Member States must not - on the sole basis of the precautionary principle - adopt national emergency measures prohibiting certain authorised genetically modified organisms (GMOs). This was decided by the EU Court of Justice in the recent Fidenato case.
While such a decision ensures a harmonized approach to GMO regulation, it undermines the possibility for Member States to prohibit the cultivation of already-authorized genetically modified crops for which there is no new scientific evidence.
Genetically modified organisms: a heated debate
Genetically modified organisms (GMOs) are a heavily debated topic. According to EU law, a GMO is “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”.
A lot of GMOs are developed to enhance the yield of our food production systems through plant disease resistance or herbicide tolerance.
However, while some believe that GMOs are key elements for solving problems caused by global population growth, others maintain that the use of GMOs will open up pandora’s box and threaten the future of mankind and our environment. This point of view was raised again recently at the EU negotiations regarding the TTIP and CETA.
European regulatory framework
Since there is no exact scientific answer to this debate, the EU has adopted a precautionary approach towards genetically modified foods on its single market. Although there are many pieces of legislation on this subject matter, these ones in particular that strictly regulate GMOs stand out:
- Regulation (EC) 1829/2003 on genetically modified food and feed
- Regulation (EC) 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms
- Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
- Directive 2009/41/EC on contained use of genetically modified micro-organisms.
The aim of this regulatory framework is threefold:
- to protect human health and animal health, and the environment by introducing a safety assessment of every GMO product before it is placed on the market;
- to establish harmonized procedures for risk assessment and authorization of GMOs;
- to ensure clear labelling and traceability of GMOs that enter the common market.
Against this background, however, the Court of Justice of the European Union (CJEU) recently delivered a seemingly surprising judgment in the Fidenato case (CJEU, 13 September 2017, C-111/16).
Fidenato and the precautionary principle
In the Fidenato case, the CJEU ruled in favour of the Italian farmer, Giorgio Fidenato, who had cultivated the GM maize MON 810 that produces a deadly chemical that combats the devastating larvae of the corn borer, a harmful pest.
Although MON 810 is allowed under EU law, Italy had prohibited the cultivation of this GM crop in its national legal order on the basis of interim emergency measures adopted in accordance with Article 54 of the General Food Law Regulation 178/2002. This Article, read in conjunction with Article 34 of Regulation No 1829/2003, allows Member States to adopt interim emergency measures if it is “evident that products authorized by or in accordance with this Regulation are likely to constitute a serious risk to human health, animal health or the environment”, and if the European Commission has failed to take those measures.
In the Monsanto and others case (CJEU, 8 September 2011, C‑58/10 to C‑68/10), the Court clarifies that the terms ‘evident’ and ‘serious risk’ must be understood as “referring to a significant risk which clearly jeopardises human health, animal health or the environment. That risk must be established on the basis of new evidence based on reliable scientific data.”
Hence, such measures can be adopted only when they are based on a risk assessment. This assessment, as it is further explained in Monsanto, lies ultimately with the European Commission and the Council of the European Union.
In this case, however, neither the Commission nor the European Food Safety Authority found any new science-based evidence about MON 810 that justified the requested emergency measures.
Therefore, the question arose whether considerations relating to the precautionary principle that go beyond the parameters of serious and evident risk to human or animal health or the environment in the use of food or feed could nevertheless justify Italy's adoption of interim emergency measures.
The Court held that a Member State must not adopt interim emergency measures for an authorized product solely on the basis of the precautionary principle as laid out in Article 7 of the General Food Law Regulation and without the conditions set out in Article 34 of Regulation No 1829/2003. The underlying reasoning is the difference between the levels of risk required: the CJEU wants to prevent the level of uncertainty required by Article 34 of Regulation No. 1829/2003 from being reduced by the precautionary principle.
Harmonized approach for authorized GMOs: a cornerstone
As a conclusion, we can see that while Member States are free to adopt emergency measures based on the sole precautionary principle for GMO products that have not yet been authorized, they can only take emergency measures for authorised GMO products if it is evident that these products are “likely to constitute a serious risk”.
By doing that, the Court ensures the safeguard of the harmonized approach to GMOs but factually disables the possibility for Member States to adopt emergency measures prohibiting the cultivation of GMOs without new scientific evidence.