What is a cosmetic safety assessment?
The expert evaluation that demonstrates a cosmetic product is safe to place on the market: what it covers, who may sign it, and when it must be revisited.
A cosmetic safety assessment is the expert evaluation of whether a cosmetic product is safe for human health under normal and reasonably foreseeable conditions of use. A qualified safety assessor examines the composition, the exposure arising from its intended use and the toxicological profile of each substance, then reasons to a conclusion and signs it. In the EU it constitutes Part B of the Cosmetic Product Safety Report (CPSR), which forms part of the Product Information File (PIF).
What the assessment covers
The requirements are set out in Article 10 and Annex I of Regulation (EC) No 1223/2009, with methodology elaborated in the SCCS Notes of Guidance. In substance, the assessor must determine whether the product is safe once the following are taken into account:
- Each substance.Its toxicological profile, chemical structure and route of exposure, and its concentration in the finished formulation. Specific consideration is given to particle size, including nanomaterials.
- Exposure.The quantity applied, frequency of application, retention time and whether the product is rinse-off or leave-on, translated into a daily exposure figure and, where a systemic endpoint applies, into a Margin of Safety derived from the NOAEL and the systemic exposure dosage.
- Site of application and target population.The anatomical site and the population for whom the product is intended. Article 10(1) requires specific assessment for products intended for children under the age of three and for products intended exclusively for external intimate hygiene.
- The product itself.Stability under foreseeable storage conditions, microbiological quality and preservative efficacy, impurities and traces, and the characteristics and interaction of the packaging material.
- Aggregate exposure.The same substance may reach the consumer through other cosmetic products.
- Undesirable effects.Data on undesirable and serious undesirable effects reported for the product or for products of comparable composition.
The assessment is an evaluation of evidence, not a testing programme. Following the Article 18 prohibitions, which have applied to finished products since 2004 and to ingredients, including for all human health endpoints, since March 2013, the assessor works from existing data, SCCS opinions, validated alternative methods, read-across and the Threshold of Toxicological Concern where its conditions of use are satisfied.
Where it sits: Part A and Part B
The CPSR has two parts. The assessment is Part B, and it can be no more reliable than the data compiled in Part A.
| Part | What it holds | Who provides it |
|---|---|---|
| Part A: safety information | Quantitative and qualitative composition, physicochemical characteristics and stability, microbiological quality, impurities, traces and packaging material information, normal and reasonably foreseeable use, exposure to the product and to the substances, the toxicological profile of each substance, and data on undesirable effects | Principally the Responsible Person and its raw material suppliers |
| Part B: safety assessment | The conclusion on the safety of the product, the labelled warnings and instructions for use, the reasoning leading to both, and the assessor's credentials, proof of qualification and signature | The qualified safety assessor |
The completed report is then placed in the PIF. See What is a Product Information File? for the other four components.
Who may sign it
Article 10(2) requires the safety assessment to be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
The assessor signs Part B with their name, address, proof of qualification and the date. That signature is a professional attestation: a named, qualified person has weighed the evidence and stands behind the conclusion, and can be called on to defend it.
Three consequences follow:
- The Responsible Person cannot sign for itself,unless the signatory personally holds the qualifications required by Article 10(2).
- Software cannot sign.A tool may compile data and draft text; the reasoning and the conclusion must be reviewed and signed by a qualified person who accepts responsibility for them.
- The credentials form part of the record.A competent authority can see who performed the assessment and whether that person was qualified to do so.
When it is required, and when it must be revisited
In the EU and the UK the assessment must be completed before the product is placed on the market — this is a precondition under Article 10(1), not a post-launch formality. It must then be kept up to date for as long as the PIF is retained: ten years from the date the last batch was placed on the market.
The assessment should be revisited whenever anything capable of affecting the safety conclusion changes:
- the formulation, including the addition, removal or reconcentration of any substance
- a raw material supplier, grade or specification, or the impurity profile that follows from it
- the intended conditions of use or the target population
- new toxicological information on a substance, a new or revised SCCS opinion, an amendment to Annexes II to VI, or a CMR reclassification under CLP
- undesirable or serious undesirable effects notified under Article 23
- a change to the packaging material or to stability or microbiological results
The US operates no CPSR. Under MoCRA, the responsible person must maintain records constituting adequate substantiation of safety for each product.
Common findings
- Confusing assessment with testing.The assessment weighs evidence. It does not imply that every product is submitted for laboratory testing, nor does a folder of test reports amount to an assessment.
- Screening ingredient names in isolation.A substance may be permissible at one concentration and restricted at another, or permitted in rinse-off and restricted in leave-on. The Annex III conditions must be applied to this formulation and this product type.
- Template reports without genuine evaluation.Text carried across from another product's report does not demonstrate that this formulation was assessed, and the absence of product-specific reasoning in Part B is readily identified at inspection.
- An unqualified signatory.A signature from a person who does not meet Article 10(2) exposes the entire report, and with it the compliance of the product.
- Incomplete Part A.Missing toxicological profiles, unjustified read-across or supplier declarations unsupported by underlying data leave the Part B conclusion without a foundation.
- Failure to update.A report drawn up for a superseded formulation does not cover the product currently on the market.
Frequently asked questions
- Is a safety assessment the same as a CPSR?
- Not quite. The assessment is Part B of the CPSR. The CPSR also comprises Part A, the safety information on which the assessment is founded.
- Who may carry out a cosmetic safety assessment?
- A qualified safety assessor: a person holding a university qualification in pharmacy, toxicology, medicine or a similar discipline, or a qualification recognised as equivalent by a Member State, as required by Article 10(2).
- Does every cosmetic product need one?
- In the EU and the UK, yes. No cosmetic product may be placed on the market until the safety assessment has been carried out.
- How long does it remain valid?
- Until something relevant changes — the formulation, the data, or the regulatory position. The report must be kept up to date and retained for ten years from the date the last batch was placed on the market.
- Can AI carry out the safety assessment?
- AI can assemble data and draft the report. The toxicological reasoning and the conclusion must be reviewed and signed by a qualified safety assessor, who bears responsibility for them.