Guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects

EFSA Journal

Volumn 10, Issue 1, 2012, Pages

[No Author Info available]

Author keywords

animal health and welfare assessment; applications; comparative approach; feed safety; food safety; GM animals; guidance; Regulation (EC) No 1829 2003; risk assessment

Indexed keywords

EID: 85053226367     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2012.2501     Document Type: Article

References (32)

1. Cochran WG and Cox GM, 1957. Experimental designs. XIV, 611 pp.
2. Codex Alimentarius, 2003. Codex principles and guidelines on foods derived from biotechnology. Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, Food and Agriculture Organization, Rome. Available from www.who.int/foodsafety/biotech/codex_taskforce/en/index.html
3. Codex Alimentarius, 2008. Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex Commission, Joint FAO/WHO Food Standards Programme, Food and Agriculture Organisation: Rome. Available from www.codexalimentarius.net/download/standards/11023/CXG_068e.pdf
4. Codex Alimentarius, 2009. Foods derived from modern biotechnology. Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, Rome. www.fao.org/docrep/011/a1554e/a1554e00.htm
5. Codex Alimentarius, 2011. Codex Alimentarius Commission Procedural Manual, 20th Edition. Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, Rome. Available from ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_20e.pdf
6. EC (European Commission), 2002. Policy areas: the directive on dangerous substances. Available from ec.europa.eu/environment/chemicals/dansub/home_en.htm
7. EFSA (European Food Safety Authority), 2006. Guidance of the Scientific Committee on a request from EFSA related to uncertainties in dietary exposure assessment. EFSA Journal, 438, 54 pp.
8. EFSA (European Food Safety Authority), 2007. Opinion of the Scientific Panel on Biological Hazards on a request from the European Parliament on certain aspects related to the feeding of animal proteins to farm animals. EFSA Journal, 576, 41 pp.
9. EFSA (European Food Safety Authority), 2008. EFSA GMO Panel Working Group on Animal Feeding Trials. Safety and nutritional assessment of GM plants and derived food and feed: The role of animal feeding trials. Food and Chemical Toxicology, 46, S2–S70.
10. EFSA (European Food Safety Authority), 2010a. EFSA Panel on Genetically Modified Organisms (GMO). Scientific opinion on statistical considerations for the safety evaluation of GMOs. EFSA Journal, 8 (1): 1250, 59 pp.
11. EFSA (European Food Safety Authority), 2010b. EFSA Panel on Genetically Modified Organisms (GMO). Scientific Opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed. EFSA Journal, 8 (7): 1700, 168 pp.
12. EFSA (European Food Safety Authority), 2011a. Scientific Opinion of the Panel on Genetically Modified Organisms (GMO) on guidance for risk assessment of food and feed on genetically modified plants. EFSA Journal, 9 (5): 2150, 37 pp.
13. EFSA (European Food Safety Authority), 2011b. Scientific Opinion of the Scientific Committee on guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed. EFSA Journal, 9 (12): 2438, 21 pp.
14. EFSA (European Food Safety Authority), 2011c. Guidance on Risk Assessment for Animal Welfare. In preparation. EFSA-Q-2007-00168.
15. Festing MFW and Altman DG, 2002. Guidelines for the design and statistical analysis of experiments using laboratory animals. Institute for Laboratory Animal Research Journal, 43 (4), 244–258.
16. Fu TJ, Abbott UR and Hatzos C, 2002. Digestibility of food allergens and nonallergenic proteins in simulated gastric fluid and simulated intestinal fluid - a comparative study. Journal of Agricultural and Food Chemistry, 50, 7154–7160.
17. ILSI (International Life Sciences Institute), 2007. Best practices for the conduct of animal studies to evaluate crops genetically modified for output traits. Int. Life Sci. Inst., Washington, DC. 194 pp.
18. Johnson PD and Besselsen DG, 2002. Practical aspects of experimental design in animal research. Institute for Laboratory Animal Research Journal, 43 (4), 202–206.
19. Kok E and Kuiper HA, 2003. Comparative safety assessment for biotech crops. Trends in Biotechnology, 21 (10), 439–444.
20. OECD (Organisation for Economic Co-operation and Development), 1993. Safety considerations for biotechnology: scale up of crop plants. OECD, Paris, 1–43. Available from www.oecd.org/dataoecd/26/26/1958527.pdf
21. Perry JN, Braak CJF, Dixon PM, Duan JJ, Hails RS, Huesken A, Lavielle M, Marvier M, Scardi M, Schmidt K, Tothmeresz B, Schaarschmidt F and van der Voet H, 2009. Statistical aspects of environmental risk assessment of GM plants for effects on non-target organisms. Environmental Biosafety Research, 8 (2), 65–78.
22. Renwick AG, Barlow SM, Hertz-Picciotto I, Boobis AR, Dybing E, Edler L, Eisenbrand G, Greig JB, Kleiner J, Lambe J, Muller DJG, Smith MR, Tritscher A, Tuijtelaars S, van den Brandt PA, Walker R and Kroes R, 2003. Risk characterisation of chemicals in food and diet. Food and Chemical Toxicology, 41 (9), 1211–1271.
23. Richardson CR, Nunnery GA, Wester DB, Cole NA and Galyean ML, 2004. Power of test considerations for beef cattle experiments: a review. Journal of Animal Science, 82 (E-suppl), E214–E222.
24. Smith M, 2002. Food safety in Europe (FOSIE): Risk assessment of chemicals in food and diet. Food and Chemical Toxicology, 40 (2–3), 141–144.
25. Taylor SCS, 1985. Use of genetic size-scaling in evaluation of animal growth. Journal of Animal Science, 61, 118–143.
26. Thomas K, Aalbers M, Bannon GA, Bartels M, Dearman RJ, Esdaile DJ, Fu TJ, Glatt CM, Hadfield N, Hatzos C, Hefle SL, Heylings JR, Goodman RE, Henry B, Herouet C, Holsapple M, Ladics GS, Landry TD, MacIntosh SC, Rice EA, Privalle LS, Steiner HY, Teshima R, Van Ree R, Woolhiser M and Zawodny J, 2004. A multi-laboratory evaluation of a common in vitro pepsin digestion assay protocol used in assessing the safety of novel proteins. Regulatory Toxicology and Pharmacology, 39, 87–98.
27. Wal JM, Hepburn PA, Lea LJ and Crevel RW, 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.
28. ® Assessment Protocols for Cattle, Pigs and Poultry.
29. ® Consortium, Lelystad, The Netherlands. Available from www.welfarequality.net/everyone
30. Wellek S, 2002. Testing Statistical Hypotheses of Equivalence. CRC Press, ISBN 1584881607, 284 pp.
31. WHO (World Health Organization), 1991. Strategies for assessing the safety of foods produced by biotechnology, Report of a Joint FAO/WHO Consultation. World Health Organization, Geneva, Switzerland. Available from www.who.int/foodsafety/publications/biotech/en/1990.pdf
32. WHO (World Health Organization)/FAO (Food and Agriculture Organization), 2000. Safety aspects of genetically modified foods of plant origin. Report of a joint FAO/WHO expert consultation on foods derived from biotechnology, 29 May- 2 June 2000. Available from www.who.int/foodsafety/publications/biotech/en/ec_june2000_en.pdf