Food and Health E-ssentials

Your regular update for technical and industry information

Your regular update for technical and industry information


The U.S. Food and Drug Administration (FDA) has amended its regulations on permitted colour additives to include the use of soy leghemoglobin in certain food products.

According to a Final Rule published in mid-december in the Federal Register, the amended regulation now permits the use of soy leghemoglobin in “ground beef analogue products” (for example, vegetable burgers), so long as the amount of soy leghemoglobin does not exceed 0.8% by weight of the uncooked group beef analogue product.

The FDA’s action was taken in response to a colour additive petition submitted by Impossible Foods, Inc., the company widely known for its plant-based alternatives to meat products. Despite objections raised by the Center for Food Safety (CFS), a public advocacy organisation, the FDA determined that the use of soy leghemoglobin is safe, and that the CFS’s objections did not provide substantive evidence to the contrary.

“As new food ingredients come to market, companies have an obligation to ensure that these ingredients are safe, including through pre-market review or consultation with the FDA,” said Dennis Keefe, Director of the FDA’s Office of Food Additive Safety. “In issuing the final rule, the FDA concluded that this colour additive use of soy leghemoglobin is safe.”

The text of the FDA’s Final Rule in connection with soy leghemoglobin as published in the Federal Register is available here

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