Article 96 The budget of the Agency
1. The revenues of the Agency shall consist of: (a) a subsidy from the Community, entered in the general budget of the European Communities (Commission Section); (b) the fees paid by undertakings; (c) any voluntary contribution from the Member States. 2. The expenditure of the Agency shall include the staff, administrative, infrastructure and operational expenses. 3. By 15 February of each year at the latest, the Executive Director shall draw up a preliminary draft budget covering the operational expenditure and the programme of work anticipated for the following financial year, and shall forward this preliminary draft to the Management Board together with an establishment plan accompanied by a provisional list of posts. 4. Revenue and expenditure shall be in balance. 5. Each year the Management Board, on the basis of a draft drawn up by the Executive Director, shall produce an estimate of revenue and expenditure for the Agency for the following financial year. This estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March at the latest. 6. The estimate shall be forwarded by the Commission to the European Parliament and the Council (hereinafter referred to as the budgetary authority) together with the preliminary draft budget of the European Communities. 7. On the basis of the estimate, the Commission shall enter in the preliminary draft budget of the European Communities the estimates it considers necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty. 8. The budgetary authority shall authorise the appropriations for the subsidy to the Agency. The budgetary authority shall adopt the establishment plan for the Agency. 9. The budget of the Agency shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Communities. Where appropriate, it shall be adjusted accordingly. 10. Any modification to the budget, including the establishment plan, shall follow the procedure referred to above. 11. The Management Board shall, without delay, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof. Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.
Article 97 Implementation of the budget of the Agency
1. The Executive Director shall perform the duties of authorising officer and shall implement the Agency's budget. 2. Monitoring of the commitment and payment of all the Agency's expenditure and of the establishment and recovery of all the Agency's revenue shall be carried out by the Accounting Officer of the Agency. 3. By 1 March at the latest following each financial year, the Agency's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities ( 53 ). 4. By 31 March at the latest following each financial year, the Commission's accounting officer shall forward the Agency's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for that financial year shall also be forwarded to the European Parliament and the Council. 5. On receipt of the Court of Auditors' observations on the Agency's provisional accounts, pursuant to Article 129 of Regulation (EC, Euratom) No 1605/2002, the Executive Director shall draw up the Agency's final accounts under his own responsibility and forward them to the Management Board for an opinion. 6. The Management Board shall deliver an opinion on the Agency's final accounts. 7. By 1 July of the following year at the latest, the Executive Director shall send the final accounts, together with the opinion of the Management Board, to the European Parliament, the Council, the Commission and the Court of Auditors. 8. The final accounts shall be published. 9. The Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board. 10. The European Parliament, upon a recommendation from the Council, shall, before 30 April of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.
Article 98 Combating fraud
1. In order to combat fraud, corruption and other unlawful activities, the provisions of Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) ( 54 ) shall apply without restrictions to the Agency. 2. The Agency shall be bound by the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) ( 55 ) and shall issue, without delay, the appropriate provisions applicable to all of its staff. 3. The decisions concerning funding and the implementing agreements and instruments resulting from them shall explicitly stipulate that the Court of Auditors and OLAF may carry out, if necessary, on-the-spot checks of the recipients of the Agency's funding and the agents responsible for allocating it.
Article 99 Financial rules
The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Regulation (EC, Euratom) No 2343/2002 unless specifically necessary for the Agency's operation and with the Commission's prior consent.
Article 100 Legal personality of the Agency
1. The Agency shall be a body of the Community and shall have legal personality. In each Member State it shall enjoy the most extensive legal capacity accorded to legal persons under their laws. In particular it may acquire and dispose of movable and immovable property and may be a party to legal proceedings. 2. The Agency shall be represented by its Executive Director.
Article 101 Liability of the Agency
1. The contractual liability of the Agency shall be governed by the law applicable to the contract in question. The Court of Justice shall have jurisdiction pursuant to any arbitration clause contained in a contract concluded by the Agency. 2. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its servants in the performance of their duties. The Court of Justice shall have jurisdiction in any dispute relating to compensation for such damages. 3. The personal financial and disciplinary liability of its servants towards the Agency shall be governed by the relevant rules applying to the staff of the Agency.
Article 102 Privileges and immunities of the Agency
The Protocol on the Privileges and Immunities of the European Communities shall apply to the Agency.
Article 103 Staff rules and regulations
1. The staff of the Agency shall be subject to the Regulations and Rules applicable to officials and other servants of the European Communities. In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing authority. 2. The Management Board shall, in agreement with the Commission, adopt the necessary implementing provisions. 3. The Agency's staff shall consist of officials assigned or seconded by the Commission or Member States on a temporary basis and of other servants recruited by the Agency as necessary to carry out its tasks. The Agency shall recruit its personnel on the basis of a staffing plan to be included in the multiannual work programme referred to in Article 78(d).
Article 104 Languages
1. Regulation No 1 of 15 April 1958 determining the languages to be used in the European Economic Community ( 56 ) shall apply to the Agency. 2. The translation services required for the functioning of the Agency shall be provided by the Translation Centre of the bodies of the European Union.
Article 105 Duty of confidentiality
Members of the Management Board, members of the Committees and of the Forum, experts and officials and other servants of the Agency, shall be required, even after their duties have ceased, not to disclose information of the kind covered by the duty of professional secrecy.
Article 106 Participation of third countries
The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of third countries to participate in the work of the Agency.
Article 107 Participation of international organisations
The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of international organisations with interests in the field of chemicals regulation to participate as observers in the work of the Agency.
Article 108 Contacts with stakeholder organisations
The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and relevant stakeholder organisations.
Article 109 Rules on transparency
To ensure transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the safety of substances on their own, in mixtures or in articles which is not of a confidential nature.
Article 110 Relations with relevant Community bodies
1. The Agency shall cooperate with other Community bodies to ensure mutual support in the accomplishment of their respective tasks in particular to avoid duplication of work. 2. The Executive Director, having consulted the Committee on Risk Assessment and the European Food Safety Authority, shall establish rules of procedure concerning substances for which an opinion has been sought in a food safety context. These rules of procedure shall be adopted by the Management Board, in agreement with the Commission. This Title shall not otherwise affect the competences vested in the European Food Safety Authority. 3. This Title shall not affect the competences vested in the European Medicines Agency. 4. The Executive Director, having consulted the Committee on Risk Assessment, the Committee on Socio-economic Analysis and the Advisory Committee on Safety, Hygiene and Health Protection at Work, shall establish rules of procedure concerning worker protection issues. These rules of procedure shall be adopted by the Management Board, in agreement with the Commission. This Title shall not affect the competences vested in the Advisory Committee on Safety, Hygiene and Health Protection at Work and the European Agency for Health and Safety at Work.
Article 111 Formats and software for submission of information to the Agency
The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. Member States, manufactures, importers, distributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1). For the purposes of registration, the format of the technical dossier referred to in Article 10(a) shall be IUCLID. The Agency shall coordinate the further development of this format with the Organisation for Economic Cooperation and Development to ensure maximum harmonisation.
Article 117 Reporting
1. Every five years, Member States shall submit to the Commission a report on the operation of this Regulation in their respective territories, including sections on evaluation and enforcement as described in Article 127. The first report shall be submitted by 1 June 2010. 2. Every five years, the Agency shall submit to the Commission a report on the operation of this Regulation. The Agency shall include in its report information on the joint submission of information in accordance with Article 11 and an overview of the explanations given for submitting information separately. The first report shall be submitted by 1 June 2011. 3. Every three years the Agency, in accordance with the objective of promoting non-animal testing methods, shall submit to the Commission a report on the status of implementation and use of non-animal test methods and testing strategies used to generate information on intrinsic properties and for risk assessment to meet the requirements of this Regulation. 4. Every five years, the Commission shall publish a general report on: (a) the experience acquired with the operation of this Regulation, including the information referred to in paragraphs 1, 2 and 3 and; (b) the amount and distribution of funding made available by the Commission for the development and evaluation of alternative test methods. The first report shall be published by 1 June 2012.
Article 118 Access to information
1. Regulation (EC) No 1049/2001 shall apply to documents held by the Agency. 2. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests of the concerned person: (a) details of the full composition of a mixture ; (b) without prejudice to Article 7(6) and Article 64(2), the precise use, function or application of a substance or mixture , including information about its precise use as an intermediate; (c) the precise tonnage of the substance or mixture manufactured or placed on the market; (d) links between a manufacturer or importer and his distributors or downstream users. Where urgent action is essential to protect human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph. 3. The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001, including appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request, by 1 June 2008. 4. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman or of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the Treaty respectively.
Article 119 Electronic public access
1. The following information held by the Agency on substances whether on their own, in mixtures or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e): (a) without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: — hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; — hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; — hazard class 4.1; — hazard class 5.1; (a) without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: — hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; — hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; — hazard class 4.1; — hazard class 5.1; (b) if applicable, the name of the substance as given in EINECS; (c) the classification and labelling of the substance; (d) physicochemical data concerning the substance and on pathways and environmental fate; (e) the result of each toxicological and ecotoxicological study; (f) any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I; (g) the guidance on safe use provided in accordance with Sections 4 and 5 of Annex VI; (h) analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans. 2. The following information on substances whether on their own, in mixtures or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned: (a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous; (b) the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within which a particular substance has been registered; (c) the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e); (d) information, other than that listed in paragraph 1, contained in the safety data sheet; (e) the trade name(s) of the substance; (f) subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for non-phase-in substances referred to in paragraph 1(a) of this Article for a period of six years; (g) subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following: (i) as an intermediate; (ii) in scientific research and development; (iii) in product and process orientated research and development. (g) subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following: (i) as an intermediate; (ii) in scientific research and development; (iii) in product and process orientated research and development.
Article 120 Cooperation with third countries and international organisations
Notwithstanding Articles 118 and 119, information received by the Agency under this Regulation may be disclosed to any government or national authority of a third country or an international organisation in accordance with an agreement concluded between the Community and the third party concerned under Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals ( 57 ) or under Article 181a(3) of the Treaty, provided that both the following conditions are met: (a) the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation; (b) the third party protects the confidential information as mutually agreed.
Article 121 Appointment
Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for cooperating with the Commission and the Agency in the implementation of this Regulation. Member States shall place adequate resources at the disposal of the competent authorities to enable them, in conjunction with any other available resources, to fulfil their tasks under this Regulation in a timely and effective manner.
Article 122 Cooperation between competent authorities
The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States all the necessary and useful support to this end.
Article 123 Communication to the public of information on risks of substances
The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in mixtures or in articles, with a view to coordinating Member States in these activities.
Article 124 Other responsibilities
Competent authorities shall submit electronically to the Agency any available information that they hold on substances registered in accordance with Article 12(1) whose dossiers do not contain the full information referred to in Annex VII, in particular whether enforcement or monitoring activities have identified suspicions of risk. The competent authority shall update this information as appropriate. Member States shall establish national helpdesks to provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in particular in relation to the registration of substances in accordance with Article 12(1), in addition to the operational guidance documents provided by the Agency under Article 77(2)(g).
Article 125 Tasks of the Member States
Member States shall maintain a system of official controls and other activities as appropriate to the circumstances.
Article 126 Penalties for non-compliance
Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission no later than 1 December 2008 and shall notify it without delay of any subsequent amendment affecting them.
Article 127 Report
The report referred to in Article 117(1) shall, in relation to enforcement, include the results of the official inspections, the monitoring carried out, the penalties provided for and the other measures taken pursuant to Articles 125 and 126 during the previous reporting period. The common issues to be covered in the reports shall be agreed by the Forum. The Commission shall make these reports available to the Agency and the Forum.
Article 128 Free movement
1. Subject to paragraph 2, Member States shall not prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance, on its own, in a mixture or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation. 2. Nothing in this Regulation shall prevent Member States from maintaining or laying down national rules to protect workers, human health and the environment applying in cases where this Regulation does not harmonise the requirements on manufacture, placing on the market or use.
Article 129 Safeguard clause
1. Where a Member State has justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of a substance, on its own, in a mixture or in an article, even if satisfying the requirements of this Regulation, it may take appropriate provisional measures. The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving reasons for its decision and submitting the scientific or technical information on which the provisional measure is based. 2. The Commission shall take a decision in accordance with the procedure referred to in Article 133(3) within 60 days of receipt of the information from the Member State. This decision shall either: (a) authorise the provisional measure for a time period defined in the decision; or (b) require the Member State to revoke the provisional measure. 3. If, in the case of a decision as referred to in paragraph 2(a), the provisional measure taken by the Member State consists in a restriction on the placing on the market or use of a substance, the Member State concerned shall initiate a Community restrictions procedure by submitting to the Agency a dossier, in accordance with Annex XV, within three months of the date of the Commission decision. 4. In the case of a decision as referred to in paragraph 2(a), the Commission shall consider whether this Regulation needs to be adapted.
Article 130 Statement of reasons for decisions
The competent authorities, the Agency and the Commission shall state the reasons for all decisions they take under this Regulation.
Article 131 Amendments to the Annexes
The Annexes may be amended in accordance with the procedure referred to in Article 133(4).
Article 132 Implementing legislation
The measures necessary to put the provisions of this Regulation efficiently into effect shall be adopted in accordance with the procedure referred to in Article 133(3).
Article 133 Committee procedure
1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 4. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 5. The Committee shall adopt its Rules of Procedure.
Article 134 Preparation of establishment of the Agency
1. The Commission shall afford the necessary support towards the establishment of the Agency. 2. For that purpose, until such time as the Executive Director takes up his duties following his appointment by the Management Board of the Agency in accordance with Article 84, the Commission, on behalf of the Agency, and using the budget provided for the latter, may: (a) appoint personnel, including a person who shall fulfil the administrative functions of the Executive Director on an interim basis; and (b) conclude other contracts.
Article 135 Transitional measures regarding notified substances
1. The requests to notifiers to provide further information to the competent authority in accordance with Article 16(2) of Directive 67/548/EEC, shall be considered as decisions adopted in accordance with Article 51 of this Regulation. 2. The requests to a notifier to provide further information for a substance in accordance with Article 16(1) of Directive 67/548/EEC, shall be considered as decisions adopted in accordance with Article 52 of this Regulation. Such substance shall be regarded as being included in the Community rolling action plan in accordance with Article 44(2) of this Regulation and shall be regarded as being chosen in accordance with Article 45(2) of this Regulation by the Member State whose competent authority has requested further information in accordance with Article 7(2) and Article 16(1) of Directive 67/548/EEC.
Article 136 Transitional measures regarding existing substances
1. The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in application of Article 10(2) of Regulation (EEC) No 793/93, shall be considered as decisions adopted in accordance with Article 52 of this Regulation. The competent authority for the substance shall be the competent authority from the Member State identified as rapporteur in accordance with Article 10(1) of Regulation (EEC) No 793/93 and shall carry out the tasks of Article 46(3) and Article 48 of this Regulation. 2. The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in application of Article 12(2) of Regulation (EEC) No 793/93, shall be considered as decisions adopted in accordance with Article 52 of this Regulation. The Agency shall identify the competent authority for the substance to carry out the tasks of Article 46(3) and Article 48 of this Regulation. 3. A Member State whose rapporteur has not forwarded by 1 June 2008 the risk evaluation and, where appropriate, the strategy for limiting the risks, in accordance with Article 10(3) of Regulation (EEC) No 793/93, shall: (a) document information on hazard and risk in accordance with Annex XV, Part B of this Regulation; (b) apply Article 69(4) of this Regulation on the basis of the information referred to in point (a); and (c) prepare a documentation of how it considers that any other risks identified would need to be addressed by action other than an amendment of Annex XVII of this Regulation. The information referred to above shall be submitted to the Agency by 1 December 2008.
Article 137 Transitional measures regarding restrictions
1. By 1 June 2010, the Commission shall, if necessary, prepare a draft amendment to Annex XVII in accordance with either of the following: (a) any risk evaluation and recommended strategy for limiting risks that has been adopted at Community level in accordance with Article 11 of Regulation (EEC) No 793/93 as far as it includes proposals for restrictions in accordance with Title VIII of this Regulation but for which a decision under Directive 76/769/EEC has not yet been taken; (b) any proposal, which has been submitted to the relevant institutions but has not yet been adopted, concerning the introduction or the amendment of restrictions under Directive 76/769/EEC. 2. Until 1 June 2010, any dossier referred to in Article 129(3) shall be submitted to the Commission. The Commission shall, if necessary, prepare a draft amendment to Annex XVII. 3. Any amendment to the restrictions adopted under Directive 76/769/EEC from 1 June 2007 shall be incorporated in Annex XVII with effect from 1 June 2009.
Article 138 Review
1. By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to registration or subject to registration but manufactured or imported in quantities of less than 10 tonnes per year. However, for substances meeting the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008, the review shall be carried out by 1 June 2014. en carrying out the review the Commission shall take into account all relevant factors, including: (a) the costs for manufacturers and importers of drawing up the chemical safety reports; (b) the distribution of costs between actors in the supply chain and the downstream user; (c) the benefits for human health and the environment. On the basis of these reviews, the Commission may, if appropriate, present legislative proposals to extend this obligation. 2. The Commission may present legislative proposals as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established, and after publishing a report on the following: (a) the risks posed by polymers in comparison with other substances; (b) the need, if any, to register certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other. 3. The report, referred to in Article 117(4), on the experience acquired with the operation of this Regulation shall include a review of the requirements relating to registration of substances manufactured or imported only in quantities starting at one tonne but less than 10 tonnes per year per manufacturer or importer. On the basis of that review, the Commission may present legislative proposals to modify the information requirements for substances manufactured or imported in quantities of one tonne or more up to 10 tonnes per year per manufacturer or importer, taking into account the latest developments, for example in relation to alternative testing and (quantitative) structure-activity relationships ((Q)SARs). 4. The Commission shall carry out a review of Annexes I, IV and V by 1 June 2008, with a view to proposing amendments, if appropriate, to them in accordance with the procedure referred to in Article 131. 5. The Commission shall carry out a review of Annex XIII by 1 December 2008, to assess the adequacy of the criteria for identifying substances which are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, with a view to proposing an amendment to it, if appropriate, in accordance with the procedure referred to in Article 133(4). 6. By 1 June 2012 the Commission shall carry out a review to assess whether or not to amend the scope of this Regulation to avoid overlaps with other relevant Community provisions. On the basis of that review, the Commission may, if appropriate, present a legislative proposal. 7. By 1 June 2013 the Commission shall carry out a review to assess whether or not, taking into account latest developments in scientific knowledge, to extend the scope of Article 60(3) to substances identified under Article 57(f) as having endocrine disrupting properties. On the basis of that review the Commission may, if appropriate, present legislative proposals. 8. By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend the scope of Article 33 to cover other dangerous substances, taking into account the practical experience in implementing that Article. On the basis of that review, the Commission may, if appropriate, present legislative proposals to extend that obligation. 9. In accordance with the objective of promoting non-animal testing and the replacement, reduction or refinement of animal testing required under this Regulation, the Commission shall review the testing requirements of Section 8.7 of Annex VIII by 1 June 2019. On the basis of this review, while ensuring a high level of protection of health and the environment, the Commission may propose an amendment in accordance with the procedure referred to in Article 133(4).
Article 139 Repeals
Directive 91/155/EEC shall be repealed. Directives 93/105/EC and 2000/21/EC and Regulations (EEC) No 793/93 and (EC) No 1488/94 shall be repealed with effect from 1 June 2008. Directive 93/67/EEC shall be repealed with effect from 1 August 2008. Directive 76/769/EEC shall be repealed with effect from 1 June 2009. References to the repealed acts shall be construed as references to this Regulation.
Article 140 Amendment of Directive 1999/45/EC
Article 14 of Directive 1999/45/EC shall be deleted.
Article 141 Entry into force and application
1. This Regulation shall enter into force on 1 June 2007. 2. Titles II, III, V, VI, VII, XI and XII as well as Articles 128 and 136 shall apply from 1 June 2008. 3. Article 135 shall apply from 1 August 2008. 4. Title VIII and Annex XVII shall apply from 1 June 2009. This Regulation shall be binding in its entirety and directly applicable in all Member States.