In summary, ECJ Advocate General, Michal Bobek, said NPBTs should be exempt from European GMO rules, except, for example, where gene editing was used to insert foreign DNA in a precise location.
“Mutagenesis techniques are exempt from the obligations of the GMO Directive provided that they do not involve the use of recombinant nucleic acid molecules or GMOs other than those produced by one or more of the methods listed in Annex I B [of Directive 2001/18/EC].”
Individual states, such as France, could set out their own rules on NPBTs, provided they complied with EU legislation, according to the opinion.
Presently, organisms developed through classical mutagenesis breeding techniques are regulated as conventional and are exempt from the EU’s main GMO regulation, Directive 2001/18/EC.
Opponents of the new crop breeding technology such as Greenpeace, GM Freeze, and Friends of the Earth argue the resulting plants are GMOs legally and scientifically.
But proponents of NPBTs say the process does not involve the transfer of genes between species as in GMOs and is a valuable tool to enhance crops or boost yields. Indeed, there is a lot of excitement in the research community over the potential of NPBTs for the feed sector and food security in general.
An ECJ Advocate General’s legal opinion is non-binding and advisory for the panel of judges who decide the case, but, nonetheless, is viewed as important in informing the final ruling. The ECJ is expected to issue its ruling in this case in this summer.
NPBTs, according to a datasheet from think tank, Farm Europe, are methods allowing the development of new plant varieties with desired traits, by modifying the DNA of the seeds and plant cells. They are called ‘new’ because these techniques have only been developed in the last decade and have evolved rapidly in recent years.
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 this morning the ECJ Advocate General's opinion provides some welcome clarification.
She said Bobek's statement that the “generic category labelled ‘mutagenesis’ should logically encompass all those techniques that are, at the given moment relevant for the case in question, understood as forming part of that category, including any new ones," indicates that newer forms of mutagenesis such as precise mutation using gene editing techniques should be included with other mutagenesis tools in the category exempt from the GMO regulations.
“The opinion goes on to suggest that as long as member states respect EU law, it should be up to individual member states to decide whether to subject organisms derived by mutagenesis to legislation.”
She said one area that remains slightly unclear in the opinion is that the exemption of mutagenesis techniques only applies where recombinant nucleic acids are not used.
“The term ‘recombinant nucleic acids’ is still open to different interpretations.
“However, overall this is a very welcome opinion that will hopefully encourage further use of valuable new technologies in the production of improved crops. We eagerly await the judgement from the EU Court of Justice later in the year.”
In 2016, the Council of State, the highest administrative court in France, asked the ECJ to rule on whether NPBTs should, in fact, be regulated according to EU GMO law and whether countries could ban them.
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.
Their regulation has been under review by the European Commission (EC) since then.
According to the EU organic food and farming movement, the ECJ Advocate General has missed an opportunity to clarify the legal status of NPBTs.
IFOAM-EU said Bobek's opinion merely confirms the existing exemption from the requirements of the GMO legislation for plants obtained through mutagenesis techniques, and fails to provide effective criteria that would allow to make a distinction between old and new GE techniques developed in recent years.
Eric Gall, IFOAM EU policy manager, said:
"The General Advocate confirms that GMOs obtained by other techniques than transgenesis are indeed GMOs from a legal point of view, and should be regulated as such, but he ignores the intention of the legislator back in 1990, which was to only exempt from risk assessment, techniques which were used since the 1960s and which had 'a long safety record'.
“There are no legal or scientific reasons to exempt from risk assessment, traceability and labelling, recently developed genetic engineering which have nothing to do with the mutagenesis of the 1960s, however they are called by their proponents. Exempting these new genetic engineering [techniques] from a risk assessment would be a blatant denial of the precautionary principle and of the citizens’ right to know how their food is produced."
IFOAM EU said it urges the ECJ to take into account the intentions of the legislator when Directive 2001/18 was adopted and the international obligations of the EU under the Convention on Biological Diversity, which it says provides a definition of modern biotechnologies.