The European Commission has recently published a Notice to Stakeholders (the Notice). The Notice outlines potential for greater obligations and compliance burden post-Brexit on EU companies with UK based importers. It also calls into question the continuing validity of conformity certificates issued by a UK Notified Body. Potentially affected companies should start considering the effect on their business now.

Much EU product regulation currently places principal obligations on the importer of products or components into the EU from third countries (e.g. China). Other EU companies to which these products are then supplied are treated as ‘distributors’, with much reduced obligations. Product legislation also often requires certificates of conformity to be issued, confirming that the product in question complies with the relevant legislation and applicable standards. In some cases, certain legislation also provides for the obligation to have an ‘authorised representative’ (e.g. legislation on medical devices) or a ‘responsible person’ (cosmetic products) established in the EU. Even where there is no obligation to do so, manufacturers can often choose to appoint an authorised representative to discharge some of their obligations.

The Notice confirms that post-Brexit once the UK becomes a ‘third country’, subject to anything being agreed to the contrary:

  • there is the potential for economic operators across the EU who are currently ‘distributors’ to become ‘importers’ for the purposes of EU product regulation, with the additional obligations that go with it;
  • ‘authorised representatives’ or ‘responsible persons’ established in the UK will no longer be recognised as such, and so new entities within the remaining EU member states will need to be identified; and
  • where economic operators hold conformity certificates issued by a UK Notified Body prior to the withdrawal date and plan to continue placing the product concerned on the EU-27 market as from the withdrawal date, they should consider either applying for a new certificate issued by an EU-27 Notified Body or arranging for a transfer of the file and the corresponding certificate from the UK Notified Body to an EU-27 Notified Body, which would then take over the responsibility for that certificate.

So, for example, where the pre-Brexit importer was based in the UK, with distributors in other EU countries, those distributors will be considered importers post-Brexit if they import products from the UK and then place them on the EU market. Generally speaking, the additional obligations of importers as opposed to distributors include, amongst other things, ensuring that the appropriate conformity assessment procedure has been carried out by the manufacturer, and that the manufacturer has drawn up the technical documentation, affixed the relevant conformity marking (e.g. CE marking), fulfilled his traceability obligations and accompanied, where relevant, the product by the instructions and safety information.

Companies in the EU whose supply chains currently see them import products from the UK should start thinking about whether they might be considered importers post-Brexit, and if so analyse what additional obligations they will be placed under, and ensure they are set up to discharge such obligations. Similarly, companies who have appointed authorised representatives or responsible persons established in the UK will need to consider alternative appointments in an EU-27 member state.

A list of legislation from the Commission’s information system on notified organisations (NANDO database) is available here. Economic operators who have had conformity certificates issued by a UK Notified Body in accordance with any of that legislation need to start thinking about the situation described in (iii), and consider whether they want to apply for a new certificate issued by an EU-27 Notified Body or arrange for a transfer of the file and the corresponding certificate from the UK Notified Body to an EU-27 Notified Body.