Brussels,

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.

9. Timelines
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.

The active substances that could replace pesticides

In order to reduce the use of pesticides, EU foreseens a specific procedure.

​For plant protection pesticides products (PPPs) containing  active substances defined in  (EC) Regulation No 1107/2009 , Member States are required, when assessing an application for an authorisation, to evaluate if they can be replaced (substituted) by other adequate solutions (chemical or non-chemical).
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The constantly updated version of the Commission Implementing Regulation (EU) No 540/2011 of the Regulation (EC) No 1107/2009 lists the candidates for substitution.

Special plant products: the Basic Substances

Basic substances are active substances that are not primarily used as plant protection products but may still have value for plant protection. To be approved as "basic," they must meet specific criteria, including not causing immediate or delayed harm to human and animal health or unacceptable environmental effects.

Approved basic substances are listed in Part C of the Annex to Regulation 540/2011 and included in the Pesticides Database. The database also includes substances with pending approvals. Review Reports for each substance provide details of approved uses and conditions.

The rules governing the procedure of approval apply as set out in the following document: Working document on the procedure for application of basic substances to be approved in compliance with Article 23 of Regulation (EC) No 1107/2009; SANCO/10363/2012 rev.10.

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

Applications for basic substance approvals must be submitted using the IUCLID format via the EFSA submission portal. Applicants can seek pre-submission advice from EFSA, and information on studies supporting the application must be provided.
The Commission checks the application's compliance with pre-submission requirements and test reports before confirming its validity.

Validity of active substance approval and its renewal

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.
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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.

Chlorpyrifos & Chlorpyrifos-methyl 
Chlorpyrifos (sometimes referred to as chlorpyrifos-ethyl) and chlorpyrifos-methyl are insecticides used to control insect pests on a range of crops. Chlorpyrifos-methyl is also used to treat stored cereal grain and empty warehouses.
Read more about the approval process.

Glyphosate
Glyphosate is an active substance used in PPPs control plants, which means it's a herbicide
Read more about the approval process.

Neonicotinoids
Neonicotinoids are active substances used in plant protection products to control harmful insects, which means they are insecticides
Read more about the approval process