. 2. The competent authorities responsible for exercising supervision on a consolidated basis may recognise the validity of the specific own-funds definitions applicable to the institutions concerned under Chapter IV in the calculation of their consolidated own funds. Section 4 Monitoring and control of large exposures Article 28 1. Institutions shall monitor and control their large exposures in accordance with Articles 106 to 118 of Directive 2006/48/EC. 2. By way of derogation from paragraph 1, institutions which calculate the capital requirements for their trading-book business in accordance with Annexes I and II, and, as appropriate, Annex V to this Directive, shall monitor and control their large exposures in accordance with Articles 106 to 118 of Directive 2006/48/EC subject to the amendments laid down in Articles 29 to 32 of this Directive. 3. By 31 December 2007, the Commission shall submit to the European Parliament and to the Council a report on the functioning of this Section, together with any appropriate proposals. Article 29 1. The exposures to individual clients which arise on the trading book shall be calculated by summing the following items: (a) the excess — where positive — of an institution's long positions over its short positions in all the financial instruments issued by the client in question, the net position in each of the different instruments being calculated according to the methods laid down in Annex I; (b) the net exposure, in the case of the underwriting of a debt or an equity instrument; and (c) the exposures due to the transactions, agreements and contracts referred to in Annex II with the client in question, such exposures being calculated in the manner laid down in that Annex, for the calculation of exposure values. For the purposes of point (b), the net exposure is calculated by deducting those underwriting positions which are subscribed or sub-underwritten by third parties on the basis of a formal agreement reduced by the factors set out in point 41 of Annex I. For the purposes of point (b), pending further coordination, the competent authorities shall require institutions to set up systems to monitor and control their underwriting exposures between the time of the initial commitment and working day one in the light of the nature of the risks incurred in the markets in question. For the purposes of point (c), Articles 84 to 89 of Directive 2006/48/EC shall be excluded from the reference in point 6 of Annex II to this Directive. 2. The exposures to groups of connected clients on the trading book shall be calculated by summing the exposures to individual clients in a group, as calculated in paragraph 1. Article 30 1. The overall exposures to individual clients or groups of connected clients shall be calculated by summing the exposures which arise on the trading book and the exposures which arise on the non-trading book, taking into account Article 112 to 117 of Directive 2006/48/EC. In order to calculate the exposure which arises on the non-trading book, institutions shall take the exposure arising from assets which are deducted from their own funds by virtue of point (d) of the second subparagraph of Article 13(2) to be zero. 2. Institutions' overall exposures to individual clients and groups of connected clients calculated in accordance with paragraph 4 shall be reported in accordance with Article 110 of Directive 2006/48/EC. Other than in relation to repurchase transactions, securities or commodities lending or borrowing transactions, the calculation of large exposures to individual clients and groups of connected clients for reporting purposes shall not include the recognition of credit risk mitigation. 3. The sum of the exposures to an individual client or group of connected clients in paragraph 1 shall be limited in accordance with Articles 111 to 117 of Directive 2006/48/EC. 4. By derogation from paragraph 3 competent authorities may allow assets constituting claims and other exposures on recognised third-country investment firms and recognised clearing houses and exchanges in financial instruments to be subject to the same treatment accorded to those on institutions laid out in Articles 113(3)(i), 115(2) and 116 of Directive 2006/48/EC. Article 31 The competent authorities may authorise the limits laid down in Articles 111 to 117 of Directive 2006/48/EC to be exceeded if the following conditions are met: (a) the exposure on the non-trading book to the client or group of clients in question does not exceed the limits laid down in Articles 111 to 117 of Directive 2006/48/EC, those limits being calculated with reference to own funds as specified in that Directive, so that the excess arises entirely on the trading book; (b) the institution meets an additional capital requirement on the excess in respect of the limits laid down in Article 111(1) and (2) of Directive 2006/48/EC, that additional capital requirement being calculated in accordance with Annex VI to that Directive; (c) where 10 days or less has elapsed since the excess occurred, the trading-book exposure to the client or group of connected clients in question shall not exceed 500 % of the institution's own funds; (d) any excesses that have persisted for more than 10 days must not, in aggregate, exceed 600 % of the institution's own funds; and (e) institutions shall report to the competent authorities every three months all cases where the limits laid down in Article 111(1) and (2) of Directive 2006/48/EC have been exceeded during the preceding three months. In relation to point (e), in each case in which the limits have been exceeded the amount of the excess and the name of the client concerned shall be reported. Article 32 1. The competent authorities shall establish procedures to prevent institutions from deliberately avoiding the additional capital requirements that they would otherwise incur, on exposures exceeding the limits laid down in Article 111(1) and (2) of Directive 2006/48/EC once those exposures have been maintained for more than 10 days, by means of temporarily transferring the exposures in question to another company, whether within the same group or not, and/or by undertaking artificial transactions to close out the exposure during the 10-day period and create a new exposure. The competent authorities shall notify the Council and the Commission of those procedures. Institutions shall maintain systems which ensure that any transfer which has the effect referred to in the first subparagraph is immediately reported to the competent authorities. 2. The competent authorities may permit institutions which are allowed to use the alternative determination of own funds under Article 13(2) to use that determination for the purposes of Articles 30(2), 30(3) and 31 provided that the institutions concerned are required to meet all of the obligations set out in Articles 110 to 117 of Directive 2006/48/EC, in respect of the exposures which arise outside their trading books by using own funds as defined in that Directive. Section 5 Valuation of positions for reporting purposes Article 33 1. All trading book positions shall be subject to prudent valuation rules as specified in Annex VII, Part B. These rules shall require institutions to ensure that the value applied to each of its trading book positions appropriately reflects the current market value. The former value shall contain an appropriate degree of certainty having regard to the dynamic nature of trading book positions, the demands of prudential soundness and the mode of operation and purpose of capital requirements in respect of trading book positions. 2. Trading book positions shall be re-valued at least daily. 3. In the absence of readily available market prices, the competent authorities may waive the requirement imposed in paragraphs 1 and 2 and shall require institutions to use alternative methods of valuation provided that those methods are sufficiently prudent and have been approved by competent authorities. Section 6 Risk management and capital assessment Article 34 Competent authorities shall require that every investment firm, as well as meeting the requirements set out in Article 13 of Directive 2004/39/EC, shall meet the requirements set out in Articles 22 and 123 of Directive 2006/48/EC, subject to the provisions on level of application set out in Articles 68 to 73 of that Directive. Section 7 Reporting requirements Article 35 1. Member States shall require that investment firms and credit institutions provide the competent authorities of their home Member States with all the information necessary for the assessment of their compliance with the rules adopted in accordance with this Directive. Member States shall also ensure that internal control mechanisms and administrative and accounting procedures of the institutions permit the verification of their compliance with such rules at all times. 2. Investment firms shall report to the competent authorities in the manner specified by the latter at least once every month in the case of firms covered by Article 9, at least once every three months in the case of firms covered by Article 5(1) and at least once every six months in the case of firms covered by Article 5(3). 3. Notwithstanding paragraph 2, investment firms covered by Articles 5(1) and 9 shall be required to provide the information on a consolidated or sub-consolidated basis only once every six months. 4. Credit institutions shall be obliged to report in the manner specified by the competent authorities as often as they are obliged to report under Directive 2006/48/EC. 5. The competent authorities shall oblige institutions to report to them immediately any case in which their counter parties in repurchase and reverse repurchase agreements or securities and commodities-lending and securities and commodities-borrowing transactions default on their obligations. CHAPTER VI Section 1 Competent authorities Article 36 1. Member States shall designate the authorities which are competent to carry out the duties provided for in this Directive. They shall inform the Commission thereof, indicating any division of duties. 2. The competent authorities shall be public authorities or bodies officially recognized by national law or by public authorities as part of the supervisory system in operation in the Member State concerned. 3. The competent authorities shall be granted all the powers necessary for the performance of their tasks, and in particular that of overseeing the constitution of trading books. Section 2 Supervision Article 37 1. Chapter 4 of Title V of Directive 2006/48/EC shall apply mutatis mutandis to the supervision of investment firms in accordance with the following: (a) references to Article 6 of Directive 2006/48/EC shall be construed as references to Article 5 of Directive 2004/39/EC; (b) references to Article 22 and 123 of Directive 2006/48/EC shall be construed s references to Article 34 of this Directive; and (c) references to Articles 44 to 52 of Directive 2006/48/EC shall be construed as references to Articles 54 and 58 of Directive 2004/39/EC. Where an EU parent financial holding company has as subsidiary both a credit institution and an investment firm, Title V, Chapter 4 of Directive 2006/48/EC shall apply to the supervision of institutions as if references to credit institutions were to institutions. 2. Article 129(2) of Directive 2006/48/EC shall also apply to the recognition of internal models of institutions under Annex V to this Directive where the application is submitted by an EU parent credit institution and its subsidiaries or an EU parent investment firm and its subsidiaries, or jointly by the subsidiaries of an EU parent financial holding company. The period for the recognition referred to in the first sub-paragraph shall be six months. Article 38 1. The competent authorities of the Member States shall cooperate closely in the performance of the duties provided for in this Directive, particularly where investment services are provided on the basis of the freedom to provide services or through the establishment of branches. The competent authorities shall on request supply one another with all information likely to facilitate the supervision of the capital adequacy of institutions, in particular the verification of their compliance with the rules laid down in this Directive. 2. Any exchange of information between competent authorities which is provided for in this Directive shall be subject to the following obligations of professional secrecy: (a) for investment firms, those imposed in Article 54 and 58 of Directive 2004/39/EC; and (b) for credit institutions, those imposed in Articles 44 to 52 of Directive 2006/48/EC. CHAPTER VII Disclosure Article 39 The requirements set out in Title V, Chapter 5 of Directive 2006/48/EC shall apply to investment firms. CHAPTER VIII Section 1 Article 40 For the purposes of the calculation of minimum capital requirements for counterparty risk under this Directive, and for the calculation of minimum capital requirements for credit risk under Directive 2006/48/EC, and without prejudice to the provisions of Part 2, point 6 of Annex III to that Directive, exposures to recognised third-country investment firms and exposures to recognised clearing houses and exchanges shall be treated as exposures to institutions. Section 2 Powers of execution Article 22 1. The Commission shall decide on any technical adaptations in the following areas in accordance with the procedure referred to in Article 42(2): (a) clarification of the definitions in Article 3 in order to ensure uniform application of this Directive; (b) clarification of the definitions in Article 3 to take account of developments on financial markets; (c) adjustment of the amounts of initial capital prescribed in Articles 5 to 9 and the amount referred to in Article 18(2) to take account of developments in the economic and monetary field; (d) adjustment of the categories of investment firms in Article 20(2) and (3) to take account of developments on financial markets; (e) clarification of the requirement laid down in Article 21 to ensure uniform application of this Directive; (f) alignment of terminology on and the framing of definitions in accordance with subsequent acts on institutions and related matters; (g) adjustment of the technical provisions in Annexes I to VII as a result of developments on financial markets, risk measurement, accounting standards or requirements which take account of Community legislation or which have regard to convergence of supervisory practices; or (h) technical adaptations to take account of the outcome of the review referred to in Article 65(3) of Directive 2004/39/EC. 2. None of the implementing measures enacted may change the essential provisions of this Directive Article 42 1. The Commission shall be assisted by the European Banking Committee established by Commission Decision 2004/10/EC (12) of 5 November 2003 (hereinafter referred to as ‘the Committee’). 2. Where reference is made to this paragraph, the procedure laid down in Article 5 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 7(3) and 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months. 3. Without prejudice to the implementing measures already adopted, upon expiry of a two-year period following the adoption of this Directive, and by 1 April 2008, the application of the provisions of this Directive requiring the adoption of technical rules, amendments and decisions in accordance with paragraph 2 shall be suspended. Acting on a proposal from the Commission and in accordance with the procedure laid down in Article 251 of the Treaty, the Parliament and the Council may renew those provisions and, to that end, shall review them prior to the expiry of the period or by the date referred to in this paragraph, whichever the earlier. 4. The Committee shall adopt its Rules of Procedure Section 3 Transitional provisions Article 43 Article 152(1) to (7) of Directive 2006/48/EC shall apply, in accordance with Article 2 and Chapter V, Sections 2 and 3 of this Directive, to investment firms calculating risk-weighted exposure amounts, for the purposes of Annex II to this Directive, in accordance with Articles 84 to 89 of Directive 2006/48/EC, or using the Advanced Measurement Approach as specified in Article 105 of that Directive for the calculation of their capital requirements for operational risk. Article 44 Until 31 December 2012, for investment firms the relevant indicator for the trading and sales business line of which represents at least 50 % of the total of relevant indicators for all of their business lines calculated in accordance with Article 20 of this Directive and points 1 to 4 of Part 2 of Annex X to Directive 2006/48/EC, Member States may apply a percentage of 15 % to the business line ‘trading and sales’. Article 45 1. Competent authorities may permit investment firms to exceed the limits concerning large exposures set out in Article 111 of Directive 2006/48/EC. Investment firms need not include any excesses in their calculation of capital requirements exceeding such limits, as set out in Article 75(b) of that Directive. This discretion is available until 31 December 2010 or the date of entry into force of any modifications consequent to the treatment of large exposures pursuant to Article 119 of Directive 2006/48/EC, whichever is the earlier. For this discretion to be exercised, the following conditions shall be met: (a) the investment firm provides investment services or investment activities related to the financial instruments listed in points 5, 6, 7, 9 and 10 of Section C of Annex I to Directive 2004/39/EC; (b) the investment firm does not provide such investment services or undertake such investment activities for, or on behalf of, retail clients; c) breaches of the limits referred to in the introductory part of this paragraph arise in connection with exposures resulting from contracts that are financial instruments as listed in point (a) and relate to commodities or underlyings within the meaning of point 10 of Section C of Annex I to Directive 2004/39/EC (MiFID) and are calculated in accordance with Annexes III and IV of Directive 2006/48/EC, or in connection with exposures resulting from contracts concerning the delivery of commodities or emission allowances; and (d) the investment firm has a documented strategy for managing and, in particular, for controlling and limiting risks arising from the concentration of exposures. The investment firm shall inform the competent authorities of this strategy and all material changes to it without delay. The investment firm shall make appropriate arrangements to ensure a continuous monitoring of the creditworthiness of borrowers, according to their impact on concentration risk. These arrangements shall enable the investment firm to react adequately and sufficiently promptly to any deterioration in that creditworthiness. 2. Where an investment firm exceeds the internal limits set according to the strategy referred to in point (d) of paragraph 1, it shall notify the competent authority without delay of the size and nature of the excess and of the counterparty. Article 46 By way of derogation from Article 20(1), until 31 December 2011 competent authorities may choose, on a case-by-case basis, not to apply the capital requirements arising from point (d) of Article 75 of Directive 2006/48/EC in respect of investment firms to which Article 20(2) and (3) do not apply, whose total trading book positions never exceed EUR 50 million and whose average number of relevant employees during the financial year does not exceed 100. Instead, the capital requirement in relation to those investment firms shall be at least the lower of: (a) the capital requirements arising from point (d) of Article 75 of Directive 2006/48/EC; and b) 12/88 of the higher of the following: (i) the sum of the capital requirements contained in points (a) to (c) of Article 75 of Directive 2006/48/EC; and (ii) the amount laid down in Article 21 of this Directive, notwithstanding Article 20(5). If point (b) applies, an incremental increase shall be applied on at least an annual basis. Applying this derogation shall not result in a reduction in the overall level of capital requirements for an investment firm, in comparison to the requirements as at 31 December 2006, unless such a reduction is prudentially justified by a reduction in the size of the investment firm's business. Article 47 Until 31 December 2009 or any earlier date specified by the competent authorities on a case-by-case basis, institutions that have received specific risk model recognition prior to 1 January 2007 in accordance with point 1 of Annex V may, for that existing recognition, treat points 4 and 8 of Annex V to Directive 93/6/EEC as those points stood prior to 1 January 2007. Article 48 1. The provisions on capital requirements as laid down in this Directive and Directive 2006/48/EC shall not apply to investment firms whose main business consists exclusively of the provision of investment services or activities in relation to the financial instruments set out in points 5, 6, 7, 9 and 10 of Section C of Annex I to Directive 2004/39/EC and to whom Directive 93/22/EEC (13) did not apply on 31 December 2006. This exemption is available until 31 December 2010 or the date of entry into force of any modifications pursuant to paragraphs 2 and 3, whichever is the earlier. 2. As part of the review required by Article 65(3) of Directive 2004/39/EC, the Commission shall, on the basis of public consultations and in the light of discussions with the competent authorities, report to the Parliament and the Council on: (a) an appropriate regime for the prudential supervision of investment firms whose main business consists exclusively of the provision of investment services or activities in relation to the commodity derivatives or derivatives contracts set out in points 5, 6, 7, 9 and 10 of Section C of Annex I to Directive 2004/39/EC; and (b) the desirability of amending Directive 2004/39/EC to create a further category of investment firm whose main business consists exclusively of the provision of investment services or activities in relation to the financial instruments set out in points 5, 6, 7, 9 and 10 of Section C of Annex I to Directive 2004/39/EC relating to energy supplies (including electricity, coal, gas and oil). 3. On the basis of the report referred to in paragraph 2, the Commission may submit proposals for amendments to this Directive and to Directive 2006/48/EC Section 4 Final provisions Article 49 1. Member States shall adopt and publish, by 31 December 2006, the laws, regulations and administrative provisions necessary to comply with Articles 2, 3, 11, 13, 17, 18, 19, 20, 22, 23, 24, 25, 29, 30, 33, 34, 35, 37, 39, 40, 41, 43, 44, 50 and the Annexes I, II, III, V, VII. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from 1 January 2007. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the directives repealed by this Directive shall be construed as references to this Directive. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 50 1. Article 152(8) to (14) of Directive 2006/48/EC shall apply mutatis mutandis for the purposes of this Directive subject to the following provisions which shall apply where the discretion referred to in Article 152(8) of Directive 2006/48/EC is exercised: (a) references in point 7 of Annex II to this Directive to Directive 2006/48/EC shall be read as references to Directive 2000/12/EC as that Directive stood prior to 1 January 2007; and (b) point 4 of Annex II to this Directive shall apply as it stood prior to 1 January 2007. 2. Article 157(3) of Directive 2006/48/EC shall apply mutatis mutandis for the purposes of Articles 18 and 20 of this Directive. Article 51 By 1 January 2011, the Commission shall review and report on the application of this Directive and submit its report to the Parliament and the Council together with any appropriate proposals for amendment. Article 52 Directive 93/6/EEC, as amended by the Directives listed in Annex VIII, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex VIII, Part B. References made to the repealed directives shall be construed as being made to this Directive and should be read in accordance with the correspondence table set out in Annex IX. Article 53 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 54 This Directive is addressed to the Member States.