Regulatory updates in Chile: considerations for placing chemicals on the market

Chile is a country with rapidly developing regulatory framework; most recently the implementation of their version of “REACH”-inspired regulation means that those importing substances into the country are now required to notify substance information. Alongside REACH-like regulations, Chile also has requirements related to Safety Data Sheets (SDS), Poison Centre Notifications (PCN) and Emergency Response (ER).

Chile REACH

Chile has published and has implemented a “REACH”-inspired regulation (Decree 57/2019) which requires notification of hazardous substances that fall into scope. These substances must be notified according to the following four deadlines:

1. The first deadline (2024):
   This deadline applied to hazardous substances intended for industrial use. The Chilean Government published a list of notified substances in December 2024, accessed through the official platform here.
2. The second deadline (2025):
   The current notification window is open for substances classified as hazardous under the Globally Harmonized System (GHS) and exceeding 1 tonne for non-industrial use. Companies must notify the Ministry of Health by 30th August 2025, alongside submitting a SDS for each substance.

Meeting these deadlines is critical to avoiding potential penalties and ensuring that your substances are listed as compliant with Chile’s growing regulatory landscape.

Under Supreme Decree 57:2019, substances contained within mixtures must be reported if the total imported or manufactured mass of the substance contained within equals or exceeds one tonne and the substance is classified for health or environmental hazards and is present in the mixture at a concentration exceeding the cut-off values below:

N.B. Table values expressed in percentage by weight, except for gasogenous mixtures expressed by volume.

Classification, Labelling and Safety Data Sheets

Chile’s adoption of the GHS is another important regulatory development. However, Chile’s approach to GHS diverges from some other countries in the region, making it essential to understand these specific nuances:

1. GHS applies broadly in Chile
   Unlike countries such as Brazil and Mexico, where GHS is limited to workplace products, Chile has adopted GHS for both industrial/professional and consumer products. This broader scope impacts a wider range of substances and products, requiring technical managers to ensure compliance across multiple product categories.
2. Classification list for chemicals
   Chile has adopted a classification list based primarily on EU standards. This list serves as a minimum classification list, allowing companies to use more stringent classifications if additional data supports such changes. Regulatory professionals should be vigilant in ensuring that their substances are correctly classified and regularly updated.
3. SDS Requirements (NCh 2245:2021)
   In Chile, SDS must comply with the national standard NCh 2245:2021, which aligns with GHS revision 8, and any updates to a substance’s classification, risk management measures, or use restrictions must be reflected in the SDS within six months of receiving new information. SDS in Chile must also be authored in Spanish.

Managing these nuances highlight the importance of staying on top of Chile’s evolving GHS and SDS standards.

Chile Poison Centre Notifications

For products intended for consumer use, an emergency number in Chile for a poison control centre must appear on the label, and this poison control centre must at least have the SDS of the product available to provide first aid instructions.

For products intended for professional or industrial use, the supplier must provide the recipient directly with a SDS. The poison control centre indicated in section 1.4 of the SDS must also be provided a copy of the SDS.

Chile Emergency Response

An Emergency Response (ER) telephone number is required in section one of the SDS for Chile. A telephone number in Chile must be used and a response provided on a 24/7 basis. Where products are available to consumers a Chilean telephone number of a Poison Centre is required. In both cases people responding to calls require access to the product SDS as a minimum.

Solutions for your business

Ricardo's team of chemical regulatory experts can provide:

• Safety Data Sheet authoring, auditing and management solutions
• Support with Poison Centre Notifications for Chile - and other regions
• Chemical emergency response 

Having all three solutions by one provider enables organisations to streamline their compliance, ensuring consistent and accurate regulatory submissions across all services, reducing the risk of errors or omissions. This consistency of data minimises discrepancies between SDSs, Poison Centre notifications, and emergency advice while reducing administrative burden and creating efficiencies, saving time and resources.

Contact our chemical experts today.