Pesticides Procedural Steps
The European Union (EU) has taken several measures to regulate and control the use of pesticides to ensure the protection of human health and the environment.
1. Application Submission
Applicants submit applications for approval or amendment of approval of active substances to a Member State (Rapporteur Member State - RMS) following procedural rules. The RMS may be supported by a co-rapporteur Member State (co-RMS). Prior to submission, applicants can seek pre-submission advice from EFSA and the RMS. There is a common structure for the DAR/RAR agreed by the EU and OECD. The template can be found on the guidelines webpage.
2. IUCLID Format
Applications must be submitted in IUCLID format, allowing sharing with Member States, EFSA, and the Commission. Dossiers must comply with data requirements set out in relevant regulations: Regulation (EU) 2021/428 of 10 March 2021, Regulation EU 283/2013 and its associated Communication and Regulation 284/2013 and its associated Communication, as last amended.
3. Admissibility Check
The RMS performs an admissibility check on the application.
4. Draft Assessment Report (DAR)
The RMS prepares a Draft Assessment Report (DAR) and submits it to EFSA for peer-review. EFSA coordinates the peer-review process and conducts public consultations. If necessary, the RMS can request the applicant to provide additional information during the evaluation. According to the legislation, the RMS has to submit its assessment to the Commission and to EFSA 1-1.5 years after the admissibility of the application for a first approval or 13 months for a renewal of approval. There is a common structure for the DAR/RAR agreed by the EU and OECD. The template can be found on the guidelines webpage
5. EFSA Conclusions
EFSA issues its conclusions on whether the active substance meets approval criteria.
6. Commission's Draft Regulation
Based on EFSA's conclusions, RMS assessment, and other factors, the Commission proposes a draft Regulation for approval or non-approval, along with a Review Report.
7. Standing Committee Opinion
The Standing Committee on Plants, Animals, Food and Feed (ScoPAFF) delivers its opinion on the Commission's proposal.
8. Adoption and Publication
Following a favorable opinion from ScoPAFF, the Commission adopts the Regulation, which is published in the EU Official Journal.
The evaluation of applications for first approval generally takes 3 years and 7 months on average. Renewal applications must be submitted at least 3 years before the active substance's current approval expiry.
10. Evaluation Report
In May 2020, the Commission published a report on the evaluation of EU legislation on plant protection products and pesticide residues.