Constituent Update: FDA Authorizes Soy Leghemoglobin as a Color Additive

FDA Authorizes Soy Leghemoglobin as a Color Additive

July 31, 2019

The U.S. Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products (e.g., “veggie” burgers). The FDA is taking this action in response to a color additive petition submitted by Impossible Foods, Inc. requesting FDA to issue a regulation listing the use of soy leghemoglobin as a color additive in food.

This final rule is in response to a color additive petition submitted by Impossible Foods, Inc., filed on November 5, 2018. The FDA reviewed the information and data submitted by the firm, 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 color additive.

Upon publication of this final rule, the color additive petition process allows for a 30-day period to file objections by any person adversely affected.

All objections must include the Docket No. FDA–2018–C–4464 for “Listing of Color Additives Exempt from Certification; Soy leghemoglobin.”

To submit objections electronically:

Follow the instructions on https://www.regulations.gov.

To submit objections containing marked and identified confidential information:

Send to FDA at:

Dockets Management Staff (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

All objections must follow the instructions in the final rule.

Additional Information:

• Federal Register Notice
• FDA In Brief: FDA approves soy leghemoglobin as a color additive