Request a DemoOn February 9, 2021, Chile released Decree 57/2019 Regulations on Classification, Labeling, and Notification of Hazardous Substances and Mixtures (hereinafter referred to as Decree 57), which implements REACH-like chemical regulation and GHS standard together in its national law.
1. Authoritative Body
The Regional Ministerial Secretariats of Health (SEREMI de Salud) within their territory of competence and in their capacity as Health Authority, shall be responsible for overseeing the application and compliance of these regulations.
The Ministry of Health (MINSAL) and Ministry of Environment (MMA) shall be responsible for promulgating official list and technical guidance for implementation of this regulation.
2. Registration
2.1. Registration Scope
As per Decree 57, every manufacturer or importer of a hazardous substance or mixture in quantities above 1t/yr shall register in the substance notification system (Plataforma de Notificación) through the Single Window portal of the Environmental Authority.
New substances used as explosives or as active ingredients for pesticides for agricultural use and for health and domestic use are exempt from registration.
Note: Registration is only applicable for local manufacturer and importer. Chile has no Only Representative structure, and foreign manufacturers have no obligation to register their substances.
2.2. Required Information
The required submitted information include:
Identity of the notifier (manufacturer, importer, legal representative, etc)
Identity of the substance(s), including IUPAC nomenclature, CAS number, hazard classification, etc
Quantity of the substance manufactured or importer per year
Intended uses
Safety data sheet (SDS)
2.3. Initial Registration window
The initial registration period for industrial hazardous substances has commenced on February 9, 2024 and ended on August 30, 2024 (Click here to learn more). From 2024-2029, Chile will gradually roll out registration schemes for substances and mixtures of industrial and non-industrial use. The deadline details are listed below:
| Type of substance | Deadlines for notification |
| Substance for industrial use | February 9 to September 30, 2024 (concluded) |
| Substance for non-industrial use | February 9 to August 30, 2025 |
| Substances contained in mixtures for industrial use | February 9 to August 30, 2027 |
Substances contained in mixtures for non-industrial use | February 9 to August 30, 2029 |
2.4. New Substances
Once the initial registration completes, the Ministry of Environment (MMA) will issue a Resolution with all the notified substances until December 31, 2029.
Substances not covered by this resolution shall be considered "new substances" and shall be notified prior to commercialization, importation or manufacture. In case of importing new substances, the Health Authority will grant the respective import authorization only if the notification process for those substances has been previously verified.
3. Prioritization and Risk Assessment
On January 5, 2024, Chile notified to WTO the Resolution approving the prioritization and selection procedure and the risk assessment procedure for chemical substances of interest for 60-day comments.
The prioritization procedure establishes criteria for selecting chemicals that will be evaluated for their risks to human health and the environment. The criteria for prioritization of chemical substances or substances contained in mixtures include:
Hazard class and category to human health and the environment
Annual imported or manufactured volume
Sector of use
Based on the hazard level, tonnage and intened uses, the respective scores for each substance shall be counted by adding scores for the abovementioned criteria. (See Table 1-3)
Table 1. Categorization of chemical substances, according to class and category of hazard to health and the environment
| Classification | Low | Medium | High | ||||||
Health hazard/score | 1 | 3 | 5 | 6 | 7 | 8 | 9 | 10 | 12 |
Respiratory or skin sensitization | Cat 1B | Cat 1A | |||||||
Germ cell mutagenicity | Cat 2 | Cat 1B | Cat 1A | ||||||
Carcinogenicity | Cat 2 | Cat 1B | Cat 1A | ||||||
Reproductive toxicity | Cat 2 | Lactation | Cat 1B | Cat 1A | |||||
Specific target organ toxicity (Single exposure) | Cat 3 | Cat 2 | Cat 1 | ||||||
Specific target organ toxicity (Repeated exposure) | Cat 2 | Cat 1 | |||||||
Hazardous to the aquatic environment (Acute) | Cat 1 | ||||||||
Hazardous to the aquatic environment (Chronic) | Cat 4 | Cat 3 | Cat 2 | Cat 1 | |||||
Table 2. Categorization of chemical substances, according to annual import or manufacturing volume
| Classification | Low | |||
| Quantity/Score | 1 | 2 | 3 | 4 |
Annual imported or manufactured volume for substances or substances contained in a mixture | > 1 /yr and<10 ton/year | > 10 t/yr and < 100t/yr | > 100 t/yr and < 1000t/yr | > 1000 t/yr |
Table 3. Categorization of chemical substances, according to sectors of use
| Classification | Low | Medium | |
Substance usage/Score | 1 | 3 | 5 |
| Intended use | Industrial | Professional | Domicilary |
Substances that score more than 15 points will be considered substances of interest, which will require risk assessment from their manufacturers and importers. MMA will notify the obligated entities to carry out risk assessment within 18 months.
If the risk assessment determines that the chemical presents an unacceptable risk to humans and/or the environment, then the importer or manufacturer of the substance must implement additional and complementary risk management measures. The MINSAL and MMA shall additionally consider implementing restrictions or prohibitions on certain uses of these substances.