The European Commission plans to make the authorisation period for active substances used in pesticides unlimited, except in specific cases concerning the most dangerous substances, according to a draft regulation on the simplification of food safety rules, obtained by Agence Europe.
The simplification package (‘omnibus’), which the Commission is due to adopt on 16 December, introduces targeted changes to Regulation 1107/2009 on the placing of pesticides on the market, as requested by the European Agriculture Ministers (see EUROPE 13755/14).
According to the proposal, given that most approved active substances have already been subject to at least one renewal and that new active substances are expected to have better toxicological and ecotoxicological properties, it is proposed that approvals of active substances and authorisations of products containing them should become “unlimited in time”, with the exception of active substances that are candidates for substitution and those presenting “properties of concern for human or animal health or the environment”.
Nevertheless, in order to maintain a high level of protection for human and animal health and the environment, it will remain possible to set time limits for approvals, if this is deemed appropriate in the light of the risk assessment prior to the approval decision. The Commission and the Member States will be able to periodically select a certain number of active substances, depending on the resources available, for which a full renewal procedure will be triggered, while retaining the possibility of carrying out ad hoc reviews. According to the Commission, this approach will enable resources to be used more efficiently, with Member States and the European Food Safety Authority (EFSA) able to devote their resources to active substances and plant protection products for which a re-evaluation is justified, as well as to assessing applications for approval of new active substances.
In the eyes of environmental organisations, such a measure would pave the way for unlimited authorisations for pesticides, unlike current legislation where the EU approves them for a maximum of ten years (or fifteen for low-risk active substances).
MRL. Regulation 396/2005 concerns maximum residue levels (MRLs) for pesticides. In its vision for agriculture, the Commission announced the principle that the most dangerous pesticides, banned in the EU for health or environmental reasons, should not be reintroduced into the EU via imported products. These include mutagenic or carcinogenic substances, substances toxic to reproduction and substances that disrupt the endocrine system.
Furthermore, the term ‘import tolerance’ is often misunderstood. It is therefore proposed to delete this term and to specify that the definition of best agricultural practice applies in the same way to the EU and to any third country for the setting of MRLs.
To implement this principle, the proposal specifies that, for such substances, MRLs will be set at the level of the limit of quantification (technical zero) and that no MRLs based on best agricultural practice in third countries, or Codex maximum limits, will be set.
Draft regulations: https://aeur.eu/f/jl5 (Original version in French by Lionel Changeur)