Food

Agency Additional Correspondence Letter GRAS Notice No. GRN 000043

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CFSAN/Office of Food Additive Safety

April 21, 2010

Gary L. Yingling
K & L Gates LLP
1601 K Street NW
Washington, DC 20006-1600

Re: GRAS Notice No. GRN 000043

Dear Mr. Yingling:

The Food and Drug Administration (FDA) is responding to the supplement dated November 20, 2009, that you submitted on behalf of Novozymes North America, Incorporated (Novozymes), regarding an additional use for the subject of GRAS Notice No. GRN 000043. Novo Nordisk BioChem North America, Incorporated (Novo Nordisk, now Novozymes) initially submitted GRAS Notice No. GRN 000043 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 April 28, 2000, filed it on April 28, 2000, and designated it as GRAS Notice No. GRN 000043.

The subject of the notice is lipase enzyme preparation derived from Aspergillus oryzae carrying a gene encoding lipase from Thermomyces lanuginosus (lipase enzyme preparation). The notice informed FDA of the view of Novo Nordisk (now Novozymes) that lipase enzyme preparation is GRAS, through scientific procedures, for use in dough, baked goods, and the fats and oil industry. In a letter dated September 22, 2000, FDA informed Novo Nordisk (now Novozymes) that the agency had no questions at that time regarding the conclusion of Novo Nordisk (now Novozymes) that the subject of the notice is GRAS under the intended conditions of use.

In the supplement dated November 20, 2009, you informed FDA of Novozymes’ determination that lipase enzyme preparation is GRAS for use as an enzyme in brewing beer at a level of 0.4 percent total organic solids (TOS) of lipase by weight of food (0.0018 gram (g) TOS per liter (L) of beer). A subsequent communication from Novozymes dated January 27, 2010, discusses the exposure level of lipase used in brewing beer; Novozymes states that the lipase enzyme preparation is intended to increase the free fatty acid profile in wort from 100 percent barley to the same level as in wort from 100 percent malt. Novozymes states that the lipase enzyme will be completely inactivated during wort boiling and should be mostly removed during filtration and further processing of the beer. Novozymes states that the final beer product would be expected to have only negligible levels of enzyme residue.

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 Novozymes’ supplement which states that lipase enzyme preparation is GRAS for use as an enzyme in brewing beer at a level of 0.4 percent TOS of lipase by weight of food (0.0018 g TOS per L of beer), FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing lipase enzyme preparation. Accordingly, this response should not be construed to be a statement that foods that contain lipase enzyme preparation, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

Conclusions

Based on the information provided by Novo Nordisk (now Novozymes) in GRAS Notice No. GRN 000043, the supplement from Novozymes dated November 20, 2009, and the subsequent communication from Novozymes dated January 27, 2010, the agency has no questions at this time regarding Novozymes’ conclusion that lipase 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 lipase enzyme preparation. As always, it is the continuing responsibility of Novozymes 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 GRAS Notice No. GRN 000043, 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.

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

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