Agency Response Letter GRAS Notice No. GRN 000642
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
October 12, 2016
Duane Johnson, Ph.D.
439 Grand Ave., Suite 118
Bigfork, MT 59911
Re: GRAS Notice No. GRN 000642
Dear Dr. Johnson:
The Food and Drug Administration (FDA) is responding to the notice, dated March 18, 2016, that you submitted 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 March 25, 2016, filed it on May 4, 2016, and designated it as GRAS Notice No. GRN 000642.
The subject of the notice is camelina oil. The notice informs FDA of the view of CamStar, LLC (CamStar) that camelina oil is GRAS, through scientific procedures, for use as a replacement for other edible oils in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy replacements, fats and oils, grain products and pasta, milk and milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods, soft candy, and soups and soup mixes at 3.0 grams per serving. CamStar states camelina oil is not intended to be used in any products regulated by the U.S. Department of Agriculture.
As part of its notice, CamStar includes the statement of a panel of individuals (CamStar’s GRAS panel) that evaluated the data and information that are the basis for CamStar’s GRAS determination. CamStar considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. CamStar’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evaluated estimates of dietary exposure, method of production, and product specifications as well as published and unpublished studies supporting the safety of camelina oil. Based on this review, CamStar’s GRAS panel concluded that camelina oil that meets its established food grade specifications is GRAS under the conditions of its intended use.
CamStar describes camelina oil as partially refined edible oil extracted from the Camelina sativa plant. The resulting ingredient contains a mixture of triglycerides with primarily oleic, linoleic and linolenic fatty acids and erucic acid levels under 2%. The notifier states that camelina oil is a bright yellow clear liquid at ambient temperature.
CamStar describes the manufacturing of camelina oil using two extraction methods. Camelina seeds are cleaned, crushed and pressed. The oil is extracted from the camelina seed at temperatures less than 120oC (cold-press technology) within the expeller. Free oil is collected; 8-10% of the oil remains in the meal. Alternatively, during solvent/press extraction, expeller pressing can be done at any temperature below 149°C. Free oil is recovered and crushed seeds are further extracted with an organic solvent; less than 1% of oil remains in the meal. The crude oil resulting from either method is filtered and centrifuged for clarification and then partially refined by degumming prior to storage. CamStar states that all processing aids used in the manufacture of camelina oil such as citric acid, tocopherols, cellulose filters, rosemary extract, and activated carbon are suitable, food-grade materials used in accordance with current good manufacturing practice.
CamStar provides specifications for camelina oil, including limits for lead (≤ 0.1 milligrams per kilogram (mg/kg)), arsenic (≤ 0.1 mg/kg), and microbial contaminants. CamStar notes that analyses of three representative, non-consecutive lots confirmed the product complies with the specifications. CamStar states that camelina oil is stable for 18 months when stored unopened under dry conditions in a dark container between 10 and 20ºC.
CamStar provides dietary exposure estimates for camelina oil using the 2005-2006 National Health and Nutrition Examination Survey food consumption data. Two-day average dietary intake data were used to generate dietary exposure estimates. The mean exposure to camelina oil for the U.S. population aged 2 years or above is estimated at 9 grams per person per day (g/p/d) (150 mg/kg bodyweight (bw)/d for a 60 kg individual) and 18 g/p/d (300 mg/kg bw/d for a 60 kg individual) at the 90th percentile.
CamStar detailed the fatty acid composition of camelina oil, which is similar to other commonly consumed vegetable oils. CamStar stated that camelina oil would utilize normal fatty acid absorption, distribution, metabolism and elimination pathways. CamStar completed a literature review and discussed the published studies. CamStar reviewed a published 13-week porcine subchronic study, in which pigs received up to 15% camelina oil in their diet (corresponding to 8.9 g/kg bw/day and 10.2 g/kg bw/d, for females and males, respectively). At the highest dose tested, there were no observed adverse effects. In addition, CamStar reviewed a published six week study in which hypercholesterolemic adults consumed 30 g/d of camelina oil with no adverse effects. Furthermore, CamStar discussed that it is highly unlikely that humans would elicit an allergic response to camelina oil as there was no measurable protein in the oil. CamStar notes that Health Canada concluded that the use of camelina oil as a food presents no food safety concerns and certified it as safe for use as a food since 2010, and many European countries have registered camelina oil as food oil.
Based on the totality of evidence, CamStar concludes that the intended use of camelina oil is GRAS.
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 its review of CamStar’s notice that camelina oil is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing camelina oil. Accordingly, this response should not be construed to be a statement that foods that contain camelina oil, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by CamStar, as well as other information available to FDA, the agency has no questions at this time regarding CamStar’s conclusion that camelina oil 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 camelina oil. As always, it is the continuing responsibility of CamStar 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 0642, 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.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition