UK Cosmetics Notification Guidance

1. Background Introduction

The UK Cosmetic Regulation was first introduced in 1978 and has undergone several revisions since then, including most recently in 2021 after Brexit. The current version of the regulation is based on the European Union's Cosmetics Regulation (EC) No 1223/2009 and includes additional requirements specific to the UK.

The main regulations include:

• Regulation (EC) No 1223/2009 and The Cosmetic Products Enforcement Regulations 2013: Applicable to England, Scotland, and Wales (Great Britain).
• Regulation (EC) No 1223/2009 and The Cosmetic Products Enforcement Regulations 2013: Applicable to Northern Ireland.

In the United Kingdom (England, Scotland, and Wales), conducting a cosmetic business requires compliance with relevant regulations. The UK cosmetic regulations are designed to ensure that all cosmetics sold in the UK (both locally manufactured and imported from abroad) are safe and suitable for use. These regulations set out the rules and requirements for cosmetic product safety, labelling, advertising, and distribution. For cosmetic products placed on and sold in the Northern Ireland market, a separate process applies, following the EU Cosmetic Regulation. Failure to comply with UK cosmetic regulations may result in fines, product recalls, and reputational damage to the company. Therefore, cosmetic businesses should stay updated on regulatory changes and ensure compliance with all necessary requirements.

This guideline is based on the requirements of the related UK cosmetic regulation and aims to assist cosmetic-related enterprises in standardizing the notification process, ensuring compliance with UK regulations, and facilitating smooth market entry.

2. Definition of Cosmetics

The definition of cosmetics in the UK is the same as in the EU. According to the the EU Cosmetics Regulation (EC) No 1223/2009, “‘cosmetic product’means 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 with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.”

3. Classification of Cosmetics

The definition of cosmetics in the UK is the same as in the EU. According to the the EU Cosmetics Regulation (EC) No 1223/2009, the assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the product.

The competent authorities of EU Member States are responsible for making the final determination on whether a product falls within the cosmetic product category. For products that exist on the borderline between cosmetics and other product categories, known as "borderline products", the European Commission has issued a series of guidance documents to provide clarification.

• Borderline products manual on the scope of application of the Cosmetics Regulation (EC) No 1223/2009
• Guidance document on the demarcation between the Cosmetic Products Directive 76/768 and the Medicinal Products Directive 2001/83 

4. Cosmetics Regulatory Authorities

The regulatory authorities for cosmetics in the United Kingdom include the Secretary of State and the Office for Product Safety & Standards (OPSS).

• The Secretary of State is primarily responsible for formulating and amending cosmetic regulations, overseeing the overall regulatory framework for the cosmetics industry, and ensuring consumer safety.
• The Office for Product Safety & Standards (OPSS) is responsible for market surveillance of cosmetic products, ensuring compliance with UK cosmetic regulations. It monitors the safety of cosmetic products, ensuring they do not contain prohibited or restricted substances. Additionally, OPSS manages the UK Submit Cosmetic Products Notification (SCPN) system, through which businesses must submit product notifications.

5. Requirements for Placing Cosmetics on the UK Market

To place cosmetics on the UK market, they must comply with related cosmetics regulations. Follows are the key compliance requirements and the listing process:

• Responsible Person: Similar to EU Cosmetic Regulation, where all cosmetic products must have a Responsible Person (RP) based in EU, who makes sure safety measures are followed and legal obligations are met.
• Product Information File (PIF): A PIF in English must be kept by the Responsible Person (RP).
• Product safety: Product safety is a top priority for the UK Cosmetic Regulations. A safety assessment that takes into account the product's intended use, the concentration and purity of its ingredients, and any potential risks associated with its use.
• Labelling: The labelling of cosmetic products must include information about their safe use.
• Advertising/Claims: All claims made about a cosmetic product must be truthful, not misleading, and backed up by evidence.
• Notification: In the UK, all cosmetic products must be notified to the Notification Portal before they can be placed on the market. (For cosmetic products that have not been notified on the Cosmetic Product Notification Portal (CPNP) and are being placed on the UK market after 31 December 2020, you will need to notify these products using the UK’s Submit Cosmetic Product Notifications (SCPN) service before they can be placed on the GB market.)
• Keep Records: This includes records of the product testing, labelling, and notification.

6. Responsibilities and Qualification Requirements for Responsible Person

A Responsible Person (RP) is a natural or legal capable person who is designated by a cosmetic product manufacturer, importer, or distributor to be responsible for ensuring the safety of the cosmetic product they place on the market. The RP should have access to all relevant information about the cosmetic product, including the manufacturing process, formulation, and safety assessments.

6.1 Qualification Requirements for Responsible Person

In the UK, the RP is required under the Cosmetic Products Enforcement Regulations 2013. The regulations require that the Responsible Person (RP) be established within theUK. The RP name and address need to appear on the product label, so the RP can be contacted by both Authorities and consumers if needed.

6.2 Responsibilities for Responsible Person

The main duties of a RP include:

• Ensuring that the cosmetic product complies with all applicable regulations, including GMP;
• Ensuring that the cosmetic product has undergone a safety assessment by a qualified professional;
• Ensuring that the cosmetic product is labelled correctly with all necessary information, including ingredients, warnings, and instructions for use;
• Maintaining documentation of the safety assessment and product information for at least 10 years after the product is placed on the market, updated in case of any regulatory/toxicological evolution, undesirable effects raised by consumers, formula update, or any relevant change;  
• Cooperating with authorities in the event of a product recall or safety concern.

7. Documentation Requirements for Cosmetics Notification

Cosmetic product notification in the UK must be submitted through the UK/EU Cosmetic Product Notification Portal (SCPN or CPNP), ensuring compliance with the Cosmetic Products Enforcement Regulations 2013 issued by the UK.

7.1 Submit Cosmetic Products Notification (SCPN) Notification

Great Britain (GB): Before placing a cosmetic product on the market, the UK-based Responsible Person (RP) must submit a simplified online notification through the UK Submit Cosmetic Products Notification (SCPN) system. If the product is also marketed in Northern Ireland (NI), a Responsible Person based in NI or the EU must be designated, and NI regulations must be followed.

Northern Ireland (NI): Before placing a cosmetic product on the market, the Responsible Person (based in NI or the EU) must submit a simplified online notification through the EU Cosmetic Product Notification Portal (CPNP).

The cosmetic product notification requirements in the UK and the EU are largely consistent. The essential notification documents include:

• Product category and product name
• Name and address of the Responsible Person (RP), where the Product Information File (PIF) must be stored and made available for inspection
• Country of origin for imported products
• Information on the Member State(s) where the product is placed on the market
• Contact details
• If the product contains nanomaterials, information on the substance and details on reasonably foreseeable exposure conditions must be provided
• Name and CAS number (or EC number) of substances classified as category 1A or 1B carcinogenic, mutagenic, or toxic for reproduction (CMR)
• General information on product formulation (to facilitate emergency and appropriate medical measures)

7.2 Product Information File (PIF)

A Product Information File (PIF) is an essential document required for the registration of cosmetic products in the UK. It is a compilation of all the necessary information and data regarding the safety, quality, and efficacy of a cosmetic product. The PIF must be kept available at all times by the Responsible Person (RP), up to ten years after market launch. The file should be updated regularly, as it is subject to inspection by the Authorities.

A PIF should include the following information:

• Product description
• Product composition
• Manufacturing method
• Stability testing
• Packaging information
• Safety assessment
• Claims
• Labeling

7.3 Cosmetic Product Safety Report (CPSR)

Cosmetic products are regulated by both the EU and the UK to ensure their safety for human use. A critical part of this process is the Cosmetic Product Safety Report (CPSR), which outlines the safety information for each cosmetic product. The CPSR is a comprehensive document that includes information on the formulation, manufacturing process, and safety assessment of each cosmetic product.

The CPSR should contain the following information:

• Product Information: The CPSR must contain a description of the cosmetic product, including its intended use, the name and address of the responsible person, and the product category.
• Formulation: The CPSR must contain a full and detailed list of ingredients in the product, including their concentration.
• Manufacturing Process: The CPSR must describe the manufacturing process of the product, including information on quality control, batch control, and stability testing.
• Safety Assessment: The CPSR must include a safety assessment of the cosmetic product. This assessment should take into account the potential risks associated with the product's ingredients and the manufacturing process. The safety assessment should also consider the likelihood and severity of adverse effects resulting from the product's use.
• Post-Marketing Surveillance: The CPSR must include information on post-marketing surveillance activities. This information should detail the measures taken to monitor the safety of the product after it has been placed on the market.

8. Testing Requirements for Cosmetics Notification

The UK cosmetic regulations have largely adopted the EU Cosmetic Regulation (EC 1223/2009). Therefore, before being placed on the UK market, cosmetic products must undergo a series of safety and compliance assessments. According to the regulations, the following are key responsibilities related to product safety:

• Safety Assessment: Before a cosmetic product enters the UK market, manufacturers must ensure its safety for human use. This includes conducting a safety assessment, considering the intended use of the product, the concentration and purity of ingredients, and any potential risks that may arise during use.
• Ingredient Safety: All ingredients used in cosmetic products must be safe for human use. Manufacturers must ensure that the concentration and purity of each ingredient fall within safe limits and that no harmful or prohibited substances are used.
• Microbiological Safety: Cosmetic products must not contain harmful microorganisms that could pose a risk to human health. Manufacturers must ensure that their products are produced in a hygienic environment and undergo microbiological testing to confirm that they are free from harmful bacteria, fungi, and other microorganisms.

9. Cosmetics Notification Timeline

If the product has already been placed on the EU market and the EU CPNP notification has been completed, the UK notification process can be expedited.

10. Post-Market Supervision Requirements for Cosmetics

After a cosmetic product is placed on the UK market, it must comply with a series of regulatory requirements to ensure its safety and compliance. Among these, regular inspections by the competent authority and reporting of adverse reactions are key post-market surveillance measures.

10.1 Regular Inspections by the Competent Authority

In the UK, the Office for Product Safety and Standards (OPSS) is responsible for overseeing cosmetics on the market to ensure compliance with UK cosmetic regulations. OPSS conducts regular inspections of marketed cosmetic products through the following methods:

• Market Surveillance: Checking whether product labels comply with regulations, whether the Product Information File (PIF) is complete, whether the product contains prohibited or restricted substances, and whether the product meets safety standards (e.g., microbiological contamination, heavy metal content, etc.).
• Product Testing: OPSS may conduct laboratory testing on certain products to verify their safety.
• Online and Offline Market Surveillance: Non-compliant products may be removed from the market or subject to corrective actions.

10.2 Reporting of Adverse Reactions

Cosmetic companies or the Responsible Person (RP) must continuously monitor the safety of their products and maintain records of consumer adverse reactions.

• Undesirable Effects (UE): Minor adverse reactions do not need to be reported directly to OPSS but must be recorded in the Product Information File (PIF).
• Serious Undesirable Effects (SUE): The Responsible Person (RP) must report to OPSS within 15 days and provide the information includes product name and batch number, details of the affected consumer, specific description of the adverse reaction, possible cause analysis, etc.

Our services

• Responsible Person (RP)
• Preliminary review of formula and label
• Safety assessment
• Create an accurate PIF
• Labelling design
• CPNP submission

If you need any assistance or have any questions, please get in touch with us via cosmetic@cirs-group.com.