Cosmetic Product Safety Report (CPSR): structure, data and safety assessment

The responsible person ensures that, before the product is placed on the market, it has undergone a safety assessment and a safety report has been set up in accordance with Annex I. The intended use and the anticipated systemic exposure to individual ingredients must be taken into account, and data from all existing sources must be reviewed with an appropriate weight-of-evidence approach.

The assessment itself, Part B, is 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.

Annex I divides Part A into ten sections: quantitative and qualitative composition, physical/chemical characteristics and stability, microbiological quality, impurities, traces and information about the packaging material, normal and reasonably foreseeable use, exposure to the cosmetic product, exposure to the substances, toxicological profile of the substances, undesirable effects and serious undesirable effects, and further information on the product.

The first four sections come almost entirely from development and quality assurance: formula, raw-material specifications, stability and microbiology data, packaging details. The more cleanly this data is attached to the formula version, the fewer queries the assessor has.

Part B has four sections: the assessment conclusion, labelled warnings and instructions of use, the reasoning, and the assessor’s credentials and approval of Part B. The conclusion is a statement on the safety of the product in relation to Article 3 of the Regulation.

In the reasoning the assessor explains the scientific considerations, assesses margins of safety and possible interactions between the substances, and takes into account how stability affects safety. For products intended for children under the age of three, and for products intended exclusively for external intimate hygiene, Annex I requires a specific assessment.

The complete composition with quantities and the chemical identity of each substance, where possible with chemical name, INCI, CAS and EINECS/ELINCS number, and its intended function. For perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier are sufficient. In addition, raw-material specifications and information on purity, impurities and traces.

Also the results of stability testing, the microbiological specifications and the results of the preservation challenge test, information on the packaging material, and the intended use: product type, site of application, amount, frequency and target group. If the product or a predecessor is already on the market, known undesirable effects belong here too.

A safety assessment is valid for the composition that was assessed. When a raw material, a supplier, a use concentration or the packaging changes, you check whether the assessment still holds. The Regulation also requires the report to be updated with relevant information arising after the product is placed on the market.

In practice: the report should be visibly tied to a formula version, and every new version should raise the question of whether the assessor needs to see it.

There are no fixed prices, and reliable figures depend on the individual case. The effort is driven mainly by the number of raw materials and the quality of their documentation, the product type and target group, such as products for children under three, missing stability or microbiology data, and the number of variants.

Complete documents the first time save the most time: every query from the assessor costs time on both sides.

In practice an assessor typically asks for: the complete formula of the version to be assessed, with percentages and the function of each substance. The specifications and safety data sheets of the raw materials; for perfume and aromatic compositions the name, code number and supplier. Information on purity, impurities and traces.

In addition, the stability test report, the microbiological specification and the result of the preservation challenge test, information on the packaging material, a description of the use with amount, frequency, site of application and target group, and the draft labelling with the intended warnings.

A safety report exists for formula version 3 of a face cream. In version 4 the preservative is changed. That alters the composition in Part A section 1, probably the results of the preservation challenge test in section 3, and the toxicological profile in section 8. The assessor receives the new formula, the raw-material documents and the new test results, and judges whether an addendum is sufficient or a new assessment is needed.

If, by contrast, the same raw material in the same specification is merely sourced through a different distributor, the data relevant to the assessment generally does not change. The check should be documented all the same.

A development system can provide the composition per version, attach raw-material data and test results, and show where limits in the annexes are touched. The conclusion on safety is drawn by the assessor. An automated check does not replace a safety assessment under Article 10.