January 4, 2022
by Raissa Havens, regulatory specialist, UL's Supply Chain team
Colombia published Decree 1630/2021 on Nov. 30, 2021, aiming to further advance the sound chemical management of industrial use substances. Chemical management tools were initially presented with the “National Profile of Chemical Substances in Colombia,” published in 2012 and updated in 2017. On Oct. 5, 2016, the document 3868 CONPES (National Council for Economic and Social Policy) “Risk Management Policy Associated with the Use of Chemical Substances” was published, containing more detailed information on the proposed sound management of chemicals. In January 2019, Law 1950 was published, approving the agreement for Colombia to adhere to the Organization for Economic Co-operation and Development (OECD).
Decree 1630/2021 applies to importers, manufacturers, distributors, transporters, and users of chemical substances. The following substances are exempt from the requirements of this decree:
- Substances regulated under specific regulations relating to their use or those predicted to be covered by a specific regulation in the future
- Substances of unknown or variable composition, complex reaction products or biological materials (UVCB)
- Chemical substances of natural origin without chemical processing
- Substances that result from a chemical reaction due to their exposure to environmental factors or from the storage of another product, as well as sub-products that have not been manufactured, imported or marketed as such
- Substance or ion hydrates
- Polymers, including monomer units and additives that are part of them
- Substances that are in customs transit
- Non-isolated intermediates
- Samples without commercial value
Management tools, which are further outlined in this article, have been established by the decree to allow employees who work with and use these substances the ability to identify the substances and their environmental and health risks as well as to work on programs to manage and reduce these risks.
National Inventory of Chemical Substances for Industrial Use
The Inventory database will contain information on imported and manufactured chemical substances and publicly provide information on the substances' quantities, identified uses, and hazards. The goal is to strengthen the knowledge about chemicals that present some type of hazard and prevent major accidents associated with the use of these chemicals.
Manufacturers and importers of a chemical substance for industrial use, if handling more than 100kg per year — whether mono-constituent, multi-constituent or incorporated into mixtures — must provide the following information to this database:
- Identity of the manufacturer/importer
- Annual production or import quantity of the chemical
- Identification of the chemical substance, including CAS number (when applicable)
- Substance’s hazard classification according to Decree 1496 of Aug. 6, 2018
- Identified uses
Over the next six months, different ministries in Colombia will develop software and instructions on how to submit information on the substances. The final deadline for providing information in the inventory is three years after the software and instructions are published. However, if the substance is new, manufacturers and importers will have six months to submit the information.
Chemical substances prioritization instrument
For certain substances identified as a priority for the protection of health and/or the environment, the Ministries of Environment and Sustainable Development, Health and Social Protection and Labor will define the criteria and specific information required, based on the information provided in the National Inventory.
New chemicals risk evaluations
If a substance is not in the National Inventory, or its identified use is not listed therein, but it meets the conditions to be considered a priority for the protection of health and/or the environment, a risk evaluation for that substance will be required from the manufacturers or importers.
Chemicals reduction and risk management programs
Manufacturers or importers will also be responsible for creating programs for the reduction and risk management of the chemicals that meet the conditions to be considered a priority for health and/or the environment. Different ministries will define the criteria for the creation and implementation of these programs and the information that must be available to users of these chemical substances.
Environmental and health monitoring of chemical substances for industrial use
With the purpose of monitoring and adopting measures to prevent, mitigate, reduce and control environmental and adverse health effects, Colombian authorities will implement different tools to obtain information such as hazard identification and exposure of the chemical substances for industrial use.
For example, the Ministry of the Environment and Sustainable Development will establish a mechanism to capture environmental information on pollutant releases and transfers generated from the industrial use of chemicals. The Ministry of Health and Social Protection, specifically in charge of the Toxicological Management System, will implement health monitoring initiatives. This will further ensure that those responsible for the chemicals provide the necessary information on the hazard identification, exposure, and health effects from the use of such chemicals.
This decree enters into force on Nov. 30, 2021.
Recommended action items
- Review the chemical substances used and/or handled as well as amounts that are being placed on the market in Colombia and verify the following:
- Deadlines for submission of chemical substance information
- Risk control requirements and implementation of a management program of the substances used or handled at the workplace
Decree 1630 of Nov. 30, of 2021 – Regarding the Sound Management of Chemical Substances for Industrial Use
Decree 1496 of Aug. 6, 2018 – Which adopts the Globally Harmonized System of Classification and Labeling of Chemical Products and other provisions on chemical safety issues
CONPES Document 3868 of Oct. 5, 2016 – “Risk Management Policy Associated with the Use of Chemical Substances”