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Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102903
Status
Published
Date of creation
2011-12-09 16:27 UTC (andrew.bowers@cbd.int)
Date of publication
2011-12-09 16:27 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • Armenia
Contact officer for report
Coordinates
Artashes Ziroyan
Head of Bioresources Management Agency
Ministry of Nature Protection of Armenia
1/3 P. Byuzand
Yerevan
Armenia, 0010
Phone:+37410 52 79 52
Fax:+37410 52 79 52
Email:artashes.ziroyan@yahoo.com
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Bioresources Management Agency of the Ministry of Nature Protection of Armenia
Submission
10. Date of submission
2011-12-09
11. Time period covered by this report
Start date
2007-09-12
Time period covered by this report
End date
2011-12-31
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 partially in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • 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?
  • No
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • No
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
The Ministry of Nature Protection of RA is recognised as National Focal Point and Competent National Authority by the Government Decree No 1219-N of 02.09. 2004.

Other RA laws  that indirectly apply to biosafety, in particularly: Law on Standardization (1999), law on Flora (1999), Law on Fauna (2000), Law on Environmental Supervision (2005), Law on Food Safety (2006), Law on Specialy Protected Natural Areas (2006), Law on  Animal Feed (2008).
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
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • No
24. Here you may provide further details on the implementation of Article 5 in your country:
The pruduction, preparation, packaging, selling, export, import of the  medicines are regulated by Law on Medicines. In accordance with the art.8 of the given law the active material and the modified micro-organisms that are used  for the preparation of these medicines through genetic engineering should be mentioned on the medicines.

The medicines and medicaments may be exported or imported from / to RA based on the certificate of export or import  issued by the Ministry of Health of RA.

The  transboundary movement of LMOs which are pharmaceuticals for humans  are addressed by other relevent international agreements or organisations.
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 Republic of Armenia doesn't regulate the transit  and contained use of LMOs.
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?
  • No
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?
  • No
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • No
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?
  • No
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?
  • No
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:
The Republic of Armenia has few sampling laboratories and scientific potential to detect and identify LMOs, but the following is lacking:  Law(s) / regulations / administrative measures for the operation of the AIA procedure and intentional introduction of LMOs into the environment.
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?
  • No
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • No
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?
  • No
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • No
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:
There  are no legal acts that determine special import procedures envisaged for LMOs for use as food or feed.

The defenition of GMP, as well as the marking order, if they are  genetically modified foods, are determined according to RA law on "Food safety".

According to RA law on animal feed one of the marking  requirements of the market of feed, materials in contact with feed and feed additives in the Republic of Armenia is to mark " genetically modified feed or food additives" in Armenian, if its composition in the feed or feed additives is more than 0.9 %.

In addition to the above mentioned the marketing order on market of genetically modified milk and dairy products, meat and meat products, egg and egg products in the Republic of Armenia  is determined by a range of regulations, if the food product is GM.
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?
  • No
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?
  • No
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?
  • No
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?
  • 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?
  • No
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
93. Here you may provide further details on the implementation of Article 15 in your country:
Training for experts and experience exchange are necessary in this field.
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?
  • No
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes, to some extent
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • No
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
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:
The RA food safety system development strategy  and the action plan for the implementation of the strategy  were approved by the RA Government minute decree N 45 17.11.2011.  According to the action plan the rules on LMOs should be improved  till the end of 2014 to protect human life and health, animal health and welfare, conserve environment and biodiversity, as well as to protect consumers' benefits in the national legislation field of regulatory items of food and feed that contain GMO.
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, to some extent
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?
  • No
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?
  • No
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
115. Here you may provide further details on the implementation of Article 18 in your country:
The details of the answer to question 108 are mentioned under the point 63.

Regarding the question 113 it should be mentioned that the country has few sampling laboratories and scientific potential to identify GMOs, but training and experience exchange are necessary for documentation .

Regarding the question 114 it should be mentioned that in the following was approved by the order N16 of the Minister of Health of RA 08.09.2010.

(a). Food product subject to expertise on the existance of Genetically modified microorganisms (GMMs) and /or  genetically modified doublicate micro-organisms(GMDMs)

(b). Genetically modified microorganisms and food product based on  GMO allowed for the use  in food production.

(c). Food sampling norms  for  laboratory research on GMMs and / or GMDMs.

(d). Laboratory research scheme on the food product based on GMMs and / or GMDMs .

(e).Additional methods of hygienic sampling  / testing  during the expertise on GMMs  and / or GMDMs.

(f) Laboratory research scheme on food that contains Living  GMDMs .
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, some 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?
  • No
123. Here you may provide further details on the implementation of Article 19 in your country:
The Ministry of  Nature Protection of RA is recognised as National Focal Point and Competent National Authority by the Governmental decree No.1219-N of 2004 to implement Article 19 . 
National Focal Points on Cartagena Protocol and BCH are appointed and in duty to provide communication and connections with the CP Secretariat. The National databases and information are regularly submitted and available via domestic BCH website (http://www.biosafety.am).
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 not available
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 only partially available 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?
  • 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?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • No
128. Has your country experienced difficulties accessing or using the BCH?
  • No
129. If you answered Yes to question 128, has your country reported these problems to the BCH or the Secretariat?
  • Not applicable
130. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • No
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • No
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)?
  • 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
  • Building Capacity for Effective Participation in the BCH (Phase I)
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?
  • No
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 assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Identification of LMOs, including their detection
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
148. Has your country developed a capacity-building strategy or action plan?
  • No
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:
Armenia accessed the GEF funds and benefited from the GEF Technical assistance to develop biosafety capacities in the country, particularly for Development NBF project and BCH I projects.
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?
  • No
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, to a limited extent
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes, to a limited extent
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes, to a limited extent
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, to a limited extent
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • 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?
  • More than 5
160. Here you may provide further details on the implementation of Article 23 in your country:
The public information on LMOs in the Republic of Armenia is implemented according to RA law on Freedom of Information (2003).

The public participation in the decision making process, education  and dissemination of information concerning the LMOs  is ensured via national BCH website management, workshops and public, including discussions with NGOs, trainings, development and publication of brochures, as well as mass media, by the Bioresources management agency under the Ministry of Nature Protection of RA.
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?
  • No
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • No
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?
  • Not applicable
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?
  • No
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes, First report only
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
  • Lack of relevant information at the national level
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 main impediment factor for the implementation of the minutes is the absence of the main national legal act regulating the sphere of biosafety, other normative-legal acts and guidelines derived from it.

Despite the fact that the marking orders on GMOs, GMFFs  are defined by certain legal acts, they are not implemented as according to RA national legislation their applying mechanisms should be determined based on the main legal act regulating relations in the target sphere.

In addition, there is a financial resources need for  the study of experience and training of policy makers and executors of this field, as well as for the development of the legal acts.

Re: Q. 14 - The National Assembly of the Republic of Armenia ratified the Cartagena Protocol of CBD on March 16, 2004
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.
The filling out of the reporting format was very useful, helpful and  instructive, particularly in identifying the current situation of biosafety insurance and detecting the existing problems, for which we express our deepest gratitude to the CBD  and CP Secretariats,  and we hope to receive further assistance / support for the solution of the problems.