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.
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.
- Procedure for new active substances for specific cases (conclusion under finalisation but not yet adopted by EFSA, or adopted but no voting on draft Regulation took place at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) by the date of application of the new ED criteria introduced by Regulation EU 2018/605).
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.
- Procedure for renewal for specific cases (conclusion under finalisation but not yet adopted by EFSA, or adopted by EFSA but no voting on draft Regulation took place at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) by the date of application of the new ED criteria introduced by Regulation EU 2018/605).
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. For basic substances, the application is submitted by the applicant (including Member States) directly to the European Commission (Unit E4 – Pesticides and biocides at: sante-consult-e4 [at] ec.europa.eu), who then forwards the application to EFSA for its scientific evaluation.