New GMO Directive Enters Into Force - New Regulations Adopted in England

Yesterday was the deadline for EU Member States to implement into national law the provisions of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms. The old Directive 90/220/EEC has been repealed.

In the UK, DEFRA has complied with this obligation by introducing The Genetically Modified Organisms (Deliberate Release) Regulations 2002 with effect from 17 October. These new Regulations cover England. Regulations have yet to be adopted by the devolved administrations in Scotland and Wales (and may be delayed in Northern Ireland by the suspension of the Assembly).

The new regime introduces significant changes:

• In future, all new commercial approvals will be limited to 10 years and thereafter must be reassessed;
• There is a deadline for renewal of existing approvals by 17 October 2006. A special procedure (by way of derogation) exists to encourage early renewal of existing consents;
• There is an express requirement for environmental risk assessments to be carried out, covering both the indirect and long-term effects of GMOs (including the wider impact upon biodiversity);
• An obligation has been introduced on consent-holders to conduct mandatory post-market monitoring of approved GMOs for any unanticipated effects, and to report any effects which would alter the original risk assessment (to indicate a risk to human health or the environment);
• In future, there will be mandatory periods of public consultation before decisions are taken on applications for consents to release GMOs. The aim has been to allow time for public discussion as part of the GM regulatory process, rather than in the context of commercial plant varieties approved for marketing by addition to the National (Seed) List;
• Once a GMO is approved, unless new evidence arises which raises doubts as to its original risk assessment and the safeguard clause is invoked, Member States shall not prohibit, restrict or impede the free circulation of a GMO or products containing that GMO;
• There will be mandatory labelling for all GMOs exploited commercially in the EU to ensure traceability throughout the production and supply chain; and
• Antibiotic resistance marker genes that may have adverse effects on human health and the environment will be phased out.

It will be interesting to see if other Member States adopt the new Directive in their national law so promptly, given the de facto moratorium which presently exists in a number of Member States. It is expected that with these additional controls in place, the GM approval process will resume across the EU, especially given the push for action by the US in trade negotiations.

There are apparently also still "active" ongoing discussions over the form of mandatory labelling required, with the UK reluctant to adopt the current proposal given the likely reluctance of consumers to purchase products labelled as "GM".

Herbert Smith has a dedicated team to service the requirements of the agribio sector, led by Mark Shillito (partner) and including Joel Smith (senior assistant). Amongst other things, we advise on all matters involving plant breeding and biotechnology, including the grant, licensing and enforcement of patents and plant breeders’ rights in the UK and EU, the approval and regulation of GMOs and issues relating to royalty-collection schemes.

© Herbert Smith 2002

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