PUBLICATION OF REGULATION (EU) NO 2023/1545 ON THE LABELLING OF NEW ALLERGENS
On July 27, 2023, it was published in the OJEU Regulation (EU) No 2023/1545 known as the “Allergens” Regulation. It amends Regulation (EC) No 1223/2009 regarding the mention of allergenic fragrance substances on the label of cosmetic products.
But what is this new regulation? Neo Cosmetics explains everything here.
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 refers to a volatile and odorous substance, which is regularly found in cosmetic products, generally coming from the perfuming ingredients used (essential oils, perfumes, aromas, hydrosols, etc.). They are generally found at the end of the INCI list under the following names :
- Geraniol
- Citral
- Linalool
- Limonene
In rare cases, these can cause allergic reactions on some sensitive skin at the application site immediately after use. Therefore, in order to inform users of these products of their presence, it must be mentioned on the product labeling.
» In the event of a skin reaction following the use of a cosmetic product, the user can have a diagnosis made by a dermatologist, allowing a name to be put to the allergen in question.
» Then, simply reading the list of ingredients will allow the user to avoid using the product to which he or she is at risk of intolerance.
Since July 2023, a new regulation has been published. This adds 57 new allergens . There are now a total of 81 allergens to be labeled on the INCI list.
The number of allergens has been expanded in order to protect consumers, particularly those with allergies, by providing as much information as possible on the presence of allergens in the product.
Deadline for application of labelling of new allergens:
- 3 years for placing products on the market: until July 31, 2026
- 5 years for the provision of products (withdrawal from the market of non-compliant products): until July 31, 2028
How is Neo Cosmetics preparing for this new regulation?
All DIPs ( product information files ) are now written to take these new allergens into account.
For products currently being formulated, we offer both INCI lists, with and without the new allergens. We give customers the option of notifying allergens today or waiting for future production. Compliance will be mandatory by July 2026.
For products already on the market, we are offering a DIP update. This update brings all cosmetic products into compliance with this new regulation.
If you would like more information on this subject, you can contact us at this email address: info.neo-cosmetique@fr
Sources:
- COSMED Document: EU – Regulation (EU) No. 2023/1545 on the labelling of new allergens July 2023
- COSMED Document: Allergen Labeling Guide_April 2024