1. Introduction
On November 13, 2024, Law No. 15.022/2024 was enacted, establishing Brazil’s National Inventory of Chemical Substances and setting forth rules for risk assessment and management of chemical substances utilized, produced, or imported into the country. Inspired by international best practices, particularly Europe’s REACH regulation, Law No. 15.022/2024 introduces, for the first time in Brazil, a comprehensive registry and a structured system for risk assessment and chemical substance management. Below, we detail key provisions of the law and provide updates regarding its ongoing regulatory process, currently under public consultation.
2. Key Provisions of Law No. 15.022/2024
- National Registry of Chemical Substances: The law creates the National Registry of Chemical Substances, designed to populate the National Inventory and consolidate a publicly accessible database of chemicals produced or imported domestically. This registry serves as the core component of the Inventory, compiling technical data on each substance—including chemical identity (chemical name, CAS number), production or import volumes, and declared uses—as detailed in forthcoming regulatory guidelines.
- Criteria for Mandatory Registration: Registration in the Inventory is mandatory for all chemical substances (individually or within mixtures) whose annual production or import equals or exceeds one metric ton (based on a three-year average). Manufacturers and importers meeting this threshold must submit relevant information or face sanctions for non-compliance. The Chemical Substances Deliberative Committee may establish lower thresholds, requiring registration of substances below one metric ton when technically justified. Notably, mixtures and articles themselves are exempt from registration—only the substances they contain must be registered. Certain substances, such as low-concern polymers, monomers embedded in polymers, and related materials, are also explicitly exempted.
- Technical Committees and Governance: Law No. 15.022/2024 provides for specialized bodies to oversee the inventory and the risk assessment process, notably the Technical Committee for Chemical Substance Assessment and the Chemical Substances Deliberative Committee. These committees comprise experts from diverse sectors (health, environment, industry, commerce, metrology). The Technical Committee analyzes substance data and proposes risk management measures, whereas the Deliberative Committee holds decision-making authority over risk assessments and restrictions, and can define complementary technical criteria and further exclusions via regulations. These bodies ensure controls and restrictions are scientifically justified and based on rigorous multidisciplinary analyses.
- Scope and Exclusions: Law No. 15.022/2024 broadly covers nearly all chemical substances manufactured, imported, or used in industrial processes within Brazil. However, lawmakers have specifically excluded certain substances, such as radioactive materials and those exclusively for national defense. Also exempted are substances governed by other specific regulations, including foods and food additives, pharmaceuticals (including medical gases and devices), agrochemicals, veterinary products, cosmetics and hygiene products, cleaning agents, fertilizers, soil conditioners, and others listed explicitly in the law. Additionally, developmental substances, research-only substances, waste, non-isolated intermediates, and certain naturally occurring materials (ores, unmodified essential oils) are also excluded, as detailed in Article 3 of the law. Importantly, the law safeguards intellectual property rights over unpublished studies submitted for registering new substances: if manufacturers or importers conduct unique risk studies in Brazil for novel substances, these data remain confidential for up to 10 years, protecting against misuse by competitors and encouraging the generation of new scientific and technical information.
3. Implementation Timeline Law No. 15.022/2024
Law No. 15.022/2024 imposes a series of obligations and deadlines for both the public sector and the covered private sector. Some of the key statutory deadlines are:
| Event/Obligation | Deadline |
| Regulation of the Law (Executive Decree) | 180 days from enactment (May 2025 – already overdue) |
| Public consultation on draft Decree | May 13, 2025, to June 13, 2025 (initially launched, suspended; to reopen for additional 60 days) |
| Development of IT systems (Registry) | Within 3 years of law publication (by November 2027) |
| Companies’ data submission (Complete Inventory) | Within 3 years after system availability (deadline for registering all mandatory substances) |
4. Regulatory Process and Public Consultation
Law No. 15.022/2024 mandated a 180-day period following its enactment for issuing an executive decree detailing operational procedures, assigning responsibility to the Executive Branch—particularly Brazil’s Ministry of Environment and Climate Change (MMA)—to oversee this effort.
On May 13, 2025, MMA opened a public consultation on the draft regulatory decree through the “Participa + Brasil” platform. Initially intended to last 30 days (until June 13, 2025), the consultation was temporarily suspended shortly after opening for necessary adjustments to the draft decree. In an official statement, MMA indicated it will soon reopen the public consultation with corrections in place and extend the participation window by an additional 60 days.
The public consultation represents a strategic opportunity for businesses and industry groups to actively shape the regulatory framework governing chemical substance management in Brazil. It allows the private sector to provide technical input and practical suggestions, thereby refining the regulatory decree and ensuring future obligations are feasible and practical for businesses.
Meaningful participation, supported by data-driven contributions, scientific evidence, and practical expertise, enhances the quality of the regulatory process. Constructive dialogue among regulators, industry, academia, and civil society significantly increases the likelihood that the final National Inventory of Chemical Substances regulations will strike the appropriate balance—protecting public health and the environment while accounting for the technical and economic viability for industry stakeholders.
The Cescon Barrieu Government Relations team remains available for further clarifications and guidance on the points outlined in this briefing.
