Chemical regulation in Latin America
Cristina Garcia of Knoell Iberia provides a comprehensive overview of chemical regulations across Latin America
Latin America is a huge and diverse region. Predominantly Spanish and Portuguesespeaking, it extends from Mexico ' s northern border to South America ' s southern tip, encompassing major economies like Brazil, Argentina and Mexico, alongside smaller Central American and Caribbean countries.
Major trade blocs such as Mercosur, the Andean Community( CAN) and the Pacific Alliance play a key role in shaping regulatory harmonisation and market access for the chemical industry. These blocs align standards mainly in cosmetics, food contact materials and medical products, while industrial chemicals remain subject to national regulations.
Mercosur and CAN adopt binding regional decisions incorporated into domestic law, whereas the Pacific Alliance promotes voluntary alignment to facilitate trade. Other blocs, including the Central American Integration System( SICA) and the Caribbean Community( Caricom), pursue broader economic cooperation with limited regulatory integration.
Brazil: The INSQ
According to Abiquim, the Brazilian Chemical Industry Association, Brazil ' s chemical industry is among the world’ s largest, trailing only China, the US, Japan, Germany and South Korea. Despite this growth, regulatory gaps persisted, leaving numerous potentially hazardous substances unregulated. Historically, Brazil regulated chemicals solely through sector-specific legislation covering, among others, pharmaceuticals, cosmetics, pesticides and sanitising products, with additional controlled substance lists maintained by federal police and military authorities.
In November 2024, Law 15.022 / 2024 was sanctioned, establishing the National Inventory of Chemical Substances( INSQ), a milestone that positions Brazil among nations with advanced chemical monitoring and risk assessment systems. The law creates a comprehensive framework for chemical substance registration, risk assessment and risk management, establishing two central pillars: the National Registry of Chemical Substances and the INSQ. It is often referenced as‘ Brazil REACH’, due to its structural similarity to the EU REACH Regulation.
Chemical substances manufactured or imported in quantities of ≥1 tonne / year must be registered in the inventory, including information on identity, quantity, classification and intended uses. Exemptions apply to mixtures, articles and certain polymer components, while polymers require registration unless considered to be‘ low concern’.
Substances already listed or newly introduced are prioritised for risk assessment based on factors such as carcinogenicity, persistence, bioaccumulation and international alerts. Depending on the assessment outcomes, authorities may implement risk management measures such as concentration limits, authorisation requirements, restrictions or prohibitions on manufacture, import or use.
Implementation presents significant challenges. Foreign manufacturers can collaborate with Brazilian importers through a dedicated online registration platform, exchanging confidential information with authorities without disclosure to importers. Alternatively, they may appoint an Exclusive
Representative, similar to an Only Representative under REACH.
Law 15.022 / 2024 is now in effect, with official regulations expected soon. The online registration platform is expected to be launched in November 2027 and companies will have three years to complete inventory registration, with finalisation required by November 2030.
Chile: Decree 57 / 2019
Before Decree 57 / 2019, Chile lacked unified life-cycle chemical legislation. Regulations were fragmented across sectoral instruments focused primarily on storage, occupational safety and hazardous substance importation. The main regulatory texts addressed storage at facilities exceeding certain tonnage thresholds, relying on Chilean
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