Friday, September 7, 2012

Acacia (gum arabic) in Food

In a notice published in the Federal Register on December 20, 2011 (76 FR 78866), FDA announced that a food additive petition (FAP 1A4784) had been filed by Nexira, c/o Keller and Heckman LLP, 1001 G St. NW., Suite 500 West, Washington, DC 20001. The petition proposes to amend the food additive regulations in Sec. 172.780 Acacia (gum arabic) (21 CFR 172.780) to provide for the expanded safe use of acacia gum (gum arabic) in food.

Under 21 CFR 171.1(c)(H), either a claim of categorical exclusion under 21 CFR 25.30 or Sec. 25.32 (21 CFR 25.32) or an environmental assessment under 21 CFR 25.40 is required to be submitted in a food additive petition. A claim of categorical exclusion under Sec. 25.32(k) was submitted with the petition, which applies to substances added directly to food that are intended to remain in food through ingestion by consumers and that are not intended to replace macronutrients in food. The Agency reviewed the claim of categorical exclusion submitted by the petitioner and stated in the original filing notice its determination that, under Sec. 25.32(k), the proposed action was of a type that does not individually or cumulatively have a significant effect on the human environment, and therefore, neither an environmental assessment nor an environmental impact statement is required.

However, upon further review of the petition, the Agency has decided that the food additive may act to replace macronutrients in food and, therefore, the categorical exclusion in Sec. 25.32(k) is not applicable for the proposed action. The Agency informed the petitioner of this decision, who subsequently submitted an environmental assessment.

The potential environmental impact of this petition is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the Agency is placing the environmental assessment submitted with the petition that is the subject of this notice on public display at the Division of Dockets Management.

Comments are due by October 4, 2012.

Find Out More

Contact: Questions may be directed to Ellen Anderson who is with the FDA Center for Food Safety and Applied Nutrition in College Park, Maryland at 240 402 1309; e-mail:

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