Suchergebnisse

© 2020 European Food Safety Authority. ; The scope of application EFSA‐GMO‐DE‐2012‐111 is for food and feed uses, import and processing of genetically modified (GM) soybean SYHT0H2 in the European Union. Soybean SYHT0H2 was developed to confer tolerance to the herbicidal active substances mesotrione and other p‐hydroxyphenylpyruvate dioxygenase (HPPD)‐inhibiting herbicides and glufosinate ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues except for sequence similarity of AvHPPD‐03 to bacterial haemolysins that was considered in food/feed safety assessment. The outcome of the comparative analysis (agronomic/phenotypic and compositional characteristics) did not need further assessment except for the changes in seed levels of α‐tocopherol and γ‐tocopherol that were assessed for food and feed relevance. The GMO Panel does not identify toxicological and allergenicity concerns for the AvHPPD‐03 and PAT proteins expressed in soybean SYHT0H2 and finds no evidence that the genetic modification would change the overall allergenicity of soybean SYHT0H2. The nutritional impact of food/feed from soybean SYHT0H2 is expected to be the same as that of food/feed from the conventional counterpart and commercial non‐GM soybean reference varieties. The GMO Panel concludes that soybean SYHT0H2 is as safe as and nutritionally equivalent to the conventional counterpart and the tested non‐GM soybean reference varieties, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean SYHT0H2 grains into the environment, soybean SYHT0H2 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean SYHT0H2. In conclusion, the GMO Panel considers that soybean SYHT0H2, as described in this application, is as safe as its conventional counterpart and the tested non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

The scope of application EFSA-GMO-DE-2016-133 is for food and feed uses, import and processing ofgenetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed toconfer tolerance to the herbicidal active substances glyphosate and glufosinate-ammonium. Themolecular characterisation data and bioinformatic analyses do not identify issues requiring food/feedsafety assessment. None of the identified differences in the agronomic/phenotypic and compositionalcharacteristics tested between maize MZHG0JG and its conventional counterpart needs furtherassessment, except for early stand count (pre-thinning). The GMO Panel does not identify safetyconcerns regarding the toxicity and allergenicity of the mEPSPS and PAT proteins as expressed inmaize MZHG0JG, andfinds no evidence that the genetic modification would change the overallallergenicity of maize MZHG0JG. The nutritional impact of food/feed derived from maize MZHG0JG isexpected to be the same as that of food/feed derived from the conventional counterpart andcommercial non-GM maize reference varieties. The GMO Panel concludes that maize MZHG0JG isnutritionally equivalent to and as safe as the conventional counterpart and non-GM maize referencevarieties tested, and no post-market monitoring of food/feed is considered necessary. In the case ofaccidental release of viable maize MZHG0JG grains into the environment, maize MZHG0JG would notraise environmental safety concerns. The post-market environmental monitoring plan and reportingintervals are in line with the intended uses of maize MZHG0JG. In conclusion, the GMO Panel considersthat maize MZHG0JG, as described in this application, is as safe as its conventional counterpart andthe tested non-GM maize reference varieties with respect to potential effects on human and animalhealth and the environment. ; Peer Reviewed

Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) for the renewal of its authorisation as zootechnical feed additive for pigs for fattening, minor porcine species for fattening and turkeys for fattening. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive Avemix® XG 10 with calcium carbonate + wheat flour and Avemix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) noted that no data were submitted to support compliance of the formulation of Avemix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both forms of the additive remain safe for pigs for fattening, minor porcine species for fattening and turkeys for fattening, consumers and the environment. Regarding the safety for the user, Avemix® XG 10 formulated with calcium carbonate + sepiolite and Avemix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of Avemix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in all its formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.