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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109358
Status
Published
Date of creation
2015-11-24 13:54 UTC (Dubravka.Stepic@mzoip.hr/5823)
Date of publication
2015-11-24 13:54 UTC (Dubravka.Stepic@mzoip.hr/5823)

Origin of report
1. Country
  • Croatia
Contact officer for report
Coordinates
Ms. Dubravka Stepić
Senior Advisor
Ministry of Environmental and Nature Protection
Radnička road 80
Zagreb
Croatia, HR-10000
Phone:+385 01 48 66 146
Fax:+385 01 48 66 100
Email:dubravka.stepic@mzoip.hr
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
- Ministry of Health (Ms. Valentina Zoretić-Rubes)
-  Ministry of Science, Education and Sports, Directorate for Science (Ms. Andreja Jakovac)
- Ministry of Agriculture: Directorate for food quality and phytosanitary affairs (Ms. Tisa Vizek Borovina, Višnja Ljubetić); Directorate for veterinary and food security (Ms. Jasna Matičić)
- President of the Council for GMOs (Mr. Domagoj Šimić)
- President of the Committee for Contained Use (Ms. Dušica Vujaklija)
- President of the Committee for Release of GMOs into the Environment (Ms. Martina Šašić Kljajo)
Submission
10. Date of submission
2015-11-24
11. Time period covered by this report
Start date
2011-10-01
11. Time period covered by this report
End date
2015-10-31
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is fully in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2008
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
  • Other laws, regulations or guidelines that indirectly apply to biosafety
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
21. Here you may provide further details on the implementation of Article 2 in your country
National biosafety framework became operational in 2008 when both the Council for GMOs and two Committees (Committee for contained use of GMOs, Committee for intentional/deliberate release of GMOs into the environment) have been established and started to work. In the period covering the Second National Report (September 2007 - September 2011) and until 1 July 2013 when Republic of Croatia became the 28th Member State of the EU, all national legislation (biosafety laws and regulations, other laws, regulations indirectly applicable to biosafety) had been already in line with the comprehensive EU legal framework for ensuring safety in the development, use and transfer of GMOs. It means that provisions of the Directive 2001/18/EC, Regulations (EC) No 1829/2003, Regulation (EC) No 1830/2003, Regulation (EC) No 1946/2003, Regulation (EC) No 641/2004, Directive 2009/41/EC, Commission Regulation 619/2011, and of the Commission Implementing Regulation (EU) No 503/2013 have been transposed into the national legislation and all national legislation was in line with the EU framework.
Republic of Croatia had been actively involved in the preparation of the Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory.
Article 5 - Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • No
24. Here you may provide further details on the implementation of Article 5 in your country:
EU pharma legislation provides that a medicinal product may only be placed on the market in the EU if it has received a marketing authorisation, granted either by the European Commission or by a member state.
As regards medicinal products containing or consisting of GMOs, the assessment for a marketing authorisation must include an environmental risk assessment in line with the requirements of the Directive 2001/18/EC.  Regulation (EC) No 1946/2003 mirrors the provisions of the Protocol as regards exports of pharmaceuticals.
Currently, Croatia does not have any explicit reference to pharmaceuticals in the national legislation relevant to GMOs.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
This question is relevant to indicator 1.8.1 of the Strategic Plan
  • Yes
26. Does your country regulate the contained use of LMOs?
This question is relevant to indicators 1.1.2 and 1.8.2 of the Strategic Plan
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
Regulation (EC) No 1946/2003 addresses transboundary movement of GMOs with the aim to ensure coherent implementation of the provisions of the Cartagena Protocol in the EU. It establishes rules for the transit of GMOs and for the transboundary movement of GMOs intended for contained use, in line with the provisions of the Cartagena Protocol.
According to Article 13 of Regulation (EC) No 1946/2003, the exporter shall ensure notification of the transit of GMOs to Parties that have taken the decision to regulate transit of GMOs through their territory and have informed the BCH of this decision.
Transit procedures through the EU are regulated by the EU transport legislation and the Customs Code to which Republic of Croatia has to comply with as a Member State of the EU.
Provisions of the Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms have been also transposed into the national GMO Act and relevant secondary legislation.
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 OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. 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
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • No
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • No
38. 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
39. 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
46. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment
In regards to the implementation of Articles 7-10, Republic of Croatia as a Member State of the EU has to follow EU domestic legislative framework which is compatible with the provisions of the Cartagena Protocol.
A company intending to market a GMO in the EU for intentional introduction into the environment must first obtain an authorisation to this end. The authorisation procedure for placing the GMO on the market involves all Member States, as authorised products are granted free movement througout the territory of the EU. The so-called "notification" or "application" submitted by the interested company must include a full evaluation of potential risks to human and animal health and to the environment. It is only after this decision is finally adopted on the basis of a prior risk assessment that the company can proceed with the marketing of the GMO in the EU.
A person or a company who wishes to introduce GMOs into the environment for experimental purposes must first obtain written authorisation from the compentent national authority of the Member State whithin whose territory the experimental release is to take place. Hence, the authorisation procedure is simpler than the one referred above The authorisation is given on the basis of an assessment of the risks presented by the GMO or GMOs for the environment and human health.
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
47. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
49. 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?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes
50. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
This question is relevant to indicator 1.1.2 of the Strategic Plan
  • Yes
51. Has your country indicated its needs for financial and technical assistance and capacity-building in respect of LMOs-FFP?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • Yes
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • No
58. 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
In the period covering the Second national report (Sept 2007 - Sept 2011) and until June 2013, Republic of Croatia implemented Article 11 of the Cartagena Protocol under its own national legislation on GMOs which had been in line with the EU legislation already.
Since decisions taken for placing on the market of LMOs-FFP are taken for the whole European Union and not by the MS individually, in the period after 1 July 2013, Republic of Croatia has followed comprehensive legal framework for intentional movements of GMOs within the EU and for imports of GMOs that are intended for direct use for food or feed, or for processing. Since July 2013, Republic of Croatia has been involved in the decision making procedure at the EU level on this matter.
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
60. Has your country ever received a request for a review of a decision?
  • No
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
66. Here you may provide further details on the implementation of Article 12 in your country
In regards to the implementaiton of Article 12, Republic of Croatia as a Member State of the EU has to follow EU legislation which includes Directive 2001/18 (Article 20) and Regulation 1829/2003 (Articles 21 and 22).
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • Yes
68. Has your country ever applied the simplified procedure?
  • No
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
71. Here you may provide further details on the implementation of Article 13 in your country
Neither EU nor the Republic of Croatia has made use of the simplified procedure for imports of LMOs as specified in Article 13.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
76. Here you may provide further details on the implementation of Article 14 in your country
Republic of Croatia has not entered into any bilateral, regional or multilateral agreements or arrangements as per Article 14(1). Thus no such information has been posted on the BCH.
On 1 July 2013 Republic of Croatia joined the EU and became its 28th Member State. It means that existing EU legislative framework for intentional movements of GMOs within the EU and for imports of GMOs into the EU is also applicable in the Republic of Croatia.
Articles 15 & 16 – Risk Assessment and Risk Management
77. Has your country established a national framework for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?
  • Yes
79. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
This question is relevant to indicator 2.2.3 of the Strategic Plan
a) Risk assessment:
  • One or more
b) Management / Control:
  • One or more
c) Monitoring:
  • One or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • No
84. Does your country have the capacity to detect, 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?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • No
88. 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?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • No
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • No
94. 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
95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
96. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
This question is relevant to indicator 2.2.4 of the Strategic Plan
  • Yes
97. Here you may provide further details on the implementation of Articles 15 and 16 in your country
Republic of Croatia as a Member State of the EU follows the EU domestic legal framework on GMOs that is based on a comprehensive system of risk assessment and risk management dealing with releases into the environment or placing on the market of GMOs, whether imported into or developed within the EU.
The notification provided by the company intending to market a GMO must include a full risk assessment of the risks to human and animal health and to the environment, which is assessed by the European Food Safety Authority (EFSA). EFSA makes final decisions on authorisation with an active involvement of Member States, notably as regards the authorisation of GMOs for cultivation, where they carry out the intial risk assessment. The aim of the environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, both direct and indirect, immediate or delayed, on human health and the environment.
So far, experts in Croatia had some experience in conducting risk assessments of LMOs, mainly LMOs that are destined for contained use, but much less in conducting risk assessments of LMOs that are destined for field trials, cultivation, commercial purposes, direct use as food, feed, or for processing. However, our experts are familiar with new developments in the area of risk assessment in general and under the Cartagena Protocol. Republic of Croatia has had two members in the AHTEG on RA and RM for many years and they shared their information and knowledge on new developments on RA and RM under the Protocol with other experts at the national level. Although some of our experts have been invited regularly to the workshops organized at the EU level to update their knowledge, additional training and hands-on experience would be welcomed particularly for regulators and administrators in the country as well as for other experts.
Article 17 – Unintentional transboundary movements and emergency measures
98. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes, to some extent
99. 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
100. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
This question is relevant to indicator 1.8.3 of the Strategic Plan
  • Yes
101. 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
105. Here you may provide further details on the implementation of Article 17 in your country
Article 14 of Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.
Article 18 – Handling, transport, packaging and identification
106. 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
107. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
108. 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?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing types of documentation
110. 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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing types of documentation
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?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing types of documentation
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • No
115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
116. How many customs officers in your country have received training in the identification of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • None
117. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
118. How many laboratory personnel in your country have received training in detection of LMOs?
This question is relevant to indicator 2.3.1 of the Strategic Plan
  • One or more
119. Does your country have reliable access to laboratory facilities for the detection of LMOs?
This question is relevant to indicator 2.3.2 of the Strategic Plan
  • Yes
120. How many laboratories in your country are certified for LMO detection?
This question is relevant to indicator 2.3.3 of the Strategic Plan
  • One or more
121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?
This question is relevant to indicator 2.3.4 of the Strategic Plan
  • One or more
122. Here you may provide further details on the implementation of Article 18 in your country:
As a Member State of the EU, Republic of Croatia follows a comprehensive legal framework which addresses the topic of handling, transport, packaging and identification of LMOs (Art. 18 of the Cartagena Protocol).  This legal framework includes the following Regulations and Directive: Regulation (EC) No 1829/2003 and its implementing Regulation (EC) No 641/2004, Regulation (EC) No 1830/2003, Regulation (EC) No. 1946/2003, Regulation (EC) No 65/2004, Commission Regulation 619/2011 and Directive 2008/68/EC (inland transport of dangerous goods).
As regards Article 18(1) of the Cartagena Protocol, Directive 2008/68/EC contains appropriate rules on the safe transport, handling and packaging.
As regards Article 18(2)(a) of the Cartagena Protocol, Regulation (EC) No 1829/2003, Regulation (EC) No 1830/2003, Regulation (EC) No 65/2004  and Regulation (EC) No 1946/2003 stipulate all requirements of exporters.
As regards Article 18(2)(b) and (c) of the Cartagena Protocol, particularly relevant to exporters is Article 12 of the Regulation (EC) No 1946/2003 which stipulates further obligations of exporters in regards to the GMOs that are intended for contained use.
Article 19 – Competent National Authorities and National Focal Points
123. 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
124. 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
125. Here you may provide further details on the implementation of Article 19 in your country
There is a close collaboration and information sharing among competent national authorities (CNAs) at the national level. Regular meetings are held and members of different CNAs have the opportunity to discuss all issues relevant to GMOs. Furthermore, all national opinions in regards to the authorisation of new LMOs and/or extension of current ones at the EU level requested by the European Commission have been result of discussions among different CNAs at the national level and their agreements prior to taking decisions and submitting the final opinions.
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
126. Please provide an overview of the status of the mandatory 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.
This question is relevant to indicator 3.1.5 of the Strategic Plan
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
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
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
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
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
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
g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
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
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
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
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
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
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
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
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
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
128. 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
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, always
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • No
131. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
132. 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:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • One or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • One or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National Libraries
135. Here you may provide further details on the implementation of Article 20 in your country
Channels of communication and regular meetings of all competent national authorities (ministries) had been established for many years and Cartagena Protocol/Biosafety Clearing-House National Focal Point (CPB/BCH NFP) in the Ministry of Environmental and Nature Protection has been in regular contacts with the members from other ministries who are involved in the work on biosafety and GMO issues. Members from other ministries have been informed of their obligations of sharing relevant biosafety information with the BCH NFP (e.g. information on decisions under their responsibility) in order to make this information available on the Biosafety Clearing-House.
During this reporting period some biosafety related publications had been published and made available to the national libraries and in bookshops. Furthermore, some biosafety events such as press conferences, round tables and public hearings were held in order to exchange relevant biosafety information, raise awareness and enable wider public participation.
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. Here you may provide further details on the implementation of Article 21 in your country
As a Member State of the EU, Republic of Croatia follows EU legislative framework relevant to confidential information. Provisions on confidentiality are stipulated in the Directive 2001/18/EC (Article 25), Regulation (EC) No 1829/2003 (Article 30) and Regulation(EC) No 1946/2003 (Article 16).
All provisions on confidentiality make clear what information shall never be considered as confidential, notably as regards the general description of the GMO, the name and address of the authorisation holders, the risk assessment information and any methods and plans for emergency responses.
Article 22 – Capacity-building
139. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
This question is relevant to indicator 1.2.6 and 3.1.8 of the Strategic Plan
  • No
140. 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
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
145. If you answered Yes to question 144, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 157.
  • Very difficult
146. 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)
147. 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, to some extent
148. If you answered Yes to question 147, in which of the following areas were these activities undertaken?
  • Human resources capacity development and training
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • Yes
152. If you answered Yes to question 151, 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
  • Public awareness, participation and education in biosafety
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Taking into account risks to human health
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • No
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • No
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • 1 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
157. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds
In the past, Republic of Croatia expressed its interest to be included in the UNEP-GEF Project "Implementation of the National Biosafety Framework". At the end, project has not been realized due to different reasons but mainly because of the UNEP-GEF.
Implementation of Article 22 has a very broad scope and Parties still have a lot of capacity building needs at the national level. Implementation requires continuous efforts and financial means that Parties usually do not have available at the national level. Therefore, capacity building initiatives and projects in the field of biosafety for the effective implementation of different provisions of the Protocol are still very much needed and financial support required by the UNEP-GEF should be made continuously at disposal to Parties even in the case Parties do not express biosafety issue as their only national priority within the biodiversity thematic area.
Strengthening capacity of the UNEP-GEF is also required which will facilitate apropriate and timely assistance to Parties in submitting their project proposals and their timely processing. UNEP-GEF should make an additional effort to make forms and procedure for project application less complex. Also financial cycles of the GEF should be better tailored and timely aligned with the requests of Parties and COP-MOP/COP decisions.
Article 23 – Public awareness and participation
158. 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
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • No
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • No
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
Republic of Croatia does not have awareness and outreach strategy on biosafety but in implementation of Article 23 of the Cartagena Protocol, Croatia applies components that are stated under Outreach strategy of the Protocol as well as relevant elements of the Strategic Plan.
162. Has your country established a biosafety website searchable archives, national resource centres or sections in existing national libraries dedicated to biosafety educational materials?
This question is relevant to indicators 2.5.3 and 5.3.3 of the Strategic Plan
  • Yes
163. 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?
This question is relevant to indicator 5.2.1 of the Strategic Plan
  • None
164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
165. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
166. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
This question is relevant to indicator 2.5.1 of the Strategic Plan
  • Yes
167. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Yes
168. If you answered Yes to question 167, please indicate the modalities used to inform the public:
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • National website
  • Newspaper
  • Forums
  • Public hearings
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • Forums
170. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
171. How many academic institutions in your country are offering biosafety education and training courses and programmes?
This question is relevant to indicator 2.7.1 of the Strategic Plan
  • One or more
172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:
This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan
  • One or more
173. 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
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • No
175. 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?
  • More than 5
176. Here you may provide further details on the implementation of Article 23 in your country
As a Member State of the EU, Republic of Croatia has to follow EU legislation which promotes public awareness and participation as an integral part of its regulatory framework.
The main legal instrument to align EU Member States legislation with the provisions of the Aarhus Convention on access to information is Directive 2003/4/EC of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC. To further support citizens' rights of access to information, the EU has also adopted Directive 2003/35/EC on public participation, Regulation 1049/2001 of 30 May 2001 regarding public access to European Parliament, Council and Commission documents.
An amendment to the Aarhus Convention was adopted in May 2005. This amendment makes more specific the obligations placed on Parties with regard to public participation in genetically modified organism (GMO) decision-making processes. Relevant Community law governing GMOs, and in particular Directive 2001/18/EC and Regulation (EC) No 1829/2003, incorporates provisions for public participation in decision-making on GMOs (Article 9, 24 and Article 5 respectively) consistent with the amendment to the Aarhus Convention (Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters). Republic of Croatia has not yet ratified the GMO Amendment.
Consequently, under the national legislation, Republic of Croatia has also obligation to provide public with the drafts of all upcoming laws and regulations in order to enable public consultation and their participation in the decision making process regarding LMOs. Public consultations usually last for 30 days which is in accordance with the national legislation and Aarhus Convention.
Article 24 – Non-Parties
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • No
179. Has your country ever exported LMOs to a non-Party?
  • No
183. Here you may provide further details on the implementation of Article 24 in your country:
As regards imports of LMOs, the EU applies its domestic legislative framework to all imports of LMOs, whether these originate from parties or non-parties to the Protocol.
As a Member State of the EU, Republic of Croatia has not entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs.
Article 25 – Illegal transboundary movements
184. 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
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
186. 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?
If you replied Never to question 186 please go to question 191
  • Never
191. Here you may provide further details on the implementation of Article 25 in your country
In regards to the implementation of Article 25, as a Member State of the EU, Republic of Croatia follows legal framework of the EU on this issue.
According to Directive 2001/18/EC, it is the Member States that are obliged to take domestic measures to prevent and penalize illegal transboundary movements of GMOs. European legislation contains explicit obligations on Member States to lay down rules on penalties applicable to infringements of the provisions of European regulations. It further states that these penalties shall be effective, proportionate and dissuasive.
Specific requirements on Member States to determine penalties applicable to breaches of European and national GMO regulations can be found in the Directive 2001/18/EC on the deliberate release into the environment of GMOs (Article 33), Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms (Article 18), Regulation (EC) No 1829/2003 on genetically modified food and feed (Article 45) and Regulation (EC) No 178/2002 laying down general principles and requirements of food law (Article 53). The Commission adopted stricter requirements with a new Decision on emergency measures in 2011 (Commission Decision 2011/884/EU) with further amendments introduced in 2013 (Commission Decision 2013/287/EU). The latter Decision is still in force.
Article 26 – Socio-economic considerations
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • No
193. 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
194. 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?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • One or more
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
As a Member State of the EU, Republic of Croatia has been involved in the preparation of new Directive (EU) 2015/412 which gives the possibility to the Member States to take opt-out decisions on GMO cultivation (restrict or prohibit cultivation of GMOs in their territory) based on legitimate considerations different from the risk assessment undertaken in the context of the authorisation procedure at the EU level, such as socio-economic concerns, town and country planning, land use and general environmental policy objective different to risks.
Republic of Croatia does not have its own means to conduct studies on socio-economic impacts of GMOs but is closely monitoring new developments at the EU level and under the Cartagena Protocol on Biosafety including on-line forums and work of the AHTEG on socio-economic considerations.
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • No
197. Here you may provide further details on the implementation of Article 26 in your country
At the country level, issue of socio-economic considerations has been relevant for the question of co-existence between conventional, organic and GM crops.
So far at the EU level there is a Recommendation issued by the Commission in 2010 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming. Furthermore, Best Practice Documents (BPDs) for the coexistence of GMOs with conventional and organic crops developed by the European Coexistence Bureau are also available (ECoB - http://ecob.jrc.ec.europa.eu/). To date the ECoB published BPDs for maize, honey and soybean production, and BPDs on cotton and potato production are under preparation.  
Also at the EU level, a technical working group (the "European GMO Socio-Economics Bureau" - ESEB) has been established to organise and facilitate the exchange of technical and scientific information regarding the socio-economic implications of the cultivation and use of GMOs between Member States and the Commission. The first Reference Document "Framework for the socio-economic analysis of the cultivation of genetically modified crops", setting a general framework for the socio-economic analysis of GMO cultivation, has been finalised and published in 2005 (https://ec.europa.eu/jrc/en/eseb/documents.). ESEB is in the process of drafting a reference document for measurement of socio-economic impacts in the EU Member States of the cultivation of insect resistant maize. Next reference documents will concern Herbicide Tolerant (HT) Maize, HT soya and HT sugarbeet.
Recent Directive (EU) 2015/412 gives the possibility to the Member States to take opt-out decisions on GMO cultivation (restrict or prohibit cultivation of GMOs in their territory) based on legitimate considerations different from the risk assessment undertaken in the context of the authorisation procedure at the EU level, such as socio-economic concerns, town and country planning, land use and general environmental policy objective different to risks. In this context, the methodologies and indicators for measuring socio-economic impacts drawn in the abovementioned ESEB's Reference Documents might be useful when adopting opt-out decisions on GMO cultivation based on socio-economic concerns.
At present, Republic of Croatia is in the process of preparing the national strategy on coexistence.
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
199. If you answered No to question 198, is there any national process in place towards becoming a Party?
  • Yes
200. 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?
This question is relevant to indicator 2.4.1 of the Strategic Plan
  • No
201. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
This question is relevant to indicators 1.5.2 and 2.4.2 of the Strategic Plan
  • No
202. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress
In the Republic of Croatia, steps have been taken to initiate the procedure of ratification of the Supplementary Protocol under the Cartagena Protocol on Biosafety. Working group that is responsible for preparation of the national law enacting the Supplementary protocol has been established and its work is still ongoing. We still need to translate a text of the Supplementary protocol and continue our work on the law itself. Usually, soon after such law is put in place, a ratification procedure itself goes very fast. Ratification of the Supplementary Protocol is expected before the end of 2016. 
Article 28 – Financial Mechanism and Resources
203. 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?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • Not applicable
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • Yes
b) Enforcement system:
  • Yes
205. Has your country submitted all the previous due National Reports?
  • Yes