Our Regulatory Service recently received some clarification requests about managing allergies in Dossier Manager.
Fragrant provider cards often include, in addition to the 26 allergens indicated in the text of the European Regulation, other technical substances, or derivatives thereof.
In Dossier Manager, INCIs preloaded with the allergen feature correspond to the 26 substances to be declared on label if their concentration exceeds the limits specified in the text of the European Regulation. Technical substances, possibly present in the composition of the perfume, which appear to be allergic but do not fall into the official list, do not present the allergen function automatically.
The user, if necessary, may attribute the above-described technical substances to the allergen function in the INCI dictionary section or in the technical specification of the raw material. However, this type of choice entails the risk of underestimating the amount of an allergen, in the calculation that allows it to "filter", and not to expose on the label allergens.
For example: If the PERFUME supplier's tab there is listed:
- LIMONENE x%
- D-Lemonene y%
It may be that the two percentages may be lower than the filter threshold individually and then be removed from the display on the label. In this case, our suggestion is instead to indicate the INCI composition of the scent in question, the sum of allergen percentages and its derivatives in the same allergen voice, and hence:
- LIMONENE x + y%
LIST OF 26 ALLERGIES
Amyl cinnamal Amylcinnamyl alcohol
Hydroxyisohexyl 3-cyclohexene carboxaldehyde