Malawi | BCH-NR5-MW-282371 | Fifth National Report on the Implementation of the Cartagena Protocol on Biosafety

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?

National measures are fully in place

EN

8. Which specific instruments are in place for the implementation of national biosafety measures? (select all that apply)

One or more national biosafety laws
One or more national biosafety regulations
One or more sets of biosafety guidelines
Other laws, regulations or guidelines that indirectly apply to biosafety

Please provide further information on the instruments in place:

Malawi has the following legal instruments: the Biosafety Act of 2002, Biosafety (Management of GMOs) Regulations of 2007, National Biotechnology and Biosafety Policy of 2008, Guidelines for risk assessment of food and feeds derived from GM crops, Guidelines for Genome Editing, Guidelines for regulating stack events, CFT guidelines, Trial Manager Handbook, Biosafety Inspectors hand book

EN

9. Has your country integrated biosafety in national sectoral and cross-sectoral strategies, action plans, programmes, policies or legislation?

Yes

EN

10. Does your country have resources for biosafety from national budgets?

Yes

EN

Are these resources adequate:

No

EN

11. Does your country have qualified staff to administer functions directly related to biosafety?

Yes

EN

12. If you answered Yes to question 11, how many qualified staff members are in place whose functions are directly related to biosafety?

10 or more

EN

Is this number adequate:

No

EN

13. Please use the space below to provide further details on the implementation of Article 2 in your country:

Biosafety has been mainstreamed across the higher education, forestry, health, and agriculture sectors in Malawi. Within these sectors, there are qualified personnel working directly on biosafety matters, some of whom serve on the technical committee responsible for reviewing biotechnology-related applications in accordance with the Biosafety Act of 2002 and its associated regulations. In addition, biosafety has been integrated into the revised National Biodiversity Strategy and Action Plan (NBSAP) through the inclusion of a dedicated biosafety target.

EN

Article 5 – Pharmaceuticals

14. Does your country regulate the transboundary movement, handling or use of living modified organisms (LMOs) which are pharmaceuticals for humans?

Yes

EN

15. Please use the space below to provide further details on the implementation of Article 5 in your country:

LMOs which are pharmaceutical for human are regulated under the Ministry of Health

EN

Article 6 – Transit and contained use

16. Does your country regulate the transit of LMOs?

Yes, to some extent:

EN

Additional Information

The Biosafety Act of 2002 does not explicitly address the transit of living modified organisms (LMOs). Instead, the Act applies to activities such as the importation, development, production, testing, release, use, and application of genetically modified organisms and requirement for permits for such activities.

EN

17. Does your country regulate the contained use of LMOs?

Yes

EN

18. Has your country taken a decision concerning the import of LMOs for contained use?

No

EN

19. Please use the space below to provide further details on the implementation of Article 6 in your country:

Contained use of LMOs is regulated to prevent escape from contained facilities

EN

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?

Yes

EN

21. Has your country established legal requirements for the accuracy of information contained in the notification provided by exporters under its jurisdiction?

Yes

EN

22. In the current reporting period, has your country received a notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?

Yes

EN

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)?

Yes, always

EN

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?

Yes, always

EN

25. If you answered Yes to question 22, has your country informed the following of its decision(s):

a. The notifier?

Yes, always

EN

b. The Biosafety Clearing-House (BCH)?

Yes, always

EN

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?

Yes

EN

Please specify how many

3

EN

27. If you answered Yes to question 26, what percentage of your country’s decisions fall into the following categories?

Approval of the import/use of the LMO(s) with conditions (100)

Were the reasons for the conditions provided?

Yes, always

EN

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?

1 to 4

EN

29. If you answered under question 28 that LMOs were approved, have these LMOs actually been imported into your country?

Yes, always

EN

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:

Malawi is currently conducting confined field trials for three genetically modified maize events NK603, MON 87427 × MON 89034 × MIR162 × NK603, and MON 89034 to assess their efficacy in herbicide tolerance and resistance to fall armyworm

EN

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?

Yes

EN

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?

Yes

EN

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?

1 to 4

EN

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?

Yes

EN

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?

1 to 4

EN

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:

In 2021, a permit was granted to CP Foods Limited to import soymeal derived from genetically modified soybeans from South Africa. In 2023, a separate permit was issued to Speedy’s Food Industries Ltd to procure genetically modified maize from South Africa for feed processing. However, the GM maize importation did not take place due to foreign exchange constraints

EN

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?

Yes

EN

38. In the current reporting period, has your country reviewed and/or changed a decision regarding an intentional transboundary movement of an LMO?

No

EN

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:

a. The notifier?

b. The BCH?

44. Please use the space below to provide further details on the implementation of Article 12 in your country:

Section 19 of the Biosafety Regulations of 2007 provides for review of the decision made under the Biosafety Act, it allows the applicant to apply for a review in cases where additional information has become available that may have material effect on the decision including any condition or requirement imposed under the licence or permit including any changes in circumstances that can affect the outcomes of the risk assessment.

EN

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?

Yes

EN

46. In the current reporting period, has your country applied the simplified procedure?

Yes

EN

47. If you answered Yes to question 46, for how many LMOs has your country applied the simplified procedure?

1 to 5

EN

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?

No

EN

49. Please use the space below to provide further details on the implementation of Article 13 in your country:

For Bt Cotton (MON15985 ) approved in the country, importation of the same event just requires the importer to provide evidence that the consignment only contained the event already approved in Malawi. Such evidence includes laboratory confirmation and no need for the Committee that is responsible for review and approval of biotechnology activities and product to convene and review dossier and risk assessment reports

EN

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?

None

EN

51. If you answered under question 50 that agreements or arrangements were established, please provide a brief description of their scope and objective:

EN

52. Please use the space below to provide further details on the implementation of Article 14 in your country:

EN

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?

Yes

EN

To which LMOs does this requirement apply (select all that apply):

For imports of LMOs for intentional introduction into the environment
For imports of LMOs intended for direct use as food or feed, or for processing
For decisions regarding domestic use, including placing on the market, of LMOs that may be subject to transboundary movements for direct use as food or feed, or for processing

54. Has your country established a mechanism to conduct risk assessments prior to taking decisions regarding LMOs?

Yes

EN

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?

Yes

EN

56. If you answered Yes to question 55, how many risk assessments were conducted?

1 to 9

EN

57. If you answered Yes to question 55, please indicate the scope of the risk assessments (select all that apply):

LMOs for intentional introduction into the environment for experimental testing or field trials
LMOs for intentional introduction into the environment for commercial purposes
LMOs for direct use as feed
LMOs for processing

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?

Yes, always

EN

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?

Yes, in all cases

EN

b. relevant traditional knowledge of indigenous peoples and local communities?

No

EN

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?

Yes

EN

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

Yes, to some extent:

EN

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?

Yes

EN

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

No

EN

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?

No

EN

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?

a. Risk assessment:

Yes

EN

b. Risk management:

Yes

EN

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?

Yes

EN

68. Does your country have specific needs for further guidance on specific topics of risk assessment of LMOs?

Yes

EN

Additional Information

guidance document on risk assessment for genetically modified birds

EN

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?

a. Detect:

Yes

EN

b. Identify:

No

EN

c. Assess the risk:

Yes

EN

d. Monitor:

Yes

EN

70. In the current reporting period, how many people in your country have been trained in risk assessment, risk management and monitoring of LMOs?

a. Risk assessment:

10 to 49

EN

Is this number adequate:

No

EN

b. Risk management:

10 to 49

EN

Is this number adequate:

No

EN

c. Monitoring:

10 to 49

EN

Is this number adequate:

No

EN

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

Yes

EN

Which materials/guidance are being used

Manual on risk assessment of LMOs developed by the CBD Secretariat ³

72. Please use the space below to provide further details on the implementation of Articles 15 and 16 in your country:

Malawi has been using the guidance document developed by the CBD Secretariat as a reference material during risk assessment reviews. To date, the country has not developed any Living Modified Organisms (LMOs) and as such, has not conducted any risk assessments itself. Instead, it has reviewed risk assessments submitted by developers seeking approval for the introduction of LMOs into Malawi's environment or for the importation of LMOs for food and feed purposes. While no formal training on risk assessment was held during the reporting period, key elements of the process were periodically discussed in biosafety meetings including on job training.

EN

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?

No

EN

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?

None

EN

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?

None

EN

77. Does your country have the capacity to take appropriate measures in response to unintentional transboundary movements?

Yes

EN

78. Please use the space below to provide further details on the implementation of Article 17 in your country:

Malawi has porous borders, and its capacity to effectively manage the unintentional transboundary movement of Living Modified Organisms is limited. Currently, only formal border posts are equipped to handle such matters, where customs officers have been trained to identify LMOs and ensure that the necessary documentation accompanies any transboundary movements. Furthermore, the Biosafety Regulation of 2007 provide for measures to be undertaken in case of any accidental release of genetically modified organisms.

EN

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?

Yes

EN

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?

Yes

EN

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?

Yes

EN

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?

Documentation specific to LMOs

EN

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?

Yes

EN

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?

Documentation specific to LMOs

EN

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?

Yes

EN

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?

Documentation specific to LMOs

EN

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

Yes, to some extent:

EN

Additional Information

More technical and financial capacity is required for effective monitoring and enforcement in the borders.

EN

88. In the current reporting period, how many customs officers in your country have received training in the identification of LMOs?

10 to 49

EN

Is this number adequate:

No

EN

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

Yes

EN

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?

Yes

EN

b. use of resource materials and detection methods to detect and identify LMOs?

Yes

EN

91. Does your country have access to and use tools to detect and identify LMOs?

a. access to tools?

Yes

EN

b. use of tools?

Yes

EN

92. Does your country have access to and use certified reference materials necessary to detect and identify LMOs?

a. access to certified reference materials?

Yes

EN

b. use of certified reference materials?

Yes

EN

93. How many laboratory personnel in your country have received training in detection of LMOs?

10 to 49

EN

Is this number adequate:

No

EN

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?

Yes

EN

b. technical infrastructure for identification of LMOs

No

EN

95. How many laboratories in your country are certified for LMO detection?

1 to 4

EN

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?

1 to 4

EN

97. Please use the space below to provide further details on the implementation of Article 18 in your country:

Through the GEF-6 Regional Project aimed at strengthening institutional capacity for living modified organism (LMO) detection to support biosafety decision-making, Malawi enhanced its capacity in LMO sampling and detection. The project also provided training to border personnel on the identification and verification of documentation required for the transboundary movement of LMOs. However, the project did not cover identification of LMOs, and as a result, capacity gaps in this area remain.

EN

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?

Not applicable, only one competent national authority was designated

EN

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?

Yes

EN

100. Has your country undertaken initiatives to strengthen collaboration among national focal points, competent national authority(ies) and other institutions on biosafety-related matters?

Yes

EN

Additional Information

The CNA always engage with all relevant stakeholders in biosafety decision making

EN

101. Please use the space below to provide further details on the implementation of Article 19 in your country:

Although Malawi has only one competent authority, involvement of all relevant sectors in biosafety decision making through the National Biosafety Regulatory Committee has been instrumental in ensuring inclusive and coordination in matters of biosafety.

EN

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))

Information available and in the BCH

EN

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)

Information available and in the BCH

EN

c. Bilateral, multilateral and regional agreements and arrangements (Article 14, paragraph 2, and Article 20, paragraph 3 (b))

Information not available

EN

d. Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3(e))

Information available and in the BCH

EN

e. Decisions regarding transit of LMOs (Article 6, paragraph 1)

Information not available

EN

f. Decisions regarding import of LMOs for contained use (Article 6, paragraph 2)

Information not available

EN

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)

Information not available

EN

h. Information concerning cases of illegal transboundary movements of LMOs (Article 25, paragraph 3)

Information not available

EN

i. Decisions regarding the importation of LMOs for intentional introduction into the environment (Article 10, paragraph 3)

Information available and in the BCH

EN

j. Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)

Information not available

EN

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)

Information not available

EN

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)

Information not available

EN

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

EN

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

Information not available

EN

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))

Information not available

EN

p. LMOs exempted from the advance informed agreement procedure (Article 13, paragraph 1(b))

Information available but not in the BCH

EN

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 and in the BCH

EN

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:

Documentation on this aspect was misplaced but will be made available on the BCH soon

EN

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?

Yes

EN

105. In the current reporting period, has your country used the information available in the BCH in its decision-making processes on LMOs?

Yes, always

EN

106. In the current reporting period, has your country experienced difficulties accessing or using the BCH?

No

EN

107. Does your country have a national biosafety clearing-house?

No

EN

108. Please use the space below to provide further details on the implementation of Article 20 in your country:

All focal points under the protocol are within Environmental Affairs Department which has made coordination easy, the country had an incomplete national biosafety clearing house based on Hermes but with the progress now made on the BCH, there is need to migrate to Bioland. ]

EN

Article 21 – Confidential information

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

Yes

EN

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

Yes, always

EN

111. Please use the space below to provide further details on the implementation of Article 21 in your country:

The Biosafety Act has provision on managing confidential information amongst members of the committee responsible for reviewing dossiers and regarding confidential information from the applicant

EN

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?

No

EN

113. Has your country received external support for the development and/or strengthening of human resources and institutional capacities in biosafety?

Yes

EN

114. If you answered Yes or Yes, to some extent to question 113, how was this support made available?

Regional channels
Multilateral channels

115. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?

No

EN

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?

No

EN

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?

Yes

EN

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)?

Institutional capacity and human resources
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
Implementation of the documentation requirements under Article 18.2 of the Protocol
Taking into account risks to human health
Liability and redress

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?

Yes

EN

121. In the current reporting period, has your country carried out a capacity-building needs assessment?

Yes

EN

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

Yes

EN

123. If you answered Yes to question 122, which of the following areas still need capacity-building (select all that apply)?

Institutional capacity and human resources
Integration of biosafety in cross-sectoral and sectoral legislation, policies and institutions (mainstreaming biosafety)
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
Scientific, technical and institutional collaboration at subregional, regional and international levels
Sampling, detection and identification of LMOs
Socioeconomic considerations
Scientific biosafety research relating to LMOs
Taking into account risks to human health
Liability and redress

124. If you answered Yes to question 122, has your country prioritized its capacity-building needs?

No

EN

125. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?

Yes

EN

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:

Malawi has received both technical and financial support from development partners specifically from the African Union Development Agency/New Partnership for Africa Development (AUDA/NEPAD) and Program for Biosafety Systems (PBS), to strengthen its technical capacity across various aspects of biosafety. Although Malawi has had access to GEF funding, accessing this funding for biosafety initiatives has remained challenging, as priority is often accorded to impact-focused projects.

EN

Article 23 – Public awareness and participation

127. Is biosafety public awareness, education and/or participation addressed in legislation or policy in your country?

Yes

EN

128. Has your country established a mechanism to ensure public access to information on LMOs?

Yes

EN

Additional Information

The Biosafety Act provide for public access to information on LMOs and the Minister responsible for environment is mandated by laws to create public awareness on biosafety matters.

EN

129. Has your country established a mechanism to facilitate and promote public participation, including consultation, in the decision-making process regarding LMOs?

Yes, to some extent:

EN

Additional Information

The Biosafety Act of 2002 has provision for public participation in decision making regarding applications for general release of LMOs in the environment, however the provision is silent for confined field trials, contained use and importation for food and feed, Furthermore the engagement is not extensive as the application is just circulated in two main newspapers therefore leaving out local communities who cannot read,

EN

130. Has your country informed the public about existing modalities for public participation in the decision-making process regarding LMOs?

Yes, to some extent:

EN

Additional Information

under the Open Forum for Agriculture Biotechnology (OFAB), the country has oriented the media including journalists on biosafety approaches in decision making.

EN

131. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs?

Not applicable (no decisions were taken)

EN

132. In the current reporting period, has your country made the results of decisions regarding LMOs available to the public?

No

EN

133. Has your country informed the public about the means to access the Biosafety Clearing-House?

Yes

EN

134. Has biosafety been addressed or integrated in educational and training programmes in your country?

Yes

EN

135. Does your country have in place a national communication strategy on biosafety?

Yes

EN

Additional Information

Malawi has a Biosafety communication strategy developed in 2021 and its still valid and has been useful in guiding awareness programmes.

EN

136. Does your country have any awareness and outreach programmes on biosafety?

Yes

EN

Additional Information

The NCA has an outreach sectional that is responsible for education, awareness and outreach of all matters related to biodiversity including biosafety and environment in general. Commemorations of IDB always covers elements of biosafety.

EN

137. Does your country currently have a national biosafety website?

No

EN

138. In the current reporting period, has your country accessed resource materials for facilitating and promoting public awareness, education and participation in biosafety?

Yes

EN

139. Please use the space below to provide further details on the implementation of Article 23 in your country:

Malawi’s National Biosafety Clearing-House is still in draft form and is currently operating on the HERMES platform. There is a need to migrate to the Bioland platform in order to enhance its functionality. In the interim, the country utilizes the website of the Competent National Authority (https://ead.gov.mw) to disseminate information and report on activities related to biodiversity and biosafety

EN

Article 24 – Non-Parties

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

No

EN

141. In the current reporting period, has your country imported LMOs from a non-Party?

Yes

EN

142. In the current reporting period, has your country exported LMOs to a non-Party?

No

EN

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?

Yes, always

EN

144. Please use the space below to provide further details on the implementation of Article 24 in your country:

Malawi has imported the following maize events from the United State of America for confined field trials; NK 603, and MON87427 XMON 89034X MIR 162 X NK603.

EN

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?

Yes

EN

146. In the current reporting period, how many cases of illegal transboundary movements of LMOs has your country become aware of?

1 to 4

EN

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?

Yes

EN

148. Please use the space below to provide further details on the implementation of Article 25 in your country:

EN

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?

Yes

EN

150. Has your country used resource materials for taking socioeconomic considerations into account?

No

EN

151. In the current reporting period, have socioeconomic considerations arising from the impact of LMOs been taken into account in decision-making?

Yes, always

EN

152. Please use the space below to provide further details on the implementation of Article 26 in your country:

The country still need capacity to be able to prioritize key socioeconomic issues to be considered during biosafety decision making.

EN

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?

5,000 to 49,999 USD

EN

Article 33 – Monitoring and reporting

Article 33 requires Parties to monitor the implementation of its obligations under the Cartagena Protocol and to report to the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on measures taken to implement the Protocol.

154. Does your country have in place a system to monitor and enforce the implementation of the Cartagena Protocol?

Yes

EN

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;

Yes

EN

b. identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity? (Article 16(5)).

No

EN

c. research and information exchange on any socioeconomics impacts of LMOs? (Article 26(2))

No

EN

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))

No

EN

e. strengthening capacities for the implementation of the Protocol?

No

EN

156. In the current reporting period, has your country engaged in bilateral, regional or multilateral activities for the implementation of the Protocol?

Yes

EN

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

No

EN

b. mechanisms for involving relevant stakeholders from different sectors

Yes

EN

158. Please use the space below to provide further details on biosafety cooperation in your country:

EN

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?

Yes

EN

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?

National measures are partially in place

EN

161. Which instruments are in place for the implementation of the Supplementary Protocol (select all that apply)?

No instruments are in place

Please provide further information on the instruments in place:

EN

162. Does your country have administrative or legal instruments that require response measures to be taken:

a. In case of damage resulting from LMOs?

Yes

EN

b. In case there is sufficient likelihood that damage will result if response measures are not taken?

Yes

EN

163. If you answered Yes to question 162a, do these instruments impose requirements on an operator (select all that apply)?

Yes, the operator must inform the competent authority of the damage
Yes, the operator must take response measures

164. If you answered Yes to question 162a, do these instruments require the operator to take response measures to avoid damage?

Yes

EN

165. If you answered Yes to question 162a or 162b, do these instruments provide for a definition of “operator”?

Yes

EN

166. If you answered Yes to question 165, which of the following could be an ‘operator’ (select all that apply)?

Permit holder
Developer
Producer
Exporter
Importer

167. Has a competent authority been identified for carrying out the functions set out in the Supplementary Protocol?

Yes

EN

Additional Information

Environmental Affairs Department, the CNA for the Cartagena protocol on Biosafety has been identified as the CNA for the Supplementary Protocol.

EN

168. If you answered Yes to question 167, what measures may the competent authority take (select all that apply)?

Identify the operator that caused the damage
Evaluate the damage
Determine response measures to be taken by operator
Implement response measures
Recover costs and expenses of the evaluation of the damage and the implementation of any response measures from the operator

169. Does your country have measures in place to provide for financial security for damage resulting from LMOs?

No

EN

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)?

Yes, in court rulings

172. Have there been any occurrences of damage resulting from LMOs in your country?

No

EN

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:

The current Biosafety law includes provisions on liability and redress in the event of damage caused by living modified organisms, which will be further strengthened during the ongoing revision of the legislation

EN

Other information

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:

The country is currently in the process of revising its biosafety legal framework; however, progress has been slow due to limited financial resources. These constraints have hindered the completion of consultations with key stakeholders on outstanding areas that require consensus and a comprehensive review.

EN

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:

The reporting template was generally easy to complete; however, there were a few areas where the binary “Yes/No” response options were not adequate. For example, in Question 76, where capacity is limited, selecting “Yes” may not accurately reflect the situation on the ground.

EN

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