COSMESERVICE

REGULATION 2023/1545 CHANGES THE ALLERGEN LIST

28/07/2023

ALLERGENS AT COSMETIC PRODUCTS, NEW AMENDMENT PUBLISHED. REGULATION 2023/1545 CHANGES THE ALLERGEN LIST FROM 24 TO 80 SUBSTANCES.

The draft was published in September 2022

As was already communicated, the 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 these substances must be declared when present at certain concentrations in cosmetic products.

These substances are mainly present in fragrances, which are organic compounds with characteristic, usually pleasant, odours. They are widely used in perfumes and other perfumed cosmetic products, but also in many other products such as detergents, fabric softeners and other household products.

Why these substances are listed?

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.

When a person has already been sensitised to an allergen, a much lower concentration of it is sufficient to trigger symptoms of an allergy. The percentage of the population allergic to fragrance allergens in the Union can be estimated to be 1–9 %. For the purposes of primary prevention, a restriction of fragrance allergens may be sufficient. However, sensitised persons may develop symptoms when they are exposed to lower concentrations. As a measure of secondary prevention, it is important to provide information on the presence of individual fragrance allergens in cosmetic products.

An initiative of the European Commission to protect consumers

In response to the request of the Commission for an update of the list of individually labelled fragrance allergens, the Scientific Committee on Consumer Safety (SCCS) adopted an opinion at its plenary meeting of 26-27 June 2012 and confirmed that the fragrance allergens listed in entries 45 and 67–92 of Annex III to Regulation (EC) No 1223/2009 are still relevant. Furthermore, it identified 56 additional fragrance allergens, listed in Regulation 2023/1545, which have clearly caused allergies in humans and which have currently no requirement for individual labelling.

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.

Which substances will be listed and in which amount?

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

Deadlines and adaptation periods for cosmetic products

As the updated list of fragrance allergens at Regulation 2023/1545 is likely to result in entries in Annex III to Regulation (EC) No 1223/2009 combining existing and new restrictions, it is necessary to provide that cosmetic companies should continue to apply existing restrictions while working to apply the new ones.

With regard to the new restrictions, cosmetic companies and manufacturers should be allowed a reasonable period of time to adapt to them by making adjustments to product formulations and containers, ensuring that only cosmetic products complying with the new requirements are placed on the market.

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

There are numerous changes and adaptations that the cosmetics industry must face continuously to adjust to the standards and regulations set in Europe and around the world. From Cosmeservice we want to keep you up to date with all the changes that affect the sector, in order to anticipate and be prepared for the entry into force of new standards and regulations.

Please contact us at info@cosmeservice.com if you need any advice about this subject.

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