Public Consultation Opens on Decree Regulating Brazil’s Law No. 15.022/2024 on Chemicals Inventory and Risk Management

On May 13, the Ministry of the Environment and Climate Change (MMA) officially launched a public consultation on the draft Decree intended to implement Law No. 15.022 of November 13, 2024. The law establishes the National Inventory of Chemical Substances and outlines procedures for the assessment and management of risks posed by chemicals produced, imported, or used within Brazil.

The consultation, led by the Secretariat for Urban Environment and Environmental Quality, will remain open until June 13, 2025. Interested parties must log in to the government’s platform to participate. 

Objective: Minimizing Risks to Health and the Environment

The proposed Decree provides a comprehensive regulatory framework aimed at systematically managing chemical substances and their potential risks. It establishes mechanisms to:

• Register chemical substances used, produced, or imported in Brazil;

• Prioritize substances for risk assessment;

• Assess risks to human health and the environment; and

• Implement risk management measures.

Key Provisions in the Draft Decree

• Thresholds for Registration: Chemicals that exceed 1 tonne/year of production or import (average over the past three years) must be registered.

• Committee Structure: The Technical Committee for Chemical Substances Assessment and a Deliberative Committee will oversee evaluation and decision-making processes.

• Use of Alternative Methods: The decree strictly regulates the use of animal testing, requiring it only as a last resort.

• Confidential Business Information (CBI): Provisions are included to protect trade secrets, with a clear process for requesting confidentiality.

• Fees and Enforcement: The decree introduces a Chemical Substance Registration, Evaluation, and Inspection Fee (TCAFSQ) and details the responsibilities of various regulatory bodies such as IBAMA, ANVISA, INMETRO, and the Ministry of Labor and Employment.

Call for Public Participation

Stakeholders from industry, academia, civil society, and government are encouraged to contribute comments and suggestions. The decree represents a critical milestone in the development of Brazil’s chemical regulatory infrastructure, offering a strategic tool to improve risk management, public health, and environmental safety. For more information and access to the draft decree, you can find it here (in Portughese).