
EU Set to Debate ‘One Substance, One Assessment’ Chemicals Package to Overhaul Safety Rules
MEPs to debate 'one substance, one assessment' rule to simplify EU chemical safety laws. Industry must prepare for regulatory change.

Brazil has enacted its version of the REACH regulation with the approval of Law No. 15,022 on 13 November 2024. Known as "Brazil REACH," this groundbreaking legislation introduces a National Inventory of Chemical Substances, aligning the nation with other standards like the European Union’s REACH framework. The law aims to reduce health and environmental risks by mandating the registration, evaluation, and control of chemical substances used, produced, or imported within Brazil.
Law No. 15,022 establishes Brazil’s National Inventory of Chemical Substances, requiring detailed reporting on substances exceeding one tonne of annual production or importation. The legislation mirrors the EU’s REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) in its structure and objectives, marking a significant step towards aligning Brazil with international chemical safety practices.
The law sets stringent guidelines for manufacturers and importers to disclose critical information, including chemical hazard classifications, intended uses, and production volumes. It aims to centralise data, enhance oversight, and provide a foundation for comprehensive risk management.
Under Brazil REACH, companies are required to:
Register chemical substances with the National Inventory if they meet the one-tonne annual threshold.Provide data on hazard classifications, production volumes, and uses, adhering to the Globally Harmonised System (GHS) for chemical labelling.Update records annually by 31 March for any changes in production or use.Submit additional information for substances classified as hazardous, including potential risks to human health or the environment.
Mixtures, low-risk polymers, and certain substances such as those used for defence or research purposes are exempt from registration. However, their components may still need to be documented if they meet the specified criteria.
The law grants a three-year timeline for the establishment of the digital infrastructure necessary for the National Inventory. Companies must comply with the registration requirements within this period to avoid penalties, which can include fines, operational restrictions, or suspension of activities. Annual updates are mandatory to maintain compliance and ensure data accuracy.
Brazil REACH draws heavily from the EU REACH framework, particularly in its focus on health and environmental safety, data transparency, and corporate accountability. By adopting the GHS system and prioritising risk-based evaluations, the regulation seeks to harmonise Brazil’s approach with international best practices, making it easier for Brazilian businesses to engage in global trade.
Brazil REACH signifies a milestone in chemical safety governance, reinforcing the country’s commitment to sustainable industrial practices. A legislative source commented, "This regulation demonstrates Brazil’s readiness to lead on chemical safety in Latin America." With its robust requirements and alignment with global standards, Brazil REACH is poised to advance public health and environmental protection.




MEPs to debate 'one substance, one assessment' rule to simplify EU chemical safety laws. Industry must prepare for regulatory change.

The EU’s 2025 Work Programme will introduce a chemicals industry package in Q4 2025, aiming to simplify compliance, reduce administrative burdens, and enhance digital reporting.

This strategy aims to advance chemical safety through science, collaboration, and knowledge, emphasising the protection of human health and the environment.
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