Cosmetic Product Safety Report (CPSR) — What It Is and Who Needs One

When I first encountered the EU’s Cosmetic Product Safety Report requirement while working with a North American brand on their European launch, the immediate question from the brand’s quality director was: “Is this like our internal safety review?” The answer was no — and explaining why that distinction matters is the purpose of this article.

The CPSR is not an internal safety review. It is a formal, structured document with legally defined content requirements, and Part B — the safety assessment — must be signed by a qualified safety assessor whose credentials are specified in the Regulation. A CPSR that does not meet these requirements does not satisfy the legal obligation, regardless of how thorough the underlying safety work may be.

This article is for cosmetic brand owners, regulatory affairs managers, and quality directors preparing for EU market entry. It explains what the CPSR must contain, who is qualified to sign it, and how to commission one effectively.

The Legal Basis

Article 10 of Regulation (EC) No 1223/2009 requires that, in order to demonstrate that a cosmetic product complies with the Regulation, the Responsible Person must ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.

Annex I of the Regulation specifies the required content of the CPSR in detail. The report has two parts: Part A (Cosmetic Product Safety Information) and Part B (Cosmetic Product Safety Assessment).

Part A: Cosmetic Product Safety Information

Part A is the data compilation section. It must contain:

Quantitative and qualitative composition of the cosmetic product. This means the full ingredient list with INCI names and the concentration of each ingredient in the finished product. For fragrance compounds, the trade name and the identity of the supplier are required; individual fragrance components do not need to be listed in Part A unless they are subject to specific restrictions.

Physical and chemical characteristics and stability of the cosmetic product. This includes appearance, colour, odour, pH, viscosity, and stability data under normal and reasonably foreseeable storage conditions. Stability testing should be conducted under conditions that reflect the product’s intended storage and use environment.

Microbiological quality. The microbiological specifications for the finished product and the results of challenge testing (preservative efficacy testing) must be included. The applicable standard is ISO 11930:2019 (or its current version). Products intended for use around the eyes, on mucous membranes, or on broken skin are subject to stricter microbiological limits.

Impurities, traces, information about the packaging material. Any impurities in raw materials and traces of prohibited substances must be addressed. The packaging material must be assessed for potential migration of substances into the product.

Normal and reasonably foreseeable use. The intended use, target population (including any vulnerable groups such as children or pregnant women), and the body areas to which the product will be applied must be described.

Exposure to the cosmetic product. A quantitative exposure assessment must be conducted for each relevant route of exposure (dermal, oral, inhalation) based on the product’s use pattern.

Exposure to the substances. For each substance in the formulation, the systemic exposure dose (SED) must be calculated based on the product’s exposure profile.

Toxicological profile of the substances. The toxicological data for each substance must be reviewed and documented. This includes data on acute toxicity, skin and eye irritation, skin sensitisation, phototoxicity, mutagenicity/genotoxicity, and — for substances with significant systemic absorption — subchronic and chronic toxicity, reproductive toxicity, and carcinogenicity.

Undesirable effects and serious undesirable effects. Any known undesirable effects associated with the product or its ingredients must be documented.

Information on the cosmetic product. Any other relevant information, including results of consumer studies or clinical tolerance testing, should be included.

Part B: Cosmetic Product Safety Assessment

Part B is the safety assessment itself. It must contain:

Assessment conclusion. A clear conclusion on the safety of the cosmetic product for human health under normal and reasonably foreseeable conditions of use.

Labelled warnings and instructions for use. Any warnings or instructions for use required to ensure safe use of the product must be specified.

Reasoning. The scientific reasoning underlying the safety conclusion must be documented, including the methodology used, any assumptions made, and how uncertainties have been addressed.

Assessor credentials and signature. Part B must be signed by the safety assessor, and the assessor’s qualifications must be documented. 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 credential requirement is non-negotiable. A safety assessment signed by someone who does not hold the required qualifications does not satisfy the legal requirement, regardless of their practical experience.

Who Needs a CPSR?

Every cosmetic product placed on the EU market needs a CPSR. There are no exemptions based on product type, sales volume, or company size. A small brand selling a single product in one EU member state needs a CPSR for that product, just as a multinational corporation does.

The CPSR must be in place before the product is placed on the market. It cannot be prepared retrospectively after the product is already on shelves.

How to Commission a CPSR

When commissioning a CPSR from an external safety assessor or regulatory consultancy, provide the following:

Full quantitative formulation with INCI names and concentrations
Raw material specifications and Safety Data Sheets for all ingredients
Manufacturing process description
Finished product specifications (physical, chemical, microbiological)
Stability data
Packaging material specifications
Intended use description and target population
Any existing safety or clinical data for the product or its ingredients

The quality of the CPSR is directly dependent on the quality and completeness of the information provided. Incomplete or inaccurate formulation data leads to an incomplete safety assessment.

Practical Action Step

Use this checklist when preparing to commission a CPSR:

Confirm the safety assessor holds a qualifying degree in pharmacy, toxicology, medicine, or a similar discipline
Prepare a complete quantitative formulation with INCI names and concentrations
Obtain raw material specifications and SDS documents for all ingredients
Commission or obtain stability testing data
Commission or obtain preservative efficacy testing data (ISO 11930)
Prepare a clear description of intended use, application area, and target population
Confirm the CPSR will be structured in accordance with Annex I of Regulation (EC) No 1223/2009
Allow adequate time in your launch timeline — a thorough CPSR typically takes several weeks to complete

The CPSR is the cornerstone of EU cosmetics compliance. Consult a qualified EU regulatory expert if you have questions about the requirements or the commissioning process.

Care Europe coordinates Cosmetic Product Safety Reports for brands entering the EU market, working with a network of qualified safety assessors. Contact us to discuss your product portfolio.

Cosmetic Product Safety Report (CPSR) — What It Is and Who Needs One