Croatia | BCH-NR2-HR-102638 | Second National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

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Second National Report on the Implementation of the Cartagena Protocol on Biosafety (NR2)
  |  
BCH-NR2-HR-102638-2   |   PDF   |   Print   |  
last updated: 31 Oct 2011
General Information


- Ministry of Health and Social Welfare (Ms. Valentina Zoretić – Rubes) <br />- Ministry of Science, Education and Sports, Directorate for Science (Ms. Andreja Jakovac)&nbsp;&nbsp; <br />- Ministry of Agriculture, Fisheries and Rural Development: <br />a) Directorate for Agricultural and Food Industry (Ms. Andreja Martonja Hitrec and Ms. Andreja Bišćan Rendulić)&nbsp;&nbsp; <br />b) Directorate for Agricultural and Phytosanitary Inspection (Ms. Vesna Bereček)&nbsp; <br />c) Directorate for Veterinary Inspection (Ms. Meira Bosnić and Mr. Darko Vidaković) <br />d) Directorate for Food Safety and Quality (Ms.&nbsp; Jelena Meštrić) <br />- Ministry of Regional Development, Forestry and Water Management (Mr. Goran Videc and Mr. Zrinoslav Galović ) <br />- Ministry of Environmental Protection, Spatial Planning and Construction (Ms. Solveg Kovač) <br />- President of the Council for GMOs (Dr. Hrvoje Fulgosi)<br />- President of the Committee for Contained Use of GMOs (Dr. Dušica Vujaklija) <br />- President of the Committee for Relelase of GMOs into the Environment (Dr. Domagoj Šimić)<br />
EN

30 Sep 2007
30 Sep 2011
Party to the Cartagena Protocol on Biosafety
Article 2 – General provisions
A domestic regulatory framework is fully in place
EN
  • One or more national biosafety laws
  • One or more national biosafety regulations
No
EN
Yes
EN
More than 10
EN
Yes
EN
Article 5 – Pharmaceuticals
No
EN
Article 6 – Transit and Contained use
Yes
EN
Yes
EN
Yes
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
Yes
EN
Yes
EN
n/a
EN
Yes
EN
Yes, to some extent
EN
Yes
EN
Yes
EN
No
EN
No
EN
None
EN
None
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
No
EN
Croatian market might have only GMOs that have been approved in the European Union. In the case of unapproved GMOs, competent national authority responsible for carrying out official control shall apply the procedure and measures in accordance with Article 65 of the Act on GMOs (OG 70/05 and 137/09).
EN
Article 12 – Review of decision
Yes
EN
No
EN
No
EN
None
EN
Article 13 – Simplified procedure
Yes
EN
No
EN
None
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
Yes
EN
n/a
EN
Republic of Croatia will become the Member State of the Euroepan Union in 2013.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;
EN
Since the effective date of becoming a Member State is not yet in force, the information in regards to Article 14 has not been posted yet on the BCH. However, all legislation of the EU relevant to GMOs has been transposed into the national legislation and has been already posted on the BCH.
EN
Article 15 – Risk assessment
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
No
EN
n/a
EN
n/a
EN
None
EN
n/a
EN
n/a
EN
Article 16 – Risk management
Yes
EN
Yes
EN
Yes, to some extent
EN
Yes
EN
No
EN
Yes
EN
Article 17 – Unintentional transboundary movements and emergency measures
Yes
EN
Yes
EN
Yes
EN
Never
EN
Article 18 – Handling, transport, packaging and identification
Yes
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
Yes
EN
Yes
EN
Article 19 – Competent National Authorities and National Focal Points
Yes
EN
Yes
EN
Yes, more than one
EN
Yes
EN
Yes, all information
EN
Yes
EN
Yes
EN
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Yes
EN
Yes
EN
Yes, always
EN
No
EN
n/a
EN
Yes
EN
In order to promote the Cartagena Protocol on Biosafety and further implement its Article 20, the national biosafety portal will become public and completely in function in the near future. The portal will facilitate information sharing of biosafety news and information from the national and international level, will improve collaboration and flow of biosafety information among different stakeholders and will increase public awareness, knowledge and understanding of the provisions of the Protocol and relevant biosafety issues.
EN
Article 21 – Confidential information
Yes
EN
Yes, always
EN
Article 22 – Capacity-building
No
EN
No
EN
Yes
EN
Yes
EN
Average
EN
  • Development of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
Yes
EN
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Identification of LMOs, including their detection
  • Scientific biosafety research relating to LMOs
Yes
EN
Yes
EN
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
Yes
EN
Yes
EN
Article 23 – Public awareness and participation
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
None
EN
Article 24 – Non-Parties
No
EN
No
EN
No
EN
n/a
EN
Article 25 – Illegal transboundary movements
Yes
EN
Yes
EN
Never
EN
Article 26 – Socio-economic considerations
Not applicable
EN
No
EN
Article 27 – Liability and Redress
No
EN
Yes
EN
Article 33 – Monitoring and reporting
Yes, First report only
EN
Other information
Comments on reporting format
Survey on indicators of the Strategic Plan (2014)
2008
EN
The Republic of Croatia annualy financially supports the Secretariat of the CBD for the implementation of the Cartagena Protocol and its activities. There is no additional funding beyond the regular national budgetary allocation.
EN
1 per year or more
EN
In the period from 2007 to 2013 many short-term training programmes have been offerred at the national level. They have been organized under the UNEP-GEF BCH Project or supported by the TAIEX/EC. These workshops have been delivered at the national level targeting the regulatory administrative staff of the competent national authorities and staff dealing with official controls and enforcement. In addition, our experts are members of the ENGL network and they are often invited by the Joint Research Centre of the European Commission (JRC) that manages the GMO programme and organizes training activities on detection methods of GMOs.
EN
No
EN
Although Republic of Croatia does not have in place its own functional national mechanism for coordinating biosafety capacity-building initiatives, these initiatives are coordinated among the European Commission's units responsible for biotechnology policy, financial issues and GMO detection methods. In the past, many such initiatives have been offered to our institutions and our experts.
EN
n/a
EN
No
EN
Only predictable and reliable funding within the regular budgetary allocation is covering the IT services and maintenance of the national biosafety portal as well as the employment of staff working in the competent national authorities/ministries.
EN
None
EN
No
EN
No
EN
No
EN
So far, Republic of Croatia has not been in a position to assess any application provided by any applicant.
EN
No
EN
No
EN
In the case of need, the Republic of Croatia should consult available scientific knowledge, literature and experience of the other Member States of the EU on the risk assessment of GMOs taking also into account the opinions/guidance documents of the EU institutions such as the European Food Safety Authority (EFSA), JRC and others such as the AHTEG under the Cartagena Protocol. Opinions of the Council of GMOs and both Committees as well as opinions of the legal persons responsible for conducting risk assessment of GMOs at the national level would be the most important in providing guidance and advice on risk assessment of GMOs to the competent national authorities.
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Although the Republic of Croatia does not have its own guidance for the purpose of ensuring the safe handling, transport, and packaging of LMOs, Croatia as a Member State of the EU is obliged to implement such guidance that already exist at the EU level. The EU has developed a comprehensive legal framework on GMOs, which also addresses the issues of handling, transport and packaging of LMOs. Existing EU legislation contains appropriate rules on the safe transport, handling and packaging of GMOs. These rules are contained in: - Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (last amended by Commission Directive 2003/28/EC; and - Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (last ammended by Commission Directive 2003/29/EC)
EN
No
EN
Republic of Croatia does not have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making. However, socio-economic considerations will be part of the future LMO decisions at least from the point of view of cost-effectiveness of the GMOs. Although currently there is no national strategy on co-existence between conventional, organic and GM crops, its preparation has been envisaged in the near future. In preparation of this strategy and national co-existence measures, Republic of Croatia will take into consideration a Recommendation on guidelines for the development of national strategies and best practices issued by the European Commission (13 July 2010) in line with Article 31 of Directive 2001/18/EC and the conclusions of the Environment Council of December 2008. Republic of Croatia carefully monitors ongoing discussions on socio-economic considerations under the Protocol which are to define precise socio-economic indicators to be monitored in the long run, and the appropriate rules for data collection. Further, the Republic of Croatia will be informed about any new piece of information such as „Reference Documents“ and/or other outputs that might be issued by recently established technical working group at the level of the European Union, i.e. the European GMO Socio-Economics Bureau (ESEB).
EN
None
EN
So far, Republic of Croatia has not used any peer-reviewed published material for the purpose of elaborating or determining national actions with regards to socio-economic considerations. However, it will take into consideration all available relevant documents issued by the Secretariat of the CBD, ESEB at the EU level and other published material that will be considered by the Committee for deliberate release of GMOs into the environment and the Council for GMOs.
EN
No experience.
EN
Yes
EN
Republic of Croatia has the capacity to take appropriate measures in the event that an LMO is unintentionally released. Capacity also includes detection capacity, information channels to inform Member States of the European Union allowing for rapid dissemination of the information and if necessary the expertise of the national and the European Union Reference Laboratory for GM Food and Feed. Relevant to this question are articles of the following EU legislation: Article 50 of the Regulation 178/2002 on the general principles of food law that sets up a Rapid Alert System for Food and Feed which is a means of allowing rapid dissemination of the information in case of unintentional release of GMOs; Article 14 of Regulation 1946/2003 that provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures and the Regulation (CE) No. 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.
EN
One or more
EN
10 or more
EN
None
EN
Yes
EN
Currently, Republic of Croatia has two national reference laboratories responsible for identification of GMOs that are part of the European Network of GMO Laboratories (ENGL).
EN
Yes
EN
Some biosafety workshops organized so far at the national level had included some elements of the training material and/or technical guidance documents in risk assessment and risk management of LMOs.
EN
Yes
EN
Yes
EN
None
EN
There were some trainings at the national level organized and tailored for the needs of custom officers but no specific training covered the identification of LMOs except the general theoretical principles of the procedure(s). Further training and hands-on experience in this area would be needed.
EN
One or more
EN
In our two laboratories for detection of LMOs, there are less than 10 professionals that have received training in detection of LMOs.
EN
Yes
EN
There are two laboratories that are also part of the ENGL network.
EN
One or more
EN
At the national level, only two laboratories are certified for LMO detection. - Laboratory for the quantification and risk assessment of GMOs in located in the Croatian Institute for Public Health in Zagreb. This laboratory is authorized for testing raw materials and finished products, food for human consumption and livestock feed. In 2009, the laboratory has been authorized and accredited to the ISO/IEC 17025 and from 1 July 2009 has gained a full membership in the ENGL network. - The second laboratory is located in Osijek in the Institute for Seed and Seedlings. This laboratory is authorized to test, control and do monitoring of GMOs and products containing and/or consisting of, or derived from GMOs in the seed material, plant germplasm, planting material of forest species and hybrids for use in the forestry.
EN
One or more
EN
At the national level, both laboratories certified for LMO detection are operational.
EN
No
EN
Some financial and/or technical assistance for capacity-building in the area of liability and redress relating to LMOs would be necessary and even more in light of the recently adopted Nagoya Kuala Lumpur Supplementary Protocol.
EN
Yes
EN
The liability provisions of the Nagoya-Kuala Lumpur Supplementary Protocol are covered by the Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004, on environmental liability with regard to the prevention and remedying of environmental damage, which establishes a framework based on the „polluter pays“ principle, according to which the polluter pays and repairs when environmental damage occurs. At the national level, the Ministry for Environmental and Nature Protection is responsible for the implementation of national legislation on environmental liability. Currently the Republic of Croatia does not have civil liability rules and procedures and/or domestic law that provides for response measures for damage to biodiversity resulting from LMOs. Some additions to the existing GMO legislation will be necessary particularly as a part of the ratification procedure of the Nagoya Supplementary Protocol.
EN
Yes
EN
Taking into account the implementation of the provision on public awareness and participation under the Cartagena Protocol and obligations under the Aarhus Convention, but also according to the Act on GMOs, public participation is involved in every procedure of a decision-making.
EN
  • National website
  • Newspaper
  • Public hearings
None
EN
5 or more
EN
Some biosafety training materials and/or online modules are available to the professionals but not to the general public.
EN
Yes
EN
Yes
EN
5 or more
EN
In the last two years three TAIEX workshops have been held at the national level and several public consultations and hearings.
EN
50 or more
EN
National biosafety portal has a numerous biosafety documents and/or publications issued by the EU, FAO, EFSA and other organizations involved in the issues of GMOs and they have been made available to the public. Also one part of the national biosafety portal is dedicated to the category of News. Under this category new publications are announced with the link provided.
EN
  • National website
None
EN
No
EN
Currently there is no national awareness and outreach programmes on biosafety. However, elements of the Outreach strategy under the Cartagena Protocol have been implemented in the past activities and have been covered through the national biosafety portal.
EN
Yes
EN
See question No. 40. Some elements of the outreach/communication strategy on biosafety prepared by the Secretariat of the Convention on Biological Diversity and the Cartagena Protocol on Biosafety have been implemented.
EN
25 or more
EN
To date numerous documents and educational materials such as technical guidance documents on biosafety issues have been made available through the national biosafety portal.
EN