Pesticide evaluations: frequently asked questions

EFSA is responsible for the peer review of active substances used in plant protection products in the EU. It is also responsible for the risk assessment of the maximum residue levels (MRLs) of pesticides permitted in products of plant or animal origin sold in the EU. These tasks are carried out respectively by EFSA’s Pesticides Peer Review Unit and Plant Health & Pesticides Residues Unit in line with procedures and deadlines set out in EU legislation.

Frequently Asked Questions

Some general questions that we often receive are available in our Connect.EFSA portal dedicated FAQ page.

1. Are the requirements the same for all active substance evaluations?

The data requirements for all active substance applications are contained in Commission Regulation EU 283/2013 and for plant protection products in Commission Regulation EU 284/2013, including the associated list of test methods and guidance documents. With regard to date requirements see also the European Commission’s web page collecting the Guidelines on Active Substances and Plant Protection Products.

Regulation (EC) No 1107/2009 sets out the provisions regarding applications for approval of an active substance or for amendment to the conditions of an approval, while Commission Implementing Regulation (EU) 2020/1740 sets out the provisions necessary for the implementation of the renewal procedure of an active substance.

2. What happens when EFSA receives a Draft Assessment Report (DAR) or Renewal Assessment Report (RAR) on an active substance?

Upon receipt, EFSA checks the DAR/RAR to verify that it contains the necessary information, according to the Completeness checklist for assessment reports provided in Appendix A to the Administrative Guidance on Peer-review of pesticide active substances. EFSA contacts the Rapporteur Member State (RMS) in case the assessment report is considered incomplete or if it requires amendments. EFSA may consider that the peer review should start only when the assessment report is satisfying the requirements listed in the checklist. EFSA distributes the DAR or RAR to the applicant(s) and the Member States for commenting. 

To allow the public to comment, the sanitised draft DAR/RAR is also published on Open.EFSA portal. EFSA and Member States comprehensively peer review the DAR/RAR to guarantee the highest possible standards. If necessary, discussions also take place between expert scientists from the regulatory authorities of the Member States at the Pesticides peer-review experts meetings to conclude on specific points. 

EFSA then drafts conclusions summarising the outcome of the peer review process, which are sent to the applicant, the Commission and published on the EFSA Journal.

3. Where can I find all published documents related to an application?

For all the pesticide applications for which the Union law contains provisions for EFSA to provide a scientific output (e.g. New Active Substance (NAS), renewal or MRL application), published documents are available on the Open.EFSA portal.

Interested parties can find an application by browsing to the “Questions” section and by searching the application of interest using relevant keywords such as the name of the pesticide active substance or (when known) the specific EFSA Question Number. Interested parties should select a search result to display the related information and the “Supporting documents” section where it is possible to find all the available documents, such as the notified information of studies and the link to the non-confidential IUCLID dossier. During public consultations the available documentation (e.g. the sanitised draft DAR/RAR) is available under the dedicated Consultations page. 

Following the publication of the EFSA conclusions on the peer review of pesticides, the revised DAR/RAR and the peer review report are made available on the Open.EFSA portal (see “Supporting documents”).

The “first stage” of the review of existing active substances (before 2005), was performed by the European Commission and the Member States without the participation of EFSA. For this reason, no document issued before 2005 (e.g. assessment reports) is available on the Open.EFSA portal, but you can directly request them to the relevant competent authorities in Member States.

4. What are Maximum Residue Levels (MRLs)?

According to Article 3(d) of Regulation (EC) No 396/2005, maximum residue levels (MRLs) are the upper levels of pesticide residues that are legally permissible in or on food or animal feed, based on good agricultural practice (GAP) and the lowest exposure necessary to protect vulnerable consumers. More information on MRLs is available in the dedicated topic page on the EFSA website.

5. How do I apply for an MRL to be revised/set?

The procedures for MRLs applications are set by Articles 6 to 11 and Article 14(1) of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin. 

Applications for new or revised MRLs can be submitted in IUCLID format via the Central submission system (ECHA Cloud Services), at any time through a national contact point in line with Article 6 of Regulation (EC) No 396/2005. Applicants can refer to the MRL Application manual for IUCLID which provides an introduction to the regulatory framework for MRL submissions and the requirements describing the conditions in which an MRL application is needed. The manual can be used by applicants when preparing an MRL application.

The evaluating Member State (EMS) in close cooperation with EFSA, assesses new MRL applications for an active substance/crops combination, performs a consumer risk assessment and determines the recommended MRLs.

6. How long does the review of MRL take?

In line with Article 11 of Regulation (EC) No 396/2005 EFSA shall provide a reasoned opinion on the risks to the consumer associated with the application at least within three months (which may be extended to six months if more detailed evaluations need to be carried out) from the date of receipt of the application. If EFSA requests supplementary information, the time limit laid down shall be suspended until that information is provided (stop the clock events).

7. Short cuts for applicants