EU&UK Cosmetics Notification

Regulatory Background

The EU Cosmetics Regulation (EC) No. 1223/2009, published on December 11, 2009, is the primary legislation governing cosmetics marketed in the European Union. It fully replaced the Cosmetics Directive (76/768/EC) on July 11, 2013. The regulation applies not only to EU member states but also to the European Economic Area (EEA), which includes Norway, Iceland, and Liechtenstein.

In the UK, cosmetics are regulated under the UK Cosmetics Regulations, which were originally based on EU law and have been updated several times, most notably after Brexit in 2021. The current UK framework is aligned with EU Regulation 1223/2009 but includes specific national requirements.

Both regulations mandate that every cosmetic product placed on the EU or UK market must have a designated Responsible Person who ensures compliance with all legal obligations.

Who is the Responsible Person?

The Responsible Person is the legal entity accountable for ensuring that a cosmetic product complies with all applicable regulations.

• If the manufacturer is established in the EU/UK, they typically act as the Responsible Person.

• If the manufacturer is outside the EU/UK, the importer may assume this role.

• A distributor who markets the product under their own name may also act as the Responsible Person.

• Alternatively, a manufacturer or importer may appoint a third-party legal entity within the      EU/UK through a written mandate.

Compliance Obligations of the Responsible Person

The Responsible Person must:

1. Ensure product safety and  regulatory compliance throughout the product lifecycle.

2. Monitor and report any adverse reactions.

3. Take corrective actions (e.g., recall) for non-compliant products.

4. Maintain and provide relevant documentation—including the Product Information File (PIF)—for at least 10 years after the product is placed on the market.

To fulfill these obligations, the Responsible Person must possess relevant legal knowledge and maintain effective product data management.

Compliance Process

Required Information for Notification (CPNP/SCPN)

• Product name and category

• Responsible Person details and contact information

• Country of origin

• First destination market

• Product formula

• Packaging images

Required Documents for Certified Product Safety Report (CPSR)

• Basic product information (name, description, intended use)

• Complete formula list

• MSDS and COA for all ingredients

• Allergen information (up to 80 substances) and IFRA certificate (if applicable)

• Test reports: microbiology, heavy metals, hazardous substances

• Preservative challenge test report

• Stability test report

• Packaging material compatibility and safety data

Product Information File (PIF) Requirements

• Certified Product Safety Report (CPSR)

• Description of manufacturing process

• GMP declaration or certificate

• Non-animal testing statement

• Evidence supporting product claims

• Label images (inner and outer packaging)