Note to economic operators and related Q&A document for Brexit published on the SANTE webpage

The United Kingdom notified of its intention to withdraw from the European Union. This means that unless the withdrawal agreement 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 United Kingdom will then become a ‘third country’.

In this regard, 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) are reminded that 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, all applicants for an active substance or plant protection product are reminded of certain legal repercussions stemming from currently applicable rules of Union law if the United Kingdom becomes a third country. 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 MRLs1 . As regards 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 e.g., 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 the rapporteur or evaluating Member State may be required.

Please find the note to economic operators and the related Q&A document for Brexit on the SANTE website here (see related documents box on right hand side of webpage).