S.L. 549.60 Art. 8Handling of modifications and new information.

(1) In the event of any modification of, or unintended change to, the deliberate release of a GMO or of a combination of

GMOs which could have consequences with regard to risks for human health and the environment after the competent authority has given its written consent, or if new information has become available on such risks, either while the notification is being examined by the competent authority or after the competent authority has given its written consent, the notifier shall immediately:

(a) take the measures necessary to protect human health and the environment;

(b) inform the competent authority in advance of any modification or as soon as the unintended change is known or the new information is available;

(c) revise the measures specified in the notification.

(2) If information becomes available to the competent authority referred to in sub-regulation (1) which could have significant consequences with regard to risks for human health and the environment or under the circumstances described in sub-regulation (1), the competent authority:

(a) shall evaluate such information and make it available to the public;

(b) may require the notifier to modify the conditions of, suspend or terminate the deliberate release and shall inform the public thereof;

(c) may require the notifier to defray or contribute towards any or all of the costs incurred by it in order to protect human health and the environment.

(3) With respect to both sub-regulations (1) and (2) above, the notifier shall amend the notification on which consent was granted and submit the amended notification to the competent authority.

(4) Where the competent authority receives an amended notification in accordance with sub-regulations (1) and (2), it shall deal with the amended notification as if it were a new notification under regulation 6 in relation to the proposed modified deliberate release.

(5) The notifier shall not proceed with the proposed modified deliberate release unless he has received written consent from the competent authority.