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Allergen Calculation

It is a requirement of the Cosmetics Directive 7 th Amendment that the 26 potential allergens should be listed on the label if they are in excess of specified quantities.

The ingredients listing should include (in addition to the existing list of ingredients) a list of “26 potential allergens” that are present in the final product at amounts greater than 0.001 % in a leave on product
(eg lotions, creams, wipes etc) or if more than 0.01% in a rinse-off product (eg shampoos, shower gels, soaps etc). They are commonly found in many natural essential oils and all 26 are fragrance ingredients.

1. Example of calculation of an ingredient that is a part of a fragrance:

The fragrance is used as a “leave-on” Cologne and added at 18%.  The ingredient Benzyl salicylate is a part of the fragrance at a level of 2.8%.
% of ingredient (benzyl salicylate) in fragrance = 2.8% (A)
% of fragrance in product = 18% (B)
Therefore % of benzyl salicylate in final product = A x B x 0.01 = 2.8 x 18x 0.01 = 0.504
Since this figure exceeds the limit of 0.001% in a leave-on, then benzyl salicylate is to be on the label.

2. Example of the addition of a fragrance at 1.2% to a body lotion.
The fragrance contains cinnamal as a part of the fragrance at a level of 0.3 %
% of ingredient (cinnamal) in fragrance = 0.06% (A)
% of fragrance in product = 1.2% (B)
Therefore % of cinnamal in final formula = A x B x 0.01 = 0.06 x 1.2 x 0.01 = 0.00072
Since this is less than the limit of 0.001% that would require labelling for a leave-on, cinnamal is not listed on the label

3. Example of an essential oil added to a body lotion.

The essential oil lavender is added to the lotion at a level of 1.2%. It is reported that this sample of lavender oil contains 38% of Linalool (one of the 26 allergens).
% of linalool in the essential oil = 38% (A)
% of essential oil in a body lotion= 1.2% (B)
Therefore % of linalool in final formula = A x B x 0.01 = 38 x 1.2x 0.01= 0.456
Since this exceeds the limit of 0.001 % for a leave-on then linalool is to be listed.

This information resource was kindly donated by a respectable cosmetic chemist who wishes to remain annoymous.

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