BELGIAN BIOSAFETY SERVER : Directive 90/220/EEC
[Contents] [Previous] [Next]

Article 5

Member States shall adopt the provisions necessary to ensure that:

(1) any person, before undertaking a deliberate release of a GMO or a combination of GMOs for the purpose of research and development, or for any other purpose than for placing on the market, must submit a notification to the competent authority referred to in Article 4 (2) of the Member State within whose territory the release is to take place;

(2) the notification shall include:

(a) a technical dossier supplying the information specified in Annex II necessary for evaluating the foreseeable risks, whether immediate or delayed, which the GMO or combination of GMOs may pose to human health or the environment, together with the methods used and the bibliographic reference to them and covering, in particular:

(i) general information including information on personnel and training,

(ii) information relating to the GMO(s),

(iii) information relating to the conditions of release and the receiving environment,

(iv) information on the interactions between the GMO(s) and the environment,

(v) information on monitoring, control, waste treatment and emergency response plans;

(b) a statement evaluating the impacts and risks posed by the GMO(s) to human health or the environment from the uses envisaged;

(3) the competent authority may accept that releases of a combination of GMOs on the same site or of the same GMO on different sites for the same purpose and within a limited period may be notified in a single notification;

(4) the notifier shall include in the notification information on data or results from releases of the same GMOs or the same combination of GMOs previously or currently notified and/or carried out by him either inside or outside the Community.

The notifier may also refer to data or results from notifications previously submitted by other notifiers, provided that the latter have given their agreement in writing;

(5) in the case of a subsequent release of the same GMO or combination of GMOs previously notified as part of the same research programme, the notifier shall be required to submit a new notification. In this case, the notifier may refer to data from previous notifications or results from previous releases;

(6) In the event of any modification of the deliberate release of GMOs or a combination of GMOs which could have consequences with regard to the risks for human health or the environment or if new information has become available on such risks, either while the notification is being examined by the competent authority or after that authority has given its written consent, the notifier shall immediately:

(a) revise the measures specified in the notification,

(b) inform the competent authority in advance of any modification or as soon as the new information is available,

(c) take the measures necessary to protect human health and the environment.


BELGIAN BIOSAFETY SERVER : Directive 90/220/EEC
[Contents] [Previous] [Next]