Category Archives: News

Webinar on Almanac evaluation and introduction of upcoming collaborative trial

In correspondence with the EURL BVL workplan for the current work period, the EURL BVL will offer a webinar focusing on two topics for all interested NRLs on Thursday, 15 December 2022:

15.12.2022, 9:30 – 10:30 a.m. CET: Almanac data base

This webinar deals with the method data collection. Most NRLs have meanwhile entered their method performance data into the Almanac data base. In the webinar, we will give an overview of the results obtained so far, show substance-group-specific evaluations and will answer open questions on data entry and the use of the data base.

15.12.2022, 11:00 – 12:00 a.m. CET: Laboratory-comprehensive validation study – multi-analytes/multi-substance-groups in milk

In the past working periods several laboratory-comprehensive validation studies with participants from many NRLs were organised and successfully finalised. The benefits from participation in such studies are :

Provision of a detailed method description, practical training (if required), provision of standard substances
Provision of a validation plan (and a time frame to be followed)
Provision of an individual and a laboratory-comprehensive validation report
Complete method validated in accordance with CIR (EU 2021/808) – if participation was successful

The participating laboratories should have the respective resources to carry out the analysis according to the method description and the validation plan in the provided time frame.

Our new validation study will mainly cover substance groups B2e, A6 (nitroimidazoles, CAP), B1 and A3 (corticosteroids) in the matrix milk. The method was devised as a confirmatory method, but can also be used for screening. The detection can be carried out on either LC/MSMS instruments or HRMS instruments. The practical part of the validation study will start in 2023. It would be very much appreciated if you could consider to participate in this study, given the respective resources are available in your lab and there is need for such a method.

During the webinar the details of the method including the list of analytes will be provided. Furthermore, a validation plan and a timetable for the validation study will be presented (implementation of the method, training (if applicable), test run, validation runs, reporting, final evaluation). In the follow-up to the webinar, we will hold a question-and-answer-session for your questions with regard to a possible participation in the study.

If you wish to participate in one – or both – parts of the webinar, please fill in and submit your registration no later than 9 December 2022 (details have been provided to NRLs by e-mail).

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.

Regulations supplementing Reg. (EU) 2017/625 published

Due to transitory measures, several annexes to CD 96/23/EC have remained in force even after publication of the revised official control regulation Reg. (EU) 2017/625. The provision given therein have now been updated and published in new regulations. Commission Delegated Regulation (EU) 2022/1644 of 7 July 2022 contains information on substance groups and commodity groups to be controlled, as well as criteria for sampling strategies. Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 gives detailed information on the preparation of the multi-annual national control plans (MANCP). Both newly adopted regulations will apply from 15 December 2022.

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.

SARAF Webinar on EU food legislation

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.

New EFSA VMPR data visualisation tool

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.

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!

2022 EURL Berlin Proficiency Tests

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.

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.