Scientific Opinion on application (EFSA‐GMO‐BE‐2011‐101) for the placing on the market of herbicide‐tolerant genetically modified oilseed rape MON 88302 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

Panel, Efsa Ans

doi:10.2903/j.efsa.2014.3701

Cited by 7 publications

(11 citation statements)

References 130 publications

(193 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…EFSA, 2008; EFSA GMO Panel 2012, 2014. No new information on allergenicity of the newly expressed protein that might change the previous conclusions of the EFSA GMO Panel has become available.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 33mentioning

confidence: 99%

“…The EFSA GMO Panel has previously assessed this protein in the single events (see Table 1), as well as in other GMO applications (e.g. EFSA GMO Panel, 2014) and no safety concern for humans and animals was identified. The EFSA GMO Panel is not aware of any new information that would change these conclusions.…”

Section: Toxicological Assessment Of Newly Expressed Proteins 28mentioning

confidence: 99%

See 1 more Smart Citation

Scientific Opinion on an application (Reference EFSA‐GMO‐NL‐2011‐100) for the placing on the market of the herbicide‐tolerant, increased oleic acid genetically modified soybean MON 87705 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

2015

EFS2

View full text Add to dashboard Cite

The EFSA GMO Panel previously assessed the two single events combined to produce soybean MON 87705 × MON 89788 and did not identify safety concerns. No new data on the single events affecting the previous conclusions were identified. No differences in composition requiring further assessment were observed between soybean MON 87705 × MON 89788 and its comparator, except for the intended trait i.e. an altered fatty acid profile. Nutritional assessment on soybean MON 87705 × MON 89788 oil and oil‐containing food products did not identify concerns on human health and nutrition. There are no concerns regarding the use of feedingstuffs from defatted soybean meal MON 87705 × MON 89788. The EFSA GMO Panel is of the opinion that soybean MON 87705 × MON 89788 is as safe, and at least as nutritious, as its comparator and commercial soybean varieties. There is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of soybean MON 87705 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from soybean MON 87705 × MON 89788 to environmental bacteria does not give rise to any safety concern. The post‐market environmental monitoring plan and reporting intervals are in line with the scope of the application. The EFSA GMO Panel considers that the information available for soybean MON 87705 × MON 89788 addresses the scientific comments raised by Member States. The EFSA GMO Panel concludes, considering the scope of the application, that soybean MON 87705 × MON 89788 is as safe as its comparator and non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment. The GMO Panel recommends a post‐market monitoring plan, focusing on import data and, if needed, on consumption data for the European population, for the marketed foods and feed.

show abstract

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 33mentioning

confidence: 99%

Section: Toxicological Assessment Of Newly Expressed Proteins 28mentioning

confidence: 99%

Scientific Opinion on an application (Reference EFSA‐GMO‐NL‐2011‐100) for the placing on the market of the herbicide‐tolerant, increased oleic acid genetically modified soybean MON 87705 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

2015

EFS2

View full text Add to dashboard Cite

show abstract

“…The CP4 EPSPS protein has also been previously assessed in other GM applications (e.g. EFSA GMO Panel, 2012, 2014. The EFSA GMO Panel is not aware of any new information that would change these conclusions.…”

Section: Toxicological Assessment Of Newly Expressed Proteins 28mentioning

confidence: 99%

“…see Table 1; EFSA GMO Panel, 2012, 2014. No new information on allergenicity of the single events that might change the previous conclusions of the EFSA GMO Panel has become available.…”

Section: Assessment Of Allergenicity Of the Newly Expressed Proteins 30mentioning

confidence: 99%

Scientific Opinion on application (EFSA‐GMO‐NL‐2012‐108) for the placing on the market of the herbicide‐tolerant genetically modified soybean MON 87708 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

2015

EFS2

View full text Add to dashboard Cite

Single events MON 87708 and MON 89788 were combined to produce the stack two-event soybean MON 87708 × MON 89788. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single soybean events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as well as compositional data of soybean MON 87708 × MON 89788, did not give rise to food/feed and environmental safety concerns. The EFSA GMO Panel considers that there is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of soybean MON 87708 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering the scope of application EFSA-GMO-NL-2012-108, potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from soybean MON 87708 × MON 89788 to environmental bacteria does not give rise to any safety concern. The post-market environmental monitoring plan and reporting intervals are in line with the scope. In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87708 × MON 89788 addresses the scientific comments raised by Member States and that the soybean MON 87708 × MON 89788, as described in this application, is as safe as its non-GM comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of its scope. Soybean containing the single events MON 87708 (expressing DMO) and MON 89788 (expressing CP4 EPSPS) were assessed previously and no concerns were identified for human and animal health or environmental safety. No safety issue was identified by updated bioinformatic analyses, nor reported by the applicant concerning the two single soybean events, since the publication of the respective scientific opinions. Consequently, the EFSA GMO Panel considers that its previous conclusions on the safety of the single soybean events remain valid.The two-event stack soybean MON 87708 × MON 89788 was produced by conventional crossing to produce soybean tolerant to dicamba and glyphosate-based herbicides. The EFSA GMO Panel evaluated soybean MON 87708 × MON 89788 with reference to the scope and appropriate principles described in its guidelines for the risk assessment of GM plants and derived food and feed, the environmental risk assessment of GM plants and the post-market environmental monitoring of GM plants. The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins. An evaluation of the comparative analyses of the compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expr...

show abstract

“…The studies on the resistance of the CP4 EPSPS protein to degradation by proteolytic enzymes presented in the current application have been previously risk assessed by the EFSA GMO Panel (e.g. EFSA GMO Panel, 2012a, 2014.…”

Section: Assessment Of the Allergenicity Of The Newly Expressed Protementioning

confidence: 99%

Scientific Opinion on the application (EFSA‐GMO‐BE‐2012‐110) for the placing on the market of tissue‐selective herbicide‐tolerant genetically modified maize MON 87427 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

2015

EFS2

View full text Add to dashboard Cite

Maize MON 87427 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 5-enolpyruvyl-shikimate-3-phosphate synthase (EPSPS) protein, in all tissues except for the male reproductive tissues, conferring tissue-selective tolerance to glyphosate. The molecular characterisation of maize MON 87427 did not give rise to safety issues. Agronomic and phenotypic characteristics as well as compositional data of maize MON 87427 did not raise food/feed and environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein. The nutritional value of maize MON 87427 is not expected to differ from that of non-genetically modified (GM) maize varieties. There are no indications of an increased likelihood of establishment or spread of feral maize plants. Given its intended use in food and feed, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with an unlikely, but theoretically possible, horizontal gene transfer from maize MON 87427 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application for maize MON 87427. In conclusion, the EFSA Panel on Genetically Modified Organisms considers that the information available for maize MON 87427 addresses the scientific comments raised by Member States and that the maize MON 87427, as described in this application, is as safe as its conventional counterpart and non-GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of the application.

show abstract

Scientific Opinion on application (EFSA‐GMO‐BE‐2011‐101) for the placing on the market of herbicide‐tolerant genetically modified oilseed rape MON 88302 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

Cited by 7 publications

References 130 publications

Scientific Opinion on application (EFSA‐GMO‐NL‐2012‐108) for the placing on the market of the herbicide‐tolerant genetically modified soybean MON 87708 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

Scientific Opinion on the application (EFSA‐GMO‐BE‐2012‐110) for the placing on the market of tissue‐selective herbicide‐tolerant genetically modified maize MON 87427 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

Contact Info

Product

Resources

About