- August 9, 2023
- Posted by: MDSS Cosmetics
- Category: Cosmetics
Fragrance allergens for cosmetic products: New EU Regulation provides significant changes in labelling requirements
Regulation (EU) 2023/1545 was published on 26th July 2023[1], regarding labelling of fragrance allergens in cosmetic products. It introduces 56 new fragrance substances to Annex III, plus updates to some already existing entries.
The new Regulation follows the SCCS opinion on fragrance allergens in cosmetic products of June 2012 (SCCS/1459/11[2]). This opinion confirmed that the fragrance allergens already listed in Annex III of the Regulation (EC) No 1223/2009 are still relevant, while 56 additional fragrance allergens which were clearly found to cause allergies in humans were not listed.
Manufacturers and other economic operators are granted transitional periods of 3 and 5 years, i.e. non-compliant cosmetic products can be placed on the EU market until 31st July 2026, and made available on the EU market until 31 July 2028. These periods shall allow manufacturers to adapt their products to the new requirements in terms labelling and formulations, or withdraw non-compliant cosmetic products from the market accordingly.
The percentage of the EU population allergic to particular fragrances can be estimated to 1–9 %[3]. Different measures have been established to protect the whole population from acquiring fragrance allergies and to protect already sensitised individuals from developing allergies.
Fragrance substances are organic compounds with characteristic odours, mostly used in specifically prepared mixtures. They are widely used in creams, shower gels, after shaves and other perfumed cosmetic products, but also in many other consumer products such as detergents, air freshener sprays, etc.
In accordance with Article 19.1(g) of the Cosmetics Regulation 1223/2009, cosmetic products shall be made available on the EU market only where the list of ingredients is indicated on its packaging. Fragrance mixtures, often commercially available, artificial compositions consisting of 100+ individual substances, must be referred to by the terms “Parfum’ or “Aroma” in the list of ingredients.
Those fragrance substances mentioned accordingly in Annex III of the Cosmetics Regulation must be indicated additionally when their concentration exceeds 0.001% in leave-on products, and 0.01% in rinse-off products. At this time, this is the case for 24 substances (Annex III-45 + 67-92). The EU Regulation 2023/1545 establishes the number of 56 additional fragrance allergens to this list.
[1] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2023_188_R_0001
[2] https://eur-lex.europa.eu/legal-content/de/ALL/?uri=CELEX:32009R1223
[3] https://op.europa.eu/en/publication-detail/-/publication/71005243-433b-11eb-b27b-01aa75ed71a1/language-en/format-PDF/source-search