U.S. flag An official website of the United States government
  1. Home
  2. Food
  3. News & Events from CFSAN
  4. CFSAN Constituent Updates
  5. FDA Announces Effective Date for Final Rule Adding Soy Leghemoglobin to List of Color Additives Exempt from Certification
  1. CFSAN Constituent Updates

FDA Announces Effective Date for Final Rule Adding Soy Leghemoglobin to List of Color Additives Exempt from Certification

What's New

December 17, 2019

The U.S. Food and Drug Administration (FDA) is providing notice that the stay of the effective date for the final rule amending the color additive regulations to allow for the safe use of soy leghemoglobin as a color additive in ground beef analogue products (e.g., “veggie burgers”) is now lifted. This announcement follows the agency’s review of objections submitted by the Center for Food Safety (CFS), a public advocacy organization. The FDA has concluded that CFS’s objections do not raise genuine and substantial issues of fact and do not provide any substantive evidence that would justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. Therefore, the request for the hearing is denied and the final rule adding the regulation is effective.

Additional Information:

Original Constituent Update

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.

Subscribe to CFSAN Constituent Updates

Get email updates delivered to your inbox.