Decree 57/2019 - Regulations on Classification, Labeling, and Notification of Hazardous Substances and Mixtures establishes a comprehensive framework for the management of hazardous chemicals in Chile, in line with the Globally Harmonized System (GHS) for Classification and Labelling of Chemicals. Implemented on February 9, 2021, the Decree mandates that manufacturers and importers notify the authorities of hazardous substances and mixtures exceeding one tonne per year, contributing to the development of a centralized national inventory of industrial chemicals. The inventory is currently under development, and the exact number of substances will be determined upon its completion.
The Decree defines hazardous substances based on the GHS criteria, which include physical hazards (e.g. flammability, explosiveness), health hazards (e.g. toxicity, carcinogenicity), and environmental hazards (e.g. aquatic toxicity). Substances meeting these criteria are subject to the provisions of the Decree.
Implementation Schedule:
To facilitate compliance, the Decree outlines a phased implementation schedule:
Substances for Industrial Use: Effective February 9, 2022.
Substances for Non-Industrial Use: Effective February 9, 2023.
Mixtures for Industrial Use: Effective February 9, 2025.
Mixtures for Non-Industrial Use: Effective February 9, 2027.
Registration deadlines are set at two years after each effective date, providing stakeholders with a structured timeline for compliance. On December 30, 2024, the Ministry of the Environment published the first list of hazardous substances for industrial use reported in 2024 under Resolution No. 7,595. It includes 866 substances.
Obligations for Substances:
Included in the Inventory:
Notification: Manufacturers and importers must submit detailed information, including chemical identity, classification, labelling, and Safety Data Sheets (SDS).
Compliance: Ensure that labelling and SDSs comply with GHS standards.
Risk Assessment: Participate in risk assessments for priority substances as required.
Not Included in the Inventory (New Substances):
Pre-Market Notification: Prior to manufacture or import, companies must notify the authorities and provide the necessary data for evaluation.
Approval: Await assessment and approval before market entry.
Compliance: Once approved, comply with all relevant regulations, including GHS labelling and SDS requirements.
The Decree allows confidentiality claims for proprietary information such as specific chemical identities or formulations. Companies must submit justification for such claims, which will be evaluated by regulatory authorities to balance commercial interests with public health and environmental safety.
By adopting GHS standards and establishing a national chemical inventory, Decree 57/2019 enhances regulatory oversight, promotes safe chemical management, and aligns Chile’s practices with international standards.
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