Comments to the ruling of the Conseil d´Etat on mutagenesis techniques and GMO directive

The Court of Justice, whose decisions are not subject to appeal, decided on the basis of filed documents that all plants bred with the aid of in vitro mutagenesis techniques after the Release Directive came into force (12.03.2001) are considered as genetically modified organisms (GMOs) and must therefore be subjectde to all regulations arising from genetic engineering and environmental protection legislation.

The Court of Justice has given the Government a period of 6 months to adapt the current Environmental Law (Art. D 531-2, letter a) to this judgment. The High Council for Biotechnology is to compile a list of in vitro mutagenesis methods which have been used for a long time and which, as experience shows, are not associated with any damage to "public health or the environment". For these, a derogation similar to that in Annex I B of the Release Directive 2001/18/EC should then be applied. 

Furthermore, the government must identify 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 the Genetic Engineering Law and the Environmental Protection Law. Plants that have not been included in the catalogue of varieties in accordance with these regulations must be removed from the catalogue of varieties and withdrawn from the market.

In addition, the Court pointed out that the authority (ANSES) should identify and assess potential risks to humans and the environment from herbicide-tolerant plants obtained by in vitro mutagenesis. This evaluation is to define cultivation conditions for such plants that reduce the use of herbicides.  

Furthermore, the Court is of the opinion that that the precautionary principle must be applied to in vitro mutagenized plants and in particular to herbicide-tolerant plants.

The Council of State did not grant the request for a moratorium on the cultivation of in vitro mutagenized plants, in particular herbicide-tolerant plants.

 

In vitro mutagenesis procedures: Similar to the CJEU ruling this summarizes all in vitro mutagenesis procedures lead to genetic changes in an organism. On the one hand they include the classical procedures such as treatment with mutagenic chemical agents or high-energy radiation. Those lead to uncontrolled and unpredictable numerous random mutations in the genetic material. On the other hand, the Court also include new procedures, which derive from the possibilities of CRISPR/Cas, TALEN, ODM procedures. In general, these methods lead to a desired mutation in the genome, only. Common to all procedures is to bred a plant with new useful characteristics. 

Although the ruling only applies to France, its implementation into national law will have far-reaching consequences on innovation, free trade and competitiveness within and for the European Union. However, it further highlights that the EU Commission must promptly adapt genetic engineering law to the state of the art in science and technology. Individual state regulations should be avoided. 

The ruling anticipates a European regulation. For France it means that in vitro mutated plants that were approved after 2001 but have not yet undergone the EU safety assessment may no longer be cultivated and products from these plants may no longer be traded. International trade will thus be restricted! 

Listing and classification of in vitro mutagenesis by the High Council for Biotechnology:

The listing of these mutagenesis methods is in principle to be welcomed although the EU Commission should have done this already years ago within the discussion on new breeding methods. Hence does the French government already execute a pre-justification? It is unclear to what extent the High Council for Biotechnology can (may) contact the EU Commission. It is clear, however, that within the set period it is not possible to coordinate with the EU Commission and the member states.

Review of the catalogue of varieties: The listing of in vitro mutagenized plants (dead line 12.03.2001 ??) which have not passed the prescribed safety assessment will be difficult, if not impossible. For most plants not the entire breeding process is known including that of the initial crossing partners. The revision period of nine months is far too short. The possible deletion of plants from the catalogue of varieties raises legal questions as the ruling and its implementation have retroactive effect on existing (European) regulations.

Conclusion: The judgement represents a further obstacle for modern plant breeding and restricts the possibilities of small and medium-sized breeding companies to survive in international competition. 

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