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 Pesticide peer review and Pesticide residues Units 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?
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’. 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 Pesticide peer review 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. The EFSA Administrative guidance on the peer review of pesticide active substances describes all possible status assigned to questions. Further information: ROQ tutorial video
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, please contact: E4 – Pesticides and biocides, European Commission’s Directorate-General for Health and Food Safety (DG SANTE), European Commission.
3. Is there an official list of all approved active substances?
Yes, there is list of approved active substances in the EU. If an active substance is on the list it is possible to apply for national authorisation of a plant protection product containing that active substance. The Member States take the final decisions on whether individual products with specific use recommendations are allowed on the market in their countries.
Active substances are approved for a maximum of 10 years. It is possible to apply for the renewal of approval. The rules for the renewal of approval of active substances are provided under Regulation EC 1107/2009. The Commission Implementing Regulation EU 844/2012 sets out the provisions for the implementation of the renewal procedure for active substances. Details on the renewal (AIR) programme renewal are available on the dedicated page in the EC website.
4. I am a new applicant. How do I prepare an application?
The marketing and use of pesticides is covered by Regulation EC 1107/2009. The specific data requirements for applicants are contained in Commission Regulation EU 283/2013 and Commission Regulation EU 284/2013. 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.
For the approval of a new active substance (NAS) or the renewal of an approval of an active substance, applicants have to submit an application dossier containing scientific information and studies to the rapporteur Member State and co-rapporteur Member State. The rapporteur Member State and co-rapporteur Member State are appointed to carry out an initial risk assessment based on the technical dossier, according to agreed evaluation procedures set out in the legislation. A Draft Assessment Report (DAR) or a Renewal Assessment Report (RAR) is then submitted to EFSA for a peer review.
EFSA has published an administrative guidance for applicants and Member States detailing the procedure of the peer review process, the documents EFSA requires from applicants and how applicants can file a claim for confidentiality. It also gives practical advice on how to present data and information relevant for the application. Further guidance on scientific aspects is available in the guidance documents and technical reports in the scientific guidance and additional resources sections.
The European Commission provides comprehensive advice on the procedure for approval of an active substance and on procedural and technical aspects for 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 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.
6. 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 (see Question 10).
7. 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 Pesticide 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.
8. How long does the approval process take?
The approval process for new active substances is described in Regulation EC 1107/2009 and for renewals in Commission Implementing Regulation EU 844/2012. The rapporteur Member State (see Question 4, above) sends the applicant a written acknowledgement within 45 days from receipt of the application for new active substances or within one month in case of applications for renewals. If any of the requirements are missing from the dossier, the applicant has a maximum of three months in case of new active substances and one month in case of renewals to complete the dossier with the missing information. Once the dossier is deemed complete, the rapporteur Member State starts assessing the active substance and has 12 months to submit its Draft Assessment Report (DAR) or Renewal Assessment Report (RAR) to EFSA. EFSA then makes the DAR/RAR available for comments, for a period of 60 days, to the applicant, Member States and the public. EFSA adopts a conclusion on a new active substance within 120 days (excluding experts consultation and stop the clock events) after the commenting period. The relevant period for adopting a conclusion regarding renewal procedure is 5 months or 120 days from receipt of the revised RAR, when additional information on the endocrine disrupting properties is requested during the peer review. The above mentioned periods are extended when additional information (stop the clock events) and consultation with experts are considered necessary. These periods are explicitly laid down in the legislation. Commission is then responsible for approval or non-approval of the active substances.Agendas and minutes of the Standing Committee on Plants, Animals, Food and Feed (ScoPAFF) meetings are published on the European Commission website:
9. Do I need to pay?
Currently, EFSA does not charge a fee for its scientific evaluations. Rapporteur Member States may charge a fee in order to recover the costs associated with their work.
10. Where can I find all published documents related to an application?
For new active substances, under Regulation EC1107/2009, EFSA publishes the “sanitised” summary dossiers in the EFSA's Register of Questions (“Pesticides Dossiers” tab). For renewal procedures, under Regulation EU844/2012, EFSA publishes also the sanitised application. During public consultations of DAR/RAR the sanitised version of the assessment reports is available under “open consultations”. After the public consultation the documents remain available on the EFSA website under “closed consultations”.
Background documents of the conclusions of pesticides are also published following the publication of the Conclusion and can be retrieved following the direct link provided at the bottom of the conclusion publication page on the EFSA website or alternatively by going to the specific EFSA Question Number in the Register of Questions, clicking on ‘Opinion/Report Number’ and then to the ‘Documents’ section.
As regards old Rapporteur Member States assessment reports not available under “closed consultations” or not available under the List of available rapporteur Member State assessment Reports (published before March 2015) you should get in contact with the Member State Competent Authority.
It’s important to note that 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 DAR nor conclusion is available on EFSA website, but you can directly request it to the rapporteur member state.
11. 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 authorisations of substances, products, claims, processes or organisms for their placing or use on the European Union market. 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 active 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, as well as other administrative or authorisation-related issues, such as import requirements, information on specific brands or products on the market, please contact the European Commission (see Question 2, above).
12. 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 Pesticides Unit adopts a Reasoned Opinion on the setting or modification of MRLs.
13. 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.
14. 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).
15. Short cuts for applicants
- Application procedure for active substances: Regulation EC 1107/2009
- National contact points
- Requirements for technical dossiers for active substances: EC comprehensive guidelines
- EFSA’s guidance documents: scientific and administrative guidance
- Flowcharts on NAS and AIR procedures
- Requirements for Maximum Residue Levels: EC comprehensive guidelines
- Contact regarding authorisation: European Commission’s Directorate-General for Health and Food safety - DG SANTE