Applications
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.
Requirements relating to applications for MRLs
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:
(i)
a summary of the application;
(ii)
the main substantive arguments;
(iii)
an index of the documentation;
(iv)
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.
Evaluation of applications
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.
Submission of evaluated applications to the Commission and the Authority
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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
