The Requirements for Fragrances Used in Cosmetics in America

According to FDA regulations, if a product adds fragrance ingredients to make the person more attractive, it’s a cosmetic under the law, for instance, perfumes, colognes, and aftershave should all be regulated as cosmetics. However, some products add fragrances for therapeutic purposes, such as aromatherapy products that could relieve muscle pain or headaches, and fragrance products that help sleep. These kinds of fragrance products are generally regulated as pharmaceuticals. Other products that may contain fragrance ingredients, but are not applied to the body, including detergent, fabric softener, and carpet freshener, are under the administration of the Consumer Product Safety Commission.

New regulations in MoCRA

MoCRA requires cosmetics to label all allergens contained in the product labeling. The fragrance allergens in cosmetics are generally brought in by fragrance ingredients or plant ingredients. FDA is expected to complete the draft by June 29, 2024, and will complete the formal guidance document within 180 days after the end of the public comment period.

Suppose the competent department has reasonable reasons to believe that some ingredients in fragrance have caused severe adverse reactions. In that case, it can request the responsible person to provide a list of specific ingredients or ingredient categories of fragrance in the product.

Current requirements

Currently fragrance ingredients in cosmetics are not subject to approval, but enterprises must ensure that it will not cause safety problems when consumers use cosmetics with fragrance. Fragrance ingredients are usually regarded as trade secrets and can be identified as "Fragrance" or "Flavor" on the cosmetics label, without listing the specific components of the fragrance.

The International Fragrance Association (IFRA) has formulated practical regulations based on the safety evaluation results of the Research Institute for Fragrance Materials (RIFM). The management of fragrance mainly adopts the forbidden list and restricted list, including the forbidden requirements, restricted requirements, and quality specification requirements. The 51st edition of the standard document was officially released on June 30, 2023:

• For new products, the IFRA standard prohibiting certain ingredients will be implemented from August 30, 2023. For components with limited scope and specification requirements, implementation will begin on March 30, 2024.
• For existing products, the IFRA standard prohibiting the use of certain ingredients will be implemented from July 30, 2024, while for ingredients with limited scope and specification requirements, it will be implemented from October 30, 2025.
• Divided into 12 categories, not limited to cosmetics.

Category	Product Type
Category 1	Leave-on products generally applied to lips
Category 2	Leave-on products generally applied to axillae
Category 3	Products generally applied to the face using fingertips
Category 4	Fragrancing products generally applied to the neck, face, and wrists
Category 5	Leave on products applied to the face and body using the hands (palms)
Category 6	Products with lip and oral exposure
Category 7	Products applied to hair with hand contact
Category 8	Products with significant anogenital exposure
Category 9	Rinse off products with body and hand exposure
Category 10	Household care products with mostly hand contact
Category 11	Products with intended skin contact but a minimal transfer of fragrance to the skin from the inert substrate
Category 12	Products not intended for direct skin contact, minimal or insignificant transfer to skin

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