The Cosmetic Product Safety Report (CPSR): A Technical Guide

The Cosmetic Product Safety Report (CPSR) is the documented scientific basis on which a cosmetic product is judged safe for human health, and without which it may not lawfully be placed on the United Kingdom or European Union market. It is not a certificate of conformity and it is not a test result. It is a reasoned toxicological opinion, prepared and signed by a qualified safety assessor, that the product as formulated, packaged and used is safe under normal and reasonably foreseeable conditions of use within the meaning of Article 3.

Legal basis and governing guidance

The requirement arises from Article 10 of Regulation (EC) No 1223/2009, which obliges the Responsible Person to ensure that a safety assessment is carried out and a CPSR drawn up before a product is placed on the market. The content and structure of the report are prescribed by Annex I to the Regulation, and the methodology is elaborated in Commission Implementing Decision 2013/674/EU. The scientific basis for the evaluation of individual ingredients is set out in the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, currently the 12th revision (SCCS/1647/22). In Great Britain the same obligations apply through the assimilated UK Cosmetics Regulation, enforced by the Office for Product Safety and Standards.

Part A: the safety information

Part A of Annex I is the compilation of the data on which the assessment depends. The assessor cannot reach a defensible conclusion without it, and a deficiency in Part A is the most common reason an assessment cannot be completed. It comprises ten defined elements:

1. Quantitative and qualitative composition, identifying every ingredient by INCI name and function, with its concentration, and the composition of any substances of concern.
2. Physical and chemical characteristics and stability, covering the specifications of the raw materials and the finished product, and the stability of the product under reasonably foreseeable storage conditions, which establishes the minimum durability and the period after opening.
3. Microbiological quality, including the specifications and, for products susceptible to microbial growth, the preservation efficacy demonstrated by challenge testing to ISO 11930.
4. Impurities, traces and information on the packaging material, addressing the purity of substances, any traces of prohibited substances under Article 17, and the relevant characteristics of the container in contact with the product.
5. Normal and reasonably foreseeable use, which determines the exposure scenario and must be consistent with the labelling and presentation.
6. Exposure to the cosmetic product, quantifying the amount applied, the frequency, the site and surface area of application, and whether the product is retained on or rinsed from the skin.
7. Exposure to the substances, deriving the systemic exposure to each substance of concern from the exposure to the product.
8. The toxicological profile of the substances, the scientific core of Part A, addressing each relevant endpoint: acute toxicity, irritation and corrosivity, skin sensitisation, dermal absorption, repeated-dose toxicity, mutagenicity and genotoxicity, carcinogenicity where relevant, reproductive toxicity, toxicokinetics, and photo-induced toxicity where the substance absorbs ultraviolet radiation.
9. Undesirable effects and serious undesirable effects, including any data available on the product or comparable products.
10. Information on the cosmetic product, capturing any further relevant data, such as existing studies on the finished product.

Part B: the safety assessment

Part B is the assessor’s evaluation of the Part A data and the reasoned conclusion that follows from it. It has four components: the assessment conclusion, a statement on safety within the meaning of Article 3; the labelled warnings and instructions for use that the assessment requires; the reasoning, which must make the scientific logic explicit and reference the SCCS opinions, expert panel conclusions and toxicological literature relied upon; and the credentials and approval of the assessor.

The Margin of Safety

For each substance presenting a potential systemic risk, the central quantitative tool is the Margin of Safety. It is the ratio of the No Observed Adverse Effect Level, established from the most relevant repeated-dose toxicity study, to the Systemic Exposure Dosage arising from the product’s intended use:

MoS = NOAEL / SED

The Systemic Exposure Dosage is derived from the daily quantity of product applied, the concentration of the substance, its dermal absorption, and a standard body weight of 60 kg. A Margin of Safety of at least 100 is generally required for a substance to be considered safe at the concentration used. The factor of 100 is not arbitrary: it combines a tenfold factor for interspecies extrapolation, from the test species to the human, with a further tenfold factor for intraspecies variability among individuals. Where the calculated margin falls below 100, the concentration must be reduced, the ingredient reconsidered, or additional data provided to refine the exposure estimate before the product can be assessed as safe.

The qualified safety assessor

Part B may only be completed by a person who satisfies Article 10(2), holding a diploma or other evidence of formal qualification in pharmacy, toxicology, medicine or a similar discipline. The conclusion is a professional judgement for which the named assessor takes responsibility, and the assessor’s qualifications form part of the report.

The CPSR within the Product Information File

The CPSR is the pivotal document of the Product Information File required under Article 11, but it is not the only condition of lawful supply. The complete file, the notification through the CPNP in the European Union or the SCPN in Great Britain, the labelling required by Article 19, and the obligations of the Responsible Person must each be satisfied independently. A valid CPSR does not, on its own, make a product compliant.

When a CPSR must be reviewed

The assessment reflects the product as it stood when the report was signed. It must be revisited when the formulation changes, when new toxicological data or a new SCCS opinion affects an ingredient, when a substance is restricted or prohibited by amendment to the Annexes, when a raw material or supplier specification changes, or when undesirable effects in the field indicate that the original conclusion should be re-examined.

What the assessment requires from you

To prepare a CPSR an assessor needs the full quantitative formulation with INCI names and percentages, the raw material documentation including specifications, safety data sheets and certificates of analysis, the manufacturing method and confirmation of Good Manufacturing Practice to ISO 22716, the stability and compatibility data, the microbiological specifications and challenge test where applicable, the packaging details, and the intended use and claims. Where data are absent, for example a missing preservation efficacy test or dermal absorption value, the gap must be closed by testing before the assessment can conclude.

Common reasons a product does not pass first time

The recurring obstacles are a restricted substance present above its permitted Annex III limit; a preservation system that fails challenge testing or is absent from a product that requires one; a Margin of Safety below 100 for a substance of concern, typically a fragrance allergen or a UV filter at high inclusion; missing toxicological data on a novel or poorly characterised ingredient; and impurity levels, particularly of heavy metals, that are not kept as low as technically achievable. Each is resolvable, but each must be resolved before, not after, the product reaches the market.