Agency Response Letter GRAS Notice No. GRN 000002
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CFSAN/Office of Premarket Approval
May 27, 1998
Mr. T.W. Kirk
United Grain Growers Limited
201 Portage Avenue, Box 6600
Canada R3C 3A7
Re: GRAS Notice No. GRN 000002
Docket No. 98S-0104
Dear Mr. Kirk:
This responds to your letter dated February 9, 1998, which was received on February 11, 1998, requesting that the Food and Drug Administration (FDA) convert GRAS Petition No. GRP 5G0416 to a GRAS notice. This conversion request was submitted to FDA in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997). In your submission, which was cosigned by Mr. William Hill of United Grain Growers Limited and Mr. Donald H. Frith of the Flax Council of Canada (the Council), you state that the Council, which submitted the GRAS petition, has consented to this conversion request and that United Grain Growers Limited has assumed full responsibility with respect to the converted petition. FDA designated your conversion request as GRAS Notice No. GRN 000002.
Your request states that you have determined that solin oil is generally recognized as safe (GRAS) for use as a general purpose cooking, frying, and salad oil and as an ingredient in margarine, shortenings, and other food products. GRAS Petition No. GRP 5G0416 provides the following information regarding solin oil: Solin oil is derived from seeds of the species Linum usitatissimum L, a species developed from traditional flax (linseed) by mutation breeding, involving its exposure to chemical mutagens or gamma-rays. Solin oil is a mixture of triglyceride esters comprised of glycerol esterified with various fatty acids, mainly palmitic, stearic, oleic, linoleic, and linolenic acid. A defining characteristic of solin oil is that its α-linolenate content, determined as α-linolenic acid, is not more than 5 per cent of the component fatty acids. Solin oil would substitute for other vegetable oils (particularly sunflower oil) and vegetable oil blends. The technical effects of solin oil would be the same as those of the vegetable oil and oil blends for which it would substitute (e.g., as a heat transfer agent, lubricant, and textural ingredient).
GRAS Petition GRP 5G0416 also discusses published scientific articles relating to (1) the breeding and characteristics of low linolenic flax cultivars; (2) mutagenic treatment of traditional flax seeds and genetic analysis of mutants selected to produce solin varieties; (3) processing of seeds and refining of solin oil; (4) physical characteristics and chemical analyses (including fatty acid composition) of solin oil; and (5) flavor quality and thermal stability of solin oil. The petition further discusses unpublished information relating to (1) storage stability and sensory analysis of solin oil; (2) quality analyses of solin varieties in terms of oil content, protein content, and fatty acid composition; and (3) research, development, and commercialization of solin oil in Canada and Australia. The petition included an estimate of the maximum potential consumption of solin oil based on complete substitution of solin oil for sunflower oil, given the similarities in fatty acid composition. Based on information in the petition, domestic disappearance of sunflower oil in the United States in 1993 was approximately 200 million pounds, equivalent to a per capita annual consumption of 0.774 pounds (or a daily intake of about 1 gram per person). The petition included specifications for food grade solin oil; these specifications set limits or standards for -linolenic acid, color, free fatty acid, peroxide value, and unsaponifiable matter. Based upon the foregoing data and information, United Grain Growers Limited concluded that the subject use of solin oil is GRAS.
Based on the information provided by United Grain Growers Limited, as well as the information in GRP 5G0416 and other information available to FDA, the agency has no questions at this time regarding the conclusion of United Grain Growers Limited that solin oil is GRAS under the proposed conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of solin oil. As always, it is your continuing responsibility to ensure that food ingredients that you market 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 this letter has been made available for public review and copying at the agency's Dockets Management Branch (Docket No. 98S-0104). As mentioned in our March 5, 1998, letter acknowledging receipt of your conversion request, a copy of your conversion request is likewise available in Docket No. 98S-0103.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition