To sell cosmetics in the United Kingdom, an UK Responsible Person (with offices in the UK) is legally mandatory. The United Kingdom formally left the European Union on January 31, 2020. Cosmetics companies had until December 31, 2020 (transition period) to comply with the requirements of the “The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34”, the so-called “UK Cosmetics Regulation”.
So since January 31, 2020, any company wishing to sell cosmetic products in the United Kingdom, requires a Responsible Person (RP), established within the United Kingdom to be designated for each cosmetic product marketed within the UK territory. The role of the Responsible Person (often also called an UK Legal Representative or the UK Legal Representation), is to ensure continued product compliance with cosmetics regulations and safety regarding human health.
A Responsible Person is a legal or natural person who ensures the compliance of each cosmetic product in the UK market with relevant obligations as set forth in this Regulation. It can be the manufacturer (if based in the UK), the importer, the distributor or a third party located in the UK who has been designated by a written mandate.
An extension to the deadline for labelling cosmetic products with the UK Responsible Person (RP) when placing products on the market in Great Britain (GB) has been granted.
Following the departure of the UK from the EU Single Market in December 2020, the UK Cosmetics Regulation entered into force with a two-year transitional provision allowing companies to implement necessary changes, namely labelling compliance for cosmetics. The two-year grace period was due to expire on 31 December 2022, after which time all products placed on the GB market would have been required to be in full compliance with the UK Cosmetic Regulation or be otherwise withdrawn from the market.
OPSS have reviewed the requirement to label the product with the UK RP and have decided to extend this transitional provision for a total period of five years, until 31 December 2025. Until this date, the name and address of the responsible person and the country of origin requirements are satisfied where there is compliance with the requirements of Article 19(1)(a) of the EU Cosmetic Products Regulation (EU CPR). Please note that this does not take into consideration compliance with non-EU Regulations, and does not exempt companies from having to comply with all other aspects of the UK Cosmetics Regulation, including notification and ingredient compliance. Companies are encouraged to use this additional time to make the remaining changes to cosmetics labels.
Main changes to Regulations
The main changes to note that took effect at 11pm on 31 December are:
- 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;
- Responsible Person: There must be a Responsible Person based in the UK under the new regime;
- 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;
- Labelling: 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;
- 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;
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.
- 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@businessandtrade.gov.uk;
- 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;
- Importers: Since 1 January 2021 UK Businesses who bring cosmetic products into GB from an EU Member State are ‘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;
- 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.
Scope and Objective
The Regulation applies to all cosmetic products made available on the GB market. There is separate guidance available for placing cosmetic products on the market in Northern Ireland. Because of the way ‘making available on the market’ is defined, the Regulation applies to any supply of cosmetic products in the course of a commercial activity, including situations where products are given away for free. The Regulation has two aims: to ensure the functioning of the GB market, and to ensure a high level of protection for human health.
Definitions
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
A cosmetic product may be a substance or mixture of a number of substances, and it may come in one or more than one part to be combined by the user.
Manufacturer
The ‘Manufacturer’ is any person or business who manufactures a cosmetic product or has the product designed or manufactured, and market it under their name or trademark.
Importer
The ‘Importer’ is any person or business established in the UK who places a cosmetic product from a country outside the United Kingdom on the GB market. This includes products that are placed on the market in Great Britain from Northern Ireland, where that product was supplied to a Northern Ireland business from outside the UK, including the EU or EEA. There are different rules that apply when these Northern Ireland businesses place qualifying Northern Ireland goods on the market in Great Britain.
Distributor
A ‘Distributor’ is a person or business, other than the Manufacturer or the Importer, that supplies a cosmetic product on the GB market. It includes what are commonly known as retailers or wholesalers. Professional outlets such as hairdressers are also classed as Distributors for those products sold or given to customers (consumers). There may be multiple Distributors of the product in the supply chain.
Making Available
‘Making available’ on the market is any supply of a cosmetic product for distribution, consumption or use in the course of a commercial activity. This holds regardless of any associated payment (i.e. whether in return for payment or free of charge). “Making available” will refer to supply on the GB market.
Placing on the Market
‘Placing on the market’ means the first making available (supply) of a cosmetic product on the GB market from 31 December 2020.
Nanomaterial
Nanomaterials are defined in the Regulation as materials that are ‘insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100nm.’
Undesirable Effect / Serious Undesirable effect
An ‘Undesirable Effect’ is an adverse effect to human health that occurs following the normal or reasonably foreseeable use of a cosmetic product. There should be a demonstrable link between the affected person and the product.
A ‘Serious Undesirable Effect” (SUE) is an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.
Competent Authority and Enforcement Authorities
The “competent authority” and the “enforcement authorities” are the Secretary of State, and local authority trading standards in England and Wales and Scotland (local weights and measures authorities). The Secretary of State may also authorise others to be the competent authority.
Safety
A product must be safe for human health under normal and reasonably foreseeable conditions of use. Manufacturers in the first instance should consider the conditions of use which can be reasonably foreseen prior to placing a product on the market. They must therefore look beyond what they consider to be the intended use of a product, and put themselves in the position of the average user of the product – envisaging how they would reasonably consider using it. The safety requirement does not cover misuse of a cosmetic product (except where it is a reasonably foreseeable misapplication of the product). Ultimately it is for the Responsible Person to ensure that this obligation is complied with.
The Article provides that the presentation of the cosmetic product must take into account the requirements of The Food Imitations (Safety) Regulations 1989 (SI 1989 No. 1291) which concern dangerous imitations. The key provision in these Regulations is that no person shall supply, expose for supply or possess for supply any manufactured goods which are ordinarily intended for private use and are not food, but which:
- have a form, odour, colour, appearance, packaging, labelling, volume or size which is likely to cause persons, in particular children, to confuse them with food and in consequence to place them in their mouths or suck them or swallow them
- where such action mentioned above is taken in relation to them, may cause death or personal injury
The UK Government has been unequivocal in its commitment to unfettered access for Northern Ireland goods moving to the rest of the UK market, and to guaranteeing this in legislation. This means that you will be able to place qualifying Northern Ireland goods on the market in Great Britain without additional approvals.
