Are organisms that are the product of mutagenesis subject to the GMO Directive on deliberate release?


In case C-528/16 proceedings were brought between the French agricultural union and eight associations (the Applicants) against the French Prime Minister and the French Minister for Agriculture, the Food Processing Industry and Forestry (French Ministers) regarding the interpretation of Articles 2 and 3 , as well as Annexes IA and IB, of Directive 2001/18/EC (the Directive), which sets out requirements and obligations on those that deliberately release genetically modified organisms (GMOs) into the environment, plus interpretation of Article 4 of Directive 2002/53/EC (as amended). This article focuses on the CJEU’s decision regarding whether organisms obtained by mutagenesis are subject to the Directive.

The Directive

The CJEU noted the key provisions from the Directive providing the legal context for this query:


The CJEU referred to Recitals 4-6, 8, 17, 44 and 55 of the Directive. Importantly, the CJEU noted that (Recital 4) organisms released into the environment may reproduce and cross national frontiers and the effects of this may be irreversible; (Recital 8) the precautionary principle was taken into account when drafting the Directive and must be taken into account when implementing it; (Recital 17) the Directive should not apply to organisms obtained through certain techniques of GM that are conventionally used in a number of applications and have a long safety record; and (Recital 55) it is important to follow closely the development and use of GMOs.


Article 2(2) of the Directive sets out the meaning of a GMO[1] as an organism whose genetic material has been altered in an unnatural way. It states that “Within the terms of this definition:

  1. genetic modification occurs at least through the use of the techniques listed in Annex I A, part 1;
  2. the techniques listed in Annex I A, part 2, are not considered to result in genetic modification” (emphasis added).

Article 3(1) then sets out that the Directive “shall not apply to organisms obtained through the techniques of genetic modification listed in Annex I B.” Annex IB itself states “Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are: (1) mutagenesis…”

National Arguments

The Applicants submitted that mutagenesis techniques have evolved to produce similar outcomes to transgenesis, e.g. they can produce herbicide-resistant varieties. Organisms produced by such techniques/ methods were potentially not subject to the obligations of the Directive, even though the Applicant submitted these varieties present risks to health and the environment.

However, the French Ministers argued the application was unfounded as the risks arose from the grower’s cultivation practices rather than the GMOs themselves. Also, they argued the new techniques of directed mutagenesis are similar to spontaneous or randomly introduced mutations and unintentional mutations can be eliminated by crossing techniques.

The French court decided to refer to question to the CJEU as, while conventional in vivo mutagenesis had been used for decades without identified risks, it was not possible to determine the extent of the risks relating to the new techniques (e.g. random mutagenesis applied in vitro to plant cells and directed mutagenesis techniques) and the court thought said risks would be, in part, similar to those of transgenesis. Also the increased rate of mutations from the new techniques led to higher risk.

Decision of the Grand Chamber[2] of the CJEU:

The CJEU had to determine whether Article 2(2) of the Directive means organisms obtained by techniques/ methods of mutagenesis constitute GMOs and if so, whether Article 3(1) (read in conjunction with part 1 of Annex IB and recital 17) meant such organisms are excluded from the scope of the Directive.

The CJEU concluded that Article 2(2) must be interpreted as meaning organisms obtained by mutagenesis constitute GMOs. The Court reasoned that mutations brought about by mutagenesis (in this case intended to produce herbicide-resistant varieties) constitute alterations to the genetic material and techniques that involve chemical or physical mutagenesis agents, as well as other techniques that involve genetic engineering, alter genetic material in a way that does not occur naturally. Furthermore, while mutagenesis is not listed in part 1 of Annex IA, this does not exclude it from being a GM technique as part 1 is not an exhaustive list[3].  In addition, mutagenesis is not included in the exhaustive list of techniques not resulting in GMOs in part 2 of Annex IA and mutagenesis is referred to in Annex IB (i.e. the list of techniques/ methods of GM excluded from the Scope of the Directive under Article 3(1)).

The CJEU therefore needed to determine whether GMOs obtained by mutagenesis were excluded from the requirements of the Directive under Article 3(1). The Court stated that while legislation should be interpreted strictly, reading Article 3(1) solely in conjunction with point 1 of Annex IB did not provide conclusive guidance on which techniques should be excluded. It was necessary to consider the context of the wording and the objectives of the rules; the CJEU referred to the recitals (listed above) and importantly recital 17, which sets out when something should be excluded from the scope of the Directive.

The CJEU concluded that Article 3(1) when read with point 1 of Annex IB “cannot be interpreted as excluding… organisms obtained by means of new techniques/methods of mutagenesis which have appeared or have been mostly developed since Directive 2001/18 was adopted. Such an interpretation would fail to have regard to the intention of the EU legislature, reflected in recital 17”. Therefore, “Article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex I B to that directive and in the light of recital 17 thereof, must be interpreted as meaning that 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 are excluded from the scope of that directive” (emphasis added).

It was then determined by the CJEU that Article 4(4) of Directive 2002/53/EC should be read in light of the above interpretation. Therefore, it “must be interpreted as meaning that genetically modified varieties obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are exempt from the obligations laid down in that provision”; however, other techniques would not be so exempt.


There has been a question hanging over the interpretation of these provisions for some time leading to uncertainty in the industry as to whether an organism obtained by mutagenesis was always exempt from the Directive or whether there was a requirement to comply with the GMO legislation in some instances. Therefore, the clarification from the CJEU adds some certainty as to what will be caught by the Directive, although the decision may not be welcomed by all (especially those hoping for a blanket exemption for all mutagenesis techniques).

However, as recital 55 provides for the legislation to follow the development of GMOs closely it remains to be seen whether over time techniques/ methods currently caught by the CJEU’s interpretation become exempt as they become more widely used and gain a proven safety record. Therefore, this judgment still leaves the door open for arguments as to when a mutagenesis technique/ method will be deemed exempt.

[1] “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.”
[2] This case sat as the full court, i.e. the Grand Chamber (rather than Chambers of 3-5 judges). This occurs when a Member State or an institution which is a party to the proceedings so requests, and in particularly complex or important cases.
[3]Part 1 of Annex 1A is a list of techniques/ methods that would constitute GM. It includes the wording “inter alia”, and so is not an exhaustive list.