Required Report: Required - Public Distribution

Date: November 20, 2023
Report Number:

MX2023-0052

Report Name: Agricultural Biotechnology Annual
Country: Mexico
Post: Mexico City
Report Category: Biotechnology and Other New Production Technologies

Prepared By:

Adriana Otero Arnaiz

Approved By: Alexander Chinh
Report Highlights:
Mexico's biotechnology regulatory policy environment has become increasingly uncertain under thecurrent administration. The government has not approved any applications for genetically engineered(GE) products for food and feed use since May 2018 and has not approved any permits for planting GE
crops since 2019. The government has also denied or not provided a decision on 34 planting permit
applications for GE cotton and denied one application for GE alfalfa. In February 2023, a new Corn
Decree entered into force, replacing the December 2020 Corn Decree. The new Corn Decree imposes animmediate prohibition on the use of GE corn for “human consumption,” which the decree defines
narrowly as corn used in Mexico’s masa and tortilla production. The uncertainty in the regulatoryenvironment has made it difficult for businesses to invest in biotechnology in Mexico.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILYSTATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICYExecutive Summary
Mexico’s biotechnology regulatory policy environment has become increasingly uncertain under thecurrent administration. In February 2023, a new Corn Decree entered into force, imposing an immediateban on the use of GE corn in dough and tortillas, calling for the gradual replacement of GE corn forindustrial uses and livestock feed, and banning the use of glyphosate by 2024. The 2023 decree replaced
the December 2020 Corn Decree, which had banned the use of GE corn for human consumption andrequired the phasing out of glyphosate by March 2024.
The Government of Mexico (GOM) has not reported approvals on applications for GE products for foodand feed use since May 2018 and has not approved any permits for planting GE crops since 2019. Since
2019, the GOM has denied or not provided a decision on 37 planting permit applications for GE cottonand denied one application for GE alfalfa. For products of microbial biotechnology, Mexico’s regulation
only requires notification to federal authorities, with no additional regulatory steps required. This
regulation has allowed the GE microbial sector to develop, producing billions of dollars’ worth ofinternational trade in related products.

2

TABLE OF CONTENTS
CHAPTER 1: PLANT BIOTECHNOLOGYPART A: Production and Trade
PART B: Policy
PART C: Marketing
CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: Production and Trade
PART E: Policy
PART F: Marketing
CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: Production and Trade
PART H: Policy
PART I: Marketing3

CHAPTER 1: PLANT BIOTECHNOLOGYPART A: PRODUCTION AND TRADEa) RESEARCH AND PRODUCT DEVELOPMENT
Mexico’s National Service for Food Health, Safety, and Quality (SENASICA), an agency of theSecretariat of Agriculture and Rural Development (SADER), has not approved any GE planting
applications for experimental, pilot programs, or commercial use since 2019.
b) COMMERCIAL PRODUCTIONIn Mexico, SADER issues planting permits for GE crops. The permits are issued to seed companies for a
specified number of hectares in a specified region. Seed companies can then sell directly to producers
within the approved region.
CottonCotton is the only GE crop produced commercially in Mexico. GE traits for cotton that are approved to
be planted in Mexico include the following: resistance to lepidopteran insects, tolerance to theherbicides dicamba, glufosinate ammonium, and glyphosate. Planted area and yield are constrained bylimited access to innovative seed technology and high input costs. The GOM has not approved any GE
cotton planting permits since 2019. GOM has restricted glyphosate imports under the Corn Decree
published in December 2020 and replaced by a new one in February 20231, which phases out thechemical’s use by March 2024. Due to the lack of approval of new varieties, the GE cotton seeds
imported from the United States are out-of-date varieties, many of which are being phased out of
production. The lack of newer seeds is drastically affecting production, with MY2023/24 cotton plantedarea forecast at 150,000 hectares (ha), a 49 percent reduction compared to MY2028/19, when planting
reached a record 243,000 ha (See: Cotton and Products Update). Producers report that they rely upon
saved or outdated seeds, resulting in yield uncertainty and volatility in some growing areas (see report
MX2023-0043).
Industry submitted 19 applications for GE cotton planting in 2019 and 15 applications in 2020, all ofwhich the GOM rejected. In 2021 and 2022, there were no GE cotton planting permit applications. In
2023, industry submitted three applications for experimental field trials of new cotton events. The GOM
has not ruled on these applications.
SoybeanThere have been no applications for planting GE soybeans since 2013.
Corn
There have been no applications for planting GE corn since 2014 (see Report MX2013-2075: Mexican
Judge Blocks GE Corn Permits).
Alfalfa
1

Publication of the Corn Decree in the Official Gazette in Spanish:
https://www.dof.gob.mx/nota_detalle.php?codigo=5679405&fecha=13/02/2023

4

In 2021 there was one application for commercial release of GE alfalfa, which the GOM rejected.
c) EXPORTS
GE product exports do not require notification of GE content, but notification for intent to propagate theorganisms, following international standards, is required.
As Mexico is a significant yarn, fabric, textile, and apparel producer, most cotton produced or imported
is used domestically, with only a small portion exported. During the last five years, exports have been
mainly to Turkey, Pakistan, and China. MY 2023/24 cotton exports are forecast at 300,000 bales, a
reduction of 33 percent from the previous MY due to the lower global consumption.
d) IMPORTS
The Federal Commission for Protection Against Sanitary Risk (COFEPRIS), a part of the Secretariat of
Health, authorizes the importation of GE crops for food and feed. Before May 2018, 181 different eventswere authorized: alfalfa (4), cotton (36), rice (1), rapeseed (10), tomato (3), lemon (2), corn (90), potato(6), sugar beet (1), and soybean (28). Since that date, there have been no public reports of authorizations
for new products.
CottonMexico imports GE cotton from the United States to meet nearly 50 percent of its domestic demand.
Cotton imports from the United States are forecasted in MY 2023/24 at 0.9 million bales, no increase
from the previous MY.
Corn
After China, Mexico is the world’s second-largest corn importer, with supplies mainly from countries
that produce GE corn, such as the United States, Brazil, Argentina, and South Africa. Imports haveincreased recently, with MY2023/24 forecast levels reaching 18 million metric tons (MT), accounting
for approximately 39.4 percent of Mexico’s national consumption.
Soybeans
Mexico is the world’s third largest importer of GE soybeans, with supplies from the United States andBrazil. Soybean imports for MY2023/24 are forecast to reach 6.4 million MT, accounting for
approximately 97.6 percent of Mexico’s national consumption.
Rapeseed
Almost all rapeseed (canola) consumed in Mexico are GE varieties imported from Canada and theUnited States, with only a small amount produced domestically. Mexico is forecasted to import 1.5
million MT in MY2023/24.
e) FOOD AID
Mexico is not a recipient of food aid.
f) TRADE BARRIERS
5On February 13, 2023, Mexico published a new Corn Decree in its official gazette, replacing theDecember 2020 Corn Decree. The new Corn Decree places imposes an immediate prohibition on the useof GE corn intended for “human consumption,”.
According to the National Register of Biosafety (NRB) maintained by the Intersecretarial Commission
for Biosafety of Genetically Modified Organisms (CIBIOGEM), COFEPRIS has not issued any official
authorizations on applications for GE products for food and feed use since May 2018. However, on
November 11, 2022, multiple secretariats jointly published a GOM status report on progress towards
implementing the 2020 Corn Decree. The report states that during 2021 and 2022, COFEPRIS issued 14
formal denials for GE products intended for food and feed use. According to the GOM report, the denied
products include seven corn events, four cotton events, two canola events, and one soybean event, all ofwhich contained traits for tolerance to glyphosate.

6PART B: POLICYa) REGULATORY FRAMEWORK
Legal term (inSpanish)Organismo
Genéticamente
Modificado
(OGM)

Legal
Term (inEnglish)Genetically
Modified
Organism(GMO)

Laws and
Regulations where
term is used
 Biosafety Law
 Implementation
Rules of the
Biosafety Law(Bylaws)
 Agreement to
Determine theCenters ofOrigin Notification
Process for theConfined Use of
GE organisms
 GE seeds
labeling standard Risk assessmentof GE plants
during theexperimental andpilot stages
standard Corn Decree
establishingvarious actions
regardingglyphosate andgeneticallymodified corn.

Legal Definition

Any living organism, human beings
exempted, having acquired a new
genetic combination, originatedthrough the specific use of modern
biotechnological techniques defined inthis Law, if the techniques used are theones established in this Law or in the
Mexican official norms derived fromit.
Modern biotechnology: It isconsidered the application of in vitro
techniques of nucleic acids, including
recombinant deoxyribonucleic acid
(DNA and RNA) and the direct
injection of nucleic acids into cells andorganelles, or the fusion of cells
beyond the taxonomic family,
exceeding the natural physiologicalbarriers of reproduction or
recombination; these are nottechniques commonly used in
traditional reproduction and selection,
and are used to originate geneticallymodified organisms, and will be
determined in the Mexican official
norms derived from this Law(Biosafety Law).

Mexico’s comprehensive biotech regulation is the Law on Biosafety of Genetically Modified
Organisms (hereafter the Biosafety Law), published in the Federal Register (Diario Oficial) in March
2005. This law regulates the research, planting, and import/export of biotech-derived products.
Mexico’s Biosafety Law and its Implementation Rules (Bylaws) are designed to promote the safe use ofmodern biotechnology and prevent and control the possible risks associated with using and applying
biotechnology products to human health, plant and animal health, and environmental well-being.
In November 2012, the GOM published the Agreement to Determine the Centers of Origin and Centers7

of Genetic Diversity of Corn in Mexico. This agreement is part of the legal process required by
Mexico’s Biosafety Law. The agreement includes a map delineating the areas in eight northern states of
Mexico (Baja California, Baja California Sur, Chihuahua, Coahuila, Nuevo León, Tamaulipas, Sinaloa,
and Sonora) where the planting of GE corn is prohibited. This agreement also restricts the storage andmovement of GE corn within this area.
In April 2011, GOM published in the Federal Register the Notification Process for the Confined Use of
GE Organisms. The Mexican Biosafety Law states that the “confined use” of a “GMO” is any activity
carried out with physical barriers or a combination of chemical or biological barriers to be used to limit
contact with people and the environment effectively.
In December 2014, the GOM published a labeling standard that includes general labeling specifications
for GE seeds for planting, cultivation, and agricultural production. This standard took effect in June
2015. This Mexican Norm (NOM) establishes the characteristics and content of the labels for GE seeds
and propagation materials intended to be released as a crop or for agricultural production. According toProvisions 9 and 12 of the Biosafety Law, it is necessary to lay out in a NOM the information andcharacteristics of the labels for GE seeds.
In 2018, a standard was published that establishes the requirements for the risk assessment of GE plants
during the experimental and pilot stages of cultivation.
Biotechnology Related Regulations
On April 4, 2020, a Congressional Decree2 called the Native Corn Protection Law was published thatreinforces many provisions of the Biosafety Law and related regulations. The law establishes a newcommission (not yet established) to advise the president regarding the conservation of native cornvarieties.
The GOM published the Organic Products Law in the Federal Register on February 7, 2006, which
specifies biotechnology-related requirements for organic products:● Provision 27 states that the use of all materials, products, ingredients, or inputs that come from,or have been produced using, genetic engineering is prohibited in the entire production chain oforganic products, and such products must be labeled as GE-free;● The use of substances or forbidden materials referred to in Provision 27 that alter the organic
characteristics of the products is prohibited;● SADER can impose a fine on any firm or individual found guilty of violating the law.
Secretariats and Agencies Responsible for Biotechnology Regulation
The Biosafety Law outlines the responsibilities and jurisdictions of Mexican secretariats and agencies
tasked with monitoring and enforcing biotechnology regulations. The duties and the roles of thesecretariats are as follows:
The Secretariat of Agriculture and Rural Development (SADER): SADER assesses the potential
risks of imported or national GE organisms to animal, plant, and aquatic health, the environment, and2

As opposed to Congressional legislation, Congressional Decrees are passed only in the Senate and have to do with national
security.

8

biological diversity. This assessment is done on a case-by-case basis, considering the specificcharacteristics of the GE product and the intended use. SADER also reviews the risk assessments ofeach application for cultivation of GE plants. This review ensures that the potential risks of GE crops arecarefully considered before they are planted in the environment. SADER is responsible for deciding
what activities are permissible for planting crops, livestock, and fisheries, and issues permits andreceives notifications from the users for those activities. SADER also provides guidelines andparameters for all experiments and activities related to GE animals, plants, or microorganisms. These
recommendations include experimental field trials, pilot program releases, commercial releases,
marketing, and GE animal, plant, or microorganism imports. SADER is responsible for monitoring andmitigating the effects that accidental or permitted release of GE animals, plants, or microorganisms may
cause to animals, plants, aquatic health, and biological diversity.
The National Service of Agri-food Health, Safety, and Quality (SENASICA): SENASICA is an
Agency within SADER that protects agricultural, aquaculture, and livestock resources from pests anddiseases of quarantine importance. It also regulates and promotes the application and certification offood contamination and risk reduction systems and their agri-food quality to facilitate national andinternational trade in goods of plant and animal origin.
The Secretariat of Environment and Natural Resources (SEMARNAT): SEMARNAT protects theenvironment, which includes biodiversity and wildlife species. Domesticated species fall under thecompetence of SADER. SEMARNAT analyzes and assesses all applications for planting and thepotential risks that activities (planting, production, or use) carried out with GE animals, plants, or
microorganisms may cause to the environment and biological diversity of wild species. This analysis isbased on risk assessment studies and results drafted and filed by interested parties. In addition,
SEMARNAT is responsible for permitting and licensing activities that involve the environmental releaseof GE wildlife species and is charged with providing guidelines and parameters for such activities.
SEMARNAT also monitors the effects on the environment or biological diversity that the accidental
release of GE animals, plants, or microorganisms may cause. In instances where SADER has primary
responsibility, SEMARNAT is still responsible for issuing binding bio-safety opinions before SADER’s
resolution. NOTE: SADER (through SENASICA) issues permits for the environmental release of crops,
livestock, and fisheries, although SEMARNAT renders a binding opinion to SADER beforehand
through their interagency process.)
The Secretariat of Health (SALUD): SALUD, through COFEPRIS, is to ensure the food safety of GEderived agricultural products destined for use as medicines, for human, and for animal consumption.
SALUD also assesses studies drafted and filed by interested parties on the safety and potential risks of
GE animals, plants or microorganisms authorized events under the Biosafety Law.
The Intersecretarial Commission for Biosafety of Genetically Modified Organisms (CIBIOGEM):CIBIOGEM is a government agency that coordinates biotechnology policy and applications for theplanting and consumption of GE products. CIBIOGEM is part of the National Council of Humanities,
Science, and Technology (CONAHCYT), which is an agency that promotes all forms of scientific andtechnological research. CIBIOGEM does not enforce any laws, but it develops and implements thegovernment's overall strategy for GE products. CIBIOGEM comprises of representatives from six
secretariats: SADER, SEMARNAT, SALUD, Finance and Public Credit, Economy, and Education.
CIBIOGEM’s presidency is held for two years on a rotating basis among the Secretariats of SADER,SEMARNAT, and SALUD. Currently, the Secretary of SADER is in the second year of its tenure as

9

President of the Commission. CIBIOGEM has a Vice President, permanently held by the Director
General of CONAHCYT. According to the Biosafety Law, CIBIOGEM is led by an Executive Secretarynominated by CONAHCYT after consultations with the member Secretariats and then approved by the
President of Mexico.
b) APPROVALS/AUTHORIZATIONSIn Mexico, approval (authorization) for GE products for consumption is distinguished from approval(permits) for planting or environmental release. While authorizations for products for consumption are
definitive (not time-limited), permits for planting are usually limited to one growing period and must be
granted every planting/harvesting cycle. SADER regulates environmental release in the case ofdomesticated species (crops, livestock, and fishery), and SEMARNAT in the case of wild species.
SEMARNAT is the agency responsible for issuing binding biosafety opinions, which is done before any
resolution can come from SADER.
COFEPRIS is responsible for approving GE products for consumption, and does not distinguish between
consumption for food or feed. From 1995 to 2018, Mexico approved 188 GE commodities for food andfeed use, including 90 corn events authorized for consumption. Under the Biosafety Law, COFEPRIS
has a maximum of 6 months to rule after receiving a completed application for a product for
consumption. The authorities must publish the list of accepted applications in the NRB. Prior to 2018,
while the 6-month maximum for approval was not always met, the approval process occurred relatively
smoothly. However, since May 2018, COFEPRIS has yet to report any authorizations for GE food andfeed products, and there is no information in the NRB about the applications for GE food and feed
products.
A permit for releasing GE crops into the environment is required for planting and importing seeds. The
procedure for approving permits for experimental, pilot, or commercial release of GE crops is complex,
as multiple commissions and committees inside SADER and SEMARNAT must provide opinions about
the release (for further details see SADER website here). Although the central approving authority is
SADER (through SENASICA), SEMARNAT issues a binding opinion.
Cultivation Permit Approval Process:
●
●
●

●

The applicant must present a complete dossier to SENASICA (Art. 5, 16, 17, and 19 of the
Biosafety Rules) for the GE crop according to the release phase (experimental, pilot, orcommercial).
SENASICA will review (within 10 days) whether the dossier is complete and request any
missing information. SENASICA will submit the dossier to SEMARNAT, which has threedays to request additional information if needed.
Once received, the complete dossier must be published by the authorities in the NRB.
SENASICA will make the application available for public consultation. Any person may issue
their opinion, including the Governments of the States. These opinions must be technicallyand scientifically supported and received within 20 business days, and SENASICA willconsider the views published for establishing additional biosecurity measures.
SENASICA will consult with the National Institute of Statistics and Geography (INEGI), the10National Institute of Forestry, Agricultural and Livestock Research (INIFAP), the National
Institute of Ecology and Climate Change (INECC), the National Commission for the
Knowledge and Use of Biodiversity (CONABIO), and the National Forestry Commission(CONAFOR).
● SEMARNAT is responsible for issuing a biosecurity report as a binding opinion before theresolution by SENASICA. This report must follow an analysis and risk assessment based on
the study prepared and presented by the interested parties regarding the possible risks the GE
crop may pose to environment and biological diversity.
● SENASICA will issue its resolution on the release permit based on the analysis of theinformation and documentation provided by the interested party.
● SENASICA may issue the permit to carry out the release activity and may establish
monitoring, control, and other measures in addition to those that were proposed by theinterested party; or SENASICA may deny permission in the following cases:o If the request does not comply with the provisions of the Biosafety Law or the
regulations as requirements for granting the permit.
o If the information provided by the interested party, including that relating to
the possible risks that the GE crop could cause, is false, incomplete, orinsufficient.
o If SENASICA concludes that the risks presented by the GE crop in question
would adversely affect human health or biological diversity, or cause serious or
irreversible damage to animal, plant, or aquaculture health.
●
SENASICA will resolve the permit request, including those related to importation, within
the following maximum periods, counted from the business day after the request has been
admitted: six months for experimental release to the environment; three months for releaseto the environment in a pilot program; and four months for commercial release to theenvironment. These timelines are not always met.
More information on cultivation permit approval process can be found here.
c) STACKED OR PYRAMIDED EVENT APPROVALS/AUTHORIZATIONSThe Biosafety Law does not require additional reviews for stacked or pyramid events if the stackcombines two or more already approved GE traits. However, in practice, the GOM regulators consider
these to be different events from the parental ones and will evaluate them independently.
d) FIELD TESTINGThe GOM has denied all permits for planting GE crops in Mexico since 2019, and all denials were due
to opinions by SEMARNAT. There were no applications during 2022. Three GE cotton applications
submitted in 2023 are pending resolution.
e) INNOVATIVE BIOTECHNOLOGIES
Mexico has not issued regulations regarding innovative biotechnologies, such as genome editing, inplants or plant products. Genome editing is under discussion by technical departments within SADER.
f) COEXISTENCE

11

Biosafety Law Provision 90 establishes that GE crop-free zones may be considered to protect organic
agricultural products and others of interest to the soliciting community. GE-free zones can beestablished when GE crops coincide with the same species of organic agricultural products, and theircoexistence is not viable, or GE crops would not comply with the normative requirements for theircertification.
SADER has the purview to determine GE-free zones with input from CIBIOGEM and the National
Commission for the Understanding and Utilization of Biodiversity.
g) LABELING AND TRACEABILITY
The Biosafety Law Provision 101 requires labeling only when there a substantial difference between aconventional product and the corresponding GE product. Since 2021, Mexico’s Congress has consideredseveral GE-labeling initiatives, seven of which have not yet been voted on in committee. The eighth
initiative, the General Law on Adequate and Sustainable Food, was approved by the Senate on
September 19, 2023, and submitted to the Chamber of Deputies (lower house of Congress) for
consideration.
The nine initiatives introduced since 2021 propose a variety of reforms to various laws, including theGeneral Law on Health, the Biosafety Law, the Federal Penal Code, and the General Law on Ecological
Balance and Environmental Protection.
Recent GE-labeling initiatives/the proposals’ Congressional sponsors:Adequate Food Law/Rivera: The Mexican Senate approved a bill to create a legal mechanism for
the State to ensure that all Mexicans are provided with healthy and culturally appropriate food.
The bill's proposed labeling requirements for genetically engineered products are unclear.



GE Labeling/Sanchez: Initiative to reform the General Law on Health and the Federal Law on
Consumer Protection to require the labeling of GE products.

Federal Penal Code/Fuentes: Initiative to reform the Federal Penal Code to establish criminal
penalties for the failure to label GE products.

Biosafety Law/Ecological Balance Law/Contreras: Initiative to reform the Biosafety Law and theGeneral Law on Ecological Balance and Environmental Protection to strengthen the regulation of
GE products.

Biosafety Law/Rojas: Initiative to reform the Biosafety Law to require the labeling of GE
products and to establish a public registry of GE products.



Health Law/Biosafety Law/Vazquez: Initiative to reform the General Law on Health and theBiosafety Law to require the labeling of GE products and to strengthen the regulation of GE
products.



Health Law/Ecological Balance Law/Carrillo: Initiative to reform the General Law on Healthand the General Law on Ecological Balance and Environmental Protection to require the labelingof GE products and to strengthen the regulation of GE products.

12



Health Law/Rivera: Initiative to reform the General Law on Health to require the labeling of GE
products and to establish criminal penalties for the failure to label GE products.



http://bit.ly/3Ysb77R: Initiative to reform the Biosafety Law to require the labeling of GE
products and to establish a public registry of GE products.

h) MONITORING AND TESTING
There has been no monitoring activity reported since 2018. Authorities responsible for the monitoring
programs are SADER and SEMARNAT. CIBIOGEM coordinates two monitoring networks. The first is
the Mexican Network of Laboratories for Detection of GMOs, which comprises government, public, andprivate laboratories that comply with standards for detection. The network facilitates detections where atrusted resolution in amount and kind of GE crop is needed, for example, as evidence in intentional orunintentional release. The second monitoring network is the Mexican Network for Monitoring ofGMOs, whose aim is to monitor for the presence of unauthorized GE plants or animals and their impact(positive or negative) on the environment. Government, public institutions, and biotechnology
companies are part of this network. Monitoring is done regularly (but randomly) or following acomplaint of unintended release.
i) LOW LEVEL PRESENCE (LLP) POLICYIn Mexico, there is no LLP policy or tolerance for detecting unauthorized events in food or
feed. Mexico treats unauthorized GE events in seeds as impurities. As with other impurities, there is a 2
percent foreign material tolerance in imports of GE seed.
j) ADDITIONAL REGULATORY REQUIREMENTS
The Biosafety Law and the Implementation Rules (Bylaws) established more than 100 requirements forthe approval of GE crops. There are no additional requirements. Recipients of commercial permits are
required to report every growing season on the implementation of biosafety measures.
k) INTELLECTUAL PROPERTY RIGHTS (IPR)
Mexico is part of the World Intellectual Property Organization (WIPO), the World Trade Organization(WTO), as well as the International Union for the Protection of New Varieties of Plants (UPOV).
Mexico has legislation to address industry intellectual property rights, including agricultural
biotechnology, under its Law of Industrial Property.
l) CARTAGENA PROTOCOL RATIFICATION
In 2002, the Mexican Senate ratified the Cartagena Protocol on Biosafety (CPB).
m) INTERNATIONAL TREATIES AND FORUMS
Mexico is part of the International Plant Protection Convention (IPPC) and a member of Codex
Alimentarius (Codex since 1969), the World Organization for Animal Health (OIE), and theOrganization for Economic Cooperation and Development (OECD). Mexico usually sends a delegation
to participate in the biotechnology working groups at these international forums.
The agriculture chapter of the United States-Canada-Mexico Agreement (USMCA) details commitments

13and coordination on agricultural biotechnology. USMCA requires the United States, Mexico, andCanada to make the approval process for crops produced with biotechnology publicly available,encourage producers to submit concurrent applications for approval, and ensure that decisions on those
applications are made in a timely manner. Further, when an import into a member country is found tohave a low-level presence of an unapproved crop produced with biotechnology, the importing country is
to act quickly to not unnecessarily delay the shipment. USMCA established a Working Group for
Cooperation on Agricultural Biotechnology to facilitate the information exchange and advancetransparent, science and risk-based regulatory approaches and policies in other countries andinternational organizations. The provisions of USMCA apply to crops produced through conventional
biotechnology, including recombinant DNA methods, and newer technologies, such as genome editing.
n) RELATED ISSUESNone.
PART C: MARKETINGa) PUBLIC/PRIVATE OPINIONS
Non-governmental organizations (NGOs) are very active opponents of biotechnology in Mexico. Crop
Protection, Science and Technology (PROCCYT) is a private organization representing the major
biotechnology developers and crop protection. The organization’s main objectives are promoting
biotechnology’s positive use and sharing and disseminating scientific knowledge to policymakers,
lawmakers, and the public.
b) MARKET ACCEPTANCE/STUDIESIn general, Mexican consumers, producers, importers, and retailers remain disengaged from thebiotechnology debate, with the latter often opting to let industry trade associations conduct significant
lobbying and educational outreach. Mexican consumers generally base purchase decisions on price andquality of food rather than its genetic composition.
CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: PRODUCTION AND TRADEa) RESEARCH AND PRODUCT DEVELOPMENT
Mexico does not have GE animals under development that might be commercialized within the next five
years.
b) COMMERCIAL PRODUCTION
Forma Food is a start-up that manufactures meat in vitro from the culture of muscle cells of the animal.
c) EXPORTS
Mexico does not export any GE animals.
d) IMPORTS
Mexico is highly dependent upon imports of genetics for artificial insemination in livestock
production, particularly for milk cows.

14e) TRADE BARRIERS
None.
PART E: POLICYa) REGULATORY FRAMEWORKFor more information on terminology and definitions used by Mexico to refer to agricultural
biotechnology, see Chapter 1, Part B, sub-paragraph a. The same regulation applied to GE plants is
applicable to the commercialization of GE animals and insects. In Mexico, biotechnology regulation is
generally applied to species and does not make a particular differentiation among plants, animals, or
microorganisms. As in the case of plant biotechnology, the Biosafety Law and its Implementation Rules
and Agreements are the comprehensive legal framework that regulates the development, commercial
use, import, and disposal of GE animals or products derived from these animals. Similarly, SADER,SEMARNAT, and SALUD are the Mexican Secretariats that monitor and enforce biotechnology
regulations for animal biotechnology.
The responsibilities and roles of the Mexican Secretariats are the same as indicated for Plant
Biotechnology. The introduction of GE animals for food or feed use would require authorization from
COFEPRIS, while the production of GE animals would require a permit from SADER. Public
perception in Mexico toward GE plants would likely affect the decisions related to animal
biotechnologies.

b) APPROVALS/AUTHORIZATIONSNone.
c) INNOVATIVE BIOTECHNOLOGIES
Mexico has not issued regulations regarding innovative biotechnologies, such as genome
editing, in animals or animal products. The topic is under discussion, primarily at the technicallevel.
d) LABELING AND TRACEABILITY
Same regulations as GE plants.
e) ADDITIONAL REGULATORY REQUIREMENTS
Same regulations as GE plants.
f) INTELLECTUAL PROPERTY RIGHTS (IPR)
Same regulations as GE plants.
g) INTERNATIONAL TREATIES AND FORUMS
Mexico is a member of Codex Alimentarius but does not participate in working groups related toanimal biotechnology. In the Biotechnology Regulation Working Group of the Organization of
Economic Cooperation and Development (OECD), where Mexico actively participates, other countries
have raised issues related to GE fish, insects, and microorganisms. Mexico contributed to the generationof the consensus documents.

15h) RELATED ISSUESNone.
PART F: MARKETINGa) PUBLIC/PRIVATE OPINIONS
There is no current outspoken opposition to cloned or GE animals. However, there could be opposition
to GE animals in the future, considering that a small segment of the public is opposed to GE crops. In
general, the public lacks knowledge about GE animals.
b) MARKET ACCEPTANCE/STUDIESNone.
CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: PRODUCTION AND TRADEa) COMMERCIAL PRODUCTION
Food and agricultural applications of microbial biotechnology include the development of functional
foods, such as prebiotics and probiotics, and the creation of various inputs, products and processes usedin the primary sector and in the food and beverage industry, such as alcoholic beverages and lactic
products, among others.
Some examples of companies using microbial biotechnology in Mexico and their resulting products
include: The use of biocatalysts to produce capsaicinoids. Eliminating the need to plant and harvest asingle plant enables the production of a wide variety of capsaicinoids with modulable sensation(levels of heat), controlled and standardized pungency, and suitable physical properties. (Applied
Biotec Cuernavaca; location: Morelos)

The production and use of biopreservative microorganisms for the control of pathogenic anddeteriorating microorganisms in fresh cheeses. (Sigma Alimentos Lácteos; location: Jalisco)The production of enzymes for industrial uses: starches, detergents, textiles, tannery, brewery,bakery, dairy, supplements, proteins, marinades, animal nutrition, sugar, fruits, and vegetables.
(Enmex; location: Estado de México)A biofertilizer based on the bacterium Azospirillum brasilense, which was developed by theuniversity UNAM and transferred for commercialization to the Mexican company Biofactory
Siglo XXI.

The biological fungicide Fungifree AB®, based on a bacterium antagonistic to the fungus thatcauses anthracnose that attacks mango, papaya, and avocado crops, which was developed by
UNAM’s Institute of Biotechnology (IBT).

AnascorpTM, an antivenom against scorpion stings, which was developed at IBT and ismarketed in Mexico and the United States.

16b) EXPORTS
Mexico exports many products that use microbial biotechnology in their production chain. From June
2022 to May 2023, Mexico exported $42 million in cheese and curd, $5.5 billion in beer, $6 million inwine, $571 million in condiments and sauces, $36 million in enzymes, and $534 million in fruit juice,among other products.
c) IMPORTS
Mexico imports many products that use microbial biotechnology in their production chain. From June
2022 to May 2023, Mexico imported $832 million in cheese and curd, $30 million in beer, $400 million
in wine, $482 million in condiments and sauces, $146 million in enzymes, and $98 million in fruit juice,among other products.
d) TRADE BARRIERS
None.
PART H: POLICYa) REGULATORY FRAMEWORKFor more information on terminology and definitions used by Mexico to refer to agricultural
biotechnology, see Chapter 1, Part B, subparagraph a. As in the case of plant and animal biotechnology,
the Biosafety Law and its Implementation Rules and Agreements are the comprehensive legal
framework that regulates the development, commercial use, import and disposal of GE microbes or
products derived from these microbes. Similarly, SADER, SEMARNAT, and SALUD are the Mexican
Secretariats that monitor and enforce biotechnology regulations for microbial biotechnology.
The responsibilities and roles of the Mexican Secretariats are the same as indicated for Plant
Biotechnology. The inclusion of GE microbes in a product intended for food and feed use would require
an authorization from COFEPRIS, while the confined production of GE microbes would require a
notification to SADER.
b) APPROVALS/AUTHORIZATIONSThere is no need for approvals if the use of the GE microbe will be confined. Only a notification isneeded. There are no applications for permits for the release of GE microbes into the environment.
c) LABELING AND TRACEABILITY
Same regulations as GE plants.
d) MONITORING AND TESTING
Same regulations as GE plants.
e) ADDITIONAL REGULATORY REQUIREMENTS
Same regulations as GE plants.
f) INTELLECTUAL PROPERTY RIGHTS (IPR)
Same regulations as GE plants.

17g) RELATED ISSUESNone.
PART I: MARKETINGa) PUBLIC/PRIVATE OPINIONSNo recent pollsb) MARKET ACCEPTANCE/STUDIESNo recent studies

Attachments:
No Attachments

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