Regulation of Cosmetics in the United Kingdom

On 2 December 2020, the UK Government published the "Brexit Transition: the new rules for 2021". The rules refer to the fact that from 1 January 2021, the UK will have its own cosmetics notification database: the Submit Cosmetic Products Notification (SCPN) service. If goods are placed on the UK market, then a cosmetic notification will need to be made. This means that post-Brexit, cosmetic products destined for the UK and the EU will need to be notified separately!

In the UK, the UK government has enacted laws or regulations relating to cosmetics. The body that regulates cosmetics is the Medicines and Healthcare products Regulatory Agency (MHRA).

Laws that the United Kingdom Enforces for Cosmetics:

The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (G/TBT/N/GBR/49)

This Guide is for businesses placing cosmetics products on the market in Great Britain (GB). Great Britain is England, Scotland and Wales. If you are placing cosmetic products on the market in Northern Ireland, you should read the separate guidance for placing cosmetic products on the market in Northern Ireland. This guide is designed to help you understand Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. The Regulation sets out requirements that must be met before cosmetics products can be placed on the GB market. The purpose of the Regulation is to safeguard public health and establish a fully competitive market.

The scope of the product regulation remains unchanged. However, in addition to the measures included in the original notification, the UK government intends to extend the recognition of goods on the UK market that comply with EU requirements and labels for a further two years, until 31 December 2024. The previously announced measures will allow actions taken under the EU conformity assessment procedure before 31 December 2024 to be considered as actions taken under the UK conformity assessment procedure for the duration of the issued certificate or until 31 December 2027, whichever is earlier. Products will be required to carry the UKCA mark after 31 December 2024 and be subject to conformity assessment by a UK accreditation body when the certificate expires or after 31 December 2027, whichever is earlier. The measure will also extend until 31 December 2027 the current law which allows the use of labels or accompanying documents to add importer information and the UK conformity mark to product information rather than affixing it to the product. It will also extend the current law that allows EU principals (rather than UK principals) to be involved in cosmetics until 31 December 2027.

Key changes to UK cosmetic regulations

Nevertheless, cosmetic companies should still be clearly aware of and actively respond to the significant changes in compliance with UK cosmetic regulations. Key changes to comply with the UK Cosmetics Regulations.

Placing on the market: the term 'placing on the market' means the first making available of a product on the market of Great Britain after the end of the transition period. "Making available" refers to supply on the GB market; [Article 2]

Responsible Person: There must be a Responsible Person based in the UK under the new regime; [Articles 4, 5 and 5A]

Product Information File: An up to date Product Information File (PIF) must be maintained in English, and made available to market surveillance and enforcement authorities at the UK address provided when asked to do so; [Article 11]

Labeling: There will be a seven year see footnote 1 transition period from 1 January 2021 before businesses have to include the UK Responsible Person details on product labels, provided the EU responsible person details are included. This will enable existing stocks to make their way through the supply chain and reflects the typical shelf-life of a cosmetic and business' labelling cycles; [Article 19]

UK Submit Cosmetic Product Notification (SCPN) service: The UK Government has established a cosmetic product notification service to replace the EU's Cosmetics Products Notification Portal (the 'CPNP') in Great Britain; [Article 13]

Notification of cosmetic products to Secretary of State (via UK SCPN service):

For products that have not previously been notified to the Commission via the CPNP or have not been placed on the EEA market, or are placed on the GB market after 31 December 2020, UK Responsible Persons will need to provide full information to the Secretary of State via the UK SCPN service before they can be placed on the market. [Article 13]

Serious Undesirable Effects (SUEs): SUEs should be notified on the new UK SUE form. Information on any SUE should be notified to OPSS at seriousundesirableeffects@beis.gov.uk; [Article 23]

Products with nanomaterials: Where the inclusion in a cosmetic product of relevant nanomaterials has not been notified to the Commission prior to the end of the transition period on 31 December 2020, a cosmetic product containing novel nanomaterials not used for the purposes of colourant, preservative, or UV-filter must be notified to the Secretary of State, via the UK's Submit Cosmetic Product Notification Portal by the Responsible Person 6 months prior to it being placed on the GB market; [Article 16]

Importers: From 1 January 2021 UK Businesses who bring cosmetic products into GB from an EU Member State will become 'importers' where they would previously have been 'distributors'. The importer of a cosmetic product, whether from the EU or another country, becomes a Responsible Person by default, although they may appoint an agent to act as the Responsible Person for them. There are particular provisions for Northern Ireland businesses who place products from countries outside of the UK (including the EEA) on the market in Great Britain; [Articles 2 and 4]

Unfettered access: The government has committed to deliver unfettered access for qualifying Northern Ireland goods to the rest of the UK market. Cosmetic products that are placed on the market in Northern Ireland (in accordance with the European Union Regulation (EC) No 1223/2009 on Cosmetic Products, as it applies in Northern Ireland) can be sold in the rest of the UK with no additional approvals. To protect consumers across the UK, Northern Ireland businesses who are Responsible Persons, must notify the GB regulator via the UK Submit Cosmetic Product Notification (SCPN) service with the cosmetics' ingredients and alert the GB regulator if their product is found to be unsafe. This will not require any new information to be collated: only that the same information provided to the EU via the CPNP service is also provided to the Secretary of State. This only applies to products that are placed on the GB market after the transition period. This approach applies to qualifying Northern Ireland goods. Further detail is available in Appendix 7.

Definition of "Cosmetic Product"

The definition of a cosmetic product comprises three parts: a function, field of application, and product composition. All parts of the definition must be satisfied.The Regulation specifies six functions in relation to external parts of the human body for products that may be cosmetic products, namely:

to clean
to perfume
to change the appearance
to protect
to keep in good condition
to correct body odours

The field of application of cosmetics is to the external parts of the human body; that is one or more of the following sites:

the epidermis
the hair system
the nails
the lips
the external genital organs
the teeth
the mucous membranes of the oral cavity

For R&D and Further Manufacturing ONLY.