Chile Takes Steps to Regulate Disinfectants

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.