CPSR explained for UK cosmetic safety reports and assessors
A CPSR records a cosmetic's safety information and assessment. Learn what GB reports contain, who can sign them and what to prepare for an assessor.
CPSR explained for UK cosmetics
CPSR means Cosmetic Product Safety Report. Before placing a cosmetic on the Great Britain market, the responsible person must ensure a safety assessment is completed and the report prepared. Article 10 sets that duty.
The report brings together product safety information and a qualified assessor's evaluation. It belongs in the Product Information File (PIF). It is not a government-issued certificate or a product notification. Article 11 sets the file requirements.
The duties below apply to Great Britain: England, Scotland and Wales. Northern Ireland follows a different regime, explained below.
What does a cosmetic product safety report contain?
A CPSR has two parts. Part A supplies the evidence. Part B records the assessor's conclusion and the reasons for it. Annex I sets their minimum contents.
| Part | Contents | Responsibility |
|---|---|---|
| Part A: cosmetic product safety information | Formula, product properties, exposure, toxicology and other safety evidence | The responsible person provides the information |
| Part B: cosmetic product safety assessment | Safety conclusion, necessary warnings, scientific reasoning and signed assessor details | A suitably qualified safety assessor carries out the assessment |
This division is also explained in the GB statutory guidance. Hiring an assessor does not transfer the responsible person's compliance duty.
Part A needs more than an ingredient list
The evidence must describe the finished product and how people will use it. An ingredient list or supplier certificate alone cannot replace that assessment. Annex I, Part A requires information covering:
- The quantitative and qualitative formula, including ingredient identities, amounts and functions.
- Physical and chemical characteristics, plus stability under reasonably foreseeable storage conditions.
- Microbiological quality, including relevant specifications and preservation challenge-test results.
- Impurities, traces and relevant packaging characteristics, including purity and stability.
- Normal and reasonably foreseeable use, supported by the proposed label instructions and warnings.
- Exposure to the product and its ingredients, considering application site, amount, frequency, duration and users.
- Ingredient toxicological profiles, including relevant irritation, sensitisation and systemic effects.
- Available data on undesirable and serious undesirable effects, plus other relevant product safety information.
Exposure deserves care. The assessment must consider intended use and anticipated systemic exposure to individual ingredients in the final formulation. Article 10 requires an appropriate weight-of-evidence approach.
For ingredient identity, provide chemical names and INCI names, plus CAS and EINECS/ELINCS identifiers where possible. Perfume compositions need their name, code and supplier. Product exposure information should identify application area, exposure routes and relevant user populations. Annex I specifies these details.
The toxicology section also needs to address relevant absorption, impurities and ingredient interactions. It includes margins of safety based on no-observed-adverse-effect levels where relevant, with reasons for omissions. Annex I also requires relevant packaging characteristics, including purity and stability. Gather these details before asking the assessor to reach a conclusion.
Part B must explain the conclusion
The assessor records whether the cosmetic is safe, the warnings or instructions needed, and the scientific reasoning. Part B also needs the assessor's name, address, qualification evidence, date and signature. Specific assessment is required for products intended for children under three and products exclusively for external intimate hygiene. These requirements appear in Annex I, Part B.
Paying for a report does not guarantee a positive conclusion. The Commission guidelines recognise conclusions of safe, safe with restrictions and not safe.
Who can sign a cosmetic safety assessment?
The assessor must hold formal qualifications following university study, both theoretical and practical, in pharmacy, toxicology, medicine or a similar discipline. Formal qualification evidence following a course recognised as equivalent by the Secretary of State is also accepted. Cosmetics experience alone does not meet this qualification requirement. See Article 10(2).
Ask for qualification evidence before commissioning the work. The report itself must include that evidence, so a claim of experience is not enough. Annex I specifies the assessor details required.
Article 10(2) does not expressly require a UK-issued degree or UK residence. That does not establish automatic acceptance of every overseas qualification. Keep this separate from the responsible person's UK-establishment requirement in the GB guidance.
How to get a cosmetic product safety report in the UK
Start with the formula and product evidence, rather than a request for a certificate. The practical task is to give a qualified assessor enough information to evaluate the finished cosmetic against Annex I.
Send the full formula, relevant supplier documents, packaging details, intended users and proposed directions for use. Include existing stability, microbiological and adverse-effect information. Ask the assessor to identify gaps before agreeing further testing. These materials support the evidence categories required by Annex I.
If you sell cosmetic soap or bath bombs, ask which exact formulations the assessment covers. Do not assume it covers every fragrance or colour variant. Nor should a small manufacturer assume an exemption: GOV.UK guidance includes commercial free samples and products used on the public by professionals within its scope.
Agree the testing needed for your product
There is no universal commercial cosmetic testing package in Annex I. The evidence must support the particular product's assessment. The Commission guidelines allow scientifically justified omissions of irrelevant or unnecessary information. The justification belongs in Part A and must be validated by the assessor in Part B.
The Commission guidelines distinguish low-microbiological-risk products from those needing microbiological quality tests or challenge tests. Any omission needs scientific justification. This does not give every soap or water-free product an automatic exemption. Stability and packaging evidence still matter. Neither Annex I nor the Commission guidelines prescribe one universal stability duration or new patch testing for every cosmetic. Use the guidelines for scientific guidance and the GB legislation for legal requirements.
Keep the report in the PIF and review changes
Once completed, place the CPSR in the PIF. The file also needs the product description, manufacturing method and GMP statement, relevant claims evidence and specified animal-testing data. In GB, retain it for ten years after the date the last batch was placed on the market. Information must be in English and readily accessible to the authority at the notified address. See Article 11.
The CPSR must stay current when relevant new information emerges. Article 10 sets no universal annual renewal or fixed expiry date. Formula changes, new scientific evidence, restrictions, changed use and adverse-effect trends can prompt review under the Commission guidelines. A review does not always mean a completely new report. SCPN notification remains a separate pre-market obligation, as the GB guidance explains.
How much does a CPSR cost?
The assessment provisions do not set an assessment fee. Request a quote from the assessor rather than treating an advertised price as an official tariff.
Ask whether the quote includes compiling Part A, any additional testing, revisions and formula variants. An unclear quote leaves you unable to tell what you are buying. Agree the scope before commissioning the work.
Does the same CPSR cover Northern Ireland?
Do not assume GB arrangements are enough. Northern Ireland follows EU cosmetics rules under the Windsor Framework. Its guidance specifies an NI/EEA-established responsible person, EU CPNP notification and an EU-recognised safety assessor. Check qualification acceptance for the intended market rather than assuming GB acceptance proves NI or EU acceptance. See the Northern Ireland statutory guidance.
RegAffairs AI provides a citation-backed answer on CPSR requirements. The qualified assessor must still complete and sign Part B under Annex I.