1.Member States shall take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice (GLP) as laid down in Annex I to this Directive.
2.Paragraph 1 shall apply also where other Community provisions provide for the application of the principles of GLP in respect of tests on chemical products to evaluate their safety for man and/or the environment.
When submitting results, the laboratories referred to in Article 1 shall certify that the tests have been carried out in conformity with the principles of GLP referred to in that Article.
1.Member States shall adopt the measures necessary for verification of compliance with the principles of GLP. These measures shall include, in particular, inspections and study checks in accordance with the recommendations of the OECD in this area.
2.Member States shall notify to the Commission the name or names of the authority or authorities responsible for verifying compliance with the principles of GLP, as referred to in paragraph 1. The Commission shall inform the other Member States thereof.
The Commission may adapt Annex I to technical progress, with regard to principles of GLP.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 4(2).]
Textual Amendments
F1 Inserted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.
1. The Commission shall be assisted by the Committee established by Article 29(1) of Council Directive 67/548/EEC (1) .
2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.]
Textual Amendments
F2 Substituted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.
1.Where Community provisions require application of the principles of GLP following the entry into force of this Directive for tests on chemical products, Member States may not, on grounds relating to the principles of GLP, prohibit, restrict or impede the placing on the market of chemical products if the principles applied by the laboratories concerned are in conformity with those mentioned in Article 1.
2.Should a Member State establish on the basis of detailed evidence that the application of the principles of GLP and the verification of their application for tests on chemical substances show that, although a chemical substance has been examined in accordance with the requirements of this Directive, it presents a danger to man and the environment, the Member State may provisionally prohibit or make subject to special conditions the marketing of that substance on its territory. It shall immediately inform the Commission and the other Member States thereof and give the grounds for its decision.
The Commission shall, within six weeks, consult the Member States concerned and then give its opinion and take suitable measures without delay.
[F2The Commission may adopt implementing measures to introduce necessary technical adaptations of this Directive.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 4(2).
In the case referred to in the third subparagraph, the Member State which adopted the safeguard measures may maintain them until the entry into force of those adaptations.]
Textual Amendments
F2 Substituted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.
Directive 87/18/EEC is hereby repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition of the Directives set out in Annex II, part B.
References made to the repealed Directive shall be construed as being made to this Directive and shall be read in accordance with the correlation table in Annex III.
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.