Updating risk management recommendations to limit exposure of non-target Lepidoptera of conservation concern in protected habitats to Bt-maize pollen

Using mathematical model ling , the EFSA GMO Panel ha s previously quantified the risk to non - target (NT) Lepidoptera of conservation concern, potentially occurring within protected habitats, associated with the ingestion of Bt - maize pollen deposited on their host plants. To reduce the estimated larval mortality to a negligible level, an isolation distance of 20 and 30 m was recommended between protected habitats and the nearest fields of maize MON 810/Bt11 and 1507, respectively. Here , the EFSA GMO Panel refines its model predictions , accounting for new ly reported information on maize pollen deposition over long distances . For its calculations , the EFSA GMO Panel considered three exposure scenarios at a range of isolation distances, at two protection levels and for a range of lepidopteran species, including hypothetical ones, with a wide spectrum of sensitivities to Bt toxins . An analysis of various sources of uncertainties affecting the exposure of NT Lepidoptera to Bt - maize pollen was conducted, in order to provide quantitative estimates of realistic exposure levels. The EFSA GMO Panel therefore provides risk managers with a tool to estimate and mitigate the risk for NT Lepidoptera of conservation concern. In contrast to its previous o utcomes obtained for unrealistically large levels of exposure that would not be expected in practice, the EFSA GMO Panel reports here mortality estimates for a more realistic level of exposure. The EFSA GMO Panel concludes that its previous recommendation for a 20 m isolation distance around protected habitats, within which maize MON810/Bt11 should not be cultivated, remains valid. New calculations show that the previously recommended isolation distance of 30 m from the nearest maize 1507 field would still protect NT Lepidoptera with known levels of sensitivity, including the ‘highly - sensitive’ Plutella xylostella . Should hypothetical species with greater sensitivities exist, larger isolation distances would be needed to ensure the desired level of protection

Scientific Opinion on a request from the European Commission related to the prolongation of prohibition of the placing on the market of genetically modified oilseed rape event GT73 for import, processing and feed uses in Austria

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of the genetically modified oilseed rape event GT73 for import, processing and feed uses in Austria. The EFSA GMO Panel assessed whether the submitted documentation comprised new scientific information that would change or invalidate the conclusions of its previous risk assessments on oilseed rape GT73. The EFSA GMO Panel also considered the relevance of the concerns raised by Austria in the light of the most recent data published in the scientific literature. The authorised uses of oilseed rape GT73 exclude cultivation, but data on gene flow, persistence and invasiveness derived from cultivation were considered as a worst case, representing conditions where exposure and potential impact are expected to be the highest, to assess possible environmental impacts resulting from seed import spills. In the documentation provided by Austria and in the scientific literature, the EFSA GMO Panel could not identify new scientific evidence that indicates that the import, processing and feed uses of oilseed rape GT73 in the EU pose a significant and imminent risk to the environment. The EFSA GMO Panel does not consider the occurrence of occasional feral oilseed rape GT73 plants, pollen dispersal and consequent cross-pollination as environmental harm in itself. In conclusion, the EFSA GMO Panel considers that, based on the documentation supplied by Austria and a review of recent scientific literature, there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape GT73

Scientific Opinion on a request from the European Commission for the assessment of the new scientific elements supporting the prolongation of prohibition of the placing on the market of maize MON 863 for food and feed purposes in Austria

Austria notified the European Commission of its new scientific elements justifying the prolongation for three additional years of the implementation of a national safeguard measure prohibiting the placing on the market of genetically modified maize MON 863 in Austria. Subsequently, the European Commission asked the European Food Safety Authority (EFSA) to assess the new scientific information supporting the prolongation of the prohibition. Having considered the information provided by Austria and all relevant scientific publications, the EFSA Panel on Genetically Modified Organisms (GMO Panel) concluded that the new scientific elements submitted by the Austrian Authorities do not lead EFSA to reconsider the conclusions in its opinions on maize MON 863

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

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

Guidance on allergenicity assessment of genetically modified plants

This document provides supplementary guidance on specific topics for the allergenicity risk assessment of genetically modified plants. In particular, it supplements general recommendations outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013. The topics addressed are non-IgE-mediated adverse immune reactions to foods, in vitro protein digestibility tests and endogenous allergenicity. New scientific and regulatory developments regarding these three topics are described in this document. Considerations on the practical implementation of those developments in the risk assessment of genetically modified plants are discussed and recommended, where appropriate. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority

Scientific Opinion supplementing the conclusions of the environmental risk assessment and risk management recommendations for the cultivation of the genetically modified insect resistant maize Bt11 and MON 810

The EFSA GMO Panel was asked by the European Commission to apply its mathematical model to simulate and assess potential adverse effects resulting from the exposure of non-target Lepidoptera to maize Bt11 or MON 810 pollen under hypothetical agricultural conditions, and to provide information on the factors affecting the insect resistance management plan, additional to that in its 2011 Statement supplementing the evaluation of the environmental risk assessment and risk management recommendations on insect resistant genetically modified maize Bt11 for cultivation. Here, risk managers are provided with additional evidence and further clarifications to those previous conclusions and risk management recommendations. This Scientific Opinion provides background scientific information to inform the decision-making process; the EFSA GMO Panel reiterates that risk managers should choose risk mitigation and management measures that are proportionate to the level of identified risk according to the protection goals pertaining to their regions