These are the words engraved onto the UK’S newly released 50 pence coin, released in commemoration of its’ departure from the European Union. This symbol is the first official marker that Brexit really is happening and it’s here to stay. With the Brexit referendum voted in as a majority back in June 2016, nearly four years later, the official Brexit day is finally upon us today on the 31st of January 2020. With that being said, there is no need for panic as nothing has changed for your business quite yet.
According to the EU withdrawal agreement 2018, the UK will now enter an 11 month transition period, until the 31st of December 2020. What does this mean for your business? Whilst the UK is officially no longer a member of any European political institution, it will still be subject to usual EU regulations during this period whilst the UK and EU work furiously to agree the final terms of the divorce agreement before the transition period ends. Bare in mind, an extension of the transition period by up to two years is possible, but this must be agreed before the 1st of July 2020 – although the prime minster has stated he will not seek this extension. If no agreement is reached between the UK and EU before the end of the transition period, a ‘no deal’ Brexit will take place.
Either way, for now business is as usual. However, we do advise you use this time to prepare for regulatory changes which may come into force after December. RNI consulting are here to help you every step of the way. With consultants in the UK, EU and USA we are perfectly positioned to provide regulatory guidance for businesses inside and outside the UK. Here’s what we expect:
When it comes to nutrition products, if a ‘no deal’ does occur following the transition period, the UK will retain most of EU law through the Nutrition (Amendment) (EU Exit) Regulation 2019 with the main change being the transfer of responsibility from the European Commission to 4 administrations across the UK, being England, Ireland, Scotland and Wales which will legislate independently. The UK will also have its’ own register for health claims as well as vitamins, minerals and other substances for addition to foods. With regards to novel foods, responsibility for their approval will pass from the European Food Safety Authority (EFSA) to the UK Food Standards Agency (FSA), with the approval process remaining more or less the same.
With regards to medical devices, two possibilities remain: The UK may stay within the EU regulatory system, or in the case of a ‘no deal’, the Medicines and Healthcare Products Regulatory Agency (MHRA) may become the sovereign regulator in the UK. If a free trade agreement is made following the transition period, then the UK will stay within the EU regulatory system, whereby The new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) will replace old EU Directives and apply on May 25th 2020 and 2022 respectively. In the case of a ‘no deal’ Brexit, these new EU Regulations will be transposed into UK law through the UK MDR (Amendment etc) (EU exit) Regulations 2019. However, it is anticipated that notified bodies based in the UK will no longer be recognized by the EU at the end of this year. This means that CE-mark certificates issued by them will not be valid.
For Cosmetics, it is likely that the UK will transpose EU regulation into a new UK Cosmetic Regulation. The Cosmetics Instrument which is part of the Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019 will take effect in the case of a ‘no deal’ Brexit. For products outside the UK, two Responsible Persons will be required, one for the UK and one for the EU. This would result in two independent Product Information Files and Product notifications in the Cosmetic Product Notification Portal (CPNP). Changes to product labelling may also be necessary.
Get in touch with our team of scientific and regulatory experts so that we can guide you with your transition through Brexit. Whether it be acting as both your UK and EU Responsible Person for cosmetic products or medical devices, or ensuring your products meet new UK regulations, RNI is here to make this transition stress-free for you and your business.