Fragrance Labeling Requirements
The Federal Food, Drug & Cosmetic Act defines a product as a cosmetic if it is intended to be applied to a person’s body to cleanse it or make the person more attractive. Examples of cosmetic fragrance products include perfume, cologne, aftershave, shampoo, lipstick and skin moisturizers.
The U.S. Food & Drug Administration (FDA) categorizes as drugs fragrance products that are applied to the body for therapeutic use; for example, if the manufacturer claims that the fragrance material helps “ease muscle aches” and “helps you sleep.” While FDA does regulate cosmetics and personal care products, it does not regulate aromatherapy products.
Some scented products are categorized as both a cosmetic and a drug because they have two intended uses. Examples include toothpaste that contains fluoride and makeup that contains sunscreen.
The Consumer Product Safety Commission (CPSC) regulates cleaning and other products people use in the home, such as laundry detergents, fabric softeners, dryer sheets, room fresheners and carpet fresheners.
Under the Fair Packaging and Labeling Act (FPLA), FDA and the Federal Trade Commission (FTC) require an ingredient declaration on consumer goods. The FPLA directs FDA and FTC to issue regulations requiring all consumer goods be labeled to disclose net contents, the identity of the commodity, and the name and place of business of the product’s manufacturer, packer or distributor. FDA administers FPLA for food, drugs, cosmetics and medical devices, and FTC administers FPLA to products that are used in the home.
Ingredient Safety and Testing
Diethylphthalate (DEP) is a phthalate commonly used in fragrance as a solvent (a liquid that can dissolve other substances) and a fixative (a substance that can help fragrance last longer on the skin). Its trade names include neantine, peilatinol A and solvanol. Fragrance-containing products that include DEP have not been found to pose a risk to human health as currently used. In 2002, the Cosmetic Ingredient Review Expert Panel reaffirmed its original conclusion that DEP was safe to use in cosmetic products.
The International Fragrance Association (IFRA) and the Research Institute for Fragrance Materials (RIFM) work together to test fragrances for safe use. IFRA’s standards are the basis of the fragrance industry’s system for achieving the safe use and enjoyment of fragrance. For more than 50 years, RIFM has been conducting research and developing safety profiles for fragrance materials and their uses.
At RIFM, scientists test fragrances for safety using a four-step assessment that must be completed before a fragrance can be approved for inclusion in consumer products:
Hazard identification: Determine if the fragrance may cause an adverse reaction such as a skin rash.
Dose-response assessment or hazard quantification: Establish how much exposure to the fragrance would cause an adverse effect.
Exposure assessment: Determine how the fragrance will be used and the amount of the fragrance ingredient that will be used.
Risk characterization: Test the fragrance on consumer products to determine an acceptable exposure level.