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Risk Assessment generated by a regulatory process
(RA)
published: 11 Mar 2023
last updated: 01 Mar 2025
Determination for the Safety Assessment of Soybean DAS44406-6 for Direct Use as Food, Feed and for Processing
EN
20 Jan 2017
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph,
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DAS-444Ø6-6 - Enlist E3™ Soybean-| Dow AgroSciences | Resistance to 2,4-Dichlorophenoxyacetic acid, Resistance to herbicides (Glufosinate, Glyphosate)
- DA-BPI Biotechnology Office [ English ]
The safety of the newly expressed proteins and the whole food/feed with respect to potential toxicity, allergenicity and nutritional characteristics.
Homology searches comparing the amino acid sequence of the AAD12 protein to known sequences did not indicate any safety concerns. Specifically, the AAD-12 protein does not resemble known allergens or toxins.
Potential unintended effects of the AAD-12 protein or transformation process did not manifest as compositional changes for DAS-444Ø6- 6 soybean, nor were any adverse effects observed in animals fed DAS444Ø6-6 soybean. Soybean DAS44406-6 was found to be as nutritious as conventional soybean.
The mode of action for the AAD-12 protein is enzymatic catalysis of 2,4-D degradation, and efficient catalysis of reactions with alternative substrates of biological origin has not been identified, suggesting high specificity. No meaningful similarities between the amino acid sequence of the AAD-12 protein and the sequences of toxins or allergens have been identified. The AAD-12 protein has shown no unusual stability in the presence of digestive enzymes or heat, and the primary structure is degraded by the toasting process used to make soybeans safe for consumption by monogastric animals, including humans. Furthermore, very high doses of the purified AAD-12 protein are not toxic to mice. The low exposure and lack of identified hazard suggest a very low risk for the AAD-12 protein.
The risks are acceptable/manageable.
Based on the agronomic and phenotypic characteristics of soybean DAS-44406-6 tested under field conditions, none of the differences identified between soybean DAS-44406-6 and its conventional counterpart required further assessment. Additionally, no relevant differences were observed between soybean DAS-44406-6 and its conventional counterpart with regard to seed germination when tested under controlled conditions. No differences in composition requiring further assessment for food/feed safety were found between soybean DAS-44406-6 and its conventional counterpart.
There are no indications of an increased likelihood of establishment and spread of feral soybean DAS-44406-6 plants in the case of accidental release into the environment of viable GM soybean seeds.
Event-specific detection method for the quantification of soybean DAS-44406-6 by Real-time PCR
Yes
Yes
Yes
Yes
Yes
Crop composition studies are conducted to detect unintended effects of the GE protein or the transgenesis process. Results of the analysis indicated that there are no differences in the proximate, fiber, mineral, amino acid, fatty acid, vitamins, antinutrient and secondary metabolite levels of soybean DAS-44406-6 and the non-transgenic soybean that can be considered biologically relevant. These results confirmed the expectation that the composition of soybean was not adversely altered by expression of the AAD-12 protein or the insertion of the soybean DAS-444Ø6-6 genetic construct.
- EFSA Online Library [ English ]
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