The uncertainty surrounding the legal status of NBT led to the discussion whether these techniques lead to products that are subject to the EU GMO legislation (EU Directive 2001/18/EU on Deliberate Release of Genetically Modified Organisms). On 25th July 2018, the European Court of Justice (ECJ) delivered its ruling on Case C-528/16 which aims to clarify the legal status of mutagenesis. The judgment found that (a) organisms obtained by mutagenesis techniques are to be considered genetically modified organisms (GMOs) within the meaning of Directive 2001/181 (Directive), and (b) the express exemption of mutagenesis in Annex 1B of the Directive applies only to organisms obtained by means of techniques of mutagenesis which have conventionally been used in a number of applications and have a long safety record, which may, however, be the subject of national legislation. The pronunciation doesn't unravel the tangles of the regulation of the technologies in agriculture emerged in the debate on the OGMs – product/process approach, risk-benefit assessment/precautionary principle - neither answers to the questions set by the new techniques that allow to get products in everything similar to those obtainable with the traditional techniques and from them indistinguishable. A debate followed on the need to update the legislation of technological innovation in the specific field of genetic applied to varietal improvement .
Quale disciplina per l'editing genomico in agricoltura?
Eleonora Sirsi
2019-01-01
Abstract
The uncertainty surrounding the legal status of NBT led to the discussion whether these techniques lead to products that are subject to the EU GMO legislation (EU Directive 2001/18/EU on Deliberate Release of Genetically Modified Organisms). On 25th July 2018, the European Court of Justice (ECJ) delivered its ruling on Case C-528/16 which aims to clarify the legal status of mutagenesis. The judgment found that (a) organisms obtained by mutagenesis techniques are to be considered genetically modified organisms (GMOs) within the meaning of Directive 2001/181 (Directive), and (b) the express exemption of mutagenesis in Annex 1B of the Directive applies only to organisms obtained by means of techniques of mutagenesis which have conventionally been used in a number of applications and have a long safety record, which may, however, be the subject of national legislation. The pronunciation doesn't unravel the tangles of the regulation of the technologies in agriculture emerged in the debate on the OGMs – product/process approach, risk-benefit assessment/precautionary principle - neither answers to the questions set by the new techniques that allow to get products in everything similar to those obtainable with the traditional techniques and from them indistinguishable. A debate followed on the need to update the legislation of technological innovation in the specific field of genetic applied to varietal improvement .I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
