In response to a March 2012 GRAS petition from Danone Trading B.V., The Netherlands, FDA issued a “no objection letter" to the use of canola oil in infant formulas in the United States.
This allows the use of canola oil (also known as low erucic acid rapeseed oil) as a source of fat in term infant formulas at levels up to 31% of total fat blend in the formula. Because infant formula has requirements for total fat and levels and ratio of essential fatty acids, Danone had stated that canola oil will combined with other oils to meet these requirements.
Danone’s scientific GRAS panel looked at the chemical and nutritional composition of canola oil, preclinical feeding studies in neonatal pigs using canola oil with varying levels of erucic acid, clinical studies with infants fed formulas containing canola oil comprising up to 40% of total fats, and uses of canola oil in infant formulas in Europe. Based on this information, the panel concluded that canola oil, when produced in compliance with current good manufacturing practices and meeting food grade specifications, is GRAS under the conditions of its intended use.
Once an infant formula product is formulated, the FDA requires that the manufacturer must provide FDA assurance of the nutritional quality of that particular formulation before marketing it. The regulations have provisions that include requirements for certain labeling, nutrient content (listed in 21 CFR 107.100), manufacturers quality control procedures that assure the nutrient content, in addition to as company records and reports.
