Guidance Documents

The EURL Guidance Documents to the Revision of Commission Decision 2002/657 EC (Draft Commission Implementing Regulation SANTE 11188) 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 the draft Commission Implementing Regulation SANTE 11188 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 publication of first version. The 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, five technical EURL Guidance Documents are planned:

  • EURL Guidance Document on the quality control during routine analysis (ongoing method performance verification)
  • EURL Guidance Document on confirmation method validation
    • NRL consultation until 15 September, 2021
  • EURL Guidance Document on the extension of methods
  • EURL Guidance Document on validation of screening methods
    • currently under discussion within an EURL expert group
  • EURL Guidance Document on the validation of HRMS methods

Additionally, there are two EURL Guidance Documents on substances:

  • EURL guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrices
  • 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