Deliberate release into the environment of GMOs

Directive 2001/18/EC on the deliberate release into the environment of GMOs (repealing Directive 90/220/EEC) was transposed into Irish Law under the GMO (Deliberate Release) Regulations, S.I. No 500 of 2003 in October 2003.

'Deliberate release is defined as ‘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’ (Article 3, S.I. No 500 of 2003).

Two types of deliberate release are covered by the GMO (Deliberate Release) Regulations 2003.
                                                                                                                                                                                           1. Deliberate release of GMOs for any other purpose than for placing on the market also known as a Part B release (dealt with   under Part B of Directive 2001/18/EC),
2. Placing on the market of GMOs as or in products also known as a Part C release, (dealt with under Part C of Directive 2001/18/EC).

Deliberate release of GMOs for any other purpose than for placing on the market (Part B release)

Notifications to release a GMO into the environment for any other purpose than placing on the market (i.e. for purposes of research and development) are considered by the Environmental Protection Agency (EPA).  Such a release may only proceed with the prior agreement of the EPA and in conformance with any conditions imposed by the EPA.                                            
                                                                                                                                                                                                 The deliberate release of GMOs for any other purpose than placing on the market includes:
• field trials in the case of GM plants or any experimental release into the environment;
• clinical trials involving human medicinal products containing or consisting of GMOs.       
                                                                                                                                                                                                    The EPA review period for notifications submitted under Part B of Directive 2001/18/EC is 90 days which includes a 30-day public consultation period.


Public Consultation

Under Article 15, the notifier is required to place a public notice in a newspaper informing the public of the proposed deliberate release and inviting members of the public to make representations to the EPA in respect of the notification within a 28 day period (Article 16)

The format of the public notice is set out under Article 15(1).
This must be completed within 14 days of receipt of the notification by the EPA.
As part of this procedure public representations are invited.


Confidential Information
Confidential information is dealt with under Article 10 of the GMO (Deliberate Release) Regulations, S.I. No 500 of 2003. A procedure dealing with the receipt, handling and control of confidential information sets out the format in which confidential information must be submitted to the EPA in order to ensure its safekeeping. It is strongly advised that the notifier inform the EPA of the proposed inclusion of confidential information in the notification


Placing on the market of GMOs as or in products

This relates to the placing of products containing or consisting of GMOs on the European market. 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’.
                                                                                                                                                                                                Placing of a GMO product on the market is a centralised procedure. 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, using the Irish Competent authority (EPA) as lead or evaluating Competent Authority, should contact the EPA to arrange pre-application discussions.

For further information contact our Environmental Licensing Programme at:

Office of Environmental Sustainability

PO Box 3000

Johnstown Castle Estate

County Wexford

Telephone Locall 1890 33 55 99 or 053 91 60600

Email:- licensing@epa.ie