Brazil Key Chemical Regulatory Insights 2024

On November 13, 2024, Brazilian President Lula sanctioned Law 15.022/24, previously known as PL 6120/24, establishing the National Inventory of Chemical Substances. This law establishes a comprehensive framework for effective risk assessment and management of chemical substances in Brazil. Previously, Brazil regulated chemicals through sector-specific laws covering areas such as pharmaceuticals, cosmetics, pesticides, sanitizing products, and explosives. With this new law, Brazil joins a select group of countries with advanced systems for monitoring chemicals entering its market and assessing risks to human health and the environment.  

At the core of the law is the National Inventory of Chemical Substances, a tool designed to assess and control the risks associated with chemical substances used, produced or imported into the national territory. Its main objective is to minimize adverse effects on health and the environment.  

This milestone is the result of collaboration between several Brazilian stakeholders, including the Ministry of the Environment and Climate Change (Ministério do Meio Ambiente e Mudança do Clima), the Brazilian Chemical Industry Association (Abiquim) and the National Chemicals Safety Commission (Conasq).  

Regulations are expected to be published in early 2025 that will further elaborate on key elements of the law. One such regulation is expected to define the operational framework of the Committees responsible for overseeing the evaluation of chemical substances.  

• Brazil Launches Public Consultations on Herbal Medicine Regulations 
  On November 27, 2024, Anvisa launched three public consultations to revise the regulatory framework for herbal medicines, with the aim of improving access, sustainability, and growth of the industry. Proposed changes include simplifying registration, revising restrictions, and updating pesticide residue lists. Stakeholders have until March 5, 2025, to submit their feedback. Read more here. 

• Brazil Proposes Stricter Lead Limits in Paints 
  The Brazilian Senate is reviewing Projeto de Lei Nº 3.428/2023, which aims to reduce the lead content in paints from 600 ppm to 90 ppm. Industrial and maritime paints will still be allowed to contain up to 600 ppm, but will have to carry warning labels in Portuguese. If enacted, manufacturers and importers will have one year to comply, and the existing Law 11.762/2008 will be repealed. Read more here. 

• Brazil Updates Cosmetics Regulations with RDC 907/2024 
  On September 23, 2024, ANVISA introduced RDC 907/2024, replacing several previous regulations to streamline compliance for cosmetics, personal hygiene, and perfume products. The update includes stricter labeling, mandatory registration, and enhanced microbiological controls. Companies must comply with these new requirements to avoid penalties. Read more here.