Site search

Global links

Sister sites

... 37. If tests are performed, they should comply with the relevant requirements of protection of laboratory animals, set out in Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes⁽¹⁰⁾, and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances⁽¹¹⁾. ...

... 37. If tests are performed, they should comply with the relevant requirements of protection of laboratory animals, set out in Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes⁽¹⁰⁾, and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances⁽¹¹⁾. ...

... 97. The effective communication of information on chemical risks and how they can be managed is an essential part of the system established by this Regulation. Best practice from the chemicals and other sectors should be considered in the preparation of guidance by the Agency to all stakeholders. ...

... 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. ...

... 118. Disclosure of information under this Regulation is subject to the specific requirements of Regulation (EC) No 1049/2001. That Regulation sets binding deadlines for the release of information as well as procedural guarantees, including the right of appeal. The Management Board should adopt the practical arrangements for application of those requirements to the Agency. ...

... 2. The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31. ...

... 4. Ecotoxicological and toxicological tests and analyses shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission or the Agency and with the provisions of Directive 86/609/EEC, if applicable. ...

... (a) spreading good practice and highlighting problems at Community level; ...

... (d) identifying enforcement strategies, as well as best practice in enforcement; ...

... 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. ...

... 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 preparations or in articles, with a view to coordinating Member States in these activities. ...

... 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. ...