Opinion of the Scientific Panel on genetically modified organisms [GMO] on an application (Reference EFSA GMO BE 2004 07) for the placing on the market of insect-protected glyphosate-tolerant genetically modified maize MON863 × MON810 × NK603, for food and feed uses, and import and processing under Regulation (EC) No 1829/2003 from Monsanto

EFSA Journal

Volumn 3, Issue 7, 2005, Pages

[No Author Info available]

Author keywords

CP4 EPSPS; Cry1Ab; Cry3Bb1; Directive 2001 18 EC; environment; feed safety; food safety; glyphosate resistance; GMOs; human health; import; insect protection; maize; MON 810; MON 863; MON 863 MON 810 NK603; MON 863 5 MON 81 6 MON 6 3 6; NK603; NptII; Regulation (EC) No 1829 2003

Indexed keywords

EID: 85078381211     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2005.256     Document Type: Article

References (39)

1. ACNFP, 1996. ACNFP Report on Processed Products from GM Insect-Resistant Maize (Annex IV). In: ACNFP Annual Report 1996. Advisory Committee on Novel Foods and Processes, London, pp. 55–64. www.food.gov.uk/multimedia/pdfs/acnfp_app_i-vi.pdf.
2. Ahmad, A., Wilde G.E., Zhu K.Y., 2005. Detectability of Coleopteran-specific Cry3Bb1 protein in soil and its effect on nontarget surface and below-ground arthropods. Environ. Entomol., 34, 385–394.
3. Bennett, P. M., Livesey, C. T., Nathwani, D., Reeves, D. S., Saunders, J. R. and Wise, R., 2004. An assessment of the risks associated with the use of antibiotic resistance genes in genetically modified plants: report of the Working Party of the British Society for Antimicrobial Chemotherapy. J. Antimicrob. Chemother., 53, 418–431. jac.oupjournals.org/cgi/reprint/53/3/418.pdf.
4. Bjorklund A.K., Soeria-Atmadja D., Zorzet A., Hammerling U., Gustafsson M.G., 2005. Supervised identification of allergen-representative peptides for in silico detection of potentially allergenic proteins. Bioinformatics, 21(1);39–50.
5. CAC, 2003. Codex principles and guidelines on foods derived from biotechnology. Joint FAO/WHO Food Standards Programme, Food and Agriculture Organisation, Rome. ftp://ftp.fao.org/codex/standard/en/CodexTextsBiotechFoods.pdf.
6. Crickmore, N., Zeigler, D.R., Feitelson, J., Schnepf, E., Van Rie, J., Lereclus, D., Baum, J. and Dean, D.H., 1998. Revision of the nomenclature for the Bacillus thuringiensis pesticidal crystal proteins. Microbiol. Mol. Biol. Rev. 62, 807–813.
7. Dunlap, F.G., White, P.J., Pollak, L.M., 1995. Fatty acid composition of oil from exotic corn breeding materials. Journal of the American Oil Chemists' Society 72, 989–993.
8. EC, 1990. Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms. OJ L117, 15–27. europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=gN&numdoc=31990L0220&model=luichett.
9. EC, 1997. Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients OJ L43, 1–6. europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=g N&numdoc=31997R0258&model=guichett.
10. EC, 1998a. Commission Decision of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220/EEC. OJ L131, 32–33. europa.eu.int/eur-lex/pri/en/oj/dat/1998/l_131/l_13119980505en00320033.pdf.
11. EC, 1998b. Summary of notifications received in 1997 by the Commission pursuant to Article 5 of European Parliament and Council Regulation (EC) No 258/97. Official Journal of the European Communities C 200, 16. europa.eu.int/eur-lex/pri/en/oj/dat/1998/c_200/c_20019980626en00160016.pdf.
12. EC, 1998c. Commission Decision of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line Bt-11), pursuant to Council Directive 90/220/EEC. europa.eu.int/eur-lex/pri/en/oj/dat/1998/l_131/l_13119980505en00280029.pdf.
13. EC, 1999. Summary of notification received in 1998 by the Commission pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council. europa.eu.int/eur-lex/pri/en/oj/dat/1999/c_181/c_18119990626en00220022.pdf.
14. EC, 2001. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. OJ L106, 1–39. europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_106/l_10620010417en00010038.pdf.
15. EC, 2003. Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. OJ L268, 1–23. europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00010023.pdf.
16. EC, 2004a. 2004/643/EC: Commission Decision of 19 July 2004 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L. line NK603) genetically modified for glyphosate tolerance (notified under document number C(2004) 2761)(Text with EEA relevance). OJ, L295, 35–37. europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_295/l_29520040918en00350037.pdf.
17. EC, 2004c. Commission Decision of 19 May 2004 authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2004) 1865). OJ, L300, 48–51. europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2004/l_300/l_30020040925en00480051.pdf.
18. EC, 2005. 2005/448/EC: Commission Decision of 3 March 2005 authorising the placing on the market of foods and food ingredients derived from genetically modified maize line NK 603 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C (2005) 580). OJ, L158, 20–22. europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2005/l_158/l_15820050621en00200022.pdf.
19. EFSA, 2003a. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Notification (Reference CE/ES/00/01) for the placing on the market of herbicide-tolerant genetically modified maize NK603, for import and processing, under Part C of Directive 2001/18/EC from Monsanto (Question No EFSA-Q-2003-003). EFSA Journal 10, 1–13 www.efsa.eu.int/science/gmo/gmo_opinions/176/opinion_gmo_03_final_en1.pdf.
20. EFSA, 2003b. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the safety of foods and food ingredients derived from herbicide-tolerant genetically modified maize NK603, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto (QUESTION NO EFSA-Q-2003-002). EFSA Journal 9, 1–14. www.efsa.eu.int/science/gmo/gmo_opinions/177/opinion_gmo_02_final_en1.pdf.
21. EFSA, 2004a. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Notification (Reference C/DE/02/9) for the placing on the market of insect protected genetically modified maize MON 863 and MON 863 × MON 810, for import and processing, under Part C of Directive 2001/18/EC from Monsanto (Question No EFSA-Q-2003-089). EFSA Journal 49, 1–25. www.efsa.eu.int/science/gmo/gmo_opinions/381/opinion_gmo_06_en1.pdf.
22. EFSA, 2004b. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the safety of foods and food ingredients derived from insect-protected genetically modified maize MON 863 and MON 863 × MON 810, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 by Monsanto (Question No EFSA-Q-2003-121). EFSA Journal 50, 1–25. www.efsa.eu.int/science/gmo/gmo_opinions/383/opinion_gmo_07_en1.pdf.
23. EFSA, 2004c. 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, 1–94. www.efsa.eu.int/science/gmo/gmo_guidance/660_en.html.
24. EFSA, 2004d. Opinion of the Scientific Panel on Genetically Modified Organisms on the use of antibiotic resistance genes as marker genes in genetically modified plants. EFSA Journal 48, 1–18 www.efsa.eu.int/science/gmo/gmo_opinions/384_en.html.
25. EFSA, 2005. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the notification (Reference C/F/96/05.10) for the placing on the market of insect-tolerant genetically modified maize Bt11, for cultivation, feed and industrial processing, under Part C of Directive 2001/18/EC from Syngenta Seeds. (Question No EFSA-Q-2004-012) EFSA Journal (2005) 213, 1–33. www.efsa.eu.int/science/gmo/gmo_opinions/922/gmo_opinion_ej213_bt11maize_cultivation_en1.pdf.
26. Metcalfe, D.D., Astwood, J.D., Townsend, R., Sampson, H.A., Taylor, S.L. and Fuchs, R.L., 1996. Assessment of the allergenic potential of foods derived from genetically engineered crop plants. Crit. Rev. Food. Sci. Nutr., 36(S), 165–186.
27. Moreno-Fierros, Ruiz-Medina, E.J., Esquivel, R.L., Lopez-Revilla, R., Pina-Cruz S., 2003. Intranasal Cry1Ac protoxin is an effective mucosal and systemic carrier and adjuvant of Streptococcus pneumoniae polyssacharides in mice. Scand J Immunol, 57; 45–55.
28. Nap, J.P., Bijvoet, J. & Stiekema, W.J., 1992. Biosafety of kanamycin-resistant transgenic plants: an overview. Transgenic Res., 1, 239–249.
29. OECD, 1998. Test Guideline 408. Repeated Dose 90-day Oral Toxicity Study in Rodents. In: OECD Guidelines for the testing of chemicals. Organization for Economic Cooperation & Development, Paris.
30. Redenbaugh, K., Hiatt, W., Martineau, B., Lindemann, J. and Emlay, D., 1994. Aminoglycoside 3′-phosphotransferase II: review of its safety and use in the production of genetically engineered plants. Food Biotech., 8, 137–165.
31. SCF, 2002. Opinion on a request to place genetically modified sweet maize line Bt11 on the market (expressed on 17 April 2002). europe.eu.int/comm/food/fs/sc/scf/out129_en.pdf.
32. SCP, 1998a. Opinion of the Scientific Committee on Plants regarding submission for placing on the market of genetically modified, insect-resistant maize lines notified by the Pioneer Genetique S.A.R.L. Company (notification No C/F/95/12-01/B). europa.eu.int/comm/food/fs/sc/scp/out10_en.html.
33. SCP, 1998b. Opinion of the Scientific Committee on Plants regarding the genetically modified, insect resistant maize lines notified by the Monsanto Company. europa.eu.int/comm/food/fs/sc/scp/out02_en.html.
34. SCP, 1998c. Opinion of the Scientific Committee on Plants on the Genetically Modified Maize Lines Notified by the Novartis Company (Notification C/GB/96/M4/1). europe.eu.int/comm/food/fs/sc/scp/out05_en.html.
35. SCP, 2000. Opinion of the Scientific Committee on Plants on the submission for placing on the market of genetically modified insect resistant and glufosinate ammonium tolerant (Bt-11) maize for cultivation. Notified by Novartis Seeds SA Company (notification C/F/96/05-10). europa.eu.int/comm/food/fs/sc/scp/out86_gmo_en.html.
36. Soeria-Atmadja, D., Zorzet, A., Gustafsson, M & Hammerling, U., 2004. Statistical evaluation of local alignment features for prediction of allergenicity using supervised classification algorithms. Int. Arch. Allergy Immunol., 133, 101–112.
37. Vazquez-Padron R.I., Moreno-Fierros L., Neri-Bazan L., De la Riva G.A. and Lopez-Revilla R., 1999a. Intragastric and intraperitoneal administration of Cry1Ac protoxin from Bacillus thuringiensis induce systemic and mucosal immune response in mice. Life Sciences, 64, 1897–1912.
38. Vazquez R.I., Moreno-Fierros L., Neri-Bazan L., De la Riva G.A. and Lopez-Revilla R., 1999b. Bacillus thuringiensis Cry1Ac protoxin is a potent systemic and mucosal adjuvant. Scand J Immunol, 49, 578–584.
39. Vazquez-Padron R.I., Moreno-Fierros L., Neri-Bazan L., Martinez-Gil A.F., De la Riva G.A. and Lopez-Revilla R., 2000. Characterization of the mucosal and systemic immune response iduced by Cry1Ac protein from Bacillus thuringiensis HD 73 in mice. Braz. J. Med. Biol. Res., 33, 147–155.