According to the Act on Genetically Modified Organisms ("Official
Gazette" No. 70/2005, 137/2009), the competent national authority
responsible for performing expert and administrative activities, in
case of deliberate release of GMOs into the environment, is the
central state body responsible for nature protection in the
Ministry of Environmental and Nature Protection.
The Ministry of Environmental and Nature Protection and its
Directorate for Nature Protection has the following duties:
• Officially receives notifications for deliberate release of GMOs
into the environment (e.g. in the case of field trials, for
scientific research purpose and other non-commercial
• Issues the approval for deliberate release of GMOs into the
environment, on the basis of the opinion which was previously
obtained from the Committee for Release of GMOs into the
Environment and accordingly issues a decision on the deliberate
release of GMOs into the environment.
• Issues the approval to the final user of the GMO for which
placement on the market for breeding purposes has been approved.
The competent national body shall issue the breeding approval if
all the prescribed requirements have been met, subject to prior
approval from the central state administration bodies competent for
health issues, agriculture, fisheries and rural development and
• Authorizes the legal persons responsible for producing risk
assessments for deliberate release of GMOs into the environment,
with the consent of the central state administration body
responsible for health issues.
• Carries out inspection supervision activities over
deliberate/unintended release of GMOs into the environment.
• In the case of unintentional transboundary movements of GMOs and
urgent measures, the Ministry has to be notified and informed in
accordance with the Article 17 of the Cartagena Protocol on
Biosafety (art. 17(2)).
• In case of unplanned/uncontrolled spread of GMOs into the
environment, the Ministry in cooperation with other competent
national authorities approves the plan of measures to be applied in
such cases; brings and implements the program for removing
the consequences of the uncontrolled spread of GMO into the
• In case of unplanned spread of GMOs into the environment which
might have significant negative consequences on biological
diversity, environment and human health, the Ministry informs the
states under risk or under potential risk, and when necessary,
appropriate international organisations, and makes them available
all information needed for determining appropriate measures through
the BCH mechanism.
• Keeps and maintains a special register of GMOs in accordance with
its jurisdiction and competence.
Also, the Ministry of Environmental and Nature Protection is the
competent national authority responsible for implementation of the
Cartagena Protocol on Biosafety to the Convention on Biological
Diversity ("Official Gazette-International Agreements", No.
07/2002). Accordingly, the Cartagena National Focal Point (CPB NFP)
and the BCH NFP have been designated within the Ministry of
Environmental and Nature Protection.
Inspection supervision over activities related to deliberate
release of GMOs is a responsibility of the Nature Protection
Inspection (NPI), one of the Directorates within the Ministry. NPI
is obliged to inspect cases of deliberate release of GMOs into the
environment and to act accordingly in any situation where suspicion
that a GMO or product containing and/or consisting of, or
originating from GMOs is being released into the environment, or
deposited into the environment in violation of the provisions of
the GMO Act or of its Ordinances related to deliberate release of
GMOs into the environment.