Nutramedic &Cosmetics
Regulation 2023/1545 Amends the List of Fragrance Allergens in Cosmetics These substances are mainly present in fragrances of synthetic or natural origin and are components of essential oils, as well as individual essential oils in their entirety. The list of fragrance allergens in cosmetic products is expanded with 56 new allergens.
T AUTHOR:
Gordana Gorinšek, MSc in Phytomedicine, Cosmetic Product Safety Assessor, Expert Consultant for Cosmetic Product Safety and Regulatory Affairs
46
he European Commission published Regulati on (EU) 2023/1545 on July 27, 2023, amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council regarding the labeling of fragrance allergens in cosmetic products. This amendment expands the existing list of fragrance allergens. By adding new fragrance substances to the list, specifically, 56 new allergens that must be listed in the ingredient list on the product informa tion (declaration) when present in certain concen trations in cosmetic products, the number of fragran ce allergens has now increased to a total of 80 sub stances. These substances are mainly present in fragran ces of synthetic or natural origin and are components of essential oils, as well as individual essential oils in their entirety. They are widely used in perfumes and other scented cosmetic products, as well as in many other products such as detergents, fabric softeners, and other household items. The goal of Regulation 2023/1545 is to protect the population from developing fragrance allergies (pri mary prevention) and to protect sensitive individuals from developing allergy symptoms (secondary pre vention). Contact allergy is a lifelong altered specific reactivity of the human immune system that can lead to eczema (allergic contact dermatitis) upon re-exposure to a sufficient quantity of allergen. The percentage of the Union's population allergic to fra grance allergens is estimated at 1-9%. For primary prevention, limiting fragrance aller gens may be sufficient. However, individuals sensi tized to a particular allergen can develop symptoms when exposed to concentrations of allergens lower than the maximum permitted levels. As a measure of secondary prevention, it is important to inform sen sitive individuals about the presence of specific fra grance allergens in cosmetic products so they can avoid contact with substances to which they are al lergic. In response to the Commission's request to up date the list of individually labeled fragrance aller gens, the Scientific Committee on Consumer Safety (SCCS) issued its opinion at a plenary session held from June 26 to 27, 2012, confirming that the fra
grance allergens listed in entry 45 and entries 67 to 92 of Annex III of Regulation (EC) No 1223/2009 re main relevant. Furthermore, it identified 56 addi tional fragrance allergens listed in Regulation 2023/ 1545, which have already caused allergies in humans and for which there is currently no requirement for individual labelling. In light of the SCCS's opinion, it can be concluded that there is a potential risk to human health arising from the use of additional fragrance allergens, and it is necessary to inform consumers about the pres ence of these allergens in cosmetic products. Regulation (EU) 2023/1545 adds new fragrance substances to the existing list of fragrance allergens that must be individually specified when present in concentrations exceeding: • 0.001% leave-on products and • 0.01% in rinse-off products. The new fragrance substances that must be listed on the product information are: • Pinus Mugo • Pinus Pumila • Cedrus Atlantica Oil/Extract • Turpentine • Alpha-Terpinene • Terpinolene • Myroxylon Pereirae Oil/Extract • Rose Ketones • 3-Propylidenephthalide • Lippia citriodora absolute • Methyl Salicylate • Acetyl Cedrene • Amyl Salicylate • Anethole • Benzaldehyde • Camphor • Beta-Caryophyllene • Carvone • Dimethyl Phenethyl Acetate • Hexadecanolactone • Hexamethylindanopyran • Linalyl Acetate • Menthol • Trimethylcyclopentenyl Methylisopentenol
