Doing Business in Brazil

17. Regulatory law

09/18/19

17.1 Introduction

State intervention in the economy

Brazilian regulatory legislation has been updated in line with the trends directed by the economic and social development of the country and in the world. Currently, there is no doubt that the economic scenario is globalized, and therefore the regulatory alignment of developed and developing nations is increasingly important for the promotion of commercial, financial and economic practices. A latent sign of the scenario presented is the ongoing efforts employed by Brazil to integrate the select group of countries members of the OECD (Organization for Economic Cooperation and Development).

Regulatory Law in Brazil has ceased to be an obstacle to economic development, and it has increasingly be deemed as a means of communication and adjustment to the needs of the market and the development it has promoted to the duties of the public sector of police, management and surveillance of activities in the society.

17.2 Brazilian regulatory law in the areas of Health (Life Sciences), Food and Technology

17.2.1 Regulatory Law in health – Life Sciences 

Regulatory Law applicable to life sciences and health must be assessed from the perspective of a federative country. This includes the coordinated action of health authorities at the federal, state and municipal levels. At the federal level, the National Health Surveillance Agency (“ANVISA”) has jurisdiction, among others, to coordinate the National Health Surveillance System and promote the protection of the population’s health, by controlling the production and commercialization of some products and services subject to health surveillance. At the state and municipal levels, we have Local Health Surveillance Authorities with additional jurisdiction in relation to the Union for certain issues related to health protection, including inspection and licensing of activities within their jurisdictions. For more information, please see item 19.

The Life Sciences industry address and deals with sciences that, in any way, relate to living organisms such as plants, animals, human beings, including the development of pharmaceuticals, health products, cosmetics, personal care products, sanitizing products, food, among others. It is a highly regulated and complex segment, wherein each product category has its own regulation under the terms of the applicable health legislation. Below we will present brief notes on the regulations applicable to such products, with the exception of medicines, which is dealt with in item 19 of this Guide.

In general, a company in the industry that intends to carry out its activities in Brazil must obtain certain licenses and authorizations for the company itself and for products from ANVISA and other decentralized bodies that are part of the National Health Surveillance System, such as Local Health Surveillance Authorities, including state and municipal. Among the main applicable licenses and authorizations are: (i) federal operation authorization (AFE) issued by ANVISA; (ii) local license to operate the establishment (LF) issued by the state or municipal Health Surveillance Authority, depending on the location and type of activity to be conducted; (iii) product registration, registry or notice with ANVISA; and (iv) certification of good practices.

Health products are defined as equipment, apparels, materials, devices or systems for medical, dental or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation or contraception, and which do not use pharmacological, immunological or metabolic means to perform their main function in human beings, being able however to be aided in its functions by such means.  It is a huge list of products in several categories, such as in vitro diagnostics, medical equipment, orthopedic implants and materials for use in health.

Health products are divided into 4 risk classes, according to the rules of ANVISA applicable regulation, currently Resolution RDC 185/01.

The products classified in Classes III and IV, as they are of high and maximum risk, respectively, are subject to registration with the Agency. Examples of these classes of products are infusion pumps, anesthesia kits, catheters, orthopedic fixation systems and associated devices, system for injection of radiological contrast, surgical wires and tapes, hearing implants and stents. Registration with ANVISA is valid for 10 years.

The products classified in Class I and II, as they are of low and medium risk, respectively, are subject to notice and registry (cadastro). As an example, products of class I and II are products for orthodontics (bracket, wire, cements and components), bandages, adhesive tapes, bandages, wheelchairs, collection bags, probes, contact lenses and disposable needles and syringes. The act of notice and registry (cadastro) basically differs in terms of the need for ANVISA to issue a concession decision (required only for registry – cadastro), which is the term used by ANVISA to regularize products that are exempt from registration itself. The notice and registry (cadastro) are valid for an undefined period of time.

The company is responsible, by applying the rules provided for in Resolution RDC 185/01, for defining and classifying its product in the applicable class taking into account, for this purpose, (i) the purpose indicated by the manufacturer (intended function), and not the class of risk attributed to other similar products, (ii) if the product performs functions that may be classified in different classes of risk, the most critical risk class will be adopted, (iii) the most critical use if the product has no indication to be used on a specific part of the body, among others.

In turn, products for in vitro diagnosis are also divided into 4 classes of risk, considering the risk to the individual and the risk to public health, according to Resolution RDC 36/15. The criteria used to classify products for in vitro diagnosis are, among others, indication of use; importance of the information provided to the diagnosis, and relevance and effect of the result for the individual and public health.

After being introduced to the market, the health product must continue to be monitored by the responsible company (manufacturer or importer), in order to monitor any possible deviation from safety and effectiveness. Deviation can be understood as the departure from product quality parameters with a risk to patient safety and health. In case of deviation, the company should generally initiate a field action procedure – corrective measure to reduce the risk of collateral effects related to the use of a medical product already sold -, under the terms of the applicable regulation.

Personal hygiene products, cosmetics and perfumes, defined as preparations consisting of natural or synthetic substances, for external use in the various parts of the body, with the sole or main purpose of cleaning, perfuming, altering their appearance and/or correcting body odors, and either protecting them or keeping them in good condition, are also divided into categories, currently established by Resolution RDC 7/15. They are:

(i)Grade 1: they have basic or elementary properties, the proof of which is not initially necessary and does not require detailed information on how to use and restrictions on use. Examples of Grade 1 products are: perfumes, lipstick and lip gloss, some make-up (without photo-protection purpose), makeup remover, deodorant (except those with antiperspirant action) and nail polish.

(ii)Grade 2: have specific indications, which characteristics require proof of safety and / or efficacy, in addition to information and care, mode and restrictions of use. Examples of Grade 2 products are: suntan lotion, sunscreen (including for use by children), antiseptic hand gel, hair straightening and dyeing product, insect repellent (including for use by children).

Only Grade 2 products have to be registered with ANVISA. Registration is also valid for 10 years. Grade 1 products are subject to prior communication to ANVISA by means of notice.

Such ANVISA Resolution also determines mandatory labeling criteria for personal hygiene products, cosmetics and perfumes. Objectively speaking, the following information, among other, has to be provided: product name and category to which it belongs, brand, product registration number, batch, expiration date, country of origin, manufacturer / importer / holder, method of use, warnings and restrictions of use (if applicable), ingredients / composition and specific labeling, if necessary.

With the appearance of organic products for personal hygiene, cosmetics and perfumes, ANVISA has included the issue of regularization of organic products in its regulatory agenda, alleging the existence of a Law and Decree (that is, Law 10.831/03 and Decree 6.323/07) that define the requirements for organic products, but the absence of specific requirements for organic cosmetic products has made it difficult to certify this product category.

Sanitizers are products defined as a substance or preparation for application on objects, fabrics, inanimate surfaces and environments, intended for cleaning, hygiene and disinfection. Examples of sanitizers are insecticides, rodenticides, disinfectants and detergents. Among other categories, sanitizers are classified according to their risk, sale and use.

As for risk, sanitizers are divided into (i) products of risk I, which are subject to notice; and (ii) products of risk II, which are subject to registration. The requirements that have to be met for each of the product categories and types are provided for in RDC 42/09, RDC 59/10 and RDC 32/13. The sanitizing registration is valid for 10 years.

As for sale and use, sanitizers are divided into two categories: (i) for professional use, which may not be sold directly to the public, and have to be applied or handled exclusively by a professional or specialized company; and (ii) over-the-counter sanitizing product, which is the product that can be sold to the public. ANVISA has specific rules for each type of sanitizing product with regard to its labeling.

17.2.1 Regulatory Law in the Food Industry 

In Brazil, food is regulated mainly by two bodies: (i) the Ministry of Agriculture, Livestock and Supply (“MAPA”); and (ii) the National Health Surveillance Agency (ANVISA). MAPA is responsible for regulating animal products, beverages (alcoholic and non-alcoholic), and fresh vegetable products. ANVISA is responsible for regulating and controlling processed foods in general, food additives and technology aids, packaging, equipment and devices in contact with food, as well as for inspecting food in commerce.

Depending on the food, the establishment and the food itself must be registered with MAPA. For example, vegetable products that have to be registered with MAPA are the products standardized by the Ministry, under the terms of Law 9.972/00 and its regulations. The products can be verified in a list available on the MAPA1 website. In turn, establishments that carry out interstate or international sales of animal products have to be registered with the Department of Inspection of Animal Products, as determined by Decree 9.013/17.

Within the scope of ANVISA, the foods that must be registered are established by Exhibit II of RDC 27/10, as foods with functional or health claims, children foods, enteral nutrition formulas, and new foods and new ingredients. Registration is valid for 5 years. There are also foods exempt from registration, but the company must inform the Local Health Surveillance Authority of the beginning of their manufacture (Exhibit I of RDC 27/10). This is the case of foods for weight control, chocolate and cocoa products, vegetable oils, vegetable fats and vegetable cream, and cereal products, starches, flours and bran. The procedures are detailed in RDC 22/00 and RDC 23/00.

ANVISA also determines the technical regulation of food. That is, it establishes the identity and the minimum quality characteristics for some food. For example, cereal products, similar, flour and bran are regulated by RDC 263/05.

Food labeling is also the responsibility of ANVISA. The mandatory elements are, for example, sale name of the food, list of ingredients, net content, origin, batch, expiration date and nutritional information (nutritional table) (RDC 259/02 and RDC 360/03). Some rules require the inclusion of additional information in the labeling: warning on the presence of Genetically Modified Organisms (Decree 4.680/03); warning on the presence of gluten (Law 10.674/03); declaration on the presence of lactose (RDC 136/17), and warning on the presence of some food that cause food allergies (RDC 26/15).

17.2.1 Regulatory Law in the Technology Industry 

Biotechnology is defined by the UN Convention on Biological Diversity as the use of knowledge about biological processes and the properties of living beings, in order to solve problems and create useful products.

In a broader sense, it comprises the handling of microorganisms, plants and animals, with a view to obtaining processes and products of interest to society. Strictly speaking, it refers to state-of-art techniques of molecular and cellular biology, including genetic engineering.

The regulatory framework for biotechnology in Brazil aims to reconcile important issues related to national sovereignty over genetic resources, the strengthening and competitiveness of national bio-industry, the biosafety of living beings and the environment, as well as the right to information and free choice of consumer.

In this scenario, it is worth highlighting the main regulatory aspects of two increasingly important biotechnology issues in Brazil, namely: Regulation of GMOs and Regulation of activities with genetic heritage and traditional knowledge associated with the Brazilian biodiversity.

Genetically Modified Organisms (GMOs) and their by-products (products obtained from GMOs with no autonomous capacity to replicate, or with no viable form of GMOs) are all those that are changed by receiving one or more genes via genetic technology. In view of the risks that such changes may pose to the ecosystems, agriculture and human health, they are subject to national and international biosafety standards.

Among GMOs, the transgenic that has been applied in several industries stands out, among which: 

  • agriculture, with versions of soy, corn, cotton, pumpkin, sugar beet, sugar cane, beans, transgenic papaya;
  • health, in the development of insulin for the treatment of diabetes, as well as for immunizations and other medicines; food, with fungi, yeast and transgenic bacteria applied in cheese, wine, beer, bread manufacturing processes, among others;
  • chemicals, in the creation of transgenic enzymes for degreasing cleaning products, such as soap and detergents.

The main standards related to GMOs, their by-products and biosafety in Brazil are Law 11.105/2005 (“National Biosafety Policy”) and its regulatory Decree No. 5.591/2005, which establish safety standards and inspection mechanisms on construction, cultivation, production, handling, transport, transfer, import, export, storage, research, sale, consumption, release into the environment and disposal of GMOs and their by-products in the country. Other rules related to the issue may be found at http://ctnbio.mctic.gov.br/normas-e-leis. In order to conduct any activities with GMOs and their by-products in the Country, it is necessary the issue of the Biosafety Quality Certificate (“CQB”) by Comissão Técnica Nacional de Biossegurança (the National Technical Biosafety Commission) (“CTNBio), an advisory deliberative multidisciplinary collegiate body, linked to the Ministry of Health, Science, Technology, Innovations and Communications. CTNBio is also responsible for monitoring the technical and scientific development and progress in the areas of biosafety, biotechnology and bioethics.

In addition, they are bodies for registration and inspection of GMO-containing products and their by-products: the Ministry of Fisheries and Agriculture (‘MPA“), Ministry of Agriculture, Livestock and Supply (“MAPA”), Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Renováveis (the Brazilian Institute of the Environment and Natural Renewables Resources (“IBAMA”) and the National Health Surveillance Agency (“ANVISA”). 

In accordance with Law No. 11.105/2005, food and food ingredients intended for human or animal consumption, which contain or are produced from GMOs or by-products in any percentage, shall have to contain information on their labels. Labeling is regulated by Decree No. 4.680/2003. 

In the past, only products with GMOs in excess of 1% should have the information on the label. However, due to recent decisions rendered in two public civil actions, which dealt primarily with consumers’ right to information, the determination of labeling in any percentage has become mandatory for all products with GMOs.

As Brazil is a signatory member of the Convention on Biological Diversity – (“CDB”), it is required to observe the guidelines on biodiversity, which in summary have three primary objectives: (i) conservation of biological diversity, (ii) sustainable use of natural resources, and (iii) fair and equitable sharing of their benefits. To this end, Brazilian legislation has been evolving with regard to the set of rules and procedures for regulating activities with components of its biodiversity, in order to ensure compatibility with the CDB objectives and the protection of its biodiversity resources. 

The legal framework for Brazilian biodiversity is basically composed by Federal Law No. 13.123/2015 (“Biodiversity Law”) and its Regulatory Decree No. 8.772/16, in addition to other rules and guidelines issued by Conselho de Gestão do Patrimônio Genético (the Management Board of the Genetic Heritage (“CGEN”), linked to the Ministry of the Environment (“MMA”), responsible for the coordination, development and implementation of policies for management of genetic heritage (“PG”) and related traditional knowledge (“CTA”) to Brazilian biodiversity.

The activities associated with PG consist of actions that use generic information on plant, animal, microbial species (bacteria, microalgae, etc.), fungi of Brazilian biodiversity, as well as microorganisms that have been isolated from substrate existing in the national territory, the territorial sea, the exclusive economic zone or the continental shelf.

In turn, activities with CTA are those that use information or practices from indigenous populations, communities or traditional farmers about the properties or direct/indirect uses associated with PG.

In accordance with the rules in force on the matter, activities involving PG and CTA, inclusive, without limitation, access for technological research or development, forwarding of samples abroad, and notice of exploration of finished product or reproductive material, among others indicated in the Biodiversity Law, must have a registry with SISGEN (Sistema Nacional de Gestão do Patrimônio Genético (the National Genetic Heritage Management System), an on-line platform operated by CGEN.

It is worth mentioning that the Brazilian Biodiversity Law does not apply to human genetic heritage, nor does it allow access to the PG or CTA to be made by foreign individuals, or access to practices harmful to the environment, the cultural reproduction and the health human.

1 – https://www.gov.br/agricultura/pt-br/assuntos/inspecao/produtos-vegetal/registro/cgc_mapa/listagem-de-produtos-passiveis-de-registro-no-cgc-mapa


Authors: Pedro Szajnferber De Franco Carneiro, Gustavo Swenson Caetano, Paula Alice Barroso Cruz Thompson, Daniela Guarita Jambor and Lourenço Costa.

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