Date of Entry into Force: August 16, 2023
Transition Period: Placing new products: July 31, 2026; availability of existing products: July 31, 2028
The expansion of the allergen list has introduced new regulatory and enforcement challenges. Therefore two regulatory approaches to the naming of allergens are suggested in Annex III of the Regulation, referred as “stand-alone nomenclature” and “group name”.
Approach: In Annex III, if the “h” column specifies the group name to be used, then this is a Grouped allergen entry; if the h column does not specify any group name, then this is a stand-alone allergen entry.
Example of Stand-alone Allergen Entry
In this example, if geraniol is present in the finished product at a concentration above 0.001% for leave-on products and 0.01% for rinse-off products, the allergen must be labelled as ‘Geraniol’ in the ingredients list.
Example of Group Name of Allergens
As in this example, if a leave-on product contains 0.0008% “Citrus Aurantium Amara Flower Oil” and 0.002% “Citrus Aurantium Dulcis Flower Oil”, the sum of these exceeds the threshold value for leave-on products. Therefore, the two allergens should be labelled with the group name “Citrus Aurantium Flower Oil”.
If the company wishes to add the individual names “Citrus Aurantium Amara Flower Oil” and “Citrus Aurantium Dulcis Flower Oil” as additional information, this is possible but not required.
With the addition of new allergens, labeling your ingredients list has become more difficult. Let our expert team review or prepare the compliant ingredient & allergen labeling for you. To ensure your cosmetic product labels are compliant, check out our Cosmetic Label Review service!
