January 27, 2000

Dale F. Adolphe, President
Canola Council of Canada
400-167 Lombard Avenue
Winnipeg, Manitoba
CANADA R3B 0T6

Re: GRAS Notice No. GRN 000033

Dear Mr. Adolphe:

The Food and Drug Administration (FDA) is responding to the notice, dated October 8, 1999, 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)). FDA received your notice on October 22, 1999 and designated it as GRAS Notice No. GRN 000033.

The subject of your notice is low erucic acid oil derived from Brassica juncea. The notice informs FDA of the view of Canola Council of Canada that low erucic acid oil derived from Brassica juncea is GRAS, through scientific procedures, for use in margarine and shortening and as a salad and frying oil.

Your notice includes published information regarding the development of low erucic acid oil derived from Brassica juncea, its chemical composition (relative to fatty acids, sterols, tocopherols, and unsaponifiable fractions), specifications, characteristic properties, and potential utilization. According to your notice, Brassica juncea seeds, from which the oil is derived, have been bred to be low in glucosinolates. The oil that is produced from Brassica juncea seeds is produced by the same extraction and refining processes that are used to produce low erucic acid rapeseed oil, which is derived from Brassica napus or Brassica campestris. Low erucic acid oil derived from Brassica juncea contains five principal fatty acids (palmitic, stearic, oleic, linoleic and linolenic) and has an erucic acid content of approximately 0.2%. Low erucic acid oil derived from Brassica juncea will meet all of the specifications for low erucic acid rapeseed oil in the Food Chemicals Codex, 4th edition (1996). In your view, low erucic acid oil derived from Brassica juncea is substantially equivalent to low erucic acid rapeseed oil derived from Brassica napus or Brassica campestris.

FDA has affirmed the GRAS status of low erucic acid rapeseed oil derived from Brassica napus or Brassica campestris (21 CFR 184.1555). Under 21 CFR 184.1555, low erucic acid rapeseed oil derived from Brassica napus or Brassica campestris is also known as canola oil. Because you consider low erucic acid oil derived from Brassica juncea to be substantially equivalent to low erucic acid rapeseed oil derived from Brassica napus or Brassica campestris, you intend to market low erucic acid oil derived from Brassica juncea as "canola oil."

Based on the information provided by the Canola Council of Canada, as well as other information available to FDA, the agency has no questions at this time regarding the Canola Council of Canada’s conclusion that low erucic acid oil derived from Brassica juncea 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 low erucic acid oil derived from Brassica juncea. As always, it is the continuing responsibility of the Canola Council of Canada and its member companies to ensure that food ingredients that these firms market are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

As representatives of the Office of Premarket Approval discussed with you prior to your submission of GRN 000033, the use of "canola oil" as the common or usual name for low erucic acid oil derived from Brassica juncea is the purview of the Office of Food Labeling in the Center for Food Safety and Applied Nutrition. If you have any questions about the appropriate labeling of low erucic acid oil derived from Brassica juncea, you may refer those questions to the Office of Food Labeling at (202)205-5229.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the Office of Premarket Approval's homepage on the World Wide Web.

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