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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
103042
Status
Published
Date of creation
2012-01-27 19:33 UTC (andrew.bowers@cbd.int)
Date of last update
2012-02-13 19:07 UTC (andrew.bowers@cbd.int)
Date of publication
2012-02-13 19:07 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • Serbia
Contact officer for report
Coordinates
Vanja Kojić
senior adviser for biosafety
Ministry of Agriculture, Trade, Forestry and Water Management / Plant Protection Directorate
Omladinskih brigada Stree No. 1
Belgrade
Serbia, 11070
Phone:+381 11 311 75 91
Fax:+381 11 311 70 94
Email:vanja.kojic@minpolj.gov.rs
Submission
10. Date of submission
2012-01-27
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?
  • Only a draft framework exists
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • No
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?
  • One
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • No
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • No
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • No
26. Does your country regulate the contained use of LMOs?
  • No
28. Here you may provide further details on the implementation of Article 6 in your country:
The procedure for issuing approval for use GMO in closed systems shall be initiated based on the application submitted by the developerdeveloper, user or their authorized representative in the Republic of Serbia (hereinafter referred to as: the applicant). The application shall be submitted to the Ministry of Agriculture, and the approval in the form of a decision shall be issued by the Minister, based on the opinion of the Expert Council for Biosafety, expert-advisory body, with designation for conduction of risk assessment.
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, to some extent
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?
  • No
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?
  • Yes
39. If you answered Yes to question 38, how many LMOs has your country approved to date for import for intentional introduction into the environment?
  • Less than 5
40. If you answered Yes to question 38, how many LMOs, not imported, has your country approved to date for intentional introduction into the environment?
  • None
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • 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
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
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:
In accordance with Article 2 of Law on GMO ("Official Gazette of Republic of Serbia", No. 41/2009) we have general ban on placing on the market of GMO and product of GMO (this including also GM food and feed) as well as on commercial growing of GMOs.
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
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
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?
  • No
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?
  • No
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • Yes
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • No
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Yes, always
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • No
90. In the current reporting period, if your country has taken decisions regarding LMOs, how many risk assessments were conducted in the context of these decisions?
  • None
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • No
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • No
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?
  • No
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes, to some extent
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?
  • No
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?
  • No
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?
  • No
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?
  • No
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?
  • No
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
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?
  • No
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?
  • No
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, to some extent
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes, to some extent
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, one
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
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, to some extent
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 but not 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 not available
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 but not in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available but not in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information available but not in the BCH
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 available but not in the BCH
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available but not in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available but not in the BCH
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information 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 available but not in the BCH
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information available but not in the BCH
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information available but not in the BCH
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 available but not in the BCH
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available but not in the BCH
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • No
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?
  • No
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?
  • No
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
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?
  • Yes
136. If you answered Yes to question 135, how were these resources made available?
  • Regional channels
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)?
  • Yes
140. Has your country ever initiated a process to access GEF funds for building capacity in biosafety?
  • Yes
141. If you answered Yes to question 140, how would you characterize the process?
Please add further details about your experience in accessing GEF funds under question 150.
  • Easy
142. Has your country ever received funding from the GEF for building capacity in biosafety?
  • Development of national biosafety frameworks
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?
  • Identification of LMOs, including their detection
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • 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
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Socio-economic considerations
  • Handling of confidential information
  • 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?
  • No
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes, to some extent
152. Has your country established a biosafety website?
  • No
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes, to a limited extent
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?
  • No
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?
  • No
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • None
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
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • No
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • No
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • No
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • No
183. If your country did not submit previous reports, indicate the main challenges that hindered the submission
  • Lack of financial resources to gather the necessary information
  • 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.
In the Republic of Serbia, GMO issues are regulated since 2001. when was adopted the Law on Genetically Modified Organisms ("Official Gazette of FRY", No. 21/2001). This law had regulated the conditions for contained use, deliberate release into the environment, and placing on the market of GMOs and products of GMOs, as well as the conditions and measures for the prevention and elimination of adverse effects occurring on the occasion of contained use, production of and trade of GMOs and products of GMOs. In accordance with this law were adopted the following by-laws: Regulation on contained use of GMOs ("Official Gazette of FRY", No. 62/2002), Regulation on deliberate release of GMOs and products of GMOs into the environment ("Official Gazette FRY", No. 62/2002), Regulation on placing GMOs and products of GMOs on the market ("Official Gazette of FRY", No. 62/2002), Regulation on the content and data of the Register of GMOs and products of GMOs ("Official Gazette of FRY", No. 66/2002).

National Assembly of the Republic of Serbia is 29.05.2009. adopted a new Law on genetically modified organisms ("Official Gazette RS", No. 41/2009). This law regulates only experimental work with GMOs (use of GMOs in closed systems and deliberate release of GMOs into the environment for establishing experimental field plots with GMOs. In The Law on GMO ("Official Gazette RS", No. 41/2009)  Article 2 is prescribed by the prohibition of placing on the market of GMOs and products of GMOs, as well as by the prohibition of commercial growing of GMOs, quote: "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". Given that the ban of placing on the market of  GMOs and products of GMOs, and the ban of commercially growing of GMOs is not in compliance with EU legislation in this area, Ministry of Agriculture, Trade, Forestry and Water Management (competent authority for all GMO issues) are drafted a Draft Law of changes and amendments to the law on genetically modified organisms, in order to harmonize it with relevant EU legislations.

In the MoATFWM activities related to GMOs are carried out by: Plant Protection  Directorate, and Veterinary Directorate.

Besides the MoATFWM, in the activities in the field of GMOs participate: Expert Council for Biological Safety, and accredited laboratories.

• Veterinary Directorate controls the feed of GMOs at all stages of production, processing and placing on the market through: Department of Border Veterinary Inspection and the Department of Veterinary Inspection.

In accordance with Article 6 of the Law on Genetically Modified Organisms, for the considerations of professional issues and providing expert opinion related to GMOs, Expert Council for Biological Safety has been established, consisting of 18 members chosen among outstanding scientists and experts in the fields that are relevant for bio safety (biologists, geneticists, entomologists, ecologists, veterinarians, agronomists, nutritionists, toxicologists, allergists and other professions).

Testing of GMOs and GMO products for the purpose of identification and quantification of genetic modification is carried out by laboratory accredited by the MoAFWM. The authorization is issued by the Minister.

Re: Q. 14 -

The matter of GM crops in the Republic of Serbia is regulated by:

• Law on Genetically Modified Organisms (Official Gazette of RS, No. 41/09), and

• The Law on Food Safety (Official Gazette of RS, No. 41/09).

The Law on Genetically Modified Organisms (in force since 10.06.2009) shall govern the procedure for issuing approvals for use genetically modified organisms (hereinafter referred to as: GMO)  in closed systems, for deliberate release into the environment of GMO (field trials with GMOs), conditions for use in closed systems and for deliberate release into the environment, handling, packaging and transport of GMOs and products containing of GMO, as well as other issues of importance for GMO and products containing of GMO.

Article 2 of the Law on Genetically Modified Organisms stipulates the prohibition of marketing of GMOs and GMO products, as well as the ban on commercial cultivation of GMO: "None of modified living organism or a product containing genetically modified organisms can not be put on the market, or grown for commercial purposes on the territory of Republic of Serbia ". According to thia article, no modified living organism or a product containing modified living organisms can not be placed on the market, or be grown commercially in the Republic of Serbia.

The Law on Food Safety stipulates the first marketing of genetically modified food (GMO foods) and genetically modified feed (GMO animal feed), the method of issuing permits for the first placement on the market of GMO food and GMO feed records of licenses issued, traceability and labelling of GMOs in particular GMO food and feed, and inspections in these fields. According to this Law, genetically modified food and genetically modified feed is: • genetically modified organisms used as food and feed; • food and feed containing or consisting of genetically modified organisms; • food and feed produced or containing ingredients produced from genetically modified organisms. Food and feed must not: • has a harmful impact on human health, animal health or on the environment; • mislead the consumer; • differs from food and feed, i.e. ingredients of food and feed for which it is intended to be used as a substitution, to the extent that calls for questioning of its nutritive value.

For the first placement on the market of genetically modified food and genetically modified feed in the Republic of Serbia, business operator that is distributing food or feed must be licensed in accordance with the provisions of this Law and special regulations. Permit is issued by the Minister, based on the prior opinion of the expert scientific advice, in accordance with the regulation concerning the conditions for the marketing of genetically modified food and genetically modified feed.

It is evident that both laws, the Law on GMOs and Law on Food Safety , must be changed because they are in contrary to each other:on the one hand the Law on Genetically Modified Organisms prohibits commercial growing and marketing of GMOs and products of GMO , including GM food and GM feed, and on the other hand The Law on Food Safety, prescribes procedures for issuing permits for trade in GM food and GM feed.