The Food and Drug Administration (FDA or we) is responding to objections that it received from the Center for Food Safety on the final rule entitled “Listing of Color Additives Exempt from Certification; Soy Leghemoglobin,” which published on August 1, 2019. The final rule amended the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products.
After reviewing the objections, FDA has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. We are also providing notice that the administrative stay of the effective date for this color additive regulation is now lifted.
In a notification published in the Federal Register of December 13, 2018 …. we announced that we filed a color additive petition (CAP 9C0314) submitted by Impossible Foods, Inc …. The petition proposed to amend the color additive regulations …. “Listing of Color Additives Exempt from Certification,” to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products such that the amount of soy leghemoglobin protein does not exceed 0.8 percent by weight of the uncooked ground beef analogue product.
Following the publication of the final rule for the safe use of soy leghemoglobin as a color additive in ground beef analogue products, we received a submission from the Center for Food Safety providing objections and requesting a hearing on each objection.
Despite its allegations, the Center for Food Safety has not established that we have overlooked significant information contained within the record in reaching our conclusion that the use of soy leghemoglobin in ground beef analogue products is safe. In such circumstances, we have determined that the objections do not raise any genuine and substantial issue of fact that can be resolved by an evidentiary hearing …. Accordingly, we are denying the requests for a hearing.
Furthermore, after evaluating the objections, we have concluded that the objections do not provide any basis for us to reconsider our decision to issue the final rule authorizing the use of soy leghemoglobin in ground beef analogue products. Accordingly, we are not making any changes in response to the objections.
Read full, original article: ACTION: Final rule; response to objections and denial of public hearing requests; removal of administrative stay.