REACH (Regulation (EC) No 1907/2006) is the new Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007 and its main obligations started applying on 1 June 2008. It streamlines and improves the former legislative framework on chemicals of the European Union (EU).
Article 13.4 of REACH Regulation (EC) No 1907/2006 requires that ecotoxicological and toxicological tests and analyses shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission or the Agency and with the provisions of Directive 86/609/EEC, if applicable.
(N.B.: No other international standards have yet been recognized as being equivalent to GLP.)
Annex XI of REACH (GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X) provides for some exemptions for existing data in case that testing does not appear scientifically necessary.
For more information see also section R.4.2 (Reliability of information) in the Guidance on information requirements and chemical safety assessment.
The European Chemicals Agency (ECHA) has been established to manage and in some cases to carry out the technical, scientific and administrative aspects of REACH. It receives the pre-registrations and registrations and will co-ordinate the evaluation, authorisation and restriction processes.