by Susana Planas MunGavin, MSc
Colombia’s Decree 1496 of August 6, 2018 brought the Colombian legal system relating to the classification of hazardous chemicals in line with the requirements established under revision 6 of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
The implementation of GHS in Colombia is to be carried out in stages as established under Articles 18 to 22 of Decree 1496. The competent authorities must ensure that GHS is correctly implemented by those responsible for activities that involve the extraction, production, import, storage, transport, distribution, marketing and use of chemical products that are hazardous according to the criteria established under revision 6 of GHS.
Pursuant to this purpose, the Labour Ministry, published on April 4, 2020 a draft Resolution to better define the responsibilities and prevention and control measures that employers must implement in the workplace according to the classification, labeling and hazard communication of chemicals used. These measures refer typically to maintenance of inventories of hazardous chemicals used in the workplace, providing employee training on the safe handling and risk of chemicals, ensuring that labels/Safety Data Sheets (SDSs) are available, ensuring that emergency control measures are available for the containment of accidental spills and that medical assistance, in the event of accidental poisoning or damage to health resulting from the use or exposure to chemicals, is available.
In order to ensure the steady implementation of GHS requirements across workplaces where hazardous chemicals are used or handled by employees, the Labour Ministry agreed to enforce GHS in stages:
- Pure substances within 24 months after the issuance of the final Resolution
- Mixtures within 36 months after the issuance of the final Resolution
The Draft Resolution would require all hazardous chemicals handled in the workplace to be clearly labelled in Spanish and include the following:
- Product identification (same as on the Safety Data Sheet, SDS)
- Identification of the supplier, including name, address and telephone number of the manufacturer, importer and/or distributor
- Signal word (Danger/Warning)
- Hazard Statement(s)
- Precautionary Statement(s)
- Lot number
- Net content, unless this is provided elsewhere on the packaging
- For mixtures, the identify of each of the hazardous ingredients or components (unless a Trade Secret applies)
Manufacturers and importers of chemical products would be required to ensure GHS hazard classifications are provided at all times.
Furthermore, the employer would be expected to request information from manufacturers or importers on the hazard classifications of any chemicals supplied to the workplace. Importers may re-label products, if they do not meet GHS requirements, before making them available in the market.
However, as established under Decree 1496, finished pharmaceutical products, food additives, cosmetics and pesticide residues in food, have all been exempted from GHS labeling requirements.
The draft Resolution also identifies cut-off concentrations that would apply for the classification and labeling of mixtures that are carcinogenic, toxic to reproduction or with effects on or through lactation.
Carcinogenic, toxic for reproduction and Specific Target Organ Toxicity (STOT) classifications must be provided on the label and SDS of mixtures, when at least one component has been identified as Category 1 or 2 carcinogen, toxic for reproduction or STOT, and in the following cut-off concentrations:
Carcinogen cut-off concentrations
|Carcinogen Category 1A (Group 1 IARC) – Known to have carcinogenic potential for humans||=> 0.1 percent|
|Carcinogen Category 1B / Category 2 – Presumed / Suspected (Groups 2A/2B IARC) –||=> 1 percent (Labeling is optional if present in a concentration >=0.1 per cent and <1 percent, but must be included in SDS)|
Toxic for reproduction or with effects on or via lactation cut-off concentrations
|Toxic for Reproduction Category 1A/1B – Known or presumed or with effects on or via lactation||=> 0.3 percent (Labeling is optional if present in a concentration >=0.1 percent and <0.3 per cent, but must be included in SDS)
|Toxic for Reproduction Category 2 – Suspected||=> 3 percent (Labeling is optional if present in a concentration >=0.1 percent and <3 per cent, but must be included in SDS)|
STOT cut-off concentrations:
|STOT Category 1/2:||=> 10 percent (Labeling is optional if present in a concentration >=1.0 percent and <10 per cent, but must be included in SDS)
*The chemical mixture is not required to be labelled as carcinogenic, toxic for reproduction or with effect on or through lactation or STOT if it contains < 0.1 percent concentration of the component of concern leading to such health hazard classifications.
SDS must be made available in Spanish and conform to the Guidelines provided in Annex 4 of GHS Revision 6.
The Draft Resolution would permit small containers, with less than 30 millilitre capacity, to display only the product name on the label. Any additional information can be provided alternatively, such as in a separate information sheet which must be accessible to employees at all times.
All labels and SDSs of chemicals used at the workplace would have to be revised by the employer at least once every five years.
Authorities, namely the Ministry for Agriculture and Rural Development, Ministry for Transport and the Ministry for Health and Social Protection, will further determine the implementation of GHS rules for the following specific activities:
- chemical pesticides for agricultural use as regulated under Pesticidas Químicos de Uso Agrícola (PQUA),
- chemical products in the transport stage and
- chemical products aimed at the consumer.
Draft 2020 Resolution issued by the Ministry of Work, Health and Social Protection establishing the measures that employers must carry out for the implementation of the Global Harmonized System for the Classification and Labeling of Chemicals at the workplace
Decree 1496 of August 6, 2018 adopting the Globally Harmonized System of Classification and Labeling of Chemical and adopting further provisions related to chemical safety
Latin America, Colombia, GHS, Hazardous Chemicals, Labeling, Classification, Safety Data Sheets, Decree 1496
Never Miss an Update:
UL’s global Regulatory Assurance Team contains more than 50 regulatory analysts worldwide, serving customers in six continents, with multi-lingual support in more than 30 languages. Our team can help you navigate the complex, ever changing regulatory landscape to understand and execute your compliance obligations.
For all of the latest regulatory news and the most important industry updates, sign up for our monthly Regulatory Round-Up Newsletter.