Skip to main content
NCBI home page
EFSA Journal logoLink to EFSA Journal
. 2011 Dec 16;9(12):2479. doi: 10.2903/j.efsa.2011.2479

Scientific Opinion on application EFSA‐GMO‐RX‐MON1445 for renewal of the authorisation for continued marketing of cottonseed oil, food additives, feed materials and feed additives produced from cotton MON 1445 that were notified as existing products under Articles 8(1)(a), 8(1)(b) and 20(1)(b) of Regulation (EC) No 1829/2003 from Monsanto

EFSA Panel on Genetically Modified Organisms (GMO)
PMCID: PMC13093208  PMID: 42016008

Abstract

This scientific opinion evaluates the risk assessment for the authorisation for continued marketing of genetically modified herbicide tolerant cotton MON 1445 for food and feed produced from it. Cotton MON 1445 contains single copies of functional CP4 epsps and npt II expression cassettes and an aad A gene as non‐functional element. Stability of the inserted DNA was confirmed over several generations. Bioinformatic analyses and levels of recombinant proteins did not reveal safety issues. No biologically relevant differences were identified in the compositional, phenotypic and agronomic characteristics of cotton MON 1445 in comparison to its conventional counterpart and its composition fell within the range of non‐GM cotton varieties, except for CP4 EPSPS and NPTII proteins. No toxicity and allergenicity issues were identified regarding the newly expressed protens. Products from cotton MON 1445 do not contain viable plant parts. Insert structure in cotton MON 1445 may facilitate the stabilisation of the npt II gene in plasmids of environmental bacteria through double homologous recombination. However, considering the expected low frequency of gene transfer from cotton MON 1445 to bacteria compared to that between bacteria, and the very low exposure to DNA from cotton MON 1445, the EFSA GMO Panel concludes that the contribution of horizontal gene transfer to the environmental prevalence of npt II genes is negligible. Potential interactions of cotton MON 1445 with non‐target organisms and the abiotic environment were not considered to be an issue because of low exposure levels. A post‐market environmental monitoring plan is not required. The EFSA GMO Panel concludes that the information available for cotton MON 1445 addresses the questions raised by the Member States and that MON 1445‐derived products are as safe as products derived from the conventional counterpart in the context of their intended uses.

Keywords: GMO, cotton, MON 1445, Roundup Ready®, herbicide tolerance, risk assessment, food and feed safety, environment, food and feed produced from, Regulation (EC) No 1829/2003, renewal

EFSA Panel on Genetically Modified Organisms (GMO) ; Scientific Opinion on application EFSA‐GMO‐RX‐MON1445 for renewal of the authorisation for continued marketing of existing cottonseed oil, food additives, feed materials and feed additives produced from cotton MON 1445 that were notified under Articles 8(1)(a), 8(1)(b) and 20(1)(b) of Regulation (EC) No 1829/2003 from Monsanto. EFSA Journal 2011;9(12):2479. [1–28] doi: 10.2903/j.efsa.2011.2479.

Panel members: Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, József Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean‐Michel Wal

Correspondence: gmo@efsa.europa.eu

Acknowledgement: The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed Safety and Environment for the preparatory work on this scientific opinion, Willem Seinen as external expert and EFSA's staff members Yann Devos (ENV), Zoltán Divéki (MC), Andrea Germini (FF), Ana Gomes (MC), Karine Lheureux (ENV) and Nancy Podevin (MC) for the support provided to this EFSA scientific opinion.

Adoption date: 30 November 2011

Published date: 16 December 2011

Question number: EFSA‐Q‐2007‐143

On request from: European Commission on application (EFSA‐GMO‐RX‐MON1445) submitted by Monsanto

References

  1. ACNFP (Advisory Committee on Novel Foods and Processes) , 2002, online. Request for an Article 5 opinion on the substantial equivalence of cottonseed oil and food ingredients derived from Roundup® Ready cotton. Available from: www.food.gov.uk/multimedia/pdfs/cottonseedoilRRfinalopinion.pdf
  2. Assaad FF and Signer ER, 1990. Cauliflower mosaic virus P35S promoter activity in Echerichia coli . Molecular Genetics and Genomics, 223, 517–520. [DOI] [PubMed] [Google Scholar]
  3. Atkins FM, Wilson M, Bock SA, 1988. Cottonseed hypersensitivity: new concerns over an old problem. Journal of Allergy and Clinical Immunology, 82, 242–250. [DOI] [PubMed] [Google Scholar]
  4. Brigulla M and Wackernagel W, 2010. Molecular aspects of gene transfer and foreign DNA acquisition in prokaryotes with regard to safety issues. Applied Microbiology and Biotechnology, 86, 1027–1041. [DOI] [PubMed] [Google Scholar]
  5. Codex Alimentarius , 2009. Foods derived from modern biotechnology. Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme. Rome, Italy, 85 pp. [Google Scholar]
  6. de Vries J and Wackernagel W, 2002. Integration of foreign DNA during natural transformation of Acinetobacter sp. by homology‐facilitated illegitimate recombination. Proceedings of the National Academy of Sciences USA, 99, 2094–2099. [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. Duggan PS, Chambers, PA , Heritage, J , and Forbes, JM , 2000. Survival of free DNA encoding antibiotic resistance from transgenic maize and the transformation activity of DNA in ovine saliva, ovine rumen fluid and silage effluent. FEMS Microbiology Letters, 191, 71–77. [DOI] [PubMed] [Google Scholar]
  8. Duggan PS, Chambers, PA , Heritage, J , and Forbes, JM , 2003. Fate of genetically modified maize DNA in the oral cavity and rumen of sheep. British Journal of Nutrition, 89, 159–166. [DOI] [PubMed] [Google Scholar]
  9. EFSA (European Food Safety Authority) , 2006a. Guidance document for the renewal of authorisations of existing GMO products lawfully placed on the market, notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003. EFSA Journal, 435, 1–14. [Google Scholar]
  10. EFSA (European Food Safety Authority) , 2006b. Guidance document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed. EFSA Journal, 99, 1–100. [Google Scholar]
  11. EFSA (European Food Safety Authority) , 2009. Statement of EFSA on the consolidated presentation of the joint Scientific Opinion of the GMO and BIOHAZ Panels on the Use of Antibiotic Resistance Genes as Marker Genes in Genetically Modified Plants and the Scientific Opinion of the GMO Panel on Consequences of the Opinion on the Use of Antibiotic Resistance Genes as Marker Genes in Genetically Modified Plants on Previous EFSA Assessments of Individual GM Plants . EFSA Journal, 1108, 1–8. [Google Scholar]
  12. EFSA Panel on Genetically Modified Organisms (GMO) , 2010. Scientific Opinion of the Panel on Genetically Modified Organisms (GMO) on the assessment of allergenicity of GM plants and microorganisms and derived food and feed. EFSA Journal, 8 (7), 1–168. [Google Scholar]
  13. FEDIOL (Federation of EU Oil and Proteinmeal Industry) , online. Statistics. Available from: www.fediol.be/site/index.php?section=11&menu=102
  14. Genbank , 2010, online. Availaible from: www.ncbi.nlm.nih.gov/genbank/
  15. Hülter N and Wackernagel, W , 2008. Double illegitimate recombination events integrate DNA segments through two different mechanisms during natural transformation of Acinetobacter baylyi . Molecular Microbiology, 67, 984–995. [DOI] [PubMed] [Google Scholar]
  16. ILSI (International Life Sciences Institute) Crop Composition Database Version 2.0, 2007, online. Availaible from: www.cropcomposition.org
  17. Jonas DA, Elmadfa I, Engel KH, Heller KJ, Kozianowski G, König A, Müller D, Narbonne JF, Wackernagel W and Kleiner J, 2001. Safety considerations of DNA in food. Annals of Nutrition and Metabolism 45, 235–254. [DOI] [PubMed] [Google Scholar]
  18. Lewin A, Jacob D, Freytag B and Appel B, 1998. Gene expression in bacteria directed by plant‐specific regulatory sequences. Transgenic Research, 7, 403–411. [Google Scholar]
  19. Malanin G, Kalimo K, 1988. Angioedema and urticaria caused by cottonseed protein in whole grain bread. Journal of Allergy and Clinical Immunology, 82, 261–264. [DOI] [PubMed] [Google Scholar]
  20. Mercer DK, Melville CM, Scott KP and Flint HJ, 1999a. Natural genetic transformation in the rumen bacterium Streptococcus bovis JB1. FEMS Microbiology Letters, 179, 485–490. [DOI] [PubMed] [Google Scholar]
  21. Mercer DK, Scott KP, Bruce‐Johnson WA, Glover LA and Flint HJ, 1999b. Fate of free DNA and transformation of the oral bacterium Streptococcus gordonii DL1 by plasmid DNA in human saliva. Applied and Environmental Microbiology, 65, 6–10. [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Mercer DK, Scott KP, Melville CM, Glover LA and Flint HJ, 2001. Transformation of an oral bacterium via chromosomal integration of free DNA in the presence of human saliva. FEMS Microbiology Letters, 200, 163–167. [DOI] [PubMed] [Google Scholar]
  23. Nordgård L, Nguyen T, Modtvelt T, Benno Y, Traavik T and Nielsen KM, 2007. Lack of detectable update of DNA by bacterial gut isolates grown in vitro and by Acinetobacter baylyi colonizing rodents in situ. Environmental Biosafety Research, 6, 149–160. [DOI] [PubMed] [Google Scholar]
  24. OECD (Organisation for Economic Co‐operation and Development) , 2009. Consensus document on compositional considerations for new varieties of cotton (Gossypium hirsutum and Gossypium barbadense): key food and feed nutrients and anti‐nutrients. Series on the Safety of Novel Foods and Feeds, No 11. ENV/JM/MONO(2004)16.
  25. Percival AE, Wendel, JF and Stewart JM, 1999. Taxonomy and germplasm resources. In: Cotton: origin, history, technology, and production. Eds Smith CW, and Cothren JT. John Wiley & Sons, New York, 33–64. [Google Scholar]
  26. Rizzi A, Raddadi N, Sorlini C, Nordgård L, Nielsen KM and Daffonchio D, 2012. The stability and degradation of dietary DNA in the gastrointestinal tract of mammals ‐ implications for horizontal gene transfer and the biosafety of GMOs. Critical Reviews in Food Science and Nutrition, 52, 142–161. [DOI] [PubMed] [Google Scholar]
  27. SCP (Scientific Committee on Plants) , 1998, online. Opinion of the Scientific Committee on Plants on the genetically modified cotton line, tolerant to glyphosate herbicide notified by the Monsanto Company (notification C/ES/97/01). Available from ec.europa.eu/food/fs/sc/scp/out17_en.html
  28. van den Eede G, Aarts H, Bukh HJ, Corthier G, Flint HJ, Hammes W, Jacobsen B, Midtvedt T, van der Vossen J, von Wright A, Wackernagel W and Wilcks A, 2004. The relevance of gene transfer to the safety of food and feed derived from genetically modified (GM) plants. Food and Chemical Toxicology 42, 1127–1156. [DOI] [PubMed] [Google Scholar]
  29. Verstraete F, in press. Risk management of undesirable substances in feed following updated risk assessments. Toxicology and Applied Pharmacology, doi: 10.1016/j.taap.2010.09.01. [DOI] [PubMed]

Articles from EFSA Journal are provided here courtesy of Wiley

RESOURCES