The EFSA GMO Panel previously assessed the two single events that are combined to produce soybean MON 87769 × MON 89788 and did not identify safety concerns. No new data on these single events, leading to a modification of the original conclusions on safety, were identified. The molecular, agronomic, phenotypic and compositional data on soybean MON 87769 × MON 89788 did not give rise to safety concerns. The Panel considers that there is no reason to expect interactions between the single events to impact on food and feed safety. There were no concerns regarding the potential toxicity or allergenicity of soybean MON 87769 × MON 89788, and no evidence that the genetic modification significantly changes the overall allergenicity. Because of the lack of data on dietary exposure to refined bleached deodorised oil from soybean MON 87769 × MON 89788, the EFSA GMO Panel could not complete the human health and nutrition assessment. There are no concerns regarding the use of feedingstuffs derived from defatted toasted MON 87769 × MON 89788 soybean meal. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Potential interactions of soybean MON 87769 × MON 89788 with biotic and abiotic environments were not considered relevant to this application. The unlikely, but theoretically possible, transfer of recombinant genes from soybean MON 87769 × MON 89788 to environmental bacteria is not of safety concern. The post-market environmental monitoring plan and reporting intervals conform with the scope of this application. In conclusion, the Panel could not complete the food and feed safety assessment of soybean MON 87769 × MON 89788 because of the lack of an appropriate nutritional assessment. The Panel concludes that soybean MON 87769 × MON 89788 is unlikely to have adverse effects on the environment in the context of application EFSA-GMO-NL-2010-85.
Just Published: October, 2015
Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel
The present opinion has the format of a risk profile and presents potential biological and chemical hazards as well as allergenicity and environmental hazards associated with farmed insects used as food and feed taking into account of the entire chain, from farming to the final product. The opinion also addresses the occurrence of these hazards in non-processed insects, grown on different substrate categories, in comparison to the occurrence of these hazards in other non-processed sources of protein of animal origin. When currently allowed feed materials are used as substrate to feed insects, the possible occurrence of microbiological hazards is expected to be comparable to their occurrence in other non-processed sources of protein of animal origin. The possible occurrence of prions in non-processed insects will depend on whether the substrate includes protein of human or ruminant origin. Data on transfer of chemical contaminants from different substrates to the insects are very limited. Substrates like kitchen waste, human and animal manure are also considered and hazards from insects fed on these substrates need to be specifically assessed. It is concluded that for both biological and chemical hazards, the specific production methods, the substrate used, the stage of harvest, the insect species and developmental stage, as well as the methods for further processing will all have an impact on the occurrence and levels of biological and chemical contaminants in food and feed products derived from insects. Hazards related to the environment are expected to be comparable to other animal production systems. The opinion also identifies the uncertainties (lack of knowledge) related to possible hazards when insects are used as food and feed and notes that there are no systematically collected data on animal and human consumption of insects. Studies on the occurrence of microbial pathogens of vertebrates as well as published data on hazardous chemicals in reared insects are scarce. Further data generation on these issues are highly recommended.
The EFSA ANS Panel was asked to deliver a scientific opinion re-evaluating octyl gallate (E 311) as a food additive. The Panel considered that, whilst from theoretical considerations octyl gallate could be metabolised to octyl alcohol and gallic acid, there were insufficient data to demonstrate the rate and extent of octyl gallate metabolism in vivo. Having reviewed the data on the toxicokinetics (rate and extent of metabolism) of propyl, octyl and dodecyl gallate in a previous EFSA evaluation of propyl gallate, the Panel concluded that the available metabolism data on gallates were insufficient to provide a basis for the read-across of systemic toxicity data on propyl, octyl and dodecyl gallate to be valid. The Panel noted the absence of concern for genotoxicity and the lack of increase in the number of tumours in the long-term study. However, owing to the lack of detailed reports on carcinogenicity and chronic toxicity studies with octyl gallate and the absence of a basis for read-across for systemic toxicity from propyl gallate data, the Panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of octyl gallate. The Panel identified a no observed adverse effect level of 50 mg/kg body weight per day in a reproductive toxicity study. Overall, the available database was too limited to either establish an acceptable daily intake or serve as a basis for a margin of safety approach to be applied with confidence. The Panel concluded that, although a safety concern was unlikely from the single use (chewing gum) for which usage and analytical data were provided, an adequate assessment of the safety of octyl gallate as a food additive in all its currently permitted uses would require a sufficient toxicological database in line with its current guidance for submission for food additive evaluations.
Scientific Opinions: Statements of the Scientific Committee/Scientific Panel
In 2009 and 2010, the EFSA GMO Panel concluded the assessment of genetically modified (GM) maizes MIR604, MIR604 × GA21, MIR604 × Bt11 and MIR604 × GA21 × Bt11. These maizes were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. On 23 July 2015, the European Commission (EC) received from Syngenta new nucleic acid sequencing data on maize event MIR604 and updated bioinformatic analyses using the new sequencing data. EC tasked EFSA to analyse these data and to indicate whether the previous conclusions of the EFSA GMO Panel on the above-listed GM maizes remain valid. The EFSA GMO Panel used the appropriate principles described in its guidelines for the risk assessment of GM plants to analyse the received data. The new sequencing data indicated a single base pair difference compared to the sequencing data originally provided, located in a non-coding region of the insert. which had already been present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment remain valid. The new sequencing data and the bioinformatic analyses performed on the new sequence did not give rise to safety issues. Therefore, the GMO Panel concludes that the original risk assessment of event MIR604 as a single and as a part of stacked events remains valid.
In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Germany, received an application from Nisso Chemical Europe to modify the existing maximum residue levels (MRL) for the active substance acetamiprid in leafy brassica (Chinese cabbages, kales). In order to accommodate for the intended uses of acetamiprid, Germany proposed to raise the existing MRLs from the limit of quantification of 0.01 mg/kg to 1.5 mg/kg. Germany drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. The intended use on leafy brassica is adequately supported by residue data but no MRL is recommended by EFSA since an acute consumer intake concern cannot be excluded when considering the acute reference dose for acetamiprid proposed by the EFSA PPR panel in a previous assessment.
Scientific Reports of EFSA
In a paper published in PLoS One and entitled ‘Laboratory rodent diets contain toxic levels of environmental contaminants: Implications for regulatory tests’, Mesnage et al. (2015) analysed commercial laboratory rodent diets for environmental contaminants and genetically modified organisms (GMOs). In samples from 13 different commercial rodent diets obtained from five continents, the authors of the study report the presence of pesticides, heavy metals, polychlorinated dibenzo-p-dioxins and dibenzofurans, and GMOs. The paper by Mesnage et al. (2015) provides a useful addition to the already existing knowledge in the field. However, there are several limitations with the methodological approach used by the authors, including insufficient information about the test material and methodology used, incomplete reporting of the data, and inappropriate interpretation of legislation and results. The vast majority of pesticides were absent (below the limit of detection), and where detected, the levels of pesticides, heavy metals and dioxins were only just above the limit of detection in the feed samples but below regulatory levels for feed and foodstuffs. Only in a limited number of feed diets did the authors report levels of lead that exceeded the maximum levels specified by legislation for foodstuffs. The application of the ADI concept to claim the existence of a health risk in rodents or to demonstrate background levels of diseases or disorders in rodents has no scientific justification. In an interview conducted with Dr Samsel, the farmwars.info website reports on the presence of glyphosate in three different rodent diets. The information reported on the website is not supported by sufficient detail or a reference to permit a full scientific review. In conclusion, no new scientific elements were provided that would impact on the validity of regulatory feeding tests in the EU.