A complete package is the single biggest factor in how fast you get a CPSR. With everything in place a report takes 2–4 weeks. When documents arrive one by one, the same report takes three to six months, because each gap stops the assessment and starts a new round of emails across three companies and two time zones.
The checklist
| # | Document | Who usually has it | Why the assessor needs it |
|---|---|---|---|
| 1 | Product description: name, category, function, body area, target users (adults, children under 3), leave-on or rinse-off, directions, amount per use | Brand | Sets the exposure scenario for every calculation |
| 2 | Quantitative formula: each raw material with trade name, supplier, INCI name, CAS/EC number, exact % w/w and function | Manufacturer (OEM/ODM) | Basis of Part A, section 1 and all margin of safety calculations |
| 3 | Raw material specifications (TDS) and safety data sheets (SDS) | Raw material suppliers, via the manufacturer | Identity, purity, impurities, physical form |
| 4 | Composition of blends: extracts in solvent, pre-preserved raw materials, colour and pigment dispersions | Raw material suppliers | Hidden preservatives and solvents must be counted in the final product |
| 5 | Impurity statements where relevant: heavy metals, 1,4-dioxane in ethoxylated ingredients, nitrosamines with amines, residual monomers, PAHs in mineral oils | Raw material suppliers | Part A, section 4 (impurities and traces) |
| 6 | Fragrance documents: IFRA certificate for the right product category and a declaration of all allergens listed in Annex III, with their % in the fragrance | Fragrance house | Allergen labelling above 0.001 % (leave-on) or 0.01 % (rinse-off), now for more than 80 allergens |
| 7 | Finished product specification: appearance, odour, pH, viscosity, density | Manufacturer | Part A, section 2 |
| 8 | Stability study in the final or equivalent packaging: protocol, conditions, duration, results | Manufacturer or test lab | Part A, section 2; supports the shelf life or PAO on the label |
| 9 | Microbiology: challenge test (ISO 11930) for water-containing products and microbiological limits (ISO 17516) of a batch | Manufacturer or test lab | Part A, section 3 |
| 10 | Packaging: material in contact with the product, compatibility or migration data, supplier declarations | Manufacturer, packaging supplier | Part A, section 4; packaging can release substances into the product |
| 11 | Manufacturing and GMP: description of the manufacturing method and an ISO 22716 certificate or GMP statement | Manufacturer | Required in the PIF (Art. 11 and Art. 8) |
| 12 | Label artwork: all panels, claims, warnings, nominal content, batch code, date of minimum durability or PAO | Brand, designer | The assessor sets warnings and checks that the label matches the assessment |
| 13 | Claim evidence: SPF test, clinical or consumer test results, "dermatologically tested", "for sensitive skin" | Brand, test lab | Required in the PIF; some claims need specific tests |
| 14 | Undesirable effects data: complaints and reactions from markets where the product is already sold | Brand | Part A, section 9 |
| 15 | Existing safety documents: safety files for Korea's MFDS, China's NMPA filing, a US MoCRA safety substantiation, an old CPSR | Brand, previous consultant | Often reusable and can save time |
Specific categories need more: sunscreens need SPF and UVA tests (ISO 24444, ISO 24443 or equivalent) and a check of every UV filter against Annex VI; hair dyes need checks of each dye and its mixing ratio against Annex III; products for children under three need a separate exposure scenario; aerosols need the propellant and particle size.
The gaps that cause the longest delays
These come up again and again when non-EU packages reach a safety assessor:
- Ranges instead of exact percentages. "Glycerin 3–5 %" cannot be used for a margin of safety calculation. The assessor needs the exact figure for the formula that will be produced.
- Fragrance allergen declaration for 26 allergens only. Declarations issued before 2023 usually cover only the old list. New products placed on the EU market from 31 July 2026 must label the expanded list from Regulation (EU) 2023/1545. Ask the fragrance house for an updated declaration.
- Unknown composition of blends. A botanical extract supplied in butylene glycol with phenoxyethanol brings two more ingredients into your formula. Without the supplier's composition the INCI list and the preservative check are wrong.
- No challenge test. Water-based products without preservative efficacy data are one of the most frequent reasons a conclusion is delayed.
- Old INCI names. The EU glossary of common ingredient names was replaced by Decision (EU) 2025/1175, mandatory for labels from 30 July 2026. Labels designed for Korea or the US often use names the EU no longer accepts.
- The manufacturer does not want to share the formula. This is normal for OEM and ODM production. The solution is a confidentiality agreement and direct transfer from the manufacturer to the assessor. The brand does not need to see the formula.
How to send documents safely
We sign an NDA before any formula is shared. If the manufacturer does not want the brand or the agency to see the formula, it can send the documents to us directly.
Send what you have, even if the package is incomplete. In the free document audit we check it and return one list of everything missing within 48 hours, instead of asking for documents one at a time.
If the formula changes after you send the package, tell us straight away. A CPSR written for the wrong version of a formula is worthless.
What happens after the documents are complete
- We confirm the package is complete and fix the delivery date in the contract.
- The software runs the data search and calculations: exposure, margin of safety per ingredient, annex checks, fragrance allergens per SKU, INCI names against the 2025 glossary.
- The assessor reviews the results, decides on warnings and writes the conclusion.
- You receive the CPSR in English, a list of label changes, and, if ordered, the PIF and the CPNP notification in your Responsible Person's account.
FAQ
What documents are required for CPNP notification?
The notification itself needs the product category, the formulation (frame or exact), the Responsible Person's details, the country of origin, the label and packaging photos, and information on CMR substances and nanomaterials. But the Responsible Person should notify only after the CPSR and the PIF are ready, so in practice you need the whole checklist above.
Do I need new tests for the EU if I already sell in Korea, China or the US?
Often not. Stability and microbiology data from your home market can be used if they were done on the same formula and suitable packaging. The assessor decides. SPF tests and some claims may need EU-recognised methods.
Can the safety assessor work with a formula in Korean or Chinese?
Yes, if the INCI names, CAS numbers and percentages are clear. Supplier documents in Korean or Chinese slow the work down, and English versions save time.
How long should documents be kept?
The Responsible Person keeps the PIF, including the CPSR and the supporting data, for 10 years after the last batch is placed on the market (Art. 11).
Sources
- Regulation (EC) No 1223/2009 on cosmetic products, Articles 8, 10, 11, 13 and Annex I
- Commission Implementing Decision 2013/674/EU: guidelines on Annex I
- Commission Regulation (EU) 2023/1545: fragrance allergens
- Commission Implementing Decision (EU) 2025/1175: glossary of common ingredient names
- SCCS Notes of Guidance, 12th revision