Tag Archives: Legislation

Commenting process for the EURL Guidance document on confirmation method validation initated

The Commission Implementing Regulation 2021/808 which lays down requirements for the performance of methods for the analysis of veterinary drug residues has entered into force on 10 June, 2021. In order to support the implementation of the new CIR, COM has asked the EURLs to provide guidance documents dealing with specific topics which might require supplemental information. The EURLs have drafted several documents, which have been presented during the meetings of the Working Group on Residues of Veterinary Medicinal Products in Food of Animal Origin and during the EURL workshops. The guidance documents are the EURL interpretation of CIR (EU) 2021/808 and are meant as a support for all laboratories, but they are not seen as mandatory to follow and other approaches are possible, if comparable results are achieved. Still, the guidance documents also aim at a harmonised interpretation of CIR (EU) 2021/808 and the EURLs have therefore initiated commenting processes involving the NRLs. Regarding the EURL Guidance document on ongoing quality control the commenting process has come to an end, the document has been finalised and is available here. The comments for the draft EURL Guidance document on method extension have also been reviewed. The first official version is currently in preparation and will soon be published, as well.

We are pleased to announce that a draft version of the EURL Guidance document on confirmation method validation has been compiled and submitted to the NRLs for their comments and suggestions. All NRLs are asked to provide their feedback to the EURLs by 15 September, 2021. As a final step all comments will then be reviewed and the draft will be amended. It is expected that the final version of this document will be published towards the end of 2021.

Commission Implementing Regulation (EU) 2021/808 published (Revision of CD 2002/657/EC)

In 2015 the Expert Committee on Residues of Veterinary Medicinal Products indicated that a review of Commission Decision (CD) 2002/657/EC is considered necessary. Subsequently, the EURLs were asked to support DG SANTE in this process. In the following years the EURLs carried out surveys among the NRLs on their view on required changes in this Commission Decision, produced first drafts and discussed the drafts during the annual EURL workshops. Finally, DG SANTE prepared a draft revision (SANTE 11188:2018) which was discussed several times at the Working Group on Residues of Veterinary Medicinal Products and was finally voted on at the SC PAFF in the end of 2020. The document is now published in the Official Journal of the European Union as “Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing Decisions 2002/657/EC and 98/179/EC” and enters into force in June 2021.