Agency Additional Correspondence Letter GRAS Notice No. GRN 000192
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CFSAN/Office of Food Additive Safety
December 14, 2012
Sagi 2000 Industrial park
P.O.Box 6, Migdal HaEmeq
Re: GRAS Notice No. GRN 000192
Dear Ms. Meiri-Bendek:
The Food and Drug Administration (FDA) is responding to the supplement dated June 17, 2012, that you sent regarding changes in the method of manufacture and specifications for the subject of GRN 000192. Additional clarifying information regarding the supplement was received on September 6, 2012. You submitted GRN 000192 on behalf of Enzymotec Ltd. (Enzymotec) 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). The subject of the notice is high 2-palmitic acid vegetable oil1 (prepared by enzymatic modification of palm stearin). The notice informed FDA of the view of Enzymotec that high 2-palmitic acid vegetable oil is GRAS, through scientific procedures, for use in term and pre-term infant formulas at levels up to 70% of total fat, to replace all added fat in baby and toddler foods (including meat and poultry products), and to replace all added fat in processed foods in general (excluding meat and poultry products). In a letter dated August 3, 2006, FDA informed Enzymotec that the agency had no questions at that time regarding Enzymotec’s conclusion that high 2-palmitic acid vegetable oil is GRAS under the intended conditions of use.
In the original notice, Enzymotec described a two-step process for the method of manufacture of high 2-palmitic acid vegetable oil. The first step involved the randomization of palm stearin fatty acids by treatment with the chemical catalyst, sodium methoxide. Randomized palm stearin is then neutralized and bleached. The second step in the manufacturing process is an enzymatic transesterification reaction where the randomized palm stearin is enzymatically transesterified with fatty acids from either palm kernel oil or high oleic sunflower oil. The oil then undergoes bleaching and steam distillation/deodorization processes. In the supplement dated June 17, 2012, you informed FDA that (Step 1) the randomization of palm stearin would no longer be part of the method of manufacture. Rather, the manufacturing process now begins with non-randomized palm stearin, produced through standard refining and fractionation processes used in the fats and oils industry. The enzymatic transesterification reaction (formerly Step 2), between palm stearin and fatty acids (primarily oleic) from palm kernel or sunflower oils is maintained in the method of manufacture; only the starting material (nonrandomized) is different.
In the supplement dated June 17, 2012, Enzymotec provides a table comparing the specifications included in GRN 000192 and the new specifications. The following specifications have been updated: the level of 2-palmitic acid is now > 52% of total palmitic acid in sn-2 position (decreasing from 62-70%); additional heavy metals specifications have been added for cadmium (< 0.02 milligrams per gram (mg/g)), arsenic (< 0.1 mg/g), and mercury (< 0.2 mg/g), replacing the specification for total heavy metals. Enzymotec also provides batch analyses (n=6) to show that the ingredient meets new specifications. According to these analyses, palmitic acid represents approximately 54.6-56.2 % of all the fatty acids found at the sn-2 position.
Enzymotec has concluded that high 2-palmitic acid vegetable oil produced under the new method of manufacture and specifications is GRAS and will not result in any changes to the safety of the ingredient when used as described in GRN 000192.
Based on the information provided by Enzymotec in GRN 000192, the supplement dated June 17, 2012, additional clarifying information received on September 6, 2012 and other information available to FDA, the agency has no questions at this time regarding Enzymotec’s conclusion that high 2-palmitic acid vegetable oil is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of high 2-palmitic acid vegetable oil. As always, it is the continuing responsibility of Enzymotec 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 000192, 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 at www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
1Throughout the notice and supplement, Enzymotec refers to the ingredient that is the subject of GRN 000192 by trade name and the common or usual name of “high 2-palmitic acid vegetable oil,” referring to the content of palmitic acid at the sn-2 position of the glycerol backbone. FDA notes that names used within GRAS response letters are for purposes of the letter only. FDA issued additional correspondence for GRN 000131, stating that our use of the term “high 2-palmitic vegetable oil” in the December 4, 2003, response letter should not be considered an endorsement or recommendation of that term as an appropriate common or usual name for the purpose of declaring the substance in the ingredient statement of foods that contain that ingredient. Issues associated with labeling and the appropriate common or usual name of a food are the responsibility of the Office of Nutrition, Labeling, and Dietary Supplements in the Center for Food Safety and Applied Nutrition.