The Cosmetic Product Safety Report documents the scientific safety assessment of a finished cosmetic product under normal and reasonably foreseeable conditions of use.
CPSR Part A and Part B
Part A covers composition, physicochemical properties and stability, microbiological quality, impurities and packaging, use, exposure, toxicological profile, undesirable effects and other relevant information. Part B contains the conclusion, warnings, reasoning and assessor credentials.
The conclusion must remain traceable to the underlying evidence. The assessor should be able to explain how each material fact influences the safety of the finished product.
Formula quality and raw-material documentation
A complete qualitative and quantitative formula with clear identification of each raw material is required. For complex mixtures, composition, function, impurities, specifications and conditions of use matter.
An unclear fragrance composition, incomplete specifications or missing toxicological data often lead to additional questions. A safety conclusion should not rely on undocumented assumptions.
Practical checkpoint
Every conclusion should be linked to the exact formula, document and market-material version. This makes it possible to demonstrate which evidence supported the regulatory decision.
Exposure and margin of safety
Exposure is assessed according to product type, application site, amount, frequency, duration, route of exposure and target population. Systemic and local effects are considered for relevant ingredients.
The margin of safety is one assessment tool, not a substitute for expert evaluation of the whole dataset. Children, sensitive skin, the eye area, mucous membranes or professional use may require particular attention.
Stability, microbiology and packaging
The assessment should consider whether the product retains the expected quality and safety throughout use. Stability, packaging compatibility and microbiological evidence should match the product and proposed period of use.
Packaging can affect protection, dosing, contamination and material migration. The information required should be proportionate to the packaging material, formula and associated risk.
When a CPSR must be reviewed
A reassessment may be required after a relevant change in formula, raw material, supplier, use, target population, packaging, ingredient status or availability of new safety information.
Change control should ensure that potential impact is evaluated before the changed product is manufactured or placed on the market.
Frequently asked questions
Who may prepare a CPSR?
The assessment must be performed by a person holding the formal qualifications required by the Cosmetics Regulation.
Can one CPSR cover several shades?
Only where all variants are clearly identified and their differences are adequately assessed.
Is laboratory testing always mandatory?
The type and extent of evidence depend on the product and risk; the assessor must justify why the available evidence is suitable.
Official sources and further reading
This article is for general information and does not replace an assessment of the specific product, formula and supply chain. Legislation and guidance may change after publication.