Published by IFOAM Organics Europe
In the last decades, the European Union’s (EU) rules on marketing and cultivation of genetically modified organisms (GMOs) has been a reference for GMO laws worldwide. It served as a benchmark regulation, setting high standards for environmental safety, health, and transparency. As the EU is a major importer and exporter of food and animal feed, its strict rules serve as incentive to harmonize production rules with EU standards for market access.
However, the EU might give up its position as a front-runner in strict regulation. As a new legal framework for new genetic engineering techniques is on the horizon, will the EU opt for a ‘lighter regulation’, inspired by the Americas, or will it go its own, pioneering way once more?
New genetic engineering techniques fall under EU’s current GMO Directive
In the European Union, the current GMO Directive (2001/18/EC) and connected regulations prescribe mandatory risk assessment, traceability throughout the food chain, and consumer labelling.
Recently, the question rose as to whether products from new genetic engineering techniques, also referred to as ‘new breeding techniques’ or ‘new genomic techniques’, fall under the scope of the current regulation. In 2018, the European Court of Justice ruled that: “European Union’s legislation on genetically modified organisms (GMOs) also applies to GMOs resulting from the use of new mutagenesis techniques. It confirmed that only organisms obtained through techniques which have “conventionally been used in a number of applications and have a long safety record“ can be excluded from EU GMO law”.
While this clarified the legal situation and confirmed the existing regulation is fit-for-purpose for new technologies, the ruling was not consistently implemented by the EU’s Member States and coordinated by the European Commission. This created regulatory uncertainty, while products developed with the new techniques were already marketed in Canada and the US, for example.
In other parts of the world, decisions have been made about regulation or non-regulation. In the USA, some products from newGM varieties are currently not classified as ‘GMO’ and exempted from regulation, while in Australia, Brazil and Argentina, varieties without foreign DNA are not regulated. Canada opts for a slightly different approach, regulating only products if there's a ‘novel trait’ (with legal uncertainty on what classifies as a 'novel trait').