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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102353
Status
Published
Date of creation
2011-09-28 11:54 UTC (ruth.rupreht@gov.si)
Date of publication
2011-09-28 11:54 UTC (ruth.rupreht@gov.si)

Origin of report
Country
  • Slovenia
Contact officer for report
Coordinates
dr. MARTIN BATIČ
Head of the biotechnology department
MINISTRY OF THE ENVIRONMENT AND SPATIAL PLANNING (MESP)
DUNAJSKA 48 1000 LJUBLJANA SLOVENIA
Ljubljana
Slovenia, 1000
Phone:+ 386 1 478 7440
Fax:+ 386 1 478 7422
Email:martin.batic@gov.si
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
MINISTRY OF THE ENVIRONMENT AND SPATIAL PLANNING, MINISTRY OF AGRICULTURE, FOOD AND FORESTRY, MINISTRY OF HEALTH
Submission
10. Date of submission
2011-09-28
11. Time period covered by this report
Start date
2007-10-01
Time period covered by this report
End date
2011-09-28
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
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
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?
  • Less than 5
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:
The principal aim of the biosafety system is effective supervision of the handling of GMOs. The biosafety system establishes the necessary infrastructure and decision-making procedures. The legislative and administrative framework for the area of GMOs in Slovenia is established in accordance with the legal order of the EU and the Cartagena Protocol on Biosafety.
The Management of Genetically Modified Organisms Act (MGMO) was adopted in July 2002. The Act regulates the handling of GMOs and determines measures for prevention and decrease of possible harmful effects on the environment, especially with regard to the preservation of biodiversity, and people's health. The Act reflects provisions of the EU Directives regulating GMO's and of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. 
After entering the EU, the Management of Genetically Modified Organisms Act was amended in July 2004 to fully transpose provisions of EU Directives regulating GMO's.
In 2010 Management of Genetically Modified Organisms Act was amended to include provisions of the new Directive 2009/41/EC on the contained use of genetically modified micro-organisms and brought new structure of the Slovene Scientific Committees for GMOs.
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes, to some extent
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • Yes
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 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 Directive 2001/18/EC. Regulation 1946/2003 mirrors the provisions of the Protocol as regards exports of pharmaceuticals.                                                      
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?
  • Partially
28. Here you may provide further details on the implementation of Article 6 in your country:
The Management of Genetically Modified Organisms Act (MGMO) regulates the handling of GMMs and also GM animals in the contained use to preventi and decrease of possible harmful effects on the environment, especially with regard to the preservation of biodiversity, and people's health. The Act reflects provisions of the EU Directive 2009/41 regulating GMM's. 
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?
  • Yes
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
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
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
50. 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:
Slovenia, as a part of EU, is regularly involved in the authorisation procedures for placing of the GMOs on the market.
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?
  • No
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:
Reference to the report of the European Union.
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
71. Here you may provide further details on the implementation of Article 12 in your country:
Reference to the report of the European Union.
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?
  • No
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
76. Here you may provide further details on the implementation of Article 13 in your country:
Reference to the report of the European Union.
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?
  • Yes, always
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:
Slovenia is an EU Member State since 1st of May 2004 and as such all the EU Acquis communautaire is applicable to Slovenia.
Consolitated versions of the treaty on European Union and of the treaty establishing the European community from 29.12.2006 Official Journal of the European Union C321 E/1
80. Here you may provide further details on the implementation of Article 14 in your country:
The procedure as specified in Article 13. of the Protocol is not in use in Slovenia.
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)?
  • Yes, always
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Yes, always
93. Here you may provide further details on the implementation of Article 15 in your country:
In compliance with the Slovene Management of Genetically Modified Organisms Act (MGMO Act) which is consistent with the EU legal framework for GMO authorisations are based on a prior risk assessment. A notification of a GMO indended to contained use, deliberate release into the environment or placing on the market must include a full risk assessment of the risks to human and animal health and to the environment.
Risk assessment conducted on the "case by case" basis, taking into account scientific aspects in accordance with the procedures established in Community and domestic legislation, is carried out in the first place by the notifier and then evaluated by the Scientific Committee for contained use or Scientific Committee for deliberate release of GMO's into the environment and placing on the market, which are two national scientific advisory technical bodies in order to provide professional assistance to ministries responsible for decision making on GMO's.
Since Slovenia become a member of European Union it cooperates with other EU countries for the purposes specified in Articles 15 and 16 of the Protocol.
The notifier is obliged to pay administrative fee only which does not exceede app.100USD. A regulation according which Slovenia will be able to charge a part of virtual costs of an application processing is in preparation.
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
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?
  • Yes
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
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
The objective of a risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of GMOs may have. The risk assessment should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used should be proposed. An adequate monitoring plan should also be proposed.
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?
  • No
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
107. Here you may provide further details on the implementation of Article 17 in your country:
Reference to the report of the European Union.
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?
  • Yes
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
115. Here you may provide further details on the implementation of Article 18 in your country:
The EU approval process for GMOs requires validation of an event-specific detection method for the relevant GMO. Validation of GMO detection methods in the EU is carried out by the European Union Reference Laboratory for GM Food Feed (JRC).
Slovenia has several laboratories for the detection of GMOs. Laboratory at the Slovene National Institute of Biology is nominated as Slovene National Reference Laboratory for GMO detection by Slovenian authorities. Slovene laboratories are members of the ENGL network and are acredited according to ISTA standards.
Slovene custom authorities have established border control and alert system and closely cooperate with custom authorities of other EU countries.
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
123. Here you may provide further details on the implementation of Article 19 in your country:
Reference to the report of the European Union.
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 available and in the BCH
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 not available
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:
Reference to the report of the European Union.
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
134. Here you may provide further details on the implementation of Article 21 in your country:
A notifier may in a notification of a GMO according to MGMO Act specify data which are business and intellectual property rights and which should be treated in the notification procedure as confidential. Notwhitstanding, a notifier may not claim as confideantial the data as follows:
1. the name and surname, business name, address and registered office of the notifier,
2. the site of contained use,
3. the general characteristics of the GMO.
4. the class of the contained use,
5. containment measures, and
6. data on possible adverse and other effects on the environment or human health.
The ministry shall issue a decision within seven days after receiving a complete notification by which it decides which data from the notification will be protected as confidential in the procedure.
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?
  • Yes
136. If you answered Yes to question 135, how were these resources made available?
  • Bilateral channels
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Regional channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • No
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
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • 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, a few
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • Risk management
  • Public awareness, participation and education in biosafety
  • Socio-economic considerations
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
150. 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:
Reference to the report of the European Union.
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, to a limited extent
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • Yes
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
160. Here you may provide further details on the implementation of Article 23 in your country:
Reference to the report of the European Union.
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
167. Here you may provide further details on the implementation of Article 24 in your country:
Reference to the report of the European Union.
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
175. Here you may provide further details on the implementation of Article 25 in your country:
Reference to the report of the European Union.
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?
  • Yes, to a limited extent
178. Here you may provide further details on the implementation of Article 26 in your country:
Reference to the report of the European Union.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
181. 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:
Reference to the report of the European Union.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
Other information
184. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.
Reference to the report of the European Union.
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.
Reference to the report of the European Union.
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
  • 2002
Here you may provide further details
Slovenia mobilizes around 20.000 USD/year to support the implementation of the Cartagena Protocol (including financial support to specific activities of the CBD Secretariat such as AHTEG and workshops ).
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
Besides the EU level Slovene national biosafety training workshops are organised twice a year by the Slovene national reference laboratory for GMO testing.
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • Yes
Here you may provide further details
Capacity-building initiatives are coordinated by The ministry in cooperation with National reference laboratory.
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
  • 5,000 USD or more
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
The programming process for the Slovenian budget is based on the biennial adoption frame. No preliminary embarking is yet agreed but Slovenia is looking positively at the activities of the Cartagena Protocol.
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
  • Yes
Survey 9.b) Risk management
  • Yes
Here you may provide further details
Slovene GMO legislation introduced the provisions of the Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms which provides a framework for the environmental risk assessment of genetically modified organisms and contains several annexes related to the risk assessment and risk management.    Besides these legislative guidance documents, the European Food Safety Authority also published several scientific guidance documents on risk assessment that are available on their website:  http://www.efsa.europa.eu/en/gmo/gmoguidance.htm  The Joint Research Centre also published several guidance documents on detection of GMOs that are available on their website:  http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm.
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
  • Yes
Here you may provide further details
The guidance documents referred to in question 9 are used by the European Food Safety Authority and/or by Member States to assess the applications provided by applicants in view to get a market approval in the European Union.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • Yes
Here you may provide further details
Slovenia is a partner in the discussions under the Codex Alimentarius and the Organisation for Economic Co-operation and Development (OECD).
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
Here you may provide further details
Slovenia conducts a risk assesment for every LMO notified to the EU.
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
Here you may provide further details
The EU domestic legal framework provides for   - detection and identification tools for GMOs to be placed on the market: these methods are provided by the applicants, are validated by the European Union Reference Laboratory for GM Food Feed (website: http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx), and controls are implemented by Member State's authorities.  - risk assessments prior to the authorization of GMOs (see question 3), aiming to assess potential risks to the environment (including the biodiversity), human and animal health, that are evaluated by the European Food Safety Authority and/ or the Member States;  - monitoring of experimental releases of GMOs and of GMOs placed on the market: the monitoring strategy is proposed by the applicant in the application, assessed by the European Food Safety Authority and/ or the Member States, specified in the authorization decision, implemented by the applicant, controlled by the Member States, and the results and methods of the monitoring are assessed by the Member States and the European Food Safety Authority for cultivation applications. The JRC maintains a public database on "Deliberate Release and Placing on the EU Market of GMOs - GMO Register" at: http://gmoinfo.jrc.ec.europa.eu/
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
  • Yes
Here you may provide further details
The EU has developed a comprehensive legal framework on GMOs, which also addresses the issues of handling, transport and packaging.   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 amended 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
  • Yes
Here you may provide further details
Socio-economic considerations have been relevant for Slovenia at a level of co-existence between conventional, organic and GM crops.  In that respect Slovenia developed its national co-existence measures in 2009 according to article 26.a of the Directive 2001/18 EC which addresses socio-economic considerations through the  establishment of the co-existence criteria.
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
  • 50 or more
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
Article 50 of Regulation 178/2002 on the general principles of food law set 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 a GMOs. On that basis emergency plan for custom and inspection survey and sampling is prepared and executed. National reference laboratory is recruted for testing. If neccessary, adequate measures are taken.
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
  • 50 or more
Survey 19.b) Monitoring
  • 10 or more
Survey 19.c) Management / Control
  • 10 or more
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
In Slovenia National Reference Laboratory (NRL) for GMO and GM Food Feed has been nominated and is responsible for the scientific assessment and validation of detection methods for GMO and GM Food and Feed as part of the EU authorisation procedure and as well as for the cases of unauthorised events. NRL is a member of ENGL, the European Network of GMO Laboratories.
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
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
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • One or more
Here you may provide further details
Training to custom officers and inspectors was organized at national level.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 10 or more
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
The NRL has sophisticated laboratory facilities.
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
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
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. The directive is introducet in the Slovene legal framework.
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
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
  • Mailing lists
  • Public hearings
  • Slovene biosafety portal: http://www.biotechnology-gmo.gov.si/
Survey 32. If you indicated multiple modalities for public participation in the question above, which one was most used?
indicator 2.5.2
  • National website
Here you may provide further details
Slovene biosafety portal: http://www.biotechnology-gmo.gov.si/
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • 5 or more
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • One or more
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
  • One or more
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
  • One or more
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
  • One or more
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
Survey 41. If you answered yes to the question above, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place.
indicator 5.3.1
E.g. local, national, etc.,
NRL and other research institutions.
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
Slovenia promotes transparency and stakeholders consultation.
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • 5 or more