EUROPE: New Low Risk criteria published
31 August 2017
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3 October 2017
This Notice from DG SANTE reminds applicants that, unless the withdrawal agreement (‘Brexit’) establishes another date or the period is extended by the European Council, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019 (‘the withdrawal date’). The United Kingdom will then become a ‘third country’.
In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, all applicants for an active substance or plant protection product are reminded of certain legal repercussions.
In particular, applicants should consider that, according to Union law, UK as a third country will not be able to act as rapporteur Member State, zonal rapporteur Member State or evaluating Member State for MRLs anymore.
As regards submissions of new applications, applicants should take into account the expected timelines of different regulatory procedures in which the UK would be acting and should consider taking the relevant actions. For example, where there is a risk that those procedures are not concluded by the date when the UK will leave the Union, applicants may choose by preference another Member State to carry out the evaluation or assessment.
Concerning those on-going procedures for which the UK is currently carrying out an assessment or evaluation, applicants should carefully monitor their progress. Where there are clear indications that the procedure will not be concluded by the withdrawal date, taking account of the uncertainties as well as the regulatory framework, applicants should consider taking the necessary actions. For example, a change of the rapporteur or evaluating Member State may be required.
The Commission Services are working with Member States and EEA countries in order to establish a coordinated way forward for a timely communication, agreement and technical transfer of the file in case that change is needed. This will be particularly relevant for the review programme of existing active substances, for which the UK was assigned by law (Commission Implementing Regulation (EU) 686/2012) as rapporteur and co-rapporteur Member State.
The Commission Services stand ready to provide further clarification and will provide a series of Questions & Answers (Q&A) in relation to Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005. They will be made publicly available on a dedicated page of the Directorate-General for Health and Food Safety: http://ec.europa.eu/food/plant/pesticides/approval_active_substances_en
This page will be updated with further practical information and relevant Q&A pairs, and will be subsequently expanded, where necessary.
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