Allergens

On September 15, 2022, the European Union notified the World Trade Organization (WTO) of the draft regulation on the labeling of allergens, fragrances in cosmetic products. The current list of allergens will be expanded to include 61 additional fragrance ingredients, essential oils or other components.

Currently, the EU Cosmetics Regulation stipulates that 25 ingredients (there were 26 before the Lilial ban) must be declared on the label when their concentration exceeds: 0.001% in products that remain on the skin; 0.01% in products that are washed off the skin.

Annex III of the EU Regulation on cosmetic products lists those allergens and labeling restrictions. In this way, consumers who have certain sensitization reactions and who are aware of the content of allergens in cosmetic products, can avoid unwanted reactions to the cosmetic product. Fragrances are referred to as "perfume" or "flavor" in the ingredients list. These allergens are often ingredients of essential oils and various plant components.

It is very important to list the allergens:

• So that patients in clinical practices could identify the allergens with which they came into contact.
• So that allergic people can avoid substances they cannot tolerate.

The draft regulation is now open for comments for 60 days. After that, the European Commission intends to publish the final act in the first half of 2023. Consequently, the update will require many cosmetic brands to modify their product labels, which is expensive.

In light of this, the law provides for an adjustment period for the industry to adapt to the new requirements.

Manufacturers of cosmetic products will have: 5 years to place new products on the EU market in accordance with the current provisions; 3 years for selling products already on the market.