Official websites use .gov
A .gov website belongs to an official government organization in the United States.
Secure .gov websites use HTTPS
A lock ( A locked padlock
) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.
South Africa - Country Commercial GuideSABS South Africa has a well-developed standards regime that is largely based on compulsory, regulator-lead definition, and qualification. South Africa has developed many standards over several decades that reflect specific conditions that relate to the natural and human environment. The South African Bureau of Standards (SABS) is a specialized South African statutory agency responsible for the promotion and maintenance of standardization and quality relating to commodities and the rendering of services. It is a specialized agency of the Department of Trade and Industry. Its tasks include:
SANAS SABS is accredited nationally by the South African National Accreditation System (SANAS) and is recognized internationally by Netherlands-based Raad voor Accreditatie (RvA). SABS belongs to both the International Organization of Standardization (ISO) and the International Electrotechnical Commission (IEC). Accordingly, it issues pharmaceutical and industrial standards that conform to those of the ISO.
Reciprocity SABS follows the standards of the ISO, the IEC and the European Committee for Standardization (CEN) and does not automatically recognize the standards of the United States. British Industry Standards and the Deutsche Industry norm are favored in the SABS systems for historic and technical reasons. Products sourced from these countries enjoy quasi-automatic accreditation.
U.S. experience In practice, U.S. companies have been able to comply with South African standards when importing goods into South Africa. Based on a survey of U.S. firms already established in South Africa, the standards maintained by SABS have not been a major trade-inhibiting factor; the automotive and pharmaceutical sectors are an exception and receive more attention. All foreign suppliers pursuing compliance with South African standards have experienced slow processing of applications for Letters of Authority (LoAs), in some cases to the extent of risking technology redundancy.
Termination Manufacturers have the option of paying SABS to test and approve their products. This option is rarely exercised. Though SABS has the right to terminate the sale of products if it receives enough complaints, there have been very few cases of this happening.
Environmental Management System The standards issued by the SABS are in accordance with the Environmental Conservation Act and are enforced on all imports and exports. All foreign companies establishing themselves in South Africa need to have their Environmental Management System (EMS) certified. This certification needs to be updated every year to ensure that the company is observing South African standards.
Agriculture The Directorate of Plant Health and Quality within the National Department of Agriculture (https://www.dalrrd.gov.za/index.php/core-business/agricultural-production/plant-health/plant-health) is responsible for setting standards for certain agricultural and agricultural-related products. These standards cover aspects such as composition, quality, packaging, marketing, and labeling as well as physical, physiological, chemical, and microbiological analyses.
Consumer Products The Standards Act, Nr. 29 of 1993 gave SABS the power to be involved in the regulations governing consumer protection. There are voluntary and compulsory standards. Only 53 of SABS’s approximately 5,000 standards are mandatory. However, depending on the laws, other standards may be considered compulsory as well (i.e., electricity standards) and it may create uncertainty for businesses. Reports indicate that SABS is taking a tougher line on companies that violate mandatory standards around consumer protection, this comes in the wake of the amended Consumer Protection Act of 2008, which, from 1 April 2011, changed many aspects of business in South Africa by introducing new legislation concerning manufacturers and service providers. This legal framework aims to protect the consumer through controls on product liability, sales and marketing practices and fairness in consumer contracts, among other issues.
The following is a list of the major South African organizations involved in the management of the standards regime:
SABS - South African Bureau of Standards, the Government agency regulating standards.
website: https://www.sabs.co.za/
Human Science Research Council (HSRC) – works with non-governmental organizations (NGOs), international development agencies, and the Government on large-scale, social-scientific projects. HSRC is also involved in the homologation of academic standards: https://hsrc.ac.za/
South African Health Products Regulatory Authority (SAHPRA, previously known as the Medicines Control MCC) regulates medicine and devices in South Africa.
The ePing SPS&TBT platform (https://epingalert.org/), or “ePing”, provides access to notifications made by World Trade Organization (WTO) Members under the Agreements on Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT), distributed by the WTO from January 16, 1995 to present. ePing is available to all stakeholders free of charge and does not require registration unless the user wishes to receive customized e-mail alerts. Use it to browse notifications on past as well as new draft and updated product regulations, food safety and animal and plant health standards and regulations, find information on trade concerns discussed in the WTO SPS and TBT Committees, locate information on SPS/TBT Enquiry Points and notification authorities, and to follow and review current and past notifications concerning regulatory actions on products, packaging, labeling, food safety and animal and plant health measures in markets of interest.
Notify U.S., operated and maintained by the National Institute of Standards and Technology (NIST) since 2003 to distribute and provide access to notifications (and associated draft texts) made under the WTO TBT Agreement for US stakeholders, has reached its end of life. Per obligation under the TBT Agreement, each WTO Member operates a national TBT (and an SPS) Enquiry Point. National TBT Enquiry Points are authorized to accept comments and official communications from other national TBT Enquiry Points, which are NOT part of the WTO or the WTO Secretariat. All comment submissions from U.S. stakeholders, including businesses, trade associations, U.S domiciled standards development organizations and conformity assessment bodies, consumers, or U.S. government agencies on notifications to the WTO TBT Committee should be sent directly to the USA WTO TBT Inquiry Point. Refer to the comment guidance at https://tsapps.nist.gov/notifyus/data/guidance/guidance.cfm for further information. This guidance is provided to assist U.S. stakeholders in the preparation and submission of comments in response to notifications of proposed foreign technical regulations and conformity assessment procedures.
The following is a list of the major South African organizations involved in conformity assessment:
NMISA - National Metrology Institute of South Africa develop primary scientific standards of physical quantities for SA
SABS - South African Bureau of Standards, a government agency regulating standards.
website: https://www.sabs.co.za/
SANAS – South African National Accreditation System
NRCS – National Regulator of Compulsory Specifications, a government agency overseeing EHS standards and consumer protection.
Certain items require product certification:
Medicines All medicines, including supplements and complementary medicines, as well as medical and IVD devices must be evaluated and registered with the South African Health Products Regulatory Authority (SAHPRA). The Medicines and Related Substances Act 1965 (Act 101 of 1965) can be found under: https://www.sahpra.org.za/acts-and-regulations/
Delays Some foreign companies have experienced delays in system certification -– this is generally seen due to capacity issues at the SABS and the National Regulator of Compulsory Standards (NRCS) that have been addressed over the past year. In the case of ICT companies, this has been a business inhibitor, due to the rapidly changing requirements of end-users, as well as the short lifecycle of certain technologies.
The following is a list of organizations involved in accreditation in South Africa:
International Accreditation Forum (IAF) whose members are required to maintain high standards when accrediting companies. Please see https://iaf.nu/en/home/.
The SABS is the statutory repository of all relevant standards. These can be obtained in electronic format from the SABS at https://www.sabs.co.za/.
All proposed and final technical regulations are published in the Government Gazette.
To subscribe to the printed (hard copy) of the Government Gazette, please contact:
The Government Printing Works
E-mail: jpe@print.pwv.gov.za
Essential points on labeling/marking:
Label compliance for pharmaceutical and medical products are described in the Medicines and Related Substances Act 1965 (Act 101 of 1965) found at: https://www.sahpra.org.za/acts-and-regulations/
The South African Bureau of Standards
Tel: +27 (0)12 428 7911; Fax: +27 (0)12 344 1568
National Department of Agriculture (NDA)
