Under the ruling, bakers may use the yeast at levels not to exceed 400 international units (I.U.) of vitamin D per 100 grams in the finished foods, up from 90 I.U. previously. The F.D.A. acted in response to a petition filed by Lallemand, Inc., which markets yeast with vitamin D.
In its 2009 petition, Lallemand sought approval of vitamin D2 yeast as a dual purpose nutrient supplement and leavening agent or dough relaxer in yeast-containing baked foods.
Specifically, the foods named in the petition are yeast-leavened baked foods, baking mixes and yeast-leavened baked snack foods. Later, the petition was amended to exclude the use of the additive as a dough relaxer.
In background on the petition and the agency’s considerations, the F.D.A. noted vitamin D, including vitamin D2, is affirmed as generally recognized as safe in food as a nutrient with several limitations:
Food Maximum levels/100 gram
Breakfast cereal 350 I.U.
Grain products and pasta 90 I.U.
Milk 42 I.U.
Milk products 89 I.U.
Additionally, vitamin D has been affirmed as GRAS in a wide range of additional products, including infant formula, margarine, calcium-fortified fruit juices, meal replacement and other types of bars and cheese substitutes.
While essential to human health, excessive intake of vitamin D may be harmful, elevating blood plasma calcium levels, the F.D.A. said. Much of the F.D.A.’s work on the petition was around analysis conducted by Lallemand as to whether approval of the condition could lead to excessive intake. The company generated data estimating mean and 90th percentile estimates of vitamin D intake for consumers of current products in addition to proposed uses.
Lallemand estimated, and the F.D.A. approved, the methodology for the estimate, that intake of vitamin D from all food sources for the U.S. population at the 90th percentile would be 1,670 I.U. per day, including consumers of yeast-leavened baked products covered by the petition.
While a 1997 group at the Institute of Medicine established an upper limit of 2,000 I.U. per day for anyone older than 1 year of age, the F.D.A. noted the limits were raised last year.
In the revisions, the I.O.M. established upper limits for vitamin D intake to 2,500 I.U. for children 1 year to 3 years of age, 3,000 for children aged 4 to 8, and 4,000 for children aged 9 to 18 and adults.
“The I.O.M. considers the U.L. as the highest usual intake level of a nutrient that poses no risk of adverse effects when the nutrient is consumed over long periods of time,” the F.D.A. said.
The F.D.A. said Lallemand produces its vitamin D bakers yeast by exposing yeast to ultraviolet light. In its findings, the agency said it does not consider U.V. lighted treated bakers yeast to be a safety concern since the treatment does not “produce any new components of toxicological concern.”
In its review of the safety of the dietary intake of vitamin D2 that would result from approval of the petition, the F.D.A. concluded that the 1,670 I.U., anticipated as the 90th percentile intake level, is below the lowest upper limit set by the I.O.M. for individuals 1 year old and older.
“Based on all data relevant to vitamin D2 bakers yeast reviewed by the agency, F.D.A. concludes that there is a reasonable certainty that no harm will result from the use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products within the limits proposed by Lallemand,” the F.D.A. said. “Thus, vitamin D2 bakers yeast is safe for the proposed uses, and the agency concludes that the food additive regulations should be amended as set forth in this document.”
According to a spokesperson at Lallemand, fortification of baked foods with vitamin D other than bakers yeast remains capped at 90 I.U. per 100 grams.
