On 9 February 2021 the Ministry of Health of Chile published Decree 57, Regulation on Classification, Labelling, and Notification of Hazardous Chemicals and Mixtures. This regulation applies to manufacturers and importers of dangerous chemical substances and mixtures that are based in Chile. Foreign manufacturers have no obligation under Decree 57.


In Chile, chemical notification will commence for the following sectors at the associated deadline:

  • Substances for industrial use—9 February 2024
  • Mixtures for industrial use—9 February 2027
  • Substances of non-industrial use—9 February 2025
  • Mixtures of non-industrial use—9 February 2029

The chemical notification system under Chile’s REACH-inspired regulation is now live. The notification period commenced on February 9, 2024, and will end on August 30, 2024. As specified above, the first deadline is targeting industrial hazardous substances which are manufactured or imported into Chile in quantities over 1 ton per year.

Who is Impacted?

The notification obligation applies to companies in Chile that manufactured or imported more than one tonne of hazardous substances or mixtures for industrial use in 2022 or 2023. It should be noted that once the substance has been notified, subsequent reporting is then due every two years thereafter.

When a substance has been originally notified by one company, it will then be listed on the chemical inventory. The government plans to publish the first national inventory by 31 December 2024.

Chemical Inventory:

The chemical inventory will include all the substances that have been notified to the ministry. The initial notifier provides the necessary information about the substance, including its classification, hazards, and other relevant details. Therefore, if a substance is already listed on the inventory, then the manufacturer/importer is only required to carry out reporting every two years thereafter. This reporting obligation is less comprehensive than the notification required to get the substance on the national inventory. It focuses on basic information about the substance. Full notification is required where the substance is not listed on the inventory, this is a more thorough process.

Notification Details:

As the national inventory has not yet been published, it is recommended that companies should notify any substance that they import and/or manufacture in quantities of 1 tonne or more to ensure that it is included in the inventory.

Foreign manufacturers are unable to notify their substances in Chile as there is no Only Representative structure in place. Therefore, if foreign manufacturers wish to ensure that their substances are included on the inventory in Chile, they must work closely with their Chilean importer(s) in order to do this.

Please contact H2 Compliance for any assistance with achieving compliance under Chile’s Decree 57.

Published May 21, 2024