Pesticide evaluation requests

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 by EFSA’s Pesticides Unit in line with procedures and deadlines set out in EU legislation.

Frequently Asked Questions

  1. I have submitted an active substance for safety evaluation. How can I check the status of EFSA’s evaluation?
  2. I am not sure if my active substance requires approval. Who should I contact?
  3. Is there an official list of all approved active substances?
  4. I am a new applicant. How do I prepare an application?
  5. Are the requirements the same for all active substance evaluations?
  6. What happens when EFSA receives a Draft Assessment Report on an active substance?
  7. How long does the approval process take?
  8. Do I need to pay?
  9. Does EFSA authorise active substances?
  10. What are Maximum Residue Levels?
  11. How do I apply for an MRL to be revised/set?
  12. Short cuts for applicants

  1.  I have submitted an active substance for safety evaluation. How can I check the status of EFSA’s evaluation?

    All requests forwarded to EFSA for evaluation are given an EFSA Question Number (e.g. EFSA-Q-2009-12345) in the Register of Questions (ROQ), which describes the status and progress of EFSA’s scientific work. To find a request, click on the ‘Question’ option in the top menu of the ROQ, then in the ‘Question type’ field select ‘Application’ and select the relevant ‘food sector area’ (in this case any one of five types of ‘Pesticides peer review’ evaluations as defined by the specific legislation). You can then search using key words or a Question number if you know it. After you have located the required request, the Status column indicates the current stage of the evaluation. A question is marked ‘Finished’ when EFSA’s Pesticides Unit adopts a Conclusion on the peer review of an active substance. If a Conclusion has been published, it is available via the ‘View’ link. Further information: ROQ User Guide

  2.  I am not sure if my active substance requires approval. Who should I contact?

    If the substance is not on the list of approved active substances, you need to make an application (see Question 4, below). If you are not sure whether your substance meets the definition of an active substance you should consult Regulation EC 1107/2009, in particular Articles 2 and 3. If you have any further questions related to the approval of active substances used in plant protection products, please contact: Unit E1 – Chemicals, Contaminants, Pesticides, Directorate-General for Health and Consumers (DG SANCO), European Commission.

  3.  Is there an official list of all approved active substances?

    Yes, there is a list of approved active substances in the EU. If a substance is on the list it is possible to apply for national authorisation of a plant protection product containing that substance. The Member States also take decisions at national level on whether individual products with specific use recommendations remain on the market in their countries.

  4.  I am a new applicant. How do I prepare an application?

    The marketing and use of pesticides in plant protection is covered by Regulation EC 1107/2009. The specific data requirements for applicants are contained in Regulation EC 544/2011 and Regulation EC 545/2011. The rules specify a comprehensive risk assessment and authorisation procedure for active substances and products containing these substances. Each active substance has to be proven safe in terms of human health, including residues in the food chain, animal health and the environment. Applicants are obliged to provide data showing that a substance can be used safely with respect to human health, animal health and the environment.

    For the review of each active substance, applicants have to submit an application dossier through a national contact point containing scientific information and studies. A Member State is appointed rapporteur to carry out an initial risk assessment based on the technical dossier, according to agreed evaluation procedures, and to prepare a Draft Assessment Report (DAR). The DARs are then provided to EFSA for a peer review.

    The European Commission provides comprehensive advice on procedural and technical aspects of preparing a dossier.

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

    The data requirements for all active substance applications are contained in Regulation EC 544/2011 and Regulation EC 545/2011 as well as in the European Commission’s advice on procedural and technical aspects of preparing a dossier.

  6.  What happens when EFSA receives a Draft Assessment Report on an active substance?

    The Draft Assessment Report (DAR) is made publicly available on the EFSA website to allow for public comments. Scientists from EFSA’s Pesticides Unit and the Member States comprehensively peer review the DAR to guarantee the highest possible standards. If necessary, discussions also take place between expert scientists from the regulatory authorities of the Member States. All DARs can be accessed at any time on the EFSA website by request. EFSA then drafts conclusions summarising the outcome of the peer review process, which are sent to the Commission and published on the EFSA website.

  7.  How long does the approval process take?

    This process is described in Regulation EC 1107/2009. The rapporteur Member State (see Question 4, above) sends the applicant a written acknowledgement within 45 days of receiving the application. If any of the requirements are missing from the dossier, the applicant has a maximum of three months to submit the missing information. Once the dossier is deemed complete, the rapporteur starts assessing the active substance and has 12 months to submit its Draft Assessment Report (DAR) to EFSA. EFSA then makes the DAR available for public comments, after which it has 120 days to adopt a conclusion.

  8.  Do I need to pay?

    Currently, EFSA does not charge a fee for its scientific evaluations. However, this practice is under review by the EU decision-makers. Rapporteur Member States may charge a fee in order to recover the costs associated with their work.

  9.  Does EFSA authorise active substances?

    No. The approval of active substances is not within EFSA’s remit. In the European food safety system, scientific risk assessment (the responsibility of EFSA) is done independently from risk management, which includes approvals. Taking into account EFSA’s conclusions, the European Commission decides whether or not to include an active substance in the list of approved active substances. This determines whether an application can be made in an EU Member State for a plant protection product containing that substance. The Member States also take decisions at national level on whether individual products with specific use recommendations can be authorised or remain on the market in their countries. If you have any further questions related to the approval of active substance used in plant protection products, please contact the European Commission (see Question 2, above).

  10.  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 provides 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 Pesticides Unit adopts a Reasoned Opinion on the setting or modification of MRLs.

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

    The European Commission’s website provides comprehensive guidance and an application form.

  12.  Short cuts for applicants

Ask a question about applications

I have carefully checked both the legislation and guidance documents and I still have a question related to my application – what should I do?

 

See also

Pesticides

Pesticides homepage