The Deliberate Release into the Environment of Genetically Modified Organisms Regulations (SL 549.60) of 2010, give effect to Directive 2001/18/EC on the deliberate release into the environment of GMOs (repealing Directive 90/220/EEC). ‘Deliberate release means ‘any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment’.
Two types of deliberate release are covered by the GMO (Deliberate Release) Regulations 2003.
- Deliberate release of GMOs for any other purpose than for placing on the market also known as a Part B release, (because it is dealt with under Part B of Directive 2001/18/EC)
- Placing on the market of GMOs as or in products also known as a Part C release, (because it is dealt with under Part C of Directive 2001/18/EC)
Deliberate release of GMOs for any other purpose than for placing on the market
The deliberate release of GMOs for any other purpose than placing on the market (i.e. for purposes of research and development), includes:
- Field trials in the case of GM crops
- Hospital clinical trials where Genetically Modified Micro-organisms (GMMs) are used for gene delivery systems for medicinal purposes, for example the administration of a GM vaccine or using a GM virus to deliver a gene therapy product to animals/humans
Applications to release a GMO into the environment for research and development purposes are considered by ERA. Such a release may only proceed with the prior agreement of the ERA and in conformance with any conditions imposed by the ERA.
The notification requirements for deliberate release applications are specified here. A guidance note for the deliberate release of a GMO for any other purpose than for placing on the market has been prepared to provide help and assistance to users who wish to apply to the ERA for consent to release a GMO for research and development purposes.
As part of this procedure public representations are invited.
Placing on the market of GMOs as is or in products
This relates to the placing of products containing or consisting of GMOs on the European market (examples include the marketing of GM crops for cultivation by EU farmers). The term placing on the market is defined in Directive 2001/18/EC as ‘making available to third parties whether in return for payment or free of charge’.
Authorisation for the placing of a GMO product on the market is issued at European level. The procedure is a centralised one that involves the European Commission and all EU Member States. Further to the entry into force in 2003 of Regulation (EC) No. 1829/2003 on GM food and feed, almost all applications are submitted under a single authorisation procedure under Regulation (EC) No. 1829/2003 (“one door – one key”). Since 2003, only a few dossiers relating to non-food/non-feed GMOs (GM cut flowers, GM starch potato), have been processed under Directive 2001/18/EC.
A person or organisation proposing to place a product containing or consisting of a GMO on the market under Directive 2001/18/EC, ERA as lead or evaluating Competent Authority, should contact the ERA to arrange pre-application discussions.
