Active substances are approved for maximum period of 10 years. Under Directive 91/414/EEC two programmes of renewal were initiated: one under Regulation EC 737/2007 (AIR- 1 programme) and the second one under Regulation EU 1141/2010 (AIR-2 programme).
Under Regulation EC 1107/2009, the rules for the renewal of approval of active substances are provided in Articles 14 to 20.
For all active substances which are not covered by AIR-1 or AIR-2, detailed rules for their renewal are laid down in Regulation EU 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market.
A new functional inbox has been created regarding the renewals of active substances. All correspondence shall be sent to SANTE-PESTICIDES-RENEWAL-OF-APPROVAL@ec.europa.eu
Regulation EU 1141/2010 sets rules for a group of 31 active substances.
Renewal Guidance on implementation of Regulation EU 1141/2010 provides additional guidance concerning the procedure. Also a list of the EU countries' competent authorities for renewals was published.
List of Admissible applications received under Regulation EU 1141/2010.
For 150 active substances whose approval expires between 1 January 2013 and 31 December 2018 (AIR-3 programme), a list of Rapporteur Member States and Co-rapporteur Member is published in Regulation EU 686/2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances whose approval expires by 31 December 2018 at the latest.
For a number of active substances it was necessary to extend the period of approval to enable applicants to prepare their applications according to the format and provisions of Regulation EU 844/2012. A detailed overview of (extended) expiry dates, dates for application and submission dates for supplementary dossiers for the renewal is provided in the Draft Working Document - Renewal Programme (SANCO/2012/11284). It must be emphasised that some of the figures given in this document are indicative dates. It is recommended to refer to the dates provided in the relevant acts adopted.
The approval of an active substance can be renewed upon application. According to Article 3(6) of Regulation EU 844/2012 the Commission shall publish, for each active substance, the names and the addresses of the applicants whose applications have been submitted by the date provided for in the first subparagraph of Article 1(1) and contain all the elements provided for in Article 2. Document SANCO/10148/2014 provides an overview of the applications submitted pursuant to Regulation EU 844/2012.
For active substances whose approval expires between 1 January 2019 and 31 December 2021 a work programme has been created. The list of Rapporteur Member States and Co-rapporteur Member concerning these active substances is published in Regulation EU 2016/183, amending Regulation EU 686/2012.
Active substances have been divided into four groups based on the initial expiry date and presumed characteristics of the substance. Presumed low-risk substances and substances that may fail to meet the approval criteria are prioritised in the work programme. For a number of active substances it was necessary to extend the period of approval. A detailed overview of (extended) expiry dates, dates for application and submission dates for supplementary dossiers for the renewal is provided in the Draft Working Document - Renewal Programme.
The applicant must submit an application for renewal three years before the current deadline if they wish to renew the approval of the substance. Only when an application is received will the Commission take action and extend the current approval period. If an application is not received, the current expiry date will remain.