Classification, Labeling, and Notification of Hazardous Substances and Mixtures Regulation in Chile

Chile, as a member of the Organization for Economic Cooperation and Development (OECD), was required to implement GHS into their national law. That took place on February 9, 2021 through the publication in the Official Gazette of the Classification, Labeling, and Notification of Hazardous Substances and Mixtures Regulation. It was developed by the Ministry of the Environment and Ministry of Health with the participation of civil society and industry.

The regulation establish criteria and obligations that manufacturers and importers of hazardous substances and mixtures must comply with. It applies to substances and mixtures that are not regulated by specific laws and that are classified as dangerous according to the hazard criteria defined under Title III of this newly published regulation.

Nuclear substances, pharmaceutical, food and animal consumption food products, cosmetics, medical devices, fertilizers, pesticide food residues and hazardous waste, are not included since they have their specific regulations. For example, food products are regulated by Supreme Decree 977 of 1996 under the Ministry of Health. Law 18,302 oversees nuclear safety regulation and cosmetics are regulated under Supreme Decree 239, of 2002. Other exceptions are substances and mixtures intended for scientific research and development, non-isolated intermediates and minerals of natural origin under certain conditions.

The Ministry of Health will approve, by resolution, an official list of classification of substances, which will be used as minimum reference for the classification and will contain classes and hazard categories of these substances.

Under Title IV, the labeling requirements are defined, including the minimum information that should be in Spanish on the label. While there is a new requirement for the labels to include an in-country 24/7 emergency response number as supplementary information, manufacturers and importers should always assure their in-country designated emergency responders have an access to an updated SDS in addition to having appropriate contractual arrangements in place. Additionally, information on how to properly use the product is also required.

Regarding Safety Data Sheet content, under Title V the requirements and obligations are outlined which specify what information should be included under each section of the SDS. In section 8, “Exposure controls/personal protection”, for example, the applicable occupational exposure limits should be described as established in Supreme Decree No. 594, of 1999, of the Ministry of Health, which approves the Regulation on sanitary and environmental conditions in workplaces, or amendments.

Notification

A notification to the environmental authority must be done by manufacturers or importers of substances and importers of a substance contained in a mixture, classified as dangerous. The information further specified must be submitted in the Substance Notification System, through the Single Window of the Environmental Authority portal, if those substances are in quantities equal to or greater than 1 ton per year.

The information that should be provided must include:

• Identity of the notifier:
  • Name, address, telephone and email address
• Identity of the substance(s):
  • Name and CAS number
  • Hazard classification of the substance, indicating the class and category of hazard, as established in this regulation.
  • Quantity of the substance manufactured or imported per year, expressed in mass ranges.
  • Intended uses. In the case of substances contained in mixtures, the corresponding use of the mixture must be indicated.

The notification must be made every two years, with the deadline being August 30, considering what was manufactured and imported in the previous two calendar years.

Risk Evaluation

The Ministry of Health and the Ministry of the Environment will select certain substances which will require a risk assessment from their manufacturers and importers. Within 18 months from the publication of this regulation, a Resolution will be published, which will determine the technical criteria of the risk evaluation, as well as the criteria for the definition of the substances of interest that must be evaluated.

The transition period for this regulation to enter into force is determined from the date of when this regulation was published, which was February 9, and is as following:

Recommended Action Items

Check if your company works with any substances and mixtures for which this regulation would apply and:

• Update labels and safety data sheets accordingly;
• Notify the environmental authority through the notification platform in case you manufacture or import substances or mixtures that contain substances in quantities equal to or greater than 1 ton per year.

References

Regulation on the Classification, Labeling, and Notification of Hazardous Substances and Mixtures: https://www.diariooficial.interior.gob.cl/publicaciones/2021/02/09/42876/01/1892688.pdf