“Organisms obtained by the in vitro application of a technique/method of mutagenesis which has conventionally been used in a number of in vivo applications and has a long safety record with regard to those applications are excluded from the scope of that directive,” found the ECJ in a decision published on February 7.
The technique of mutagenesis can be applied in vitro - the mutagenic agents are applied to plant cells; the whole plant is then artificially reconstituted - or in vivo - the mutagenic agents are applied to the whole plant or plant parts.
In plants, both in vivo and in vitro random mutagenesis relies on the application of physical and chemical mutagens to increase the frequency of mutations, thus accelerating the selection of varieties with beneficial agronomic traits, according to an EFSA opinion.
Heated debate in France
The ECJ ruling may settle a debate, which has been heated in France, on the nature of random in vitro mutagenesis techniques.
In 2020, the Conseil d’État, France’s top administrative court, determined that organisms obtained via in-vitro mutagenesis techniques should be subject to GMO regulation - EU Directive 2001/18.
French agricultural trade union, the Confédération Paysanne, and eight other associations had brought a case to that court concerning the exclusion of certain techniques or methods of mutagenesis from the scope of the French law implementing EU Directive 2001/18.
The French authorities did not adopt any measures aimed at ensuring the implementation of the decision of the Conseil d’État, however. As such the nine French associations and trade bodies brought another case before the same court seeking a penalty payment ruling to ensure the implementation of its 2020 decision.
The Conseil d’Etat, which had leaned heavily on the contentious 2018 ECJ judgment on new genome techniques (NGTs) in forming its 2020 ruling, subsequently asked the Luxembourg based court to intervene, to specify whether in vitro random mutagenesis should fall within the scope of the GMO directive or not.
EU farmer representatives, Copa and Cogeca, welcomed the latest ECJ ruling, saying European agriculture needs to access the benefits of innovation to be more sustainable and achieve the ambition as set out in the EU Green Deal.
“Plant breeders should be able to consider certain mutagenesis techniques in their breeding programs, reducing by 10 years the time to market. European farmers are currently facing many challenges like extreme weather conditions, price volatility, and bans on plant protection products, making its essential to get access to improved breeds.”
The French Association of Plant Biotechnology (AFBV) also weighed in on the deliberations at the top EU court. That organization said it understands from the ruling that mutagenesis, whether by in vivo or in vitro techniques, benefits from the exclusion regime set out in the GMO legislation. Echoing the EU farming body, it said such techniques will support the development of new innovative plant varieties essential to agriculture, to produce food while meeting the challenges of reduced inputs, climate change and the EU Farm to Fork strategy.
Garlich von Essen, secretary general, Euroseed, endorsed the court's findings as well, saying the ECJ judgement provides the long-awaited legal clarity that is needed by breeders and seed producers for the marketing of plant varieties that have been on the EU market for years.
But Guy Kastler, one of the founders of the Confédération Paysanne, lamented the ruling, adding that the decision could trigger the marketing and cultivation of unregulated GMOs, without any labelling or regulation to know which technique has been used.
EU feed sector eagerly awaits EC report on NGTs
The EU Commission (EC) is intending to publish a new legislative proposal for NGTs in the second quarter of 2023, and Alexander Döring, secretary general, European Feed Manufacturers' Federation (FEFAC), told us last December that the industry eagerly anticipates its arrival.
“The European feed manufacturing sector is promoting the use of NGTs to boost the potential of EU plant protein production. Stakeholders across the board have marked GMO legislation as no longer fit for purpose with new innovations in plant breeding. However, the debate on how the NGT proposal will take us forward will remain controversial.”
A review of NGTs undertaken by the EC in April 2021 concluded that such plant breeding technology could contribute to a more sustainable food system under the EU Green Deal and the EU Farm to Fork Strategy. That study also determined the current GMO legislation, adopted in 2001, is hampering plant breeding research potential in the EU and it does not consider whether products have the potential to contribute to sustainability.