Chile Regulatory News

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 ...

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. 

The newly introduced Draft Regulation on Disinfectants in Chile aims to establish a comprehensive framework governing the registration, manufacture, importation, storage, distribution, and dispensing ...

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.

On the 28th of June, Chilean authorities delivered an important update via webinar on the progress of implementing Chile's regulation, based on the Decree 57/2021. The focus of this update centered ...

On the 28th of June, Chilean authorities delivered an important update via webinar on the progress of implementing Chile's regulation, based on the Decree 57/2021. The focus of this update centered around the introduction of some requirements to register hazardous industrial substances, known as "Notificación de substancias," on the country's online platform. The announcement highlighted crucial information regarding registration requirements, deadlines, and key updates from the recent event. 

Under the GHS regulation in Chile, manufacturers and importers of a substance, as well as importers of a substance contained within a hazardous mixture, are obligated to notify the new system with the required information. This notification process applies to substances or mixtures with quantities equal to or exceeding 1 ton per year. However, for substances contained within mixtures, notification is solely necessary for those posing risks to the environment and human health, provided their concentrations surpass the specified values outlined in Regulation, Art. 291. 

To facilitate a smooth transition, the Chilean authorities have set phased-in deadlines for registration based on different substance categories. The deadlines are as follows: 

• Industrial Substances – August 30, 2024 

• Industrial Substances Contained in Mixtures – August 30, 2027 

• Non-Industrial Substances – August 30, 2025 

• Non-Industrial Substances Contained in Mixtures – August 30, 2029 

It is important to note that the initial registration for industrial substances will encompass information from the preceding two-year period, in this case the years 2022 and 2023. 

At present, the GHS registration system in Chile does not accommodate foreign manufacturers' participation. The absence of provisions for foreign manufacturers, even through the involvement of local agents such as the Colombia's OR, designed to protect Confidential Business Information (CBI), necessitates potential reforms to the Chilean regulation (Decree 57/2021) to enable such participation. 

During the event, Chilean authorities also unveiled other updates regarding the implementation of the GHS regulation: 

• In an effort to ensure an efficient and effective registration process, the government plans to conduct a new Beta Test of the revised online platform. This test is scheduled to take place in the later months of 2023, allowing industries to engage with the system, test its functionality, and provide valuable feedback. 

• Accessible Substance Registration Database: By the end of 2023 or the beginning of 2024, the substance registration database is expected to be accessible to all. This database will serve as a comprehensive repository of registered hazardous substances, facilitating easy access to vital information. 

You can find more info at: GHS - Chile - Ministerio de Salud

On 2 May 2023 the Chilean Ministry of the Environment (MMA) published Resolution No. 410/2023 that requests producers (including importers) of priority products to declare the quantity of products the...

On 2 May 2023 the Chilean Ministry of the Environment (MMA) published Resolution No. 410/2023 that requests producers (including importers) of priority products to declare the quantity of products they have introduced to Chile during 2022. The Resolution relates to the EPR Law (Law 20920; Establishment of a Framework for Waste Management, Extended Producer Responsibility and Recycling) that requires producers of priority products to create management systems to meet mandatory take-back targets. The requested information must be submitted by 30 June 2023 through the website of the Pollutant Release and Transfer Register.

Resolution No. 410/2023 applies to producers of the following priority products:

• Lubricating oils

• Electrical and electronic equipment

• Batteries and small batteries

• Containers and packages (including those producers that introduce in the market less than 300 kg of containers, reusable containers and containers belonging to the subcategory "others")

• Bicycle, wheelchair, and solid tires

• Newspapers and magazines

Under the EPR law a producer of a priority product is defined as any who:

• sells a priority product for the first time in the national market,

• sells a priority product acquired from a third party that is not the first distributor under its own brand

• imports a priority product for their own professional use

Producers must report the amount of priority products in cubic meters and/or tons brought into the Chilean market during 2022.

On April 21, 2023, Chile approved a Technical Guide of Recommendation for the Labelling of Cosmetic Products. This regulation aims to provide guidelines on packaging and labeling requirements to ensur...

On April 21, 2023, Chile approved a Technical Guide of Recommendation for the Labelling of Cosmetic Products. This regulation aims to provide guidelines on packaging and labeling requirements to ensure the safe use of cosmetics in Mexico. The regulation lists specific labeling requirements that manufacturers or importers of cosmetic products must adhere to, such as product denomination, cosmetic use, health registry number, registry number, series, validity period, net content, country of origin, manufacturer/importer/owner, use mode, warnings, specific labeling for special products, ingredients, and storage and conservation conditions.

The objective of this regulation is to promote the protection of the health conditions of the Mexican population by reducing the risks associated with the use of cosmetic products. Compliance with these requirements will be monitored by the Institute of Public Health and the Ministry of Health, who will serve as the regulatory authorities.

It's important to note that this regulation applies specifically to cosmetic products marketed in Mexico, regardless of their country of origin. Manufacturers and importers must ensure that their products comply with these labeling requirements before they can be sold in the Mexican market. Failing to comply with these requirements could result in fines or other regulatory actions. Therefore, manufacturers and importers should pay close attention to this new regulation and ensure that their products meet all the requirements listed in the Technical Guide of Recommendation for the Labelling of Cosmetic Products.

On 11 January 2023, the Chilian environmental authority approved Resolution 15 which aims to control the import of hazardous substances to the country and authorizes the GHS-based “List of Classific...

On 11 January 2023, the Chilian environmental authority approved Resolution 15 which aims to control the import of hazardous substances to the country and authorizes the GHS-based “List of Classification of Substances”. Additionally, Resolution 15 includes a list of substances and mixtures that are classified as dangerous.  

Hazardous chemicals listed in Table 1 of Article 5 of the Resolution require importers to obtain a Customs Destination Certificate and an Authorization of Import, Use and Disposition. The Regional Secretariats of Environment are responsible for the authoring of these documents. 

The list of substances is, nevertheless, not exhaustive, and therefore, some hazardous chemicals are subject to additional specific regulations that are not covered by Resolution 15. These are among others: hazardous chemicals that are considered weapons; liquids and gases of general use; ozone layer-depleting substances; radioactive substances; equipment that generates ionizing radiation; formulations of pesticides for exclusive agricultural use; and chemical weapons. Importers of these chemicals must comply with the specific regulations that apply to them. 

The Chilean Ministry of Health has revised its import controls for hazardous substances, aiming to streamline some aspects of the process and align the list with the GHS classification system. The upd...

The Chilean Ministry of Health has revised its import controls for hazardous substances, aiming to streamline some aspects of the process and align the list with the GHS classification system. The updated list is outlined in Resolution 15/2023, which replaces Resolution 408/2016, and was published in the Official Gazette on January 11th. The new standard categorizes substances by hazard type in accordance with the GHS classification, and also includes a list of exempt substances, review procedures, and a simplified process for importing lower-risk substances. Importers of listed substances must now request custom destination certificates and use and disposal authorizations through a digital portal. The custom destination certificates and use and disposal authorisations will be reviewed and approved or denied by regional health ministerial secretariats. Inspections may also be conducted to verify the conditions of the imported substances or mixtures. Substances that do not pose risks to human health will be granted permits upon verification of required documentation.

The new regulations will be phased in gradually to align with the GHS implementation schedule, with non-industrial use substances being affected from 9th of February, industrial use mixtures from 9th of February 2025, and non-industrial use mixtures from 9th of February 2027.

Substances that are exempt:

• Explosives;
• liquids and gases for energy use;
• radioactive substances or equipment that generates ionizing radiation;
• substances depleting the ozone layer that only present danger to the environment;
• pesticides exclusively for agricultural use;
• substances regulated by the Chemical Weapons Convention.