People search for "CPSR example" or "CPSR template" because they want to know what they are buying. A template shows the headings. What separates a real report from a filled-in template is what sits under those headings, and that is what this guide describes.
Part A: cosmetic product safety information
| # | Section (Annex I) | What it should contain |
|---|---|---|
| 1 | Quantitative and qualitative composition | Every ingredient with INCI name, CAS/EC number, exact concentration and function; fragrance as a whole plus its allergens; composition of blends |
| 2 | Physical/chemical characteristics and stability | Specification of the finished product (appearance, pH, viscosity, density); stability conditions and results; the basis for shelf life or PAO |
| 3 | Microbiological quality | Microbiological limits for the category; challenge test results and the conclusion on preservation; special attention to eye-area products, children's products and damaged skin |
| 4 | Impurities, traces, information about the packaging material | Technically unavoidable traces of prohibited substances and why they are safe; purity of raw materials; packaging material and its compatibility |
| 5 | Normal and reasonably foreseeable use | How the product is used, including foreseeable misuse; warnings that follow from it |
| 6 | Exposure to the cosmetic product | Body area, amount per application, frequency, leave-on or rinse-off, target users, routes (skin, inhalation for sprays, oral for lip products) |
| 7 | Exposure to the substances | Exposure for each ingredient, usually as the systemic exposure dosage (SED) in mg/kg body weight per day |
| 8 | Toxicological profile of the substances | For each relevant ingredient: the point of departure (NOAEL or similar) with its source, dermal absorption, margin of safety, local effects (irritation, sensitisation), annex status |
| 9 | Undesirable effects and serious undesirable effects | Data from markets where the product or similar products are sold; cosmetovigilance records |
| 10 | Information on the cosmetic product | Other relevant data: claim tests, human tolerance studies, studies on similar products |
Section 8 is usually the longest and the most important. In a typical cream or serum it covers 20–40 ingredients, and each entry needs a source an inspector can check.
Part B: cosmetic product safety assessment
| # | Section | What it should contain |
|---|---|---|
| 1 | Assessment conclusion | A clear statement that the product is safe for human health under normal and reasonably foreseeable use, or not |
| 2 | Labelled warnings and instructions of use | Every warning required by the annexes (for example, for vitamin A, certain preservatives, hair dyes) and any the assessor adds |
| 3 | Reasoning | Why the assessor reached the conclusion: how margins of safety, local tolerance, microbiology, stability and impurities support it |
| 4 | Assessor's credentials and approval of Part B | Name, qualification under Article 10(2), date and signature |
Part B is where the assessor takes personal responsibility. That is why Article 10(2) requires a diploma in pharmacy, toxicology, medicine or a similar discipline.
A worked margin of safety example
The margin of safety (MoS) compares the dose at which no adverse effect was seen in a study with the dose a consumer absorbs from the product. The SCCS Notes of Guidance set the method. Here is a simplified example for a fictional ingredient, to show the kind of calculation section 8 contains. The values are illustrative, not data for any real substance.
Product: face cream, leave-on. Ingredient X: 2 % in the formula.
| Step | Value | Where it comes from |
|---|---|---|
| Relative daily exposure to face cream | 24.14 mg/kg bw/day | SCCS Notes of Guidance, exposure table for face cream |
| Concentration of ingredient X | 2 % | Formula (section 1) |
| Dermal absorption | 50 % | SCCS default when no measured data exist |
| SED = 24.14 × 0.02 × 0.5 | 0.24 mg/kg bw/day | Calculation |
| NOAEL, 90-day oral study | 100 mg/kg bw/day | Study report or ECHA dossier, cited |
| Oral bioavailability | 50 % | SCCS default |
| Systemic point of departure = 100 × 0.5 | 50 mg/kg bw/day | Calculation |
| MoS = 50 ÷ 0.24 | ≈ 207 | A value of at least 100 is generally considered acceptable |
A real report does this for every ingredient where it is relevant, explains when a margin of safety is not needed (for example, for water or substances with no systemic absorption), and gives the source of each number. A report that lists ingredients without these numbers has skipped the core of section 8.
Our software runs these calculations from a database of 44,000 points of departure and 90,000 ECHA dossiers. The assessor checks the sources and the result and writes the conclusion.
Eight questions to check a CPSR you received
- Does Part B name the assessor and state a qualification that meets Article 10(2)?
- Does the composition in section 1 match your current formula and the INCI list on the label?
- Is there an exposure scenario for your product type and target users, not a generic one?
- Does section 8 give a point of departure with a source, the SED and the MoS for the relevant ingredients?
- Are the fragrance allergens calculated for each scent against the current Annex III list?
- Are there stability and microbiology results, or a reasoned explanation of why they are not needed?
- Do the warnings in Part B appear on your label?
- Does the report refer to the current annexes, including the 2025 and 2026 Omnibus bans and the 2025 ingredient glossary?
If any answer is "no", the report may still be accepted by a distributor, but it will not hold up when an inspector reads it.
How we show our reports
We show a complete sample CPSR on a short call and walk you through each section, instead of sending files. Your first report can be a €45 pilot, so you can judge the work on your own product before ordering more.
FAQ
Is there an official CPSR template?
There is no mandatory template. Annex I sets the required content, and Commission Implementing Decision 2013/674/EU gives guidelines for each section. Providers use their own layout as long as all sections are covered.
How long is a CPSR?
There is no set length. A balm with five ingredients produces a short report; a fragranced cream with 30 ingredients produces a much longer one, most of it in section 8.
In which language should a CPSR be written?
In a language the competent authority of the Responsible Person's country can easily understand (Art. 11). English is widely used. We write in English.
Does a CPSR expire?
There is no fixed expiry date, but it must be kept up to date. Changes in the formula, raw material suppliers, the label, the annexes or scientific opinions require a review.
Sources
- Regulation (EC) No 1223/2009, Article 10, Article 11 and Annex I
- Commission Implementing Decision 2013/674/EU: guidelines on Annex I
- SCCS Notes of Guidance, 12th revision: exposure values, default absorption, margin of safety