The FDA says it has taken this action in response to a colour additive petition submitted by Impossible Foods Inc. requesting the FDA to issue a regulation listing soy leghemoglobin as a colour additive for use in such products.

“We are in the midst of a revolution in food technology that in the next 10 years will likely lead to more innovations in food and ingredient production than there have been in the past half century. As these new products and ingredient sources come to the market, the FDA has a responsibility to provide the appropriate regulatory oversight to protect public health by ensuring that these new foods and food ingredients are safe,” said Dennis Keefe, Ph.D., director of the Office of Food Additive Safety in the FDA’s Center for Food Safety and Applied Nutrition. “As part of these efforts, today the FDA has approved Impossible Foods’ color additive petition for the use of soy leghemoglobin in alternative, non-animal protein sources, like vegetable burgers. After a thorough review of available scientific information, the FDA has concluded that this use is safe. This action will allow the use of soy leghemoglobin in uncooked beef analogue products sold directly to consumers, such as in food retail settings.”

Impossible Foods previously marketed soy leghemoglobin to optimize flavour in ground beef analogue products intended to be sold to consumers in its cooked form, for example, in a restaurant setting.

Impossible Foods submitted a colour additive petition in 2018 because the company intends to sell uncooked, red-coloured ground beef analogue products containing soy leghemoglobin directly to consumers. The FDA determined that this direct-to-consumer use of soy leghemoglobin required pre-market approval as a colour additive, because the reddish-brown colouring is important to the appearance and marketability of the food as ground beef analogue.

The FDA reviewed the information and data submitted by the company, as well as other relevant information, and concluded that there is a reasonable certainty of no harm from this use of soy leghemoglobin as a colour additive.

Upon publication of the final rule in the Federal Register, the colour additive petition process allows for a 30-day period to file objections by any person adversely affected. Should no objections be raised, the direct-to-consumer sale of uncooked, red-coloured ground beef analogue products containing soy leghemoglobin will be allowed.