European Commission’s Plans for a Special Regulation of Plants Created by New Genomic Techniques

Abstract

(Series Information) European Papers - A Journal on Law and Integration, 2024 9(1), 21-38 | European Forum Insight of 15 April 2024 | (Table of Contents) I. Introduction. - II. Context. - III. The draft regulation in detail. - III.1 Category 1 NGT plants. - III.2 Category 2 NGT plants. - III.3. Provisions for delegated and implementing acts as well as guidance material. - IV. Assessment of different scientific aspects in the regulation. - IV.1. Scientific reasoning of equivalence criteria as given in Annex I. - IV.2. Scientific reasoning of risk assessment criteria as given in Annex II. - V. Assessment of different legal aspects in the draft regulation. - V.1. Deliberate releases of cat 1 plants and committee procedure. - V.2 Precautionary principle. - V.3. Cartagena protocol. - v.4. Amendment of Annex I via delegated act. - VI. Ongoing discussion | (Abstract) This Insight explains in detail, yet easily understandable, the contents of the European Commission’s draft regulation on plants obtained by certain new genomic techniques and their food and feed. It critically comments on the underlying scientific considerations and discusses potential legal issues – the precautionary principle being one of them, though arguably not the most important one. Finally, the Insight summarizes the ongoing discussions and developments regarding the draft regulation. The Authors also hint at potential amendments, which might resolve some of the remaining problems.

Keywords

• environmental law
• genetic engineering
• new genomic techniques
• genome editing
• risk assessment
• precautionary principle