Good laboratory practice: tests on chemical substances

SUMMARY OF:

Directive 2004/10/EC — rules on the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances

WHAT IS THE AIM OF THE DIRECTIVE?

It codifies the EU legislation on the application of the principles of good laboratory practice (GLP) and the verification of their applications for tests on chemical substances and repeals Directive 87/18/EEC.

KEY POINTS

• The directive requires EU countries to take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Regulation (EC) No 1272/2008 on the classification, packaging and labelling of chemicals and their mixtures, comply with the principles of good laboratory practice as laid down in Annex I to the directive.
• It also applies where other EU rules provide for the application of the principles of GLP to tests on chemical products to evaluate their safety for human health and/or the environment.
• The tests are carried out on chemical products 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.
• EU countries must adopt the measures necessary to verify compliance with the principles of good laboratory practice including, in particular, inspections and checks conducted in accordance with the relevant principles of the Organisation for Economic Cooperation and Development.
• EU countries 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 comply with this directive.
• An EU country may provisionally ban or make subject to special conditions the marketing of a chemical product on its territory, where the application of the principles of GLP and the verification of their application for tests on chemical substances show that, although it has been examined in accordance with the requirements of this directive, it presents a danger to human health or the environment.

FROM WHEN DOES THE DIRECTIVE APPLY?

It has applied since 11 March 2004. The Directive 2004/10/EC codifies and replaces Directive 87/18/EEC and its subsequent amendments. The original Directive 87/18/EEC had to become law in the EU countries by 30 June 1988.

BACKGROUND

For more information, see:

• Good Laboratory Practice (European Commission).

MAIN DOCUMENT

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) (OJ L 50, 20.2.2004, pp. 44-59)

Successive amendments to Directive 2004/10/EC have been incorporated in the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, pp. 1-1355)

See consolidated version.

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 (OJ L 396, 30.12.2006, pp. 1-849). Text republished in corrigendum (OJ L 136, 29.5.2007, pp. 3-280)

See consolidated version.

Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (OJ L 50, 20.2.2004, pp. 28-43)

See consolidated version.

last update 06.09.2018