Six months after the transition period expired, Alex Fotheringham, Operations Director – Cosmetics of MSL Solution Providers, reflects on the regulatory changes and the issues that have arisen as a result of the UK’s exit from the EU
Despite having officially left the European Union 18 months ago, it is only in the past six that the true effects of the UK’s withdrawal have been felt. Indeed, once the transition period ended, it became clear that a large part of the cosmetics and personal care industry in both the UK and EU was ill prepared for the post-Brexit regulatory requirements.
You might question why these brands and manufacturers did not take steps to get ready. After all, following the emphatic vote to ‘get Brexit done’ in the December 2019 General Election, the UK’s exit seemed assured. However, the negotiations and transition period were very uncertain throughout, and despite the Government announcing plans and timelines, many remained unconvinced that anything would actually happen.
Thankfully, there were no surprises in the implementation of the changes and in fact, everything that did change was known well in advance (at least a year). This provided ample time to prepare and those who did so have benefitted over the past six months.
Responsible Person (RP)
One of the biggest post-Brexit changes for the beauty and personal care industry relates to the Responsible Person (RP). Products sold in the UK and the EU are now subject to two different RP requirements: EU and UK RP.
From 1st January 2021, all UK based RPs became invalid in the EU. This has left businesses that did not arrange a legitimate alternative in time in a precarious position, with its EU importer taking on the role. This means the importer has the associated liabilities and can now request significant amounts of, potentially confidential, data to undertake its duties. The RP is responsible for ensuring the product is safe for use and must be able to discuss technical and safety issues with the relevant Competent Authority. This requires access to potentially sensitive information.
Worryingly, importers are often not even aware of their newly appointed responsibilities until they are inspected by a national authority. Once this has happened, it is too late for the correct RP to be put in place.
Other obligations include completing the EU CPNP (or the SCPN in the UK) notification, compiling and holding the Product Information File (PIF), and listing its name and address on the product packaging.
To help companies gain regulatory compliance and continuous access to both the EU and UK markets without having to deal with multiple service providers, MSL Solution Providers is able to offer a dual Responsible Person service. It has a wholly owned subsidiary business in Dublin, Ireland, enabling it to act as the EU RP for UK businesses, whilst its Greater Manchester-based UK HQ means the team can also act as the UK RP for EU businesses wishing to trade within the UK too.
UK notification database
When the UK Cosmetic Regulation came into force on the 1st January 2021, it brought with it some significant changes in the way products are regulated in the UK. One being the introduction of the UK’s new ‘Submit Cosmetic Product Notifications’ (SCPN) portal. The vast majority of the industry had not had previous access to the system before it went live and were subsequently faced with getting to grips with using it for the first time during the 90 day transitional window for UK notifications.
Fortunately, some initial teething problems aside, the UK SCPN has been a good system to use and The Office for Product Safety and Standards (OPSS), who runs the portal, has been quick to answer any questions, making changes to the system to correct issues and add functionality. However, as the portal launched as an ‘incomplete’ system, key functionality remains missing. This is well understood by OPSS, who have a road map in place for development. Nevertheless, some of these problems made the initial 90 day window difficult for many companies, particularly those who were ill prepared for the changes that came into force on 1st January 2021.
From the EU’s perspective, official rules have not changed. However, the UK’s relationship to them has and this has led to various problems.
Despite being advised that the EU CPNP (Cosmetic Product Notification Portal) would deactivate UK entities after 31st December 2020, some businesses were not prepared for their access to products notified by a UK-based Responsible Person (RP) to be removed from the EU system. For these products, a full re-notification by an EU-based entity has been required.
In addition, there were issues with the access removal carried out by the CPNP administrators. For example, access to some ‘sub-entities’ in the EU CPNP were incorrectly removed, due to their link to a UK address. However, these were quickly resolved.
As a third country, the UK is now subject to customs requirements, which involves much more bureaucracy than before. Take Portugal for example.
According to Article 22 of the Decree Law 189/2008 of 24 September, importers of cosmetic products in the Portuguese market must supply to the customs authorities in Portugal specific documentation, that will allow for the goods to be cleared.
To submit a legal request for a document of conformity, there is a group of papers / information that is required to be submitted to the Portuguese National Authority of Medicines and Health Products (INFARMED). This includes:
1. Current form for requesting a document of conformity, duly completed, in Word format;
a) Identification (name, address, telephone and e-mail) of the importer;
b) Identification (name) and direct contacts (phone and e-mail) of the responsible technician;
c) Identification (CPNP reference, full name and manufacturing batch number) of the cosmetic products to be imported.
2. Written mandate with clear and unequivocal identification of the importer, responsible person, and cosmetic products to be imported, dated and signed by both.
3. Declaration, duly dated and signed by the importer and responsible technician, whereby the importer declares that he is assisted by the responsible technician, who, in turn, declares that, regardless of the link to the importer, assumes jointly and severally the responsibility for complying with the provisions in Decree-Law No. 189/2008, of 24 September, in its current wording, and in the applicable regulations to cosmetic products.
4. Curriculum vitæ of the responsible technician, duly dated and signed by the responsible technician, including: personal information (name, address, telephone and e-mail), academic qualifications, professional experience and, attached, the qualification certificate.
Packaging of products marketed in the UK now needs to be updated; however, brands and manufacturers have until 31st December 2022 to make the necessary changes. These include printing the country of origin and the relevant RP to labels.
Products sold in the UK, which are made in the EU, will need to have the specific country noted, e.g. Made in Italy/France
Products sold in the EU, which are made in the UK, will need to be labelled: ‘Made in the UK’.
For an industry that was so ill-prepared for such huge changes, the cosmetics sector has managed to continue trading surprisingly well. However, at the moment, the UK is still heavily tied to EU legislation – with the UK replicating many of the same regulations. Therefore, the future might not be quite so plain sailing.
There are many unknowns ahead of us. We do not know what will happen when the EU issues new legislative changes, nor how the UK will manage these. We do not yet understand how the UK will handle ingredient restriction changes, how closely we will align with the EU, nor how the UK will manage being a third country.
It is set to be an interesting journey but can be made all the smoother with a specialist partner to help navigate the changes. Now Brexit has actually happened, there is no longer any uncertainty – changes are inevitable. As a specialist supplier of Regulatory and Responsible Person services to the cosmetics and personal care industry, MSL Solution Providers helped hundreds of clients get ready before the end of the transition period and is continuing to help many more navigate the changes post-Brexit.
According to research, in early December 2020, despite the exhortations from ministers, companies across every significant sector said that they could not finalise their Brexit planning because the terms of future trade remained opaque.
Orange Square, a leading distributor of luxury niche fragrance, faced such challenges. Partnering with MSL Solutions Providers, a specialist supplier of Regulatory and Responsible Person services to the cosmetics and personal care industry, MSL Solution Providers was able to advise on the impact of the UK’s withdrawal from the EU and pro-actively work with them to put into place all the necessary solutions. In this case, MSL has taken on the role as the UK Responsible Person and has processed the notifications on the UK SCPN.
Tracy Munro, Operations Director at The Orange Square Company, comments: "Brexit presented a number of complex planning challenges for us as a business. Lack of clarity on the regulatory detail right up to the point the transition period expired added to this problem. We needed somebody living and breathing the anticipated regulatory changes who could provide some clear guidance and practical hands-on support. The experts at MSL did just this for us, explaining in clear, uncomplicated language what steps we needed to take to stay compliant. We have been extremely impressed with the MSL team – its experience and knowledge has been invaluable."