A Cosmetic Product Safety Report is one of the most important documents required before a cosmetic product can be placed on the European Union market.
However, not every CPSR provides the same level of scientific depth, documentation quality or practical value.
A low-cost report may appear sufficient until:
- a retailer requests supporting evidence
- an authority reviews the PIF
- the formula changes
- a consumer reaction is reported
- a supplier can no longer provide the same raw material
- the product is expanded into another variant
A strong cosmetic product safety assessment should not simply confirm that a product is safe. It should show how that conclusion was reached, which evidence was used and which conditions or warnings are required.
What is a cosmetic product safety assessment?
Before a cosmetic product is placed on the EU market, the Responsible Person must ensure that it has undergone a safety assessment based on relevant information and that a CPSR has been prepared in accordance with Annex I of Regulation (EC) No 1223/2009.
The CPSR has two main parts:
Part A: Cosmetic Product Safety Information
Part A collects the information needed to assess the product.
Part B: Cosmetic Product Safety Assessment
Part B contains the safety assessor’s conclusion, reasoning, required warnings and professional approval.
The reasoning is critical. EU guidance describes it as the core of the safety assessment because it explains how the assessor reached the final conclusion from the available information.
Who is allowed to complete the safety assessment?
Part B must be completed by a qualified safety assessor.
The assessor must hold an appropriate formal qualification in pharmacy, toxicology, medicine or a similar discipline, or a qualification recognised as equivalent by an EU Member State.
A software platform may support data collection or calculations. It does not replace the professional judgement and responsibility of the qualified assessor.
What information should a good CPSR include?
1. Exact qualitative and quantitative composition
The safety assessor needs the complete finished-product formula.
This should include:
- every raw material
- the percentage used
- the composition of mixtures
- the intended function of each ingredient
- fragrance or flavour identifiers
- regulated substances within complex mixtures
Trade names alone are usually insufficient because they do not reveal the substances that require toxicological assessment.
For fragrances, the identity of the supplier and relevant regulated-substance information should be available to the Responsible Person and safety assessor.
2. Physical and chemical characteristics
The assessment should consider relevant properties of:
- individual substances
- raw-material mixtures
- the finished cosmetic product
Depending on the product, this may include:
- pH
- viscosity
- appearance
- solubility
- particle size
- density
- relevant specifications
- analytical reference methods
These properties can influence exposure, stability, performance and safety.
3. Product stability
The assessment should use evidence showing that the cosmetic remains stable under reasonably foreseeable storage and use conditions.
Stability data may help assess:
- physical separation
- colour or odour changes
- pH changes
- viscosity changes
- degradation
- container interaction
- preservative performance
- expected shelf life
A generic statement from the manufacturer is weaker than a documented stability programme appropriate to the product.
4. Microbiological quality
Microbiological safety is especially important for products containing water, products used around the eyes and products used by vulnerable consumers.
Relevant evidence may include:
- microbiological specifications
- total viable counts
- absence of specified microorganisms
- preservation-challenge testing
- packaging protection
- manufacturing controls
Not every product requires the same test programme. If specific data are considered unnecessary, the absence should be scientifically justified.
5. Impurities, traces and packaging information
The safety assessment must consider more than intentionally added ingredients.
Potential concerns may arise from:
- raw-material impurities
- residual solvents
- heavy metals
- nitrosamines
- processing residues
- degradation products
- packaging interactions
- substances migrating from the container
EU guidance states that toxicologically relevant impurities and unintended substances should be identified and considered in the assessment.
6. Intended and reasonably foreseeable use
Exposure depends on how the product is actually used.
The assessor should understand:
- application area
- frequency of use
- amount used
- rinse-off or leave-on status
- exposure duration
- target population
- professional or consumer use
- foreseeable misuse
A face cream, shampoo, lip product and baby product cannot be assessed using identical exposure assumptions.
7. Exposure to the cosmetic product
The assessment should estimate consumer exposure based on realistic use.
Relevant factors may include:
- application amount
- application frequency
- body surface area
- exposure route
- retention factor
- body weight
- target population
These inputs form the basis for assessing exposure to individual ingredients.
8. Exposure to individual substances
The assessor evaluates how much of each relevant ingredient may become systemically available.
This may involve calculating the Systemic Exposure Dosage and comparing it with toxicological reference values.
The calculation must reflect the actual concentration in the finished product and the intended product use.
9. Toxicological profile of each relevant substance
A robust assessment considers toxicological endpoints that may include:
- acute toxicity
- irritation
- corrosion
- sensitisation
- repeated-dose toxicity
- mutagenicity
- carcinogenicity
- reproductive toxicity
- toxicokinetics
- phototoxicity
- local effects
- human experience
Not every endpoint will have complete data. Where information is missing, the assessor should explain the scientific approach used to reach a conclusion.
10. Undesirable and serious undesirable effects
The safety assessment is not frozen at launch.
Information about consumer reactions and serious undesirable effects should be collected, documented and made available to the safety assessor. Relevant new information may require the CPSR to be revised.
A brand therefore needs a post-market process, not only a pre-launch document.
11. Relevant information about the product
This section may include additional information that affects the assessment, such as:
- user studies
- compatibility data
- clinical or instrumental studies
- experience with similar formulas
- reported reactions
- safety history
- supporting scientific literature
The value of this information depends on its relevance and quality.
What should Part B contain?
Assessment conclusion
The assessor should clearly state whether the product is:
- safe
- safe subject to restrictions or conditions
- not safe
If a product is not considered safe, it cannot be treated as compliant and should not be placed on the market.
Warnings and instructions for use
The CPSR should identify any warnings or instructions required to ensure safe use.
These may result from:
- regulatory annexes
- the product format
- the target population
- exposure conditions
- professional use
- specific safety findings
Scientific reasoning
The report should explain how the assessor evaluated:
- identified hazards
- consumer exposure
- data quality
- uncertainties
- margins of safety
- relevant restrictions
- combined evidence
A conclusion without transparent reasoning is difficult to defend.
Assessor credentials and approval
The report should include the assessor’s:
- name
- address
- qualifications
- date
- signature or secure electronic approval
There should be a clear link between the approved assessment, the exact formula and the assessment date.
Common weaknesses in low-quality safety assessments
Warning signs include:
- no clear formula version
- incomplete raw-material composition
- no meaningful impurity assessment
- generic toxicology text
- missing exposure reasoning
- absent packaging consideration
- no explanation for missing tests
- unclear warnings
- no evidence of assessor qualifications
- no update process
- identical text across unrelated products
The issue is not whether a report is long. The issue is whether its conclusions are traceable and scientifically justified.
CPSR versus PIF: what is the difference?
The CPSR is part of the broader Product Information File.
The PIF must also contain:
- a clear product description
- manufacturing-method information
- a statement on good manufacturing practice
- evidence supporting claimed effects where relevant
- relevant animal-testing information
The PIF must be kept for ten years after the last batch is placed on the market.
A CPSR without the remaining PIF documentation does not create a complete EU product file.
When does a CPSR need to be updated?
A review may be required following:
- formula changes
- supplier changes
- new impurity information
- new fragrance or colour variants
- packaging changes
- revised use instructions
- new target populations
- reported undesirable effects
- new regulatory restrictions
- new scientific evidence
The Responsible Person must ensure the CPSR remains current in light of relevant information generated after launch.
How Makrolife supports cosmetic safety assessments
Makrolife can coordinate the complete safety-assessment process, including:
- formula and document review
- supplier-data gap analysis
- testing recommendations
- toxicological assessment
- CPSR preparation
- PIF support
- packaging and label consistency checks
- result interpretation
- update assessments
- ongoing compliance monitoring
The aim is not only to produce a signed report. It is to create a defensible safety file that remains useful throughout the product lifecycle.
Does your CPSR reflect the actual marketed product?
A safety assessment is only as reliable as the formula, data and assumptions behind it.
Request a Cosmetic Product Safety Assessment or existing-CPSR review from Makrolife.