Cosmetic & Consumer Compliance
Cosmetic product safety reports (CPSR)
Before a cosmetic can be sold in the EU or UK, its safety must be assessed and documented in a cosmetic product safety report (CPSR). We prepare CPSRs that combine product data (Part A) with a reasoned safety assessment (Part B), so that the Responsible Person can place the product on the market with confidence.
- Legal basis EU Regulation (EC) No 1223/2009, Article 10 and Annex I; UK equivalent
- Typical inputs Full formula, ingredient data, stability and microbiology results
- You receive CPSR Parts A and B
Overview
About Cosmetic Product Safety Reports
Part A of the CPSR collects the safety information: quantitative formula, physical and microbiological stability, impurities and traces, packaging, normal and foreseeable use, exposure, ingredient toxicological profiles and undesirable effects. Part B is the safety assessor’s conclusion, warnings and reasoning.
For each ingredient we review the toxicological profile, calculate systemic exposure and the margin of safety (MoS), consider local effects such as irritation and sensitisation, and check regulatory restrictions. The assessment reflects the product type, the users and how the product is applied.
Use cases
When this service helps
New product launches
A CPSR for each product before it is placed on the market.
Reformulations
Update the assessment when the formula or a supplier changes.
Range extensions
Assess shade or fragrance variants efficiently.
Market entry from outside Europe
Bring non-EU products up to EU documentation standards.
Scope
What the service covers
- Formula review against EU Annexes II–VI (prohibited, restricted, colourant, preservative and UV-filter lists)
- Ingredient toxicological profiles from supplier data, SCCS opinions and literature
- Exposure calculation for the product type and target population
- Margin-of-safety calculation for relevant ingredients
- Assessment of impurities, traces and packaging interactions
- Review of stability, preservative efficacy and microbiological results
- Safety assessor’s conclusion, warnings and instructions for use (Part B)
Who does what
Product testing (stability, challenge test, microbiology, user tests) is performed by laboratories. The Responsible Person in the EU or UK keeps the CPSR within the product information file and notifies the product through the official portal.
What is a margin of safety?
The margin of safety compares a no-observed-adverse-effect level (NOAEL) from toxicology studies with the estimated systemic exposure from using the product. For most ingredients, an MoS of at least 100 is generally considered to indicate that the product is safe.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Collect dataFormula, specifications, supplier documents and test results.
- Screen complianceIngredients are checked against regulatory annexes.
- Assess safetyExposure and margin-of-safety calculations with toxicological review.
- ConcludePart B conclusion, warnings and conditions of use are written.
Deliverables
What you receive
CPSR Part A
Compiled safety information on the product and its ingredients.
CPSR Part B
The safety assessor’s assessment and conclusion.
Data gap list
Any missing information needed before the report can be finalised.
Technical basis
Guidelines we work to
- Regulation (EC) No 1223/2009EU Cosmetics Regulation; Article 10 and Annex I define the safety report.
- Commission Implementing Decision 2013/674/EUGuidelines on Annex I to help prepare the CPSR.
- SCCS Notes of GuidanceScientific Committee on Consumer Safety guidance on testing and safety evaluation of cosmetic ingredients.
- UK Cosmetics RegulationRetained and amended EU rules applying in Great Britain.
What we need from you
- Full quantitative formula with INCI names
- Raw material specifications and supplier safety data
- Fragrance allergen and impurity information
- Stability, preservative efficacy and microbiological test results
- Packaging details and intended use instructions
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
EU and UK: a CPSR is mandatory. Other markets (for example ASEAN, the GCC or India) do not always require a CPSR in this format, but many accept or request an equivalent safety assessment as part of the product information file or registration.
FAQs
Cosmetic Product Safety Reports (CPSR): frequently asked questions
How long does a CPSR take?
Once all formula and supplier data are available, a standard leave-on or rinse-off product can usually be assessed quickly; missing supplier data is the most common cause of delay.
Can one CPSR cover several shades?
Variants with very similar formulas can often be covered in one assessment, provided the differences are assessed.
Do you need our full formula?
Yes. A safety assessment requires the full quantitative formula. We treat it as confidential and can sign an NDA.
Talk to us about Cosmetic Product Safety Reports
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
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+91 99894 74590 - Emailbd@globaxa.in
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