Nathalie Vernin

Publication of Regulation (EU) No. 2023/1545 on the Labeling of New Allergens

On July 27, 2023, Regulation (EU) n°2023/1545, known as the “Allergens” Regulation, was published in the OJEU. It amends regulation (EC) n°1223/2009 concerning the labeling of allergenic fragrances on cosmetic products.

But what is this new regulation? Neo Cosmetics explains it all here.

Current Requirements

Currently, the regulation requires the labeling of 24 allergens on the INCI list. These allergens must be labeled on the INCI list if they are present in the cosmetic product at a concentration exceeding 0.001% for leave-on products and 0.01% for rinse-off products.

What is a Cosmetic Allergen?

A cosmetic allergen is a volatile, odorous substance regularly found in cosmetic products, generally originating from the fragrance ingredients used (essential oils, perfumes, aromas, hydrolats, etc.). They are generally found at the end of the INCI list under the following names: Geraniol, Citral, Linalool, Limonene…

In rare cases, they can cause allergic reactions on sensitive skin immediately after use. This is why, in order to inform users of these products of their presence, it must be mentioned on the product label. In the event of a skin reaction following the use of a cosmetic product, the user can consult a dermatologist for a diagnosis, to put a name to the allergen in question. Then, simply reading the list of ingredients will enable the user to avoid using the product to which he or she presents a risk of intolerance.

New Regulation

Since July 2023, a new regulation has been published. It adds 57 new allergens. There are now a total of 81 allergens to label on the INCI list.

The number of allergens has been extended to protect consumers, particularly allergy sufferers, by providing as much information as possible on the presence of allergens in the product.

Application Deadline for New Allergen Labelling:

  • 3 years for the marketing of products: until July 31, 2026
  • 5 years for making products available (withdrawal of non-compliant products from the market): until July 31, 2028

How is Neo Cosmetics Preparing for These New Regulations?

All DIPs (product information files) are already being drafted to take these new allergens into account.

For products currently being formulated, we offer both INCI lists with and without the new allergens. We leave customers the choice of notifying allergens now, or waiting until the next production run. Compliance will be mandatory by July 2026.

For products already on the market, we offer a DIP update. This update brings all cosmetic products into line with the new regulations.

If you would like more information on this subject, please contact us at this e-mail address:

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