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... 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. ...

... 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. ...

... 5. The chemical safety report need not include consideration of the risks to human health from the following end uses: ...

... 13. disposal considerations; ...

... 8. A chemical safety report prepared in accordance with paragraph 4 of this Article need not include consideration of the risks to human health from the end uses set out in Article 14(5). ...

... Aim of authorisation and considerations for substitution ...

... 4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b): ...

... Within nine months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency at the request of the Commission, and the views of interested parties referred to in point (a) of Article 69(6). ...

... 1. Within 12 months of the date of publication referred to in Article 69(6), the Committee for Socio-economic Analysis shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to point (b) of Article 69(6), if there are any. The Agency shall publish the draft opinion on its website without delay. The Agency shall invite interested parties to give their comments on the draft opinion no later than 60 days from the publication of that draft opinion. ...

... 1. Where, in accordance with Article 77, a Committee is required to provide an opinion or consider whether a Member State dossier conforms with the requirements of Annex XV, it shall appoint one of its members as a rapporteur. The Committee concerned may appoint a second member to act as co-rapporteur. For each case, rapporteurs and co-rapporteurs shall undertake to act in the interests of the Community and shall make a declaration of commitment to fulfil their duties and a declaration of interests in writing. A member of a Committee shall not be appointed rapporteur for a particular case if he indicates any interest that might be prejudicial to the independent consideration of that case. The Committee concerned may replace the rapporteur or co-rapporteur by another one of its members at any time, if, for example, they are unable to fulfil their duties within the prescribed time limits, or if a potentially prejudicial interest comes to light. ...