Opinion of the Scientific Panel on Dietetic products, nutrition and allergies (NDA) related to a notification from Cognis, ADM and Cargill on vegetable oils-derived phytosterols and phytosterol esters from soybean sources pursuant to Article 6 paragraph 11 of Directive 2000/13/EC
Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Hannu Korhonen,
Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley,
Andreu Palou, Hildegard Przyrembel, Seppo Salminen, John (Sean) J Strain, Stephan Strobel,
Inge Tetens, Henk van den Berg, Hendrik van Loveren and Hans Verhagen.
Acknowledgment
The Scientific Panel on Dietetic Products, Nutrition and Allergies wishes to thank Taraneh
Dean, Martin Stern and Jean-Michel Wal for their contributions to the draft opinion.
No abstract available
Soy is a common dietary constituent and allergic reactions to soy proteins are well described. Soy allergy prevalence studies are lacking. Estimated prevalences are about 0.5% in the general population with about 3-6% of allergic children being allergic to soy proteins. Clinical reactions are similar to those observed with other major food allergens, such as milk, egg or peanut.
The application covers phytosterol esters produced from vegetable oil (soybean oil). Phytosterol esters are currently commercially available in selected foods in several EU countries. The EU regulations limit exposure to a maximum of 3 grams per day of phytosterols through labelling requirements and maximum concentrations in certain food categories in order to avoid intakes above the recommended limits from multiple sources of intake. Plant sterols under consideration are derived from soybean oil deodorised distillates.
The applicant has conducted an analytical study which has improved sensitivity and specificity of protein analysis. In a clinical study with 32 soy protein allergic patients, none reacted during skin testing and 31 did not reveal any adverse allergic reaction when challenged with up to 3 grams of phytosterols. One patient reported oral allergy symptoms that could not be demonstrated to be IgE dependent. The Panel considers that this clinical study is insufficient to predict the likelihood that the product may trigger an allergic reaction in susceptible individuals.
Considering the information provided by the applicant regarding the starting material, the subsequent production process, and the demonstration of low residual protein content, the Panel considers that it is unlikely that vegetable oils derived phytosterols and phytosterol esters from soybean sources will trigger a severe allergic reaction in susceptible individuals.
Allergenicity, phytosterols, plant sterols, protein content, neutralised, refined, bleached, deodorised, vegetable oil (soybean oil).
