Open letter to the members of the ENVI Committee on the regulation of plants derived from new genomic techniques
Cover letter to the members of the ENVI Committee
Paris, Zwijnaarde and Karlsruhe, 19 January 2024
Madame, President of the European Parliament,
Dear member of the ENVI Committee,
On 8 December, the AFBV (Association Française des Biotechnologies Végétales), EU-SAGE (European Sustainalbe Agriculture Through Genome Editing) and the WGG (Wissenschatftskreis Genomik und Gentechnik) sent you an open letter co-signed by 183 European scientists calling for the rapid adoption of the draft NGT regulation published by the Commission on July 5 2023 to allow the development, production and marketing of plant varieties bred using NTGs (targeted mutagenesis and cisgenesis).
Since then, we have received many additional signatures from several European Union Member States and even beyond, demonstrating the interest of the signatories in having access to these technologies and the products obtained. You will find attached the open letter with the list of more than 480 signatories from 23 Member States and other countries.
During this period, we have noted two issues which are attracting the attention of co-legislators and stakeholders and which are being used as arguments to delay reaching a consensus before the end of the current mandate:
- Intellectual property: This is an important element of innovation in all fields. In the case of plants, a balance is established between plant breeders' rights (PBRs) and patents. The Spanish Presidency's compromise proposal, which calls on the Commission to expedite its investigation into the impact of intellectual property on the use of NGTs and to make proposals to facilitate the use of this intellectual property by December 2025 at the latest, before the NGT regulation applies if adopted by May 2024, is a good approach. Amongst such improvements, the breeder's exemption which has recently been included in the unitary patent should be extended to all Member States. It will facilitate the use in breeding of varieties which include patented traits.
- ANSES (the French’s government’s food safety agency) opinion on Annex I of the draft regulation: ANSES has not questioned the principle of the proposal put forward by the Commission. In fact, it made comments, as other parties have done, on the definitions of terms used in the criteria and on the thresholds that have been proposed for certain criteria. To do this, the Commission analysed numerous scientific publications to determine, for example, how many changes could occur with conventional selection methods, and set a threshold significantly lower. It should also be noted that a number of comments on these criteria by ANSES and other stakeholders have already been taken into account in the compromise proposal put forward by the Spanish Presidency and in the proposed amendments from the AGRI and ENVI Committees. It is also important to point out that, while the nature of the modifications made to the NTG plants enables them to be considered as conventionally bred plants, it is the trait(s) contributed by these NTGs that are considered for marketing. It is important to remember that, as with conventionally bred varieties, these NTG varieties and the characteristics they contribute will be assessed by breeders and will be subject to the regulatory procedures applied to conventionally bred plants before being marketed.
These issues, on which proposals have already been made as described above, do not justify delaying the legislative process. We hope that you will be able to reach an agreement and support this proposal so Europe can benefit quickly from these products as is already the case in several countries. Such proposal will allow, without further delay, the development of NGT varieties that will help Europe achieve the objectives it has set itself. Please consider that we are responsible for what we do and also for what we choose not to do.
We thank you for your kind consideration,
Georges FREYSSINET Prof. Dr. Klaus-Dieter JANY
Président Chairman
Association Française des Association of Genomics and
Biotechnologies Végétales (AFBV) and Genetic Engineering e.V. (WGG)
e.mail: afbv.secretariat@gmail.com jany@wgg-ev.de
Website: https://www.biotechnologies-vegetales.com/ https://www.wgg-ev.de/
Prof. Dr. Em. Dirk Inze
Chairman
European Sustainable Agriculture
Through Genome Editing (EU-SAGE)
Dirk.inze@psb.vib-ugent.be
https://www.eu-sage.eu/
Paris, Zwijnaarde and Karlsruhe, 19 January 2024
Open letter
to the President of the European Parliament, Ms. Roberta Metsola
and Members of the European Parliament
New genomic techniques (NGTs) are key to achieving greater sustainability of agriculture and food sovereignty in Europe.
Ambitious objectives have been set at the European level to ensure food sovereignty while maintaining the sustainability of its agriculture, which has to cope with climate change while reducing the use of inputs including water, fertilizers and plant protection products.
To achieve these goals, a continuous flow of innovation is needed. This requires accelerating the development of new plant varieties adapted to the environmental constraints described above. This presupposes that these new varieties can withstand environmental stresses such as drought or extreme temperatures (abiotic stress) and be resistant to diseases and pests (biotic stress). The rapid introduction of such varieties will only be possible if breeders have access to all the available techniques without preconceptions and under the right conditions. However, this is not currently the case in Europe, since the GMO legislation applicable to NGTs, which dates back to 2001, is not adapted to these recent technologies.
Many results are already published and the first NGT varieties have become available
The potential of NGTs is already demonstrated by the number of scientific publications worldwide. More than 800 are currently listed in the EU-SAGE1 database covering the range of traits described above and applied to 70 different plant species. GMO legislation, which has already been adapted in several countries around the world, has authorized the marketing of the first NGT varieties such as a GABA-enriched tomato in Japan, a bitterless kale in the United States, or a reduced browning banana in the Philippines. More are to come if we consider, for example, the number of NGT plants listed in the USDA2 or Health Canada3 databases.
The Commission's proposed regulation
Aware of this situation, the European Commission presented in July 2023 a proposal for the regulation of varieties bred using NGTs (targeted mutagenesis and cisgenesis). This proposal was eagerly awaited by all actors involved in the research and development of these new varieties in Europe. It provides that plants bred using NTGs and that could also occur naturally or be produced by conventional breeding techniques will not be subject to the EU’s GMO legislation. They would be subject to the regulations applied to conventionally bred varieties. These NGT plants would have to meet certain criteria based on the modified genome sequence. They would be verified by a competent authority, listed on a public database and their seed bags would be labelled "NGT-1 plants". Other NGT plants would remain subject to the rules and requirements of EU GMO legislation, with a risk assessment tailored to take into account the diversity of their risk profiles and address the challenges of detection.
Need for expeditious adoption of the proposed regulation
Rejecting the application of NGTs to plants would prevent Europe from participating effectively, together with other countries, in addressing the challenges facing agriculture worldwide. Europe must have the ambition to remain a major player in food production in its own interest and in the interest of the planet. We believe that the Commission's proposed regulation of NGT plants meets the needs of the stakeholders involved in the food production chains. The adoption of this proposal, subject to certain clarifications, several of which have already been taken into account by the draft amendment of the European Parliament's ENVI Committee, and others which may be included at a later date in the implementing acts provided for in the draft, must be implemented very quickly to allow the development of the first NGT varieties before the end of the decade, thus helping Europe to achieve the objectives it has set itself.
The signatories are available to provide you with further information and answer any questions you may have.
