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First establishment of MRLs
1. MRLs for products covered by Annex I shall be first established and listed in Annex II in accordance with the procedure referred to in Article 45(2), incorporating the MRLs provided for under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, taking into account the criteria mentioned in Article 14(2) of this Regulation. 2. Annex II shall be established within 12 months from the entry into force of this Regulation.
First establishment of temporary MRLs
1. Temporary MRLs for active substances for which a decision on inclusion or non-inclusion in Annex I to Directive 91/414/EEC has not yet been taken shall be first established and listed in Annex III to this Regulation, unless already listed in Annex II hereto, in accordance with the procedure referred to in Article 45(2), taking into account the information provided by the Member States, where relevant the reasoned opinion mentioned in Article 24, the factors referred to in Article 14(2) and the following MRLs: (a) remaining MRLs in the Annex to Directive 76/895/EEC; and (b) hitherto unharmonised national MRLs. 2. Annex III shall be established within 12 months from the entry into force of this Regulation in accordance with Articles 23, 24 and 25.
Information to be provided by the Member States on national MRLs
Where an active substance is not yet included in Annex I to Directive 91/414/EEC and where a Member State has set, by the date of entry into force of Annex I to this Regulation at the latest, a national MRL for that active substance for a product covered by Annex I to this Regulation, or has decided that no MRL is required for that active substance, the Member State concerned shall notify the Commission, in a format and by a date to be established in accordance with the procedure referred to in Article 45(2), of the national MRL, or the fact that no MRL is required for an active substance, and where relevant and at the request of the Commission: (a) the GAP; (b) where the critical GAP is applied in the Member State and, where available, summary data on supervised trials and/or monitoring data; (c) the acceptable daily intake and, if relevant, the acute reference dose used for the national risk assessment, as well as the outcome of the assessment.
Opinion of the Authority on data underlying national MRLs
1. The Authority shall provide a reasoned opinion to the Commission on potential risks to consumer health arising from: (a) temporary MRLs that may be included in Annex III; (b) active substances that may be included in Annex IV. 2. In preparing the reasoned opinion referred to in paragraph 1, the Authority shall take into account the scientific and technical knowledge available, and in particular, information provided by the Member States as required by Article 23.
Setting of temporary MRLs
Taking into account the opinion of the Authority, if such an opinion is necessary, temporary MRLs for active substances referred to in Article 23 may be set and listed in Annex III pursuant to Article 22(1) or, as appropriate, the active substance may be included in Annex IV pursuant to Article 5 (1). Temporary MRLs shall be set at the lowest level that can be achieved in all Member States on the basis of good agricultural practice.
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