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.

The European Commission published Regulation (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 information (declaration) when present in certain concentrations in cosmetic products, the number of fragrance allergens has now increased to a total of 80 substances.

AUTHOR:

Gordana Gorinšek, MSc in Phytomedicine, Cosmetic Product Safety Assessor, Expert Consultant for Cosmetic Product Safety and Regulatory Affairs

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. 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 (primary prevention) and to protect sensitive individuals from developing allergy symptoms (secondary prevention). 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 fragrance allergens is estimated at 1-9%.

For primary prevention, limiting fragrance allergens may be sufficient. However, individuals sensitized 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 sensitive individuals about the presence of specific fragrance allergens in cosmetic products so they can avoid contact with substances to which they are allergic.

In response to the Commission's request to update the list of individually labeled fragrance allergens, 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 remain 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 presence 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

• Beta­Caryophyllene

Carvone

Dimethyl Phenethyl Acetate

• Hexadecanolactone

• Hexamethylindanopyran

• Linalyl Acetate

• Menthol

Trimethylcyclopentenyl Methylisopentenol

• Salicylaldehyde

• Santalol

• Sclareol

Terpineol

• Tetramethyl acetyloctahydronaphthalenes

• Trimethylbenzenepropanol

• Vanillin

• Cananga Odorata Oil/Extract

Cinnamomum Cassia Leaf Oil

Cinnamomum Zeylanicum Bark Oil

• Citrus Aurantium Flower Oil

• Citrus Aurantium Peel Oil

• Citrus Aurantium Bergamia Peel Oil

• Citrus Limon Peel Oil

Lemongrass Oil

Eucalyptus Globulus Oil

• Eugenia Caryophyllus Oil

• Jasmine Oil/Extract

• Juniperus Virginiana Oil

• Laurus Nobilis Leaf Oil

Lavandula Oil/Extract

Mentha Piperita Oil

• Mentha Viridis Leaf Oil

• Narcissus Extract

• Pelargonium Graveolens Flower Oil

• Pogostemon Cablin Oil

Rose Flower Oil / Extract

• Santalum Album Oil

• Eugenyl Acetate

• Geranyl Acetate

• Isoeugenyl Acetate

• Pinene

Given the new restrictions, cosmetic manufacturers are allowed a reasonable period of adjustment to implement changes in product formulations to ensure that only cosmetic products compliant with the new legal requirements are placed on the market.

The adaptation to the new requirements will follow these timelines:

• 3 years for introducing new cosmetic products to the EU market, until July 31, 2026. 5 years for cosmetic products that are already available on the EU market, until July 31, 2028.

References:

Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products.

Commission Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on Cosmetic Products.