Brussels, 23 January 2018
PLANT PROTECTION PRODUCTS
The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that unless a ratified withdrawal agreement1 establishes another date, all Union primary and secondary law will cease to apply to the United Kingdom from 30 March 2019, 00:00h (CET) (‘the withdrawal date’).2 The United Kingdom will then become a ‘third country’.3
Preparing for the withdrawal is not just a matter for European and national authorities, but also for private parties.
In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, business operators involved in the activities falling under the scope of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and Regulation (EC) No 396/2005 on maximum residue levels of pesticides (MRLs), including applicants for an active substance or plant protection product, are reminded of certain legal repercussions stemming from currently applicable rules of Union law, which need to be considered when the United Kingdom becomes a third country. Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, the EU rules in the field of plant protection products and pesticides no longer apply to the United Kingdom. In particular, business operators should consider that, according to Union law, third countries cannot act as rapporteur Member States, zonal rapporteur Member States or evaluating Member States for MRLs4.
1 Negotiations are ongoing with the United Kingdom with a view to reaching a withdrawal agreement.
2 Furthermore, in accordance with Article 50(3) of the Treaty on European Union, the European Council, in agreement with the United Kingdom, may unanimously decide that the Treaties cease to apply at a later date.
3 A third country is a country not member of the EU.
4 With the exception of contracting states of the European Economic Area (“EEA”).
Concerning submissions of new applications, business operators should take into account the expected timelines of different regulatory procedures in which the United Kingdom would be acting as, for example, rapporteur Member State, zonal rapporteur Member State or evaluating Member State for MRLs. Taking account of the aforementioned uncertainties as well as the regulatory framework, business operators should consider taking the relevant actions. For example, where there is a risk that those procedures are not concluded by the date when the United Kingdom 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 United Kingdom is currently carrying out an assessment or evaluation, business operators 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, business operators should consider taking the necessary actions. For example, a change of rapporteur or evaluating Member State may be required.
The Commission services is working with Members States and EEA countries to establish a coordinated way forward for the timely communication, agreement and technical transfer of the file in case change is needed. This will be particularly relevant for the review programme of existing active substances, for which the United Kingdom was assigned by law (Commission Implementing Regulation (EU) 686/2012) as rapporteur and co-rapporteur Member State.
The website of the Commission on approval of active substances (http://ec.europa.eu/food/plant/pesticides/approval_active_substances_en) provides general information concerning the approval of active substances as well as a series of Questions & Answers (Q&A) in relation to Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005. These pages will be updated with further information and relevant Q&A pairs, where necessary.
European Commission Directorate-General for Health and Food Safety.
This article contains European Union public sector information which is reproduced pursuant to Commission Decision of 12 December 2011 on the reuse of Commission documents (2011/833/EU)