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October 24, 2013
Prepared by: Steve L. Taylor, Ph.D., Co-Director
and Joe L. Baumert, Ph.D., Co-Director
In our expert opinion, soy ink is not hazardous to soy-allergic consumers. The allergens in soybeans have been identified as naturally occurring proteins present in soybeans. However, soy ink is made from highly refined soybean oil that is obtained from soybeans by hot solvent extraction, bleaching, and deodorizing (so-called RBD or refined, bleached and deodorized soybean oil). Highly refined soybean oil contains negligible levels of residual protein far below any leve l that can elicit allergic reactions in sensitive individuals in our expert opinion.
The lack of allergenicity of soybean oil to soybean-allergic individuals has been established in a clinical challenge trial conducted with 8 soy-allergic subjects (Bush, R. K., S. L. Taylor, J. A. Nordlee, and W. W. Busse. Soybean oil is not allergenic to soybean-sensit ive individuals. J. Allergy Clin. Immunol. 76: 242-245 [1985]). Soybean-allergic individuals are not advised to avoid the consumption of soybean oil by most allergists.
Furthermore, the Food Allergen Labeling & Consumer Protection Act in the U.S. specifically exempts highly refined oils from its source labeling provisions. Thus, circumstances will exist where there is no regulatory requirement to declare the presence of so y ink when it is used in food products. While the Food & Drug Administration has not yet clearly defined what is meant by the term, "highly refined", RBD soybean oil is almost certainly going to fall within the scope of that definition and should in our expert opinion. Typically, soy ink is applied to packaging where food labeling regulations do not apply but in any case, we believe that there is no risk to soy-allergic consumers.
Updated 28 October, 2013