Nathalie Moll is Secretary General of EuropaBio, the European association for Bioindustries.
The uniqueness of the EU GMO authorisation system
No other regulated product category scores as high as GMOs in terms of number of product application dossiers that: a) cannot be agreed to by a regulatory committee and therefore end up in an Ambassadors’ or Ministers’ vote (100% of the time) and, b) never result in a qualified majority neither in favour nor against (99.9% of the time).
The GM product approval system is the only system in the EU that has a large backlog of products awaiting assessment or voting. This is compelled by the lack of respect for regulatory timelines by authorities, as recognised in Court rulings. Other regulated sectors have had backlogs which have been dealt with –not so with GM.
Why is this? The EU has what’s said to be “the most stringent regulatory system for GMOs in the world”, world class leading scientists making up its Food Safety Authority and officials in charge of processing dossiers through the system.
Simplifying to the extreme, the EU regulatory system for this and other sectors calls for independent scientific assessment of products by EFSA with resulting opinions being “voted” upon by national policy makers. In other regulated areas, this system seems to work well and on time. Policy makers generally trust the scientific recommendations of the independent EU Agencies and move to approve at regulatory committee level.
In the GMO area, a vicious circle of lack of approvals and decreased trust in the technology and the regulatory process is being perpetuated. The fact that policy makers don’t make decisions on dossiers (no QMVs) despite EFSA concluding products are safe, supposedly because of lack of public trust, decreases public trust in the products and perpetuates the vicious circle of: no vote, no trust, no vote. There is a need for leadership by policy makers to take decisions on products.
Solutions, rather than more problems
Another obstacle to effective implementation is that regulatory requirements are constantly changing while products can remain in the approval system for a decade or more. This makes updating dossiers a constant activity and does nothing to ensure timely processing and reduction of the backlog.
More worrying still, and a disconcerting signal for other industries, is that changes in regulatory requirements in the GMO field sometimes occur in response to political pressure; the so-called policy-based science rather than science-based policy. This has an impact on the companies and decreases public trust in the regulatory system that is not science-based.
Add to all the above, the influence of the anti-GMO movement. Notwithstanding 15+ years of commercialisation around the world and 2,500 separate authorisations being granted by public authorities in 59 countries, this sector’s attempts to share information about the benefits of its products is continuously marred by unsubstantiated allegations regarding safety. For the record, there has never been a substantiated health issue related to GMOs since their introduction.
The negative consequences for Europe
Quintessential European companies have said they have moved out of Europe because of the dysfunctional and unpredictable authorisation system for GMOs. Beyond the GM area, the negative precedent of “politics over science” is already affecting boardroom investment decisions in Europe in other sectors.
Besides the growing lack of predictability for companies applying for approvals, EFSA’s scientific credibility with the public decreases as policy makers overrule EFSA’s assessments. Doubt and mistrust among the public regarding the institutions and the technology lingers.
Moreover, Europe is not offering its farmers the freedom to choose what to grow, when and where. Even worse, those same farmers import GMOs from 3rd countries in great quantities to respond to our need for animal feed protein. In 2013 the EU imported 38.5 million tons of soy and maize protein - over 85% was GM - equal to 64 kilos per EU citizen per year.
Things are changing
There are growing voices from leading farming, scientific and public health groups that have concluded that GM technologies have a role to play in addressing the food and feed needs of a rapidly growing population.
Public opinion is also changing, as the November 2013 Food Standards Agency survey[i] of UK consumers’ found when they asked what food issues people were concerned with. Unprompted, only 5% referred to biotech or GM. Similarly, Eurobarometer polled 16,000 Europeans in 2010 and only 8% spontaneously said they are worried about GM in food[ii]. Not quite the “overwhelming opposition” some claim.
In very recent times, media seem warier of repeating alarmist stories propagated by extreme campaign groups, especially in light of the overwhelming scientific consensus that GM products are safe, and the reputation of some of these groups for promoting dubious science. The 2012 scare study on rats from France is a good example. The study was rejected by public safety authorities around the world as “methodologically flawed”. Public scientists were more direct, describing it as “…gross scientific misconduct and attempting fraud”, and that “…the media was played like a fiddle”.
In 2013 over 18 million farmers actively chose to grow GM crops around the world because they derive direct benefits, such as higher yields, improved quality and higher incomes. The newer crops now planted outside the EU include maize that maintains yield under irregular water supply and soy products with low trans fats.
The European approval system for GMOs has certainly proven it is unique, now could it just become “functional, predictable and effective” please?