Guidance Documents

The EURL Guidance Documents to Commission Implementing Regulation (EU) 2021/808 shall provide technical instructions for official control laboratories active in the field of veterinary drug residue analysis according to Regulation (EU) 2017/625. The documents’ status will be that of associated documents to CIR (EU) 2021/808, representing the EURLs’ interpretation of this document. Following the EURL Guidance Documents minutely will not be mandatory and different implementations are possible. However, a comparable level of quality must be achieved if deviation from the approaches outlined in the EURL Guidance Documents is intended.

Before the adoption of an EURL Guidance Document, an initial draft is prepared. From this, an EURL consolidated version is prepared which is then presented to the NRLs for discussion. The NRLs’ comments are evaluated by the EURLs and the document amended before the publication of a first version. The EURL Guidance Documents are seen as ‘living’ documents and NRLs are welcome to submit their feedback in order to further improve the quality of the EURL Guidance Documents.

Currently, six technical EURL Guidance Documents have been published or are currently discussed:

  • EURL Guidance Document on the quality control during routine analysis (ongoing method performance verification); finalised (version 1.2)
  • EURL Guidance Document on confirmation method validation; finalised (version 1.1)
  • EURL Guidance Document on the extension of methods; finalised (version 1.0)
  • EURL Guidance Document on validation of screening methods; currently under discussion within the EURLs
  • EURL Guidance Document on standard addition in the field of the analysis of residues of pharmacologically active substances; finalised (version 1.1, Spreadsheet_MSA)
  • EURL Guidance Document on the validation of HRMS methods

Furthermore, two EURL Guidance Documents on substances are available:

  • EURL guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrices; finalised (version 2.0)
  • EURL guidance on substances included in the substance categories listed in Annex I of SANTE 2017/11987 (draft Commission Implementing Regulation); currently under discussion within the EURLs

The harmonised position of the European Commission and the three EURLs 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 is given in the document available below:

  • Regarding the status of substances listed in Table 1 of CR (EU) No 37/2010 (version 23.11.2022)

The EURL Wageningen has collated a reflection paper on natural growth promoting substances in biological samples: