Brazil REACH: A new chapter in chemical safety governance

In November 2024, Brazil became the latest nation to take decisive action on chemical safety with the introduction of Law No. 15,022, popularly referred to as “Brazil REACH.” This comprehensive legislation establishes a National Inventory of Chemical Substances and a robust regulatory framework for evaluating and managing chemical risks. The move places Brazil at the forefront of chemical safety governance in Latin America, aligning it with international standards and setting the stage for more sustainable industrial practices.

Brazil REACH reflects a growing global recognition of the need for stringent oversight of chemicals that impact human health and the environment. Modelled after the European Union’s REACH framework (Registration, Evaluation, Authorisation, and Restriction of Chemicals), the legislation is tailored to Brazil’s unique industrial landscape while addressing international demands for safer and more sustainable practices.

The law mandates the creation of the National Inventory of Chemical Substances, a comprehensive database cataloguing chemical substances manufactured, used, or imported within the country. Its aim is to centralise information, enhance transparency, and enable a thorough risk assessment of substances that may pose significant threats.

The backbone of Brazil REACH: The national inventory

Under Brazil REACH, manufacturers and importers are required to register any chemical substance that exceeds one tonne of annual production or import. The registration process involves submitting detailed information, including:

• Hazard Classifications: Following the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
• Production Volumes: Quantifying the annual amounts produced or imported.
• Intended Uses: Documenting how substances will be applied in various sectors.

By requiring this data, Brazil REACH provides a foundation for identifying chemicals that may harm people or the environment, ensuring they are subject to appropriate risk management measures.

Risk management framework

The law goes beyond data collection by implementing a thorough framework for assessing and controlling risks. Chemicals are prioritised for evaluation based on specific criteria, such as:

• Toxicity to human health or the environment
• Bioaccumulation potential
• Persistence in the ecosystem
• Known or suspected carcinogenic, mutagenic, or reproductive toxicity properties.

For substances identified as high-risk, Brazil REACH provides a range of management options, including:

1. Restricting their production or use.
2. Setting concentration limits in products.
3. Improving safety data sheets and labelling.
4. Imposing outright bans in extreme cases.

This multi-tiered approach ensures that the most hazardous substances are tightly controlled or eliminated from circulation.

Exemptions and special considerations

While Brazil REACH aims to cover a wide range of substances, it includes exemptions for certain products and materials already governed by other regulations. For instance:

• Radioactive materials, defence-related substances, and waste are excluded.
• Products like food, medicines, cosmetics, and pesticides fall under existing specific legislation.

These exemptions avoid duplicative regulatory burdens while maintaining oversight of critical sectors.

Additionally, polymers classified as “low-concern,” natural substances, and some fats and oils are also excluded, provided they meet specified criteria.

Implementation timeline and compliance

To facilitate the transition, Brazil REACH includes a three-year timeline to establish the necessary digital infrastructure for the National Inventory. During this period, businesses are expected to adapt their processes and ensure compliance with registration requirements.

Companies must update their submissions annually by March 31 to reflect changes in production volumes or uses. Non-compliance could result in penalties, including fines, restrictions on operations, or suspension of activities.

Fostering sustainability

Brazil REACH is not just about regulation—it represents a commitment to sustainability. By prioritising chemical safety, the law supports broader goals of environmental protection, public health improvement, and economic growth.

Key sustainability measures include:

Promoting a Circular Economy: Encouraging reuse and recycling of materials through better chemical management.

Minimising Waste: Implementing risk-based restrictions that limit the release of hazardous substances into ecosystems.

Alternative Testing Methods: Brazil REACH mandates the use of non-animal testing methods where possible, aligning with global efforts to reduce animal experimentation.

Such measures demonstrate Brazil’s alignment with international sustainability frameworks and its dedication to addressing the environmental impacts of industrial growth.

Challenges and opportunities for industry

While Brazil REACH presents significant opportunities for sustainable development, it also poses challenges for businesses. Compliance will require companies to:

• Enhance supply chain transparency.
• Invest in data collection and reporting systems.
• Adapt to new operational constraints on certain substances.

However, the benefits of compliance are substantial. By aligning with global chemical regulations, Brazilian businesses can enhance their competitiveness in international markets. Harmonisation with the Globally Harmonised System (GHS) simplifies trade and ensures access to markets with stringent safety requirements.

Moreover, Brazil REACH’s risk-based approach encourages innovation in safer alternatives and sustainable practices, opening doors to new business opportunities.