Not black and white: the regulatory status of plants from new breeding methods

Date:06-13-2018


By Garlich von Essen, Secretary General, European Seed Association (ESA) and Petra Jorasch, Manager Plant Breeding & Innovation Advocacy, European Seed Association (ESA)

The Advocate General takes a differentiated view when assessing the regulatory status of plants resulting from new breeding methods.

The latest plant breeding methods like genome editing can help to more efficiently develop plant varieties that are more resilient to climate change, have a reduced need for inputs, and deliver a wide range of diverse and healthy food. This fits with the objectives of the future CAP, which will require farmers to do more with less. However, it is still uncertain to what extent EU plant breeders and farmers will be able to embrace the latest breeding methods since the regulatory status of plants resulting from these methods is yet to be clarified. Breeders, scientists and regulators are waiting for the Court of Justice of the EU (CJEU) to rule on some decisive legal questions relating to a few of the most important new breeding methods. While some environmental lobby groups claim that all products resulting from the new methods are “hidden GMOs” or “GMOs through the back door“, scientists, the breeding sector, some member states and not least the Court’s Advocate General (AG) Bobek take a differentiated view.

European Court of Justice’s decision is imminent

In December 2014, 9 organisations initiated legal proceedings against parts of French law implementing the GMO Directive. They argue that plant varieties resulting from traditional or new forms of mutagenesis constitute ‘new hidden GMOs’ and need to be regulated as such. The French Conseil d’Etat subsequently referred these questions to the CJEU to ascertain whether organisms resulting from (new forms of) mutagenesis techniques should indeed be subject to the GMO legislation and also sought clarification over whether the overall validity of the GMO Directive is brought into question by the precautionary principle. On 18 January 2018 AG Bobek delivered his opinion in this case.

Scope of the GMO definition

In this Opinion, the AG clarifies that it first needs to be assessed whether an organism constitutes a GMO at all. The defining criterion in this respect is whether its genetic alteration could also occur naturally.

Secondly, the AG argues that both new and old mutagenesis techniques can be exempted from the obligations of the GMO Directive, depending on the specific process used in such techniques.

Combining both aspects, the AG makes a distinction between three different categories:

1. Organisms resulting from mutagenesis techniques which don’t constitute GMO’s;
2. Organisms resulting from mutagenesis techniques which constitute GMOs, but which are exempted from the obligations of the GMO Directive; and
3. Organisms resulting from mutagenesis techniques which constitute GMOs.

With such interpretation, attention is given both to the breeding process (how is the organism created) and the end result (the genetic characteristics of the final plant product). The categories are significant as each carries specific obligations and/or restrictions, which would have very different impacts for the plant breeding and wider agricultural sectors.

Taking the precautionary principle into account

The AG concludes that there is no evidence that the validity of the GMO Directive is undermined by the precautionary principle. This is in line with ESA’s position that the precautionary principle is already fully enshrined in all relevant EU legislation, including the GMO Directive, and must not be seen as an additional and separate legal framework. ESA also shares the AG’s observations that there is no knowledge of any concrete risks for the health or environment which are connected to mutagenesis, and that ‘general doubts’ do not equal an identified risk.

In line with regulatory requirements beyond Europe

The AG’s assessment is very much in line with several regulatory approaches around the world, such as in Argentina, Brazil, Chile and the US where regulators have already confirmed that organisms which are indistinguishable from plants that could have been produced by conventional breeding methods or could occur naturally are not to be regulated as GMOs. From “farm to fork”, these non-GMO plants would be treated and regulated as products of conventional breeding, and subject to the applicable legislative framework.

Why is this case so important?

After over 10 years of discussion and numerous studies commissioned by the European Commission, this case will be a decisive step in finally clarifying the regulatory status of plants resulting from some of the latest breeding methods. This will in turn determine whether or not they can be taken up by researchers, breeders and farmers in the EU in practice. Plant breeders and scientists around the world believe that there is enormous potential in these methods to speed up the development of varieties more resilient to climate change and better tailored to the diverse needs of farmers and consumers. However, if the Court would subject the plants obtained with these methods to the regular GM legislation and associated costs and uncertainties of market approval, it is likely that much of this potential is lost for Europe or exported to third countries. This would have significant economic and environmental consequences and question the future of plant breeding innovation in Europe.

What next?

The Court ruling is expected for the summer. If the Court follows the AG’s Opinion, we can expect a differentiated approach that will not be black and white but reflect the technical specificities of the various applications of the different breeding methods. This would be an important step for the EU to embrace innovation in plant science and breeding at both private and public levels.