The new policy for GM crop cultivation, to be unveiled tomorrow, aims to draw a line under years of stalemate between countries that support GMOs and those opposed to their cultivation.
At present, EU member states are only able to restrict GM crop cultivation under strict conditions, as authorisation licences are valid across the 27-country bloc, in accordance with the principles of the EU single market.
The plans would allow large-scale commercial planting in pro-GM countries such as Spain, the Netherlands and the Czech Republic, opening up new markets for major biotech companies, while at the same time legally endorsing existing GM bans in countries like Italy, Austria and Hungary.
The legislative proposal seeks to insert a new article (Article 26b) into the 2001 Directive on the Deliberate Release of GMOs. The proposed new article allows member states to prohibit cultivation provided that the reasons are not related to GMOs' adverse effects on health and their environment, or to their socio-economic impact.
Health and environmental concerns can continue to be raised using the existing safeguard clause (Article 23 of the directive).
Meanwhile, prohibition on socio-economic grounds will be authorised under a new Commission Recommendation on guidelines to prevent GM contamination of conventional and organic crops, which will also be tabled tomorrow. The guidelines are set to replace 2003 Commission guidance on national co-existence measures.
Speeding up authorisation processes
The draft new texts also stress that member states should adopt "a more positive stance" on GMO authorisation at the risk assessment stage and "avoid" seizing the safeguard clause to address non-scientific issues.
The idea is to trade a broader right to restrict GM crop cultivation on national territory in exchange for some member states dropping their long-standing opposition to GM crops.
For years, EU member states in the Council of Ministers have been unable to reach a qualified majority for or against GMO authorisations, referring the matter back to the Commission, which has invariably authorised them via a special regulatory procedure.
NGOs denounce flawed proposal
Under the proposed deal, the GMO approval process would therefore speed up.
But environmental NGOs Friends of the Earth and Greenpeace argue that restrictions on invoking Article 26b would limit the set of admissible grounds for bans mainly to ethical concerns.
According to them, national decisions based on ethical grounds are likely to be subject to legal challenges brought by crop companies due to the difficulty of defining "objective" criteria in the field of ethics, they stress.
A legal opinion on the draft proposal commissioned by the two NGOs argues that it does not provide the legal certainty that member states need in order to adopt permanent bans on GMOs that have received EU approval.
NGOs also note that while the Commission proposals address the banning of GM crops by national governments, there is nothing to protect conventional and organic farmers in countries that decide to allow them.
Business worried about legal uncertainties, single market
EuropaBio, the European bio-industry association, says the Commission's plan to "nationalise" the GMO issue should be seen as positive step.
But it notes that the "devil is in the detail," arguing that the draft proposals could in practice cause legal uncertainty as farmers will be able to challenge their national authorities for restricting access to products, for example.
The industry underlines the importance of allowing all EU farmers the same choice of technology once it has received scientific approval from the European Food Safety Authority (EFSA).
In this regard, EuropaBio notes that tomorrow's proposals represent a move away from the EU single market as they would allow member states to restrict products on non-scientific grounds.
New environmental risk assessment guidelines under way
Before a GM plant can be cultivated in the EU it has to undergo an extensive Environmental Risk Assessment (ERA) to identify any possible adverse effects it may have on the environment.
Following criticism from some member states, the European Commission mandated the European Food Safety Authority's GMO panel to revise the agency's guidelines on environmental risk assessments.
The guidelines assess, for example, the persistence and invasiveness of a GM plant, including plant-to-plant gene transfers, its impact on non-target organisms and criteria for setting up field trials.
However, a report analysing the EFSA's draft guidelines for the environmental risk assessment of genetically engineered plants, presented by the Greens in the European Parliament last week (6 July), argues that the agency fails to properly address risks posed by genetically engineered plants.
The report stresses that there is a "basic misconception" in EFSA's thinking, which assumes that genetically engineered plants are similar to those obtained by conventional breeding. The Greens argue they are fundamentally different.
Marco Contiero, GM policy officer at Greenpeace, added that if this concept of "substantial equivalence" were taken as a basis, it would be impossible to assess unpredictable long-term effects of GM plants.
French Green MEPs José Bové and Sandrine Bélier said that together with the Commission's upcoming new policy on GM crop cultivation, the EFSA's current environment risk assessment proposals "would allow companies to reduce risk assessment to just a few studies and to speed up market authorisation for the EU territory overall".