Colombia Reach Regulation for Various Sectors

Country

Colombia

National Regulation

Status

In force – fully active

Regulation name

Comprehensive management of industrial chemicals

Gestión integral de las sustancias químicas de uso industrial - link

Objective

Adopt mechanisms and other provisions for the comprehensive management of industrial chemicals, which are identified and classified as hazardous by the GHS

Implementation date

Publication 7th April 2021

Scope

Imported or produced hazardous substances

Further

substance lists

• Chemical substance: A chemical element and its compounds in the natural state or obtained by any production process, including additives necessary to preserve the stability of the product and impurities resulting from the process used, but excluding solvents which may be separated without affecting the stability of the substance or changing its composition.​
• Naturally occurring chemical substance of natural origin without chemical processing: Substance occurring naturally as such, unprocessed or processed only by chemical means.​
• Non-isolated chemical intermediate: Substance that is manufactured and consumed or used for chemical processes of transformation into another substance (synthesis), which during this process is not intentionally extracted (except for sampling).​
• Monoconstituent chemical: A chemical substance in which one constituent is present at a minimum concentration of 80% (pip) and contains up to 20% (pip) of impurities. A monoconstituent substance is named after the main constituent.​
• Multi-constituent chemical substance: It is defined by its quantitative composition, in whose concentration more than one constituent is present z 10% (pip) and < 800/ (pip). The multi-constituent substance is the result of a chemical reaction in the manufacturing process.​
• New chemical substance: A substance imported or manufactured in the country after the deadline established in paragraph 6 of Article 2.2.7B.1.2.2 of this Chapter and not listed in the National Inventory of Industrial Chemical Substances.​
• Industrial use: Refers to any processing, formulation, consumption, storage, preservation, treatment, packaging, filling, blending, mixing, production of an article or any other use of a chemical or mixture in industry.​

Exemption

There are 13 items exempted from compliance requirements. They are chemicals addressed by already existing regulations (e.g., pharmaceuticals and cosmetics), unknown or variable composition, complex reaction products or of biological materials (UVCB), impurities, articles, natural substances, substances resulting from environmental factors exposure, substances without commercial values, polymers and monomers, intermediaries, and substances in customs transit.

It should be noted that the Decree applies to the management of SQUI throughout its life cycle, excluding the waste management stage, given that this was regulated by Decree 4741 of 2005, now incorporated in the DUR of the Environment.

Affected

stakeholders

Producers and importers of substances ≥ 100 kg per annum

Requirements

It is required to provide the following information:

·        substance annual production and import amount

·        substance identification, including CAS number

·        risk assessment and classification according to the GHS

·        identified substance uses

And to do the following:

·        follow SDS and label standards

·        submit information to the national inventory

·        design, implement and make public risk reduction and managements actions                     programs

Non-

compliance

-

Comments

Possibly, a new version will come out including aspects pointed by the public consultation

SDS / GHS Regulation

Status

In force (GHS 6th revision) - transitional period

Regulation name

Legislation:

·        Decreto 1.496/2018 (general GHS) - link

Resolution:

·        Resolución 0773/2021| Ministry of labor - link

Implementation date

Workplace:

·        April 7, 2023 for substances

·        April 7, 2024 for mixtures

Language

Spanish

Comments

Implementation still depends on ministries to countersign the decree and publish resolutions. The Ministry of labor is the first to endorse a resolution.