A comprehensive system of mutual recognition

“The UK proposes that the future trading relationship should be underpinned by a comprehensive system of mutual recognition which covers a broad range of sectors and regulatory activity. As part of a dynamic regulatory relationship, the comprehensive system of mutual recognition would establish a broad range of reciprocal measures allowing compliance activity undertaken at a national level to be recognised in both the UK and EU markets and recognise the underlying technical requirements.

This compliance activity would include features of existing Free Trade Agreements, for example mutual acceptance of “good practice” inspections such as Good Laboratory Practice and Good Manufacturing practice, conformity assessments, accreditation practices. lt could also include licensing regimes, such as those used io move products with security implications, and recognising labelling requirements.

To ensure that both parties can rely on each other’s authorities to comply with the relevant rules, the mutual recognition of conformity assessment and inspection will continue to be based on a jointly agreed accreditation framework, as is the case for other similar international agreements. ln some sectors, nominated individuals are required to interact with authorities or perform a certain role, for example a Qualified Person is required for testing and batch release of medicines for the EU market. The UK proposes a system of mutual recognition, which would enable authorities and businesses based in either the UK or the EU to conduct compliance activity for the UK and the EU markets.

In order to fully secure the UK’s objective of one approval in one country for both markets, the comprehensive system of mutual recognition would include provisions for recognition of equivalence of technical requirements. Mutual recognition of each other’s regulations and compliance activity capitalises on the fact that the UK is entirely aligned with the EU on day one and respects that businesses with highly integrated supply chains and trade want to minimise the disruption they could experience upon exit.

The EU has established a range of measures with other countries to make it easier to operate across dlfferent regulatory areas, whilst reassuring both parties about public safety. ln many cases, these agreements have brought divergent regulatory regimes closer together, or are underpinned by commitments to align with EU regulation.

For example, the EU has agreed mutual recognition provisions in free trade agreements with Canada and South Korea as well as standalone mutual recognition agreements with New Zealand, USA and Australia, which address barriers to divergent regulatory regimes by recognising the competence of authorities to designate third party organisations to carry out testing. Mutual recognition of conformity alone, however, will not be enough for the EU-UK’s future relationship not meet the principle of having only one relationship because it does approval in one country.

By contrast, arrangements within the EU-Switzerland bilateral have a closer regulatory relationship for manufactured goods, which has resulted in a greater degree of maiket access. The EU-Swiss agreement is a mixed model, with a mutual recognition agreement across a broader range of sectors underpinned by recognising the equivalence of legislation, which means that a single assessments can be accepted in both markets for relevant products. ln the UK’s proposal, this system would be supported by a robust governance mechanism.

Checking products before they go on sale is only part of the story. The UK has always, and will continue, to carry out a robust programme of risk-based market surveillance to ensure that products which are dangerous or potentially harmful to the environment do not reach consumers. This]ncludes both intercepting non-compliant products as they enter the UK, as well as checks

on products already on the market and exchanging information with market surveillance authorities in other member states. lt protects consumers in both the EU and the UK, and means that UK exports to the EU do not pose a greater risk to consumers in the EU than they do today. To support a comprehensive system of mutual recognition, the UK and EU should continue to exchange information to ensure effective market surveillance in our respective territories, and allow reciprocal access to relevant databases and systems.”