Case C‑528/16

Confédération paysanne and Others

v

Premier ministre
and
Ministre de l’Agriculture, de l’Agroalimentaire et de la Forêt

(Request for a preliminary ruling from the Conseil d’État (France))

(Reference for a preliminary ruling — Deliberate release of genetically modified organisms into the environment — Mutagenesis — Directive 2001/18/EC — Articles 2 and 3 — Annexes I A and I B — Concept of ‘genetically modified organism’ — Techniques/methods of genetic modification conventionally used and deemed to be safe — New techniques/methods of mutagenesis — Risks for human health and the environment — Discretion of the Member States when transposing the directive — Directive 2002/53/EC — Common catalogue of varieties of agricultural plant species — Herbicide-tolerant plant varieties — Article 4 — Acceptability of genetically modified varieties obtained by mutagenesis for inclusion in the common catalogue — Human health and environmental protection requirement — Exemption)

Summary — Judgment of the Court (Grand Chamber), 25 July 2018

1.        Approximation of laws — Deliberate release into the environment of genetically modified organisms — Directive 2001/18 — Genetically modified organism — Concept — Organisms obtained by means of techniques/methods of mutagenesis — Included

(European Parliament and Council Directive 2001/18, Art. 2(2)(a) and (b) and 3(1) and Annex I A and B)

2.        Approximation of laws — Deliberate release into the environment of genetically modified organisms — Directive 2001/18 — Scope — Organisms obtained by means of techniques/methods of mutagenesis conventionally used in a number of applications and deemed to be safe — Not included — Organisms obtained by means of new techniques/methods of mutagenesis — Included

(European Parliament and Council Directive 2001/18, Recital 17, Art. 3(1), and Annex I B, point 1)

3.        Agriculture — Common catalogue of varieties of agricultural plant species — Directive 2002/53 — Acceptance of varieties for inclusion in the common catalogue — Conditions — Compliance with human health and environmental protection requirements — Exemption — Genetically modified varieties obtained by means of techniques/methods of mutagenesis conventionally used in a number of applications and deemed to be safe

(Council Directive 2002/53, Art. 4(4))

4.        Approximation of laws — Deliberate release into the environment of genetically modified organisms — Directive 2001/18 — Organisms obtained by means of techniques/methods of mutagenesis conventionally used in a number of applications and deemed to be safe — Option for the Member States to subject such organisms to the obligations laid down in that directive or to other obligations — Conditions

(European Parliament and Council Directive 2001/18, Art. 3(1) and Annex I B, point 1)

1.      Article 2(2) of 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 must be interpreted as meaning that organisms obtained by means of techniques/methods of mutagenesis constitute genetically modified organisms within the meaning of that provision.

In that regard, Article 2(2)(a) of Directive 2001/18 states that, for the purpose of the definition of a GMO, genetic modification occurs at least through the use of the techniques listed in part 1 of Annex I A to that directive. Although part 1 of Annex I A to that directive does not explicitly refer to techniques/methods of mutagenesis, that fact is not such as to exclude organisms obtained by means of those techniques/methods from coming under the definition of a GMO in Article 2(2) of the directive. It should be noted, first, that, as follows from the expression ‘inter alia’ in the first sentence of part 1 of Annex I A to Directive 2001/18, the list of genetic modification techniques in that part is not exhaustive. Consequently, that list cannot be regarded as excluding genetic modification techniques other than those to which it specifically refers. Secondly, it must be noted that the EU legislature has not included mutagenesis in the exhaustive list of techniques not resulting in a genetic modification, referred to in Article 2(2)(b) of Directive 2001/18, read in conjunction with part 2 of Annex I A to that directive. On the contrary, mutagenesis is expressly cited, in Annex I B to that directive, as one of the techniques/methods of ‘genetic modification’ referred to in Article 3(1) of that directive, relating to organisms that have to be excluded from the scope of the directive.

(see paras 33-37, 54, operative part 1)

2.      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.

In those circumstances, Article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex I B to that directive, cannot be interpreted as excluding, from the scope of the directive, 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 of the directive, to exclude from the scope of the directive only organisms obtained by means of techniques/methods which have conventionally been used in a number of applications and have a long safety record. It follows that an interpretation of the exemption in Article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex I B thereto, which excludes organisms obtained by means of techniques/methods of mutagenesis from the scope of that directive, without any distinctions, would compromise the objective of protection pursued by the directive and would fail to respect the precautionary principle which it seeks to implement.

(see paras 51, 53, 54, operative part 1)

3.      Article 4(4) of Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species, as amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003, 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.

(see para. 68, operative part 2)

4.      Article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex I B to that directive, in so far as it excludes from the scope of that directive 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, must be interpreted as meaning that it does not have the effect of denying Member States the option of subjecting such organisms, in compliance with EU law, in particular with the rules on the free movement of goods set out in Articles 34 TFEU to 36 TFEU, to the obligations laid down in that directive or to other obligations.

The EU legislature excluded those organisms from the scope of that directive, without specifying in any way the legal regime to which they may be subject. In particular, it does not follow from that directive that the fact that 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 its scope means that persons concerned could proceed freely with their deliberate release into the environment or with the placement on the market of such organisms as or in products within the European Union.

Therefore, the exemption in Article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex I B to that directive, cannot be interpreted as preventing Member States from legislating in that area.

(see paras 80-82, operative part 3)