Re-use of Test Documentation

The Convention on Animal Experiments of the Council of Europe (Art. 29) and the European Union Directive on Animal Experiments (Art. 22) compel the member states to mutually recognise test results from safety checks.

In order to avoid multiple tests on vertebrate animals, various EU directives also require that first applicants and second applicants for substances agree upon joint use of the results of safety tests.

EU provisions governing the avoidance of multiple testing are contained inter alia in Directive 91/414/EEC concerning the placing of plant protection products on the market and in Directive 98/8/EC concerning the placing of biocidal products on the market.

Various national provisions, such as the Plant Protection Act (Pflanzenschutzgesetz) (§§ 14 ff.), the Act on Protection against Hazardous Substances (Chemikaliengesetz) (§ 20a), the Biocidal Products Act (Biozidgesetz) (§ 20a) and the Genetic Engineering Act (Gentechnikgesetz) (§ 17), put these provisions into concrete form and compel first applicants to make test data available to third parties (compulsory use of experimental data) where the insights obtained are dependent on animal experiments.

Convention on Animal Experiments of the Council of Europe  Online version

Directive 86/609/EEC (Directive on Animal Experiments)  Online version

Cited EU Directives:  

Directive 91/414/EEC (plant protection products)  Online version

Directive 98/8/EC (biocidal products)  Online version

Cited national provisions:

Plant Protection Act (PflSchG) Online Version (German)

Act on Protection against Hazardous Substances (ChemG) Online Version (German)

Biocidal Products Act Online Version (German)

Genetic Engineering Act Online Version (German)

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