Required Report: Required - Public Distribution

Date: November 13, 2023
Report Number:

VM2023-0059

Report Name: Agricultural Biotechnology Annual
Country: Vietnam
Post: Hanoi
Report Category: Biotechnology and Other New Production Technologies

Prepared By:

Thu PhamApproved By: Ralph Bean
Report Highlights:
This report provides updated information about the adoption of agricultural biotechnology in Vietnam.
In the first six months of 2023, Vietnam approved six outstanding biotech corn hybrids for cultivation
after the country suspended its appraisal process since 2017. Biotech corn continues to be adopted in awide range of regions in the country due to its resilience in the face of pests and climate impacts. The
country remains a major importer of biotech crops and products, including soybeans, corn, distiller’sdried grains with solubles (DDGS), soybean meal, and cotton.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILYSTATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICYEXECUTIVE SUMMARY
MARD Approved Outstanding Biotech Corn Hybrids for Cultivation
As of June 2023, the Ministry of Agriculture and Rural Development (MARD) approved six
outstanding biotech corn hybrids for cultivation. They were the latest approvals after 7 years since the
Ministry suspended its appraisal process in 2017. According to MARD, these hybrids, containing
stacked-events resistant to glyphosate and Lepidoptera, were approved under Circular 29/2014 on
Exceptional Recognition of Biotechnology Advantages. These hybrids were tested in field trials andwent through the MARD Biosafety Committee review in 2016.
MARD Acknowledged New Applications for Food and Feed Use
MARD resumed the acknowledgement of new applications for food and feed use in 2023. The Ministry
opened public consultations for the first batch of four applications in April 2023. This included two
applications of herbicide resistant traits for canola and two applications of herbicide and pest resistant
traits for cotton. In the second batch of acknowledgement in September, MARD accepted three more
applications, including two biotech events for corn and one event for soybeans. As of October 2023,
public consultations for the second batch of applications are ongoing. At the same time, MARD invited
new technical advisors for the GE Food and Feed Safety Committee to review these applications. To
date, MARD has approved 52 biotech events for food and feed use in corn, soybeans, alfalfa, cotton,
canola, and sugar beets.
Biotech Corn Continued to Gain Public Acceptance
Cultivation of biotech corn continues to grow in the main corn-producing regions as it has proveneffective in combating pests, including fall armyworm (FAW). In 2022, industry estimated the biotech
corn area at around 220,000 hectares (ha) while demand for GE seed is increasing. Biotech corn is
gaining popularity as farmers appreciate the benefits of the technology in mitigating damage caused byharmful pests, reducing insecticide costs, and resilience to drought conditions.

TABLE OF CONTENTSEXECUTIVE SUMMARY................................................................................................................ 2
CHAPTER 1: PLANT BIOTECHNOLOGY ................................................................................. 4
PART A: PRODUCTION AND TRADE .................................................................................................................... 4
PART B: POLICY ...................................................................................................................................................... 7
PART C: MARKETING ........................................................................................................................................... 20
CHAPTER 2: ANIMAL BIOTECHNOLOGY ....................................................................................................... 21
PART D: PRODUCTION AND TRADE .................................................................................................................. 21
PART E: POLICY .................................................................................................................................................... 22
PART F: MARKETING............................................................................................................................................ 23

CHAPTER 3: MICROBIAL BIOTECHNOLOGY..................................................................... 24
PART G: PRODUCTION AND TRADE .............................................................................................................. 24
PART H: POLICY .................................................................................................................................................. 24
PART I: MARKETING .......................................................................................................................................... 27

CHAPTER 1: PLANT BIOTECHNOLOGYPART A: PRODUCTION AND TRADEa) RESEARCH AND PRODUCT DEVELOPMENT
Vietnam has developed a key program on the application of biotechnology in agriculture with the aimof creating new plant varieties with high productivity, improved quality, and which improve thecompetitiveness of farm produce. In 2020, MARD reported several research projects using genetic
engineering (GE) in plants: i) Research on drought-tolerant events in corn; ii) Designing transgenic
vectors to create insect-resistant soybeans; iii) Research on selecting and creating GE soybean lines
resistant to stem borers and fruit borers; iv) Research on creating breeding lines in corn with enhanced
starch synthesis. However, according to MARD, these research projects for GE plants were conductedin the laboratory and have not yet reached the stage of commercial production.
Regarding innovative biotechnology, Vietnam reported several research activities using CRISPR/Cas9:i) Using genome editing to improve aroma and blight resistance traits on key rice varieties; ii) Researchon improving the sugar and amino acid content of tomato through gene mutation using the
CRISPR/Cas9 system; iii) Using CRISPR/Cas9 system to improve resistance to ringspot virus inpapaya; iv) Using CRISPR/Cas9 system to create cucumber varieties with virus-resistance.
In terms of field testing for risk assessment of GE crops, Vietnam first allowed field testing of GE cornin 2010. Field testing must be conducted in confined fields on a large-scale, and under MARD’s strict
control. During 2010-2016, MARD issued field testing permits for GE corn and recognized field-testing
results for five biotech events resistant to herbicides and Lepidotera. That allowed biotech developers toapply for Certificates of Biosafety for these recognized events, then conduct field trials for the purposeof cultivation for GE corn hybrids containing the recognized events.
MARD approved 16 biotech corn hybrids, containing recognized events, for cultivation during 20142016. After that, the Ministry suspended issuance of field testing permits and delayed the approval
process for cultivation during 2017-2022.
MARD recently resumed the approval process for cultivation since GE corn has continued to prove
productive and effective, especially in combating FAW. In the first six months of 2023, MARD
approved six outstanding GE corn hybrids, including five hybrids containing stacked events resistant toherbicide and Lepidotera, and one hybrid containing a single event resistant to herbicide. In March 2023,
MARD recognized the field-testing results, conducted in 2016, of MIR162, a biotech event reported
resistant specifically to FAW in corn. This will allow the developer of MIR162 to apply for a Certificateof Biosafety and initiate the commercialization of GE corn hybrids containing this event in Vietnam.

In addition to GE corn, Vietnam allows field testing for risk assessment of GE cotton and soybeans, butthere were no applications on field testing of GE cotton and soybean. As of October 2023, there are no
new applications on field testing for risk assessment of GE corn in Vietnam.
b) COMMERCIAL PRODUCTION
Vietnam currently only approves the cultivation of GE corn. To date, MARD has approved a total of 22
biotech corn hybrids for commercialization in Vietnam. Most of them contain stacked events resistant
to insects and herbicides. However, only nine varieties have been commercialized in the local market.
Since MARD recently approved six GE corn hybrids for cultivation, industry expects some of them will
be commercialized next year.
There has been a significant increase in planting of insect-resistant biotech corn since 2019, after FAW
started to spread in the country. The biotech corn area marked record growth in 2020, exceeding one
hundred thousand hectares for the first time since Vietnam adopted the commercialization of biotech
corn. In 2023, industry estimates show that the biotech corn area maintained around 220,000 ha eventhough the overall total corn production area continued to decline during recent years (GAIN Report
VM2023-0019).
Biotech corn is mainly produced for feed use, either for grains or as silage, due to high demand in thefeed and livestock industry. During recent years, corn growers reported benefiting from higher prices inthe domestic market due to global supply chain disruptions. According to the industry, the adoption
levels of biotech corn varies among different geographical areas in Vietnam. Biotech corn area islargest in the Central Highland and Mekong Delta regions, where FAW exists at high levels, and GE
corn significantly helps to increase farmers’ income. The Northwest and North Central regions ofVietnam have also seen high levels of GE corn adoption due to its effectiveness in saving costs forherbicides and pesticides.
Most GE corn seed used in the domestic market is produced domestically. Major developers reported
they domestically produce up to 100% of GE seeds in the Vietnam market and partly for export to other
ASEAN countries.
A study on the economic and environmental benefits of GE corn in Vietnam was published in
September 2020.1 The report showed that GE corn varieties out-performed conventional varieties inyield by 15 percent and reduced the cost of production by between $26.47- $31.30 USD per ha. The
average amount of herbicide used in the GE planting area was 26 percent lower than the average value
for the conventional corn area. Overall farm income of farms that planted GE corn increased between$196 USD per ha (relative to equivalent conventional varieties) and $330 USD per ha (average of allconventional varieties). Approximately 60 percent of farmers also reported an improvement in grain

1

Graham Brookes & Tran Xuan Dinh (2021) The impact of using genetically modified (GM) corn/maize in Vietnam: Resultsof the first farm-level survey, GM Crops & Food, 12:1, 71-83, DOI: 10.1080/21645698.2020.1816800

quality that is likely related to reduced levels of mycotoxins in GE corn compared with conventional
corn hybrids.
c) EXPORTS
There is no official data on Vietnam’s exports of GE products. Vietnam does export corn and soy oil.
Vietnam’s soybean crushers rely on imported soybeans.
Vietnam exported 250,000 metric tons of corn in 2022, down 53 percent compared to the previous year,
due to lower imports and less demand in Association of Southeast Asian Nations (ASEAN) countries.
These exports are mainly re-exports of imported corn, given that the domestic production is mainly
consumed locally. (GAIN Report VM2023-0019).
Vietnam exported about 59,000 metric tons of soy oil in MY 2021/22 with South Korea accounting for77 percent of total exports (GAIN Report VM2023-0015). According to the Food Safety Law, Vietnam
issues certificates of free sale, health certificates, or other certification for exports upon request byimporting countries.
d) IMPORTS
Vietnam imports a number of GE plant products, including soybeans, soybean meal, soybean oil, corn,distiller’s dried grains with solubles (DDGS), cotton, and alfalfa. Excluding imported cotton used in the
textile industry, and soybean oil, the majority of Vietnam’s GE product imports are utilized as feed forthe country’s growing livestock and aquaculture sectors. Vietnam is increasingly dependent upon
imported GE feed ingredients as domestic supplies are unable to satisfy growth in these sectors. GE
products must be approved for food and feed use by MARD before importation.
The following table shows imports of GE products and byproducts to Vietnam. The United States is thedominant supplier of DDGS, soybeans, and cotton, while Argentina and Brazil are the two largest
suppliers of corn and soybean meal.
Commodity

Quantity (million tons)
MY 2021/22
MY 2022/23(estimated)
Corn
9.2
10.5
DDGS*
1.31
1.2
Soybeans
1.84
2.0
Soybean meal
5.16
5.2
Cotton1.44
1.37
Source: GAIN Report VM2023-0019, VM2023-0013, VM2023-0015* Data reported for calendar yeare) FOOD AID

Reportedly, Vietnam provided food aid for some countries for the purpose of humanitarian assistance. In
April 2023, Vietnam donated 5,000 tons of rice to Cuba following an announcement made during the2022 visit of the Cuban Prime Minister to Vietnam.
f) TRADE BARRIERSAs of October 2023, no official trade barriers affecting GE agricultural products have been reported.
However, since Vietnam remains a major importer of biotech crops and related products, it is one of themain markets where developers are seeking approval in advance of commercialization in producing
countries. The prolonged review and approval period for food and feed use continues to raise concerns
about unpredictable procedures, which could disrupt trade and increase the likelihood of unapproved
varieties entering the market.
PART B: POLICYa) REGULATORY FRAMEWORK
Law on Biodiversity
The Law on Biodiversity, ratified by the National Assembly in 2008, is the first law legalizing
provisions of “genetically modified organisms” (“GMO”) and risk management of “GMO” in Vietnam.
Previously, Vietnam managed “GMOs” under the 2005 Regulation on Biosafety, but this regulation did
not detail the approval process for GE organisms and GE-derived products. The Law on Biodiversity,that took effect on July 1, 2009, provides a legal basis for the GVN to outline the approval process andresponsibilities of line ministries.
Legal term (inofficial language)

Legal Term (inEnglish)Sinh vật biến đổi
gen

Geneticallymodified organism(GMO)Sản phẩm của sinhvật biến đổi gen

Products of GMOs

Laws and
Regulations where
term is used
Law onBiodiversity(Article 3.27)

Decree 69/2010
guiding the Law on
Biodiversity on
Biosafety for
GMOs, Genetic
Specimens andProducts of GMOs
- Article 3.2

Legal Definition (inEnglish)Genetically modified
organism means anorganism whose genetic
structure has been modified
by the gene transfer
technology.
Products of GMOs areproducts that wholly or
partly contain ingredients
originating from GMOs,
including genetic specimens
of GMOs that can’t
themselves create neworganisms under natural
conditions

Biosafety Decrees
Decree 69/2010 on Biosafety of GE Organisms, Genetic Specimen, and Products Derived from GE
Organisms
On June 21, 2010, the GVN issued Decree 69/2010/ND-CP on Biosafety, replacing the 2005 Biosafety
Regulation. Decree 69 provides a framework on the management of GE organisms, GE products, andthe approval of GE plants for food and feed use as well as for cultivation. Decree 69 was revised in 2011
after the Food Safety Law (FSL) re-assigned the food safety management of GE plants from the
Ministry of Health (MOH) to MARD. Since Decree 108 (revising Decree 69) took effect on January 15,
2012, MARD became the sole ministry responsible for reviewing and issuing Certificates for Food andFeed Approval for GE plants in Vietnam.
Decree 118/2020 revising Decree 69 on Biosafety
On October 2, 2020, GVN issued Decree 118/2020 revising Decree 69/2010 on Biosafety. The revisionfocuses on amending and supplementing provisions on field testing of biotech crops for biosafetyassessments. This decree has provided a regulatory basis to resume the field testing of biotech corn forbiosafety assessments which was suspended since 2017. In addition, this decree details provisions on
the renewal of Certificates for Food and Feed Approval and Certificates of Biosafety in the case of achange to an applicant’s information.
Decree 123/2018 Amending and Supplementing Conditions for Trade and Business in Agriculture
On September 17, 2018, GVN issued Decree 123/2018 amending and supplementing a number ofconditions for trade and business in agriculture. This decree amended Articles 37, 38, 39, and 40 of
Decree 69/2010 on biosafety to consolidate the conditions for import, production, and trade of GE foodand feed. Decree 123 maintains the requirements that GE products used for food and feed must obtain acertificate of food/feed approval prior to importation, production, and trade in Vietnam.
Food and Feed Import Approval
The review and approval process to issue Certificates of Food and Feed Approval for GE crops isregulated under MARD’s Circular 2/2014/TT-BNNPTNT. This circular entered into force on March 10,
2014. According to this circular, a GE event is approved for food and feed use if it meets one of thefollowing conditions: either it has been approved for use as food and/or feed in five developed countries(defined as a country with advanced biotechnology policies in the OECD and/or in the G20) or the GE
Food and Feed Safety Committee concludes that the GE product does not contain uncontrolled risks tohumans and/or the environment. All submissions of GE products must be posted on MARD’s website
for a 30-day public comment period. After that, the submissions must be circulated for the GE Food andFeed Safety Committee’s review before being submitted to MARD’s leadership for approval. Circular
2/2014 also provides the procedure to revoke Certificates of Food and Feed Approval for GE crops inaccordance with Decree 69/2010.

GE Food and Feed Safety Committee
This committee was established under MARD Circular 2/2014 to advise MARD’s leadership on theissuance and withdrawal of Food and Feed Use Certificates. The committee has a term of three years
and includes twelve members, from MARD, Ministry of Natural Resources and Environment(MONRE), Ministry of Health (MOH), the Ministry of Science and Technology (MOST), the Ministryof Industry and Trade (MOIT) and some experts in relevant fields. The current committee wasestablished on December 9, 2020. The committee retained its chairman and vice chairman from theprevious term and added four new members from technical agencies under MARD. As of October 2023,
MARD stated that they are in the process of re-organizing the committee since some members are nolonger eligible.
Biosafety Approval for Environmental Release
Field Testing for Risk Assessment
According to Decree 69/2010 on Biosafety, GE crops must be tested in-field, in both confined-field andlarge-scale trials, to evaluate their effects on the environment and biodiversity in specific conditions in
Vietnam, in advance of rearing, planting, and purposeful release into the environment. The procedurefor biosafety field-testing, revised under Decree 118/2020, stipulates that MARD is responsible for
granting and revoking a permit for field-testing. The results of field-testing must be reviewed andapproved by the Committee of GE Crop Risk Assessment established by MARD.
GE Crop Risk Assessment Committee
The GE Crop Risk Assessment Committee, first established in 2014, reviewed and approved thebiosafety field-testing for five GE events in corn for the purpose of cultivation in Vietnam. The
committee ended its term in September 2020. Even though the GVN issued Decree 118 in 2020,
Revising and Supplementing Provisions for GE Crop Risk Assessments, MARD has yet to re-establish
the committee. However, MARD noted that due to Decree 118, the committee will be ad-hoc, withmembers nominated once MARD acknowledges a submission, and the committee will be dissolved after
completing its appraisal.

MONRE Biosafety Certification
A Certificate of Biosafety is required for the release of GE plants into the environment in Vietnam. The
procedure for granting and revoking the Certificate of Biosafety is regulated under MONRE’s Circular
8/2013/TT-BTNMT. This circular entered into force on July 1, 2013. Accordingly, MONRE shallestablish its National Biosafety Committee to review an application for the Biosafety Certificate after

MARD approves field testing results for the biotech event. In 2014-2016, MONRE issued Biosafety
Certificates for 5 biotech events in corn based on MARD’s approval of risk assessment results.
Cultivation Approval
Currently, all GE hybrids adopted for cultivation in Vietnam were recognized as exceptional cases
under MARD’s Circular 29/2014. The Crop Production Law (CPL), that went into effect on January 1,
2020, provides provisions related to field trials, breeding, trading, and quality management of GE
varieties. However, the CPL does not clarify the procedures for cultivation approval for GE varieties.
The CPL continues to refer to the Biodiversity Law regarding risk assessments and biosafety
certifications for GE crops.
Exceptional Approvals for GE Hybrids
According to MARD’s Circular 29/2014 on Exceptional Recognition of Biotechnology Advantages, aGE hybrid must be tested in field trials to demonstrate its equivalence with its host variety, except for
those affected by the transgenic events. The demonstration trial of GE hybrids can be conducted at thesame time as the risk assessment.
Accordingly, a GE hybrid can be exceptionally recognized for cultivation in Vietnam, providing that its
host variety is already recognized for cultivation, and meets the following conditions:i) the GE hybrid containing gene-transferred events that have been granted a Biosafety Certificate, as
well as a Certificate for Food/Feed Use.
ii) the GE hybrid has been compared with the host variety and undergone a risk assessment; andiii) the GE hybrid is equivalent to the host variety in the main characteristic morphological traits, except
for those affected by the transgenic events.
In cases where the GE hybrid has undergone a risk assessment, the owner of the GE hybrid can apply
for a demonstration trial with the host variety. The demonstration trial must be conducted on both asmall and large scale. The small-scale field trial will be conducted during one crop season in two
different places. The large-scale field trial will be conducted during one crop season at one location ofat least one hectare. The small-scale field trial can be conducted before or at the same time as the largescale field trial.
Cultivation Approval Under the Crop Production Law (CPL)
According to the CPL, a plant variety is subject to field testing prior to applying for cultivation approval.
The testing procedures include: 1) Testing for distinctness, uniformity, and stability (DUS) of plantvarieties; 2) Testing for the cultivating value and the use value (VCU) of the variety, which includes: a)Controlled testing, b) Small-scale field testing; and c) Large-scale field testing. The CPL requires GEvarieties to undergo an environmental risk assessment in advance of the testing for cultivation
recognition.
Since the CPL provides general provisions on the field testing and cultivation approval for plantvarieties, there are disparities in interpretation of the law regarding GE crops. Industry expects that
MARD will approve GE varieties for cultivation under the same procedures with conventional varieties,
MARD still refers to the Law on Biodiversity and the Law on Science and Technology for GE variety
approvals. Decree 94/2020 dated December 13, 2019, guiding the CPL, stipulates that GE varieties are
permitted for import for field testing (for the purpose of cultivation registration) after obtaining both a
Certificate of GE Food/Feed Approval and a Certificate of Biosafety.
National Standards for DUS and VCU testing
In October 2021, the Ministry of Science and Technology (MOST) issued the National Standards for
DUS testing (TCVN 13382) and VCU testing (TCVN 13381) for corn and rice, which were drafted by
the National Testing Center for Plant Varieties, MARD. The standards are the key requirements fordemonstration trials of new varieties for cultivation approval under the CPL. However, during thedevelopment of the standard TCVN 13881 Part 2 for corn, industry was concerned about the lack ofnecessary guidance for examination of resistant traits in biotech varieties, which will challenge thedesign of field trials as well as the appraisal of testing results for new variety recognition. In 2023,
industry continues to seek more guidance on DUS testing for GE corn from the MARD.
Additional Regulations Governing Aspects of Agricultural Biotechnology
Master Plan for Development of Agricultural Bioindustry to 2030
On March 24, 2021, the GVN issued a master plan to outline the development of the agriculturalbioindustry in Vietnam to 2030. This master plan was developed as a follow-up to the GVN’s Decision
on Restructuring in Agriculture, and in accordance with the Law on High Technology and the Law on
Science and Technology. This master plan aims to: i) facilitate research and application of
biotechnology in a group of key agricultural products to increase quality and productivity, adapt toclimate change, and resist pests and disease; ii) increase investment in local agricultural biotechnology
industries; and iii) upgrade capacities in plant breeding technologies, gene technologies, and animal andplant cell technologies.
Regarding plant breeding, this plan sets objectives in applying gene technologies, plant cell technologies
and new technologies to create new varieties with high-quality, high-yield, climate-resilient and diseaseresistant traits for key crops. The plan sets an objective to approach and master techniques in genome
editing, and to develop a genomic selection system in plant breeding. The plan highlights areas forinternational cooperation to support the adoption of new technologies in Vietnam, including thedevelopment of biosafety assessment policies and regulations in harmonization with international
regulations; technical exchanges, and training in genome editing and new breeding technologies.

Furthermore, the plan covers outreach to stakeholders and policy makers about the benefits of newtechnologies.
MONRE Regulations on Providing and Exchanging Information and Databases on GE Organisms
On August 22, 2012, MONRE issued Circular 09/2012/TT-BTNMT on the Regulation of the Provision
and Exchange of Information and Databases on GE Organisms. The circular entered into force on
October 8, 2012. According to this circular, MONRE is responsible for developing a database on GE
organisms, including: Bilateral or multilateral agreements on the biosafety of GE organisms that Vietnam participatesin or has already signed.
 Current regulations on GE organisms.
 Results of research projects and programs on the safety of GE products.
 Biosafety certificates, food/feed approval certificates and permits for field testing, Validation offield-testing results, decisions to accredit or revoke laboratories qualified for conducting
research on GE products, decisions on which facilities are allowed to conduct GE crop fieldtesting, permit or decision on imports of GE products that are not on the list of GE products
allowed for use as food/feed.
 Reports on field-trials for risk assessment as regulated in Decree 69; and Information on field testing of GE organisms, planting areas of GE crops, and the list of
local/foreign consultants on biosafety, and modern biotechnology and other biotech related
information or documents.
MOST Regulation on Guidance to Certify Laboratories Qualified for GE Research
On October 20, 2012, MOST issued Circular 20/2012/TT-BKHCN regarding the Regulation ofProcedures to Certify a Lab for Permission to Conduct GMO Research. The full Circular (inVietnamese) can be found at: https://thuvienphapluat.vn/van-ban/linh-vuc-khac/thong-tu-20-2012-ttbkhcn-huong-dan-dieu-kien-trinh-tu-va-thu-tuc-cong-nhan-162294.aspx
MOST Regulation on Biosafety Management of GE Research and Development
The principles of biosafety management for research on GE crops are provided in MOST’s Circular
21/2012 regulating the Research and Development of Genetically Engineered Organisms in Vietnam.
Accordingly, research on GE crops must be implemented within the regulatory framework of scienceand technology, including the Law on Science and Technology, the Law on Biodiversity, and the Food
Safety Law (FSL). All research on GE products must be carried out in MOST certified laboratories inaccordance with Circular 20/2012/TT-BKHCN.
b) APPROVALS/AUTHORIZATIONSApproval for Environment ReleaseDuring 2014-2016, MONRE issued biosafety certificates for five biotech events in corn. The list of GE
traits granted a biosafety certificate is available (in Vietnamese) at: http://antoansinhhoc.vn/gmo/danhmuc-da-cap-phep-vi/
MONRE is currently reviewing the application of Biosafety Certificate for MIR162 since MARD
approved the field-testing result of the event. The public consultation for the event was closed in July
2023.
Approval for Cultivation
MARD resumed the cultivation approval for GE corn hybrids in 2023. To date, MARD approved 22 GE
corn hybrids for cultivation in Vietnam. Most approved biotech corn varieties carry stacked events
tolerant to both lepidopteran and glyphosate, but a small number of approved varieties carry a single
event tolerant to lepidopteran or glyphosate separately.
Food and Feed Use Approval
MARD accepted 4 new applications of biotech events for canola and cotton in April 2023. These
applications are currently under MARD’s review process for approval. As of August 2021, MARD has
approved a total of 52 biotech events for soybeans, corn, alfalfa, sugar beets, and cotton. All of these
biotech events for soybean, corn, canola and sugar beet are approved for food and feed use, but those forcotton and alfalfa are approved only for feed use.
According to Circular 2/2014 on Food and Feed Approval, MARD keeps updating the lists of approved
GE events and the list of received GE dossiers (in Vietnamese) on the website:
http://agrobiotech.gov.vn/Default.aspx
Below is the current list of food and feed approvals:

No.

Crop

Event

Date of Approval

Traits1.

Corn

MZIR098

Aug 24, 2021

Insect protected

2.

Corn

MON 87419

Aug 23, 2021

Dicamba and glufosinate tolerant

3.

Soybean

DAS-81419-2

June 23, 2021

Glufosinate toleranceand Lepidopteran insect protected

4.

Corn

DP ØØ 4114-3

June 23, 2021

Glufosinate tolerance & Lepidoptera& Coleoptera tolerance

5.

CottonT304-40

Sep 14, 2020
(only for feed)

Lepidopteran insect protected andAmmonium glufosinate tolerant

6.

CottonGHB 119

Dec 16, 2020
(only for feed)

Insect protected and ammonium
glufosinate tolerant

7.

CottonMON 88701

Dec 16, 2020
(only for feed)

Dicamba and glufosinate tolerant

8.

Alfalfa

KK 179Dec 16, 2020
(only for feed)

Reduced Lignin

9.

Cotton

LL Cotton 25

Ammonium glufosinate tolerant

10.

Corn

MON 87411

Sep 14, 2020
(only for feed)
Sep 14, 202011.

CottonGHB 614

Jul 15, 2020
(only for feed)

12.

CottonCOT 102

Lepidoptera insect protected

13.

Soybean

MON 87751

Jul 15, 2020
(only for feed)
Jul 15, 2020

14.

Soybean

FG 72

Feb 19, 2020

15.

CanolaRF3

Feb 19, 2020

Glyphosate tolerance & Isoxaflutole
herbicide tolerance
Ammonium glufosinate tolerant

16.
17.

Sugar beet
Canola

H7-1
MON 88302

Feb 19, 2020
Feb 19, 2020

Glyphosate tolerant
Glyphosate tolerant

18.
19.

CanolaCotton

RT 73
MON 15985

Glyphosate tolerant
Insect protected

20.

CottonMON 88913

21.
22.

CanolaCorn

MS8
DAS-40278-9

Feb 19, 2020
Jan 21, 2020
(only for feed)
Jan 21, 2020
(only for feed)
Jan 21, 2020
Sep 20, 201923.

Soybean

DAS-68416-4

Sep 20, 201924.

Soybean

DAS-44406-6

Sep 20, 201925.

Alfalfa

J101

26.

Alfalfa

J163

Sep 20, 2019
(only for feed)
Sep 20, 2019
(only for feed)

2.4-Dichlorophenoxyacetic herbicide
tolerance, Glufosinate herbicide
tolerance
2.4-Dichlorophenoxyacetic herbicide
tolerance, Glyphosate herbicide
tolerance, Glufosinate herbicide
tolerance
Glyphosate herbicide tolerance

Corn rootworm protected andglyphosate tolerant
Ammonium glufosinate tolerant

Lepidopteran insect protected

Glyphosate tolerant
Ammonium glufosinate tolerant
2.4-Dichlorophenoxyacetic herbicide
tolerance

Glyphosate herbicide tolerance

27.

Corn

3272

Feb 25, 201928.

Soybean

OH2

Feb 25, 2019

29.
30.
31.
32.
33.
34.

SoybeanSoybean
Corn
Corn
Corn
Corn

CV 127DP-305423-1
DAS 59122-7
MIR6045307
TC1507

Feb 25, 2019Oct 25, 2018
Oct 25, 2018
Aug 12, 2016
Jun 2, 2016
Jan 19, 2016

35.

Corn

T25

Sep 9, 201536.

Soybean

A5547-127

Sep 9, 201537.

Soybean

A2704-12

Sep 9, 2015

38.

Corn

MON87427

Sep 9, 2015

39.
40.

Corn
Soybean

MON87460
MON87769

Sep 9, 2015
Sep 9, 2015

41.

Corn

MON88017

Sep 9, 2015

42.
43.
44.

Corn
SoybeanSoybean

MON81040-3-2
MON87705

Sep 9, 2015
Apr20, 2015
April 20, 2015

45.
46.

SoybeanSoybean

MON87701
MON87708

April 20, 2015
April 20, 2015

47.
48.
49.

SoybeanCorn
Corn

MON89788
GA21
MON89034

Dec 24, 2014
Dec 10, 2014
Aug 11, 2014

50.
51.

Corn
Corn

NK603
Bt11

Aug 11, 2014
Aug 11, 2014

Expression of alpha-amylase
AMY797E
Gluphosinate- ammonium tolerant and
HPPD inhibitor
Herbicide tolerance
Herbicide tolerance, fatty oil acid
Herbicide tolerance, Insect tolerance
Resistance to corn rootworm
Resistance to corn rootworm
Resistance to diseases and pests –Insects – Lepidoptera (butterflies andmoths)
Herbicide tolerant, glufosinate
ammonium
Herbicide tolerant, glufosinate
ammonium
Herbicide tolerant, glufosinate
ammonium
Herbicide tolerant – Glyphosate(commercial Roundup), modified fortissue selective glyphosate tolerance
Drought-tolerant
Modified fatty acid composition to
Omega 3
Herbicide tolerant- Glyphosate andResistance to Insects – provides
protection against corn rootworm
Resistance to European corn borer
Glyphosate herbicide tolerance
Increased oleic acid and Glyphosate
herbicide tolerance (commercial
Roundup)Resistance to Insects – Lepidoptera
Dicamba Tolerant Soybean,
Resistance to herbicides
Glyphosate herbicide tolerance
Resistance to herbicides – Glyphosate
Resistance to diseases and pests –Insects – Lepidoptera (butterflies andmoths)
Glyphosate herbicide tolerance
Resistance to diseases and pests –Insects – Lepidoptera (butterflies andmoths) Resistance to herbicides –

52.

Corn

MIR162

Aug 11, 2014

Glufosinate
Resistance to diseases and pests –Insects – Lepidoptera (butterflies andmoths)c) STACKED or PYRAMIDED EVENT APPROVALS
According to MONRE’s Circular 8/2013, a GE plant bearing a molecular stacked event is subject to theapproval of a biosafety certificate. The approval procedure for GE plants bearing stacked events isregulated under the same procedure for single events. Similarly, MARD Circular 2/2014, regulates thecertification of food and feed approval for both single and stacked events.
d) FIELD TESTING
According to Circular 72/2009, dated November 17, 2009, MARD allows field testing for the purposeof biosafety evaluation and commercialization for three GE crops – corn (Zea mays L.), cotton(Gossypium spp.), and soybeans [(Glycline max (L.) Merrill]. To date, MARD has only issued permits
for conducting field trials of GE corn.
Field testing of GE crops is currently regulated under Decree 69/2010 guiding the Law on Biodiversity
and Decree 118/2020 amending a number of articles of Decree 69/2010. During 2010-2016, MARD
issued field testing permits for GE corn under its Circular 69/2009, but the Ministry repealed thiscircular in 2020. MARD did not issue any new permits for field testing during 2017-2022. e)
INNOVATIVE BIOTECHNOLOGIES
Vietnam has expanded its outreach to explore regulatory approaches for gene editing and innovative
biotechnologies. MARD continues to participate in the APEC High Level Policy Dialogue on
Agricultural Biotechnology (HLPDAB) with high interest in regulatory approaches for gene editing andgene-edited products. As discussed in the gene editing webinar hosted by the Foreign Agricultural
Service (FAS) Hanoi in July 2022, one of the key policy advisors called on regulatory managers that
Vietnam should develop a regulation to pave the way for the adoption of new breeding technologies,
such as gene editing.
In terms of regulatory consultation, BCA/MONRE, hosted a series of workshops to discuss theapproach to research, application, and commercialization of gene-edited crops. At the first workshop
held in October 2022, BCA shared their viewpoints about reviewing the Cartagena Protocol and theLaw on Biodiversity. Post will continue to participate in the workshops held by MONRE to learn more
about their perspective.
Previously, Vietnam supported the International Statement on Agricultural Applications of Precision
Biotechnology submitted to the World Trade Organization Committee on the Application of Sanitaryand Phytosanitary Measures in November 2018. This is a non-binding document that reiterates highlevel approaches regarding the fair, science-based treatment of precision biotechnology.
f) COEXISTENCE
On August 29, 2018, the GVN issued Decree 109 on Organic Agriculture that aims to promote organic
production in Vietnam. This decree bans the use of GE technology and inputs in organic production
systems. In addition, this decree allows the GVN to provide up to 100 percent funding to identify areas
eligible for organic production and certify products conforming to Vietnamese standards on organic
agriculture. This decree is available (in Vietnamese) at: https://luatvietnam.vn/nong-nghiep/nghi-dinh109-2018-nd-cp-ve-nong-nghiep-huu-co-166604-d1.html.
As of November 2020, MARD reported that Vietnam’s organic farming area had significant growthfrom 2016-2020 (GAIN Report VM2021-0069). Organic cultivation area reached 63,000 ha in 2021. A
set of national standards for organic production was issued in 2017, but industry reports a lack of aneffective and widely recognized organic certification mechanism.
g) LABELING AND TRACEABILITY
Vietnam does not require labeling for bulk commodities and raw materials but requires labeling for
packaged food and feed containing GE ingredients. According to MOST, goods containing GE
ingredients must follow labeling requirements provided in Decree 69/2010 on Biosafety for GMOs andProducts of GMOs, Decree 43/2017 on Goods Labeling, and Decree 15/2018 guiding the Food Safety
Law.
Article 43 of Decree 69/2010, applicable for goods in general, provides that “…goods containing GMOs
or products thereof exceeding 5% of each constituent shall, apart from complying with the law on goods
labeling, show information related to the GMOs on the goods labels”.
Decree 15/2018/ND-CP, specifically for foods, requires that “…foods containing at least one GM
ingredient that exceeds 5% of the total ingredients, must represent information related to the GMOs”(GAIN Report VM8016). In addition, Decree 43/2017 requires a statement of “Thực phẩm biến đổi gen”
or “biến đổi gen” (“Genetically modified food” or “genetically modified”) must represent in accompany
with the names of GE ingredients on labels of packaged foods containing the GE ingredients.
On the other hand, Decree 15/2018 states that labeling is not required in the following cases:Packaged food containing GE ingredients without detection of the modified genes or products ofthe modified genes in the food.
Fresh GE foods and unpackaged processed GE foods sold directly to consumers.
GE foods used in emergencies, such as natural disasters or epidemics.

h) MONITORING AND TESTING

Currently, Vietnam does not have a monitoring or testing regime in place to evaluate the biotech
content in imported food products or food products domestically produced for consumption in Vietnam.
In 2019, MOST issued Standard TCVN 12613 on the Methods of Analysis for the Detection of
Genetically Modified Organisms and Derived Products. This standard, developed by the National
Institute of Food Control (NIFC/MOH), is based on International Organization for Standardization(ISO) Standard 21570:2005. The standard provides a framework of quantitative methods, using thepolymerase chain reaction (PCR) and real time PCR, for the detection of “GM” corn, rice, soybeans,
and tomatoes in food. Per the Law on Standards and Technical Regulations, this standard is notmandatory, but laboratories, approved by MOST, can apply this standard for quantitative detection ormonitoring of “GM” content in food and feed. NIFC has been approved by MOST for quantitative
testing of “GM” content in food and feed.
In 2023, MARD continues to develop standards of detection methods for GE events in corn andsoybeans. According to MARD, since they established the National Laboratory for GMO Testing, theyneed to standardize detection methods for GMOs in the fields of agriculture. MARD first opened the
public consultation for four standards in January 2023 and continued posting two drafts for publiccomments in August 2023. The standards are still in the drafting process and will be submitted to
MOST for their final review and approval per the Law on Standards and Technical Regulations.
i) LOW LEVEL PRESENCE (LLP) POLICY
Vietnam does not have an LLP policy. MARD is a frequent observer at the Global Low-Level Presence
Initiative meetings.
j) ADDITIONAL REQULATORY REQUIREMENTS
None at this time.
k) INTELLECTUAL PROPERTY RIGHTS (IPR)
Under the Intellectual Property Law (IPL) 50/2005/QH11, Vietnam has a regulatory structure in place
to protect the rights of plant variety developers. The IPL provides the foundation for intellectual
property rights protection in Vietnam and covers plant varieties, including those derived fromagricultural biotechnology. The IPL was ratified by the National Assembly (NA) in 2005 and enteredinto force on July 1, 2006.
Part four of the law outlines the rights and protections for plant varieties and details the process for
obtaining plant variety protection.
According to the IPL, the Certificate of Plant Variety Protection is valid for 25 years for trees andgrapes; and 20 years for other crops. The certificate applies for the whole of Vietnam.
The full IP Law 50/2005/QH11 in English can be found at:http://pvpo.mard.gov.vn/DetailInfomation.aspx?InfomationID=IN00000037
Government Decree 88/2010/ND-CP, published on August 16, 2010, provides additional clarification
on aspects of the IPL as it relates to plant variety protection. The full Decree 88 in English is availableat:
http://pvpo.mard.gov.vn/DetailInfomation.aspx?InfomationID=IN00000305
On February 28, 2013, MARD issued Circular 16/2013, which stipulates the Guidelines on theProtection of Plant Variety Rights. The circular guides the implementation of a number of establishedcontent rights for plant varieties, representing rights to plant varieties, assessment of plant variety
rights, and forms of protection of plant varieties. MARD issued Circular 03/2021 dated June 21, 2021,
to revise and supplement some provisions of Circular 16/2013 regarding the registration procedures forplant protection.
In June 2022, the National Assembly adopted a revision of IPL 07/2022/QH15 that amends andsupplements provisions on trademark registration and plant variety protection. As of October 2023,
Decree 88/2010 remains unchanged.
l) CARTAGENA PROTOCOL RATIFICATION
Vietnam became a member of the Cartagena Protocol in April 2004 and regularly participates inmeetings. As stipulated by the Cartagena Protocol, the Vietnam Environmental Administration (VEA)
is the Cartagena Protocol Focal Point (NFP) of Vietnam. MONRE has developed a website(http://antoansinhhoc.vn/en/) to serve as the Biosafety Clearing-House for biotech information,
regulations, and Certificates issued by MONRE and MARD per Article 20 of the Cartagena Protocol.
Steering Committee for the Implementation of the Nagoya Protocol on Access and Benefit
Sharing
On March 17, 2014, the Vietnamese Prime Minister signed Resolution 17/NQ-CP regarding Vietnam
joining the Nagoya Protocol, which covers access to genetic resources, equitable sharing, andreasonable interests arising from the use of genetic resources within the Biodiversity Convention.
On September 2017, MONRE established a Steering Committee for the implementation of the Nagoya
Protocol on Access and Benefit Sharing (ABS). The Committee is chaired by a MONRE Vice-Ministerwith representatives from the VEA and relevant agencies of MONRE, MARD, MOST, and Lao Cai
Province. MONRE implemented the ABS project to support the implementation of Nagoya Protocol
from 2017-2020. In September 2020, MONRE issued Circular 10/2020 on Reporting Access to Genetic
Resources and Sharing Benefits from the Use of Genetic Resources.
GVN Decree 59/2017/ND-CP on the Management of Access to Genetic Resources and Benefit
Sharing from Their Utilization

On May 12, 2017, the GVN issued Decree 59/2017/ND-CP, regarding the Management of Access to
Genetic Resources and Benefit Sharing from Their Utilization. As regulated in Article 5 of the Decree,
MONRE is the for the Nagoya Protocol. The NFP is responsible for implementing the unified
management and monitoring of activities relating to the granting, renewal, and withdrawal of licenses
for access to genetic resources. The NFP is responsible for liaising, providing information, andcoordinating the information exchange with the Secretariat of the Convention on Biological Diversity
via the Access and Benefit-Sharing Clearing-House in accordance with the Nagoya Protocol.
Regarding the granting, renewal, and withdrawal of licenses to access genetic resources, Article 6 of theDecree states: MARD shall grant, renew, and withdraw licenses to access genetic resources of agricultural cropvarieties, livestock, aquatic species, and forest seedlings; and MONRE shall grant, renew, and withdraw licenses to access genetic resources other than thosespecified in Clause 1 of this Article.
m) INTERNATIONAL TREATIES AND FORUMS
Vietnam became a member of Codex Alimentarius in 1989 and the International Plant Protection
Convention in 2005. The Vietnam Codex Office is under the management of the Ministry of Health’s
Vietnam Food Administration: http://codex.gov.vn/vi/news/van-phong-ub-codex-viet-nam/n) RELATED ISSUES
No information available.
PART C: MARKETINGa) PUBLIC/PRIVATE OPINIONS
According to industry, corn growers’ acceptance for GE corn has increased significantly since FAW
established in Vietnam. Major developers reported the ratio of GE seeds accounted for up to 50 percent,or event higher, of their total sales of corn seeds. Corn growers are also interested in better profit
margins due to improved crop yields and lower input costs of pesticides and labor. Most farmers who
have grown GE corn expressed high levels of satisfaction with the technology, with less than 10 percent
of users indicating that the additional cost of the seed was too high. However, farmers also cited thehigher price of GE seeds in relation to conventional seeds as one of the reasons for not trying the newtechnology (Brookes and Tran, 2020).
b) MARKET ACCEPTANCE/STUDIESThe market continues to grow for imported biotech corn, soybeans, and DDGS to meet the increasing
demands of the livestock and aquaculture feed industry. Vietnam remains a major importer with most
suppliers being countries producing GE corn, soybean, and related products. As the GVN stated that

Vietnam is not competitive in producing corn and soybeans, Vietnam has enhanced bilateral activities
to ensure the trade flow of these products, with the high level of acceptance of GE products. The GVN
reduced the Most-Favored-Nation (MFN) tariff on corn from 5 to 2 percent on December 30, 2021
(GAIN Report VM2021-0097).

CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: PRODUCTION AND TRADEa) RESEARCH AND PRODUCT DEVELOPMENT
Cloned Animals
In March 2021, the National Institute of Animal Science (NIAS)/MARD reported successfully cloning
a local specialty pig breed from somatic cells of ear tissue. The institute launched the project in 2017, to
study the cloning of pigs by somatic cell nuclear transfer technology. According to NIAS, the successhas opened research opportunities to apply cloning technology in conservation of endangered animals
and breeding valuable livestock.
Previously, NIAS reported success in improving the freezing process of embryos in vivo and in vitro
and transferring embryos to dairy cows and pig sows for reproduction. The institute also successfullycloned pig embryos using somatic cell nuclear transfer and succeeded in transferring cloned embryos
into surrogate sows.
In a webinar on animal biotech held by Post in August 2022, the Institute of Biotechnology (IBT) noted
its research on the application of animal reproductive biotechnology (ART) for conservation ofendangered species.
GE Animals
In January 2023, Kraig Biocraft Laboratories, announced that the company delivered the first two
hybrid-cross silkworm strains to its production partner in Vietnam. These strains were developed in thecompany’s hybridization program, which aims to create GE silkworm strains adapted to the local
production environment. As of May 2023, the company reported that its cross-breeding program tocreate commercial lines of spider silkworm is ongoing. Previously, Kraig Biocraft Laboratories
announced that the company was granted a business license to begin its operations for silk production in
Lam Dong Province.
b) COMMERCIAL PRODUCTION
No commercial licenses of cloned animals or GE animals have been issued in Vietnam.

c) EXPORTS
No information available.
d) IMPORTS
No information available.
e) TRADE BARRIERS
No information available.
PART E: POLICYa) REGULATORY FRAMEWORK
Law on Biodiversity 2008 and Decree 69/2010
The Law on Biodiversity adopted in 2008, and Decree 69/2010 regulate both GE plants and GE animals.
However, the implementation of the Law on Biodiversity focuses on GE plants. MONRE and MARD
have not provided any guidance on GE animals in Vietnam.
Law on Animal Husbandry and Decree Guiding the Law on Animal Husbandry
Vietnam’s National Assembly passed the Law on Animal Husbandry (AHL) in November 2018. Thislaw, like the Law on Biodiversity, provides a definition of genetically modified livestock animals as“Genetically modified domesticated animal means domesticated animal whose genetic structure has
been modified by the use of gene transfer technology.” The AHL bans the “illegal import, production,
release, and use of genetically modified animals and products of genetically modified animals.” The
AHL allows the cloning of animals for study purposes and assigns the GVN to detail provisions on arisk assessment for genetically modified animals.
The GVN issued Decree 13 on January 21, 2020, to detail the implementation of the AHL. Decree 13
provides provisions on the conservation of genetic resources of livestock breeds but has no further
details on genetically modified livestock animals.
Legal term (inofficial language)

Legal Term (inEnglish)Vật nuôibiến đổi gen

Geneticallymodified
domesticatedanimalNhân bản vô tínhvật nuôi

Cloning ofdomesticatedLaws and
Regulations where
term is used
Law on Animal
Husbandry (Article
17.1)

Law on Animal
Husbandry (Article

Legal Definition (inEnglish)Genetically modified
domesticated animal means
livestock whose genetic
structure has been modified
by the gene transfer
technology.
Cloning of domesticatedanimals

17.3)b) APPROVALS/AUTHORIZATIONS
No information available.
c) INNOVATIVE BIOTECHNOLOGY
No information available.
d) LABELING AND TRACEABILITY
No information available.
e) ADDITIONAL REGULATORY REQUIREMENTS
No information available.
f) INTERLLECTUAL PROPERTY RIGHTS (IPR)
No information available.
g) INTERNATIONAL TREATIES AND FORUMS
No information available.
h) RELATED ISSUES
No information available.
PART F: MARKETINGa) PUBLIC/PRIVATE OPINIONSNo information available.
b) MARKET ACCEPTANCE/STUDIES
No information available.

animals means the use ofcloning techniques to create
domesticated animal clones
from somatic cells.

CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: PRODUCTION AND TRADEa) COMMERCIAL PRODUCTION
There are neither official statistics nor estimates on commercial production of microbial biotechnology
products in Vietnam. Vietnam reported several research to create recombinant enzymes or proteins forfood use or industrial production, but most research reached at a laboratory scale and have notprogressed to commercial production.
b) EXPORTS
There are neither official statistics nor estimates on export of microbial biotechnology products from
Vietnam. However, according to Trade Data Monitor (TDM), in 2022, Vietnam exported more than$400,000 USD of enzymes and prepared enzymes (HS code 3507), mainly to Asian countries. There are
no reports of exporting products under HS code 3507 exported to the United States in 2022. Vietnam
also exports products that may contain microbial biotech-derived food ingredients, like beverage, dairy
products, and processed products.
c)

IMPORTS

There are neither official statistics nor estimates on import of microbial biotechnology products in
Vietnam. However, according to TDM, imports of enzymes and enzyme preparations to Vietnam underthe HS code 3507, were valued at $83.6 million USD in 2022. Post estimates most of the imported
enzymes, used in the food and feed industry, are derived from microbial technology, given that the main
suppliers for Vietnam are the United States, China, and the EU. Likewise, Vietnam imports alcoholic
beverages, dairy products, and products that may contain micro biotech-derived food ingredients.
d) TRADE BARRIERS
There are no reports on trade barriers affecting products derived from microbial biotechnology reported
in Vietnam.

PART H: POLICYa) REGULATORY FRAMEWORKCurrently, biotech-derived microbes are regulated under the Law on Biodiversity as the law provides
general requirements on “genetically modified organisms”. In addition, the Food Safety Law provides
general requirements on food safety for “genetically modified food” that cover microbial biotechderived food ingredients. However, the FSL does not require pre-market approval for biotech-derived
microbes food ingredients such as enzymes, coloring, flavoring, nutrients, sweeteners, thus MOH

currently manages these products based on their purpose of use as food additives.

Legal term (inofficial language)

Legal Term (inEnglish)Laws and
Regulations where
term is used
Law onBiodiversity Article 3.27

Sinh vật biến đổi
gen

Geneticallymodified organisms(GMOs)

Sản phẩm của sinhvật biến đổi gen

Products of GMOs

Decree 69/2010
guiding the Law on
Biodiversity on
Biosafety for
GMOs, Genetic
Specimens andProducts of GMOs
- Article 3.2Thực phẩm
biến đổi gen

Geneticallymodified food (GMfood)

Law on Food
Safety - Article
2.24, Article 15

Legal Definition (inEnglish)Genetically modified
organism means anorganism whose genetic
structure has been modified
by the gene transfer
technology.
Products of GMOs areproducts that wholly or
partly contain ingredients
originating from GMOs,
including genetic specimens
of GMOs that can’t
themselves create neworganisms under natural
conditions
Genetically modified foods
are foods that contain one orseveral ingredients that aremodified by genetechnology.

Biodiversity Law
Under the Law on Biodiversity, the GOV issued Decree 69/2010 on June 21, 2010, which specifies
requirements on biosafety approval for “GMOs” and “Products of GMOs”. However, according to
MARD and MONRE, these requirements are aimed more at GE crops, thus they are not technicallyapplicable for biotech-derived microbes. These ministries affirmed that they received a few requests
regarding the biosafety approval for biotech-derived microbes and products thereof, but they are still
exploring Decree 69/2010 for application.
Food Safety Law
The FSL, entered into force on July 1, 2011, provides an overview framework to ensure the safety offoods and food ingredients in Vietnam. Currently, the FSL provides a definition of “GM foods” at
Article 2.24, that covers microbial biotech-derived food ingredients. Accordingly, Article 15 of the FSL
requires “GM food” must comply with i) general requirements for conventional food provided at Article
10 of the FSL; ii) regulatory requirements on ensuring the safety for human health and environment
stipulated by the GOV. In addition, the FSL also requires GMs food to bear a Certificate of Free Sale orHealth Certificate for the importation to Vietnam.
Under the FSL, the GOV currently provides Decree 15/2018 guiding the FSL, but this decree continues
to refer to Decree 69/2010 guiding the Law on Biodiversity regarding “Products of GMOs” which are
more applicable to products of GE crops.
Since the FSL and Decree 15/2018 provides no further requirements on pre-market approval for foodingredients like enzymes, coloring, flavoring, nutrients, sweeteners derived from genetically engineering
microbes, MOH, the single ministry in charge of food safety for food additives, currently manages theseproducts based on their purpose of use as food additives.
Article 17 of the FSL sets safety requirements for food additives including: i) to conform with technicalregulations on food additives and food processing aids; ii) to have use instructions written on their labels
in Vietnamese and the language of the country of origin; iii) to be on the List of Food Additives
Permitted for Use in Vietnam; iv) to register or declare conformity with technical regulations prior tomarket sale.
Food Additives Management
Food additives are currently regulated under MOH’s Circular 24/2019 (GAIN report VM2019-0066).
This circular, taking effect on October 16, 2019, provides the List of Food Additives Permitted for Usein Vietnam and safety conditions for food additives use. Accordingly, food additives on the permissible
list are allowed for import to Vietnam, providing that importers self-declare product conformity.
There are several enzymes listed on the List of Permissible Food Additives, including alpha-amylasefrom Aspergillus oryzae var., alpha-amylase from Bacillus subtilis, carbohydrase from Bacillus
licheniformis, protease from Aspergillus oryzae var, bromelain, lysozyme. Other substances such as
riboflavin, colorings, flavorings, etc. are also included in the permissible list.
Vietnam first notified a draft circular amending the Food Additives Circular to the World Trade
Organization (WTO) on August 12, 2021, as G/SPS/N/VNM/123. Vietnam re-notified the draft circularamending the Food Additives Circular as G/SPS/N/VNM/140 on July 29, 2022.
As of October 2023, MOH updated that it has issued the Amendment of Circular 24/2019. The newcircular, which allows an automatic update of the List of Permissible Food Additives according to thelatest Codex standards on food additives, will take effect from November 9, 2023.
b) APPROVALS
Vietnam has no regulations in place on pre-market approval for biotech-derived microbes and microbial
biotech-derived food ingredients.
c) LABELING AND TRACEABILITY

In addition to mandatory labeling requirements for food, according to the FSL and GVN’s Decree 15
guiding the FSL, a phrase “genetically modified food” must be displayed on labels of foods containing“GMOs” or products of “GMOs” exceeding five percent of total ingredients.
d) MONITORING AND TESTING
Vietnam has no regulations on testing and monitoring of microbial biotech-derived food ingredients or
food products.
e) ADDITIONAL REGULATORY REQUIREMENTS
No information available.
f) INTELLECTUAL PROPERTY RIGHTS (IPR)
No information available.
g) RELATED ISSUES
No information available.
PART I: MARKETINGa) PUBLIC/PRIVATE OPINIONS
Vietnam has a long history of consuming fermented foods, such as alcohol, soy sauce, fish sauce,
fermented pork, etc., thus consumers are familiar with products of microbial technology. Dairy products,
beverages, and bakery products are popular among young consumers in Vietnam. Post is not aware ofany public concerns regarding microbial biotech-derived food ingredients.
b) MARKET ACCEPTANCE/STUDIESThe market continues to grow for enzymes and enzyme preparations to meet the increasing demands ofthe food and feed industry in Vietnam. The main consumers of enzymes and enzyme preparations in
Vietnam are the brewing, beverage, bakery, food processing, and feed segments.

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