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NIIM1122: Preliminary Report

The preliminary report for the proficiency test NIIM1122 is now available on the FIS-VL. The objective of this proficiency test was to allow the participants to assess the performance of their routine methods for the analysis of nitroimidazoles in porcine muscle. All participants are asked to have a look at their results and communicate any deviations from the results they submitted to the EURL Berlin by 30 January 2023.

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.

2023 EURL Berlin Proficiency Tests

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.

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.