Colombia's Decree 1630/2021, also known as Gestión integral de las sustancias químicas de uso industrial (Comprehensive Management of Industrial Chemicals), in force since November 30, 2021, establishes a robust framework for the regulation of industrial and consumer chemicals in line with international standards to enhance chemical safety. It mandates the development of a national chemical inventory, which is currently underway. The inventory will include industrial chemicals identified as hazardous under the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Substances in commerce before the publication of the inventory will be eligible for inclusion.
The Decree requires registration of chemicals manufactured or imported in quantities above 100 kg per year, while notification for smaller quantities is voluntary, offering flexibility for smaller companies. Listed chemicals will be subject to standard labelling, classification, and reporting obligations, while non-listed chemicals will require pre-market risk assessment and notification. The Decree also includes provisions for the protection of sensitive data.
Key Features of Decree 1630/2021
REACH-Inspired Regulation: Modelled after the European Union’s REACH framework, the decree emphasizes hazard identification, risk assessment, and management.
Applicability: Targets industrial chemicals classified as hazardous according to GHS criteria, promoting alignment with global safety standards.
Registration Requirements: Manufacturers and importers must register substances above 100 kg per year and provide detailed data on their properties, hazards, and intended uses.
Confidentiality Provisions: Provisions allow companies to protect confidential information, such as trade secrets and specific chemical formulations, subject to validation by regulatory authorities.
Deadline for Registration: Manufacturers and importers have until May 30, 2025, to register their substances in the new inventory.
Cutoff Date for Inclusion: Substances in commerce before the inventory is published will be eligible for registration, with subsequent entries treated as new substances.
Regulatory Obligations:
Listed Chemicals: These substances are subject to standard hazard requirements, including GHS-compliant labelling and submission of Safety Data Sheets (SDS).
Non-Listed Chemicals (New Substances): Pre-market notification, comprehensive hazard assessment, and approval are required prior to market entry.
Colombia’s chemicals management framework reflects a commitment to public health and environmental protection, while aligning with international trade requirements. The development of the national inventory will be a significant milestone, providing a comprehensive database to guide regulatory and risk management decisions.
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