The European Union has expanded to 81 the number of fragrance allergens that must be labeled in the ingredient list of cosmetics, a measure that, according to the Spanish Agency of Medicines and Medical Devices (AEMPS), "improves information for allergic people and strengthens consumer protection".
As recalled by the AEMPS, the novelty has been introduced by Regulation (EU) 2023/1545, which will come into application in this regard in August, a regulation that specifies the allergens of these elements that must be individually labeled when they exceed certain concentration levels (0.001% in rinse-off products and 0.01% in leave-on products).
Fragrance allergens are natural or synthetic substances that can cause an allergic reaction in some people sensitive to them, while being safe for the rest of consumers. They are found in essential oils, perfumes, and other cosmetics, as well as in consumer products.
Regarding consumers, it has stated that fragrance allergens "are safe and do not pose a risk to non-sensitized people." However, "they can cause allergic reactions in sensitized people, that is, people who have developed a specific allergy to certain ingredients."
"The new regulation does not imply that cosmetic products are less safe, but rather offers additional safety guarantees, improving the information available on the labeling so that sensitized people can choose the most suitable products for them" and consumers "will be able to find these substances in the ingredient list of the products."
In relation to the industry, it has explained that the new Regulation introduces new labeling requirements for certain fragrance allergens and "establishes a transitional period and differentiates between two concepts: 'introduction on the market' and 'commercialization'." They affirm, on the other hand, that the date to be taken into account to determine the application of the new requirements is not the manufacturing date of the product, but the date of its first availability on the European Union market.
The AEMPS has clarified that products introduced to the market until July 31, 2026, may continue to be marketed until July 31, 2025, even if they do not yet incorporate the new allergen labeling, and has taken the opportunity to recommend that all companies keep all documentation that allows them to prove the date of introduction of the products to the market, such as invoices, delivery notes, or distribution records.