In November 2024, Brazil enacted Law No. 15,022, commonly referred to as Brazil REACH, to regulate the registration, risk assessment, and management of chemical substances. This landmark legislation aims to reduce risks to human health and the environment while promoting sustainable chemical use.

For businesses operating in Brazil or exporting to this dynamic market, compliance with Brazil REACH is essential. At REACH24H, we provide expert consulting to ensure your business meets all regulatory requirements efficiently and effectively.

What is Brazil REACH?

Brazil REACH establishes the National Inventory of Chemical Substances and introduces stringent processes for managing chemicals across their lifecycle.

Key Aspects of Brazil REACH

• Applies to: chemical substances produced, imported, or used in Brazil in quantities ≥1 ton per year.
• Exemptions: Includes certain categories like radioactive materials, cosmetics, pharmaceuticals, food additives, and defense-related substances, etc.
• Requirements: Focuses on registration, risk assessment, and risk management measures to ensure safety and sustainability.

Who Must Comply with Brazil REACH?

• Local Manufacturers & Importers: Responsible for registering and managing compliance directly under Brazil REACH.
• Foreign Exporters: Must appoint a local representative to handle regulatory obligations, similar to the “Only Representative” model under EU REACH.

Exemptions Under Brazil REACH

While Brazil REACH covers a wide range of chemical substances, certain categories are excluded:

• Radioactive materials
• Food and food additives
• Cosmetics
• Pharmaceuticals and medical devices
• Waste and unintentional byproducts
• Substances used for defense, research, or under customs control
• Metal alloys for structural purposes
• Explosives
• …

Access global chemical inventories, hazard classifications, and compliance obligations—enter your CAS number or chemical name on ChemCheck  →  Check Your Chemicals Now

Registration Obligations Under Brazil REACH

Companies will have a three-year window to register existing substances and establish the National Inventory of Chemical Substances (INSQ)  once the system is operational.

Any chemical substance not listed in the National Inventory of Chemical Substances (INSQ) will be considered a new chemical substance.

New chemical substances manufactured or imported in quantities of 1 ton or more per year must be registered through the registration system in Brazil to ensure compliance with Brazil REACH.

Registration Data Required Under Brazil REACH

• Producer/importer details
• Annual production/import volumes
• Substance identification (CAS number, IUPAC name)
• GHS hazard classification
• Recommended uses

* Regarding to new chemical substance, additional technical documents are required for registration.

Prioritization and Risk Assessment Criteria

The registered chemical substances and new chemical substances will be selected and prioritized for risk assessment regarding human health and the environment based on the following criteria:

• Hazard properties: PBT substances, Carcinogenicity, mutagenicity, reproductive toxicity, and endocrine disruptors.
• Exposure potential: Impact on human health or the environment.
• International alignment: Substances flagged under global agreements.

The government may request additional data within 120 days for further assessment, and high-risk substances may face restrictions, authorizations, or bans.

Confidential Business Information (CBI) Under Brazil REACH

While information submitted to the National Inventory of Chemical Substances (INSQ) is generally accessible to the public, certain data is not considered confidential under Brazil REACH. These include:

• Identification of the chemical substances
• Declaration of recommended uses
• Hazard classification
• Results related to the impact on health and the environment
• Conclusions of the risk assessments

However, manufacturers or importers have the option to request protection for the identity of the chemical substance and its CAS number for up to 5 years. This request ensures that proprietary information is safeguarded, providing a balance between transparency and business confidentiality.

How REACH24H Supports Your Business

• Exclusive Local Representative Services: Act as your designated representative to manage compliance in Brazil.
• Chemical Substance Registration: Prepare and submit accurate data to ensure timely registration.
• Inventory Management: Help list your substances in the National Inventory of Chemical Substances for uninterrupted market access.
• Risk Assessment Support: Conduct detailed evaluations and submit supporting data for priority chemicals.
• Confidential Information Protection: Assist with CBI claims to safeguard proprietary data like CAS numbers and formulations.
• Regulatory Updates & Consultation: Provide ongoing guidance on Brazil REACH updates, so your business stays ahead of compliance requirements.

Why Choose REACH24H for Brazil REACH Compliance

REACH24H is a trusted partner to over 9,000 clients across 20+ countries, delivering global chemical compliance solutions. Backed by 100+ experts and 15+ years of experience, we provide precise, localized support to navigate complex regulations. With 8 global branches, we’ve contributed to industry standards and earned recognition from government agencies.

Email: customer@reach24h.com  | Contact Us