Decree No. 57/2019 establishes Chile’s Regulation on the Classification, Labelling, and Notification of Hazardous Substances and Mixtures. The regulation aligns Chile’s chemical management system with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Published on 9 February 2021, the Decree requires manufacturers and importers to notify the authorities of hazardous substances and mixtures manufactured or imported in quantities above one tonne per year.
This notification system supports the creation and updating of Chile’s National Chemical Inventory. 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.
To facilitate compliance, the Decree outlines a phased implementation schedule:
|
Substance/mixture type |
Use type |
Notification deadline |
|
Hazardous substances |
Industrial use |
August 30, 2024 (completed) |
|
Hazardous substances |
Non-industrial use |
August 30, 2025 (completed) |
|
Hazardous mixtures |
Industrial use |
August 30, 2027 |
|
Hazardous mixtures |
Non-industrial use |
August 30, 2029 |
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 over 860 substances. And the list of over 10 hazardous substances for non-industrial use notified during 2025, thrught the Resolution 09425/2025 in September 2025
The following information must be provided when submitting a notification to the authorities:
Notifier information:
Substance information:
Once published, the inventory is updated every two years based on biennial notifications. Substances not included in the current inventory are considered “new substances” and require pre-market notification,
including the submission of hazard classification, labelling information, and a Safety Data Sheet (SDS) in Spanish. Manufacturing or importing such substances above the one-tonne threshold is not permitted until
approval is granted.
The Decree allows confidentiality claims for undisclosed 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.