# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 6.2.1: Non-viable residues

Extent: E+W+S+N.I.

A non-viable micro-organism is a micro-organism that is not capable of replication or of transferring genetic material.
If relevant quantities of the micro-organism or of produced metabolites, especially toxins, have been found to be persistent in points 2.4 and 2.5, full experimental residue data as provided for in Section 6 of Part A of this Annex is required, if concentrations of the micro-organism and/or its toxins in or on the treated foodstuffs or feedingstuffs are expected to occur in concentrations higher than under natural conditions or in a different phenotypic state.
In accordance with Regulation (EC) No 1107/2009, the conclusion concerning the difference between natural concentrations and an elevated concentration due to treatment with the micro-organism, is to be based on experimentally obtained data, and not on extrapolations or calculations using models.
Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/6/division/6.2/division/6.2.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-6/division-6.2/division-6.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.