(a) Identity. (1) The color additive myoglobin is a stabilized product of controlled fermentation of a non-pathogenic and non-toxicogenic strain of the yeast, Komagataella phaffii, genetically engineered to express the myoglobin protein from Bos taurus. Myoglobin protein is the principal coloring component of the color additive and imparts a red color.

(2) Color additive mixtures made with myoglobin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.

(b) Specifications. Myoglobin must conform to the following specifications and must be free from impurities, other than those named, to the extent that such impurities may be avoided by good manufacturing practice:

(1) Myoglobin protein purity on protein basis (weight/weight), not less than 85 percent.

(2) Lead, not more than 0.01 milligrams per kilogram (0.01 parts per million).

(c) Uses and restrictions. Myoglobin may be safely used in ground meat and ground poultry analogue products (i.e., plant-based ground meat- and poultry-like food products subject to FDA regulation) where the amount of myoglobin protein does not exceed 2 percent by weight of the uncooked analogue product.

(d) Labeling. The label of the color additive and of any mixture prepared therefrom intended solely or in part for coloring purposes must conform to § 70.25 of this chapter.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore, batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act.

[90 FR 5594, Jan. 17, 2025]