After the estimation of exposure to the cosmetic product in its point 6, Annex I requires the calculation of the exposure to the substances it contains. No need for long speeches: according to the Guidelines, a simple equation is enough!
Annex I requires that the “data on the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6” be supplied.
This requirement applies to every substance contained in the finished product; three data are needed to comply with it:
• The percentage of the substance in the finished product, an information that should appear in the CPSR, as per the Section 1 of the Annex, which deals with the qualitative and quantitative formula: XS
• The quantity of product applied per kilogramme of body weight (bw) and per day, an information that should appear in the CPSR, as per the Section 6 of the Annex, corresponding to the exposure to the product: Q
• The retention factor of the product, an information available in the Notes of guidance for the testing of cosmetic substances and their safety evaluation, already used for the Section 6: R.
Then, apply the following equation to get the exposure to a substance, say, substance 1:
> Exposure to S1 (mg/kg bw/day) = XS1 x Q x R
If we take the example of face care formula detailed in the sheet …
