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.
The School for Advanced Residue Analysis in Food (SARAF) organised a webinar dealing with recent changes in EU food legislation, especially with regard to CIR 2021/808 and changes compared to CD 2002/657. A representative of DG SANTE and the heads of the three EURLs active in the field of veterinary drug residue analysis presented an overview on current activities of the European Commission dealing with the implementation of Reg. (EU) 2017/625, the guidance on the validation of confirmation methods using the conventional and the alternative approach and the state of play for the guidance document on screening method validation. The presentations are available in the section “FAQ” and also from the SARAF website.
During the EURL Berlin workshop conducted last week, colleagues from EFSA kindly presented a new tool visualising the 2020 results from the monitoring of veterinary medicinal product residues in Europe. The new tool allows for displaying the overall results, a summary per VMPR animal product group, as well as detailed statistics on substances within each animal product group. The tool is available here and will also be linked on the EURL website under “Network” for future reference.
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!
The EURL Berlin is planning to organise two proficiency tests in 2022. Scheduled for the first and second quarter is a proficiency test on the determination of beta-agonists in bovine urine (BETA0422). Participating laboratories will be provided with 3-4 incurred samples containing an unknown number and amount of beta-agonists. The test items are projected to ship in April.
The EURL Berlin’s second PT in 2022 is planned for the third and fourth quarter. As regards the substance group of interest, there are currently two options. The PT will either deal with the analysis of coccidiostats in liver or the analysis of nitroimidazoles in porcine muscle. The laboratory network will be informed which PT will be organised as soon as a decision has been taken. Further details on all PTs will be announced in due time.
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.
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.
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.
As we have announced during the EURL Berlin workshop, the first data entry interval on the online database for the collection of method validation data starts today. You can access “ALMANAC – AnaLytical Method vAlidatioN dAta Collection” at https://almanac-methods.de. The collection and evaluation of the data is a task of the EURL laid down in Regulation (EU) 2017/625. With the launch of “ALMANAC” it is now possible for the NRLs to check and amend their method validation data during defined data entry intervals. Outside of these data entry intervals the data can be browsed but not edited. Additionally, it is possible to search the database for laboratories analysing specific matrix-analyte combinations (no display of method parameters). The data from the last method collection initiated by the EURL Berlin is already available in the database at https://almanac-methods.de. All NRLs are now asked to check/update and confirm the entries linked to their laboratory and should add the information of methods covering analytes within the EURL Berlin’s sphere of responsibility which are not yet included in the database. The deadline for this first data entry interval is 15 September, 2021. For a general overview of ALMANAC, please refer to the presentation given during the 2020 EURL workshop (link to FIS-VL).
An account with access to the respective laboratory data has been provided to all eligible laboratories. If there are any problems with the accounts or if you have any question concerning ALMANAC, please contact the EURL at email@example.com. As there is currently no detailed manual available, the EURL Berlin is planning a short training session in the form of a webmeeting for interested users. The meeting is scheduled for 8 July 2021, 10-11.30 a.m. CEST and an official invitation will be sent soon.
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.