Chile to Start Initial Registration for Industrial Chemicals Soon

Chile has opened its chemical registration system under its REACH-inspired regulation (Decree 57). The registration period shall commence on February 9, 2024 and end on August 30, 2024, targeting industrial hazardous substances manufactured or imported into Chile in quantities over 1 ton per year. This initial notification period covers 2022 and 2023.

Additionally, Chile has released an Instruction to Decree 57, which serves as an important regulatory instrument for registration database. In it, the authorities explain in details the steps for registration as both local manufacturer and local importer. (Note: Foreign manufacturers have no obligation to register their substances. Chile has no Only Representative structure.) It also clarify by providing examples for what is defined by “substance for industrial use” as follows:

Definition: Substance whose intended use and application are carried out in manufacturing activity and production processes. (Article 3, Decree 57)

• Example of a substance used in manufacturing activity: substance used in any facility within a manufacturing industry that is part of the industry, such as in the laboratory, in cleaning and disinfecting machinery or facilities, in machinery repair.

• Example of a substance used in production processes: substance used as a raw material or as an additive in a process for the production of a finished product.

To help industries better identify substances requiring registration, the following substances will be considered:

• Substances listed in the Official List published through Resolution No.777/2021

• Substances that have some specific regulation, such as explosives or substances controlled by the General Directorate of National Mobilization (DGMN)

• Solutions where the substance cannot be stabilized on its own, but requires a solvent

• Substances used for energy or used as raw materials for the manufacture of liquid or gaseous fuels

• Substances or active ingredients for the formulation of pesticides for domestic, health and agricultural use and for the formulation of fertilizers

Submitted information

According to Decree 57, the following information must be submitted by a manufacturer or importer:

• 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 imported per year

• Intended uses

• Safety data sheet (SDS)

Chile registration schedules

As a reminder, this initial registration does not apply to substances contained in industrial-use mixtures. From 2024 to 2029, Chile will progressively roll out its registration schemes, depending on whether it is a substance or mixture for industrial or non-industrial use, with the deadlines detailed below:

Background

On February 9, 2021, Chile released Decree 57/2019 Regulations on Classification, Labeling, and Notification of Hazardous Substances and Mixtures, which implements GHS standard and REACH-like chemical regulation together in its national law. Later on August 23, 2021, the Ministry of Health published Resolution No. 777/2021 as a supporting document to Decree 57, approving the official list of classification of substances with their classes and hazard categories, to be used as further reference for manufacturers and importers based in Chile to classify their products. 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 days comments.