HCPC Brands EuropeCPSR Safety Assessment
Before any cosmetic product can be placed on the EU market, its safety must be demonstrated in a Cosmetic Product Safety Report — the single most important document in the Product Information File. HCPC Brands Europe B.V. commissions and reviews CPSRs through certified toxicologists, covering both the safety information and the formal safety assessment.
Part A — Cosmetic Product Safety Information
The evidence base the assessment is built on: quantitative and qualitative product composition, physical/chemical characteristics and stability, microbiological quality, impurities and packaging material interactions, normal and reasonably foreseeable use, exposure calculation, and the toxicological profile of every ingredient — with particular attention to local toxicity, skin sensitisation, and any UV-related photo-induced toxicity where relevant.
Part B — Cosmetic Product Safety Assessment
The assessor's conclusion: a clear statement on the product's safety under Article 3, any labelled warnings or instructions of use required as a result, and the scientific reasoning connecting that conclusion back to the evidence in Part A — including, where relevant, a discussed margin of safety.
The Weight-of-Evidence Approach
Rather than applying a single pass/fail test, a safety assessor weighs all available evidence together — toxicological data, exposure estimates, and where relevant read-across from structurally similar, already-assessed substances — to reach an overall, scientifically justified conclusion. A central tool in this approach is the Margin of Safety: broadly, the ratio between the highest dose at which no adverse effect is observed in the available data and the estimated real-world exposure from the product. A sufficiently large margin supports a conclusion of safety; a narrow or negative margin signals the need for further data, reformulation, or restriction. This reflects the standard scientific approach used by the EU's Scientific Committee on Consumer Safety when evaluating individual cosmetic ingredients.
What's Included in Our Service
- CPSR drafting — Part A and Part B prepared to Annex I structure by a qualified toxicologist.
- Existing CPSR review — checked for completeness, correct reasoning, and up-to-date ingredient data.
- Testing coordination — support arranging stability, microbial challenge, and toxicological testing where gaps exist.
- Ongoing updates — the report is revisited whenever reformulation or new safety information requires it.
Regulatory Framework
Our Process
- 1. Intake — formulation, packaging, intended use, and any existing test data.
- 2. Data review & gap analysis — we identify missing toxicological or stability data before drafting begins.
- 3. Assessment — a qualified toxicologist drafts Parts A and B.
- 4. Integration — the completed CPSR is incorporated into your Product Information File.
Frequently Asked Questions
What is a Cosmetic Product Safety Report (CPSR)?
The CPSR is the core safety dossier within the PIF. It has two parts: a fact-gathering part covering composition, intended use, ingredient toxicological profiles and exposure data, and a conclusion part in which a qualified safety assessor states whether the product is safe and explains the reasoning.
Who is qualified to sign off a cosmetic product safety assessment?
Only a person holding a university-level qualification in pharmacy, toxicology, medicine, or a comparable discipline (or an equivalent recognised by an EU Member State) may sign off the safety assessment underlying a CPSR. This is a specific, checkable credentialing requirement, not a general competence standard.
What is the difference between CPSR Part A and Part B?
Part A collects the underlying safety information — product composition, intended use and exposure, ingredient toxicological and purity profiles, and any known undesirable effects. Part B is the assessor's conclusion: a statement on the product's safety, any labelling implications, and the scientific reasoning connecting Part A's data to that conclusion.
Is the safety assessment a fixed, standardised checklist?
No. The assessment is carried out case-by-case using a weight-of-evidence approach, considering both the hazard profile of each ingredient and the realistic exposure conditions of the finished product, rather than applying a single uniform test.
Does the CPSR need to be updated after the product is already on the market?
Yes. The safety report must be kept up to date in light of any additional relevant information that emerges after the product has been placed on the market, including cosmetovigilance data on undesirable effects.
What is the "margin of safety," and why does it matter in a CPSR?
The margin of safety compares the highest dose at which no adverse effect has been observed in the available toxicological data against the estimated real-world exposure from actual product use. A sufficiently wide margin supports a safety conclusion; a narrow one signals that further data, a lower use concentration, or a formulation change may be needed before the product can be considered safe.
See also our Product Information File and Responsible Person pages, or our full Cosmetics Glossary & FAQ.
Need a CPSR prepared for your product?
Get in touch →