PURPOSE : to harmonise at the European level the maximum residue levels (MRLs) of pesticides permitted in products of plant and animal origin.
CONTENT : the proposed draft Regulation of the European Parliament and the Council replaces the four Council Directives on Maximum Residue Levels (MRLs) for plant protection products.
The primary objectives of the proposal are to consolidate and to simplify the existing legislation in this area and to define the roles of the different actors, particularly that of the EFSA in the process. To this end, existing legislation was examined in the fifth Simpler Legislation for the Internal Market (SLIM V) exercise of the Commission during 2001, the recommendations of which are incorporated in the proposal. A secondary objective is to solve existing practical, Single Market and third-country trade problems.
The consequence of this draft Regulation entering into force will be that all MRLs for plant protection products will become harmonised after a transitional 'phase-in' period, and will thenceforth only be set at the European level. It removes all trade barriers that were the result of the current situation whereby Member States can set their own national MRLs in the absence of Community MRLs.
It provides for the role of the European Food Safety Authority (EFSA) and of the Commission in the process of setting MRLs. Risk assessment will become a responsibility of EFSA acting with its network of experts and institutes in the Member States and where EFSA will have the responsibility for giving an opinion on the safety of each MRL. The Commission will be responsible for the risk management, by deciding on the setting of MRLs based on the opinion of EFSA.
Member States authorities will provide EFSA with data on national diets, the authorisations and their agricultural practices. EFSA will base its opinions on assessments of these data, other data obtained in the process of evaluation of active substances under Directive 91/414/EEC and additional data to be supplied by applicants.
MRLs not yet harmonised both for existing and new substances, previously set at the national level will be compiled by EFSA, screened for their safety based on the data available and set as temporary MRLs. These MRLs will be revisited on a substance-by-substance basis after the final conclusions on each of the 91/414/EEC evaluations.
In all cases where there is no use of a pesticide on a commodity or when no data are available to demonstrate that residues do not endanger consumer health, no residues may be permitted at levels higher than 0.01 mg/kg which is an enforceable default for zero. Exceptions will be made for substances where a level of 0.01 is not safe for the consumer by setting MRLs at a lower level.�