Opinion of the Panel on dietetic products, nutrition and allergies [NDA] related to a notification from Cognis, ADM and Cargill on natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate and natural D-alpha tocopherol succinate 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 and include systemic anaphylaxis.
The application covers natural mixed tocopherols (vitamin E, E306) and a range of D-alpha tocopherols derived from vegetable oil (soybean oil). Natural mixed tocopherols are mainly used as antioxidants in fatty foods at a concentration of about 50 mg/kg (referring to the fat fraction of the specific food). This corresponds to an intake of about 0.03μg soy protein assuming a fat intake of 60-80 g/day (3-4 mg tocopherols). Natural mixed tocopherols are also used as dietary supplements. Natural mixed tocopherols and D-alpha tocopherols under consideration are derived from soybean oil deodorised distillates.
The applicant has conducted analytical studies which have improved sensitivity and specificity of protein analysis. In a clinical study in 32 soy allergic patients, none reacted during skin testing to tocopherols and 31 did not reveal any adverse allergic reaction to a maximum dose of 500 mg mixed tocopherols. One patient reported oral allergy symptoms. 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 natural mixed tocopherol/D-alpha tocopherols from soybean sources will trigger a severe allergic reaction in susceptible individuals.
Opinion of the NDA Panel related to a notification from Cognis, ADM and Cargill on natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate and natural D-alpha tocopherol succinate from soybean sources pursuant to Article 6, paragraph 11 of Directive 2000/13/EC
