The major change in FDA Cosmetic Label Rules under MoCRA is the requirement to list Fragrance Allergens on your product label list of ingredients. The FDA will publish its list of Fragrance Allergens that are required to be listed by mid-year 2024 and the Fragrance Allergens must appear on your product label by year-end 2024. Expect that the Fragrance Allergens that are required to be listed by the FDA will follow the Fragrance Allergens listing requirements in the European Union.

In September 2023, the EU expands the list for Fragrance Allergens that must be listed to 82 compounds. The European Commission amendment to Annex III of Regulation 1223/2009 sums up 82 fragrances individually required to be declared as allergens if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.

What can Cosmetic Brands do to ensure compliance?

Fragrances are generally complex mixtures of individual chemical compounds and their compositions are usually regarded as trade secrets by fragrance manufacturers. The International Fragrance Association (IFRA) is a global organization that has established standards for the safe use of fragrances in cosmetic products.

Ask your fragrance supplier to provide to you a Certificate Of Conformity with IFRA standards and a list of allergens in your fragrances that are on the EU Fragrance Allergens List.

Brands are not exempt from listing fragrance allergens if they are using essential oils to fragrance their products as essential oils contain many of the fragrance allergens that are required to be listed. If you are using essential oils, ask your essential oil supplier to provide to you a list of fragrance allergens contained in each essential oil you are using.

“New allergens” that may require listing include: Menthol, Terpineol, Linalyl Acetate, Camphor, Vanillin, Geraniol derivatives: Geranial and Geranyl Acetate, as well as well-known essential oils, such as: ylang-ylang oil (Cananga Odorata Flower Oil), cinnamon oil (Cinnamomum Zeylanicum Bark Oil), or lavender oil (Lavandula Officinalis Flower Oil).

Here’s the full list of 82 fragrance allergens that will be required to be listed in the EU: https://lnkd.in/enNv9SWg

Cosmetic Product Labels

Another change in the FDA Labeling Rules under MoCRA is that you will be able to include electronic contact information on your cosmetic product label. By December 29, 2024, cosmetic product labels must include certain contact information (domestic address, phone number, or electronic contact information, which may include a website and e-mail) through which the Responsible Person (ie: the Brand) for the product can receive Adverse Event reports.