Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐UK‐2006‐34) for authorisation of food and feed containing, consisting of and produced from genetically modified maize 3272

Abstract

Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified (GM) maize 3272 (EFSA- GMO-UK-2006-34). The applicant conducted new agronomic, phenotypic and compositional analysis studies on maize 3272 and assessed the allergenic potential of AMY797E protein, addressing elements that remained inconclusive from previous EFSA opinion issued in 2013. The GMO Panel is of the opinion that the agronomic and phenotypic characteristics as well as forage and grain composition of maize 3272 do not give rise to food and feed safety, and nutritional concerns when compared to non-GM maize. Considering the scope of this application and the characteristics of the trait introduced in this GM maize, the effect of processing and potential safety implications of specific food or feed products remain to be further investigated. Regarding the allergenic potential of AMY797E protein and considering all possible food and feed uses of maize 3272, the Panel concludes that the information provided does not fully address the concerns previously raised by the Panel in 2013. Owing to the nature and the knowledge available on this protein family, it is still unclear whether under specific circumstances the alpha-amylase AMY797E has the capacity to sensitise certain individuals and to cause adverse effects. To further support the safety of specific products of maize 3272, the applicant provided thorough information relevant for the allergenicity assessment of dried distiller grains with solubles (DDGS), which is the main product of interest for importation into the EU. Having considered the information provided on this product, the Panel is of the opinion that under the specific conditions of use described by the applicant, DDGS produced from maize 3272 does not raise concerns when compared to DDGS from non-GM maize.

Allergic to bureaucracy? Regulatory allergenicity assessments of novel food: Motivations, challenges, compromises, and possibilities

“…Discovering a potentially allergenic protein presents several risk management and communication options (MHLW, 2020;National Agrifood Health and Quality Service, 2002). The regulatory body can choose to disregard the allergenicity and permit the food to be marketed or to ban it entirely (EFSA GMO Panel, 2019b). In response, manufacturers may contemplate modifying the product, accordingly or gathering more safety evidence (EFSA GMO Panel, 2019b).…”

“…The regulatory body can choose to disregard the allergenicity and permit the food to be marketed or to ban it entirely (EFSA GMO Panel, 2019b). In response, manufacturers may contemplate modifying the product, accordingly or gathering more safety evidence (EFSA GMO Panel, 2019b). The second line of defense involves mandatory labeling of major allergens on product packaging, which enables IDFA to make informed choices (FDA, 2021h).…”

Reducing Topdressing N Fertilization with Variable Rates Does Not Reduce Maize Yield

“…Practical motivation embraces the optimization of the trajectories in the field with a consequent reduction in the use of fuel and fertilizer, waste of pesticides, and labour hours [26,30]. In the present case study, located in eastern Lombardy (Italy), maize production is experiencing relevant variability, being caused mainly by the low price on the market and pest control regulations and limits, which results in increased imports from countries outside the EU [31]. It was observed that dairy farmers hardly adhere to the organic recommended fertilizer application rates due to the high availability of manure and slurry [28,[32][33][34][35][36]; however, to ensure high crop yields, topdressing mineral N is used despite the purchase and environmental costs [37].…”