Africa Biotechnology Regulatory Experience

2023

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Legal Status

Biotech & biosafety policy (2008)
Biosafety Bill still under review by Govt.
National Environment Act 2019
Plant and Seed Act 2007

Competent Authority

Uganda National Council for Science and Technology (UNCST) – National Biosafety Committee

Biosafety Regulations/Guidelines

Guidelines for containment (2006)
National Guidelines for Field Trials of GE Plants (Revised 2011); and SOPs (2012)
Standard Operating Procedures for NBC (Revised 2012).
Inspection Manual (2007)
Genome Editing draft
Import and Export draft

Participating Institutions/Agencies

National Focal Point – Ministry of Water & Environment
Institutional Biosafety Committees (IBCs)
Uganda National Bureau of Standards
National Environment Management Authority
Ministry of Agriculture, Animal Industry and Fisheries
National Drug Authority

Regulatory Review and Approval Process (Currently for Research Only)

ETHIOPIA

Ratification

CBD – July 1994
Cartagena Protocol on Biosafety – January 2004
Nagoya Protocol on Benefit Sharing October 2014
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress – Non-Party

Legal Status

Biosafety (Amendment) Proclamation No.896 /2015
Biosafety Proclamation No.655/2009
Establishment Council of Ministers Regulation No. 411/2017.

Competent Authorities

Ministry of Environment, Forest and Climate Change
Environmental Protection Authority (EPA)
National Bio-safety Advisory Committee

National Focal Point

Environmental Protection Authority (EPA)
Biosafety and Invasive Alien Species Directorate

Biosafety Regulations/Guidelines

Participating Institutions/Agencies

Ethiopian Standards Agency
Ethiopian Institute of Biodiversity
Ministry of Health
Ministry of Agriculture – National Seed Approval Committee
Addis Ababa University,
Ethiopian Biotechnology Institute
Ethiopian Institute of Agricultural Research

Regulatory Review and Approval Processes

CFTs approvals

Insect resistance maize
Drought tolerant maize

Environmental Approvals

Insect-resistant cotton

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SUDAN

Ratification

CBD – January 1996
Cartagena Protocol on Biosafety – September 2005
Nagoya Protocol on Benefit Sharing October 2014
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress – Non-Party

Legal Status

National Biosafety Law No.15 of 2010.
Amendments Law – (Unification of Environment Councils) of 2020
Legislation No.3 of 2020
National Biosafety Policy, 2005

Competent Authority

Sudan National Biosafety Council (SNBC)

National Focal Points

Higher Council for Environment and Natural Resources
National Biosafety Council (SNBC)

Biosafety Regulations/Guidelines

Participating Institutions/Agencies

Ministry of Environment and Physical Development
Ministry of Science and Technology
Sudan International University (SIU)
Sudanese Standards and Metrology Organization

Regulatory Review and Approval Processes

CFTs approvals

Herbicide and insect-resistant cotton

Environmental Approvals

Insect-resistance cotton since 2012

TANZANIA

Ratification

CBD – October 1994
Cartagena Protocol on Biosafety – April 2003
Nagoya Protocol on Benefit Sharing October 2014
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress – Non-Party

Legal Status

Environment Management Act of 2000
The Environmental Management (Biosafety) Regulations, 2009
National Biotechnology Policy (2010)

Competent Authority

The Environment Division, Office of the Vice-President
National Biotechnology Advisory Committee (NBAC)
National Biosafety Committee (NBC)

National Focal Point

The Environment Division, Office of the Vice-President

Biosafety Regulations/Guidelines

Environmental Management Act (Cap. 191);
Guidelines for coexistence between GE and conventional crops

Participating Institutions/Agencies

Tanzania Food and Drugs Authority
Ministry of Education Science and Technology
Tanzania Commission for Science and Technology
Tanzania Bureau of Standards
Institutional Biosafety Committees (IBC)

Regulatory Review and Approval Processes

(Currently for Research Only)

CFTs approvals

Drought-tolerant and insect-resistant maize.

Environmental Approvals

None

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Legal Status

Biotech & biosafety policy (2008)
Biosafety Bill still under review by Govt.
National Environment Act 2019
Plant and Seed Act 2007

Competent Authority

Uganda National Council for Science and Technology (UNCST) – National Biosafety Committee

Biosafety Regulations/Guidelines

Guidelines for containment (2006)
National Guidelines for Field Trials of GE Plants (Revised 2011); and SOPs (2012)
Standard Operating Procedures for NBC (Revised 2012).
Inspection Manual (2007)
Genome Editing draft
Import and Export draft

Participating Institutions/Agencies

National Focal Point – Ministry of Water & Environment
Institutional Biosafety Committees (IBCs)
Uganda National Bureau of Standards
National Environment Management Authority
Ministry of Agriculture, Animal Industry and Fisheries
National Drug Authority

Regulatory Review and Approval Process (Currently for Research Only)

EGYPT

Ratification

CBD September 1994
Cartagena Protocol on Biosafety March 2004
Nagoya Protocol on benefit sharing October 2014
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress – Non-Party

Legal Status

Decree 85 (1995) Establishing the NBC
Decree 136 (1995) Establishing obligation to obtain NBC permit before any work with GMOs
Decree 242 Requires approval by the Supreme Council on Food Safety for GMOs to be imported for food
Decree 1648 Protocol for GM seed registration
Decree 767 To Establish the Competent Authority
Biosafety Draft Bill 2016 – currently at Cabinet Level

Competent Authority

Egyptian Environmental Affairs Agency
Ministry of State for Environmental Affairs

National Focal Point

Minister Advisor of Biodiversity & CBD National Focal Point
Ministry of State for Environmental Affairs, Nature Conservation

Biosafety Regulations/Guidelines

Memorandum of Understanding on the detection of GMOs between the EEAA and the City of Scientific Research and Technological Applications
Memorandum of Understanding on the detection of GMOs between the EEAA and Ministry of Health
Memorandum of Understanding on the detection of GMOs between the EEAA and Cairo University

Participating Institutions/Agencies

The National Food Safety Agency of Egypt (NFSA)
Ministry of Health
Cairo University

Regulatory Review and Approval Processes

CFTs approvals

Insect-resistance maize
Drought-resistant maize

Environmental Approvals

Insect-resistant maize (from 2008 to 2012)

ETHIOPIA

Ratification

CBD – July 1994
Cartagena Protocol on Biosafety – January 2004
Nagoya Protocol on Benefit Sharing October 2014
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress – Non-Party

Legal Status

Biosafety (Amendment) Proclamation No.896 /2015
Biosafety Proclamation No.655/2009
Establishment Council of Ministers Regulation No. 411/2017.

Competent Authorities

Ministry of Environment, Forest and Climate Change
Environmental Protection Authority (EPA)
National Bio-safety Advisory Committee

National Focal Point

Environmental Protection Authority (EPA)
Biosafety and Invasive Alien Species Directorate

Biosafety Regulations/Guidelines

Participating Institutions/Agencies

Ethiopian Standards Agency
Ethiopian Institute of Biodiversity
Ministry of Health
Ministry of Agriculture – National Seed Approval Committee
Addis Ababa University,
Ethiopian Biotechnology Institute
Ethiopian Institute of Agricultural Research

Regulatory Review and Approval Processes

CFTs approvals

Insect resistance maize
Drought tolerant maize

Environmental Approvals

Insect-resistant cotton

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SUDAN

Ratification

CBD – January 1996
Cartagena Protocol on Biosafety – September 2005
Nagoya Protocol on Benefit Sharing October 2014
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress – Non-Party

Legal Status

National Biosafety Law No.15 of 2010.
Amendments Law – (Unification of Environment Councils) of 2020
Legislation No.3 of 2020
National Biosafety Policy, 2005

Competent Authority

Sudan National Biosafety Council (SNBC)

National Focal Points

Higher Council for Environment and Natural Resources
National Biosafety Council (SNBC)

Biosafety Regulations/Guidelines

Participating Institutions/Agencies

Ministry of Environment and Physical Development
Ministry of Science and Technology
Sudan International University (SIU)
Sudanese Standards and Metrology Organization

Regulatory Review and Approval Processes

CFTs approvals

Herbicide and insect-resistant cotton

Environmental Approvals

Insect-resistance cotton since 2012

TANZANIA

Ratification

CBD – October 1994
Cartagena Protocol on Biosafety – April 2003
Nagoya Protocol on Benefit Sharing October 2014
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress – Non-Party

Legal Status

Environment Management Act of 2000
The Environmental Management (Biosafety) Regulations, 2009
National Biotechnology Policy (2010)

Competent Authority

The Environment Division, Office of the Vice-President
National Biotechnology Advisory Committee (NBAC)
National Biosafety Committee (NBC)

National Focal Point

The Environment Division, Office of the Vice-President

Biosafety Regulations/Guidelines

Environmental Management Act (Cap. 191);
Guidelines for coexistence between GE and conventional crops

Participating Institutions/Agencies

Tanzania Food and Drugs Authority
Ministry of Education Science and Technology
Tanzania Commission for Science and Technology
Tanzania Bureau of Standards
Institutional Biosafety Committees (IBC)

Regulatory Review and Approval Processes

(Currently for Research Only)

CFTs approvals

Drought-tolerant and insect-resistant maize.

Environmental Approvals

None

Click here to add your own text

Legal Status

Biotech & biosafety policy (2008)
Biosafety Bill still under review by Govt.
National Environment Act 2019
Plant and Seed Act 2007

Competent Authority

Uganda National Council for Science and Technology (UNCST) – National Biosafety Committee

Biosafety Regulations/Guidelines

Guidelines for containment (2006)
National Guidelines for Field Trials of GE Plants (Revised 2011); and SOPs (2012)
Standard Operating Procedures for NBC (Revised 2012).
Inspection Manual (2007)
Genome Editing draft
Import and Export draft

Participating Institutions/Agencies

National Focal Point – Ministry of Water & Environment
Institutional Biosafety Committees (IBCs)
Uganda National Bureau of Standards
National Environment Management Authority
Ministry of Agriculture, Animal Industry and Fisheries
National Drug Authority

Regulatory Review and Approval Process (Currently for Research Only)

EGYPT

Ratification

CBD September 1994
Cartagena Protocol on Biosafety March 2004
Nagoya Protocol on benefit sharing October 2014
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress – Non-Party

Legal Status

Decree 85 (1995) Establishing the NBC
Decree 136 (1995) Establishing obligation to obtain NBC permit before any work with GMOs
Decree 242 Requires approval by the Supreme Council on Food Safety for GMOs to be imported for food
Decree 1648 Protocol for GM seed registration
Decree 767 To Establish the Competent Authority
Biosafety Draft Bill 2016 – currently at Cabinet Level

Competent Authority

Egyptian Environmental Affairs Agency
Ministry of State for Environmental Affairs

National Focal Point

Minister Advisor of Biodiversity & CBD National Focal Point
Ministry of State for Environmental Affairs, Nature Conservation

Biosafety Regulations/Guidelines

Memorandum of Understanding on the detection of GMOs between the EEAA and the City of Scientific Research and Technological Applications
Memorandum of Understanding on the detection of GMOs between the EEAA and Ministry of Health
Memorandum of Understanding on the detection of GMOs between the EEAA and Cairo University

Participating Institutions/Agencies

The National Food Safety Agency of Egypt (NFSA)
Ministry of Health
Cairo University

Regulatory Review and Approval Processes

CFTs approvals

Insect-resistance maize
Drought-resistant maize

Environmental Approvals

Insect-resistant maize (from 2008 to 2012)