US FDA upholds approval of Lallemand vitamin D2 baker’s yeast

13-Mar-2014 - By Kacey Culliney+
'AB Mauri has not established a basis for modification or revocation of the regulation authorizing the use of vitamin D2 baker’s yeast,' says the FDA
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The US Food and Drug Administration has upheld its authorization of Lallemand’s enriched yeast after investigating objections from AB Mauri.

The US FDA has maintained its ruling that Lallemand’s UV-treated vitamin D2-enriched baker’s yeast can be used as a dual purpose ingredient – a nutritional supplement and leavening agent at levels that do not exceed 400 IU of vitamin D2 per 100g in the finished baked item.

“We have concluded that AB Mauri has not established a basis for modification or revocation of the regulation authorizing the use of vitamin D2 baker’s yeast,” it wrote in the ruling, found HERE.

Lallemand initially filed its food additive petition in December 2009 and the FDA ruled it as safe for use in August 2012.

The following month, AB Mauri North America wrote a letter to the FDA with two objections. The ingredients firm challenged whether vitamin D2 levels could be accurately controlled and declared following baking and also said that if the FDA approved vitamin D2 supplementation in baked goods at higher levels than currently permitted it should ensure better control by considering use of vitamin D3 instead.

Can vitamin D2 be accurately controlled?

AB Mauri had questioned whether vitamin D2 levels could be accurately controlled through the baking stages and provided independent analysis on samples of the enriched yeast that it claimed showed varied vitamin D2 levels.

However, the FDA said AB Mauri had failed to provide the manufacturer’s certificates of analysis or information on the samples and had also failed to identify the analytical method used. “Therefore the information provided by AB Mauri is not sufficient to demonstrate that there was a difference in the analyzed vitamin D2 levels and the vitamin D2 levels which Lallemand claims is typical for this product,” it continued.

The FDA clarified that bakers using the enriched yeast would have the information necessary to use the additive in conformance with the provisions of the regulation.

Wouldn’t vitamin D3 be better?

AB Mauri had also questioned whether vitamin D3 would be a better alternative, citing two peer-reviewed journals that suggested at similar levels it was more effective for humans than vitamin D2.

However, the FDA said: “Our evaluation of the petition was based solely on the safety of the proposed use of vitamin D2 baker’s yeast in yeast-containing baked goods. Therefore, expanding the scope of the final rule to provide for the safe use of vitamin D3 is beyond the scope of the petition submitted by Lallemand.”

The FDA suggested that if AB Mauri was interested in obtaining approval for the expanded use of vitamin D3 in food, they should file a petition.

EFSA's approval came in the wake of scientific objections from member states

Concerns also raised in Europe

Earlier this year, the European Food Safety Authority (EFSA) filed its approval for Lallemand’s vitamin D2 baker’s yeast. However, its scientific opinion also came in the wake of concerns raised by EU member states.

Concerns in the EU included the possible presence of newly formed components like lipids and proteins after UV treatment, a need for intake estimates of breads consumed in Europe and a lack of dose specification for bakers, among others relating to the UV processing and stability of ingredient in end products.

EFSA’s full filing on the enriched yeast can be found HERE.

Related topics: Regulation, Vitamins & premixes