Law-ref.org REACH - Registration, Evaluation and Authorisation of Chemicals
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PREAMBLE     [go to this PREAMBLE]
... 9. The assessment of the operation of the four main legal instruments governing chemicals in the Community, i.e. Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(3), Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(4), Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(5) and Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances(6), identified a number of problems in the functioning of Community legislation on chemicals, resulting in disparities between the laws, regulations and administrative provisions in Member States directly affecting the functioning of the internal market in this field, and the need to do more to protect public health and the environment in accordance with the precautionary principle. ...
... 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. ...
... 25. The responsibility to assess the risks and hazards of substances should be given, in the first place, to the natural or legal persons that manufacture or import substances, but only when they do so in quantities exceeding a certain volume, to enable them to carry the associated burden. Natural or legal persons handling chemicals should take the necessary risk management measures in accordance with the assessment of the risks of substances and pass on relevant recommendations along the supply chain. This should include describing, documenting and notifying in an appropriate and transparent fashion the risks stemming from the production, use and disposal of each substance. ...
... 25. The responsibility to assess the risks and hazards of substances should be given, in the first place, to the natural or legal persons that manufacture or import substances, but only when they do so in quantities exceeding a certain volume, to enable them to carry the associated burden. Natural or legal persons handling chemicals should take the necessary risk management measures in accordance with the assessment of the risks of substances and pass on relevant recommendations along the supply chain. This should include describing, documenting and notifying in an appropriate and transparent fashion the risks stemming from the production, use and disposal of each substance. ...
... 42. To avoid overloading authorities and natural or legal persons with the work arising from the registration of phase-in substances already on the internal market, that registration should be spread over an appropriate period of time, without introducing undue delay. Deadlines for the registration of these substances should therefore be set. ...
... 50. It is in the public interest to ensure the quickest possible circulation of test results on human health or environmental hazards of certain substances to those natural or legal persons which use them, in order to limit any risks associated with their use. Sharing of information should occur where this is requested by any registrant, in particular in the case of information involving tests on vertebrate animals, under conditions that ensure a fair compensation for the company that has undertaken the tests. ...
... 65. In addition, it is necessary to instil confidence in the general quality of registrations and to ensure that the public at large as well as all stakeholders in the chemicals industry have confidence that natural or legal persons are meeting the obligations placed upon them. Accordingly, it is appropriate to provide for recording which information has been reviewed by an assessor possessing appropriate experience, and for a percentage of registrations to be checked for compliance by the Agency. ...
... 69. To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable. Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority. ...
... 77. In view of workability and practicality considerations, both as regards natural or legal persons, who have to prepare application files and take appropriate risk management measures, and as regards the authorities, who have to process authorisation applications, only a limited number of substances should be subjected to the authorisation procedure at the same time and realistic deadlines should be set for applications, while allowing certain uses to be exempted. Substances identified as meeting the criteria for authorisation should be included in a candidate list for eventual inclusion in the authorisation procedure. Within this list, substances on the Agency's work programme should be clearly identified. ...
... 98. In the interests of efficiency, the staff of the Agency Secretariat should perform essentially technical-administrative and scientific tasks without calling on the scientific and technical resources of the Member States. The Executive Director should ensure the efficient execution of the Agency's tasks in an independent manner. To ensure that the Agency fulfils its role, the composition of the Management Board should be designed to represent each Member State, the Commission and other interested parties appointed by the Commission in order to ensure the involvement of stakeholders, and the European Parliament and to secure the highest standard of competence and a broad range of relevant expertise in chemicals safety or the regulation of chemicals, whilst ensuring that there is relevant expertise in the field of general financial and legal matters. ...
... 105. In the light of the increased responsibility of natural or legal persons for ensuring safe use of chemicals, enforcement needs to be strengthened. The Agency should therefore provide a Forum for Member States to exchange information on and to coordinate their activities related to the enforcement of chemicals legislation. The currently informal cooperation between Member States in this respect would benefit from a more formal framework. ...
... 106. A Board of Appeal should be set up within the Agency to guarantee processing of appeals for any natural or legal person affected by decisions taken by the Agency. ...
... 107. The Agency should be financed partly by fees paid by natural or legal persons and partly by the general budget of the European Communities. The Community budgetary procedure should remain applicable as far as any subsidies chargeable to the general budget of the European Communities are concerned. Moreover, the auditing of accounts should be undertaken by the Court of Auditors in accordance with Article 91 of Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(12)107. . ...
... 110. The Agency should provide the infrastructure needed for natural or legal persons to meet their obligations under the data-sharing provisions. ...
... 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. ...
... 127. It is appropriate for the provisions of this Regulation to enter into force in a staggered way to smooth the transition to the new system. Moreover, a gradual entry into force of the provisions should allow all parties involved, authorities, natural or legal persons as well as stakeholders, to focus resources in the preparation for new duties at the right times. ...


ARTICLE-3: Definitions     [go to this ARTICLE]
... 4) Producer of an article: means any natural or legal person who makes or assembles an article within the Community; ...
... 9) Manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community; ...
... 11) Importer: means any natural or legal person established within the Community who is responsible for import; ...
... 13) Downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user; ...
... 14) Distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties; ...
... (b) on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities; ...


ARTICLE-8: Only representative of a non-Community manufacturer     [go to this ARTICLE]
... 1. A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title. ...
... 1. A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title. ...


ARTICLE-79: Composition of the Management Board     [go to this ARTICLE]
... 2. Members shall be appointed on the basis of their relevant experience and expertise in the field of chemical safety or the regulation of chemicals whilst ensuring there is relevant expertise amongst the board members in the fields of general, financial and legal matters. ...


ARTICLE-83: Duties and powers of the Executive Director     [go to this ARTICLE]
... 2. The Executive Director shall be the legal representative of the Agency. He shall be responsible for: ...


ARTICLE-92: Persons entitled to appeal, time-limits, fees and form     [go to this ARTICLE]
... 1. Any natural or legal person may appeal against a decision addressed to that person, or against a decision which, although addressed to another person, is of direct and individual concern to the former. ...


ARTICLE-100: Legal personality of the Agency     [go to this ARTICLE]
... 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. ...
... 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. ...
... 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. ...
... 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. ...