Cosmetic Product Safety Reports (CPSR): What US Brands Must Address Before Entering the EU and UK Markets

American beauty companies planning to expand into the European Union or the United Kingdom face a fundamentally different regulatory environment than the one they operate under in the United States. While the Modernization of Cosmetics Regulation Act (MoCRA) introduces new obligations related to facility registration, product listing, and safety substantiation, it does not impose a prescribed structure for how cosmetic safety must be documented.

By contrast, EU and UK cosmetics legislation is built around a formalised, product-specific safety assessment system. Every cosmetic product and each of its individual SKUs must be supported by a Cosmetic Product Safety Report (CPSR) before it can be legally placed on the market.

The CPSR is not an internal reference document. It is a legally enforceable record that authorities may request during inspections and market surveillance activities. Where documentation is incomplete, inconsistent, or misleading, regulators have the power to suspend sales, order withdrawals, and impose financial penalties.

What is the CPSR?

The Cosmetic Product Safety Report forms the scientific and legal foundation of cosmetic compliance in the European Union. Regulation (EC) No 1223/2009 requires that no cosmetic product may be placed on the EU market unless a CPSR has been completed and signed by a qualified safety assessor. A product offered for sale without a valid CPSR is, by definition, non-compliant.

The CPSR is part of the wider Product Information File (PIF), which must be maintained at the address of the Responsible Person and made available to competent authorities upon request. The United Kingdom applies equivalent requirements under the UK Cosmetics Regulation.

Importantly, the CPSR is not a marketing document or a supplier-level safety summary. It is a product-specific assessment of risk that considers the finished formulation, its intended use, and reasonably foreseeable misuse.

The two-part structure of the CPSR

Part A: Cosmetic product safety information

Part A brings together the scientific data necessary for a safety assessment. This includes formulation details, information on raw materials, manufacturing considerations, stability and microbiological quality, as well as packaging compatibility.

Part B: Cosmetic product safety assessment

Part B contains the expert safety opinion. A qualified assessor evaluates the data presented in Part A and determines whether the product is safe under normal and reasonably foreseeable conditions of use. This assessment must be signed and dated. Without a valid Part B, the CPSR has no legal standing.

For non-EU manufacturers, weaknesses in Part A directly undermine the credibility of the safety conclusion in Part B.

Scientific expectations behind the CPSR

A frequent misconception among US brands is that a CPSR can be compiled primarily from supplier safety data sheets. In practice, EU and UK authorities expect the assessment to reflect the finished cosmetic product.

Depending on the formulation and product category, authorities may expect data addressing microbiological quality, stability over the declared shelf life, and interactions between the formulation and its packaging.

The role of the Responsible Person

Every cosmetic placed on the EU or UK market must be linked to a Responsible Person established locally. The Responsible Person holds legal accountability for compliance, including the existence and maintenance of the CPSR and the wider Product Information File.

Conclusion

The Cosmetic Product Safety Report is not an administrative formality. It is a legally binding, science-based assessment that underpins cosmetic compliance in the EU and UK.

At Annel, we support US cosmetic brands with EU and UK market entry through CPSR coordination, Responsible Person services, and ongoing regulatory compliance oversight.