EU completes new rules for active ingredient renewals

By CnAgri2012-09-20 19:06:07 Print

The EU Standing Committee on the Food Chain and Animal Health has approved in July the new rules which will result in changes to the procedure for renewing active ingredients approvals under Regulation 1107/2009 (the new Pesticides Regulation).

On 13 July 2012, the Standing Committee on the Food Chain and Animal Health approved the proposal submitted by the Commission for an implementing Regulation setting out the provisions necessary for the implementation of the renewal procedure for active ingredients, as provided for in Regulation (EC) No 1107/2009. It should therefore be adopted shortly by the Commission and published in the Official Journal.

The revised renewal procedure will apply from the 1 January 2013 and will cover the third active ingredient renewal project (AIR-3), relating to the renewal of the substance approvals set to expire between mid-2016 and 2018.

The new Implementing Regulation provides for the format and content of the application, which must include a list of the new information the applicant intends to submit and which must be submitted to the Rapporteur Member State (RMS) no later than three years before the expiry of the approval. The RMS will have one month to confirm that the application is complete. The applicant also has the possibility to request a meeting with the Rapporteur MS to discuss the application (before the submission of the dossier).

The applicant must submit the supplementary dossier with the data no later than 30 months before the expiry of the approval. If there is more than one applicant, the dossier must be submitted jointly (or specify the reasons for not doing so). The RMS has one month to decide on the admissibility of the application, following which it will have 12 months to prepare and submit the draft renewal assessment report, which will notably have to include a recommendation on whether the substance should be renewed, considered as "low-risk" or candidate for substitution. This deadline can be extended by an additional period of 12 months if additional data is required.

The draft assessment report will then be circulated to the other Member States and made available to the public for the submission of comments within 60 days. EFSA will then have five months to adopt its conclusion. If additional information is requested by EFSA, the applicant has one month to submit the data, which must be evaluated by the RMS within 60 days. After EFSA has adopted its conclusion, the Commission will have six months to present the renewal report and the proposed draft Regulation to the EU Regulatory Committee (the Standing Committee), which will give its opinion on the basis of which the Commission will adopt the Regulation.

In the meantime, the Commission has also adopted an implementing Regulation (Commission Implementing Regulation (EU) 686/2012) which allocates to Member States, for the purposes of the renewal procedure, the responsibility for 'the evaluation of active ingredients whose approval expires by 31 December 2018 at the latest'. A rapporteur Member State and a co-rapporteur Member State have been assigned to each substance included in the Annex to the Regulation. The allocation of positions between the Member States is designed to ensure an equitable distribution of work and responsibilities.