New Regulatory Framework for Chemical Substances in Latin America

The regulation of chemical substances in Latin America is undergoing a significant transformation, driven by the adoption of new regulatory frameworks that seek to increase safety, protect the environment and align with international standards. Brazil, Chile, Colombia and Peru are at the forefront of these changes, adopting measures that strengthen the management of chemical substances.

Brazil: Legislative Advances

On November 13, 2024, Brazil launched the new National Chemical Safety Law, establishing a historic regulatory framework for the management of chemical substance risks in the country.

The legislation, supported by associations such as the Brazilian Chemical Industry Association - Abiquim, creates a National Inventory of Chemical Substances. The new regulation requires that all chemical substances produced or imported in Brazil be registered in a public database, ensuring greater transparency and safety in sectors such as plastics, paints, cosmetics, sanitizing products and hospital supplies.

Main Provisions:

Risk Assessment and Management: Prioritizing substances of greatest concern, with specific control measures.

Public Registry of Substances: Publicly accessible inventory, establishing criteria and deadlines for registrations.

Accountability and Compliance: Manufacturers and importers must ensure compliance, with clear penalties for violations.

Implementation of the new law should bring environmental and economic advances, strengthening Brazil's position as the sixth largest global chemical market.

Link to the Law: https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/L15022.htm

Chile: Comprehensive Regulatory Framework

Chile has moved forward with Decree 57/2021, which regulates the classification, labeling and notification of hazardous substances. This decree is aligned with the Globally Harmonized System (GHS) and requires the registration of hazardous chemicals when their production or import exceeds one ton per year.

Chilean Regulatory Highlights:

Adoption of GHS: Applicable to industrial and consumer products.

Mandatory National Registration: For substances above specified limits.

Safety Data Sheets (SDS): Companies must provide SDS to ensure safe handling.

The registration process began in February 2024, reinforcing Chile's commitment to regulatory modernization.

Decree Link: https://bcn.cl/2nluj

Colombia: Regulatory Reforms

Colombia also implemented significant advances with Decree 1630/2021, inspired by the European Union's REACH model. This decree requires the registration of industrial substances classified as hazardous in quantities exceeding 100 kg per year.

Key Points of Colombian Regulation:

Registration of Hazardous Substances: Detailed requirements for manufacturers and importers.

GHS Compliance: International classification and labeling criteria.

Online Registration System (RSQUI): Deadline for registration of industrial chemicals is May 31, 2025.

Link to Decree: https://dapre.presidencia.gov.co/normativa/normativa/DECRETO%201630%20DEL%2030%20DE%20NOVIEMBRE%20DE%202021.pdf

RSQUI System: https://servicios.mincit.gov.co/rsqui/login.php

Peru: New Regulatory Framework

Peru introduced Legislative Decree No. 1570, in force since May 2023. The new regulation establishes the National Registry of Chemical Substances (RENASQ) and defines procedures for risk assessment of priority substances.

Key Elements of Peruvian Regulation:

Creation of RENASQ: National inventory to track chemical substances.

GHS Adoption: Standardization of Risk and Safety Information.

Decree Link: https://busquedas.elperuano.pe/dispositivo/NL/2181948-2%20

Regional and Business Impacts

The simultaneous advancement of these regulatory frameworks signals a growing trend in Latin America to improve chemical safety and environmental management. In addition to aligning with international standards, these countries are setting benchmarks for other nations in the region.

Implications for Businesses:

Compliance Challenges: Companies will need to adapt to new regulatory requirements.

Market Access: Foreign manufacturers will face increased scrutiny and will need to adjust their strategies to operate in the region.

Conclusion

The evolution of chemical regulations in Latin America reflects a growing commitment to protecting public health and the environment. With Brazil, Chile, Colombia, and Peru adopting models inspired by REACH and GHS, companies must prepare for new compliance challenges and contribute to safer and more sustainable chemical management in the region. This regulatory change not only strengthens safety, but also positions Latin America as a proactive player in global chemical governance.