Guidance document on residue analytical methods

EUROPEAN COMMISSION Directorate General Health and Consumer Protection

Guidance document onresidue analytical methods

This document provides guidance to applicants and Member States on the data requirements and assessment for residue analytical methods for post-registration control and monitoring purposes.

This document therefore attempts to provide guidance to Member States on possible interpretations of the provisions of section 4, part A of Annex II and section 5, part A of Annex III of Council Directive 91/414/EEC as amended by Commission Directive 96/46/EC which represent the minimum validation requirements for residue analytical methods. In certain cases it may be essential to validate methods on a larger scale (e.g. an increased number of fortification levels or additional test matrices). In cases where the guideline cannot be followed, full justification must be submitted and this will be evaluated on a case by case basis.

This document has been conceived as an opinion of the Commission Services and elaborated in co-operation with the Member States. It does not however intend to produce legally binding effects and by its nature does not prejudice any measure taken by a Member State within its implementation prerogatives of Directive 91/414/EEC, nor any case law developed with regard to this provision. This document also does not preclude the possibility that the European Court of Justice may give one or another provision direct effect in Member States.