Glossary | Cosmetics Regulations

Cosmetic Product Safety Report (CPSR)

What is a Cosmetic Product Safety Report (CPSR)?

A Cosmetic Product Safety Report (CPSR) is a mandatory safety document that must be completed for every cosmetic product before it is placed on the EU market under Regulation (EC) No 1223/2009. It provides a comprehensive assessment of the product’s safety for human health and must be prepared or reviewed and signed off by a qualified cosmetic safety assessor. The CPSR forms a core part of the Product Information File (PIF) that the Responsible Person is required to maintain.

Why It Matters

The CPSR is the primary evidence that a cosmetic product is safe for its intended use. Without a completed and valid CPSR, a cosmetic product cannot lawfully be placed on the EU market.  It is a non-negotiable prerequisite for market access, not an optional compliance document.

Competent authorities can request access to the CPSR at any time as part of their market surveillance activities. An absent, incomplete, or inadequate CPSR can result in the product being withdrawn from the market, enforcement action against the Responsible Person, and significant reputational damage for the brand.

For cosmetic brands, contract manufacturers, and ecommerce sellers, ensuring every product has a valid and up-to-date CPSR in place before going to market is one of the most important steps in EU cosmetics compliance.

What is a Cosmetic Product Safety Report (CPSR)

Key Requirements

Who Is Required to Have a CPSR?

A CPSR is required for every cosmetic product placed on the EU market, and it is the responsibility of the Responsible Person to ensure one is in place. This applies to:

  • All cosmetic products placed on the EU market regardless of product type or risk level
  • Products sold through any channel, including physical retail and online marketplaces

This requirement applies under:

The CPSR must be prepared by a person with a relevant qualification in pharmacy, toxicology, medicine, or a similar discipline, as specified in the regulation.

What a CPSR Must Include

Under Annex I of the EU Cosmetics Regulation, a CPSR consists of two parts:

  • Part A — Cosmetic Product Safety Information — includes information on the product’s quantitative and qualitative composition, physical and chemical properties, microbiological quality, impurities, packaging material, normal and reasonably foreseeable use, exposure assessment, and toxicological profile of the substances used.
  • Part B — Cosmetic Product Safety Assessment — contains the safety assessor’s conclusions on the safety of the product, labelling warnings where applicable, reasoning and scientific justification, and the assessor’s credentials and signature.

CPSR and the Responsible Person

The Responsible Person is legally accountable for ensuring that a valid CPSR is in place for every cosmetic product they are responsible for on the EU market. The CPSR must be maintained as part of the Product Information File and kept up to date throughout the product’s lifecycle. Where a product’s formulation, packaging, or intended use changes, the CPSR must be reviewed and updated accordingly.

Frequently Asked Questions

A CPSR must be prepared by a qualified safety assessor holding a degree or equivalent qualification in pharmacy, toxicology, medicine, or a similar discipline as specified in Annex I of the EU Cosmetics Regulation. The assessor must sign off Part B of the report.

Yes. If the product’s formulation, raw materials, packaging, or intended use changes, or if new safety information becomes available, the CPSR must be reviewed and updated to reflect these changes before the product continues to be placed on the market.

In some cases, a CPSR may cover a range of products with the same or very similar formulations, but this must be carefully assessed by the safety assessor. Each product in the PIF must be clearly identified and individually addressed within the report.

Need EU cosmetics compliance support?

Euverify provides Responsible Person services for cosmetic brands and manufacturers placing products on the EU market under the EU Cosmetics Regulation. Our team supports CPNP notification, product information file management, regulatory communication, and ongoing compliance management.