New EU Regulation Expands Labeling Requirement for Fragrance Allergens in Cosmetic Products
On July 26, 2023, Regulation (EU) 2023/1545 was published in the Official Journal of the European Union, bringing significant changes to the existing Cosmetics Regulation (EC) No. 1223/2009 regarding the labeling of fragrance allergens in cosmetic products.
What's new?
The new regulation adds a total of 56 additional fragrance allergens to Annex III of the Cosmetics Regulation. These must be labeled when present in concentrations of 0.001% in leave-on products (products that remain on the skin) and 0.01% in rinse-off products (products that are washed off). The labeling will follow the same principles as before, meaning that affected manufacturers will need to adjust their product labels.
This expanded labeling requirement particularly affects numerous essential oils and natural extracts.
Adjustments to existing entries in Annex III
Existing entries in Annex III have also been modified. For instance, common substance names have been updated to the latest version of the Common Ingredients Glossary (CosIng). In addition, similar substances have been grouped together to simplify and streamline the labeling process. Special attention should also be given to products marked with ** in Annex III. These must comply with the new restrictions during the transitional period starting August 15, 2023.
Key deadlines for cosmetic producers:
As a producer and distributor of cosmetic products, it's important to keep the following transitional deadlines in mind:
- Since August 15, 2023, entries in Annex III marked with ** can no longer be marketed if they exceed the new maximum limits.
- By July 31, 2026, only cosmetic products that meet the new labeling requirements may be placed on the market.
- From July 31, 2028, only compliant products may be offered on the EU market.
These deadlines provide companies with the time to phase out non-compliant products and make the necessary adjustments.
