Colombian Chemical Regulation
Colombia REACH (THE DECREE 1630)
What is Colombia REACH?
In 2017, Colombia updated its national profile of chemical substances and issued the National Profile of Chemical Substances: Volume II. The document provided information on chemicals and the amount that circulated in the country. Also in the document, the Colombian authoritiescompiled a list of prioritized chemical substances based on the GHS 6th revision.
THE DECREE 1630
On the 30th of November 2021, the Ministry of Environment and Sustainable Development of Colombia published Decree 1630/2021 on chemicals management requiring the registration of industrial chemicals (as such or in mixtures) that are identified as hazardous under UN GHS – if they are manufactured in or imported into Colombia in quantities above 100 kilograms per year. Consequently, and as a step forward, Colombia’s Ministry of Commerce has launched this year an online registration system for industrial chemicals – known as RSQUI – that will initially require manufacturers and importers to submit the following information:
- Identity of the manufacturer or importer of the chemical substance for industrial use
- Annual production or import of the chemical substance for industrial use (as such or in mixtures).
- Chemical substance identity, including CAS number (where applicable)
- Hazard classification, according to the sixth revision of GHS, which Colombia adopted in 2018 -Decree 1496; and
- Identified uses.
EXEMPTIONS FROM DECREE 1630
- Those chemical substances that have a specific regulation for their use, as well as those that in the future will have such regulation [e.g., pesticides, cosmetics, cleaning products, food additives, etc.]
- Substances of unknown or variable composition, complex reaction products or biological materials – UVC
- Articles.
- Impurities.
- Substances of natural origin without chemical processing.
- Substances that result from a chemical reaction as a consequence of exposure to environmental factors (air, humidity, sunlight, microbial organisms) or from storage of another product, during the end use of other products that have not been manufactured, imported or marketed as such.
- Substances that are not manufactured, imported or marketed as such resulting from a chemical reaction.
- By-products that have not been imported or marketed as such.
- Hydrates of a substance or hydrated ions.
- Polymers, including monomeric units and additives that are part of the polymers.
- Substances in customs transit.
- Non-isolated intermediates.
- Samples of no commercial value.
If you are not otherwise exempt, you must register.
NOTIFICATION OBLIGATIONS
Registration is all done online in Spanish. Once registered as a reporting entity, the registrant has access to the instructions detailing what information is required to register a chemical. Here’s what will be required according to Decree 1630/2021:
- Identity of the manufacturer/importer.
- Annual production or import quantity of the chemical from the years 2021, 2022 and 2023.
- Identification of the chemical substance, including CAS number (when applicable).
- Substance’s hazard classification according to Decree 1496 of Aug. 6, 2018.
- Identified uses.
THE NATIONAL CHEMICAL INVENTORY
After the first notification deadline, authorities are expected to consolidate the gathered information and publish an official Chemical Inventory.
This Chemical Inventory is a database that allows the identification of each chemical substance produced or imported into the country with the purpose of associating the respective quantities, identified uses, and hazardousness.
Manufacturers and importers have the duty to keep the data up-to-date and submit information to the portal whenever new information is available. Updates on produced or imported substances are mandatory once a year.
What is the deadline?
The final deadline for providing the information is May 30, 2025. The first National Inventory of Industrial Chemical Substances (Inventario Nacional de Sustancias Químicas de Uso Industrial) will be created on May 31, 2025, based on the chemicals registered over the next three years.
If your chemicals are not registered before the May 31, 2025 cut-off, they will be considered “new substances” and subject to additional hurdles.
How can Foreign Manufacturers register their products?
Foreign manufacturers can register their product, but the local importer must be involved. They can use an Exclusive Representative Abroad (Representante Exclusivo del Exterior or “REE”) to protect confidential business information (CBI) from their local importer and/or customers. The REE allows the foreign manufacturer to share confidential information with the government through the encrypted database while ensuring the customer/importer in Colombia does not have access to that information.
