La
Court of Justice
EU has finally ruled on the so-called
new GMOs
. (1) Stating that organisms made by new genetic manipulation techniques –
New Plant Breeding Techniques
,
NPBTs
– must be subject to the same rules as in Europe for
GMOS
traditional. (2)
New GMOs, José Bové vs. Emmanuel Macron
The European dispute originated in France, thanks to Confédération paysanne-the agricultural union founded by José Bové-and 8 environmental associations. That they have appealed to the Council of State in Paris against the Prime Minister and the Minister of Agriculture, Agribusiness and Forestry.
The Macron government has insisted on keeping in place a national rule that mutagenesis does not qualify as genetic manipulation. Where, on the other hand, mutagenesis (or cisgenesis) differs from transgenesis only in that the modification is carried out on the genome itself, without inserting genetic traits from other organisms.
Directive 2001/18/EC at the time excluded seeds obtained by mutagenesis from the obligations for GMOs (authorization, monitoring, risk assessment, traceability, labeling). Considering mutagenesis one of the ‘genetic modification techniques conventionally used in various applications with a long tradition of safety.’ (3)
Modern mutagenesis techniques
have, however, evolved to the point where plant varieties (e.g., canola) that are resistant to
pesticides
broad-spectrum (e.g., glyphosate, or glyphosate, dicamba). Manipulations similar to those that once required the use of transgenesis techniques.
The judges of Luxembourg They were therefore called by those in Paris. Deciding whether the rules established in Europe for ‘classic’ GMOs (from transgenesis) should also apply to ‘new GMOs’ (from mutagenesis). And the Advocate General at the Court of Justice-blind to the assets to be protected, as well as Czech in nationality-has spoken in the negative.
New GMOs, the ruling of the EU Court of Justice
Instead, the EU Court of Justice – in disregarding the Advocate General’s c(i)eco findings – clarified that organisms obtained through mutagenesis qualify as GMOs because their genetic material is nonetheless modified in ways that do not occur in nature. (4)
The exemption from GMO rules in the 2001 directive, in the Court’s view, does not apply to NPBTs or NBTs. Indeed ‘risks associated with the use of such new techniques or new methods of mutagenesis could be similar to those resulting from the production and dissemination of GMOs through transgenesis. (…)
The direct modification of genetic material of an organism by mutagenesis makes it possible to achieve the same effects as the introduction of a foreign gene into that organism, and (…) the development of such new techniques or methods makes it possible to produce genetically modified varieties at a rate and in quantities not comparable to those resulting from the application of traditional methods of random mutagenesis.’ (5)
Long live the Court!
Dario Dongo and Giulia Torre
Notes
(1) Judgment 25.7.18, Case C-528/16
(2) NPBTs are understood to be the ‘New techniques for plant crossing. In this case, the term interbreeding is meant at the DNA level and not at the level of male and female reproductive cells. Such techniques are very complex and range from the use for mutagenesis of oligonucleotides to that of zinc-binding proteins, but the prevalent and most promising technology has the unpronounceable acronym Crisps-Cas9 (…)’. From the glossary to the paper presented by the CNR, Department of Bioagri-food Sciences, at the Hearing before the Senate Committee on Agriculture on Affair (591), ‘New technologies in agriculture, with particular reference to the use of sustainable and precision biotechnology’
(3) See dir. 2001/18/EC, Recital 17. Croesus wheat, for example, was developed through the use of gamma radiation. So as to adapt the DNA of the original wheat to the agronomic needs
(4) A GMO is defined as ‘an organism, other than a human being, whose genetic material has been altered in a way that does not occur naturally by mating and/or natural genetic recombination’ (dir. 2001/18/EC, art. 2)
(5) Judgment referred to in footnote 1, item 48