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U.S. Department of Health and Human Services

Food

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Agency Response Letter GRAS Notice No. GRN 000008

CFSAN/Office of Premarket Approval

March 2, 1999

Ms. Lori Gregg
Novo Nordisk BioChem North America, Inc.
77 Perry Chapel Church Road
Box 576
Franklinton, NC 27525-0576

Re: GRAS Notice No. GRN 000008

Dear Ms. Gregg:

The Food and Drug Administration (FDA) is responding to your notice, dated October 12, 1998, that you submitted 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)). FDA received your notice on October 14, 1998, and designated your notice as GRAS Notice No. GRN 000008.

Your notice states that Novo Nordisk BioChem North America, Inc. (Novo) has determined, based on scientific procedures, that pectin esterase enzyme preparation from Aspergillus oryzae carrying the gene coding for pectin esterase from Aspergillus aculeatus is GRAS for use as a processing aid, primarily in fruit and vegetable products, at minimum levels necessary to achieve the desired effect in accordance with current good manufacturing practices. Your notice describes (1) generally available information about the technical effect of a pectin esterase enzyme preparation obtained by fermentation of a genetically modified strain of A. oryzae containing a gene encoding pectin esterase derived from A. aculeatus;(2) published information about the host microorganism A. oryzae; (3) information about the production microorganism, i.e., A. oryzae containing the gene encoding pectin esterase derived from A. aculeatus; (4) the manufacturing process, which includes standard methods for the fermentation, processing, and formulation of the enzyme preparation; (5) information about processing aids used in the manufacture of the enzyme preparation; and (6) a published article that describes toxicity studies conducted with the enzyme preparation. In your notice, you estimate dietary exposure to the enzyme preparation and consider the exposure to substances (e.g., methanol) that are a product of the enzyme reaction. Your notice states that the enzyme preparation meets the specifications for enzyme preparations provided in the Food Chemicals Codex (4th ed., 1996) and the specifications for enzyme preparations provided by the Joint FAO/WHO Expert Committee on Food Additives, including a specification that no mycotoxins are detected.

Based on the information provided by Novo, as well as other information available to FDA, the agency has no questions at this time regarding Novo's conclusion that pectin esterase enzyme preparation from Aspergillus oryzae carrying the gene coding for pectin esterase from Aspergillus aculeatus is GRAS under the proposed conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of this enzyme preparation. As always, it is your continuing responsibility to ensure that food ingredients that you market are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

In accordance with proposed 21 CFR 170.36(f), a copy of this letter, as well as a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1), is available for public review and copying in the public reading room of the agency's Freedom of Information Staff.

Sincerely,
   
Alan M. Rulis, Ph.D.
Director
Office of Premarket Approval
Center for Food Safety and Applied Nutrition