Part 1:
The Opinion of the Advocate General in Case C-688/21
(in vitro random mutagenesis)
DECISION OF THE ADVOCATE GENERAL MACIEJ SZPUNAR of 27 October 2022(1) in Case C-688/21
Confédération paysanne, Réseau Semences Paysannes, Les Amis de la Terre France, Collectif Vigilance OGM et Pesticides 16, Vigilance OG2M, CSFV 49, OGM: dangers, Vigilance OGM 33
against
Premier ministre, Ministre de l'Agriculture et de l'Alimentation,
Other party to the proceedings: Fédération française des producteurs d'oléagineux et de protéagineux
The summary of the opinion of Advocate General Szpunar on the classification of plants derived from in vitro random mutagenesis is available in English in the ► press release of the European Court of Justice (CJEU), only. The ► detailed opinion with the reasoned statements on the recommendation to the ECJ "In vitro random mutagenesis falls within the scope of the derogation in Annex I A No. 1 of the Deliberate Release Directive 2001/18/EC" has not yet been translated into English.
As usual for decisions of the CJEU, an Advocate General analyses the facts from a legal and scientific point of view. In this case, the classification of plants bred with the help of in vitro random mutagenesis methods. From the analysis of the factual situation, he then makes a reasoned recommendation for a decision by the CJEU. The Advocate General's recommendations are not binding on the decision of the CJEU.
Opinion of the Advocate General
In his introduction (RN 1 - 8), Advocate General Szpunar deals in general with mutagenesis methods, their applications and effects on plants. Then, in RN 8, he indicates the concern of the legal proceedings: "In the present case, the question is whether varieties resulting from in vitro random mutagenesis, hitherto considered to be excluded from the scope of the legislation in question and a number of which are cultivated in the Union, including the pesticide-resistant varieties of oilseed rape at issue in the main proceedings, are now covered by that legislation and will most probably have to share the fate of the transgenic varieties."
In the section "Legal framework" (RN 9 - 13), he provides purely formal information on the applicable legislation, the Release Directive 2001/18/EC including the ► notification procedure (EU) 2015/1535. With regard to the Release Directive, he particularly highlights the exemption for procedures/methods of genetic modification namely mutagenesis in Annex I B No. 1. The legislator has not differentiated between in vivo and in vitro random mutagenesis in the Release Directive.
In the following sections "Facts of the case, original proceedings and questions “referred to a preliminary ruling (RN 14 - 21), it sets out facts and the results / findings from the original proceedings, including the ► CJEU judgment (C-528/16), and assesses them in part.
As one of the defendants questions the admissibility of the applicants' questions arising from the interpretation of the Release Directive, Advocate General Szpunar is of the opinion that these are very much admissible, but cannot be answered clearly and uniformly by the Court as formulated. He therefore proposes that the CJEU go beyond these questions (RN 22) and will therefore reformulate the question.
In his preliminary remarks (RN 23 - 30), he once again addresses the extent to which in vitro random mutagenesis and targeted mutagenesis are covered by the Release Directive. In doing so, he states that,
a) Targeted mutagenesis is not excluded from the scope of the Release Directive 2001/18/EC and,
following the CJEU ruling, was only developed and applied after the Directive came into force.
b) in vitro random mutagenesis was not explicitly dealt with in the CJEU ruling and no differentiation was
made between in vivo and in vitro random mutagenesis. The CJEU had not made any evaluation of
both procedures
c) the decisive factor for answering the questions was whether in vitro random mutagenesis was
excluded from the scope of the release directive.
The section "Submissions of the parties" (RN 31 - 35) will not be discussed here. The explanations on this are in principle already given in the section "Background" (Part 2).
In the section "Rephrasing of the questions referred for a preliminary ruling" (RN 36 - 43), Advocate General Szpunar explains in detail (RN 36 - 42) his proposal for a rephrasing of the questions and in paragraph 43 he formulates his proposal: "I therefore propose that the questions referred for a preliminary ruling in the present case be understood as essentially relating to the question of whether Art. 3(1) of Directive 2001/18, in conjunction with Annex I B No.1 thereto, is to be interpreted in the light of its 17th recital as meaning that in vitro random mutagenesis falls within Annex I B No. 1 thereto."
In simpler terms, does the exemption in Annex I B No. 1 include in vitro random mutagenesis?
In section "Examination of the reworded questions" (RN 44 - 69) Advocate General Szpunar examines the correctness of his reworded questions from a scientific and legal point of view and states right away in RN 44 that it cannot be denied, either for scientific or legal reasons, that in vitro mutagenesis is not covered by the exception. With regard to the scientific consideration, he refers to the statements in the opinions of the ► EFSA and the ► HCB. With regard to the genetic modifications, a differentiation between in vivo and in vitro random mutagenesis is not justified (RN 45) and the procedure and occurrence of the mutations is identical in both cases. This is independent of whether intact plants, single cells or tissue are subjected to the mutation procedure. This also includes somaclonal changes. In line with the EFSA and HCB opinions, he too is of the opinion that in vivo and in vitro random mutagenesis are not two different procedures, but the same procedures for the induction of random mutations.
As the CJEU in its judgement (C-528/16) on mutagenesis only includes methods developed and applied after the entry into force of the Deliberate Release Directive in its scope, Advocate General Szpunar strongly points out that in vitro random mutagenesis was already applied in plant breeding long before 2001 (RN 65). The legislator was already aware of these applications of in vivo and in vitro random mutagenesis at that time and did not make a distinction between the two methods when legislating on the Release Directive and excluded both methods from the scope of the Release Directive.
Conclusion
On the basis of the facts and the assessment of the facts, Advocate General Szpunar concludes that in vitro random mutagenesis falls within the exemption of the Deliberate Release Directive and he will therefore propose to the CJEU that Article 3 (1) 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 (GMOs) is not applicable. March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, in conjunction with Annex I B No. 1 thereto, must be interpreted in the light of its 17th recital as meaning that in vitro random mutagenesis falls under Annex I B No. 1 of the Directive.
As already mentioned at the beginning, the Advocate General's Opinions are only recommendations for the CJEU. The Court of Justice is not bound by them and does not have to follow them. As a rule, however, the CJEU follows the recommendations of the Advocate General. However, it should be remembered that this is not always the case, as was just the case with the mutagenesis ruling (CJEU C-528/16).
Now we will have to wait and see how the CJEU's ruling turns out!
Part 2:
Background to „The Opinion of the Advocate General in Case C-688/21 “
The decision of the Conseil d'Etat
France had to react promptly to the CJEU ruling
(► C-528/16) on the legal classification of mutagenesis methods under genetic engineering law and to take a decision. This was done
► on 07.02.2020 (
► non official translation) by the Conseil d' État (the Council of State), France's highest administrative court. It ruled on the basis of the case file that all plants bred with the help of in-vitro mutagenesis processes are genetically modified organisms (GMOs) and must therefore be subject to all regulations under genetic engineering and environmental protection legislation. The Court has set the government a deadline of 6 months to adapt the environmental law (Art. D 531-2, letter a) to this judgement. The High Council for Biotechnology is to compile a list of in vitro mutagenesis methods that have been used for a long time and are known not to cause any harm to "public health or the environment". For these, an exemption similar to Annex I B of the Release Directive 2001/18/EC is to be applied. Furthermore, the government must determine within nine months which plants included in the catalogue of varieties (2002/53/EC) have been produced by in vitro mutagenesis procedures and are now subject to the provisions of genetic engineering law and the Environmental Protection Act. Plants that have not been included in the catalogue according to these regulations must be removed from the catalogue and taken off the market.
The notification procedure
The implementation of this Decree (Order) has a potential impact on the common internal market and therefore France had to submit it to the Commission for notification in accordance with ► Directive (EU) 2015/1535. Directive (EU) 2015/1535 requires Member States to notify the Commission of any draft technical regulation before its adoption. From the date of notification of the draft, a three-month standstill period - during which the notifying Member State cannot adopt the technical regulation in question - allows the Commission and the other Member States to examine the notified text and react appropriately.
France had submitted the ► draft decree for notification on 06. May 2020. Until 07. August 2020, the Commission as well as the member states had to react to this draft. By the end of the period, Finland, Austria and Sweden had submitted comments and the Commission, Denmark, Italy, the Netherlands, Spain and the Czech Republic had submitted detailed opinions. Due to the submission of detailed comments, the standstill period was extended until 2020-11-06-11. France must answer on these comments and take them into account when implementing the decree.
Summary of the detailed opinion of the Commission
► Communication 315 from the Commission - TRIS/(2020) 02950, Notification: 2020/0280/F, 2020/0281/F, 2020/0282. The Commission has serious concerns for a notification of the three French draft decrees 2020/0280/F, 2020/0281/F, 2020/0282. It considers that the drafts are in breach of Article 3(1) and Annex I B of the Release Directive 2001/18/EC, as well as Article 14 of Directive 2002/53/EC and Article 14 of Directive 2002/55/EC (the Seeds Directives)
Legal reasons
The decision of the Conseil d’Etat and the three draft documents derived from it introduce a distinction between in vitro and in vivo random mutagenesis which finds no support (1) in the CJEU opinion, (2) in the EU legislation and (3) in the scientific development of these techniques.
(1) First regarding the CJEU, the court in its reasoning referred to the “application of conventional
methods of random mutagenesis” without distinguishing further between in vivo and in vitro random
mutagenesis and distinguished them from “new techniques/methods of mutagenesis which have
appeared or have been mostly developed since Directive 2001/18 was adopted”.
(2) Second, the Union legislator has never differentiated between in vivo and in vitro random
mutagenesis either: Annex I B of the deliberate release Directive does refer to mutagenesis in
general without any further specification.
(3) Third, mutagenesis is a process by which the genetic information of an organism is changed,
resulting in a mutation. Mutagenesis may occur spontaneously in nature, or as a result of exposure
to mutagens. Mutagenesis as a tool to increase genetic variation in plant breeding was developed in
the first half of the 20th century. The techniques were initially applied in vivo and progressively,
since around the 1970s, introduced in vitro steps in the procedures. Since then, treatments on
plants, seeds, part of plants and single cells have been more and more common in laboratory (in
vitro). The result of the application of these techniques gives no basis to distinguish between in vivo
and in vitro random mutagenesis. There is rather a continuum in genomic changes caused by in vivo
and in vitro random mutagenesis and their subsequent regeneration to plants.
It is worth noting, however, that the Conseil d’Etat restricts the notion of in vitro random mutagenesis to those techniques that consist in subjecting in vitro cultured plant cells to chemical or physical mutagens. However, any regenerated mutant plant relies on mutagenesis of single cells that go into the germ line of the plant, disregarding whether the mutagenesis is made on a plant, plant part or on cell cultures.
Regarding the historical development of the technology, the Commission points out to the French Authorities that the Conseil d’Etat did not consider when the techniques of random in vitro mutagenesis appeared or had been developed, i.e., before the adoption of Directive 2001/18/EC.
Deletion from the Catalogue
Based on the arguments above, in vivo and in vitro random mutagenesis cannot be considered two different techniques, the deletion from the Official Catalogue of the species and varieties of plants cultivated in France of varieties obtained from in vitro random mutagenesis seems unjustified. These varieties would not be considered GMOs subject to the requirements of the GMO legislation as they fall within the exemption in Article 3(1) of the deliberate release Directive, read in conjunction with point 1 of Annex I B, and in light of recital 17 of that Directive. Based on EU legislation and this ruling no distinction should be made, contrary to the ruling of the Conseil d’Etat, between the techniques of in vivo and in vitro mutagenesis. There is no basis either for restricting the notion of in vitro random mutagenesis only to those techniques that consist in subjecting in vitro cultured plant cells to chemical or physical mutagenesis. There is also no basis or evidence, either, supporting the conclusion that the techniques used for the herbicide tolerant varieties of rapeseed that would be delisted from the French Catalogue are not exempt from the obligations in Article 4(4) of Directive 2002/53 and do not have a long safety record.
The Commission stresses the need for a harmonized approach at EU level as to the application of all consequences. The Union legislation has never distinguished between in vitro and in vivo mutagenesis and the provisions in question – Articles 2 and 3 and Annex IB of the deliberate release Directive have never been amended since their adoption. Therefore, it is difficult to understand the intention of the French Authorities to apply Article 14 of Directive 2002/53/EC to remove the varieties of agricultural plants listed in the French national catalogue which have been identified as resulting from random in vitro mutagenesis by subjecting plant cells grown in vitro to chemical or physical mutagens, as the present case would not appear justified under the criteria in Article 14.
Different legal classifications of in vivo and in vitro random mutagenesis procedures would create a conflict with EU legislation for organic farming under regulations (EC) No 834/2007 and EU 2018/848), because plants resulting from techniques exempted under Annex I B are used in organic farming.
Conclusion: The Commission considers a differentiation between in vitro and in vivo random mutagenesis procedures is unjustified and inadmissible. The Commission does not consider in vitro and in vivo random mutagenesis methods to be two different techniques.
Concerns about trade barriers
The implementation of the draft would result in plants produced by in vitro mutagenesis processes or involving such processes in the breeding process being classified as GMOs in France alone and regulated as such. Such plants would then be removed as the national (French) catalogue of varieties, but not necessarily from the Common EU Variety Catalogue. As a result, the varieties listed in the Common EU Variety Catalogue will remain freely marketable throughout the EU, except in France. (The same applies to products derived from such plants.) The notification of the draft would limit the freedom of movement in the common internal market. Externally, the EU could not act as more than a common market. In addition, the notification would lead to obstacles to the free movement of crops and organic products.
Conclusion: The Commission sees serious implications for the free movement of goods within the EU and in international trade (WTO).
On the basis of the Commission's detailed opinion and article 6(2) of Directive (EU) 2015/1535, the French Government is obliged to comment on the submissions. The government must inform the Commission of any changes in the draft resulting from the Commission's opinion. This deadline expires on 09/11/2020. If the Government fails to comply with these obligations, the Commission may open proceedings under Article 258 of the Treaty on the Functioning of the European Union (referral to the CJEU).
Council of State appeals to the CJEU on the legal classification of plants obtained by in vivo and in vitro random mutagenesis procedures (Case C-688/21)
According to the decision of the State Council, plants obtained by in vitro random mutagenesis are to be classified as genetically modified and the laws are to be amended accordingly. The amendment of the law required the initiation of a notification procedure, which France initiated with Procedures 2020/280/F. The notification procedure is currently suspended and the French government has not been able to amend the law so far. Similarly, the government has not yet produced the required report on the risk assessment of herbicide-tolerant plants.
The Confédération paysanne and Others brought an action against these failures before the Council of State and the Council of State ruled ► in its judgment of 08.11.2021 that, the enforcement of Articles 2 and 3 of the decision of 7 February 2020 be suspended and the CJEU should be asked for a decision on the classification of plants bred by in vivo and in vitro random mutagenesis.
The Conseil d’État refers the following questions:
“1. Is Article 3(1) 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, read in conjunction with point 1 of Annex I B to that directive and in the light of recital 17 of the Directive, to be interpreted as meaning that, in order to distinguish from amongst techniques/methods of mutagenesis those techniques/methods which have conventionally been used in a number of applications and have a long safety record, within the meaning of the judgment of the Court of Justice of 25 July 2018, consideration need be given only to the methods by which the mutageneous agent modifies the genetic material of the organism, or must account be taken of all the variations in the organism induced by the process used, including somaclonal variations, which may affect human health and the environment? “
2. Is Article 3(1) of Directive 2001/18/EC of 12 March 2001, read in conjunction with point 1 of Annex I B to that directive and in the light of recital 17 of the Directive, to be interpreted as meaning that, in order to determine whether a technique/method of mutagenesis has conventionally been used in a number of applications and has a long safety record, within the meaning of the judgment of the Court of Justice of 25 July 2018, account need be taken only of open field cultivation of the organisms obtained using that method/technique, or may account also be taken of research work and publications that do not relate to such cultivation and, in relation to that work and those publications, is consideration to be given only to work and publications relating to risks for human health or the environment?”
Request for a preliminary ruling from the Conseil d’État (France) lodged on 17November 2021– Confédération paysanne and Others v Premier minister, Ministre de l’Agriculture et de l’Alimentation (Case C-688/21)
Summary of the request for a preliminary ruling pursuant to Article 98(1) of the Rules of Procedure of the Court of Justic
The two questions contain considerable "explosive material", especially as the High Council for Biotechnology and the EFSA have already issued their opinions on possible differences between the two procedures at the genetic level. Both competent authorities have not been able to identify any differences here, regardless of whether the mutagenesis procedures are carried out in vivo or in vitro.
bgf-Jany 2022-11-10