Quick Answer: To prepare an EU Cosmetic Product Safety Report (CPSR), a brand should provide its qualified safety assessor with the final quantitative and qualitative formula, ingredient identities and supplier data, stability and microbiological evidence, packaging information, intended use and exposure details, final label and claims, and any available undesirable-effect data. Annex I of Regulation (EC) No 1223/2009 sets the minimum report headings; the exact supporting evidence depends on the finished product.
Last reviewed: 25 September 2026. Editorial review: MOOYAM cosmetic compliance content team. This B2B checklist is operational guidance, not a universal test order or legal advice.
Why is a document checklist needed before the safety assessment?
A qualified assessor cannot evaluate an abstract product idea. The assessment concerns a specific finished formula, its reasonably foreseeable use and available scientific evidence. Article 10 and Annex I of Regulation (EC) No 1223/2009 require the EU Responsible Person to ensure a product safety assessment and a CPSR before placing a cosmetic on the market. Commission Implementing Decision 2013/674/EU explains how Annex I information should be assembled and reasoned through. It allows reliable evidence from supplier data, literature, product studies, comparable formulations and other sources where relevant; it does not turn every supplier PDF into an automatic safety conclusion.
This article is a handoff checklist for brand owners, importers and OEM/ODM partners. For the definition, Part A/Part B distinction and assessor qualification, read what a CPSR is. Here the focus is on what to collect, who usually has it, and which mismatches delay review.
Which documents should a brand assemble?
Start by identifying the commercial SKU and its version. One folder should connect the final formula, packaging, label, use instructions, ingredient and test data. Annex I has ten Part A information headings and four Part B assessment headings; that legal structure is more reliable than a generic “10 documents” vendor list. The assessor may ask for additional data to address a particular ingredient, population or exposure scenario.
| Evidence group | What to provide or identify | Why the assessor needs it |
|---|---|---|
| Final composition | Exact qualitative and quantitative formula, ingredient chemical identity where possible, INCI names, functions, perfume code and supplier details where relevant. | Connects hazards and exposure to the actual finished product, not only the public ingredient list. |
| Physical/chemical and stability evidence | Product and raw-material characteristics, stability observations under foreseeable storage and any formulation specifications. | Supports expected product condition through its marketed use. |
| Microbiology and preservation | Relevant microbiological specifications and preservation challenge-test results where required by Annex I and justified for the product. | Addresses microbial risk, especially for vulnerable uses and populations. |
| Impurities and packaging | Raw-material purity/impurity information, relevant packaging characteristics and compatibility evidence. | Identifies safety-relevant contamination, migration or stability concerns. |
| Use and exposure | Product category, application site, amount, frequency, duration, user population, instructions and warnings. | Sets the exposure assumptions for product and ingredient risk assessment. |
| Toxicology and other safety information | Substance toxicological profiles, relevant supplier or literature references, available undesirable effects and other product data. | Supports the assessor’s weight-of-evidence reasoning and Part B conclusion. |
Do not assume every row equals a single compulsory laboratory report. Annex I specifies information to be considered; evidence may be provided through several reliable records. The 2013 Commission guidelines say that if an item of required data is unavailable, its absence should be explained and scientifically justified where appropriate. The qualified assessor decides whether the total evidence is adequate.
What should be in the product brief?
A concise brief can prevent unnecessary back-and-forth. Identify the finished SKU name and formula code; whether it is leave-on or rinse-off; where it is applied; whether children, compromised skin or professional use are anticipated; the packaging material and closure; the proposed shelf-life approach; and the final label and marketing claims. A moisturiser described as ordinary appearance care and the same formula promoted with a medical claim do not present the same regulatory question. The assessor must see the actual product presentation, and the brand must resolve any classification issue before launch.
Provide each shade, fragrance, size or packaging variation in a version matrix. Do not claim one report automatically covers all variants. Ask the assessor whether a grouped assessment is scientifically supportable and document the rationale. If a supplier changes an ingredient grade, inform the assessor and EU Responsible Person rather than quietly replacing a document in the folder.
Who supplies which information?
Manufacturers often hold the quantitative formulation, manufacturing specifications and test reports; brands hold market positioning, claims and final artwork; raw-material and packaging suppliers hold technical specifications; the EU Responsible Person coordinates compliance and file access. The assessor reviews evidence and completes Part B. Responsibilities should be stated in a written handoff list, especially when a private-label brand works with a factory outside the EU.
| Document owner | Typical contribution | Quality check before sending |
|---|---|---|
| OEM/ODM manufacturer | Final formula version, INCI list, COA/specification as applicable, stability and microbiology data, packaging compatibility, manufacturing and batch records. | Do records match the approved commercial formula, material suppliers and pack? |
| Ingredient or packaging supplier | Raw-material identity and purity information, relevant SDS/specifications, fragrance documentation and packaging material details. | Are the documents current, readable, traceable and linked to the actual material grade? |
| Brand owner/importer | Intended use, final claims, instructions, label artwork, market route, variant list and consumer feedback. | Has all marketing copy been checked against what the assessor will evaluate? |
| EU Responsible Person and assessor | Evidence requests, gap resolution, safety reasoning, warnings, approved CPSR and subsequent updates. | Can the RP retrieve the final report and support records for the Product Information File? |
How should the files be organised?
- Assign one SKU/version identifier. Include formula code, pack code and artwork revision in the index.
- Separate final from developmental evidence. Clearly mark pilot samples, obsolete formula versions and unapproved claims.
- Map records to Annex I headings. Include a source and date for each factual input.
- Keep a question log. Record assessor data requests, answer owners and closure dates.
- Confirm report-to-label alignment. Warnings and instructions in Part B should reach final artwork approval.
- Set change control. The RP and assessor need prompt notice of formulation, supplier, packaging, use or safety-evidence changes.
Commission Implementing Decision 2013/674/EU says the CPSR should be transparent and well-argued. A report can reference information held in other accessible records, but references must enable the competent authority and assessor to find the supporting material. A folder of unidentified attachments can be harder to defend than a shorter indexed file with clear version control.
Which missing documents commonly delay a CPSR?
- A public INCI list without quantitative composition or ingredient identity.
- Stability data for a different pack, formula or fragrance variation.
- No microbiological rationale or preservation evidence for a water-containing product.
- Raw-material specifications that do not identify the grade actually used.
- Final label and claims sent after the assessor has signed the conclusion.
- No explanation for unavailable evidence or for exposure assumptions.
These are delay risks, not a declaration that every product must undergo the same tests. A qualified assessor should decide what additional studies or scientific justification are necessary for the particular product. The European Commission’s scientific and technical assessment page describes the role of expert safety evaluation and official guidance.
FAQ: CPSR document handoff
Is an INCI list enough for a CPSR?
No. Annex I calls for quantitative and qualitative composition and other safety information. An INCI list alone does not reveal concentrations or the complete exposure basis.
Does every product need the same set of laboratory reports?
No fixed universal package is stated in Annex I. The assessor reviews the product and available evidence, then identifies any justified additional data need.
Can the manufacturer keep the formula confidential?
Confidentiality can be managed through secure disclosure to the qualified assessor and appropriate RP arrangements, but the assessment still needs accurate quantitative composition and traceable ingredient data.
Should the label be final before the CPSR is signed?
The assessor should assess the intended use, claims, warnings and directions that will be marketed. Material changes to those elements may require review before launch.
Who retains the finished CPSR?
The EU RP must keep it within the Product Information File in accordance with Article 11. The assessor and manufacturer may also keep relevant working records under their own agreements.
Official sources
- Regulation (EC) No 1223/2009, Article 10 and Annex I — EUR-Lex.
- Commission Implementing Decision 2013/674/EU — EUR-Lex.
- Scientific and technical assessment — European Commission.
Preparing a manufacturing handoff? MOOYAM provides cosmetic OEM/ODM manufacturing and technical documentation support for international beauty brands. Our OEM/ODM process can help assemble formula, sample, quality and packaging records; the qualified assessor and EU RP determine regulatory sufficiency.
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.