Food

Agency Response Letter GRAS Notice No. GRN 000665

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See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory

CFSAN/Office of Food Additive Safety

December 14, 2016

Gary L. Yingling
Morgan, Lewis & Bockius LLP
1111 Pennsylvania Avenue, NW
Washington, DC 20004

Re: GRAS Notice No. GRN 000665

Dear Mr. Yingling:

The Food and Drug Administration (FDA, we) is granting your request, on behalf of Taradon Laboratory (Taradon), to cease our evaluation of GRN 000665. We received the notice, dated July 15, 2016, that you submitted on behalf of Taradon in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal) on July 18, 2016, and filed it on August 26, 2016. We received the request to cease our evaluation on October 21, 2016.

FDA published the GRAS final rule on August 17, 2016 (81 FR 54960), with an effective date of October 17, 2016. As GRN 000665 was pending on the effective date of the GRAS final rule, we requested some additional information consistent with the format and requirements of the final rule on October 18, 2016. We did not receive an amendment responding to this request.

The subject of the notice is a combination of the enzymes lactoperoxidase and glucose oxidase, glucose, sodium thiocyanate, and sucrose ('combination'). The notice informs us of the view of Taradon that the 'combination' is GRAS, through scientific procedures, for use in fresh cheeses, frozen dairy desserts, fermented milk, flavored milk drinks, and yogurt at a level of 300 milligrams per liter of milk. In this combination, the lactoperoxidase enzyme catalyzes the oxidation of the sodium thiocyanate component using glucose oxidase as enzymatic source of hydrogen peroxide to generate intermediate products with antibacterial properties.

In telephone conversations on October 6, 2016, and October 19, 2016, we discussed our questions about the notice with you. In general, our questions related to the subject of the GRAS conclusion. Importantly, we noted that the subject of the safety studies in the notice is the sodium thiocyanate component and not the 'combination' that is the stated subject of GRN 000665. Therefore, we discussed the opportunity of asking us to cease our evaluation GRN 000665 and resubmitting a GRAS notice for sodium thiocyanate for a maximum use level needed to achieve the intended technical effect. We also discussed that the resubmission would include the safety studies for sodium thiocyanate in GRN 000665, as well as additional information on the safety of the other components of the 'combination.'[1]

In accordance with 21 CFR 170.275(b)(3), the text of this letter responding to GRN 000665 is accessible to the public at www.fda.gov/grasnoticeinventory.

Sincerely,

Antonia Mattia, Ph.D.
Director
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

 

[1] GRN 000665 cites the GRAS conclusions in GRN 000089 and GRN 000196, for food uses of glucose oxidase (in combination with other ingredients and based on common use of food) and lactoperoxidase (a protein constituent in bovine milk basic protein fraction) respectively, to support the safety of uses of these components of the 'combination.' We note that the identity and intended uses of the subjects of GRNs 000089 and 000196 are different from those described in GRN 000665.

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