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 firstname.lastname@example.org. 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.
The latest report on the results from the monitoring of veterinary medicinal product residues and other substances in live animals and animal products is now available here. The report summarises monitoring data collected in 2019.
The latest report on pesticide residues in food in the European Union is now available here. The EU-coordinated control programm analyses samples including matrices from animal origin. The report summarises monitoring data collected in 2019.
In the light of the unpredictable events, the board of the EuroResidue Conferences Foundation has decided to postpone again the Euroresidue IX event. The EuroResidue IX Conference is now planned for 23-25 May 2022.
As a consequence of the EURL evaluation, the Commission stated that EURLs with overlapping or similar responsibilities should agree upon their work more closely. The agreement with the Commission is also indispensable. For this reason at least one meeting of the 4 EURLs for residues and a representative of the European Commission is necessary per year. Moreover, an additional exchange among the EURLs with respect to an agreed strategy, increased efficiency and exploiting synergy effects is required.