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Le symposium sur les tests cliniques et précliniques
Tuesday, February 5, 2013Focus

Annex I.A.6 - Exposure to the cosmetic product

© CosmeticOBS-L'Observatoire des Cosmétiques

This Section 6 of Annex I is a direct result of the data provided in Section 5 concerning normal and reasonably foreseeable use, and also has a direct impact on Section 7 on exposure to the substances contained in the product. The aim: estimating the level of exposure, an essential factor in assessing the safety of the product.

Reading time
~ 17 minutes

The Annex I details which exposure data must be provided:
1) The site(s) of application
2) The surface area(s) of application
3) The amount of product applied
4) The duration and frequency of use
5) The normal and reasonably foreseeable exposure route(s)
6) The targeted (or exposed) population(s) - Potential exposure of a specific population shall also be taken into account.

The document points out further points.
• The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. exposure might need to be calculated per unit area of skin or per unit of body weight)
• The possibility of secondary exposure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.)
• Particular consideration shall be given to any possible impacts on exposure due to particle sizes.

Data and calculation

In fact, the type of exposure to the cosmetic product shall be described the most accurately possible, by giving figures for every characteristic, when available.

Data to be detailed

Some data are those given in the description of the normal foreseeable use (Point 5); others may come by reasoning …

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