EU review of active substances

The EU review programme of active substances in plant production products is based on Council Directive 91/414/EEC. This council directive is part of the harmonisation of the European market of food and feed. In principle, a plant production product can only be authorised in the Member States when its active substance is included in Annex I of this directive (positive list of active substances).

Active substances are assessed in a community procedure

Active substances which were on the market in any of the 15 Member States before 1993 are referred to as existing active substances (EAS). As new active substances (NAS), they have to be evaluated on the basis of the directive. For a better handling the evaluation of the existing active substances was split in four stages. An EAS which is not supported by a company will be taken from the market. New active substances enter the programme „as they come“.

A company notifies its active substance at the European Commission and submits a dossier to a Member State which acts as Rapporteur (RMS). A dossier comprises all the study reports, data and information which are required in the council directive. The dossier is evaluated by the RMS, the results are summarised in a draft assessment report (DAR). The DAR is then discussed by all Member States and the European Food Safety Authority (EFSA) in a peer review. At the end of this process, the Standing Committee on the Food Chain and Animal Health (SCFA) decides on the inclusion or non-inclusion of the active substance in Annex I of the council directive.

The BVL coordinates the German participation in the evaluation programme and advises the Federal Government.