# Council Directive 2005/25/EC of 14 March 2005 amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms (Text with EEA relevance), Division 2.6.2.2: Viable residues

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

(a) Member States shall evaluate the possibility of exposure of humans or animals to viable residues via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account:
the likelihood of survival, the persistence and multiplication of the micro-organism in or on crops, food or feed. The various development stages/life cycle of the micro-organism should be addressed,
information concerning its ecological niche,
information on fate and behaviour in the various parts of the environment,
the natural occurrence of the micro-organism (and/or a related micro-organism),
data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods in the case of post-harvest uses) and additional data on application as provided for in Annex IIIB,
where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same micro-organism or which result in the same residues.
(b) Member States shall evaluate the specific information concerning the ability of viable residues to persist or grow in the host and the ability of such residues to cause effects/reactions in the host. In particular, the following information should be taken into account:
the medical data and toxicity, infectivity and pathogenicity studies provided for in Annex IIB, and the results of the evaluation thereof,
the development stages/life cycle of the micro-organism under typical environmental conditions (e.g. in or on the treated crop),
the mode of action of the micro-organism,
the biological properties of the micro-organism (e.g. host specificity).
The various development stages/life cycle of the micro-organism should be addressed.
(c) In the event that viable residues are considered to be toxicologically relevant for humans and/or animals and if exposure is not considered negligible, the actual levels in or on the edible parts of treated crops should be determined, taking into consideration:
analytical methods for the viable residues,
the growth curves of the micro-organism under optimal conditions,
the possibilities of extrapolating data from one crop to another.

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Source: https://www.legislation.gov.uk/eudr/2005/25/annex/division/B/division/2/division/2.6/division/2.6.2/division/2.6.2.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2005-25/annex/division-B/division-2/division-2.6/division-2.6.2/division-2.6.2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.