The safety assessment of cosmetic products under current European legislation (Regulation 1223/2009) requires detailed consideration of local health effects (ie those occurring at the site of application) as well as systemic (internal) health effects for each individual product ingredient. Systemic health effects are driven by the total quantity of the ingredient to which the consumer is exposed, which, in turn, is dependent on the level of that particular ingredient within the product, the amount of product used on a daily basis, the manner in which it is intended to be used and the extent to which the ingredient can penetrate the skin. A level of internal exposure is estimated, compared against a toxicological reference value and used to derive a ‘margin of safety’ value for that ingredient. A margin of safety of 100 or greater is generally considered to demonstrate a safe level of exposure. In contrast, local health effects are primarily driven by the level of the ingredient in the product and do not require significant skin penetration.
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