Scientific Opinion on application (EFSA‐GMO‐UK‐2007‐43) for the placing on the market of herbicide tolerant genetically modified soybean 356043 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Pioneer

Abstract

This scientific opinion is an evaluation of a risk assessment for the genetically modified herbicide tolerant soybean 356043 for food and feed uses, import and processing. Soybean 356043 contains a single copy of intact gat4601 and Glycine max‐hra cassettes at a single insertion locus. The results of the bioinformatic analyses of the insert and the flanking regions, and the levels of newly expressed proteins did not raise a safety concern. The comparative analysis of phenotypic and agronomic characteristics indicated that soybean 356043 is not different from its conventional counterpart. In the composition, differences were identified between 356043 soybean and its conventional counterpart in the newly expressed proteins Glycine max‐HRA and GAT4601, and the levels of the fatty acids heptadecanoic, heptadecenoic and heptadecadienoic acid and the acetylated amino acids N‐acetylaspartate (NAA) and N‐acetylglutamate (NAG). The safety assessment of the newly expressed proteins Glycine max‐HRA and GAT4601 identified no concerns regarding potential toxicity and allergenicity. Heptadecanoic, heptadecenoic and heptadecadienoic acid are present in the diet and the intake of small amounts of these fatty acids via food or feed is not expected to produce adverse effects. NAA and NAG are normal constituents in the mammalian metabolism and the estimated increases in their intake are considered low when related to the normal intake of L‐aspartic acid and L‐glutamic acid. Further toxicological, allergenicity and nutritional analysis provided no indications of adverse effects. There are no indications of an increased likelihood of establishment and spread of feral soybean plants, except in the presence of the glyphosate and ALS‐inhibiting herbicides neither a risk caused by a possible transfer of the recombinant gene from soybean 356043 to environmental micro‐organisms. The EFSA GMO Panel considers that the information available for soybean 356043 addresses the scientific comments raised by the Member States and states that the soybean 356043, as described in this application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses.

Guidance on allergenicity assessment of genetically modified plants

“…Rather, an integrated, stepwise, case-by-case approach should be used in the assessment of the newly expressed protein(s) in relation to its(their) potential to cause CD. This overall strategy is in line with the general principles followed for the allergenicity assessment of newly expressed protein(s) as defined by EFSA (EFSA GMO Panel, 2011) and. In this context and briefly, the first step in the assessment should consider the available information on the source of the protein and on the human exposure to the protein itself.…”

“…There is evidence that gastrointestinal digestion can affect the immunogenicity of dietary proteins related to both IgE and non-IgE-mediated adverse reactions to foods (see Annex B). Therefore, in vitro protein digestion can be used as an additional piece of information in the weight-of-evidence approach followed for the allergenicity assessment of newly expressed proteins, because no single test is fully predictive of the allergenic potential of a protein EFSA GMO Panel, 2011). The pepsin resistance test is the most commonly used digestion test for this assessment, in line with international guidelines ), the EFSA Guidance Document (2011) and Implementing Regulation (EU) No 503/2013 (IR503/2013).…”

“…The pepsin resistance test is the most commonly used digestion test for this assessment, in line with international guidelines ), the EFSA Guidance Document (2011) and Implementing Regulation (EU) No 503/2013 (IR503/2013). EFSA previously highlighted the limitations of the classical pepsin resistance test for allergenicity risk assessment and recommended that resistance to digestion of (novel) proteins should be evaluated using other in vitro digestibility methods designed to more closely simulate the conditions of the human digestion process (EFSA GMO Panel, 2010, 2011.…”

Scientific Opinion on an application by Pioneer (EFSA‐GMO‐NL‐2007‐47) for the placing on the market of the herbicide‐tolerant, high‐oleic acid, genetically modified soybean 305423 × 40‐3‐2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

“…The GMO Panel has previously assessed these proteins in the context of the single events (Table 1), as well as in other soybean events (EFSA GMO Panel 2011d, 2012b and no safety concern for humans or animals was identified. The GMO Panel is not aware of any new information that would change these conclusions.…”

Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003

“…nutritionally enhanced crops, P erez- Massot et al, 2013;EFSA GMO Panel, 2014) or in cases of expected unintended compositional changes (e.g. EFSA GMO Panel, 2011b).…”