Cosmetic Product Safety Report (CPSR): Full Requirements Guide

Every cosmetic product sold in the EU must have a Cosmetic Product Safety Report (CPSR) before it reaches the market. Not after a complaint. Not after a recall. Before. This is a hard requirement under EU Cosmetics Regulation (EC) No 1223/2009, and it applies to every product — from a €3 lip balm to a €300 serum.

Yet we regularly encounter brands — including established North American companies with years of FDA compliance experience — who have never heard of a CPSR, or who confuse it with a certificate of analysis or a safety data sheet. The CPSR is none of those things. It is a structured scientific document that forms the legal foundation of your product’s EU market authorisation.

What Is a Cosmetic Product Safety Report (CPSR)?

A Cosmetic Product Safety Report is a mandatory document required under Article 10 of EU Cosmetics Regulation (EC) No 1223/2009. It is a scientific assessment of the safety of a cosmetic product, prepared by a qualified Cosmetic Safety Assessor (CSA), that demonstrates the product is safe for human health under normal or reasonably foreseeable conditions of use.

The CPSR is not a test result. It is not a certificate. It is a comprehensive scientific document that integrates information about the product’s formula, the safety of each ingredient, the toxicological profile of the finished product, and the assessor’s professional conclusion about safety.

Without a valid CPSR, a cosmetic product cannot legally be placed on the EU market. The Responsible Person (the EU-based entity legally responsible for the product) must hold the CPSR as part of the Product Information File (PIF) and make it available to competent authorities on request.

What Must a CPSR Contain?

EU Cosmetics Regulation (EC) No 1223/2009, Annex I, specifies the minimum content of the CPSR. It is divided into two parts:

Part A: Cosmetic Product Safety Information

Part A contains the factual information about the product:

1. Quantitative and qualitative composition
The full formula, including all ingredients with their INCI names, concentrations (as percentages), and function. Trade names and supplier information for complex ingredients (e.g., botanical extracts, fragrances) must be included.

2. Physical/chemical characteristics and stability
Physical description of the product (appearance, colour, odour, pH, viscosity), and stability data demonstrating the product remains within specification throughout its shelf life. Stability testing should follow SCCS (Scientific Committee on Consumer Safety) guidance — typically accelerated stability at 40°C/75% RH and real-time stability at 25°C/60% RH.

3. Microbiological quality
Results of microbiological testing of the finished product, including challenge testing (preservative efficacy testing) demonstrating the product’s preservative system is effective. The SCCS recommends testing according to ISO 11930 or equivalent.

4. Impurities, traces, information about the packaging material
Information about potential impurities in raw materials (e.g., heavy metals in mineral-derived ingredients, nitrosamines in amine-containing formulas) and any interaction between the product and its packaging.

5. Normal and reasonably foreseeable use
Description of how the product is used — application site, frequency, amount applied, consumer population (adults, children, elderly). This defines the exposure scenario for the safety assessment.

6. Exposure to the cosmetic product
Calculated systemic exposure dose (SED) for each ingredient, based on the exposure scenario defined above. The SED calculation uses standard default values from SCCS guidance for skin absorption, body surface area, and retention factors.

7. Exposure to the substances contained in the cosmetic product
For ingredients with potential systemic effects, the SED is compared to the acceptable systemic exposure (AoS) derived from the ingredient’s toxicological profile.

8. Toxicological profile of the substances
For each ingredient, a summary of the available toxicological data: acute toxicity, skin and eye irritation, skin sensitisation, repeated dose toxicity, reproductive toxicity, genotoxicity, carcinogenicity, and any special concerns (e.g., endocrine disruption, nanomaterial status).

9. Undesirable effects and serious undesirable effects
Any known adverse effects associated with the product or its ingredients, including data from post-market surveillance.

10. Information on the cosmetic product
Any other relevant information, including clinical studies, consumer studies, or special population considerations.

Part B: Cosmetic Product Safety Assessment

Part B is the assessor’s professional conclusion:

1. Assessment conclusion
The Cosmetic Safety Assessor’s conclusion that the product is safe under normal and reasonably foreseeable conditions of use, or that it is not safe and the reasons why.

2. Labelled warnings and instructions for use
The assessor’s recommendations for any warnings or instructions that must appear on the label as a condition of the safety conclusion.

3. Reasoning
The scientific reasoning supporting the safety conclusion, including how the assessor evaluated the toxicological data and exposure calculations.

4. Assessor’s credentials and signature
The assessor must sign Part B and provide evidence of their qualifications. Under EU Cosmetics Regulation, the assessor must hold a diploma in pharmacy, toxicology, medicine, or a similar discipline.

Who Can Prepare a CPSR?

The CPSR must be prepared by a qualified Cosmetic Safety Assessor. The regulation specifies that the assessor must hold a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine, or a similar discipline.

This is not a role that can be filled by a quality manager, a chemist, or a regulatory affairs specialist without the appropriate academic background. The assessor’s credentials are part of the CPSR document and will be scrutinised by competent authorities.

In practice, most brands work with independent Cosmetic Safety Assessors — typically toxicologists or pharmacists with specific cosmetic safety assessment experience — who prepare the CPSR as a service. Fees for CPSR preparation typically range from €500 to €3,000 per product depending on formula complexity.

How Long Does a CPSR Take to Prepare?

For a straightforward product with a simple formula and readily available ingredient safety data, a CPSR can be prepared in 2 to 4 weeks. For complex products — those with novel ingredients, nanomaterials, high-risk ingredient combinations, or products intended for children — preparation can take 2 to 4 months.

The bottleneck is usually ingredient safety data. If the product contains ingredients for which comprehensive toxicological data is not readily available in published literature or ingredient supplier dossiers, the assessor may need to commission additional testing or request data from suppliers.

What Triggers a CPSR Update?

A CPSR is not a one-time document. It must be updated whenever there is a change that could affect the product’s safety profile:

• Formula change (addition, removal, or concentration change of any ingredient)
• Change in packaging that could affect product stability or ingredient migration
• New toxicological data for any ingredient (e.g., new SCCS opinion, new regulatory restriction)
• Change in intended use or consumer population
• New adverse event data from post-market surveillance

Brands that treat the CPSR as a one-time compliance exercise and fail to update it when formulas change are exposed to significant regulatory risk.

CPSR and the Product Information File (PIF)

The CPSR is one component of the Product Information File (PIF), which must be maintained by the Responsible Person for each cosmetic product on the EU market. The PIF also includes:

• Product description
• GMP compliance evidence (ISO 22716)
• Manufacturing method and safety assessment evidence
• Proof of claimed effects (if any)
• Data on animal testing

The PIF must be kept for 10 years after the last batch of the product is placed on the market and must be available to competent authorities within a reasonable time on request.

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The CPSR is the scientific heart of EU cosmetic compliance. Getting it right — with a qualified assessor, complete ingredient data, and a thorough stability and microbiological testing programme — is the difference between a product that sails through market surveillance and one that generates a competent authority inquiry.

At Care Europe, we coordinate CPSR preparation for brands entering the EU market, connecting them with qualified Cosmetic Safety Assessors and managing the full documentation process. Contact us at [email protected].