The EURL guidance document on method extension is now available as version 2.0. A table highlighting the required samples for the reduced validation scheme in accordance with the conventional validation approach has been updated. The EURLs hope that this will facilitate the implementation of the approach and encourage the submission of additional feedback in order to improve the overall quality of the guidance documents.
In a field adjacent to the control of residues of veterinary medicinal products in foods, Commission Regulation (EU) 2023/915 has been adopted recently and will enter into force from 25th May, 2023. This Commission Regulation repeals Regulation (EC) No 1881/2006 and deals with maximum levels of certain contaminants in food. The document may be retrieved from EUR-Lex.
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.
We are pleased to announce that the EURL workshop organised by the ANSES-Fougeres is planned for 20-22 June 2023 as an on-site event in Fougeres. We are very much looking forward to meeting everyone in person once again and hope for fruitful discussions. Information on the registration and a preliminary programme will be made available by the end of March.
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.
We are pleased to announce that the EURL workshop organised by the BVL is planned for 3-5 May 2023 as an on-site event in Berlin. We are very much looking forward to meeting everyone in person once again and hope for fruitful discussions. Information on the registration and a preliminary programme will be made available in April.
We are pleased to announce that the final report for the proficiency test NIIM1021: Nitroimidazoles in plasma is now available. Thank you for your patience. Please retrieve your copy from the FIS-VL. We also would like to ask you to fill out the follow-up questionnaire. All participants have received the password via e-mail.
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.
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.
The EURL Berlin is planning to organise two proficiency tests in 2023. Scheduled for the first and second quarter is a proficiency test on coccidiostats in liver. The participants will be provided with 3-4 test items produced from incurred samples.
Due to the positive feedback to the first proficiency test using standard solutions conducted in 2021 (STRD0521), the EURL Berlin has decided to conduct a PT of the same type in late 2023. Participating laboratories will be provided with 3-4 mix solutions of analytes belonging to several substance groups and are asked to determine the analyte contents. This PT shall give the participants the opportunity to check their own standard solutions against a gravimetrically prepared solution.
Laboratories eligible for participation in any of the projected PTs will be contacted in due time regarding the registration process.