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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102489
Status
Published
Date of creation
2011-10-07 20:19 UTC (andrew.bowers@cbd.int)
Date of last update
2011-11-09 19:46 UTC (andrew.bowers@cbd.int)
Date of publication
2011-11-09 19:46 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • Bulgaria
Contact officer for report
Coordinates
Tatiana Sultanova
Head of Unit
Ministry of Environment and Water
22 Maria Louiza blvd.
Sofia
Bulgaria, 1000
Phone:+359 2 940 61 23
Fax:+359 2 940 61 27
Email:tsultanova@moew.government.bg
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
MoEW
Submission
10. Date of submission
2011-09-29
11. Time period covered by this report
Start date
2007-09
Time period covered by this report
End date
2011-09
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • 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:
As a Member State (MS) of European Union (EU), Bulgaria applies the European legislation. The main European legal measures include:

- Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms

- Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, covering the field testing of GMOs (mainly Part B) and the placing on the market of GMOs as well as products containing or consisting of GMOs, e.g. for cultivation, import or processing into industrial products (mainly Part C). The Annex to this report lists further implementing measures relating to Part B and Part C of Directive 2001/18/EC.

- Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms covers exports of GMOs to third countries and unintentional movements of GMOs.

- Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, covering the placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs.

- Regulation (EC) No 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.

- Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 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.

Directives 2001/18/EC and 2009/41/EC are transponed in national legislation by Bulgarian Genetically Modified Organisms Act, , which entered into effect since 01.06.2005.

The European Regulations are directly applicable at national level.
Bulgarian Genetically Modified Organisms Act has as its objective to protect human health and the environment when carrying out the above mentioned activities in accordance with the precautionary principle, which means priority protection of human health and the environment if any potential harmful effects are likely to be realized, regardless of the existing economic interests or the unavailability of sufficient scientific data.

Complementary, two national regulations are in force since October, 2005:
Regulation on the contained use of GMOs and Regulation on the deliberate release and placing on the market of GMOs.

The development, handling, transport, transfer and release of LMOs, intended for direct use as food or for processing is covered by the Bulgarian Law of Foodstuffs, which enetered into effect since 01.01.2005.
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 contained use, the release into environment, the placing on the market, the import, export and transit of medical products for human use, wich consist of or contain a GMO or are produced from GMOs, are regulated by the Bulgarian Medicinal Products in Human Medicine Act.

Products for veterinary use, wich consist of or contain a GMO or a combination of GMOs, are regulated by the Bulgarian Veterinary Practices Act.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
- Contained use:

Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms

- Transit:

 Regulation 1946/2003 addresses transboundary movement of GMOs, and specifically requirements for exports of GMOs to third countries as well as for unintentional transboundary movements. According to Article 13 of the Regulation 1946/2003, the exporter shall ensure notification of the transit of GMOs through their territory and have informed the BCH of this decision.

 Transit procedures through the EU are regulated by the EU transport legislation and the Customs Code.

Directive 2009/41/EC are transponed in national legislation by Bulgarian Genetically Modified Organisms Act and Regulation on the contained use of GMOs, which are entered into effect since 2005.

Regulation 1946/2003 is directly applicable at national level.
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Not applicable
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • Not applicable
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • Not applicable
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
50. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment:
Bulgaria has not been a Party of import during the reported period. However, as a Member State (MS) of the EU, Bulgaria is a part of the common Community market, decisions for placing GMOs on which are taken on the EU level. In that relation Bulgaria participated, since January 1st, 2007 (the date of full membership in the EU), in the EU authorisation procedure. According to the said procedure (Directive 2001/18/EC, Regulation 1829/2003/EC) each decision taken requires full evaluation of the risk for the human health and the environment. This risk assessment is prepared by the notifier and reviewed by all the MS.

A person or a company who wishes to introduce GMOs into the environment for experimental purposes must first obtain written authorisation from the Bulgarian compentent national authority whithin whose territory the experimental release is to take place. Hence, the authorisation procedure is simpler than the one referred above. The authorisation is given on the basis of an assessment of the risks presented by the GMO -or GMOs- for the environment and human health.

According to Bulgarian GMO Act the risk assessment should be carried out in a scientifically sound and transparent manner, based on available scientific and technical data and the required information may vary depending on the type of the GMOs concerned, the intended use thereof and the potential receiving environment, taking into account, inter alia, GMOs already released into the environment.

According to the EU legislation, which Bulgaria complies with, a monitoring plan is required (Council Decision 2002/811/EC). 
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • Yes
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • Yes
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • No
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, covering the placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs.

- Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 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.

Regulations 1829/2003 and 641/2004 are directly applicable at national level.

At national level the placing on the market, the import, export and transit of GMOs, intended for use in or as feed, genetically modified feed, feed containing ingredients prodused from GMOs, are regulated by the Bulgarian Feedingstuffs Act and Veterinary Practices Act.

At national level the placing on the market, the import, export and transit of GMOs, intended for use in or as food, genetically modified food, food containing ingredients prodused from GMOs, are regulated by the Bulgarian Foodstuffs Act.    
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
71. Here you may provide further details on the implementation of Article 12 in your country:
Bulgaria has no decisions taken during the reporting period. 
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
73. Has your country ever applied the simplified procedure?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
76. Here you may provide further details on the implementation of Article 13 in your country:
Bulgaria has not made use of the implified procedure for imports of LMOs as specified in Article 13.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • No
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • No
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Not applicable
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • Yes, always
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • None
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • Not applicable
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Not applicable
93. Here you may provide further details on the implementation of Article 15 in your country:
According to Bulgarian GMO Act the risk assessment should be carried out in a scientifically sound and transparent manner, based on available scientific and technical data and the required information may vary depending on the type of the GMOs concerned, the intended use thereof and the potential receiving environment, taking into account, inter alia, GMOs already released into the environment.

In accordance with the precautionary principle, environmental risk assessments must be based on the following principles:

 GMO characteristics and GMO use that have the potential to cause adverse effects are to be compared to characteristics and use of the non-modified organism from which the GMO is derived;

 Risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data;

 Risk assessment should be carried out on a case by case basis;

 New information on the GMO and its effects may need to be readdressed in order to determine whether the risk has changed and whether there is a need for amending the risk management accordingly.

 Identification of characteristics which may cause adverse effects. These characteristics will vary from case to case and may include direct effects on human health or the environment as well as indirect effects occurring through a causal chain of events, through interactions with other organisms, transfer of genetic material or changes in use or management. As observations of indirect effects are likely to be delayed, immediate effects during the period of the release of the GMO as well as delayed effects that become apparent at a later stage or after termination of the release need to be considered.

 Evaluation of the potential consequences of each adverse effect, if it occurs.

 Evaluation of the likelihood of the occurrence of each identified potential adverse effect.

 Estimation of the risk posed by each identified characteristic of the GMO.

 Application of management strategies for risks from the deliberate release or marketing of GMOs.

 Determination of the overall risk of the GMO

According to the EU legislation, which Bulgaria complies with, a monitoring plan is required.

The design of the monitoring plan should, among others:

 Be detailed on a case by case basis;

 Take into account the characteristics of the GMO, its use and scale of use, and the range of relevant environmental conditions;

 Incorporate general surveillance for unanticipated adverse effects;

 Provide for case-specific monitoring for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed and indirect effects which have been identified in risk assessment.;

 Provide for the use of already established routine surveillance practices where appropriate

Bulgaria has no decisions taken during the  reporting period.   
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
According to the EU legislation, which Bulgaria complies with, a monitoring plan is required (Council Decision 2002/811/EC).

The measures are adopted on the EU level (Regulation 1946/2003/EC) and at national level a contact point for receiving information for such movements is determined and made available to the BCH.

According to Bulgarian GMO Act the risk assessment should be carried out in a scientifically sound and transparent manner, based on available scientific and technical data and the required information may vary depending on the type of the GMOs concerned, the intended use thereof and the potential receiving environment, taking into account, inter alia, GMOs already released into the environment.   
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • No
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
107. Here you may provide further details on the implementation of Article 17 in your country:
Article 14 of Regulation 1946/2003, wich 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
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • Yes
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • Yes
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
115. Here you may provide further details on the implementation of Article 18 in your country:
The measures are adopted on the EU level.

The EU has developed a comprehensive legal framework on GMOs, which also addresses the issues of handling, transport, packaging and identification requirement covered by Article 18. Of the recently adopted legal acts, the following are of direct relevance to the implementation of Article 18:

 Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms;

 Regulation (EC) 1829/2003 of 22 September 2003 on genetically modified food and feed; and

 Regulation (EC) 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.

The three Regulations entered into force in 2003. The latter two have been applicable since mid-April 2004. Two implementing Regulations in this area also took effect in April 2004:

 Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003; and

 Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms.    

The European Regulations are directly applicable at national level.
The development, handling, transport, transfer and release of LMOs, except food, food ingredients and pharmaceuticals for human and veterinary use which contain or consist of LMOs or combination of LMOs, are covered by the Bulgarian GMO Act, which entered into effect since 01.06.2005.

The development, handling, transport, transfer and release of LMOs, intended for direct use as food or for processing is covered by the Bulgarian Law of Foodstuffs, which enetered into effect since 01.01.2005.

According to the provisions of the Bulgarian GMO Act each exporter must enclose to the risk assessment the proposed methods for safe handling, storage, transport and use, including packaging, labeling, record keeping, destruction and emergency procedures. By the virtue of the same law measures are taken to assure the presence of the documentation cited in the above questions i.e.:

 the documentation accompanying LMOs that are destined for contained use clearly identifies them as LMOs and specifies any requirements for safe handling, storage, transport and use; contact point; name and address of the person to whom the LMOs are consigned in the importing country and the unique identifier(s) of the LMO(s);

 the documentation accompanying LMOs that are intended for intentional introduction into the environment, clearly identifies them as LMOs and  includes:

o the unique identifier(s) , if such has been assigned to the relevant LMO(s);

o the identity and relevant traits and characteristics of the GMOs;

o any requirements for the safe use, storage and transport of these GMOs;
o the name, address and telephone number of a contact point for further information and, as appropriate, the name, address and telephone number of the person whereto the GMOs are consigned;

o a declaration that the export is in conformity with the requirements of the Protocol.

LMOs for direct use as food or feed, or for processing are into the scope of the Bulgarian Law on Foodstuffs, and the documentation accompanying them is especially stipulated by the Ordinance for the requirements for the labeling and the presenting of the foods. According the latter in the documents accompanying LMOs-FFP is used:

o the wording "LMO" or " Produced from LM [ name of the ingredient]" next to the concrete ingredient in the list of the ingredients

o the wording " consists of LM [name of the organism]" or " consists of [name of the ingredient], produced from LM [ name of the organism]"

o the wording "LMO" or "produced from LM [name of the organism]" is clearly stated at the label when there is no ingredient list.
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, more than one
119. In case your country designated more than one competent national authority, has your country conveyed to the Secretariat the respective responsibilities of those authorities?
  • Yes
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
121. In case your country has designated more than one competent national authority, has your country established a mechanism for the coordination of their actions prior to taking decisions regarding LMOs?
  • Yes
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
123. Here you may provide further details on the implementation of Article 19 in your country:
Bulgaria has designated national focal points for the Cartagena Protocol and Biosafety Clearing-House and competent authorities. The information is available through BCH.
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information not available
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information not available
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information not available
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information not available
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information not available
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information not available
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information not available
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, always
128. Has your country experienced difficulties accessing or using the BCH?
  • No
130. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
131. Here you may provide further details on the implementation of Article 20 in your country:
Due to lack of decisions taken during reporting period, the same information is not available through BCH.
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
134. Here you may provide further details on the implementation of Article 21 in your country:
Part Six of Bulgarian Genetically modified organisms Act allows applicants to indicate wich information submitted under the Act they wish to be treated as confedential and also what information shall never be considered as confedential. The following information shall never be treated as cofedential: general description of the GMO, the name and address of the authorisation holders, the risk assessement information and any methods rand plans for emergency responses (article 105).
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • No
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • 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
  • Scientific biosafety research relating to LMOs
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • No
146. Does your country still have capacity-building needs?
  • Yes
147. If you answered Yes to question 146, indicate which of the following areas still need capacity-building.
  • Institutional capacity
  • Human resources capacity development and training
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • Yes
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
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 Natonal Report under Cartagena Protocol.
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • Yes
160. 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 GMO Act - e.g. public hearings before taking decision for the release into the environment or placing at the market of GMOs. In order to inform the public before the hearings the information about the certain case is accessible via Internet.

The Bulgarian Biodiversity Portal is a part of the global information exchange network established by the Convention on Biodiversity (Clearing House Mechanism - CHM). Its purpose is to offer directly or provide links to the information on biodiversity. From this portal is publicly accessible the Biosafety Clearing House.    
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • No
163. Has your country ever exported LMOs to a non-Party?
  • No
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
175. Here you may provide further details on the implementation of Article 25 in your country:
Penalty measures in cases of infrigement of Regulation 1946/2003/ES are forseen in the Bulgarian Genetically modified organisms Act.
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Not applicable
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to a limited extent
178. Here you may provide further details on the implementation of Article 26 in your country:
Although Bulgaria has not been a Party of import during the reported period, the provisions of the Bulgarian GMO Act stipulate that socio-economic impact (s) must be taken into account before each placing on the market/import of LMOs.
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
Bulgaria has signed the Supplementary Protocol and has undertaken steps and procedures towards a prompt ratification of this Protocol.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
183. If your country did not submit previous reports, indicate the main challenges that hindered the submission
  • Not applicable
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.
Re: Q. 14 - Entry into force 23, September 2003

Re: Q. 130 - Yes and No
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 
Survey on indicators of the Strategic Plan (2014)
In decision BS-VI/15, Parties requested the Executive Secretary to conduct a dedicated survey to gather information corresponding to indicators in the Strategic Plan that could not be obtained from the second national reports or through other existing mechanisms.

The answers to the survey are displayed below.
When did your national biosafety framework become operational?
indicator 1.1.1
  • 2005
Here you may provide further details
Currently no additional funding is provided by GEF, EU funds, other funds or private donors. The expenses for analytical laboratories, training of the personal and control activities are provided from the national budget.
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 1 per year or more
Here you may provide further details
One course specifically dedicated to GMO biosafety takes place each year organized by the head of the National Reference laboratory. In addition biosafety issues are in part of curriculum of some of courses read at universities for graduate and undergraduate students.
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • No
Here you may provide further details
There is no dedicated national coordination mechanism for biosafety capacity-building initiatives, but there is coordination between public administration bodies and national Consultative Commission on GMO regarding requirements for training the personal working with GMO.
Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
indicator 1.2.5
  • No funds mobilized
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • Yes
Here you may provide further details
The expenses for analytical laboratories, training of the personal, control activities and other activities related to implementation of the protocol are provided from the national budget. Funds are allocated depending on the projected expenses and the fiscal situation.
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • One or more
Here you may provide further details
Bulgarian public bodies, analytical laboratories and academic institutions participate in the activities related to LMO on EU level, for example those of EFSA, European Union Committees and Working Parties, European Network of GMO Laboratories (ENGL), etc.
Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?
indicator 1.3.1.1
Survey 9.a) Risk assessment
  • Yes
Survey 9.b) Risk management
  • Yes
Here you may provide further details
National legislation adopts the requirements of EU Directive 2001/18/EC and other relevant acts in the area of risk assessment and management. In case of necessity the relevant guidance documents are used.
Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?
indicator 1.3.1.2
  • No
Here you may provide further details
See comment on question 9
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • Yes
Here you may provide further details
See comment on question 9
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • No
Here you may provide further details
Currently activity of Bulgarian authority related to risk assessment is in the area of contained used of GMO and medicinal products containing GMOs (clinical trials, etc.).
Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
indicator 1.4.2
Survey 13.a) Identify
  • Yes
Survey 13.b) Assess
  • Yes
Survey 13.c) Monitor
  • Yes
Here you may provide further details
Bulgaria has the necessary administrative and laboratory framework for identification, assessment and monitoring of LMOs.
Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
indicator 1.6.4
  • Yes
Here you may provide further details
The legislative framework includes the relevant EU Regulations, Bulgarian Food Law and specific guidance issued in the area.
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • Yes
Here you may provide further details
Bulgarian GMO Law includes provisions for public participation and economic analysis in the process of LMO decision making.
Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
indicator 1.7.1
  • 10 or more
Here you may provide further details
Currently, due to restrictions in field trials and commercial cultivation of LMOs Bulgaria has very limited experience in LMO decision making related to those fields. National authorities follow the developments in the area of socio-economic considerations, including those published as peer-reviewed materials.
Survey 17. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making?
indicator 1.7.3
Currently, due to restrictions in field trials and commercial cultivation of LMOs Bulgaria has very limited experience in LMO decision making related to those fields.
Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
indicator 1.8.3
  • Yes
Here you may provide further details
There are procedures for identification of unintentional release of LMO and taking measures to deal with the situation in an appropriate manner.
Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
indicator 2.2.3
Survey 19.a) Risk assessment
  • 10 or more
Survey 19.b) Monitoring
  • 10 or more
Survey 19.c) Management / Control
  • 10 or more
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
indicator 2.2.5
  • Yes
Here you may provide further details
Materials issued EFSA and JRC are currently most frequently used for training and technical guidance.
Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?
indicator 2.2.6
Survey 22.a) Sufficient
  • Yes
Survey 22.b) Effective
  • Yes
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • One or more
Here you may provide further details
Custom personal is mainly trained in taking samples when necessary, while identification takes place in specialized analytical laboratories.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 10 or more
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Here you may provide further details
There are currently four analytical laboratories that are specialized in the area of LMO detection and hold ISO/IEC 17025 accreditation.
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
Here you may provide further details
All four of the above laboratories are currently operational.
Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
indicator 2.4.1
  • Yes
Here you may provide further details
One member of staff of 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, Riga, Latvia, 9-11 May 2012.
Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
indicator 2.4.2
  • Yes
Here you may provide further details
Bulgarian GMO Law and Law for responsibility of prevention and remediation of damage to the environment contain the necessary provisions.
Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
indicator 2.5.2
  • Yes
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • National website
  • Newspaper
  • Public hearings
  • Members of NGOs participate in the work of Consultative Commission on GMO and its work is open for public unless confidential information is discussed.
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • 5 or more
Here you may provide further details
See comment on question 4. In addition institutions with permit for contained used of GMO should provide the necessary biosafety training to the personal.
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • 10 or more
Here you may provide further details
Training materials from EFSA, JRC, BCH, etc. are available on-line to the interested parties.
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • Yes
Survey 35.b) Enforcement system
  • Yes
Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.
indicator 4.3.1
  • 10 or more
Here you may provide further details
Additionally see comments on questions 4 and 33 above.
Survey 37. Please indicate the number of biosafety related publications that has been made available in your country in the last year.
indicator 4.3.2
  • 50 or more
Here you may provide further details
See comment on question 34 above.
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • Publications usually are accessed directly through the websites of their primary source (journal, institutional, etc.)
Survey 39. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
indicator 5.2.1
  • 5 or more
Here you may provide further details
Bulgaria co-operate with other countries within the framework of EU.
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • No
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • No
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • 10 or more
Here you may provide further details
See comment on question 34 above.