Report Name: Agricultural Biotechnology Annual

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY

STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY

Required Report: Required - Public Distribution Date: December 08, 2023

Report Number: BR2023-0027

Country: Brazil

Post: Brasilia

Report Category: Biotechnology and Other New Production Technologies

Prepared By: Carolina Castro

Approved By: Joseph Degreenia

Report Highlights:

Brazil is the second-largest producer of biotech crops in the world with 105 events approved. For the

2022/2023 crop season, FAS Brasilia forecasts 68 million hectares planted with GE traits. Adoption

rates for soybeans and cotton reached 99 percent and for corn, 95 percent. Continued use of

biotechnology seeds has been a major contributor to yield growth in Brazil since its adoption. The

National Technical Commission (CTNBio) is responsible in Brazil for assessing the safety of new

technologies such as GE animal technology, genome editing including CRISPR technology, and

microbial biotechnology. In addition to GE plants, this report provides updates on several aspects of

these new technologies.

EXECUTIVE SUMMARY

Brazil is the second-largest producer of biotech crops in the world with 105 events approved between

plants, animals, and microbial events, only behind the United States. This report is separated in three

major sections: plant biotechnology, animal biotechnology, and microbial biotechnology. As of the

2022/2023 crop season, almost the entirety of the Brazilian soybeans, cotton, and corn productions were

genetically engineered. These are major commodities exported by Brazil, and its participation in the

global market on these commodities affect global food availability and prices. Brazil has domestic

research and development of biotechnologies, and the Brazilian regulatory framework designates

specific responsibilities for different governmental ministries and regulatory agencies. The National

Technical Biosafety Commission (CTNBio) is a multidisciplinary collegiate body composed of

scientists who perform the safety assessments of biotechnologies in Brazil. Brazil has a zero-tolerance

for imports of unapproved events. Overall, market acceptance of biotechnology in Brazil is widespread,

especially among producers.

In October 2023 Brazil, Argentina, Paraguay and Uruguay created an International Network for the

biosafety of products derived from modern biotechnology, an initiative that will establish common

procedures and harmonize standards for assessing the biosafety of products, reducing cost and time.

This report was prepared by the Office of Agricultural Affairs Brasília, for U.S. exporters of domestic

food and agricultural products. While every possible care has been taken in the preparation of this

report, information provided may not be completely accurate either because policies have changed since

its preparation, or because clear and consistent information about these policies was not available. The

OAA is available to answer questions and receive any comments, corrections or suggestions about this

report and to provide assistance to export U.S. agricultural products to Brazil:

Office of Agricultural Affairs (OAA)

U.S. Embassy

Av. das Nações, Quadra 801, Lote 3

70403-900 Brasilia, DF

Tel: +55 (61) 3312-7000

Fax: +55 (61) 3312-7659

E-mail: [email protected]

TABLE OF CONTENTS

CHAPTER 1: PLANT BIOTECHNOLOGY

PART A: Production and Trade

PART B: Policy

PART C: Marketing

CHAPTER 2: ANIMAL BIOTECHNOLOGY

PART D: Production and Trade

PART E: Policy

PART F: Marketing

CHAPTER 3: MICROBIAL BIOTECHNOLOGY

PART G: Production and Trade

PART H: Policy

PART I: Marketing

CHAPTER 1: PLANT BIOTECHNOLOGY

PART A: PRODUCTION AND TRADE

a) RESEARCH AND PRODUCT DEVELOPMENT

According to the International Service for the Acquisition of Agri-Biotech Applications (ISAAA), in

2022 Brazil was the second largest producer of biotech crops in the world and the top developing

country that planted biotech crops. Brazilian and multinational seed companies and public sector

research institutions are working on the development of various genetically engineered (GE) plants.

Currently, there are a number of GE crops in the pipeline awaiting commercial approval, of which the

most important are potatoes, papaya, rice, and citrus. Most of these crops are in the early stages of

development and approval.

On November 11, 2021, CTNBio approved a GE variety of wheat that is drought tolerant and expresses

the HB4 sunflower gene. This approval allowed for the world’s first occurrence of commercial trade and

production of a GE wheat variety. Brazil approved the import of this product in the form of flour, but it

was not approved to be imported as unmilled grain or as seeds for cultivation. As the situation currently

stands, the GE wheat is planted and milled in Argentina, and the wheat flour is imported into Brazil. The

wheat was first given conditional approval in Argentina in October 2020, with the requirement that it

must also be approved in Brazil before being fully commercialized, as Brazil is the main export market

for Argentine wheat. Back then, Brazilian wheat and confectionary industry associations had pushed

back against this approval and even threatened litigation and possible rejection of Argentine wheat

imports.

On November 17, 2021, the Brazilian Wheat Industry Association, Abitrigo, sent an official letter to the

Ministry of Agriculture asking it to convene the National Biosafety Council (CNBS) to review the

decision of CTNBio – which reports to CNBS. CTNBio is responsible for the technical decision on

biological risk, and their decision is definitive. However, CNBS can revoke the decision based on social

and economic factors, rather than biosafety reasons. In late May 2022, media cited that MAPA had

decided not to convene a CNBS meeting to discuss the approval of HB4 wheat. A December 2021 study

showed that 70 percent of consumers accepted the consumption of this wheat variety (see more details in

Part C: Marketing; section A) Public/Private Opinions). Despite this wide public acceptance, Abitrigo

was still against the variety, according to the media.

Embrapa has planted close to 70 square meters of the HB4 wheat in Brasilia in a controlled trial in

partnership with the Argentinean developer Bioceres. HB4 is a wheat seed genetically modified with

HaHB4 gene, from the sunflower plant and resistant to drought and the pesticide glufosinate ammonium,

an herbicide approved in Brazil that kills weeds when it is used at the beginning of planting. The wheat

was planned to be harvested in August 2022 and other experiments should take place in following

seasons, so Embrapa can evaluate the benefits and limitations of that GE wheat variety production in

Brazil.

Before the Argentinean company had legal approval of HB4 wheat commercialization in Brazil,

CTNBio was concerned about the access into the Brazilian market with lack of official procedures. On

that occasion, the Commission proposed the Brazilian and Argentinean regulatory agencies to formally

submit the mutual request to have CTNBio evaluate it, instead of assessing a third party without a clear

method. The Commission then provided a technical opinion to officially authorize the use and marketing

of the product. To meet the new demand in Brazil, therefore, the Argentinean company had to pass the

Quality and Safety Certificate and create a National Registration Number of Legal Persons (CNPJ in

Portuguese) in Brazil. The company combined efforts with the Argentinean National Institute of

Agricultural Technology (INTA in Argentine) to come up with the ideal technology to use. This whole

request by CTNBio to have mutual procedures between the regulatory agencies, in this case INTA and

Embrapa, gave rise to have the method replicated at Mercosur level.

In early March 2023 Brazil approved the planting and sale of HB4, when Abitrigo published an official

statement on the case, informing that the Association is in favor of innovative developments that will

bring benefits to the health and food security of Brazilians. It emphasized that, since the approval of the

import of TGM flour (HB4), they did not offer considerable demonstrations by Brazilian consumers

regarding the use of GE. With regard to operational risks, the Association stated that there could be a

regulatory conflict between the approval of the flour and the granting of HB4 use. However, the final

statement was that approval of the planning, import and commercialization of transgenic wheat (HB4) in

the Brazilian national territory by CTNBio reassures the different players in the market and that the final

word will be with consumers. Consumers in Brazil are logical and rational, tied to price, especially due

to budget constraints from Brazilian households.

The initial results of the research are likely to be available in three years. The Ministry of Agriculture is

in the formal process of registering cultivars, seeds, and seedlings of genetically engineered wheat.

Brazil has been importing the flour with GE wheat for human consumption since November 2021, but

now Brazilian farmers will be able to plant the GE wheat seed in their country. With this, Brazil became

the second nation, after Argentina, to approve a variety for this purpose.

For human consumption only, food from HB4 wheat has already been approved for import either in the

form of wheat flour or as finished products such as baked goods in Australia, New Zealand, Indonesia,

South Africa, Colombia, Nigeria, and the United States. Those countries are not authorized to plant

genetically engineered wheat.

Historically, Brazil has always depended on imports to be able to supply the domestic market with

wheat. For this reason, national producers see in the release of HB4 an opportunity to increase Brazilian

production. However, HB4 will take time to reach the field because of the tests being conducted by

Embrapa, which will define whether the new seeds from Argentina have drought tolerance in the

Brazilian environment.

CTNBio states that genetically engineered wheat is safe for the environment, human and animal health,

based on data from the scientific literature and information from experts presented at a public hearing

that the Commission held. The drought tolerance is crucial for planting in regions with excessive

drought, which is the case in central-western Brazil. It withstands veranicles and allows wheat planting

to advance into less explored areas. Wheat from the Brazilian Midwest has been proven to be of good

quality.

Despite the advances, Brazil still depends on imports to supply the domestic market. For 2023, CONAB

predicts that Brazil should produce 10.5 million tons of wheat but will need to buy another 5.8 million

tons to meet domestic consumption.

According to Abitrigo, Brazil imports 85 percent of Argentina's wheat. Until March 2023, only

conventional wheat was purchased. The cultivated area of HB4 wheat was more than 50,000 hectares in

Argentina in 2022 but has not yet reached commercial scale.

The expectation for the next Brazilian wheat harvest is that it will have very little planting of GE wheat,

since the decisions took place after the definitions of seed purchases, according to analysts. However,

according to reports, it is likely to pick up area in the coming years, as the GE wheat is more resilient

and could bring greater stability in production.

If Embrapa's tests prove positive, the next phase will be seed multiplication and only then will the GE

wheat reach the producer, who in turn will analyze whether it will be economically viable and less risky

in the field. Embrapa estimated that it will take between three to five years for the new GE seed to

produce results in Brazil.

Abimapi, the association that represents manufacturers of biscuits, pastas, breads and cakes in Brazil,

stated that the approval of the cultivation and marketing of GE wheat in Brazil is positive because it

potentially allows the increase of the domestic supply of the cereal, which could reduce the costs for the

baking industry.

Once the tests reach their final stage, authorization will need to be granted by CTNBio for commercial

scale production, and the GE seed developer will need to arrange for a system of royalties’ payments.

b) COMMERCIAL PRODUCTION

As of October 3, 2022, CTNBio data shows that there are 105 GE events approved for commercial

cultivation in Brazil, of which 55 events are for corn, 23 for cotton, 18 for soybeans, six for sugarcane,

two for eucalyptus, and one for a virus resistant variety dry edible bean.

With 56 million hectares in 2021, Brazil accounts for 30.6 percent of the total cultivated area in the

world. It is only behind the United States, and is followed by Argentina, Canada, India, and China. FAS

Brasilia forecasts close to 68 million hectares planted with GE traits, to be confirmed once final numbers

are published. The widespread adoption of GE events in Brazil has contributed to record soybean and

corn crops in recent years, and the main traits are herbicide tolerance, and insect resistance. Biotec-

LATAM

reports the following adoption rates in Brazil:

 Soybeans: The adoption rate of GE soybean seeds in 2022 was 99 percent.

https://biotec-latam.com/en/

 Corn: The adoption rate of GE corn seeds in 2022 was 95 percent.

 Cotton: The adoption rate of GE cotton in 2022 was 99 percent.

 Sugarcane: The adoption rate of GE sugarcane in 2022 was 0.45 percent.

 Dry Edible Beans: the adoption rate of GE dry edible beans in 2022 was 0.17 percent.

 Eucalyptus: Although recently approved, GE eucalyptus is not yet commercially cultivated.

c) EXPORTS

Brazil’s economy is still recovering from the negative impacts of the pandemic on its GDP growth,

employment, and most sectors of the economy. For 2023, the Brazilian Central Bank (BCB) forecasts

GDP to grow 2.64 percent due to a positive performance of agribusiness at the beginning of the year,

BCB estimates the sector to grow ten percent.

Brazil is one of the leading exporters of GE soybeans, corn, and cotton. China is the main importer of

Brazilian GE soybeans and cotton. Brazil also exports to the European Union, as well as other Asian

countries. Corn exports are mainly bound for Iran, followed by Egypt, Spain, Japan, and South Korea.

Brazil is also an exporter of conventional soybeans, although these exports are expected to fall due to the

declining production area. According to trade sources, planting conventional soybeans is more

expensive, and the 10-15 percent price premium barely covers the extra cost of production.

d) IMPORTS

The COVID-19 pandemic created significant disruption for the Brazilian economy, and the value of the

domestic currency plummeted in 2020. The Brazilian real has struggled to regain ground since, as noted

on the following table.

As a result, Brazilian commodity exports saw significant expansion, leaving unmet demand on the

domestic market, particularly for corn and soybeans: two crops used by the livestock industry for feed.

Under pressure from the livestock and poultry sectors, the government of Brazil adopted a measure to

facilitate imports of corn and wheat into the country.

In June 2021 the National Technical Commission on Biosecurity (CTNBIO) issued the Normative

Instruction 32, simplifying the approval process for biotechnology traits in corn and soybean designated

for human consumption and for animal feed. This effectively guaranteed that any imported corn from

the United States could be quickly approved for food and feed uses in Brazil.

Despite the Brazilian government's engagement to promote imports from outside of Mercosur, 99.16

percent of corn imports from January to August 2023 came from Paraguay. FAS Brasilia does not

anticipate significant volumes of corn from outside Mercosur to enter the Brazilian market this season.

e) FOOD AID

Brazil is not a food aid recipient from the United States. In Brazil, food aid for humanitarian purposes is

governed by Law 12429 of 2011, updated by Law 13001 of 2014. The 2011 law stipulates which

countries can receive Brazilian food aid and which products can be sent, and limits of tonnage, per year.

Per the law, the only countries that can receive Brazilian humanitarian food aid are: Bolivia, El

Salvador, Guatemala, Haiti, Nicaragua, Zimbabwe, Cuba, country-members of the Community of

Portuguese Language Countries, Palestine National Authority, Sudan, Ethiopia, Central African

Republic, Democratic Republic of Congo, Somali, Niger, and North Korea. The products and annual

limits as established by the laws are: rice (up to one million tons), dry edible beans and corn (up to one

hundred thousand tons, each), powdered milk (up to ten thousand tons), and vegetable seeds (up to one

ton). The Brazilian National Supply Company (CONAB) administers the program with the Brazilian

Ministry of External Affairs. The Ministry works with the United Nations World Food Program and

determines the amounts and destination of the donations. Brazil can also donate food aid as emergency

assistance to people in vulnerabilities caused by migration fluxes caused by humanitarian crises, as

established on Law 13684 of 2018.

From 2011 to 2022, CONAB has donated at the ports of origin in Brazil approximately 358,000 tons of

basic foods, such as rice, corn grains and beans, to 45 countries. The guidelines for Purchase with

Simultaneous Donation (CDS in Portuguese) operations of the Food Acquisition Program (PAA) were

updated on September 11, 2023, through the manual that consolidates the normative provisions by

CONAB and will guide the next actions related to donations.

f) TRADE BARRIERS

Brazil has a zero-tolerance policy for imports of unapproved GE events.

PART B: POLICY

a) REGULATORY FRAMEWORK

In Brazil, biotechnology is regulated by different governmental ministries and regulatory agencies, such

as the Ministry of Environment (MMA), Ministry of Agriculture, Livestock, and Food Supply (MAPA),

Ministry of Science, Technology, and Innovations (MCTI), and the Ministry of Health. Each of these

ministries have different roles in the regulation of biotechnology in Brazil. Under the MCTI falls the

National Technical Biosafety Commission (CTNBio), the multidisciplinary collegiate body that

performs safety assessments of biotechnologies in Brazil. Under the Ministry of Health falls ANVISA,

the Brazilian Health Regulatory Agency, whose role in biotechnology is to promote the protection of the

population`s health, through sanitary control of production and consumption of all products destined for

human use, including those approved by CTNBio for commercial release.

In 1995, Brazil published its first biosafety law, Law 8974/1995, governing “genetic engineering

techniques” and the release into the environment of “genetically modified organisms”. Ten years later,

Law 11105 of March 25, 2005, revoked the first law and outlined the regulatory framework for

agricultural biotechnology in Brazil. Law 11105 is still in place and is the overarching regulatory

framework on biotechnologies. It is further regulated by Decree 5591 of November 22, 2005

. Minor

amendments to the second biosafety law are present in Law 11460 of 2007. The most up-to-date version

of Law 11105/2005 is available in Portuguese in this link

, and compiles all changes made to it after its

publication.

There are several other pieces of legislation that compose the entire regulatory framework for

biotechnologies in Brazil. All legislation related to biotechnology is compiled by CTNBio at the Norms

and Laws link on their website

and is available in Portuguese. Some of the legislation on that link is

also available in English by changing the language on the top right corner of the website to English.

Prior to its use, the product needs to abide by all applicable regulations by the different governmental

bodies.

There are two main governing bodies regulating agricultural biotechnology in Brazil:

1. The National Biosafety Council (CNBS, in Portuguese). This council falls under the

Office of the President and is responsible for the formulation and implementation of the

national biosafety policy in Brazil. It establishes the principles and directives of

administrative actions for the federal agencies involved in biotechnology. It evaluates

socio-economic implications and national interests regarding the approval for commercial

use of biotech products. No safety considerations are evaluated by CNBS. Under the

Chief of Staff of the Office of the President, CNBS is comprised of 11 government

bodies and needs a minimum quorum of six members to approve any relevant issue.

2. The National Technical Biosafety Commission (CTNBio) was initially established in

1995 under the first Brazilian biosafety law (Law 8974/1995). However, under the

English version available at CTNBio`s website at http://ctnbio.mctic.gov.br/en/decretos/-

/asset_publisher/fV9lwZYqwou5/content/decreto-presidencial-n-5-591-de-22-11-2005

http://www.planalto.gov.br/ccivil_03/_Ato2004-2006/2005/Lei/L11105.htm#art42

http://ctnbio.mctic.gov.br/normas-e-leis

current law, CTNBio was expanded from 18 to 27 primary members to include official

representatives from 9 bodies of the federal government; 12 specialists with scientific and

technical knowledge from 4 different areas: animal health, plant, environment, and

human health (3 specialists from each area); and six specialists from other areas:

consumer defense, human health, environment, biotechnology, family farming, and

worker’s health. All members have an alternate, therefore, CTNBio in total has 54

members, which are elected for a term of two years with a possibility of being re-elected

for an additional two years. CTNBio is under the Ministry of Science, Technology, and

Innovations. All technical issues are debated and approved by CTNBio. Imports of any

agricultural commodity for animal feed or for further processing, or any ready-to-

consume food products, and pet food containing biotech events must be pre-approved by

CTNBio. Approvals are on a case-by-case basis and the timeline is indefinite. Law

11460 of March 21, 2007, modified Article 11 of Law 11105 of March 24, 2005, and

established that a simple majority of the 27 CTNBio primary board members is needed to

approve new biotechnology products.

In a June-18-2008 meeting, CNBS decided that it would only review administrative appeals that are of

national interest, involving social or economic issues, as per the Brazilian biotechnology laws. CNBS

will not evaluate technical decisions on biotech events that are approved by CTNBio. CNBS considers

all approvals of biotech events by CTNBio as conclusive. This important decision, along with the

change in majority voting, eliminated a major barrier for the approval of biotech events in Brazil.

Brazilian legislation makes distinctions between GE plant products containing DNA in the final form of

the product and those products of GE plants that do not. It also makes a distinction between GE plant

products considered living (able to increase in size or number) versus non-living. Article 3 of the

Biosafety Law of 2005 states the definitions of what Brazil considers as “genetically modified

organism”, and a “genetically modified organism” by-product. It defines “GMO” as “an organism the

genetic material of which – DNA/RNA has been modified by any genetic engineering technique”, and a

by-product is “a product obtained from a GMO and that is not capable of autonomously replicating, or

that does not contain a feasible GMO form”.

Paragraphs 1 and 2 of this article also bring relevant information on what is not considered a “GMO” or

a “GMO” by-product, as below:

“Paragraph 1 It is not considered a GMO that which results from direct introduction

techniques into an organism, provided this does not entail the use of recombinant

DNA/RNA molecules or GMOs, including in vitro fecundation, conjugation,

transduction, transformation, polyploid induction and any other natural process.

Paragraph 2. It is not considered a GMO by-product a chemically defined pure substance

obtained from biological processes that do not contain GMOs, heterologous protein nor

recombinant DNA.”

In regard to regulatory approval/authorization treatment for different types of applications, when the

applicant submits the documentation for CTNBio`s risk analysis evaluation, it is up to them to define

which will be the applications of the product being submitted for evaluation. For each type of

application request, the applicant needs to provide supporting data to the safety of the product fort that

specific application. It is common for GE plants commercialized as seeds to have a statement similar to

this in the application: “Commercial release for cultivation, production, manipulation, transportation,

transfer, commercialization, import, export, storage, release, and disposal of this ‘genetically modified

organism (GMO)` and its by-products, as well as its progenies and exemption of a post-commercial

release monitoring plan”. The evaluation period for plants can vary from two to six meetings, depending

on the complexity of the process and the rapporteur`s time availability. Other factors that can influence

the timeline for approvals/authorization for a product are: the quality of the documentation provided, the

CTNBio meetings schedule, restrictions related to confidential data, etc. Commercial plant approvals do

not have an expiration date, nor re-registration is required. However, it is important to note that although

approvals do not have expiration dates, they can be reviewed shall a new scientific data is reported by

the applicant or by scientific literature. In these cases, CTNBio will evaluate if the new information has

an impact in the biosafety of the product and if it remains safe or not.

In 2020 the Ministers of Science and Technology of Brazil and Argentina and the Minister of Education

and Culture of Uruguay signed a Memorandum of Understanding to create the Latin American Center

for Biotechnology (CABBIO) to support research and trainings. By using the research infrastructure of

the three countries, the goal is to maintain a knowledge-generating pole, including the participation of

the private sector and the exchange between biotechnology companies and scientific and technical

teams. Since its creation, CABBIO has offered webinars, short and graduate courses.

On August 22, 2023, the Brazilian Federal Supreme Court decided, by majority of eight to three votes,

to maintain the competence of the CTNBio to approve the commercialization of genetically engineered

organisms. The trial took place in a virtual plenary and validates parts of the Biosafety Law, which

covers the supervision, creation and study of genetically engineered organisms and genetically altered

foods. The action was initiated in 2005 (Law 11105/2005

) by the Attorney General's Office (PGR) and

was approved in the same year.

In 18 years of operation, the commission approved 260 “GMOs” for use in the Brazilian market, with no

detection of environmental, human, or animal health issues. Considering those approved materials, 45

percent are plants, mainly soybean, corn, and cotton seeds, but also beans, sugarcane, eucalyptus, and

wheat. The flow of products from other areas, such as vaccines, therapies, and medicines, has been

increasing.

Available in Portuguese at https://www.planalto.gov.br/ccivil_03/_Ato2004-2006/2005/Lei/L11105.htm

Brazil´s Review Process for GE Products

Source: CTNBIO, adapted to English by FAS Brasilia.

i. Legal terms Table

The following legal terms table is by no means exhaustive of all legal framework involving

biotechnologies in Brazil. It is organized by alphabetical order of the legal term in English.

Legal Term

(in Portuguese)

Legal Term

(in English)

Laws and

Regulations

where term is

used

Legal Definition (in English)

Agroinfiltração/

Agroinfecção

Agroinfiltration/

agroinfection

CTNBio

Normative

Resolution

16/2018

Foliage (or other somatic tissue)

infiltrated with Agrobacterium sp. or

gene constructs containing the gene of

interest to obtain a temporary

expression at high levels located in the

infiltrated area or with viral vector for

systemic expression without the

modification being transmitted to

subsequent generations.

Requerente

Applicant

CTNBio

Normative

Resolution

32/2021

Any legal entity, holder of a Quality

Certificate in Biosafety – CQB, which

intends to conduct a commercial

release, according to this Normative

Resolution.

Embriões

congelados

disponíveis

Available frozen

embryo

Decree

5591/2005

An embryo frozen on or before March

28, 2005, after three years from the

date of its freezing have elapsed

genitor.

Clonagem

Cloning

Law

11105/2005;

Decree

5591/2005

An asexual reproduction process,

artificially produced, based on a sole

genetic patrimony, by using or not

genetic engineering techniques.

Clonagem para fins

reprodutivos

Cloning for

reproductive

means

Law

11105/2005

Cloning the end purpose of which is to

make an individual.

Liberação

Planejada no Meio

Ambiente

Commercial

release in the

environment

CTNBio

Normative

Resolution

35/2021

Commercial release in the

environment of a GMO and its

derivatives, for experimental

evaluations under monitoring, in

accordance with the dispositions of

this Normative Resolution.

Dano

Damage

CTNBio

Normative

Resolution

32/2021

Harm to the environment and/or

human, animal, and plant health.

Perigo

Danger

CTNBio

Normative

Resolution

32/2021

Any chemical, physical or biological

component that causes potential

damage.

Ácido

desoxirribonucléico

- ADN, ácido

ribonucléico - ARN

Deoxyribonucleic

acid - DNA,

ribonucleic acid -

RNA

Law

11105/2005;

Decree

5591/2005

Genetic material which contains

determining information about

transmissible hereditary characters to

progeny.

Organismo doador

Donor organism

CTNBio

Normative

Resolution

32/2021

Organism which donates one DNA or

RNA sequence to the genetic

transformation of the receptive

organism or those whose original

DNA or RNA sequences are modified

in vitro or synthetized before the

insertion in the receptive organism.

Células-tronco

embrionárias

Embryonic stem

cells

Law

11105/2005;

Decree

5591/2005

Embryonic cells that are capable of

modifying the cells of any organism

tissue.

Elemento regulador

da expressão

gênica

Gene expression

regulating

element

CTNBio

Normative

Resolution

21/2018

DNA/RNA sequences involved in the

gene expression regulation, such as

those responsible for the codification

of the transcription factors, micro

RNAs and other elements

scientifically known as related to the

gene expression regulation.

Técnica de

silenciamento

gênico

Gene silencing

technique

CTNBio

Normative

Resolution

21/2018

Genetic engineering technique by

which the expression of a gene is

negatively regulated.

Construção

genética

Genetic construct

CTNBio

Normative

Resolution

32/2021

Genetic sequence containing one or

more codifying regions and the

genetic elements needed for its

transcriptional regulation.

Engenharia

genética

Genetic

engineering

Law

11105/2005;

Decree

5591/2005;

CTNBio

Normative

Resolution

32/2021

The activity of manipulating

DNA/RNA recombinant molecules.

Transformação

genética

Genetic

transformation

CTNBio

Normative

Resolution

32/2021

Activity of modifying, in a controlled

manner, the genetic material present in

an organism through the integration of

an exogenous DNA.

Microrganismo

geneticamente

modificado - MGM

"Genetically

Modified

Microorganism -

GMM"

CTNBio

Normative

Resolution

21/2018

Microorganism whose genetic

material - DNA/RNA has been

modified by any genetic engineering

technique.

Organismo

geneticamente

modificado - OGM

"Genetically

modified

organism -

GMO"

Law

11105/2005;

Decree

5591/2005;

CTNBio

Normative

Resolution

32/2021

An organism the genetic material of

which – DNA/RNA has been modified

by any genetic engineering technique.

Genitores

Genitors

Decree

5591/2005

The final users of in vitro fertilization.

Derivado de MGM

"GMM" by-

product

CTNBio

Normative

Resolution

21/2018

A product obtained from a "GMM"

and that is not capable of

autonomously replicating, or that does

not contain a feasible "GMM" form.

Atividade de uso

comercial de OGM

e seus derivados

"GMO" and

"GMO"

derivatives

commercial use

activity

Decree

5591/2005

Any activity not included as research,

and involving cultivation, production,

manipulation, transport, transfer,

marketing, import, export, storage,

consumption, disposal and discarding

of "GMO" and its derivatives for

commercial purposes.

Derivado de OGM

"GMO" by-

product

Law

11105/2005;

Decree

5591/2005;

CTNBio

Normative

Resolution

32/2021

A product obtained from a "GMO"

and that is not capable of

autonomously replicating, or that does

not contain a feasible "GMO" form.

Célula germinal

humana

Human germinal

cell

Law

11105/2005;

Decree

5591/2005

The mother cell responsible for

forming gametes which are found in

the female and male sexual glands and

their direct progeny in any ploid

degree.

Construção

genética idêntica

Identical genetic

construct

CTNBio

Normative

Resolution

35/2021

Genetic construct which contains the

same genes and promotors that result

in the same expression product inside

the same species.

Fertilização in vitro

In vitro

fertilization

Decree

5591/2005

The fusion of gametes conducted by

any technique of extracorporeal

fertilization.

Tecnologias

genéticas de

restrição do uso

Limited use

genetic

technologies

Decree

5591/2005

Any process of human intervention to

generate or multiply plants

"genetically modified" to produce

sterile reproductive structures, as well

as any form of genetic manipulation

with the purpose of activating or

deactivating genes related to plant

fertility by external chemical

inductors.

Microrganismo

Microorganism

CTNBio

Normative

Resolution

21/2018

All microscopic biological entity, uni

or pluricellular capable of reproducing

or transferring genetic material,

including virus and other classes that

come to be known.

Plano de

monitoramento

pós-liberação

comercial

Monitoring plan

after commercial

release

CTNBio

Normative

Resolution

32/2021

Pool of procedures to monitor the

effects derived from the commercial

release of the GMO and its derivatives

on the environment and to the human

and animal health.

Risco

negligenciável

Negligible risk

CTNBio

Normative

Resolution

32/2021

Risk associated to a reduced damage

with negligible likelihood to take

place over the probable term of the

GMO commercial use.

Embriões inviáveis

Non-viable

embryo

Decree

5591/2005

An embryo with genetic alterations

evidenced by preimplant diagnosis,

according to the Ministry of Health

specific rules, whose development has

been interrupted by spontaneous

absence of cleavage for a period

exceeding twenty-four hours from the

in vitro fertilization, or an embryo

with morphologic alteration that

adversely affects its full development.

Mutagênese

direcionada por

oligonucleotídeo

Oligonucleotide

Directed

Mutagenesis

CTNBio

Normative

Resolution

16/2018

A synthesized oligonucleotide

containing one or a few nucleotide

alterations complementary to the

targeted sequence, on being

introduced into the cell, may cause

substitution, insertion or deletion in

the target sequence through the

cellular repair mechanism

(microorganisms, plants, animals, and

human cells).

Organismo

Organism

Law

11105/2005;

Decree

5591/2005;

CTNBio

Normative

Resolution

32/2021

Each and every biological entity that is

capable of reproducing or transferring

genetic material, including virus and

other classes that may be made

known.

Responsável legal

Person legally in

charge

CTNBio

Normative

Resolution

32/2021

Individual responsible for conducting

the commercial release, according to

CTNBio norms.

Responsável legal

Person legally in

charge

CTNBio

Normative

Resolution

35/2021

Individual responsible for conducting

the commercial release in the

environment, according to CTNBio

norms.

Técnicas

Inovadoras de

Melhoramento de

Precisão

Precision

breeding

innovation

techniques

CTNBio

Normative

Resolution

16/2018

Are based on a set of new

methodologies and approaches that

differ from the transgenic genetic

engineering strategy that results in the

absence of recombinant DNA/RNA in

the final product.

Florescimento

Precoce

Precocious

flowering

CTNBio

Normative

Resolution

16/2018

Silencing and/or super-expression of

genes related to flowering by

inserting genetic modification into the

genome and subsequent

separation or through transient

expression by viral vector.

Organismo

receptor

Receptive

organism

CTNBio

Normative

Resolution

32/2021

Organism that will receive the DNA

sequence.

Moléculas de

ADN/ARN

recombinante

Recombinant

DNA/RNA

molecules

Law

11105/2005;

Decree

5591/2005;

CTNBio

Normative

Resolution

32/2021

Molecules manipulated outside live

cells through changes made to natural

or synthetic DNA/RNA segments that

can multiply in a live cell, or yet,

DNA/RNA molecules resulting from

this multiplication; DNA/RNA

synthetic segments equivalent to

natural DNA/RNA are also

considered.

Atividade de

pesquisa

Research activity

Decree

5591/2005

Any activity conducted in a

laboratory, under field containment, as

part of the process of obtaining a

GMO and its derivatives, or

assessment of the GMO and its

derivatives biosafety involving, in the

experimental context, construction,

cultivation, manipulation, transport,

transfer, import, export, storage,

disposal to the environment and

discarding of GMO and its derivatives.

Melhoramento

Reverso

Reverse breeding

CTNBio

Normative

Resolution

16/2018

Inhibiting meiotic recombination in

heterozygous plants selected for the

trait of interest in order to produce

homozygous parental lines.

Risco

Risk

CTNBio

Normative

Resolution

32/2021

Probability of the occurrence of

damage, and its likely consequences,

due to the exposure to the danger.

Risco

Risk

CTNBio

Normative

Resolution

35/2021

Probability of an adverse event.

Avaliação de risco

Risk assessment

CTNBio

Normative

Resolution

32/2021

Combination of procedures or

methods, by which it is identified and

evaluated, on a case-by-case basis, the

risk. The risk assessment must include

steps to identify and classify the risk;

estimation of its occurrence;

evaluation of its consequences and

determination of the risk estimate.

Metilação do DNA

dependente do

RNA

RNA-dependent

DNA

methylation

CTNBio

Normative

Resolution

16/2018

Methylation driven by RNA

interference (“RNAi”) in RNAi

homologous promoter regions in order

to inhibit target gene transcription in

live beings.

Tecnologia para

produção de

sementes

Seed producing

technology

CTNBio

Normative

Resolution

16/2018

Inserting fertility-restoring genetic

modification in naturally malesterile

lines in order to multiply these lines

maintaining the male-sterile condition

but not transmitting the genetic

modification to descendants.

Risco não

negligenciável

Significant risk

CTNBio

Normative

Resolution

32/2021

Risk associated to any damage with

actual likelihood to take place over the

probable term of the GMO

commercial use.

Construção

genética similar

Similar genetic

construct

CTNBio

Normative

Resolution

32/2021

Non-identical genetic construct whose

differences do not result in identity

alterations the expression products.

Mutagênese sítio

dirigida

Site-Directed

Mutagenesis

CTNBio

Normative

Resolution

16/2018

Methylation driven by RNA

interference (“RNAi”) in RNAi

homologous promoter regions in order

to inhibit target gene transcription in

live beings.

Produto combinado

Stacked product

CTNBio

Normative

Resolution

32/2021;

CTNBio

Resolution

35/2021

"Genetically modified organism"

which contains more than one

transformation event.

Clonagem

terapêutica

Therapeutic

cloning

Law

11105/2005

Cloning the end purpose of which is to

produce embryonic stem cells for

therapeutic purposes.

RNAi uso

tópico/sistêmico

Topical/systemic

use RNAi

CTNBio

Normative

Resolution

16/2018

Use of double-stranded RNA

(“dsRNA”) with targeted-gene

homologous sequence specifically

silencing this gene or genes.

Engineered dsRNA molecules may be

introduced/absorbed into the cell from

the environment.

Evento de

transformação

Transformation

event

CTNBio

Normative

Resolution

32/2021;

CTNBio

Resolution

35/2021

Event with one or multiple insertions

of one (same) genetic construct

inserted in the receptive organism

genome, as a result of the genetic

transformation.

Vetor viral

Viral Vector

CTNBio

Normative

Resolution

16/2018

Inoculation of live beings with

recombinant viruses (DNA or RNA)

expressing the genetic modification

and amplification of the gene of

interest through viral replication

mechanisms without host genome

modification.

b) APPROVALS/AUTHORIZATIONS

Cotton

Crop -

Year

Trait Category

Applicant

Event

(Commercial

Name)

Trait

Description

Document

Number/Uses within

Brazil

Cotton

2023

Herbicide Tolerant

BASF

LLCotton25 x

GBH811

(GLI)

Herbicide

tolerance to

glyphosate

base and

inhibitory

herbicides

8540/2023

Release into the

environment of the

cotton variety;

commercial use

Cotton

2022

Insects and pests

resistant

Monsanto

MON 15985

Resistant to

certain

Insects and

pests

8038/2022

Commercial Release

of MON 15947 cotton,

obtained through the

segregation and

selection of MON

15985 cotton

Cotton

2021

Insect Resistant

Syngenta

Seeds Ltda

COT102

Insect

Resistant

RN32

Not available

Cotton

2019

Herbicide Tolerant,

Insect Resistant

BASF

GHB811 x

T-304-40 x

GHB119 x

COT102 x

COT102

Herbicide

Tolerant, Insect

Resistant

6405/2019

Textile Fibers

Food and Feed

Cotton

2019

Herbicide

Tolerant/Insect

Resistant

Dow

DAS-21023-5 x

DAS – 24236-5

x SYN-IR102-7

x DAS-81910-7

Herbicide

Tolerant Insect

resistant

6657/2019

Textile Fibers Food

and Feed

Cotton

2018

Herbicide Tolerant

Insect Resistant

Monsanto

COT102 x

MON15985 x

MON88913 x

MON88701

(BGIIIRRFlexD

GT)

Herbicide

Tolerant, Insect

Resistant

6139/2018

Textile Fibers

Food and Feed

Cotton

2018

Herbicide Tolerant

Insect Resistant

Monsanto

MON88913 x

MON88701

(RRFlexDGT)

Herbicide

Tolerant, Insect

Resistant

6139/18

Textile Fibers

Food and Feed

Cotton

2018

Herbicide Tolerant

Insect Resistant

BASF

T304-40 x

GHB119 x

COT102

Herbicide

Tolerant, Insect

Resistant

6130/18

Textile Fibers

Food and Feed

Cotton

2018

Herbicide Tolerant

Dow

DAS 81910

(Enlist)

Herbicide

Tolerant

6107/18

Textile Fibers

Food and Feed

Cotton

2018

Insect Resistant

Dow

DAS-21023-5 x

DAS24236-5 x

SYN-IR102-7

(Widestrike 3)

Insect

Resistant

5955/18

Textile Fibers

Food and Feed

Cotton

2017

Herbicide Tolerant

Insect Resistant

Bayer

GHB614 x

T304-40 x

GHB119 x COT

102

Herbicide

Tolerant Insect

Resistant

5400/17

Textile Fibers Food

and Feed

Cotton

2017

Herbicide Tolerant

Monsanto

MON88701

(DGT)

Herbicide

Tolerant

5429/17

Textile Fibers Food

and Feed

Cotton

2016

Herbicide Tolerant

Insect Resistant

Monsanto

COT102 x

MON15985 x

MON88913

(BGIIIRRFlex)

Herbicide

Tolerant Insect

Resistant

5155/16

Textile Fibers Food

and Feed

Cotton

2012

Herbicide Tolerant

Insect Resistant

Bayer

GHB614 x

T304-40x

GHB119

(GlytoIxTwinLin

Gossypium

hirsutum L.

3286/12

Textile Fibers Food

and Feed

Cotton

2012

Herbicide Tolerant

Insect Resistant

Monsanto

MON 15985 x

MON 88913

(BGIIFlex)

Herbicide

Tolerant Insect

Resistant

3365/12

Textile Fibers Food

and Feed

Cotton

2012

Herbicide Tolerant

Bayer

GHB614 x

LL Cotton 25

(GTxLL)

Gossypium

hirsutum L.

3290/12

Textile Fibers Food

and Feed

Cotton

2011

Herbicide Tolerant

Monsanto

MON 88913

Gossypium

hirsutum L.

2956/11

Textile Fibers Food

and Feed

Cotton

Herbicide Tolerant

Bayer

T 304-40 x GHB

Gossypium

2795/11

2011

Insect Resistant

119

(TwinLink)

hirsutum L.

Textile Fibers Food

and Feed

Cotton

2010

Herbicide Tolerant

Bayer

GHB 614

(GlyTol)

Gossypium

hirsutumm L.

2754/10

Textile Fibers Food

and Feed

Cotton

2009

Herbicide Tolerant

Insect Resistant

Monsanto

MON 531 x

MON 1445

(Round Ready

BGRR)

Gossypium

hirsutum L.

Glyphosate

Herbicide

2051/09

Textile Fibers Food

and Feed

Cotton

2009

Insect Resistant

Monsanto

MON 15985

(Bollgard II)

Gossypium

hirsutum L.

1832/09

Textile Fibers Food

and Feed

Cotton

2009

Insect Resistant

Herbicide Tolerant

Dow

AgroScience

281-24-236 x

3006-210-23

(Widestrike)

Gossypium

hirsutum L.

Herbicide

glufosinate

ammonium

1757/09

Food and Feed

Cotton

2008

Herbicide Tolerant

Bayer

LL Cotton 25

(Liberty Link)

Gossypium

hirsutum L.

Glyphosate

Herbicide

Ammonium

1521/08

Textile Fibers Food

and Feed

Cotton

2008

Herbicide Tolerant

Monsanto

MON 1445

(Roundup

Ready)

Gossypium

hirsutum L.

Glyphosate

Herbicide

1598/08

Textile Fibers Food

and Feed

Cotton

2005

Insect Resistant

Monsanto

MON 531

(Bollgard 1)

Lepidoptera

Order

513/05

Textile Fibers Food

and Feed

Source: CTNBio, updated on June 21, 2023

Corn

Crop -

Year

Trait Category

Applicant

Event

(Commercial

Name)

Trait

Description

Document

Number/ Uses

within Brazil

Corn

2023

Insect Resistant

Monsanto

MON 95275

Insect Resistant

Not available

Post-commercial

release monitoring

plan

Corn

2023

Herbicide Tolerant

Syngenta

Bt11 x MIR162 x

NK603

(Zea mays L.)

Herbicide

Tolerant

8405/2023

Cultivation,

production,

handling,

transport, transfer,

marketing, import,

export, storage,

release, and

disposal

Corn

2022

Insect Resistant

Syngenta

3272

Insect Resistant

7891/2022

Cultivation and

exemption from

monitoring plan

Corn

2022

Insect Resistant

Helix

Semenentes e

Mudas

EH913

Resistance to

lepidoptera

insect

8064/2022

Commercial use,

planned release

into the

environment

Corn

2022

Herbicide Tolerant

Monsanto

MON87429

Herbicide

Tolerant

8035/2022

Exemption from

post- commercial

release monitoring

Corn

2022

Herbicide Tolerant

Insect Resistant

Syngenta

Seeds Ltda

3272 x Bt11 x

MIR162 x GA21

Herbicide

Tolerant

Insect Resistant

7897/2022

Cultivation,

production,

handling,

transport, transfer,

marketing, import,

export, storage,

release, and

disposal

Corn

2021

Herbicide Tolerant

Insect Resistant

Corteva

DP4114-3

Herbicide

Tolerant

Insect Resistant

7501/2021

Food and Feed

Import

Corn

2021

Herbicide Tolerant

Insect Resistant

Monsanto

MON 87427 ×

MON 95379 ×

MON 87411

Herbicide

Tolerant

Insect Resistant

7429/2021

Release into the

environment,

commercial use

and any other

activities

Corn

2020

Insect Resistant

Monsanto

MON 95379

Insect Resistant

7222/2020

Not available

Corn

2020

Herbicide Tolerant

Insect Resistant

Dow

MON-89034-3 x

DAS-01507-1 x

SYN-IR162-4 x

MON-00630-6 x

DAS 40278-9 (and

undercombinations)

Herbicide

Tolerant

Insect Resistant

6862/2020

Food and Feed

Corn

Herbicide Tolerant

DuPont

NK603 x T25 x

Herbicide

6797/2020

2020

DAS-40278

Tolerant

Food and Feed

Corn

2019

Herbicide Tolerant

Monsanto

MON 87427 x

MON 89034 x

MIR162 x NK603

(and

undercombinations)

Herbicide

Tolerant

6519/2019

Food, Feed,

Imports

Corn

2019

Herbicide Tolerant

Insect Resistant

Monsanto

MON 87427 ×

MON 87419 ×

NK603

Herbicide

Tolerant

Insect Resistant

6448/2019

Not available

Corn

2019

Herbicide Tolerant

Insect Resistant

Dow

MON87427-7 x

MON89034-3 x

DAS01507-1 x

MON87411-9 x

DAS59122-7 x

DAS40278-9

Herbicide

Tolerant and

Insect Resistant

6363/2019

Food, Feed,

Imports

Corn

2018

Insect Resistant

Syngenta

MZIR 098

Approved only

for human and

animal food

6115/18

Food,

Feed

Imports

Corn

2018

Insect Resistant

Herbicide Tolerant

Dow

MON 89034 x

TC1507 x

MIR162 x

NK603 x

DAS40278-9

(PowerCore Ultra

Enlist)

Insect Resistant

Herbicide

Tolerant

6035/18

Food, Feed,

Imports

Corn

2017

Herbicide Tolerant

Insect Resistant

Dow

MON89034 x

TC1507 x

NK603 x

MIR162

(PowerCore Ultra)

Herbicide

Tolerant

Insect Resistant

5425/17

Food, Feed,

Imports

Corn

2017

Insect Resistant

Syngenta

MIR162 x

MON89034

Insect Resistant

5412/17 e

6310/2019

Food, Feed,

Imports

Corn

2017

Herbicide Tolerant

Insect Resistant

Syngenta

Bt11 x

MIR162 x

MON89034

(VIP4)

Herbicide

Tolerant

Insect Resistant

5412/17

Food, Feed,

Imports

Corn

2017

Herbicide Tolerant

Insect Resistant

Syngenta

Bt11 x

MIR162 x

MON89034 x

GA21

(VIP4TG)

Herbicide

Tolerant

Insect Resistant

5412/17

Food, Feed,

Imports

Corn

2016

Drought Stress

Monsanto

MON87460

Approved only

for human and

animal food

5224/16

Food, Feed,

Imports

Corn

2016

Amylase

Thermostability

Increase

Syngenta

3272

(Enogen)

Approved only

for human and

animal food

5226/2016

e 7891/2022

Food, Feed,

Imports

Corn

2016

Herbicide Tolerant

Monsanto

MON87427

Herbicide

Tolerant

5221/16

Food, Feed,

Imports

Corn

2016

Herbicide Tolerant

Insect Resistant

Monsanto

MON97411

Herbicide

Tolerant

Insect Resistant

5162/2016

Food, Feed,

Imports

Corn

2016

Herbicide Tolerant

Insect Resistant

Dow

AgroSciences

MON89034 x

MON88017 x

TC1507 x

DAS59122-7

(SmartStax)

Herbicide

Tolerant

Insect Resistant

5128/16

Food, Feed,

Imports

Corn

2016

Herbicide Tolerant

Insect Resistant

Dow

AgroSciences

MON89034 x

TC1507 x

NK603 x

DAS40278-9

(PowerCore Enlist)

Herbicide

Tolerant

Insect Resistant

4949/16

Food, Feed,

Imports

Corn

2015

Fertility

Restauration

Du Pont

SPT 32138

(32138 Mantenedor

SPT)

Fertility

Restauration

4865/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Insect Resistant

Syngenta

BT11 x MIR162

(VIP2)

Herbicide

Tolerant

Insect Resistant

4764/15

Food, Feed,

Imports

Corn

2015

Insect Resistant

Syngenta

5307

(Agrisure

Duracade)

Insect

Resistant

4764/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Insect Resistant

Syngenta

BT11 x

MIR162 x

MIR604 x

TC1507 x

5307 x

GA21

(Agrisure Duracade

5222)

Herbicide

Tolerant

Insect

Resistant

4764/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Dow

AgroSciences

DAS40278-9 x

NK603

(Enlist RR)

Herbicide

Tolerant

4763/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Insect Resistant

Du Pont

TC1507 x

MON810 x

Herbicide

Tolerant

4465/15

Food, Feed,

MIR162

Undercombinations

approved and

already referred

previously

Insect

Resistant

Imports

Corn

2015

Insect Resistant

Du Pont

(RN15)

MON 810 x

MIR162

Insect

Resistant

4409/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Insect Resistant

Du Pont

(RN15)

MIR162 x

NK603

Herbicide

Tolerant

Insect

Resistant

4409/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Insect Resistant

Du Pont

(RN15)

TC1507 x

MIR162

Herbicide

Tolerant

Insect

Resistant

4409/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Insect Resistant

DuPont

(RN15)

TC1507 x

MON 810 x

MIR 162 x

NK603

Herbicide

Tolerant

4409/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Insect Resistant

DuPont

(RN15)

TC1507 x

MIR162 x

NK603

Herbicide

Tolerant

Insect

Resistant

4409/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Monsanto

NK603 x T25

Glyphosate and

Glufosinate

Herbicides

4407/15

Food, Feed,

Imports

Corn

2015

Herbicide Tolerant

Dow Agro

Science

DAS 40278-9

(Enlist)

Herbicide

Tolerant

4406/15

Food, Feed,

Imports

Corn

2014

Insect Resistant

Syngenta

MIR 604

Insect Resistant

4207/14

Food, Feed,

Imports

Corn

2014

Herbicide Tolerant

Insect Resistant

Syngenta

Bt11 x

MIR162 x

MIR604 x

GA21

(Viptera4)

Glyphosate

Tolerant

Glufosinate

Ammonium

4207/14

Food, Feed,

Imports

Corn

2013

Herbicide Tolerant

Insect Resistant

DuPont and

Dow

AgroSciences

MON89034 x

MON88017 x

DAS-01507-1

(Herculex XTRA

maize)

Glyphosate

Herbicide

Ammonium

3674/13 and

7467/2021

Food, Feed,

Imports

Corn

2011

Herbicide Tolerant

Insect Resistant

Monsanto

MON 89034 x

MON 88017

Glyphosate

Herbicide

3045/11

Food, Feed,

Imports

Corn

2011

Herbicide Tolerant

Insect Resistant

DuPont

TC1507 x

MON 810

Glyphosate

Herbicide

Ammonium

3021/11

Food, Feed,

Imports

Corn

2011

Herbicide Tolerant

Insect Resistant

DuPont

MON 810 x

TC 1507 x

NK 603

(Optimum

Intrasect)

Glyphosate

Herbicide

Lepidoptera R.

2955/11

Food, Feed,

Imports

Corn

2010

Herbicide Tolerant

Insect Resistant

Monsanto and

Dow

Agrosciences

MON 89034 x

TC 1507 x

NK 603

(Power Core

PW/Dow)

Glyphosate

Herbicide

Ammonium

2753/10

Food, Feed,

Imports

Corn

2010

Herbicide Tolerant

Insect Resistant

Monsanto

MON 88017

(Yield Guard VT)

Glyphosate

Herbicide

Ammonium

2761/10

Food, Feed,

Imports

Corn

2010

Herbicide Tolerant

Insect Resistant

Monsanto

MON 89034 x

NK 603

(PRO2)

Glyphosate

Herbicide

Ammonium

2725/10

Food, Feed,

Imports

Corn

2010

Herbicide Tolerant

Insect Resistant

Syngenta

BT 11 x

MIR 162 x

GA 21

(TL TG Viptera)

Glyphosate

Herbicide

Ammonium

2722/10

Food, Feed,

Imports

Corn

2009

Insect Resistant

Monsanto

MON 89034

(Pro)

Lepidoptera

Resistant

2052/09

Food, Feed,

Imports

Corn

2009

Herbicide Tolerant

Insect Resistant

DuPont

TC1507 x NK603

(HR Herculex/RR2)

Glyphosate Tole

rant Insect

Resistant

2053/09

Food, Feed,

Imports

Corn

2009

Insect Resistant

Syngenta

MIR162

(Viptera-MIR162)

Lepidoptera

Resistant

2042/09

Food, feed,

Imports

Corn

2009

Herbicide Tolerant

Insect Resistant

Syngenta

BT 11 x GA 21

(TL/TG)

Glyphosate

Tolerant

Lepidoptera R.

2040/09

Food, Feed,

Imports

Corn

2009

Herbicide Tolerant

Insect Resistant

Monsanto

NK603 x MON810

(YGRR2)

Glyphosate

Tolerant

Lepidoptera R.

2041/09

Food, Feed,

Imports

Corn

2008

Herbicide Tolerant

Insect Resistant

Dupont and

Dow

AgroScience

TC1507

(Herculex)

Glyphosate

ammonium

Herbicide

Tolerant

1679/08

Food and Feed

Corn

2008

Herbicide Tolerant

Syngenta

GA 21

(TG)

Glyphosate

Tolerant

1597/08

Food and Feed

Corn

2008

Herbicide Tolerant

Monsanto

NK 603

(Roundup Ready 2)

Glyphosate

Tolerant

1596/08

Food and Feed

Corn

2008

Insect Resistant

Herbicide Tolerant

Syngenta

Bt 11

(TL)

Lepidoptera

resistant

1255/08

Food and Feed

Corn

2007

Herbicide Tolerant

Bayer

T 25

(Liberty Link)

Ammonium

Glyphosate

tolerant

987/07

Food and Feed

Corn

2007

Insect Resistant

Monsanto

MON 810

(Yield Guard)

Lepidoptera

resistant

1100/07

Food and Feed

Source: CTNBio, updated on June 21, 2023

Soybeans

Crop -

Year

Trait Category

Applicant

Event

(Commercial

Name)

Trait

Description

Document

Number/Uses within

Brazil

Soybeans

2023

Glyphosate

herbicide

resistance

GDM

GTS 40- 3-2 x

A5547-127

(Roundup Ready)

Glysophate

and

ammonium

glusophinate

herbicide

tolerant

8565/2023

Release for free

registration, use, testing,

sowing, transportation,

storage, marketing,

consumption,

importation, and disposal

Soybeans

2021

Herbicide

Tolerant

BASF

GMB151

Nematode

resistance and

selectivity to

HPPD-

inhibiting

herbicides

7306/2021

Commercial use

Soybeans

2019

Herbicide

Tolerant

TMG

HB4 and HB4 x

Herbicide and

Drought

Tolerant

6540/2019

Food and Feed

Soybeans

2018

Herbicide

Tolerant

Insect Resistant

Monsanto

MON87751 x

MON87708 x

MON87701 x

MON89788

Herbicide

Tolerant

Insect

Resistant

5832/18

Food and Feed

Soybeans

2018

GM-HRA; GM-

FAS2-1 (partial

sequence); cp4

epsps (aroA:CP4)

Du Pont

DP-305423-1 x

MON 04032-6

(Plenish x Plenish;

Plenish RR1)

GM-HRA;

GM-FAS2-1

(partial

sequence); cp4

epsps

(aroA:CP4)

5821/18

Food and Feed

Soybeans

2017

Herbicide

Tolerant

Dow

DAS 44406-6 x

DAS 81419-2

Herbicide

Tolerant

5500/2017

Food and Feed

Insect Resistant

(Conkesta Enlist

E3)

Insect

Resistant

Soybeans

2017

Herbicide

Tolerant

Monsanto

MON 87708 x

MON 89788

(Xtend)

Herbicide

Tolerant

5392/17

Food and Feed

Soybeans

2017

Insect Resistant

Monsanto

MON 87751

Insect

Resistant

5398/17

Food and Feed

Soybeans

2016

Herbicide

Tolerant

Monsanto

MON 87708

Herbicide

Tolerant

5330/17

Food and Feed

Soybeans

2016

Herbicide

Tolerant

Insect Resistant

Dow Agro

Science

DAS 81419-2

(Conkesta)

Herbicide

Tolerant

Insect

Resistant

5148/16

Food and Feed

Soybeans

2015

Herbicide

Tolerant

Bayer

FG72 x A5547-

127

Herbicide

Tolerant

4866/15

Food and Feed

Soybeans

2015

Herbicide

Tolerant

Dow Agro

Science

DAS 44406-6

(Enlist E3)

Herbicide

Tolerant

4867/15

Food and Feed

Soybeans

2015

Herbicide

Tolerant

Bayer

FG72

Herbicide

Tolerant

4750/15

Food and Feed

Soybeans

2015

Herbicide

Tolerant

Dow Agro

Science

DAS 68416-4

(Enlist)

Herbicide

Tolerant

Gluphosinate

ammonium

4410/15

Food and Feed

Soybeans

2010

Herbicide

Tolerant

Insect Tolerant

Monsanto

MON 87701 x

MON 89788

(Intacta RR2 PRO)

Glyphosate

Herbicide

Tolerant

Insect

Resistant

2542/10 e

7245/2020

Food and Feed

Soybeans

2010

Herbicide

Tolerant

Bayer

A2704-12

(Liberty Link)

Gluphosinate

ammonium

2286/10

Food and Feed

Soybeans

2010

Herbicide

Tolerant

Bayer

A5547-127

(Liberty Link)

Herbicide

Tolerant

2273/10

Food and Feed

Soybeans

2009

Herbicide

Tolerant

BASF

Embrapa

BPS-CV 127-9

(Cultivance)

Herbicide

Tolerant

Imidazolinone

class

2236/09

Food and Feed

Soybeans

1998

Herbicide

Tolerant

Monsanto

GTS-40-3-2

(Roundup Ready)

Glyphosate

Herbicide

Tolerant

Com 54/98

Food and Feed

Source: CTNBio, updated on June 21, 2023

Bean

Crop - Year

Trait Category

Applicant

Event

(Commercial

Name)

Trait Description

Bean

2011

Disease

Resistant

Embrapa

Embrapa 5.1

Resistant to Bean

Golden Mosaic Virus

Source: CTNBio, updated on June 21, 2023

Eucalyptus

Crop - Year

Trait

Category/Description

Applicant

Event

(Commercial

Name)

Document number

Eucalyptus 2023

Antibiotic Tolerant

Suzano

1521K059

8093/2023

Eucalyptus 2023

Herbicide Tolerant

Suzano

955P082

8396/2023

Eucalyptus 2023

Herbicide Tolerant

Suzano

955S024

8352/2023

Eucalyptus 2022

Herbicide Tolerant

Suzano

751K022

8281/2022

Eucalyptus 2022

Herbicide Tolerant

Suzano

955S019

8072/2022

Eucalyptus

2021

(pending CNBS

decision)

Herbicide Tolerant

Suzano

751K032

7788/2021

Eucalyptus

2015

Growth Increase

Increases wood

volume

Futuragene

H421

4408/15

Source: CTNBio, updated on June 21, 2023

Sugarcane

Crop - Year

Trait Category

Applicant

Event

(Commercial

Name)

Document Number

Sugarcane 2022

Insect Resistant

CTC

CTC-92015-7

7988/2022

Sugarcane 2021

Insect Resistant

CTC

CTC95019-5

7482/2021

Sugarcane 2020

Insect Resistant

CTC

CTC79005-2

7246/2020

Sugarcane 2020

Insect Resistant

CTC

CTC75064-3

6827/2020

Sugarcane 2019

Insect Resistant

CTC

CTC93209-4

7140/2020

Sugarcane 2018

Insect Resistant

CTC

CTC91087-6

6235/18

Sugarcan 2017

Insect Resistant

CTC

CTB141175/01-A

5483/17 and 6974/2020

Source: CTNBio, updated on June 21, 2023

Wheat Flour

Crop - Year

Trait Category

Applicant

Event

(Commercial

Name)

Document

Number

Wheat Flour

2023

Herbicide

Tolerant

TMG

IND-00412-7

8407/2023

Wheat Flour

2021

Drought

Resistance

Herbicide

Tolerant

TMG

IND-00412-7

7795/2021

Source: CTNBio, updated on June 21, 2023

c) STACKED OR PYRAMIDED EVENT APPROVALS/AUTHORIZATIONS

Stacked events follow the same approval process as single events, as they are treated as new events. In

early 2020, CTNBio published Normative Resolution 24, which changed the approval process for

stacked events. The resolution aimed to reduce the approval time of an event to 6-7 months, compared to

the previous average of 2-3 years. However, if one of the events in the stack does not have previous

approval by CTNBio, the requestor will have to present full agronomic data and a risk analysis, which

could take 2-3 years.

In June 2021, CTNBio revoked this norm by publishing the Normative Resolution 32

, which is

currently in force. For stacked events which have an event that is yet unapproved, the norm remains the

same previously explained in Normative Instruction 24. This Resolution establishes that for food and

feed, CTNBio no longer will need to evaluate combined events obtained from conventional breeding of

single events that were previously approved by CTNBio. Translation of the articles related to this

change is below:

Art. 13. For the exclusive purposes of human and animal consumption, the technical

opinions for the commercial release of risk class 1 transformation events and their

derivatives contemplate the food safety assessment of isolated and combined events.

Single paragraph. The isolated and combined events referred to in the caput may be used

commercially for food and feed alone, in mechanical mixtures and in products combined

with other transformation events.

Available in Portuguese at http://ctnbio.mctic.gov.br/resolucoes-normativas/-

/asset_publisher/OgW431Rs9dQ6/content/resolucao-normativa-n%C2%BA-32-de-15-de-junho-de-

2021?redirect=http%3A%2F%2Fctnbio.mctic.gov.br%2Fresolucoes-

normativas%3Fp_p_id%3D101_INSTANCE_OgW431Rs9dQ6%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_

mode%3Dview%26p_p_col_id%3Dcolumn-

2%26p_p_col_count%3D3%26_101_INSTANCE_OgW431Rs9dQ6_advancedSearch%3Dfalse%26_101_INSTANCE_Og

W431Rs9dQ6_keywords%3D%26_101_INSTANCE_OgW431Rs9dQ6_delta%3D15%26p_r_p_564233524_resetCur%3Dfa

lse%26_101_INSTANCE_OgW431Rs9dQ6_cur%3D1%26_101_INSTANCE_OgW431Rs9dQ6_andOperator%3Dtrue

Art. 14. For plant and animal production purposes, CTNBio, under consultation and based

in technical criteria, can dispense the analysis and issuance of a new technical opinion of

stacked products in which the transformation events that compose it have been previously

approved for commercial release by CTNBio (…).

d) FIELD TESTING

In accordance with article 14 of the Law 11105/2005, CTNBio is responsible for granting prior approval

for all field trials in Brazil. The technology provider must obtain a Certificate of Quality in Bio Safety

(CQBs) from CTNBio to perform field-testing. All providers must create an Internal Biosafety

Commission (CIBio) and indicate for each specific project a principal researcher, defined in CTNBio’s

regulations as the “Principal Technical Officer.” The provider’s CIBio is an essential component for

monitoring and testing the work of genetic engineering, manipulation, production, and transportation of

GE crops, as well as enforcing biosafety regulations.

e) INNOVATIVE BIOTECHNOLOGIES

There are no changes in the regulatory framework regarding innovative biotechnologies.

On January 15, 2018, CTNBio published Normative Resolution (NR) 16

, which established the

requirements to evaluate Precision Breeding Innovation (TIMP, in Portuguese) and encompasses

genome edited products. CTNBio regulates genome edited products on case-by-case basis and exempts

these products from regulation when there is no insertion of transgenes. Thus, in some cases, the full risk

assessment and management of “GMOs” must be applied, while in other cases products deriving from

innovative precision improvements may be exempt.

Specialists consider this a hybrid system, focusing mainly on the characteristics and safety of the final

product. It considers whether an introduced genetic material is absent, as well as the risk level

classification of the modified organism. When applicable, it also considers information on how the

manipulated genes or genetic elements function and whether the product has already been approved for

marketing in other countries.

According to NR 16, CTNBio can exempt new products from “GMO” regulatory assessment. However,

since Brazil’s previous provisions consisted of “GMO” regulation heavily triggered by the genetic

engineering procedures used, NR 16 contains an annex with a list of genetic engineering procedures that

may create a product not considered a “GMO”. The list includes the following techniques: 1. Precocious

Available in Portuguese at: http://ctnbio.mctic.gov.br/en/resolucoes-normativas/-

/asset_publisher/OgW431Rs9dQ6/content/resolucao-normativa-n%C2%BA-16-de-15-de-janeiro-de-

2018?redirect=http%3A%2F%2Fctnbio.mctic.gov.br%2Fen%2Fresolucoes-

normativas%3Fp_p_id%3D101_INSTANCE_OgW431Rs9dQ6%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%2

6p_p_mode%3Dview%26p_p_col_id%3Dcolumn-

2%26p_p_col_count%3D3%26_101_INSTANCE_OgW431Rs9dQ6_advancedSearch%3Dfalse%26_101_INSTANCE

_OgW431Rs9dQ6_keywords%3D%26_101_INSTANCE_OgW431Rs9dQ6_delta%3D15%26p_r_p_564233524_rese

tCur%3Dfalse%26_101_INSTANCE_OgW431Rs9dQ6_cur%3D2%26_101_INSTANCE_OgW431Rs9dQ6_andOperat

or%3Dtrue

flowering; 2. Seed producing technology; 3. Reverse breeding; 4. RNA-dependent DNA methylation;

5.Site-Directed Mutagenesis; 6. Oligonucleotide Directed Mutagenesis; 7. Agroinfiltration/

agroinfection; 8. Topical/systemic use RNAi; and, 9. Viral Vector. It includes the caveat that the

resolution is not limited to these examples and may ultimately apply to other forthcoming technologies.

Please see an informal translation of NR 16 in the appendix of this report.

Brazil approved its first agricultural product resulting from CRISPR technology in 2018: an edible corn

that contains a higher concentration of amylopectin. The grain has two types of starch: amylose (25

percent) and amylopectin (75 percent). The Brazilian agricultural research service (EMBRAPA) is

developing projects using CRISPR technology in four crops: soybeans, corn, edible beans, and

sugarcane.

On September 1

, 2022, in a CTNBio meeting, the Commission considered that the editing of the

soybean genome, conducted by Embrapa with the CRISPR technique to deactivate some anti-nutritional

factors, results in conventional (non-transgenic or not-“genetically modified”) soybeans, allowing it to

be exempt from biotechnology regulations. More details about this case can be found in this EMBRAPA

article

, available in English. FAS Brasilia has no further information about developments for the other

crops.

According to CTNBio Annual Report 2021

, during the entire year of 2021, the National Technical

Biosafety Commission (CTNBio) received 13 consultation letters (versus ten in 2020) under the terms of

article two of the referred regulation regarding several products (not listed by CTNBio).

f) COEXISTENCE

There are no new developments in this area.

Law 11105 of March 2005 established the legal framework under which GE crops can be produced and

marketed in Brazil. Conventional, or non-GE, crops are produced throughout the country, with

agricultural zoning and environmental limitations mostly applicable in the Amazon biome.

Law 9456 of April 25, 1997

, called the Plant Variety Protection Law, established the legal framework

for registration of both GE and non-GE seeds, but the law does not favor one over the other. Decree

https://www.embrapa.br/en/busca-de-noticias/-/noticia/73468020/gene-edited-to-reduce-anti-nutritional-factors-soybeans-

get-green-light

Available in Portuguese at;

http://ctnbio.mctic.gov.br/en/c/document_library/find_file_entry?p_l_id=583965&noSuchEntryRedirect=http%3A%2F%2Fc

tnbio.mctic.gov.br%2Fen%2Frelatorios-anuais%2F-

%2Fasset_publisher%2FDeibhjOs37Q0%2Fdocument%2Fid%2F2306922%3Fredirect%3Dhttp%253A%252F%252Fctnbio.

mctic.gov.br%252Fen%252Frelatorios-

anuais%253Fp_p_id%253D101_INSTANCE_DeibhjOs37Q0%2526p_p_lifecycle%253D0%2526p_p_state%253Dnormal%

2526p_p_mode%253Dview%2526p_p_col_id%253Dcolumn-

2%2526p_p_col_count%253D1&fileEntryId=2306920&redirect=http%3A%2F%2Fctnbio.mctic.gov.br%2Fen%2Frelatorios

anuais%3Fp_p_id%3D101_INSTANCE_DeibhjOs37Q0%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%

3Dview%26p_p_col_id%3Dcolumn-2%26p_p_col_count%3D1

Available in Portuguese at: http://www.planalto.gov.br/ccivil_03/leis/l9456.htm

2366 of November 5, 1997

, established the National Plant Varieties Protection Service under the

Ministry of Agriculture, Livestock, and Food Supply (MAPA) and regulates the registration of GE and

non-GE seeds. Normative Resolution 04/07

, issued by CTNBio, established rules specifically for GE

corn, regarding the coexistence of GE and non-GE crops in Brazil.

g) LABELING AND TRACEABILITY

On April 29, 2015, Brazil’s House of Representatives approved Draft Bill 4148/2008 to amend the

current GE-labeling legislation (Decree 4680/2003). The new bill establishes that only products that

have more than one percent GE material in their final composition must be labeled. Another important

change is the decision to withdraw the requirement for a GE label of a “T” symbol in black in a yellow

triangle. The bill is still under consideration in the Brazilian Senate and the last movements on it were in

2015. Decree 4680/2003

remains in force, per the information below.

On April 24, 2003, the President of Brazil published in Brazil’s Federal Register (“Diário Oficial”)

Decree 4680/03, establishing a tolerance limit of one percent for food and food ingredients destined for

human or animal consumption containing or being produced with biotech events. The Decree declared

that consumers need to be informed of the biotech nature of the product. It applies to bulk shipments,

raw material, packaged food, feed, or other products derived from and/or containing ingredients from

GE plants.

On December 26, 2003, the Ministry of Justice published Ordinance 2658/03

, approving the

regulations for the use of the transgenic “T” logo, see below.

Available in Portuguese at: http://www.planalto.gov.br/ccivil_03/decreto/1997/d2366.htm

Available in English at: http://ctnbio.mctic.gov.br/en/resolucoes-normativas/-

/asset_publisher/OgW431Rs9dQ6/content/resolucao-normativa-n%C2%BA-4-de-16-de-agosto-de-

2007?redirect=http%3A%2F%2Fctnbio.mctic.gov.br%2Fen%2Fresolucoes-

normativas%3Fp_p_id%3D101_INSTANCE_OgW431Rs9dQ6%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_

mode%3Dview%26p_p_col_id%3Dcolumn-

2%26p_p_col_count%3D3%26_101_INSTANCE_OgW431Rs9dQ6_advancedSearch%3Dfalse%26_101_INSTANCE_Og

W431Rs9dQ6_keywords%3D%26_101_INSTANCE_OgW431Rs9dQ6_delta%3D15%26p_r_p_564233524_resetCur%3Dfa

lse%26_101_INSTANCE_OgW431Rs9dQ6_cur%3D3%26_101_INSTANCE_OgW431Rs9dQ6_andOperator%3Dtrue

Available in Portuguese at: http://www.planalto.gov.br/ccivil_03/decreto/2003/d4680.htm

Available in Portuguese at: https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-

pecuarios/alimentacao-animal/arquivos-alimentacao-animal/legislacao/portaria-no-2-658-de-22-de-dezembro-de-

2003.pdf/view

Source: Reproduction, Senate

It applies to biotech products for either human or animal consumption, with content above one percent,

and does not differentiate between products containing DNA and those that do not. The requirement

became effective on February 27, 2004. On April 2, 2004, the Civil Cabinet of the Presidency published

Interministerial Normative Instruction 1

, signed by four cabinet ministers (Civil Cabinet, Justice,

Agriculture, and Health), establishing the conditions by which Ordinance 2658/03 enforced the labeling

of products containing biotech events above the one percent limit. In addition to the Brazilian Health

Regulatory Agency (ANVISA), MAPA, Ministry of Justice, Normative Instruction 1 also authorized

state and municipal consumer defense officials to enforce the labeling requirements.

h) MONITORING AND TESTING

Monitoring and testing in Brazil relate to risk assessment. CTNBio’s obligations are, among others, to

conduct case-by-case risk assessments of activities and projects concerning GE crop events and their by-

products, to authorize GE crop research activities. Its obligations are also to identify activities and

products resulting from the use of GE crops and their by-products that could potentially cause

environmental degradation or endanger human health. CTNBio issues final decisions about cases in

which the activity is a potential or effective cause for environmental degradation, as well as about the

need for environmental permits. CTNBio’s decision binds other Brazilian government agencies to the

biosafety aspects of GE crops and their by-products.

The Ministry of Agriculture, Livestock, and Food Supply (MAPA) conducts monitoring of GE crop

events. According to the legislation in force, MAPA oversees inspection of these events intended for

agriculture, animal use, and related fields in the agricultural industry. The Ministry of Health, through

the National Surveillance Agency (ANVISA), also inspects the events for toxicology, while the Ministry

Available in Portuguese at: https://www.gov.br/agricultura/pt-br/assuntos/insumos-agropecuarios/insumos-

pecuarios/alimentacao-animal/arquivos-alimentacao-animal/legislacao/instrucao-normativa-interministerial-no-1-de-1o-de-

abril-de-2004.pdf

of the Environment – through the Brazilian Institute of Environment and Renewable Natural Resources

(IBAMA) – monitors and inspects the events and their impact on the environment.

i) LOW LEVEL PRESENCE (LLP) POLICY

Brazil has a zero-tolerance policy for imports of unapproved GE events.

j) ADDITIONAL REGULATORY REQUIREMENTS

An event approved by CTNBio requires no further review.

k) INTELLECTUAL PROPERTY RIGHTS (IPR)

Brazil’s current biosafety law, which provides a clear regulatory framework for the research and

marketing of new GE crops in the country, has encouraged Brazil’s federal government to embrace and

protect new technologies that benefit agriculture. In Brazil, intellectual property rights for biotechnology

are covered under the Industrial Property Law, Law 9279

, from 1996, which safeguards the rights to

collect royalties on the use of seeds which contain valid intellectual property. Multinational companies

such as Bayer, Syngenta, Corteva, and BASF have licensing agreements with EMBRAPA to develop

GE crops – mostly soybeans, corn, and cotton. In general, at the beginning of the new crop year,

technology providers negotiate payment agreements for the collection of royalties with individual

Brazilian states and farmer associations. Bayer also pursues an export-licensing scheme to collect

royalties on shipments of soybeans and soybean products at ports of destination in countries where

Bayer has a patent on the Roundup Ready soybean technology.

In 2021, BASF, Bayer, Corteva, and Syngenta created the project “Cultive Biotec” (Cultivate Biotech),

an initiative to promote a collective management model for the recognition of intellectual property, open

to any companies that provide biotechnology products protected by intellectual property rights, and

which have the intention of commercializing their products in the Brazilian market. The goal is to

develop a collective industry solution, and with that, create a structured environment for the recognition

of intellectual property rights, which will allow new soybeans biotechnologies to enter the Brazilian

market. The model envisions that at the points of delivery for the grains, there will be testing done and

the producers will be able to pay the royalties (if they haven’t already done so) at the point of delivery.

All royalties will be paid for within this system, which reduces the bureaucracy for the producers who

plant different technologies. Producers now will no longer need to go into different systems to pay for

the royalties, segregate production at the farms, at the silos, or deliver different technologies at different

locations. This system will allow for companies to benefit from their royalties being properly paid,

regardless of whether the seeds had been purchased that year or saved from the previous crop, assuring

the maintenance of investment in innovation and new technologies entering the market. As this system

will be used by major big biotech companies, the Brazilian anti-trust body, Cade, had to evaluate the

request in order to make sure this was in the best interest of the population. Cultive Biotec received

Available in Portuguese at: https://www.planalto.gov.br/ccivil_03/leis/l9279.htm

Cade’s approval on August 5, 2021. More information on this project, can be found at their website

available in Portuguese.

Update on Bayer court cases in Brazil:

In July 2019, Bayer (formerly Monsanto) was required to deposit, in escrow, the full amount of royalties

paid by soybean producers for Intacta RR2 PRO seeds (patent PI0016460-7) as the result of a lawsuit

filed by the Brazilian Association of Soybean Producers (APROSOJA). The lawsuit seeks to annul

Bayer’s patent for not meeting the requirements of Brazil’s intellectual property laws. A hearing on this

case was scheduled for the end of August 2019, but it was postponed.

On October 9, 2019, Bayer won an important decision in Brazil’s Superior Court of Justice (STJ). The

court found that the company could charge royalties to rural producers who plant its GE soybeans. This

lawsuit against Bayer specifically deals with the company’s Roundup Ready soybean and was filed

collectively by unions of rural producers in the state of Rio Grande do Sul who were seeking protection

to use harvested GE seeds for replanting and for selling soybeans as food or raw material without having

to pay extra royalties. The plaintiffs argued that the issue should be analyzed from the perspective of

Brazil’s “Cultivars Law” rather than the country’s intellectual property regulations.

According to the STJ ruling, Industrial Property Law 9279 of 1996 prohibits the patenting of parts of

living beings found in nature. However, there is an exception for “GMOs" that meet requirements such

as novelty and industrial application. According to the ruling, farmers are not obligated to buy GE

soybean seeds, but they must bear the royalty costs if they choose to plant a specific variety. The STJ’s

precedent is important because it might have a bearing on the APROSOJA case.

In August 2022, a Mato Grosso judge issued an injunction that Bayer needs to deposit in escrow a third

of the total amount it has received in royalties since 2018 for the technology RR2 PRO. The total

amount is reaching R$ 2.5 billion (about 470 million dollars). According to Aprosoja, R$ 1.3 billion is

owed due to the patent that expired in 2018. However, there is a second patent, expired in December

2020, which – per the Association – would be valued at R$ 1.2 billion. In total, there are three patents

that include the Intacta technology.

l) CARTAGENA PROTOCOL RATIFICATION

On August 12, 2020, Brazil´s Official Gazette published Legislative Decree 136

, which ratifies

Brazil´s participation in the Nagoya Protocol (an accessory to the Convention on Biological Diversity).

The treaty establishes rules for the division between countries of monetary and non-monetary benefits,

resulting from genetic research with biodiversity (such as plants and animals) and the use of traditional

knowledge from indigenous and local communities.

In November 2003, Brazil ratified the United Nations’ Cartagena Protocol on Biosafety (under the UN

Convention on Biological Diversity). Brazil sends delegations to the COP-MOP meetings and serves at

the Cartagena Protocol on Biosafety Ad-Hoc Technical Expert Groups (CBD AHTEGs).

https://www.cultivebiotec.com.br/

Available in Portuguese at: https://www2.camara.leg.br/legin/fed/decleg/2020/decretolegislativo-136-11-agosto-2020-

790527-norma-pl.html

m) INTERNATIONAL TREATIES AND FORUMS

During a meeting of the U.S.-Brazil High Level Working Group in April 2021, Brazil reiterated that the

country promotes science-based standards and definitions in international fora with an aim to remove

unscientific sanitary and technical barriers to trade. In 2022 and 2023, the working group has not held

any meetings.

Brazil is a member of the International Plant Protection Convention (IPPC), where it is represented by

the MAPA Head of the Plant Health and Agricultural Inputs Department. Brazil is also an active

member of the Codex Alimentarius, which it joined in 1968, and is represented by the Ministry of

External Relations (MRE) at the body. Locally, the GoB has created a coordination body, called “Brazil

Codex Alimentarius Coordination,” headed by the National Institute of Metrology Standardization and

Industrial Quality (Inmetro), and is composed of several government stakeholders, such as MRE,

MAPA, the Ministry of Economy, ANVISA, Ministry of Science, Technology, and Innovations,

Ministry of Justice, and sector specific confederations such as the industry, the agriculture, and the

commerce federations.

Brazil’s positions in these international fora are similar to those of the United States. FAS Brasilia does

not have access to Brazil’s statements or positions discussed at these international fora and is not aware

of any Brazilian positions that have affected U.S. agricultural exports to Brazil.

In October 2023, during an official trip to Argentina, the Minister of Science, Technology and

Innovation, Luciana Santos, signed a Memorandum of Understanding between Brazil, Argentina,

Paraguay and Uruguay, creating the International Network for the Biosafety of Products Derived from

Modern Biotechnology, ABRE-Bio. The joint action initiative establishes procedures to reduce cost and

time, including GE risk assessment. Moreover, it requires the determination of the regulatory status of

products derived from New Breeding Technologies (NBTs) and other products of modern

biotechnology. In addition to the MCTI, the network has the participation of Argentina's Ministry of

Economy and the Ministries of Agriculture and Livestock of Paraguay and Uruguay.

This scientific-technological cooperation is a pioneering action in the risk assessment of modern

biotechnology products, defining a model that can be mirrored in other markets while also benefiting

small entrepreneurs.

A Memorandum of Understanding was also signed between Finep, MINCyT and the Argentine agency

R+D+i to finance research and development projects of common interest. The MoU also aims to

exchange best practices and promote joint activities to improve collaboration between organizations in

both countries in RD&I.

n) RELATED ISSUES

Brazil continues to collaborate with the United States to conduct joint outreach in third countries.

Global food security and the role of biotechnology therein is a driving force behind enhanced

collaboration. Asynchronous approvals are a relevant issue for biotech companies in Brazil. Although

China has moved ahead with the approval of several new traits of interest to Brazilian soybean

exporters, the European Union (EU) has not. MAPA has been more vocal and engaged with the EU to

speed up the approval process.

PART C: MARKETING

a) PUBLIC/PRIVATE OPINIONS

Public perception regarding GE plants in the country varies by audience. As the second-largest adopter

of biotechnology in the world, Brazilian farmers’ and ranchers’ acceptance of these techniques is very

well established throughout the entire country. In 1998, when the first plant approval took place in

Brazil – for soybeans – there was a movement against “transgenic” plants. The resistance was stronger

from the consumers, which were boosted by campaigns against “genetically modified organisms”.

As time passed, acceptance increased, although some concern remains on the consumer side. For

instance, a poll conducted in the second quarter of 2016 regarding public perceptions of GE products

concluded that 80 percent of Brazilians are concerned with the word “transgenic,” and that 33 percent

of Brazilians think that consuming these products can do harm. According to Brazilian analysts, the bad

image of “transgenic” products is related to the high use of pesticides in Brazil. The poll also showed

that most Brazilians do not know which GE plants are grown in Brazil. FAS Brasilia was unable to find

newer research covering biotechnologies acceptance broadly for 2022.

In 2021, Brazil approved the GE drought-resistant wheat in Brazil. In May 2022, the Brazilian

Association of Biscuits, Pasta, and Industrialized Breads and Cakes (Abimapi, in its Portuguese

acronym) published the results of a December 2021 research conducted to analyze acceptance (or not) to

this new variety of wheat amongst consumers. The research showed that 72 percent of the 3135

consumers interviewed said they did not have any major concerns about eating food products produced

from the GE wheat. This result was paradigmatic, as it was believed that consumers would not accept it.

This result made Abimapi, which originally opposed the approval, to accept it, as the consumers polled

in 12 state capitals have demonstrated to be in favor of the product.

From those polled by the research, 1790 people said they know what a transgenic food is and from

those, 75.5 percent said they are aware they consume “genetically modified” food (as almost the entirety

of soybeans and corn in Brazil is genetically engineered). A small percentage of people said they were

unaware they consume genetically engineered food, but once informed, the majority said they would not

have a problem with it. From the 1345 consumers who answered they did not know what a transgenic

food is, 71.4 percent of them said they would consume it after receiving information. Specifically related

to the genetically engineered wheat flour, 71.8 percent of the overall polled consumers said they would

not have any restrictions to it being added to food products such as bread, biscuits, pasta, and cakes.

In the past, there were cases of biotechnology industries and research institutions being invaded by

opposers in Brazil, such as the 2015 case in which the Landless Movement invaded a research institute

and destroyed GE-eucalyptus research plants. This same group also invaded a Bayer site in Jacareí – SP

on June 10, 2022 to protest against agrochemicals – but was not able to enter the compound, and only

vandalized the exterior of the site. The Brazilian Consumer Defense Institute (IDEC, in its Portuguese

acronym) still campaigns against genetically engineered foods, such as in the “No to Transgenic wheat

on our bread”, which included a petition for signature.

The results of the Abimapi research, however, may indicate that overall consumers perception of

genetically engineered plants may be evolving and shifting to a more favorable perspective to

biotechnologies.

b) MARKET ACCEPTANCE/STUDIES

There are no new developments in this area.

Acceptance of GE crops in Brazil is widespread among producers. Farmers and ranchers are in favor of

biotechnology and understand the benefits associated with the adoption on these new agricultural

techniques, such as increased yields, reduced use of crop protection products, and reduced losses due to

diseases. In Brazil, 67 percent of GE crop area is used for soybeans, 31 percent is used for corn, 2

percent is used for cotton, and less than one percent of crop area is used for both sugarcane and beans.

That number represents 31 percent of the total area of GE crops harvested in the world, according to

CropLife Brazil.

The following organizations offer articles/data regarding Brazil-specific studies on the marketing of GE

plants and plant products. Nearly all studies are in Portuguese, however, Embrapa has material also

available in English:

Brazilian Food Industry Association (ABIA)

Brazilian Agricultural Research Corporation (EMBRAPA)

Error! Hyperlink reference not valid.

CropLife Brasil (CLB)

Biotec-LATAM

Error! Hyperlink reference not valid.

https://www.abia.org.br/

https://www.embrapa.br/en/international

https://croplifebrasil.org/

https://biotec-latam.com/en/

CHAPTER 2: ANIMAL BIOTECHNOLOGY

PART D: PRODUCTION AND TRADE

a) RESEARCH AND PRODUCT DEVELOPMENT

EMBRAPA has successfully bred GE dairy cattle and has research on recombinant proteins. Two calves

born in 2013 are part of this research. Other project focused on the use of GE technology to improve the

health of beef cattle and increase cattle weight. Additionally, two GE goats produced in the state of

Ceará have high levels of a human antimicrobial proteins proven effective in treating diarrhea in young

pigs. The research demonstrated the potential for food products from GE animals to benefit human

health. This project was carried out in cooperation with the University of California at Davis.

Brazil has a well-developed research system for cloned animals under the national coordination of

EMBRAPA. EMBRAPA Genetic Resources and Biotechnology unit is responsible for animal

reproduction, one of the areas most advanced in EMBRAPA in biotechnology. They have developed

several techniques and introduced them in the productive sector, such as in vitro fertilization (IVF),

transfer, and embryo sexing, amongst others. One of the key areas the unit devotes attention to is cloning

by nuclear transfer. Cloning research started in the late 1990s in Brazil, mostly focused on cattle. In

March 2001, Brazil was successful in cloning a Simmental heifer, named "Vitória" (Victory). The

second clone was born in 2003 from cells of a deceased Holstein cow and was named "Lenda da

EMBRAPA" (EMBRAPA’s legend). The third clone, Porã, was born in April 2005 from the native cow

breed “Junqueira” that is on an endangered species list. The fourth clone, called Piatã, was born in

August 2010, is an offspring of Porã, and also from the Junqueira cow breed. All these clones had

offspring, which demonstrates the good reproductive potential and motherly abilities of the animals used

in the process. In 2016, the biotechnology animal reproduction team of the EMBRAPA unit developed a

technology called Intrafollicular Transfer of Immature Oocytes (TIFOI, in its Portuguese acronym). This

is a biotechnique that resembles IVF but has the additional benefit that it does not need to be performed

at a laboratory, so farmers and ranchers can receive the embryos with the same agility as IVF at the

comfort of their farms.

EMBRAPA Genetic Resources and Biotechnology unit also works on genetic resources conservation of

domestic animals such as cattle, swine, goats, horses, donkeys, and sheep. The conservation is targeted

to preserve native species found in Brazil at the time of colonization, to avoid the extinction of species.

EMBRAPA started the conservation program in 1983 and has been building the program since. More

recently, the unit began conserving wild vertebrate species from Brazil.

b) COMMERCIAL PRODUCTION

In regard to genome edited cattle, CTNBio has evaluated three cases to date (2022) for commercial

production. The first case was the 2018 polled bull, from the semen of a Holstein crossbred bull

generated by TALENs technology. This hornless dairy cattle from genome-edited cell lines was

developed by the company Acceligen in partnership with University of California-Davis. This

consultation was later retrieved by the company, as the U.S. Federal Drug Administration detected the

presence of plasmid backbone in the bull`s genome. The second case was in 2021 for a double muscle

(muscle hypertrophy) bull generated by TALENs technology from a Nelore breed bull semen. The third

case was also in 2021, for an Angus breed bull and cow generated by CRISPR/Cas9 technology. The

trait for these two cattle was thermotolerance (slick hair). These three cattle cases were evaluated by

CTNBio and were not considered a “genetically modified organism”.

In June 2021, the Massachusetts-based company AquaBounty Technologies received CTNBio’s

approval for the commercial release of its GE Atlantic salmon in Brazil. ISAAA notes that CTNBio

assessed AquaBounty's application to ensure that it met the relevant standards and regulatory

requirements and concluded that the sale and consumption of AquaBounty's GE salmon is safe for the

environment and human health. CTNBio's approval followed approvals by the U.S. Food and Drug

Administration and Health Canada, making AquaBounty the first and only company in the world to have

its GE Atlantic salmon approved in these three major markets.

Brazil has 58 GE vaccines released by CTNBio for commercial use, 5 microorganisms, and four GE

animals.

c) EXPORTS

None for commercial use.

d) IMPORTS

None for commercial use.

e) TRADE BARRIERS

FAS Brasilia is not aware of any restrictions on imports from the United States of live animals,

reproductive material, or livestock products. Brazil is a significant importer of U.S. animal genetics,

mostly cattle semen.

PART E: POLICY

a) REGULATORY FRAMEWORK

GE animals and GE vaccines are governed by the same legislation as GE plants are subject to the

approval of CTNBio. See Regulatory Framework, under Chapter 1, Part B (Policy) in this report.

Animal cloning and their products, although approved and permitted by the same legal framework

referred above, do not have a specific regulatory framework approved in Brazil either at federal or state

levels.

Since there is no regulation in place for cloned animals and their products, MAPA cannot authorize any

imports to Brazil of cloned animals or their derived products, such as meat or dairy.

A Draft Bill (PLS 73, dated March 7, 2007), which passed the Senate on February 20, 2013, and was

sent to the Chamber of Deputies with a new identification (PL 5010/13), hasn’t yet been fully approved

by the Brazilian Congress. Bill 5010/13 proposes to regulate the cloning of animals, including wild

animals and their offspring. It also proposes to make MAPA responsible for the registration of all

institutions, both private and public, that conduct research on cloned animals, including the authorization

for commercial sales and imports of cloned animals for genetic or food purposes. The approval on

December 7, 2022, of a version of the bill at the Commission of Agriculture, Livestock, Food Supply,

and Rural Development is the last movement of the analysis process.

For a table of legal terms relevant to animal biotechnology in Brazil, see see Chapter 1, Part B,

Sub-paragraph A.

b) APPROVALS/AUTHORIZATIONS

GENETICALLY ENGINEERED ANIMALS APPROVED COMMERCIALLY IN BRAZIL

Product

Animal

Company

Document/Year

Atlantic Salmon

(Salmo salar),

transgenic for growth

hormone

Fish

Aquabounty

7450/2021

Moth Spodoptera

frugiperda, lineage

OX5382G

Fall Armyworm

moth

Oxitec

7350/2021

Aedes aegypti,

second generation

lineage of OX5034

Mosquito

Oxitec

6946/2020

Aedes aegypti,

lineage OX513A

Mosquito

Oxitec

3964/2014

Source: CTNBio, updated on May 16, 2023.

LIVE VACCINES AND DERIVED PRODUCTS FROM GENETICALLY ENGINEERED

ORGANISMS APPROVED COMMERCIALLY IN BRAZIL FOR HUMAN/ANIMAL

CLINICAL USE

Product

Characteristics

Company

Document/Year

PUREVAX RCPCh

FeLv

Multiple vaccine against

feline viral rhinotracheitis,

calicivirus, chlamydiosis,

panleukopenia and feline

leukemia

Boehringer

Animal Health do

Brasil Ltda.

8431/2023

Yescarta

It is a gene therapy of

genetically modified

autologous T cells directed

to the recognition of the

glycoprotein antigen CD19 -

marker for neoplastic cells.

Treatment of

oncological

disease - Relapsed

or refractory Large

B-Cell Lymphoma

and Relapsed or

refractory

Follicular

8242/2022

Lymphoma.

Roctavian

It is a gene therapy vector,

incompetent for replication,

being an inactive version of

a non-pathogenic wild type

of adenoassociated

virus/serotype 5 (AAV5) that

has been modified to contain

the factor VIII gene.

Indication:

Treatment of

severe hemophilia

A (congenital

factor VII

deficiency).

8241/2022

Oncept

Canine melanoma DNA

vaccine

Boehringer

Animal Health do

Brasil Ltda.

8182/22

Vaxxitek HVT + IBD

+ ILT

Recombinant, frozen live

virus vaccine against Marek

and Gumboro diseases

Boehringer

Ingelheim Animal

Health do Brasil

Ltda.

7912/22

Ciltacabtagene

autoleucel

Commercial Release of

ciltacabtagene autoleucel

(cilta-cel, JNJ-68284528),

indicated for treatment of

multiple myeloma

Janssen-Cilag

Farmacêutica Ltda

7779/2021

Poulvac Procerta

Poulvac Procerta HVT-IBD

– Frozen live vector vaccine

against Gumboro and Marek

Diseases

Novartis

Biociências S.A.

7666/2021

Kymriah

KYMRIAH, tisagenlecleucel

(CTL019) treatment for

Refractory acute B-cell

lymphoblastic leukemia and

in post-transplant relapse, in

second relapse or in later

relapse

Novartis

Biociências S.A.

7502/2021

Covid-19 Vaccine

Commercialization of the

GAM-COV-VAC

(SPUTNIK V) Vaccine,

against SARS-CoV-2,

developed by the Gamaleya

Institute (Russia)

União Química

Farmacêutica

Nacional S.A

7440/2021

Covid-19 Vaccine

Commercialization of the

Covid-19 vaccine

(Ad26.COV2.S1 –

recombinant and

incompetent replicant),

indicated for the active

immunization in prevention

Janssen-Cilag

Farmacêutica Ltda

7400/2021

of the disease caused by

severe acute respiratory

syndrome Ccoronavirus type

2 (SARSCoV-2)

Covid-19 Vaccine

Commercialization of the

recombinant Covid-19

vaccine based on

microorganism of Risk Class

1 (ChAdOx1+nCoV19)

Instituto de

Tecnologia em

Imunobiológicos-

Bio Manguinhos

(FIOCRUZ)

7292/2021

FVAX-20SA01

Vaccine

Specific Vaccine against

Strepstococcus for captive-

bred tilapia

Tevah Consultoria

Empresarial,

Regulatória,

Governamental e

Engenharia Ltda.

7480/2021

CIRCOGARD

Recombinant Vaccine

Vaccine against Swine

Circovirus Type 2 (PCV2)

Eco Animal

Health do Brasil,

Comércio de

Produtos

Veterinários Ltda

7449/2021

G608 Vaccine

Vaccine against Edema

Disease in piglets,

inactivated

Ceva Saúde

Animal

7340/2021

Poulvac Procerta HV-

Poulvac Procerta HV-ND

Vaccine – Vectorized live

frozen vaccine against

Marek and Newcastle

diseases

Zoetis Indústria de

Produtos

Veterinários Ltda

7249/2020

CIRCO/MYCOGARD

Recombinant Vaccine

against Swine Circovirus and

Mycoplasma

hyopneumoniae

Eco Animal

Health do Brasil,

Comércio de

Produtos

Veterinários Ltda

7239/2020

Lamzede

LAMZEDE, commercial

name of active component

alfavelmannase, which is a

human recombinant alpha-

mannosidase, indicated for

treatment of adult and

pediatric patients who suffer

from lysosomal alpha-

mannosidade enzyme

deficiency

Chiesi

Farmacêutica Ltda

7201/2020

Avian Recombinant

Vaccine Code

1A89.R0

Avian Vaccine for the

Prevention against Marek

Disease, Newcastle Disease

Ceva Saúde

Animal LTDA

7055/2020

and Gumboro Diseas

Zolgensna

Commercialization of Live

Recombinant Vaccine for

pediatric patients with Spinal

Muscular Atrophy (SMA)

Novartis

Biociência S.A.

6495/2020

(INNOVAX ND –

ILT)

Commercialization of a

Recombinant Live Vaccine

against Marek Disease,

Newcastle Disease, Infectiou

Laryngotracheitis, derived

from a GMO (INNOVAX

ND-ILT)

Merck Sharp &

Dohme Saúde

Animal Ltda

6923/2020

MHYOSPHERE PCV

Commercialization of an

innactivated vaccine. The

active substance

MHYOSPHERE PCV ID is

a inactivated recombinant

strain of Mycoplasma

hyopneumoniae

Hipra Saúde

6910/2020

LUXTURNA

(voretigene

neparvovec)

Genetic Therapy

LUXTURNA (voretigene

neparvovec) which is

indicated for the treatment of

adult and pediatric patients

with eyesight loss due to

hereditary retinal dystrophy

caused by bialletic RPE65

gene mutations

Novartis

Biociências S.A.

6849/2020

Fostera Gold PCV MH

Innactivated Vaccne Against

Pork and Mycoplasma

hyopneumoniae

Zoetis Industria de

Produtos

Veterinários

6221/2018

Avipro Megan VAC 1

Live Vaccine against

Salmonella in Broiler

chicken

Elanco Saúde

Animal

6220/2018

PREVEXXION RN

Vaccine for Marek Diseas in

Birds

Merial Saúde

Animal Ltda

6162/2018

Avian Recombinant

Vaccine Code

1062.R0

Against Marek Disease and

Avian Influenza

Ceva

5997/2018

Recombinant Vaccine

Against Pork

Circovirus type 2

Marek Disease and Avian

Influenza

Ourofino Saúde

Animal Ltda

6056/2018

TROVAC-NDV

Live Recombinant Virus

Vaccine for Newcastle

Disease and Avian Yaws

Merial Saúde

Animal LTDA

6055/2018

Ingelvac Provenza

Swine Influenza Live

Modified Virus Vaccine

Boehringer

6062/2018

Newxxitek HVT+ND

Live Vaccine for Marek

Disease, Newscastle Disease

– Marek Diases as vector,

Serotype 3

Merial

5861/2018

INNOVAX ND-IBD

Live Recombinant Vaccine

for Marek Disease,

Newscastle Disease and

Gumboro Disease

Merial

5836/18

Purevax Felv

Feline Leukemia Live

Vaccine

Merial

5935/2018

PROTEQFLU

Equine Influenza Vaccine

Merial

5486/2017

PUREVAX

RAIVA Vaccine

Feline Raibes Vaccine

Merial

5407/2017

Biotech Vac

Salmonella Vaccine

Avian Salmonellosis

Vaccine

Vetanco do Brasil

Importação e

Exportação Ltda

5331/2017

OncoVEXGM-CSF

Melanomas Treatment

Lab. Bergamo

5099/2016

HIPRABOVIS IBR

MARKER LIVE

Bovine Herpes Vaccine

Hipra

5005/2016

Bay98

Immunostimulant

Bayer

4915/2016

Dengvaxia

Dengue Vaccine

Sanofi Aventis

4759/2015

Dengue Vaccine

1,2,3,4

Dengue Vaccine

Inst. Butantan

4673/2015

Bovela

Bovine Diarrhea

Boehringer

4594/2015

B058

Swine Circovirus

Ourofino

4202/2014

PRO-VAC

Circomaster

Swine Circovirus

Vencofarma

4090/2014

Vectormune HVT-LT

Avian Laryngotracheitis

Marek Disease, Serotype 3

Ceva

4304/2014

ProteqFlu

Equine Influenza

Merial

3637/2013

ProteqFlu TE

Equine Influenza and tetanus

Merial

3636/2013

InnovaxND

Birds/Marek and Newcastle

Intervet

3265/2012

INNOVAX ILT

Birds/Marek and

Laryngotracheitis

Intervet

2872/2011

Vectormune FP-LT-

Avian yaws, avian

laryngotracheitis and Avian

encephalomyelitis

Ceva

2958/2011

Vectormune FP-LT

Avian yaws and avian

laryngotracheitis

Ceva

2957/2011

PouvacSt

Birds/Salmonellosis

Fort Dodge

2741/2010

Vectormune HVT-

NDV

Birds/Marek-Newcastle

Ceva

2279/2010

Vectormune HVT-IBD

Birds/Marek-Gumboro

Ceva

2280/2010

Vectormune FP-

MG+AE

Birds/Roup-

Encephalomyelitis

Ceva

2226/2009

Vectormune FP-MG

Birds/Roup-Mycoplasma

Ceva

2214/2009

Poulvac

Birds/E. coli

Fort Dodge

2146/2009

P. Circumvent

Swine/Circovirus

Intervet

1591/2008

Ingelvac

Swine/Circovirus

Boehringer

1427/2008

Suvaxyn PCV2

Swine/Circovirus

Fort Dodge

1300/2008

Vaxxitek MD/IBD

Birds/Marek-Gumboro

Merial

Com 99/04

Recombivax

Haemophilus type B and

Hepatitis B conjugate

vaccine (COMVAX)

Merck Sharp

Dhome

Farmacêutica

Ltda.

Com 99/00

Recombitek

Dogs/Viruses

Merial

Com 38/98

Source: CTNBio, updated on May 16, 2023

c) INNOVATIVE BIOTECHNOLOGIES

Animal biotechnology has been vigorously evolving in Brazil. The 1980s were marked by pro-nuclear

microinjections of embryos to produce transgenic animals, which efficiency was very low. Nuclear

transfer cloning dominated the 1990s, with the birth of Dolly the sheep in Scotland, and in Brazil with

the birth of Vitória, an EMBRAPA-produced cow. In the 2000s, other techniques were incorporated into

the scientific toolkit. Since 2010, the CRISPR technology has come to dominate the area of animal

reproduction biotechnology in Brazil.

The focus of Brazilian research today is the prevention and curing of animal diseases, which are the

major problem of producers. For instance, ticks cause damage to Brazilian livestock, costing producers

more than R$9 billion a year, according to EMBRAPA. But there are other problems, such as the horn

fly. The CRISPR technology can be a tool in the search for solutions to these production irritants, either

through the production of medicines in animal milk or to cure diseases that afflict the

herds. EMBRAPA’s Genetic Resources and Biotechnology Center is in the process of mastering and

establishing the methodology to edit of bovine genomes.

On October 4, 2018, CTNBio determined that the genome-edited hornless cow produced by the

U.S. company Recombinetics, to be a conventional animal. Brazil made this determination based on

Normative Resolution 16. The Ministry of Agriculture, Livestock, and Food Supply (MAPA) has not

issued any notification or regulation about this decision by CTNBio. After the U.S. Food and Drug

Administration found a fragment of bacterial DNA used to deliver the hornless trait to the bull in the

cow in the States, the company withdrew its application in Brazil. In 2021, other two cattle cases were

“non-GMO” by CTNBio, there were myostatin knockout of a Nelore bull, for the double muscle

(muscle hypertrophy) trait, and the slick allele Angus cattle to improve heat-tolerance developed via

CRISPR/Cas 9.

Another case analyzed by CTNBio was the Nile tilapia generated by CRISPR/Cas9 technology. This

tilapia has increased growth rate (to augment fillet yield) and feed conversion and was not considered a

“genetically modified organism” in 2019.

d) LABELING AND TRACEABILITY

The same regulations and laws as described under Chapter 1, Part B (Policy), Section (g) apply to GE

animals, although some specific requirements such as labeling and traceability have not yet been

developed for GE animals. Brazilian consumer laws apply to all products of GE plants, GE animals, or

animal cloning in terms of basic and general information about the product for the consumer.

e) ADDITIONAL REGULATORY REQUIREMENTS

FAS Brasilia is not aware of any additional regulatory requirements.

f) INTELLECTUAL PROPERTY RIGHTS (IPR)

The Brazilian Biosafety Law, which provides a clear regulatory framework for the research and

marketing of new biotechnology crops in the country, has encouraged the GOB to embrace and protect

new technologies that benefit agriculture.

g) INTERNATIONAL TREATIES AND FORUMS

Brazil is a member of both the Codex Alimentarius (CODEX) and the World Organization for Animal

Health (OIE). FAS Brasilia is not aware of any official statements by Brazilian officials at these

international fora related to animal biotechnology. However, several Brazilian scientists participate in

international seminars or workshops related to this theme, including those sponsored by USDA.

h) RELATED ISSUES

On April 10, 2014, CTNBio approved the first commercial release of GE mosquitoes in Brazil. A British

company, Oxitec, which was sold to U.S.-based Intrexon, produced the GE Aedes aegypti mosquitoes

(OX513A). Despite commercial approval by CTNBio, Brazil’s National Health Surveillance Agency

(ANVISA), under the Ministry of Health, and equivalent to the Food and Drug Administration (FDA) in

the United States, has not approved the commercial use of OX513A in Brazil, but instead provided a

Temporary Special Registry (RET, in Portuguese) for research use.

In July 2022, Anvisa has decided that “genetically modified” mosquitos used as control vectors for

public health are subject to sanitary regulation, so as to assure the sanitary safety of the use and its

efficacy. Anvisa will need to analyze and grant registration of such products after it performs its

evaluation of safety and efficacy. The agency is now working a new set of rules under their regulatory

agenda on macroorganisms for biological control of vectors and pathogens in the urban environment. On

the specific case for the Oxitec mosquito, as it is an innovative and distinct technology from all other

products regulated at this point, Anvisa will establish an instrument similar to the RET to regulate the

use of this mosquito in research throughout Brazil to produce the scientific evidence needed on its safety

and efficacy.

Oxitec also has another Aedes aegypti mosquito, a second generation one (OX5034) approved in 2020

by CNTBio, and a Spodoptera frugiperda moth (OX5382G) approved in 2021 by CTNBio. Based on

this July 2022 decision by Anvisa, FAS Brasilia assumes that the second-generation mosquito and the

moth will likely be impacted by the decision, just as the OX513A mosquito. Oxitec has other projects

targeted at Brazil in different stages at this point.

PART F: MARKETING

a) PUBLIC/PRIVATE OPINIONS

FAS Brasilia is not aware of any public studies about producer or consumer acceptance of these new

technologies, although genetic engineering has been increasingly used to enhance animal genetics in

Brazil.

b) MARKET ACCEPTANCE/STUDIES

FAS Brasilia is not aware of any market studies or surveys related to consumer acceptance of these new

technologies.

CHAPTER 3: MICROBIAL BIOTECHNOLOGY

PART G: PRODUCTION AND TRADE

a) COMMERCIAL PRODUCTION

Although Brazil is the second-largest producer of GE plants in the world, with over 20 years of

successful adoption of biotech plant events, research and application of microbial biotechnology is more

recent, dating back only to 2010. CTNBio has approved several food ingredients and other products

derived from microbial biotechnology, which are listed below.

b) EXPORTS

Brazil exports several products that contain microbial biotech-derived food ingredients such as yeast and

alkaline protease. FAS Brasilia does not have a list of specific products, quantities, or values exported.

FAS Brasilia is also not aware of specific export documentation for such products.

c) IMPORTS

Brazil imports enzymes and other products that contain microbial biotech-derived food ingredients, but

CTNBio must approve any request for imports on a case-by-case basis.

d) TRADE BARRIERS

FAS Brasilia is not aware of any trade barriers for these products.

PART H: POLICY

a) REGULATORY FRAMEWORK

Microbial biotechnology is governed by the same legislation as GE plants, animals, and vaccines, and is

subject to analysis and approval by CTNBio. See Regulatory Framework, under Chapter 1, Part B

(Policy) of this report.

For a table of legal terms related to microbial biotechnology in Brazil, see Chapter 1, Part B, Sub-

paragraph A.

b) APPROVALS/AUTHORIZATIONS

GENETICALY ENGINEERED MICROORGANISMS AND DERIVED PRODUCTS

APPROVED COMMERCIALLY IN BRAZIL FOR INDUSTRIAL USE

Product

Characteristics

Company

Document/Year

Saccharomyc

es cerevisiae,

Linhagens

"Commercial Release of “GMO”

Derivative Yeast Saccharomyces

cerevisiae Strains M32465, M32679 and

Lallemand

Soluções

Biológicas ltda.

8344/2022

M32465,

M32679 and

M32680

M32680 to be used in the production of

ethanol"

Saccharomyc

es cerevisiae

GICC03587

(GPY10138)

"Commercial Release of “GMO”

Derivative Yeast Saccharomyces

cerevisiae GICC03587 (GPY10138)

developed for ethanol production"

Danisco Brasil

Ltda.

8343/2022

Saccharomyc

cerevisiae lin

eage M12156

Commercial release of “GMO”

Saccharomyces cerevisae strain M12156

and derivatives for ethanol production

from corn

Lallemand

Soluções

Biológicas Ltda.

8271/2022

TRP-Prosin

Commercial release of “GMO” derivative

TRP-Prosin or dryed Corynebacterium

glutamicum strain KCCM 80346 for

animal feed manufacturing

CJ do Brasil

Indústria e

Comércio de

Produtos

Alimentícios Ltda.

8264/2022

Saccharomyc

es cerevisae

lineages

M32292,

M32376 e

M32379

Commercial release “GMO”

Saccharomyces cerevisae (M32292,

M32376 and M32379) for ethanol

production from sugarcane

Lallemand

Soluções

Biológicas Ltda.

8263/2022

Saccharomyc

es cerevisae

lineage

PRCH20080 -

FS0436

Commercial release “GMO”

Saccharomyces cerevisae strain

PRCH20080-FS0436 for ethanol

production

Danisco Brasil

Ltda.

8243/2022

Saccharomyc

es cerevisae

lineage

Y62840

Commercial release “GMO”

Saccharomyces cerevisae strain 62840

for vanillin production

Amyris

Biotecnologia do

Brasil Ltda.

7978/2022

Saccharomyc

es cerevisae

(SCY014)

Saccharomyces cerevisae SCY017 to be

used in ethanol production

Novozymes Latin

America LTDA

7780/2021

Saccharomyc

es cerevisae

(SCY018)

Saccharomyces cerevisae SCY017 to be

used in ethanol production

Novozymes Latin

America LTDA

7752/2021

Saccharomyc

es cerevisae

(strain

Y67383)

Saccharomyces cerevisae (Strain

Y67383) genetically engineered for

steviol glycoside Reb-M production

Amyris

Biotecnologia do

Brasil LTDA

7663/2021

Saccharomyc

es cerevisae

(SCY017)

Saccharomyces cerevisae SCY017 to be

used in ethanol production

Novozymes Latin

America LTDA

7662/2021

Saccharomyc

es cerevisae

Saccharomyces cerevisae M23541 to be

used in corn-based ethanol production

Lallemand Brasil

LTDA

7661/2021

M23541

S.cerevisae

(GICC03578

and

GICC03588)

Yeast for ethanol production

Danisco Brasil

LTDA

7643/2021

Saccharomyc

es cerevisae

M24296

Yeast for corn-based ethanol production

Lallemand Brasil

Ltda

7561/2021

Saccharomyc

es cerevisae –

CelluXTM 4

Yeast for ethanol production

BioSpringer do

Brasil Indústria de

Alimentos S.A.

7481/2021

Saccharomyc

es cerevisae

Strains

(SCY015 and

SCY016)

SCY015 contains a glucoamylase gene

distinct organisms and a alpha amylase

gene of another genetically engineered

microorganism. Lineage SCY016

contains a glucoamylase gene of a

distinct organism, a alpha amylase gene

Novozymes Latin

American LTDA

7398/2021

Alpha

Amylase

enzyme

(GICC03561)

Alpha Amylase enzyme (GICC03561)

Danisco Brasil

Ltda

7250/2020

Prototheca

moriformis

Strain S9120

Strain S9120 of the microorganism

Prototheca moriformis

Corbion Produtos

Renováveis Ltda

7205/2020

L-Lysine

(BestAmino)

Additive for feed preparation for animals

such as birds and swine

CJ do Brasil

Indústria e

Comércio de

Produtos

Alimentícios Ltda

7056/2020

Soy

Leghemoglob

in produced

by the

genetically

engineered

Picchia

pastoris

The derivate is destined for adding in

analogous products of ground beef for

human consumption

Jomakol

Representações e

Serviços Ltda

7060/2020

Saccharomyc

es serevisae

M15419

Industrial Production of Corn-based

Ethanol fuel

Lallemand Brasil

Ltda

7059/2020

Derivative of

alpha amylase

enzyme

microorganis

Product derivative from the genetically

engineered organism alpha amylase

enzyme (GICC03556) destined for the

formulation of washing machine and dish

washer soaps to assist in the removal of

Danisco Brasil

Ltda

7002/2020

(GICC03556)

starch origin stains

Derivative of

genetically

engineered

microorganis

Corynebacteri

Glutamicum

Product derivative from the genetically

engineered organism Granulated

VALPro, composto por L-Valine 70% for

animal feed use

CJ do Brasil Ind. E

Com. De Produtos

Alimentícios Ltda

6925/2020

Saccharomyc

es cerevisae

(Y63348)

Saccharomyces cerevisae genetically

engineered (Strain Y63348) and its

derivatives

Amyris do Brasil

Ltda

6.822/2020

Granulated

Tryptophan

TRP Pro

Derivative of genetically engineered

microorganism, Granulated Tryptophan

TRP Pro (LTriptofano 60%)

CJ do Brasil

Industria e

Comercio de

Produtos

Alimentícios Ltda

6.821/2020

S. cerevisiae

(GICC03506)

Yeast for the production of ethanol fuel

for the ethanolic fermentation from

carbohydrates and grains processing

Danisco Brasil

Ltda

6729/2019

Threonym

Derivative ofgenetically engineered

microorganism – Granulated Threonym

THR Pro (L-Treonina 75%)

CJ do Brasil

Industria e

Comercio de

Produtos

Alimentícios Ltda

6623/2019

Substilisin

Derivative of genetically engineered

microorganism Substilisin (GICC03528)

Danisco do Brasill

Ltda.

6592/2019

Saccharomyc

es cerevisiae

lineage

Y47220

Commercial release “GMO”

Saccharomyces cerevisiae strain Y47220

for the production of steviol and

derivatives

Amyris

Biotecnologia do

Brasil Ltda.

6.551/2019

S. cerevisiae

(SCY011)

Saccaromyces cerevisae microorganism

to be used in the commercial production

of ethanol – Lineage SCY011

Novozymes Latin

America Ltda

6507/2019

Corynebacteri

glutamicum

strain

DM24.60

Genetically engineered microorganism of

the bacteria Corynebacterium

glutamicum strain DM24.60 and its

derivative for the use in industrial yeast

and its derivative for animal feed as feed

aditive

Evonik Degussa

do Brasil

6476/2019

Alpha

amylase

(GICC03469)

“GMO” derivative of alpha amylase

(GICC03469)

Danisco

6063/2018

Alpha

amylase

GICC03515

Commercial release “GMO” derivative

alpha-amylase (Bacillus licheniformis

strain GICC03515) for application in the

Danisco Brasil

Ltda.

6.237/2018

area of cleaning products

Saccharomyc

es cerevisiae

lineage

Y27011

Commercial release of “GMO”

Saccharomyces cerevisae strain Y27011

and its derivatives for the production of

farnesene

Amyris

Biotecnologia do

Brasil Ltda.

6.165/2018

licheniformis

Alpha amylase of Cytophaga sp

expressed in Bacillus lichenifromis

Du Pont do Brasil

6152/2018

Saccharomyc

es cerevisiae

lineage

Y22021

Saccharomyces cerevisae Yeast

genetically engineered (strain Y22021)

and its derivatives

Amyris do Brasil

5827/2018

Saccharomyc

es cerevisiae

lineage

SCY010

Commercial release “GMO”

Saccharomyces cerevisiae strain SCY010

for use in ethanol production

Novozymes Latin

America Ltda.

5.941/2018

Hemicellulase

“GMO” derivative of Hemicellulase

Du Pont do Brasil

5798/2018

A-glucosidase

“GMO” derivative of alpha glucosidase

Du Pont do Brasil

5797/2018

GICC03299

“GMO” derivative of a-amylase

Du Pont do Brasil

5496/2017

S1260

Saccharomyces cerevisae (S1260) for the

comercial production of ethanol.

Novozymes Latin

America Ltda

5333/2017

S8885

Prototheca moriformis microorganism

Solazyme Brasil

Óleos Renováveis

e Bioprodutos Ltda

5286/2016

M10682

Saccharomyces cerevisae Yeast

Lallemand Brasil

Ltda

5285/2016

S8695

Prototheca moriformis microorganism

Solazyme Brasil

Óleos Renováveis

e Bioprodutos Ltda

5238/2016

Derivative

Import of alcaline protease

Du Pont do Brasil

5153/2016

S6697

Prototheca moriformis microorganisms

for the production of triglycerides e

bioproducts.

Solazyme Brasil

Óleos Renováveis

e Bioprodutos Ltda

4768/2015

S5223

Prototheca moriformis lineage S5223 for

the production of triglycerides and

bioproducts

Solazyme Brasil

Óleos Renováveis

e Bioprodutos Ltda

4675/2015

Celere-2L

Genetically engineered microorganisms

and its derivatives of the biological risk

class I

Bio Celere

Agroindustrial

Ltda

4526/2015

Bioproduct

S5223

Prototheca moriformis microorganism

derivative

Solazyme Brasil

Óleos Renováveis

e Bioprodutos Ltda

4203/2014

RN1016

Yeast (Saccharomyces cerevisiae)

lineage genetically engineered for the

production of ethanol

Bio Celere

Agroindustrial

Ltda

3877/2013

S2014

Prototheca moriformis for the production

Solazyme Brasil

3775/2013

of triglycerides and bioproducts

Óleos Renováveis

e Bioprodutos Ltda

Y5056

Yeast (Saccharomyces cerevisiae)

genetically engineered for the production

of Farnesene

Amyris do Brasil

3287/2012

Y1979

Yeast (Saccharomyces cerevisiae)

genetically engineered for the production

of Farnesene

Amyris do Brasil

2281/2010

Source: CTNBio, updated on May 16, 2023.

c) LABELING AND TRACEABILITY

FAS Brasilia is not aware of any specific regulation for labeling of microbial biotechnology products.

However, Brazilian consumer laws apply to all GE products sold to consumers. In addition, according to

Decree 4680/2003, products that contain more than one percent GE material in their final composition

must be labeled.

d) MONITORING AND TESTING

CTNBio’s obligations are, among others, to conduct case-by-case risk assessments of activities and

projects concerning GE microbial biotechnology products and their by-products, to authorize GE

microbial research activities, and to identify activities and products resulting from the use of GE

microbial technology and their by-products that could potentially cause environmental degradation or

endanger human health. CTNBio issues final decisions about cases in which the activity is a potential or

effective cause for environmental degradation, as well as about the need for environmental permits.

CTNBio’s decision binds other Brazilian government agencies as to the biosafety aspects of GE

microbial biotechnology and their by-products.

e) ADDITIONAL REGULATORY REQUIREMENTS

FAS Brasilia is not aware of any additional regulatory requirements aside from the laws and regulations

described above, which also apply to other GE products.

f) INTELLECTUAL PROPERTY RIGHTS (IPR)

The current biosafety laws, which provide a clear regulatory framework for the research and marketing

of biotechnology crops and related products, as well as for innovative technologies, have encouraged

Brazil’s federal government to embrace and protect these technologies that benefit agriculture. FAS

Brasilia is not aware of any IPR laws or regulations specific to microbial biotechnology products.

g) RELATED ISSUES

FAS Brasilia is not aware of any related issues.

PART I: MARKETING

a) PUBLIC/PRIVATE OPINIONS

FAS Brasilia is not aware of any public concern about microbial biotechnology since it is a recent

innovation and mainly applied to food. The Brazilian public has little knowledge or awareness about this

type of GE product.

b) MARKET ACCEPTANCE/STUDIES

There are no specific studies regarding market acceptance of microbial biotechnology products and

derived products.

APPENDIX

Normative Resolution No. 16, of January 15, 2018 (Informal Translation)

Establishes the technical requirements for submitting a request for consultation to CTNBio on

Innovative Techniques for Improvement of Precision Breeding

THE NATIONAL TECHNICAL BIOSAFETY COMMISSION - CTNBio, in the use of its legal and

regulatory authority and in compliance with the provisions contained in items XV and XVI of article 14

of Law 11105 of March 24, 2005;

CONSIDERING the need to evaluate the Innovative Precision Breeding Technique (TIMP, in

Portuguese) which also encompasses the so-called New Breeding Technologies -NBTs, considering the

precepts provided for in Law No. 11105 of March 24, 2005;

Considering that Law 11105 of 2005 defines recombinant DNA/RNA molecules, genetic engineering

and genetically modified organisms - GMOs in items III, IV and V of its article three, respectively;

Whereas TIMPs encompass a set of new methodologies and approaches differ from the genetic

engineering strategy by transgene, as it results in the absence of recombinant DNA/RNA in the final

product;

Whereas TIMPs can introduce innovative uses of molecular biology tools, which can result in:

1. In the precise editing of genomes, by induction of specific mutations, generating or modifying

wild and/or mutated alleles without transgene insertion(s);

2. In genetic transformation and/or control of gene expression (activation/inactivation);

3. In epigenetic regulation of the expression of genes by natural mechanisms without genetic

modification in the individual;

4. In genetic transformation and/or control of gene expression with genes of sexually compatible

species;

5. In temporary and non-inheritable genetic transformation of cells and tissues;

6. On permanent or non-host infection of genetically modified viral elements;

7. In the creation of alleles with autonomous inheritance and potential of recombination with the

possibility of altering a whole population (gene drive); and

8. In the construction of heterologous genes or new copies of homologous genes.

Resolve:

Article 1. Examples of Innovative Techniques for Improvement of Precision (TIMP), but not limited to

these, are the technologies described in Annex I that are part of this Normative Resolution, which may

originate a product not considered as a Genetically Modified Organism (GMO) and derivatives, as

defined in Law 11105 of March 24, 2005.

Paragraph one. The product referred to in the heading of this article is defined as the offspring, lineage

or product of a process that uses Innovative Precision Improvement Techniques in one of its

development stages.

Paragraph two. The cases to be classified are not limited to the technologies described in Annex I, since

the rapid and continuous advancement of different technologies may provide new products, to which the

provisions of this Normative Resolution will also apply.

Paragraph three. The products referred to in the main paragraph of this article imply at least one of the

following characteristics:

I - product with proven absence of recombinant DNA/RNA, obtained by a technique employing

GMOs as a parent;

II - product obtained by technique using DNA/RNA that will not multiply in a living cell;

III - product obtained by a technique that introduces targeted site mutations, generating gain or

loss of gene function, with the proven absence of recombinant DNA/RNA in the product;

IV - a product obtained by a technique where there is a temporary or permanent expression of

recombinant DNA/RNA molecules, without the presence or introgression of these molecules in

the product; and

V - a product where techniques employing DNA/RNA molecules are used which, whether

absorbed or not systemically, do not cause permanent modification of the genome.

Sole paragraph. In the case of a product obtained from a GMO with the favorable opinion of CTNBio

for commercial release, the conditions described will apply only to the characteristic introduced by

TIMP.

Article 2. In order to determine whether the product obtained by TIMP will be considered as a GMO

and its derivatives, pursuant to article three of Law 11105 of 2005, the applicant must submit a request

to CTNBio.

Paragraph one. The consultation shall be instructed with the information contained in Annex II of this

Normative Resolution.

Paragraph two. Once the consultation with CTNBio has been filed, its extract will be published in the

Official Gazette of the Union and distributed to one of the members, titular or alternate, to report and

prepare a final opinion.

Paragraph three. The final opinion of the member shall be based on a case-by-case analysis of the proof

of compliance at least one of the conditions described in § three of article One of this Normative

Resolution.

Paragraph four. For the products and technologies obtained using the techniques exemplified in Annex I,

CTNBio's decision will observe compliance with one or more of the conditions described in § 3 of

article one of this Normative Resolution and will be conclusive regarding the application of the

definitions of articles three and four of Law 11105 of 2005.

Article 3. The final opinion referred to in paragraph 2 of art. Two of this Normative Resolution shall be

submitted to at least one of the Standing Sectoral Subcommittees, in agreement with the parental

organism and the proposed use of the technique submitted for consultation and, after its approval, shall

be referred to the CTNBio plenary for deliberation.

Sole paragraph. The Subcommittees will have a deadline of up to ninety days for analysis and

elaboration of opinions and may be extended for the same period by decision of the CTNBio plenary.

Article 4. CTNBio may, because of consultation and with due scientific justifications, request additional

information or studies.

Article 5. The situations not foreseen in this Normative Resolution will be evaluated and defined, case

by case, by CTNBio.

Article 6. This Normative Resolution comes into force on the date of its publication.

ANNEX I: Examples of Innovative Precision Improvement Techniques (TIMP)

1. TECHNIQUE: Early Flowering.

1.1 SUMMARY OF THE TECHNIQUE: Silencing and/or overexpression of genes related to

flowering by insertion of genetic modification into the genome and subsequent segregation or by

temporary expression by viral vector.

2. TECHNIQUE: Technology for Seed Production.

2.1 TECHNICAL SUMMARY: Insertion of genetic modification for restoration of fertility

in naturally male-sterile lines in order to multiply these lines maintaining the male-sterility

condition, without, however, transmitting the genetic modification to the offspring.

3. TECHNIQUE: Reverse improvement.

3.1 SUMMARY OF THE TECHNIQUE: Inhibition of meiotic recombination in selected

heterozygous plants for the characteristic of interest in order to produce homozygous parental

lines.

4. TECHNIQUE: Methylation of RNA-Dependent DNA.

4.1 TECHNICAL SUMMARY: Methylation directed by interfering RNAs ("RNAi") in

promoter regions homologous to RNAi with the objective of inhibiting the transcription of the

target gene in living beings.

5. TECHNIQUE: Mutagenesis Target Site.

5.1 TECHNICAL SUMMARY: Protein or riboprotein complexes capable of causing site-

directed mutagenesis in microorganisms, plants, animals and human cells.

6. TECHNIQUE: Oligonucleotide Directed Mutagenesis.

6.1 TECHNICAL SUMMARY: Introduction into the cell of an oligonucleotide synthesized

complementary to the target sequence, containing one or a few nucleotide changes, which may

cause substitution, insertion or deletion in the target sequence through the cell repair mechanism

(microorganisms, plants, animals and human cells).

7. TECHNIQUE: Agro infiltration/Agro infection.

7.1 TECHNICAL SUMMARY: Leaves (or other somatic tissue) infiltrated with

Agrobacterium sp. or gene constructs containing the gene of interest to obtain temporary

expression at high levels located in the infiltrated area or with viral vector for systemic

expression, without the modification being transmitted to subsequent generations.

8. TECHNIQUE: RNAi topical/systemic use.

8.1 TECHNICAL SUMMARY: Use of double stranded RNA ("dsRNA") sequence

homologous to the target gene(s) for specific silencing of such gene(s). The engineered dsRNA

molecules can be introduced/absorbed by the cell from the environment.

9. TECHNIQUE: Viral Vector.

9.1 SUMMARY OF THE TECHNIQUE: Inoculation of living organisms with recombinant

virus (DNA or RNA) expressing the genetic modification and amplification of the gene of

interest through the mechanisms of viral replication, without modification of the host genome.

ANNEX II:

1. Regarding the original organism (Parental), inform:

1. The identification of the genetic technology, purpose and intended use of the resulting

organism and its derivatives;

2. The taxonomic classification, from family, to the most detailed level of the organism to be

released, including, where appropriate, subspecies, cultivar, pathovar, strain and serotype;

3. The risk classification of the genetically modified organism in accordance with Normative

Resolution 2 of November 27, 2006;

4. The gene(s) and/or genetic element(s) handled, the organism(s) of origin and their specific

functions, where applicable;

5. The genetic strategy(ies) used to produce the desired modification(s); the genetic map(s) of

the building(s) used in the process indicating, with all genetic elements present;

6. Molecular characterization of the result of manipulation in the recipient organism (parent and

product), where applicable, providing information related to: (1) number of manipulated copies

(e.g. number of genomic sequences, number of alleles, etc.); (2) location in the genome of the

manipulated region, where possible; (3) identify the presence of unintentional genetic

modifications (off-target), when applicable.

7. The product of expression of the manipulated genomic region(s), described in detail, where

applicable.

2. Regarding the product (offspring, lineage, or final product) inform):

1. Proof of the absence of recombinant DNA/RNA molecules, using molecular methods.

2. Whether the product containing DNA/RNA molecules for topical/systemic use has the

recombinant ability to enter into target species and/or non-target species.

3. Whether the product covered by the application is commercially approved in other countries.

4. If the product uses the gene drive principle that may allow the phenotypic change conferred to

have the potential to spread throughout the recipient organism population, explain the care to

monitor the organism using at least two strategies.

5. How the possibility of potential unintentional (off-target) effects of the technology that may

be present in the product has been assessed.

Attachments:

No Attachments