6.RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEEDU.K.
Introduction U.K.
(i)The information provided, taken together with that for one or more preparations containing the micro-organism, must be sufficient to permit an evaluation to be made as to the risk for man and/or animals, arising from exposure to the micro-organism and its residual traces and metabolites (toxins) remaining in or on plants or plant products.U.K.
(ii)In addition, the information provided must be sufficient to:U.K.
permit a decision to be made as to whether or not the micro-organism can be approved,
specify appropriate conditions or restrictions to be associated with any approval
where relevant, set maximum residue levels, preharvest intervals to protect consumers and waiting periods, to protect workers handling the treated crops and products.
(iii)For the evaluation of risk arising from residues, experimental data on levels of exposure to the residue may not be required where it can be justified, that the micro-organism and its metabolites are not hazardous to humans in the concentrations that could occur as a result of authorised use. This justification can be based on open literature, on practical experience and on information submitted in Sections 1, 2 and 3 and Section 5.U.K.
6.1. Persistence and likelihood of multiplication in or on crops, feedingstuffs or foodstuffs U.K.
A substantiated estimation of persistence/competitiveness of the micro-organism and relevant secondary metabolites (especially toxins) in or on the crop under the environmental conditions prevailing at and after the intended use, taking into account in particular the information provided in Section 2, has to be delivered.
Moreover, the application shall state to which extent and on which basis it is considered that the micro-organism can (or cannot) multiply in or on the plant or plant product or during processing of raw products.
6.2. Further information required U.K.
Consumers may be exposed to micro-organisms for a considerable time as a result of the consumption of treated food commodities; potential effects on the consumers must, therefore, be derived from chronic or semi-chronic studies, so that a toxicological end point, such as the ADI, can be established for risk management.
6.2.1. Non-viable residues U.K.
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.
6.2.2. Viable residues U.K.
If the information submitted in accordance with point 6.1 suggests persistence of relevant amounts of the micro-organism in or on treated products, food or feed, possible effects on humans and/or animals must be investigated, unless it can be justified from Section 5, that the micro-organism and its metabolites and/or degradation products are not hazardous to humans in the concentrations and of the nature that could occur as a result of authorised use.
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.
The persistence of viable residues needs special attention if infectiveness or pathogenicity to mammals has been found in points 2.3 and 2.5 or in Section 5 and/or if any other information suggests a hazard to consumers and/or workers. In this case the competent authorities may require studies similar to those provided for in Part A.
Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.