Client
A company that manufactures cosmetic products.
Background
Under Regulation (EC) 1223/2009, cosmetics within the European Union should not be placed on the market if they are harmful to health under normal or reasonably foreseeable conditions of use. This is ensured through the production of a Cosmetic Product Safety Report (CPSR) in which the toxic potential of the product and its constituents is evaluated, alongside the product’s stability and microbiological quality. An assessment of overall safety should be carried out by a suitably qualified individual. In line with these requirements, bibra was asked to produce a CPSR on a skin cream with multiple ingredients.
Approach and outcome
Toxicological monographs were put together on each of the individual constituents of the skin cream.
Searches for toxicity data were carried out on a wide range of databases. The first port-of-call was bibra’s inhouse TRACE database which includes Expert Group reports from the European Commission’s Scientific Committee on Consumer Safety (SCCS) and US Cosmetic Ingredient Review (CIR) Panels. Data searches were also carried out using a range of external databases.
The key toxicity data were identified and summarised for each constituent. Where possible, bibra was informed by Expert Group reviews. All relevant routes of exposure and endpoints (including irritation, acute and repeated-dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and skin sensitisation) were considered. From each available dataset, appropriate Points of Departure (PoDs) such as No-Observed-Adverse-Effect-Levels (NOAELs) and Lowest-Observed-Adverse-Effect-Levels (LOAELs) were selected. Based on the data, none of the constituents was expected to be genotoxic.
Information on dermal absorption was used to calculate worst-case Systemic Exposure Doses (SEDs) for product users. Margins of Safety (MoS) were then determined by dividing the critical PoDs by the worst-case SEDs. The MoS figures were considered in the context of sources of uncertainty to allow conclusions on health risks from each individual constituent, and from the product as a whole.
