Chile became the first country in Latin America to impose a national chemical regulation in February 2021. Chile’s Ministry of Health released Decree 57, Regulation on Classification, Labeling, and Notification of Hazardous Chemicals and Mixtures on February 9, 2021, which formally implements GHS labelling for chemical products, however some products such as cosmetics, pharmaceuticals, and food additives are excluded from the GHS requirement.
The new legislation targets manufacturers and importers of chemicals and dangerous substances that are not regulated by other regulations. Notifiers are requested to provide information on chemicals when dealing with 1 ton per year or above via the environmental authority portal. The notification is made on a biennial basis concerning the import or produced quantity every two years with the deadline on August 30th.
Decree 57 also outlines the compulsory compliance of GHS in the country, a standard until then has been voluntary.
Jul-25-2023
The Ministry of Health of Chile has taken a significant step in providing clarity for businesses dealing with chemicals by publishing a comprehensive white paper. This document aims to help companies understand how two distinct chemical lists, namely Decree 594/1999 and Resolution 777/2021, interact with each other.
The guide explains that Decree 57/2019, mandated the development of a reference list for the classification of the most common chemicals. This reference list, now adopted by Resolution 777/2021 is primarily intended for chemical classification purposes, including GHS (Globally Harmonized System) and SDS (Safety Data Sheet) requirements.
It is crucial to note that the older occupational health and safety regulation, Decree 594/1999, was designed with a different focus – that of assessing occupational exposures to chemicals.
The new guide issued by the Ministry of Health is an attempt to resolve any confusion that may have arisen due to the presence of these two lists. As part of this effort, the guide includes an annex that facilitates a comparison between the substances listed in the decree (Decree 594/1999) and those listed in Resolution 777/2021. This comparison will help businesses and stakeholders understand the distinctions and similarities between the two lists and how they apply to different regulatory aspects.
By providing this valuable resource, the Ministry of Health seeks to support companies in navigating the regulatory landscape effectively and ensuring the safe handling and management of chemicals in the workplace.
Jul-17-2023
The newly introduced Draft Regulation on Disinfectants in Chile aims to establish a comprehensive framework governing the registration, manufacture, importation, storage, distribution, and dispensing of disinfectants in any form. These disinfectants are designed for use on surfaces, inanimate objects, environments, water, fabrics, textiles, chemical products, and other materials whose mechanism of action is carried out through chemical reactions. Additionally, the regulation encompasses disinfectant devices that rely on physical action for their effectiveness.
While the regulation's scope initially appears broad, there are equally broad exemptions that clarify certain areas not covered by its provisions. Disinfectants for use on the skin of individuals as pharmaceutical products or cosmetics, as well as those intended for animal consumption or as additives in food, fall under these exemptions. Medical devices, descaling agents that do not claim effectiveness on biofilm or microorganism elimination, and surface cleaning products that do not contain active ingredients known for regulated actions are also exempted from the regulation.
The draft regulation demonstrates a comprehensive approach, covering numerous aspects of disinfectant regulation. It addresses product registration, manufacturing standards, importation controls, storage requirements, and guidelines for packaging and labeling. In line with global best practices, the regulation adopts the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for substances falling within its scope.
Public participation and feedback are vital in shaping the final regulation. To ensure transparency and accountability, a 60-day public comment period commenced on July 3rd, following the notification to the World Trade Organization (WTO). This period allows stakeholders, including experts, industry representatives, and the general public, to provide valuable insights and perspectives on the proposed regulation, thereby contributing to its refinement.
As the draft regulation progresses through the consultation period, it is expected to undergo further analysis and evaluation. By incorporating stakeholder feedback and expert input, Chile aims to fine-tune the regulation, enhancing its effectiveness, practicality, and alignment with the needs of the local context.
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