The Federal Food, Drug & Cosmetic (FD&C), Act of 1938 made food color additive
certification mandatory and transferred the authority for its testing from USDA to FDA.
To market a new food or color additive
, a manufacturer must first petition FDA for its approval.
Impossible Foods says heme isn't a color additive
as currently used in cooked Impossible Burgers sold in restaurants.
This action is based on new scientific data that show there is no longer a reasonable certainty that there is no harm from the use of lead acetate as a color additive
. In 1980, based on information presented in a color additive
petition, the FDA originally permitted the use of lead acetate as a color additive
in certain hair dye products that are typically applied over a period of time to achieve a gradual coloring effect.
(10) A separate amendment in 1960 mandated premarket approval for all color additives
, both synthetic colors (e.g., FD&C Blue 2) and "natural" colors derived from animal, vegetable, and mineral sources (e.g., cochineal extract).
As noted above, while the regulation talks generally about authorized food additives, it specifically provides that color additives
be authorized for use in dietary supplements and that GRAS substances be GRAS for use in a dietary ingredient or dietary supplement.
The first set of chemicals for review includes: diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion; lead acetate, which is used as a color additive
in hair dye; methylene glycol/formaldehyde, which is used in hair treatments; propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion; and quaternium-15, which is used as a preservative in a wide range of products including shampoo, skin creams and cleansers.
* Color Additive
Petitions (FDA recommendations for submission of chemical and technological data on color additives
for food, drugs or cosmetics) (2/93)
ZSK corotating intermeshing twin-screw extruders in MEGAcompounder or MEGAvolume design for compounding polyolefins, engineering resins, color additive
masterbatches, and blending reinforced plastics.