On Tuesday 21 April, the EU Council of Ministers is due to adopt without debate the Regulation on plants obtained using certain new genomic techniques (NGT) and their products.
At the meeting of the Committee of Permanent Representatives of the Member States to the EU (Coreper) on 19 December, Slovenia, Croatia, Slovakia, Austria, Hungary and Romania indicated that they would vote against the text, while Bulgaria, Germany and Belgium announced their intention to abstain at the time of the vote.
The vote in plenary session of the European Parliament should take place at the earliest during the Strasbourg session from 18 to 21 May. The plenary session at the end of April (27-30 April, in Strasbourg) will first have to confirm the adoption of the text by the EU Council (see EUROPE 13796/8). The European Parliament’s Committee on the Environment will then have to vote on the text again and may table and vote on new amendments, in accordance with the second reading procedure, which lays down stricter rules on the admissibility of amendments (Rule 69 of the European Parliament’s Rules of Procedure).
In an analysis note, the EU Council considers that the general structure of the European Commission’s proposal has been maintained, with a distinction between two categories of plants derived from NGTs.
Category 1 includes plants derived from NGTs that are equivalent to conventional plants, i.e. the genetic modification introduced through NGTs could also occur naturally or be obtained by conventional breeding. These plants are subject to a verification procedure, under which a national competent authority or the Commission establishes that they are indeed equivalent to conventional plants. Once this equivalence has been confirmed, category 1 NGT plants are exempt from the requirements of GMO legislation.
Category 2 includes plants derived from NGTs with more complex modifications that do not contain foreign DNA. These plants are subject to a notification procedure or an authorisation procedure, in accordance with GMO legislation. Unlike genetically modified plants containing foreign DNA, category 2 NGT plants benefit from limited derogations. In particular, risk assessment and monitoring requirements are more flexible and can be adapted to the risk profile of the plants.
Sustainability-related criteria have also been introduced to determine the eligibility of NGT plants for category 1, in the form of a negative list (or exclusion list) of characteristics set out in a new annex to the regulation. The characteristics on this list are considered likely to have negative effects on sustainability. If one of the traits borne by the NGT plant and intended to be conveyed by the genetic modification is on that list, the NGT plant is excluded from category 1 and is therefore subject to authorisation, traceability and monitoring requirements as well as other provisions on category 2 NGT plants.
Patents. A number of safeguards address concerns on potential adverse impacts of the patenting of NGT plants and related licensing and transparency practices, in particular with regard to breeders’ access to plant biological material and techniques, and risks of market concentration, explains the EU Council’s note.
The compromise provides for the drafting of a Code of Conduct with certain commitments by patent owners and licensing platforms. Although the Code is voluntary in nature, the Commission will oversee its development, monitor its implementation and, if necessary, take further action, including proposing legislation.
Transparency, access and legal certainty are also enhanced through the submission of information on patents or published patent applications as well as of a declaration on the willingness of patent holders to licence on fair and reasonable terms. This information must be attached to the verification request for category 1 NGT plant status and made public in a database.
The Commission will also publish guidance for the purpose of assisting operators on matters relating to plant intellectual property, establish an NGT plant patent expert group, and assess the impact of the patenting of NGT plants.
Category 1 NGT plants are exempt from labelling requirements, with the exception of plant reproductive material. The labelling requirements set out in the GMO legislation continue to apply to category 2 NGT plants.
Neither category 1 nor category 2 NGT plants or their products may be used in organic production, despite the exemption of category 1 NGT plants and products from GMO legislation. However, the adventitious or technically unavoidable presence of category 1 NGT plants and products in organic production shall not constitute non-compliance with the Organics Regulation.
Coexistence measures applicable to category 2 NGT plants remain optional for Member States. They also retain the possibility to opt out from cultivation of category 2 NGT plants on their territory.
The EU Council’s position “fully reflects the compromise reached in the negotiations between the Council and the European Parliament with the support of the Commission”, the note concludes, adding that the regulation “will contribute to facilitating innovation, increasing sustainability, enhancing the competitiveness of the EU agri-food sector, and maintaining a high level of protection of health and of the environment”.
Link to the note: https://aeur.eu/f/lhi
Link to the regulation: https://aeur.eu/f/lhk (Original version in French by Lionel Changeur)