Key takeaways
- Part A covers the assessor's credentials, the formula and the toxicology.
- Part B covers the labelling, the warnings and the conclusion.
- A CPSR is formula-specific and must be revised when the formula changes.
The cosmetic product safety report, or CPSR, is the document that establishes a cosmetic is safe for its intended use. It is written by a qualified safety assessor with the relevant qualifications, and it is part of the product information file that must exist before a product is placed on the EU market.
1. Part A
Part A covers the assessor’s credentials, the formula with concentrations, the intended use and exposure, the toxicological profiles of the ingredients, and the assessment of the finished product including any interaction. It is the technical core.
2. Part B
Part B covers the labelling, the warnings, the instructions, the conclusion and the assessor’s signature. It is short and it is the part a reviewer reads first. A Part B that says “safe” without referencing the exposure assumptions is a Part B that invites a challenge.
3. Exposure
The assessor needs the intended use: face or body, leave-on or rinse-off, adult or child, and the amount used per application. A body lotion and a lip balm with the same formula have different exposure and can have different conclusions. The brief must state the use.
4. Ingredient data
The assessor works from the ingredient list and the supplier data. A novel ingredient without published toxicology needs more work and may need a read-across. A formulator who introduces an unusual active late in the process delays the CPSR and therefore the launch.
5. Restricted ingredients
The EU has annexes of restricted and prohibited substances with concentration limits and warnings. The CPSR must show that every restricted ingredient is within its limit and that the required warnings appear on the label. A product at the limit is compliant and has no margin for process variation.
6. Stability and compatibility
The CPSR relies on the stability data and the pack compatibility data. A formula that is safe in a jar and unstable in a tube is a different risk. The assessor should see the pack and the stability results, not only the formula.
7. Changes
A change to the formula, the pack material, the use or the concentration requires a CPSR revision. A fragrance change is a formula change. Brands that treat the CPSR as a one-time deliverable end up with a file that no longer describes the product.
8. Cost and time
A CPSR typically costs a few hundred to a few thousand dollars depending on complexity, and takes 2 to 4 weeks. A simple formula is at the low end; a formula with novel actives, colourants and a spray application is at the high end. The time is on the critical path.
9. Who can write it
The assessor must hold a qualification in pharmacy, chemistry, biology or a related discipline, and have the relevant experience. A self-declared assessor is not sufficient. The credentials are recorded in Part A and are checked by the authority.
10. Other markets
Other markets have analogous documents under different names: a safety assessment, a product safety data sheet or a registration dossier. A CPSR is a good foundation and is not a substitute for a local requirement. The dossier has to be assembled per market.
11. Where it fits
Safety files run across the night cream range; the responsible person detail continues in the responsible person entry.
Reference: CPSR templates and safety assessment records, 2025
