The designation of an INCI name for a cosmetic ingredient does not imply that the substance is safe for use as a cosmetic ingredient, nor does it indicate that its use as a cosmetic ingredient complies with the laws and regulations of the United States or any other country. INCI names do not imply standards or grades of purity.
The assignment of an INCI name does not imply that the ingredient is “approved,” “certified,” or “endorsed” by the Council or any other organization or governmental body. Conversely, if an ingredient does not have an INCI name, it does not mean that the ingredient may not or should not be used in finished cosmetic and personal care products.
INCI names published in the International Cosmetic Ingredient Dictionary and Handbook are recognized by the U.S. Food and Drug Administration as the labeling names that must be used for cosmetic ingredient labeling under U.S. regulation 21 CFR 701.3. This recognition of the Dictionary does not imply that the ingredients contained therein are considered to be “safe” or “approved” for use by the FDA.
NOTE: The suitability for use of any ingredient as a component of a finished cosmetic product is solely the responsibility of the finished product manufacturer.
Manufacturers intending to produce and/or market cosmetic products in the United States are urged to consult applicable regulations. These regulations may be found in the U.S. Code of Federal Regulations, Title 21 (21 CFR). Additionally, the U.S. Food and Drug Administration’s website for cosmetics is an excellent source of regulatory information: https://www.fda.gov/www.fda.gov. Manufacturers are also urged to check notices in the U.S. Federal Register and to familiarize themselves with state laws and regulations that may provide additional information regarding the manufacture and sale of cosmetic products. For detailed information on the labeling of cosmetic and personal care products in the United States, see the current edition of the Council’s Labeling Manual, available in the Council’s e-bookstore: https://www.personalcarecouncil.org/.
Firms marketing products in countries outside the United States should consult the laws and regulations in those countries for information on their legal requirements. For information on the laws and regulations of many countries, see the latest edition of the International Regulatory/ Resource Manual, or the International Cosmetic Legal and Regulatory Database, https://irdb.personalcarecouncil.org/, both available from the Council.