Category Archives: ANSES

Updated MMPR Guidance Document

The EURLs are pleased to announce that the guidance document on minimum method performance requirements (MMPRs) has been updated and version 2.0 is now available. The changes with regard to the previous version pertain to residue definitions and matrix changes, as well as clarifications regarding the MMPRs to be considered for authorised pharmacologically active substances, for which no MRL has been set for a specific matrix or species. In addition, the MMPR document has been endorsed by the Standing Committee on Plants, Animals, Food and Feed, which is certainly a significant contribution to harmonised residue control throughout the European Union.

EURL Guidance Document on Confirmation Method Validation published

In order to support the harmonised interpretation and the implementation of the Commission Implementing Regulation 2021/808 laying down requirements for the performance of methods for the analysis of veterinary drug residues, COM has asked the EURLs to provide guidance documents dealing with specific aspects which might require supplemental information. Now, the EURL Guidance Document on Confirmation Method Validation has been finalised and is available as of today.

The document provides suggestions for the validation of confirmation methods based on the conventional and the alternative validation approach. Furthermore, the document’s annex offers an overview of the major differences in requirements laid down in Commission Decision 2002/657/EC and Commission Implementing Regulation (EU) 2021/808.

The drafts of the guidance document on confirmation method validation were presented and discussed during the meetings of the Working Group on Residues of Veterinary Medicinal Products in Food of Animal Origin and during the EURL workshops. Additionally, all NRLs had the opportunity to provide comments in order to increase the document’s practicality.

Although the guidance document represents the EURLs’ interpretation of CIR (EU) 2021/808 and is meant as a support for all laboratories, it is not seen as mandatory to follow. Other approaches are possible, if they provide plausible and comparable results. However, we sincerely hope that you will find the document useful, especially in conjunction with the EURL Guidance document on method extension, also available from the EURL website.

Guidance document on method extension published

In order to support the harmonised interpretation and the implementation of the Commission Implementing Regulation 2021/808 laying down requirements for the performance of methods for the analysis of veterinary drug residues, COM has asked the EURLs to provide guidance documents dealing with specific aspects which might require supplemental information. Now, the EURL guidance document on method extension has been finalised and is available as of today.

The document provides some general reflections on the extension of analytical methods to additional analytes, matrices or the adaption of the validated concentration range. Furthermore, model approaches and practical examples for the extension of methods previously validated applying the conventional and the alternative validation approach are introduced.

The drafts of the guidance document were presented and discussed during the meetings of the Working Group on Residues of Veterinary Medicinal Products in Food of Animal Origin and during the EURL workshops. Additionally, all NRLs had the opportunity to provide comments and suggestions in order to increase the document’s practicality. Although the guidance document represents the EURLs’ interpretation of CIR (EU) 2021/808 and is meant as a support for all laboratories, it is not seen as mandatory to follow. Other approaches are possible, if they provide plausible and comparable results.

2021 EURL Fougères Proficiency Tests

In 2021 2 PTs will be organised:

Ø  PT1 – Multi-Screening and Confirmation of Chloramphenicol Residues in Meat and considering the new RPA of 0.15 µg/kg (March-May 2021)
Ø  PT2 – Multi-Screening and Confirmation of Group B1 Authorized Antimicrobial Residues in Milk   (October-December 2021)

Or  PT2 could be possibly replaced by a collaborative study you should receive more details during the period March-May : Ø  COLLAB TEST – Collaborative study for LC-MSMS / LC-HRMSMS instruments for Multi-Screening / Confirmation of Group B1-B2 Authorized VMP Residues in Extracts of Milk and Meat (October-December 2021)

New common website

As a consequence of the EURL evaluation, the Commission stated that EURLs with overlapping or similar responsibilities should agree upon their work more closely. The agreement with the Commission is also indispensable. For this reason at least one meeting of the 4 EURLs for residues and a representative of the European Commission is necessary per year. Moreover, an additional exchange among the EURLs with respect to an agreed strategy, increased efficiency and exploiting synergy effects is required.