The requirements regarding residue analytical methods are specified in the Regulations (EU) No 544/2011 and (EU) No 545/2011 (former Annex II and III of Directive 91/414/EEC) and are explained in Guidance Document SANCO/825/00.

Information on revised Guidance Document SANCO/825/00 "Pesticide Residue Analytical Methods"

Guidance Document SANCO/825/00 on Pesticide Residue Analytical Methods has been thoroughly revised after ten years. New legal regulations have been taken into consideration, the document has been adapted to current technical knowledge and certain issues have been clarified. The Guidance Document is used by the EU evaluation program for active substances, for setting maximum residue levels in the context of Regulation (EC) No 396/2005 and for zonal authorisations for plant protection products. The Guidance Document will probably have to be revised again when the data requirements are updated (former Annex II and III of Directive 91/414/EEC).

Requirements for representative matrices and for the scope of validation and the specificity of confirmatory methods which have been described in Germany in greater detail up to now through separate publications are also described in the new revision 8.1 of Guidance Document SANCO/825/00. As far as the need for methods for animal matrices is concerned, there has been a change in view of the fact that methods are now generally required if maximum residue levels are set. This replaces the graduated approach which was published in the Journal for Consumer Protection and Food Safety, volume 4, booklet 3 + 4, page 412 - 414.

The main changes in the new revision of SANCO/825/00 rev. 8.1 affect the following points:

In general

• Analytical techniques considered commonly available (adapted to current technical knowledge)
• Calibration requirements
• Requirements for confirmatory methods
• Commercial availability of analytical standards

Food of plant and animal origin

• The need for methods (required if maximum residue levels are set or applied for according to Regulation (EC) No 396/2005)
• Multi-methods have priority
• Extension of recognised multi-methods (international standard multi-methods)
• Validation in an independent laboratory (not required for multi-methods if the analyte/matrix combination has already been validated by more than one laboratory)
• Usual limit of quantification
• Concentration-dependent values for recovery and precision (adaption to OECD Guidance Document on Pesticide Residue Analytical Methods)
• Data on extraction efficiency

Soil, water, air and body fluids and tissues

• Necessary data for soil and surface water used
• Limit of quantification which has to be observed for soil
• Additional non-target organism (Chironomus sp.) for surface water
• Additional concentration limit (AECinhalation) for air for substances which are toxic when inhaled
• Confirmatory methods for air (not required if confirmatory methods for soil and water are already available)
• Additional matrices for body fluids (serum, plasma and urine; only one suitable matrix must be examined)