If tests are performed, they should comply with the relevant requirements of protection of
laboratory animals, set out in Council Directive 86/609/EEC of 24 November 1986 on the
approximation of laws, regulations and administrative provisions of the Member States
regarding the protection of animals used for experimental and other scientific purposes 1 ,
and, in the case of ecotoxicological and toxicological tests, good laboratory practice,
set out in 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 application for tests on chemical substances 2 .
(38) The generation of information by alternative means offering equivalence to prescribed tests
and test methods should also be allowed, for example when this information comes from
valid qualitative or quantitative structure activity models or from structurally related
substances. To this end the Agency, in cooperation with Member States and interested
parties, should develop appropriate guidance. It should also be possible not to submit
certain information if appropriate justification can be provided. Based on experience
gained through RIPs, criteria should be developed defining what constitutes such
justification.
(39) In order to help companies, and in particular SMEs, to comply with the requirements of
this Regulation, Member States, in addition to the operational guidance documents
provided by the Agency, should establish national helpdesks.