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Fifth National Report on the Implementation of the Cartagena Protocol on Biosafety
(NR5 )
last updated: 25 Aug 2026
General Information
2. Contact person submitting the report
To view the current National Focal Point information, click
here .
Organizations/stakeholders who were consulted or participated in the preparation of this report
4.
Time period covered by this report
5. If your country is not a Party to the Cartagena Protocol on Biosafety, is there any national process in place towards becoming a Party?
6. Please use the space below to provide any further details:
Article 2 – General provisions
Article 2 requires each Party to take the necessary and appropriate legal, administrative and other measures to implement its obligations under the Protocol
7. Has your country introduced the necessary national measures for the implementation of the Protocol?
8. Which specific instruments are in place for the implementation of national biosafety measures? (select all that apply)
Other laws, regulations or guidelines that indirectly apply to biosafety
Please provide further information on the instruments in place:
9. Has your country integrated biosafety in national sectoral and cross-sectoral strategies, action plans, programmes, policies or legislation?
10. Does your country have resources for biosafety from national budgets?
Are these resources adequate:
11. Does your country have qualified staff to administer functions directly related to biosafety?
12. If you answered Yes to question 11, how many qualified staff members are in place whose functions are directly related to biosafety?
13. Please use the space below to provide further details on the implementation of Article 2 in your country:
Article 5 – Pharmaceuticals
14. Does your country regulate the transboundary movement, handling or use of living modified organisms (LMOs) which are pharmaceuticals for humans?
15. Please use the space below to provide further details on the implementation of Article 5 in your country:
Article 6 – Transit and contained use
16. Does your country regulate the transit of LMOs?
17. Does your country regulate the contained use of LMOs?
18. Has your country taken a decision concerning the import of LMOs for contained use?
19. Please use the space below to provide further details on the implementation of Article 6 in your country:
Articles 7 to 10: Advance informed agreement (AIA) and intentional introduction of LMOs into the environment
20. 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?
21. Has your country established legal requirements for the accuracy of information contained in the notification provided by exporters under its jurisdiction?
22. In the current reporting period, has your country received a notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
23. If you answered Yes to question 22, did the notification(s) contain complete information (at a minimum the information specified in Annex I to the Cartagena Protocol on Biosafety)?
24. If you answered Yes to question 22, has your country acknowledged receipt of the notification(s) to the notifier within ninety days of receipt?
25. If you answered Yes to question 22, has your country informed the following of its decision(s):
b. The Biosafety Clearing-House (BCH)?
26. In the current reporting period, has your country taken a decision in response to the notification(s) regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
27. If you answered Yes to question 26, what percentage of your country’s decisions fall into the following categories?
Were the reasons for the conditions provided?
Were the reasons for the prohibition provided?
28. If you answered Yes to question 26, how many LMOs has your country approved for import for intentional introduction into the environment?
29. If you answered under question 28 that LMOs were approved, have these LMOs actually been imported into your country?
30. Please use the space below to provide further details on the implementation of Articles 7 to 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:
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
31. Does your country have law(s), regulation(s) or administrative measures for decision-making regarding domestic use, including placing on the market, of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing?
32. Has your country established legal requirements for the accuracy of information to be provided by the applicant regarding the domestic use, including placing on the market, of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing?
33. In the current reporting period, how many decisions has your country taken regarding domestic use, including placing on the market, of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing?
34. Does your country have law(s), regulation(s) or administrative measures for decision-making regarding the import of LMOs for direct use as food or feed, or for processing?
35. In the current reporting period, how many decisions has your country taken regarding the import of LMOs for direct use as food or feed, or for processing?
36. Please use the space below to 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 that may be subject to transboundary movement for direct use as food or feed, or for processing:
Article 12 – Review of decisions
37. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
38. In the current reporting period, has your country reviewed and/or changed a decision regarding an intentional transboundary movement of an LMO?
39. If you answered Yes to question 38, how many decisions were reviewed and/or changed?
40. If you answered Yes to question 38, were any of the reviews triggered by a request from the Party of export or the notifier?
41. If you answered Yes to question 40, did your country provide a response within ninety days setting out the reasons for the decision?
42. If you answered Yes to question 38, were any of the reviews initiated by your country as the Party of import?
43. If you answered Yes to question 42, did your country, within thirty days, set out the reasons for the decision and inform:
44. Please use the space below to provide further details on the implementation of Article 12 in your country:
Article 13 – Simplified procedure
45. Has your country established a mechanism for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
46. In the current reporting period, has your country applied the simplified procedure?
47. If you answered Yes to question 46, for how many LMOs has your country applied the simplified procedure?
48. If you answered Yes to question 46, has your country informed the Parties through the BCH of the cases where the simplified procedure was applied?
49. Please use the space below to provide further details on the implementation of Article 13 in your country:
Article 14 – Bilateral, regional and multilateral agreements and arrangements
50. How many bilateral, regional or multilateral agreements or arrangements relevant to biosafety has your country established with other Parties/non-Parties?
51. If you answered under question 50 that agreements or arrangements were established , please provide a brief description of their scope and objective:
52. Please use the space below to provide further details on the implementation of Article 14 in your country:
Articles 15 & 16 – Risk assessment and risk management
53. Does the domestic regulatory framework of your country require risk assessments of LMOs to be conducted?
To which LMOs does this requirement apply (select all that apply):
54. Has your country established a mechanism to conduct risk assessments prior to taking decisions regarding LMOs?
Conducting risk assessment or risk management
55. In the current reporting period, has your country conducted any kind of risk assessment of LMOs, including for contained use, field trials, commercial purposes, direct use as food, feed, or for processing?
56. If you answered Yes to question 55, how many risk assessments were conducted?
57. If you answered Yes to question 55, please indicate the scope of the risk assessments (select all that apply):
58. If you answered Yes to question 55, were risk assessments conducted for all decisions taken on LMOs for intentional introduction into the environment or on domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing?
59. If you answered Yes to question 55, have you considered:
a. other available scientific evidence, as referred to in Article 15 of the Protocol?
b. relevant traditional knowledge of indigenous peoples and local communities?
60. If you answered Yes or In some cases to question 59(b), was this information considered in a scientifically sound manner?
61. Has your country established appropriate mechanisms, measures and strategies to regulate and manage risks identified in the risk assessment of LMOs?
62. Has your country taken appropriate measures to prevent unintentional transboundary movements of LMOs including such measures as requiring a risk assessment to be carried out prior to the first release of a LMO? 1
63. 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?
64. Has your country established a mechanism for monitoring potential effects of LMOs released into the environment?
65. Does your country have measures to identify LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
66. Has your country had access to or used any resource materials, including guidance documents, for the purpose of conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
67. If you answered Yes to question 66(a) or (b), 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) 2 for conducting risk assessment or risk management, or for evaluating risk assessment reports submitted by notifiers?
68. Does your country have specific needs for further guidance on specific topics of risk assessment of LMOs?
Capacity-building in risk assessment or risk management
69. Does your country have the capacity to detect, identify, assess the risk of and/or monitor LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
70. In the current reporting period, how many people in your country have been trained in risk assessment, risk management and monitoring of LMOs?
71. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
Which materials/guidance are being used
72. Please use the space below to provide further details on the implementation of Articles 15 and 16 in your country:
Article 17 – Unintentional transboundary movements5 and emergency measures
5 In accordance with the operational definition adopted in decision CP-VIII/16, “‘Unintentional transboundary movement’ is a transboundary movement of a living modified organism that has inadvertently crossed the national borders of a Party where the living modified organism was released, and the requirements of Article 17 of the Protocol apply to such transboundary movements only if the living modified organism involved is likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, in the affected or potentially affected States.”
73. Has your country established measures to notify affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations in case of a release under its jurisdiction that leads, or may lead, to an unintentional transboundary movement?
74. In the current reporting period, how many releases of LMOs occurred under your country’s jurisdiction that led, or may have led, to an unintentional transboundary movement?
75. If you answered under question 74 that a release occurred , has your country notified affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations?
76. In the current reporting period, how many times has your country become aware of an unintentional transboundary movement into its territory?
77. Does your country have the capacity to take appropriate measures in response to unintentional transboundary movements?
78. Please use the space below to provide further details on the implementation of Article 17 in your country:
Article 18 – Handling, transport, packaging and identification
79. 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?
80. Has your country taken measures to require that documentation accompanying LMOs-FFP, in cases where the identity of the LMOs is not known , clearly identifies that they may contain LMOs and are not intended for intentional introduction into the environment, as well as a contact point for further information?
81. Has your country taken measures to require that documentation accompanying LMOs-FFP, in cases where the identity of the LMOs is known , clearly identifies that they contain LMOs and are not intended for intentional introduction into the environment, as well as a contact point for further information?
82. If you answered Yes or Yes, to some extent to question(s) 79, 80 and/or 81, what type of documentation accompanying LMOs does your country require?
83. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as LMOs , and specifies any requirements for the safe handling, storage, transport and use, as well as the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
84. If you answered Yes or Yes, to some extent to question 83, what type of documentation does your country require for the identification of LMOs that are destined for contained use?
85. 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 the Cartagena Protocol applicable to the exporter?
86. If you answered Yes or Yes, to some extent to question 85, what type of documentation does your country require for the identification of LMOs that are intended for intentional introduction into the environment?
87. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
88. In the current reporting period, how many customs officers in your country have received training in the identification of LMOs?
89. Has your country established procedures for the sampling and detection of LMOs?
90. Does your country have access to and use resource materials and detection methods to detect and identify LMOs?
a. access to resource materials and detection methods to detect and identify LMOs?
b. use of resource materials and detection methods to detect and identify LMOs?
91. Does your country have access to and use tools to detect and identify LMOs?
92. Does your country have access to and use certified reference materials necessary to detect and identify LMOs?
a. access to certified reference materials?
b. use of certified reference materials?
93. How many laboratory personnel in your country have received training in detection of LMOs?
94. Does your country have reliable access to technical infrastructures, such as laboratories for the detection and identification of LMOs?
a. technical infrastructure for detection of LMOs?
b. technical infrastructure for identification of LMOs
95. How many laboratories in your country are certified for LMO detection?
96. If you answered under question 95 that certified laboratories exist in your country , how many of them are currently operating in the field of the detection of LMOs?
97. Please use the space below to provide further details on the implementation of Article 18 in your country:
Article 19 – Competent national authorities and national focal points
98. 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?
99. 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?
100. Has your country undertaken initiatives to strengthen collaboration among national focal points, competent national authority(ies) and other institutions on biosafety-related matters?
101. Please use the space below to provide further details on the implementation of Article 19 in your country:
Article 20 – Information-sharing and the Biosafety Clearing-House (BCH):
102. 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 6 and whether it has been submitted to the BCH:
a. Existing 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))
b. Legislation, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
c. Bilateral, multilateral and regional agreements and arrangements (Article 14, paragraph 2, and Article 20, paragraph 3 (b))
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))
e. Decisions regarding transit of LMOs (Article 6, paragraph 1)
f. Decisions regarding import of LMOs for contained use (Article 6, paragraph 2)
g. Notifications regarding the release under your country’s jurisdiction that leads, or may lead, to an unintentional transboundary movement of a LMO that is likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
h. Information concerning cases of illegal transboundary movements of LMOs (Article 25, paragraph 3)
i. Decisions regarding the importation of LMOs for intentional introduction into the environment (Article 10, paragraph 3)
j. Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
k. 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)
l. 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 to the Protocol (Article 11, paragraph 6)
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)
n. Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
o. Cases where intentional transboundary movement may take place at the same time as the movement is notified to your country (Article 13, paragraph 1(a))
p. LMOs exempted from the advance informed agreement procedure (Article 13, paragraph 1(b))
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))
103. Please provide a brief explanation if you answered that the information is available but not in the BCH or only partially available in the BCH to any item under question 102:
104. Has your country established a mechanism for the coordination among the BCH national focal point, the Cartagena Protocol national focal point, and the competent national authority(ies) for making information available to the BCH?
105. In the current reporting period, has your country used the information available in the BCH in its decision-making processes on LMOs?
106. In the current reporting period, has your country experienced difficulties accessing or using the BCH?
107. Does your country have a national biosafety clearing-house?
108. Please use the space below to provide further details on the implementation of Article 20 in your country:
Article 21 – Confidential information
109. Has your country established procedures to protect confidential information received under the Protocol?
110. Does your country allow the notifier to identify information that is to be treated as confidential?
111. Please use the space below to provide further details on the implementation of Article 21 in your country:
Article 22 – Capacity-building
112. Does your country have predictable and reliable funding for its capacity-building needs for the effective implementation of the Protocol?
113. Has your country received external support for the development and/or strengthening of human resources and institutional capacities in biosafety?
114. If you answered Yes or Yes, to some extent to question 113, how was this support made available?
115. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
116. If you answered Yes to question 115, how was this support made available?
117. In the current reporting period, has your country used its GEF STAR allocation for biosafety activities?
118. In the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
119. If you answered Yes or Yes, to some extent to question 118, in which of the following areas were these activities undertaken (select all that apply)?
120. If you answered Yes or Yes, to some extent to question 118, did your country use capacity-building materials, including online resources, for the development and/or strengthening of capacity-building?
121. In the current reporting period, has your country carried out a capacity-building needs assessment?
122. Does your country still have capacity-building needs?
123. If you answered Yes to question 122, which of the following areas still need capacity-building (select all that apply)?
124. If you answered Yes to question 122, has your country prioritized its capacity-building needs?
125. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
126. Please use the space below to provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
Article 23 – Public awareness and participation
127. Is biosafety public awareness, education and/or participation addressed in legislation or policy in your country?
128. Has your country established a mechanism to ensure public access to information on LMOs?
129. Has your country established a mechanism to facilitate and promote public participation, including consultation, in the decision-making process regarding LMOs?
130. Has your country informed the public about existing modalities for public participation in the decision-making process regarding LMOs?
131. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs?
132. In the current reporting period, has your country made the results of decisions regarding LMOs available to the public?
133. Has your country informed the public about the means to access the Biosafety Clearing-House?
134. Has biosafety been addressed or integrated in educational and training programmes in your country?
135. Does your country have in place a national communication strategy on biosafety?
136. Does your country have any awareness and outreach programmes on biosafety?
137. Does your country currently have a national biosafety website?
138. In the current reporting period, has your country accessed resource materials for facilitating and promoting public awareness, education and participation in biosafety?
139. Please use the space below to provide further details on the implementation of Article 23 in your country:
140. Has your country entered into any bilateral, regional, or multilateral agreement(s) with non-Parties regarding transboundary movements of LMOs?
141. In the current reporting period, has your country imported LMOs from a non-Party?
142. In the current reporting period, has your country exported LMOs to a non-Party?
143. If you answered Yes to question 141 and/or 142, were the transboundary movements of LMOs consistent with the objective of the Cartagena Protocol on Biosafety?
144. Please use the space below to provide further details on the implementation of Article 24 in your country:
Article 25 – Illegal transboundary movements 7
7 In accordance with the operational definition adopted in decision CP-VIII/16, “‘Illegal transboundary movement’ is a transboundary movement of living modified organisms carried out in contravention of the domestic measures to implement the Protocol that have been adopted by the Party concerned”
145. 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 the Cartagena Protocol?
146. In the current reporting period, how many cases of illegal transboundary movements of LMOs has your country become aware of?
147. If you indicated under question 146 that your country became aware of cases of illegal transboundary movements , has the origin of the LMO(s) been established?
148. Please use the space below to provide further details on the implementation of Article 25 in your country:
Article 26 – Socio-economic considerations
149. Does your country have any specific approaches or requirements that facilitate how socioeconomic considerations should be taken into account in LMO decision-making?
150. Has your country used resource materials for taking socioeconomic considerations into account?
151. In the current reporting period, have socioeconomic considerations arising from the impact of LMOs been taken into account in decision-making?
152. Please use the space below to provide further details on the implementation of Article 26 in your country:
Article 28 – Financial mechanism and resources
153. In the current reporting period, how much funding (in the equivalent of US dollars) has your country mobilized to support implementation of the Cartagena Protocol beyond the regular national budgetary allocation?
Article 33 – Monitoring and reporting
Article 33 requires Parties to monitor the implementation of its obligations
154. Does your country have in place a system to monitor and enforce the implementation of the Cartagena Protocol?
Cooperation
Goal B.4 of the Implementation Plan for the Cartagena Protocol addresses cooperation and coordination on biosafety issues at the national, regional and international levels. Questions related to this goal are presented below, including questions related to cooperation under different provisions of the Protocol.
155. In the current period, has your country cooperated with other Parties in:
a. exchange of scientific, technical and institutional knowledge;
b. identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity? (Article 16(5)).
c. research and information exchange on any socioeconomics impacts of LMOs? (Article 26(2))
Does this include research and information exchange on socioeconomic impacts of LMOs on indigenous peoples and local communities?
d. public awareness, education and participation? (Article 23(1)(a))
e. strengthening capacities for the implementation of the Protocol?
156. In the current reporting period, has your country engaged in bilateral, regional or multilateral activities for the implementation of the Protocol?
157. Does your country have mechanisms in place for involving indigenous peoples and local communities and relevant stakeholders from different sectors in the implementation of the Protocol?
a. mechanisms for involving indigenous peoples and local communities
b. mechanisms for involving relevant stakeholders from different sectors
158. Please use the space below to provide further details on biosafety cooperation in your country:
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress
Parties to the Cartagena Protocol that are not yet Party to the Supplementary Protocol are also invited to respond to the questions below
159. Is your country a Party to the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress?
Is there any national process in place towards becoming a Party to the Supplementary Protocol?
160. Has your country introduced the necessary measures for the implementation of the Supplementary Protocol?
161. Which instruments are in place for the implementation of the Supplementary Protocol (select all that apply)?
Please provide further information on the instruments in place:
162. Does your country have administrative or legal instruments that require response measures to be taken:
a. In case of damage resulting from LMOs?
b. In case there is sufficient likelihood that damage will result if response measures are not taken?
163. If you answered Yes to question 162a, do these instruments impose requirements on an operator (select all that apply)?
164. If you answered Yes to question 162a, do these instruments require the operator to take response measures to avoid damage?
165. If you answered Yes to question 162a or 162b, do these instruments provide for a definition of “operator”?
166. If you answered Yes to question 165, which of the following could be an ‘operator’ (select all that apply)?
167. Has a competent authority been identified for carrying out the functions set out in the Supplementary Protocol?
168. If you answered Yes to question 167, what measures may the competent authority take (select all that apply)?
169. Does your country have measures in place to provide for financial security for damage resulting from LMOs?
170. If you answered Yes to question 169, what type of financial security measures are in place (select all that apply)?
171. Does your country have rules and procedures on civil liability that address damage resulting from LMOs, or has such damage been recognized in court rulings (select all that apply)?
172. Have there been any occurrences of damage resulting from LMOs in your country?
173. If you answered Yes to question 172, have response measures been taken?
174. Please use the space below to provide further details on any activities undertaken in your country towards the implementation of the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress:
175. Please use this field to provide any other information on issues related to national implementation of the Cartagena Protocol and the Supplementary Protocol, including any obstacles or impediments encountered:
Comments on reporting format
176. Please use this field to provide any information on difficulties that you have encountered in filling in this report, and suggestions for its improvement:
