The Committee of Permanent Representatives of the Member States to the EU (Coreper) could reach agreement, on Friday 12 June, on the text of the Council mandate on simplifying certain rules on placing pesticides on the market, with a view to launching negotiations with the European Parliament.
As regards Regulation 1107/2009 (placing on the market of plant protection products), some of the proposed amendments have highlighted diverging views among the delegations, notably on these issues (see EUROPE 13876/10).
The systematic renewal of approvals for active substances, followed by the renewal of authorisations for plant protection products, is subject to lengthy delays. The Commission has therefore proposed that approvals for active substances should become unlimited in duration, with the exception of substances that are candidates for substitution and those approved under the derogation provided for in Article 4(7) (necessary to control a serious danger to plant health).
The Commission proposed the possibility of targeted reassessments of active substances and scheduled renewals of authorisations for plant protection products (PPPs), in addition to the ad hoc reviews already provided for.
In response to the diverging views among Member States, the compromise text from the Cyprus Presidency, seen by Agence Europe, proposes introducing unlimited duration approvals and authorisations only for low-risk active substances.
For other active substances (not low-risk), it is proposed to extend the duration of the first approval to 15 years (compared with 10 at present) and that of renewals to 25 years (compared with 15) where the renewal procedure is not already ongoing (in which case, the current duration of 15 years would remain applicable).
The current maximum durations would be maintained for substances that are candidates for-substitution (7 years) and for active substances approved under Article 4(7) (5 years). The text also provides for a five-year extension of the approval period for active substances after their first approval, as well as a 10-year extension for those for which approval has already been renewed at least once, in order to provide additional time to reduce the current backlog of ongoing renewal procedures.
As regards the definition of biocontrol substances and their envisaged fast-track access to the market, many delegations considered that the proposed definition was too broad and liable to include substances with a toxic mode of action or hazardous properties, which should not benefit from accelerated approval procedures. The text from the Cyprus Presidency of the Council retains the definition proposed by the Commission, aligns that of plant biostimulants with the Fertilising Products Regulation and distinguishes biostimulants from plant protection products covered by Regulation 1107/2009. In addition, it proposes that accelerated procedures should apply only to low-risk active substances.
The amendment proposed by the Commission to facilitate the mutual recognition of authorisations for PPPs containing biocontrol or low-risk substances, by tacit agreement within 120 days, raised concerns among many delegations. In response to those concerns, the Cyprus Presidency proposes making mutual recognition by tacit agreement optional and applicable only to PPPs containing low-risk active substances. In addition, Member States deciding not to apply tacit authorisation would have to inform the Commission as soon as possible.
MRL. The Commission proposes that, for substances that are not approved in the Union and that have certain particularly hazardous properties, the maximum residue levels (MRLs) based on good agricultural practices in third countries or on the Codex Alimentarius may be lowered to the limit of quantification (corresponding to a ‘technical zero’) if considered appropriate in the light of the outcome of an individual impact assessment and taking into account compliance with international rules.
The text from the Cyprus Presidency maintains the principle proposed by the Commission of lowering existing MRLs to a ‘technical zero’ for a given substance, provided that the individual impact assessment justifies it. It broadens the scope of the substances concerned not only to those displaying certain particularly hazardous properties, but also to those the specific conditions of use of which lead to unacceptable risks for bees or groundwater.
The text also maintains the possibility of providing for transitional provisions allowing products already in the distribution chain to continue to be marketed for a specified period. Despite criticism from some delegations, a majority of them supported the Presidency compromise text. Work is reportedly continuing at a technical level to improve the text. (Original version in French by Lionel Changeur)