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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109073
Status
Published
Date of creation
2015-10-23 15:13 UTC (andrew.bowers@cbd.int)
Date of publication
2015-10-23 15:13 UTC (andrew.bowers@cbd.int)

Origin of report
1. Country
  • Czech Republic
Contact officer for report
Coordinates
Zuzana Doubkova
National Focal Point for Cartagena Protocol on Biosafety
Ministry of the Environment
Vrsovicka 65, 100 10.
Prague 10
Czech Republic
Phone:+420 267 122 922
Fax:+420 267 126 922
Email:zuzana.doubkova@mzp.cz
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Czech Commission for the Use of Genetically Modified Organisms and Genetic Products - advisory body to the Ministry of the Environment; Ministry of Agriculture; supervisory authorities; universities and research institutions;  NGOs
Submission
10. Date of submission
2015-10-23
11. Time period covered by this report
Start date
2011-10
11. Time period covered by this report
End date
2011-09
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
  • 2001 or earlier
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • 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 Czech Republic is a member state of the European Union, therefore the Czech legislative framework has been harmonised with the European Union legislation. The EU legislation is listed and described in the parallel 3rd National Report of the European Union.
In the Czech Republic, the first basic national legal instrument regarding the use of GMOs was adopted already in 2000. Since February 2004, the Act 78/2004, on the Use of Genetically Modified Organisms and Genetic Products, as amended, with an implementing Decree 209/2004 have been in force. The Act transposes EU Directives 2001/18/EC and 2009/41/EC, therefore it covers the contained use, deliberate release of GMOs into the environment (e. g. field trials) and placing on the market of GMOs as or in products. It has been in force since February 2004.
General rules on the co-existence of genetically modified crops with conventional and organic farming are set by the Act 252/1997, on Agriculture, as amended, and specified by the Decree 89/2006, on detailed conditions for growing a genetically modified variety, as amended.
Re Q16: Amendments of some Acts and corresponding Decrees related to biosafety are under way, on the basis of recent developments and knowledge and in compliance with the new EU legislation.
More information is available through the Czech national node of the BCH at http:http://www.mzp.cz/biosafety
The EC Regulations 1829/2003 and 503/2013 concerning the authorisation of GM food and feed, Regulation 1830/2003 on traceability and labelling of GMOs and GM food and feed, Regulation 1946/2003 implementing the Cartagena Protocol and relevant implementing decisions have been directly applicable in the Czech Republic since its accession to the EU in May 2004. For more information on EU legislation, please refer to the EU report.
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:
According to the EU Regulation 726/2004, a medicinal product containing LMOs may only be placed on the market in the European Union after it has received a marketing authorisation granted by the centralised EU procedure. The assessment preceding the registration must include an environmental risk assessment in line with the requirements of Directive 2001/18/EC.
EU Regulation 1946/2003 reflects the provisions of the Protocol as regards the export of LMOs, including 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:
Act 78/2004, on the Use of Genetically Modified Organisms and Genetic Products, as amended, and its implementing Decree 209/2004, on Detailed Conditions for the Use of Genetically Modified Organisms and Genetic Products, as amended, transpose Directive 2009/41/EC on the contained use of genetically modified micro-organisms, and covers contained use of other GM organisms (plants and animals) as well.
- Transit:
Act 78/2004, on the Use of Genetically Modified Organisms and Genetic Products, as later amended and its implementing Decree 209/2044, on Detailed Conditions for the Use of Genetically Modified Organisms and Genetic Products, as amended, apply also for export, import and transit of GMOs and genetic products.
EU Regulation 1946/2003 that is directly applicable in the Czech Republic, addresses transboundary movement of GMOs, and specifically sets requirements for exports of GMOs to third countries.
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
  • No
38. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
39. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
46. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment
Since its accession to the European Union in May 2004, the Czech Republic has applied the EU legislative framework as described in the EU National Report.
Notifications for placing GMOs on the market are processed at EU level. The EU legislation sets requirements for the information to be contained in notification dossiers. The authorisation procedure involves all EU Member States, as authorised products are granted free movement throughout the EU territory. The final decision is adopted by voting of all Member States.
Applications for intentional introduction of GMO into the environment for other purposes than placing on the market (experimental release, field trials) are submitted and processed at the national level. The authorisations are issued by the Czech Competent Authority. These cases have not involved transboundary movements so far.
Re Q37: It is not quite clear whether this question concerns intentional introduction into the environment generally or only the cases regarding intentional transboundary movements (covered by Q35). The answer of corresponding Q40 in the Czech Republic 2nd national report referred to approvals of field trials, that is intentional introduction into the environment not involving transboundary movements. If the Q37 in this report covers only LMOs subjected to transboundary movements, the answer is none.
Data on experimental releases of GMOs are available in the Czech node of BCH
http://www.mzp.cz/Biosafety/decisiones.html
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
It has to be noted that the import of GMOs intended for direct use for food or feed or for processing, is covered by the directly applicable EU Regulations. Decisions for placing GMOs-FFP on the market in the European Union are taken at the EU level by all the Member States. The authorisations apply for the whole EU territory, the transport within the Union is not considered as import or export. The Czech Republic as a Member State participates in the assessment and decision-making procedures.
All decisions are subsequently published by the European Commission in the European Biosafety Clearing-House (BCH) and not in the individual Member States' BCHs.
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
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
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • Yes
73. If you answered Yes to question 72, how many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
This question is relevant to indicator 1.2.8 of the Strategic Plan
  • One or more
74. If you answered Yes to question 72, has your country informed the Parties through the BCH of the agreements or arrangements?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • Yes, always
75. If you answered Yes to question 72, please provide a brief description of the scope and objective of the agreements or arrangements entered into
The Czech Republic has been a Member State of the European Union since 2004. EU is a regional arrangement with common market rules, including transboundary movements of goods.
76. Here you may provide further details on the implementation of Article 14 in your country
The Czech Republic as a Member State of the European Union implements the EU legislative framework. Transport of goods within the EU is not considered as import or export.
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:
  • 10 or more
b) Management / Control:
  • 10 or more
c) Monitoring:
  • One or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
82. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
83. Are the currently available training materials or technical guidance on risk assessment and/or risk management of LMOs sufficient?
This question is relevant to indicator 2.2.6 of the Strategic Plan
  • No
84. Does your country have the capacity to detect, identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • 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):
  • Commercial production
  • Field trial
  • LMOs for Contained use
  • LMOs for direct use as food
  • LMOs for direct use as feed
  • LMOs for processing
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
  • Yes, always
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
Risk Assessment
The European Union legal framework, based on a prior risk assessment before authorisation for the use of GMOs is given, and is applicable in the Czech Republic. The overarching aim of the environmental risk assessment is, on a case-by-case basis, to identify and evaluate potential adverse effects of the GMO, direct and indirect, immediate or delayed, on human health and the environment. Notifications for the use of GMOs must include a full assessment of the risks to human and animal health and to the environment, which is than reviewed by EU and/or national Authorities and experts.
In case of placing the GMOs on the market, the review of the risk assessment is conducted at the EU level by the European Food Safety Authority (EFSA) and EU Member States. Special procedure is applied in cases when the notification includes commercial cultivation. The Czech Ministry of Agriculture in close cooperation with its advisory body - the Scientific Committee for Genetically Modified Food and Feed - regularly participates in the European authorization procedure for genetically modified crops intended for direct use as food or feed, or for processing, under EU Regulation 1829/2003.
As regards the contained use and intentional introduction into the environment for experimental testing or field trials, the risk assessment is conducted at national level. Environmental risks are dealt with by the Czech Commission for the Use of GMOs and Genetic Products  (expert advisory body to the Ministry of the Environment). Health risks are reviewed by the Ministry of Health.
The risk assessment should be performed in a scientifically-sound and transparent manner, based on up-to-date knowledge. Its results have to be reevaluated if new information on the GMO and its effects is obtained.
For training of experts and for the risk assessment, the Czech Competent Authorities and their advisory bodies use the methodology set by the EU legislation (e.g. Commission Implementing Regulation 503/2013) and EFSA guidelines, as well as manuals and guidance documents developed by the CPB AHTEG on RA/RM.
Re Q83: Technical guidance on specific topics should be further developed, namely as regards organisms resulting from the use of new gene techniques.
Risk Management
The authorisation decisions always set conditions for the use of GMOs, based on the risk assessment results. These conditions include requirements for monitoring - observations of potential effects of GMOs on health and environment. The monitoring is conducted both by the authorisation holder and by the supervision authorities.
The Czech Environmental Inspectorate is the main Competent Authority on state supervision of the use of GMOs (contained use, intentional introduction into environment and unauthorised GMOs). It cooperates with other supervision Authorities responsible for various agendas related to biosafety: Czech Agriculture and Food Inspection Authority in charge of food inspections and control; Central Institute for Supervising and Testing in Agriculture in charge of seeds, phytosanitary regulations, plant protection products and quality of feed; State Veterinary Administration as to animal related supervision; State Institute for Drug Control as medicinal products are concerned;  Customs Administration in charge of export and import supervision.
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
Article 14 of Regulation (EC) 1946/2003 that is directly applicable in the Czech Republic provides for measures to prevent unintentional transboundary movements of GMOs and appropriate responses, including emergency measures.
However, transfer within the European Union is not considered as a transboundary movement according to the relevant EU legislation - Regulation (EC) 1946/2003 states that "transboundary movement" means the intentional or unintentional movement of a GMO between one Party or non-Party and another Party on non-Party, excluding intentional movements between Parties within the Community. The Czech Republic is an inland country, not on the border of EU, so it does not serve as a point of entry into EU for commodities and seeds.
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
  • One or more
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
  • 5 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
  • 5 or more
122. Here you may provide further details on the implementation of Article 18 in your country:
The Czech Republic follows the EU comprehensive legal framework on GMOs, which also addresses the issues of handling, transport, packaging and identification covered by Article 18.
However, transfer within the European Union is not considered as a transboundary movement. The Czech Republic is an inland country, not on the border of EU, so it is not a point of entry into EU for seeds and commodities from third countries. The only GMOs that are imported / exported directly to or from the Czech Republic are GMOs intended for contained use. In these cases, the entry point is the airport.
The Czech Act No 78/2004 Coll., on the Use of GMOs and Genetic Products, sets in Art. 25 the requirements for the import and export of GMOs intended for contained use.
The certified laboratories for the detection of GMOs, serving also for the Competent Authorities, are:
National Reference Laboratory for GMOs Testing and DNA Fingerprinting, Crop Research Institute, Prague
Laboratory of the Centre for Health, Nutrition and Food in Brno, National Institute of Public Health
Laboratory of the Department of Biochemistry and Microbiology, Institute of Chemical Technology, Prague
Laboratory of Central Institute for Supervising and Testing in Agriculture, Brno
Laboratory of State Veterinary Administration, Jihlava
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?
  • Not applicable
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
State administration:
The Competent Authority for the use of GMOs in the Czech Republic is the Ministry of the Environment. The Ministry of the Environment is the Competent Authority for the Cartagena Protocol on Biosafety and for the EU Regulation 1946/2003 as well.
The Ministry of Agriculture of the Czech Republic is the Competent Authority for genetically modified food and feed.
Detailed information including contacts is available in BCH.
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
126. Please provide an overview of the status of the mandatory information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
This question is relevant to indicator 3.1.5 of the Strategic Plan
a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information available and 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 and 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 and 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 and 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 not available
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available and 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?
  • Yes, to some extent
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
  • 10 or more
133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • One or more
134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:
This question is relevant to indicator 4.3.2 of the Strategic Plan
  • National website
  • Meetings of the Czech Commission on the Use of Genetically Modified Organisms and Genetic Products; workshops for decision-makers, experts or general public.
135. Here you may provide further details on the implementation of Article 20 in your country
Question 126: Part of the information is available at the European Union BCH, including harmonised EU legislation (126 c). The Czech node of BCH provides links to this website.
Question 126 i: Only final decisions on contained use and experimental introduction of GMOs into the environment are issued at the national level in the Czech Republic. Final decisions on commercial release are made at the European Union level and are available at the EU BCH.
Questions 126 j: Any information according to Article 14, paragraph 4 published at the European level in the EU BCH would be valid also for the Czech Republic.
Question 126 k, l: Decisions according to the Article 11, paragraph 1 and 4 are taken at the European Union level and are obligatory also for the Czech Republic. All these decisions are made available in the EU BCH.
Questions 126 m: Article 11, paragraph 6 is not relevant for the Czech Republic as it is neither a developing country nor Party with an economy in transition.
Question 128: One person has been appointed both the BCH National Focal Point and Cartagena Protocol National Focal Point in the Czech Republic. This person also works for the Czech competent authority for CPB. Coordination with other authorities involved in biosafety issues has been established.
Question 132: Special workshops were organized for decision-makers at the highest level, for specialists as well as for general public (Ministry of the Environment, Ministry of Agriculture), international and regional events see Capacity-building activities. The Czech Commission for the Use of Genetically Modified Organisms and Genetic Products is an important body for cooperation of specialists and coordination among responsible authorities, it serves for sharing topical information as well and its open meeting once a year aims to inform the public about biosafety activities. Radio broadcasting special programmes are focused on the general public.
Question 133: Numerous publications were prepared and issued within the UNEP/GEF Projects, both in Czech and in English. During the last year, the Ministry of Agriculture re-edited publications distributed during specialized workshops, and Ministry of the Environment prepared topical information for national and international authorities and for the interested public.
Question 134: Besides the national BCH, operated by the Ministry of the Environment,  information on the LMOs intended for direct use as food or feed is available at the website focused on food safety, operated by the Ministry of Agriculture.
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?
  • In some cases only
138. Here you may provide further details on the implementation of Article 21 in your country
The Czech Act 78/2004, paragraph 9, as well as the relevant European legislation, listed in the EU report, define which information can be identified and treated as confidential.
It has to be noted that the confidentiality provisions make clear what information should never be identified as confidential, namely a general description of the GMO, name and address of the notifier, risk assessment and emergency response plans.
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
  • Yes
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?
  • Yes
141. If you answered Yes to question 140, how were these resources made available?
  • Multilateral channels
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
143. If you answered Yes to question 142, how were these resources made available?
  • Regional channels
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?
  • Yes
148. If you answered Yes to question 147, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Scientific biosafety research relating to LMOs
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
  • Yes
150. If you answered Yes to question 149, has this information been submitted to the BCH?
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.
  • Risk assessment and other scientific and technical expertise
  • Public awareness, participation and education in biosafety
  • Identification of LMOs, including their detection
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
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
  • Yes
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?
  • Yes
157. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds
Questions 142-143: Special workshops were held in the Czech Republic for countries demanding support on bilateral basis. Series of regional training workshops were organized in cooperation with FAO and Ministry of Agriculture, with expert support of the Ministry of the Environment. Czech experts assisted in the EU workshops in some EU accession countries.
Questions 144-146: UNEP/GEF Projects contributed greatly to the development of NBF, especially to enhancement of  institutional and authorities cooperation, to capacity-building and public awareness.
Questions 147-154: In spite of a number of experienced specialists in the Czech Republic, the country still has need for its own capacity-building, especially due to recent scientific development in biosafety. The need is monitored for inner purposes and therefore it was not submitted to the BCH. Capacity-building strategy is a part of broader national strategies (such as environmental education) and their action plans.
Question 155: Biotechnology and biosafety issues are included in educational programmes of universities. E.g. Charles University Prague organizes a special course on biotechnology in general and its use in various branches with high participation of students, in spite of its optional character. Agricultural University Prague, Faculty of Natural Sciences - Hradec Kralove University, Pharmaceutical Faculty Brno and South Bohemian University Ceske Budejovice have biotechnology and its safe handling included in their compulsory programmes. Other universities range these issues in their broader curricula.
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
Biosafety strategy forms a part of broader national strategies (e.g. Strategy for Sustainable Development, National Biodiversity Strategy, State Programme on Environmental Education and Public Awareness, Food Safety Strategy, Action Plan on Health and the Environment)
Biosafety focused programmes are developed through:
Czech Commission on the Use of Genetically Modified Organisms and Genetic Products (especially its open meeting for the public once a year), meetings with the public, media, websites of authorities (Ministry of the Environment, Ministry of Agriculture).
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
  • 10 or more
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
  • Public hearings
  • As to field trials, local boards and media.
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
  • 5 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
  • 25 or more
173. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?
  • Yes
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
Biosafety issues are included in broader national strategies and legislation, such as those on environmental education. Awareness programmes are developed in cooperation with educational institutions, nature conservation organizations, centres for environmental education, muzea, some NGOs.
The right to information is based on national legislation, namely the Act 106/1999 on Free Access to Information, ammended in 2006, and the Act 123/1998 on the Right to Environmental Information, ammended through the Act 132/2000 and Act 6/2005. As a Party to the Aarhus Convention and to its Ammendement on Public Participation in Decisions on the Deliberate Release in the Environment and Placing on the Market of Genetically Modified Organisms, the Czech Republic implements the obligations of this Convention.
The public is always consulted during the authorisation process of field trials, by means of the Ministry's website and official boards of relevant regional authorities. In case of objections or negative comments made by the public, a public hearing must be organised by the Ministry of the Environment.
Public consultations regarding the notifications for placing LMOs on the market are organised at the EU level.
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?
  • No
183. Here you may provide further details on the implementation of Article 24 in your country:
Act 78/2004 Coll., which is in line with the EU legislation on GMOs, applies to all imports / exports of LMOs, whether these originate from parties or non-parties to the Protocol. The LMOs imported from non-party were intended for contained use.
Article 25 – Illegal transboundary movements
184. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
186. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
If you replied Never to question 186 please go to question 191
  • Never
191. Here you may provide further details on the implementation of Article 25 in your country
It has to be noted that transfer within the European Union is not considered as a transboundary movement according to the relevant EU legislation - Regulation (EC) 1946/2003 states that "transboundary movement" means the intentional or unintentional movement of a GMO between one Party or non-Party and another Party on non-Party, excluding intentional movements between Parties within the Community. The Czech Republic is an inland country, not on the border of EU, so it does not serve as a point of entry into EU for commodities and seeds.
No illegal transboundary movements have been recorded during the current reporting period. Besides general surveillance, the Czech Environmental Inspectorate has monitored for possible occurrence of LMOs that have been detected in other countries, e.g. GM ornamental fish.
Article 26 – Socio-economic considerations
192. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
This question is relevant to indicator 1.7.2 of the Strategic Plan
  • No
193. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Not applicable
194. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
This question is relevant to indicator 1.7.1 of the Strategic Plan
  • 5 or more
195. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making? Please give details:
This question is relevant to indicator 1.7.3 of the Strategic Plan
Socio-economic considerations are relevant at national level as regards the co-existence between conventional, organic and GM crops. The Czech Republic adopted its rules for co-existence in 2006 by the amendment of the Act 252/1997 on Agriculture. The details are set by the implementing Decree  89/2006, on detailed conditions for growing of genetically modified variety, as amended by Decree 58/2010.
The Czech Republic participated in discussions and information exchange on socio-economic issues at the European Union level.
196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to some extent
197. Here you may provide further details on the implementation of Article 26 in your country
The Czech Republic as a Member State of the European Union follows EU guidelines and recommendations related to GM crops cultivation and possible impacts of this activity on various areas, including socio-economic aspects. Based on the 2010 European Commission Recommendations on guidelines for the development of national strategies and best practices to ensure the co-existence of genetically modified crops with conventional and organic farming, the Czech Republic has developed its national legislation on co-existence measures for GM maize, soybean and potato. Already from the first GM crop cultivation in 2005 (Bt-maize MON810), the co-existence rules have been applied. Since 2006 the general co-existence rules for GM crops cultivation became part of the Czech Act 252/1997, on Agriculture, as amended. For selected crops (potato, maize, soybean) details are further specified by Decree 89/2006, on Detailed Conditions for GM Crop Cultivation, as amended.
In spite of the fact that there is ten years experience with GM maize cultivation in the Czech Republic, data on socio-economic implications of GMO cultivation are rather scarce to become statistically significant and assessable. It is due to a low cultivation area of Bt-maize, which did not exceed 9 000 hectares even in the best year 2008. Since 2010 the cultivation area of MON 810 has gradually decreased, falling to less than 1 000 ha in 2015. 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. The situation with GM crops cultivation may get even worse following the recent Directive 2015/412, which gives the possibility to the Member States to restrict or prohibit the cultivation of GMOs in their territory. Under this new Directive, Member States may adopt opt-out decisions on GMO cultivation based on compelling grounds distinct from the environmental risk assessment undertaken in the context of the authorisation procedure at EU level.
On the other hand the European Commission in 2013 established a technical working group named the "European GMO Socio-Economics Bureau - ESEB" 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. This team is composed of experts from the Member States (the Czech Republic did nominate its own bureau member but Czech experts take part in the working groups activities) and the Commission. The ESEB has compiled topics, indicators, methodological guidelines and potential data sources to carry out analyses of socio-economic effects in the Member States and across the EU. Thus, detailed guidelines to perform analyses of socio-economic effects of relevant crops will be useful soon also for the Czech Republic.
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 Czech Republic ratified the Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress to the CPB in February 2012.
The Czech Republic as a member of the EU has already relevant legislation in place:
At the EU level:
Directive 2004/35/EC of the European Parliament and of the Council on environmental liability with regard to the prevention and remedying of environmental damage
At the national level:
Act 167/2008, on prevention of ecological damage and its remedies and on amendments of some acts, that transposes the Directive 2004/35/EC into the domestic legislation
Regulation of the Government 295/2011 on the way of risk assessment of environmental damage and detailed conditions of financial security - provides further details on financial aspects in relation to environmental liability
Act 89/2012, Civil Code
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
  • 5,000 USD or more
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
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 Member States are concerned, there are two levels of implementation of the Protocol, the EU level and national level.
Therefore this national report refers to the EU report where relevant.
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
Some questions concern different reporting periods: At the very beginning of this report, it is written that the reporting period is 2011 - 2015. In spite of that, Q132 requires data for two last years and Q133 for the last year.