Chile Regulatory News

On 26 January 2024, the Ministry of Health of Chile published Law No. 21646 in the Diario Oficial de la Republica de Chile, which prohibits animal testing in the preparation of cosmetics.  The law...

On 26 January 2024, the Ministry of Health of Chile published Law No. 21646 in the Diario Oficial de la Republica de Chile, which prohibits animal testing in the preparation of cosmetics. 

The law adds the following text to Article 108 of the Sanitary Code: 

The use of animals for the safety and efficacy testing of cosmetic, hygiene, and personal odorization products, and each of the ingredients, combination of ingredients, or final formulations is prohibited.    

To ensure the protection of human health, by the standards of this code, manufacturers must use alternative testing methods that do not involve animals to demonstrate the safety and effectiveness of cosmetics, personal care, and odorization products and all of their ingredients.  

Amended Clauses in Law No. 20.380 on the protection of animals:

An exception to the prohibition on animal testing is made if the following conditions are met: 

1. There is no alternative method or strategy to the use of animals recognized by the Public Health Institute or by the Organization for Economic Cooperation and Development to demonstrate safety parameters. 

2. The ingredients are subject to restriction in their concentration for cosmetic use. These ingredients are listed in the database of cosmetic ingredients used by the Public Health Institute. 

3. The cosmetic ingredient is widely used and cannot be replaced by another ingredient that can perform a similar function. 

The law will take effect twelve months after its publication in the Official Gazette (27 January 2025).

On 31 January, the Ministry of the Environment approved the draft regulation of Law No. 21.368, which regulates the disposal of single-use plastics and plastic bottles and modifies the legal bodies it...

On 31 January, the Ministry of the Environment approved the draft regulation of Law No. 21.368, which regulates the disposal of single-use plastics and plastic bottles and modifies the legal bodies it indicates—better known as the Single-Use Plastics Law—and submitted it for public consultation.

In Chile, approximately 23,000 tonnes of waste from single-use plastics are generated, with a significant percentage ending up in the sea or left in landfills, rivers, parks, and public roads. The Single-Use Plastics Law, enacted in August 2021, aims to protect the environment and reduce waste generation by limiting the supply of single-use products in plastic and regulating disposable plastic bottles.

The Act primarily regulates two matters. Firstly, the dispensing of single-use products in food establishments, and secondly, the management of both returnable and disposable plastic bottles for beverages.

The regulation aims to establish requirements and procedures for the granting of the certificates outlined in the Law, as well as to specify other obligations established in the Law.

The preliminary draft will be open for public consultation for a period of 35 working days (until 27 March) through the public consultation platform https://consultasciudadanas.mma.gob.cl/portal. During this time, all those interested in the regulation are invited to inform themselves, participate, and incorporate their opinions or observations on the aforementioned platform or in writing at the Office of Parties of the same or at the corresponding Regional Ministerial Secretariats of the Environment.

This citizen consultation process includes webinars and talks to provide information about the Law and the draft regulation in particular.

Chile's chemical industry is launching its Chemical Registration System under the Decree 57. This development aims to enhance chemical safety and regulatory oversight in the country. As the registrat...

Chile's chemical industry is launching its Chemical Registration System under the Decree 57. This development aims to enhance chemical safety and regulatory oversight in the country. As the registration database opens its doors, industries dealing with industrial hazardous substances face a crucial window for compliance – from February 9 to August 30, 2024.

Understanding the Registration Requirement

The registration requirement applies to covered substances manufactured in or imported into Chile in quantities exceeding 1 ton per year. The initial reporting period spans 2022 and 2023, setting the stage for a thorough assessment of chemical products within this timeframe.

Local Manufacturers and Importers 

The Instruction Guide underscores the distinction between local manufacturers and local importers, providing clear guidance on the registration process for each category. It is crucial to note that foreign manufacturers are exempt from the registration obligation, and Chile does not have an Only Representative structure in place.

Defining Hazardous Substances

The Instruction Guide provides more definition of industrial hazardous substances that must be registered during the initial deadline. This clarification ensures a comprehensive understanding of the substances that fall under the regulatory ambit.

Chile's Chemical Registration System is a landmark initiative in bolstering chemical safety and regulatory compliance. As the registration period for industrial hazardous substances commences, stakeholders are urged to engage proactively. The Instruction Guide serves as a crucial document ensuring a smooth transition towards a safer and more compliant chemical landscape in Chile. 

Chile is driving itself further into the land of chemical regulation, presenting another milestone with the introduction of the Draft Chemical Prioritization and Risk Assessment Regulation. This stan...

Chile is driving itself further into the land of chemical regulation, presenting another milestone with the introduction of the Draft Chemical Prioritization and Risk Assessment Regulation. This stands as a second phase in the journey of chemical registration, evolving from the foundational framework established by Decree 57/2021. 

The roots of this regulatory evolution extend back to Decree 57/2021, a significant initiative that implemented the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and mandated the notification of hazardous substances. Now, building upon this foundation, Chile takes another step forward with the introduction of the Draft Regulation on Prioritization and Risk Assessment. 

This draft sets explicit criteria for the selection of substances subjected to evaluation, emphasizing their potential impact on both human health and the environment. Delving into the collaboration opportunities, risk assessment procedures, and the inclusion of foreign manufacturers, the draft provides an understanding of the regulatory landscape. 

In the event that a chemical is deemed to pose an unacceptable risk, manufacturers and importers are in need to implement supplementary risk management measures. These measures are then integrated into the product documentation, ensuring a proactive approach to mitigating potential hazards. 

The prioritization process introduces a scoring system, evaluating substances based on hazardousness, annual volume, and intended use sector. Substances surpassing a predetermined threshold undergo a manufacturer/importer risk assessment, fostering a examination of potential risks. 

The Draft is available for sixty days for public comments at the WTO, commencing on January 5, 2024.  

Chile's commitment to chemical safety is evident, as it seeks not only to regulate but to foster a collaborative and informed approach towards chemical management. The global community will be watching as Chile's regulatory landscape continues to evolve, setting a precedent for comprehensive and forward-thinking chemical governance. 

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