Introduction
Colombia has officially launched its first National Industrial Chemicals Inventory, listing 4,473 substances. This inventory is accessible via an interactive platform. Substances not included in this inventory are classified as "New Substances" (or "nueva" in Spanish), requiring enterprises to submit a New Substance Notification within six months of exceeding the 100 kg production or import threshold.
For businesses seeking Confidential Business Information (CBI) protection, a Colombian Foreign Representative (REE) can be appointed to handle confidentiality applications.
Understanding the Regulatory Framework: Colombia REACH
Colombia's chemical regulation, known as Colombia REACH (Decree 1630/2021), mandates local manufacturers and importers to notify industrial hazardous substances and components in mixtures with an annual production or import volume of ≥100 kg. The framework incorporates four key management tools:
National Industrial Chemicals Inventory (now published)
Tool for Prioritizing Chemical Substances
Health and Environmental Risk Assessment
Plans for Reducing and Managing Health or Environmental Risks
Overview of the National Industrial Chemicals Inventory
The newly released inventory is hosted on an interactive platform divided into four sections:
Primary and secondary uses of registered substances
Headquarter locations for registrants
Hazard information for notified substances
User-integrated operation section
This platform provides enterprises with access to notification data for the 4,473 listed substances. Substances not appearing in the inventory are automatically classified as "New Substances" and subject to additional regulatory requirements.
Compliance for New Substances
For substances classified as "New Substances" with annual production or import volumes of ≥100 kg, manufacturers or importers must submit a New substance notification within six months of reaching the threshold. The information must include:
The date the 100 kg/year threshold was reached
Confirmation of whether the substance meets the forthcoming Prioritization Criteria (Yes/No)
A Health and Environmental Risk Assessment Report if the substance meets the Prioritization Criteria.
Upcoming Prioritization Tool and Risk Assessment Requirements
During the Latin American Chemicals Regulation Cooperation Forum (LARCF) held in October, Colombian officials plans to release the Chemical Prioritization Tool early next year. Key updates include:
New Substances meeting the Prioritization Criteria and posing potential health or environmental risks will require a Health and Environmental Risk Assessment
For new uses of substances already listed in the inventory that meet the Prioritization Criteria, a similar risk assessment will be required to evaluate risks associated with the new use
Next Steps for Enterprises
As the first Latin American country to implement a comprehensive chemical regulation system, Colombia is setting a precedent for regional chemical management. Enterprises involved in chemical production or import should:
Review the National Industrial Chemicals Inventory to determine whether their substances are listed
Prepare for the release of the Chemical Prioritization Tool and ensure compliance with forthcoming requirements
Monitor updates on Colombia REACH to stay informed of regulatory changes.
REACH24H Consulting Group will continue to provide timely updates and professional guidance to help enterprises navigate compliance with Colombia REACH.
For more information and inquiries, please feel free to contact us at customer@reach24h.com.
