GMO Regulation Changes (England)

In its first Brexit de-regulation foray (of relevance to this blog) – the UK government today seeks views on its plans to change its regulation of genetically modified organisms (GMOs) in England – here.

The consultation ends on 17 March 2021.

Part 1 of the consultation focuses on the regulation of gene edited (GE) organisms possessing genetic changes which could anyway have been introduced by traditional breeding.

Part 2 of the consultation engages separately and starts gathering views on the wider regulatory framework governing genetically modified organisms (GMOs).

Depending on the results of part 1, DEFRA may change the legislation to amend the definition of a GMO as it applies in England. Currently GMOs are defined in section 106 of the Environmental Protection Act 1990 (amended by the GMO Deliberate Release Regulations). This would mean that the law would not apply to organisms produced by gene editing (GE) and other genetic technologies if they could have been developed using traditional breeding methods. DEFRA’s view is that organisms produced by GE or by other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods.

The responses from part 2 of the consultation will be used by the UK government to inform policy development and stakeholder engagement plans on any potential wider GMO reform.

On 25 July 2018 the Court of Justice of the European Union (CJEU) clarified that organisms obtained by mutagenesis are genetically modified organisms (GMOs) as defined in the European Directive 18/2001/EC. The journal Nature has a useful summary article on this technical field – here.

Note – the Court also clarified that organisms obtained by mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record are exempt from those obligations, on the understanding that the Member States are free to subject them, in compliance with EU law, to the obligations laid down by the directive or to other obligations.

The ECJ Press Release on the matter is here.

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