Opinion of the scientific panel on genetically modified organisms (GMO Panel) of the European Food Safety Authority (EFSA).
Conclusion
A2704-12 soybean is as safe as conventional soybean and therefore in the context of its proposed use it is unlikely to have an adverse effect on human or animal health or on the environment.
Different parameters, such as cultivation properties, ingredients, phenotype were compared.
Compositional analysis
Proximate analysis: fibres, certain secundary metabolites (isoflavones), the most important nutrients, fatty and amino acid composition, minerals, vitamins and unwanted anti-nutrients (trypsin inhibitors):
No statistical differences were observed.
Safety of food and feed
New protein
PAT
Studies on mice by injection of the protein: no reference to acute toxicity.
The protein is not homologous to known protein toxins.
Allergenicity of the new protein
This lack of allergenicity was expected based on the rapid degradation of the protein and its enzymatic activity in simulated human gastric and intestinal fluids.
The protein is not homologous to known protein allergens.
Assessment for gm food and feed
Feeding studies with broiler data on body weight gain and feed intake did not indicate differences between treatments groups (GM vs. non GM soybean).
Nutritional equivalence
Animal feeding studies included studies in rats, dairy cows, pigs, chicken, catfish and quail. Animals were fed either with raw cracked soybean or with unprocessed or processed soybean meal:
All studies show no harmful to health effects.
Enviromental safety
Cross- pollination
The scope of this application EFSA-GMO-NL-2005-18 is for food and feed uses, import and processing and excludes cultivation. Therefore, the environmental risk assessment is limited to accidental release into the environment of GM soybean seeds during transportation and processing for food and feed uses.
Field trails
Evaluation of field trials in the United States and Canada show no alteration of survival, multiplication or dissemination characteristics compared to its conventional counterparts.