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Good laboratory practice: tests on chemical substances

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Good laboratory practice: tests on chemical substances

By means of this Directive, the European Union guarantees the quality of tests on chemical products, avoids the repetition of tests caused by divergent laboratory practices in the different Member States and protects animals by limiting the number of animal experiments through the mutual recognition of results obtained on the basis of standard methods.

ACT

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 applications for tests on chemical substances (codified version) [See amending act(s)].

SUMMARY

This directive substantially amends and repeals Directive 87/18/EEC on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice (GLP) and the verification of their applications for tests on chemical substances.

The Directive requires Member States to 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.

It also applies where other Community provisions provide for the application of the principles of GLP to tests on chemical products to evaluate their safety for man and/or the environment.

The tests conducted on these different elements seek to obtain data on their properties and their safety with regard to human health and the environment.

When submitting results, laboratories must certify that the tests were carried out in accordance with the principles of good laboratory practice.

Member States must adopt the measures necessary for verification of compliance with the principles of good laboratory practice including, in particular, inspections and checks conducted in accordance with the recommendations of the Organisation for Economic Cooperation and Development (OECD) in this area.

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 are in conformity with this directive.

Should a Member State establish 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 or the environment, the Member State may provisionally prohibit or make subject to special conditions the marketing of that product on its territory.

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 2004/10/EC

11.03.2004

-

OJ L 50 of 20.02.2004

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 219/2009

20.4.2009

-

OJ L 87 of 31.3.2009

RELATED ACTS

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [Official Journal L 396 of 30.12.2006].

Last updated: 11.11.2010

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