Today the Council has reached a provisional agreement with the European Parliament on a set of rules that establish a legal framework for new genomic techniques (NGTs).
The regulation aims to improve the competitiveness of the agrifood sector and ensure a level playing field for European operators, while boosting food security and reducing external dependencies. The regulation ensures robust protection for human and animal health, as well as the environment, while contributing to EU sustainability goals.
The provisional agreement guarantees a simplified process for NGT plants equivalent to conventional plants and addresses concerns regarding intellectual property and access to seeds.
New genomic techniques can help us do more with less. The regulation will allow us to develop new plant varieties that are more resilient to climate change and require less fertilisers or pesticides. Our farmers and agri-food sector will be better equipped to innovate and continue to produce healthy and safe food for our citizens.
Jacob Jensen, Danish Minister for Food, Agriculture and Fisheries
The term NGTs covers a variety of techniques that adapt seeds in a way that can also occur in nature or through conventional breeding techniques.
By using those techniques, improved plant varieties can be developed faster and with specific features that can respond to the challenges the agrifood sector is facing. For instance, those new varieties may be more resilient to the effects of climate change, such as drought or floods and require less use of fertilisers and pesticides.
Category 1 NGT plants
The provisional agreement maintains the principle that NGT-1 plants are equivalent to conventional plants, in line with the Council’s negotiating mandate and the Commission proposal. National authorities must verify that NGT plants belong to category 1, but their offspring do not need to be subsequently verified.
NGT-1 plants and products will not be labelled, keeping in mind the principle of equivalence. The only exception to this are seeds and other plant reproductive material of NGT-1 plants, which should be labelled. This would not entail a disproportionate burden for plant breeders, but it would allow operators to ensure a NGT-free chain, if they wish to do so.
Furthermore, Parliament and Council agreed on an exclusion list of intended traits that shall be excluded from the NGT-1 category.
Both the Council and Parliament concurred that tolerance to herbicides and ‘production of a known insecticidal substance’ will be on the exclusion list and cannot be one of the intended traits for category 1 NGT plants. This change to the Commission proposal will ensure that such plants are classed as NGT-2 and therefore remain subject to authorisation, traceability and monitoring.
Category 2 NGT plants
Plants with more complex or less “natural-equivalent” genomic modifications are classified under category 2. For NGT-2 plants, both the Council and the Parliament agreed with the Commission’s proposal to maintain the existing GMO legislation requirements, including mandatory labelling of products.
If the label includes information on the traits that were modified, it must cover all the relevant traits. This was introduced by the Council, to ensure that consumers have access to accurate and comprehensive information.
The Council and Parliament agreed to allow member states to opt out from the cultivation of NGT-2 plants on their territory.
The agreement also includes optional coexistence measures. This means that member states can take measures to avoid the unintended presence of NGT-2 plants and other products, if they wish to do so.
Protection of intellectual property
Patent rules are governed by the EU’s Biotech Directive. Nonetheless, the NGTs regulation addresses concerns voiced by plant breeders and farmers on patenting.
In particular, when applying to register a category 1 NGT plant or product, companies or breeders must submit information on all existing or pending patents. The patenting information must be included in a publicly available database.
Furthermore, on a voluntary basis, companies or breeders can also provide information on the patent holder’s intention to licence the use of a patented NGT 1 plant or product, under equitable conditions.
The Council and the Parliament agreed on the creation of a patenting expert group, focusing on the effect of patents on NGT plants, composed of experts from all member states, the European Patent Office and the Community Plant Variety Office.
One year after the entry into force of the regulation, the Commission will publish a study on the impact of patenting on innovation, on the availability of seeds to farmers and on the competitiveness of the EU plant breeding sector. The Commission will then indicate what follow-up measures are needed or publish a legislative proposal to address any issues found in the study.
Next steps
The provisional agreement will now have to be endorsed by the Council and the Parliament before it can be formally adopted.
Background
In the last decade, a variety of NGTs have been developed based on advances in biotechnology. Those new technologies did not exist in 2001, when the EU legislation on GMOs was adopted. That is why plants obtained through NGTs are currently subject to the same rules as GMOs.
The new rules would ensure that NGT plants available on the EU market are as safe as conventionally bred varieties. The agreement covers plants that contain small modifications to their genetic material (targeted mutagenesis) or insertions of genetic material from the same plant or from crossable plants (cisgenesis, including intragenesis). GMOs continue to be regulated by the EU legislation on GMOs, which remains unchanged.
Fonte: Conselho Europeu
