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.

European Commission published on the 27th of July 2023 Regulation 2023/1545, the amendment to the cosmetic regulation adding new substances to be declared on the ingredient list of the products.

The new amendment (EU) 2023/1545 will add 56 new substances to the allergens list, and the list is up to 80 substances.

In light of the SCCS opinion, it can be concluded that there is a potential risk to human health arising from the use of the additional fragrance allergens identified by the SCCS and that it is necessary to inform consumers about the presence of those fragrance allergens.

Regulation (EU) 2023/1545 adds new substances to the existing list of allergens to be individually mentioned, when present in a concentration that exceeds:

  • 0,001 % in leave-on products; and
  • 0,01 % in rinse-off products.

This amendment, Regulation 2023/1545, aligns the names of existing allergens to those of the latest Common Ingredients Glossary, updates CAS and EC numbers to avoid mistakes, and also groups similar substances in one entry for clarity and simplicity.

The new substances that must be declared on the labels when present at the product 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
  • 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

Regulation 2023/1545 aims to avoid contact allergies, warning consumers about the presence of these substances in cosmetic products. Contact allergy is a life-long, altered specific reactivity in the human immune system and, upon re-exposure to a sufficient amount of an allergen, eczema (allergic contact dermatitis) may develop. Cosmetic companies should continue to apply existing restrictions while working to apply the new ones, allowing a reasonable period of time to comply with new restrictions.

Regulation 2023/1545 confirms the transition period mentioned in the draft Regulation that we already know.

Beauty brands will have to adapt the labels to the new requirements according to the following timelines:

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

More information can be found here