The CPSR: What the Cosmetic Product Safety Report Is, Its Two Parts, and Who Can Sign It

• The CPSR is the technical document at the core of every EU cosmetic product's compliance: required by Art. 10(1) of Regulation (EC) 1223/2009, it must exist before the product can reach the market.
• It has two distinct parts: Part A (10 sections of safety information) and Part B (the signed safety assessment carried out by a university-qualified professional).
• The CPSR is a component of the Product Information File (PIF) — not a separate obligation — and must remain current for as long as the product is on the market.

1. What is the CPSR and which article requires it?

The CPSR (Cosmetic Product Safety Report) is the safety report that demonstrates a cosmetic product is safe for human health under normal and reasonably foreseeable conditions of use. It is the technical document through which the responsible person discharges the safety obligation.

The legal basis is Article 10(1) of Regulation (EC) 1223/2009: the Responsible Person must ensure that a safety assessment is performed and that a CPSR is drawn up in accordance with Annex I of the Regulation, before the product is placed on the market. The provision further requires that the report be kept up to date "in view of additional relevant information generated subsequent to placing the product on the market."

Three practical consequences follow:

• The CPSR must exist before first market placement — it cannot be drawn up retrospectively.
• A CPSR that does not reflect the current formula makes the product non-compliant, regardless of its actual safety.
• The CPSR is element (b) of Article 11(2): it is a component of the Product Information File (PIF), not a standalone obligation running in parallel to it.

2. Part A: the safety information (10 sections)

Part A of the CPSR, as set out in Annex I of Regulation 1223/2009, compiles product safety information in 10 sections. This part can be compiled by the regulatory team of the manufacturer or the Responsible Person; it does not require the specific university qualification that Part B demands.

Sections 1 and 8 are the most data-intensive. Section 1 requires the complete composition with chemical identity (INCI, CAS, EINECS/ELINCS). Section 8 requires toxicological profiles for all substances, including assessment against the restrictions in Annexes II to VI of the Regulation. CMR substances directly affect sections 4 and 8 — their presence, even as technically unavoidable traces, must be documented and justified. The CosIng CMR list can be used to identify which ingredients carry this classification.

Commission Implementing Decision 2013/674/EU provides non-binding guidelines to help operators meet the data requirements of each Part A section.

3. Part B: the safety assessment (4 sections)

Part B of the CPSR contains the safety assessment proper. Unlike Part A, Part B must be signed exclusively by the qualified assessor meeting the Article 10(2) requirements. Its 4 sections are:

Section 1 (assessment conclusion) is the formal declaration that the product is safe for human health. Section 3 (reasoning) explicitly connects the Part A data to the Part B conclusion: the assessor must explain how the exposure data, toxicological profiles and conditions of use support the safety conclusion. Section 4 is where the assessor's credentials, signature, and assessment date appear.

Commission Implementing Decision 2013/674/EU provides practical (non-binding) guidance on the minimum content of each Part B section, in particular on structuring the reasoning and the requirements for the conclusion statement.

4. Who can sign the CPSR? Article 10(2) requirements

Article 10(2) of Regulation 1223/2009 specifies precisely who may carry out the Part B safety assessment:

"The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of 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, or a course recognised as equivalent by a Member State."

Key points from this wording:

• The named disciplines are pharmacy, toxicology and medicine. The phrase "similar discipline" opens the door to other qualifications, provided the Member State recognises them as equivalent.
• In Case C-13/17 (Advocate General Opinion, 14 December 2017, Fédération des entreprises de la beauté v French Ministers), the Advocate General interpreted this provision and concluded that the application of the equivalence criteria is a matter for the national courts. This opinion did not result in a final CJEU judgment and does not establish a binding list of equivalent disciplines.
• Depending on Member State recognition, professionals with background in veterinary medicine, biochemistry or ecotoxicology with sufficient demonstrated toxicological experience may qualify.
• There is no definitive CJEU list of "similar disciplines" that automatically qualify — eligibility is partly Member State-dependent.
• The assessor's credentials must appear in Part B section 4 of the CPSR.

5. Commission Implementing Decision 2013/674/EU: the practical guidelines

Commission Implementing Decision 2013/674/EU (25 November 2013) sets out guidelines on Annex I of Regulation 1223/2009. It is available at EUR-Lex (CELEX:32013D0674). Its purpose is to provide non-binding guidance to help operators meet the minimum data requirements for each Part A section and to correctly structure Part B.

These guidelines do not modify the legal content of Annex I but provide practical reference points on the expected level of detail in each section.

At the methodological level, the reference document for safety assessors is the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, currently in its 12th revision, document reference SCCS/1647/22 (adopted 15 May 2023, published 22 December 2023, available at the European Commission Health publications page). This document provides the toxicological testing methodology used to generate the data that goes into Part A section 8 and feeds Part B reasoning. It is a document of the Scientific Committee on Consumer Safety (SCCS), not of the legislator — its content is scientific methodology, not regulatory text.

6. CPSR vs. PIF: not the same thing

A common point of confusion is treating the CPSR and the PIF as the same document. They are not:

• The CPSR (Art. 10) is one of five elements that must be included in the PIF.
• The PIF (Art. 11) is the complete compliance dossier that contains the CPSR plus: the product description, the GMP compliance statement (Art. 11(2)(c)), evidence substantiating any claimed effects where the nature or effect of the product justifies it (Art. 11(2)(d)), and animal testing data (Art. 11(2)(e)).

The PIF — including the CPSR — must be retained for 10 years from the date the last batch of the product was placed on the market, at the address of the Responsible Person within the EU.

As a result, when the CPSR is out of date, it does not merely breach Article 10 — it also invalidates the PIF as a whole, because element (b) of Article 11(2) is deficient.

7. When must the CPSR be updated?

Article 10(1) is explicit: the CPSR must be kept up to date "in view of additional relevant information generated subsequent to placing the product on the market." In practice, the update triggers are:

• New post-market safety information: the explicit obligation in Article 10(1).
• Formula change: any change to composition may alter exposure and the toxicological profile, requiring at minimum a Part A review and, depending on the scope of the change, a full reassessment.
• Change of raw material supplier: if the ingredient specifications differ, the toxicological profile may change.
• New SCCS opinion on an ingredient used in the formula: a new scientific evaluation may introduce toxicological data that changes the conclusion.
• New Annex II or III restriction affecting an ingredient in the product: a change in the regulatory framework for an ingredient requires verifying whether the CPSR remains valid under the new conditions. Active regulatory monitoring is the mechanism for detecting these changes before they take effect.
• Post-market signals of serious undesirable effects (SUEs): a pattern of adverse effects may justify reviewing the exposure assumptions and the safety conclusion.

A CPSR that does not reflect the current state of the product is treated by authorities as a missing CPSR for compliance purposes: the Article 10 obligation is not fulfilled by having drawn up the report at some point in the past.

8. How CosIng and ingredient data fit into the CPSR

Ingredient data — in particular the data derived from the regulatory framework of Annexes II–VI — is essential for compiling Part A of the CPSR:

• Section 1 requires complete identification of each ingredient with its INCI name, CAS number and, where applicable, EINECS/ELINCS number.
• Section 4 requires documentation of impurities and traces, including justification for technical unavoidability when prohibited Annex II substances are present.
• Section 8 incorporates the toxicological profile of each substance, which frequently draws on SCCS opinions — many of which are linked in the CosIng database.

When Annexes II–VI are updated — for example when a substance moves from Annex III to Annex II — the assessor must verify whether the CPSR remains valid under the new conditions. Systematically checking the regulatory status of every formula ingredient before the assessor begins Part B is the step that prevents errors and rework.

The CosIng search tool allows you to look up the Annex under which each INCI ingredient appears, its entry number, conditions of use, and any associated SCCS scientific opinions.

9. Frequently asked questions

What is a Cosmetic Product Safety Report (CPSR)? The CPSR is the mandatory technical document that demonstrates a cosmetic product is safe for human health under reasonably foreseeable conditions of use. It is required by Article 10(1) of Regulation (EC) 1223/2009 and must be drawn up in accordance with Annex I before the product is placed on the market. It consists of Part A (safety information) and Part B (safety assessment signed by a qualified assessor).

What are the two parts of the CPSR and what does each contain? The CPSR has two parts. Part A contains 10 sections of product safety information: quantitative and qualitative composition, physical/chemical characteristics and stability, microbiological quality, impurities and traces, normal and foreseeable use, exposure to the product, exposure to substances, toxicological profile, undesirable effects, and product information. Part B contains 4 sections: assessment conclusion, labelled warnings, reasoning, and the assessor's credentials and approval.

Who can sign the CPSR? What qualifications are required? Under Article 10(2) of Regulation 1223/2009, only a person holding a diploma or other evidence of formal qualifications awarded on completion of a university course in pharmacy, toxicology, medicine or a similar discipline — or a course recognised as equivalent by a Member State — can carry out the Part B safety assessment. The assessor's credentials must appear in Part B section 4.

When must the CPSR be updated? Article 10(1) requires the CPSR to be kept up to date in view of any additional safety-relevant information generated after the product is placed on the market. Practical triggers include: formula change, change of raw material supplier, new SCCS opinion on an ingredient used in the formula, new Annex II or III restriction affecting an ingredient, and post-market signals of serious undesirable effects (SUEs).

What is the difference between the CPSR and the PIF? The CPSR (Art. 10) is a mandatory component of the PIF (Art. 11). The PIF is the complete compliance dossier that contains the CPSR plus four other mandatory elements: product description, GMP compliance statement, evidence of claimed effects (where applicable), and animal testing data. Without a valid CPSR, the PIF is incomplete and the product is non-compliant.

What does Article 10 of Regulation 1223/2009 say about the CPSR? Article 10(1) states that the Responsible Person must ensure that a safety assessment is performed and that a CPSR is drawn up in accordance with Annex I before the product is placed on the market. The report must be kept up to date in view of any additional safety-relevant information generated after market placement. Article 10(2) sets out the qualification requirements for the assessor who signs Part B.