Agency Response Letter GRAS Notice No. GRN 000654
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
December 19, 2016
Cheryl R. Dicks, MS, RAC
GRAS Associates, LLC
27499 Riverview Center Blvd., Suite 212
Bonita Springs, FL 34134
Re: GRAS Notice No. GRN 000654
Dear Ms. Dicks:
The Food and Drug Administration (FDA, we) completed our evaluation of GRN 000654. We received the notice, dated April 12, 2016, that you submitted on behalf of IOI Loders Croklaan, USA, LLC (IOI) 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) on June 1, 2016, and filed it on June 28, 2016. We received an amendment containing clarifying information on September 1, 2016.
FDA published the GRAS final rule on August 17, 2016 (81 FR 54960), with an effective date of October 17, 2016. As GRN 000654 was pending on the effective date of the GRAS final rule, we requested some additional information consistent with the format and requirements of the final rule. We received an amendment responding to this request on October 27, 2016.
The subject of the notice is cocoa butter substitute manufactured using palm oil stearin and stearic acid (cocoa butter substitute). The notice informs FDA of the view of IOI that cocoa butter substitute is GRAS, through scientific procedures, for use as an ingredient in confections and frostings at levels of 10-30%, in coatings of soft candy at levels of 25-40%, and in sweet sauces and toppings at levels of 5-30%. IOI notes that cocoa butter substitute will only be added to foods for which a standard of identity does not exist.
Our use of the term, “cocoa butter substitute manufactured using palm oil stearin and stearic acid” or “cocoa butter substitute” in this letter is not our recommendation of that term as an appropriate common or usual name for declaring the substance in accordance with FDA's labeling requirements. Under 21 CFR 101.4, each ingredient must be declared by its common or usual name. In addition, 21 CFR 102.5 outlines general principles to use when establishing common or usual names for nonstandardized foods. Issues associated with labeling and the common or usual name of a food ingredient are under the purview of the Office of Nutrition and Food Labeling (ONFL) in the Center for Food Safety and Applied Nutrition. We did not consult with ONFL regarding the appropriate common or usual name for “cocoa butter substitute manufactured using palm oil stearin and stearic acid” or “cocoa butter substitute.”
IOI describes cocoa butter substitute (CAS registry number: 91079-12-8) as predominantly fat (>99 grams (g) fat/100 g product). The fat phase is triglycerides (average 99.7%), with traces of monoglycerides and diglycerides and a limited amount of unsaponifiable matter. The triglycerides 1,3-dipalmitoyl-2-oleylglycerol (POP), 1-palmitoyl-2-oleyl-3-stearoylglycerol (POSt), and 1,3-stearoyl-2-oleylglycerol (StOSt) account for 75% of the ingredient.
The first step in the manufacturing process of cocoa butter substitute involves an interesterification reaction between palm oil stearin, a triglyceride fraction rich in palmitate, and stearic acid. This is accomplished by using a lipase enzyme preparation. The resulting mixture of triglycerides (POP, POSt, and StOSt) is distilled to remove excess free fatty acids, and fractionated to further enrich the POP, POSt, and StOSt content. Any remaining diglycerides and monoglycerides are then hydrolyzed using a second lipase enzyme preparation. A final refining step removes the fatty acids and glycerol released from this enzymatic reaction. IOI states that the manufacturing process differs from that described in 21 CFR 184.1259(a)(1)(ii) in that it uses stearic acid instead of ethyl stearate and includes a second enzymatic step to further reduce the monoglyceride and diglyceride concentrations to acceptable levels for optimal crystallization performance. IOI states that the entire process is performed in accordance with current good manufacturing practices, using food grade raw materials.
IOI provides specifications for cocoa butter substitute, including >90 % triglycerides (≤7% diglycerides, ≤1% monoglycerides, and ≤1% free fatty acids); ≥98% total glycerides; clear color; acetone (< 1 milligram/kilogram (mg/kg)); hexane (≤ 5 mg/kg); and lead (≤ 0.10 mg/kg).
IOI estimates the dietary exposure to cocoa butter substitute from its intended uses in foods using the data from the 2011-2012 National Health and Nutrition Examination Survey. The estimated dietary exposures for eaters only were 5 g/day (84 mg/kg bodyweight (bw)/day) at the mean and 11.2 g/day (185 mg/kg bw/day) at the 90th percentile. Since the intended uses will be substitutional for cocoa butter substitutes currently in use, IOI considers that there is no increase in cumulative exposure.
IOI discusses data and information supporting the safety of cocoa butter substitute. IOI relies on the published data considered for the safety of enzymatically esterified substitute oil (ESO) derived from high oleic safflower oil and stearic acids, heated transesterified palm oil, and a triglyceride mixture produced by enzymatic acidolysis of palm oil stearin and oleic acid (high 2-palmitic vegetable oil). IOI describes a published 90-day oral toxicity study on ESO in rats that showed no adverse effects at 3 milliliters (mL)/kg bw. IOI summarizes a published chronic toxicity study in rats fed heated transesterified palm oil up to 15% of the diet for one year; no adverse effects were observed. Further, IOI discusses a published reproductive and postnatal developmental toxicity study in rats fed high 2-palmitic vegetable oil up to 15% of their diet (equivalent to 10 g/kg bw/day) and concludes that there were no unexpected toxicants. IOI also reports that these transesterified fats and oils are not mutagenic as demonstrated in bacterial reverse mutation tests.
IOI describes the long history of safe consumption of cocoa butter, other cocoa butter substitutes, and cocoa butter equivalents across the world. IOI discusses the metabolic fate of constituents of cocoa butter substitute, the triglycerides which are metabolized to free fatty acids for use in other biological processes.
IOI includes the report of a panel of individuals (IOI’s GRAS panel). Based on its review, IOI’s GRAS panel concluded that cocoa butter substitute is safe under the conditions of its intended use.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, 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 our evaluation of IOI’s notice concluding that cocoa butter substitute is GRAS under its intended conditions of use, we did not consider whether section 301(ll) or any of its exemptions apply to foods containing cocoa butter substitute. Accordingly, our response should not be construed to be a statement that foods containing cocoa butter substitute, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information that IOI provided, as well as other information available to FDA, we have no questions at this time regarding IOI’s conclusion that cocoa butter substitute manufactured using palm oil stearin and stearic acid is GRAS under its intended conditions of use. This letter is not an affirmation that cocoa butter substitute manufactured using palm oil stearin and stearic acid is GRAS under 21 CFR 170.35. Unless noted above, our review did not address other provisions of the FD&C Act. Food ingredient manufacturers and food producers are responsible for ensuring that marketed products are safe and compliant with all applicable legal and regulatory requirements.
In accordance with 21 CFR 170.275(b)(2), the text of this letter responding to GRN 000654 is accessible to the public at www.fda.gov/grasnoticeinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
 The lipase enzyme preparation is the subject of either GRN 000043, GRN 000216, or 21 CFR 184.1420.
 This lipase enzyme preparation is the subject of GRN 000068.
 IOI includes studies on ESO as they were submitted in support of GRASP 8G0348, which requested that 21 CFR 184.1259 be amended to affirm that the use of safflower or sunflower oil in the manufacturing process for cocoa butter substitute is GRAS.
 The FDA responded in a letter dated December 4, 2003, stating that the agency had no questions at that time regarding the notifier's GRAS determination in GRN 000131.