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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102638
Status
Published
Date of creation
2011-10-31 12:22 UTC (Dubravka.Stepic@mzoip.hr/5823)
Date of publication
2011-10-31 12:22 UTC (Dubravka.Stepic@mzoip.hr/5823)

Origin of report
Country
  • Croatia
Contact officer for report
Coordinates
Ms. Dubravka Stepic
Head, Protection of Genetic Diversity Section
Ministry of Culture
Runjaninova 2
Zagreb
Croatia, HR-10000
Phone:+385 1 48 66 146
Fax:+385 1 48 66 100
Email:dubravka.stepic@min-kulture.hr
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
- Ministry of Health and Social Welfare (Ms. Valentina Zoretić - Rubes)
- Ministry of Science, Education and Sports, Directorate for Science (Ms. Andreja Jakovac)  
- Ministry of Agriculture, Fisheries and Rural Development:
a) Directorate for Agricultural and Food Industry (Ms. Andreja Martonja Hitrec and Ms. Andreja Bišćan Rendulić)  
b) Directorate for Agricultural and Phytosanitary Inspection (Ms. Vesna Bereček) 
c) Directorate for Veterinary Inspection (Ms. Meira Bosnić and Mr. Darko Vidaković)
d) Directorate for Food Safety and Quality (Ms.  Jelena Meštrić)
- Ministry of Regional Development, Forestry and Water Management (Mr. Goran Videc and Mr. Zrinoslav Galović )
- Ministry of Environmental Protection, Spatial Planning and Construction (Ms. Solveg Kovač)
- President of the Council for GMOs (Dr. Hrvoje Fulgosi)
- President of the Committee for Contained Use of GMOs (Dr. Dušica Vujaklija)
- President of the Committee for Relelase of GMOs into the Environment (Dr. Domagoj Šimić)
Submission
10. Date of submission
2011-10-31
11. Time period covered by this report
Start date
2007-09-30
Time period covered by this report
End date
2011-09-30
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • No
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • No
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Not applicable
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes, to some extent
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • Yes
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • Yes
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • No
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
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).
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • Yes
73. Has your country ever applied the simplified procedure?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • Yes
78. If you answered Yes to question 77, has your country informed the Parties through the BCH of the agreements or arrangements?
  • Not applicable
79. If you answered Yes to question 77, please provide a brief description of the scope and objective of the agreements or arrangements entered into:
Republic of Croatia will become the Member State of the Euroepan Union in 2013.                                                                                                         
80. Here you may provide further details on the implementation of Article 14 in your country:
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.
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • No
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • No
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Not applicable
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • Not applicable
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • None
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • Not applicable
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Not applicable
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes, to some extent
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • No
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • Yes
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • No
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • Yes
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, more than one
119. In case your country designated more than one competent national authority, has your country conveyed to the Secretariat the respective responsibilities of those authorities?
  • Yes
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
121. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information available and in the BCH
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information not available
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information not available
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information not available
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information not available
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information not available
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, always
128. Has your country experienced difficulties accessing or using the BCH?
  • No
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Not applicable
130. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
131. Here you may provide further details on the implementation of Article 20 in your country:
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.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • Yes
140. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
141. If you answered Yes to question 140, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 150.
  • Average
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Development of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • 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
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • Yes
146. Does your country still have capacity-building needs?
  • Yes
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • 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
148. Has your country developed a capacity-building strategy or action plan?
  • Yes
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • No
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • None
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • No
163. Has your country ever exported LMOs to a non-Party?
  • No
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Not applicable
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • No
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes, First report only
Survey on indicators of the Strategic Plan (2014)
In decision BS-VI/15, Parties requested the Executive Secretary to conduct a dedicated survey to gather information corresponding to indicators in the Strategic Plan that could not be obtained from the second national reports or through other existing mechanisms.

The answers to the survey are displayed below.
When did your national biosafety framework become operational?
indicator 1.1.1
  • 2008
Here you may provide further details
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.
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 1 per year or more
Here you may provide further details
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.
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • No
Here you may provide further details
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.
Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
indicator 1.2.5
  • No funds mobilized
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • No
Here you may provide further details
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.
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • None
Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?
indicator 1.3.1.1
Survey 9.a) Risk assessment
  • No
Survey 9.b) Risk management
  • No
Here you may provide further details
Republic of Croatia has not adopted its own or has not used any guidance document for the purpose of conducting RA and/or RM, but in the case of a need it would be obliged to follow all applicable EU directives, regulations, decisions and guidance documents that already exist at the EU level.    Beside the Annex III of the Cartagena Protocol and Directive 2001/18/EC and its annexes, from time to time, some EU institutions such as EFSA and JRC also issue guidance documents for the purpose of conducting risk assessment and/or risk management. In addition, the AHTEG on Risk Assessment under the Cartagena Protocol is also responsible for issuing guidance document(s) on risk assessment and/or risk management.     At the EU level, Directive 2001/18/EC on the deliberate release of GMOs into the environment provides a framework for the environmental risk assessment of GMOs and contains several annexes related to the risk assessment and risk management:  - Annex II of this Directive provides for the principles for the environmental risk assessment,  - Annex III specifies the information that is required to carry out the risk assessment,   - Annex IV specifies additional information that is requried for organisms to be placed on the market,  - Annex VII describes the general principles to be followed in the design of the monitoring plan.    Furthermore, Decision 2002/623 of 24 July 2002 establishes guidance notes supplementing Annex II of Directive 2001/18/EC and Decision 2002/811/EC establishes guidance notes supplementing Annex VII of Directive 2001/18/EC.    Regulation 1829/2003 on GM food and feed organisms provides a framework for the risk assessment of food and feed consisting of, containing or produced from GMOs. Implementing Regulation 503/2013 on applications for authorisation of GM food and feed in accordance with Regulation (EC) No. 1829/2003 provides for specific rules on the information needed for their assessment.
Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?
indicator 1.3.1.2
  • No
Here you may provide further details
So far, Republic of Croatia has not been in a position to assess any application provided by any applicant.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • No
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • No
Here you may provide further details
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.
Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
indicator 1.4.2
Survey 13.a) Identify
  • Yes
Survey 13.b) Assess
  • Yes
Survey 13.c) Monitor
  • Yes
Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
indicator 1.6.4
  • No
Here you may provide further details
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)
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • No
Here you may provide further details
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).
Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
indicator 1.7.1
  • None
Here you may provide further details
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.
Survey 17. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making?
indicator 1.7.3
No experience.
Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
indicator 1.8.3
  • Yes
Here you may provide further details
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.
Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
indicator 2.2.3
Survey 19.a) Risk assessment
  • One or more
Survey 19.b) Monitoring
  • 10 or more
Survey 19.c) Management / Control
  • None
Here you may provide further details
Some experts have been invited by the Joint Research Centre of the European Union to the general training courses on detection of GMOs in food and feed samples as well as to Ad-hoc training courses for the experts of the National Reference Laboratories under the Regulation (EC) 882/2004.    Few workshops at the national level covered topics of risk assessment and risk management but so far there has not been any practical experience in the area of risk assessment, monitoring and risk management.
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
Here you may provide further details
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).
Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
indicator 2.2.5
  • Yes
Here you may provide further details
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.
Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?
indicator 2.2.6
Survey 22.a) Sufficient
  • Yes
Survey 22.b) Effective
  • Yes
Here you may provide further details
Training materials and technical guidance documents on risk assessment and risk management of LMOs are necessary and particularly effective in case when a country lacks its own capacity in those fields. Since countries' priorities and needs could be very different and could include interest in different kind of GMOs, it would be necessary to have available such documents for as many type of GMOs is possible. This is particularly important for the "stucked" GMOs that are quite complex but it also applies to risk assessments of GM fish and GM trees.
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • None
Here you may provide further details
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.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • One or more
Here you may provide further details
In our two laboratories for detection of LMOs, there are less than 10 professionals that have received training in detection of LMOs.
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Here you may provide further details
There are two laboratories that are also part of the ENGL network.
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Here you may provide further details
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.
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
Here you may provide further details
At the national level, both laboratories certified for LMO detection are operational.
Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
indicator 2.4.1
  • No
Here you may provide further details
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.
Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
indicator 2.4.2
  • Yes
Here you may provide further details
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.
Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
indicator 2.5.2
  • Yes
Here you may provide further details
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.
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • National website
  • Newspaper
  • Public hearings
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • None
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • 5 or more
Here you may provide further details
Some biosafety training materials and/or online modules are available to the professionals but not to the general public.
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • Yes
Survey 35.b) Enforcement system
  • Yes
Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.
indicator 4.3.1
  • 5 or more
Here you may provide further details
In the last two years three TAIEX workshops have been held at the national level and several public consultations and hearings.
Survey 37. Please indicate the number of biosafety related publications that has been made available in your country in the last year.
indicator 4.3.2
  • 50 or more
Here you may provide further details
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.
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • National website
Survey 39. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
indicator 5.2.1
  • None
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • No
Here you may provide further details
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.
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • Yes
Here you may provide further details
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.
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • 25 or more
Here you may provide further details
To date numerous documents and educational materials such as technical guidance documents on biosafety issues have been made available through the national biosafety portal.