Implications of Brexit for product regulation

Written on 13 Aug 2018

Is any new EU legislation expected to come into force and effect before the end of the transition period?

EU-wide drone rules drafted by the European Union Aviation Safety Agency are highly likely to be in force and effect by the end of the transition period.

The following legislation could also potentially be in place by then:

  • the Regulation on Enforcement and Compliance in the Single Market for Goods (Goods Package), which seeks to secure better compliance of harmonised products with regulations;
  • the Regulation on the Mutual Recognition of Goods, which seeks to make it easier to sell products in other member states; and
  • the New Deal for Consumers – in particular the legislation on class actions.

Is a new regulator needed, or do additional powers to be given to an existing regulator?

For the large part, we would expect that existing UK regulators will be able to step into any gaps arising out of the UK’s exit from the EU. But that could mean expanding those regulators’ powers or remits. This could include:

  • the HSE replacing the European Chemicals Agency;
  • the CAA replacing EASA; and
  • the MHRA replacing the European Medicines Agency (EMA).

Is there an existing “equivalence” or “recognition” regime for recognising Third Country regulatory regimes?

In order to supply most consumer products, into the EU, you must comply with EU-wide rules and you must also have an EU authorised representative or responsible body. This applies whichever jurisdiction you are supplying from; complying with a Third Country regulatory regime will not be sufficient, in itself, to lawfully get your products to market.

If that regime is a mirror image of the EU regime, this would help you to ensure that products sold in both territories are compliant, but would not negate any consignment testing or border checks required for imports of those goods from Third Countries.

However, the EMA currently cooperates with a number of countries and organisations outside the EU based on specific types of agreement, which enable the signatories to share confidential information and facilitate market access.

Does current UK government policy mean that (subject to the terms of a future trade agreement between the UK and the EU) material changes to regulation or enforcement are likely post-Brexit?

We do not currently envisage any such changes post-Brexit.

What should businesses be doing now to prepare for Brexit?

  • Ascertain what products you sell into the EU and work out whether you need to appoint an authorised representative or responsible person, or register with any agencies based in the EU.
  • Ensure documentation and product labelling is up to date to reflect revised position and ensure no hold ups at customs.
  • If any delays are envisaged at customs, look to ensure that sufficient supply is in place within the EU beyond the UK, to service demand.