Listing of Color Additives Exempt From Certification; Myoglobin
Published Date: 1/17/2025
Rule
Summary
The FDA just gave a green light to using myoglobin as a color additive in ground meat and plant-based meat alternatives, thanks to a request from Motif FoodWorks. This change kicks in on February 19, 2025, letting food makers add a natural color boost to their products. If anyone wants to object or ask for a hearing, they need to act by February 18, 2025—no delays allowed!
Analyzed Economic Effects
5 provisions identified: 3 benefits, 2 costs, 0 mixed.
FDA Allows Myoglobin in Plant-Based Ground Meat
The FDA now allows myoglobin to be used as a color additive in ground meat and ground poultry analogue (plant-based) products where myoglobin protein does not exceed 2 percent by weight of the uncooked product. This approval is effective February 19, 2025 and lets food makers add a red/pink color to make plant-based products look like raw meat.
Cell-Cultured Meat Producers Not Covered
The petitioned use of myoglobin does not include cell-cultured meat and poultry products, which are under the regulatory authority of the U.S. Department of Agriculture. Cell-cultured meat and poultry producers are therefore not authorized by this FDA order to use myoglobin under this rule.
Manufacturing Specs: Purity and Lead Limits
Manufacturers of the myoglobin color additive must meet specifications: myoglobin protein purity not less than 85 percent (protein basis) and lead not more than 0.01 milligrams per kilogram (0.01 parts per million). These written specifications are required for products marketed under the rule.
Batch Certification Is Not Required
The FDA determined that batch certification of the myoglobin color additive is not necessary to protect public health, so batches are exempt from certification under the Federal Food, Drug, and Cosmetic Act. This means producers do not need to obtain batch-by-batch certification for this additive.
FDA Found Myoglobin Safe at 2% Use Level
The FDA concluded that myoglobin preparation is safe for use in ground meat and ground poultry analogue products when myoglobin protein does not exceed 2 percent by weight of the uncooked product. The agency found the protein is not likely to cause allergenic responses and estimated dietary exposures that are below recommended dietary reference intakes.
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