The UK’s withdrawal from the European Union (EU) has been one of the most drawn out political events of recent years, attracting much opinion and speculation. More than four years after the referendum and just weeks before the UK is set to leave the EU on 31 December 2020, the Brexit landscape and the extent of the new relationship with the EU and its trading partners around the world is still unclear. Those importing products into the UK and exporting products from the UK into the EU are under intensifying pressure to ensure measures are in place to avoid significant impacts despite this uncertainty.
Changing regulatory requirements
The potential for loss of access to critical supply chains for vaccinations, pharmaceuticals and food has received well-deserved attention over this time, though concern has focused primarily on changing border and customs arrangements. But changing regulatory requirements pose an equal, if far less visible, threat to continuity of supply of these and other goods. As EU regulations cease to have effect in the UK and the UK implements its own regulatory systems, there is a substantially heightened risk of loss of access for failure to comply with regulatory obligations. This could affect essential medical supplies, food, raw materials, specialised finished products such as aerospace components, medical devices and construction products, and even everyday consumer products such as cosmetics and household cleaning supplies.
This change has implications for organisations across the world. The UK Government and HSE have been working behind the scenes to set up clear and functional legislation, IT systems, guidance and support necessary to help minimise disruption and avoid chaos in the coming months. However, many essential questions are yet to be resolved. It is essential companies sit up, pay attention and begin to act now.
Product safety and supply chain challenges
Product safety is one of the most complex areas of regulation in the EU, requiring a deep understanding of science as well as the law. The UK will set up similar regulations to those governing the spectrum of chemicals, products and uses in the EU but regulation and policy are expected to diverge from the EU over time, demanding more resources from companies to track and comply with requirements.
Organisations urgently need to reassess their supply chains and ensure that they will be able to maintain compliance. Many will need to deliver highly technical chemical registrations for the first time and/or adjust their supply chain arrangements. These companies face a particularly steep learning curve in order to prepare and comply in a timely manner – expert advice will pay dividends in such cases. Thousands of new notifications, registrations and authorisations will be needed in the EU in the run up to the end of 2020 and in the UK over the next 7 years. Many companies will need to establish local representatives in the UK and/or the EU to perform these regulatory duties on their behalf and avoid burdening their customers with regulatory obligations.
Companies need to identify the chemicals they manufacture and import or export to determine their regulatory responsibilities and deadlines to maintain access to both the UK and EU markets.
The new UK Conformity Assessed marking
From 1st January 2021, a new UK Conformity Assessed (UKCA) marking will apply in the UK to most goods subject to the EU CE marking, such as construction products and medical devices, and to aerosols. While there will be a transition period of a year in most cases, in some cases the new UKCA marking will apply immediately.
How Ramboll can help
Ramboll is working with clients from the UK, Europe and beyond to ensure business continues as usual on 1 January 2021, advising on compliance strategies, moving existing registrations and authorisations to the EU and preparing for UK downstream user import notifications that will start shortly. We have extended our existing REACH Only Representative and cosmetic products Responsible Person services to cover the UK, allowing many of our clients from Europe, America and Asia-Pacific to continue to access the UK market with peace of mind.
Ramboll’s Heath Sciences team has almost 40 years’ experience in chemical and product registration. Our scientists and regulatory specialists work together to provide seamless support to help companies place their products safely and in compliance with regulations anywhere in the world. Our teams in the UK and mainland Europe have been working closely with regulators and industry to help our clients prepare for and manage the change effectively and painlessly.