The EU requires the labeling of 56 additional allergens in cosmetic products

Synthetic or natural fragrances such as essential oils are almost always present in cosmetic products. Unfortunately, fragrances and fragrance ingredients can trigger a contact allergy or cause skin irritation in hypersensitive individuals.

Currently, in accordance with Article 19 of Regulation (EC) no. 1223/2009 on cosmetic products, only 25 fragrance allergens must be listed on the cosmetic product label. The Scientific Committee on Consumer Safety (SCCS) published an opinion in 2012 identifying 56 additional fragrance allergens that apparently cause allergies in humans. In addition, the committee recommended that fragrance substances such as prehaptens and prohaptens, which are converted to known contact allergens by air oxidation or bioactivation, should be treated as equivalent to fragrance allergens and subject to the same restrictions. Based on this report, the EU Commission issued a draft amendment to Regulation 1223/2009, which requires the labeling of additionally identified allergens. The list of allergens will thus increase to more than 80 individual substances, which will have to be listed on the label if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.

What needs to be done

Companies will have to either adjust their formulations or change the labeling of a large volume of products in the coming years. The proposed amendment gives cosmetic companies and fragrance manufacturers three years after the date of entry into force of this regulation to place on the Union market cosmetic products that contain these substances and do not comply with the restrictions. At the same time, it allows a reasonable period, 5 years after the date of entry into force of this regulation, for the withdrawal of cosmetic products that do not comply with the new requirements.

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European Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, Impact assessment study on fragrance labelling on cosmetic products : final report, Publications Office, 2020,

Proposed amendments to Annexes II and III of the Regulation 1223/2009,