Listed below are links to PDF documents of all the acts and regulations that are directly relevant to the regulation of GMOs in South Africa. Also included are direct links to the Department of Agriculture, Forestry and Fisheries’ (DAFF’s) biosafety resources including a link to their webpage, guideline documents and relevant application forms.
DEPARTMENT OF AGRICULTURE, FORESTRY AND FISHERIES (DAFF)
These pieces of legislation regulate all activities with GMOs, including confined research and development, field trials, general release and the import/export of any GMO. See GMO Act resources and guidelines below for more details.
DEPARTMENT OF HEALTH (DoH)
These pieces of legislation control the sale, manufacture and importation of foodstuffs, cosmetics and disinfectants to ensure their quality and safety. The Codex Alimentarius principles and guidelines are accepted as policy for the food/feed safety requirements of GMOs by the DoH. Regulation 25 relates to the labelling of GM derived foodstuffs. The DoH’s guidelines for the food/feed safety assessment of GMOs are included in the “Guideline document for working with GMOs” (see DAFF guidelines below).
DEPARTMENT OF ENVIRONMENTAL AFFAIRS (DEA)
With regards to GMOs the NEMBA confers to the South African National Biodiversity Institute (SANBI) the responsibility to monitor and report on the potential environmental impacts of GMOs released into the environment in South Africa and also establishes a mechanism whereby the Minister of Environmental Affairs may request an environmental impact assessment (EIA), as outlined under the National Environmental Management Act (NEMA), for a particular GMO.
NEMA regulates products, activities and developments to ensure that they are socially, environmentally and economically sustainable. The environmental release of GMOs is one of the listed activities under this act, which may require an EIA as enabled under NEMBA. The DEA has provided general guidance with regards to the criteria that may trigger an EIA for a GMO, the general objectives of EIAs and the administrative procedure to follow should the trigger requirements be met (see DEA Guidance document below). To date the criteria for an EIA have not been triggered and consequently no EIAs have been conducted for any of the GMOs that have been released into the environment.
NOTE: An EIA should not be confused with an environmental risk assessment (ERA), which is done for all GMOs as required by the GMO Act.
DEPARTMENT OF TRADE AND INDUSTRY (DTI)
The act aims to establish national norms and standards relating to consumer protection by, amongst others, ensuring access to information. Section 7 of the listed regulation outlines the labelling requirements for GMO goods.
The website of the Biosafety division of the Directorate: Genetic resources that regulates GMO activities in South Africa.
A guideline document providing guidance on various aspects of GMO regulation including risk assessment and risk management for different activities such as contained use, field trials or environmental release; food safety assessments; containment requirements for different activities with GMOs in facilities such as laboratories or greenhouses.
This includes the application forms for the registration of a facility; trial release; commodity clearance; contained use; general release; import for contained use; import for general release or commodity clearance; import for trial release into the environment; export for contained use or use as food, feed or processing; export for intentional release into the environment; commodity use for food, feed or processing; export time extension; GMO status certification for export and an affidavit.
These SOPs outline the conditions for the registration of a facility and the conditions for exemption from the requirements for a permit for academic and research institutions respectively.
Outlines the public notification requirements for activities involving field trials, commodity clearance and general release.
Specifies the fees for permits for different activities with GMOs including the registration of a facility, permits for contained use, field trial applications, commodity clearance applications and general release applications.
BIOSAFETY SOUTH AFRICA
A brief outline of the process to be followed when registering a facility for GM use.
A guide when applying for the import and trial release of GMOs.
An investigation of the conditions under which particular RMS may be beneficial to mitigating identified risks or decreasing regulatory requirements so that sound regulatory decisions can be made while harnessing the benefits of biotechnology.
Late stage research and development, and regulatory roadmap for commercialising GM products in South Africa.