Following the 7th amendment to Directive 2003/15/EC, which established an initial list of 26 substances, some 56 new allergens have officially been added to the list of allergens to be controlled in cosmetics, with the publication of Regulation (EU) 2023/1545.
Manufacturers must now control these 55-57 allergenic substances and 25 natural extracts in cosmetic raw materials and ingredients, as well as in finished products, and indicate them on their packaging when their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
The deadlines for complying with these new requirements are 3 years to withdraw non-compliant cosmetic products from the market and 5 years for those having been placed on the market before the new labeling provisions become applicable.
As a result:
- only cosmetic products complying with the new requirements will be placed on the EU market from July 31, 2026. This allows companies to make adjustments in product formulation.
- Cosmetic products which do not comply with these new requirements and which were placed on the market before the new labelling provisions became applicable must be withdrawn from July 31, 2028.