Last Updated on September 17, 2026

What Goes in a Cosmetic Product Safety Report (CPSR), Item by Item

A Cosmetic Product Safety Report, or CPSR, is the safety assessment every cosmetic product needs before it can be placed on the EU or UK market. It’s required under Article 10 of Regulation (EC) No 1223/2009, must follow the structure set out in Annex I, and must be prepared by a qualified safety assessor holding a degree in pharmacy, toxicology, medicine, or a similar discipline. No CPSR, no legal route to market, regardless of how good the product itself is.

It has two parts. Part A is the safety information: everything the assessor needs to work from. Part B is the assessment itself: the assessor’s professional conclusion, built on Part A. The CPSR then becomes one component of the wider Product Information File (PIF), alongside the product description, GMP statement, claims evidence, and any animal testing data, which the Responsible Person has to keep accessible for ten years after the last batch is placed on the market.

Here is exactly what goes into each part, plus what usually goes wrong.

Part A: Cosmetic Product Safety Information

1. Quantitative and qualitative composition. Every substance in the product, identified by chemical name, INCI name, CAS number, and EC number where available, plus what each substance is there to do. For perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier. In practice, this section is only as good as the raw material specifications and certificates of analysis the assessor is given, so gaps here usually trace back to incomplete supplier documentation.
   
2. Physical and chemical characteristics and stability. The physical and chemical properties of the substances, mixtures, and finished product, plus how stable the product is under normal storage conditions. This is where stability test data (accelerated ageing, real-time storage) gets referenced, not just described.
   
3. Microbiological quality. The microbiological specifications of the raw materials and finished product, with particular care for products used around the eyes, on mucous membranes, on damaged skin, on children under three, on elderly people, or on people with compromised immune systems. Includes preservation challenge test results, which show the product’s preservative system actually works against microbial contamination over its shelf life, not just on paper.
   
4. Impurities, traces, and packaging material. The purity of substances and mixtures, evidence that any traces of prohibited substances are technically unavoidable, and the relevant characteristics of the packaging, particularly its purity and stability. Packaging compatibility testing (does the formula interact with the container) feeds in here too.
   
5. Normal and reasonably foreseeable use. How the product is actually going to be used, justified against the warnings and instructions on the label. “Reasonably foreseeable” covers misuse a consumer might plausibly make, not just the instructions on the box.
   
6. Exposure to the cosmetic product. Data covering where on the body it’s applied, the surface area involved, how much product is used, how often and for how long, the exposure route, and the population using it, including any specific population that might be more exposed or more vulnerable. A leave-on face cream and a rinse-off shampoo generate very different exposure profiles even with overlapping ingredients, which is why this can’t be copied across products.
   
7. Exposure to the substances. The same exposure analysis, but for the individual substances in the product, based on the exposure data gathered in item 6.
   
8. Toxicological profile of the substances. The toxicological profile for every relevant endpoint, with particular attention to skin and eye irritation, skin sensitisation, and photo-induced toxicity where UV absorption is relevant. This includes the margin of safety calculation based on the no observed adverse effect level, and consideration of particle size (including nanomaterials), impurities, and how substances interact with each other. This is usually the most time-consuming section, since it often means pulling toxicological data from SCCS opinions, published literature, or supplier dossiers rather than generating it from scratch.
   
9. Undesirable effects and serious undesirable effects. All available data on undesirable effects linked to the product, or to similar products, including statistical data where it exists. For a brand-new product with no market history, this section leans more heavily on read-across from similar existing formulations.
   
10. Other relevant information. Anything else that supports the safety case, such as existing human volunteer studies or substantiated findings from risk assessments carried out in other contexts.
    

Part B: Cosmetic Product Safety Assessment

1. Assessment conclusion. A clear statement on whether the product is safe under Article 3. This has to be an unambiguous conclusion, not a hedge.
   
2. Labelled warnings and instructions. A statement on what warnings or usage instructions need to appear on the label as a result of the assessment. If Part A flagged that a substance in Annex III carries a mandatory warning, it has to show up here and then actually make it onto the label.
   
3. Reasoning. The scientific explanation behind the conclusion and the labelling statement, built on the information in Part A. This must include a specific assessment for products intended for children under three and for products intended for external intimate hygiene, an assessment of how the substances might interact with each other, and justification for any toxicological profiles that weren’t fully considered.
   
4. Assessor’s credentials. The name and address of the safety assessor, proof of their qualification, and the date and signature approving Part B. A CPSR without this is incomplete regardless of how thorough Part A and the rest of Part B are.
   

What you need to have ready before you commission one

A CPSR moves faster when the assessor isn’t waiting on you for basic inputs. Useful to have on hand: the full formulation with exact concentrations, raw material specifications and certificates of analysis from your suppliers, any existing stability and packaging compatibility data, preservation challenge test results, your intended label copy and claims, and your GMP documentation (compliance with ISO 22716 under Article 8). Brands that gather this before reaching out generally get a CPSR back faster than brands that assemble it as they go.

Common reasons a CPSR gets rejected or challenged

A handful of gaps come up repeatedly during reviews and market surveillance checks:

• The Part B reasoning skips the specific assessment required for children under three or for intimate hygiene products, even though the product falls into one of those categories.
• The margin of safety calculation is missing or not justified, rather than simply stated.
• The assessor’s qualification isn’t documented, or the signature and date are missing entirely.
• The CPSR was written once and never revisited, even though the formulation changed, a claim was added, or a substance in it was newly restricted under an Omnibus amendment.
• The CPSR doesn’t match what’s actually on the CPNP or SCPN notification, usually because one was updated and the other wasn’t.
• The INCI list isn’t ordered by concentration the way the label requires.
• UK and EU ingredient restrictions are treated as identical when they’ve since diverged.

A few things worth knowing

The CPSR isn’t a one-time document. Article 10(1)(c) requires it to be kept up to date as new safety data comes in, and Article 13(7) requires the CPNP notification to be updated without delay whenever the underlying information changes. Treat the two as linked: a formulation change means updating both, not just the one that’s easier to get to.

Does every colour or scent variant need its own CPSR? If the composition changes, meaning a different colourant, a different fragrance, or a different active, a separate CPSR is required. If only the shade name changes and the ingredients are identical, the same CPSR can be used with updated product references.

How long does a CPSR take to prepare? It depends almost entirely on how complete your formulation, supplier, and testing documentation is when you hand it over. A well-documented single-ingredient-count product moves faster than a complex, multi-ingredient formula with gaps in the supporting data.

Who can legally sign off a CPSR? Only someone holding a university qualification in pharmacy, toxicology, medicine, or a similar discipline, or a qualification a Member State recognises as equivalent. This has to be documented in Part B, not just assumed.

If you’re putting together a CPSR for a new product, or checking whether an existing one actually covers everything above, see our CPSR service page for how our cosmetics compliance team can prepare or review one for you.