Post Brexit cosmetics regulation in the UK and EU

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How to navigate cosmetics regulation in the UK and EU after BREXIT

TJAŠA GRUM of CE.way Regulatory Consultants Ltd reveals how to deal with these complex markets

On 1 January 2021, the Brexit transition period ended and the UK began the year with its own cosmetics regulation. The transition period began following the departure of the UK from the EU on 31 January 2020, and it lasted until the end of December 2020, allowing some time for companies to make final preparations for

Brexit.

With the UK having its own cosmetics regulation, it puts an additional burden on companies who sell their product in the UK and

EU as they now have to follow two sets of cosmetics regulations.

However, the UK cosmetics regulation more or less mirrors the

EU cosmetics regulation 1223/2009, which makes it easier to comply with both regulations, although it does also mean that a lot of work has to be duplicated.

UK Cosmetics regulation

Firstly, it is important to emphasise that the UK cosmetics regulation applies to Great Britain, which includes England, Scotland, and Wales. It does not apply to Northern Ireland, which still follows the EU cosmetics regulation 1223/2009 as it is specified in the Northern Ireland Protocol.

UK Cosmetics Regulation is included within Schedule 34 of the UK Statutory Instrument (SI) Product Safety and Metrology et. (Amendment etc.) (EU Exit) regulation 2019.

Although we said that the UK cosmetics regulation is very similar to the EU cosmetics regulation, it requires certain changes, which companies have to be aware of. This includes a new cosmetic notification through the UK notification portal, the need for a UK-based responsible person, and re-labelling to include new RP details and country of origin, where needed.

With the UK having its own cosmetics regulation, it puts an additional burden on companies who sell their product in the UK and EU as they now have to follow two sets of cosmetics regulations.

Responsible person (RP) and Product information file (PIF)

If companies want to sell their products in the EU and UK market, they have to make sure they have a responsible person (RP) based in the EU and one in the UK. If products are sold only in the EU, then the company only has to assign an EU-based responsible person to their products. On the other hand, if the company only sells their products to the UK, they only need a UK-based responsible person for their products. The role of the responsible person can be taken up by the manufacturer (if they are based in the EU for products sold in the EU or in the UK for products sold in the UK). If not, then they need to assign this role to a third party, who has to accept the role in writing.

Like in the EU, products sold in the UK also require a product information file (PIF). PIF must be made available at the UK RP address, and it has to be in English. Additionally, an RP has to ensure that the safety assessments are done by safety assessors, whose qualifications are recognisable in the UK. The same applies to the EU. UK safety assessors have to check if their qualifications are recognisable in the EU.

Labelling – country of origin and RP name and address

Since the UK regulation lays down the requirement for the UK RP, this also means that the label of the product sold in the UK has to bear the UK RP name and address. The same requirement applies in the EU, meaning that products sold in the EU need to have the EU RP name and address on their labels. If a product is sold in the EU and UK, then the label needs to include both the EU and UK RP name and address.

All products sold in Great Britain (GB) need to bear the name and address of the UK Responsible Person from 31 December 2022.

Another labelling requirement to keep in mind is the country of origin. Now that the UK is a third country for the EU and vice versa, products made in the UK need to bear on their labels ‘Made in the UK’ if they are sold in the EU. On the other hand, products made in any of the EU Member states and sold in the UK need to have the specific country of origin on their labels.

The last labelling requirement for

the UK is applicable only to aerosols, which under Schedule 13 of the Product Safety and Metrology SI require the addition of ‘UKCA compliance mark’. This is an equivalent of the ‘reversed epsilon’, which is known under the EU cosmetics regulation.

The UKCA marking is compulsory from 1 January 2022. Until then, aerosols sold in GB can carry either the reversed epsilon or the UKCA mark.

Until 31 December 2022, the UKCA marking may be affixed to a label affixed to or a document accompanying the dispenser. From 1 January 2023, the UKCA marking must be affixed directly to the product.

If companies want to sell their products in the EU and UK market, they have to make sure they have a responsible person (RP) based in the EU and one in the UK.

Submit Cosmetic Product Notifications (SCPN)

As from the first day of 2021, the UK also has its own cosmetic notification portal called Submit Cosmetic Product Notifications (SCPN). Every product sold in the UK needs to be notified to SCPN before being placed on the market. The notification has to be done by the responsible person, the same as in the EU.

SCPN allows the RPs to upload existing notifications from the EU notification portal – Cosmetic product notification portal (CPNP). The RPs have the option to export the notifications from the CPNP and upload them on the SCPN. This shortens the time needed for the notification.

The following information is required for a cosmetic product notification via SCPN • the category and name of the cosmetic product • the name of the responsible person • where the Product Information

File (PIF) is kept • details of a named contact for urgent enquiries • details of any nanomaterials the cosmetic product contains • details of any carcinogenic, mutagenic, or toxic for reproduction (CMR) substances the cosmetic product contains • the chemical details of substances • a summary of the ingredients • a product’s label • a photograph of the cosmetic product packaging.

For new products, which are placed on the GB market after 31 December 2020 and have not been notified on the EU’s CPNP, RPs need to submit new notifications, which include the above-mentioned list of documents. The notifications have to be done before the products can be placed on the GB market.

For existing products, which are already present on the GB market and have been notified through the EU’s CPNP before 1 January 2021, the deadline for notification to the SCPN is 31 March 2021.

Tjaša Grum has a Bachelor’s degree in Cosmetic Science and a Master’s degree in Biochemistry from the University of Ljubljana, Slovenia. She is a Regulatory Consultant at CE.way Regulatory Consultants Ltd, which offers regulatory and testing services for cosmetic products.

Email tjasa@ceway.eu