Chemical regulations
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Chile - Supreme Decree N° 57 of 2019
How to understand Supreme Decree N° 57?
Supreme Decree No. 57 of 2019, issued by the Ministry of Health in conjunction with the Ministry of the Environment, is the cornerstone of chemical safety in Chile. This regulation aims to protect human health and the environment by standardizing how chemical hazards are classified and communicated across the country.
Supreme Decree No. 57 is the national regulation that defines the requirements for the classification, labeling, notification, and risk assessment of hazardous substances and mixtures in Chile. Its implementation marked a major regulatory milestone by formally adopting the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
The technical criteria of this decree are based on the United Nations GHS 7th Revised Edition (Purple Book). The law mandates that manufacturers and importers identify the intrinsic hazards of their products before they are marketed or used, ensuring that everyone in the supply chain has accurate information regarding physical, health, and environmental hazards.
What are the key points of a Safety Data Sheet (SDS) in Chile?
The Safety Data Sheet (SDS) is the primary tool for communicating safety information throughout the industrial and professional supply chain. According to Title V of the regulation, the critical requirements include:
- Mandatory Provision: Suppliers must provide an SDS in Spanish, free of charge (in paper or digital format), for any substance or mixture classified as hazardous.
- 16-Section Structure: The SDS must strictly follow the standard GHS 16-section format, including product identification, hazard identification, composition, first aid measures, firefighting measures, exposure controls, and physical-chemical properties.
- Technical Competence: The regulation explicitly requires that the SDS be prepared by competent persons with professional technical training and verifiable experience in chemical or toxicological fields (Art. 271).
- Updates: The SDS must be updated within 6 months of the emergence of new significant scientific information or changes to the hazard classification.
- Emergency Contact Numbers: It is mandatory to include local emergency telephone numbers in Chile that are available 24/7 and equipped to provide guidance during chemical emergencies.
Labeling requirements according to Supreme Decree N° 57?
Labeling serves as the first line of hazard communication for the end-user. Decree 57 sets rigorous standards to ensure that information is both legible and easy to understand:
- Required Elements: Labels must include product identifiers, hazard pictograms, signal words (Danger or Warning), hazard statements (H-statements), precautionary statements (P-statements), and local Chilean supplier information.
- Pictograms: These must consist of a black symbol on a white background with a red diamond-shaped border. Specific precedence rules apply to avoid clutter (e.g., if the "Skull and Crossbones" for acute toxicity is present, the "Exclamation Mark" is typically omitted).
- Language and Visibility: All information must be in Spanish. Elements must be clearly and indelibly marked, contrasting sharply with the background of the container.
- Dimensions: Label size is regulated based on the container's capacity (e.g., for containers exceeding 500 liters, the label must be at least 148 x 210 mm).
- Consumer Products: For products intended for the general public, it is mandatory to include precautionary statements P101, P102, and P103, which relate to keeping the product out of reach of children and reading the label before use.
Other Relevant Chemical Safety Considerations in Chile?
Beyond classification and labeling, there are critical administrative and sector-specific processes in Chile:
- Substance Notification System: Manufacturers or importers of hazardous chemical substances classified under the criteria of MINSAL-MMA Decree 57/19 must notify the Chemical Substances Notification Platform of each substance imported and/or manufactured.
- Storage Regulations (DS 43): Any company storing chemical products must comply with DS 43/2015, which regulates safety conditions in warehouses, segregation distances, and fire control systems. Decree 57 complements DS 43 by defining which products fall into these regulated categories.
- Mining and Agriculture Sectors: In the mining sector, compliance with the Mining Safety Regulation (DS 132) is vital. In agriculture, pesticides for agricultural use are still managed by the Agriculture and Livestock Service (SAG), though they are progressively aligning with GHS communication standards.
- Extended Producer Responsibility (EPR Law): Companies must consider not only the safety of the product but also the management of its packaging and containers at the end of their lifecycle under the framework of Law 20,920.
What are the mandatory training requirements in Chile?
Chilean law is strict regarding the training of workers who handle chemicals. While Decree 57 focuses on communication, it works in tandem with other labor laws to mandate training:
- GHS/SGA Training: Employers must ensure that workers understand the new symbols and hazard statements adopted under Decree 57. This is part of the "Right to Know" or the Obligation to Inform (ODI).
- Supreme Decree No. 40 (Art. 21): Establishes the obligation for employers to promptly inform all workers about the risks involved in their tasks, preventive measures, and correct work methods. This includes the proper interpretation of SDSs and labels.
- Supreme Decree No. 594: Requires that all personnel working with hazardous substances receive specific training on the chemical risks they are exposed to and the correct use of Personal Protective Equipment (PPE).
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