Law-ref.org REACH - Registration, Evaluation and Authorisation of Chemicals
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implementation [Global Index]


PREAMBLE     [go to this PREAMBLE]
... 4. Pursuant to the implementation plan adopted on 4 September 2002 at the Johannesburg World Summit on sustainable development, the European Union is aiming to achieve that, by 2020, chemicals are produced and used in ways that lead to the minimisation of significant adverse effects on human health and the environment. ...
... 14. This Regulation will generate information on substances and their uses. Available information, including that generated by this Regulation, should be used by the relevant actors in the application and implementation of appropriate Community legislation, for example that covering products, and Community voluntary instruments, such as the eco-labelling scheme. The Commission should consider in the review and development of relevant Community legislation and voluntary instruments how information generated by this Regulation should be used, and examine possibilities for establishing a European quality mark. ...
... 18. Responsibility for the management of the risks of substances should lie with the natural or legal persons that manufacture, import, place on the market or use these substances. Information on the implementation of this Regulation should be easily accessible, in particular for SMEs. ...
... 24. In preparation for this Regulation, the Commission has launched REACH Implementation Projects (RIPs), involving relevant experts from stakeholder groups. Some of those projects aim at developing draft guidelines and tools which should help the Commission, the Agency, Member States, manufacturers, importers and downstream users of substances to fulfil, in concrete terms, their obligations under this Regulation. This work should enable the Commission and the Agency to make available appropriate technical guidance, in due time, with regard to the deadlines introduced by this Regulation. ...
... 47. In accordance with Directive 86/609/EEC, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of chemicals, wherever possible. The use of animals should be avoided by recourse to alternative methods validated by the Commission or international bodies, or recognised by the Commission or the Agency as appropriate to meet the information requirements under this Regulation. To this end, the Commission, following consultation with relevant stakeholders, should propose to amend the future Commission Regulation on test methods or this Regulation, where appropriate, to replace, reduce or refine animal testing. The Commission and the Agency should ensure that reduction of animal testing is a key consideration in the development and maintenance of guidance for stakeholders and in the Agency's own procedures. ...
... 95. The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public. The Agency should also play a pivotal role in coordinating communication around this Regulation and in its implementation. The confidence in the Agency of the Community institutions, the Member States, the general public and interested parties is therefore essential. For this reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency. ...
... 101. The Management Board of the Agency should have the necessary powers to establish the budget, check its implementation, draw up internal rules, adopt financial regulations and appoint the Executive Director. ...
... 116. Regular reports by the Member States and the Agency on the operation of this Regulation will be an indispensable means of monitoring the implementation of this Regulation as well as trends in this field. Conclusions drawn from findings in the reports will be useful and practical tools for reviewing this Regulation and, where necessary, for formulating proposals for amendments. ...
... 119. Apart from their participation in the implementation of Community legislation, Member State competent authorities should, because of their closeness to stakeholders in the Member States, play a role in the exchange of information on risks of substances and on the obligations of natural or legal persons under chemicals legislation. At the same time, close cooperation between the Agency, the Commission and the competent authorities of the Member States is necessary to ensure the coherence and efficiency of the global communication process. ...
... 123. The measures necessary for the implementation of this Regulation and certain amendments to it should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(18). ...
... 123. The measures necessary for the implementation of this Regulation and certain amendments to it should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(18). ...
... Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35). Directive as last amended by Directive 2001/58/EC (OJ L212, 7.8.2001, p. 24). ...


ARTICLE-7: Registration and notification of substances in articles     [go to this ARTICLE]
... 8. Any measures for the implementation of paragraphs 1 to 7 shall be adopted in accordance with the procedure referred to in Article 133(3). ...


ARTICLE-13: General requirements for generation of information on intrinsic properties of substances     [go to this ARTICLE]
... 1. Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across). Testing in accordance with Annex VIII, section 8.6 and 8.7, Annex IX and Annex X may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex XI, section 3. ...


ARTICLE-15: Substances in plant protection and biocidal products     [go to this ARTICLE]
... Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10). Regulation as last amended by Commission Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27). ...
... Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 224, 21.8.2002, p. 23). Regulation as last amended by Commission Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23). ...


ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures     [go to this ARTICLE]
... (d) the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him in the safety data sheet; ...


ARTICLE-47: Coherence with other activities     [go to this ARTICLE]
... 2. In order to ensure a harmonised approach to requests for further information, the Agency shall monitor draft decisions under Article 46 and shall develop criteria and priorities. Where appropriate, implementing measures shall be adopted in accordance with the procedure referred to in Article 133(3). ...


ARTICLE-77: Tasks     [go to this ARTICLE]
... (m) keeping a Manual of Decisions and Opinions based on conclusions from the Member State Committee regarding interpretation and implementation of this Regulation; ...


ARTICLE-83: Duties and powers of the Executive Director     [go to this ARTICLE]
... (f) the preparation of the statement of revenue and expenditure and the implementation of the budget of the Agency pursuant to Articles 96 and 97; ...


ARTICLE-96: The budget of the Agency     [go to this ARTICLE]
... 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     [go to this ARTICLE]
... 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. ...
... 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     [go to this ARTICLE]
... 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-103: Staff rules and regulations     [go to this ARTICLE]
... 2. The Management Board shall, in agreement with the Commission, adopt the necessary implementing provisions. ...


ARTICLE-117: Reporting     [go to this ARTICLE]
... 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. The first report shall be submitted by 1 June 2011. ...


ARTICLE-118: Access to information     [go to this ARTICLE]
... 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. ...


ARTICLE-120: Cooperation with third countries and international organisations     [go to this ARTICLE]
... (a) the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation; ...


ARTICLE-121: Appointment     [go to this ARTICLE]
... 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-126: Penalties for non-compliance     [go to this ARTICLE]
... 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-128: Free movement     [go to this ARTICLE]
... 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 preparation 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. ...


ARTICLE-132: Implementing legislation     [go to this ARTICLE]
... Implementing legislation ...


ARTICLE-138: Review     [go to this ARTICLE]
... 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. ...