Safety Assessment: Ensuring Consumer Protection & Compliance
Cosmetics Regulation 1223/2009 aims to ensure the safety of cosmetic product for the consumers. This means that each cosmetic product must be the subject of a safety assessment performed by a qualified person, before the product can be placed on the EU market.
The safety assessment report (SAR) is a toxicological evaluation of your product’s documentation, throughout the formula review and the necessary tests to be conducted (challenge test, stability test, compatibility test, etc…). The safety assessment shall also indicate the mandatory warnings to be visible by the consumer on the cosmetic product labels, if any.
A safety assessment process includes:
- Ingredient characterization through relevant physicochemical data, purity, profile of impurities and chemical structure.
- 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 and global ecotoxicity including an understanding of how the product is used: the amount, frequency, duration of intended use and 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.
As a solution, we offer:
- To support with the Safety assessment according to EU regulations
- To review documents for you and check whether the ingredients used in the product are restricted or banned in the EU. This can lead to complex situation with preformulated ingredients
- To check that the necessary tests were conducted properly
- Based on the no observed adverse effects level (NOAEL), we can calculate the margins of safety (MoS)
- To prepare the cosmetics safety assessment report.
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