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Third National Report on the implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
109038
Status
Published
Date of creation
2015-10-16 10:07 UTC (tsultanova@moew.government.bg)
Date of publication
2015-10-16 10:07 UTC (tsultanova@moew.government.bg)

Origin of report
1. Country
  • Bulgaria
Contact officer for report
Coordinates
Mrs Tatyana Sultanova
State Expert
Ministry of Environment and Water
22 Maria Louiza Blvd
Sofia
Bulgaria, 1000
Phone:+359 2 9406123
Fax:+359 2 9406127
Email:tsultanova@moew.government.bg
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Ministry of Agriculture and Food
Ministry of Health
Bulgarian Food Safety Agency
Bulgarian Drug Agency
National Customs Agency
Submission
10. Date of submission
2015-10-16
11. Time period covered by this report
Start date
2011-10-01
11. Time period covered by this report
End date
2015-09-30
Party to the Cartagena Protocol on Biosafety
Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
14. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
This question is relevant to indicators 1.1.1, 2.1.1, 2.1.2, and 3.1.2 of the Strategic Plan
  • A domestic regulatory framework is fully in place
15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?
This question is relevant to the indicator 1.1.1 of the Strategic Plan
  • 2005
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?
  • More than 10
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country
As a member state of European Union, Bulgaria applies the relevant EU legislation. EU legal acts concerning Genetically Modified Organisms (GMO)/ Living Modified Organisms (LMO) include:
- Directive 2009/41/EC on the contained use of genetically modified micro-organisms;
- Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms;
- Directive 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms in their territory;
- Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms;
- Regulation (EC) No 1829/2003 on genetically modified food and feed;
- Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms;
- Commission Regulation (EC) No 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation;
- Commission Regulation (EC) No 1981/2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms;
- Commission Regulation 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired;
- Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006.
European Regulations are directly applicable at national level.
Directives 2001/18/EC and 2009/41/EC are transposed in national legislation by Bulgarian Law on GMO, Bulgarian Regulation on the contained use of GMOs and Regulation on the deliberate release and placing on the market of GMOs.
LMOs intended for direct use as food or for processing are regulated by Bulgarian Food Law and those for feed by the Bulgarian Feed Law on Feeds.
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?
  • Partially
24. Here you may provide further details on the implementation of Article 5 in your country:
The medical products for human use, which consist of or contain GMO or are produced from GMOs, are regulated by the Bulgarian Law on Medicinal Products in Human Medicine.
The medicinal products for veterinary use are regulated by the Bulgarian Law on Veterinary Practices.
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?
  • Partially
28. Here you may provide further details on the implementation of Article 6 in your country:
- Contained use:
Directive 2009/41/EC on the contained use of genetically modified microorganisms is implemented in the Law on GMO and Regulation on the contained use of GMOs.
- Transit:
Regulation (EC) 1946/2003 addresses transboundary movement of GMO and in particular the 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 GMO through their territory and BCH has to be informed.
Procedures for transit of GMO are stipulated in Bulgarian national legislation. Under the provisions of Article 99 of the Law on GMO, the operator which intends to transit GMO through the territory of Bulgaria is required to submit written notification to the Ministry of Environment and Water, containing mandatory information. Minister of Environment and Water issues written certificate to the notifier at the latest three days before the transit. In addition, the Ministry of Environment and Water notifies the Customs Agency and the Ministry of Agriculture and Food for each issued certificate for transit of GMO.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol OR a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
This question is relevant to indicators 1.1.2 and 3.1.4 of the Strategic Plan
  • Yes
30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
31. If you answered Yes to question 30, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
32. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
33. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
34. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.4 of the Strategic Plan
  • No
35. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
This question is relevant to indicator 1.1.5 of the Strategic Plan
  • No
38. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
39. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
46. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment
Bulgaria has not been a Party of import during the reporting period. However, as a member state of the European Union, Bulgaria is part of the EU Single Market. Decisions for placing GMOs on the market are taken at EU level. Bulgaria has been participating since 1st January 2007 (the date of full membership in the EU), in the authorisation procedure. The procedure requires full evaluation of the risks for human health and environment. Those risk assessments are prepared by the notifiers and reviewed by all member states.
An operator who wishes to introduce GMOs into the environment for experimental purposes must first obtain written authorisation from the Bulgarian competent authority (Bulgarian Ministry of Environment and Water). The authorisation is given on the basis of a risk assessment of that GMO for the environment and human health.
According to Bulgarian Law on GMO risk assessments should be carried out in scientifically sound and transparent manner, based on the available scientific and technical data. Required information may vary depending on the type of GMO concerned, intended use and potential receiving environment, taking into account, inter alia, GMOs already released into the environment.
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)?
  • No
Article 12 – Review of decision
59. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
60. Has your country ever received a request for a review of a decision?
  • No
61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
66. Here you may provide further details on the implementation of Article 12 in your country
Bulgaria has not taken any decisions during the reporting period.
Article 13 – Simplified procedure
67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
68. Has your country ever applied the simplified procedure?
  • No
70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
71. Here you may provide further details on the implementation of Article 13 in your country
Bulgaria has made no use of the simplified procedure for import of LMOs as specified in Article 13.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • 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
  • No
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
Bulgaria is member state of European Union. Bulgarian public bodies, analytical laboratories and academic institutions participate in the activities related to LMO on EU level, for example EFSA, EU Committees and Working Parties, European Network of GMO laboratories (ENGL), etc.
Bulgaria has been Party to the Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (Aarhus Convention) since 2003 and has ratified on 6th March 2007 the amendment on GMO, adopted by the Meeting of the Parties to the Convention through decision II/1, taken at its second session (Almaty, 25-27 May 2005).
76. Here you may provide further details on the implementation of Article 14 in your country
In addition to the activities described above, Bulgarian representatives have participated in capacity building activities organised by CBD Secretariat.
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:
  • 10 or more
80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • Yes
81. Is your country using the "Manual on Risk Assessment of LMOs" (developed by CBD Secretariat) for training in risk assessment?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • 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
  • Yes
84. Does your country have the capacity to detect, identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
This question is relevant to indicators 1.4.2 and 1.6.3 of the Strategic Plan
a) Detect:
  • Yes
b) Identify:
  • Yes
c) Assess:
  • Yes
d) Monitor:
  • Yes
85. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicators 1.3.1 of the Strategic Plan
a) Risk assessment:
  • Yes
b) Risk management:
  • Yes
86. Is your country using the "Guidance on Risk Assessment of LMOs" (developed by the Online Forum and the AHTEG on Risk Assessment and Risk Management) for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
This question is relevant to indicator 2.2.5 of the Strategic Plan
  • No
87. Has your country adopted any common approaches to risk assessment with other countries?
This question is relevant to indicator 1.3.2 of the Strategic Plan
  • Yes
88. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
This question is relevant to indicator 1.4.1 of the Strategic Plan
  • Yes
89. Has your country ever conducted a risk assessment of an LMO including any type of risk assessment of LMOs, e.g. for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
This question is relevant to indicator 1.3.3 of the Strategic Plan
  • Yes
90. If you answered Yes to question 89, please indicate the scope of the risk assessments (select all that apply):
  • Field trial
  • LMOs for Contained use
91. If you answered Yes to question 89, were the summary reports of the risk assessments submitted to the BCH?
This question is relevant to indicator 3.1.5 of the Strategic Plan
  • No
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?
  • 10 or less
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
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
As a member state of the European Union, Bulgaria applies the EU legislative framework related to Risk Assessment and Risk Management of LMO.
All risk assessments performed during the current reporting period related to contained use of LMO concerned registration of laboratory facilities. One risk assessment related to intentional introduction of LMO into the environment was for clinical trial of medicinal product for human use.
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, which is directly applicable at national level, provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.
Article 18 – Handling, transport, packaging and identification
106. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
107. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
108. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
This question is relevant to indicator 1.6.1 of the Strategic Plan
  • Yes
109. If you answered Yes or Yes, to some extent to question(s) 107 and/or 108, what type of documentation does your country require for the identification of LMOs-FFP?
  • Existing types of documentation
110. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
111. If you answered Yes or Yes, to some extent to question 110, what type of documentation does your country require for the identification of LMOs that are destined for contained?
  • Existing types of documentation
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
This question is relevant to indicator 1.6.2 of the Strategic Plan
  • Yes
113. If you answered Yes or Yes, to some extent to question 112, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
  • Existing types of documentation
114. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
This question is relevant to indicator 1.6.4 of the Strategic Plan
  • 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
  • One or more
121. How many of the certified laboratories in the previous question are currently operating in the detection of LMOs?
This question is relevant to indicator 2.3.4 of the Strategic Plan
  • One or more
122. Here you may provide further details on the implementation of Article 18 in your country:
Bulgaria applies the comprehensive EU legal framework on GMOs, which also addresses the issues of handling, transport, packaging and identification requirements covered by Article 18.
Article 19 – Competent National Authorities and National Focal Points
123. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
124. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
125. Here you may provide further details on the implementation of Article 19 in your country
Bulgaria has designated competent authorities and national focal points for the Cartagena Protocol and Biosafety Clearing-House. The information is available through 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 not available
d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information 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 not available
j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information not available
l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information not available
m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information not available
n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information not available
127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
128. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
129. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, always
130. Has your country experienced difficulties accessing or using the BCH?
This question is relevant to indicator 4.1.8 of the Strategic Plan
  • No
131. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
132. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years:
This question is relevant to indicator 4.3.1 of the Strategic Plan
  • 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
  • 50 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
  • Publications are usually accessed directly through the websites of their primary source (journal, institutional, etc).
Article 21 – Confidential information
136. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
137. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
138. Here you may provide further details on the implementation of Article 21 in your country
Part Six of Bulgarian Law on GMO stipulates that applicants may indicate which information submitted under the Law should be treated as confidential. Under Article 105 the following information is always available to the public: general description of the GMO, the name and address of the authorisation holders, the risk assessment information, plans for emergency responses, etc.
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, to some extent
Here you may provide further details
Bulgarian representatives took part in different capacity building activities organised by EU and by CBD Secretariat.
141. If you answered Yes to question 140, how were these resources made available?
  • Regional channels
142. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
145. If you answered Yes to question 144, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 157.
  • Average
146. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Implementation of national biosafety frameworks
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
  • Identification of LMOs, including their detection
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Taking into account risks to human health
149. During the current reporting period, has your country carried out a capacity-building needs assessment?
This question is relevant to indicator 1.2.1 of the Strategic Plan
  • No
151. Does your country still have capacity-building needs?
This question is relevant to indicator 1.2.7 of the Strategic Plan
  • Yes, a few
152. If you answered Yes to question 151, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Public awareness, participation and education in biosafety
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Taking into account risks to human health
153. Has your country developed a capacity-building strategy or action plan?
This question is relevant to indicator 1.2.2 of the Strategic Plan
  • No
154. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
This question is relevant to indicator 1.2.4 of the Strategic Plan
  • No
155. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
This question is relevant to indicator 1.2.3 of the Strategic Plan
  • 1 per year or more
156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
157. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds
Two Projects- GEF-UNEP "Implementation of National Biosafety Frameworks Project" (02.2002-02.2006) and PHARE Project BG04/IB/EN/02 -"Transposition and Implementation of the Environmental Acquis on Genetically Modified Organisms at national Level"(10.2005-7.2007) were reported by Bulgaria in First National Report under Cartagena Protocol.
To Q 147: Two additional positions for biosafety experts were established in the Ministry of Environment and Water (MoEW).
Seminars and training were organised for the staff of the regional directorates of the MoEW responsible for control of GMO.
The biosafety experts from MoEW underwent additional training on laboratory biosafety.
To Q 155: One course organized by the head of the National reference laboratory dedicated to GMO biosafety takes place annually. In addition, biosafety-related topics are part of curriculum of several university courses for graduate and undergraduate students.
Article 23 – Public awareness and participation
158. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
159. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
This question is relevant to indicator 5.3.2 of the Strategic Plan
  • No
160. Does your country have any awareness and outreach programmes on biosafety?
This question is relevant to indicator 5.3.1 of the Strategic Plan
  • No
161. If you answered Yes to question 160, please indicate what entity is responsible for carrying out the programmes and/or services and at which level the programmes take place (e.g. local, national, etc.):
This question is relevant to indicator 5.3.1 of the Strategic Plan
Not applicable
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
  • 5 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
  • Newspaper
  • Mailing lists
  • Public hearings
169. If you indicated more than one modality for public participation in question 168, which one was most used?
This question is relevant to indicator 2.5.2 of the Strategic Plan
  • 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
  • 10 or more
173. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • 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?
  • Less than 5
176. Here you may provide further details on the implementation of Article 23 in your country
Consulting the public in the decision-making process regarding LMOs is foreseen in the Bulgarian Law on GMO, e.g. public hearings before taking decision for the release into the environment or placing at the market of GMOs (see below for details). Referring to Q175, such procedures have not been carried, as no application for such activities have been received.
The procedures for public participation regarding release of GMOs into the environment and placing on the market of GMOs are similar. For the first procedure the Ministry of Environment and Water (MoEW) is the competent authority and for the second - the Ministry of Agriculture and Food (MAF).
Within 45 days after the Advisory Commission on GMOs delivers an opinion on an application for release of a GMO into the environment, the MoEW organizes public consultation/hearing. During the public hearing, a summary of the application dossier and the risk assessment and Commission's opinion are presented. Not later than 30 days prior to the hearing, the subject, date and venue of public consultation as well as the place where the necessary information is available to stakeholders are announced on the Internet site of MoEW, in one national daily newspaper, through the local media and by posting notices in the mayoralties in the area where the release is to take place. When considering placing on the market of GMOs, the MAF makes available to the public a summary of application dossier and the risk assessment report. The hearing is held within 30 days. The MAF summarizes the remarks and comments made during the consultation and sends them to the European Commission. That procedure is carried out only when the assessment report states that the GMO may be placed on the market.
The website of the MoEW maintains public registers of: issued permits for release of GMOs into the environment; location and size of the areas authorized for the release of GMOs. The website of the MAF maintains public registers of: issued permits for placing GMOs on the market; the information on the genetic modification for the purpose of facilitating the post-marketing control and inspection of GMOs as or in products.
To Q 163: Bulgaria cooperates with other countries within the framework of EU.
To Q 171: Refer to Q 157. In addition, institutions with permit for contained use of GMO should provide the necessary biosafety training of the personal.
To Q 172: Training materials from EFSA, JRC, BCH, etc. are available on-line to the interested parties.
Article 24 – Non-Parties
177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
178. Has your country ever imported LMOs from a non-Party?
  • No
179. Has your country ever exported LMOs to a non-Party?
  • No
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
Penalties for infringement of Regulation (EC) 1946/2003 are stipulated in the Bulgarian Law on GMO.
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
  • Yes
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
  • 10 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
At present, due to restrictions on field trials and commercial cultivation of LMOs Bulgaria has very limited experience in decision making related to those areas.
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
Discussions related to socio-economic considerations are ongoing at the national and EU level including information exchange with European Commission and other EU member states.
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
  • Yes
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
To Q 200: One staff member from Bulgarian Ministry of Environment and Water has participated in inter-regional workshop on capacity building needs for the implementation of the Nagoya - Kuala Lumpur Supplementary Protocol on liability and redress in Riga, Latvia, 9 - 11 May 2012.
To Q 201: Bulgarian Law on GMO and Law on Liability for Prevention and Remedying Environmental Damage.
Article 28 – Financial Mechanism and Resources
203. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
This question is relevant to indicator 1.2.5 of the Strategic Plan
  • Not applicable
Article 33 – Monitoring and reporting
204. Does your country have in place a monitoring and/or an enforcement system for the implementation of the Cartagena Protocol?
This question is relevant to indicator 3.1.6 of the Strategic Plan
a) Monitoring system:
  • Yes
b) Enforcement system:
  • Yes
205. Has your country submitted all the previous due National Reports?
  • Yes
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.
To Q 203: Currently no additional funding is provided by GEF, EU funds, or other funds or private donors. The expenses for analytical laboratories, training the personal and control activities are provided from the national budget.
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
No further comments.