How are fragrances regulated?
According to the Code of Federal Regulations, a fragrance is “any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product.” Fragrances are regulated the same as any other ingredient used in cosmetics and personal care products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), giving the Food and Drug Administration (FDA) broad legal authority to protect the public.
Many other products that may contain fragrance ingredients, but are not applied directly to the body, are regulated by the Consumer Product Safety Commission (CPSC), not the FDA. Here are some examples:
- Laundry detergents
- Fabric softeners
- Dryer sheets
- Room air fresheners
- Carpet fresheners
Labeling of Fragrance Ingredients
If a cosmetic product is marketed on a retail basis to consumers, such as in stores, online or person to person, it must have a list of ingredients. In most cases, each ingredient must be listed individually but fragrances are an exception and only need to be labeled as “fragrance.” The scents you love are typically comprised of many different ingredients and finding the right combination is a complex, time-consuming endeavor. This is why fragrance manufacturers consider the exact composition of their creations to be highly confidential business information. FDA recognizes this, which is why they allow product manufacturers to list fragrance components collectively on the label under the heading of ‘fragrance.’
For similar reasons, in the European Union (EU), perfume mixtures are labeled collectively as “parfum,” except for 26 recognized fragrance allergens, which must be listed individually by name when present in a product at concentrations greater than 0.001% for leave-on products or 0.01% for rinse-off products.
Fragrance ingredients in cosmetics must meet the same requirements for safety as other cosmetics ingredients. They must be safe for consumers when used according to labeled directions or as people customarily use them. This is a responsibility that companies that use fragrances in their products take very seriously.
The safety of fragrance ingredients is assessed by a comprehensive program operated by the International Fragrance Association (IFRA). In operation since 1973, the program, includes a Code of Practice (the Code) covers the manufacture and handling of all fragrance materials, and includes fragrance safety standards, which limit or ban the usage of certain fragrance materials. The conclusions of the IFRA safety review are published in the IFRA Code of Practice, which provides critical guidance to fragrance formulators and users to establish product safety.
Scientific review of fragrance ingredients is conducted by the Research Institute for Fragrance Materials (RIFM). RIFM is a non-profit scientific institute, founded in 1966 for the purpose of generating and evaluating safety data on fragrance ingredients. RIFM evaluates and distributes scientific data on the safety assessment of fragrance raw materials found in perfumes, cosmetics, shampoos, creams, detergents, air fresheners and candles, among other personal and household products. RIFM’s Database of Fragrance is the most comprehensive source worldwide for toxicology data, literature and information on the safety evaluation of fragrance materials. The scientific foundation of RIFM is built around its independent Expert Panel (REXPAN), made up of toxicologists, pharmacologists, dermatologists and environmental scientists, none of whom has any other connection to the fragrance industry and whose work involves the safety evaluation of fragrance ingredients under conditions of intended use. The results of the REXPAN evaluations are published in peer-reviewed scientific journals, and their decisions regarding restrictions of use are published in the IFRA Standards.
Fragrance Allergies and Sensitivities
As described in the safety sections above, fragrance and cosmetics/personal care product manufacturers are diligent in assessing the safety of fragrances and their ingredients. A very small percentage of individuals may be allergic or sensitive to certain ingredients in cosmetics, food or other products, even if those ingredients are safe for most people. Although some substances may have the potential to cause allergic reactions, they can still be formulated into consumer products at safe levels. This is also the case for fragrance ingredients.
Some components of fragrance formulas may have a potential to cause allergic skin reactions (i.e., dermal sensitization) or sensitivities for some people. It is possible to conduct a safety assessment using a methodology known as Quantitative Risk Assessment (QRA) to determine safe use levels of fragrance ingredients in a variety of consumer product types. More information on QRA can be found on the IFRA and RIFM websites.
FDA does not require allergen labeling for cosmetics as they do for some food. So, if you know you have specific fragrance allergies, you may want to choose products that are marketed as ‘fragrance free’ and check the ingredient list carefully. If consumers have specific questions, they may also contact the manufacturer directly. Most companies provide a toll-free telephone number or website where consumers can get more product detail.
A small segment of the population identifies as extremely sensitive to many of the materials found in everyday life, including fragrances. This is sometimes referred to as “multiple chemical sensitivity (MCS)” or “environmental illness (EI),” although neither have been formally recognized as a clinical syndrome or disease. In addition, the United States Department of Justice has specifically rejected the characterization of MCS or EI as a “disability” under the Americans with Disabilities ACT (ADA).
Substances that impart an odor to a product. Transparency
Everyone deserves the right to know what’s in their products, and a right to understand. PCPC and its member companies have a long-standing commitment to product safety and ingredient transparency. In today’s digital world with a constant influx of information available, people have grown used to having easy access to product information. This is why IFRA developed the IFRA Transparency List, an online registry of all fragrance ingredients used in consumer goods worldwide. Their website lists the ingredients they use in developing their products. In addition, many of PCPC’s member companies have taken a series of voluntary steps to enhance transparency and provide fragrance information to consumers and other stakeholders and added the “Voluntary Contact Allergen Disclosure Guideline” to the PCPC Consumer Commitment Code. Product labels also contain company contact information for consumers to use if they have questions about specific products or ingredients.