Procedure for setting temporary MRLs in certain circumstances
Article 16
1. The Regulation referred to in Article 14(1) may also set a temporary MRL to be included in Annex III in the following circumstances: (a) in exceptional cases, in particular where pesticide residues may arise as a result of environmental or other contamination or from uses of plant protection products pursuant to Article 8(4) of Directive 91/414/EEC; or (b) where the products concerned constitute a minor component of the diet of consumers, and do not constitute a major part of the diet of relevant subgroups, and, where relevant, of animals; or (c) for honey; or (d) for herbal infusions; or (e) where essential uses of plant protection products have been identified by a Decision to delete an active substance from, or not to include an active substance in, Annex I to Directive 91/414/EEC; or (f) where new products, product groups and/or parts of products have been included in Annex I, and one or more Member States so request, in order to allow any scientific studies necessary for supporting an MRL to be undertaken and evaluated, provided that no unacceptable safety concerns for the consumer have been identified. 2. The inclusion of temporary MRLs as referred to in paragraph 1 shall be based on the opinion of the Authority, monitoring data and an assessment demonstrating that there are no unacceptable risks to consumers or animals. The continued validity of the temporary MRLs referred to in paragraphs 1(a), (b), (c) and (d) shall be reassessed at least once every 10 years and any such MRLs shall be modified or deleted as appropriate. The MRLs referred to in paragraph 1(e) shall be reassessed at the expiry of the period for which the essential use was authorised. The MRLs referred to in paragraph 1(f) shall be reassessed when the scientific studies have been completed and evaluated, but no later than four years after their inclusion in Annex III.