You have picked your safety assessor, you are ready to commission a Cosmetic Product Safety Report, and then comes the question that stalls most brands: what exactly do you need to hand over? Knowing the documents needed for CPSR preparation up front is the single biggest thing you can do to keep the project fast, accurate and free of frustrating back-and-forth. This guide walks through every document a competent assessor will ask for, explains why each one matters, and tells you who in your supply chain usually holds it — so you can gather a complete pack before you place the order.
The good news: none of this is mysterious. A CPSR is only as good as the data it is built on, so the requirements are simply the raw materials of a proper safety evaluation. Once you see how the pieces fit together, assembling them becomes a checklist exercise. If you want the wider picture of what the report contains, our CPSR explained guide is a useful companion to this one.
Key takeaways
- The foundation of every CPSR is the full quantitative formula — INCI names with exact percentages, adding to 100%.
- You will also need raw material specifications, supplier safety data sheets and Certificates of Analysis to prove what actually went into the product.
- Fragrance and allergen data (IFRA certificate plus a full allergen breakdown) is essential and increasingly scrutinised under the new labelling rules.
- Manufacturing method and GMP (ISO 22716) evidence, plus stability, packaging-compatibility and — where relevant — microbiological and challenge-test results complete the technical picture.
- The brand supplies label artwork, intended claims, PAO/shelf life and the target user and market; the manufacturer and raw-material suppliers supply almost everything else.
Why a CPSR asks for so much documentation
Under Regulation (EC) No 1223/2009, a cosmetic cannot legally be placed on the EU market until a qualified assessor has completed a safety assessment (Article 10) and produced a safety report in the Annex I format. Annex I has two parts: Part A, the safety information (composition, physical and chemical characteristics, microbiological quality, impurities, exposure, toxicological profile), and Part B, the assessor’s reasoning and conclusion. Every document you provide feeds one of those Part A headings — the assessor is legally required to base their conclusion on real, verifiable data and cannot sign off on a product they cannot fully characterise.
The same pack also becomes the backbone of your Product Information File (PIF) under Article 11, so a clean pack does double duty: it speeds up the assessment and populates your PIF at once. For the ordering process end to end, see our walkthrough on how to get a CPSR for your cosmetic product, and if budget is on your mind, how much a CPSR costs explains what drives the price.
The full quantitative formula (INCI names and exact percentages)
This is the non-negotiable starting point. The assessor needs the complete formulation expressed as INCI names with the exact percentage of each ingredient, adding up to 100%. A range, a “roughly”, or a marketing-friendly ingredient list will not do — the toxicological calculations that underpin the whole report depend on precise concentrations, especially for any substance restricted under Annexes II to VI (preservatives, colorants, UV filters and restricted substances all have maximum permitted levels).
If you developed the product with a contract manufacturer or a freelance formulator, they hold this document. Some manufacturers guard their formula as intellectual property; in that case they can send it to the assessor under confidentiality rather than to you directly — that is completely normal and keeps the project moving. The INCI names used here must also match what appears on your pack, so it is worth reading our guide to EU cosmetic ingredient labelling (INCI) alongside your formula.
Raw material specifications, SDS and Certificates of Analysis
Knowing the percentages is not enough — the assessor has to know what each ingredient actually is. That means, for every raw material in the formula, a set of supporting documents from the raw-material supplier:
- Technical data sheet / specification — describes the material, its grade, purity and any relevant physical or chemical properties.
- Safety data sheet (SDS, sometimes still called an MSDS) — the standardised hazard document under REACH/CLP that flags any classified substances and gives handling data.
- Certificate of Analysis (CoA) — confirms that a specific batch of the raw material actually met its specification.
These come from your ingredient suppliers, usually routed through your manufacturer, who buys the raw materials. A CoA on the finished product is valuable too, as it evidences the batch you are actually selling. If a document is missing, a lab can issue a Certificate of Analysis to close the gap.
Note: Gaps in raw-material paperwork are the most common reason a CPSR stalls. Ask your manufacturer for the full pack of specifications, SDS and CoAs before you place your order — chasing 15 suppliers after the clock has started is what turns a two-week job into a two-month one.
Fragrance and allergen breakdown
If your product is fragranced, the assessor needs the fragrance house’s documentation, not just the trade name. Two documents matter most: an IFRA certificate (confirming the fragrance is used within the International Fragrance Association’s safe-use limits for your category) and a full allergen declaration listing the declarable fragrance allergens and their concentrations.
This matters more than ever. Regulation (EU) 2023/1545 expanded the list of fragrance allergens that must be named on the label to around 80 substances, with new products needing to comply by 31 July 2026 and existing stock allowed to sell through until 31 July 2028. Because the same data drives both the assessment and your label wording, it needs to be accurate. The fragrance supplier holds these documents; your manufacturer can usually obtain them for you.
Manufacturing method, GMP and product stability
The assessor evaluates the product as it is actually made, so they need a description of the manufacturing method and confirmation that it follows Good Manufacturing Practice. The recognised standard is ISO 22716, and a statement or certificate of GMP compliance from your manufacturer is the usual evidence.
Alongside the process, the assessor considers how the product behaves over time and in its pack:
- Stability data — evidence, often from an accelerated stability and compatibility test, that the product stays safe and unchanged across its intended shelf life.
- Packaging-compatibility data — confirmation that the product and its container do not interact in a way that affects safety.
- Microbiological quality and preservative efficacy — for water-containing products, results from a microbiological test and a preservative efficacy (challenge) test demonstrating the preservative system controls contamination in normal use.
These come from a testing laboratory or your manufacturer. Anhydrous products such as oils, balms or solid soaps may not need challenge testing, but the assessor will still expect a justification. Our overview of cosmetic laboratory testing requirements breaks down which analyses apply to your product.
Warning: Do not commission expensive lab testing blind. A good assessor will tell you which test reports your particular formula genuinely needs — ordering a full stability, microbiological and challenge-test panel for a product that does not require all three wastes money, while skipping one that is required will block your report entirely.
Labelling, claims and intended use
The final pieces come from you, the brand. The assessor needs to see the product as the consumer will:
- Finished-product label artwork — so ingredient lists, warnings and mandatory symbols can be checked against Article 19 labelling requirements.
- Intended claims — what you plan to say the product does, which must be substantiated and compliant with Article 20 and the common criteria for claims.
- Period after opening (PAO) or shelf life — informed by your stability data.
- Target user and market — for example, a face cream for adults, a product for children, or a leave-on versus rinse-off application. This defines the exposure assumptions the whole assessment is built on.
Intended use matters more than it looks: a leave-on cream carries a very different exposure profile from one rinsed off within seconds, and the same formula aimed at children may need a stricter evaluation. Getting this right at the start prevents a redo later.
Your CPSR document checklist at a glance
Use the table below as your pre-order checklist. Tick off each row before you place your order and the assessment should run without avoidable delays.
| Document | Why it’s needed | Who usually provides it |
|---|---|---|
| Full quantitative formula (INCI + exact %) | The basis of every toxicological and restricted-substance calculation | Formulator or contract manufacturer |
| Raw material specifications / technical data sheets | Confirms the identity, grade and purity of each ingredient | Raw-material suppliers (via manufacturer) |
| Safety data sheets (SDS/MSDS) | Flags classified substances and hazard/handling data | Raw-material suppliers |
| Certificates of Analysis (CoA) | Proves the batch met its specification | Suppliers (raw materials) and manufacturer (finished product) |
| IFRA certificate + allergen declaration | Confirms safe fragrance use and drives allergen labelling | Fragrance house (via manufacturer) |
| Manufacturing method + GMP (ISO 22716) statement | Shows the product is made under controlled, safe conditions | Manufacturer |
| Stability and packaging-compatibility data | Supports shelf life and confirms product–pack safety | Testing lab or manufacturer |
| Microbiological and preservative-efficacy (challenge) results | Demonstrates contamination control in water-based products | Testing laboratory |
| Finished-product label artwork | Checked against labelling and mandatory-symbol rules | Brand |
| Intended claims, PAO/shelf life, target user and market | Defines exposure assumptions and claim compliance | Brand |
Bringing it all together
Ordering a CPSR feels daunting until you realise it is really an exercise in gathering documents you should have anyway: a precise formula, honest supplier paperwork, the right test reports, and a clear picture of how your product is labelled and used. Assemble that pack before you order and you remove almost every source of delay — most hold-ups are missing CoAs or vague formulas, not the assessment itself.
If you would like a hand knowing exactly which documents your product needs — and someone to chase the gaps and turn it all into a compliant report — our Cosmetic Product Safety Report service is built for precisely this. We will tell you what to collect, flag anything missing, and complete the Part A and Part B report your product needs to reach the EU market.
Frequently asked questions
What is the single most important document for a CPSR?
The full quantitative formula — every ingredient listed by INCI name with its exact percentage, totalling 100%. Without it the assessor cannot perform the toxicological and restricted-substance calculations that the whole report depends on, so it should be the first thing you secure from your formulator or manufacturer.
My manufacturer won’t share the full formula with me — can I still order a CPSR?
Yes. It is common for a manufacturer to treat the formula as confidential intellectual property. In that case they can send the quantitative composition directly to the safety assessor under a confidentiality agreement rather than to you. The assessment still goes ahead; you simply are not the one holding the formula.
Do I need lab test reports before I order the CPSR?
It depends on your product. Water-containing products usually need microbiological and preservative-efficacy (challenge) results plus stability data, while anhydrous products such as oils and solid soaps often do not. The best approach is to let the assessor confirm which tests apply first — see our overview of cosmetic laboratory testing requirements — so you only pay for the analyses you genuinely need.
What’s the difference between an SDS and a Certificate of Analysis?
A safety data sheet (SDS/MSDS) describes a substance’s hazards, classification and handling under REACH/CLP — it is about the material in general. A Certificate of Analysis confirms that a specific batch actually met its agreed specification. A CPSR typically needs both: the SDS to characterise the ingredient and the CoA to prove what you received.
Who provides the fragrance allergen information?
The fragrance house that supplied your scent, usually via your manufacturer. They issue an IFRA certificate and an allergen declaration listing the declarable allergens and their levels. This data matters more than ever under Regulation (EU) 2023/1545, which expanded the allergens that must be named on labels, with new products complying by 31 July 2026.
Will gathering these documents also help with my other EU obligations?
Very much so. The same pack forms the core of your Product Information File under Article 11 and feeds your CPNP notification, so nothing is wasted. Planning how to get a CPSR early means you build the documentation once and reuse it across your whole compliance file.
