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Cinquième rapport national sur l'application du Protocole de Cartagena sur la biosécurité
(NR5)
last updated: 25 févr. 2026
Informations générales
Personne :Ms Nompumelelo MkhonzaRegistrar: Genetically modified Organisms, Directorate: Genetic ResourcesTéléphone : +27 12 3196382,Télécopieur : +27 12 3196298,E-mail : NompumeleloM@nda.gov.za,Site Web :Organisations reliéesNational Department of Agriculture ()Hamilton St, Harvest House Building,Pretoria, 0001
P/Bag X973, Afrique du SudTéléphone : +27 12 3196382,Télécopieur : +27 12 3196298,E-mail : NompumeleloM@nda.gov.za,Site Web :
To view the current National Focal Point information, click
here.
Government Departments serving on the GMO Executive Council established under the GMO Act, 1997 (Act No. 10 of 1997)
Department of Forestry, Fisheries and the Environment
Department of Agriculture
Department of Science, Technology and Innovation
Department of Health
Department of Trade, Industry and Competition
Department of Water and Sanitation
Department of Employment and Labour
Public Entities
South African National Biodiversity Institute
Biosafety South Africa
Agricultural Research Council
Council for Scientific and Industrial Research
Border Management Authority
GMO technology developers, seed companies, traders and industry representatives
Corteva Agriscience
Syngenta
Bayer
BASF
CropLife SA
South African National Seed Organization (SANSOR)
Limagrain SA
Triotrade
Enza Zaden
South African Cereal & Oilseed Trade Association (SACOTA)
Farmers Associations
Grain SA
GMO Testing Laboratories
University of the Free State
SciCorp Laboratories
Civil Society Organisations
African Centre for Biodiversity (ACB
EN
25 févr. 2026
01 oct. 2019
30 sept. 2025
Non
FR
Article 2 – Dispositions générales
L’article 2 exige que chaque Partie prenne les mesures juridiques, administratives et autres mesures nécessaires et appropriées pour s'acquitter de ses obligations au titre du Protocole
Les mesures nationales sont pleinement en place
FR
- Une ou plusieurs lois nationales pour la prévention des risques biotechnologiques
- Une ou plusieurs réglementations nationales sur la prévention des risques biotechnologiques
- Une ou plusieurs séries de directives sur la prévention des risques biotechnologiques
- D’autres lois, réglementations ou directives qui s’appliquent indirectement à la prévention des risques biotechnologiques
Further details provided in section 13.
EN
Oui
FR
Oui
FR
Non
FR
Oui
FR
10 ou plus
FR
Oui
FR
South Africa has put in place legal and administrative measures for the effective implementation of its obligations under the Cartagena Protocol on Biosafety, such include the following legal frameworks: • Genetically Modified Organisms Act, 1997 (Act No. 15 of 1997), the principal legislation for the regulations of GMOs, provides for an administrative system through which authorizations for any activity involving GMOs are granted through the issuance of the relevant permits. This Act was amended to fully align the SA legislation to the Protocol (GMO Amendment Act, 2006 (Act No. 23 of 2006). • National Environmental Management Act, 1998 (Act No. 107 of 1998) (provides for environmental impact assessment of selected categories of GMOs). • National Environmental Management Biodiversity Act, 2004 (Act No. 10 of 2004) (provides for long term monitoring of potential impacts of GMOs in commercial production) • Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) (deals with safety standards as well as labelling of certain class of foodstuffs derived from GMOs) • Consumer Protection Act, 2008 (Act No. 68 of 2008) (deals with labelling of GMOs) Several guidelines are in place to support the implementation of the biosafety framework in South Africa, which include: • Environmental Risk Assessment Framework for Genetically Modified Organisms: a guidance document (2008) • Risk analysis of Contained Use Research and Development activities with Genetically Modified Aquatic Organisms in South Africa (2011) • ERA guidance document for GM Pharmaceuticals (unpublished) • Guidance on compositional analysis and feeding studies data requirements for commodity clearance and general release applications, with emphasis on stacked events • Guideline for submission of annual reports • Guidelines for compiling a public notification • Guideline for submission of time extension requests for current permits issued under the GMO Act • Standard operating procedures with regard to regulation 4 of the GMO Act • Standard operating procedures with regard to regulation 2(2) of the GMO Act • Guidelines for working with genetically modified organisms • Guidelines for use by the Advisory Committee when considering applications • The Post-Market Monitoring Framework for Genetically Modified Organisms (GMOs) in South Africa (unpublished) There are over 21 permanent staff members in the various government departments serving on the GMO Act Executive Council, namely: Department of Agriculture (DoA), Department of Forestry, Fisheries and the Environment (DFFE), Department of Health (DoH), Department of Water and Sanitation (DWS), Department of Trade, Industry and Competition (the dtic), Department of Science, Technology and Innovation (DSTI) as well as the Department of Employment and Labour (DEL). The staff in the Office of the Registrar at the DoA, which is the Competent National Authority, are responsible for administering the GMO Act, 1997 (Act No 15 of 1997), including performing the administrative functions required under the Protocol. Staff in the other departments have biosafety as part of their overall functions. The South African National Biodiversity Institute (SANBI) has a unit responsible for the assessment, monitoring, and reporting of any impacts of GMOs released into the environment. Furthermore, the GMO Act makes provision for the appointment of inspectors responsible for monitoring compliance to permit conditions as stipulated in GMO permits issued in terms of the GMO Act, among other responsibilities. Biosafety has been integrated into various national sectoral and cross-sectoral strategies, action plans, programmes, policies or legislation, including Agriculture, Environment, Health as well as Science, Technology and Innovation. The White Paper on the Conservation and Sustainable Use of South Africa’s Biodiversity gazetted in 2023, includes a policy objective on biosafety with the focus on enhancing implementation of biosafety measures to minimise risk to biodiversity. South Africa’s second generation National Biodiversity Strategy and Action Plan for the period 2015-2025 which incorporated biosafety related activities, is being reviewed and updated to align with the Kunming-Montreal Global Biodiversity Framework (KM-GBF). The 3rd iteration of the NBSAP, which will cover a ten year period from 2026 includes a biosafety thematic area with a national target and high level actions to achieve the target, in line with Target 17 of the KM-GBF. Furthermore, a detailed national plan with key activities has been developed to facilitate implementation of the two plans under the Protocol, i.e. Implementation Plan and Capacity building Action Plan. The budget allocation for biosafety is mainly supported through the National Treasury system. The budget is largely sufficient for essential services and functions. However, there is a need to mobilise additional resources from various sources to supplement government fiscus, particularly to fund GMO post release assessment, monitoring and research aimed at filling knowledge gaps and informing (strengthen) policy and regulatory processes.
EN
Article 5 – Produits pharmaceutiques
Oui
FR
The transboundary movement of pharmaceuticals which are LMOs is managed like any other activity. The regulatory framework allows for a cross-sectoral assessment of all activities, as a result, LMOs which are pharmaceuticals to humans would also be assessed by the South Africa Health Products Regulatory Authority, an entity of the National Department of Health.
EN
Article 6 – Transit et utilisation en milieu confiné
Oui
FR
Oui
FR
Oui
FR
Contained use of LMOs is regulated under the GMO Act; and implemented through provisions in the GMO Act Regulations (R No. 120 of 2010). However, GMOs used under conditions of contained use for research/development and academic purposes, at containment levels 1 and 2 within a facility registered in accordance with the GMO Act; are exempted from the requirement of a permit in terms of the regulations. A contained use permit is required once the research is scaled up from basic research to product development, or when the containment level is above 2. South Africa (SA) has a transit policy; this policy holds that LMOs may only transit the territory of SA to another country if the receiving country confirms their acceptance of the consignment.
EN
Articles 7 à 10 : Accord préalable donné en connaissance de cause et introduction intentionnelle d’OVM dans l’environnement
Oui
FR
Oui
FR
Oui
FR
Oui, toujours
FR
Oui, toujours
FR
Oui, toujours
FR
Non
FR
Oui
FR
50
FR
- Approbation de l’importation / utilisation d’un ou plusieurs OVM sous conditions (100)
- Demande de renseignements supplémentaires pertinents (50)
Oui, toujours
FR
10 ou plus
FR
Oui, toujours
FR
The GMO Act provides for the decision-making for the first and subsequent transboundary movement of LMOs. All GMO applications are subjected to a multidisciplinary process of scientific evaluation. The Advisory Committee (AC), comprising of scientific experts is responsible for the evaluation of risk assessment data of all applications, following which a recommendation is submitted to the Executive Council (EC). Decision to permit an activity or not is made by the Executive Council (EC), an intergovernmental decision-making body. The EC considers the recommendations of the AC, compliance with various policies and comments from members of the public or interested parties. The decision-making process (especially timelines) is impacted by the following: a. The involvement of different government departments b. The legal prescript of consensus decision-making c. Inadequate information provided by the applicants. d. The potential impact of new scientific information which needs to be assessed.
EN
Article 11 – Procédure à suivre pour les organismes vivants modifiés destinés à être utilisés directement pour l'alimentation humaine ou animale, ou à être transformés
Oui
FR
Oui
FR
10 ou plus
FR
Oui
FR
10 ou plus
FR
The GMO Act provides for the decision-making for LMOs intended for direct use as food or feed, or for processing. All applications for LMOs intended for direct use as food or feed, or for processing are subjected to a multidisciplinary process of scientific evaluation. The Advisory Committee (AC), comprising of scientific experts is responsible for the evaluation of risk assessment data of all applications, following which a recommendation is submitted to the Executive Council (EC). Decision to permit an activity or not is done by the Executive Council (EC), an inter-governmental decision-making body.
EN
Article 12 – Examen des décisions
Oui
FR
Non
FR
The GMO Act makes provision for the Executive Council, an inter-governmental decision-making body, to reconsider any decision taken by it, if it receives new and relevant scientific or technological evidence about activities conducted in terms of the GMO Act, which may have an impact on the risk assessment and risk management measures. In the current reporting period, South Africa has not reconsidered a decision taken regarding an intentional transboundary movement of an LMO. The GMO Act also makes provision for an appeal to be lodged against a decision taken in terms of the Act, in which case an appeal board appointed on a case-by case, may confirm, set aside, substitute or amend the decision which is subject to the appeal, taking into consideration new scientific or technical evidence or any other information that is, in the opinion of the appeal board, directly applicable to the appeal.
EN
Article 13 – Procédure simplifiée
Non
FR
Non
FR
FR
Article 14 – Accords et arrangements bilatéraux, régionaux et multilatéraux
5 à 9
FR
South Africa did not enter into any new biosafety related agreements during the reporting period, however, implements its obligations under various existing bilateral, regional and multilateral agreements and arrangements. South Africa is signatory to several multilateral agreements that directly or indirectly address biosafety, including: • Cartagena Protocol on Biosafety • Convention on Biological Diversity • Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization • Codex Alimentarius Commission • International Plant Protection Convention • World Trade Organization (WTO) Agreements South Africa is also a member of the African Union, including related agreements such as the African Continental Free Trade Area (AfCFTA) agreement. Furthermore, South Africa is a member of the regional economic communities (RECs), notably, the Southern African Development Community (SADC), including related Protocols and Agreements.
EN
In 2018, South Africa embarked on a process to develop a Regional Engagement Strategy for Biosafety with the objective to strengthen South Africa’s contribution to the region’s biosafety efforts by providing support to African countries, based on expressed needs and through various platforms, in setting up and implementing National Biosafety Frameworks (NBF). The Strategy consists of a vision which is geared towards an “Effective and clear policies on the regulation of modern biotechnology across Africa to ensure sustainable use and protection of biodiversity, while enhancing trade, food security and cooperation in biosafety”. The strategy is guided by the four SOs as outlined below: SO1: Support the development and implementation of National Biosafety Frameworks; SO2: Strengthen capacity for regulating GMOs; SO3: Promote regional dialogue on biosafety; and SO4: Facilitate information sharing Activities undertaken under the Strategy include: • Participation in the development of the SADC Biodiversity Strategy and Action Plan (BSAP) for the period 2025-2035, which is aligned to the goals and targets of the Kunming-Montreal Global Biodiversity Framework and features biosafety elements. • Participation in the African Group of Negotiators discussions on biosafety in preparation for and during negotiations of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety and for relevant agenda items under the Conference of the Parties to the Convention on Biological Diversity and its subsidiary bodies, i.e. the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) and Subsidiary Body on Implementation (SBI), including the biosafety target during the drafting of the Kunming-Montreal Global Biodiversity Framework adopted in December 2022. Biosafety South Africa, an entity of the DSTI, also collaborated with various institutions in Africa and globally on biosafety, including: • Kenya National Biosafety Authority, collaboration on new breeding techniques (NBT) regulation. • Zambia, National Biosafety Authority, collaboration on GMO and NBT regulation. • Namibia, bilateral R&D agreement, collaboration on NBT regulation. • Angola, discussions on GMO regulation development. • Serving as a member of AUDA-NEPAD expert oversight committees • Development of a GMO communication toolbox under the Food and Agriculture Organization. • Organising the International Society for Biosafety Research (ISBR), biennial biosafety symposia with worldwide representation and collaboration.
EN
Articles 15 et 16 – Évaluation des risques et gestion des risques
Oui
FR
- Pour les importations d'OVM destinés à être introduits intentionnellement dans l'environnement
- Pour les importations d'OVM destinés à être utilisés directement pour l'alimentation humaine ou animale, ou à être transformés
- Pour les décisions concernant une utilisation sur le territoire nationale, y compris la mise sur le marché, d’OVM pouvant faire l’objet de mouvements transfrontières et destinés à être utilisés directement pour l'alimentation humaine ou animale, ou à être transformés
- Pour les importations d’OVM destinés à une utilisation en milieu confiné
Oui
FR
Oui
FR
50 à 99
FR
- OVM destinés à une utilisation en milieu confiné (conformément à l’article 3)
- OVM destinés à une introduction intentionnelle dans l'environnement, ou à des essais expérimentaux ou sur le terrain
- OVM destinés à une introduction intentionnelle dans l'environnement à des fins commerciales
- OVM destinés à être utilisés directement pour l'alimentation humaine
- OVM destinés à être utilisés directement pour l'alimentation animale
- OVM destinés à être transformés
Oui, toujours
FR
Oui, dans tous les cas
FR
Non
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Non
FR
Oui
FR
Operationalising protection goals into assessment endpoints.
EN
Oui
FR
Oui
FR
Oui
FR
Oui
FR
10 à 49
FR
Non
FR
1 à 9
FR
Non
FR
1 à 9
FR
Non
FR
Oui
FR
- Manuel sur l’évaluation des risques présentés par les OVM, élaboré par le Secrétariat de la CBD 3
- Directives sur l'évaluation des risques présentés par les OVM, élaborées par le Forum en ligne et le GSET sur l'évaluation des risques et la gestion des risques 4
Risk Assessment is an integral part of South Africa’s regulatory framework, as provided for in the GMO Act. South Africa’s approach is multifaceted. Applicants are required to submit risk assessments as part of the dossiers. This includes the common format for risk assessment in accordance with Annex III of the Cartagena Protocol on Biosafety. The AC reviews the risk assessments submitted by the applicants and conduct risk assessment to confirm the accuracy of the conclusion made by the applicant and to make recommendations to the EC. The EC reviews the risk assessments submitted by the applicants, and considers the recommendations of the AC in their assessment of the applications to inform decision making. South Africa developed “Environmental Risk Assessment (ERA) Framework for genetically modified: a guidance document” in 2008. Other supplementary guidance include: • Risk analysis of contained use research and development activities with genetically modified aquatic organisms in South Africa (2011); • Environmental Risk Assessment Framework: Guidance Document for Genetically Modified Plant-Made Pharmaceuticals (2016) (unpublished); • The Post-Market Monitoring Framework for Genetically Modified Organisms (GMOs) in South Africa (unpublished) Various resources, including certain elements of the guidance documents development under the Cartagena Protocol on Biosafety have informed the review and updating of existing national guidance documents, such as incorporating problem formulation phase and defining assessment endpoints. Genetically Modified Organisms approved for commercial release are released under a conditional general release permit where permit holders are required to conduct case specific monitoring for a certain period of time to confirm the findings of the ERA. This is further supported through the long term impact based assessment, monitoring and reporting mandated to the South African National Biodiversity Institute (SANBI) through the National Environmental Management: Biodiversity Act, 2004 (Act No. 10 of 2004). The SANBI published the first national report on GMO assessment and monitoring, titled “An initial assessment of the impacts on biodiversity from GMOs released into the environment in South Africa 2021” Resources, skills and capacity for GMO monitoring are limited within SANBI. South African regulators participated in risk assessment training workshops: • 1st and 2nd Global Congress On New and Emerging Genetic Biocontrol Technologies, Kenya, 2023 and Ghana, 2025 respectively. • International Training Course on Risk Assessments of Living Modified Organisms, Brazil – June 2025 • Global risk assessment workshop, Canada, 2023 The SANBI’s GMO assessment unit trained four interns in biosafety and GMO monitoring, addressing the scarcity of skills in this niche field. The SANBI participated and presented at the “Workshop on Post-Release Environmental Monitoring of Gene Drive-Modified Mosquitoes” that took place near Washington DC in Reston, Virginia, 8 June to 17 June 2024. The SANBI expert formed part of the Resource Team for the 5-day International Training Course on Risk Assessments convened by the Secretariat of the CBD in June 2025 to support capacity-building and development activities on risk assessment of LMOs, with a focus on LMOs containing engineered gene drives Biosafety South Africa provided risk assessment training to other countries, including Eswatini and Mozambique. South Africa, through SANBI, formed part of the Ad Hoc Technical Expert Group on risk assessment and risk management, July 2025.
EN
Article 17 – Mouvements transfrontières non intentionnels5 et mesures d’urgence
5 Conformément à la définition opérationnelle adoptée dans la décision CP VIII / 16, un « mouvement transfrontière non intentionnel est un mouvement transfrontière d'un organisme vivant modifié qui a traversé par inadvertance les frontières nationales d'une Partie où l'organisme vivant modifié a été libéré, et les exigences de l'article 17 du Protocole ne s'appliquent à ces mouvements transfrontières que si l'organisme vivant modifié en question est susceptible d'avoir des effets négatifs importants sur la conservation et l'utilisation durable de la diversité biologique, en tenant compte également des risques pour la santé humaine, dans les États touchés ou potentiellement affectés. »
Non
FR
Aucun
FR
Aucun
FR
Non
FR
Although South Africa has a designated contact point for emergency measures (Article 17), capacity is required to trace unintentional transboundary movement.
EN
Article 18 – Manipulation, transport, emballage et identification des OVM
Oui
FR
Non
FR
Oui
FR
Documentation propre aux OVM
FR
Oui
FR
Documentation propre aux OVM
FR
Oui
FR
Documentation propre aux OVM
FR
Oui
FR
Aucun
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
10 à 49
FR
Oui
FR
Oui
FR
Oui
FR
1 à 4
FR
1 à 4
FR
South Africa is required to take measures ensuring that LMOs subject to intentional transboundary movement (exports) are accompanied by documentation identifying the LMOs and providing contact details of persons responsible for such movement. The details of these requirements vary according to the intended use of the LMOs but require that certain basic requirements be fulfilled. These are: • A letter indicating the intent of the potential exporter • Completed application forms • Payment of appropriate fees in terms of the GMO Act • Notification of the country of import into whose environment the LMO will be introduced intentionally • Affidavit from applicant • Acknowledgement and confirmation by the Party of Import to the intended introduction of the LMO to its environment. However, failure by the Party of Import to acknowledge receipt of a notification shall not imply its consent to the proposed import. • A permit for exportation is only issued when the Registrar of the GMO Act has received written consent (original) from the Party of Import or via the potential exporter. The export permit will contain at least the following information: Identification of the LMO (relevant traits/characteristics of the LMO); Requirements for the safe handling, storage, transport and use; Contact details for further information on the exporter, the importer; and A declaration that the transboundary movement is in accordance with the Protocol’s requirements. South Africa has four GMO testing laboratories registered under the GMO Act, namely: • The GMO Testing Facility of the University of the Free State (UFS) • SciCorp Laboratories • Intertek Agriculture laboratory • Greenhill Laboratories The UFS GMO Testing Facility is the longest running diagnostic laboratory providing GMO testing services. The facility was established in 2004 and provides commercial service for GMO detection to enable the food industry to comply with national and international regulations. The facility performs identification and quantification of all GM crop events approved in South Africa for which there are validated testing methods and certified reference material. The facility employs six scientists who have been trained and are competent in LMO detection. The facility serves as the hub of the Southern African Network of GM Detection laboratories (SANGL) which comprises of laboratories from Angola, Botswana, Democratic Republic of Congo, Eswatini, Lesotho, Madagascar, Namibia, Malawi, Mozambique, South Africa, Tanzania, Zambia and Zimbabwe. During the reporting period the laboratory also used its experience and expertise from years of providing GMO testing services to train laboratory personnel from various facilities in South Africa and other African countries in detection, sampling and analysis of GMOs, including training of trainers to capacitate them on training others in the field. Training workshops undertaken during the reporting period include: • The LMO qualitative detection. MCP-ICLT Training of Trainers Workshop on LMO qualitative detection, 5 to 8 November 2019, GMO Testing Facility, Bloemfontein, South Africa. • The LMO quantitative detection. MCP-ICLT Training of Trainers Workshop on LMO quantitative detection, 06 May to 02 June 2022, online. • Detection, sampling and analysis of LMOs and their products. Ministry of Environment for the Implementation of the National Biosafety Framework Project, 07-09 August 2023, Amman, Jordan. • The LMO detection and Biosafety decision-making. Strengthening the implementation of National Frameworks in Southern Africa (SINBF), 16-18 June 2025, Windhoek, Namibia. • The GMO detection method verification and measurement of uncertainty. National Commission on Research, Science and Technology of Namibia, 29 September to 8 October 2025, Online. The SciCorp Laboratories is a private laboratory that conducts qualitative and quantitative GMO testing and the facility meets the scientific and laboratory testing needs of the agricultural and food industries. The GMO testing facilities registered in South Africa have ISO17025 accreditation in terms of the International Organization for Standardization The lack of validated detection methods and certified reference material for some of new GM events poses a challenge to provision of detection and identification services for regulatory compliance.
EN
Article 19 – Autorités nationales compétentes et correspondants nationaux
Sans objet, seulement une autorité nationale compétente a été désignée
FR
Oui
FR
Oui
FR
Further details provided in section 101
EN
The Department of Agriculture (DoA) is the Competent National Authority (CNA) and administers the GMO Act. The Department of Forestry and Fisheries and the Environment (DFFE) is the National Focal Point (NFP) and liaises with the Secretariat on all matters pertaining to the Cartagena Protocol on Biosafety. The GMO Act makes provision for the appointment of the Executive Council, an intergovernmental decision-making body, and the CNA and NFP are part of the EC. In deciding to permit or reject an activity the EC considers, amongst others, compliance with relevant policies, legislation, strategies of the sector and inputs from members of the public or interested parties.
EN
Article 20 – Échange d’informations et Centre d’échange pour la prévention des risques biotechnologiques
Informations disponibles et transmises au Centre d’échange pour la prévention des risques biotechnologiques
FR
Informations disponibles et transmises au Centre d’échange pour la prévention des risques biotechnologiques
FR
Informations disponibles, mais non transmises au Centre d’échange pour la prévention des risques biotechnologiques
FR
Informations disponibles et transmises au Centre d’échange pour la prévention des risques biotechnologiques
FR
Information non disponible
FR
Informations disponibles, mais non transmises au Centre d’échange pour la prévention des risques biotechnologiques
FR
Information non disponible
FR
Information non disponible
FR
Informations disponibles et transmises au Centre d’échange pour la prévention des risques biotechnologiques
FR
Information non disponible
FR
Informations disponibles et transmises au Centre d’échange pour la prévention des risques biotechnologiques
FR
Informations disponibles et transmises au Centre d’échange pour la prévention des risques biotechnologiques
FR
Information non disponible
FR
Information non disponible
FR
Information non disponible
FR
Information non disponible
FR
Informations disponibles et transmises au Centre d’échange pour la prévention des risques biotechnologiques
FR
Contained use of LMOs is regulated under the GMO Act; and implemented through provisions in the GMO Act Regulations (R No. 120 of 2010). However, GMOs used under conditions of contained use for research and academic purposes, at containment levels 1 and 2 within a facility registered in accordance with the GMO Act; are exempted from the requirement of a permit in terms of the regulations.
EN
Oui
FR
Oui, dans certains cas
FR
Non
FR
Non
FR
The Registrar of the GMO Act from the Department of the Agriculture is currently the National Focal Point for the BCH. South Africa currently utilises the Global BCH and the website of the Department of Agriculture as information sharing platforms. Information that is currently on the global BCH include national laws and regulations, previous national reports, Annex III Risk Assessments, and decisions taken on commodity clearance and general release applications. The risks assessments that are made available on the Central Portal are the non-confidential business annex III risk assessments submitted by applicants.
EN
Article 21 – Informations confidentielles
Oui
FR
Oui, toujours
FR
In South Africa, the GMO applications are submitted in two versions with confidential business information (CBI) and non-confidential business information. The non-CBI is made available for public scrutiny under the Promotion of Access to Information Act, 2000 (PAIA). Non-Confidential Business Information copy (NON-CBI copy), is a copy where any information that is regarded as confidential business information is deleted. The GMO Act provides that the following information shall not be kept confidential: (a) The general description of the GMOs, the name and address of the applicant, and the purpose of the contained use or release and the location of use; (b) The methods and plans for the monitoring of the GMOs and for emergency measures in the case of an accident. The summary of scientifically based risk assessment of the impact on the environment and human and animal health.
EN
Article 22 – Renforcement des capacités
Oui, dans une certaine mesure
FR
Further details provided in section 126.
EN
Oui
FR
- Voies bilatérales
- Voies régionales
- Voies multilatérales
Oui
FR
Further details provided in section 126
EN
- Voies bilatérales
- Voies régionales
- Voies multilatérales
Non
FR
Oui
FR
- Capacités institutionnelles et ressources humaines
- Intégration de la prévention des risques biotechnologiques dans la législation, les politiques générales et les institutions intersectorielles et sectorielles (intégration de la prévention des risques biotechnologiques)
- Évaluation des risques et autre expertise scientifique et technique
- Gestion des risques
- Sensibilisation, participation et éducation du public en matière de prévention des risques biotechnologiques
- Échange d'informations et gestion des données, y compris participation au Centre d'échange pour la prévention des risques biotechnologiques.
- Collaboration scientifique, technique et institutionnelle aux niveaux infrarégional, régional et international
- Identification des OVM, y compris leur détection
- Mesures pour gérer les mouvements transfrontières non intentionnels et/ou illicites d’OVM
- Recherche scientifique en matière de prévention des risques biotechnologiques liés aux OVM
- Prise en compte des risques pour la santé humaine
Oui
FR
Oui
FR
Oui
FR
- Capacités institutionnelles et ressources humaines
- Évaluation des risques et autre expertise scientifique et technique
- Gestion des risques
- Collaboration scientifique, technique et institutionnelle aux niveaux infrarégional, régional et international
- Transfert de technologie
- Échantillonnage, détection et identification des OVM
- Mesures pour gérer les mouvements transfrontières non intentionnels et/ou illicites d’OVM
- Recherche scientifique en matière de prévention des risques biotechnologiques liés aux OVM
- Prise en compte des risques pour la santé humaine
- Responsabilité et réparation
Oui
FR
Oui
FR
Capacity building trainings conducted/ initiatives implemented: • South Africa convened the third national training workshop for the UNEP-GEF Project for Sustainable Capacity Building for Effective Participation in the BCH (BCH III) in March 2020 • The SANBI’s GMO assessment unit supported two students with projects focussing on aspects relating to biosafety • The SANBI trained four interns on biosafety and GMO monitoring, addressing the scarcity of skills in this niche field. • The SANBI as the CBD Subregional Technical Cooperation Support Centre conducted a capacity building needs assessment for the KM-GBF, including Target 17. • Biosafety South Africa provided training to National Biosafety Authorities (NBAs), students, industry organisation and start-up companies, incubators, universities and research institutions on regulation and compliance, risk analysis and science communication. • The Advisory Committee held a workshop on tiered risk assessment for new genomic techniques under the GMO Act in October 2025. Capacity building training South African biosafety personnel participated in: • South Africa participated in the Michigan State University biosafety training held in 2022, 2023 and 2024 • 1st and 2nd Global Congress On New and Emerging Genetic Biocontrol Technologies, Kenya, 2023 and Ghana, 2025 respectively. • International Training Course on Risk Assessments of Living Modified Organisms, Brazil – June 2025 • Global risk assessment workshop, Canada, 2023 • Workshop on Post-Release Environmental Monitoring of Gene Drive-Modified Mosquitoes” that took place near Washington DC in Reston, Virginia, June 2024. Capacity building training South Africa provided to other countries: • South African regulators hosted the Ethiopian Biosafety Committee Delegates as part of their Study Tour in March 2020, where South Africa shared national experience on implementing a national biosafety framework. • The SANBI expert formed part of the Resource Team for the 5-day International Training Course on Risk Assessments convened by the Secretariat of the CBD in June 2025 • The SANBI formed part of the Ad Hoc Technical Expert Group on risk assessment and risk management, July 2025 • Biosafety South Africa provided training and support to various grouping, including regulators, pre- and postgraduate students, research groups and industry groups in the areas of regulatory framework development, regulation and compliance, risk analysis and science communication. The target includes International and Regional Development Agencies, National Government Departments, National Biosafety Authorities (NBAs), industry organisations, incubators, start-ups, universities and research institutions. Countries reached include Kenya, Zambia, Eswatini, Namibia, Angola, Mozambique and Brazil. • The Agricultural Research Council collaborated with the African Agricultural Technology Foundation (AATF) in April 2024 to host the second biosafety regulators retreat attended by delegates from 16 African countries, including Madagascar, Angola, Namibia, DRC, Botswana, Zambia, Malawi, and Mozambique.
EN
Article 23 – Sensibilisation et participation du public
Oui
FR
Oui
FR
further details provided in section 139.
EN
Oui
FR
Oui
FR
1 à 4
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Further details provided in section 139
EN
Oui
FR
Further details provided in section 139.
EN
Oui
FR
www.nda.gov.za
EN
Oui
FR
The GMO Act makes provision for public notification of proposed release or commodity clearance (FFP) of genetically modified organisms through printed media and/or other means of effective communication. The public can access the following: • The non-confidential business information (non-CBI) copy of GMO applications under the Promotion of Access to Information Act, 2000 (PAIA). • Information on regulated GMO activities on the website of the Department of Agriculture (https://www.nda.gov.za/index.php/core-business/agricultural-production/planthealth/genetic-resources) The biosafety communication strategy is primarily implemented by Biosafety South Africa based on resources availability and for specific needs. The strategy was developed to create awareness of the biosafety systems in place in South Africa to ensure safe and sustainable research, development, regulation and commercialisation of GM and related biotechnologies. Through the communications strategy, there are school outreach programs, young professionals, academia and general public outreach programs through various communication channels including radio and social media platforms. Awareness raising activities undertaken by Biosafety South Africa include: • Organised and collaborative public engagements - such as the Biosafety SA’s biennial “Sustainable Bio-innovation Symposium”( 2019, 2020 and 2023); Exhibitions at NAMPO; SciFest; Science Forum SA; World Science Forum; and BIO Africa; • Science and risk communication advocacy, strategy development, and resources; • Traditional media interviews and expert database with an average of five articles per year in printed and online magazines and two radio interviews; • Awareness on social media platforms such as Biosafety SA, Bioeconomy SA Portal, ISBR LinkedIn, Facebook, and Instagram profiles with 1-2K followers each; and • Science communication research support, during the reporting period, Biosafety SA, supported three (3) postgraduate students and sponsored communication events. GMO Industry Stewardship Promotion and trade facilitation Industry association, Crop Life South Africa (CLSA) focuses on advocacy efforts at ensuring compliance to stewardship and responsible use of available Insect Resistance (IR) and Herbicide Tolerance (HT) tolerant traits by end users, notably smallholder farmers. The advocacy efforts have focused on Integrated Pest Management (IPM), Personal Protective Equipment (PPE), good agricultural practices, and refugia management to raise awareness and understanding of the technology, how it works, and what responsible use looks like. Stewardship advocacy has included farmer-focused campaigns with activities such as: • Biotech maize demonstration trials (Limpopo province); • Smallholder farmer training (Limpopo province); • Farmer indabas (Food for Mzansi); • Extension officer training (Limpopo province); and • Media publications, advocacy, and the development of resource material in several local languages. Industry association further provide support to trade association stakeholders to maintain synchronization of biotech trait approvals between South Africa and key trading partners and clarifying import documentation requirements in targeted export markets to ensure adherence to protocol and regulatory provisions relating to transboundary movement of LMOs. Crop Life South Africa (CLSA) and South African Cereals and Oilseeds Association (SACOTA) held workshops and roundtables with representatives from Argentina, Brazil, and China. Civil Society The African Centre for Biodiversity (ACB) implements various programmes focusing on horizon scanning, research and analysis, communications, capacity building, information sharing and advocacy work. The ACB facilitates consultations and dialogues with various groups to inform public awareness and participation in decision making. The ACB produces various resources including media alerts, blogs, briefing papers, statements, public comments, fact sheets, news, objections, petitions, press releases, reports and videos.
EN
Article 24 – Non-Parties
Non
FR
Oui
FR
Oui
FR
Oui, toujours
FR
FR
Article 25 – Mouvements transfrontières illicites 7
7Conformément à la définition opérationnelle adoptée dans la décision CP VIII / 16, « les mouvements transfrontières illicites sont des mouvements transfrontières d'organismes vivants modifiés qui contreviennent aux mesures nationales d'application du Protocole adoptées par la Partie concernée »
Oui
FR
Aucun
FR
FR
Article 26 – Considérations socioéconomiques
Oui
FR
Oui
FR
Oui, toujours
FR
South Africa’s biosafety regulatory process includes socio-economic considerations. It is designed to ensure alignment with national policy/regulation, through representation by several government departments in the decision-making committee. Hence unless a socio-economic impact study is triggered (i.e. commissioned, reported and published), this process is not designed to be a peer-reviewed process. However, the South African regulatory framework, through the GMO Act seeks to provide measures to promote the responsible development, production, use and application of LMOs. In this, decision-making takes into consideration various aspects including biosafety of LMOs to humans and the environment as well as socio-economic considerations. Socio-economic considerations are informed by a number of elements and South Africa, through the Department of Science, Technology and Innovation, have developed a Bio economy Strategy in 2013 which advocates the adoption of science and technology, including harnessing modern biotechnology, to address the country’s socio-economic development goals of poverty reduction and improved quality of life, while ensuring continued economic growth. In addition, the Bio-economy Strategy’s objective for agriculture is to strengthen agricultural biosciences innovation to ensure food security, enhance nutrition and improve health, as well as enable job creation through the expansion and intensification of sustainable agricultural production and processing. These interventions should be driven by strategic need as well as market demand. The strategy also advocates for biotechnology research and utilisation of skills and solutions emerging from the research to be effectively transferred to emerging, small-scale and commercial farmers. It further calls for Science councils and universities to respond by developing human capacities and technological capabilities; and industry should participate directly to guide and extract value from developments and to create new, globally competitive products that create jobs and wealth and improve the quality of life of South Africans.
EN
Article 28 – Mécanisme de financement et ressources financières
5 000 à 49,999 USD
FR
Article 33 – Suivi et établissement de rapports
L'article 33 exige que les Parties assurent un suivi du respect de leurs obligations au titre du Protocole de Cartagena et rendent compte à la Conférence des Parties siégeant en tant que réunion des Parties au Protocole de Cartagena sur les mesures prises pour appliquer le Protocole.
Oui
FR
Coopération
Le but B.4 du plan de mise en œuvre pour le Protocole de Cartagena aborde la coopération et la coordination sur les questions relatives à la prévention des risques biotechnologiques aux niveaux national, régional et international. Les questions relatives à ce but sont indiquées ci-dessous, y compris les questions relatives à la coopération au titre de différentes dispositions du Protocole.
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
Oui
FR
South Africa cooperates at various levels on matters relating to implementation of the Protocol. At national level, government departments serving on the EC cooperate on all biosafety matters, including decision-making on GMO activities, development of policies, legislation, regulations and guidelines, as well as participation in various forums. At regional level, South Africa is a member of SADC and AU and cooperation includes: • Participating in regional and continental engagements on various biosafety matters, including developing positions for COP-MOP negotiations, and participation during the negotiations. • Cooperating on the development of strategies and plans, such as the SADC biodiversity strategy and action plan aligned to the KM-GBF • Participation in the Southern African Network of GMO Detection Laboratories The South African National Biodiversity Institute (SANBI) hosts the Subregional Technical and Scientific Cooperation (TSC) Support Centre for Southern Africa, servicing Angola, Botswana, Lesotho, Malawi, Mozambique, Namibia, Seychelles, South Africa, and Zimbabwe by facilitating collaboration, capacity building, and the exchange of technical expertise to address environmental challenges affecting Southern Africa. The SANBI undertook a capacity needs assessment for all the represented countries between July and September 2025, including in the area of biosafety. South Africa is a member of the African Ministerial Conference on the Environment (AMCEN) and hosted the 17th Ordinary Session from 11 to 15 November 2019, under the theme “taking action for Environment Sustainability and Prosperity in Africa”, whose focus was mainly to support the development of the Kunming-Montreal Global Biodiversity Framework, including Target 17. At international level, South Africa cooperates with various countries, such as the Group of Like-Minded Megadiverse Countries, on biosafety topics of common interest. South Africa is an active member of the G20 and held the Presidency of the G20 from 1 December 2024 to 30 November 2025. Discussions highlighted biotechnology as key to sustainable, innovation-driven growth and the role of biodiversity for sustainable development, also emphasising the conservation of biodiversity, the sustainable use of resources, and the just and equitable sharing of the benefits arising from the use of genetic resources in line with the objectives of the CBD. South Africa is a member of BRICS, representing Brazil, Russia, India, China, and South Africa and cooperates on biosafety matters including discussions under the Protocol. In relation to the involvement of indigenous peoples and local communities and relevant stakeholders from different sectors, the GMO Act also makes provision for public notification of proposed release or commodity clearance of genetically modified organisms. The NEMA establishes procedures to facilitate and promote public participation in environmental governance. The Act stipulates that the participation of all interested and affected parties in environmental governance must be promoted, and all people must have the opportunity to develop the understanding, skills and capacity necessary for achieving equitable and effective participation, and that participation by vulnerable and disadvantaged persons must be ensured. The 2019 White Paper on Science, Technology and Innovation (STI) aims to foster a society that actively values and uses STI. Furthermore, the Bio-economy Strategy (2013) advocates for ‘initiatives to promote public understanding of the technologies. The DSTI commissions surveys on public perception on biotechnology periodically.
EN
Protocole additionnel de Nagoya – Kuala Lumpur sur la responsabilité et la réparation
Les Parties au Protocole de Cartagena qui ne sont pas encore Parties au Protocole additionnel sont invitées comme les autres à répondre aux questions ci-dessous
Non
FR
Oui
FR
Further details provided in section 174.
EN
Aucune mesure n'a encore été prise
FR
- Aucun instrument n'est en place [ Veuillez fournir des précisions sur les instruments en place ]
FR
Oui
FR
Oui
FR
- Oui, l’opérateur doit informer l'autorité compétente des dommages
- Oui, l’opérateur doit évaluer les dommages
- Oui, l’opérateur doit prendre des mesures d'intervention
Oui
FR
Oui
FR
- Le titulaire du permis
- La personne qui a mis l’OVM sur le marché
- Le développeur
- Le producteur
- L’auteur de la notification
- L’exportateur
- L’importateur
- Le transporteur
- Le fournisseur
Non
FR
Non
FR
- Oui, dans d’autres instruments : [Veuillez préciser] (Section 61 of the Consumer Protection Act 68 of 2008.)
Non
FR
South Africa is currently not a party to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. The GMO Act which is the principal law regulating activities with GMOs has provisions on liability which stipulates that liability for damage cause by activities relating to a GMO shall be borne by the “user” concerned, where user means a person who conducts an activity with a GMO. The Consumer Protection Act provides for liability where damage is caused by goods including GMOs or products thereof. Firstly, with regard to damage, the CPA provides that: “Harm for which a person may be held liable in terms of this section includes – (a) The death of, or injury to, any natural person; (b) An illness of any natural person; (c) Any loss of, or physical damage to, any property, irrespective of whether it is movable or immovable; and (d) Any economic loss that results from harm contemplated in paragraph (a), (b) or (c) The NEMA creates a liability regime for addressing environmental damage in line with the polluter pays principle. The NEMA stipulates that “the costs of remedying pollution, environmental degradation and consequent adverse health effects and of preventing, controlling or minimising further pollution, environmental damage or adverse health effects must be paid for by those responsible for harming the environment” However, the matter of financial security remains unaddressed. The NEMA was not drafted with the specific purpose to cover damage caused by GMOs or GMO related activities. Furthermore, NEMA does not take into account the possible breadth of claims that might arise and the resultant costs that may be associated with clean-up and restoration, the scale of which certainly necessitates the provision of a financial mechanism. A process is underway to undertake an assessment of the modalities of financial security mechanisms and identifying appropriate entities that could provide such financial security.
EN
Autres informations
Genetically modified organisms, and modern biotechnology more broadly, continue to play an important role as one of the technologies that can help address sustainable development challenges and contribute to the South African government’s priorities around food security, poverty reduction, public health, economic growth and job creation. This contribution transcends national borders, further contributing to SADC priorities, Africa’s seven aspirations on increased agricultural production, development driven by science, technology and innovation as well as conservation and sustainable use of biodiversity as outlined in the African Union Agenda 2063 as well as the 17 global sustainable development goals. The suite of policies, legislative frameworks, strategies, plans and programmes continue to provide an enabling environment for effective participation in biotechnology research and development and facilitate delivery and access to innovative products and solutions in major sectors, including agriculture, health, food and environment, as well as trade. South Africa aims to ensure that its national biosafety framework remains adaptive and responsive to the rapidly advancing technology, including through its national contribution to the ambitious targets set out in the Kunming-Montreal Global Biodiversity Framework.
Commentaires sur le modèle du rapport
Responses to certain questions, for example, under Article 20, must make provision for “not applicable” option.