The judgement is expected in about 18 months.
The Council of State, the highest administrative court in France, wants the ECJ to rule on whether NPBTs should, in fact, be regulated according to EU GMO law, whether they should be categorized as GM varieties in EU legislation and whether countries could ban NPBTs.
Since the definition of eight NPBTs by a European expert group in 2007, there has been an ongoing debate on whether the resulting plants and their products fall within the definition of GM in scientific and legal terms.
Regulatory standstill
Their regulation has been under review by the European Commission (EC) since then.
The legal team of the EU executive is looking specifically at whether NPBTs should fall under Directive 2001/18/EC on the deliberate release of GMOs into the environment, which provides the requirements to determine if something is considered a GMO or not.
The Commission’s opinion was due by the end of 2015, but the procedure was postponed. The findings were then expected at the end of the first quarter of 2016, but were still not forthcoming.
Opponents of NPBTs such as Greenpeace, GM Freeze, and Friends of the Earth argue the plants resulting from such techniques are GMOs legally and scientifically.
‘No changes to DNA sequences in plants’
But proponents of the crop technology say otherwise:
Dr Wendy Harwood, a senior scientist engaged in crop transformation research in the UK at the Norwich-based plant science facility, John Innes Centre, told FeedNavigator previously regulators need to classify new plant breeding techniques in the same way as traditional breeding methods and do not label them GM.
She said the new breeding methods allow plant genome modifications indistinguishable from those introduced by conventional breeding and chemical or physical mutagenesis: “The next generation plants derived using NPBTs show no changes to the DNA sequence itself and, therefore, cannot be considered GM."
Harwood argued NPBTs such as genome editing and cisgenesis provide plant breeders with faster methods to boost crop performance as they allow more precise modification of plant genomes than was previously possible. “There is huge excitement in the research community over their potential for the feed sector and food security in general,” added the scientist.
Such plant breeding techniques involve plants being transformed only with their own genetic materials or those from closely related species capable of sexual hybridization; NPBTs have been used successfully by a team at Denmark’s Aarhus University to increase the phytase activity in barley.
However, until regulatory clarity is provided, the commercial application and sale of these products in the EU is hampered.
Over a dozen companies and research institutes joined forces in 2011 to plead the case for NPBTs at the European level via the NBT Platform. They say GM regulations should not be applied to these new plant breeding methods as such a move would form an impediment to innovation.
“Regulators should focus on the outcome and the resulting benefits in terms of crop quality these techniques can generate for food and feed, rather than focusing on the technology used. There have been concerns about the unintentional effect arising from crop transformation technology but these have remained unfounded,” stressed Harwood, in an earlier interview with this publication.