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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109122
Status
Published
Date of creation
2015-11-01 00:38 UTC (natalia.mogelska@enviro.gov.sk)
Date of publication
2015-11-01 00:38 UTC (natalia.mogelska@enviro.gov.sk)

Origin of report
1. Country
  • Slovakia
Contact officer for report
Coordinates
Natalia Mogelska
National Focal Point for Cartagena Protocol on Biosafety
The Ministry of Environment - Department of Environmental Risk and Biosafety
Nam. L. Stura 1
Bratislava
Slovakia, 812 35
Phone:+421 2 5956 2717
Fax:+421 2 5956 2508
Email:natalia.mogelska@enviro.gov.sk
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
European Commission - Directorate General for Health and Food Safety, The Ministry of Agriculture and Rural Development of Slovak Republic, The Slovak Inspection of Environment, universities
Submission
10. Date of submission
2015-10-31
11. Time period covered by this report
Start date
2011-10-01
11. Time period covered by this report
End date
2015-10-30
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
  • 2002
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more sets of biosafety guidelines
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 Act on the use of genetic technologies and genetically modified organisms No. 151/2002 Coll., as amended, became effective on 1st April 2002. The Decree No. 399/2005 Coll. of the Ministry of Environment of the Slovak Republic implements the Act. These legal measures are based on the Directive 2009/41/EC on the contained use of genetically modified micro-organisms and Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms. All approval procedures for import of GMOs are common for all Member States of the European Union.
For more information see the 3rd national report of the European Union.
Article 5 - Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes
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:
A medicinal product may be placed on the market in the European Union only 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 Directive 2001/18/EC. The 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?
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:
- Contained use:
The Act 151/2002 Coll. on the use of genetic technologies and genetically modified organisms, as amended. Decree 399/2005 Coll. of the Ministry of Environment of the Slovak Republic implements the Act.
- Transit:
Regulation 1946/2003 addresses transboundary movement of GMOs, and specifically requirements for exports of GMOs to third countries as well as for unintentional transboundary movements. According to Article 13 of the Regulation 1946/2003, the exporter shall ensure notification of the 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. 
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
  • Yes
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
  • Yes
36. If you answered Yes to question 35, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • More than 10
37. If you answered Yes to question 35, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • None
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?
  • Less than 5
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?
  • Less than 5
40. With reference to the decisions taken on intentional transboundary movements of LMOs for intentional introduction into the environment, has your country received a notification from the Party(ies) of export or from the exporter(s) prior to the transboundary movement?
  • Yes
41. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes
42. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Yes
43. Has your country informed the notifier(s) and the BCH of its decision(s)?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
44. What percentage of your country’s decisions fall into the following categories?
  • Approval of the import/use of the LMO(s) with conditions
100%
45. In cases where your country approved an import with conditions or prohibited an import, did it provide reasons on which its decisions were based to the notifier and the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
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
The Slovak Republic applies its domestic legislative framework instead of the Protocol's advanced informed agreement procedure. This framework is compatible with the provisions of the Protocol.
The authorisation procedure for intentional introduction into the environment is common for all Member States of the European Union as described in the EU 3rd national report. The experimental introduction of GMOs into the environment is decided by each Member State independently, the decision-making on placing on the market involves all EU-Member States, as authorised products are granted free movement throughout the territory of the EU.
In the current reporting period Slovakia received two applications on field trials with genetically modified maize NK603 x MON810 and MON89034 x NK603 (imported also from country outside the European Union) and sugarbeet H7-1 (imported from an EU-Member State, under EU-legislation not considered as an import).
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
  • No
52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • Yes
53. How many LMOs-FFP has your country approved to date?
  • More than 10
54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?
  • More than 10
56. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
57. Has your country informed the Parties through the BCH of its decision(s) regarding domestic use, including placing on the market, of LMOs-FFP within 15 days?
  • Yes, always
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
With regard to the decisions taken for placing on the market of LMOs-FFP, it has to be noted that those decisions are taken for the whole European territory and not by the MS individually. All decisions are subsequently published by the European Commission in the European Biosafety Clearing-House (BCH).
The authorisation procedure for placing on the market of the GMOs intended for food or feed is regulated by Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, covering the placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs.
The decision also states, if the GMO is authorised for cultivation. In the Slovak Republic the  conditions of commercial cultivation of GM crops are determined by the Act No. 184/2006 Coll. on the cultivation of genetically modified plants in agricultural production, as amended and by the implementing Decree No. 69/2007 Coll.
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
The Slovak Republic received requests for change of its decisions regarding an intentional transboundary movement of  LMOs, but not in the current reporting period and only the amount of  imported LMOs was changed. The decision itself was not reviewed. 
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?
  • No
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
The EU has not 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
The Slovak Republic has not entered into any bilateral, regional or multilateral agreements or arrangements as per Article 14(1) since entering the European Union.
The Slovak Republic relies on the existing legislative framework for intentional movements of GMOs within the European Union and for imports of GMOs into the European Union.
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:
  • 50 or more
b) Management / Control:
  • 10 or more
c) Monitoring:
  • 10 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
  • No
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
  • No
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
  • Yes
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
  • No
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
  • Yes
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
  • Yes
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
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Field trial
  • LMOs for Contained use
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • In some cases only
92. If you answered Yes to question 89, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs for direct use as food, feed, or for processing?
  • Yes, always
93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?
  • More than 10
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
Q91:  Only the summary reports of the risk assessment of field trials were submitted to the BCH in the current reporting period. The summary reports of the risk assessment of contained use were not submitted to the BCH.
In Slovak Republic is the European legal framework aplicated, which is based on a prior risk assessment before authorisation is given. The EU has put in place a comprehensive system of risk assessment and risk management dealing with experimental 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), with an active involvement of Member States, notably as regards the authorisation of GMOs for cultivation, where they carry out the initial 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.
The principles of the environmental risk assessment are listed in the 3rd  EU national report.
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
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
Q:101 This year, the Central Control and Testing Institute of Agriculture (National Reference Laboratory for GMOs) found by one importer a soybean seed contaminated by two allowed transgenes, but not allowed for cultivation in the EU. Both transgenes were found on the threshold of the detection limit. For production of seed the product must be  clean, therefore the soybean seed could be used only as feed. According to the considerations of  the EU that any reference to Article 17 of the Cartagena Protocol shall be focused on the release of an GMO, rather than on the unintentional transboundary movement which results or may result from that release, this case does not fall under the scope of the Article 17.
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
  • Yes
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
  • 10 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:
Q: 116  - Each GMO must have accompanying documents. If the customs officers suspect that a product is a not labeled GMO, then the appropriate control authorities are called.
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
The European Union has designated its own competent authority and focal point, while EU Member States have also designated their own national focal points and competent authorities. There is close collaboration and information sharing between EU and national administrations.
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 but only partially available in the BCH
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information available but not in the BCH
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 not available
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 available and in the BCH
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available but not in the BCH
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 available but not in the BCH
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 available but not in the BCH
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 available and in the BCH
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information available but not in the BCH
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 available but only partially available in the BCH
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • No
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, in some cases
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
  • 5 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
  • 10 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
  • website of the university or other institution, library of the university
135. Here you may provide further details on the implementation of Article 20 in your country
Q126i refers to the current reporting period.
Q126q: The risk assessment summaries of the contained use were not published in the BCH.
Decisions regarding LMOs for direct use as food, feed and processing that are valid also for the Slovak Republic were published in the BCH by the EU.
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
The EU applies its domestic legislative framework instead of the Protocol's advance informed agreement procedure. This framework is compatible with the provisions of the Protocol. It contains confidentiality provisions that apply equally to domestic and foreign producers of GMOs. 
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.
  • Average
146. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Development of national biosafety frameworks
  • Implementation 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?
  • No
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, a few
152. If you answered Yes to question 151, indicate which of the following areas still need capacity-building.
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Scientific biosafety research relating to LMOs
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
  • 5 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
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
Q140: The answer refers to the current reporting period. In the past (between 2001 and 2005) there were two PHARE projects - Twinning with Italy and Twinning with Austria. The PHARE projects are oriented to the adoption EU environmental legislation and to cover gaps in biosafety system in governmental control and inspection.
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
  • Yes
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
  • Yes
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
Slovakia does not have an outreach programme especially on biosafety, but has one national research and development programme for biotechnology called  "Comprehensive solution of support for the efficient use of infrastructure for research and development" funded by the Ministry of Education, Science, Research and Sport of the Slovak Republic.
The basic objective of the project of this national research and development programme was to build the Biotechnology Center of the Slovak Republic BITCET as a center of excellence in this area.
This center has further built centers and sub-centers in the field of genomics, proteomics, bioinformatics and cell engineering. These centers have been equipped with modern facilities and unique instrumentation in Slovakia.
BITCET - Biotechnology Centre of Slovakia - is an association of 18 organizations of basic and applied research as Slovak Academy of Sciences, Slovak universities and the Ministry of Health and the Ministry of Agriculture and Rural Development.
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
  • The Collection of Laws
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
  • National website
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
  • 10 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?
  • 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
EU legislation on GMOs promotes public awareness and participation as an integral part of its regulatory framework - see the 3rd EU national report.
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?
  • Yes
179. Has your country ever exported LMOs to a non-Party?
  • No
180. If you answered Yes to questions 178 or 179, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes
181. If you answered Yes to questions 178 or 179, was information about these transboundary movements submitted to the BCH?
  • Yes, always
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
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?
  • No
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
  • None
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to some extent
Here you may provide further details
The European Commission has set up a technical working group  - the "European GMO Socio-Economics Bureau"  (ESEB) composed of experts from the Member States and the Commission. The ESEB started its work in January 2013.
The mission of the ESEB is 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. On the basis of this process, the ESEB will develop Reference Documents that will enable a science-based assessment of these impacts in the Member States and across the EU.
The scope of the ESEB will cover the impacts of GM crop cultivation in the EU, and the impacts of the use of these GM crops for food, feed or industrial purposes (along the whole food/industrial chain, and marketing to consumers). It should focus on particular crops/traits or products of direct relevance to the European Internal Market that are currently approved or awaiting approval for cultivation and use at EU level.  
197. Here you may provide further details on the implementation of Article 26 in your country
In Slovakia there is ten years experience with GM maize cultivation (MON810), but data on socio-economic implications of GMO cultivation are limited. It is due to a low cultivation area (2012 - 189 ha, 2013 - 99,9 ha, 2014 - 411 ha, 2015 - 104 ha). Behind this data are numerous aspects, beginning from the generally negative attitude of the EU public to GM crops, higher administration requirements for GMO growers, problems with selling the harvest, high GM seed cost, up to a limited interest of leading seed distributors to import GM seed into EU nowadays.
Article 27 – Liability and Redress
198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • 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
  • Yes
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
The EU legislation on liability for environmental damage is already fully consistent with the adopted Supplementary Protocol and in the Slovak Republic it is transposed in the Act 359/2007 Coll. on the prevention and remedying of environmental damage. The Slovak Republic ratified this protocol on 28 April 2015.
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