Soy leghemoglobin authorised as a colour additive for veggie burgers

The US Food and Drug Administration (FDA) has announced that it is amending the colour additive regulations to provide for the safe use of soy leghemoglobin in plant-based, non-animal derived ground beef analogue products (eg veggie burgers).

The FDA has said it is taking this action in response to a petition submitted by Impossible Foods, Inc. requesting the FDA to issue a regulation listing for the use of soy leghemoglobin as a colour additive in food filed on 5 November 2018.

Soy leghemoglobin is the stabilised product of controlled fermentation of a non-pathogenic and non-toxicogenic strain of the yeast, genetically engineered to express soy leghemoglobin protein, the principal colouring component.

The FDA has approved the use of soy leghemoglobin as a colour additive in food in response to a petition submitted by Impossible Foods.

Based on information in the petition, soy leghemoglobin preparation contains no more than nine percent soy leghemoglobin protein, minor quantities of P. pastoris yeast proteins, and optional stabilisers sodium chloride and sodium ascorbate. The colour additive is stored either as a frozen liquid or in a spray-dried form.

The FDA has said it concurs with the petitioner that the genetic modifications made to generate the non-toxigenic and non-pathogenic production strain are well-characterised and the production process conforms to good manufacturing practice.

In addition to specification limits for lead, arsenic, mercury, and cadmium, the FDA is requiring a specification for the minimum purity of soy leghemoglobin protein as a percent of the total protein in the colour additive.

Based on the data and information in the petition and other available relevant information, the FDA has concluded that the petitioned use of soy leghemoglobin as a colour additive in ground beef analogue products is safe, provided the amount of soy leghemoglobin protein does not exceed 0.8 percent by weight of the uncooked product. It further concludes that this colour additive will achieve its intended technical effect and is suitable for the petitioned use. Therefore, it is amending the colour additive regulations to provide for its safe use. 

Upon publication of this final rule, the colour additive petition process allows for a 30-day period to file objections by any person adversely affected. If no objections are issued this rule is effective from 4 September 2019.