Clinical trials with GMOs: Database

(Note: cette page n'existe qu'en anglais - Nota: deze pagina bestaat enkel in het Engels)

The SBB maintains a database of all the genetically modified micro-organisms (GMM) that have been notified in Belgium for clinical trials.

Click here to access this database.

The following information is available, when relevant, for notifications that include a deliberate release (so not those notifications that are labled as "contained use only" :

General information about the decision procedure

For deliberate releases notified AFTER 21 February 2005

Decision are taken according to the Royal Decree of 21 February 2005. This Decree implements Directive 2001/18/EC repealing Directive 90/220/EEC.
According to the Royal Decree, it is forbidden to proceed to the deliberate release of a GMO into the environment without the prior authorisation (written consent) of the Competent Authority (CA). The standard authorisation procedure is described in Chapter II of the Decree. Accordingly, the CA takes its final decision in particular (i) on the basis of the results of a scientific evaluation of the notification performed by the Biosafety Advisory Council and (ii) on the basis of the results of a 30-days public consultation at the beginning of the procedure.

For deliberate releases notified BEFORE 21 February 2005

The Royal Decree of 18 December 1998 applied. This Decree implemented Directive 90/220/EEC and subsidiary Directives and Decisions.
According to this Decree, it was forbidden to proceed to the deliberate release of a GMO into the environment without the prior authorisation (written consent) of the Competent Authority (CA).

By default the classical authorisation procedure was followed by the notifier. In this case, the final decision of the CA was taken on the basis of the results of a scientific evaluation of the notification performed by the Biosafety Advisory Council.
According to Article 9 §1 of the Royal Decision, a single notification was needed for releases of a combination of GMO's on the same site or for releases of the same type of GMO on different sites, provided that these releases were performed in the same goal and during a defined period.
Article 9 §2 of the Royal Decision applied in case of repetition of a deliberate release in the framework of a research programme having already been authorised. In this case, a new notification was needed but the notifier could make reference to informations provided with the previous notification and to the results of the corresponding releases.

Simplified procedure: When enough knowledge, data and sufficient experience had been obtained for certain types of genetically modified plants concerning the necessary prerequisites for safety to human health and the environment, the notifier might request the application of a simplified procedure, according to Article 9 §3 of the Royal Decree. Specific criteria were established (see the Commission decisions 93/584/EEC and 94/730/EC) for experimental releases with transgenic plants. In case of a simplified procedure, the release could be spread over several years and locations. In Belgium distinction was made between the first year and the subsequent years of simplified procedures. For the first year of the simplified procedure one general consent was given by the competent authority after consultation of the Biosafety Advisory Council following the same modalities as for the classical authorisation procedure. For the subsequent years of a release authorised as a simplified procedure, a yearly consent had to be requested from the competent authority, after submission of the exact location and the size of field trials foreseen in that year as well as a report of the releases of the previous year. In that case the evaluation was carried out by the Division of Biosafety and Biotechnology (SBB) that communicated its advice to the competent authority.

"Summary Notification Information Format" (SNIF)

(available from 18 October 2002)

Within the framework established by the Directive 2001/18/EC for the exchange of information between the competent authorities and the Commission, the competent authority of the Member State within whose territory the deliberate release is to take place must then send a summary, in accordance with a specific format, of the notification to the Commission, which in turn must forward copies to the other Member States. That "Summary notification information format" (SNIF) reflects the need to enable the fullest possible exchange of relevant information, presented in a standardised and easily comprehensible manner. It is also used by the European Commission to make basic information about the release available to the public.

The databases provide PDF version of SNIFs that have been submitted under Directive 2001/18/EC (e.g. after 17 October 2002).
The complete list of SNIF is available from the JRC website.

Public information from the notifier

(available from 2003)

In Belgium, the Royal Decrees for the deliberate release of GMOs have always foreseen that each notification should contain information intended specifically for the public.
The former Royal Decree of 18 December 1998 (implementing the European Directive 90/220/EEC) provided in article 8§1 that each application for experimental purposes had to contain a proposal of information for the public. In order to give a clear framework to the notifier on how to draft this public dossier, guidelines were set up by the Division of Biosafety and Biotechnology (SBB) in close collaboration with external experts specialised in the field of public information.
The new Royal Decree of 21 February 2005 (implementing Directive 2001/18/EC) gives the public dossier a central role in informing citizens. In addition to the SNIF (Summary Notification Information Format) as a mean to inform the public, Article 13§2(g) and Annex VIIIA of the Royal Decree provide that the information intended for the public must at least contain the following elements :

  • A didactic description of the GMO;
  • The nature and goal of the foreseen deliberate release;
  • The framework of research and/or development;
  • The potential advantages of the deliberate release;
  • The assessment of the potential risks for human health and the environment linked to the deliberate release;
  • The proposed measures to limit the potential risks, to control and to ensure follow-up of the deliberate release.

The main objectives of the public dossier is to inform citizens about the activities of companies or research institutes in the biotechnology field, and to stimulate public awareness and education. The delivered information should enable citizens to gather knowledge, to weigh up the risks and benefits, to form a proper opinion about these products, etc. In addition, it is important to pay attention to the accessibility of these public dossiers. The public dossier should be readable and understandable. It is therefore important to use a comprehensible language, which is accessible to everyone. Scientific terminology and concepts should be explained, advertising messages and affirmative statements which are not scientifically founded should be avoided, as these are generally received by the public with suspicion and scepticism, and a good transparent argumentation should be used. The notifier has complete responsibility about the contents of this public dossier. The notifier can be contacted for specific questions or further information as each public dossier contains the co-ordinates of the notifier.

The public dossiers for deliberate releases of genetically modified micro-organisms are available from 2001 for the deliberate release of GM plants and from 2003 for the deliberate release of GM micro-organisms.