UK Cosmetics Compliance Requirements and Procedures

About the UK Cosmetics Regulation

The main content of the UK cosmetics regulation is highly similar to EU Regulation No 1223/2009, but it has been localized and revised after Brexit. Key elements of the UK cosmetics compliance process include appointing a responsible person (RP) within the UK, establishing and maintaining a comprehensive product information file (PIF), ensuring label compliance, and completing product notifications. Thorough understanding and strict adherence to these requirements is the foundation for successfully introducing cosmetics to the UK market.

Core Compliance Elements

1. Responsible Person (RP)

Any cosmetic sold in the UK must appoint a legal entity or individual within the UK as the RP, who is legally responsible for the final compliance of the product on the UK market. The main responsibilities of the RP include:

• Ensure that the product complies with all UK regulatory requirements
• Maintain the PIF of the product within the UK
• Submitting product notifications through the "Submit Cosmetic Product Notifications " (SCPN) portal of the UK government
• Ensuring that the product labels comply with all mandatory requirements
• Monitoring any adverse reactions after the product's launch and reporting them to the competent authorities in a timely manner
• Cooperating with the authorities when necessary to carry out market supervision or product recall measures

2. Product Information File (PIF)

PIF is a comprehensive collection of evidence documents regarding product safety and compliance. Every cosmetic product sold in the UK must have a complete and English-language PIF. The PIF must be kept by the RP at their UK address and must be retained for at least 10 years after the product's last market release, for inspection by the authorities at any time.

The PIF must include the following main parts:

(1) Product description

A detailed description of the product's name, functions, intended use, physical form, etc.

(2) Cosmetics Product Safety Report (CPSR)

The CPSR is issued by a qualified safety assessor, certifying that the product is safe for human use under normal and reasonably foreseeable usage conditions.

The CPSR is the most important and core component of the PIF, which is divided into two parts:

• Part A (Safety Information): Contains all the data used for safety assessment, such as the complete formulas, SDS and COA of raw materials, physical and chemical properties, stability data, microbial quality, impurities and trace substances information, packaging material characteristics, normal and reasonably foreseeable use methods, exposure pathways for the product and its components, etc.
• Part B (Safety Assessment): The safety assessor conducts a comprehensive risk assessment based on the data in Part A, arrives at the final conclusion about the product's safety, and proposes any necessary warnings or instructions for use.

(3) Good Manufacturing Practice (GMP) evidence

Proof that the product was produced under conditions compliant with cosmetic GMP standards (such as ISO 22716). GMP evidence is usually a GMP certification certificate or self-declaration.

(4) Evidence supporting efficacy claims

If the product has any efficacy claims, scientific evidence must be provided to support the authenticity and verifiability of these claims.

(5) Animal testing declaration

Confirmation that the product and any of its components did not undergo animal testing during development. Both the UK and the EU prohibit animal testing for cosmetic finished products and ingredients.

3. Product Label Requirements

(1) Language

All mandatory information on the product containers and outer packaging must be in English.

(2) Mandatory information

The product label must clearly, legibly and indelibly display the following contents:

• RP name and UK address
• Country of origin (if the product is not manufactured in the UK)
• Nominal content (by weight or volume)
• Best Before End (BBE) or Period After Opening (PAO)
• Cautionary instructions and warnings
• Batch number or reference number
• Product functions
• Component list

Compliance Process Steps

Step 1: Designate the RP

Designating an RP is the first step before the product can legally be marketed. The RP must be an entity or an individual within the UK. For manufacturers outside the UK, it is usually necessary to appoint an importer in the UK or a third-party compliance service company as the RP.

Step 2: Establish and Maintain the PIF

• Document collection

Initiate the collection of all product information files, including all SDS, COA, product formulas, production processes, stability test data and microbial test reports for all raw materials.

• CPSR preparation

Entrust a qualified safety assessment expert to prepare the CPSR. The assessor will conduct a scientific assessment of all the data and issue a safety conclusion, which will be a core component of the PIF.

• PIF organization and review

Systematically organize all the collected documents and have professionals review them to ensure their completeness and compliance.

Step 3: Ensure the Compliance of Product Labels

Design and produce labels for product containers and outer packaging, and complete the final review and confirmation of the labels before the product is launched to the market.

Step 4: UK Product Notification

• Platform

RP must submit product information via the SCPN online portal.

• Submission

Notification of the product must be completed before it is first launched on the UK market.

• Content

The notification requires the submission of basic product information, RP details, PIF storage address, formula overview, product label images, information on nanomaterials or CMR substances, as well as emergency contact details.

• Variant

If the basic product formula is the same, only "variants" that differ in color, fragrance, or minor physical form typically require only one SCPN notification, and all variant details should be included in the notification.

Step 5: Continuous Compliance and Post-Market Monitoring

• PIF maintenance

The PIF is not a one-time document. Any changes in the formula, updates to regulations, new safety data, or reports of adverse reactions must be promptly updated in the PIF.

• Adverse reaction reports

Serious Undesirable Effects (SUEs) related to product use must be collected, evaluated, and promptly reported to the OPSS by RP.

• Market supervision

Cooperate with the UK regulatory authorities for market supervision and inspection.

Our Services

After Brexit, the cosmetics regulatory system in the UK gradually diverged from that of the EU. Proregulations is familiar with the latest developments of the UK regulatory authorities and is committed to providing forward-looking, comprehensive compliance services to customers, accelerating product launches and seizing market opportunities.

Our services include, but are not limited to:

• Regulation interpretation, consultation and training
• UK cosmetic registration strategy planning
• Establishment, review and maintenance of PIF
• UK-based RP
• Product label review
• Cosmetics notification
• Post-Market compliance support

Proregulations responds quickly to customer needs and provides customized, full-process services, covering regulatory consultation during the initial development stage of cosmetics to regulatory maintenance after launch, reducing the compliance risks of products. If you are interested in our services, please contact us.

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