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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000032

CFSAN/Office of Premarket Approval

April 20, 2000

Gary L. Yingling
McKenna and Cuneo, L.L.P.
1900 K Street, N. W.
Washington, D.C. 20006-1108

Re: GRAS Notice No. GRN 000032

Dear Mr. Yingling:

The Food and Drug Administration (FDA) is responding to the notice, dated October 13, 1999, that you submitted on behalf of Rohm Enzyme GmbH 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 the notice on October 14, 1999 and designated it as GRAS Notice No. GRN 000032.

The subject of the notice is the pectin lyase enzyme preparation obtained from a Trichoderma reesei (formerly classified as Trichoderma longibrachiatum), which contains a recombinant gene encoding pectin lyase (also called pectin transeliminase) from Aspergillus niger var. awamori. The notice informs FDA of the view of Rohm Enzyme GmbH that the pectin lyase enzyme preparation is GRAS, through scientific procedures, for use as a processing aid for the preparation of fruit and vegetable juices, purees and concentrates by various production processes, including the pulp wash processes and in-line pulp wash processes in the processing of citrus fruits. According to Rohm Enzyme GmbH, the pectin lyase preparation will be used for the degradation of the pectin to lower the viscosity and to clarify juices at a dose of 5 to 100 parts per million (ppm) to accomplish the intended technical effect in accordance with current good manufacturing practices.

The notice describes (1) published information pertaining to the safety of the various components of the production organism, including the host (T. reesei) and the donor (Aspergillus niger) organisms; (2) published information about the safety evaluation of microbial-derived food-grade enzyme preparations, including commercial pectinase enzyme preparations; (3) published information about the technical effect of the enzyme preparation; (4) published information related to the production process of the pectin lyase enzyme preparation; (5) scientific publications and recommendations issued by international organizations on the safety of enzymes used in food processing including enzymes derived from genetically modified microorganisms; and (6) unpublished studies conducted with the production strain and the pectin lyase enzyme preparation from A. niger.

The notice states that the pectin lyase 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 Expert Committee on Food Additives (JECFA; a joint committee of the Food and Agriculture Organization/World Health Organization).

Based on the information provided by Rohm Enzyme GmbH, as well as other information available to FDA, the agency has no questions at this time regarding the conclusion of Rohm Enzyme GmbH that the pectin lyase enzyme preparation is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of the pectin lyase enzyme preparation. As always, it is the continuing responsibility of Rohm Enzyme GmbH to ensure that food ingredients that the firm markets 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 the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the Office of Premarket Approval's homepage on the World Wide Web.

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