# Official Journal L 177/2012

| | ISSN 1977-0677
  doi:10.3000/19770677.L_2012.177.eng |
| --- | --- |
| Official Journal
  of the European Union | L 177 |
| | |
| English edition | Legislation | Volume 557 July 2012 |

ISSN 1977-0677

doi:10.3000/19770677.L_2012.177.eng

Official Journal

of the European Union

L 177

English edition

Legislation

Volume 557 July 2012

---

| Contents | | I   Legislative acts | page |
| --- | --- | --- | --- |
| | | DECISIONS |
| | * | Decision No 602/2012/EU of the European Parliament and of the Council of 4 July 2012 on amendments to the Agreement Establishing the European Bank for Reconstruction and Development (EBRD) extending the geographic scope of EBRD operations to the Southern and Eastern Mediterranean | 1 |

Contents

I   Legislative acts

page

DECISIONS

*

Decision No 602/2012/EU of the European Parliament and of the Council of 4 July 2012 on amendments to the Agreement Establishing the European Bank for Reconstruction and Development (EBRD) extending the geographic scope of EBRD operations to the Southern and Eastern Mediterranean

1

| | | II   Non-legislative acts |
| --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | | 2012/364/EU |
| | * | Council Decision of 25 June 2012 on the position to be taken by the European Union in the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement | 5 |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) No 603/2012 of 30 April 2012 amending Regulation (EU) No 1236/2010 of the European Parliament and of the Council laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries | 9 |
| | * | Commission Regulation (EU) No 604/2012 of 3 July 2012 establishing a prohibition of fishing for saithe in VI; EU and international waters of Vb, XII and XIV by vessels flying the flag of Spain | 10 |
| | * | Commission Implementing Regulation (EU) No 605/2012 of 4 July 2012 prohibiting fishing activities for traps registered in Spain, fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and in the Mediterranean Sea | 12 |
| | * | Commission Implementing Regulation (EU) No 606/2012 of 4 July 2012 prohibiting fishing activities for traps and longliners flying the flag of or registered in Italy, fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and in the Mediterranean Sea | 14 |
| | * | Commission Implementing Regulation (EU) No 607/2012 of 6 July 2012 on the detailed rules concerning the due diligence system and the frequency and nature of the checks on monitoring organisations as provided for in Regulation (EU) No 995/2010 of the European Parliament and of the Council laying down the obligations of operators who place timber and timber products on the market (
  1
  ) | 16 |
| | * | Commission Implementing Regulation (EU) No 608/2012 of 6 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil (
  1
  ) | 19 |
| | | Commission Implementing Regulation (EU) No 609/2012 of 6 July 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables | 23 |
| | | DIRECTIVES |
| | * | Commission Directive 2012/20/EU of 6 July 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include flufenoxuron as an active substance for product-type 8 in Annex I thereto (
  1
  ) | 25 |

II   Non-legislative acts

INTERNATIONAL AGREEMENTS

2012/364/EU

*

Council Decision of 25 June 2012 on the position to be taken by the European Union in the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

5

REGULATIONS

*

Commission Delegated Regulation (EU) No 603/2012 of 30 April 2012 amending Regulation (EU) No 1236/2010 of the European Parliament and of the Council laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries

9

*

Commission Regulation (EU) No 604/2012 of 3 July 2012 establishing a prohibition of fishing for saithe in VI; EU and international waters of Vb, XII and XIV by vessels flying the flag of Spain

10

*

Commission Implementing Regulation (EU) No 605/2012 of 4 July 2012 prohibiting fishing activities for traps registered in Spain, fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and in the Mediterranean Sea

12

*

Commission Implementing Regulation (EU) No 606/2012 of 4 July 2012 prohibiting fishing activities for traps and longliners flying the flag of or registered in Italy, fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and in the Mediterranean Sea

14

*

Commission Implementing Regulation (EU) No 607/2012 of 6 July 2012 on the detailed rules concerning the due diligence system and the frequency and nature of the checks on monitoring organisations as provided for in Regulation (EU) No 995/2010 of the European Parliament and of the Council laying down the obligations of operators who place timber and timber products on the market (
  1
  )

1

16

*

Commission Implementing Regulation (EU) No 608/2012 of 6 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil (
  1
  )

1

19

Commission Implementing Regulation (EU) No 609/2012 of 6 July 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

23

DIRECTIVES

*

Commission Directive 2012/20/EU of 6 July 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include flufenoxuron as an active substance for product-type 8 in Annex I thereto (
  1
  )

1

25

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

---

I Legislative acts

DECISIONS

| 7.7.2012 | EN | Official Journal of the European Union | L 177/1 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/1

---

DECISION No 602/2012/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 4 July 2012

on amendments to the Agreement Establishing the European Bank for Reconstruction and Development (EBRD) extending the geographic scope of EBRD operations to the Southern and Eastern Mediterranean

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 212 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Acting in accordance with the ordinary legislative procedure (1),

Whereas:

| (1) | Since its establishment in 1991, the European Bank for Reconstruction and Development (EBRD) has assisted the Central and Eastern European countries in their transition towards open market economies and the promotion of private and entrepreneurial initiative. The geographic scope of EBRD operations should be extended to the Southern and Eastern Mediterranean in order to promote similar objectives. In response to the economic and political situation in countries of the Southern and Eastern Mediterranean, the EBRD has developed a phased approach to starting its activities that will take into consideration the specificity of the region. |
| --- | --- |

(1)

Since its establishment in 1991, the European Bank for Reconstruction and Development (EBRD) has assisted the Central and Eastern European countries in their transition towards open market economies and the promotion of private and entrepreneurial initiative. The geographic scope of EBRD operations should be extended to the Southern and Eastern Mediterranean in order to promote similar objectives. In response to the economic and political situation in countries of the Southern and Eastern Mediterranean, the EBRD has developed a phased approach to starting its activities that will take into consideration the specificity of the region.

| (2) | According to the Report of the Board of Directors to the Board of Governors on the geographic expansion of the Bank’s region of operations to the Southern and Eastern Mediterranean, the Southern and Eastern Mediterranean consists of the countries that have a shoreline on the Mediterranean, as well as Jordan which is closely integrated into this region. |
| --- | --- |

(2)

According to the Report of the Board of Directors to the Board of Governors on the geographic expansion of the Bank’s region of operations to the Southern and Eastern Mediterranean, the Southern and Eastern Mediterranean consists of the countries that have a shoreline on the Mediterranean, as well as Jordan which is closely integrated into this region.

| (3) | In response to the 2011 events in the Southern and Eastern Mediterranean, on 8 March 2011 the Commission and the High Representative of the Union for Foreign Affairs and Security Policy presented a Joint Communication entitled ‘A Partnership for Democracy and Shared Prosperity with the Southern Mediterranean’ signalling the Union’s strong political and economic support to the region. The Joint Communication included an option to extend the EBRD’s mandate to cover the countries of the Southern Neighbourhood, building on the EBRD’s experience over the last 20 years. The European Council of 24 and 25 March 2011 broadly endorsed the contents of that Joint Communication. In its Resolution of 7 April 2011 on the review of the European Neighbourhood Policy – Southern Dimension, the European Parliament invited the EBRD to change its statute in order to participate in the financial assistance process. |
| --- | --- |

(3)

In response to the 2011 events in the Southern and Eastern Mediterranean, on 8 March 2011 the Commission and the High Representative of the Union for Foreign Affairs and Security Policy presented a Joint Communication entitled ‘A Partnership for Democracy and Shared Prosperity with the Southern Mediterranean’ signalling the Union’s strong political and economic support to the region. The Joint Communication included an option to extend the EBRD’s mandate to cover the countries of the Southern Neighbourhood, building on the EBRD’s experience over the last 20 years. The European Council of 24 and 25 March 2011 broadly endorsed the contents of that Joint Communication. In its Resolution of 7 April 2011 on the review of the European Neighbourhood Policy – Southern Dimension, the European Parliament invited the EBRD to change its statute in order to participate in the financial assistance process.

| (4) | In May 2011, the G8 leaders launched the Deauville Partnership to help the countries of the Southern and Eastern Mediterranean in their transition towards free, democratic and tolerant societies and called on the EBRD to extend its geographic scope in order to leverage its experience and support the transition of those countries to embrace the principles of multi-party democracy, pluralism and market economy. |
| --- | --- |

(4)

In May 2011, the G8 leaders launched the Deauville Partnership to help the countries of the Southern and Eastern Mediterranean in their transition towards free, democratic and tolerant societies and called on the EBRD to extend its geographic scope in order to leverage its experience and support the transition of those countries to embrace the principles of multi-party democracy, pluralism and market economy.

| (5) | The expansion of EBRD operations to the Southern and Eastern Mediterranean reflects support by the Union and the international community for the hope, encouraged by the Arab Spring, for a transition in that region towards market economies and pluralistic democratic societies. |
| --- | --- |

(5)

The expansion of EBRD operations to the Southern and Eastern Mediterranean reflects support by the Union and the international community for the hope, encouraged by the Arab Spring, for a transition in that region towards market economies and pluralistic democratic societies.

| (6) | Bearing in mind the fragility of the economies in the EBRD’s new countries of operation and the social inequalities which were one of the root causes of the turmoil of the Arab Spring, the representatives of the Union in the governing bodies of the EBRD should encourage the EBRD to broaden its focus on private-sector development, in order also to contribute, through its financing, to the achievement of socially and environmentally sustainable societies, as elaborated in the relevant Millennium Development Goals, and in line with Article 3(5) and Article 21 of the Treaty on European Union. In particular, the representatives of the Union in the governing bodies of the EBRD should encourage the EBRD’s contribution to the transition towards energy-efficient, socially inclusive, open market economies while taking into account the social, poverty, civil and human rights context. |
| --- | --- |

(6)

Bearing in mind the fragility of the economies in the EBRD’s new countries of operation and the social inequalities which were one of the root causes of the turmoil of the Arab Spring, the representatives of the Union in the governing bodies of the EBRD should encourage the EBRD to broaden its focus on private-sector development, in order also to contribute, through its financing, to the achievement of socially and environmentally sustainable societies, as elaborated in the relevant Millennium Development Goals, and in line with Article 3(5) and Article 21 of the Treaty on European Union. In particular, the representatives of the Union in the governing bodies of the EBRD should encourage the EBRD’s contribution to the transition towards energy-efficient, socially inclusive, open market economies while taking into account the social, poverty, civil and human rights context.

| (7) | By Resolutions 137 and 138, adopted on 30 September 2011, the Board of Governors of the EBRD voted in favour of the necessary amendments to the Agreement Establishing the EBRD (the ‘Agreement’), enabling it to expand the geographical scope of EBRD operations to the Southern and Eastern Mediterranean while maintaining its commitment to its existing countries of operation. All EU Governors of the EBRD, including the Governor representing the Union, voted in favour of those amendments. |
| --- | --- |

(7)

By Resolutions 137 and 138, adopted on 30 September 2011, the Board of Governors of the EBRD voted in favour of the necessary amendments to the Agreement Establishing the EBRD (the ‘Agreement’), enabling it to expand the geographical scope of EBRD operations to the Southern and Eastern Mediterranean while maintaining its commitment to its existing countries of operation. All EU Governors of the EBRD, including the Governor representing the Union, voted in favour of those amendments.

| (8) | By its Resolution 134, adopted on 21 May 2011, the Board of Governors of the EBRD stressed that the planned extension of the EBRD’s mandate should be achieved without requiring additional capital contributions from its shareholders. |
| --- | --- |

(8)

By its Resolution 134, adopted on 21 May 2011, the Board of Governors of the EBRD stressed that the planned extension of the EBRD’s mandate should be achieved without requiring additional capital contributions from its shareholders.

| (9) | Pursuant to Article 56 of the Agreement, the Board of Governors of the EBRD is to ask all members whether they accept the proposed amendments. |
| --- | --- |

(9)

Pursuant to Article 56 of the Agreement, the Board of Governors of the EBRD is to ask all members whether they accept the proposed amendments.

| (10) | The representatives of the Union in the governing bodies of the EBRD should use their best endeavours to encourage the EBRD to monitor its operations closely, particularly in countries where there is a lack of political accountability, where civil and human rights are infringed or where high levels of corruption persist. Furthermore, the representatives of the Union in the governing bodies of the EBRD should use their best endeavours to ensure that the principles of prudential banking, transparency and anti-fraud, as invoked in Decision No 1219/2011/EU of the European Parliament and of the Council of 16 November 2011 concerning the subscription by the European Union to additional shares in the capital of the European Bank for Reconstruction and Development (EBRD) as a result of the decision to increase this capital (2), are taken into account in the activities of the EBRD in the new countries of operation. |
| --- | --- |

(10)

The representatives of the Union in the governing bodies of the EBRD should use their best endeavours to encourage the EBRD to monitor its operations closely, particularly in countries where there is a lack of political accountability, where civil and human rights are infringed or where high levels of corruption persist. Furthermore, the representatives of the Union in the governing bodies of the EBRD should use their best endeavours to ensure that the principles of prudential banking, transparency and anti-fraud, as invoked in Decision No 1219/2011/EU of the European Parliament and of the Council of 16 November 2011 concerning the subscription by the European Union to additional shares in the capital of the European Bank for Reconstruction and Development (EBRD) as a result of the decision to increase this capital (2), are taken into account in the activities of the EBRD in the new countries of operation.

| (11) | In carrying out its activities in the Southern and Eastern Mediterranean, the representatives of the Union in the governing bodies of the EBRD should encourage the EBRD to continue its close engagement with the Union and collaboration with civil society, as well as to develop further its close cooperation with the European Investment Bank and other European and international public financing institutions, in order to make full use of their comparative advantages. The EBRD should also avoid duplicating the activities of such other public financing institutions. |
| --- | --- |

(11)

In carrying out its activities in the Southern and Eastern Mediterranean, the representatives of the Union in the governing bodies of the EBRD should encourage the EBRD to continue its close engagement with the Union and collaboration with civil society, as well as to develop further its close cooperation with the European Investment Bank and other European and international public financing institutions, in order to make full use of their comparative advantages. The EBRD should also avoid duplicating the activities of such other public financing institutions.

| (12) | Before the EBRD approves a potential new country of operation, it should make a detailed technical assessment of the economic and political conditions existing in the country concerned, including: an assessment of that country’s commitment to principles of multi-party democracy, pluralism and market economics, as enshrined in Article 1 of the Agreement, an assessment of transition gaps, and a review of activities of other international financing institutions in that country and of the priorities in relation to which the EBRD could best make use of its unique knowledge and skills. In discussing those assessments, the representatives of the Union in the governing bodies of the EBRD should encourage the EBRD to take full account of the views of the Union. |
| --- | --- |

(12)

Before the EBRD approves a potential new country of operation, it should make a detailed technical assessment of the economic and political conditions existing in the country concerned, including: an assessment of that country’s commitment to principles of multi-party democracy, pluralism and market economics, as enshrined in Article 1 of the Agreement, an assessment of transition gaps, and a review of activities of other international financing institutions in that country and of the priorities in relation to which the EBRD could best make use of its unique knowledge and skills. In discussing those assessments, the representatives of the Union in the governing bodies of the EBRD should encourage the EBRD to take full account of the views of the Union.

| (13) | In the report that the Commission will present in accordance with Decision No 1219/2011/EU by the end of the fourth Capital Resources Review for the period of 2011-15, the Commission should take into account the extension of the EBRD’s work in the Southern and Eastern Mediterranean. |
| --- | --- |

(13)

In the report that the Commission will present in accordance with Decision No 1219/2011/EU by the end of the fourth Capital Resources Review for the period of 2011-15, the Commission should take into account the extension of the EBRD’s work in the Southern and Eastern Mediterranean.

| (14) | With respect to the EBRD’s contribution to the transition of the prospective countries of operation in the Southern and Eastern Mediterranean towards well-functioning, sustainable, modern market economies, the representatives of the Union in the governing bodies of the EBRD should invite the EBRD to report on its performance annually and to conduct comprehensive assessments of its impact on building such economies in advance of its quinquennial capital resources reviews. |
| --- | --- |

(14)

With respect to the EBRD’s contribution to the transition of the prospective countries of operation in the Southern and Eastern Mediterranean towards well-functioning, sustainable, modern market economies, the representatives of the Union in the governing bodies of the EBRD should invite the EBRD to report on its performance annually and to conduct comprehensive assessments of its impact on building such economies in advance of its quinquennial capital resources reviews.

| (15) | The amendments to the Agreement should therefore be approved on behalf of the Union, |
| --- | --- |

(15)

The amendments to the Agreement should therefore be approved on behalf of the Union,

HAVE ADOPTED THIS DECISION:

Article 1

The amendments to Articles 1 and 18 of the Agreement, which extend the geographical scope of EBRD operations, are hereby approved on behalf of the Union.

The text of the amendments is set out in the Annex for informative purposes.

Article 2

The Governor of the EBRD representing the Union shall, on behalf of the Union, communicate to the EBRD the Declaration of Acceptance of the amendments.

Article 3

As part of the annual report to the European Parliament, the Governor of the EBRD representing the Union shall also report on the EBRD’s activities and operations in the Southern and Eastern Mediterranean.

Article 4

This Decision shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

Done at Strasbourg, 4 July 2012.

For the European Parliament

The President

M. SCHULZ

For the Council

The President

A. D. MAVROYIANNIS

---

(1)  Position of the European Parliament of 13 June 2012 (not yet published in the Official Journal) and decision of the Council of 26 June 2012.

1

(2)  OJ L 313, 26.11.2011, p. 1.

2

---

ANNEX

AMENDMENTS TO THE AGREEMENT ESTABLISHING THE EUROPEAN BANK FOR RECONSTRUCTION AND DEVELOPMENT

Article 1 of the Agreement Establishing the Bank shall be amended to read as follows (new text in italics):

‘Article 1

Purpose

In contributing to economic progress and reconstruction, the purpose of the Bank shall be to foster the transition towards open market-oriented economies and to promote private and entrepreneurial initiative in the Central and Eastern European countries committed to and applying the principles of multiparty democracy, pluralism and market economics. Subject to the same conditions, the purpose of the Bank may also be carried out in Mongolia and in member countries of the Southern and Eastern Mediterranean as determined by the Bank upon the affirmative vote of not less than two-thirds of the Governors, representing not less than three-fourths of the total voting power of the members. Accordingly, any reference in this Agreement and its annexes to “Central and Eastern European countries”, “countries from Central and Eastern Europe”, “recipient country (or countries)” or “recipient member country (or countries)” shall refer to Mongolia and each of such countries of the Southern and Eastern Mediterranean as well.’

Article 18 of the Agreement Establishing the Bank shall be amended to read as follows (new text in italics):

‘Article 18

Special funds

| (i) | The Bank may accept the administration of Special Funds which are designed to serve the purpose and come within the functions of the Bank in its recipient countries and potential recipient countries. The full cost of administering any such Special Fund shall be charged to that Special Fund. |
| --- | --- |

(i)

The Bank may accept the administration of Special Funds which are designed to serve the purpose and come within the functions of the Bank in its recipient countries and potential recipient countries. The full cost of administering any such Special Fund shall be charged to that Special Fund.

| (ii) | For the purposes of subparagraph (i), the Board of Governors may, at the request of a member which is not a recipient country, decide that such member qualifies as a potential recipient country for such limited period and under such terms as may seem advisable. Such decision shall be taken by the affirmative vote of not less than two-thirds of the Governors, representing not less than three-fourths of the total voting power of the members. |
| --- | --- |

(ii)

For the purposes of subparagraph (i), the Board of Governors may, at the request of a member which is not a recipient country, decide that such member qualifies as a potential recipient country for such limited period and under such terms as may seem advisable. Such decision shall be taken by the affirmative vote of not less than two-thirds of the Governors, representing not less than three-fourths of the total voting power of the members.

| (iii) | The decision to allow a member to qualify as a potential recipient country can only be made if such member is able to meet the requirements for becoming a recipient country. Such requirements are those set out in Article 1 of this Agreement, as it reads at the time of such decision or as it will read upon the entry into force of an amendment that has already been approved by the Board of Governors at the time of such decision. |
| --- | --- |

(iii)

The decision to allow a member to qualify as a potential recipient country can only be made if such member is able to meet the requirements for becoming a recipient country. Such requirements are those set out in Article 1 of this Agreement, as it reads at the time of such decision or as it will read upon the entry into force of an amendment that has already been approved by the Board of Governors at the time of such decision.

| (iv) | If a potential recipient country has not become a recipient country at the end of the period referred to in subparagraph (ii), the Bank shall forthwith cease any special operations in that country, except those incident to the orderly realisation, conservation and preservation of the assets of the Special Fund and settlement of obligations that have arisen in connection therewith. |
| --- | --- |

(iv)

If a potential recipient country has not become a recipient country at the end of the period referred to in subparagraph (ii), the Bank shall forthwith cease any special operations in that country, except those incident to the orderly realisation, conservation and preservation of the assets of the Special Fund and settlement of obligations that have arisen in connection therewith.

2.   Special Funds accepted by the Bank may be used in its recipient countries and potential recipient countries in any manner and on any terms and conditions consistent with the purpose and functions of the Bank, with the other applicable provisions of this Agreement, and with the agreement or agreements relating to such Funds.

3.   The Bank shall adopt such rules and regulations as may be required for the establishment, administration and use of each Special Fund. Such rules and regulations shall be consistent with the provisions of this Agreement, except for those provisions expressly applicable only to ordinary operations of the Bank.’

---

II Non-legislative acts

INTERNATIONAL AGREEMENTS

| 7.7.2012 | EN | Official Journal of the European Union | L 177/5 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/5

---

COUNCIL DECISION

of 25 June 2012

on the position to be taken by the European Union in the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

(2012/364/EU)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43(2), 114(1) and 207(2), in conjunction with 218(9) thereof,

Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing the Agreement on the European Economic Area (1), and in particular Article 1(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State (2) is to be incorporated into the Agreement on the European Economic Area (‘EEA Agreement’). |
| --- | --- |

(1)

Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State (2) is to be incorporated into the Agreement on the European Economic Area (‘EEA Agreement’).

| (2) | Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (3) is to be incorporated into the EEA Agreement. |
| --- | --- |

(2)

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (3) is to be incorporated into the EEA Agreement.

| (3) | Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (4) is to be incorporated into the EEA Agreement. |
| --- | --- |

(3)

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (4) is to be incorporated into the EEA Agreement.

| (4) | Decision No 768/2008/EC sets out common principles and reference provisions for future legislation harmonising the conditions for the marketing of products and a reference text for existing legislation. |
| --- | --- |

(4)

Decision No 768/2008/EC sets out common principles and reference provisions for future legislation harmonising the conditions for the marketing of products and a reference text for existing legislation.

| (5) | Regulation (EC) No 764/2008 repeals Decision No 3052/95/EC of the European Parliament and of the Council of 13 December 1995 establishing a procedure for the exchange of information on national measures derogating from the principle of the free movement of goods within the Community (5) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Regulation (EC) No 764/2008. |
| --- | --- |

(5)

Regulation (EC) No 764/2008 repeals Decision No 3052/95/EC of the European Parliament and of the Council of 13 December 1995 establishing a procedure for the exchange of information on national measures derogating from the principle of the free movement of goods within the Community (5) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Regulation (EC) No 764/2008.

| (6) | Regulation (EC) No 765/2008 repeals Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries (6) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Regulation (EC) No 765/2008. |
| --- | --- |

(6)

Regulation (EC) No 765/2008 repeals Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries (6) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Regulation (EC) No 765/2008.

| (7) | Decision No 768/2008/EC repeals 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 harmonization directives (7) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Decision No 768/2008/EC. |
| --- | --- |

(7)

Decision No 768/2008/EC repeals 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 harmonization directives (7) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Decision No 768/2008/EC.

| (8) | Annex II to the EEA Agreement should therefore be amended accordingly. |
| --- | --- |

(8)

Annex II to the EEA Agreement should therefore be amended accordingly.

| (9) | The position of the Union in the EEA Joint Committee should therefore be based on the attached draft Decision, |
| --- | --- |

(9)

The position of the Union in the EEA Joint Committee should therefore be based on the attached draft Decision,

HAS ADOPTED THIS DECISION:

Article 1

The position to be taken by the Union in the EEA Joint Committee on the proposed amendment to Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement shall be based on the draft Decision of the EEA Joint Committee attached to this Decision.

Article 2

This Decision shall enter into force on the day of its adoption.

Done at Luxembourg, 25 June 2012.

For the Council

The President

C. ASHTON

---

(1)  OJ L 305, 30.11.1994, p. 6.

1

(2)  OJ L 218, 13.8.2008, p. 21.

2

(3)  OJ L 218, 13.8.2008, p. 30.

3

(4)  OJ L 218, 13.8.2008, p. 82.

4

(5)  OJ L 321, 30.12.1995, p. 1.

5

(6)  OJ L 40, 17.2.1993, p. 1.

6

(7)  OJ L 220, 30.8.1993, p. 23.

7

---

DRAFT

DECISION No .../2012 OF THE EEA JOINT COMMITTEE

of

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area, as amended by the Protocol adjusting the Agreement on the European Economic Area, and in particular Article 98 thereof,

Whereas:

| (1) | Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State (1) is to be incorporated into the Agreement on the European Economic Area (‘EEA Agreement’). |
| --- | --- |

(1)

Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State (1) is to be incorporated into the Agreement on the European Economic Area (‘EEA Agreement’).

| (2) | Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (2) is to be incorporated into the EEA Agreement. |
| --- | --- |

(2)

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (2) is to be incorporated into the EEA Agreement.

| (3) | Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (3) is to be incorporated into the EEA Agreement. |
| --- | --- |

(3)

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (3) is to be incorporated into the EEA Agreement.

| (4) | Decision No 768/2008/EC sets out common principles and reference provisions for future legislation harmonizing the conditions for the marketing of products and a reference text for existing legislation. |
| --- | --- |

(4)

Decision No 768/2008/EC sets out common principles and reference provisions for future legislation harmonizing the conditions for the marketing of products and a reference text for existing legislation.

| (5) | Regulation (EC) No 764/2008 repeals Decision No 3052/95/EC of the European Parliament and of the Council of 13 December 1995 establishing a procedure for the exchange of information on national measures derogating from the principle of the free movement of goods within the Community (4) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Regulation (EC) No 764/2008. |
| --- | --- |

(5)

Regulation (EC) No 764/2008 repeals Decision No 3052/95/EC of the European Parliament and of the Council of 13 December 1995 establishing a procedure for the exchange of information on national measures derogating from the principle of the free movement of goods within the Community (4) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Regulation (EC) No 764/2008.

| (6) | Regulation (EC) No 765/2008 repeals Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries (5) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Regulation (EC) No 765/2008. |
| --- | --- |

(6)

Regulation (EC) No 765/2008 repeals Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries (5) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Regulation (EC) No 765/2008.

| (7) | Decision No 768/2008/EC repeals 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 harmonization directives (6) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Decision No 768/2008/EC. |
| --- | --- |

(7)

Decision No 768/2008/EC repeals 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 harmonization directives (6) which is incorporated into the EEA Agreement. The EEA Agreement should therefore be amended to take account of Decision No 768/2008/EC.

| (8) | Annex II to the EEA Agreement should therefore be amended accordingly, |
| --- | --- |

(8)

Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Chapter XIX of Annex II to the EEA Agreement shall be amended as follows:

| (1) | the text of point 3b (Council Regulation (EEC) No 339/93) shall be replaced by the following:
  ‘32008 R 0765: Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
  The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:






  (a) | the following shall be added at the end of Article 4(2):
  “Liechtenstein shall also have recourse to the national accreditation body of Switzerland for the product sectors covered by the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment and in respect of which EU and Swiss requirements are deemed equivalent pursuant to Article 1(2) and (3) of that Agreement”. |
| --- | --- | --- |

(1)

the text of point 3b (Council Regulation (EEC) No 339/93) shall be replaced by the following:

‘32008 R 0765: Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

(a)

the following shall be added at the end of Article 4(2):

“Liechtenstein shall also have recourse to the national accreditation body of Switzerland for the product sectors covered by the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment and in respect of which EU and Swiss requirements are deemed equivalent pursuant to Article 1(2) and (3) of that Agreement”.

| (b) | Products exported from Liechtenstein to the other Contracting Parties may be subjected to border controls according to Articles 27-29.’; |
| --- | --- |

(b)

Products exported from Liechtenstein to the other Contracting Parties may be subjected to border controls according to Articles 27-29.’;

| (2) | the text of point 3d (Council Decision 93/465/EEC) shall be replaced by the following:
  ‘32008 D 0768: Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).’; |
| --- | --- |

(2)

the text of point 3d (Council Decision 93/465/EEC) shall be replaced by the following:

‘32008 D 0768: Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).’;

| (3) | the text of point 3f (Decision No 3052/95/EC of the European Parliament and of the Council) shall be replaced by the following:
  ‘32008 R 0764: Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (OJ L 218, 13.8.2008, p. 21).
  The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:
  The Regulation shall only apply to products covered by Article 8(3) of the Agreement.
  The Regulation shall not apply to Liechtenstein in relation to products covered by Annex I, Chapters XII and XXVII of Annex II and Protocol 47 to the Agreement, as long as the application of the Agreement between the European Community and the Swiss Confederation on trade in agricultural products is extended to Liechtenstein.’; |
| --- | --- |

(3)

the text of point 3f (Decision No 3052/95/EC of the European Parliament and of the Council) shall be replaced by the following:

‘32008 R 0764: Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (OJ L 218, 13.8.2008, p. 21).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

The Regulation shall only apply to products covered by Article 8(3) of the Agreement.

The Regulation shall not apply to Liechtenstein in relation to products covered by Annex I, Chapters XII and XXVII of Annex II and Protocol 47 to the Agreement, as long as the application of the Agreement between the European Community and the Swiss Confederation on trade in agricultural products is extended to Liechtenstein.’;

| (4) | the following shall be inserted in point 3h (Directive 2001/95/EC of the European Parliament and of the Council):
  ‘, as amended by:






  — | 32008 R 0765: Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 (OJ L 218, 13.8.2008, p. 30).’. |
| --- | --- | --- |

(4)

the following shall be inserted in point 3h (Directive 2001/95/EC of the European Parliament and of the Council):

‘, as amended by:

—

32008 R 0765: Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 (OJ L 218, 13.8.2008, p. 30).’.

Article 2

The texts of Regulations (EC) No 764/2008 and (EC) No 765/2008 and Decision No 768/2008/EC in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on ..., provided that all the notifications under Article 103(1) of the EEA Agreement have been made to the EEA Joint Committee (7).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, .

For the EEA Joint Committee

The President

The Secretaries to the EEA Joint Committee

---

(1)  OJ L 218, 13.8.2008, p. 21.

1

(2)  OJ L 218, 13.8.2008, p. 30.

2

(3)  OJ L 218, 13.8.2008, p. 82.

3

(4)  OJ L 321, 30.12.1995, p. 1.

4

(5)  OJ L 40, 17.2.1993, p. 1.

5

(6)  OJ L 220, 30.8.1993, p. 23.

6

(7)  [No constitutional requirements indicated.] [Constitutional requirements indicated.]

7

---

REGULATIONS

| 7.7.2012 | EN | Official Journal of the European Union | L 177/9 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/9

---

COMMISSION DELEGATED REGULATION (EU) No 603/2012

of 30 April 2012

amending Regulation (EU) No 1236/2010 of the European Parliament and of the Council laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1236/2010 of the European Parliament and of the Council of 15 December 2010 laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries and repealing Council Regulation (EC) No 2791/1999 (1), and in particular Article 51(d) thereof,

Whereas:

| (1) | Regulation (EU) No 1236/2010 incorporates into Union law the provisions of the Scheme of control and enforcement (‘the Scheme’) established by a recommendation adopted by the North-East Atlantic Fisheries Commission (NEAFC) at its Annual Meeting on 15 November 2006, and subsequently amended by several recommendations at the Annual Meetings in November 2007, 2008 and 2009. |
| --- | --- |

(1)

Regulation (EU) No 1236/2010 incorporates into Union law the provisions of the Scheme of control and enforcement (‘the Scheme’) established by a recommendation adopted by the North-East Atlantic Fisheries Commission (NEAFC) at its Annual Meeting on 15 November 2006, and subsequently amended by several recommendations at the Annual Meetings in November 2007, 2008 and 2009.

| (2) | At its Annual Meeting in November 2011, NEAFC adopted Recommendation 9: 2012 amending Article 14 of the Scheme on the communication of reports and messages to the NEAFC Secretary. |
| --- | --- |

(2)

At its Annual Meeting in November 2011, NEAFC adopted Recommendation 9: 2012 amending Article 14 of the Scheme on the communication of reports and messages to the NEAFC Secretary.

| (3) | Under Articles 12 and 15 of the Convention on future multilateral cooperation in the North-East Atlantic fisheries approved by Council Decision 81/608/EEC (2), that recommendation came into force on 3 February 2012, |
| --- | --- |

(3)

Under Articles 12 and 15 of the Convention on future multilateral cooperation in the North-East Atlantic fisheries approved by Council Decision 81/608/EEC (2), that recommendation came into force on 3 February 2012,

HAS ADOPTED THIS REGULATION:

Article 1

In Article 12 of Regulation (EU) No 1236/2010, the following paragraph 1a is inserted after paragraph 1:

‘1a.   The reports referred to in Article 9 may be cancelled by means of a cancellation report.

If a report requires a correction, it shall be cancelled by way of a cancellation report. A new, corrected report shall be sent after the cancellation report and within the time limits set out in Article 9.

If the Fisheries Monitoring Centre of the flag Member State accepts the cancellation of a report, it shall communicate it to the NEAFC Secretary.’

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 April 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 348, 31.12.2010, p. 17.

1

(2)  OJ L 227, 12.8.1981, p. 21.

2

---

| 7.7.2012 | EN | Official Journal of the European Union | L 177/10 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/10

---

COMMISSION REGULATION (EU) No 604/2012

of 3 July 2012

establishing a prohibition of fishing for saithe in VI; EU and international waters of Vb, XII and XIV by vessels flying the flag of Spain

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

| (1) | Council Regulation (EU) No 44/2012 of 17 January 2012 fixing for 2012 the fishing opportunities available in EU waters and, to EU vessels, in certain non-EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements (2), lays down quotas for 2012. |
| --- | --- |

(1)

Council Regulation (EU) No 44/2012 of 17 January 2012 fixing for 2012 the fishing opportunities available in EU waters and, to EU vessels, in certain non-EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements (2), lays down quotas for 2012.

| (2) | According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2012. |
| --- | --- |

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2012.

| (3) | It is therefore necessary to prohibit fishing activities for that stock, |
| --- | --- |

(3)

It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2012 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 3 July 2012.

For the Commission, On behalf of the President,

Lowri EVANS

Director-General for Maritime Affairs and Fisheries

---

(1)  OJ L 343, 22.12.2009, p. 1.

1

(2)  OJ L 25, 27.01.2012, p. 55.

2

---

ANNEX

| No | 7/T&Q |
| --- | --- |
| Member State | Spain |
| Stock | POK/56-14 |
| Species | Saithe (Pollachius virens) |
| Zone | VI; EU and international waters of Vb, XII and XIV |
| Date | 12.6.2012 |

No

7/T&Q

Member State

Spain

Stock

POK/56-14

Species

Saithe (Pollachius virens)

Zone

VI; EU and international waters of Vb, XII and XIV

Date

12.6.2012

---

| 7.7.2012 | EN | Official Journal of the European Union | L 177/12 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/12

---

COMMISSION IMPLEMENTING REGULATION (EU) No 605/2012

of 4 July 2012

prohibiting fishing activities for traps registered in Spain, fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and in the Mediterranean Sea

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules on the common fisheries policy, (1) and in particular Article 36, paragraph 2 thereof,

Whereas:

| (1) | Council Regulation (EU) No 44/2012 of 17 January 2012 fixing for 2012 the fishing opportunities available in EU waters and, to EU vessels, in certain non EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements fixes the amount of bluefin tuna which may be fished in 2012 in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean Sea. |
| --- | --- |

(1)

Council Regulation (EU) No 44/2012 of 17 January 2012 fixing for 2012 the fishing opportunities available in EU waters and, to EU vessels, in certain non EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements fixes the amount of bluefin tuna which may be fished in 2012 in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean Sea.

| (2) | Council Regulation (EC) No 302/2009 of 6 April 2009 concerning a multiannual recovery plan for bluefin tuna in the Eastern Atlantic and Mediterranean, amending Regulation (EC) No 43/2009 and repealing Regulation (EC) No 1559/2007 (2), requires Member States for vessels less than 24 m and for traps to inform the Commission of the quota allocated to producer organisations or groups of vessels fishing with similar gear. |
| --- | --- |

(2)

Council Regulation (EC) No 302/2009 of 6 April 2009 concerning a multiannual recovery plan for bluefin tuna in the Eastern Atlantic and Mediterranean, amending Regulation (EC) No 43/2009 and repealing Regulation (EC) No 1559/2007 (2), requires Member States for vessels less than 24 m and for traps to inform the Commission of the quota allocated to producer organisations or groups of vessels fishing with similar gear.

| (3) | The Common Fisheries Policy is designed to ensure the long-term viability of the fisheries sector through sustainable exploitation of living aquatic resources based on the precautionary approach. |
| --- | --- |

(3)

The Common Fisheries Policy is designed to ensure the long-term viability of the fisheries sector through sustainable exploitation of living aquatic resources based on the precautionary approach.

| (4) | In accordance with Article 36, paragraph 2 of Council Regulation (EC) No 1224/2009, where the Commission finds that, on the basis of information provided by Member States and of other information in its possession, fishing opportunities available to the European Union, a Member State or group of Member States are deemed to have been exhausted for one or more gears or fleets, the Commission shall inform the Member States concerned thereof and shall prohibit fishing activities for the respective area, gear, stock, group of stocks or fleet involved in those specific fishing activities. |
| --- | --- |

(4)

In accordance with Article 36, paragraph 2 of Council Regulation (EC) No 1224/2009, where the Commission finds that, on the basis of information provided by Member States and of other information in its possession, fishing opportunities available to the European Union, a Member State or group of Member States are deemed to have been exhausted for one or more gears or fleets, the Commission shall inform the Member States concerned thereof and shall prohibit fishing activities for the respective area, gear, stock, group of stocks or fleet involved in those specific fishing activities.

| (5) | The information in the Commission's possession indicates that the fishing opportunities for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean Sea allocated to traps registered in Spain is deemed to have been exhausted on 20 June. The Commission has informed Spain thereof. |
| --- | --- |

(5)

The information in the Commission's possession indicates that the fishing opportunities for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean Sea allocated to traps registered in Spain is deemed to have been exhausted on 20 June. The Commission has informed Spain thereof.

| (6) | On the 7, 14 and the 21 June, Spain informed the Commission of the fact that it had imposed a stop on the fishing activities of its four traps active in the 2012 bluefin tuna fishery, with effect from 8 June for two of the traps and with effect from 14 June for one trap and with effect from 21 June for the remaining trap, resulting in the prohibition of all the activities as from 21 June 2012 at 14:00. |
| --- | --- |

(6)

On the 7, 14 and the 21 June, Spain informed the Commission of the fact that it had imposed a stop on the fishing activities of its four traps active in the 2012 bluefin tuna fishery, with effect from 8 June for two of the traps and with effect from 14 June for one trap and with effect from 21 June for the remaining trap, resulting in the prohibition of all the activities as from 21 June 2012 at 14:00.

| (7) | Without prejudice to the actions by Spain mentioned above, it is necessary that the Commission confirms the prohibition of fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W and the Mediterranean Sea as from 21 June by traps registered in Spain. |
| --- | --- |

(7)

Without prejudice to the actions by Spain mentioned above, it is necessary that the Commission confirms the prohibition of fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W and the Mediterranean Sea as from 21 June by traps registered in Spain.

HAS ADOPTED THIS REGULATION:

Article 1

Fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean Sea by traps registered in Spain shall be prohibited as from 21 June 2012 at 14:00 at the latest.

It shall also be prohibited to retain on board, place in cages for fattening or farming, tranship, transfer or land such stock caught by those traps as from that date.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 4 July 2012.

For the Commission, On behalf of the President,

László ANDOR

Member of the Commission

---

(1)  OJ L 343, 22.12.2009, p.1

1

(2)  OJ L 96, 15.4.2009, p. 1.

2

---

| 7.7.2012 | EN | Official Journal of the European Union | L 177/14 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/14

---

COMMISSION IMPLEMENTING REGULATION (EU) No 606/2012

of 4 July 2012

prohibiting fishing activities for traps and longliners flying the flag of or registered in Italy, fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and in the Mediterranean Sea

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules on the common fisheries policy, (1) and in particular Article 36, paragraph 2 thereof,

Whereas:

| (1) | Council Regulation (EU) No 44/2012 of 17 January 2012 fixing for 2012 the fishing opportunities available in EU waters and, to EU vessels, in certain non EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements fixes the amount of bluefin tuna which may be fished in 2012 in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean Sea. |
| --- | --- |

(1)

Council Regulation (EU) No 44/2012 of 17 January 2012 fixing for 2012 the fishing opportunities available in EU waters and, to EU vessels, in certain non EU waters for certain fish stocks and groups of fish stocks which are subject to international negotiations or agreements fixes the amount of bluefin tuna which may be fished in 2012 in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean Sea.

| (2) | Council Regulation (EC) No 302/2009 of 6 April 2009 concerning a multiannual recovery plan for bluefin tuna in the Eastern Atlantic and Mediterranean, amending Regulation (EC) No 43/2009 and repealing Regulation (EC) No 1559/2007, (2) requires Member States to inform the Commission of the individual quota allocated to their vessels over 24 metres and, for catching vessels less than 24 metres and for traps, at least of the quota allocated to producer organisations or groups of vessels fishing with similar gear. |
| --- | --- |

(2)

Council Regulation (EC) No 302/2009 of 6 April 2009 concerning a multiannual recovery plan for bluefin tuna in the Eastern Atlantic and Mediterranean, amending Regulation (EC) No 43/2009 and repealing Regulation (EC) No 1559/2007, (2) requires Member States to inform the Commission of the individual quota allocated to their vessels over 24 metres and, for catching vessels less than 24 metres and for traps, at least of the quota allocated to producer organisations or groups of vessels fishing with similar gear.

| (3) | The Common Fisheries Policy is designed to ensure the long-term viability of the fisheries sector through sustainable exploitation of living aquatic resources based on the precautionary approach. |
| --- | --- |

(3)

The Common Fisheries Policy is designed to ensure the long-term viability of the fisheries sector through sustainable exploitation of living aquatic resources based on the precautionary approach.

| (4) | In accordance with Article 36, paragraph 2 of Council Regulation (EC) No 1224/2009, where the Commission finds that, on the basis of information provided by Member States and of other information in its possession fishing opportunities available to the European Union, a Member State or group of Member States are deemed to have been exhausted for one or more gears or fleets, the Commission shall inform the Member States concerned thereof and shall prohibit fishing activities for the respective area, gear, stock, group of stocks or fleet involved in those specific fishing activities. |
| --- | --- |

(4)

In accordance with Article 36, paragraph 2 of Council Regulation (EC) No 1224/2009, where the Commission finds that, on the basis of information provided by Member States and of other information in its possession fishing opportunities available to the European Union, a Member State or group of Member States are deemed to have been exhausted for one or more gears or fleets, the Commission shall inform the Member States concerned thereof and shall prohibit fishing activities for the respective area, gear, stock, group of stocks or fleet involved in those specific fishing activities.

| (5) | The information in the Commission's possession indicates that the fishing opportunities for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean Sea allocated to traps and longliners flying the flag of or registered in Italy are deemed to have been exhausted. |
| --- | --- |

(5)

The information in the Commission's possession indicates that the fishing opportunities for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean Sea allocated to traps and longliners flying the flag of or registered in Italy are deemed to have been exhausted.

| (6) | On 20 June 2012 Italy informed the Commission of the fact that it had imposed a stop on the fishing activities of its traps and longline vessels active in the 2012 bluefin tuna fishery, with effect from 20 June at 13:00 for longliners and with effect from 22 June at 17:00 for traps. |
| --- | --- |

(6)

On 20 June 2012 Italy informed the Commission of the fact that it had imposed a stop on the fishing activities of its traps and longline vessels active in the 2012 bluefin tuna fishery, with effect from 20 June at 13:00 for longliners and with effect from 22 June at 17:00 for traps.

| (7) | Without prejudice to the action taken by Italy mentioned above, it is necessary that the Commission confirms the prohibition of fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W and the Mediterranean Sea, as from 20 June 2012 at 13:00 for longliners flying the flag of or registered in Italy and as from 22 June 2012 at 17:00 for traps registered in Italy. |
| --- | --- |

(7)

Without prejudice to the action taken by Italy mentioned above, it is necessary that the Commission confirms the prohibition of fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W and the Mediterranean Sea, as from 20 June 2012 at 13:00 for longliners flying the flag of or registered in Italy and as from 22 June 2012 at 17:00 for traps registered in Italy.

HAS ADOPTED THIS REGULATION:

Article 1

Fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean by longliners flying the flag of or registered in Italy shall be prohibited as from 20 June 2012 at 13:00.

It shall also be prohibited to retain on board, place in cages for fattening or farming, tranship, transfer or land such stock caught by those vessels as from that date.

Article 2

Fishing for bluefin tuna in the Atlantic Ocean, east of longitude 45° W, and the Mediterranean by traps registered in Italy shall be prohibited as from 22 June 2012 at 17:00.

It shall also be prohibited to retain on board, place in cages for fattening or farming, tranship, transfer or land such stock caught by those traps as from that date.

Article 3

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 4 July 2012.

For the Commission, On behalf of the President,

László ANDOR

Member of the Commission

---

(1)  OJ L 343, 22.12.2009, p.1

1

(2)  OJ L 96, 15.4.2009, p. 1.

2

---

| 7.7.2012 | EN | Official Journal of the European Union | L 177/16 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/16

---

COMMISSION IMPLEMENTING REGULATION (EU) No 607/2012

of 6 July 2012

on the detailed rules concerning the due diligence system and the frequency and nature of the checks on monitoring organisations as provided for in Regulation (EU) No 995/2010 of the European Parliament and of the Council laying down the obligations of operators who place timber and timber products on the market

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market (1), and in particular Articles 6(2) and 8(8) thereof,

Whereas:

| (1) | Regulation (EU) No 995/2010 obliges operators to use a framework of procedures and measures (hereinafter referred to as a due diligence system) in order to minimise the risk of placing illegally harvested timber or products derived from illegally harvested timber on the internal market. |
| --- | --- |

(1)

Regulation (EU) No 995/2010 obliges operators to use a framework of procedures and measures (hereinafter referred to as a due diligence system) in order to minimise the risk of placing illegally harvested timber or products derived from illegally harvested timber on the internal market.

| (2) | It is necessary to clarify cases in which information on the full scientific name of tree species, the sub-national region where the timber was harvested and the concession of harvest needs to be provided. |
| --- | --- |

(2)

It is necessary to clarify cases in which information on the full scientific name of tree species, the sub-national region where the timber was harvested and the concession of harvest needs to be provided.

| (3) | It is necessary to specify the frequency and nature of checks that the competent authorities need to carry out on monitoring organisations. |
| --- | --- |

(3)

It is necessary to specify the frequency and nature of checks that the competent authorities need to carry out on monitoring organisations.

| (4) | Protection of individuals with regard to the processing of their personal data within the scope of this Regulation, in particular as regards the processing of personal data obtained in the context of checks is subject to the requirements 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 (2) and to Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (3). |
| --- | --- |

(4)

Protection of individuals with regard to the processing of their personal data within the scope of this Regulation, in particular as regards the processing of personal data obtained in the context of checks is subject to the requirements 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 (2) and to Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (3).

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Forest Law Enforcement Governance and Trade Committee, |
| --- | --- |

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Forest Law Enforcement Governance and Trade Committee,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down detailed rules concerning the due diligence system and the frequency and the nature of the checks on monitoring organisations.

Article 2

Application of the due diligence system

1.   Operators shall apply the due diligence system to each specific type of timber or timber product supplied by a particular supplier within a period not exceeding 12 months, provided that the tree species, the country or countries of harvest or, where applicable, the sub-national region(s) and concession(s) of harvest remain unchanged.

2.   The first paragraph is without prejudice to operator’s obligation to maintain measures and procedures providing access to the information referred to in Article 6(1)(a) of Regulation (EU) No 995/2010 concerning each consignment of timber and timber products placed on the market by the operator.

Article 3

Information concerning the operator’s supply

1.   The information on operator’s supply of timber or timber products referred to in Article (6)(1)(a) of Regulation (EU) No 995/2010 shall be provided in accordance with paragraphs 2, 3 and 4.

2.   The full scientific name of the tree species referred to in the first indent of Article 6(1)(a) of Regulation (EU) No 995/2010 shall be provided where ambiguity in the use of the common name exists.

3.   Information on the sub-national region referred to in the second indent of Article 6(1)(a) of Regulation (EU) No 995/2010 shall be provided where the risk of illegal harvesting between sub-national regions varies.

4.   Information on the concession of harvest referred to in the second indent of Article 6(1)(a) of Regulation (EU) No 995/2010 shall be provided where the risk of illegal harvesting between concessions of harvest in a country or sub-national region varies.

For the purposes of the first subparagraph, any arrangement conferring the right to harvest timber in a defined area shall be considered a concession of harvest.

Article 4

Risk assessment and mitigation

Certification or other third-party verified schemes referred to in the first indent of the second paragraph of Article 6(1)(b) and in Article 6(1)(c) of Regulation (EU) No 995/2010 may be taken into account in the risk assessment and risk mitigation procedures where they meet the following criteria:

| (a) | they have established and made available for third-party use a publicly available system of requirements, which system shall at the least include all relevant requirements of the applicable legislation; |
| --- | --- |

(a)

they have established and made available for third-party use a publicly available system of requirements, which system shall at the least include all relevant requirements of the applicable legislation;

| (b) | they specify that appropriate checks, including field-visits, are made by a third party at regular intervals no longer than 12 months to verify that the applicable legislation is complied with; |
| --- | --- |

(b)

they specify that appropriate checks, including field-visits, are made by a third party at regular intervals no longer than 12 months to verify that the applicable legislation is complied with;

| (c) | they include means, verified by a third party, to trace timber harvested in accordance with applicable legislation, and timber products derived from such timber, at any point in the supply chain before such timber or timber products are placed on the market; |
| --- | --- |

(c)

they include means, verified by a third party, to trace timber harvested in accordance with applicable legislation, and timber products derived from such timber, at any point in the supply chain before such timber or timber products are placed on the market;

| (d) | they include controls, verified by a third party, to ensure that timber or timber products of unknown origin, or timber or timber products which have not been harvested in accordance with applicable legislation, do not enter the supply chain. |
| --- | --- |

(d)

they include controls, verified by a third party, to ensure that timber or timber products of unknown origin, or timber or timber products which have not been harvested in accordance with applicable legislation, do not enter the supply chain.

Article 5

Record keeping by operators

1.   Information concerning the operator’s supply as provided for in Article 6(1)(a) of Regulation (EU) No 995/2010 and application of risk mitigation procedures shall be documented through adequate records, which shall be stored for five years and made available for checks by the competent authority.

2.   In applying their due diligence system operators shall be able to demonstrate how the information gathered was checked against the risk criteria provided for in Article 6(1)(b) of Regulation (EU) No 995/2010, how a decision on risk mitigation measures was taken and how the operator determined the degree of risk.

Article 6

Frequency and nature of checks on monitoring organisations

1.   The competent authorities shall ensure that the checks at regular intervals referred to in Article 8(4) of Regulation (EU) No 995/2010 are carried out at least once every two years.

2.   Checks referred to in Article 8(4) of Regulation (EU) No 995/2010 shall be carried out in particular in any of the following cases:

| (a) | where a competent authority has, while carrying out checks on operators, detected shortcomings in the effectiveness or implementation by operators of the due diligence system established by a monitoring organisation; |
| --- | --- |

(a)

where a competent authority has, while carrying out checks on operators, detected shortcomings in the effectiveness or implementation by operators of the due diligence system established by a monitoring organisation;

| (b) | where the Commission has informed the competent authorities that a monitoring organisation has undergone subsequent changes as provided for in Article 9(2) of Commission Delegated Regulation (EU) No 363/2012 of 23 February 2012 on the procedural rules for the recognition and withdrawal of recognition of monitoring organisations as provided for in Regulation (EU) No 995/2010 of the European Parliament and of the Council laying down the obligations of operators who place timber and timber products on the market (4). |
| --- | --- |

(b)

where the Commission has informed the competent authorities that a monitoring organisation has undergone subsequent changes as provided for in Article 9(2) of Commission Delegated Regulation (EU) No 363/2012 of 23 February 2012 on the procedural rules for the recognition and withdrawal of recognition of monitoring organisations as provided for in Regulation (EU) No 995/2010 of the European Parliament and of the Council laying down the obligations of operators who place timber and timber products on the market (4).

3.   Checks shall be carried out without prior warning, except where prior notification of the monitoring organisation is necessary in order to ensure the effectiveness of the checks.

4.   The competent authorities shall carry out checks in accordance with documented procedures.

5.   Competent authorities shall carry out checks to ensure compliance with Regulation (EU) No 995/2010 that shall include, in particular and as appropriate, the following activities:

| (a) | spot checks, including field audits; |
| --- | --- |

(a)

spot checks, including field audits;

| (b) | examination of documentation and records of monitoring organisations; |
| --- | --- |

(b)

examination of documentation and records of monitoring organisations;

| (c) | interviews with the management and staff of the monitoring organisation; |
| --- | --- |

(c)

interviews with the management and staff of the monitoring organisation;

| (d) | interviews with operators and traders or any other relevant person; |
| --- | --- |

(d)

interviews with operators and traders or any other relevant person;

| (e) | examination of documentation and records of operators; |
| --- | --- |

(e)

examination of documentation and records of operators;

| (f) | examination of samples of the supply of operators using the due diligence system of the monitoring organisation concerned. |
| --- | --- |

(f)

examination of samples of the supply of operators using the due diligence system of the monitoring organisation concerned.

Article 7

Reports of the checks on monitoring organisations

1.   The competent authorities shall draw up reports on individual checks that they have carried out, which shall include a description of the process and techniques applied and their findings and conclusions.

2.   The competent authorities shall provide a monitoring organisation that has been subject to a check with the findings and conclusions of the draft report. The monitoring organisation may provide comments to the competent authorities within the time limit specified by the competent authorities.

3.   The competent authorities shall draw up reports referred to in Article 8(4) of Regulation (EU) No 995/2010 on the basis of the reports on individual checks.

Article 8

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 6 July 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 295, 12.11.2010, p. 23.

1

(2)  OJ L 281, 23.11.1995, p. 31.

2

(3)  OJ L 8, 12.1.2001, p. 1.

3

(4)  OJ L 115, 27.4.2012, p. 12.

4

---

| 7.7.2012 | EN | Official Journal of the European Union | L 177/19 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/19

---

COMMISSION IMPLEMENTING REGULATION (EU) No 608/2012

of 6 July 2012

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2)(c) thereof,

Whereas:

| (1) | The active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil were included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further 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 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, these substances are deemed to have been approved under that Regulation and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (5). |
| --- | --- |

(1)

The active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil were included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further 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 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, these substances are deemed to have been approved under that Regulation and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (5).

| (2) | In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its views on the draft review reports for denathonium benzoate (6), methyl nonyl ketone (7) on 2 December 2011 and for plant oils/spearmint oil (8) on 16 December 2011. The draft review reports and the views of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 1 June 2012 in the format of the Commission review reports for denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil. |
| --- | --- |

(2)

In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its views on the draft review reports for denathonium benzoate (6), methyl nonyl ketone (7) on 2 December 2011 and for plant oils/spearmint oil (8) on 16 December 2011. The draft review reports and the views of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 1 June 2012 in the format of the Commission review reports for denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil.

| (3) | The Authority communicated its views on denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil to the notifiers, and the Commission invited them to submit comments on the review reports. |
| --- | --- |

(3)

The Authority communicated its views on denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil to the notifiers, and the Commission invited them to submit comments on the review reports.

| (4) | It is confirmed that the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil are to be deemed to have been approved under Regulation (EC) No 1107/2009. |
| --- | --- |

(4)

It is confirmed that the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil are to be deemed to have been approved under Regulation (EC) No 1107/2009.

| (5) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil. It is, in particular, appropriate to require further confirmatory information as regards methyl nonyl ketone. The use of plant oils/spearmint oil should be restricted to postharvest treatment of potatoes. |
| --- | --- |

(5)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil. It is, in particular, appropriate to require further confirmatory information as regards methyl nonyl ketone. The use of plant oils/spearmint oil should be restricted to postharvest treatment of potatoes.

| (6) | A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, notifiers and holders of authorisations for plant protection products to meet the requirements resulting from amendment to the conditions of the approval. |
| --- | --- |

(6)

A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, notifiers and holders of authorisations for plant protection products to meet the requirements resulting from amendment to the conditions of the approval.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 November 2012.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 6 July 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 309, 24.11.2009, p. 1.

1

(2)  OJ L 230, 19.8.1991, p. 1.

2

(3)  OJ L 344, 20.12.2008, p. 89.

3

(4)  OJ L 379, 24.12.2004, p. 13.

4

(5)  OJ L 153, 11.6.2011, p. 1.

5

(6)  Conclusion on the peer review of the pesticide risk assessment of the active substance denatonium benzoate, EFSA Journal 2012;10(1):2483. Available online: www.efsa.europa.eu/efsajournal.htm

6

(7)  Conclusion on the peer review of the pesticide risk assessment of the active substance methyl nonyl ketone, EFSA Journal 2012;10(1):2495. Available online: www.efsa.europa.eu/efsajournal.htm

7

(8)  Conclusion on the peer review of the pesticide risk assessment of the active substance plant oils/spearmint oil, EFSA Journal 2012;10(1):2541.Available online: www.efsa.europa.eu/efsajournal.htm

8

---

ANNEX

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | Row 226 on the active substance denathonium benzoate is replaced by the following











  Number | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‧226 | Denathonium benzoate
  CAS No 3734-33-6
  CIPAC No 845 | Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate | ≥ 975g/kg | 1 September 2009 | 31 August 2019 | PART A
  Only uses as repellent may be authorised.
  PART B
  In assessing applications to authorise plant protection products containing denathonium benzoate for uses other than brushing with automatic rolling equipment in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.
  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
  In this overall assessment Member States must pay particular attention to the protection of the operators. Authorised conditions of use must prescribe the application of adequate personal protective equipment.
  Conditions of use shall include, where appropriate, risk mitigation measures.‧ |

(1)

Row 226 on the active substance denathonium benzoate is replaced by the following

Number

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‧226

Denathonium benzoate

CAS No 3734-33-6

CIPAC No 845

Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate

≥ 975g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

In assessing applications to authorise plant protection products containing denathonium benzoate for uses other than brushing with automatic rolling equipment in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

In this overall assessment Member States must pay particular attention to the protection of the operators. Authorised conditions of use must prescribe the application of adequate personal protective equipment.

Conditions of use shall include, where appropriate, risk mitigation measures.‧

| (2) | Row 238 on the active substance methyl nonyl ketone is replaced by the following:











  Number | Common Name, Identification Numbers | IUPAC Name | Purity (2) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‧238 | Methyl nonyl ketone
  CAS No 112-12-9
  CIPAC No 846 | Undecan-2-one | ≥ 975g/kg | 1 September 2009 | 31 August 2019 | PART A
  Only uses as repellent may be authorised.
  PART B
  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methyl nonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof,as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
  Conditions of use shall include, where appropriate, risk mitigation measures. Contact with food and feedcrops shall be avoided.
  The notifier shall submit confirmatory information as regards:






  (a) | the specification of the material tested in the mammalian toxicology and ecotoxicology studies; |

(2)

Row 238 on the active substance methyl nonyl ketone is replaced by the following:

Number

Common Name, Identification Numbers

IUPAC Name

Purity (2)

Date of approval

Expiration of approval

Specific provisions

‧238

Methyl nonyl ketone

CAS No 112-12-9

CIPAC No 846

Undecan-2-one

≥ 975g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methyl nonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof,as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures. Contact with food and feedcrops shall be avoided.

The notifier shall submit confirmatory information as regards:

(a)

the specification of the material tested in the mammalian toxicology and ecotoxicology studies;

| (b) | the specification with suporting batch data and validated methods of analysis; |
| --- | --- |

(b)

the specification with suporting batch data and validated methods of analysis;

| (c) | an appropriate assessment of the fate and behaviour of methyl nonyl ketone and potential transformation products in the environment; |
| --- | --- |

(c)

an appropriate assessment of the fate and behaviour of methyl nonyl ketone and potential transformation products in the environment;

| (d) | the risk to aquatic and to soil living organisms. |
| --- | --- |

(d)

the risk to aquatic and to soil living organisms.

The notifier shall submit to the Commission, the Member States and the Authority the information set out in points (a) and (b) by 30 April 2013 and the information set out in points (c) and (d) by 31 December 2015.‧

| (3) | Row 243 on the active substance plant oils/spearmint oil is replaced by the following:











  Number | Common Name, Identification Numbers | IUPAC Name | Purity (3) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‧243 | Plant oils/spear mint oil
  CAS No 8008-79-5
  CIPAC No 908 | Spearmint oil | ≥ 550 g/kg as (R)-Carvone | 1 September 2009 | 31 August 2019 | PART A
  Only uses as plant growth regulator for postharvest treatment of potatoes may be authorised.
  Member States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application.
  PART B
  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
  Conditions of use shall include, where appropriate, risk mitigation measures.‧ |

(3)

Row 243 on the active substance plant oils/spearmint oil is replaced by the following:

Number

Common Name, Identification Numbers

IUPAC Name

Purity (3)

Date of approval

Expiration of approval

Specific provisions

‧243

Plant oils/spear mint oil

CAS No 8008-79-5

CIPAC No 908

Spearmint oil

≥ 550 g/kg as (R)-Carvone

1 September 2009

31 August 2019

PART A

Only uses as plant growth regulator for postharvest treatment of potatoes may be authorised.

Member States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.‧

---

(1)  Further details on identity and specification of active substance are provided in their review report.

(2)  Further details on identity and specification of active substance are provided in their review report.

(3)  Further details on identity and specification of active substance are provided in their review report.

---

| 7.7.2012 | EN | Official Journal of the European Union | L 177/23 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/23

---

COMMISSION IMPLEMENTING REGULATION (EU) No 609/2012

of 6 July 2012

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

| (1) | Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
| --- | --- |

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

| (2) | The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 6 July 2012.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

(1)  OJ L 299, 16.11.2007, p. 1.

1

(2)  OJ L 157, 15.6.2011, p. 1.

2

---

ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | TR | 50,2 |
| ZZ | 50,2 |
| 0707 00 05 | TR | 104,1 |
| ZZ | 104,1 |
| 0709 93 10 | TR | 111,7 |
| ZZ | 111,7 |
| 0805 50 10 | AR | 90,1 |
| TR | 54,0 |
| UY | 78,0 |
| ZA | 87,5 |
| ZZ | 77,4 |
| 0808 10 80 | AR | 188,8 |
| BR | 82,4 |
| CA | 169,1 |
| CL | 110,6 |
| CN | 123,6 |
| NZ | 132,4 |
| US | 130,2 |
| UY | 68,3 |
| ZA | 114,0 |
| ZZ | 124,4 |
| 0808 30 90 | AR | 216,0 |
| CL | 123,4 |
| CN | 83,4 |
| NZ | 207,2 |
| ZA | 116,9 |
| ZZ | 149,4 |
| 0809 10 00 | TR | 182,6 |
| ZZ | 182,6 |
| 0809 29 00 | TR | 371,6 |
| ZZ | 371,6 |
| 0809 30 | TR | 191,8 |
| ZZ | 191,8 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

TR

50,2

ZZ

50,2

0707 00 05

TR

104,1

ZZ

104,1

0709 93 10

TR

111,7

ZZ

111,7

0805 50 10

AR

90,1

TR

54,0

UY

78,0

ZA

87,5

ZZ

77,4

0808 10 80

AR

188,8

BR

82,4

CA

169,1

CL

110,6

CN

123,6

NZ

132,4

US

130,2

UY

68,3

ZA

114,0

ZZ

124,4

0808 30 90

AR

216,0

CL

123,4

CN

83,4

NZ

207,2

ZA

116,9

ZZ

149,4

0809 10 00

TR

182,6

ZZ

182,6

0809 29 00

TR

371,6

ZZ

371,6

0809 30

TR

191,8

ZZ

191,8

---

(1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.

---

DIRECTIVES

| 7.7.2012 | EN | Official Journal of the European Union | L 177/25 |
| --- | --- | --- | --- |

7.7.2012

EN

Official Journal of the European Union

L 177/25

---

COMMISSION DIRECTIVE 2012/20/EU

of 6 July 2012

amending Directive 98/8/EC of the European Parliament and of the Council to include flufenoxuron as an active substance for product-type 8 in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 the second subparagraph of Article 16(2) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes flufenoxuron. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes flufenoxuron.

| (2) | Pursuant to Regulation (EC) No 1451/2007, flufenoxuron has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1451/2007, flufenoxuron has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive.

| (3) | France was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 17 March 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
| --- | --- |

(3)

France was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 17 March 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 22 September 2011, in an assessment report. |
| --- | --- |

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 22 September 2011, in an assessment report.

| (5) | It appears from the evaluations that biocidal products used as wood preservatives and containing flufenoxuron may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. Therefore, and notwithstanding the fact that flufenoxuron has not been approved in certain other areas for which the use specific risk assessments gave a different result (3), it is appropriate to include flufenoxuron for use in product-type 8 in Annex I to that Directive. |
| --- | --- |

(5)

It appears from the evaluations that biocidal products used as wood preservatives and containing flufenoxuron may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. Therefore, and notwithstanding the fact that flufenoxuron has not been approved in certain other areas for which the use specific risk assessments gave a different result (3), it is appropriate to include flufenoxuron for use in product-type 8 in Annex I to that Directive.

| (6) | In view of its characteristics, which render it persistent, liable to bioaccumulate and toxic (PBT), as well as very persistent and very liable to bioaccumulate (vPvB), in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (4), flufenoxuron should be included in Annex I for three years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed. |
| --- | --- |

(6)

In view of its characteristics, which render it persistent, liable to bioaccumulate and toxic (PBT), as well as very persistent and very liable to bioaccumulate (vPvB), in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (4), flufenoxuron should be included in Annex I for three years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.

| (7) | The Union level risk assessment of flufenoxuron used in wood preservatives only addressed treatment of wood intended to be used indoors (use classes 1 and 2 as defined by OECD (5)) or outdoors not covered and not in contact with the ground and continually exposed to the weather, protected from the weather but subject to frequent wetting or in contact with fresh water (use class 3 as defined by OECD (6)), which will not be used in animal housing or come into contact with food or feed. Unacceptable risks for the environment were identified for the in situ treatment of wood outdoors, as well as in various scenarios for outdoor use of treated wood. In view of the characteristics of flufenoxuron, it is appropriate to authorise only those uses and exposure scenarios that have been representatively addressed in the Union level risk assessment, and for which no unacceptable risk was found. |
| --- | --- |

(7)

The Union level risk assessment of flufenoxuron used in wood preservatives only addressed treatment of wood intended to be used indoors (use classes 1 and 2 as defined by OECD (5)) or outdoors not covered and not in contact with the ground and continually exposed to the weather, protected from the weather but subject to frequent wetting or in contact with fresh water (use class 3 as defined by OECD (6)), which will not be used in animal housing or come into contact with food or feed. Unacceptable risks for the environment were identified for the in situ treatment of wood outdoors, as well as in various scenarios for outdoor use of treated wood. In view of the characteristics of flufenoxuron, it is appropriate to authorise only those uses and exposure scenarios that have been representatively addressed in the Union level risk assessment, and for which no unacceptable risk was found.

| (8) | In view of the risks identified for human health for industrial and professional use it is appropriate to require that safe operational procedures be established for products authorised for such use, and that those products be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means. |
| --- | --- |

(8)

In view of the risks identified for human health for industrial and professional use it is appropriate to require that safe operational procedures be established for products authorised for such use, and that those products be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means.

| (9) | In view of the risks identified for the aquatic and terrestrial compartments, it is appropriate to require that appropriate risk mitigation measures be taken to protect those compartments, in particular that freshly treated timber be stored after treatment under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood preservatives and containing flufenoxuron be collected for reuse or disposal. |
| --- | --- |

(9)

In view of the risks identified for the aquatic and terrestrial compartments, it is appropriate to require that appropriate risk mitigation measures be taken to protect those compartments, in particular that freshly treated timber be stored after treatment under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood preservatives and containing flufenoxuron be collected for reuse or disposal.

| (10) | The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 8 containing the active substance flufenoxuron and also to facilitate the proper operation of the biocidal products market in general. |
| --- | --- |

(10)

The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 8 containing the active substance flufenoxuron and also to facilitate the proper operation of the biocidal products market in general.

| (11) | A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion. |
| --- | --- |

(11)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

| (12) | After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC. |
| --- | --- |

(12)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

| (13) | Directive 98/8/EC should therefore be amended accordingly. |
| --- | --- |

(13)

Directive 98/8/EC should therefore be amended accordingly.

| (14) | The Committee established by Article 28(1) of Directive 98/8/EC has not delivered an opinion on the measures provided for in this Directive, and the Commission therefore submitted to the Council a proposal relating to the measures and forwarded it to the European Parliament. The Council did not act within the two-month period provided for by Article 5a of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7), and the Commission therefore submitted the proposal to the European Parliament without delay. The European Parliament did not oppose the measure within four months from the abovementioned forwarding, |
| --- | --- |

(14)

The Committee established by Article 28(1) of Directive 98/8/EC has not delivered an opinion on the measures provided for in this Directive, and the Commission therefore submitted to the Council a proposal relating to the measures and forwarded it to the European Parliament. The Council did not act within the two-month period provided for by Article 5a of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7), and the Commission therefore submitted the proposal to the European Parliament without delay. The European Parliament did not oppose the measure within four months from the abovementioned forwarding,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.

Article 2

Transposition

1.   Member States shall adopt and publish, by 31 January 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 February 2014.

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.

Done at Brussels, 6 July 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 123, 24.4.1998, p. 1.

1

(2)  OJ L 325, 11.12.2007, p. 3.

2

(3)  Commission Implementing Regulation (EU) No 942/2011 of 22 September 2011 concerning the non-approval of the active substance flufenoxuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Decision 2008/934/EC (OJ L 246, 23.9.2011, p. 13); Commission Decision 2012/77/EU of 9 February 2012 concerning the non-inclusion of flufenoxuron for product type 18 in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 38, 11.2.2012, p. 47).

3

(4)  OJ L 396, 30.12.2006, p. 1.

4

(5)  OECD series on emission scenario documents, Number 2, Emission Scenario Document for Wood Preservatives, part 2, p. 64.

5

(6)  Ibid.

6

(7)  OJ L 184, 17.7.1999, p. 23.

7

---

ANNEX

In Annex I to Directive 98/8/EC, the following entry is added:

| No | Common Name | IUPAC Name
  Identification Numbers | Minimum purity of the active substance in the biocidal product as placed on the market | Date of inclusion | Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) | Expiry date of inclusion | Product type | Specific provisions (1) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘57 | flufenoxuron | 1-[4-(2-chloro-alpha,alpha,alpha-trifluoro-para-tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea
  EC No: 417-680-3
  CAS No: 101463-69-8 | 960 g/kg | 1 February 2014 | 31 January 2016 | 31 January 2017 | 8 | Flufenoxuron shall be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.
  The Union level risk assessment addressed treatment of wood which will not be used in animal housing or come into contact with food or feed. Products shall not be authorised for uses or exposure scenarios that have not been representatively addressed in the Union level risk assessment.
  Member States shall ensure that authorisations are subject to the following conditions:






  (1) | Products shall only be used for treatment of wood intended for indoor use. |

No

Common Name

IUPAC Name

Identification Numbers

Minimum purity of the active substance in the biocidal product as placed on the market

Date of inclusion

Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

Expiry date of inclusion

Product type

Specific provisions (1)

‘57

flufenoxuron

1-[4-(2-chloro-alpha,alpha,alpha-trifluoro-para-tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea

EC No: 417-680-3

CAS No: 101463-69-8

960 g/kg

1 February 2014

31 January 2016

31 January 2017

8

Flufenoxuron shall be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.

The Union level risk assessment addressed treatment of wood which will not be used in animal housing or come into contact with food or feed. Products shall not be authorised for uses or exposure scenarios that have not been representatively addressed in the Union level risk assessment.

Member States shall ensure that authorisations are subject to the following conditions:

(1)

Products shall only be used for treatment of wood intended for indoor use.

| (2) | For products authorised for industrial or professional use safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means. |
| --- | --- |

(2)

For products authorised for industrial or professional use safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means.

| (3) | Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, labels and, where provided, safety data sheets of authorised products shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.’ |
| --- | --- |

(3)

Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular, labels and, where provided, safety data sheets of authorised products shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.’

---

(1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm

1

---