Assessment of genetically modified cotton GHB811 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐ES‐2018‐154)

Abstract Cotton GHB811 was developed to confer tolerance to glyphosate and HPPD inhibitor herbicides. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between cotton GHB811 and its conventional counterpart needs further assessment, except for % lint, lint length and dihydrosterculic acid, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the 2mEPSPS and HPPD W336 proteins as expressed in cotton GHB811 and finds no evidence that the genetic modification would change the overall allergenicity of cotton GHB811. In the context of this application, the consumption of food and feed from cotton GHB811 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that cotton GHB811 is as safe as the conventional counterpart and non‐GM cotton reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable cotton GHB811 seeds into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB811. The GMO Panel concludes that cotton GHB811 is as safe as its conventional counterpart and the tested non‐GM cotton reference varieties with respect to potential effects on human and animal health and the environment.

[1]  H. Naegeli,et al.  Statement on in vitro protein digestibility tests in allergenicity and protein safety assessment of genetically modified plants , 2021, EFSA journal. European Food Safety Authority.

[2]  G. Mazzucchelli,et al.  Are Physicochemical Properties Shaping the Allergenic Potency of Plant Allergens? , 2020, Clinical Reviews in Allergy & Immunology.

[3]  J. Bresson,et al.  Human dietary exposure assessment to newly expressed proteins in GM foods , 2019, EFSA journal. European Food Safety Authority.

[4]  Julie Glanville,et al.  Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market , 2017, EFSA Supporting Publications.

[5]  S. Danishefsky,et al.  Chemical biology of glycoproteins: From chemical synthesis to biological impact. , 2019, Methods in enzymology.

[6]  Test No. 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents , 2018, OECD Guidelines for the Testing of Chemicals, Section 4.

[7]  J. Beale,et al.  Agronomic Performance and Crop Composition of Genetically Engineered Cotton Tolerant to HPPD Inhibiting Herbicides , 2018, Journal of Cotton Science.

[8]  K. Launis,et al.  Double-Mutated 5-Enol Pyruvylshikimate-3-phosphate Synthase Protein Expressed in MZHG0JG Corn (Zea mays L.) Has No Impact on Toxicological Safety and Nutritional Composition. , 2017, Journal of agricultural and food chemistry.

[9]  C. Tebbe,et al.  Explanatory note on DNA sequence similarity searches in the context of the assessment of horizontal gene transfer from plants to microorganisms , 2017 .

[10]  H. van Loveren,et al.  Guidance on allergenicity assessment of genetically modified plants , 2017, EFSA journal. European Food Safety Authority.

[11]  R. Herman,et al.  Rapid simulated gastric fluid digestion of in-seed/grain proteins expressed in genetically engineered crops. , 2016, Regulatory toxicology and pharmacology : RTP.

[12]  Antoine Messéan,et al.  Scientific Opinion on an application (EFSA-GMO-BE-2011-98) for the placing on the market of herbicide-tolerant genetically modified soybean FG72 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience , 2015 .

[13]  A. Chesson,et al.  Guidance on the agronomic and phenotypic characterisation of genetically modified plants , 2015 .

[14]  M. Traber,et al.  Vitamin E levels in soybean (Glycine max (L.) Merr.) expressing a p-hydroxyphenylpyruvate gene from oat (Avena sativa L.). , 2014, Journal of agricultural and food chemistry.

[15]  Antoine Messéan,et al.  Scientific Opinion on application (EFSA-GMO-NL-2010-77) for the placing on the market of herbicide-tolerant genetically modified cotton GHB614 LLCotton25 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience , 2014 .

[16]  Najaf Allahyari Fard,et al.  Allergenicity Study of Genetically Modified Herbicide Resistant Crops (Bioinformatics Assessment) , 2013 .

[17]  Antoine Messéan,et al.  Guidance on the Post-Market Environmental Monitoring (PMEM) ofgenetically modified plants , 2011 .

[18]  H. Kuiper,et al.  Scientific Opinion on the assessment of allergenicity of GM plants andmicroorganisms and derived food and feed , 2010 .

[19]  Antoine Messéan,et al.  Guidance on the environmental risk assessment of genetically modified plants , 2010 .

[20]  Gábor L. Lövei,et al.  Application of Systematic Review Methodology to Food and Feed Safety Assessments to Support Decision Making , 2010 .

[21]  Corinne Herouet-Guicheney,et al.  Safety evaluation of the double mutant 5-enol pyruvylshikimate-3-phosphate synthase (2mEPSPS) from maize that confers tolerance to glyphosate herbicide in transgenic plants. , 2009, Regulatory toxicology and pharmacology : RTP.

[22]  B. Tinland,et al.  General Surveillance for Import and Processing: the EuropaBio approach , 2009, Journal für Verbraucherschutz und Lebensmittelsicherheit.

[23]  Wilfried Wackernagel,et al.  Double illegitimate recombination events integrate DNA segments through two different mechanisms during natural transformation of Acinetobacter baylyi , 2008, Molecular microbiology.

[24]  Joachim Schiemann,et al.  Scientific Opinion of the Panel on Genetically Modified Organisms , 2008 .

[25]  B. Tinland,et al.  General Surveillance: Roles and Responsibilities The Industry View , 2007, Journal für Verbraucherschutz und Lebensmittelsicherheit.

[26]  G N Roberts,et al.  Roadside surveys support predictions of negligible naturalisation potential for cotton (Gossypium hirsutum) in north-east Australia. , 2007 .

[27]  W. P. Ridley,et al.  A quantitative method for the determination of cyclopropenoid fatty acids in cottonseed, cottonseed meal, and cottonseed oil (Gossypium hirsutum) by high-performance liquid chromatography. , 2007, Journal of agricultural and food chemistry.

[28]  Rowena J. Eastick,et al.  Potential for weediness of Bt cotton in northern Australia , 2006, Weed Science.

[29]  R. V. Anrooy Foods derived from modern biotechnology , 2006 .

[30]  Heimo Breiteneder,et al.  Molecular properties of food allergens. , 2005, The Journal of allergy and clinical immunology.

[31]  F. Sherman,et al.  Nα-terminal Acetylation of Eukaryotic Proteins* , 2000, The Journal of Biological Chemistry.

[32]  F Sherman,et al.  Nalpha -terminal acetylation of eukaryotic proteins. , 2000, The Journal of biological chemistry.

[33]  D. Lunt,et al.  Dietary whole cottonseed depresses lipogenesis but has no effect on stearoyl coenzyme desaturase activity in bovine subcutaneous adipose tissue. , 1997, Comparative biochemistry and physiology. Part B, Biochemistry & molecular biology.

[34]  I. Poma,et al.  Evaluation of cotton cultivar (Gossypium spp.) in the Western Sicily , 1993 .

[35]  R. Barneby,et al.  Flora of Turkey and the East Aegean Islands. , 1966 .

[36]  R. J. Evans,et al.  A REVIEW OF CYCLOPROPENOID COMPOUNDS: BIOLOGICAL EFFECTS OF SOME DERIVATIVES. , 1965, Poultry science.