Division 3.6 Exposure to the cosmetic product

The exposure assessment is an essential element of risk assessment. The aim of this section is to quantify the amount of cosmetic product coming into contact with the external parts of the human body or the teeth and the mucous membranes of the oral cavity under normal or reasonably foreseeable use for each use and the frequency of use.

The assessment of exposure to the cosmetic product shall take into consideration the findings regarding ‘normal and reasonably foreseeable use’ under section 5 of Annex I to Regulation (EC) No 1223/2009 in relation to a set of elements that are explicitly listed in section 6. Secondary exposure routes should also be taken into consideration, where appropriate.

The description of concrete conditions of use for the purpose of exposure analysis should also take the following parameters into account:

1. (a)

   product type (e.g. leave-on, rinse-off);

2. (b)

   area of application (e.g. whole body, eyes, mouth cavity);

3. (c)

   amount per application in the case of normal and reasonably foreseeable use, e.g. including when a shampoo is used as shower gel;

4. (d)

   duration and frequency;

5. (e)

   possible (foreseeable) routes of exposure (e.g. oral for lipstick and toothpaste, or inhalation for aerosols and solvents);

6. (f)

   target group for use (e.g. children under the age of three years, adults);

7. (g)

   impact of particle size on exposure.

The SCCS Notes of Guidance provide useful information on exposure calculations and particularly relevant tables^f1.

However, as the tables may not contain the daily exposure values for specific cosmetic products, other ways of calculating exposure may be used. Several alternatives are possible. For instance, calculations could be performed based on either skin surface data or user experience data.

If the available data are considered insufficient, it is recommended to assume a worse-case exposure taking into account the foreseeable conditions of use.

The specific target population and the populations otherwise exposed to the product should be kept in mind. For example, in the case of products for professional use, there will be different exposure scenarios for the targeted consumers and the exposed professionals in terms of exposure frequency, exposure duration and size of exposed skin area, possible exposure through inhalation (for example, in the case of shampoos, when assessing the risk for consumers, exposure of the scalp with a frequency of approximately once a day should be considered, whereas for hair dressers exposure of the hands several times a day should be considered).