In Brazil, genetically modified organisms (GMOs) are governed by Law No. 11,105 of March 24, 2005, which regulates principles established by the Constitution regarding the preservation of the environment and the country’s genetic patrimony, as well as the supervision of entities dedicated to research and manipulation of genetic material.

Scientific advances in the areas of biosafety and biotechnology; the protection of life, human health, and the health of animals and plants; and the observance of the precautionary principle for the protection of the environment were used as guidelines to draft Law No. 11,105. This Law, in turn, led to the creation of general rules on biotechnology research, restructuring of the national technical commission responsible for all regulation of the biotechnology sector, creation of a National Biosafety Council, and establishment of theNational Biosafety Policy.

Law No. 11,105 defines the concept of a GMO, and sets rules for the laboratories that work with them. Additionally, it establishes authorization procedures for GMO research, and establishes rules for the production and marketing of GMOs, restrictions on their release into the environment, regimes for their cultivation, requirements for reporting their release, inspections and monitoring of GMO research activities and their commercial release, implementing authorities and authorizing procedures for their release, and restrictions on GMOs in foodstuffs. Finally, it provides for the punishment of administrative violations and criminal offenses.

As for labeling, in 2003 a decree was issued to regulate the right to information, as guaranteed by federal law, regarding food and food ingredients intended for human consumptionand animal feed when they contain or are produced from GMOs.

I. Introduction

Brazil’s Biosafety Law Law No. 11,105 of March 24, 2005), passed by the Congress in 2005, put an end to the controversy surrounding genetically modified organisms (GMOs) in the country. In addition to creating general rules on biotechnology research,Law No. 11,105 regulates constitutional principles and establishes safety standardsand mechanisms for monitoring activities involving GMOs and their by-products.[1] The guidelines used for drafting this Law were the recognition of scientific advances in the areas of biosafety and biotechnology; the protection of life, human health, and the health of animals and plants; and the observance of the precautionary principle for the protection of the environment.[2]

Additionally, Law No. 11,105 created a national technical commission (CTNBio), which became responsible for all regulation of the biotechnology sector.Since then, CTNBio has approved the commercial use of about fifty GMOs, of which thirty-five are plants, including beans, cotton, corn, and soy, the latter of which is the >most cultivated GMO in the country>. According to the president of CTNBio, the rules for the release of these organisms in the country are among the strictest in the world.[3]

A genetically modified (GM) product must go through five different stages before it can be sold. First, a company must submit the project to CTNBio for approval. The Commission reviews the proposal and makes a site visit to determine whether the conditions exist for carrying out the work safely. Once the proposal is approved, development and testing can begin, and must be performed in a restricted and controlled environment. If the work site is a plant, the Ministry of Agriculture is in charge of supervising the experiment. Then, before the GM product’s commercial release, CTNBio evaluates whether the data collected correspond to the Commission’s biosecurity criteria.[4]

Prior to its marketing, however, the product is still subject to a political assessment conducted by a council of eleven ministers, who decide whether it is advantageous for the country to launch the new product on the market.[5]

In 2012, Brazil was the second major producer of GMO crops in the world, with an area of thirty million hectares dedicated to the planting of GMOs, which was only behind the United States with an area of 69 million hectares.[6]

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II. Public and Scholarly Opinion

A study conducted in 2011 by the Brazilian Agricultural Research Company (Empresa Brasileira de Pesquisa Agropecuária, Embrapa)[7] on the development of strategic communication on GMO biosafety[8] mentioned that surveys of public opinion in several studies have shown that, in general, people are aware of GMOs, but are suspicious of the “ulterior motives” behind the “defense” of GMOs.[9]

The biggest controversy involving GMOs occurred before the enactment of Law No. 11,105 and revolved around conflicting biosafety and environmental laws. This conflict led to a lawsuit (see Part VIII, below) and the subsequent approval of a new legal framework for the regulation of GMOs.

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III. Structure of Pertinent Legislation

A. Constitutional Principle

The Brazilian Constitution determines that everyone has the right to an ecologically balanced environment, which is a public good for the people’s use and is essential for a healthy life. The government and the community have a duty to defend and preserve the environment for present and future generations.[10] To ensure the effectiveness of this right, it is the government’s responsibility to preserve the diversity and integrity of the country’s genetic patrimony, and to supervise entities dedicated to research and manipulation of genetic material;[11] to require, as provided by law, a prior environmental impact study, which must be made public, on installation of works or activities that may cause significant degradation of the environment;[12] and to control the production, marketing, and employment of techniques, methods, and substances that carry a risk to life, the quality of life, and the environment.[13]

B. Law No. 11,105 of March 24, 2005

On March 24, 2005, Law No. 11,105 was issued to regulate article 225(§1)(II), (IV), and (V) of the Constitution by establishing safety norms and inspection mechanisms for the construction, cultivation, production, manipulation, transport, transfer, import, export, storage, marketing, research, consumption, environmental release, and discharge of GMOs and their by-products.[14]

Educational activities and projects concerning GMO scientific research, technological development, and industrial production are restricted to the public and private entities responsible both for compliance with Law No. 11,105 and its regulation, Decree No. 5,591 of November 22, 2005,[15] and for the eventual consequences resulting from noncompliance.[16] Individuals acting in an autonomous capacity are not allowed to develop activities and projects involving GMOs.[17]

Law No. 11,105 also created the National Biosafety Council(Conselho Nacional de Biossegurança, CNBS),[18] restructured the National Technical Commission on Biosafety
(Comissão Técnica Nacional de Biossegurança, CTNBio),[19] and provided for the National Biosafety Policy(Política Nacional de Biossegurança).

Law No. 11,105 defines GMO as an organism whose genetic material (DNA/RNA) has been modified by any genetic engineering technique.[20] It defines a GM by-product as a product obtained from a GMO that has no autonomous replication capacity or that does not contain a viable GM form.[21]

C. Law No. 8,078 of September 11, 1990

Law No. 8,078 of September 11, 1990, establishes the norms for the protection and defense of the consumer, public order, and social interest.[22] Article 6(III) of Law No. 8,078 determines that appropriate and clear information about different products and services; the correct specification of the quantity, characteristics, composition, quality, and price of products; and statements about the risks these products present are basic rights of consumers.[23]

D. Decree No. 4,680 of April 24, 2003

On April 24, 2003, Decree No. 4,680 was issued to regulate the right to information guaranteed by Law No. 8,078, regarding both food and food ingredients intended for human consumption and animal feed when they contain or are produced from GMOs.[24]

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IV. Restrictions on Research, Production, and Marketing

A. Rules for Laboratories

Pursuant to article 14(VI) of Law No. 11,105, CTNBio is responsible for establishing the biosafety requirements for the issuance of permits to operate laboratories, institutions, or companies carrying out activities related to GMOs and their by-products.[25]

To this effect, on November 27, 2006, CTNBio issued Normative Resolution No. 2, which establishes the GMO risk classification and biosafety levels to be applied in containment regimes involving the creation, cultivation, production, handling, storage, quality control, and disposal of GMOs, and the research, technological development, and educational activities related to GMOs. The Resolution provides details on, inter alia, the presentation of proposals for GMO-related projects and activities, GMO risk classification and biosafety levels, laboratory specifications and design, and containment equipment. [26]

B. Rules for Authorizing Research, Production, and Marketing

Those interested in performing the activities provided for in Law No. 11,105 must apply for a permit with CTNBio.[27] For the purposes of Law No. 11,105, research activity is defined as “activity carried out in a laboratory, containment regime, or field as part of the production process of GMOs and their by-products, or of biosafety assessment of GMOs and their by-products, which encompasses, within the experimental ambit, the construction, growing, handling, transportation, transfer, import, export, storage, release into the environment, and disposal of GMOs and their by-products.”[28]

An activity that does not fit the criteria for a research activity is considered a commercial use of GMOs and their by-products, which involves the “cultivation, production, handling, transportation, transfer, marketing, import, export, storage, use, release, or disposal of GMOs and their by-products for commercial purposes.”[29]

In addition to a permit, those interested in researching GMOs and producing and marketing them must also follow the rules established in CTNBio Normative Resolution No. 2.

C. Labeling Requirements for Distributed Products

Pursuant to article 2(§1) of Decree No. 4,680, on December 22, 2003, the Ministry of Justice issued Administrative Act (Portaria) No. 2,658, which defines and depicts the “transgenic symbol” (see below) to be used in the marketing of foods and food ingredients intended for human consumption or animal feed containing or produced from GMOs.[30]

Transgenic Symbol

Interministerial Normative Instruction (Instrução Normativa Interministerial) No. 1 of April 1, 2004, defines in Technical Regulations (Regulamento Técnico) the supplemental procedures for the implementation of Decree No. 4,680, which provides for the right to information guaranteed by Law No. 8,078 of September 11, 1990. These Regulations are annexed to theNormative Instruction.[31]

Law No. 11,105 further determines that foods and food ingredients for human consumption or animal feed containing or produced from GMOs or their by-products must contain information to this effect on their labels in accordance with the Law’s regulation (Decree No. 5,591).[32]

D. Bodies Involved in Implementation

1. CTNBio

CTNBio, which is partof the Ministry of Science and Technology, is a multidisciplinary collegial body of an advisory and deliberative character designed

to provide technical support and advice to the federal government in the formulation, implementation, and updating of the National Biosafety Policy on GMOs and their by-products, as well as in establishing technical safety standards and [providing] technical advice regarding the authorization of activities involving research and the commercial use of GMOs and their by-products, based on the assessment of their risk to human health and the environment [risco zoofitossanitário].[33]. . .

. . . CTNBio must monitor the development of, and technical and scientific progress in the areas of biosafety, biotechnology, bioethics, and related areas, aiming to increase its capacity to protect human health, animals and plants, and the environment.[34]

CTNBio is composed of members and alternates appointed by the Minister of Science and Technology, and must have twenty-seven Brazilian citizens of recognized technical abilities and outstanding scientific knowledge and performance. The members must have an academic doctoral degree with professional activity in the areas of biosafety, biotechnology, biology, human and animal health, or the environment.[35] The functioning of CTNBio is defined by the regulation of Law No. 11,105.[36]

2. CNBS

The CNBS, which operates under the authority of the Presidency of the Republic, is a superior advisory body to the President for the preparation and implementation of the National Biosafety Policy.[37]Although article 8 of Law No. 11,105 charges the CNBS with the duty of preparing and implementing the National Biosafety Policy, it appears that such a policy has yet to be prepared and implemented.

The Council is charged with establishing principles and guidelines for the administrative actions of federal agencies and entities with jurisdiction on biosafety;[38] analyzing applications for the commercial release of GMOs and their derivatives in matters regarding appropriateness, socioeconomic opportunity, and the national interest, upon the request of CTNBio;[39] and deciding, as the final hearing body, administrative cases relating to the commercial use of GMOs and their by-products.[40]

Decree No. 5,591 further regulates the activities, functioning, and composition of the CNBS, as well as the jurisdiction of the organs and entities in charge of registering, supervising, and authorizing proceedings related toGMOs and their derivatives.[41]

3. CIBio

Every institutionthatuses techniques andgenetic engineering methodsorconducts researchon GMOs andtheirby-productsmust create anInternal Biosafety Commission (Comissão Interna de Biossegurança,CIBio),besides indicatinga technicianprimarily responsiblefor eachspecific project.[42]

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V. Restrictions on Releasing Organisms into the Environment

Law No. 11,105 prohibits the release into the environment of GMOs or their by-products

• as part of research activities, without a favorable technical decision issued by CTNBio;
• during trade operations, without a favorable technical opinion issued by CTNBio;
• without a license issued by the appropriate agency or environmental entity when CTNBio considers the activity a potential cause of environmental degradation; or
• without the approval of the CNBS, in accordance with the terms of Law No. 11,105 and its regulations.[43]

TheCTNBio is the entity responsible for the establishment of technical standards regarding research and the commercial use of GMOs and their by-products based on the assessment of their risk to human health and the environment (risco zoofitossanitário).[44] Accordingly, on November 6, 2008, CTNBio issued Normative Resolution No. 6 with the norms applicable to the planned release into the environment of GM plants and their by-products.[45]

A. Protective Goals

Upon the verification of adverse effects on the environment or on human and animal health, or even upon confirmation of new scientific knowledge, the authorization for the planned release of a GM plant and its by-products may be suspended or revoked at any time by CTNBio.[46]

Any accidental release of a GM plant and its by-products must be immediately reported to the institution’s CIBio and to CTNBio. The CIBio has up to five days to send the report of corrective actions taken to CTNBio. The report must include the names of the persons or authorities that have been notified.[47] The report of an accidental release of a GM plant and its by-products does not exempt the applicant from informing the competent authorities and the people who may be affected, so that they can adopt the appropriate measures in accordance with the laws in force.[48]

B. Regimes for Cultivation

According to Normative Resolution No. 6, the release of GM plants into the environment is subject to previous approval by CTNBio,[49] and the regime of GMO cultivation must be closely monitored and reported.[50]

On August 16, 2007, CTNBio issued Normative Resolution No. 4, which establishes the minimum isolation distances to be observed between genetically modified commercial corn crops and non-genetically modified corn crops to allow the coexistence of different production systems in the field.[51] To allow coexistence, the distance between a genetically modified commercial corn crop and a non-genetically modified corn crop located in a nearby area should be no less than 100 meters (approximately 328 feet) or, alternatively, twenty meters (approximately sixty-five feet) provided that it is surrounded with at least ten rows of conventional corn plants of a similar size and vegetative cycle as the genetically modified corn.[52]

Normative Resolution No. 10 of October 2, 2013, determines that in the planned release of genetically modified citrus plants into the environment, the strategy of pollen competition should be observed by introducing three types of borders, comprising at least six lines of citrus plants, also subject to the conditions established in the Resolution.[53]

C. Reporting Requirements

The applicant (requerente)[54] must maintain records of the individual who is monitoring the planned release of GM plants into the environment. These records must include, but are not limited to, information on security measures, agronomic practices, and data collection, as well as on the storage, material transfer, and eventual disposal of the GMOs and their by-products.[55]

Both the person responsible for the applicant company and its CIBio are charged with ensuring compliance with the provisions of Normative Resolution No. 6 with respect to the planned release of a GM plant and its by-products into the environment.[56] Additionally, the company’s technical opinion concerning the planned release must inform CTNBio about any possible breach of the rules set out in Normative Resolution No. 6 and the biosecurity measures established by CTNBio.[57]

D. Inspections

According to article 16 of Law No. 11,105, the registration and inspection bodies of the Ministries of Health, Agriculture, and Environment, and the Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republicare charged, inter alia, within the field of their respective expertise, while observing the technical decisions of CTNBio, the deliberations of the CNBS, and the mechanisms established by Law No. 11,105 and its regulation, with

1. – overseeing the research activities of GMOs and their derivatives;
2. – registering and monitoring the commercial release of GMOs and their by-products[.] [58]

E. Implementing Authorities and Authorizing Procedures

After the proposal for the planned release of GM plants into the environment is approved by the company’s CIBio, the applicant must submit it for approval to CTNBio accompanied by

1. – A request for planned release; information on the institution, dated and signed by the legal representative of the company, according to Annex I of Normative Resolution No. 6;
2. – Information on the GMO plant, according to Annex II of Normative Resolution No. 6;
3. – Information on the planned release of GMO plants, according to Annex III of Normative Resolution No. 6;
4. – Maps and sketches for the planned release of GMO plants, in accordance with Annex IV of Normative Resolution No. 6; [and]
5. – A request for the import of vegetal material, when applicable.[59]

The proposal must be presented in Portuguese, with four copies, and accompanied by a digital file.[60]

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VI. Restrictions on GMOs in Foodstuffs

A. Assessment of Risks

Normative Resolution No. 5 of March 12, 2008, defines assessment of risk as a combination of procedures or methods by which the potential effects of the planned release of GMOs and derived products on the environment and on human and animal health are assessed on a case-by-case basis.[61]

The assessment of risk must identify and evaluate the potential adverse effects of GMOs and their by-products on human and animal health, on the environment, and on plants, while maintaining transparency, the scientific method, and the precautionary principle.[62]

B. Implementing Authorities and Authorizing Procedures

The commercial release of GMOs and their by-products must conform to the standards provided for in Normative Resolution No. 5, as well as the written permission issued by CTNBio in accordance with all the conditions imposed in the permit.[63]

The authorization requestfor the commercial release of GMOs must be submitted to CTNBio with theinformation requested in Annexes I, II, III, and IV of Normative Resolution No. 5, which must be dulydocumented by scientific reports of the results obtained during the planned releases into the environmentor other studies, without prejudice to other information deemed relevant by the CTNBio.[64]

C. Fodder for Livestock

The restrictions on GMOs and their by-productson foodstuffs are limited to their approval and authorization for human consumption or animal feedby the competent authorities, as described above.

D. Labeling

Law No. 11,105 determines that food and food ingredients for human consumption or animal feed containing or produced from GMOs or their by-products must provide information to this effect on their labels, in accordance with the regulation.[65]

Consumers must be informed when more than 1% of a product marketed as food for human or animal consumption contains or is produced from GMOs.[66]

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VII. Liability Regime

Without prejudice to the application of the penalties provided for in Law No. 11,105, those responsible for damage to the environment and to third parties are jointly liable for their compensation or full reparation, regardless of fault.[67]

A. Administrative Violations

Any action or omission that violates the rules set forth in Law No. 11,105 and other relevant legislation is considered an administrative violation.[68] Administrative violations must be punished as prescribed in the regulation of Law No. 11,105, regardless of precautionary measures to seize products, suspend the sales of products, and stop prohibited activities. The following sanctions are applicable:

1. a warning;
2. a fine;
3. seizure of GMOs and their by-products;
4. suspension of the sale of GMOs and their by-products;
5. halting of the activity;
6. partial or total interdiction of a business, activity or undertaking;
7. suspension of registration, license or authorization;
8. cancellation of the registration, license or authorization;
9. loss or restriction on tax incentives and benefits granted by the government;
10. loss or suspension of participation in government financed line of credit;
11. intervention in the establishment;
12. ineligibility to enter into contracts with public administration for a period of five years.[69]

It is incumbent upon the registration and inspection agencies and entities referred to in article 16 of Law No. 11,105 to establish “criteria and values,” and impose fines ranging from R$2,000 (approximately US$870) to R$1,500,000 (approximately US$652,174), which must be established according to the seriousness of the offense.[70] The fines may be applied cumulatively with other penalties provided for in article 22 of Law No. 11,105.[71] In case of recidivism, the fine will be doubled.[72] In case of continued violation, characterized by the continuation of the action or omission that was initially punished, the punishment will be applied daily until its cause ceases, without prejudice to the immediate stoppage of the activity or the interdiction of the laboratory, institution, or company responsible.[73]

B. Criminal Offenses

The release or disposal of GMOs into the environment in a way that is contrary to the standards established by CTNBio and by the agencies and entities of registration and inspection is punishable by one to four years in prison and a fine.[74] The punishment is increased by one-sixth to one-third if the offense results in damage to another’s property; one-third to one-half if harm is caused to the environment; one-halfto two-thirds if the offense results inserious bodily injury to another person; and two-thirds to double if the offense results in death.[75]

The production, storage, transport, sale, import, or export of GMOs or their by-products without authorization or in violation of the standards established by CTNBio and by registration and inspection agencies is punishable by one to two years in prison and a fine.[76]

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VIII. Judicial Decisions / Prominent Cases

The passagein 2005 of Brazil’s current Biosafety Law, Law No. 11,105, involved a decade-long history of legislative and judicial activity. On January 5, 1995, Brazil issued the first law designed to regulate activities involving GMOs and their by-products. Law No. 8,974 was issued to regulate aspects of biosafety related to the development of GMOs and their by-products in the country.[77] However, conflicts between the biosafety legislation and environmental legislation led to the need for a restructuring of the relevant legislation.[78]

The problems regarding the application of Law No. 8.974 emerged in 1998 when CTNBio issued a technical opinion (parecer técnico prévio conclusivo) in which it approved the request for commercial release of a GM soybean tolerant to a glyphosate-based herbicide without requiring the completion of an Environmental Impact Report (Relatório de Impacto Ambiental, EIA/RIMA).

The competence of CTNBio to remove the requirement was immediately challenged in court through a public civil action filed by the Office of Consumer Affairs (Instituto de Defesa do Consumidor, IDEC), which provoked an extensive and contentious process of discussions about the adoption of this technology in the country.

The discussions involved all of Brazilian civil society and had repercussions within the judiciary, executive, and legislative branches. As a result, several laws were enacted generating a complex regulatory framework with little legal certainty.

In an attempt to address these regulatory weaknesses, in late 2003 the federal government sent the Congress a bill that was the result of discussions with various stakeholders, proposing a new law.

After a year and a half of discussions in the Congress, the bill was approved, and on March 24, 2005, the President of the Republic signed Law No. 11,105, which became Brazil’s new Biosafety Law. This Law in conjunction with Decree No. 5,591 of November 22, 2005, which regulated Law No. 11,105, created a new legal framework for biosafety in the country.

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Eduardo Soares
Senior Foreign Law Specialist
March 2014

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Last Updated: 12/30/2020