EUROPE: Update of analytical guidance documents

Two updated guidance documents have been published by the European Commission as regards analytical methods:

– Guidance document on analytical quality control and method validation procedures for pesticide residues analysis in food and feed – SANTE/11813/2017 rev.0, 21 – 22 November 2017

It supersedes guidance document SANTE/11945/2015 and will be implemented by 01 January 2018. It describes the method validation and analytical quality control requirements to support the validity of data used for checking compliance with maximum residue limits, enforcement actions, or assessment of consumer exposure to pesticides in the EU.

– Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods – SANTE 2017/10632 rev.3, 22 November 2017

The purpose of this guidance document is to give advice on when and how to assess the suitability of the extraction procedures applied in pesticide residue analytical methods, e.g. as required for post-registration monitoring methods in the guidance document SANCO/825/00. However, it is not restricted to post-registration monitoring methods and it is also applicable for pre-registration residue analytical methods used for the quantification of residues in supervised field trials. The guidance document has been developed primarily for the evaluation of extraction efficiency of analytical methods for plant matrices, but the basic principles are also applicable for products of animal origin.

The procedure for evaluating extraction efficiency concerns the data requirements for:

– applications for new active substance approval and renewal of active substances  submitted 2 years after agreement on this document;

– new product authorisations and renewal of product authorisations (the data requirements used for the latest renewal or approval should be considered; no additional proof of extraction efficiency will be required when no change of the MRLs is needed);

– applications for new MRLs made 2 years after agreement on this document;

– MRL reviews and specific MRL assessments (pre- and post-registration analytical methods in line with this document will only be required if it was required for the latest approval or renewal. In case that for the Art. 12 MRL reviews and Art. 43 MRL assessments crops out of the scope of the approval or renewal process are considered, additional proof of extraction efficiency might be required but not available. In those cases no new studies should be requested at this stage; however they will need to be made available at the occasion of a new MRL application or at the next renewal of the substance).

– quality control and method validation procedures for pesticides residues in food and feed (see guidance document SANTE/11945/2015 superseded by guidance document SANTE/11813/2017).

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