Brexit: The end of EU Regulation?

Since the outcome of the referendum in May 2016, questions about the implications of Brexit have been at the forefront of political debate. The Conservative majority secured in the general election, paired with the House of Commons’ agreement of the European Union (Withdrawal Agreement) bill, makes one thing clear: the UK will be leaving the EU on 31 January 2020. But this leaves a plethora of questions to be answered.

What impact will Brexit have, for example, on a number of regulatory areas? And what subsequent steps will regulators and those carrying out regulated activities need to consider? We know the UK will be leaving the EU but we don’t know the precise terms of the deal the UK will ultimately agree. Nor do we know what will happen after 31 December 2021 – the date on which the transitional period after our departure (during which current EU law will continue to apply) is due to end. Regardless of whether the withdrawal agreement bill passes through the House of Lords without further amendment, we remain unclear on what will happen at the end of next year. Both the UK government and the European Commission have produced guidance on a number of areas. Here we consider four key regulated areas and what the UK’s departure from the EU might mean for UK plc.

FOOD LABELLING

A key feature of EU food law involves specific rules in relation to the labelling of food products. Current EU food law harmonises the labelling of food placed on the EU market. These rules apply to all food products which are sold within the EU independent of the place of production. In the event that no long-term agreement can be reached, food from the UK which is placed on the EU market may need to meet new labelling requirements.

This may include:

— Mandatory presentation of the origin, where appropriate.

— Compulsory labelling of the name or business name and address of the UK business importing the food.

— Article 5 Regulation (EC) No 853/2004 requires EU food products to include the abbreviation ‘EC’ on labels where a health or identification mark is required. However, post-Brexit UK products will need to include the name of the country of origin and not ‘EC’.

— The EU emblem may no longer be included on food products originating from the UK. This will be particularly important for importers of organic produce, as the EU organic logo may no longer be used. These suggestions are not exhaustive, so businesses placing food products on the EU market will need to review their product labels and prepare contingency plans ahead of time so that the labelling of products will remain compliant once the UK has left the EU.

MEDICAL DEVICES

Regulations governing the marketing of medical devices within the EU are in a period of transition. The Medical Devices Regulations 2002 (SI 2002 No 618 as amended) will be superseded by Regulation 2017/745 on Medical Devices on 26 May 2020. If no trade deal is agreed after the UK’s departure from the EU, the UK will no longer participate in the EU regulatory framework in relation to medical devices, which will continue to be regulated in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Regulations in anticipation of a no-deal Brexit have been drafted and take the form of the Medical Devices (Amendment etc.) (EU exit) Regulations 2019, which will amend the current regulations to provide for a new regulatory regime in the UK. This will include the creation of a new role, the UK responsible person, to replace the UK-based authorised representatives in the EU in the authorisation of such devices. At present, manufacturers of medical devices which are marketed in the EU must place a CE mark on the label to attest that the device is compliant with applicable European standards. While the CE mark will still be accepted within the UK, UK-based manufacturers who wish to sell their products.

Helen Simm is a partner in the criminal, compliance and regulatory team at Browne Jacobson brownejacobson.com