Commission Regulation (EU) No 544/2011 (repealed)Show full title

Introduction

The provisions of this Section only cover analytical methods required for post-registration control and monitoring purposes.

Post-approval monitoring might be considered for all areas of risk assessment. This is particularly the case when (strains of) micro-organisms that are non-indigenous to the intended area of application are considered for approval. For analytical methods used for generation of data as required in this Regulation or for other purposes the applicant has to provide a justification for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes.

Descriptions of methods must be provided and include details of equipment, materials and conditions used. The applicability of any internationally recognised method must be reported.

As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.

Data on specificity, linearity, accuracy and repeatability, as defined in points 4.1 and 4.2 of Part A of this Annex, are also required for methods used to analyse micro-organisms and their residues.

For this Section the following applies:

Impurities, Metabolites, Relevant metabolites, Residues	As defined in Regulation (EC) No 1107/2009
Relevant impurities	Impurities, as defined above, that are of concern for human or animal health and/or the environment

On request the following samples must be provided:

(i)

samples of the micro-organism as manufactured;

(ii)

analytical standards of relevant metabolites (especially toxins) and all other components included in the residue definition;

(iii)

if available, samples of reference substances for the relevant impurities.