title: The safety and regulatory status of food, drug and cosmetics colour additives exempt from certification.
abstract: Colour additives exempt from certification (also known as 'natural colour additives') are commonly used in the United States to colour foods, drugs and cosmetics. The US Food and Drug Administration established regulations governing the use of these colour additives, and the labelling of the products that contain them. The safety of these colour additives has been demonstrated by safety testing programs that have yielded a significant amount of toxicology data, and also by a long and well documented history of safe use in the United States and elsewhere. In this report we review the data supporting the safety of the colour additives that are exempt from certification and approved for use in the USA, and conclude that the safety of these colour additives is well supported by the available data. Relevant aspects of the regulation of these colour additives are also described.
authors.affiliation: International Association of Color Manufacturers, Washington, DC 20006, USA.
authors.forename: J B
authors.initials: JB
authors.lastname: Hallagan
authors.forename: D C
authors.initials: DC
authors.lastname: Allen
authors.forename: J F
authors.initials: JF
authors.lastname: Borzelleca
mesh_terms: D003358:Cosmetics; D005505:Food Coloring Agents / Q000633:toxicity*; D007880:Legislation, Drug; D007881:Legislation, Food; D004364:Pharmaceutical Preparations; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003358:Cosmetics; D005505:Food Coloring Agents; D004364:Pharmaceutical Preparations