Record details

Origin of report

1. Country

Serbia

Contact officer for report

Coordinates

Ms Vanja Kojic

Senior Advisor for Biosafety

Ministry of Agriculture, Forestry and Water Management/Plant Protection Directorate

Omladinskih brigada Street, No.1

Belgrade

Serbia, 11070

Phone:	+381 11 311 7191
Fax:	+381 11 311 7094
Email:	vanja.kojic@minpolj.gov.rs

Consulted stakeholders

9. Organizations/stakeholders who were consulted or participated in the preparation of this report

- Ministry of Agriculture, Forestry and Water Management: Plant Protection Directorate, Veterinary Directorate
- Ministry of Health
- Customs Administration
- Expert Council for Biosafety

Submission

10. Date of submission

2019-09-27

11. Time period covered by this report

Start date

2013-01-01

11. Time period covered by this report

End date

2018-01-01

Party to the Cartagena Protocol on Biosafety

Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?

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 partially in place

15. If you indicated that a national biosafety framework exists in the above question, when did it become operational?

This question is relevant to the indicator 1.1.1 of the Strategic Plan

2001 or earlier

16. Which specific instruments are in place for the implementation of your national biosafety framework?

One or more national biosafety laws
One or more national biosafety regulations
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, to some extent

Here you may provide further details

The budget for the operation of the national biosafety framework is part of the overall budget allocated to the Ministry of Agriculture, Forestry and Water Management, which is the national competent authority responsible for GMO issues. The budget for the work of the competent authority is established each year by the Law on the Budget of the Republic of Serbia for the current year

18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?

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?

20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?

21. Here you may provide further details on the implementation of Article 2 in your country

Regulations governing the use of GMOs exist since 2001, when the first Law on GMOs was adopted and in accordance with it the bylaws. These regulations were adopted at the federal level by the parliament of the Federal Republic of Yugoslavia, which consisted of the Republic of Serbia and the Republic of Montenegro, and applied in the period from 2001 to 2009. This Law on GMO, together with the accompanying regulations, enabled the issuing permit of all types of GMO use (contained use of GMOs, cultivation of GMOs and placing on the market of GMOs or GMO products), but following a rigorous procedure involving adequate risk analysis. After the redefinition of political relations between Serbia and Montenegro, the State Union of Serbia and Montenegro was created, and the Federal Republic of Yugoslavia ceased to exist. In 2006, Serbia and Montenegro became members of the Cartagena Protocol. In 2009, the Government of the Republic of Serbia adopted the following laws which has been regulates the field of GMOs: Law on Genetically Modified Organisms ("Official Gazette of RS", No. 41/09), Law on Food Safety ("Official Gazette of the Republic of Serbia", No. 41/09). Law on Genetically Modified Organisms (Official Gazette of RS, No. 41/09) regulates the procedure for issuing approvals for use in closed systems, for deliberate release into the environment of GMO for the purpose of carrying out experiments, demonstration experiments and development of new varieties, conditions for use in closed systems and for deliberate release into the environment GMO, handling, packaging and transport of GMOs and products containing GMO, as well as other issues of importance for GMO and products containing GMO. This law regulates only experimental work with GMOs. Also, this law prescribes prohibition of placing on the market of GMOs and products of GMOs, as well as the prohibition of commercial growing of GMOs on the territory of Republic of Serbia, which is not in compliance with Kartagena Protocol on Biosafety. However, the Food Safety Law ("Official Gazette of the Republic of Serbia", No. 41/09) prescribes procedures for the first placing on the market of GM food and GM feed in the territory of the Republic of Serbia, for labelling and traceability of GM food and feed, as well as for record keeping of approved of GM food and feed. Given that the Law on GMO and the Food Safety Law are in opposition to one another in the field of regulating GM food and feed, the Law on GMO as the law that specifically regulates GMOs is considered to be a Lex specialis, because of that the ban on the placing on the market of GMOs and GMO products in the Republic of Serbia, as defined by the Law on GMOs, is in force.

Article 5 - Pharmaceuticals

22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?

Yes, to some extent

Here you may provide further details

The Law on GMO ("Official Gazette of the Republic of Serbia", No. 41/09) is not responsible for the regulation of GMOs (LMOs) used as pharmaceuticals.
This area is partially regulated by the Law on Medicines and Medical Devices ("Official Gazette of the Republic of Serbia", No. 30/2010; 107/2012).

23. If you answered Yes to question 22, has this information been submitted to the BCH?

24. Here you may provide further details on the implementation of Article 5 in your country:

Competencies over the implementation of the Law on Medicines and Medical Devices ("Official Gazette of the Republic of Serbia", No. 30/2010; 107/2012) is under the authority of the Ministry of Health, so the Ministry of Agriculture, Forestry and Water Management has no accurate information on this issue.

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

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

27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?

28. Here you may provide further details on the implementation of Article 6 in your country:

As candidate country for EU membership, Serbia has been start with harmonisation of legislation with EU legislation in this area. Regulation (EC) No 1946/2003 on transboundary movement of GMOs, as well as the Directive 2009/41/EC on the contained use of genetically modified micro-organisms have been transposed into the Law on GMO. As we said, in Serbia, commercial cultivation of GMOs, as well as the placing on the market of GMOs and GMO products, were denied. We did not have any a notification of the transit of GMOs (LMOs). Also, we did not have applications for contained use of GMOs (LMOs). Also the transit is regulated by the Customs Law ("Official Gazette of the Republic of Serbia", No.18/2010-3, 111/2012-3, 29/2015-6, 108/2016-16, 113/2017-192 (other law)) for which the Customs Administration is competent authority .

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

30. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?

Yes, to some extent

Here you may provide further details

In accordance with the Law on GMOs (Official Gazette of RS, No. 41/09), mechanisms for decision making for the first intentional transboundary movements of LMOs for intentional introduction into the environment have been established, but only for the contained release of a GMOs for the purpose of carrying out experiments, demonstration experiments and development of new varieties.
This law prescribes prohibition of placing on the market of GMOs and products of GMOs, as well as the prohibition of commercial growing of GMOs on the territory of Republic of Serbia. The existent national law and by-laws are not in line with Carthagena Protocol on Biosafety.

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?

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?

33. Has your country established legal requirements for the accuracy of information contained in the notification?

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

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

36. If you answered Yes to question 35, how many LMOs has your country approved to date for import for intentional introduction into the environment?

Less than 5

37. If you answered Yes to question 35, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?

None

38. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?

None

39. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?

None

46. Here you may provide further details on the implementation of Articles 7-10 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs for intentional introduction to the environment

Since 2009, when the current Law on GMO was adopted, we did not have any application for the deliberate introduction of GMOs into the environment. Consequently, we have not made any decision regarding the transboundary movement of GMOs for the purpose of introduction into the environment.
In the period from 2001 to 2009 (when the Law on GMO ("Official Gazette of FRY", No. 21/2001 was in force)), permits for field trials were issued (GM corn (NK603) resistant to Roundup Ready herbicide, as well as GM Arabidopsis and GM tobacco for the purpose of detecting mines in the ground). Each of these permits was accompanied by precisely defined obligations for adequate risk management. Also, was issued the permit for the placing on the market of GM soybean meal (processed) as feed (in a form that is not live modified organism and does not pose a threat to 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

48. Has your country established legal requirements for the accuracy of information to be provided by the applicant?

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

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

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

52. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?

53. How many LMOs-FFP has your country approved to date?

Less than 5

54. In the current reporting period, how many decisions has your country taken regarding the import of LMOs-FFP?

None

55. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs-FFP?

None

58. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP

In accordance with the Law on GMO we have general ban on commercial growing of GMOs, as well as on placing on the market of GMOs and products of GMOs in Republic of Serbia

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?

60. Has your country ever received a request for a review of a decision?

61. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?

62. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?

None

Article 13 – Simplified procedure

67. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?

68. Has your country ever applied the simplified procedure?

70. In the current reporting period, how many LMOs has your country applied the simplified procedure to?

None

Article 14 – Bilateral, regional and multilateral agreements and arrangements

72. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?

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

None

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

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

Free trade agreements between Serbia and the EFTA countries, then the CEFTA countries, the Russian Federation, etc. None of these agreements is LMO-related.
Stabilization and Association Agreement between the EU and Serbia (signed 2013)

76. Here you may provide further details on the implementation of Article 14 in your country

As a candidate country for EU accession, Serbia has to harmonize domestic legislation with EU legislation. The draft of the new GMO law is under preparation and will be harmonized with the relevant EU legislation.

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, to some extent

Here you may provide further details

Yes but to some extent. The Law on GMO imply the risk assessment as the obligatory procedure that has to be a component part of decision making process. The submitted application dossier to the Competent Authority has to contain the document - assessment of the risks to human health and to the environment. Submitted application are re-evaluated by the Expert Council for Biosafety to undertake a risk assessment. The Expert Council for Biosafety is an scientific consultative advisory body that is in charge with risk assessment and scientific review of applications. The Expert Council shall operate under the "case by case" procedure, and in its activities it shall be guided by data based on scientific knowledge and observe the precautionary principle.
However, there are not sufficient experience in evaluation of risk assessment for LMOs, lack of a domestic guidelines for Risk assessment in line with the Annex III of the Protocol.There is critical needs for capacity building for training of risk evaluators and expertise for LMOs.

78. If you answered Yes to question 77, does this framework include procedures for identifying and/or training national experts to conduct risk assessments?

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:

One or more

b) Management / Control:

One or more

c) Monitoring:

One or more

80. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?

This question is relevant to indicator 2.2.5 of the Strategic Plan

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

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

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

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:

b) Identify:

c) Assess:

d) Monitor:

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:

b) Risk management:

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

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

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

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

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

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?

In some cases only

93. If you answered Yes to question 89, how many risk assessments were conducted in the current reporting period?

None

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?

95. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?

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

97. Here you may provide further details on the implementation of Articles 15 and 16 in your country

Testing of GMOs and GMO products for the purpose of detection, identification and quantification of genetic modification is carried out by laboratory designated by the Ministry of Agriculture, Forestry and Water Management. At this point, the four laboratories are designated to carry out detection, identification and quantification of genetic modifications in GMOs and products of GMO, for the needs of the Ministry of Agriculture. Members of the Expert Council for Biosafety have some experience in conducting risk assessments of LMOs, intended for contained use, as well as for field trials, but not for cultivation for commercial purposes or direct use as food, feed, or for processing. Although some of our experts have been invited to the workshops organized at the EU level to update their knowledge, additional training and hands-on experience would be welcomed particularly for regulators and administrators in the country as well as for other experts, particularly for inspections service who supervise the implementation of the Law on GMOs.

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, to some extent

Here you may provide further details

Seed and mercantile crops (maize, soybeans, swede-rape, oilseed repe, sugar beet) are compulsorily sampled at the border by the Border Phytosanitary Inspection and samples are sent to authorized laboratories for testing for the presence of GMOs.
Phytosanitary Inspection conduct monitoring of crop varieties and agricultural/food products in the local market and in the field.

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?

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

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

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, to some extent

Here you may provide further details

In accordance with the Law on GMO ("Official Gazette of Republic of Serbia", No. 41/2009) during handling, packaging and transport, including transit over the whole territory of the Republic of Serbia, the GMOs and GMO products shall be accompanied by the documentation which must contain the data clearly indicating that they are GMOs and GMO products. For use GMO in closed systems, the documentation must contain the conditions and requirements for safe handling, transport and use, the place for obtaining information, including the name and address of the person or institution that has been consigned the GMO. For deliberate release into the environment of GMO intended for field trials, the documentation must include identity and the appropriate characteristics of the GMOs and GMO products, conditions for safe handling, storage, transport and use, as well as the place for obtaining information. However, in accordance with this law, commercial growing of GMO , as well as the placing on the market of GMOs and GMO products is prohibited in Serbia.

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

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

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

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

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

115. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?

Yes, to some extent

116. How many customs officers in your country have received training in the identification of LMOs?

This question is relevant to indicator 2.3.1 of the Strategic Plan

None

117. Has your country established procedures for the sampling and detection of LMOs?

Yes, to some extent

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

One 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

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:

The Ministry of Agriculture, Forestry and Water Management, as the competent authority for GMO issues, authorized 4 laboratories for the detection, identification and quantification of genetic modification in the tested material. However, we still do not have a nominated reference laboratory to be able to ensure validation of methods for detection, identification and quantification of GMOs .

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?

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, to some extent

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 but not in the BCH

b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)

Information available but not 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 but only partially available in the BCH

e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))

Information available but only partially available 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 available but not in the BCH

i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))

Information available but not in the BCH

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 available but not in the BCH

n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)

Information not available

o) LMOs granted exemption status by each Party (Article 13, paragraph 1)

Information not available

p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)

Information not available

q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))

Information available but not in the BCH

127. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?

Yes, to some extent

Here you may provide further details

In cooperation with the TAIEX (Technical Assistance and Information Exchange Instrument of the European Commission) a series of training workshops relevant to this field were held

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, to some extent

129. Does your country use the information available in the BCH in its decision making processes on LMOs?

Yes, in some cases

130. Has your country experienced difficulties accessing or using the BCH?

This question is relevant to indicator 4.1.8 of the Strategic Plan

131. Is the information submitted by your country to the BCH complete and up-to date?

132. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years:

This question is relevant to indicator 4.3.1 of the Strategic Plan

5 or more

133. Please indicate the number of biosafety related publications that has been made available in your country in the last year:

This question is relevant to indicator 4.3.2 of the Strategic Plan

One or more

134. If biosafety related publications were made available (see question above), please indicate which modalities were preferred:

This question is relevant to indicator 4.3.2 of the Strategic Plan

National Libraries

Article 21 – Confidential information

136. Has your country established procedures to protect confidential information received under the Protocol?

137. Does your country allow the notifier to identify information that is to be treated as confidential?

Yes, always

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

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?

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?

144. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?

145. If you answered Yes to question 144, how would you characterize the process?

Please add further details about your experience in accessing GEF funds under question 157.

Average

146. Has your country ever received funding from the GEF for building capacity in biosafety?

Development of national biosafety frameworks

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?

148. If you answered Yes to question 147, in which of the following areas were these activities undertaken?

Public awareness, participation and education in biosafety
Information exchange and data management including participation in the Biosafety Clearing-House
Implementation of the documentation requirements under Article 18.2 of the Protocol

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

151. Does your country still have capacity-building needs?

This question is relevant to indicator 1.2.7 of the Strategic Plan

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
Risk assessment and other scientific and technical expertise
Risk management
Scientific, technical and institutional collaboration at subregional, regional and international levels
Technology transfer
Socio-economic considerations
Handling of confidential information
Measures to address unintentional and/or illegal transboundary movements of LMOs
Scientific biosafety research relating to LMOs
Taking into account risks to human health

153. Has your country developed a capacity-building strategy or action plan?

This question is relevant to indicator 1.2.2 of the Strategic Plan

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

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

Less than 1 per year

156. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?

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

Serbia still needs financial and technical assistance from the parties of the Cartagena Protocol and other international institutions in biosafety capacity building as well as implementing of the Cartagena Protocol.

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, to some extent

Here you may provide further details

Procedure for public participation at the decision making process prescribed by the national legislation.

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

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

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

163. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?

This question is relevant to indicator 5.2.1 of the Strategic Plan

None

164. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?

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

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

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, to some extent

Here you may provide further details

It is possible to find this information on the national website

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

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?

171. How many academic institutions in your country are offering biosafety education and training courses and programmes?

This question is relevant to indicator 2.7.1 of the Strategic Plan

One or more

172. Please indicate the number of educational materials and/or online modules on biosafety that are available and accessible to the public in your country:

This question is relevant to indicators 2.7.2 and 5.3.4 of the Strategic Plan

One 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?

174. If you answered Yes to question 173, has your country cooperated with other States and international bodies?

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?

Never

176. Here you may provide further details on the implementation of Article 23 in your country

A number of meetings and workshops organized for stakeholders and decision makers: GMO inspection - Enforcement of GMO legislation, Workshop on GMOs Food and Feed, meetings at the Serbian Academy of Sciences and Arts on biosafety
Participation in training courses in the organization of TAIEX, BTSF

Article 24 – Non-Parties

177. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?

178. Has your country ever imported LMOs from a non-Party?

179. Has your country ever exported LMOs to a non-Party?

183. Here you may provide further details on the implementation of Article 24 in your country:

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?

185. Has your country established a strategy for detecting illegal transboundary movements of LMOs?

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

In accordance with current Law on GMO, no genetically modified organisms or product containing genetically modified organisms can be traded or grown for commercial use at the territory of the Republic of Serbia

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

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

One 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

196. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?

197. Here you may provide further details on the implementation of Article 26 in your country

Article 27 – Liability and Redress

198. Has your country ratified or acceded to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?

199. If you answered No to question 198, is there any national process in place towards becoming a Party?

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

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

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

Q 199: Steps have been taken to initiate the procedure of ratification of the Supplementary Protocol under the Cartagena Protocol on Biosafety
Q 200: There are penal provisions in national legislation if the use of GMOs and GMO products causes harmful consequences for human health and the environment

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:

b) Enforcement system:

205. Has your country submitted all the previous due National Reports?

206. If you answered No to question 205, indicate the main challenges that hindered the submission:

Lack of financial resources to gather the necessary information
Lack of relevant information at the national level
Difficulty in compiling the information from various sectors

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.

The current Law on GMO ("Official Gazette of the Republic of Serbia", No. 41/09), which was adopted in 2009, regulates only experimental work with GMOs and prescribes prohibition of placing on the market of GMOs and products of GMOs, as well as the prohibition of commercial growing of GMOs on the territory of Republic of Serbia. This was reffered in 2nd National Report.
This Law is still in the force

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

Due to lack of financial and human resources Serbia has difficulties with gathering necessary information for submission of the Cartagena Protocol National Reports.