Biotech crops (often termed Genetically Modified, GM) are grown in many countries in the world. According to the ISAAA (1), global hectarage of biotech crops increased in 2016 by 3% to 185 million hectares. Ten countries grew over one million hectares and USA, Brazil, Argentina, Canada and India grew more than 10 million. In comparison the European Union (EU) grew a negligible amount (MON810 is the only GM crop approved for cultivation) and most of this is Spain. In Africa, only South Africa and Sudan planted biotech crops in 2016.

All countries have regulations for the approval of GM crops and the EU has one of the most stringent, complicated and non-science-based systems (starting from a “GMO” definition not based on the product itself, but on the way it was obtained). This has been described in detail previously (2,3,4,5) and will not be repeated here.

In the EU, the member states (EU-MS) have been presented by the previous European Commission (EC) President Barroso with an opt-out option whereby they may legally refuse to grow GM crops authorized at the EU level (this differs from the previous situation where GMO cultivation bans were in contradiction with the EU law). A large number of EU-MS have accepted this opt-out option. Another proposal, by EC President Juncker, whereby GM crop could be refused import, failed to pass, This was fortunate for Europe since it would have re-ignited a commercial war with countries producing biotech crops.

The fact that approval of GM crops, unlike other plant breeding techniques, is subjected to a political process, especially in the EU, calls for the following comments:

1) It is clear that there are no safety issues caused by currently approved GM crops (1, 6). This is disputed by numerous anti-GM activist groups, yet it has the merit of being factually correct. The EU (as well as many other countries) should thus be easily able to streamline the assessment process. While new GM constructs may need extensive scrutiny, many approvals concern similar genes in similar crops and could be dealt with rapidly.

2) The approval process is very costly and only very large multinational companies are able to afford it. In the period 2008 to 2012 the cost of bringing a new GM crop to the market was 135 M$ of which 28% was for the regulatory process (5). This cost could be drastically reduced with simplified procedures.

3) The approval process is very slow in all countries and particularly in the EU. A large part of this is due to political interference since some politicians see the need to be involved in scientific aspects (more and more often in contradiction with scientific facts). Furthermore they often turn to biased anti-GMO organizations for enlightenment. The approval process could be improved by eliminating involvement by political committees such as the EC SCFCAH which, as history shows, is 100% incapable of making decisions with a qualified majority (3).

4) A meta-analysis shows that there are large agronomic and economic benefits associated with GM crop cultivation (7) and these benefit the consumer, the farmer (particularly small farmers in developing countries), the shippers, and the producer of the GMOs. However, these potential benefits are lost when there are delays in the approval process.

5) In an ideal world, there would be international agreements regarding authorizations of GMOs. However, due to great differences between worldwide GMO regulations, such an agreement is not even under discussion. GM crops can be authorized in one country, not yet approved in another (asynchronous approvals) and even illegal elsewhere, which causes enormous difficulties since it is illegal to import even tiny quantities of unauthorized GM crop (for example in the case of accidental adventitious presence in large cargos). Such cargoes may be destroyed on arrival (2, 3, 8). This has caused trade disruptions between exporters in North and South American countries and importers such as Europe and China. It has evolved to such point that large shippers, such as Bunge or Cargill, have refused transportation with consequent economic losses for all concerned (2, 9).

6) A recent publication by Wesseler et al. (10) presents even more alarming results: “The costs of a delay can be substantial: e.g. a one year delay in approval of the Bt pod-borer resistant cowpea (a protein-rich crop) in Nigeria will cost the country about 33 million USD to 46 million USD and between 100 and 3,000 lives”. Loss of life due to malnutrition is very serious in Africa (including Benin, Niger, Nigeria, Kenya, and Uganda), and malnutrition also causes growth stunting particularly in young children: “Reducing the approval time of Genetically Engineered crops results in generating economic gains, potentially contributing to reducing malnutrition and saving lives, and can be an inexpensive strategy for reaching the Sustainable Development Goal of eradicating malnutrition by 2030”.

7) A similar conclusion was reached by Giddings et al (11) who stated “Anti-GMO activists have erected barriers to agricultural biotech innovation that could cost the poorest nations on earth up to $1.5 trillion through 2050”.

We are not claiming that the GM technology is the only needed tool, but clearly, it is of great economic and humanitarian necessity to reduce delays in GM crop approval, yet, in the EU, there is no willingness to do this. The irony of this is that the EU has itself an absolute need to import GM crops for animal feed when no non-GM alternative is available. However, EU decisions seriously influence decisions in other parts of the world where GM crops may have lifesaving impact. The conduct of EU-MS has been criticized, in an open letter to President Juncker, by a large group of international scientists headed by Professor Klaus-Dieter Jany (12). Similar appeals were made by a consortium of 124 Nobel Laureates and by EuropaBio (13-15). These appeals, for the EU to obey its own laws, fall on deaf ears.


1. ISAAA. Global status of commercialized biotech/GM crops. ISAAA Brief 52 (2016). (

2. Davison, J and Bertheau Y. (2007). European regulations on genetically modified organisms: their interpretation, implementation and difficulties in compliance. CAB Reviews: Perspectives in Agriculture, Veterinary Science, Nutrition and Natural Resources, vol 2 N°077, 1-12 (

3. Davison, J. (2010) GM plants: Science, politics and EC regulations. Plant Science 178, 94–98 (

4. Davison, J. & Ammann, K (2017). New GMO regulations for old: Determining a new future for EU crop biotechnology. GM Crops & Food. (

5. R.D. Smart, M. Blum and J. Wesseler (2016). Trends in approval times for genetically engineered crops in the United States and the European Union. Journal of Agricultural Economics (

6. FAO report (2016). Climate change, agriculture and food security. (The State of Food and Agriculture

7. W. Klümper & M. Qaim. (2014) A meta-analysis of the impacts of genetically modified crops. PloS one 9.11: e111629 (

8. CAST report (2016). The impact of asynchronous approvals for biotech crops on agricultural sustainability, trade, and innovation. (

9. Phillipson, M. & Smyth, S.S.. (2016). The legal and international trade implications of legulatory Lags in GM crop approvals. Journal of International Law and Trade Policy, 17 (2) (

10. J. Wesseler, R.D. Smart, J. Thomson and D. Zilberman (2017). Foregone benefits of important food crop improvements in Sub-Saharan Africa. PLoS ONE 12(7): e0181353. (

11. Giddings Val L., R.D. Atkinson and Wu J. (2016). Suppressing growth: how GMO opposition hurts developing nations. ITIF Information Technology & Innovation Foundation, Washington DC USA (

12. Jany et al. (2017). Plea for coherent decision-making in the EU. (

13. An Open Letter from 124 Nobel Laureates Letter Supporting Precision Agriculture (GMOs) (2016). Support Precision Agriculture (

14. EuropaBio (2017). EU nations should overcome GMO hypocrisy: Time to vote for science and reason.(

15. Moll N. (Europabio) (2014). When politics trumps science: The curious case of the EU’s GMO authorisation system. EurActiv. (

John Davison (INRA de Versailles, France [retired]) and Marcel Kuntz
(Laboratoire de Physiologie Cellulaire & Végétale, CEA CNRS INRA Université Grenoble-Alpes, 17 rue des Martyrs, 38054 Grenoble cedex 9)


  The consequences of delayed approvals of GM crops