Required Report: Required - Public Distribution
2023

Date: December 04,

Report Number:

SF2023-0036

Report Name: Agricultural Biotechnology Annual
Country: South Africa - Republic ofPost: Pretoria
Report Category: Biotechnology and Other New Production Technologies

Prepared By:

Dirk Esterhuizen

Approved By: Ali Abdi
Report Highlights:
South Africa is amongst the top-10 largest producers of genetically engineered (GE) crops in theworld and has approved 32 GE plant events for commercial cultivation since 1997. South
Africa’s robust regulatory system for GE products, which started with the introduction of the
Genetically Modified Organism (“GMO”) Act of 1997, supported the country’s leading position
in regulatory policy regarding agricultural biotechnology. However, South Africa announced adecision to uphold an October 2021 declaration to regulate products derived through “NewBreeding Techniques” (NBTs) under the current “GMO” Act, regardless of foreign DNA
presence. This risk-disproportionate approach runs counter to international best practices.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILYSTATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICYExecutive Summary:
Total bilateral agricultural trade between the United States and South Africa surged by 16
percent in 2022 to reach a record high of US$997 million. Biotechnology related exports by theUnited States to South Africa included US$48 million of processed products potentiallycontaining biotech-derived food ingredients as well as corn planting seeds (US$12 million)
which are primarily biotech varieties. The United States imported US$105 million of processed
products that could contain biotech-derived food ingredients from South Africa in 2022. The
United States did not import any GE agricultural commodities such as corn, cotton, or soybeansfrom South Africa.
South Africa possesses a highly advanced commercial agricultural industry based, inter alia, inbiotechnology research and effective plant breeding capabilities. South Africa has been involved
with biotechnology research and development for over 30 years and continues to be thebiotechnology leader on the African continent. Several local and international regulations govern
the use of GE products in South Africa. The goal of these regulations is to ensure that any
activity involving GE products is assessed with regards to potential risks to human health andthe environment prior to undertaking any such activity.
Thirty-two GE plant events have received general release approval for commercial cultivation
since 1997 in South Africa, including five new events approved the past two years. These eventsare present in three crops, namely, corn, soybeans, and cotton. More than 80 percent of corn
plantings, approximately 95 percent of soybean plantings, and virtually all cotton plantings inSouth Africa are from GE seeds. In fact, farmers in South Africa planted a record soybean areaof 1.1 million hectares in marketing year 2023/24, an upsurge of 24 percent. South Africa is also
a significant exporter of corn with average annual corn exports of more than 3.0 million metrictons over the past five years (also refer to GAIN report South Africa Grain and Feed).
After the introduction of innovative biotechnologies such as genome editing in many countries
around the world, South Africa started internal deliberations to determine regulatory policies for“NBTs”, including genome editing and derived products. In October 2021, a public notice wassent to all stakeholders announcing South Africa’s regulatory approach for “NBTs as the samerisk assessment framework that exists for GE products under South Africa’s 1997 “GMO” Act.
This means all genome edited products will be treated the same as GE products under South
Africa’s “GMO” Act, regardless of the presence of foreign DNA. The local industry launched aninternal appeal against this one-sided ruling and requested that the Minister appoint an
independent panel of experts to serve as the Appeal Board.
In December 2022, the Appeal Board found in favor of industry and recommended a sciencebased, case-by-case approach for the regulation of NBTs in South Africa. However, in an
unanticipated decision, the Minister of the Department of Agriculture, Land Reform and Rural
Development (DALRRD) announced on August 11, 2023, through a public notice (Minister final
decision on NBTs appeal), that the decision to regulate “NBTs” under the “GMO” Act of 1997
would be uphold. According to the Minister, the “GMO” Act provides the appropriate framework
to manage any potential risks associated with “NBTs.” The domestic industry is expected tocontinue to advocate for a risk-proportionate approach.

2

TABLE OF CONTENTS
CHAPTER 1: PLANT BIOTECHNOLOGY…………...………………...……...…….....….………..4
PART A: Production and Trade………….………..……….............………………………….……….4
PART B: Policy………………………………………………….……………….……………….…..13
PART C: Marketing…………………...…...……………………….……………………..….……… 26
CHAPTER 2: ANIMAL BIOTECHNOLOGY…...……………………………….………………….28
PART D: Production and Trade………….…..………………...…….………………………………..28
PART E: Policy………………………….…………………...………………………………………..28
PART F: Marketing…………………….…………….…………..…………………………………...30
CHAPTER 3: MICROBIAL BIOTECHNOLOGY………………………...………………………....31PART G: Production and Trade………..……….……………………………………………………..31
PART H: Policy………………………………….……..……………………………………………..33
PART I: Marketing………………….........…..……….……………………...……………….............35
Appendix……………………………….………………………………………………………….......363

PLANT AND ANIMAL BIOTECHNOLOGYCHAPTER 1: PLANT BIOTECHNOLOGYPART A: PRODUCTION AND TRADE(a) RESEARCH AND PRODUCT DEVELOPMENT
South Africa has been involved with biotechnology research and development for over 30 years andcontinues to be the biotechnology leader on the African continent. To date, South Africa has approved
32 GE plant events for commercial production, including five new events approved the past two years(see Table A1 in the appendix). These GE events are contained within three commodities, namely
corn, soybeans, and cotton, and include herbicide tolerance, insect resistance and drought tolerance
traits.
In the past 5 years, South Africa authorized 35 field trials permits. Table A2 in the appendix
summarizes the events, traits, products, and companies involved with the permits issued for trial
release clearance since 2018. To Post’s knowledge, there are no GE plants used to produce antibiotics
of pharmaceuticals for human or animal disease at this time.
In addition to the large multinational GE companies, like Bayer, Syngenta, BASF and Corteva,
several parastatals, universities and agricultural industry organizations in South Africa are involved ininnovative GE research. These include the following organizations:
The Agricultural Research Council’s Biotechnology Platform
The Agricultural Research Council’s Biotechnology Platform (ARC-BTP) was established in 2010 asa major strategic priority of the ARC. The role of the ARC-BTP is to create the high-throughput
resources and technologies required for applications in genomics, quantitative genetics, marker
assisted breeding, and bioinformatics within the agricultural sector. The focus of the ARC-BTP isto establish itself as both a research and service driven institution, providing an environment in whichhighly skilled researchers can be hosted and trained. The technologies established within the platform
are accessible as services to the ARC, collaborators, companies, science councils, and researchers
across the African continent. For more information, please visit the following link: ARC-BTP.
The Forestry and Agricultural Biotechnology Institute at the University of Pretoria
The Forestry and Agricultural Biotechnology Institute (FABI) is based at the University of Pretoria,
South Africa. FABI promotes the broad field of plant biotechnology through an interdisciplinary
approach and with close linkages to a wide range of academic departments. The institute has been
operational since 1998. For more information, please visit the following link FABI-UP.
The Institute for Wine Biotechnology at Stellenbosch University
The Institute for Wine Biotechnology (IWBT) was established at Stellenbosch University in 1995
(see also IWBT-US). The IWBT is an internationally recognized postgraduate training andresearch institute offering visionary training and innovative research to support the South4

African wine and grapevine industries. The IWBT's research programs follows a globally unique,integrated, and multidisciplinary approach, combining cutting edge high-throughput and systemsbased approaches derived from the core sciences of biology and chemistry with the traditional
wine sciences of viticulture and oenology. Themes include grapevine ecophysiology and molecularbiology, microbial diversity, physiology and molecular biology, analytical chemistry, andcomputational biology. Wine and related products make up a large part of South Africa’s
agricultural exports to the United States with an annual value typically exceeding US$40 million.
The South African Sugarcane Research Institute
The South African Sugarcane Research Institute (SASRI) is a world-renowned agricultural research
institute that contributes to the sustainability of the local sugar industry. Research at SASRI isclustered within four multidisciplinary programs, namely Variety Improvement, Crop Protection,
Crop Performance and Management and Systems Design and Optimization. The Variety
Improvement Program conducts research and implements strategies for the continual release of highyielding, adaptable, pest and disease resistant varieties that add value and enhance industry
productivity. Modern biotechnological approaches are deployed for the commercial development ofGE sugarcane for insect borer resistance and herbicide tolerance and to improve sugarcane drought
stress tolerance. For more information, please visit the following link: SASRI.
(b) COMMERCIAL PRODUCTION
South Africa cultivates three GE agricultural crops commercially, namely, corn, soybeans, and cotton.
In marketing year (MY) 2022/23 a total of 3.6 million hectares (MHa) of these three crops wereplanted in South Africa, of which an estimated 3.1 MHa were planted with GE seeds. Of the total GE
area, GE corn plantings represent about 71 percent or 2.2 MHa, followed by GE soybeans,representing approximately 28 percent or 880,000 ha and GE cotton representing approximately one
percent or 18,000 ha. This places South Africa among the top-10 global producers of GE crops.
Corn
Corn is the main field crop produced in South Africa and is used for both human consumption (mainly
white corn) and animal feed (mainly yellow corn) with an annual average production of more than
14.0 million metric tons (MMT). In 1997, the first GE corn event (insect resistant) was approved inSouth Africa. Since then, the country has seen a progressive and steady increase in GE corn plantings,
leading to more than 80 percent of total corn plantings today. Table 1 illustrates the plantings of GE
corn in South Africa over the past seven marketing years. Of the 2.6 MHa of corn planted in MY
2022/23, an estimated 2.2 MHa or 84 percent were planted with GE seeds.
White corn plantings in MY 2022/23 were 1.6 MHa, of which an estimated 91 percent or 1.4 MHa
were planted with GE seed. Yellow corn plantings were approximately 1.0 MHa, of which an
estimated 73 percent were planted with GE seed. A large proportion of non-GE yellow corn producedin South Africa is used in the beer brewery industry, while the rest is exported to non-GE markets. A
traceability system and dedicated non-GE grain storage facilities allow for segregation for the local
and international non-GE markets.

5

Table 1
Planting of GE corn in South Africa over the past seven years
Area planted (1,000 ha)
Marketing years

White corn

Yellow corn

2016/17
1,015
932
Total area
914
821
GE area90%
88%
GE area % of total area
2017/18
1,643
985
Total area
1,580
885
GE area96%
90%
GE area % of total area
2018/191,268
1,050
Total area
1,103
856
GE area87%
81%
GE area % of total area
2019/20
1,298
1,002
Total area
1,175
690
GE area91%
69%
GE area % of total area
2020/21
1,616
995
Total area
1,365
769
GE area
84%
77%
GE area % of total area
2021/22
1,692
1,063
Total area
1,535
765
GE area
GE area % of total area
91%72%
2022/23*
1,575
1,048
Total area
1,435
765
GE area
GE area % of total area
91%
73%
Source: Bureau for Food and Agricultural Policy (BFAP), GrainSA
Note: *Post/Pretoria estimate

Total corn
1,947
1,735
89%
2,629
2,465
94%
2,318
1,959
85%
2,300
1,865
81%
2,611
2,134
82%
2,755
2,300
83%
2,623
2,200
84%

In MY 2021/22 (information for MY 2022/23 is not yet available), approximately 70 percent of GE
seed planted consisted of stacked varieties (insect resistant and herbicide tolerant), while single insect
resistant (7 percent) and herbicide tolerant (23 percent) events in total comprised of about 30 percent
of total GE corn plantings (see also Figure 1).

6

Figure 1
The adoption trends of GE corn in South Africa
100%

GE corn adoption rate

90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

Marketing years
GE perentage of total corn area

IR = BT Insect resistanceHT = Herbicide tolerance

IR/HT = Stack geneSource: BFAPThe long-term trend in corn production indicates that South Africa is producing more corn on lessarea. In fact, South Africa’s five largest corn crops on record were produced in the past sevenyears, driven mainly by improved yields and favorable weather conditions, while planted area
declined (see Figure 2). South Africa’s corn yields have more than doubled in the past 30 years(see Figure 3) with the use of new production technologies, such as genetically engineered seed
and more efficient and effective farming practices, including precision and conservation farming.
Indications are that this trend of producing more corn on fewer hectares will continue in the
future.

7

Figure 2

18,000,000

6.0

16,000,000

5.0

14,000,000
12,000,000

4.0

10,000,000

3.0

8,000,000
6,000,000

2.0

4,000,000

1.0

2,000,000--

Marketing years
Production

Area

Yield

Linear (Yield)

Source: South African Grain Information Services (Sagis)
Figure 3
Trends in the Average Corn Yields in South Africa
6.0

5.5

Average yield (MT/ha)

5.0

4.5

4.0
3.3
3.0
2.0
1.0

2.2

1.9

1.9

1970's1980's1.3

1.0
1950's1960's1990'sPeriodSource: Sagis
Note: *Include only the first three years of the 2020’s

82000's2010's2020'sYield (MT/ha)

Area (ha) and Production (MT)Area Planted, Production and Yields of Corn in South Africa over the Past 30 Years

SoybeansSouth Africa expanded soybean area by almost 11-fold during the past 20 years (see also Figure 4).
In fact, farmers in South Africa planted a record soybean area of 1.1 MHa in MY 2023/24, an upsurgeof 24 percent from the previous marketing year, surpassing yellow corn area for the first time. Twenty
years ago, South African farmers planted a mere 100,000 ha with soybeans. As a result, soybeans
now represent more than 25 percent of the area planted with summer rainfall field crops, while 20
years ago it was only four percent. This surge has been driven by farmers’ growing interest in using
soybeans as a rotational crop with corn, a growing local demand for soybeans through extensive
investments in oilseed processing plants and the adoption of GE soybeans. GE soybeans were first
approved for commercialization in South Africa in 2001. By 2006, 75 percent of the soybean cropgrown was GE. Today, Post estimates that more than 95 percent of soybeans are planted with GE
seeds.
Figure 43,000,000

3.00

2,500,000

2.50

2,000,000

2.00

1,500,000

1.50

1,000,000

1.00

500,000

0.50

0

0.00

Marketing years
Production

Area

Yield

Source: Sagis

9

Linear (Yield)

Yield (MT/ha)

Production (MT) and Area (ha)Trends in Area Planted, Production and Yields of Soybeans in South Africa

CottonIn 1997, the first GE cotton event (insect resistance) was approved in South Africa and currently all
local cotton plantings are from GE seeds. However, cotton production is relatively small in South
Africa as farmers opt to plant more profitable crops like corn and soybeans. Cotton area stayed flat inthe 2022/23 production season at approximately 18,000 ha.
(c) EXPORTS
Exporters of GE products in South Africa must apply for a GE export permit according to the “GMO”
Act of 1997. Permit applications should be accompanied by a permit/letter of authority from theimporting countries’ Competent Authority permitting GE imports.
Corn
South Africa is a net exporter of corn in most years, except when drought limits production.
Post/Pretoria estimates South Africa will export 4.0 MMT of corn in MY2023/24 (May 1, 2023 – Apr30, 2024) after producing the second largest corn crop on record. In the first 15-weeks of MY
2023/24, South Africa already exported 1.4 MMT of corn, primarily to Taiwan, South Korea,
Vietnam, and Japan (see also Table 2).
In MY 2022/23, South Africa exported 3.7 MMT of corn to nearly 20 countries, keeping exports on
the same level as MY 2021/22. South Africa exported almost 2.2 MMT of yellow corn and 1.5 MMTof white corn. The top seven markets were Taiwan, Japan, Vietnam, Mexico, Italy, Botswana, andSouth Korea. These countries represented 75 percent of South Africa’s corn exports. Exports to the
Asian countries consisted mainly of yellow corn, while corn exports to Mexico, Italy, and Botswana
were largely white corn.

10Table 2South Africa’s Exports of Corn in MY 2022/23 and MY 2023/24
MY 2023/24*(1,000 MT)

MY 2022/23(1,000 MT)
Countries

White
corn

Yellow
corn

Total

Countries

Taiwan
0
720
720
Japan
Japan
0
605
605
TaiwanVietnam
0353
353
South Korea
Mexico337
0337
Vietnam
Italy
262
4
266
Botswana
Botswana
211
28
239
Kenya
South Korea
95
130
225
Mozambique
Namibia
101
36
137
Eswatini
Zimbabwe119
10
129
Zimbabwe
Eswatini
37
87
124
Namibia
China
0
108
108
LesothoMozambique
52
51
103
Ghana
Kenya
87
0
87
Lesotho76
985
Portugal53
053
Honduras47
047
Guatemala22022Angola0
6
6
Saudi Arabia
0
6
6
TOTAL
1,499
2,153
3,652
TOTAL
Source: Sagis*Preliminary export data from May 1 to August 11, 2023

White
corn

Yellow
corn

Total

0
0
0
0
80
52
16
12
17
1
10
2

364
350
350
127
3
0
14
16
2
15
0
0

364
350
350
127
83
52
30
28
19
16
10
2

190

1,241

1,431

Soybeans
In the past, South Africa’s trade in oilseeds was generally limited, as the bulk of production was
destined for local crushing. As a result, exports and imports were directed to oils and meals. However,with the surge in the local production of soybeans and crushing capacity reaching optimal levels,
South Africa’s soybean exports reached a historical high level on 277,504 MT in MY 2022/23.
Malaysia (144,473 MT), Thailand (52,393 MT) and Vietnam (27,531 MT) were the major markets forSouth Africa’s soybeans. So far in MY 2023/24 (March 2023 to June 2023), South Africa exported
195,551 MT of soybeans with Malaysia, Vietnam, and Thailand the main markets. Post expects South
Africa’s exports of soybeans will continue in the future on higher production and global demand. At
the end of 2022, South Africa completed export protocols with China, opening the world’s largest
soybean market for local producers.

11

Table 3
South Africa’s Exports of Soybeans in MY 2022/23 and MY 2023/24
Countries

MY 2022/23(1,000 MT)

MY 2023/24*(1,000 MT)

Malaysia

145

106

Vietnam

28

55

Thailand52

33

Zimbabwe

19

1

Bangladesh

29

0

Mozambique

5

0

Total

278

195

Source: Sagis*Preliminary export data from March 1 to June 30, 2023
CottonSouth Africa’s exports of cotton are relatively small at around 5,000 MT annually with Vietnam,
Bangladesh, and Lesotho as the most important markets.
(d) IMPORTS
South Africa allows the importation of GE crops and GE processed products that have been approvedby South African regulators for food and feed purposes (approval for cultivation is not required toimport). Table A3 in the appendix lists the 106 GE events that received commodity clearance in South
Africa since 2001 (see also Commodity Clearance Approvals). Commodity clearance means that
South Africa allows the importation of these events for the use as food and/or feed. Typically, thismeans seeds that will not be planted, but rather processed in a way that will leave them non-viable. A
complete food safety assessment is required, but the environmental assessment is not necessary in linewith the limited environmental exposure. Currently, commodity clearance approvals cover sevencrops, namely, corn, soybeans, canola, cotton, rice, wheat, and rapeseed. One new event in cornreceived commodity clearance so far in 2023. In 2022, three events received commodity clearance incorn, soybeans, and wheat.
(e) FOOD AIDSouth Africa is not a recipient of food aid even in years of drought. However, international food aid
destined for Lesotho, Eswatini, Zambia, and Zimbabwe ordinarily passes through the South African
ports. For shipments containing GE commodities to pass through South Africa, the “GMO”
Registrar’s office requires several measures, including an advance notification to ensure that proper
containment measures can be taken. A letter from the recipient country stating that it accepts the foodaid consignment and acknowledging that the consignment contains GE products is also required.

12

(f) TRADE BARRIERSDALRRD mandates that only approved GE events are allowed into South Africa under the “GMO”
Act. According to the South African regulatory procedures: “Import permits are issued for the importof GE consignments, irrespective of the crop and country, provided the exporting country has
approved the same or less number and type of events as South Africa.” The South African regulatory
procedures for approving GE events sometimes take longer than those in supplier countries.
Differences in the speed of authorizations lead to situations where products are approved forcommercial use outside South Africa but not within South Africa. These asynchronous approvals canpose significant risks to trade since South Africa applies only one percent tolerance for unintentionalpresence of GE even in food and feed.
The stakeholders in the South African grain and oilseeds industry continue to monitor forasynchronous GE approvals to ensure trade between South Africa and its trading partners, including
the United States, is not unnecessarily interrupted. As a result of this efforts to establish synchronous
approvals, the United States was able to export 53,000 MT of soybeans to South Africa in 2021.
PART B: POLICY(a) REGULATORY FRAMEWORK
Several local and international regulations govern the use of GE products in South Africa. The goal ofthese regulations is to ensure that any activity involving GE products is assessed with regards topotential risks to human health and the environment prior to undertaking any such activity.
Locally, GE agricultural plant product development is regulated by the “GMO” Amendment Act of1997 (Act 15 of 1997) and administrated by DALRRD (see also Genetically Modified Organisms
Amendment Act.pdf). Additional regulations, specifically pertaining to GE products, are also
contained under legislation in other departments of the South African government, namely:

Department of Health, e.g., food safety and labelling requirements,
Department of Forestry, Fisheries, and Environment e.g., post-release monitoring and triggers
for environmental impact assessments andthe Department of Trade and Industry, e.g., labelling.

Internationally, South Africa is a party to two agreements regarding GE products, the Cartagena
Protocol on Biosafety (with an environmental focus) and the CODEX Alimentarius (with a foodsafety focus). Collectively, these regulations establish South Africa’s National Biosafety Framework(see Table 4). Table 5 lists specific definitions related to the regulation of GE plants in South Africa.

13

Table 4

Health“GMO” Act of 1997

Environment

Socio-Economic(Provides for measures to promote the responsible development, use
and application of GE products)

South Africa’s National Biosafety Framework
National

International

Foodstuffs, Cosmetics &Disinfectants Act, 1972
Defines labelling requirements for GE
containing foods (Regulation 25, 2004)

CODEX
Alimentarius

National Environmental
Management Act, 1998
Provides general guidance withregards to the criteria that may trigger
an Environmental Impact Assessment
for GE products
National Environmental
Management Biodiversity Act, 2004
Regulates possible impacts of GE
products on biodiversity and introduces
minimum monitoring requirements,
implemented through the South Africa
National Biodiversity Institute (SANBI)

Cartagena
Protocol on
Biosafety

Consumer Protection Act, 2008
Introduced mandatory labelingrequirements for all GE products(Regulation 293, 2008)

Source: Biosafety South Africa

14

Table 5Specific Definitions Related to the Regulation of GE Plants in South Africa
Legal Term

Accident

Laws and
Regulations where
term is used
“GMO” Act

Biosafety“GMO” Act

Commodity
clearance“GMO” Act

General release“GMO” Act

Environment

National
Environmental
Management Act

Environmental“GMO” Act

Legal definition

Means any (i) incident involving an unintentional
environmental release of genetically modified
organisms that is likely to have an immediate
or delayed adverse impact on the environmentor on human or animal health within the
Republic; or(ii) unintentional transboundary movement ofgenetically modified organisms that is likely tohave an immediate or a delayed adverse impact
on the environment or on human or animal
health.
Means the level of safety when risk
management measures must be taken to avoid
potential risk to human and animal health andsafety and to the conservation of theenvironment, because of exposure to activities
with genetically modifies organisms.
Means the authorization to use a geneticallymodified organism as a food and feed, or forprocessing, but excludes the planting of agenetically modified organism as a release into
the environment.
Means the release of a genetically modified
organism into the environment by whatevermeans, where the organism is no longer
contained by any system of barriers.
Means the surroundings within which humans
exist and that are made up of—(i) the land. water and atmosphere of the earth:(ii) micro-organisms, plant, and animal life:(iii) any part or combination of (i) and (ii) andthe interrelationships among
and between them: and(iv) the physical. chemical, aesthetic, andcultural properties and conditionsof the foregoing that influence human healthand well-being.
Means the process used to assess the potential

15

impact assessment

Geneticallymodified organism“GMO” Act

impact of an activity on the environment bycollecting, organizing, analyzing, interpreting,and communicating information on suchactivity.
Means an organism the genes or genetic
material of which has been modified in a waythat does not occur naturally through mating or
natural recombination or both.

The “GMO” Act of 1997
In 1979, the South African government established the Committee on Genetic Engineering(SAGENE). SAGENE comprised of a group of South African scientists and was commissioned to act
as scientific advisory body to the government. SAGENE paved the way for the uptake ofbiotechnology in food, agriculture, and medicine in South Africa, and laid the groundwork for
implementation of the “GMO” Act of 1997. For more historical information on SAGENE andimplementation of the “GMO” Act, see SF2020-0056.
The “GMO” Act of 1997, along with its accompanying regulations, is administrated by DALRRD.
The “GMO” Act of 1997 was modified by the South African government in 2005 to bring it in linewith the Cartagena Biosafety Protocol and again in 2006 to address some economic andenvironmental concerns. These amendments to the “GMO” Act were approved on April 17, 2007, andcame into effect in February 2010, after the regulations were published. The “GMO” Act, as
amended, does not change the pre-existing preamble, which establishes the general ethos of thelegislation, namely, to subsume the need for biosafety with the imperative to promote GE productdevelopment. This encompasses the entire pipeline of GE product development, including, research(contained use and field trail activities), production (general release activities), imports and exports,
transport, and the use of GE products. All activities with GE products are monitored through the“GMO” act and its regulations according to permits issued, including permits for imports, exports,
commodity clearance, general release, field trails and contained use.
Under the “GMO” Act, a decision-making body (the Executive Council (EC)), an advisory body (theAdvisory Council (AC)), and an administrative body (the “GMO” Registrar) were established. The
main functions of these bodies are to:







Provide measures to promote the responsible development, production, use, andapplication of GE products.
Ensure that all activities involving the use of GE products be carried out in such a way as
to limit possible harmful consequences to the environment, human health, and animal
health.
Give attention to the prevention of accidents and the effective management of waste.
Establish mutual measures for the evolution and reduction of the potential risks arisingfrom activities involving the use of GE products.
Lay down the necessary requirements and criteria for risk assessments.
Establish appropriate procedures for the notification of specific activities involving the useof GE products.

16

The amendments to the “GMO” Act make it clear that a scientifically based risk assessment is aprerequisite for decision making and authorizes the EC to determine if an environmental impact
assessment is required under the National Environmental Management Act. The amendments also
added specific legislation to allow socio-economic considerations to factor into decision-making andmake those considerations significantly important in the decision-making process.
The amendments also create at least eight new provisions dealing with accidents and/or unintentionaltransboundary movement. A new definition of “accident” was created to capture two types ofsituations, namely, dealing with unintentional transboundary movements of GE products and theunintentional environmental release within South Africa.
In summary, the existence and application of the “GMO” Act and its amendments provides South
Africa with a decision-making tool that enables authorities to conduct scientific assessments of thepotential risks that may arise from any activity involving a particular GE product.
The Executive Council
The EC functions as an advisory body to the Minister of DALRRD on matters relating to GE products
and more importantly is the decision-making body that approves or rejects GE product applications.
The EC is also empowered to appoint any person knowledgeable in the field of science to serve on the
EC to provide advice. The EC consists of representatives of different departments within the South
African government. These include:








DALRRD.
Department of Forestry, Fisheries and Environment.
Department of Health.
Department of Trade, Industry and Competition.
Department of Science and Innovation.
Department of Employment and Labor.
Department of Water and Sanitation.

Before deciding on GE applications, the EC is obliged to consult with the AC. The AC is represented
on the EC through its chairperson. Decision-making by the EC is based on consensus by all themembers. When no consensus is reached, the application before the EC will be considered as having
been declined. For this reason, it is essential that all representatives on the EC have significant
knowledge of biotechnology and biosafety.
The Advisory Council
The AC consists of ten scientists who are appointed by the Minister of DALRRD. The EC advises the
Minister on the appointment of members of the AC. The role of the AC is to advise the EC on GE
applications. The AC is further supported by subcommittee members representing an extended pool ofscientific expertise from various disciplines. The AC together with the subcommittee members is
responsible for the evaluation of risk assessments of all applications as it relates to food, feed, andenvironmental impact and for submitting recommendations to the EC.

17

The Registrar
The Registrar, who is appointed by the Minister of DALRRD, is responsible for administration of the“GMO” Act. The Registrar acts on the instructions and conditions laid down by the EC. The Registrar
is responsible for examining applications to ensure conformity with the Act, issuing permits,amending, and withdrawing permits, maintaining a register, and monitoring all facilities that are used
for contained use and trial release sites. Figure 5 illustrates the GE application process in South
Africa.
The National Environmental Management Act of 1998
The National Environment Management Act is administered by the Department of Forestry, Fisheries,
and the Environment (DFFE) and provides established general principles for decision making withregards to activities that affect the environment. The Act and relevant amendments include:

National Environmental Management Act (Act no. 107 of 1998)
National Environmental Management Act Amendment Act (Act no. 8 of 2004)

The Act provides general guidance with regards to the objectives of an Environmental Impact
Assessment (EIA) of GE products, the criteria that may trigger an EIA and the administrative
procedure to follow should the trigger requirements be met.
The National Environmental Management Biodiversity Act of 2004
The National Environmental Management Biodiversity Act (Biodiversity Act) of 2004 wasestablished to protect South Africa’s biodiversity from specific threats and includes GE products as
one of those threats. Section 78 of the Act gives the Minister of DFFE the power to deny a permit for
general or trial release applied for under the “GMO” Act, if the GE product may pose a threat to any
indigenous species or the environment.
Under the Biodiversity Act, a South African Biodiversity Institute (SANBI) was also established.
SANBI is tasked to monitor and report regularly to the Minister of DFFE on the impacts of any GE
product that has been released into the environment. The legislation requires reports on the impact of
non-target organisms and ecological processes, indigenous biological resources, and the biologicaldiversity of species used for agriculture.

18

Figure 5
The GE application process in South Africa

19

The National Environmental Management Act of 1998
The National Environment Management Act is administered by the Department of Forestry, Fisheries,
and the Environment (DFFE) and provides established general principles for decision making withregards to activities that affect the environment. The Act and relevant amendments include:

National Environmental Management Act (Act no. 107 of 1998)
National Environmental Management Act Amendment Act (Act no. 8 of 2004)

The Act provides general guidance with regards to the objectives of an Environmental Impact
Assessment (EIA) of GE products, the criteria that may trigger an EIA and the administrative
procedure to follow should the trigger requirements be met.
The National Environmental Management Biodiversity Act of 2004
The National Environmental Management Biodiversity Act (Biodiversity Act) of 2004 wasestablished to protect South Africa’s biodiversity from specific threats and includes GE products as
one of those threats. Section 78 of the Act gives the Minister of DFFE the power to deny a permit for
general or trial release applied for under the “GMO” Act, if the GE product may pose a threat to any
indigenous species or the environment.
Under the Biodiversity Act, a South African Biodiversity Institute (SANBI) was also established.
SANBI is tasked to monitor and report regularly to the Minister of DFFE on the impacts of any GE
product that has been released into the environment. The legislation requires reports on the impact of
non-target organisms and ecological processes, indigenous biological resources, and the biologicaldiversity of species used for agriculture.
Foodstuffs, Cosmetic and Disinfectants Act of 1972
The Foodstuffs, Cosmetic and Disinfectants Act (Act No. 54 of 1972) of the Department of Health(DoH) controls the sale, manufacture and importation of foodstuffs, cosmetics, and disinfectants toensure their quality and safety. The DoH accepts the Codex Alimentarius principles and guidelines forthe food/feed safety requirements of GE products as policy for South Africa.
The DoH also published mandatory GE food labelling regulations in 2004 under the Foodstuffs,
Cosmetic and Disinfectants Act. Regulation 25 states that foodstuffs produced through genetic
modification – where they differ significantly from existing foodstuffs in terms of their composition,
nutritional value, mode of storage, preparation, or cooking, allergenicity or genes with human or
animal origin – must be labelled.
Consumer Protection Act of 2008
In 2008 the Consumer protection Act (Act No. 68 of 2008) was promulgated under the Department ofTrade, Industry and Competition which asserts that labelling is required for all GE goods. Draft
amendments to the GE labelling regulations were published in October 2012 that triggered serious
concerns regarding the limitations of the Act on GE labeling by the business community in South20

Africa. As a result, new GE labeling regulations under the Consumer Protection Act have not yet been
published, precluding any required GE labeling by stakeholders in the food supply chains of South
Africa.
(b) APPROVALS
Table A1 in the appendix indicates all the GE events that have been approved for general release inSouth Africa under the “GMO” Act of 1997 (see also General Release Approvals). This means these
events can be used for commercial plantings, for food and/or feed, and the import and export of these
events are allowed. Thirty-two GE plant events have received general release approval since 1997 in
South Africa. These events are present in three crops, namely corn, soybeans, and cotton (see Table 6
for a summary).
In the past two years, five new GE events received general release approval, namely, Corteva’s
pollination control technology (DP-056113-9) that is used in hybrid planting seed production andCorteva’s stacked insect resistant and herbicide tolerant events for corn and soybeans. Syngenta
released an insect resistant event for corn in 2022. Corteva’s DP-056113-9 is not a commercial trait
and there is no intent for it to enter the grain commodity supply chains. Rather it is used to ease thehybrid corn seed production process.
Table 6
The Traits and Companies Involved in South Africa’s 32 Approved GE Plant Events for Cultivation
Crop

TraitsCorn

Insect resistance (IR)Herbicide tolerance (HT)Drought tolerance
Stacked (IR & HT)Pollination control

2
1
1
3

Soybeans

Herbicide tolerance
Stacked (IR & HT)

1
1

CottonInsect resistance
Herbicide tolerance
Stacked (IR & HT)

2
2
2

2
1
3

2
6
1
1
1

Source: DALRRD
As already mentioned, Table A3 in the appendix lists the 103 GE events that received commodity
clearance in South Africa since 2001 (see also Commodity Clearance Approvals). Commodity
clearance means that South Africa allows the importation of these events for the use as food and/or
feed and that are not intended for environmental release.

21

(c) STACKED OR PYRAMIDED EVENT APPROVALSSouth Africa requires separate approval for GE planting seeds for general release that combine two or
more already approved traits, such as herbicide tolerance and insect resistance. This requirementmeans that companies effectively need to start from the beginning of the approval process for stacked
events, even when the individual traits have already been approved. The EC confirmed that eachstacked event must undergo a separate safety assessment as per the “GMO” Act. Currently, 16 stacked
events (insect resistant and herbicide tolerant) have been approved for general release in South Africa:
12 for corn and two each for cotton and soybeans.
(d) FIELD TESTING
South Africa allows for field-testing of GE crops under the “GMO” Act of 1997. Please refer to Table
A2 in the appendix for GE events that have been approved for confined field trails. All facilities
conducting GE activities must be registered with the Registrar of the “GMO” Act. A separate
application must be logged with the registrar for each facility and applications must include:






the name of the person taking responsibility for the facility,
a map of the facility that indicates the different units within the facility,
a locality map that clearly indicates where the facility is situated, including its geographic
coordinates,a science-based risk assessment of the activities within the facility, andthe proposed risk management mechanisms, measures, and strategies.

After receiving the application, the Registrar approaches the AC for consideration of the application
and a recommendation. Upon registration of a facility, the registrar furnishes the applicant with proofof registration and information on relevant guidelines. The registration of a facility is valid for aperiod of three years before an application for renewal must be submitted.
(e) INNOVATIVE BIOTECHNOLOGIES
After the introduction of innovative biotechnologies worldwide, South Africa started internaldeliberations to determine regulatory policies for “NBTs”, including genome editing and derived
products. On October 27, 2021, a public notice (see also Notice SA's regulatory approach for NBT's)
was sent to all stakeholders announcing South Africa’s regulatory approach for “NBTs.” According to
the notice, the same risk assessment framework that exists for GE products under South Africa’s
current “GMO” Act will apply to “NBTs.” South Africa’s “GMO” Act defines a “GMO” as “anorganism, the genes, or genetic material of which has been modified in a way that does not occur
naturally through mating or natural recombination or both.” Based on this definition under the“GMO” Act, the EC concluded that the current risk assessment framework that exists for GE products
would apply to all products produced using innovative biotechnologies.
The public notice caused discontent amongst international stakeholders, the local industry andacademia. As a result, the local industry, launched an internal appeal, in terms of the “GMO” Act,against this one-sided ruling and requested that the Minister appoint an independent panel of experts
to serve as the Appeal Board. The industry based its appeal on a defective consultation procedure,
incorrect interpretation of the definition of a “GMO” in terms of the “GMO” Act, and international22

best practice.
In December 2022, the Appeal Board found in favor of industry in respect of all the grounds of theappeal. The Board therefore recommended that the decision of the Executive Council regarding“NBTs” be set aside and that a consultative process be initiated and concluded within 12 months from
the Minister’s decision on this matter to develop a new regulatory framework for “NBTs.” The Appeal
Board recommended a science-based, case-by-case approach for the regulation of “NBTs” in South
Africa.
However, the Minister of DALRRD announced on August 11, 2023, through a public notice (Minister
final decision on NBTs appeal), that the EC decision to regulate “NBTs” under the “GMO” Act of1997 would be upheld. According to the Minister, the “GMO” Act provides the appropriate
framework to manage any potential risks associated with “NBTs”.
(f) COEXISTENCE
Coexistence has not been an issue that has necessitated the introduction of specific guidelines orregulations in South Africa. The government leaves the management of the approved GE field crops
to the farmers. South Africa also does not currently have a National Organics Standard in place.
(g) LABELING AND TRACEABILITY
South Africa has had compulsory GE labelling regulations in place since 2004 when the Department
of Health (DOH) introduced labelling regulations under the Foodstuffs, Cosmetics and Disinfectants
Act (1972) – Regulation 25. This regulation mandates labeling of GE foods only in certain cases,
including when allergens or genes with human or animal origin are present, and when a GE foodproduct differs significantly from a non-GE equivalent in terms of their composition, nutritional
value, mode of storage, preparation, or cooking. The rules also require validation of enhancedcharacteristic (e.g., “more nutritious”) claims for GE food products. The regulations do not address
claims that products are GE-free. To date these requirements have not been triggered for any of the
GE products/foods on the South African market and as a result none of these had to be labelled – i.e.,these foods are considered equivalent to their conventional counterparts.
In contrast, the Consumer Protection Act from the Department of Trade and Industry that has been inforce since April 1, 2011, states that all GE goods must be labelled [Section 24(6)]:(6) Any person who produces, supplies, imports, or packages any prescribed goods
must display on, or in association with the packaging of those goods, a notice inthe prescribed manner and form that discloses the presence of any geneticallymodified ingredients or components of those goods in accordance with applicableregulations.
According to the act: All food containing more than five percent GE ingredients, whether produced in South
Africa or elsewhere, needs to carry the declaration which states, "contains at least five
percent genetically modified organisms’’ in a conspicuous and easily legible manner and

23





size.
Those products that contain less than five percent of GE ingredients may be labeled"Genetically modified content is below five percent".
If it is impossible or not feasible to test goods for the presence of GE traits, the productmust be labeled "may contain GMO ingredients".
Products containing less than one percent GE content – may be labeled as “does notcontain genetically modified organisms”.

Regulation 25 is based on health and food safety concerns, while the Consumer Protection Act ispurely value-based, hinging on the consumer’s right to information to make an informed choice ordecision about food.
Draft amendments to the Act’s GE regulations were published in October 2012, in essence onlychanging the wording from “labelling genetically modified organisms” to “labelling geneticallymodified ingredients or components.” A significant implication of this change is that ingredients will
have to be labelled individually as “containing GMO’s” and not the whole product.
Serious concerns were raised regarding the limitations of the Act on GE labeling by the business
community in South Africa, but no further action has been taken by the Department to develop morepractical guidelines. As a result, new GE labeling regulations under the Consumer Protection Act
have not yet been published, precluding any required GE labeling by stakeholders in the food supply
chains of South Africa.
(h) MONITORING AND TESTINGIn South Africa, approved GE commodities are imported through a permit system under the “GMO”
Act (1997). This system applies to living GE organisms and processed commodities. Routine
inspections by authorized inspectors are allowed under the “GMO” Act to examine commodities andtake samples to test if unapproved GE are present.
(i) LOW LEVEL PRESENCE POLICYSouth Africa has a Low-Level Presence (LLP) tolerance of only one percent. However, if the productis milled or otherwise processed, there are usually no importation problems. Rather than testing forunapproved events, import permits are issued for the import of GE consignments, irrespective of thecrop and country, provided the exporting country has approved the same or less number and type of
events as South Africa.
(j) ADDITIONAL REGULATORY REQUIREMENTS
No additional seed registration is required in South Africa after GE seed is approved for generalrelease. Seed Certification is voluntary, except for specific varieties listed in the Plant Improvement
Act and on request of the breeder or owner thereof.

24

(k) INTELLECTUAL PROPERTY RIGHTS
Biotechnology companies operating in South Africa follow essentially the same procedure forcollecting technology fees as in the United States. This policy generally works because South Africa
is a signatory to the Trade-Related Aspects of International Property Rights (TRIPS) agreement of theWorld Trade Organization (WTO). Cotton and corn farmers buy new GE hybrid seed every year.
Farmers sign a one-year licensing agreement, and the technology fee is included in the price of thebag of seed for these crops.
Intellectual property right enforcement for soybeans is more complicated. Technology developers try
to collect the fee from the farmers when they deliver the harvest to the terminal. This fee can bedifficult to collect because soybeans are self-pollinated, so seed need not be purchased every year.
Also, farmers often use soybeans for on-farm feed so it might never enter commercial circulation. As
a result, the Minister of DALRRD approved a statutory levy on soybeans in 2018, according to which
seed companies can be compensated for their performance in the soybean seed market of South
Africa. The seed levy is payable to the South African Cultivar and Technology Agency (SACTA) on
an annual basis. SACTA was formed as a non-profit company, to guarantee that breeding andtechnology levies are paid to seed breeding companies and plant breeder rights holders, ensuringcontinuous research and cultivar development (see also Sactalevy). Levies on wheat and barley forthis purpose have been collected and paid by SACTA for several years.
(l) CARTAGENA PROTOCOL RATIFICATIONSouth Africa has signed and ratified the Cartagena Protocol on Biosafety in 2003. As a result,revisions made in the “GMO” Amendment Act of 2006 included changes to ensure compliances withthe provisions of the Cartagena Protocol.
(m) INTERNATIONAL TREATIES and FORUMSSouth Africa is a signatory member of the following relevant treaties:






The Agreement on the Application of Sanitary and Phytosanitary Measures of the World
Trade Organization (WTO-SPS).
Codex Alimentarius Commission (Codex).
International Plant Protection Convention (IPPC) of the Food and Agricultural Organization(FAO).
The Convention on Biological Diversity.
International Grains Agreement.

South Africa does not actively participate in discussions related to GE plants within theseinternational organizations.
(n) RELATED ISSUES
There are no other issues related to plant biotechnology that are not captured under the current
headings.

25

PART C: MARKETING(a) PUBLIC/PRIVATE OPINIONSOn the production side, South African farmers can be divided into two categories, namely,commercial, and small-scale/emerging farmers. GE products have a wide appeal with both groups
with more than 80 percent of corn, 95 percent of soybeans, and all cotton being planted with GE
seeds. Each group appreciates that GE crops use fewer inputs and have generally higher yields. Smallscale farmers also find GE crops in terms of pest and weed management easier than traditional orconventional hybrid varieties.
On the consumption side, South Africa uses almost 12 million tons of corn commercially on anannual basis, of which about half (mainly white corn) is used for human consumption. During the past
10 years, South Africa maintained an average marginal growth rate of about two percent per annum inthe consumption of corn (refer to Figure 6). This trend is mainly driven by the increase in demandthrough population growth and expansion in the local broiler industry to serve the local market.
Yellow corn is used as the primary ingredient for animal feed, especially in the broiler industry.
Chicken meat has grown to be the most important protein source in the diet of the majority of South
Africans over the past 20 years. White corn, in the form of a meal, is the staple food for many South
African households as it is a relatively inexpensive source of carbohydrates. The per capita
consumption of white corn is estimated at around 90kg per annum.
The bulk of soybeans produced in South Africa are crushed to produce both edible oil for humanconsumption and protein meal for inclusion in animal feed rations. South Africa crushed a record 2.5
MMT of oilseeds in MY 2021/22 on higher production. On the other hand, soybean demand for foodis relatively small in South Africa as it is not traditionally consumed as part of the diet.

26

Figure 6
The Consumption of Corn in South Africa

Consumption (1,000 MT)

14,00012,00010,000
8,000
6,000
4,000
2,000
0

Marketing years
Corn for foodCorn for feed

Total

Source: Sagis(b) MARKET ACCEPTANCE/STUDIESThe most recent study evaluating public perceptions of biotechnology in South Africa was released by
the Human Science Research Council (HSRC) in November 2016. The results of the study clearly
indicated that the South African public can be broadly described as “less informed, but more positive”
about biotechnology, and specifically GE products. South Africans are more than twice as likely as
Europeans to believe that GE food is safe to eat and are also significantly more likely to see GE foods
as good for the economy. The study also indicated major shifts in the public awareness of
biotechnology and attitudes that favor the purchasing of GE food from 2004 to 2015. Publicfamiliarity with the term ‘biotechnology’ more than doubled during this period, from 21 percent of the
population to 53 percent. Public awareness that GE foods form a part of their diet more than tripled,from 13 percent to 48 percent (for more information see Public perceptions of biotechnology in South
Africa).

27

CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: PRODUCTION AND TRADE(a) RESEARCH AND PRODUCT DEVELOPMENT
In South Africa, animal biotechnology is also regulated by the “GMO” Act of 1997 and any
application for research or product development will have to be approved by the EC. However, to dateno animal biotechnology product has applied for review in South Africa. Post is also not aware of any
animal clones that are under development in South Africa.
(b) COMMERCIAL PRODUCTION
There is no commercial production of GE or cloned animals in South Africa.
(c) EXPORTS
South Africa does not export products from GE or cloned animals as no commercial production iscurrently taking place.
(d) IMPORTS
South Africa allows the importation of products from GE animals that have been approved by South
African regulators for food and feed purposes (commodity clearance). Commodity clearance meansthat South Africa allows the importation of these GE events for the use as food and/or feed and thatare not intended for environmental release. South Africa’s regulators have not yet received any
application for the importation of products from GE animals.
(e) TRADE BARRIERS
Not applicablePART E: POLICY(a) REGULATORY FRAMEWORKAs mentioned, animal biotechnology is regulated by the “GMO” Act of 1997 (see Chapter 1, Part B,
sub paragraph a). On the other hand, animal cloning is not specifically regulated in South Africa,
although related regulations and Research and Development ethics guidelines are applicable,
including the Animal Improvement Act and the guidelines of the National Health Research Ethics
Council (NHREC).
The National Health Research Ethics Council (NHREC) is a statutory body established under the
National Health Act No 61 of 2003. The Act mandates the Minister of Health to establish the Council
and it sets out the NHREC’s functions, which in short involves giving direction on ethical issues
relating to health and to develop guidelines for the conduct of research involving humans and animals.

28

The Council observes and advises on international developments in health ethics issues throughliaison with relevant international organizations.
(b) Approvals
There are no GE animals approved for production in South Africa.
(c) INNOVATIVE BIOTECHNOLOGIES
Not applicable.
(d) LABELING AND TRACEABILITY
The mandatory labeling of GE products as stipulated in South Africa’s Consumer Protection Act thatcame into law on April 1, 2011, is on hold. However, if implemented, GE labeling regulations under
the Consumer Protection Act would apply to GE animals.
Currently, the label requirements for GE products under the Foodstuffs, Cosmetics and Disinfectant
Act would apply to GE animal products only in certain cases when the product differs significantly
from a non-GE equivalent.
(e) ADDITIONAL REGULATORY REQUIREMENTS
Not applicable.
(f) INTELLECTUAL PROPERTY RIGHTSSouth Africa is a signatory to the Trade-Related Aspects of International Property Rights (TRIPS)
agreement of the WTO; hence Intellectual Property Rights are supported by the government.
(g) INTERNATIONAL TREATIES and FORUMSSouth Africa is a signatory member of the following relevant treaties and forums:The Agreement on the Application of Sanitary and Phytosanitary Measures of the World
Trade Organization (WTO-SPS);
Codex Alimentarius Commission (Codex);
The World Organization for Animal Health (OIE).

South Africa does not actively participate in discussions related to GE animals within theseinternational organizations.

29

(h) RELATED ISSUES
Africa’s first cultivated meat company, based in South Africa, has initiated the process of producing
cell-cultured protein products, moving away from the traditional methods of harvesting livestock formeat. Founded in 2020, the Mzansi Meat Company seeks to use cellular agriculture technology to
grow meat from cells. Another South African company, WildBio (previously Mogale Meat) seek toprovide affordable healthy and nutritious cell cultivated meat products to a growing population
through advanced biotechnologies. However, consumer acceptance, production costs and regulatory
restrictions are major challenges to overcome.
South Africa’s current food regulations do not provide for any classification regarding lab-grownmeat. Without concerted government effort to update regulations, it could take years before labgrown meat can legally be sold in South Africa. Labelling could also be an issue, as the makers ofvegan and vegetarian products discovered recently. DALRRD demanded goods such as plantbased meatballs, vegan nuggets and vegan BBQ ribs be removed from shelves and re-labelled, forusing names commonly associated with processed meat.
PART F: MARKETING(a) PUBLIC/PRIVATE OPINIONS
Post is not aware of any research that was done to determine the public’s opinion regarding livestock
clones or GE animals in South Africa.
(b) MARKET ACCEPTANCE/STUDIES
Not applicable30

CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: PRODUCTION AND TRADE(a) COMMERCIAL PRODUCTION
Various companies in South Africa are involved in the commercial production of food ingredients.
Many of these companies use microbial biotechnology in the production process for enzymes,
additives, flavorings, colorings, vitamins, and seasonings. Food ingredient manufacturers in South
Africa are represented by two associations, namely, the South Africa Association of Food Science andTechnology (https://www.saafost.org.za/) and the South Africa Association of the Flavor andFragrance Industry (https://saaffi.co.za/). Many research institutions are also involved in microbial
biotechnology, such as: The Institute for Microbial Biotechnology at the University of the Western
Cape (see Institute for microbial biotechnology and metagenomics); Microbial, Biochemical and Food
Biotechnology Department at the University of the Free State (see Microbiology and biochemistry)
and the Institute of Biomedical and Microbial Biotechnology at the Cape Peninsula University ofTechnology (see Research technology and innovation).
b) EXPORTS
There are no official statistics on exports of microbial biotechnology products. However, South Africa
exported US$1.8 billion of processed products that might contain microbial biotech derived
ingredients in 2022 (see Figure 7). Most of the trade in microbial biotech derived products are fromvalue-added product categories, such as (1) wine and beer and (2) prepared food. The United States
represents a relatively small portion of about six percent or US$105 million of South Africa’s export
markets of these products.

31

Figure 7
South Africa’s Exports of Processed Products that Could Contain Microbial Biotech Derived
Ingredients in 2022 (millions of USD)
Cheese, $54

Enzymes, $32

Infant formula, $58
Condiments andsauces, $175

Wine and beer, $805
Fruit juice, $283

Prepared food, $388

Source: Trade Data Monitor LLCc) IMPORTS
South Africa imported US$796 million worth of food ingredients, such as enzymes, or processed
products that could contain microbial biotech-derived food ingredients in 2022 (see Figure 8). These
imports include US$48 million of processed products, potentially containing microbial biotechderived food ingredients from the United States. South Africa also imported US$70 million worth of
microbial biotech derived enzymes in 2022, of which US$10 million were imported from the UnitedStates.

32

Figure 8
South Africa’s Imports of Processed Products that Could Contain Microbial Biotech Derived
Ingredients in 2022 (millions of USD)
Cheese, $41

Infant formula, $12

Condiments andsauces, $44

Enzymes, $70
Prepared food, $331
Fruit juice, $123

Wine and beer, $175

Source: Trade Data Monitor LLCd) TRADE BARRIERSPost is not aware of any specific trade barriers that hinder the trade in processed products containing
microbial biotech derived ingredients.
PART H: POLICYa) REGULATORY FRAMEWORKSouth Africa has not employed a “process-based” review approach for food ingredients frommicrobial biotechnology sources. As a result, food ingredients from microbial biotechnology are notregulated under the South Africa’s “GMO” act as described in Chapter One, Part B of this report.
Food ingredients, however, are regulated under the Foodstuffs, Cosmetics and Disinfectants Act no.
54 of 1972 (Foodstuffs, Cosmetics and Disinfectants Act) with specific regulations for food additives,
food colorants and microbiological standards. As a result, South Africa’s food additives foodcolorants and microbiological standards regulations are developed and administered by the Ministryof Health, under the Food Control Division. This Division also represents the Department of Health on
the Executive Council of the “GMO” Act and serves as the Codex point of contact.

33

Table 7 stipulates the list of applicable additives food colorants and microbiological standards
regulations in South Africa. These regulations also specify the requirements on the use of additives
including labelling requirements.
Table 7
Existing Food Additives, Food Colorant and Microbiological Standards Regulations in South Africa(with website link)
Name of regulation
Miscellaneous additives
Regulations Relating to Food Colorant
Regulations - Additives - Sweeteners - List of Permissible Sweeteners
Regulations Relating to the Use of Sweeteners in Foodstuffs (R733/201)
Codex General Standards for Food Additives
Regulations Governing Microbiological Standards for Foodstuffs and Related Matters (R692/1997)
Source: Department of Health: Food Control Division
In the absence of a regulation pertaining to a specific additive, South Africa normally adopts theGeneral Standard for Food Additives (GSFA) of the Codex Alimentarius Commission (CAC). If an
additive is not available under the South African positive list or covered by Codex, an exporter may
request permission from the Department of Health to use such an additive. Notably, this may be along process as the Department of Health may request supporting evidence that the additive is safe for
consumption.
b) APPROVALS
Lists of permitted additives and colorants are included in the specific regulations as specified in Table
7.
c) LABELING AND TRACEABILITY
Labelling of GE-derived products in South Africa is regulated under the Foodstuffs, Cosmetics andDisinfectants Act (1972) – Regulation 25, and under the 2011 Consumer Protection Act. For a
description of these laws, see Chapter 1, Part B, sub-paragraph g (Labeling and Traceability).
General labeling regulations for processed foodstuffs and liquor also falls under the Foodstuffs,
Cosmetics and Disinfectant Act. Inspectors under the Ministry of Health at the ports of entry are
responsible for ensuring compliance with labeling regulations. According to the current regulations it
is not mandatory to include nutritional information tables on labels. However, should a label containnutritional information it has to comply with the existing labeling regulations (also see Foodstuffs,
Cosmetics and Disinfectants Act: Regulations: Labeling and advertising of foodstuffs).
34d) MONITORING AND TESTING
South Africa does not actively test for evidence of genetic engineering in imports and exports ofprocessed products.
e) ADDITIONAL REGULATORY REQUIREMENTS
Not applicablef) INTELLECTUAL PROPERTY RIGHTS (IPR)
South Africa is a signatory to the Trade-Related Aspects of International Property Rights (TRIPS)
agreement of the WTO; hence Intellectual Property Rights are supported by the government.
g) RELATED ISSUES
There are no other issues related to microbial biotechnology that are not captured under the current
headings.
PART I: MARKETINGa) PUBLIC/PRIVATE OPINIONS
Post is not aware of any research that was done to determine the public’s opinion regarding microbial
biotech in South Africa. However, as the public, in general, is relatively uninformed about the use of
microbial biotechnology, neither strongly positive nor negative opinions have been formed.
b) MARKET ACCEPTANCE/STUDIESSouth Africa has a well-developed and advanced food sector, which is a key driver in the use anddemand for food ingredients. See also reports done by FAS/Pretoria on the topic (for example South
Africa Food Processing Ingredients). Although no studies could be found focusing on an assessmentof market acceptance issues relating to the sale and use of microbial biotech derived food ingredientsin South Africa, it is safe to assume it is widely accepted in the food sector.

35

APPENDIX
Table A1
GE plant events approved for general release in South Africa
Company

Event

Crop/product

Corteva

DP-056113-9

Corn

Corteva

Corn

Corteva

MON89034xTC1507xMIR162x
NK603xDAS-40278-9
DAS-44406-6xDAS-81419-2

SoybeanCorteva

DAS-44406-6

SoybeanSyngenta

MIR162

Bayer

Trait

Year
approved
Pollination Control
2023
SystemInsect resistant
2023
Herbicide tolerant
Insect resistant
2022
Herbicide tolerant
Herbicide tolerant
2022

Corn

Insect resistant2022

MON87701xMON89788

Soybeans

2021

Syngenta

BT11xMIR162xGA21

Corn

Syngenta

BT11xMIR162x
MON89034xGA21
MON87427xMON89034x
MIR162xNK603

Corn

Insect resistant
Herbicide tolerant
Insect resistant
Herbicide tolerant
Insect resistant
Herbicide tolerant
Insect resistant
Herbicide tolerant

Bayer

Corn

2021
2021
2020

Dow AgroSciences DAS40278-9
SA
Dow AgroSciences MON89034xTC1507xNK603xD
SA
AS40278-9
Dow AgroSciences DAS40278-9xNK603
SA
Dow AgroSciences MON89034xTC1507xNK603
SA
Monsanto
MON87460

Corn

Herbicide tolerant

2019

Corn

Herbicide tolerant

2019

Corn

Insect resistant
Herbicide tolerant
Insect resistant
Herbicide tolerant
Drought tolerance

2019

Du Pont Pioneer

TC1507 x MON810 x NK603

Corn

Insect resistant
Herbicide tolerant

2014

Du Pont Pioneer

TC1507 x MON810

Corn

2014

Du Pont Pioneer

TC1507

Corn

Insect resistant
Herbicide tolerant
Insect resistant
Herbicide tolerant

36

Corn
Corn

2018
2015

2012

Syngenta

BT11xGA21

Corn

Insect resistant
Herbicide tolerant
Herbicide tolerant

2010

Syngenta

GA21

Corn

Monsanto

MON89034xNK603

Corn

Insect resistant
Herbicide tolerant
Insect resistantInsect resistant
Herbicide tolerant2010

Monsanto
Monsanto

Corn
CottonMonsanto

MON89034
Bollgard II x
RR flex (MON15985 x
MON88913)
MON88913

Cotton

Herbicide tolerant

2007

Monsanto

MON810 x NK603

Corn

2007

Monsanto

Bollgard RR

CottonMonsanto

Bollgard II, line 15985

CottonInsect resistant
Herbicide tolerant
Insect resistant
Herbicide tolerant
Insect resistantSyngenta
Monsanto

Bt11
NK603

Corn
Corn

Insect resistant
Herbicide tolerant

2003
2002

Soybeans
CottonCottonCorn

Herbicide tolerant
Herbicide tolerant
Insect resistantInsect resistant

2001
2000
1997
1997

Year
approved

Monsanto
GTS40-3-2
Monsanto
RR lines 1445 & 1698
Monsanto
Line 531/Bollgard
Monsanto
MON810/Yieldgard
Source: DALRRD

2010

2010
2007

2005
2003

Table A2
GE plant events approved for trial release since 2018
Company

Event

Crop

Trait

Monsanto

MON87427xMO89034xMIR162xNK60
3MON87701 x MON89788

Corn

Insect resistant
Herbicide tolerance
Insect resistant
Herbicide tolerance
Insect resistantDrought tolerance
Antibiotic resistantInsect resistant
Herbicide tolerance
Herbicide tolerance

MON87460xMON810

Bayer

SoybeanCorn

MON87701 x MON89788

Soybeans

GHB614 x LLCotton25

CottonMON87427 x MON89034 x MIR162 x
NK603

Corn

37

Herbicide tolerance
Insect resistant

2018
2018
2019

2019
2018
2020

MON87460 x MON810

Corn

2020

Corn

Insect resistantAbiotic resistant
Herbicide tolerance
Insect resistantInsect resistantDrought tolerance
Antibiotic resistantAbiotic tolerance
Herbicide tolerance
Abiotic tolerance
Herbicide tolerance
Abiotic tolerance
Herbicide tolerance

MON87701 x MON89788

Soybeans

Corn

Herbicide tolerance

2018

MON89034 x 1507 x NK603

Corn

2018

MON89034 x 1507 x NK603 x
DAS40278-9
DAS-44406-6

Corn
Soybeans

Herbicide tolerance
Insect resistant
Herbicide tolerance
Insect resistant
Herbicide tolerance

DAS-81419-2 x DAS-44406-

Soybeans

Herbicide tolerance
Insect resistant2020

MON87460xMON810

Bioceres

Corn

HB4

Soybean

HB4 x GTS-40-3-2

Soybean

DAS40278-9
Dow
AgroSciences
NK603 x DAS40278-9

Pioneer

Syngenta

DP-0561139

Corn

NK603 x T25 x DAS-40278-9

Corn

DP-056113-9

Corn

TC1507 x MIR162 x NK603

Corn

MON89034xTC1507xMIR162xNK603x
DAS40278-9
BT11 x MIR162 x GA21Corn

BT11xMIR162xMON89034xGA21

Corn

BT11 x MIR162 x GA21Corn

BT11xMIR162xMON89034xGA21

Corn

MIR162

Corn

BT11xMIR162xGA21

Corn

BT11xMIR162xMON89034xGA21

Corn

38

Corn

2020
2021

2022
2022
2018

2018
2020

2019
Herbicide tolerance

2020
2020

Herbicide tolerance
Insect resistant
Herbicide tolerance
Insect resistant
Herbicide tolerance
Insect resistant
Herbicide tolerance
Insect resistant
Herbicide tolerance
Insect resistant
Herbicide tolerance
Insect resistantInsect resistant2020

Herbicide tolerance
Insect resistant
Herbicide tolerance
Insect resistant

2020

2020
2018
2018
2019
2019
2020

2020

BASF

Sensako

MIR162Corn

Insect resistant2021

BT11xMIR162xGA21

Corn

2021

BT11xMIR162xMON89034xGA21

Corn

GHB614xLLCotton25

Cotton

Herbicide tolerance
Insect resistant
Herbicide tolerance
Insect resistant
Herbicide tolerance

GHB614xLLCotton25

Cotton

Herbicide tolerance

2021

HB4

Soybeans

Abiotic Resistant
Herb tolerance

2020

2021
2020

Source: DALRRD
Table A3
GE events with commodity clearance
Company

Event

Crop

Corteva

DP202216

Corn

Bioceres

HB4

Trigall Genetics

HB4

Syngenta

3272 x Bt11 x MIR162 x
MIR604 x TC1507 x 5307 x
GA21
NK603 x T25 x DAS-40278-9
Corn Herbicide tolerance
DAS-81419-2 x DAS-44406-6 Soybean Insect resistance, Herbicide
tolerance
GMB151
Soybean Insect resistance, Herbicide
tolerance
GHB811
Cotton Herbicide tolerance

2022

MON89034 x TC1507 x
MIR162 x NK603 x DAS40278- 9
MON87427 x MON87419 x
NK603
MON87427 x MON89034 x
MIR162 x MON87419 x
NK603
MON87427 x MON89034 x
MON810 x MIR162 x

Corteva
Pioneer Hi-Bred
RSA (Pty) Ltd
BASF
BASF
Pioneer Hi-Bred
RSA (Pty) Ltd
Monsanto
Monsanto

Monsanto

Trait

Enhanced grain yield,
Herbicide tolerance
Soybean Abiotic resistance,
Herbicide tolerance
Wheat Abiotic resistance,
Herbicide tolerance
Corn Insect resistance, Herbicide
tolerance

39

Year
approved
2023
2022
2022

2021
2021
2021
2021

Corn

Insect resistance, Herbicide
tolerance

2020

Corn

Insect resistant
Herbicide tolerant
Insect resistant
Herbicide tolerant

2020

Insect resistant
Herbicide tolerant

2020

Corn

Corn

2020

MON87411 x MON87419
Monsanto
MON87427 x MON89034 x
Corn Insect resistant
MON87419 x NK603
Herbicide tolerant
Monsanto
MON87427 x MON89034 x
Corn Insect resistant
TC1507 x MON87411 x
Herbicide tolerant
DAS59122-7 x MON87419
Monsanto
MON87751 x MON87701 x
Soybeans Insect resistant
MON87708 x MON89788
Herbicide tolerant
Bayer
FG72 x A5547-127
Soybeans Herbicide tolerant
DowAgroSciences MON89034 x TC1507 xCorn Insect resistant
MIR162 x NK603
Herbicide tolerant
Syngenta
BT11 x MIR162 x MIMR604 x Corn Insect resistant
5307 x GA21
Herbicide tolerant
Monsanto
MON87705 x MON87708 x
Soybeans Herbicide tolerant
MON89788
Monsanto
MON87427 x MON87460 x
Corn Insect resistantMON89034 x TC1507 x
Herbicide tolerant
MON87411 x DAS-59122-7
Drought tolerance
Monsanto
MON87427 x MON89034 x
Corn Insect resistant
MIR162 x MON87411
Herbicide tolerant
Monsanto
MON87427 x MON89034 x
Corn Insect resistant
TC1507 x MON87411 x DASHerbicide tolerant
59122-7
Monsanto
MON87427 x MON87460 x
Corn Insect resistantMON89034 x MIR162 x
Herbicide tolerant
NK603
Drought tolerance
Monsanto
MON87708 x MON89788 x
Soybeans Herbicide tolerant
A5547-127
Syngenta
BT11 x MIR162 x
Corn Insect resistantMON89034
Herbicide tolerant
Monsanto
MON87427 x MON89034 x
Corn Insect resistant
MON88017
Herbicide tolerant
Monsanto
MON89034 x MIR162
Corn Insect resistantSyngenta
Du Pont Pioneer
Monsanto
Monsanto

BT11 x MIR162 x MON89034
Corn Insect resistantx GA21
Herbicide tolerant
DP114 x MON810 x MIR604
Corn Insect resistantx NK603
Herbicide tolerant
MON87705 x MON89788
Soybean Herbicide tolerant
Modified oil/fatty acid
MON87708 x MON89788
Soybean Herbicide tolerant

Bayer
FG72
Bayer
A5547-127
DowAgroSciences DAS68416-4 x MON89788-1

40

Soybean Herbicide tolerant
Soybean Herbicide tolerant
Soybean Herbicide tolerant

2018
2018

2018
2018
2018
2018
2018
2018

2018
2018

2018

2018
2018
2017
2017
2017
2017
2016
2016
2016
2016
2016

DowAgroSciences DAS81419-2
Syngenta SA
3272 x BT11 x MIR604 x
GA21
Du Pont Pioneer
TC1507 x MON810 x
MIR162
Syngenta SA
BT11 x TC1507 x GA21
Monsanto
Monsanto
Monsanto
Monsanto
Du Pont Pioneer
Du Pont Pioneer

MON87427 x MON89034 x
MIR162 x NK603
MON87427 x MON89034 x
1507 x MON88017 x 59122
MON87460 x NK603
MON87427 x MON89034 x
NK603
TC1507 x MON810 x MIR162
x NK603
TC1507 x MIR604 x NK603

Du Pont Pioneer

TC1507 x MON810 x MIR604
x NK603
Du Pont Pioneer
TC1507 x 59122 x MON810 x
NK603
Du Pont Pioneer
TC1507 x 59122 x MON810 x
MIR604 x NK603
DowAgroSciences DAS81910-7
DowAgroSciences DAS-24236-5 x DAS-21023-5
DowAgroSciences MON89034 x TC1507 x
MON88017 x DAS-59122-7 x
DAS-40278-9
DowAgroSciences MON89034 x TC1507 x
NK603 x DAS-40278-9
Syngenta
3272 x BT11 x MIR604 x
TC1507 x 5307 x GA21
Du Pont Pioneer
DP4114
Monsanto
Syngenta
Du Pont Pioneer
Monsanto

NK603 x T25
MZHG0JG
DP73496
MON87460 x MON89034 x
NK603

Syngenta

BT11 x MIR162

41

Soybean Insect resistantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Drought tolerance
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerant
Cotton Herbicide tolerant
Cotton Insect resistant
Corn

2016
2016
2016
2016
2016
2016
2016
2016
2016
2016
2016
2016
2016
2016
2016

Insect resistant
Herbicide tolerant

2016

Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Herbicide tolerantCorn Herbicide tolerant
Canola Herbicide tolerantCorn Drought tolerance
Insect resistant
Herbicide tolerantCorn Insect resistant

2016

Corn

2016
2016
2016
2016
2016
2015

2015

Monsanto

MON87460 x MON89034 x
MON88017

Syngenta
Syngenta
Syngenta

Syngenta
Monsanto

GA21 x T25
SYHT0H2
BT11 x 59122 x MIR604 x
TC1507 x GA21
BT11 x MIR604 x TC1507 x
5307 x GA21
BT11 x MIR162 x MIR604 x
TC1507 x 5307 x GA21
MIR162
MON89034 x MON88017

Monsanto

MON87701 x MON89788

Syngenta
Syngenta

Monsanto
MON89788
DowAgrowScience DAS-44406-6
DowAgrowScience DAS-40278-9
BASF
CV127
DowAgrowScience/ MON89034 x TC1507 x
Monsanto
NK603
Syngenta
MIR604
Syngenta
BT11 x GA21
Syngenta

BT11 x MIR604

Syngenta

MIR604 x GA21

Syngenta

BT11 x MIR604 x GA21

Syngenta

BT11 x MIR162 x MIR604 x
GA21
BT11 x MIR162 x GA21

Syngenta
Syngenta
Pioneer

BT11 x MIR162 x TC1507 x
GA21
TC1507 x NK603

Pioneer
Pioneer

59122
NK603 x 59122

Pioneer

35604342

Herbicide tolerantCorn Abiotic resistance
Insect resistant
Herbicide tolerantCorn Herbicide tolerant
Soybean Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistantCorn Insect resistant
Herbicide tolerant
Soybeans Insect resistant
Herbicide tolerant
Soybeans Herbicide tolerant
Soybeans Herbicide tolerantCorn Herbicide tolerant
Soybeans Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistantCorn Insect resistant
Herbicide tolerant
Soybean Herbicide tolerant

2015

2015
2014
2014
2014
2014
2014
2014
2013
2013
2013
2012
2012
2012
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011

Pioneer

305423

Pioneer

305423 x 40-3-2

DowAgroScience

TC1507 x 59122

DowAgroScience

TC1507 x 59122 x NK603

Bayer
Bayer
Monsanto
Monsanto
Monsanto

LLRice62
LLCotton25
MON863
MON863 x MON810
MON863 x MON810 x
NK603
Monsanto
MON88017
Monsanto
MON88017 x MON810
DowAgroScience & MON89034 x TC1507 x
Monsanto
MON88017 x 59122
Monsanto
MON810 x NK603
Monsanto

MON810 x GA21

Pioneer Hi-Bred

TC1507

Monsanto
Monsanto
Syngenta
AgrEvoSyngenta
AgrEvo

NK603
GA21
Bt11
T25
Bt176
Topas 19/2, Ms1Rf1,
Ms1Rf2,
Ms8Rf3
A2704-12

AgrEvoSource: DALRRD

Attachments:
No Attachments

43

Soybean Higher oleic acid content
Herbicide tolerant
Soybean Higher oleic acid content
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerant
Rice Herbicide tolerant
Cotton Herbicide tolerantCorn Insect resistantCorn Insect resistantCorn Insect resistant
Herbicide tolerantCorn Insect resistantCorn Insect resistantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Insect resistant
Herbicide tolerantCorn Herbicide tolerantCorn Herbicide tolerantCorn Insect resistantCorn Herbicide tolerantCorn Insect resistantOilseed Herbicide tolerant
rape

2011

Soybean Herbicide tolerant

2001

2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2011
2004
2003
2002
2002
2002
2002
2001
2001
2001