Renewal of approval

Renewal of approval

Important: changes to the renewal procedure

The rules governing the renewal of approval of active substances have been revised in order to align them with the provisions of the Transparency Regulation.

Commission Implementing Regulation (EU) No 2020/1740 applies to active substances whose approval period ends on or after 27 March 2024. Applications according to those rules must be submitted no later than 3 years before the expiry of the active substance.

Commission Implementing Regulation (EU) No 844/2012 continues to apply to substances whose approval period ends before 27 March 2024 (as on 27 March 2021) The work programmes on this webpage have been updated to indicate the rules that apply for each active substance.

Active substances are first approved for up to a maximum period of 15 years (depending on the type of substance). Approval may be renewed for a period not exceeding 15 years upon application. Work programmes have been developed to allow for the systematic review of active substances.

Still under Directive 91/414/EEC (the predecessor of Regulation (EC) No 1107/2009) two programmes of renewal were initiated: one by Regulation EC 737/2007 (AIR-1 programme) and the second one by Regulation EU 1141/2010 (AIR-2 programme).

For active substances which are not covered by the AIR-1 or AIR-2 programmes, detailed rules for their renewal are laid down in either

  • 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 or
  • Regulation EU 2020/1740 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, and repealing Commission Implementing Regulation (EU) No 844/2012.

The designated rapporteur Member States and co-rapporteur Member States are set out in Commission Implementing Regulation (EU) No 686/2012.

From 27 March 2021 the application (which includes the renewal dossier) for the renewal of the approval of active substance must be submitted in the IUCLID format as laid down in Commission Implementing Regulation (EU) No 2020/1740 (unless the active substance falls under the transitional measures as set out in that Regulation). Further information on applications can be found here.

Further information on pre-submission advice, notification of studies and on confidentiality can be found in the EFSA Practical Arrangements.

All correspondence regarding the renewals of active substances shall be sent to SANTE-PESTICIDES-RENEWAL-OF-APPROVAL@ec.europa.eu

AIR-1 programme

Regulation EC 737/2007 set out the rapporteur and co-rapporteur Member States and the rules for a group of 7 active substances.

AIR-2 programme

Regulation EU 1141/2010 set out the rapporteur and co-rapporteur Member States and the 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.

AIR-3 programme

For 150 active substances whose initial approval expired between 1 January 2013 and 31 December 2018 (AIR-3 programme), the Rapporteur Member States and Co-rapporteur Member States are listed in Regulation EU 686/2012 allocating to EU countries, for the purposes of the renewal procedure, the evaluation of the active substances whose approval expired 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.

Regulation EU 844/2012 applies to all substances in this work programme.

AIR-4 programme

For active substances whose initial approval expires between 1 January 2019 and 31 December 2021 a work programme has been created, see Commission Implementing Decision 2016/C 357/05. The Rapporteur Member States and Co-rapporteur Member States for these active substances are listed in Regulation EU 686/2012 (as amended by Regulation EU 2016/183).

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 dates for submission of 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 approval period ends if they wish to renew the approval of the substance.

For substances falling under Regulation EU 844/2012, 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. 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 SANTE-2016-11734 provides an overview of the applications submitted pursuant to Regulation EU 844/2012.

Regulation EU 844/2012 applies to all substances in groups 1, 2 and 3 and 4(1)of the work programme, and some active substances in group 4(2). The remaining substances in group 4(2) are subject to the renewal rules laid down in Regulation EU 2020/1740.

The 5th renewal programme

For active substances whose approval expires between 1 January 2022 and 31 December 2024 a work programme has been created, see Commission Implementing Decision C/2018/3434. The Rapporteur Member States and co-rapporteur Member States for these active substances are listed in Regulation EU 686/2012 (as amended by Regulation EU 2018/155).

The work programme prioritises substances that are approved as Candidates for Substitution and these will be evaluated without delay. For some other substances it is necessary to potentially extend the period of approval. This is done in order to manage the workload for the evaluating authorities and to align the assessment of substances with similar properties. A detailed overview of (extended) expiry dates, dates for application and where relevant dates for submission of supplementary dossiers for the renewal is provided in the Draft Working Document establishing the fifth renewal programme – Renewal Programme

The applicant must submit an application for renewal before the approval period ends if they wish to renew the approval of the substance.

For substances falling under Regulation EU 844/2012, only when an application is received, the Commission will take action and extend the current approval period. If no application is received, the current expiry date will remain. 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 SANTE-2019-13022 provides an overview of the applications submitted pursuant to Regulation EU 844/2012.

Regulation EU 844/2012 still applies to some active substances in group 1. The remaining substances in group 1 are subject to the renewal rules laid down in Regulation EU 2020/1740.

All substances in group 2 (except for Adoxophyes orana GV strain BV-0001) fall under the renewal rules laid down in Regulation EU 2020/1740.

The 6th renewal programme and beyond

For active substances whose approval period ends between 31 March 2025 and 27 December 2028, the renewal rules laid down in Regulation EU 2020/1740 apply. The Rapporteur Member States and co-rapporteur Member States for such substances are listed in Implementing Regulation (EU) No 686/2012 (as amended by Regulation (EU) 2020/1093 of 24 July 2020). The allocation of these 28 active substances (6th renewal programme) was made in such a way that a balance is achieved as regards the distribution of the responsibilities and the work between Member States.

The applicants must submit an application for renewal no later than 3 years before the end of the approval period, if they wish to renew the approval of the substance.

For substances whose approval period ends on or after 27 December 2028, Rapporteur Member States and co-Rapporteur Member States will be assigned in advance by the Commission and will be listed in Regulation EU 686/2012.