College voor de toelating van gewasbeschermingsmiddelen en biociden

1 Background & introduction

1.1 Active substance renewals

After their first approval in the EU, active substances for plant protection products (PPPs) are subject to a re-evaluation after 7, 10 or 15 years depending on their classification. Active substances have been divided into 4 groups based on their scheduled expiration date; AIR-1 to AIR-4. For AIR-1 substances, the renewal evaluations were completed in 2011/2012. For AIR-2 substances, the renewal of the first batches apply from 1January and 1 April 2016 while the rest is expected to be renewed later in 2016 or 2017, and for AIR-3 substances the evaluations are in full progress. Re-evaluation of AIR-4 substances will be taken up in the coming years. (Available information/planning beginning 2016).Renewals in principle apply to active substances, safeners and synergists in the plant protection product. For convenience, where the term ‘active substance’ is used in this document, this also applies to safeners and synergists.  

1.2 PPP renewals

Following the active substance renewal, the authorizations of PPPs containing the active substance are up for re-evaluation as well (Article 43 of Regulation 1107/2009). For AIR-1 substances, the PPP renewals are ongoing, and these are executed under the transitional conditions of article 80 of Regulation 1107/2009. For AIR-2 substances, the PPP renewals are scheduled to start from the first quarter of 2016. These Ctgb guidelines focus on renewals for AIR-2 and higher AIR groups that should be fully executed under regulation 1107/2009, following a zonal procedure.

1.3 EU guidance on PPP renewals

The EU guidance on PPP renewals, further called EU GD art 43, (SANCO/2010/13170 rev. 13, 14 July 2015) was accepted in July 2015, and forms a starting point for authorization authorities and applicants. The Guidance Document describes the outlines of the procedures, but many details are left to be filled in, leaving room for interpretation. As PPP renewals are to be zonal applications, Ctgb and many other member states with us, strongly aim at filling in these details in a harmonized way across the EU member states. This process is ongoing. The EU GD art 43 may therefore well be subject to amendments and supplements in the near future. A revision is being prepared and expected to be published mid-2016.

This also means that the information on renewals on the Ctgb webpages is not yet complete and will be updated regularly. Stakeholders will be informed about major updates.

Questions of applicants of PPP renewals can be sent to our Ctgb Service Desk. Answers on general questions will be incorporated in these webpages on article 43 PPP renewals.

1.4 Ctgb aim

To create a robust procedure for PPP renewals that is optimally harmonized between authorization authorities in EU member states, so that the requirements are clear for applicants and Ctgb.

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