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PARERE Network

At the European level, the process for the acceptance of methods is conducted in a similar manner to that of the OECD, but in most cases OECD test guidelines are adopted directly as part of the regular adjustment of the European Test Methods Regulation 440/2008. In addition, new methods pending validation, which have been submitted to EURL ECVAM for assessment or validation, are checked by the competent authority representatives of the EU member states for their probable relevance. This process is called PARERE (Preliminary Assessment of REgulatory RElevance) and is intended to prevent methods with little or insufficient benefit for regulatory processes from being tested in a costly validation study, therefore ensuring the effective use of human and financial resources when developing and approving alternative methods.

This task of the EU member states is stipulated in European Directive 63/2010/EU for the protection of laboratory animals in Article 47 Paragraph 5 and the BfR is entrusted with this task in Article 16 g of the German Animal Welfare Act. It is performed by the Bf3R, which is an integral part of the BfR, and receives technical support from a national network that includes experts as well as national institutions.




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