Chile
Supreme Decree 57/2019

How is the GHS implemented
in Chile?

Chile implements the Globally Harmonized System (GHS) through Supreme Decree (SD) 57/2019 on the Regulation of Classification, Labeling and Notification of Hazardous Chemical Substances and Mixtures to protect human health and the environment.

What is the SD 57/2019?

Chile implements the seventh edition of the GHS through SD 57/2019 on the Regulation on Classification, Labelling and Notification of Hazardous Chemical Substances and Mixtures.

SD 57/2019 entered into force on February 9, 2021 after its publication in the Official Gazette of the Republic of Chile. SD 57/2019 is mandatory for chemical substances for industrial purposes from February 9, 2022 and from February 9, 2023 for those chemical substances for non-industrial purposes. On the other hand, chemical mixtures must comply with SD 57/2019 from February 9, 2025 if they are for industrial use, and from February 9, 2027 if they are for non-industrial use.

The regulatory entity of SD 57/2019 is the Ministry of Health.

SD 57/2019 applies to hazardous chemical products in general, although the following product categories are excluded: radioactive substances, pharmaceutical and veterinary products, foodstuffs, cosmetics, waste, medical devices, minerals of natural origin and fertilizers.

What are the most relevant points of SD 57/2019?

• Both the SDS and label must be written in Spanish language.
  • The emergency telephone number must be Chilean and available 24 hours a day for those products intended for the general public.
• Hazardous chemical substances manufactured/imported into Chile in a quantity exceeding 1 ton per year must be notified through the Substance Notification System. Notification must be made every 2 years. The notification requirements involve a risk assessment (according to Titles II and III of SD 57/2019), information on labelling (Title IV) and SDS (Title V) and following the notification process stipulated in Title VI.
  • SD 57/2019 specifies that notification is mandatory for substances, and it is mandatory for mixtures for industrial purposes from 30 August 2027 and for mixtures for non-industrial purposes from 30 August 2029.
• The following hazard categories have not been adopted under the Chilean GHS: Pyrophoric gases; Flammable liquids, category 4; Desensitized explosive, all categories; Acute toxicity (oral, dermal and inhalation), Category 5; Skin irritation, category 3; Serious eye damage and eye irritation, subcategories 2A and 2B; STOT (single exposure), category 3; Aspiration risk, category 2; Acute aquatic toxicity, categories 2 and 3.
• The guidelines for preparing the SDS are set out in Article 274 of SD 57/2019, which indicates that it must follow the format of 16 sections. In turn, the SDS:
  • Must be delivered free of charge to the receiver in printed or digital format.
  • The name of the substance and the date of last update/version should be placed on each page.
  • It must be updated after 6 months of having new hazard classification information or national restrictions/prohibitions.
• The labeling directives are regulated in Article 245 of SD 57/2019 and indicates that the minimum labeling requirements include: product and supplier identifier (including its national telephone number), pictograms, warning words, H and P phrases, additional information and quantity of the substance.
  • The dimensions of the label and pictograms are based on the size of the package.
  • Depending on the size of the container (<50 ml, ≥50-125 ml, ≥125 ml), it will be mandatory or not to place the H phrases and the warning word on the labeling (as indicated in Table 51 of SD 57/2019).

What other chemical regulatory requirements apply in Chile?

• In 2021, the Ministry of Health published Resolution 777/2021, which contains the official List of classifications of substances. This List, which contains more than 4500 substances, serves as a reference for the classification of chemical substances and mixtures in Chile.
• Decree 40/2022 published by the Ministry of Transport and Telecommunications, in force since July 21, 2022, establishes amendments to the Dangerous Goods Transport Regulation of SD 298/1994. Its objective is to determine the safety conditions of those of transporters and vehicles of hazardous chemicals.
• Chile allows substances to be marked as confidential business information (CBI) according to Law 19039. Although the name of the substance can be hidden, it will be mandatory to indicate the dangerousness (H phrases) to ensure the correct protection of the health of workers and the environment.

• Fertilizers are regulated in Law No. 21349 that establishes the rules on composition, labeling and marketing of fertilizers, issued by the Ministry of Agriculture and in force since June 26, 2021.

  In turn, SD 157/05, in force since January 1, 2008, governs pesticides for sanitary and domestic use (including disinfectant products). They must be registered with the Chilean Institute of Public Health (ISP) and are grouped into three categories: pesticides, surface disinfectants and surface sanitizers.

• Cosmetics are regulated in SD No. 239/2002 on the Regulation of the National Cosmetics Control System published by the Ministry of Health. This Supreme Decree establishes the requirements for health registration in the ISP and the control of the commercialization of products.

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