A cosmetic product safety report, universally shortened to CPSR, is the formal written safety assessment that must exist for a finished cosmetic product before it can lawfully be placed on the European Union or Great Britain market. It is a two-part document: the first part assembles the technical evidence about the formula, its ingredients, the packaging and how the product will be used, and the second part is where a qualified safety assessor reasons over that evidence and states in writing whether the product is safe. The report is not submitted to a regulator for approval — it is held in your product information file and produced on demand during an inspection or complaint investigation. The practical implication for a brand owner is that the CPSR is only as good as the data your manufacturer supplies, so the document pack should be agreed before the first production run, not after it.
Key takeaways
- The CPSR is a legal precondition, not a certificate you can buy. Annex I of Regulation (EC) No 1223/2009 sets out exactly what Part A (safety information) and Part B (safety assessment) must contain, and Part B can only be signed by a person with a recognised qualification in pharmacy, toxicology, medicine or an equivalent discipline.
- Your OEM manufacturer holds most of the input data, but the legal duty sits with you. The Responsible Person named on the pack — usually the brand owner or an appointed representative established in the market — is accountable for the report existing and being current, even when the factory arranged the assessment.
- A CPSR is formula-specific and market-specific. Change a preservative, a fragrance dose, a packaging material or a claim and the assessment must be revisited; and a European CPSR does not by itself satisfy ASEAN product information file rules or the safety-substantiation records the United States now expects.
What exactly is inside a cosmetic product safety report?
A CPSR contains two clearly separated halves: Part A gathers ten defined categories of safety information about the product, and Part B records the assessor’s reasoning, the warnings that must appear on the label, the safety conclusion and the assessor’s own credentials. This structure is prescribed in Annex I of Regulation (EC) No 1223/2009, and the European Commission published a dedicated set of guidelines on how to complete each heading in Implementing Decision 2013/674/EU. A report that omits a Part A heading is incomplete even if the conclusion is favourable, which is the most common reason an otherwise finished dossier fails an inspection.
The table below maps the two parts against who normally holds the underlying evidence. This split is the single most useful thing for a first-time brand owner to understand, because it shows which items you must extract from your factory and which come from the assessor.
| Part | Heading | What it must actually contain | Who normally supplies it |
|---|---|---|---|
| A | Quantitative and qualitative composition | Full formula with INCI names, CAS numbers and exact percentages, including fragrance and preservative systems | Manufacturer or formulator |
| A | Physical and chemical characteristics and stability | Appearance, pH, viscosity, density, plus stability and packaging-compatibility data supporting the shelf life | Manufacturer’s laboratory |
| A | Microbiological quality | Microbiological specification and, for water-containing products, preservative efficacy (challenge) test results | Manufacturer or contract laboratory |
| A | Impurities, traces and packaging material | Impurity profile of raw materials, banned-substance traces, migration and food-grade or inertness evidence for the container | Raw material and packaging suppliers |
| A | Normal and reasonably foreseeable use | Intended use, application site, frequency, rinse-off or leave-on, and predictable misuse | Brand owner |
| A | Exposure to the product | Amount applied, area of application, retention factor and exposure route for the intended population | Safety assessor, from brand-owner input |
| A | Exposure to the substances | Systemic exposure dosage calculated per ingredient from the product exposure figures | Safety assessor |
| A | Toxicological profile of the substances | Endpoint-by-endpoint toxicology for each ingredient, with the no-observed-adverse-effect level where systemic exposure occurs | Safety assessor, using supplier dossiers and published data |
| A | Undesirable effects | Any adverse reactions recorded for the product or closely comparable formulations | Brand owner and manufacturer |
| A | Information on the product | Existing human volunteer data, or well-established data on an analogous formulation being relied upon | Manufacturer or brand owner |
| B | Assessment conclusion | An explicit statement of whether the product is safe under the described conditions of use | Safety assessor |
| B | Label warnings and instructions | The specific warnings, restrictions and usage instructions that must therefore appear on the pack | Safety assessor |
| B | Reasoning | The scientific argument, including margin-of-safety calculations for systemically available substances | Safety assessor |
| B | Assessor credentials and approval | Name, qualification, proof of eligibility, signature and date | Safety assessor |
The calculation at the heart of Part B is the margin of safety, obtained by dividing the no-observed-adverse-effect level of an ingredient by the systemic exposure dosage a consumer receives from your product. Conventional practice, set out in the SCCS Notes of Guidance issued by the EU Scientific Committee on Consumer Safety, is that a margin of safety of at least 100 is required for a substance that becomes systemically available. This is why the same active at the same percentage can pass in a rinse-off cleanser and fail in a leave-on body lotion: the retention factor and application area change the exposure, not the ingredient. It is also why a formula built around a novel or restricted ingredient can stall — if the toxicological data needed to calculate that margin does not exist, no assessor can sign Part B. Restrictions and permitted maximum concentrations for individual substances are searchable in the Commission’s CosIng database, which is worth checking during custom formulation rather than at dossier stage.
Who can write a CPSR, and which markets actually require one?
Only a person holding a recognised university-level qualification in pharmacy, toxicology, medicine or an equivalent discipline may sign Part B, and the requirement is jurisdictional rather than global: the European Union and Great Britain mandate a CPSR in this exact format, while most Asian markets require a safety assessment inside a product information file and the United States requires substantiation records without prescribing a document structure. Getting this distinction right early avoids paying for the wrong dossier.
Alongside the assessor sits the Responsible Person — a named legal entity established in the market where the product is sold, identified on the label, who must keep the product information file accessible for ten years after the last batch was placed on the market. That file contains the CPSR plus the product description, a description of the manufacturing method with a statement of compliance with good manufacturing practice, proof of any claimed effects, and animal-testing data where relevant. If you import rather than manufacture locally, you are usually the Responsible Person by default, and the obligation is not transferred by an invoice from your factory.
| Market | Safety document required | Submitted to the regulator? | Local entity needed |
|---|---|---|---|
| European Union | CPSR in the Annex I Part A and Part B format, inside the product information file | No — held and produced on request; only a CPNP notification is submitted | Responsible Person established in the EU |
| Great Britain | Equivalent safety report retained under the Cosmetic Products Enforcement Regulations 2013 as amended | No — notification is made separately via the UK service | UK-based Responsible Person |
| ASEAN, including Malaysia, Singapore and Thailand | Safety assessment within a product information file under the ASEAN Cosmetic Directive | No — the file is kept by the notifying company and inspected on request | Locally registered notification holder |
| United States | Records adequately substantiating safety, as required by the Modernization of Cosmetics Regulation Act | No — but facility registration and product listing are filed | US agent for the registered facility |
A European CPSR is nonetheless the most transferable document you can commission, because its Part A data pack covers almost everything an ASEAN product information file or a United States substantiation record needs. Many brands therefore commission the CPSR first and reuse the underlying evidence when they notify elsewhere — the mechanics of that filing differ by country and are set out in our walkthrough of notifying a cosmetic product for sale and the wider guide to notification and compliance. What does not transfer is the label: warnings mandated by the assessor in Part B must appear on the artwork, so labelling and assessment have to be finalised together rather than in sequence, as our tutorial on setting up compliant cosmetic labels explains.
What must your OEM manufacturer supply, and what does a CPSR cost?
Your manufacturer must supply the complete quantitative formula, raw material specifications and safety data sheets, stability and packaging-compatibility results, microbiological specification with challenge test data, a certificate of analysis for the batch, and a written statement of compliance with good manufacturing practice — without those, an assessor cannot start. The commercial risk is that a factory quoting a low unit price may treat this documentation as a chargeable extra or, worse, decline to disclose the full formula, which makes a compliant CPSR impossible. Establish the position in writing before you place a deposit.
The checklist below is the request list we would put to any prospective supplier. Treat a refusal on the first two lines as disqualifying rather than negotiable, since no assessor will work from a partial formula.
| Document to request | Why the assessor needs it | Common supplier objection |
|---|---|---|
| Full quantitative formula with INCI names and percentages | Basis of every exposure and margin-of-safety calculation | Treated as proprietary; usually resolved by sending it directly to the assessor under confidentiality |
| Raw material specifications and safety data sheets | Identity, purity, impurity limits and supplier toxicology references | Incomplete for fragrance or botanical blends; ask for the supplier dossier, not a summary |
| Stability and packaging-compatibility report | Supports the declared shelf life and period after opening | Offered as an accelerated test only; confirm the protocol and duration |
| Preservative efficacy (challenge) test to ISO 11930 | Demonstrates microbiological protection over the claimed use period | Substituted with a plate count; a plate count is not a challenge test |
| Batch certificate of analysis | Confirms the produced batch matches the assessed specification | Issued without the tested parameters; request the actual results |
| Good manufacturing practice statement, normally against ISO 22716 | Mandatory element of the product information file alongside the CPSR | A certificate for a different site or an expired scope; check the address and validity |
| Substantiation for every marketing claim | Claims support is a separate product information file requirement | Marketing copy offered as evidence; it is not |
On cost and timing, a straightforward leave-on or rinse-off formula built entirely from well-characterised ingredients is commonly assessed for a few hundred euros or pounds per product, with more complex, high-active or restricted-ingredient formulas running into four figures; turnaround is typically one to four weeks once the data pack is complete. Those are indicative market ranges rather than quoted prices, and they vary by assessor, jurisdiction and formula complexity. The dominant variable is almost never the assessor’s fee — it is how long the missing test data takes to generate. A formula that arrives without a valid challenge test or with only two weeks of stability data can wait months, because stability testing and microbiological work run on their own clocks and cannot be compressed by paying more.
Practical next step: before signing, ask each shortlisted manufacturer three questions — will you disclose the full quantitative formula to my safety assessor under a confidentiality agreement, which of the required tests are already complete for this formula, and are the remaining tests inside your quotation or billed separately? The answers separate factories that routinely export to regulated markets from those that do not, and they belong in the same conversation as your wider document request list and your check on GMP and ISO 22716 status. Suppliers that already hold export-grade documentation are a reasonable starting shortlist, and our manufacturer directory is organised to help you build one.
Frequently asked questions
Can I use the safety report my manufacturer already has for their stock formula?
Sometimes, but only if the formula, packaging, claims and intended use are genuinely identical to what you will sell, and only if the report names a Responsible Person arrangement that covers your product. A stock formula assessment is normally written for the factory’s own reference specification, so a change of container, a fragrance addition or a different application area can invalidate the exposure calculations that support it. Ask for the report itself rather than an assurance, check that Part B is signed and dated by a named qualified assessor, and have your own assessor confirm it still applies to your finished pack.
Do I need a CPSR if I only sell in Asia or the United States?
Not in that exact format, but you do need an equivalent safety assessment. ASEAN markets require a product information file containing a safety assessment, held by the notifying company and produced on inspection, while the United States requires records that adequately substantiate the safety of the product under the Modernization of Cosmetics Regulation Act. Because a European-style CPSR data pack satisfies most of what those regimes ask for, brands planning any future export commonly commission it first rather than assembling three partial dossiers later.
How long is a CPSR valid, and when must it be updated?
A CPSR has no fixed expiry date, but it must remain accurate, which in practice means it has to be revisited whenever something material changes. Reformulation, a new supplier for a key raw material, a different container or closure, a new claim, a new target population such as children, a regulatory change affecting a permitted concentration, or an accumulation of reported undesirable effects all trigger a review. Build a periodic check into your quality routine — an annual review against the current restricted-substance lists is a reasonable minimum for an actively sold range.
This article is general educational information for beauty brand owners and sourcing teams, not legal, regulatory or toxicological advice, and it does not substitute for an assessment by a qualified safety assessor. Cost and turnaround figures are indicative market ranges gathered from published assessor and testing-laboratory pricing, not quotations, and they vary widely by jurisdiction, assessor and formula complexity. We did not audit any manufacturer or laboratory in preparing this article; requirements also differ by market and are amended periodically, so verify the current position with the relevant authority and your own assessor before relying on it. Primary sources: Regulation (EC) No 1223/2009 and its Annex I; Commission Implementing Decision 2013/674/EU; the SCCS Notes of Guidance, 12th revision; the CosIng database; the UK Cosmetic Products Enforcement Regulations 2013; the ASEAN Cosmetic Directive as published by Singapore’s Health Sciences Authority; the US Food and Drug Administration on MoCRA; and ISO 22716 and ISO 11930. Written and researched by Evelyn Chong (Cosmetic Chemist & OEM Industry Analyst). Fact-checked by Marcus Tan. Last reviewed August 2026.