EU court casts new plant breeding techniques into regulatory limbo

• Published in: Nature biotechnology Vol. 36; no. 9; pp. 799 - 800
• Main Authors: Purnhagen, Kai P, Kok, Esther, Kleter, Gijs, Schebesta, Hanna, Visser, Richard G F, Wesseler, Justus
• Format: Journal Article
• Language: English
• Published: New York Springer New York 01.09.2018; Nature Publishing Group
• Subjects: 631/1647/1513; 706/689; 706/689/280; Agrarische Economie en Plattelandsbeleid; Agricultural Economics and Rural Policy; Agricultural Economics and Rural Policy Group; Agriculture; Bioinformatics; Biomedical Engineering/Biotechnology; Biomedicine; Biotechnology; Breeding methods; BU Toxicologie Bioassays & Novel Foods; BU Toxicologie, Novel Foods & Agroketens; BU Toxicology Bioassays & Novel Foods; BU Toxicology, Novel Foods & Agrochains; correspondence; Decision making; EPS; Genetically modified organisms; In vivo methods and tests; Innovations; Ionizing radiation; Laboratorium voor Plantenveredeling; Laboratory of Plant Breeding; Law and Governance; Leerstoelgroep Agrarische economie en plattelandsbeleid; Leerstoelgroep Recht en bestuur; Liability; Life Sciences; Mutagenesis; Mutation; Organisms; PE&RC; Plant Breeding; Random mutagenesis; Recht en Bestuur; Regulatory reform; RIKILT - BU Toxicologie Bioassays & Novel Foods; RIKILT - BU Toxicology Bioassays & Novel Foods; WASS; Europe; United Kingdom > UK
• ISSN: 1087-0156; 1546-1696; 1546-1696
• DOI: 10.1038/nbt.4251

To the Editor: We previously published a Correspondence in the June issue of Nature Biotechnology1 discussing the potential implications of the Court of Justice of the European Union (CJEU) Advocate General's interpretation of how products generated by new plant breeding techniques (NBPTs) would be subject to regulation under European Union (EU; Brussels) law2. The only NPBT products that will not fall under the directive's remit (under the 'mutagenesis exemption') are those organisms obtained by means of mutagenesis that have been “obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record” (paragraph 54). [...]the provisions of the directive “cannot be interpreted as excluding from the scope of the directive organisms obtained by means of new techniques/methods of mutagenesis which have appeared or have been mostly developed since Directive 2001/18 was adopted” (paragraph 51). In the light of these constraints, the CJEU most probably saw no other option than to acknowledge that a long safety record does not exist for targeted, mutagenic NPBTs and in vitro random mutagenesis, according to “the material before the court” (paragraph 48). [...]according to the historical wording of the directive, the judges felt that NPBTs cannot be exempt from the scope of the directive. According to the referring court, the techniques in use before adoption of the directive include conventional in vivo mutagenesis through ionizing radiation and exposure to mutagenic chemicals.