Post by Elements Advisory

𝐓𝐡𝐞 𝐄𝐔 𝐭𝐚𝐤𝐞𝐬 𝐚 𝐝𝐞𝐜𝐢𝐬𝐢𝐯𝐞 𝐬𝐭𝐞𝐩 𝐨𝐧 𝐧𝐞𝐰 𝐠𝐞𝐧𝐨𝐦𝐢𝐜 𝐭𝐞𝐜𝐡𝐧𝐢𝐪𝐮𝐞𝐬 (𝐍𝐆𝐓𝐬) 🌱 The European Council has approved a new framework, moving away from a one-size-fits-all GMO approach. 𝐀𝐭 𝐭𝐡𝐞 𝐜𝐨𝐫𝐞 𝐢𝐬 𝐭𝐡𝐞 𝐜𝐨𝐧𝐜𝐞𝐩𝐭 𝐨𝐟 “𝐞𝐪𝐮𝐢𝐯𝐚𝐥𝐞𝐧𝐜𝐞”. • 𝐍𝐆𝐓-1: genetic changes that could occur naturally or via conventional breeding → equivalence verified by authorities, no full GMO assessment, no labelling except seeds  • 𝐍𝐆𝐓-2: more complex modifications → full GMO framework applies (authorisation, traceability, labelling) Notably, some traits 𝐚𝐫𝐞 𝐞𝐱𝐜𝐥𝐮𝐝𝐞𝐝 𝐟𝐫𝐨𝐦 𝐍𝐆𝐓-1, including herbicide tolerance and production of known insecticidal substances. 𝐖𝐡𝐲 𝐭𝐡𝐢𝐬 𝐦𝐚𝐭𝐭𝐞𝐫𝐬: • Classification becomes the key regulatory step • Data requirements and timelines will differ significantly • New transparency obligations on patents This new framework is expected to 𝐚𝐩𝐩𝐥𝐲 𝐟𝐫𝐨𝐦 𝐦𝐢𝐝-2028. At Elements Advisory, we can support you in: 👉 Assessing NGT-1 equivalence 👉 Defining the optimal regulatory pathway 👉 Navigating classification and authority interactions 👉 Anticipating IP and transparency requirements #NGT #Biotech #EURegulation #Innovation #Agrifood