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 The old Directive 90/220/EEC has been repealed.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
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