Brazil REACH Regulations and Chemical Management

In November 2024, Brazil enacted Law No. 15.022, commonly referred to as Brazil REACH. This landmark legislation aims to regulate the registration, risk assessment, and management of chemical substances to reduce risks to human health and the environment while promoting sustainable chemical use. Compliance is essential for any business operating in or exporting to the Brazilian market.

The regulation establishes the National Inventory of Chemical Substances (INSQ) and introduces stringent processes for managing chemicals across their entire lifecycle.

Key Aspects and Applicability

Brazil REACH applies specifically to chemical substances produced in, imported into, or used in Brazil in quantities of 1 ton or more per year.

• Local Manufacturers and Importers

These entities are responsible for directly registering and managing compliance under the law.

• Foreign Exporters

Manufacturers based outside of Brazil must appoint a local representative to handle regulatory obligations, similar to the "Only Representative" (OR) model found in EU REACH.

Exemptions Under Brazil REACH

While the law covers a wide range of chemical substances, certain categories are excluded from these specific registration requirements:

• Radioactive materials, food and food additives, and cosmetics.
• Pharmaceuticals and medical devices.
• Wastes and unintentional byproducts.
• Substances used for defense, research, or under customs control.
• Metal alloys for structural purposes and explosives.

Registration Obligations and Data Requirements

Once the system is operational, companies will have a three-year window to register existing substances and establish the initial INSQ. Any chemical substance not listed in the INSQ will be considered a new chemical substance and must be registered before being manufactured or imported in quantities of 1 ton or more per year.

Mandatory data for registration includes:

• Producer or importer details and annual production/import volumes.
• Substance identification (CAS number, IUPAC name) and GHS hazard classification.
• Recommended uses.
• For new substances, additional technical documents are required for the full registration process.

Prioritization and Risk Assessment

Registered and new chemical substances will be selected and prioritized for risk assessment based on specific criteria:

• Hazard Properties: Including 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 future restrictions or bans.

Confidential Business Information (CBI)

While information submitted to the INSQ is generally accessible to the public, certain data is not considered confidential under Brazil REACH, such as the identification of chemical substances and hazard classifications. However, manufacturers or importers can request protection for the identity of a chemical substance and its CAS number for up to 5 years to safeguard proprietary information.

Proregulations' Support for Brazil REACH

Our team offers comprehensive solutions to help you navigate the new Brazilian regulatory landscape:

• Exclusive Local Representative Services

Acting as your designated representative to manage all compliance duties in Brazil.

• Chemical Substance Registration

Preparing and submitting accurate data to ensure timely registration in the INSQ.

• Inventory Management

Assisting with the listing of substances to ensure uninterrupted market access.

• CBI Protection

Helping with claims to safeguard proprietary data like CAS numbers and specific formulations.

• Regulatory Updates and Consultation

Providing ongoing guidance on the evolving Brazil REACH requirements.

If you need to ensure your chemical products meet the new Brazil REACH standards or require local representation, please contact us.