The UK has specific regulations governing the safety, labelling, and marketing of cosmetic products. Post-Brexit, the UK has its own regulatory framework separate from the EU.
UK Cosmetics Requirements & Registration Process
This is an overview of the requirements and the registration process for cosmetics in the UK.
1. Regulatory Authority
The main regulatory body overseeing cosmetic products in the UK is the Office for Product Safety and Standards (OPSS), which operates under the Department for Business, Energy & Industrial Strategy (BEIS).
2. Definition of Cosmetics
Cosmetic products are defined as substances or mixtures intended for application to external parts of the human body (skin, hair, nails, lips, etc.) or the teeth and mucous membranes of the mouth, primarily to clean, perfume, change appearance, or protect and keep them in good condition.
3. Legal Framework
The UK Cosmetics Regulation (UKCR) applies to all cosmetic products sold in the UK market.
This includes:
1. The UK Cosmetic Regulation 2009
2. The UK Cosmetic Product Enforcement Regulation 2013
3. The Product Safety and Metrology Statutory Instrument 2019
4. Key Compliance Requirements
4.1. Responsible Person (RP)
Before a cosmetic product is placed on the UK market, a Responsible Person (RP) must be designated. The RP is responsible for ensuring compliance with the UK Cosmetics Regulation. This can be the manufacturer, importer, or a third party.
Responsibilities of the RP include:
- Ensuring product safety
- Maintaining a Product Information File (PIF)
- Submitting a Cosmetic Product Notification (CPNP) via the UK Cosmetic Products Notification Portal (UKCPNP)
4.2. Product Information File (PIF)
A PIF must be compiled and kept for each cosmetic product placed on the UK market. It should include:
- Product description
- Safety assessment and data on toxicological profile
- Manufacturing method compliance (GMP)
- Proof of effect claims
- Labelling details
4.3. Cosmetic Product Safety Report (CPSR)
The CPSR is a key document within the PIF. It consists of:
Part A: Product safety information (toxicological profile, exposure details, etc.)
Part B: Safety assessment (conducted by a qualified safety assessor)
4.4. Labelling Requirements
Cosmetic products must meet the following labelling requirements:
- Brand name and product name
- Nominal quantity
- List of ingredients in descending order by weight
- Batch number
- Use-by date (if applicable)
- Warnings (if applicable)
- Name and address of the Responsible Person
4.5. Claims and Advertising
All claims made about the product (e.g., “hypoallergenic,” “natural”) must be substantiated with evidence and not mislead consumers.
5. UK Cosmetics Registration Process
5.1. UK Cosmetic Products Notification Portal (UKCPNP)
Every cosmetic product must be registered through the UKCPNP before being placed on the UK market. This registration process involves:
1. Create an account on the UKCPNP portal.
2. Submit product details including:
- Product name and category
- Responsible Person’s details
- Product Information File (PIF) details
- Label and packaging information
3. Provide ingredient information: Each ingredient must be listed, including concentration and exposure level data.
4. Submit the notification and ensure you receive confirmation from the OPSS.
5.2. Post-Brexit Transition Considerations
Products from EU: Post-Brexit, products previously registered in the EU through the EU Cosmetic Products Notification Portal (CPNP) need to be registered separately in the UK.
Northern Ireland Protocol: The EU Cosmetic Regulation still applies to products sold in Northern Ireland, meaning that both EU and UK registrations may be required for businesses trading in both regions.
6. Good Manufacturing Practices (GMP)
Cosmetic products must be manufactured according to Good Manufacturing Practices (GMP). The ISO 22716 standard provides guidelines for ensuring quality control during manufacturing processes.
7. Safety Monitoring and Adverse Effects
Cosmetic companies must have processes in place to monitor and report any serious undesirable effects (SUE) associated with their products. The Responsible Person must notify the OPSS of any adverse reactions immediately.
Conclusion
Complying with UK cosmetics regulations is crucial for ensuring product safety and consumer trust. Following the steps outlined will help businesses successfully launch their cosmetic products in the UK market.