Search results for " GMO"
showing 5 items of 5 documents
Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐123)
2018
Abstract Maize 4114 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate‐ammonium by expression of the PAT protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non‐genetically modified (GM) comparator(s) required further assessment. There were …
Applying an operating model for the environmental risk assessment in Italian Sites of Community Importance (SCI) of the European Commission Habitats …
2013
The fast development of agro-biotechnologies asks for a harmonized approach in risk analysis of GMO's releases, where "risk analysis" entails the assessment, management and communication of risk. Risk assessment consists in the evaluation of the likelihood that a hazard occurs, associated with the presence of the receptor(s) in the receiving environment, and the determination of their potential degree of exposure to the hazard. The whole process has to be both science based and applied case by case, and it involves a very complicated procedure that needs to be transformed in an operational and standardized tool. Beginning in 2003, an expert group on behalf of the Italian Ministry of the Env…
Guidance on allergenicity assessment of genetically modified plants
2017
Abstract 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 …
Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) …
2017
Abstract This document provides guidance for the risk assessment under Regulation (EC) No 1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of Annex II of Regulation (EU) No 503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed.
Scientific Opinion on an application by Syngenta (EFSA-GMO-DE-2009-66) for placing on the market of herbicide tolerant and insect resistant maize Bt1…
2015
Question number: EFSA-Q-2009-00444 on request from Competent Authority of Germany; The EFSA GMO Panel previously assessed the four single events combined to produce a four-event stack maize Bt11 × MIR162 × MIR604 × GA21 and did not identify safety concerns. In this opinion, the EFSA GMO Panel assesses the four-event stack maize and all its subcombinations independently of their origin. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the four-event stack maize did not give rise to safety concerns and there is no reason to expect interactions between the singl…