REGULATIONS 15
individual ingredients, based on their concentration in the product) based on several factors. The site and surface area of application, the amount of product applied, the duration and frequency of use, the normal and reasonably foreseeable exposure routes and the exposed population will be defined based on the product type and the directions for use and warnings as stated on the product label (as mentioned in the section above). The SCCS Notes of Guidance3
provide exposure
calculations for some product types, but other sources of information may be used. If data are not available, a worst-case exposure is to be considered, taking into account the foreseeable conditions of use. Additional data may have to be
considered. Although the dermal route is the primary exposure route for a cosmetic product, there might be secondary exposure by other routes if the product may be inhaled (e.g. sprays, aerosols) or swallowed (e.g. lipsticks). Particle size will also have an impact on exposure (e.g. if the product is likely to be inhaled) and must be therefore taken into account.
Toxicological profile of the substances Each substance contained in the cosmetic product must have a toxicological profile in the CPSR describing its toxicological
hazard in the finished product. All relevant toxicological endpoints must be considered, paying special attention to local toxicity (skin and eye irritation), skin sensitisation and photo-induced toxicity. Data from human experience, animal studies or alternative methods may be used, provided that they are
experimentally valid and they comply with the requirements of Article 18 of the Regulation on animal testing. All sources of information must be identified. If a hazard cannot be sufficiently addressed, additional data may need to be generated. The final choice of the relevant endpoints and data will be made by the safety assessor, who will justify the decision. Through a weight of evidence approach, the safety assessor will evaluate the risk of adverse effects in humans posed by each ingredient in the formula. The systemic effects of each ingredient must be considered, and a Margin of Safety (MoS) calculated based on a No Observed Adverse Effect Level (NOAEL), taking into account all significant routes of absorption (dermal, oral or inhalation). If no such calculation can be made due to an absence of appropriate data, the safety of the ingredient must be supported by other means; any read-across to related ingredients must be substantiated and
justified. If no data are available for substances present at trace levels, the Threshold of Toxicological Concern (TTC) approach can be of use, in order to establish a concentration limit below which the probability of systemic adverse effects to human health is low.8
Ingredients
present at levels below the TTC, food materials with known higher ingestion exposure levels or substances with no bioavailability do not require a MoS calculation.
In addition to the toxicological data available for a given ingredient, the particle size, the impurities and the potential for substance interactions must be considered. Nanomaterials must be identified and assessed, as they can have special toxicological properties and, additionally, they are subject to specific regulatory restrictions.
Undesirable effects, serious undesirable effects and other information on the product A product that has not yet been put on the market will not have any reported (serious) undesirable
effects.Note 2
Nevertheless, data
available for similar products, if relevant, may be considered.
As stated in Article 10 of the Regulation: “the cosmetic product safety report shall be
April 2018
PERSONAL CARE EUROPE
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