Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance) (c. 283)

ANNEX U.K.

PART B U.K. MICRO-ORGANISMS INCLUDING VIRUSES

6. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED U.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.