Plants obtained by certain new genomic techniques and their food and feed
The European Parliament adopted a legislative resolution approving the Council's position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their products and amending Regulation (EU) 2017/625.
The regulation aims to enable the development and placing on the market of plants and products obtained by means of certain new genomic techniques (NGTs) that contribute to an innovative, resilient, sustainable, and competitive agri-food sector, while maintaining a high level of protection for human and animal health and the environment.
The main elements of the Council's position are as follows:
Classification into two categories
Plants modified using NGTs will be classified into two categories, subject to different legal obligations:
- NGT-1 - This category is for plants with a limited number and type of changes that could have occurred through conventional breeding.
- NGT-2 - This category is for plants that have undergone more extensive or complex genetic modifications. These are covered by the existing strict GMO rules and will be subject to risk assessment. They must obtain an authorisation before being commercialised in the EU.
Furthermore, they will need to obtain authorisation before being placed on the EU market.
NGT plants have to fulfil two conditions to obtain category 1 NGT plant status: 1) the criteria of equivalence of NGT plants to conventional plants (Annex I to the Commission proposal), 2) the NGT plant must not include certain traits among the traits conveyed by the genetic modification (‘herbicide tolerance’ and ‘production of a substance with known insecticidal action’) set out in Annex II. If an NGT plant does not fulfil those conditions, it will be treated as category 2.
The category 1 status verification process includes a requirement for the requester to accompany the request with scientific evidence substantiating the relation between the introduced genetic modifications and the intended trait.
Emergency measures
It is specified that the emergency measures in the legislation on food, feed, and other products also apply to Category 1 NGT plants when these are likely to pose a serious risk to human health, animal health, or the environment.
Traceability, labelling and right of refusal for Member States
Full traceability and labelling will remain obligatory for NGT-2 plants and EU countries may restrict or prohibit their cultivation even if authorised for cultivation in the EU.
Plant varieties containing or derived from an NGT-1 plant will be listed in a public EU database and all seed bags and reproductive material must be labelled NGT-1, to allow farmers to make an informed choice.
To steer the use of NGTs towards developing plants with sustainability features (e.g. climate and pest resistance), the regulation makes it mandatory to monitor the sustainability impacts of NGT plants.
Organic plants
As part of its assessment of the application of the regulation, the Commission is required to submit a report that must include producers' and consumers' perceptions of the ban on NGTs in organic production and assess the burden on organic operators resulting from the regulation.
Neither Category 1 nor Category 2 NGTs may be used in organic production, despite the exemption of Category 1 NGTs from the requirements of GMO legislation. However, the adventitious or technically unavoidable presence of category 1 NGT plants in organic production shall not constitute non-compliance with the regulation on organic production and products.
Patents
The Council's position introduces several measures concerning patents related to plants obtained through new genomic techniques (NGTs):
- establishment of a voluntary code of conduct aimed at improving patent transparency, ensuring fair licensing, and strengthening legal certainty for breeders and farmers, under the supervision of the European Commission;
- an obligation for applicants to declare relevant patents during the verification procedure for Category 1 NGT plants, and the possibility for applicants to submit a declaration of the patent holder indicating whether they intend to license NGT plants on fair and reasonable terms within the Union;
- publication by the Commission of guidelines on intellectual property issues and available support for research and development in the field of NGTs;
- an impact assessment of patenting NGT plants and a review of possible legislative measures, with a second assessment if the first is unsuccessful;
- creation of an expert group tasked with examining the effect of patents on NGT plants, which would help it to survey and exchange information on issues such as access to genetic resources, transparency on patents and innovation in the field of NGT plants.