As part of the Brexit process, the European Commission has published various notices to stakeholders, setting out the position on a number of topics from the day the UK leaves the EU, “subject to any transitional arrangement” (read: in the event of a no deal scenario). One such notice covers a number of key pieces of product legislation including: the General Product Safety Directive, Cosmetics Regulation, WEEE Directive, Batteries Directive, Toys Directive, Machinery Directive and more – all set out in an “Indicative list of Union product legislation”. This notice is key for any business selling products in the UK, where their importer, authorised representative or Notified Body is currently based in the UK.
The notice sets the scene by reminding stakeholders that preparing for withdrawal is a matter for private parties, not just the EU and national authorities. There are potentially significant legal repercussions for economic operators in particular. Once the UK leaves the EU, subject to any transitional arrangement, EU product rules will no longer apply to the UK from the withdrawal date – 30 March 2019, 00:00 CET. The following provides a high level summary of the positions set out in the notice:
- Economic operators: as a result of Brexit, an economic operator established in the EU who was previously considered a distributor because the importer of the product was a UK established entity, will become the importer of the product for the purposes of EU law. This attracts specific obligations that potentially affected businesses should be aware of.
- Authorised representatives: although not generally required, manufacturers who have appointed an authorised representative who is established in the UK should ensure that they appoint an authorised representative established in the EU. This is particularly important for products covered by EU rules where an authorised representative/responsible person is required (for example under medical devices and cosmetics rules).
- Notified Bodies: some product rules require the intervention of Notified Bodies in the conformity assessment procedure. Notified Bodies must be established in a Member State and be designated by a Member State notifying authority for performing the relevant conformity assessment tasks. UK Notified Bodies will lose their status as EU Notified Bodies and so will no longer be able to perform conformity assessment tasks under EU product rules from the withdrawal date. EU Notified Bodies also issue certificates as part of this process. The notice advises stakeholders to take the necessary steps to ensure that they will hold certificates issued by an EU-27 Notified Body to demonstrate compliance. If a UK notified body has issued a certificate, the notice advises economic operators to apply for a new certificate (issued by an EU 27 Notified Body) or to arrange for a transfer of the file and corresponding certificate (on the basis of a contractual arrangement between the manufacturer, UK Notified Body and the EU Notified Body).
It is important to remember a couple of things in relation to the above:
- The above position is subject to any transitional arrangement that is agreed between the UK and EU. The end result may look quite different, but it’s important to plan ahead anyway. In the absence of any clear sign as to what the future relationship between the UK and EU will look like, contingency plans should be put in place, as these changes have the potential to cause significant disruption to business.
- The points raised above only apply in respect of products placed on the market after the UK leaves the EU. Discussions between the UK and EU are on-going as to a solution for products placed on the market before withdrawal takes place.
We’ll continue to update on these developments as they happen.
You can find the notice to stakeholders (including the complete indicative list of Union product legislation) here: https://ec.europa.eu/growth/content/brexit-%E2%80%93-guidance-stakeholders-impact-field-industrial-products_en.
The EU’s position paper on goods placed on the EU market under EU law before the withdrawal date can be found here: https://ec.europa.eu/commission/publications/position-paper-goods-placed-market-under-union-law-withdrawal-date_en and the UK position paper is here: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/638958/Continuity_in_the_availability_of_goods_for_the_EU_and_the_UK_Position_Paper.pdf