Renewal (review) of active substances already approved for use in Plant Protection Products

Second stage of renewal (31 active substances)

A second list of substances scheduled for review and renewal (also known as the 'AIR 2' list) was published in Commission Regulation (EU) No 1141/2010 (also known as the second Renewal Regulation). This Regulation lays down the procedure for the submission and appraisal of applications for renewal. Although this part of the renewal procedure started while Directive 91/414/EEC still applied, the decisions on renewals will be taken under Regulation (EC) No 1107/2009 and active substances will have to meet the approval criteria laid out in that Regulation. A guidance document is available to support the second stage renewal process.

This second Renewal Regulation lists 31 active substances which originally had approval ('Annex I inclusion') expiry dates for 2011 and 2012. However, in order to allow time for the renewal procedure to be completed, these expiry dates have been extended to 31 December 2015 by Commission Directive 2010/77/EU of 10 November 2010.

Procedure for the second stage renewal process.

A summary flow diagram is provided to illustrate the key steps in the renewal process.

The main elements are similar to those followed for approval of new active substances but there are some differences in the detailed procedures and timelines.

The key differences are :

• Rapporteur Member States (RMSs) are set out in the Regulation and co-rapporteurs are identified to support the RMS in the assessment process.
• Producers must make an application by the deadline set in the Regulation to indicate their support for an active substance. For existing active substances more than one producer may make an application but they are expected to take all reasonable steps to make a joint submission and failure to do so must be justified.
• Applications should include an 'updating statement’ which lays out the new information that the applicant intends to submit, and should demonstrate that the new information is necessary to reflect changes:

- in data requirements;

- in scientific and technical knowledge since the first inclusion (approval) of the substance;

- to representative uses being supported for renewal.

• Where an application is considered complete, the applicant must then submit their ‘supplementary dossier’ by a separate deadline set in the Regulation. The supplementary dossier provides the data and summaries for evaluation by the RMS. Third parties may also submit information at the deadline.

• The supplementary dossier is checked for completeness in 1 month, and 14 days are allowed to address any deficiencies.

• The evaluation of the dossier must be completed by the RMS in 11 months, and a renewal assessment report (RAR) submitted to the European Commission and copied to the European Food Safety Authority (EFSA). Although additional information can be requested by the RMS during this period there is no ‘stop the clock’ provision to extend the 11 months allowed to produce the RAR.

• The RAR is circulated for comment by EFSA and a copy is also made available for public comment. The supplementary summary dossier is also made publicly available.
• The European Commission considers the comments and decides whether to ask EFSA to produce a conclusion on the risk assessment. The Commission also decides the form of that consultation i.e. whether specific points should be considered and whether to request expert consultation.

• If EFSA are consulted (and it is anticipated that this will be the case for the majority of substances) they have 6 months from the request to produce their conclusion. EFSA may request additional information from the applicant. The applicant has a maximum of 1 month to submit the information in response to a request and the RMS then has a maximum of 2 months to evaluate it on behalf of EFSA.

• The European Commission must draft a review report for the Standing Committee on the Food Chain and Animal Health within 6 months of receiving the EFSA conclusion (or within 6 months of receiving the comments, if no EFSA consultation is requested). The European Commission then propose approval or non-approval for consideration by the Standing Committee.

For summary information about the substances included in this programme and the decisions taken see the summary tables page.

Once an active substance is approved under the renewal programme all existing products containing that substance are considered in a renewal process for authorised products. Further information on this process is available in a guidance document.

Procedure for the third stage renewal process.

The development of the third stage of the renewal programme is being finalised and information will be provided here once final details are available.

It is anticipated that the procedural steps will be broadly similar to those of the second stage. It should be noted that applicants are required to submit an application no later than 3 years before the end of the approval period for the active substance (this is set out in Article 15 of Regulation (EC) No 1107/2009).