As part of Brexit, there was an amendment to the regulations about 'Responsible Persons' which meant businesses engaged with cosmetic products which were available to the public in the UK had to change their existing processes in relation to their appointment of Responsible Persons. These amendments were made by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 and came into effect on 31 December 2020 at 11pm.
By way of a reminder, some of the main changes introduced by the regulations post-Brexit included:
- A Responsible Person established in the UK needed to be appointed by a business to place a cosmetic product in the GB market. This Responsible Person would be responsible for ensuring compliance with the UK Cosmetics Regulation. Before the amendments came into place, the Responsible Person could be established in the EU.
- The Responsible Person would need to be labelled with their name and address on cosmetic products placed on the GB market.
- If cosmetic products are imported from the EU, the specific EU country must be specified as the place where it was manufactured.
- All cosmetic products, before being placed on the GB consumer market, would need to be notified to the Submit Cosmetic Product Notification portal.
Our experience of Responsible Persons in the UK
We have found that the adjustment in the run up to the changes and over the past 2 years since the changes to the regulations came into effect has been significant for businesses which were, both pre-Brexit and post-Brexit, involved in cosmetic products made available on the Great Britain market, causing them to have challenges such as:
- negotiating new Responsible Person agreements with their existing Responsible Person because of the need to adhere to the changes brought on by the post-Brexit regulation
- because the existing Responsible Person may not have been established in the UK, having to start this relationship from scratch with a Responsible Person established in the UK
- considering how they flow down their new Responsible Person agreements into their organisations to make sure that the processes which were needed to adhere to the new regulations were complied with moving forward, including implementation of training, new policies and practical steps
- many businesses in the cosmetics and pharmaceutical industry will be facing the intricacies of being engaged in Responsible Person agreements applicable in the EU alongside the new agreements applicable only for cosmetic products made available in Great Britain consumer market
- any opportunity to reconsider how the Responsible Person is appointed within the supply chain – is it the manufacturer, importer, distributor or a third party company? – the change in the regulations and the resultant consideration of Responsible Persons may have prompted a bigger overhaul of business and supply chain operations
- reconsidering other commercial terms with third parties and having to renegotiate them as well as negotiating the Responsible Person agreements
- prompting audits and review of Responsible Persons' activities such as a review of their internal records such as the PIF (Product Information File), safety reports, safety assessments, labelling and good manufacturing practice, to make sure that they are all compliant with the relevant legal requirements
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.