On December 31, 2020, the Brexit transition came to an end. Following this, cosmetic products intended for the Great Britain (England, Scotland, and Wales) market are now required to comply with UK’s retained Regulation (EC) No 1223/2009 before entering the market. The overarching goals of the Regulation is safeguarding public health and fostering a fully competitive market.

Under the terms of the Windsor Framework, Northern Ireland aligns itself with relevant EU regulations concerning the sale of manufactured goods, including cosmetics. Consequently, cosmetic products placed on the Northern Ireland market shall continue to follow the requirements in EU Regulation (EC) No 1223/2009.

Part 1 General Introduction

1.1 Evolution of UK Cosmetics Legislation

From January 1, 1973, to January 31, 2020, UK was a member state of the European Communities and its successor, the European Union (EU). On November 30, 2009, EU released the Regulation (EC) No 1223/2009 (EU Cosmetics Regulation) to supersedes the previous Directive 76/768/EEC. Effective on July 11, 2013, this regulation is directly applicable in all member states. Being part of the EU at that time, UK adopted this regulation and promulgated The Cosmetic Products Enforcement Regulations 2013 in June 2013, which establishes the enforcement powers of EU Cosmetics Regulation within the UK, as well as clarifies offences and corresponding penalties.

In March 2017, UK formally notified EU of its intention to withdraw, initiating the process of Brexit negotiations. To minimize the impact on the UK’s legal framework and businesses, the European Union (Withdrawal) Act 2018 introduced the concept of “retained EU law”, allowing for the post-Brexit retention of EU laws in the UK through their transposition into domestic laws. Subsequently, on March 27, 2019, UK issued The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 to make amendments to the retained EU laws. Schedule 34 of this regulation includes the amendments to the EU Cosmetics Regulation. The modified legal text constitutes the UK’s retained Regulation (EC) No 1223/2009 (UK Cosmetics Regulation), which took effect after the Brexit transition.  

1.2 Competent Authority

Secretary of State: The Secretary of State formulates and implements cosmetics safety policies. To ensure effective regulations, it periodically reviews their operation and impact, and enacts necessary changes based on scientific assessments.

Office for Product Safety and Standards (OPSS): OPSS is the national regulator that oversees the safety of cosmetic products. It exercises the powers of the Secretary of State in enforcing the Cosmetics Regulation. With its scientific and technical expertise, OPSS provides guidance and support to the industry, as well as collaborates closely with other competent authorities to ensure consumer safety and cosmetic compliance.

Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS): SAG-CS is commissioned by OPSS. It assesses the chemical and biological risks of non-food and non-medicinal consumer products, including cosmetic products and their ingredients. Upon request from OPSS, SAG-CS provides scientific opinions on cosmetic ingredients involved in public concerns, which contributes to the revisions of the cosmetic ingredient lists in the Cosmetics Regulation.

Part 2 Cosmetic Products

2.1 Definition

Cosmetic product is defined as any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, and external genital organs), or in contact with the teeth and the mucous membranes of the oral cavity, with the exclusive or main purpose of cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition, and/or correcting body odors.

Products supplied during any commercial activities, including situations where products are given away for free, are subject to UK Cosmetics Regulation once they satisfy the definition above.

2.2 Responsible Person

A cosmetic product cannot be placed on the market unless it has a responsible person established in the UK. For the product manufactured in the UK and placed on the UK market directly after manufacture, its manufacturer based in the UK is the responsible person. For the imported product placed on the UK market, its importer is the responsible person. Another option is that the manufacturer or importer authorizes a third party located in the UK to act as the responsible person with a written mandate. The third party shall accept the mandate in writing.

A distributor may be considered as the responsible person where the cosmetic product is placed on the market under the distributor’s name, or is modified by the distributor after being placed on the market in a way that may affect its compliance. 

2.3 Responsible Person’s Obligations

2.3.1 Good Manufacturing Practice (GMP)

To ensure cosmetic quality and protect human health, the manufacturing of cosmetic products shall comply with GMP. This compliance can be demonstrated by following the designated standard ISO 22716:2007 Cosmetics—Good Manufacturing Practices (GMP)—Guidelines on Good Manufacturing Practices (ISO 22716), which offers detailed guidance on implementing GMP during the manufacturing. Although commonly used, it is not the exclusive method for demonstrating GMP. Companies can select any GMP certification or system of their choice. However, they are obligated to prove that the chosen certification or system attains the same objectives as specified in ISO 22716.

2.3.2 Product Notification

Before a cosmetic product is made available to consumers, the responsible person shall notify the Secretary of State the following product information through the Submit Cosmetic Product Notifications (SCPN) portal. The responsible person may face a fine and a prison term of up to three months if failed to notify a cosmetic product. This fine could be unlimited in England and Wales, and up to £5,000 in Scotland and Northern Ireland. The mandatory notified items include:

• Category and name of the product

• Name of the responsible person

• Address where the product information file (PIF) is kept

• Contact details of a natural person for urgent enquiries

• Confirmation of nanomaterial presence, as well as the identification and reasonably foreseeable exposure conditions of nanomaterials (if applicable)

• Identification of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1A or 1B (if applicable)

• Frame formulation

• Original labelling and packaging (after the product is placed on the market)

The “presence of nanomaterials” requirement applies to cosmetic products that contain the nanomaterials listed in Annex 4, 5, or 6 and used as specified as colourant, preservative, or UV-filter. For products containing nanomaterials not listed in these annexes, and used for a purpose other than specified, a separate nanomaterial notification shall be done at least six months before the products are placed on the market.

It is the Secretary of State’s duty to share specific notification information with all other competent authorities and poison centers. The former will use the information received for the purposes of market surveillance, market analysis, evaluation, and consumer information, while the latter will use it for necessary medical treatment for problems related to the use of cosmetic products.

2.3.3 Production Information File (PIF)

The responsible person is required to maintain a PIF in English for cosmetic products placed on the market. The information and data that should be contained in the PIF includes:

• Description of the cosmetic product

• Cosmetic product safety report (CPSR)

• Description of the manufacturing method, and a compliance statement with GMP

• Supporting evidence for any cosmetic claims made

• Data on any animal testing performed

The responsible person shall make the PIF readily accessible at the address indicated in the notification, and keep it for ten years after the last batch of the cosmetic product was placed on the market. The PIF should be a living document, and be updated as necessary. If a product is significantly different from a same-name product previously placed on the market, an update might not be sufficient. In this case, the responsible person will have to consider creating a new PIF.

2.3.4 Safety Assessment  

Before making a cosmetic product available on the market, the responsible person shall ensure that the product’s safety has been assessed by a qualified safety professional, who should be with a university degree in pharmacy, toxicology, medicine, or a similar discipline recognized as equivalent by the Secretary of State. In the assessment, the product’s intended use, and the anticipated systemic exposure to individual ingredients in a final formulation shall be considered. An appropriate weight-of-evidence approach shall be employed for reviewing data from all existing sources.

The safety assessment should be in the form of a CPSR signed by the assessor. This report should be included in the PIF, and comprises two parts of information as follows:

2.3.5 Labelling

1) Information required on product labels

For cosmetics available on the market, their container and packaging shall bear the following information clearly and indelibly:

1. Name and address of the responsible person

2. Country of origin (for imported products)

3. Contents

4. Date of minimum durability, or period after opening (for products with a minimum durability of more than 30 months)

5. Special precautions

6. Batch number

7. Product function

8. A list of ingredients

If it is impractical to label the precautions and ingredients of a product, the information shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card. Additionally, abbreviated information or a special symbol shall be included on the container or packaging as a hint, which guides users to find the enclosed or attached precautions and ingredients information.

2) Transitional policy on product labelling

Before Brexit, the cosmetic product placed on the UK market could have a responsible person established in either UK or other EU members states. However, with the implementation of the UK Cosmetics Regulation, the responsible person is now required to be located within the UK. Consequently, for products intended for the UK market with a responsible person based in EU, modifications are required for the labeling of the responsible person's name and address, as well as the country of origin.

To mitigate the economic costs of redesigning product labels and allow existing stocks to progress through the supply chain after Brexit, a seven-year transitional period starting from January 1, 2021, has been granted for product labelling. During this period, for the product with a responsible person based in EU, the labelling requirements for the responsible person’s details, and the country of origin, are considered satisfied if the product’s labelling complies with the EU Cosmetics Regulation.

2.3.6 Claim

In labelling and advertising cosmetic products, the responsible person shall ensure that any claim made does not imply that the product has characteristics or functions it does not possess. This requirement applies to claims in the form of texts, names, trademarks, and figurative or other signs. Furthermore, the wording of claims shall comply with six common criteria set out in Commission Regulation (EU) No 655/2013, which is applicable within the legal framework of Great Britain.

2.3.7 Serious Undesirable Effects (SUE)

An SUE is one in which the normal or reasonably foreseeable use of a cosmetic leads to temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, immediate vital risk, or death. In the event of SUEs, the responsible person shall report to the Secretary of State within 30 calendar days from the date of awareness of the SUE. The report shall include:

1. All known SUEs, and those may reasonably be expected to be known to the responsible person;

2. The name of the cosmetic product concerned;

3. Any corrective measures taken by the responsible person.

Distributors, consumers, or health professionals can also report SUEs of a cosmetic product to the Secretary of State. Upon receiving such reports, the Secretary of State shall immediately disseminate the information to all relevant competent authorities and the responsible person. Competent authorities may use this information for various purposes, including in-market surveillance, market analysis, evaluation, and consumer information.

2.4 Cosmetic Products in Northern Ireland's Market

2.4.1 Noteworthy Compliance Points

Under the terms of the Windsor Framework, Northern Ireland aligns with relevant EU rules relating to the placing on the market of manufactured goods, including the EU regulation for cosmetic products. This regulation outlines the requirements that cosmetic product must meet before they are placed on the Northern Ireland market. For more details about these requirements, please refer to the article on EU Cosmetic Regulation.

While ensuring compliance with the EU Cosmetics Regulation, there are several points to consider:

• Responsible person: The responsible person can be established in either Northern Ireland or EU, but cannot in Great Britain. A manufacturer or importer can designate a third party to act as the responsible person with a written mandate, and this person shall be based in Norther Ireland or EU as well.

• Labelling: The labelling requirement of “country of origin”, applicable to imported cosmetics, also extends to cover products brought into Northern Ireland from Great Britain. For these products, the “country of origin” can be labelled as “Made in UK”.

• SUEs: For cosmetic products sold on the Northern Ireland market, SUE reports should be sent to OPSS, who will then inform the responsible person and the European Commission.

2.4.2 Unfettered Access

To maintain the integral place of Northern Ireland in the UK’s internal market, UK has committed to providing unfettered access for “qualifying Northern Ireland goods” to the rest UK market. This commitment, guaranteed by legislation, allows these qualifying goods to be placed on the market in Great Britain without additional approvals. According to The Definition of Qualifying Northern Ireland Goods (EU Exit) Regulations 2020, “qualifying Northern Ireland goods” are those in free circulation in Northern Ireland before their transfer to Great Britain. Products processed in Northern Ireland also qualify if all components are in free circulation in the UK.

Cosmetic products that can be placed on the Northern Ireland market are considered as “qualifying Northern Ireland goods”. If the corresponding Northern Ireland businesses, as responsible persons, fulfil the obligations under Northern Ireland’s law, then their products will be treated as compliant with most obligations under UK Cosmetics Regulation, including labelling, safety assessment, etc. However, to protect consumers across the UK, these businesses still need to notify cosmetic ingredients via the SCPN portal, and alert OPSS if their product is found to be unsafe.

Part 3 Cosmetic Ingredients

3.1 Ingredients Included in the Cosmetics Regulation

Annexes II to VI to the UK Cosmetics Regulation list prohibitions and restrictions on the use of ingredients in cosmetic products. The responsible person shall ensure the product's compliance by confirming that its ingredients satisfy the specified use conditions in these annexes.

1. Annex II: List of Substances Prohibited in Cosmetic Products

2. Annex III: List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions Laid Down

3. Annex IV: List of Colorants Allowed in Cosmetic Products

4. Annex V: List of Preservatives Allowed in Cosmetic Products

5. Annex VI: List of UV Filters Allowed in Cosmetic Products

In cosmetic products, the unintended presence of a small quantity of a prohibited substance is permitted, provided that it stems from the impurities of natural or synthetic ingredients, the manufacturing process, storage, or packaging, and is technically unavoidable under GMP. Moreover, such presence shall not endanger consumer safety.

3.2 Ingredients Excluded from the Cosmetics Regulation

Only colourants, preservatives, and UV filters listed in Annex 4, 5 or 6 can be used in cosmetic products, subject to specified conditions. For new ingredients serving as colourants, preservatives, or UV filters, but not listed in these annexes, a safety dossier shall be submitted to OPSS at opss.safetyassessment@beis.gov.uk for safety assessment. This requirement also applies to nanomaterials.

In preparing safety dossier, the following technical guidance can be consulted.