On February 9, 2021, Supreme Decree No. 57/2019 of the Ministry of Health, which approves the Regulation on Classification, Labeling and Notification of Hazardous Chemical Substances and Mixtures (the "Regulation"), was published in the Official Gazette.
Its enactment responds to the need to implement the Globally Harmonized System of Classification and Labeling of Chemicals (“GHS”) in Chile in order to facilitate international trade and protect human health and the environment.
The Regulation sets forth the criteria and obligations related to the classification, labeling, notification and risk assessment of hazardous substances and mixtures that manufacturers and importers must comply with, replacing the labeling regime established by the Regulation on Storage of Hazardous Substances (Supreme Decree No. 43/2015).
Main obligations for domestic manufacturers, importers and/or packers
- Safety labeling. Product identification, hazard pictogram(s), signal word(s), hazard statements, appropriate precautionary statements and supplementary information, along with the name, address and telephone number of the domestic supplier and nominal quantity of the substance or mixture must be clearly and visibly included.
- Delivery of safety data sheets to the final recipient. This obligation shall apply if the substance or mixture meets the criteria to be classified as hazardous.
- Notification of hazardous substances. Manufacturers or importers of a substance as such and importers of a substance contained in a mixture classified as hazardous, in quantities equal to or above 1 ton per year, must notify the corresponding information in the Substance Notification System, through the Single Window portal of the Environmental Authority.
Supervision and sanction
The competent Regional Offices of the Health Ministry will be in charge of supervising compliance with the Regulation’s provisions. Infringements may be sanctioned by these entities in accordance with the provisions of the Sanitary Code.
The Regulation establishes deferred terms to come into force, which fluctuate between 1 and 6 years as of the publication of the Regulation, depending on the type of substances and obligations involved.