“It is not foreseen that EFSA carry out such [safety] studies as the onus is on the [GM industry] applicant to demonstrate the safety of the GM product in question.”
– European Food Safety Authority (EFSA)
“I suggest to biotechnology companies that they publish results of studies on the safety of GM foods in international peer-reviewed journals. The general population and the scientific community cannot be expected to take it on faith that the results of such studies are favourable. Informed decisions are made on the basis of experimental data, not faith.”
– Domingo JL. Health risks of GM foods: Many opinions but few data. Science. 2000; 288(5472): 1748–1749. 
In Europe, the European Food Safety Authority (EFSA) is given the task of assessing the safety of GM foods and crops. Based on EFSA’s assessment, the EU government authorities make the final decision on whether to approve or reject the GMO.
Typically the EU member states fail to agree on whether to approve a GM crop, with most voting not to approve it, but the vote does not achieve the “qualified majority” required to reject the GMO. The decision passes to the European Commission, which ignores the desires of the simple majority of the member states and approves the GMO.
Worldwide, safety assessments of GMOs by government regulatory agencies are not scientifically rigorous. As in the US, they do not carry out or commission their own tests on the GM crop. Instead, they make decisions regarding the safety of the GMO based on studies commissioned by the very same companies that stand to profit from the crop’s approval.
The problem with this system is that industry studies have an inbuilt bias. Published reviews evaluating studies assessing the safety/hazards of products show that industry-sponsored or industry-affiliated studies are more likely to conclude that the product is safe than independent (non-industry-affiliated) studies, which are more likely to find risk. The most notorious example is industry studies on tobacco, which succeeded in delaying regulation for decades by sowing confusion about the health effects of smoking.  But a similar bias has been found in studies on other products, including pharmaceuticals,[3,4] mobile phones – and GM crops and foods. [6,7]
Often the studies that companies submit to regulatory agencies have not been published in a peer-reviewed journal and so cannot be scrutinized by the public or independent scientists.
Serious problems in the GMO regulatory process identified by civil society groups include:
• Lack of standardized testing requirements
• Lack of mandatory animal feeding studies
• Absence of long-term safety studies
• Poor quality industry tests
• Reliance on industry test data
• Data gaps
• Inadquate test methods, meaning that toxic or allergenic effects will likely be missed
• Signs of toxicity and adverse effects in industry tests and independent scientific studies being ignored or dismissed by EFSA. [8,9,10]
In addition, EFSA experts have frequently been exposed as having conflicts of interest with the GM industry. Their decisions on GM foods and crops – and the regulatory system they helped develop – have been repeatedly challenged by civil society groups, independent scientists, the media, and Members of the European Parliament as meeting the needs of industry at the expense of public health. [9,11]
Labelling: GM foods and ingredients must be labelled in the EU. However, products such as meat, milk and eggs from animals fed on GM feed do not have to be labelled. This is an important loophole as most GM crops imported into the EU go into animal feed and thus remain ‘under the radar’ of the public.
1. Domingo JL. Health risks of GM foods: Many opinions but few data. Science. 2000; 288(5472): 1748–1749.
2. Michaels D. Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health: Oxford University Press; 2008.
3. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. British Medical Journal. 2003; 326: 1167.
4. Lexchin J. Those who have the gold make the evidence: How the pharmaceutical industry biases the outcomes of clinical trials of medications. Sci Eng Ethics. Feb 15 2011.
5. Huss A, Egger M, Hug K, Huweiler-Müntener K, Röösli M. Source of funding and results of studies of health effects of mobile phone use: Systematic review of experimental studies. Environmental Health Perspectives. January 2007; 115: 1–4.
6. Diels J, Cunha M, Manaia C, Sabugosa-Madeira B, Silva M. Association of financial or professional conflict of interest to research outcomes on health risks or nutritional assessment studies of genetically modified products. Food Policy. 2011; 36: 197–203.
7. Domingo JL, Bordonaba JG. A literature review on the safety assessment of genetically modified plants. Environ Int. Feb 4 2011; 37: 734–742.
8. Then C, Potthof C. Risk reloaded: Risk analysis of genetically engineered plants within the European Union. Testbiotech e.V., Institute for Independent Impact Assessment in Biotechnology. October 2009. http://foodfreedom.wordpress.com/2009/10/29/risk-reloaded-risk-analysis-of-genetically-engineered-plants-within-the-european-union/
9. Then C, Bauer-Panskus A. European Food Safety Authority: A playing field for the biotech industry. TestBiotech. 1 December 2010. www.testbiotech.de/sites/default/files/EFSA_Playing_Field_of_ILSI.pdf
10. Antoniou M, Robinson C, Fagan J. GMO myths and truths: An evidence-based examination of the claims made for the safety and efficacy of genetically modified crops. June 2012. http://bit.ly/O0IAQS
11. Holland N, Robinson C, Harbinson R. Conflicts on the menu: A decade of industry influence at the European Food Safety Authority (EFSA). Brussels, Belgium. Corporate Europe Observatory and Earth Open Source. February 2012. http://earthopensource.org/files/pdfs/Conflicts_on_the_menu_report/Conflicts_on_the_menu_report_English.pdf