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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Related Federal Register Documents
2026-20281, Global Benchmark for Efficient Drug Pricing (GLOBE) Model
Starting November 30, 2026, Medicare will use the new GLOBE Model to help lower the cost of certain drugs for people on Original Medicare. This model changes how drug price increases are calculated, aiming to save money for both patients and the Medicare program without cutting care quality. If you’re on Medicare Part B, expect smarter drug pricing that helps keep your healthcare affordable.
2026-20276, State of Indiana: Discontinuance of Certain Commission Regulatory Authority Within the State, Notice of Agreement Between the Nuclear Regulatory Commission and the State of Indiana
Starting September 30, 2026, Indiana will take over certain nuclear material safety rules from the U.S. Nuclear Regulatory Commission. This means the state now handles the rules for some radioactive materials that aren’t enough to cause a nuclear reaction. This change helps Indiana manage its own safety standards without extra federal oversight.
2026-20224, Special Local Regulations; Marine Events Within the USCG East District-Ocean City, NJ
On October 3, 2026, from 7 a.m. to 2 p.m., the Coast Guard will enforce special rules for the Ocean City Chase Race in New Jersey to keep everyone safe on the water. Boat operators in the race area must follow instructions from Coast Guard patrols and can only enter with permission, moving slowly to avoid wakes. This means some boaters might need to plan ahead and expect delays during the event.
2026-20223, Special Local Regulations; Marine Events Within the USCG East District-Philadelphia, PA
On October 3, 2026, the Coast Guard will enforce special rules on parts of the Delaware River in Philadelphia for the Philadelphia Cup Regatta to keep everyone safe. Boat operators in the area must follow directions from Coast Guard officials and can only enter the zone with permission, moving slowly to avoid wakes. This temporary change runs from 9 a.m. to 5 p.m. and helps make the event smooth and secure without extra costs.
2026-20247, Enhanced Transparency and Public Accountability of the Supervisory Stress Test Models and Scenarios; Modifications to the Capital Planning and Stress Capital Buffer Requirement Rule, Enhanced Prudential Standards Rule, and Regulation LL
Big banks and financial institutions will see clearer and more open stress tests starting November 2, 2026. The Federal Reserve is updating how it checks banks’ financial health during tough times and sharing more info with the public. These changes aim to keep banks safer and more accountable without adding extra costs right now.
2026-20234, Fisheries Off West Coast States; Coastal Pelagic Species Fisheries; Annual Specifications; 2026-2027 Annual Specifications and Management Measures for Pacific Sardine
Starting October 2, 2026, commercial fishing for Pacific sardines off Washington, Oregon, and California is mostly off-limits to help the sardine population bounce back. Fishermen can still catch sardines for live bait, small special fisheries, or as a small part of other catches, but strict limits keep the total catch under 2,200 metric tons. These rules protect the fish and support a healthier ocean for everyone.
Previous / Next Documents
Previous: 2025-01206, Visitor Experience Improvements Authority Contracts
Starting February 18, 2025, the National Park Service can award and manage contracts to improve visitor services and facilities in national parks. This means better shops, tours, and programs for visitors, thanks to new authority from Congress. Businesses and visitors will see changes as the NPS expands and upgrades commercial services, aiming for a smoother, more fun park experience.
Next: 2025-01243, Ratification of Security Directives
The Department of Homeland Security just confirmed that pipeline owners must follow updated security rules to keep hazardous liquid and natural gas pipelines safe from cyber threats. These rules, extended through 2025 with some tweaks, help protect critical infrastructure from hackers and other risks. Pipeline operators should be ready to comply with these changes starting now, with no new fees announced.