EFSA is responsible for the peer review 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, the re-evaluation of active substances for renewal of authorisation, for the setting or changing of MRLs and for basic 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 peer reviews.
Re-evaluation of active substances
Approved active substances are re-evaluated before their expiry date under the renewal programme ( “AIR”).
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.