Introduction and Background
Colombia’s Decree 1630/2021 established a comprehensive regulatory framework for the management of industrial chemical substances. This regulation aligns with international standards, particularly the UN’s Globally Harmonized System (GHS) and supports Colombia’s accession to the OECD. It replaces and expands upon earlier provisions in Decree 1076 of 2015.
The decree introduced several regulatory instruments, including:
- A National Inventory of Chemical Substances for Industrial Use (INSQUI)
- A chemical prioritization system
- Risk evaluation and risk management programs for priority substances
The INSQUI system was launched in 2022 to facilitate registration and data management for industrial chemicals.
Who Is Affected?
The regulation applies to:
- Domestic manufacturers and importers of industrial chemicals in Colombia
- Foreign manufacturers (not directly regulated), who may appoint a Colombian Exclusive Representative (Representante Exclusivo del Exterior, or REE) to manage confidential business information (CBI)
Representante Exclusivo del Exterior (REE)
Foreign manufacturers can appoint an REE based in Colombia. The REE serves as a mechanism to protect confidential business information from local importers.
This provision allows a foreign manufacturer to share confidential information with the government through an encrypted database, while ensuring that the customer in Colombia does not have access to that information but remains in compliance with the regulation.
This provision is different from appointing an Only Representative (OR) in the EU. Instead, the REE simply passes information to the Government to keep the manufacturer’s confidential details safe.
Registration Requirements
- The obligation to register applies to hazardous substances imported or manufactured at or above 100 kg/year in Colombia.
- If a substance is already listed in INSQUI, it does not require a new registration, but annual updates may still be necessary depending on changes in volume or use.
- Substances not listed in INSQUI by May 30, 2025 will be considered “new” and require a new substance registration before being placed on the market.
Summary of the Main Obligations for Manufacturers and Importers
Entities subject to Decree 1630/2021 must:
- Register hazardous substances manufactured or imported above 100 kg/year
- Submit the following data via the INSQUI platform:
- Manufacturer/importer identity
- Annual production/import volumes
- Substance identity (including CAS number)
- GHS hazard classification
- Identified uses
- Provide data annually to the Ministry, including changes in volume or use
- Ensure compliance with OECD and GHS standards
- Implement risk management programs for prioritized substances
Key Milestones and Deadlines
Earlier this year, the final deadline for the initial registration of substances in the INSQUI system passed. This now means that any substances not registered prior to 30th May 2025, will be considered “new” and require a separate new substance registration before being placed on the market.
Summary
Decree 1630/2021 marks a significant step in Colombia’s chemical regulatory landscape, aligning it with global best practices. Companies manufacturing or importing industrial chemicals into Colombia should act promptly to ensure compliance with the INSQUI registration and requirements. The appointment of an REE is a critical option for foreign entities seeking market access for their Colombian customers without exposing any of the foreign manufacturer’s confidential information.
Need Support?
H2 Compliance is here to help. Our team of regulatory experts can guide you through the latest requirements in Colombia, whether that’s understanding the role of the REE, or helping to determine your specific obligations. H2 Compliance is happy to answer any questions you may have.
Published September November 20th, 2025
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