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 advice on procedural and technical aspects of preparing a dossier.

2. Are confidential data removed from the documents that will be published during the peer review procedure?

In the course of the peer review several documents related to the application are published on the EFSA website. Before publication, the applicant has the opportunity to remove confidential business information from such documents in line with Article 63 (2) of Regulation EC 1107/2009 laying down what information may potentially undermine the protection of commercial interests, privacy and the integrity of individuals. Once a decision on the confidentiality claim is taken, the sanitised documents are published on the EFSA website.

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

EFSA distributes the DAR or RAR to the applicant(s), and the Member States for commenting. To allow the public to comment, the DAR/RAR is also published on the EFSA website. The EFSA’s Pesticides Peer Review Unit 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 website.

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

For new active substances under Regulation EC 1107/2009, EFSA publishes the “sanitised” summary dossiers in the EFSA's Register of Questions (“Pesticides Dossiers” tab). For renewal procedures under Regulation EU 844/2012, EFSA also publishes the sanitised applications.

During public consultations of DAR/RAR the sanitised version of the assessment reports is available under the under the dedicated Consultations page.

Following the publication of the EFSA conclusions on the peer review of pesticides, background documents (e. g. revised DAR/RAR, peer review report) are available on the Register of Questions (check the specific EFSA Question Number, click on ‘Opinion/Report Number’ and then ‘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 documents issued before 2005 (e.g. assessment reports) are available on EFSA website, but you can directly request them to the relevant competent authorities in Member States.

5. What are Maximum Residue Levels (MRLs)?

Applicants seeking authorisation of a pesticide in a Member State must include in their dossier scientific information about the amounts of pesticide that are necessary to protect a crop and the residue level remaining on the crop after such treatment. If the intended use of the pesticide requires an amendment of the existing MRL set out in Regulation EC 396/2005, an application to modify the MRL needs to be submitted to the competent national authority. An MRL application may also be submitted by importers in case the legal limits need to be revised for food produced in third countries that is intended for the EU market. The European Commission makes available a list of existing MRLs. EFSA is involved in the assessment of the MRL application upon request of the European Commission. All such applications involving EFSA can be found in EFSA’s Register of Questions (ROQ) by selecting the following Food sector area: ‘Pesticide MRL Application (Reg. 396/2005 – Art. 10)’. A question is marked ‘Finished’ when EFSA’s Plant Health & Pesticides Residues Unit
adopts a Reasoned Opinion on the setting or modification of MRLs.

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

Applications should be submitted to a Member State that will proceed with the evaluation of the applications and completion of an evaluation report. EFSA will then assess the applications and evaluation reports and provide a scientific advice on MRLs in the form of a reasoned opinion. The European Commission’s website provides comprehensive guidance and an application form.

7. How long does the review of MRL take?

Regulation EC 396/2005 establishes the rules governing the setting of pesticide maximum residue levels (MRLs) at EU level. To request an authorisation for the use of a plant protection product an application should be submitted to a Member State to set or modify a MRL (according to Article 7 of Regulation EC 396/2005). An Evaluation Report is prepared by the Members State and submitted to the European Commission and EFSA. EFSA shall provide a reasoned opinion on the risks to the consumer associated with the application 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).

8. Short cuts for applicants