The Cosmetic Product Safety Report, or CPSR, is the document that says a cosmetic product is safe to use. Every cosmetic sold in the EU needs one before it goes on the market (Article 10 of Regulation (EC) No 1223/2009), and it is the main part of the Product Information File. Without a CPSR, a Responsible Person cannot notify the product in the CPNP, so nothing else in the process moves.
It is also easy to confuse with other documents. A safety data sheet from a raw material supplier is not a CPSR. Neither is a lab report on a single test, or a declaration from the factory that the product is safe. A CPSR is a structured assessment with two parts, written and signed by a qualified person, and the format is fixed in Annex I of the Regulation.
When a brand asks us to act as its Responsible Person, a valid CPSR is one of the first documents we ask for, together with the formula, the label and the GMP information. We review it, but we do not write it. How the CPSR fits into the rest of the file is explained in our article on the EU Responsible Person for cosmetics.
What a CPSR is
Article 10(1) asks the Responsible Person to make sure each product has undergone a safety assessment, based on the relevant information and set out in a report that follows Annex I. The assessment has to take the intended use and the expected systemic exposure to each ingredient into account, and weigh the data from all available sources.
In principle you need one CPSR per product. The Commission's guidelines on Annex I (Implementing Decision 2013/674/EU) allow a combined report for products in one range where the only difference is the colouring agent and that difference does not affect safety, for example a set of lipstick shades. Even then, the combination has to be justified in the report.
Part A of the CPSR: the safety information
Part A collects the facts the assessor needs. Annex I lists ten headings:
| Part A heading | What it covers in practice |
|---|---|
| 1. Quantitative and qualitative composition | the full formula, with each ingredient and its concentration |
| 2. Physical/chemical characteristics and stability | specifications of the raw materials and the product, and how long it stays stable |
| 3. Microbiological quality | specifications and test results, with extra care for sensitive users and uses |
| 4. Impurities, traces, packaging material | unwanted traces in the ingredients, and what the packaging is made of |
| 5. Normal and reasonably foreseeable use | how the product will be used, including likely misuse |
| 6. Exposure to the product | where it is applied, how much, how often and for how long |
| 7. Exposure to the substances | the exposure to each ingredient that follows from point 6 |
| 8. Toxicological profile of the substances | the hazard data per ingredient |
| 9. Undesirable effects | known side effects of this product or similar products |
| 10. Information on the product | anything else relevant to the assessment |
Most of this information comes from you, your manufacturer and your raw material suppliers. The assessor puts it together but cannot invent it, which is why a CPSR takes longest when the formula or the supplier data is incomplete.
Part B of the CPSR: the safety assessment
Part B is where the assessor gives a verdict. It has four headings: the assessment conclusion, the labelled warnings and instructions for use, the reasoning behind the conclusion, and the assessor's credentials and approval.
The second heading is the one to check against your packaging. If the assessor concludes that the product is only safe with a warning, such as "avoid contact with eyes", that warning has to appear on the label. A CPSR whose warnings are missing from the artwork does not match the product on sale.
According to the guidelines, Part B has to state the name and address of the safety assessor and be dated and signed. Proof of the assessor's qualification belongs with it, which in practice means a copy of the diploma.
The margin of safety
For each ingredient the assessor compares the exposure from your product with the level at which no adverse effect was found in studies. The result is the margin of safety (MoS). The guidelines state that it is generally accepted that the margin of safety should be at least 100 to declare a substance safe in a finished product. A low margin does not automatically mean the product is unsafe, but the reasoning in Part B then has to explain why it is still safe.
Who may sign a CPSR
Article 10(2) says the safety assessment must be carried out by a person with a diploma or other formal qualification after a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
Your manufacturer can therefore only sign the CPSR if it employs someone with that qualification. A Responsible Person does not write the report by default either; at Westwood the CPSR is something you arrange with an assessor, and we check it.
Want us to check your file? Our EU Responsible Person service for cosmetics includes a review of your PIF and CPSR before the product is notified.
The tests behind a CPSR
Three parts of the report rest on test data rather than on paperwork.
Stability and shelf life
The report has to describe how the product's minimum durability was determined. The date or period after opening on your label should follow from that, not from habit.
Microbiological tests
For most products the file needs both a preservation challenge test and microbiological tests on the finished product. The guidelines name lower-risk exceptions, such as products with an alcohol content above 20 percent, single-use products and products that cannot be opened. Products for children under three, and products used around the eyes or on mucous membranes, need extra attention.
Packaging
The assessor looks at what the primary packaging is made of and whether substances could migrate from it into the product. Changing from glass to plastic is therefore not just a purchasing decision.
Keeping the CPSR up to date
A CPSR is not finished when the product launches. Article 10(1)(c) requires the report to be kept up to date when relevant new information appears after the product is on the market. A changed formula, new toxicological data on an ingredient, a change in the rules for a substance or a pattern of complaints from users are all reasons to have the assessor look again.
A change that affects the formula usually means more than a new CPSR. The CPNP notification then needs an update too, as we explain in our article on the CPNP notification.
Your checklist when you receive a CPSR
- Check that the report covers your exact formula and the product name on your label.
- Check that Part A has all ten headings, and that test results are attached rather than promised.
- Read the conclusion in Part B and note any conditions it sets.
- Compare the warnings in Part B with your label artwork, word for word.
- Check that Part B is dated and signed, with the assessor's name, address and proof of qualification.
- If one report covers several shades, check that the combination is justified.
- Store the CPSR in the PIF, and plan a review whenever the formula, a supplier or the rules change.
Conclusion
The CPSR is the part of the cosmetics file that cannot be shortcut: a two-part report under Annex I, based on your formula and test data, and signed by a qualified assessor. Check the label warnings against Part B and keep the report current, and the rest of the process up to the CPNP notification follows much more easily.
We act as EU Responsible Person for cosmetics brands from outside the EU and review your CPSR before we notify your product. View the service and send us your file.
Sources
- Regulation (EC) No 1223/2009 on cosmetic products, consolidated version, Article 10 and Annex I. EUR-Lex.
- Commission Implementing Decision 2013/674/EU of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009. EUR-Lex.
