EU Members Reach Consensus on New Genomic Techniques Regulation
Brussels: There has been white smoke, papally speaking, in a deal among the 27 EU member states on the regulation on new genomic techniques. EU ambassadors reached a political agreement this morning on the European Commission’s proposal and are now ready to negotiate with the European Parliament, which had already agreed on the negotiating mandate on 24 April 2024.
According to Ansa News Agency, the Polish presidency leading the six-month EU Council promoted the discussion this morning in Coreper, the committee of permanent representatives to the EU, presenting a new compromise text that has been discussed at a technical level among experts from the 27 capitals over the past two months. The political mandate, an EU source explains, was “supported by a sufficient number of member states” to reach the necessary qualified majority, which is obtained when 15 out of 27 countries representing at least 65% of the EU population support the proposal.
Several sources close to the dossier indicated that Slovenia, Croatia, Hungary, Austria, Romania, and Slovakia voted against the mandate, while Germany and Bulgaria abstained. The mandate of the EU Council confirms the distinction between plants derived from new genomic techniques (NGT) of category 1, which are “considered equivalent to conventional plants” and exempted from the current rules on GMOs, and category 2 plants, which are to be labeled and subject to GMO rules. The mandate also confirms the exclusion of genomic techniques from organic farming.
Some changes are foreseen to the proposal of the EU Commission, dating back to July 2023, including the possibility for EU Member States to prohibit the cultivation of NGT plants of category 2 on their territory, and measures to avoid their involuntary presence in other products and prevent cross-border contamination. To strengthen transparency, the compromise text proposes to make it mandatory for those requesting the registration of an NGT 1 plant to declare the complete list of patents they hold. All patent information will be included in a database that will be updated periodically.
The states also request the creation of an expert group on the effects of patents on NGT plants, composed of representatives of the capitals. The Polish presidency has also strengthened the obligation for the European Commission to present two impact studies on patenting practices, particularly on the relationship with representatives of the agri-food chain. If the first study reveals any negative developments, the EU Executive would be obliged to present an ad hoc legislative proposal on patents to address any critical issues. A second study is expected four to six years after the publication of the first. Finally, the Council’s negotiating mandate states that herbicide tolerance cannot be one of the characteristics for category 1 plants to ensure that such plants remain subject to the authorisation, traceability, and monitoring requirements that are guaranteed for category 2 plants.