Overview and procedure
EFSA is responsible for the peer review of the risk assessment of active substances used in plant protection products in the EU. Each active substance (the active component against pests/plant diseases contained in the plant protection product) has to be proven safe in terms of human health, animal health and impact on the environment. EFSA is also in charge of the risk assessment of the maximum residue levels (MRLs) of pesticides permitted in products of plant or animal origin marketed in the EU.
There are different workflows for the evaluation of new active substances, amendment of approval conditions, the re-evaluation of active substances for renewal of approval, for the setting or changing of MRLs and for basic substances.
Endocrine disrupting properties
Commission Regulation EU 2018/605 introduced new scientific criteria for the determination of endocrine disrupting (ED) properties, which have been applicable since 10 November 2018 to all applications for the approval of active substances, including pending applications. As a consequence, all dossiers and assessment reports (DAR/RAR) should include an assessment of the substance’s ED properties. A guidance document on the topic, “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009” (ECHA-EFSA, 2018), has been developed for the identification of endocrine disruptors in accordance with the new criteria, as defined in Commission Regulation EU 2018/605.
For applications submitted after 10 November 2018, the initial dossier should contain the ED assessment in line with the ECHA-EFSA guidance.
For those substances for which the peer review was already at an advanced stage or completed at the time of entry into application of the new ED criteria, EFSA carries out the assessment to decide whether the ED criteria are met.
The ED procedure for new active substances is clarified by the European Commission in a letter: Conclusion on endocrine disrupting properties according to the new scientific criteria in pending applications of new active substances under Regulation EC 1107/2009.
The procedure for renewals is outlined in Commission Implementing Regulation EU 2018/1659.
An overview of the ED assessment of pesticide active substances in line with the criteria introduced by Commission Regulation EU 2018/605 and based on the ECHA/EFSA ED Guidance document (ECHA/EFSA, 2018) is provided in a dedicated report, which is regularly updated and published on this website.
New active substances
For the review of each active substance, applicants have to submit an application dossier, containing scientific information and studies, through a national contact point. A Member State is appointed as a “rapporteur” (RMS) to carry out an initial risk assessment and to prepare a Draft Assessment Report (DAR) which EFSA, together with the Member States, peer reviews.
Re-evaluation of active substances
Approved active substances are re-evaluated before their expiry date under the renewal programme (“AIR”). A Member State is appointed as a “rapporteur” (RMS) to carry out an initial risk assessment and to prepare a renewal assessment report (RAR) with the contribution of a Member State appointed as Co-rapporteur (Co-RMS), which is then peer reviewed by EFSA together with the Member States.
Maximum residue levels
Applications for setting or changing MRLs can be submitted at any time through a national contact point. A Member State is appointed to carry out an initial risk assessment and to prepare an Evaluation Report which EFSA reviews.
Basic substances are active substances that are not predominantly used as plant protection products, but which may be of value for plant protection. Specific criteria for the approval of basic substances are laid down in Article 23 of Regulation (EC) No 1107/2009. For basic substances applications, as of 27 March 2021 the application shall be submitted by the applicant via the IUCLID software application. For more details please consult the Basic substance manual”. Further information on the approval of basic substances and the applicable procedure can be found on the European Commission website and 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.
Non-dietary exposure to plant protection products
As part of the application dossier for the authorisation of a plant protection product, an assessment of the exposure of operators, workers, residents, and bystanders from representative uses of the product needs to be provided. To ensure a harmonised approach across the EU, EFSA developed in 2014 a guidance document (OPEX guidance) with an annexed calculation tool.
The first update of the guidance was published in 2022 with a new online calculator (presented in a recorded webinar). With a view to the next guidance update, EFSA also organised a stakeholder workshop to collect input on finalised, ongoing and future projects in the field.
Stakeholders wishing to submit available raw data (i.e., original study reports containing experimental information and measured values) can write to Pesticides_NDE [at] efsa.europa.eu to receive instructions on how to proceed.
Regulations and guidance
- General overview of application procedure for approval of new pesticide active substances and amendment of approval conditions
- Procedure for approval of pesticide new active substances and amendment of approval conditions under Regulation 1107/2009 and (EU)2021/428
- General overview of application procedure for renewal of approval of pesticide active substances
- Procedure for renewal of approval of pesticide active substances under Regulation (EU)2020/1740
- General overview of application procedure for Maximum Residue Levels for pesticides
- General overview of application procedure of basic substances