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Good laboratory practice: tests on chemical substances

Good laboratory practice: tests on chemical substances

Outline of the Community (European Union) legislation about Good laboratory practice: tests on chemical substances

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Good laboratory practice: tests on chemical substances

Document or Iniciative

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].

Good laboratory practice: inspection and verification of laboratory studies on all chemicals

Good laboratory practice: inspection and verification of laboratory studies on all chemicals

Outline of the Community (European Union) legislation about Good laboratory practice: inspection and verification of laboratory studies on all chemicals

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Good laboratory practice: inspection and verification of laboratory studies on all chemicals

Document or Iniciative

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) [See amending act(s)].

Summary

This Directive amends and repeals Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice.

It applies to the inspection and verification of the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals (e.g. cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) in order to assess the effect of such products on man, animals and the environment.

Each Member State designates the authorities responsible for the inspection of laboratories within its territory.

Each year, the Member States forward to the Commission and to a Committee set up by the Directive a report listing the laboratories inspected, the date of the inspection and the conclusions of the inspection.

If the inspection is positive, the Member State is the guarantor that the laboratory is GLP-compliant and this decision is binding in the other Member States.

If a Member State considers that a laboratory within its territory claiming GLP compliance does not in fact comply, it shall inform the Commission, which shall inform the other Member States. Similarly, a Member State may also request a study audit, possibly in conjunction with a new inspection, of laboratories located in another Member State.

The Annexes to the Directive include a detailed description of the procedures to be followed in monitoring GLP compliance in order to ensure that these are internationally acceptable.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2004/9/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

Successive amendments and corrections to Directive 219/2009 have been incorporated in the basic text. This consolidated version is for reference purpose only.

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].

See consolidated version