Category Archives: WFSR

EURL Guidance Document on Screening 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 Screening Method Validation has been finalised and is available as of today.

The starting point for the document was the previously available screening guideline in accordance with CD 2002/657. The three EURLs have made sure to retain well-established principles while also updating the document to meet the new requirements. The first draft was circulated within the laboratory network this summer. The NRLs’ feedback was collected and discussed during the ANSES workshop in June. The EURLs would like to sincerely thank all of you for your suggestions and remarks. The feedback was considered for the preparation of this version 1.1 of the guidance document. Although the 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. As is the case with all EURL Guidances, the document is to be understood as non-static, meaning that should you notice aspects which might require further information, you are welcome to submit your remarks to the EURLs for review.

Revised EURL guidance document on the quality control during routine analysis

The EURL guidance document on the quality control during routine analysis (ongoing performance verification) is now available as version 1.2. Taking into account the feedback received from the NRLs, a section on the selection of representative analytes on which to monitor the method performance has been introduced. The EURLs hope that this information will be helpful to the laboratories active in the field of the analysis of residues of veterinary medicinal products. The provision of constructive feedback for example during the EURL workshops or by e-mail is encouraged and helps to improve the practicality of the guidance documents.

New version of EURL reflection paper

The EURL Wageningen has updated their reflection paper on natural growth promoting substances in biological samples. The paper summarises information on the presence and formation of hormones and other growth promoting substances in food producing animals. Current approaches for enforcement are discussed and research needs for full implementation in residue control are identified.

EURL Guidance Document on Standard Addition 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 Standard Addition has been finalised and is available as of today.

Several laboratories had expressed a need for additional guidance on the application of the standard addition approach respecting the provisions of CIR 2021/808. In response, a working group tasked with drafting an EURL Guidance Document on this topic was formed. The working group members are: Ingrid Elbers (EURL WFSR), Andreia Freitas (NRL Portugal), Murielle Gaugain (EURL ANSES), Ulrike Mülow-Stollin (EURL BVL), Christelle Robert (NRL Belgium) and Ivana Varenina (NRL Croatia).

The first draft was circulated within the laboratory network this autumn. The NRLs’ feedback was collected via an online form and expressed during the WFSR workshop in November. The working group members would like to sincerely thank all of you for your suggestions and remarks. The feedback was considered for the version 1.1 of the Guidance Document which you may find attached to this e-mail. The colleagues of the EURL Wageningen also kindly created an Excel spreadsheet which may be used for calculations necessary for the multiple standard addition approach outlined in the Guidance. This Excel file has been validated according to WFSR procedures regarding the validation of spreadsheets.

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. As is the case with all EURL Guidances, the document is to be understood as non-static, meaning that should you notice aspects which might require further information, you are welcome to submit your remarks to the EURLs for review.

Harmonised position on status of substances listed in Table 1 CR(EU) No 37/2010

The responsible representatives of the European Commission and the heads of the three EURLs have agreed upon a common position regarding the status of substances listed in Table 1 of CR (EU) No 37/2010 and the consequences for the validation of analytical methods in accordance with CIR 2021/808. The harmonised interpretation is provided on the Guidance Document Sub-page.

Feedback process for the EURL Guidance document on standard addition initiated

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 addition to this document, COM asked the EURLs to provide guidance to support the implementation of the new CIR. For this purpose the EURLs have – with the NRL’s support – published several guidance documents outlining their interpretation of CIR 2021/808. These documents 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, they aim at a harmonised interpretation of CIR 2021/808 and therefore greatly benefit from the NRL’s contributions. In order to address several laboratories’ request for additional guidance on the application of the standard addition approach respecting the provisions of CIR 2021/808, a working group was formed. The working group and the EURLs are pleased to present the first draft of the Guidance Document on Standard Addition and would now like to initiate the commenting process.

As always, all NRLs are asked to provide their feedback using an online form provided by e-mail by 22 November 2022. As a final step all comments will be reviewed and the draft will be amended.

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.

Euroresidue IX

We would like to point out an upcoming conference which might be of interest for scientists working in the field of veterinary drugs. From 23-25 May 2022 Euroresidue IX will be organised in St. Michielsgestel, the Netherlands. The theme of the conference will be “Veterinary residue control, the beginning of a new era”. The programme consist of introduction and in depth lectures on legislation, screening and confirmatory technologies, sample preparation, environmental issues, future trends and risk assessment. Next to the lectures a pre-conference workshop will be organised. Please see the flyer and the link for more information.

We hope to see you all in May in the Netherlands!

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.