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CFSAN/Office of Food Additive Safety
December 22, 2015
David H. Bechtel, Ph.D.
Intertek Scientific & Regulatory Consultancy
1011 U.S. Highway 22
Bridgewater, NJ 08827
Re: GRAS Notice No. GRN 000583
Dear Dr. Bechtel:
This letter corrects our letter in response to GRAS Notice No. GRN 000583 dated November 12, 2015. In that letter, the words “as a component of various confectionery preparations, that is as drizzle, enrobing, inclusions and solid pieces applied to or incorporated into” were inadvertently omitted from the intended use statement. The purpose of this revised letter is to correct the statement regarding the intended use of the substance that is the subject of the notice.
The Food and Drug Administration (FDA) is responding to the notice, dated May 26, 2015, that you submitted on behalf of Choco Finesse, LLC 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). FDA received the notice on May 27, 2015, filed it on July 1, 2015, and designated it as GRAS Notice No. GRN 000583.
The subject of the notice is esterified propoxylated glycerols (EPGs). The notice informs FDA of the view of Choco Finesse, LLC (Choco Finesse) that EPGs are GRAS, through scientific procedures, for use as a fat replacer as a component of various confectionery preparations, that is as drizzle, enrobing, inclusions and solid pieces applied to or incorporated into baked goods and baking mixes, frozen dairy desserts and mixes, grain products and pasta, hard candy, soft candy, cough drops, processed fruits, fruit juices, and snack foods.
Our use of “esterified propoxylated glycerols” or “EPGs” in this 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. Title 21 CFR 101.4 states that 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 non-standardized foods. Issues associated with labeling and the appropriate common or usual name of a food are the responsibility of the Office of Nutrition and Food Labeling (ONFL) in the Center for Food Safety and Applied Nutrition.
As part of its notice, Choco Finesse includes the statement of a panel of individuals (Choco Finesse’s GRAS panel) that evaluated the data and information that are the basis for Choco Finesse's GRAS determination. Choco Finesse considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Choco Finesse’s GRAS panel evaluated estimates of dietary exposure, method of production, and product specifications as well as published and unpublished studies supporting the safety of EPGs. Based on this review, Choco Finesse’s GRAS panel concluded that EPGs that meets its established food grade specifications are GRAS under the conditions of its intended use.
Choco Finesse describes EPGs. EPGs are oil-like substances that resemble triglycerides with propylene glycol units (PGUs) inserted between the glycerol backbone and the fatty acid chains. Choco Finesse also describes the variety of EPGs. EPGs can be made to resemble and function like vegetable oils, semi-solids like butter, or solids like lard, depending on the source of the fatty acids and the number of PGUs inserted onto the glycerol backbone. Variations of fatty acid components, within the specifications below will yield EPGs for specific confectionary applications. The EPGs described in this notice have an average of five PGUs inserted onto the glycerol backbone, and contain fully hydrogenated fatty acids.
Choco Finesse describes the method of manufacture for EPGs. EPGs are produced by a three-step process. First, fats and oils are split into glycerol and fatty acids. Then, the glycerol is reacted with propylene oxide to produce glycerol with PGUs inserted onto its hydroxyl groups. Finally, the propylene glycol-substituted glycerol is reacted with fatty acids resulting in their esterification with the hydroxyl moieties of the PGUs to produce EPG. EPGs are then refined, filtered, and hydrogenated (if necessary). A food-grade mixture of α-, γ-, and δ-tocopherols is added to improve the stability of the product. Choco Finesse states that EPGs are manufactured in compliance with current good manufacturing practice regulations.
Choco Finesse provides specifications for EPGs including maximum trace metals (copper <0.01 milligrams per kilogram (mg/kg), iron <0.1 mg/kg, lead <0.05 mg/kg, arsenic <0.05 mg/kg), solid fat content, and limits on microbial contaminants. Analyses of non-consecutive batches show that the tested product complies with the provided specifications.
Choco Finesse uses USDA’s What We Eat in America National Health and Nutrition Examination Survey (NHANES, 2009–2010) to calculate the estimated dietary exposure to EPGs based on the food categories in which EPGs will be used and the maximum use levels in coatings (30% or 34.5%). All-person mean and 90th percentile intakes of EPGs from consumption of the proposed foods from all applications were estimated to be 5.6 g/person/day (105.8 mg/kg body weight (bw)/day) and 14.9 g/person/day (276.6 mg/kg bw/day), respectively, for the total U.S. population. Within the individual population groups, children were determined to have the greatest estimated mean intake of EPGs on an absolute basis, at 6.9 g/person/day, while male adults had the highest 90th percentile intake at 17.3 g/person/day.
Choco Finesse discusses information supporting the safe use of EPGs. Choco Finesse discusses unpublished absorption, distribution, metabolism and elimination data that shows that ingested EPGs are not significantly absorbed or metabolized, with the majority of the EPGs excreted in the feces. Choco Finesse reviewed four published genotoxicity studies (including a bacterial reverse mutation assay, mouse lymphoma assay in L5178Y tk +/- cells, a chromosomal aberration test using human lymphocytes, and unscheduled DNA synthesis tests in rats) that showed that EPGs are non-mutagenic. In addition, Choco Finesse discusses published and unpublished experimental animal studies. In these studies EPGs showed no subchronic toxicity (in mice, rat, micro pigs, and beagle dogs), no chronic toxicity (in mice, rat, micro pigs, and beagle dogs), and no adverse effects on reproduction and offspring development. Choco Finesse discusses in detail, that although EPGs animal studies have shown some decreases in measured levels of some fat-soluble vitamins, none of the animals exhibited clinical signs or microscopic evidence of vitamin deficiency, nor required vitamin supplementation. Finally, Choco Finesse discusses a published clinical study in which no adverse effects (including fat-soluble vitamin status) were observed over 8 weeks with consumption of up to 40 grams EPGs/day. Based on the totality of the data and information described above, Choco Finesse concludes that EPGs are GRAS for their intended uses in food.
Standards of Identity
In the notice, Choco Finesse states its intention to use EPGs 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.
Potential Labeling Issues
In describing the intended use of EPGs and in describing the information that Choco Finesse relies on to conclude that EPGs are GRAS under the conditions of its intended use, Choco Finesse raises a potential issue under the labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This issue comes from the intended use as a fat replacer. Under section 403(a) of the FD&C Act, a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FD&C Act lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relationship of a nutrient to a disease or health-related condition. If products that contain EPGs bear any claims on the label or in labeling, such claims are the purview of ONFL. The Office of Food Additive Safety neither consulted with ONFL on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about EPGs on the label or in labeling.
Section 301(ll) of the 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 its review of Choco Finesse’s notice that EPGs is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing EPGs. Accordingly, this response should not be construed to be a statement that foods that contain EPGs, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Choco Finesse and other information available to FDA, the agency has no questions at this time regarding Choco Finesse’s conclusion that EPGs are 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 EPGs. As always, it is the continuing responsibility of Choco Finesse 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 GRN 00 0583, 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 copying at www.fda.gov/grasnoticeinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition