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... 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. ...
... 29. Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use. In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified. The Agency should also be empowered to request that a registration be submitted if it has grounds for suspecting that the release of a substance from the article may present a risk to human health or the environment and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year. The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled. ...
... 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. ...
... 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. ...
... 114. To ensure a harmonised protection for the general public, and, in particular, for persons who come into contact with certain substances, and the proper functioning of other Community legislation relying on the classification and labelling, an inventory should record the classification in accordance with Directive 67/548/EEC and Directive 1999/45/EC agreed by manufacturers and importers of the same substance, if possible, as well as decisions taken at Community level to harmonise the classification and labelling of some substances. This should take full account of the work and experience accumulated in connection with the activities under Directive 67/548/EEC, including the classification and labelling of specific substances or groups of substances listed in Annex I of Directive 67/548/EEC. ...
... 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; ...
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-28: Duty to pre-register for phase-in substances [go to this ARTICLE]
... (b) his name and address and the name of the contact person and, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in section 1 of Annex VI; ...
... (b) his name and address and the name of the contact person and, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in section 1 of Annex VI; ...
ARTICLE-53: Cost sharing for tests without an agreement between registrants and/or downstream users [go to this ARTICLE]
... 4. The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order. ...
... 4. The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order. ...
... 4. The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order. ...
... 4. The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order. ...
... 4. The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order. ...
ARTICLE-60: Granting of authorisations [go to this ARTICLE]
... (a) the person(s) to whom the authorisation is granted; ...
ARTICLE-62: Applications for authorisations [go to this ARTICLE]
... 2. Applications for authorisation may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substance. Applications may be made by one or several persons. ...
ARTICLE-79: Composition of the Management Board [go to this ARTICLE]
... 1. The Management Board shall be composed of one representative from each Member State and a maximum of six representatives appointed by the Commission, including three individuals from interested parties without voting rights and in addition two independent persons appointed by the European Parliament. Each Member State shall nominate a member to the Management Board. The members thus nominated shall be appointed by the Council. ...
ARTICLE-85: Establishment of the Committees [go to this ARTICLE]
... 7. The Member States shall refrain from giving the members of the Committee for Risk Assessment or of the Committee for Socio-Economic Analysis, or their scientific and technical advisers and experts, any instruction which is incompatible with the individual tasks of those persons or with the tasks, responsibilities and independence of the Agency. ...
ARTICLE-86: Establishment of the Forum [go to this ARTICLE]
... 3. The members of the Forum shall be supported by the scientific and technical resources available to the competent authorities of the Member States. Each Member State competent authority shall facilitate the activities of the Forum and its working groups. The Member States shall refrain from giving the Forum members, or their scientific and technical advisers and experts any instruction which is incompatible with the individual tasks of those persons or with the tasks and responsibilities of the Forum. ...
ARTICLE-87: Rapporteurs of Committees and use of experts [go to this ARTICLE]
... 3. The provision of services by Committee members or any expert serving on a working group of the Committees or Forum, or performing any other task for the Agency shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and the employer of the person concerned. The person concerned, or his employer, shall be remunerated by the Agency in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. Where the person concerned fails to fulfil his duties, the Executive Director has the right to terminate or suspend the contract or withhold remuneration. ...
... 3. The provision of services by Committee members or any expert serving on a working group of the Committees or Forum, or performing any other task for the Agency shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and the employer of the person concerned. The person concerned, or his employer, shall be remunerated by the Agency in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. Where the person concerned fails to fulfil his duties, the Executive Director has the right to terminate or suspend the contract or withhold remuneration. ...
... 3. The provision of services by Committee members or any expert serving on a working group of the Committees or Forum, or performing any other task for the Agency shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and the employer of the person concerned. The person concerned, or his employer, shall be remunerated by the Agency in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. Where the person concerned fails to fulfil his duties, the Executive Director has the right to terminate or suspend the contract or withhold remuneration. ...
... 3. The provision of services by Committee members or any expert serving on a working group of the Committees or Forum, or performing any other task for the Agency shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and the employer of the person concerned. The person concerned, or his employer, shall be remunerated by the Agency in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. Where the person concerned fails to fulfil his duties, the Executive Director has the right to terminate or suspend the contract or withhold remuneration. ...
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. ...
... 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. ...
... 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. ...
... 2. The appeal, together with the statements of the grounds thereof, shall be filed in writing to the Agency within three months of the notification of the decision to the person concerned, or in the absence thereof, of the day on which it became known to the latter, unless otherwise provided in this Regulation. ...
... 3. A fee may be payable by persons bringing an appeal against an Agency decision, in accordance with Title IX. ...
ARTICLE-100: Legal personality of the Agency [go to this ARTICLE]
... 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. ...
ARTICLE-118: Access to information [go to this ARTICLE]
... 2. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests of the concerned person: ...
ARTICLE-134: Preparation of establishment of the Agency [go to this ARTICLE]
... (a) appoint personnel, including a person who shall fulfil the administrative functions of the Executive Director on an interim basis; and ...