Who should conduct Regulatory Impact Analysis in Brazil? Challenges in defining federal regulatory bodies^[1]*

Quem deve fazer Análise de Impacto Regulatório no Brasil? Desafios na definição dos entes reguladores federais

Luiza Szczerbacki Castello Branco^[2]**

Abstract

Regulatory Impact Analysis (RIA) is a tool that seeks to pre-estimate the positive and negative effects of regulatory proposals or their revisions, in order to promote better-informed regulatory decisions. In Brazil, its mandatory nature was established by Law nº 13,848/2019 (General Law of Regulatory Agencies) and Law nº 13,874/2019 (Economic Freedom Law), extending to the entire federal Public Administration. However, the question remains: after all, who are the regulatory entities required to carry out RIA? This exploratory study, with a qualitative approach, uses the deductive method and a literature and documentary review to investigate this question. It concludes that the conceptual uncertainty regarding what regulation is and who the regulatory entities are, compromises the implementation of RIA in the country. Pathways to advance the consolidation of this regulatory policy are proposed, including suggestions for future research and possible legislation adjustments.

Keywords

Regulatory Impact Analysis (RIA); regulation; Regulatory Entities; Federal Public Administration; Regulatory Improvement.

Resumo

A Análise de Impacto Regulatório (AIR) é uma ferramenta que busca estimar, de forma prévia, os efeitos positivos e negativos de propostas normativas ou de sua revisão, a fim de promover decisões regulatórias mais bem informadas. No Brasil, sua obrigatoriedade foi estabelecida pela Lei nº 13.848/2019 (Lei Geral das Agências Reguladoras) e pela Lei nº 13.874/2019 (Lei de Liberdade Econômica), estendendo-se a toda Administração Pública federal. Contudo, persiste a dúvida: afinal, quem são os entes reguladores obrigados a realizar AIR? Este estudo, de caráter exploratório e abordagem qualitativa, fundamenta-se no método dedutivo e em revisão bibliográfica e documental para investigar essa questão. Conclui-se que a indefinição conceitual sobre o que é regulação e quem são os entes reguladores compromete a implementação da AIR no país, propondo-se caminhos para avançar na consolidação dessa política regulatória, incluindo sugestões para pesquisas futuras e possíveis ajustes normativos.

Palavras-chave

Análise de Impacto Regulatório (AIR); Regulação; Entes Reguladores; Administração Pública Federal; Melhoria Regulatória.

1. Introduction

Regulatory Impact Analysis (RIA) is a tool which maps the positive and negative consequences of norms within a given sector. It is used to estimate the impacts of new rules before they are created, as well as the revision of existing regulations.^[3]

It became mandatory in Brazil under Article 6 of the General Law of Regulatory Agencies (Law 13.848/2019) and Article 5 of the Economic Freedom Law (Law 13.874/2019.^[4] But a key question remains: which entities are required to undergo an RIA? Beyond regulatory agencies, the LLE extends this requirement to all bodies within the federal Public Administration, including autonomous agencies and public foundations, with the proposal to issue or amend normative acts of general interest to economic agents or service users.

However, defining specific regulatory bodies in Brazil is a tortuous task. Several lists, compiled both by the Public Administration and scholars, have sought to prescribe the entities that perform regulatory functions, and thus carry out RIA, without reaching a consensus. Given this uncertainty, further discussion is needed. In this context, we will consider the federal regulatory entities in question.

We begin by defining (or attempting to define) what regulation is: the conceptualization of this term in both national and foreign doctrine. Next, we discuss the role of regulatory bodies, examining the federal regulatory bodies in Brazil, with respect to the various lists compiled. The fourth section discusses the Public Administration understanding of regulatory bodies based on data from empirical research. Lastly, we present some conclusions.

This work is limited to a discussion of regulatory bodies at the federal level, leaving aside other levels of government. Exploratory research was conducted using a qualitative-methodological approach, combining practical and theoretical aspects. To this end, a deductive method and bibliographic-documentary review techniques were adopted.

2. Defining the Term 'Regulation'

The regulatory field matured significantly in the 1970s with the emergence of George Stigler’s economic theory of regulation.^[5] It expanded rapidly during the 1980s and 1990s as regulatory bodies were established around globally.^[6]

According to Christel Koop and Martin Lodge^[7], regulation is often defined too broadly.^[8] Due to its interdisciplinary nature, the concept has been shaped by diverse disciplines, such as law, economics, political science, sociology.^[9] Yet, recognizing the fluidity of the term, the authors observe that it is commonly understood as an intentional intervention in the activities of a given population.^[10] This is typically direct—involving the establishment of norms, monitoring, and sanctions, exercised by public sector administrators over the economic activities of private sector actors.^[11]

Acknowledging the elasticity of the concept, Robert Baldwin, Martin Cave and Martin Lodge^[12], present three main senses: (i) specific commands, involving the promulgation of a set of rules applied by a specific, dedicated body; (ii) deliberate state influence, in which regulation has a broader meaning, encompassing all state actions designed to influence business or social behavior; (iii) all forms of social or economic influence, in which all mechanisms affecting behavior are considered regulatory. The authors point out that regulation is often considered an activity that restricts behavior, designed to prevent the occurrence of certain undesirable activities, but also acts as a facilitator or enabler in deregulated markets.^[13]

According to Cary Coglianese^[14], at its most basic level, it is treated as a synonym for “law”. Regulations, then, are rules or norms adopted by the government, supported by the threat of consequences, usually negative, in the form of penalties. Often aimed at businesses, they also target non-profit organizations, other government entities, and even individuals.

Vital Moreira^[15], applying a broad concept, understands regulation as the establishment and implementation of economic activity rules aimed at balanced functioning, according to certain public objectives. In this sense, the objective is to shift economic behavior away from what it would naturally be under pure market rules.

Although there is no universally accepted definition, according to the Organization for Economic Co-operation and Development (OECD)^[16] regulations are a diverse set of instruments by which governments establish requirements for businesses and citizens. Regulations include laws, formal and informal orders, and subordinate rules issued by all levels of government, as well as those issued by non-governmental or self-regulatory bodies over which governments have delegated regulatory powers.

Martin Lodge and Kai Wegrich^[17] suggest that one way to define the concept is to analyze its purposes. Despite the lack of consensus, the authors distinguish four key descriptors: (i) technocratic instruments of control that reduce uncertainty, unwanted variation, and discretionary power introduced by fickle politicians; (ii) development of norms and professional self-regulation that encourages self-accountability; (iii) minimum rules necessary for the functioning of market economies; (iv) reduction of systemic risks.^[18]

2.1. Regulation in Brazilian Administrative Law

In Brazilian Administrative Law^[19] the term also lacks a single, univocal meaning, as in national legal doctrine it is subject to a wide variety of definitions and interpretations.^[20] In general, regulation is defined as a form of state intervention in the economic behavior of private companies.^[21]

Saddy^[22] states that regulation is widely accepted in Brazilian doctrine,^[23] encompassing any form of state action that limits the choices of private individuals and even public authorities. In these terms, it may be defined as: intentional interference in the choices of third parties; or, when carried out by the State (state regulation), indirect public intervention, in the economic domain, in a permanent and systematic manner, in the conduct of public and private subjects engaged in economic or social activities.^[24]-^[25]-^[26]

Odete Medauar^[27] also acknowledges the broader conceptualization, especially when associated with the activities of regulatory agencies, including: issuing rules; monitoring compliance; granting authorizations (such as permits and concessions); imposition of sanctions; mediation of conflicts (preventing or resolving them, through public consultation; public hearings; signing of cease-and-desist agreements and adjustment agreements.

It is clear, then, that despite differing interpretations, the definition of regulation, in international and national doctrine, converges on the notion of intentional intervention by Public Authorities aimed at influencing the behavior of agents, both public and private.

This study adopts the definition of Julia Black:^[28] a continuous, targeted attempt to modify behaviors according to pre-established standards or purposes, generating widely identified results, potentially involving mechanisms for establishing standards, collecting information, and changing behavior. The author summarizes regulation as intentional, goal-oriented attempts to solve problems undertaken by both state and non-state actors.^[29]-^[30] Armed with this understanding, we will now attempt to describe the regulatory bodies themselves.

3. Regulatory Bodies

Carlos Ari Sundfeld^[31] observes that regulation, as a type of state intervention, is manifested through powers and actions with explicitly economic objectives, and other means with different justifications but inevitable economic effects. In this sense, regulation is exercised both by authorities whose mission is to oversee a specific field of activity considered as a whole, and by those with powers over the generality of economic agents.

According to Cary Coglianese^[32] a regulator may be an individual agent, such as an inspector or the head of a regulatory body, or public or governmental institutions. The ways in which regulators seek to solve problems vary, but by definition, they tend to involve the application or enforcement of regulations. Regulation is typically understood as a rule supported by consequences.^[33] Thus, regulators inspect and monitor the behavior of individuals and entities subject to government rules to ensure the results of that behavior are in compliance.

But regulators are not just enforcers and executors of rules. They perform a variety of other actions, from educating and subsidizing to resolving disputes.^[34] In addition, they gather information and undertake research in conjunction with different public actors, not only regulated industry and government, but a multitude of interested individuals and organizations.^[35]

Through various types of action, regulators respond to immense social challenges. The specific issues depend on the mandate provided by political leaders; different regulators are tasked with solving different types of problems. Hence, the various regulatory sectors and institutions associated with virtually every sphere of the economy.^[36]

Despite their diverse structures, regulators share common attributes. In democracies, there are at least four characteristics: (1) a delegated mission; (2) enormous discretionary power combined with public accountability for the use of that power; (3) complex and dynamic problems; and (4) a diverse set of regulated companies with interests that diverge (to some extent) from the regulator.^[37]

Brazil has a multitude of administrative entities performing such functions. Regulatory bodies attached to certain segments of the economy have always existed.^[38] Additionally, other organizations perform regulatory activities, such as the Central Bank of Brazil (BCB), the Securities and Exchange Commission (CVM), the Superintendence of Private Insurance (Susep).^[39]

Historically, the direct Public Administration has also exercised regulatory functions: increasing and decreasing the tax rate on financial transactions (IOF) to intervene in the purchase and sale of foreign currency (Federal Revenue Service); regulating the level of compulsory deposits of financial institutions to increase or decrease the amount of currency in circulation (Central Bank of Brazil); monitoring the quantity, quality, and rules for financing higher education with the aim of expanding the supply or access to this service (Ministry of Education); supervising the production and marketing of products of animal origin and beverages and products of plant origin (Ministry of Agriculture, Livestock and Supply).^[40]

Furthermore, Ministers of State act as potential regulators under the general powers granted by items II and IV of Article 87 of the 1988 Constitution. This is particularly true regarding their authority to issue instructions for implementing laws, decrees, and regulations (item II). In this sense, such bodies clearly operate as regulatory entities.

SEAE Normative Instruction No. 111/2020,^[41] which establishes the reference criteria for analyses regarding regulatory improvement vis-a-vis reduction of business costs, defines a regulator in Article 2, item VII, as an agency or entity of the direct, autonomous, or foundational Public Administration responsible for issuing regulation. This refers to sub-legal regulatory acts of general interest to economic agents or service users (Article 2, item VI).

Thus, particularly in Brazil, such entities are not restricted solely to regulatory agencies;^[42] they encompass any and all Public Administration bodies that regulate a given sector—social or economic—through normative or enforcement acts, thereby shaping, imposing, or incentivizing the behavior of private parties.^[43]

3.1. Federal Regulatory Bodies in Brazil

Defining a regulatory body in Brazil is a huge challenge, given the enormous diversity of entities in the three spheres of government (federal, state, and municipal) and absence of clear, uniform delimitations. This lack of precision impedes the use of Regulatory Impact Analysis (RIA): hence, the need to establish objective criteria.

The attempt to catalog these regulators has generated a variety of lists, compiled by government and researchers, each using different methodologies. The lack of consensus underlines the need for a more coordinated effort to define and standardize which bodies actually qualify.^[44]

Luiz Felipe Seixas and Nilo Saccaro Jr.^[45] criticize the lack of clarity, noting how difficult it is to define who actually must comply with mandatory RIA requirements. They note that not even Decree No. 10.411/2020, which regulates RIA, specifies a list. Given this regulatory gap, the authors propose the following premises: (i) federal direct, autonomous, and foundational Public Administration entities;^[46] (ii) the exercise of regulatory functions or powers.^[47]

In this context, the authors^[48] analyzed the regulatory frameworks of different federal entities to identify those with regulatory functions/powers, which effectively exercise them, through the issuance, amendment, and/or repeal of normative acts of general interest to economic agents or users of public services. In this way, 146^[49] regulators were identified in the scope of the federal Public Administration.

The 2022 Census of Regulators^[50], conducted by the Secretariat for Economic Advocacy (SEAE), found that 50 out of the 135 entities analyzed qualified as regulators. However, the criteria used to select them was unclear. Another limitation of the methodology was the use of a self-declaration form, in which the entities themselves registered their status.^[51]. This may lead to inconsistencies, as entities are left to assess their own functions, in lieu of external verification or standardized criteria.

Drawing on the 2022 Census of Regulators, the Secretariat for Competitiveness and Regulatory Policy of MDIC^[52] compiled a list of 237 federal, autonomous, and foundational Public Administration bodies, including collegiate organs and professional regulatory boards, with regulatory powers. 168 were identified as first-level hierarchical bodies (such as secretariats), collegiate bodies or autonomous agencies, while 69 were identified as second-level hierarchical units.

An audit report by the Office of the Comptroller General (CGU)^[53] on the use of regulatory tools analyzed a total of 40 federal Public Administration entities. Based on the 2022 Census of Regulators, the selection targeted units that self-declared as regulators, excluding those lacking the competence to issue regulatory norms and those not subject to CGU oversight. Inmetro, Susep, CVM, and ANPD were also added.^[54].

In Ruling No. 2325/2022, the Federal Court of Accounts (TCU)^[55] identified 55 federal agencies in its official list of regulators. This monitoring report evaluated federal government initiatives to upgrade the regulatory environment, specifically focused on implementation of Decree No. 10.411/2020. According to the TCU, the selection was based on a report prepared during the implementation of Decree No. 10.139/2019, encompassing the main federal bodies and entities whose actions most impact the national regulatory environment.

Although not strictly a list of regulators, TCU Ruling No. 395/2023 is also noteworthy.^[56] An audit survey report, it was designed to gather systemic data about federal and regional professional oversight councils. In a section on professional autarchies, it acknowledged that these entities possess regulatory power^[57] and are therefore subject to Decree No. 10.411/2020.

Thus, based on these lists, some important reflections may be advanced. First and foremost, is the difficulty of uniformly defining regulatory bodies. Five distinct listings revealed five different sets of regulators, demonstrating the complexity of the matter. There is no consensus, not even among government entities, on this matter.

Another key point is the significant number of federal entities that have regulatory competences or effectively perform this function. As noted by Luiz Felipe Seixas and Nilo Saccaro Jr.,^[58] notwithstanding the variety of topics, areas, and sectors involved, we must reflect on (and reconsider) the range of entities with the prerogative to create regulations of interest to economic agents or service providers.

This multiplicity can lead to fragmentation, with potentially overlapping rules and jurisdictional conflicts. Compliance costs are increased and the efficiency of policy implementation is reduced. To draw a line between secondary regulators and those whose primary mission is creating rules, Luiz Felipe Seixas and Nilo Saccaro Jr.^[59] suggest two categories: stricto sensu and lato sensu regulators.

For the former, the exercise of regulatory power is a core activity (albeit not exclusive), whose rules—economic, social, or technical—impact not only agents within a specific economic sector but also the broader community of service users and consumers. Lato sensu regulators, meanwhile, exercise regulatory functions in a residual or secondary capacity. Generally, they lack the authority to issue technical regulations or oversee specific regulated markets.^[60]

Independent of this categorization, both are obligated to conduct RIAs when issuing regulatory acts of general interest to economic agents or service users. A clear and transparent definition of who qualifies as a regulatory entity is vital to promote accountability, monitor compliance with this requirement, and increase the efficiency of RIA adoption and tracking.

4. Public Administration perceptions the Regulatory Bodies

In this section we analyze empirical research data to evaluate how effectively the federal public administration complies with mandatory RIA requirements. Given the vast size of the federal administrative structure, the sample is limited to federal Executive Branch bodies with ministerial status,^[61] autonomous agencies and public foundations identified in PGF Ordinance No. 530/2007, and any entities listed in the 2022 Census of Federal Regulators^[62] not covered by the previous criteria.^[63]

The sample excluded regulatory agencies,^[64] professional regulatory boards,^[65] and regional development superintendencies,^[66] as well as federal educational and scientific research institutions, military schools, Colégio Pedro II, and the Armed Forces funding funds,^[67] making up a total of 70 federal entities.

A structured questionnaire was administered to the 70 entities to collect empirical data. This process was facilitated by formal requests for access to information via the federal government's e-SiC or Fala.BR platforms.^[68] The questionnaire consisted primarily of descriptive (numerical and quantitative) and dichotomous (yes-or-no) questions, to assess the RIA status of each entity.^[69] The data were collected and summarized for analysis between March 28, 2023, and June 1, 2023. From this, descriptive and causal inferences were made.

One of the main findings was the redirection of requests to regulatory agencies. This was performed under the justification that the responsibility for carrying out RIAs lies with these autonomous agencies, not with the entity itself. Specifically, the Ministry of Health (MS) and the Ministry of Labor and Employment (MTE) redirected the requests to the National Health Surveillance Agency (Anvisa).^[70].

The Ministry of Mines and Energy (MME) forwarded the request to both the National Agency of Petroleum, Natural Gas and Biofuels (ANP) and the National Electric Energy Agency (Aneel).^[71] Meanwhile, the Ministry of Ports and Airports (MPOR))^[72] stated that its two regulatory agencies—the National Civil Aviation Agency (Anac) and the National Waterway Transportation Agency (Antaq)—were responsible for publishing the RIA reports.

The Office of the Attorney General (AGU)^[73] responded that RIA reports are generally produced by regulatory agencies. Consequently, the AGU passed the request on to the specialized Federal Prosecutor's Offices handling Ancine, Antaq, and Anvisa. It also suggested contacting other regulatory agencies directly to obtain more information.

This redirection raises questions about the definition of regulation and regulatory bodies within the Public Administration, especially vis-a-vis delimitation of the responsibilities of each entity involved in the regulatory process. While such agencies undoubtedly play a central role in formulating sector-specific technical standards and implementing targeted regulatory policies—backed by extensive experience in conducting RIAs—Ministries are also regulatory entities.

In this sense, it appears that there is a perception within the Public Administration that regulation is linked to an economic bias, which contributes to a limited understanding of the concept of regulation and, consequently, the applicability of RIA. The fact that the Economic Freedom Law (LLE) mandates RIAs reinforces this view. It leads directly to the interpretation that the mechanism only applies to regulations with a direct impact on the market. Thus, a terminological confusion arises in which the classification 'economic' restricts the scope of RIAs, overlooking the breadth of their application to the various regulatory activities carried out by the federal Public Administration.

Another key finding concerns the justifications provided by several entities for not conducting RIAs, presented in the table below:

Table 1 Reasons for not conducting a Regulatory Impact Assessment

Prepared by the author

Thus, based on information provided by the entities, recognition of their role as regulatory bodies is a significant challenge—many arguing their functions are limited to operationalizing activities or implementing regulations. Such a justification unduly narrows the concept by ignoring the fact that such entities include not only regulatory agencies, but all bodies that shape, enforce, or incentivizes private sector behavior through regulatory or enforcement acts.

The lack of clarity, marked by the absence of a definition of which entities are considered regulators and, consequently, required to conduct RIA, is clearly reflected in the responses. Granting each entity the freedom to decide whether it is required to conduct an RIA may result in distorted application, as they evade scrutiny by failing to identify themselves in this way.

The findings suggest a limited view of the regulatory function of Ministries, which, nonetheless, possess the authority to regulate various matters of public interest, such as the formulation of policy and regulations that directly impact strategic sectors. This points to a misconception among public servants regarding the scope of ministerial regulatory functions, highlighting institutional and culture challenges.

One possible solution lies in the draft reform of the Administrative Procedure Law (Law No. 9.784/1999), PL Bill No. 2.481/2022, currently before the Senate.^[74] The project stipulates that, before editing, amending, or revoking a regulatory act of general interest, the responsible body must conduct an RIA, including detailed information about the possible effects of the act.

Consequently, embedding RIA as a mandate within a general law on administrative procedures strengthens its universal scope, demonstrating that its application extends beyond purely market concerns to encompass every facet of the Administration's regulatory purview. This measure can help mitigate resistance and promote greater clarity as to its scope.

5. Final Considerations

As a core regulatory practice, RIA systematically weighs the potential positive and negative effects of new regulations before they take effect. Considering outcomes in advance, it ensures all final policy decisions are guided by objective evidence and empirical data rather than assumptions.

As discussed, in Brazil legal recognition of RIA was established by Law No. 13.848/2019, the General Law of Regulatory Agencies (LGA), and Law No. 13.874/2019, the Law of Economic Freedom (LLE), formalized by Decree No. 10.411/2020. As a result, RIAs are now compulsory for all federal public administration entities, autonomous agencies, and public foundations. This requirement applies to any proposed creation or modification of regulations which impact economic agents or service users.

However, as seen, there is no clear definition of which entities are required to conduct RIAs. In fact, even within the Public Administration, there is no consensus on which administrative bodies qualify as regulators. As discussed, the prevailing view within the public administration is that regulation is inherently tied to an economic bias. This encourages a narrow understanding of what regulation means and, consequently, limits the scope of where RIA can be applied. This is reinforced by the fact that the RIA mandate is established within the Economic Freedom Law.

One way of overcoming this challenge is the draft reform of the Administrative Procedure Law (Law No. 9.784/1999), PL Bill No. 2.481/2022, currently before the Federal Senate. The bill stipulates that before issuing, amending, or repealing a regulation, the agency must conduct an RIA with detailed information on the potential effects of the measure. Since this is a general law applicable to the federal Public Administration, it should be clear to the entities involved.

As noted, entities themselves have difficulty self-identifying as regulators, possibly related to a limited conception of the concept. One hypothesis is that this stems from a misconception among public servants of the true scope of the regulatory functions of their organization. This highlights a potential cultural challenge.

Consequently, there is a pressing need to define regulatory authorities based on strict criteria, while outlining precisely which agencies are legally bound by the obligation to perform RIAs. This lack of clarity undermines the effectiveness of the process, as doubt over whether the requirement is mandatory prompt organizations to bypass it.

With regard to future research, objective criteria should be developed to support the systematic identification of entities with regulatory functions at the federal level. Additionally, clear, regulated lists of the agencies will provide much-needed legal certainty. Such steps are important to stimulate the uniform adoption of RIA across the federal public sector.

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1. * Article received on October 25, 2025 and approved on December 15, 2025. DOI: https://doi.org/ 10.12660/rda.v285.2026.94612. ↑

2. ** PhD in Economic and Regulatory Law from Universidade Federal Fluminense — UFF. Master's in Public Administration and Government from Fundação Getulio Vargas — EBAPE/FGV. Postgraduate degree in Public and Private Law from Escola da Magistratura do Estado do State of Rio de Janeiro — EMERJ. Bachelor's degree in Law from Universidade Federal Fluminense — UFF. Researcher at the Regulation in Numbers program of Fundação Getulio Vargas — FGV Direito Rio. Country: Brasil. Email: luizascbranco@gmail.com. ↑

3. PORTO, Antônio José Maristrello; GAROUPA, Nuno; GUERRA, Sérgio. Análise de Impacto Regulatório: Dimensões Econômicas de sua Aplicação. Economic Analysis of Law Review, V. 10, nº 2, p. 173-190, Mai-Ago, 2019. ↑

4. AIR is regulated by Decree No. 10.411/2020. ↑

5. One of the most celebrated contributions was developed by George Stigler; see: STIGLER, George J. The Theory of Economic Regulation. The Bell Journal of Economics and Management Science, v. 2, no. 1 p. 3-21, spring 1971. According to Stigler, the central tasks of economic regulation theory are to justify who receives the benefits or who bears the burdens of regulation, what form the regulation takes, and what its effects are on the allocation of resources. Among the main theories is the public interest theory, which posits that market inefficiencies and failures drive the need for regulation. For this reason, state regulation is necessary to restore balance and fairness to business practices. Another important theory is that of capture, which occurs when large interest groups or companies begin to influence the decisions and actions of the regulator, leading the latter to cater more to the interests of economic agents than society, i.e., public interests. For a more in-depth look at the economic theories of regulation, see POSNER, Richard A. Theories of Economic Regulation. The Bell Journal of Economics and Management Science, vol. 5, no. 2, 1974, pp. 335–58. For a critical revisiting of George Stigler's economic theory, see CARRIGAN, Christopher; COGLIANESE, Cary. Capturing Regulatory Reality: Stigler's The Theory of Economic Regulation. University of Pennsylvania Law School, Institute for Law & Economic Research Paper No. 16-15July 4, 2016. ↑

6. KOOP, Christel; LODGE, Martin. What is regulation? An interdisciplinary concept analysis. Regulation & Governance, 11: 95–108, 2017, p.1. According to Sérgio Guerra, regulation in the United States began to develop in 1887, when Congress created the first modern regulatory agency, the Interstate Commerce Commission, to regulate the rates of American railroads. For a fuller review of US agency regulationg, see GUERRA, Sérgio. Agências Reguladoras: da organização administrativa piramidal à governança em rede. 2. ed. Belo Horizonte: Fórum, 2021, cap. 1. ↑

7. Ibid., p.105/106. ↑

8. The authors analyzed 109 articles published between 1970 and 2014 in the fields of business, economics, law, political science, public administration, and sociology on the topic of regulation, finding that: (i) there is a scarcity of explicit definitions of what regulation is, and (ii) the scope of the concept is broad, given the high level of abstraction. It should be noted, however, that the research focused only on English language texts. ↑

9. According to Robert Baldwin, Martin Cave and Martin Lodge (BALDWIN, Robert; CAVE, Martin; LODGE, Martin. Introduction & Fundamentals. In: Understanding Regulation. Theory, Strategy, and Practice. 2nd ed. Oxford: Oxford University Press, 2012, p. 1), regulation is a key discussion topic in a wide variety of disciplines — notably law, economics, political science and public policy, sociology, history, psychology, geography, anthropology, and management. Given the broad scope of interest, the subject requires a multidisciplinary approach. ↑

10. “Hetero regulation” is a useful term. André Saddy defines it as oversight originating from outside the target sector. In this model, public authorities regulate a third party that may or may not be a public administration entity. Ultimately, the regulatory framework does not apply to the body enforcing it. SADDY, André. Regulação estatal, autorregulação privada e códigos de conduta e boas práticas. 2. ed. Rio de Janeiro: CEEJ, 2020, p. 92. ↑

11. Koop; Lodge. What is regulation? An interdisciplinary concept analysis, op. cit., p. 11. ↑

12. Baldwin et al. Understanding Regulation, op. cit., p. 3. ↑

13. Regulation directs market management in an orderly fashion, to inhibit the potential chaos of an uncontrolled market. ↑

14. COGLIANESE, Cary. Measuring Regulatory Performance Evaluating the Impact of Regulation and Regulatory Policy. Expert Paper No. 1, OECD, Paris, 2012. ↑

15. MOREIRA, Vital. Auto-regulação profissional e Administração Pública. Coimbra: Livraria Almedina, 1997, p. 34. ↑

16. ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT — OECD. The OECD Report on Regulatory Reform: Synthesis, Paris, 1997, p.6. ↑

17. LODGE, Martin and WEGRICH, Kai. O enraizamento da Regulação de Qualidade: fazer as perguntas difíceis é a resposta. In: Desafios da regulação no Brasil. Organizadores: Jadir Dias Proença, Patrícia Vieira da Costa and Paula Montagner. Brasília: ENAP, p. 17-38, 2009, p. 22-23. ↑

18. For Lodge and Wegrich, all four views on regulation are valid, despite their contradictory natures. ↑

19. For Fernando Almeida (ALMEIDA, Fernando Dias Menezes de. Considerações sobre a “regulação” no Direito positivo brasileiro. Revista de Direito Público da Economia — RDPE, Belo Horizonte, ano 3, n. 12, p. 69-94, out./dez. 2005), there is still insufficient consensus in Brazilian legal doctrine to establish a uniform definition as applied to administrative law. ↑

20. According to André Saddy, most theorists state that regulation encompasses all state activity in the economic domain that does not involve the direct assumption of exploitation of economic activity (in a broad sense) by the State. Among these authors are Floriano Azevedo Marques Neto, Alexandre Santos de Aragão, Marçal Justen Filho, and Carlos Ari Sundfeld. Some foreign authors such as Juan de la Cruz Ferrer and Vital Moreira adopt this same understanding. For an explanation of these divergences in national doctrine, see SADDY, André. Curso de direito administrativo brasileiro: volume 2. Rio de Janeiro: CEEJ, 2023, pp. 558-559. ↑

21. Ibid., P. 557. ↑

22. Ibid., P. 560. ↑

23. Regulation occurs in six ways: public heteroregulation, private heteroregulation, public self-regulation, private self-regulation, non-state public regulation, and deregulation. According to Saddy (Ibid p. 563) heteroregulation is external regulation, carried out by someone from outside the organization, which interferes with the choices of third parties; when public, it is referred to as state regulation, interfering in the choices of both private and administrative subjects; when private, it grants powers to a private entity, that it may interfere, autonomously, in future decisions and practices. Self-regulation is the establishment, through a written document, of rules of conduct and standards of behavior by public entities or bodies (public self-regulation) or by private individuals (private self-regulation), whose objective is to limit or restrict their freedom of future choices. Julia Black (BLACK, Julia. Constitutionalizing Self-Regulation. The Modern Law Review, v. 59, n.1, 1996, p. 27) defines self-regulation as a mechanism of collective governance, in which people or institutions, acting together, exercise regulatory functions in relation to themselves and/or to those who submit to their authority. According to Floriano Marques Neto (MARQUES NETO, Floriano Azevedo. Regulação econômica e suas modulações. Revista de Direito Público da Economia, n. 28, 2009, p.38) self-regulation is established through the consensual adherence to and observance of norms and standards of action by economic agents, subjecting them to incentive mechanisms, behavioral censures and/or associative exclusion. For Rafael Oliveira (OLIVEIRA, Rafael Carvalho Rezende. Novo perfil da Regulação Estatal: Administração Pública de Resultados e Análise de Impacto Regulatório. Rio de Janeiro: Forense, 2015, p. 138) non-state public regulation is that which originates from delegation of Public Power. According to Alexandre Aragão (ARAGÃO, Alexandre Santos de. Agências reguladoras e a evolução do direito administrativo econômico. 3. ed. rev. e atual. — Rio de Janeiro: Forense, 2013, p. 32), non-state public regulation is exercised by private entities that issue binding rules enforced through legal approval, such as professional councils and sports organizations. Although these entities assume a regulatory role within their respective fields, they are not transformed into state organs; rather, the state lends them its authority through legislative or constitutional means. Deregulation occurs when the regulation of the economy is subjected solely to the free movements of the market. (Ibid., p. 34). ↑

24. Saddy, Curso de direito administrativo brasileiro, op. cit., p. 560. ↑

25. For Di Pietro (DI PIETRO, Maria Sylvia Zanella (Org.). Direito Regulatório: temas polêmicos. 2 ed. rev. e ampl. Belo Horizonte: Fórum, 2004, p. 22), in the legal field regulation is the set of rules of conduct and control of public and private economic activity and social activities not exclusive to the State, aimed at protecting the public interest. ↑

26. The technical distinction between "regulation" and "regulatory," is important here, as they are often used synonymously in legal studies and by the national legislature itself. For an analysis of this differentiation, see Almeida. Considerações sobre a “regulação” no Direito positivo brasileiro, op. cit., e MEDAUAR, Odete. Regulação e auto-regulação. Revista de Direito Administrativo. Rio de Janeiro: 228: 123-128. Apr./Jun. 2002, p. 124. ↑

27. Ibid., pp. 124 and 127. ↑

28. BLACK, Julia. Critical reflections on Regulation. London: London School of Economics and Political Science, 2002, eBooks, p. 20. ↑

29. BLACK, Julia. Regulatory discussions. Journal of Law and Society. Oxford, vol. 29, no. 1, p. 163-196, Mar 2002. ↑

30. See also Barry Barton, Tony Posner, John C. Strick, and Barry M. Mitnick. ↑

31. SUNDFELD, Carlos Ari. Serviços Públicos e Regulação Estatal. In: SUNDFELD, Carlos Ari (coord.). Direito Administrativo Econômico. Malheiros: São Paulo, 2000, p. 18. ↑

32. COGLIANESE, Cary. The Challenge of Regulatory Excellence. In: COGLIANESE, Cary. Achieving Regulatory Excellence. Brookings Institution Press, University of Pennsylvania Law School, Public Law Research Paper No. 20-19, June 26, 2020, p. 2/3. ↑

33. According to Cary Coglianese, to implement regulation, regulators often issue licenses or approvals upon demonstration by the applicant that the criteria specified in the applicable rules have been met. Coglianese cites as an example the U.S. Food and Drug Administration (FDA), which approves new drugs when it deems them safe and effective. Ibid., P. 19. ↑

34. Cary Coglianese cites as an example the US Environmental Protection Agency, which dedicates considerable effort to public education and has created dozens of voluntary programs designed to encourage companies to improve their environmental performance in ways that go beyond mere compliance. Ibid., P. 19. ↑

35. Ibid. ↑

36. Ibid. ↑

37. Ibid., P. 19. ↑

38. MENDES, Conrado Hübner. Reforma do Estado e Agências Reguladoras: estabelecendo os parâmetros de discussão. In: SUNDFELD, Carlos Ari (coord.). Direito Administrativo Econômico. Malheiros: São Paulo, 2000, p.118. ↑

39. BRASIL. Diretrizes gerais e guia orientativo para elaboração de Análise de Impacto Regulatório — AIR. Subchefia de Análise e Acompanhamento de Políticas Governamentais [et al.]. Brasília: Presidência da República, 2018, p. 23. ↑

40. Ibid. ↑

41. MINISTÉRIO DA ECONOMIA Secretaria Especial de Produtividade, Emprego e Competitividade, Secretaria de Advocacia da Concorrência e Competitividade. Instrução Normativa SEAE nº 111, de 5 de Novembro de 2020. Establishes analysis benchmarks related to regulatory improvements aimed at reducing business costs. ↑

42. Luiz Felipe Seixas and Nilo Saccaro Jr. (SEIXAS, Luiz Felipe Monteiro; SACCARO JUNIOR, Nilo Luiz. Quem faz análise de impacto regulatório no Brasil? Uma avaliação da experiência federal. Brasília, DF: Ipea, jan. 2025. 38p.: il. (Texto para Discussão, n. 3046) point out that, specifically in regulatory matters, there is a tendency to consider that only regulatory agencies or independent regulatory authorities qualify as 'regulators,' which in practice is mistaken. For Natasha Salinas e Flávio Saab (SALINAS, Natasha Schmitt Caccia e SAAB, Flávio. O papel da regulação e futuro das agências. EGP Entrevista. Ementário de Gestão Pública, 9 dez. 2024), attributing regulatory activity solely to the 11 regulatory agencies listed in Law No. 13.848/19 is as inadequate as it is outdated ↑

43. In this sense, the definition of regulatory entities aligns with the concept of regulation currently adopted, given that the latter can be synthesized as a continuous and targeted attempt to modify behavior according to pre-established standards or purposes, with the intention of generating broadly identified outcomes ↑

44. For a multifaceted debate on 'Who regulates in Brazil?', we recommend the webinar hosted by FGV Direito Rio / Projeto Regulação em Números (Regulation in Numbers Project), which highlighted differing academic and technical perspectives and analyses about which organs are—or should be—considered regulators within the federal Public Administration. FGV DIREITO RIO. Quem regula no Brasil? Perspectivas e desafios no âmbito da administração pública federal. ↑

45. Seixas; Saccaro Junior, Quem faz análise de impacto regulatório no Brasil?, op. cit., p. 13. ↑

46. According to the authors, this group includes Ministries and their respective secretariats, autarchies—including regulatory agencies—public foundations, and any collegiate bodies attached to these agencies or entities Ibid. ↑

47. The authors define this power as the ability to issue, modify, or revoke regulations that affect market players or public service users. Ibid. ↑

48. Ibid., P. 14. ↑

49. The sample of 146 regulatory entities included Ministries, autarchies, and public foundations—and their collegiate bodies—as well as secretariats, departments, coordinators, and related units, provided they hold regulatory power. It also encompassed federal professional regulatory councils. ↑

50. SECRETARIA DE ACOMPANHAMENTO ECONÔMICO — SEAE. Censo de Reguladores Federais, 2022. ↑

51. Luiz Felipe Seixas and Nilo Saccaro Jr. (Seixas; Saccaro Junior, Quem faz análise de impacto regulatório no Brasil?, op. cit., p. 14)) criticize this limitation, arguing that, as a practical consequence, many entities that are effectively regulators (creating normative acts of general interest) do not see themselves as such, exempting them — in their own view — from carrying out Regulatory Impact Analysis (RIA). ↑

52. MDIC/SECRETARIA DE COMPETITIVIDADE E POLÍTICA REGULATÓRIA. Product 2 — Report identifying federal, autarchic, and foundational Public Administration bodies, including collegiate bodies, involved in regulatory activities, 2024. ↑

53. CONTROLADORIA GERAL DA UNIÃO — CGU. Relatório de Avaliação, Órgãos e entidades reguladores federais, Exercício 2022, 2024. ↑

54. According to the CGU, they are unequivocally regulators, even though they did not declare themselves as such in the Census survey. Information from the Ministry of Transport (MT) was not considered, as it did not respond to the audit request in the established timeframe. Ibid., P. 19. ↑

55. TRIBUNAL DE CONTAS DA UNIÃO — TCU. Acórdão nº 2325/2022. Relatório de Acompanhamento. Plenário. Relator: Vital do Rêgo. Data da sessão: 19 out. 2022. ↑

56. TRIBUNAL DE CONTAS DA UNIÃO — TCU. Acórdão nº 395/2023. Relatório de Levantamento. Plenário. Relator: Augusto Sherman. Data de sessão: 8 mar. 2023. ↑

57. Given that their legal mandates specifically address the powers to authorize, regulate, and oversee the corresponding professional system. Ibid. ↑

58. Seixas; Saccaro Junior, Quem faz análise de impacto regulatório no Brasil?, op. cit., p. 18. ↑

59. Ibid. ↑

60. Ibid., pp. 18 and 20. ↑

61. According to articles 17 and 18 of Law No. 14.600, of June 19, 2023. ↑

62. Secretaria de Acompanhamento Econômico — SEAE, Censo de Reguladores Federais, op. cit. ↑

63. These are: Brazilian Forest Service (SFB), Air Force Command (Comaer), Navy Command (Cmar), Army Command (Cex), Financial Activities Control Council (Coaf), Brazilian Intelligence Agency (Abin), Federal Police (PF), and Central Bank of Brazil (BCB). ↑

64. According to Technical Note 203/2020/AS/SAGEP/SAG (PRESIDÊNCIA DA REPÚBLICA, Nota Técnica 203/2020/AS/SAGEP/SAG, 2020) RIA, which underpinned Decree No. 10.411/2020, has been used for several years in Brazil by federal regulatory agencies. Hence, the aforementioned agencies were excluded, to focus the research on institutional contexts where the practice of RIA is less established, to address a gap in the literature and provide original empirical insights. ↑

65. The exclusion was based on a audit survey carried out by the Federal Court of Accounts (TCU, Ruling No. 395/2023, op. cit.), which mapped out federal and regional professional regulatory councils, specifically examining whether they were conducting RIAs. ↑

66. With the exception of the Superintendency of the Manaus Free Trade Zone (Suframa), included because it appears in the 2022 Census of Federal Regulators. ↑

67. Regional development superintendencies, federal educational and scientific research institutions, military schools, Colégio Pedro II, and the Armed Forces funding funds were omitted because they were not listed in the Census of Federal Regulators. ↑

68. e-SIC is the Electronic System of the Citizen Information Service, which allows any person a legal entity to submit requests for access to information, based on Law No. 12.527/2011 (Access to Information Law — LAI), to the bodies and entities of the Federal Executive Branch. ↑

69. The following questions were asked: 1) whether the agency or entity knows what an RIA is; 2) whether the agency or entity has ever produced a RIA report or document; 3) if so, how many RIAs were prepared, and whether the completed RIAs were made available; 4) if no RIA was carried out, what was the reason; and finally, 5) for any other information that the respondent considered relevant. ↑

70. According to Statement 46050.024463/2023-77, forwarded from MTP to Anvisa and Statement 25072.023386/2023-18 forwarded from the MS to Anvisa. ↑

71. As per Memorandum 48003.002832/2023-61, forwarded by the Ministry of Mines and Energy (MME) to the National Agency of Petroleum, Natural Gas and Biofuels (ANP), and Memorandum 48003.003812/2023-16, forwarded by the MME to the National Electric Energy Agency (Aneel). ↑

72. As per Statement 55001.000029/2023-78. ↑

73. As per Statement 01015.002602/2023-08. ↑

74. SENADO FEDERAL. Projeto de Lei n° 2481, de 2022. ↑