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On 9 February 2021 the Ministry of Health of Chile published Decree 57 of 2019, Regulation on Classification, Labeling, and Notification of Hazardous Chemicals and Mixtures. This regulation applies to manufacturers and importers of dangerous chemical substances and mixtures.
Verisk 3E Review
In publishing Decree 57, Regulation on Classification, Labeling, and Notification of Hazardous Chemicals and Mixtures, Chile formally accepts the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) with an established implementation timeline (see below). In addition, Decree 57 initiates Chile’s new chemical reporting system.
Among other content in the GHS sections of Decree 57, you can find this information:
- The Ministry of Health will publish an official list of the classification of substances that will contain the hazard classes and categories. This Decree does not include the list of substances. In addition, the decree contains a process for presenting a less restrictive classification and for classifying substances that are not present in the list (Title II).
- A table with cut-off values that can be used throughout the regulation (Title II).
- On the classification and labeling of substances and mixtures, the decree provides classification criteria for physical, health, and environmental hazard classes (Title III).
- The decree references the United Nation’s Purple Book but does not state that it is based on a particular revision. Overall, the decree tends to follow GHS rev.6, but does contain references to other revisions of the GHS.
- General labeling specifications together with tables with required pictograms, signal words, and hazard/precautionary statements are included (Title IV).
- Both labels and Safety Data Sheets (SDSs) must be in Spanish.
- SDS information and instructions for the 16 sections including published headers and sub-headers (Title V).
Among the exclusions to the application of the GHS provision are nuclear substances, cosmetics, pesticide residues in food, hazardous waste, articles that contain dangerous substances or mixtures (explosive articles are covered), substances in transit, non-isolated intermediates, medical devices, unmodified minerals of natural origin, fertilizers that are currently regulated, pharmaceutical products for human and veterinary purposes (raw materials are not excepted), food additives (raw materials are not excepted), and animal feed (raw materials are not excepted).
Under the title of "Notification of Hazardous Substances," Decree 57 establishes a chemical reporting process, which states, in part, that every manufacturer or importer of a substance as such, and every importer of a substance contained in a mixture deemed dangerous according to the regulation, will notify the Chilean government about an amount equal to or greater than one ton annually. The Environmental Authority will establish an electronic portal for chemical reporting (Title VI).
Finally, Chile will establish risk evaluations of selected substances; the decree does not provide criteria for the risk evaluations nor does it provide an implementation timeline (Title VII).
The GHS Implementation Timeline
This regulation will come into effect according to the following calendar (Title VIII):
- Substances for industrial use—one year after publication on 9 February 2022
- Substances of non-industrial use—two years after publication on 9 February 2023
- Mixtures for industrial use—four years after publication on 9 February 2025
- Mixtures of non-industrial use—six years after publication on 9 February 2027
The decree defines substances and mixtures for industrial use as those whose anticipated intended use and application are in manufacturing and production processes.
Note that the implementation dates for chemical registration will come into effect two years from the effective dates indicated above:
- 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
Chemical registration is not required for active ingredients in pesticides for agriculture, health and home use.
Verisk 3E Analysis
Manufacturers and importers of dangerous substances and mixtures to Chile should be aware of the new chemical classification, labeling, and chemical reporting requirements and their implementation dates.