Guidance document for the risk assessment of genetically modified plants and derived food and feed by the Scientific Panel on Genetically Modified Organisms (GMO) - including draft document updated in 2008

EFSA Journal

Volumn 4, Issue 4, 2006, Pages

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EID: 85030838740     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2006.99     Document Type: Article

References (106)

1. ACRE, 2001a. Guidance on best practice in the design of genetically modified plants, March 2001. Advisory Committee on Releases to the Environment. www.defra.gov.uk/environment/acre/bestprac/consult/guidance/bp/index.htm
2. ACRE, 2001b. Guidance on the assessment of the impact on wider biodiversity from proposed cultivation of GM crops: Advisory Committee on releases to the Environment. Sub-Group on wider biodiversity issues. www.defra.gov.uk/environment/acre/biodiversity/guidance
3. ACRE, 2002a. Guidance on best practice for the presentation and use of molecular data in submissions to the Advisory Committee on Releases to the Environment. www.defra.gov.uk/environment/acre/molecdata/pdf/acre_mdr_guidance.pdf
4. ACRE, 2002b. The criteria used by ACRE to gauge harm when giving advice on the risks of releasing genetically modified organisms to the environment. www.defra.gov.uk/environment/acre/harm/pdf/acre_harm_report.pdf
5. ACRE, 2004. Guidance on Best Practice in the Design of Post-market monitoring Plans in Submissions to the Advisory Committee on Releases to the Environment. ACRE Guidance Note 16. www.defra.gov.uk/environment/acre/postmarket/acre_postmarketmonitor-guidance.pdf
6. Cellini, F., Chesson, A., Colquhoun, I., Constable, A., Davies, H.V., Engel, K.H., Gatehouse, A.M.R., Kärenlampi, S., Kok, E.J., Leguay, J.-J., Lehesranta, S., Noteborn, H.P.J.M., Pedersen, J., Smith, M., 2004. Unintended effects and their detection in genetically modified crops. Food and Chemical Toxicology, 42: 1089–1125.
7. Clark, J. H. and Ipharraguerre I. R. 2001. Livestock performance: Feeding biotech crops. J. Dairy Sci. 84 (E. Suppl.): E9–E18.
8. Codex Alimentarius, 2001. Codex Alimentarius Commission – Procedural Manual – Twelfth Edition. www.fao.org/DOCREP/005/Y2200E/y2200e00.htm#Contents
9. Codex Alimentarius, 2003. Codex principles and guidelines on foods derived from biotechnology. Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, Food and Agriculture Organisation: Rome. ftp://ftp.fao.org/codex/standard/en/CodexTextsBiotechFoods.pdf
10. Den Nijs, H. and Bartsch, D., 2004. Introgression of GM plants and the EU Guidance Note for monitoring. In: Den Nijs, H., Bartsch, D., and Sweet, J. (eds.) Introgression from Genetically Modified Plants into wild relatives and its consequences. CABI: 365–390.
11. EC, 1970. Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs. Official Journal of the European Communities. L 270: 1–17. europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=gN&numdoc=31970L0524&model=luichett
12. EC, 1982. Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition. Official Journal of the European Communities. L 213: 8–14. europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=gN&numdoc=31982L0471&model=luichett
13. EC, 1988. Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production. Official Journal of the European Communities L 184: 61–66. europe.eu.int/servlet/portail/RenderServlet?search=hefPub&lg=gn&nb_docs=25&domain=&in_force=eO&year=1988&month=&day=&coll=lO&nu_jo=184&page=61
14. EC, 1989. Council Directive 89/107/EEC of 21 December 1988 on the approximation of laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption. Official Journal of the European Communities L 40: 27–33. europe.eu.int/servlet/portail/RenderServlet?search=hefPub&lg=gn&nb_docs=25&domain=&in_force=eO&year=1989&month=&day=&coll=lO&nu_jo=40&page=27
15. EC, 1990a. Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms. Official Journal of the European Communities L 117: 1–14. europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=gN&numdoc=31990L0219&model=luichett
16. EC, 1990b. Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms. Official Journal of the European Communities L 117: 15–27. europe.eu.int/servlet/portail/RenderServlet?search=hefPub&lg=gn&nb_docs=25&domain=&in_force=eO&year=1990&month=&day=&coll=lOL&nu_jo=117&page=15
17. EC, 1991. Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. Official Journal of the European Communities L 230: 1–32. europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=gN&numdoc=31991L0414&model=luichett
18. EC, 1993. Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Official Journal of the European Communities L 214: 1–21. europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=gN&numdoc=31993R2309&model=luichett
19. EC, 1998. Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms. Official Journal of the European Communities L 330: 13–31. europa.eu.int/eur-lex/pri/en/oj/dat/1998/l_330/l_33019981205en00130031.pdf
20. EC, 2000a. Report of the Scientific Steering Committee's Working Group on Harmonisation of Risk Assessment Procedures in the Scientific Committees advising the European Commission in the area of human and environmental health - 26–27 October 2000. europa.eu.int/comm/food/fs/sc/ssc/out83_en.pdf
21. Appendices: europa.eu.int/comm/food/fs/sc/ssc/out84_en.pdf
22. EC, 2000b. Risk assessment in a rapidly evolving field: the case of genetically modified plants. Opinion expressed by the Scientific Steering Committee on 26/27 October 2000. europa.eu.int/comm/food/fs/sc/ssc/out148_en.pdf
23. EC, 2000c. Communication from the Commission on the Precautionary Principle, COM (2000) 1 final. europa.eu.int/eur-lex/en/com/cnc/2000/com2000_0001en01.pdf
24. EC, 2001a. 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. Official Journal of the European Communities L 106: 1–39. europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_106/l_10620010417en00010038.pdf
25. EC, 2001b. Commission Directive 2001/79/EC of 17 September 2001 amending Council Directive 87/153/EEC fixing guidelines for the assessment of additives in animal nutrition europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_267/l_26720011006en00010026.pdf
26. EC, 2001c. Directive 2001/79/EEC fixing guidelines for the assessment of additives in animal nutrition. Official Journal L 267, 6/10/2001 p 1-26. europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_267/l_26720011006en00010026.pdf
27. EC, 2002a. Commission Decision (2002/623/EC) of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Official Journal of the European Communities L 200: 22–33. europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_200/l_20020020730en00220033.pdf
28. EC, 2002b. Council Decision (2002/811/EC) of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Official Journal of the European Communities L 280: 27–36. europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_280/l_28020021018en00270036.pdf
29. EC, 2002c. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Official Journal of the European Communities L 31: 1–24. europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_031/l_03120020201en00010024.pdf
30. EC, 2002d. Policy areas: the directive on dangerous substances. European Commission 2002, Brussels. europa.eu.int/comm/environment/dansub/home_en.htm
31. EC, 2002e. Council Decision 2002/812/EC of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products. Official Journal of the European Communities L 280: 37–61. europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_280/l_28020021018en00370061.pdf
32. EC, 2002f. Council Directive 2002/53/EC of 13 June 2002on the common catalogue of varieties of agricultural plant species. Official Journal of the European Communities L 193: 1–11. europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_193/l_19320020720en00010011.pdf
33. EC, 2002g. Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed. Official Journal of the European Communities L 193: 33–59. europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_193/l_19320020720en00330059.pdf
34. EC, 2003a. Regulation (EC) 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. Official Journal of the European Communities L 268: 1–23. europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00010023.pdf
35. EC, 2003b. Regulation (EC) 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. Official Journal of the European Communities L 268: 24–28. europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00240028.pdf
36. EC, 2003c. Regulation (EC) 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. Official Journal of the European Communities L 268: 29–43. europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00290043.pdf
37. EC, 2003d. Guidance document for the risk assessment of genetically modified plants and derived food and feed, prepared by the Joint Working Group on Novel Foods and GMOs, 6–7 March 2003. europa.eu.int/comm/food/fs/sc/ssc/out327_en.pdf
38. EC, 2003e. Commission Decision 2003/701/EC of 29 September 2003 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market. Official Journal of the European Communities L 254: 21–28. europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_254/l_25420031008en00210028.pdf
39. EC, 2004a. Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. Official Journal of the European Communities L 50: 44–59. europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_050/l_05020040220en00440059.pdf
40. EC, 2004b. Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorization of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has been benefited from a favourable risk evaluation. Official Journal of the European Communities L 102: 14–25. europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_102/l_10220040407en00140025.pdf
41. EC, 2004c. Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_143/l_14320040430en00560075.pdf
42. EFSA, 2002. Decision of the Management Board of the European Food Safety Authority concerning the establishment and operations of the Scientific Committee and Panels. www.efsa.eu.int/mboard/mb_meetings/86/decision_panels_mb_04_en1.pdf
43. EFSA, 2003. 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). The EFSA Journal (2003) 10, 1–13. www.efsa.eu.int/science/gmo/gmo_opinions/176_en.html
44. EFSA, 2004. Opinion of the Scientific Panel on Genetically Modified Organisms on the use of antibiotic resistance genes as marker genes in genetically modified plants. The EFSA Journal, 48, 1–18. www.efsa.eu.int/science/gmo/gmo_opinions/384/opinion_gmo_05_en1.pdf
45. EFSA, 2004a. Guidance document for the risk assessment of genetically modified plants and derived food and feed, prepared by the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority, September 2004. www.efsa.eu.int/science/gmo/gmo_guidance/660/guidance_docfinal1.pdf
46. EFSA, 2004b. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the Notification (Reference C/NL/98/11) for the placing on the market of herbicide-tolerant oilseed rape GT73, for import and processing, under Part C of Directive 2001/18/EC from Monsanto. (Question N° EFSA-Q-2003-078). The EFSA Journal (2004) 29, 1–19. www.efsa.eu.int/science/gmo/gmo_opinions/174_en.html
47. EFSA, 2004c. Opinion of the GMO Panel related to the Notification for the placing on the market of insect-protected genetically modified maize MON 863 × MON 810, for import and processing, under Part C of Directive 2001/18/EC from Monsanto. (Question No EFSA-Q-2003-089). The EFSA Journal (2004) 251, 1–22. www.efsa.eu.int/science/gmo/gmo_opinions/1030/gmo_opinion_ej251_mon863x810_en1.pdf
48. EFSA, 2004d. Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the notification (Reference C/NL/00/10) for the placing on the market of insect-tolerant genetically modified maize 1507, for import and processing, under Part C of Directive 2001/18/EC from Pioneer Hi-Bred International/Mycogen Seeds. (Question No EFSA-Q-2004-011). The EFSA Journal (2004) 124, 1–18. www.efsa.eu.int/science/gmo/gmo_opinions/663/finalopinion1507maize_import2.pdf
49. EFSA, 2005a. 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 × MON 810, for import and processing, under Part C of Directive 2001/18/EC from Monsanto. (Question No EFSA-Q-2003-089). The EFSA Journal (2005) 251, 1–22. www.efsa.eu.int/science/gmo/gmo_opinions/1030/gmo_opinion_ej251_mon863x810_en1.pdf
50. EFSA, 2005b. Opinion of the Scientific Panel on Genetically Modified Organisms on an application (reference EFSA GMO BE 2004 07) for the placing on the market of insect protected glyphosate-tolerant genetically modified maize MON 863 × MON 810 × NK603, for food and feed use, import and processing under Regulation (EC) No 1829/2003 from Monsanto. (Question No EFSA-Q-2004-159). The EFSA Journal (2005) 256, 1–25. www.efsa.eu.int/science/gmo/gmo_opinions/1033/gmo_opinion_ej256_mon863xmon810xnk603_en1.pdf
51. EFSA, 2005c. Opinion of the GMO Panel r elated to the application (Reference C/BE/96/01) for the placing on the market of glufosinate-tolerant hybrid oilseed rape Ms8 × Rf3, derived from genetically modified parental lines (Ms8, Rf3), for import and processing for feed and industrial uses, under Part C of Directive 2001/18/EC from Bayer CropScience. (Question No EFSA-Q-2005-003). The EFSA Journal (2005) 281, 1–23. www.efsa.eu.int/science/gmo/gmo_opinions/1178/gmo_op_ej281_ms8xrf3_1.pdf
52. EFSA, 2005d. Opinion of the GMO Panel related to the notification for the placing on the market of insect resistant genetically modified maize Bt11, for cultivation, feed and industrial processing. (Question No EFSA-Q-2004-012). The EFSA Journal (2005) 213, 1–33. www.efsa.eu.int/science/gmo/gmo_opinions/922/gmo_opinion_ej213_bt11maize_cultivation_en1.pdf
53. EFSA, 2005e. Opinion of the GMO Panel related to the notification (Reference C/ES/01/01) for the placing on the market of insect-tolerant genetically modified maize 1507 for import, feed and industrial processing and cultivation, under Part C of Directive 2001/18/EC from Pioneer Hi-Bred International/Mycogen Seeds. (Question No EFSA-Q-2004-072). The EFSA Journal (2005) 181, 1–33. www.efsa.eu.int/science/gmo/gmo_opinions/827/op_gm08_ej181_1507_opinion_doc1_2en1.pdf
54. Ellstrand, N.C., Prentice, H.C., and Hancock, J.F., 1999. Gene flow and introgression from domesticated plants into their wild relatives. Annual Review in Ecology and Systematics 30: 539–563.
55. ENTRANSFOOD, 2004. European Network on Safety Assessment of Genetically Modified Food Crops. Food and Chemical Toxicology 42, 7, Safety Assessment, Detection and Traceability, and Societal Aspects of Genetically Modified Foods.
56. FAO, 2005. Genetically modified organisms in crop production and their effects on the environment: methodologies for monitoring and the way ahead. Expert consultation 18–20 January 2005. Food and Agriculture Organization Rome, Italy. www.fao.org/docrep/008/ae738e/ae738e00.htm#TopOfPage
57. Flachowsky, G., and Aulrich K., 2001. Nutritional assessment of feeds from genetically modified organisms. J. Anim. Feed Sci. 10 (Suppl. 1): 181–194.
58. FOSIE, 2002. Food Safety In Europe. Food and Chemical Toxicology 40, 2/3, 137–427. Risk Assessment of Chemicals in Food and Diet.
59. FOSIE, 2003. Food Safety In Europe. Food and Chemical Toxicology 41, 9, 1211–1271. Risk Characterisation of Chemicals in Food and Diet.
60. Fu, T-J., Abbott, U.R., and Hatzos, C., 2002. Digestibility of food allergens and non-allergenic proteins in simulated gastric fluid and simulated intestinal fluid – a comparative study. J. Agric. Food Chem. 50 (24): 7154–60.
61. Gebhard, F. and Smalla, K., 1998. Transformation of Acinetobacter sp. strain BD413 by transgenic sugar beet DNA. Appl Environ Microbiol. 64: 1550–1554.
62. Holm, S., 1998. NETTOX list of food plants prioritised for inclusion in a future European database. Report no.6 (of 9). EU-AIR concerted action CT 94 2185, information on inherent food plant toxicants. Danish Veterinary and Food Administration, Søborg.
63. ILSI, 2003a. Best practices for the conduct of animal studies to evaluate crops genetically modified for input traits. International Life Sciences Institute, Washington, D.C. 62 p. www.ilsi.org/file/bestpracticescas.pdf
64. ILSI, 2003b. Crop Composition Database. Accessed 2003 Jul 14. www.cropcomposition.org
65. ILSI, 2004. Nutritional and safety assessments of foods and feeds nutritionally improved through biotechnology. Comprehensive Reviews of Food Science and Food Safety. Vol. 3, 2004. www.ift.org/pdfs/crfsfs/crfsfsv3n2p0035-0104ms20040106.pdf
66. Kok, E. and Kuiper H.A., 2003. Comparative Safety Assessment for Biotech Crops. Trends in Biotechnology. 21 (10): 439–444.
67. König, A., Cockburn, A., Crevel, R.W.R., Debruyne, E., Grafstroem, R., Hammerling, U., Kimber, I., Knudsen, I., Kuiper, H.A., Peijnenburg, A.A.C.M., Penninks, A.H., Poulsen, M., Schauzu, M., Wal, J.M., 2004. Assessment of the safety of foods derived from genetically modified (GM) crops. Food and Chemical Toxicology, 42: 1047–1088.
68. Kuiper H.A., Kleter G.A., Noteborn H. P. J. M., and Kok E.J., 2001. Assessment of the food safety issues related to genetically modified foods. The Plant Journal, 27: 503–528. www.blackwellpublishing.com/plantgm/tpj1119.pdf
69. Kuiper, H.A., Kok, E.J., and Engel, K.H., 2003. Exploitation of molecular profiling techniques for GM food safety assessment. Current Opinion in Biotechnology, 14: 238–243.
70. Marvier, M., 2002. Improving risk assessment for nontarget safety of transgenic crops. Ecological Applications, 12 (4): 1119–1124.
71. Mills E. N. C., Madsen C., Shewry P.R. and Wichers, 2003. Foods allergens of plant origin-their molecular and evolutionary relationships (Review). Trends in Food Science and Technology, 14: 145–156.
72. Nannipieri, P., Ascher, J., Ceccherini, M. T., Landi, L., Pietramellara, G. and Renella, G., 2003. Microbial diversity and soil functions. European Journal of Soil Science, 54: 655–670.
73. Nielsen, K.M., Gebhard, F., Smalla, K., Bones, A.M. and van Elsas, J.D., 1997. Evaluation of possible horizontal gene transfer from transgenic plants to the soil bacterium Acinetobacter calcoaceticus BD413. Theor. Appl. Genet. 95: 815–821.
74. Nielsen, K.M. and Townsend, J.P., 2004. Monitoring and modeling horizontal gene transfer. Nature Biotechnology, 22: 1110–1114.
75. OECD a. Consensus Documents for the work on the Safety of Novel Foods and Feeds, OECD. www.oecd.org/document/9/0,2340,en_2649_34391_1812041_1_1_1_37437,00.html
76. OECD b. OECD guidelines for the testing of chemicals. OECD, Paris. www.oecd.org/document/13/0,2340,en_2649_34377_2740429_1_1_1_1,00.html
77. OECD, 1993a. Safety Considerations for Biotechnology: Scale-up of Crop Plants. OECD, 1993. www.oecd.org/dataoecd/26/26/1958527.pdf?channelId=34537&homeChannelId=33703&fileTitle=eafety+Considerations+for+Biotechnology+Scale-up+of+Crop+Plants
78. OECD, 1993b. Safety evaluation of foods derived by modern biotechnology: concept and principles. OECD, 1993. www.oecd.org/dataoecd/57/3/1946129.pdf?channelId=34537&homeChannelId=33703&fileTitle=eafety+Evaluation+of+Foods+Derived+by+Modern+Biotechnology+-+Concepts+and+Principles
79. OECD, 1995. OECD Guidelines for the Testing of Chemicals. Test No. 407: Repeated Dose 28-day Oral Toxicity Study in Rodents (adopted 27th July 1995).
80. OECD, 2003. Considerations for the safety assessment of animal feedstuffs derived from genetically modified plants. OECD, 2003 (ENV/JM/MONO(2003)10). www.olis.oecd.org/olis/2003doc.nsf/43bb6130e5e86e5fc12569fa005d004c/4502bee1ca16c943c1256d520028e259/$FILE/JT00147696.PDF
81. Perry, J.N., Rothery P., Clark, S.J., Heard, M. and Hawes, C., 2003. Design, analysis and statistical power of the Farm-Scale Evaluations of genetically modified herbicide-tolerant crops. Journal of Applied Ecology, 40: 17–31.
82. Saeglitz, C. and Bartsch, D., 2002. Plant gene flow consequences. AgBiotechNet 4, ABN 084. www.agbiotechnet.com/reviews/Abstract.asp?ID=40
83. Sanvido, O., Bigler, F., Widmer F. and Winzeler, M., 2004. Umweltmonitoring Gentechnisch Veränderter Pflanzen in der Schweiz. Schriftenreihe der FAL/Les Cahiers de la FAL 51. Agroscope FAL Reckenholz (in German).
84. Sanvido, O., Widmer, F., Winzeler, M. and Bigler, F., 2005. A conceptual framework for the design of environmental post-market monitoring of genetically modified plants. Environmental Biosafety Research 4 (2005) 13–27.
85. SCAN, 2001. Guidelines for the assessment of additives in feedingstuffs. Part II: Enzymes and micro-organisms. Opinion of the Scientific Committee on Animal Nutrition. europe.eu.int/comm/food/fs/sc/scan/out68_en.pdf
86. SCF, 1992. Guidelines for the presentation of data on food enzymes (opinion expressed 11 April 1991). 27th report series (1992) p. 13–22. GMO section 2.4 on p. 16. www.europa.eu.int/comm/food/fs/sc/scf/reports/scf_reports_27.pdf
87. SCF, 2001a. Guidance on submissions for food additive evaluations. Opinion of the Scientific Committee on Food. SCF/CS/ADD/GEN/26 Final, 12 July 2001, Brussels. europa.eu.int/comm/food/fs/sc/scf/out98_en.pdf
88. SCF, 2001b. Guidance on submissions for safety evaluation of sources of nutrients or of other ingredients proposed for use in the manufacture of foods, Opinion of the Scientific Committee on Food. SCF/CS/ADD/NUT/21 Final, 12 July 2001. europa.eu.int/comm/food/fs/sc/scf/out100_en.pdf
89. SCP, 1999. Opinion of the SCP on Bt - Resistance monitoring. Opinion expressed on 4 March 1999. europa.eu.int/comm/food/fs/sc/scp/out35_en.html
90. SSC, 2000. First Report of the Scientific Steering Committee on the Harmonisation of Risk Assessment Procedures. European Commission, Health & Consumer Protection Directorate-General. europa.eu.int/comm/food/fs/sc/ssc/out83_en.pdf Appendices: http://europa.eu.int/comm/food/fs/sc/ssc/out84_en.pdf
91. SSC, 2003. Second Report of the Scientific Steering Committee on the Harmonisation of Risk Assessment Procedures. European Commission, Health & Consumer Protection Directorate-General. europa.eu.int/comm/food/fs/sc/ssc/out361_en.pdf
92. Appendix 1: europa.eu.int/comm/food/fs/sc/ssc/out361_app1_en.pdf
93. Appendix 2: europa.eu.int/comm/food/fs/sc/ssc/out361_app2_en.pdf
94. Appendix 3: europa.eu.int/comm/food/fs/sc/ssc/out361_app3_en.pdf
95. Appendix 4: europa.eu.int/comm/food/fs/sc/ssc/out361_app4_en.pdf
96. Appendix 5: europa.eu.int/comm/food/fs/sc/ssc/out361_app5_en.pdf
97. Appendix 6: europa.eu.int/comm/food/fs/sc/ssc/out361_app6_en.pdf
98. Appendix 7: europa.eu.int/comm/food/fs/sc/ssc/out361_app7_en.pdf
99. Squire G.R., Brooks D.R., Bohan D.A., Champion G.T., Daniels R.E., Haughton A.J., Hawes C, Heard M.S., Hill M.O., May M.J., Osborne J.L., Perry J.N., Roy D.B., Woiwod I.P., and Firbank L.G., 2003. On the rationale and interpretation of the farm scale evaluations of genetically modified herbicide-tolerant crops. Phil Trans R Soc Lond B 358: 1179–1799. (and 8 associated papers by different authors in Phil Trans R Soc Lond B 358).
100. Wal J.-M., Hepburn P.A., Lea L.J., and Crevel R.W.R., 2003. Post-market surveillance of GM foods: Applicability and limitations of schemes used with pharmaceuticals and some non GM Novel Foods. Regulatory Toxicology and Pharmacology; 38: 98–104.
101. WHO/FAO, 2000. Safety aspects of genetically modified foods of plant origin. Report of a joint FAO/WHO expert consultation on foods derived from biotechnology, 29 WHO/FAO, 2000. www.fao.org/es/ESN/food/pdf/gmreport.pdf http://www.fao.org/es/esn/food/risk_biotech_aspects_en.stm
102. WHO/FAO, 2001. FAO/WHO expert consultation on foods derived from biotechnology. Evaluation of allergenicity of genetically modified foods. WHO/FAO, January 2001, Rome. www.who.int/foodsafety/publications/biotech/en/ec_jan2001.pdf http://www.fao.org/es/esn/food/risk_biotech_allergen_en.stm
103. Wilhelm, R., Beißner, L., Schiemann, J., 2003. Concept for the Realisation of a GMO Monitoring in Germany. Updated English version of “Konzept zur Umsetzung eines GVO-Monitoring in Deutschland”, Nachrichtenblatt des Deutschen Pflanzenschutzdienstes, 55: 258–272. www.biosicherheit.de/pdf/dokumente/bba_monitoring.pdf
104. Wilhelm, R., Beißner, L., Schmidt, K., Schmidtke, J., Schiemann, J., 2004a. Monitoring of the cultivation of genetically modified plants - Use of farmers’ questionnaires. Nachrichtenblatt des Deutschen Pflanzenschutzdienstes, 56: 184–188, with supplement: www.bba.de/abm-gvp/questgmmaize040823.pdf
105. Wilhelm, R., Beißner, L., Schmidt, K., Schmidtke, J., Schiemann, J., 2004b. Biometrical analysis of farmers’ questionnaires for the monitoring of the cultivation of genetically modified maize varieties – statistical evaluation of monitoring objectives. Nachrichtenblatt des Deutschen Pflanzenschutzdienstes, 56: 206–212.
106. Wilkinson, M.J., Sweet, J.B. and Poppy, G., 2003. Preventing the regulatory log jam; the tiered approach to risk assessments. Trends in Plant Science, 8, (5) 208–212.