# Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance) (2013/674/EU), Division 3.8.3: Consideration of all the significant routes of absorption

Extent: E+W+S+N.I.

Dermal, oral and inhalation routes of exposure are potentially relevant for human exposure to cosmetic products. It is essential to calculate the systemic exposure in order to compare it with the relevant NOAEL. The ratio between these two is defined as the margin of safety, which is an indicator of whether the product can be considered safe or not (see also section 3.8.4 and following).
Absorption is linked to the bioavailability of a substance, and is essential for calculating the margin of safety. Systemic exposure can be calculated as:
Systemic exposure dose SED = External exposure × absorption
Absorption can occur through several external routes: dermal, oral and inhalation.
If the intended exposure for the cosmetic product is not in line with the route of exposure in the safety data, route-to-route extrapolation should be considered.
In addition, there may also be a possibility of secondary inhalation exposure where cosmetic products contain volatile substances which can be inhaled unintentionally in the case of direct use, e.g. toluene in nail polish, various substances contained in nail modelling gels, etc.

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Source: https://www.legislation.gov.uk/eudn/2013/674/annex/division/3/division/3.8/division/3.8.3 (the official version)
Page: https://openlegislation.uk/eu-decision-2013-674/annex/division-3/division-3.8/division-3.8.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.