In a letter responding to Danone's application, the US Food and Drug Administration (FDA) said it had no questions regarding the inclusion of canola oil as a source of fat in infant formulas at levels up to 31% of the total fat blend.
“When used in combination with other oils that contain [omega-6 fatty acid] linoleic acid (LA), canola oil can be used by infant formula manufacturers to target appropriate levels of LA (8-35% of total fatty acids), and [short-chain omega-3 fatty acid] alpha-linolenic acid (ALA) at 1.75-4% of total fatty acids) and ensure the fat blend is within the recommended ratio of LA:ALA between 6:1 and 16:1."
The approval is significant "as canola oil has not previously been used in infant formula in the U.S. due to the absence of a GRAS submission to do so,” said Shaunda Durance-Tod, M.S., R.D., manager of the CanolaInfo program at the Canola Council of Canada. “Canola oil is still a relative newcomer to the marketplace.”
Canola has a higher percentage of ALA than soybean oil
At 11%, canola oil has among the highest ALA content of all edible oils (compared with 8% in soybean oil), she claimed.
“Canola oil has a lower LA:ALA ratio than other commonly used oils. In addition, canola oil is widely available at an affordable price. It is now number two by volume in the U.S.”
CanolaInfo communications manager Angela Dansby added: "The enthusiasm is just starting to build for other companies [aside from Danone] to potentially use canola oil as an ingredient in their U.S. formulas. Danone has paved the way for other infant formula manufacturers to start taking advantage of heart-healthy canola oil.
"Soybean oil is currently being used as a source of the essential fatty acids alpha-linolenic acid and linoleic acid in U.S. infant formula. However, canola oil has a higher ALA content (11% versus 8%) and less saturated fat (7% versus 15%) than soybean oil, offering a healthier fat profile overall. This might be a reason for a company to switch oils."
In its submission, which you can read here, Danone said: "Canola oil has a higher ALA content with a lower linoleic acid content than soy oil, thereby facilitating the production of infant formulas with a more optimal overall essential fatty acid profile than if soy oil is used. Canola oil is a preferred source of ALA to soy oil in countries where there are no restrictions on its use in infant formula.
"Canola oil is used safely and extensively in infant formulas throughout the world... Indeed, Danone has marketed infant formulas in many countries for many years with various levels of canola oil."