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CFSAN/Office of Food Additive Safety
July 15, 2010
Alice J. Caddow
Genencor, a Danisco Division
925 Page Mill Road
Palo Alto, CA 94304
Re: GRAS Notice No. GRN 000265
Dear Ms. Caddow:
The Food and Drug Administration (FDA) is responding to the supplement dated April 15, 2010, that you sent regarding additional uses for the enzyme preparation that is the subject of GRAS Notice No. GRN 000265. Genencor, a Danisco Division (Genencor), initially submitted GRN 000265 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 this notice on November 5, 2008, filed it on November 7, 2008, and designated it as GRN 000265.
The subject of the notice is glycerophospholipid cholesterol acyltransferase (GCAT) enzyme preparation from Bacillus licheniformis expressing a modified GCAT gene from Aeromonas salmonicida subsp. salmonicida (GCAT enzyme preparation). The notice informed FDA of the view of Genencor that the GCAT enzyme preparation is GRAS, through scientific procedures, for use as an enzyme in egg yolks, processed meat products, cheese, eggs used in bakery products, and in degumming of vegetable oils. In a letter dated June 13, 2009, FDA informed Genencor that the agency had no questions at that time regarding Genencor’s conclusion that the subject of the notice is GRAS under the intended conditions of use.
In the supplement dated April 15, 2010, you informed FDA of Genencor’s determination that GCAT enzyme preparation is GRAS for use as an enzyme in the production of ultra-high temperature (UHT) processed milk, powdered milk, and yogurt at concentrations ranging from 0.38 to 1.5 milligrams (mg) total organic solids (TOS) per kilogram (kg) of food. Genencor states that the GCAT enzyme preparation is intended to reduce the build up of denatured proteins on heated surfaces during the production of UHT milk and powdered milk, to reduce the level of cholesterol in the milk, and to ‘facilitate improved fermentation and viscosity formation during yogurt culturing’. Genencor states that the additional uses result in an increase in the maximum daily intake of the GCAT enzyme preparation from 0.13 mg TOS per kg body weight per day (mg TOS/kg bw/day) to 0.15 mg TOS/kg bw/day from all intended uses. Genencor concludes that these additional uses are GRAS.
Standards of Identity
In the notice, Genencor states its intention to use GCAT enzyme preparation in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of Genencor’s supplement stating that GCAT enzyme preparation is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing GCAT enzyme preparation. Accordingly, this response should not be construed to be a statement that foods that contain GCAT enzyme preparation, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Genencor in GRN 000265 and the supplement from Genencor dated April 15, 2010, the agency has no questions at this time regarding Genencor’s conclusion that GCAT 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 GCAT enzyme preparation. As always, it is the continuing responsibility of Genencor 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 responding to the supplement to GRN 000265, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition