Confidential Information - Contained Use

Sometimes a GMO/GMM notification to the Agency will contain confidential information, for example, proprietary information, which the notifier does not wish to be made publicly available.

Confidential information is dealt with under Article 9 of the GMO (Contained use) Regulations S.I. No 73 of 2001 (amended).

Under this article, the Agency may not keep the following information confidential:
• The name and address of the notifier and the location of the contained use;
• The purpose of the contained use and the general characteristics of the GMO involved;
• Where appropriate the class of the contained use and the level of containment;
• The evaluation of foreseeable effects and in particular any harmful effects on human health or the environment.
(Article 9(4))

A notifier requesting the Agency to treat certain information confidentially must provide an explanation for that request (Article 9(1)).

The Agency will consider the request and will decide which information, if any, will be considered confidential. (Article (9(2)).

The Agency has 14 days to consider this request and inform the notifier of its decision. (Article 9(3)).
The Agency will also decide whether the information is required by the Inspector in their review of the notification.
• If the Agency decides that the information (confidential or otherwise) will not be required by the Agency in making its decision, it will be returned to the notifier.
• If the Agency decides that the information is confidential and is required by the Agency in making its decision it will be held securely and returned to the notifier once a decision has been reached.

Submitting confidential information to the Agency
Where a notifier requests that certain information be kept confidential, the following procedure should be followed;
Procedure for submitting confidential information under the Contained Use Legislation

The notifier is advised to submit all confidential information by registered post and to notify the GMO Team of this in advance.