Quick Answer: A Cosmetic Product Safety Report (CPSR) is the documented safety assessment required for a cosmetic product before it is placed on the EU market. Under Article 10 and Annex I of Regulation (EC) No 1223/2009, it contains Part A safety information and Part B, a qualified assessor’s reasoned safety conclusion. The EU Responsible Person must ensure the report exists, is based on the final product and is updated when relevant information changes.
Last reviewed: 25 September 2026. Editorial review: MOOYAM cosmetic compliance content team. Regulatory explanation for international B2B brands; not a substitute for product-specific legal or toxicological advice.
What does a CPSR establish?
The CPSR is the evidence and professional reasoning used to assess whether a cosmetic product is safe for human health under normal or reasonably foreseeable conditions of use. Article 10 of Regulation (EC) No 1223/2009 requires the Responsible Person (RP) to ensure the assessment and report are completed before placing the product on the market. It is product-specific: a general factory certificate, ingredient list or supplier test sheet alone is not a CPSR.
A well-prepared report makes the link between a particular final formulation, its intended use, exposure, available evidence and the assessor’s conclusion. It is not a government-issued “approval” and it does not eliminate the RP’s other obligations. The European Commission’s legislation page identifies the Cosmetics Regulation and the official guidelines on Annex I; national authorities oversee compliance after products enter the market.
How do Part A and Part B differ?
Annex I sets minimum report headings. Part A assembles the product safety information. Part B contains the actual safety assessment: the conclusion, required warnings or instructions, scientific reasoning, and the assessor’s credentials and approval. Commission Implementing Decision 2013/674/EU explains that the Part A evidence can come from reliable sources, but the qualified assessor must interpret it for the finished product. Empty templates or unsupported “safe” statements do not meet that purpose.
| Report section | What it contains | Why a brand should care |
|---|---|---|
| Part A — safety information | Composition, physical and chemical characteristics, stability, microbiological quality, impurities and packaging information, use and exposure, toxicological profiles, undesirable effects and other relevant evidence. | It connects the final SKU to the data the assessor needs; gaps must be examined and justified. |
| Part B — safety assessment | Safety conclusion, labelled warnings or instructions, scientific reasoning, assessor credentials and final approval. | It documents the expert judgement and any conditions that affect the label or use. |
| Referenced supporting records | Supplier specifications, test reports, literature or other evidence identified in the CPSR. | They must be traceable and accessible; attaching a pile of files without analysis is insufficient. |
For example, a leave-on facial cream and a rinse-off cleanser have different exposure patterns. A product used near the eyes, on children under three, or for external intimate hygiene can require particular attention under Annex I. The assessor must evaluate the actual product and its reasonably foreseeable use, not apply a generic risk label to all cosmetics.
Who prepares and signs the safety assessment?
Article 10(2) requires the Part B assessment to be performed by a person with a qualifying university diploma in pharmacy, toxicology, medicine or a similar discipline, or an equivalent course recognised by a Member State. The assessor’s credentials and approval belong in Part B. The RP must ensure the CPSR exists and stays current; the assessor supplies independent scientific reasoning. A manufacturer can provide information but should not claim that ordinary production staff automatically meet the legal assessor qualification.
| Party | Core role in a CPSR project | Handoff to confirm |
|---|---|---|
| EU Responsible Person | Ensures assessment is completed before market placement and the report is kept up to date. | Approved final product specification, assessor access, and change-control route. |
| Qualified safety assessor | Evaluates Part A evidence, explains the risk reasoning and signs Part B. | Questions, data gaps, warnings and final signed conclusion. |
| OEM/ODM manufacturer | Provides relevant formula, raw-material, stability, microbiology, packaging and manufacturing data. | Version-controlled records that match commercial production. |
| Brand owner/importer | Controls final claims, label artwork, intended use and launch decisions; clarifies legal RP arrangements. | Target market, product presentation and any later changes. |
When is a CPSR needed, and where is it kept?
The report must be in place before an EU cosmetic is placed on the market. Article 11 makes the CPSR one element of the Product Information File (PIF) held by the RP. The PIF must be readily accessible to the competent authority at the RP address indicated on the label and retained for ten years after the last batch was placed on the market. A CPSR is therefore not a one-time PDF sent to a distributor and forgotten; it is part of an ongoing compliance record.
The Commission’s 2013/674/EU Annex I guidelines state that the RP and assessor should work closely together and that the assessment should be well-argued and transparent. The guideline does not prescribe one universal number of days or a single fixed test package for every product. Timing depends on data readiness, product complexity, assessor questions and any testing or reformulation needed. Start the process before committing to launch artwork or bulk production.
What changes can trigger a CPSR review?
Article 10 requires the report to be kept up to date in light of additional relevant information generated after market placement. A formulation change, new raw-material impurity data, different packaging, revised use directions, a changed claim, new safety evidence, or undesirable effects may affect the assessment. Not every administrative edit requires an entirely new report, but the RP and assessor should determine and document the effect of each material change. The EU Commission’s market-surveillance page notes that serious undesirable-effect data forms part of the CPSR and relates to mandatory reporting duties.
How should a B2B brand brief the assessor?
- Freeze a product identity: formula version, shade or fragrance variants, pack format, intended users, use area and directions.
- Identify the EU RP and qualified assessor early; agree confidentiality and secure access to quantitative composition.
- Ask the manufacturer for traceable, current specifications and relevant test evidence, not a generic “EU compliant” declaration.
- Submit final label and claim wording so that assessed use and marketed use align.
- Resolve assessor questions and document any data gap or restriction before CPNP notification and launch.
- Set a post-launch change and adverse-event communication process.
For the exact evidence package, see the companion guide to global cosmetic regulations and discuss a product-specific handoff with your RP. A supplier may retain confidential quantitative formula details while providing them securely to the qualified assessor; the RP still needs a practical way to discharge its duties.
Common CPSR misunderstandings
- “Our ISO/GMP certificate is enough.” Manufacturing controls matter, but they do not replace the final-product safety assessment.
- “The ingredient list proves safety.” Concentrations, impurities, exposure, product stability and intended use also matter.
- “A report for one SKU covers all variants.” Assess whether each variation changes composition, exposure or other safety-relevant facts.
- “CPNP approved our CPSR.” CPNP is a notification portal, not a product approval or assessment service.
Frequently asked questions
Is a CPSR mandatory for every cosmetic sold in the EU?
Article 10 requires the RP to ensure a safety assessment and CPSR for a cosmetic before it is placed on the EU market. Product-specific scope and variant treatment should be confirmed with the assessor.
Can a non-EU factory issue the CPSR?
The factory may assemble Part A inputs. Part B must be carried out by a suitably qualified safety assessor, and the EU RP must ensure the report meets the applicable requirements.
Does a CPSR include laboratory tests?
It evaluates relevant evidence, which may include testing. The law sets minimum information headings, not one identical test list for every cosmetic. The assessor determines what is needed for the product.
Is a CPSR the same as the PIF?
No. The CPSR is a key component of the broader PIF. Article 11 specifies additional PIF elements, including product description, manufacturing method and GMP statement, applicable claims evidence, and animal-testing data.
Does a CPSR expire after a fixed period?
The Regulation does not give a universal CPSR expiry date. The RP must keep it current when relevant new information arises, and the PIF has a separate retention rule.
Official sources
- Regulation (EC) No 1223/2009, Articles 10–11 and Annex I — EUR-Lex.
- Commission Implementing Decision 2013/674/EU, guidelines on Annex I — EUR-Lex.
- Cosmetics legislation — European Commission.
- Market surveillance and serious undesirable effects — European Commission.
Manufacturer support: MOOYAM provides cosmetic OEM/ODM manufacturing and technical documentation support for international beauty brands. For a planned EU SKU, our OEM/ODM team can help organize formula, quality and test records for the RP and assessor; only the qualified assessor can make the Part B safety judgement.
Regulatory requirements may change. Brands should verify current requirements with the relevant regulatory authority or a qualified compliance professional before placing cosmetic products on the market.