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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102395
Status
Published
Date of creation
2011-09-30 10:16 UTC (natalia.mogelska@enviro.gov.sk)
Date of publication
2011-09-30 10:16 UTC (natalia.mogelska@enviro.gov.sk)

Origin of report
Country
  • Slovakia
Contact officer for report
Coordinates
Mgr. Natalia Mogelska
CPB-NFP, BCH-NFP, Emergency measures Contact point
Ministry of Environment, Department of environmental risks and biosafety
Ministry of Environment of the Slovak Republic Department of environmental risks and biosafety Nam. L. Stura 1, 812 35 Bratislava Slovak Republic
Bratislava, Slovak Republic
Slovakia
Phone:+421 2 6020 1681/secretariat, +421 903 319 811
Fax:+421 2 6020 1673
Email:natalia.mogelska@enviro.gov.sk
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
European Union (European Commission)
Submission
10. Date of submission
2011-09-30
11. Time period covered by this report
Start date
2007-09-01
Time period covered by this report
End date
2011-09-30
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more 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 Slovak legislation on genetically modified organisms is in power from April 1st 2002 -   the Act on use of genetic technologies and genetically modified organisms No. 151/2002 Coll., as amended. 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 2nd 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 only be placed on the market in the European Union 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.  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?
  • 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 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?
  • 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?
  • Yes
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • More than 10
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • None
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • More than 10
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?
  • More than 10
43. 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, always
44. Did the notifications contain complete information (at a minimum the information specified in Annex I of the Cartagena Protocol on Biosafety)?
  • Yes, always
45. Has your country acknowledged receipt of the notifications to the notifier within ninety days of receipt?
  • Not applicable
46. Has your country informed the notifier(s) and the BCH of its decision(s)?
  • Yes, always
47. Has your country informed the notifier(s) and the BCH of its decision(s) in due time (within 270 days or the period specified in your communication to the notifier)?
  • Not applicable
48. What percentage of your country’s decisions fall into the following categories?
  • not applicable
%
49. 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?
  • Yes, always
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:
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 2nd 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.
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)?
  • Yes
58. How many LMOs-FFP has your country approved to date?
  • More than 10
59. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?
  • More than 10
60. 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
61. Has your country informed the Parties through the BCH of its decision(s) regarding import, of LMOs-FFP?
  • Yes, always
62. 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
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:
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 Union territory and not only for the territory of the one state, where was the application given.
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.
For information about scientific certainty on potential adverse effects of LMOs-FFP see  question 93.
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:
The Slovak Republic has received requests for change of its decisions regarding an intentional transboundary movement of  LMOs, but only the amount of  imported LMOs was changed.
The decisions itself haven´t been reviewed. 
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:
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
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
80. 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).
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.
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?
  • Yes
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?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • No
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?
  • More than 10
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 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 2nd EU national report.
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 legislative framework provides that the environmental risk assessment described under question 93 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 as well as a risk management strategy to be defined. In cases of limited data availability particular appropriate risk management has to be considered to prevent adverse effects on human health and the environment.
The monitoring plan is a part of the risk management strategy. The objective of the monitoring plan is to confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO or its use in the risk assessment are correct, and to identify the occurrence of adverse effects of the GMO or its use which were not identified in the risk assessment.
The design of the monitoring plan should, among others:
 Be detailed on a case by case basis;
 Take into account the characteristics of the GMO, its use and scale of use, and the range of relevant environmental conditions;
 Incorporate general surveillance for unanticipated adverse effects;
 Provide for case-specific monitoring for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed and indirect effects which have been identified in risk assessment;
 Provide for the use of already established routine surveillance practices where appropriate
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:
Article 14 of Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.
Article 18 – Handling, transport, packaging and identification
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 has developed a comprehensive legal framework on GMOs, which also addresses the issues of handling, transport, packaging and identification requirement covered by Article 18.
The EU approval process for GMOs requires validation of an event-specific detection method for the relevant GMO (see in particular regulation 1829/2003). Validation of GMO detection methods in the EU is carried out by the European Union Reference Laboratory for GM Food and Feed (see http://gmo-crl.jrc.ec.europa.eu/).
Regulation 1829/2003 lays down rules on labelling of all GM food and feed. GM food and feed has to be labelled as GM, except if they contain GM material in a proportion no higher than 0.9% and if this presence is adventitious or technically unavoidable.                               Regulation 65/2004 has established a system for the development and assignment of unique identifiers for genetically modified organisms. The Regulation adopts the format developed by the OECD for Unique Identifiers for Transgenic Plants, which became mandatory for the member states regulatory framework for GMOs. Moreover, the EU has extended use of this format to unique identifiers for GM micro-organisms and animals pending the development and adoption of any other specific format at an international level. The EU considers the use of the unique identifier as a key to access information available on the Biosafety Clearing-House.
Regulation 1946/2003 on transboundary movements of genetically modified organisms has set down requirements for exporters of GMOs regarding identification and documentation of GMOs, that are in line with Article 18 of the Protocol.

More details about the European rules on the safe transport, handling and packaging of GMOs are to find in the 2nd EU national report.  
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:
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)
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 but only partially available in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information 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 available but not in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available but not in the BCH
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 available but not in the BCH
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 available but not in the BCH
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 available and in the BCH
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information available but not in the BCH
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 available but not in the BCH
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, in some cases
128. Has your country experienced difficulties accessing or using the BCH?
  • Yes
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Yes
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:
There are two information sources:
on Slovak web-site http://www.gmo.sk and (in summaries) on the EU BCH site
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:
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
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • 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?
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Public awareness, participation and education in biosafety
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
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.
  • 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
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
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?
  • More than 5
160. 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 2nd EU national report.
The Slovak biosafety web-site: http://www.gmo.sk
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?
  • Yes
163. Has your country ever exported LMOs to a non-Party?
  • No
164. If you answered Yes to questions 162 or 163, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
  • Yes, always
165. If you answered Yes to questions 162 or 163, was information about these transboundary movements submitted to the BCH?
  • 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:
As regards imports of LMOs, the EU applies its domestic legislative framework to all imports of LMOs, whether these originate from parties or non-parties to the Protocol.
As regards exports of LMOs, notification requirements of the exporter to the competent authority of the Party of import established by Regulation No 1946/2003 apply regardless of whether the country of import is a Party or a non-Party to the Protocol. Copies of the respective documents are sent to the compentent authority of the member State from which the GMO is exported and to the  European Commission (Article 6).
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • No
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:
Socio-economic considerations have been relevant at Member State level for the question of co-existence between conventional, organic and GM crops. In the Slovak Republic the  conditions of commercial cultivation of GM crops are determined by the Act 184/2006 Coll. on the cultivation of genetically modified plants in agricultural production, as amended,   and by its implementing Decree 69/2007 Coll. This legislation is based on Commission Recommendation 2003/556 of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming, that was replaced by a new recommendation from 13 July 2010. The Commission has recently issued a report on the socio-economic implications of GMO cultivation, based on the contribution of the Member States.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • No
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:
The Slovak Republic is going to sign the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress very soon. The Slovak Republic will then start a procedure towards the ratification of this protocol.
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. Therefore, no legal amendments seem necessary to formally conclude the agreement.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes, First report only
183. If your country did not submit previous reports, indicate the main challenges that hindered the submission
  • not aplicable
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.
It has to be noted that as far as the EU and its MS are concerned, there are two layers of implementation of the Protocol, one at EU level and one at national level.
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.
The way in which EU legislation in relation to biosafety is structured makes it challenging to allways find a correspondence in the reporting format.  In addition, the fact that the BCH provided a locked document caused additional difficulties in the preparation of this report.
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
This figure refers to the Ministry of Environment of the Slovak Republic, which is the National Focal Point for the Cartagena Protocol.
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
The courses targeting the staff of competent authorities and the course targeting the heads of projects under the Act No. 151/2002 Coll. were count.
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • No
Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
indicator 1.2.5
  • No funds mobilized
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • No
Here you may provide further details
Budget allocations are decided on an annual basis and no reliable funding promise can be made before decisions are formally taken.
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
Besides the legislative guidance documents, Slovakia as the member of the European Union, follows also  several scientific guidance documents published by the European Food Safety Authority and by the Joint Research Centre.
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 Biosafety Committee and its Panel of Experts, which is the advisory body of the Ministry of Environment of Slovak Republic, to assess the applications provided by applicants under the Act No. 151/2002 Coll.
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
Slovakia is a Member States of the European Union, for the details please refer to the EU survey report.
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
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 Competent Authority on state supervision of the use of GMOs under the Act No. 151/2002 Coll. on the use of genetic technologies and genetically modified organisms, as amended, is the Slovak Environmental Inspectorate. It co-operates with other state supervision bodies in fulfilling this task.    Laboratories carrying out the detection of GMOs:  Central Control and Testing Institute of Agriculture   - Department of Molecular Biology is responsible for the control of manipulation with the genetically modified seeds and their following planting;  The State Veterinary and Food Administration executes the control of import, production, manipulation, handling and marketing of GM food and feed.   These two institutions serve as national reference laboratory for the Ministry of Agriculture and Rural Development, which is the Competent Authority under EC Regulation 1829/2003 on genetically modified food and feed.     For further details please refer to the EU survey report.
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
Regardless of the level of environmental risk, all genetically modified organisms are transported as dangerous goods in accordance with international conventions.   The Slovak laws governing the rights and obligations of carriers for the transport of dangerous goods are based on these international conventions  - the European Agreement concerning the International Carriage of Dangerous Goods (ADR),   - the Convention on International Rail (COTIF) and Regulation concerning the international carriage of dangerous goods by Rail (RID),   - the Convention on International Civil Aviation,   - the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (ADN).   Bodies of the European Union adopted Directive 2008/68/EC of 24 September 2008 on the inland transport of dangerous goods, which states that the international rules of transport of dangerous goods in different kinds of traffic will also apply to domestic transports.
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • No
Here you may provide further details
Slovakia doesn´t have specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making, but on the level of European Union activities to define these approaches have been started.   For further details please refer to the EU survey report.
Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
indicator 1.7.1
  • None
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
The Act No. 151/2002 Coll. states the obligation to inform immediately the Member States about any detected unauthorized introduction/release of LMO into the environment.    The user is obliged to immediately take safety measures according to the emergency plan.   In case of an accident related to contained use activities classified into risk classes 3 or 4, the user is obliged to immediately inform regional coordination centre of the Integrated Rescue System.    In case of any detected unauthorized placing to the market, usually food or feed, the Rapid Alert System for Food and Feed applies - see the EU survey report.
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
  • 50 or more
Survey 19.c) Management / Control
  • 50 or more
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
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
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
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Here you may provide further details
Central Control and Testing Institute of Agriculture - Department of Molecular Biology,    The State Veterinary and Food Administration
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.  Slovakia transposed this Directive into the Act No. 359/2007 Coll..
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
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • One or more
Here you may provide further details
Slovak University of Agriculture in Nitra  Comenius University in Bratislava
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • 5 or more
Here you may provide further details
The Slovak Competent Authorities haven´t prepared online modules.  Published training materials are used mostly by inspections.
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
Here you may provide further details
For further details please refer to the EU survey report.
Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.
indicator 4.3.1
  • 5 or more
Here you may provide further details
At least 5 events in relation to biosafety were held in the last 2 years  - training of the Heads of projects (Ministry of the Environment)   - workshop of Slovak and Czech Environmental Inspection   - seminar at National Reference Laboratory (Central Control and Testing Institute of Agriculture - Department of Molecular Biology),  - press conferences (Ministry of Agriculture and Rural Development)   - international educational event "The genetically modified plants tested under field conditions" organized by Plant Production Research Center (2011, 2012)
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
  • 10 or more
Here you may provide further details
In particular, Slovak Competent Authorities made available information on the results of controls and procedures of controls.
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
Here you may provide further details
cooperation in matters of control
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
Here you may provide further details
The Ministry of Environment of the Slovak Republic was involved in UNEP-GEF Biosafety Implementation project entitled: Support for Implementation of the National Biosafety Framework for Slovak Republic, which was carried out from 2006 to 2009.  Project was also aimed at raising public awareness.   Public information has been improved mostly on the basis of a new BCH web page, the electronic media like DVDs and some paper-prints and leaflets. It was not possible to attract media except one case, when the amended Act on GMOs was submitted to the Slovak parliament. With a help of UNDP Division Headquarters in Bratislava, we were able to give the information to the public also on National TV, radio and other relevant media in Slovakia.    Slovakia doesn´t 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.
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.,
See question 40.
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
Ministry of Health and Ministry of Agriculture and Rural Development of the Slovak Republic have prepared "Strategy on research and development in the Slovak Republic in 2020 in the field of Biomedicine and Biotechnology".   This document proposes the construction of two state research and development programmes in 2014 - 2020, which will cover the main priority directions in the field of biotechnology.  One programme will be in area of biomedical and pharmaceutical biotechnology.   The second programme will be in area of industrial and environmental biotechnology.   Consortia will be formed to tackle each task of these state programs.   A consortium will involve research institutions and also businesses operators.
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
Here you may provide further details
articles on national website,   publications thanks to to the UNEP/GEF project mentioned in question 40 (printed only in Slovak):     *National policy for the use of GMOs and products made of them in Slovakia   (Narodny ramec pouzivania geneticky modifikovanych organizmov a vyrobkov z nich na Slovensku, Ferencik  et al., VEDA 2009) - on BCH Central Portal available also in English  *Act on GMO and Decree - with commentary, 3rd arranged edition  (Hutta and Ferencik, published by VEDA, 2008)  *Risk Assessment Guidelines (Valkova and Turna, published by VEDA, 2007)  *GMOs and Biosafety in Slovakia (Bezo, Valkova and Valkovicova, published by VEDA, 2007)