Judgment of the Court of Justice Grand Chamber, 7 February 2023, Confédération paysanne and Others In vitro random mutagenesis, C-688/21

• Date: 07 February 2023
• Year: 2023

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As regards the Republic of Malta’s notification concerning its intention to submit a new classification

dossier for that substance to ECHA in the procedure for the harmonisation of the classification and

labelling of substances in accordance with Regulation No 1272/2008, allegedly confirming the

classification of mancozeb as a toxic substance for reproduction category 2, the General Court notes

that, on the date of adoption of the contested implementing regulation, that proposal by the Republic

of Malta had not yet been assessed from a scientific point of view.

Third, in the absence of any well-founded arguments formulated by the applicants, the General Court

rejects the complaint alleging that the RAC’s opinion accorded undue influence to the metabolite ETU

rather than to the substance itself.

3. RELEASE OF GENETICALLY MODIFIED ORGANISMS (GMO)

Judgment of the Court of Justice (Grand Chamber), 7 February 2023, Confédération

paysanne and Others (In vitro random mutagenesis), C-688/21

Link to the full text of the judgment

Reference for a preliminary ruling – Environment – Deliberate release of genetically modified organisms –

Directive 2001/18/EC – Article 3(1) – Point 1 of Annex I B – Scope – Exemptions – Techniques/methods of

genetic modification which have conventionally been used and have a long safety record – In vitro random

mutagenesis

In 2015, the Confédération paysanne, a French agricultural union, and eight associations whose

purpose is the protection of the environment and the dissemination of information concerning the

hazards posed by genetically modified organisms (GMOs) brought an action before the Conseil d’État

(Council of State, France) concerning the exclusion of certain techniques or methods of

mutagenesis

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from the scope of the French legislation intended to transpose Directive 2001/18

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on

the deliberate release into the environment of GMOs. In that context, the Conseil d’État (Council of

State) had submitted to the Court of Justice a request for a preliminary ruling, which gave rise to the

judgment in Confédération paysanne and Others (528/16), delivered in 2018.

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The present case follows on from that judgment, in which the Court ruled that the scope of the

Directive 2001/18 excludes only organisms obtained by means of techniques/methods of

mutagenesis which have conventionally been used in a number of applications and have a long safety

record. The Conseil d’État (Council of State) took the view that it follows from that judgment that the

organisms obtained by means of techniques/methods which appeared or were mainly developed

after the date of the adoption of that directive, namely by virtue of techniques of ‘in vitro random

mutagenesis’ must be included in the scope of Directive 2001/18.

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Accordingly, the Conseil d’État

(Council of State) issued an order and, to ensure its implementation, the French Government, in

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Technique that enables mutations to be artificially caused, with the help of chemical or physical factors, at a much faster rate (between 1 000

and 10 000 times greater) than spontaneous mutations.

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Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of

genetically modified organisms and repealing Council Directive 90/220/EEC (OJ 2001 L 106, p. 1).

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Judgment of 25 July 2018, Confédération paysanne and Others (C-528/16, EU:C:2018:583).

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Random mutagenesis refers to a process in which, after artificially causing, with the help of chemical or physical factors, mutations at a

much faster rate than spontaneous mutations, the mutations are randomly induced in the organisms. In vitro random mutagenesis is a

technique subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents, unlike in vivo random mutagenesis, which is

practised on whole plants or on parts of plants.