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BREXIT - What does it mean for registration of Plant Protection Products?

As we described in our previous article on REACH , the exit date (30 March 2019, 0:00 CET) is fast approaching. Brexit negotiations between the UK and EU continue but there is high uncertainty regarding the type of possible future relationship between the UK and the EU-27. The UK government recently issued advice covering a variety of topics to businesses and the public in case a “no deal” scenario might become true. This could also be seen at the recent “EU Exit Chemicals Stakeholder Event”, the first major public meeting held jointly by DEFRA and HSE (10 October, London), where the effect of a “no deal” scenario on the various chemical regulations currently applied in the EU was intensely discussed.

In case of “no deal” and according to the provisions of the EU Withdrawal Act, EU law will become UK law at point of exit, meaning no policy changes can be made, but improvements (e.g. of processes) and necessary “adaptations” e.g. where decision making currently lies with an EU institution. For the regulation of Plant Protection Products (PPP), including the approval of active substances (a.s.) and the management of associated risks (currently: EU 1107/2009), and the regulation of Maximum Residue Levels (MRLs) of a.s. contained in PPPs (currently: EU 396/2005) the following measures would be taken (also see the official Technical notice):

The UK would establish an independent standalone PPP regime with HSE acting as regulator, and...

…all existing a.s approvals, MRLs and PPP authorisations would be carried across to the new UK regime;

…applications considered by UK at exit date would be processed to completion under national regime, including mutual recognition applications to the UK;

…extension of 3 years would be granted for renewal of approval applications for a.s. that will expire within the 3yrs after exit date;

…a transition period for marketing seeds treated with EU approved products (3 years) and parallel trade permits (2years) in the UK would be granted;

…the sequential (2-Step) registration process would be maintained but streamlined; it can be expected that the period from submission to approval would be substantially shortened;

…following exit date, separate applications for registration in the UK and EU-27 would be required but they would be essentially the same (format and data requirements for UK applications and dossiers would remain the same as for EU applications).

…in contrast to substances currently regulated under REACH, you will not be required to have a local representative or be based in the UK to keep your products on the market.

No immediate action by businesses is required, but it is recommended to plan ahead and start thinking about application plans for the two separate regulatory regimes, EU and UK. Our Regulatory Experts at knoell are happy to help!

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Dr Iain A. MacKinnon
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