1 European Commission. A Decade of EU-funded GMO Research 2001–2010 (EU, Luxemburg, 2010).

2 Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety. (FAO, Rome; 30 September to 4 October 1996).

3 Marden, E. Risk and regulation: US regulatory policy on genetically modified food and agriculture. Boston Coll. Law Rev. 44, 733–787 (2003).

4 European Council adopted Directive 90/220/EEC Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms.

5 Coordinated Framework for Regulation of Biotechnology 51 Fed. Reg. 23302, June 26, 1986.

6 Food, F. Drug and Cosmetic Act, United States Code, 2006 Edition, Supplement 3 http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm

7 Guidance to Industry for Foods Derived from New Plant Varieties, FDA Federal Register Volume 57 – 1992 Friday, May 29, 1992.

8 EFSA GMO Working Panel. Safety and nutritional assessment of GM plants and derived foods: the role of animal feeding trials. Food Chem. Toxicol. 46, S2–S70 (2008).

9 Kuiper, H.A., Kok, E.J. & Davies, H.V. New EU legislation for risk assessment of GM food: no scientific justification for mandatory animal feeding trial. Plant Biotechnol. J. doi:10.1111/pbl12091 (21 June 2013).

10 Herman, R.A. & Price, W.D. Unintended compositional changes in genetically modified crops: 20 years of research. J. Agric. Food Chem. doi:10.1021/jf400135r (15 February 2013).

11 Herman, R.A. et al. Value of eight amino acid matches in predicting allergenicity status of proteins: an empirical bioinformatic investigation. Clin. Mol. Allergy 7, 9 (2009).

12 EFSA Panel on Genetically Modified Organisms (GMO). Scientific Opinion on Guidance for risk assessment of food and feed from genetically modified plants. EFSA Journal 2011; 9(5): 2150. [37 pp.]

13 Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology. Evaluation of Allergenicity of Genetically Modified Foods (FAO, Rome; 22–25 January 2001).

14 Nordlee, J.A. et al. Identification of a Brazil nut allergen in transgenic soybeans. N. Engl. J. Med. 334, 688–692 (1996).

15 Committee on Identifying and Assessing the Unintended Effects of Genetically Engineered Food on Human Health. Safety of Genetically Engineered Foods (The National Academies Press, Washington, DC, 2004).

16 EFSA GMO Working Panel. Safety and nutritional assessment of GM plants and derived foods: the role of animal feeding trials. Food and Chemical Toxicology, 46, S2-70 (2008).

17 Kuiper, H.A. et al. Assessment of food safety issues related to genetically modified foods. Plant J. 27, 503–528 (2001).

18 Barros, E. et al. Comparison of two GM maize varieties with a near isogenic non-GM variety using transcriptomics, proteomics and metabolomics. Plant Biotechnol. J. 8, 436–451 (2012).

19 Betton, G. et al. A critical review of the optimum duration of chronic rodent testing for the determination of non-tumourigenic toxic potential: a report by the BTS Working Party on Duration of Toxicity Testing. Hum. Exp. Toxicol. 13, 221–232 (1994).

20 Seralini, G.E. et al. Long-term toxicity of a Roundup herbicide and a Roundup tolerant genetically modified maize. Food Chem. Toxicol. 50, 4221–4231 (2012).

21 Snell, C. et al. Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: a literature review. Food Chem. Toxicol. 50, 1134–1148 (2012).

22 Domingo, J.L. & Bordonaba, J.G. A literature review on the safety assessment of genetically modified plants. Environ. Int. 37, 734–742 (2011).

23 Brake, D.G. & Evenson, D.P. A generational study of glyphosate-tolerant soybeans on mouse fetal, postnatal, pubertal and adult testicular development. Food Chem. Toxicol. 42, 29–36 (2004).

24 Brake, D.G., Thaler, R. & Evenson, D.P., Evaluation of Bt. (Bacillus thuringiensis) corn on mouse testicular development by dual parameter flow cytometry. J. Agric. Food Chem. 52, 2097–2102 (2004).

25 Brasil, F.B. et al. The impact of dietary organic and transgenic soy on the reproductive system of female adult rat. Anat. Rec. 292, 587–594 (2009).

26 Buzoianu, S.G. et al. Transgenerational effects of feeding genetically modified maize to nulliparous sows and offspring on offspring growth and health. J. Anim. Sci. 91, 318–330 (2013).

27 Buzoianu, S.G. et al. Effects of feeding Bt maize to sows during gestation and lactation on maternal and offspring immunity and fate of transgenic material. PLoS ONE 7, e47851 (2012).

28 Walsh, M.C. et al. Effects of feeding Bt MON810 maize to pigs for 110 days on peripheral immune response and digestive fate of the cry1Ab gene and truncated Bt Toxin. PLoS ONE 7, e36141 (2012).

29 Walsh, M.C. et al. Effects of feeding Bt MON810 maize to sows during first gestation and lactation on maternal and offspring health indicators. Br. J. Nutr. 109, 873–881 (2013).

30 Buzoianu, S.G. et al. Effect of feeding genetically modified Bt MON810 maize to ∼40-day-old pigs for 110 days on growth and health indicators. Animal 6, 1609–1619 (2012).

31 Buzoianu, S.G. et al. The effect of feeding Bt MON810 maize to pigs for 110 days on intestinal microbiota. PLoS ONE 7 e33668 (2012).

32 Daleprane, J.B., Feijó, T.S. & Boaventura, G.T. Organic and genetically modified soybean diets: consequences in growth and in hematological indicators of aged rats. Plant Foods Hum. Nutr. 64, 1–5 (2009).

33 Daleprane, J.B., Pacheco, J.T. & Boaventura, G.T. Evaluation of protein quality from genetically modified and organic soybean in two consecutives generations of Wistar rats. Braz. Arch. Biol. Technol. 52, 841–847 (2009).

34 Daleprane, J.B., Chagas, M.A., Vellarde, G.C., Ramos, C.F. & Boaventura, G.T. The impact of non- and genetically modified soybean diets in aorta wall remodeling. J. Food Sci. 75, 126–131 (2010).

35 Haryu, Y. et al. Longterm biosafety assessment of a genetically modified (GM) plant: the genetically modified (GM) insect-resistant Bt11 corn does not affect the performance of multi-generations or life span of mice. Open Plant Sci. J. 3, 49–53 (2009).

36 Kilic, A. & Akay, M.T. A three-generation study with genetically modified Bt corn in rats: biochemical and histopathological investigation. Food Chem. Toxicol. 46, 1164–1170 (2008).

37 Krzyzowska, M. et al. The effect of multigenerational diet containing genetically modified triticale on immune system in mice. Pol. J. Vet. Sci. 13, 423–430 (2010).

38 Battistelli, S., Citterio, B., Baldelli, B., Parlani, C. & Malatesta, M. Histochemical and morphometrical study of mouse intestine epithelium after a long term diet containing genetically modified soybean. Eur. J. Histochem. 54, 154–157 (2010).

39 Malatesta, M. et al. Fine structural analyses of pancreatic acinar cell nuclei from mice fed ongenetically modified soybean. Eur. J. Histochem. 47, 385–388 (2003).

40 Malatesta, M. et al. A long-term study on female mice fed on a genetically modified soybean: effects on liver ageing. Histochem. Cell Biol. 130, 967–977 (2008).

41 Malatesta, M. et al. Ultrastructural morphometrical and immunocytochemical analyses of hepatocyte nuclei from mice fed on genetically modified soybean. Cell Struct. Funct. 27, 173–180 (2002).

42 Malatesta, M. et al. Ultrastructural analysis of pancreatic acinar cells from mice fed on genetically modified soybean. J. Anat. 201, 409–415 (2002).

43 Malatesta, M. et al. Reversibility of hepatocyte nuclear modifications in mice fed on genetically modified soybean Eur. J. Histochem Jul-Sep 49, 237–242 (2005).

44 Vecchio, L., Cisterna, B., Malatesta, M., Martin, T.E. & Biggiogera, M. Ultrastructural analysis of testes from mice fed on genetically modified soybean. Eur. J. Histochem. 48, 448–454 (2004).

45 Séralini, G.E. et al. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem. Toxicol. 50, 4221–4231 (2012).

46 Rhee, G.S. et al. Multigeneration reproductive and developmental toxicity study of bar gene inserted into genetically modified potato on rats. J. Toxicol. Environ. Health A 68, 2263–2276 (2005).

47 Sakamoto, Y. et al. A 52-week feeding study of genetically modified soybeans in F344 rats. J. Food Hyg. Soc. Japan 48, 41–50 [article in Japanese] (2007).

48 Sissener, N.H., Sanden, M., Bakke, A.M., Krogdahl, A. & Hemre, G.-I. A long term trial with Atlantic salmon (Salmo salar L.) fed genetically modified soy; focusing general health and performance before, during and after the parr–smolt transformation. Aquaculture 294, 108–117 (2009).

49 Steinke, K. et al. Effects of long-term feeding of geneticallymodified corn (event MON810) on the performance of lactating dairy cows. J. Anim. Physiol. Anim. Nutr. (Berl.) 94, 185–193 (2010).

50 Trabalza-Marinucci, M. et al. A three year longitudinal study on the effects of a diet containing genetically modified Bt176 maize on the health status and performance on sheep. Livest. Sci. 113, 178–190 (2008).

51 Tudisco, R. et al. Fate of transgenic DNA and evaluation of metabolic effects in goats fed genetically modified soybean and in their offsprings. Animal 1, 10 (2010).