The European Commission modifies the procedure for the renewal of active substances in plant protection products

The European Commission modified the procedure for the renewal of the approval of active substances.[1]

The new procedure introduces major changes to take into account the provisions introduced by Regulation (EU) 2019/1381 of the European Parliament and the Council Regulation, which amended, among others, Regulations (EC) No 178/2002 and (EC) No 1107/2009.

First, applications for the renewal of the approval of active substances will need to be submitted via the central submission system, managed by the European Food and Safety Authority ("EFSA"), using the IUCLID software package (Article 7).

Secondly, applicants, ahead of the submission of the application for the renewal of the approval of the active substance, will need to notify the studies they intend to conduct to support the application to the central system, in order to (i) allow public consultation to be performed; (ii) enable EFSA to provide advice; (iii) carry out the studies required in support of a future application for renewal in a timely and proper manner (Article 5).

Third, a potential applicant will now have the opportunity to request from the staff of EFSA general pre-submission advice at any time before the submission of the application for renewal. EFSA will then have to inform the rapporteur Member State of the request and together they have decide if the co-rapporteur Member State is required to participate in providing the general pre-submission advice (Article 4).

Fourth, as Regulation (EU) 2019/1381 also introduced additional requirements relating to transparency and confidentiality as well as specific procedural requirements for the submission of confidentiality requests in relation to information submitted by an applicant, Article 11 clearly sets out the conditions for the assessment of confidentiality requests in the context of applications for renewal.

Fifth, Article 11 sets detailed rules on procedure regarding the submission of proposals to the European Chemicals Agency in accordance with Article 37(1) of Regulation (EC) No 1272/2008 by the rapporteur Member State during the renewal of approval of active substances pursuant to Article 14 of Regulation (EC) No 1107/2009.

Finally, Article 13 now foresees the possibility for applicants to submit additional information to Member States, the Commission and EFSA, where in its draft conclusion EFSA identifies critical issues and/or critical data gaps such that it is expected that there is no representative use of at least one plant protection product containing the active substance for which the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 would be fulfilled, and which the applicant could not have known about at the time of submission of the application and did not have the possibility to address following a request for additional information in accordance with Article 13(2). Importantly, EFSA, the rapporteur Member State and the co-rapporteur Member States have to take into consideration the applicant's comments and new information.

These amendments partly address the issues faced by applicants during the renewal procedure in relation to transparency and due process, especially in those situations where EFSA identified areas of concern at the end of the procedure without providing to applicants with the possibility to comment and address those new areas of concern.

The possibility to obtain from EFSA a pre-submission advice and to comment on critical issues identified by the Authority at the end of the procedure can certainly strengthen the transparency of the Union risk assessment in all areas of the food chain where EFSA conducts a scientific risk assessment.

The Commission Implementing Regulation will apply to the renewal of the approval of active substances whose approval period ends on or after 27 March 2024.

The new Implementing Regulation, however, will not apply to the renewal of the approval of the active substances for which a Regulation, adopted in accordance with Article 17 of Regulation (EC) No 1107/2009 on or after 27 March 2021, extends the approval period to 27 March 2024 or a later date.