1.Where a Member State envisages granting an authorisation or a provisional authorisation for the use of a plant protection product in accordance with Directive 91/414/EEC, that Member State shall consider whether, as a result of such use, an existing MRL set out in Annex II or III to this Regulation needs to be modified, whether it is necessary to set a new MRL, or whether the active substance should be included in Annex IV. If necessary it shall require the party requesting the authorisation to submit an application in accordance with Article 7.
2.All parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations, as well as commercially interested parties such as manufacturers, growers, importers and producers of products covered by Annex I may also submit an application to a Member State in accordance with Article 7.
3.Where a Member State considers that the setting, modification or deletion of an MRL is necessary, that Member State may also compile and evaluate an application for setting, modifying, or deleting the MRL in accordance with Article 7.
4.Applications for import tolerances shall be submitted to rapporteur Member States designated pursuant to Directive 91/414/EEC or, if no such rapporteur has been designated, applications shall be made to Member States designated by the Commission in accordance with the procedure referred to in Article 45(2) of this Regulation at the request of the applicant. Such applications shall be made in accordance with Article 7 of this Regulation.
1.The applicant shall include in an application for an MRL the following particulars and documents:
(a)the name and address of the applicant;
(b)a presentation of the application dossier including:
a summary of the application;
the main substantive arguments;
an index of the documentation;
a copy of the relevant GAP applying to the specific use of that active substance;
(c)a comprehensive overview of relevant concerns raised in the available scientific literature about the plant protection product and/or its residue;
(d)the data listed in Annexes II and III to Directive 91/414/EEC relating to data requirements for the setting of MRLs for pesticides including, where appropriate, toxicological data and data on routine analytical methods for use in control laboratories, as well as plant and animal metabolism data.
However, where relevant data are already publicly available, in particular when an active substance has already been evaluated under Directive 91/414/EEC or when a CXL exists and such data are submitted by the applicant, a Member State may also use such information in evaluating an application. In such cases, the evaluation report shall include a justification for using or not using such data.
2.The evaluating Member State may, where appropriate, request the applicant to provide supplementary information in addition to information required under paragraph 1 within a time limit specified by the Member State. In no event may this period exceed two years.
1.A Member State to which an application complying with Article 7 is submitted pursuant to Article 6 shall immediately forward a copy to the Authority and the Commission and draw up an evaluation report without undue delay.
2.Applications shall be evaluated in accordance with the relevant provisions of the Uniform Principles for the Evaluation and Authorisation of Plant Protection Products set out in Annex VI to Directive 91/414/EEC or specific evaluation principles to be laid down in a Commission Regulation in accordance with the procedure referred to in Article 45(2) of this Regulation.
3.By way of derogation from paragraph 1 and by agreement between the Member States concerned, evaluation of the application may be carried out by the rapporteur Member State designated pursuant to Directive 91/414/EEC for that active substance.
4.Where a Member State encounters difficulties in evaluating an application or in order to avoid duplication of work, it may be decided in accordance with the procedure referred to in Article 45(2) which Member State shall evaluate particular applications.
1.After completion of the evaluation report, the Member State shall forward it to the Commission. The Commission shall without delay inform the Member States and forward the application, the evaluation report and the supporting dossier to the Authority.
2.The Authority shall acknowledge in writing receipt of the application to the applicant, the evaluating Member State and the Commission without delay. The acknowledgement shall state the date of receipt of the application and the accompanying documents.
1.The Authority shall assess the applications and the evaluation reports and give a reasoned opinion on, in particular, the risks to the consumer and where relevant to animals associated with the setting, modification or deletion of an MRL. That opinion shall include:
(a)an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes;
(b)the anticipated LOD for the pesticide/product combination;
(c)an assessment of the risks of the acceptable daily intake or acute reference dose being exceeded as a result of the modification of the MRL; the contribution to the intake due to the residues in the product for which the MRLs was requested;
(d)any other element relevant to the risk assessment.
2.The Authority shall forward its reasoned opinion to the applicant, the Commission and the Member States. The reasoned opinion shall clearly define the basis for each conclusion reached.
3.Without prejudice to Article 39 of Regulation (EC) No 178/2002, the Authority shall make its reasoned opinion public.
1.The Authority shall give its reasoned opinion as provided for in Article 10 as soon as possible and at the latest within three months from the date of receipt of the application.
In exceptional cases where more detailed evaluations need to be carried out, the time limit laid down in the first subparagraph may be extended to six months from the date of receipt of the valid application.
2.Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until that information has been provided. Such suspensions are subject to Article 13.
1.The Authority shall, within a period of 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC after the entry into force of this Regulation, submit a reasoned opinion based in particular on the relevant assessment report prepared under Directive 91/414/EEC to the Commission and the Member States on:
(a)existing MRLs for that active substance set out in Annex II or III to this Regulation;
(b)the necessity of setting new MRLs for that active substance, or its inclusion in Annex IV to this Regulation;
(c)specific processing factors as referred to in Article 20(2) of this Regulation that may be needed for that active substance;
(d)MRLs which the Commission may consider including in Annex II and/or Annex III to this Regulation and on those MRLs which may be deleted related to that active substance.
2.For substances included in Annex I to Directive 91/414/EEC before the entry into force of this Regulation, the reasoned opinion referred to in paragraph 1 of this Article shall be delivered within 12 months of the entry into force of this Regulation.
Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.
For that purpose, a request shall be submitted to the Commission within two months after the day on which the party concerned became aware of the act or omission in question.
The Commission shall take a decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act within a set time-limit.
1.Upon receipt of the opinion of the Authority and taking into account that opinion, a Regulation on the setting, modification or deletion of an MRL or a Decision rejecting the application shall be prepared by the Commission without delay and at the latest within three months, and submitted for adoption in accordance with the procedure referred to in Article 45(2).
2.With regard to the acts referred to in paragraph 1, account shall be taken of:
(a)the scientific and technical knowledge available;
(b)the possible presence of pesticide residues arising from sources other than current plant protection uses of active substances, and their known cumulative and synergistic effects, when the methods to assess such effects are available;
(c)the results of an assessment of any potential risks to consumers with a high intake and high vulnerability and, where appropriate, to animals;
(d)the results of any evaluations and decisions to modify the uses of plant protection products;
(e)a CXL or a GAP implemented in a third country for the legal use of an active substance in that country;
(f)other legitimate factors relevant to the matter under consideration.
3.The Commission may request at any time that supplementary information be provided by the applicant or by the Authority. The Commission shall make available any supplementary information received to the Member States and the Authority.
1.The Regulation referred in Article 14(1) shall:
(a)set new or modified MRLs and list them in Annex II to this Regulation where the active substances have been included in Annex I to Directive 91/414/EEC; or
(b)where the active substances have not been included in Annex I to Directive 91/414/EEC and where they are not included in Annex II to this Regulation, set or modify temporary MRLs and list them in Annex III to this Regulation; or
(c)in the cases mentioned in Article 16, set temporary MRLs and list them in Annex III to this Regulation.
2.Where a temporary MRL is set as provided for in paragraph 1(b), it shall be deleted from Annex III by a Regulation one year after the date of the inclusion or non-inclusion in Annex I to Directive 91/414/EEC of the active substance concerned, in accordance with the procedure referred to in Article 45(2) of this Regulation. However, where one or more Member States so request, it may be maintained for an additional year pending confirmation that any scientific studies necessary for supporting an application for setting a MRL have been undertaken. In cases where such confirmation is provided, the temporary MRL shall be maintained for a further two years, provided that no unacceptable safety concerns for the consumer have been identified.
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.
Amendments to Annexes II or III needed to delete an MRL following the revocation of an existing authorisation for a plant protection product may be adopted without seeking the opinion of the Authority.