How to perform the Cosmetic Product Safety Assessment?

Although by definition, a cosmetic product must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, Responsible Persons must ensure that their cosmetic products undergo an expert scientific safety assessment before they are placed on the EU market.

As defined by the International Cooperation on Cosmetics Regulation (ICCR), the safety assessment is not a standardised procedure but should be performed by a qualified safety assessor on a case-by-case basis using the best science and it involves:

Ingredient characterisation through relevant physico-chemical data, purity and profile of impurities, and chemical structure of constituent ingredients comprising a product.
Assessment of all relevant toxicological hazard information.
Considerations with regard to the stability of ingredients and product formulation as well as their microbiological status.
Exposure assessment, including an understanding of how the product is used: the amount, frequency, and duration of intended use, as well as target users.
Calculation of safety or exposure margins (as appropriate), using the relevant dose metric for the endpoint considered.
Post Market Surveillance to support continued product safety.

Based on all the available data, the safety assessor may conclude that the product is safe for the proposed use without restrictions, is safe with restrictions and may need specific warnings or precautions or the product is not safe.

The safety assessment is provided in the form of a Cosmetic Product Safety Report (CPSR), which must be included in the Product Information File (PIF) and whose contents are laid out in Annex I to Regulation (EC) No 1223/2009. Any recommendations for the safety assessment, which are relevant to ensure consumer safety when using the product, are included in this report.

As mentioned by Cosmetics Europe in their Guidelines for the Safety Assessment of a Cosmetic Product, although it is not possible to obtain zero risk or absolute safety in any human activity, including cosmetology, reasonable efforts must be made to reduce the risk from cosmetic products to the minimum, according to the state of the art at the time.

Ensuring the safety of a cosmetic product thus involves a full process approach, from the choice of the ingredients to the marketing follow-up, and some points should be taken into account, including:

careful selection of cosmetic ingredients and raw materials;
selection of adequate packaging to maintain the quality of the product and to avoid, as far as possible, risks of misuse or accident;
applying Cosmetic Good Manufacturing Practice (GMP) Guidelines;
quality control;
appropriate labelling as regards the presentation of the product, instructions for use and disposal, warnings (if relevant) and proper action to take in case of accident;
adequate procedures in case of undesirable effects with the marketed product.

It can be a real challenge for the industry to maintain, under a stringent regulatory framework, the standards for cosmetic safety. But, maybe Cosmedesk can help you with that!

As a software company, we do not perform the safety assessments ourselves, but we can provide you with great resources to efficiently conclude this step. In addition to giving you the possibility to gather, organize and store all your cosmetic product data, Cosmedesk also offers you the automatic calculation of exposure and the Margins of Safety (MoS) according to the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation (11th Revision). We also have a toxicological database of more than 2000 cosmetic ingredients available upon request. In the end, you can successfully generate the CPSR and control its versions, if you need to add any post-market information affecting the safety of your product.

The safety assessment of your cosmetic products doesn’t need to be a painful job. Improve your work with Cosmedesk!