This section relates to field trials with genetically modified organisms (GMOs) and applies to the experimental (i.e. non-commercial) release in the environment of any GMO (e.g. plants, micro-organisms, insects, fish, mammals), with the exception of medicinal products consisting of or containing GMOs.

An individual or a company ("the notifier") who wishes to release a GMO into the environment for experimental purposes must first obtain a written authorisation from the national authority of the country within whose territory the experimental release is to take place.
In Belgium, this authorisation is currently issued in accordance with the provisions of Part B of the Royal Decree of 21 February 2005.

Submitting a notification

To obtain a written authorisation, the notifier must submit a dossier, referred to below as “notification” to the Belgian competent authority. Before submitting a notification, the notifiers are encouraged to contact the federal competent authority for clarifications on the applicable procedural requirements and the information to be included in the notification.

The information to be provided in a notification is specified in Article 13.2 and Annex III of the (amended) Royal Decree of 21 February 2005 on the deliberate release of GMOs (the consolidated version of the Royal Decree is available in French and in Dutch). The notification must include a technical dossier, providing the information necessary to carry out the environmental risk assessment (ERA) of a GMO, as well as the ERA report itself. 

The technical dossier of a notification of a release of a GM higher plant should  be structured according to Annex III B (see template in Word format). The ERA should be structured according to Annex II D.2 (see template in Word format).

The technical dossier of a notification of a release of GMOs other than higher plants should be structured according to Annex III A (see template in Word format). The ERA should be structured according to Annex II D.1 (see template in Word format).

In addition, a summary of the notification, termed SNIF (summary notification information format), should be made available in English through the EC’s E-submission Food Chain Platform.

Note: The federal competent authority may accept that releases of the same GMO or combination of GMOs on the same site or on different sites, for the same purpose and during a specified period, are subject to a single notification.

Notification procedure

For new notifications the standard authorisation procedure applies. This procedure is described in Articles 15-18 of the Royal Decree of 21 February 2005 and set out schematically in the figure below.

To summarise, the notification is received by the competent federal authority (currently the Federal Public Service Health, Food Chain Safety and Environment).
The competent authority then asks the Biosafety Advisory Council for its advice on the assessment of the potential risks for human health and the environment associated with the field trial.
In parallel, a public consultation procedure is organised and supervised by the competent authority. Comments from the public, relevant to biosafety issues, are taken into account by the Biosafety Advisory Council in drawing up its advice.
Finally, the decision on the field trial request is taken by the federal minister(s) competent for public health and the environment based on the Council's advice and the outcome of the public consultation. The regional environment minister of the Region in which the trial is to take place does, however, have a right of veto.

In addition to the standard procedure the notifier can apply for a differentiated procedure under  Article 19 of the Royal Decree of 21 February 2005. This procedure applies when sufficient experience has been obtained from releasing specific GMOs in certain ecosystems and the GMOs concerned meet the criteria set out in Annex V of the Royal Decree. This procedure involves the European Commission and the Member States.