The process of legislative reform for plants produced by new breeding techniques (new GMOs, referred to in the study as “new genomic techniques” or NGTs) has started!
On 24 September 2021, the Commission published the initial impact assessment, which is a prerequisite for launching the legislative reform process. The content of this study is open to public consultation for one month, until 22 October 2021.
It should be noted that the scope of the review is limited to “plants produced by certain new genomic techniques“, in particular directed mutagenesis and cisgenesis. The legislative proposal will cover food and feed from such plants, but animals, micro-organisms and other new genomic techniques are not covered.
The tone is set at the outset of the document: the current legislation, which subjects plants derived from these “new genomic techniques” to the GMO regulation, is no longer appropriate and should be adapted “to scientific and technological progress“.
NBTs: Mutagenesis and transgenesis
Although mention is made of “potential safety and environmental impacts, including biodiversity, coexistence with organic and non-GMO agriculture” and “concerns about labelling and consumers’ right to information and freedom of choice“, this does not seem to weigh heavily in the balance in view of all the virtues of these new genomic techniques.
Among the arguments put forward in favour of a reform of the current regulation, nothing but the very classic:
- the legal uncertainties of Directive 2001/18 (which regulates GMOs), and in particular on the definition of terms such as “mutagenesis“, “traditional use for various applications“, “long-standing safety“; the fact that these techniques can be used to produce alterations in genetic material that could also occur through natural mutations or conventional selection techniques, and that plants obtained through these techniques would, according to the EFSA (European Food Safety Agency) study, present fewer risks than those obtained through ‘conventional’ genetic mutation techniques (transgenesis) the difficulty, if not the impossibility, of distinguishing between plants derived from these techniques and those derived from conventional breeding, which makes it difficult to implement the authorisation, traceability and labelling obligations laid down by the current regulations;
- the fact that the current regulatory framework does not take into account the potential of the products of these new techniques to address societal challenges, such as sustainability (since these NGTs can produce drought-resistant plants, etc.) and other objectives of the “European Green Pact”, the “Farm to Fork” strategy and the biodiversity strategy.
While the objectives of the reform (‘the initiative’) include maintaining a ‘high level of protection of human and animal health, the desire to strengthen the competitiveness of the EU agri-food sector (and beyond) and to ensure a ‘level playing field’ for its operators is clearly stated. The argument is well-worn: European breeders, subject to the constraints of prior authorisation, traceability, labelling, etc., would be in a weaker position than their American or Asian competitors where these new techniques are not regulated. Legislation should therefore be able to “follow the evolution of science” and be “proportional to the risk involved“.
On the study
The authors of the study are therefore clearly against maintaining the status quo. Some suggestions are given for the development of the regulation:
- Include risk assessment and approval requirements proportionate to the risks involved, on a case-by-case basis, taking into account elements such as the specific technique used, the type of modification or the novelty of the trait… Compliance with safety requirements would remain a prerequisite for deliberate release or placing on the market.
- Require a “sustainability analysis” to examine whether and how these products contribute to sustainability, taking into account the criteria developed under the policy action on a framework for sustainable food systems.
- Establish appropriate traceability and labelling provisions that are applicable and enforceable, taking into account the ability of plants obtained through targeted mutagenesis and cisgenesis to contribute to a sustainable food system and to ensure the right of consumers to make informed choices.
- The study also details the possible impacts on different sectors.
In economic terms, the case is clear: the reform should encourage and facilitate the development and marketing of “safe” plants obtained through targeted mutagenesis and cisgenesis and avoid the potential negative consequences described above. The following points should be considered
- the (supposedly positive) impact on agricultural production, use of inputs, development of more resistant varieties, reduction of varietal selection costs
- the impact on innovation and research in the EU which could be stimulated by this new framework, the increase in the involvement of SMEs due to the reduction in market access costs,
- the ‘potential’ negative impacts for organic and non-GMO agriculture and the premium retail sector.
- Issues related to the contribution of intellectual property to innovation will also be explored (Editor’s note: the issue of new GMOs and patents on life are closely linked, with process patents extending to plants derived from these processes).
At the social level, the impact assessment will look at the effects of introducing a sustainability analysis to ensure that products placed on the market provide a clear added value to society, the benefits to consumers that may result from the reduction of toxin or allergenic levels or the improvement of the nutritional profile of plants, and the impact on sustainability and biodiversity at the local level (including rural areas, supply chains and minor, niche or orphan crops that meet local needs).
In terms of environmental impact, it is recalled that the proposed initiative aims to maintain a high level of environmental protection and to facilitate the development and adoption of innovative plants that may have direct and indirect environmental benefits (as NGTs provide plants that are more resistant to diseases and environmental conditions or to the effects of climate change in general, with improved agronomic or nutritional characteristics, and requiring reduced use of natural resources (e.g. water)). Concerns about the potential negative effects of NGT plants on the environment and biodiversity, for example, due to the potential displacement of traditional varieties and loss of agricultural diversity, as well as concerns about increased pesticide use, will also need to be addressed.
Last but not least, according to the authors, the initiative has the potential to contribute to a number of objectives contained in the EU Charter of Fundamental Rights, including the principle of sustainable development. Adapting the legal requirements for plants obtained through targeted mutagenesis and cisgenesis according to their level of risk, by providing new opportunities for operators in the agri-food and biotechnology system, as well as for researchers and SMEs, will enhance their freedom to conduct their activities. The impact assessment will identify and assess all limiting factors, with the aim of minimising them. It will also address potential ethical issues related to environmental, economic and social impacts.
What happens next?
A 12-week public consultation will be organised (1st semester 2022) via the “Have your say” portal.
The Commission will take into account the positions already collected in the consultation of Member States and stakeholders concerned by NGTs.
Link to the Commission’s “Have your say” page here to find the text of the initial impact assessment. It is also on this page that it is possible to submit a contribution until 22 October 2021.
Please take a few minutes and tell the Commission why you reject their plan before 22 October:
Here are some platforms that makes it easy to tell the Commission to make your input:
From Corporate Europe Observatory in English
From Slowfood in English, Italian and German
From GMWatch in English
From Demeter International in English, Spanish and German:
From AbL in German
And from the Greens/EFA in English, French, German and Italian
