Soybeans are well-recognized as allergenic foods. The soybean allergens are found in the protein fraction. The vast majority of this protein is removed in the soy lecithin manufacturing process. Soy lecithin does contain trace levels or soy proteins and these have been found to include soy allergens. However, apparently, soy lecithin does not contain sufficient soy protein residues to provoke allergic reactions in the majority of soy-allergic consumers. Many allergists do not even advise their soybean-allergic patients to avoid soybean lecithin when it is included as an ingredient on food products. From this practical standpoint, we can surmise that most soybean-allergic individuals do not react adversely to the ingestion of soybean lecithin.

Yet, there is, of course, the possibility that some of the more sensitive soybean-allergic consumers might react to ingestion of soybean lecithin, so of course we do advocate the source labeling of lecithin when it is used as a direct food ingredient.

The oily matrix of lecithin and the low protein levels provide a challenge to current analytical methodology. Regarding detection of soy lecithin in food products, the amount of soy lecithin used in most food products would leave residues at levels well below the limit of detection of currently available detection methods.

No conceivable allergenic risks would occur from the use of shared equipment for products that contain soybean lecithin and products that do not. The amount of soybean proteins that could conceivably be transferred to the next product manufactured with this shared equipment is extraordinarily low. Therefore, we feel that "allergen clean-outs are not necessary for shared equipment in situations where the first product contains soy lecithin as an ingredient and the second does not.

The new Food Allergen Labeling and Consumer Protection Act of 2004 took effect January 1, 2006. To date, FDA has not granted an exemption to soybean lecithin labeling from this law. Therefore, strictest interpretation or the law would require the labeling of soy lecithin when used in any capacity, including use as a processing aid.