Regulatory Law in the Life Sciences and Agribusiness sector plays an essential role in balancing scientific innovation and the protection of public interests. In Brazil, a country recognized for its vast biodiversity and potential for scientific research, regulation in this field is crucial to ensuring responsible access to genetic resources and to address emerging issues, such as cannabis regulation.
Before commercializing products in the Brazilian market, a company must be able to navigate a vast array of laws and regulations, especially in cases involving pharmaceuticals, seeds, pesticides, food or feed, cosmetics and medical devices. On top of that, when it comes to biotechnology related products involving genetically modified organisms (GMOs), or products derived from access to genetic resources or where traditional knowledge is associated, another layer of rules is applicable.
This complex set of rules aims at safeguarding users, and ensuring them of quality, safety and efficacy of new products via a general framework established in federal statutes, leaving the task of issuing modern regulations to keep up with new technologies to the governmental regulatory agencies.
The Brazilian Sanitary Surveillance System
The Law # 6360, enacted on September 23, 1976, is a regulatory milestone that addresses sanitary surveillance over the production, commercialization, and use of products that may pose risks to public health. Accordingly, products such as medicines, cosmetics, or those with dietary and hygiene features, must be registered by health authorities before being marketed.
- Medicines and Pharmaceutical Products: the law regulates the manufacturing, distribution, and sale of medicines, aiming for quality, safety, and effectiveness, as well as labelling which should detail use, dosage, precautions, and side effects;
- Cosmetics and Hygiene: beauty and personal hygiene products are regulated to ensure they are safe for human use, follow manufacturing, storage, and distribution standards, and that their labelling is clear and precise with information on composition, mode of use and precautionary measures;
- Dietary products: the law sets standards for their production and marketing, ensuring suitability for consumption and supplementing regular food;
- Sanitizers and Medical Devices: Cleaning products and medical devices are also regulated to ensure their quality and safety.
Law # 6360/1976 regulates the advertising of regulated products, preventing misleading information. Authorities can prohibit or recall products that pose health risks. The National Health Surveillance Agency (ANVISA) is responsible for implementing of the obligations and requirements set by this statute.
Food and Feed
The regulatory system for food seeks to ensure the safety, quality and adequacy of food available in the market. The main agencies involved are ANVISA, the Ministry of Agriculture, Livestock, and Supply (MAPA), and the National Institute of Metrology, Quality, and Technology (INMETRO).
ANVISA is responsible for regulating and controlling products and services that pose a risk to health, including food. Its main responsibilities related to food include:
- establishing sanitary standards and regulations for the production, marketing, and consumption of food;
- evaluating and approving food additives, technological aids, ingredients, and packaging;
- overseeing labeling and nutritional claims on food products;
- monitoring pesticide residues in food;
- regulating special foods, such as products intended for specific diets.
MAPA is responsible for regulating and inspecting the production of animal, plant and agricultural products. Its main tasks include:
- establishing standards for the production, inspection, certification of animal and plant products;
- conducting inspections in establishments producing animal-derived foods;
- controlling the quality of animal-derived foods such as meat, milk, and eggs;
- regulating the production of organic foods.
INMETRO is involved in metrology, quality, and safety of products, including food. Its responsibilities include:
- setting quality and safety standards for food products;
- conducting verifications of scales and measuring instruments used in food trade;
- certifying quality management systems for food companies.
In addition to these agencies, there are also state and municipal health surveillance agencies that complement the regulation and oversight of food at regional levels.
The Brazilian regulatory system for food is complex due to the diversity of food products, the associated risks and geographic scope. It aims to ensure consumer safety, product quality, and compliance with international standards, thus promoting public health and the development of the food industry, in addition to food security.
The regulatory system for animal feed is responsible for ensuring the safety, quality and efficacy of feed intended for production animals, such as livestock, poultry, swine, cattle and others. The system involves several stages of regulation, registration, control and supervision to ensure that feeds meet required standards and do not pose risks to animals and, when applicable, to human health.
MAPA is the main authority responsible for regulating and standardizing animal feeds. It issues normative instructions that establish the technical and sanitary requirements for the production, commercialization, and use of animal feeds, carrying out inspections to ensure compliance.
Ingredients and additives used in feed formulation are regulated and controlled to ensure they are safe and meet established standards. ANVISA may also be involved in controlling additives used in feeds.
Crop Protection Products and Seeds
The regulatory system for crop protection products (pesticides) oversees their production, sale and use to ensure efficacy for agricultural purposes, and safety for the human health and the environment. The system is governed by several key components:
- Registration and Approval: pesticides must be registered by MAPA before they can be legally sold and used. Companies seeking registration submit extensive data on the pesticide’s composition, effects, toxicology, environmental impact and efficacy. Such data package is analyzed by MAPA, ANVISA and the Brazilian Institute of Environment and Natural Resources (IBAMA).
- Risk Assessment: before approval, pesticides undergo thorough risk assessments to determine potential harm to human health, animals, non-target plants, and the environment. The assessment considers factors such as toxicity, persistence and potential for bioaccumulation.
- Labeling and Instructions: approved pesticides are required to have clear and comprehensive labeling, including usage instructions, dosage, application methods, and safety precautions. Labels also include withdrawal periods to ensure safe consumption of treated crops and animal products.
- Maximum Residue Limits (MRLs): maximum residue limits are established for pesticides in food products to ensure that levels in consumed items are within safe bounds.
ANVISA, MAPA and IBAMA jointly oversee pesticide use. Regular monitoring and inspections ensure compliance with regulations and standards.
Ongoing research is conducted to develop safer and more effective alternatives to conventional pesticides, such as biopesticides and integrated pest management strategies. The aim of the regulatory system is to strike a balance between agricultural productivity and protecting human health and the environment.
The regulatory system for seeds ensures the quality, traceability, and legality of seeds for agricultural use. The system encompasses various steps to guarantee that seeds meet established standards and contribute to agricultural productivity and sustainability.
Seeds intended for commercial use must be registered and approved by MAPA. Companies seeking registration provide detailed information about the seeds’ origin, characteristics and quality. They undergo testing to verify their purity, germination rate, vigor and absence of diseases or pests. Certified seeds, meeting quality criteria, receive labels indicating their class and quality attributes.
The Brazilian government maintains a collection of public domain seeds to promote genetic diversity and provide farmers with access to traditional varieties.
MAPA conducts regular market surveillance to prevent the sale of unauthorized or poor-quality seeds.
The regulatory framework seeks to balance the interests of farmers, consumers, and the agricultural industry while ensuring the availability of high-quality seeds for sustainable food production.
The Biosafety Law
The Biosafety Law in Brazil, Law # 11105/2005, addresses various aspects of modern biotechnology and the use of GMOs. The law regulates activities involving GMOs, ensuring both scientific progress and the protection of human health, the environment, and biodiversity. Here are its key aspects:
- Regulation of GMOs: the law establishes a framework for the research, development, production, and commercialization of GMOs, ensuring their responsible use.
- Environmental and Health Assessments: activities involving GMOs must undergo rigorous assessments to evaluate potential risks to human health, ecosystems, and biodiversity.
- Approval and Regulation: the law establishes a National Technical Biosafety Commission (CTNBio) responsible for reviewing and approving activities involving GMOs. Prior to registration before the ANVISA (in case of gene therapies or recombinant RNA vaccines, for instance) or MAPA (in case of GM seeds), the technology containing the GMO undergoes examination by CTNBio, which assesses the risks and benefits of proposed activities.
- Transparency and Public Participation: the law promotes transparency by requiring the publication of information related to GMOs and biosafety assessments. It encourages public participation in the decision-making process.
The Biosafety Law seeks to balance the benefits of biotechnology with the protection of the environment, human health, and socio-economic interests.
The Access and Benefit Sharing System
The legislation that governs access to genetic resources and associated traditional knowledge is established by the ” Biodiversity Law,” Law # 13123/2015, which provides a legal framework to ensure equitable benefit-sharing arising from such access.
The law outlines procedures for accessing genetic resources and information considered to be of Brazilian origin; access is defined as research and development. Traditional knowledge associated with genetic resources is recognized and protected. Entities seeking access must provide information about the intended use and benefits and benefits derived from the use of these resources must be shared with Brazil.
The law requires that prior informed consent is obtained from indigenous and local communities for accessing genetic resources and traditional knowledge associated with them. It mandates that benefits arising from the use of genetic resources and traditional knowledge are shared fairly and equitably with the providers of these resources and knowledge.
The National Genetic Heritage Management Authority (CGEN) oversees the system and regulates it, including the maintenance of the database where access activities and benefit sharing agreements are recorded and tracked.
The Brazilian Biodiversity Law seeks to promote the conservation and sustainable use of biodiversity while respecting the rights of indigenous and local communities.
Cannabis
The current regulatory framework for medical cannabis in Brazil is based on two resolutions issued by ANVISA providing for: (i) requirements for the marketing approval of cannabis-based products; and (ii) importation of Cannabis-derived products for personal health treatment purposes.
Under this framework, cannabis-based products can only be commercialized in Brazil if they have received marketing approval by ANVISA, which is valid for a five-year period. The products must meet certain requirements, including: (i) be manufactured in accordance with good manufacturing practices (GMP); (ii) contain a predominant amount of cannabidiol (CBD) and be limited in its amount of tetrahydrocannabinol (THC); (iii) be labeled with clear and accurate information that it is cannabis-based and methods of administration.
The sale of cannabis-based products is restricted to pharmacies and other authorized retailers, and patients must have a prescription from a doctor.
For patients to import cannabis-derived products for personal health treatment, they must register with ANVISA and obtain the corresponding authorization. The importation can be carried out directly by the patient or intermediated by healthcare entities. The imported product should be from a regulated establishment in its country of origin.
The Brazilian regulatory system on the use of cannabis is still evolving. Despite recent decisions from ANVISA maintaining the ban on importation of dried parts, including flowers, it still seeks to strike a balance in order to allow greater use of cannabis for medicinal purposes.
Balance is Key
Brazil’s network of regulatory agencies and laws in the realm of Life Sciences and Agribusiness is vital for promoting scientific innovation, while protecting the interests of biodiversity and society. Access to genetic resources and the regulation of cannabis are emerging areas that reflect the ongoing search for balanced solutions that benefit both scientific advancement and public welfare. As science advances and the needs of society evolve, regulation in the Life Sciences will continue to play a critical role in guiding and supporting responsible development.
Article published on the IPWatchdog.