The Chilean Ministry of Environment has announced the notification requirements for new industrial chemicals under Supreme Decree No. 57/19, the regulation governing classification, labeling, and not...

The Chilean Ministry of Environment has announced the notification requirements for new industrial chemicals under Supreme Decree No. 57/19, the regulation governing classification, labeling, and notification of hazardous substances and mixtures.

Following the notification process conducted in 2024, which covered industrial-use substances manufactured or imported in 2023 and 2024, the Ministry issued Resolution No. 7595 on December 30, 2024. This resolution approved a list of  over 850 notified industrial-use substances. According to Articles 295 and 296 of Supreme Decree No. 57/19, any chemical substance imported or manufactured after the notification deadline will be considered a new substance and must be notified prior to importation, production, or commercialization.

Key Definitions 

Industrial-use substances those whose intended use and application is carried out in manufacturing activity and productive processes. (D.S. 57/19, article 3)

Notification Details

For 2025, any new industrial-use substance not listed in Resolution No. 7595/2024 must be notified via an Excel form submitted to notificacion.sqi@mma.gob.cl before its importation or production.

In the case of importatition of a substance for industrial use, the notification must be made only the first time the substance is imported in 2025, regardless of the quantity imported and the estimated amount that will be imported throughout 2025.

In the case of manufacturing a substance, report will be needed whether it has been been manufactured it and placed on the market previously (but not notified) or before commencing use or marketing.

Entities must provide:

• Chemical name and common name (if applicable)
• CAS number (if available)
• Physical state
• Hazard classification and categories
• Estimated manufactured quantity or actual and estimated imported quantity for 2025
• Industrial-use purpose

For further details, visit the Ministry of Environment’s official notification platform.

The notification period for non-industrial chemical substances under Decree 57 will commence on February 9, 2025. This marks a futher advancement in Chile’s regulatory framework for chemical substan...

The notification period for non-industrial chemical substances under Decree 57 will commence on February 9, 2025. This marks a futher advancement in Chile’s regulatory framework for chemical substances, reinforcing the nation’s commitment to environmental and human health protection.

Companies that manufacture and/or import non-industrial chemical substances in Chile must submit their notifications by August 30, 2025. The process aims to establish a comprehensive database of chemical substances in use, enhancing risk management and regulatory oversight.

Who Must Notify?

Entities handling non-industrial chemical substances including manufacturers and importers are required to submit their  notifications.

What is a Non Industrial Chemical Substance ?

As defined in Decree 57, non-industrial chemicals are considered all substances whose intended use and application do not involve manufacturing activities or production processes. 

Key Dates to Remember:

• February 9, 2025: Start of the notification period
• August 30, 2025: Deadline for submission

For further details on the notification process, requirements, and necessary documentation, stakeholders are advised to consult Chile’sDecree 57 here (in Spanish). 

Update: The law  has came into effect on January 27, 2025, one year after its publication. On 26 January 2024, the Ministry of Health of Chile published Law No. 21646 in the Diario Oficial de la...

Update: The law  has came into effect on January 27, 2025, one year after its publication.

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. For more details, the Law No. 21.646 can be found here (in Spanish)

In a significant step towards modernizing its agricultural sector, Chile’s Ministry of Agriculture, through the Agricultural and Livestock Service (SAG), has issued Resolución 243 Exenta (Resoluti...

In a significant step towards modernizing its agricultural sector, Chile’s Ministry of Agriculture, through the Agricultural and Livestock Service (SAG), has issued Resolución 243 Exenta (Resolution 243), a comprehensive regulatory framework designed to enhance the safety and sustainability of pesticide use in the country. The resolution, published on January 14, 2025, introduces strict obligations for all stakeholders involved in the lifecycle of agricultural pesticides, from distributors to farmers and applicators.

A New Era for Agricultural Practices

The Resolution reflects Chile’s commitment to aligning its agricultural practices with international environmental and public health standards. By addressing critical issues such as pesticide drift, worker safety, and environmental contamination, it aims to reduce the risks associated with pesticide use while promoting sustainable farming practices. “This resolution is a milestone in our efforts to protect people and the environment,” said the Minister of Agriculture. “It ensures that our agricultural sector remains productive while adhering to the highest standard of safety and sustainability”.

Key Provisions of Resolución 243 Exenta

1. Sale and Distribution

   • Pesticides must be sold in their original, SAG-approved packaging.

   • Distributors must provide detailed documentation, including product names, SAG authorization numbers, and lot numbers.

   • Pesticides that are about to expire or that have been cancelled may only be sold with explicit buyer consent.

2. Storage Requirements

   • Pesticides must be stored in secure, restricted access facilities with proper hazard signage.

   • Inventories must be maintained, and expired products must be disposed of in accordance with SAG guidelines.

3. Handling and Application Practices 

   • Pesticides should only be handled by certified applicators with SAG credentials.

   • Equipment must be regularly maintained and calibrated to prevent leaks or dosage errors.

   • Pesticide applications must be announced 48 hours in advance, with exceptions for emergencies.

4. Worker Safety Protocols

   • Workers cannot re-enter treated areas before the re-entry period specified on the pesticide label.

   • Written authorization from the farm administration is required for re-entry.

5. Empty Container Management

   • Empty pesticide containers must be disposed of in accordance with label instructions and regulations.

   • Traceability records must be maintained to ensure proper disposal.

6. Service Providers

   • Companies offering pesticide application services must register with the SAG and comply with training and record keeping requirements.

Implications for Stakeholders

• Farmers and Distributors:
  The Resolution introduces enhanced record keeping and storage requirements, which may increase operational costs but will improve product safety and traceability.

• Applicators:
  Mandatory training and certification will raise professional standards, but may require additional time and financial investment.

• Environmental and Public Health:
  The regulation’s focus on minimizing pesticide drift, protecting pollinators, and ensuring proper disposal of containers is in line with global sustainability goals.

Enforcement and Compliance

SAG inspectors will oversee compliance through regular audits and field inspections. Violations of the Resolution will be subject to penalties under existing laws, including Decreto Ley Nº 3.557 and Ley Nº 18.755. Resolution 243 will take effect on January 20 2026, giving stakeholders 12 months to comply. Small-scale and indigenous farmers have been granted a 24-month transition period to comply with the training requirements, provided they obtain certification through government programs.

Resolution 243 Exenta represents a significant step forward in Chile’s efforts to balance agricultural productivity with environmental protection and worker safety. For further details, Resolution 243 can be found here (in Spanish).

In February 2021, Chile became the first country in Latin America to adopt a comprehensive national chemicals regulation, Decree 57 and its implementing Resolution 777/2021. This regulation establishe...

In February 2021, Chile became the first country in Latin America to adopt a comprehensive national chemicals regulation, Decree 57 and its implementing Resolution 777/2021. This regulation establishes a structured system for the notification and prioritization of substances, allowing for the risk assessment of selected chemicals, whether manufactured or imported. Decree 57, formally issued on February 9, 2021, aims to protect human health and the environment by mandating the implementation of Globally Harmonized System (GHS) labeling for chemical products. 

The legislation addresses both chemical substances and hazardous mixtures and mandates notification protocols under the Ministry of Health (MINSAL) and the Ministry of Environment (MMA). Notifications are required every two years, with the deadline of August 30 each year. The first notification deadline for industrial use substances was scheduled for August 30, 2024, but a revised deadline will be set, after which authorities will publish a Chemical Inventory. Non-compliance with the notification requirements will result in penalties, with specific enforcement details to be defined in future regulations.

Key News for 2024

• Chile Introduces Decree on Lubricant Oil Recycling
  On November 11, 2024, Chile issued a Supreme Decree to improve the collection, recycling, and disposal of lubricant oils in support of its sustainability goals. The Decree establishes recycling targets, producer accountability, consumer participation, and labeling requirements, with a 24-month transition period for compliance. Read more here.

• Chile Strengthens Pesticide Rules to Protect Bees
  On October 18, 2024, Chile's Ministry of Agriculture introduced Exempt Resolution No. 7,068 to improve ecotoxicological standards for pesticides, with an emphasis on bee protection. The regulation mandates clear toxicity classifications, bee hazard pictograms, and notification requirements for beekeepers prior to pesticide application. Read more here.

• Chile Opens Public Consultation on Fertilizer and Biostimulant Regulation
  Chile’s Agricultural and Livestock Service (SAG) has opened a public consultation to update the fertilizer and biostimulant regulation under Law No. 21.349. The proposed updates include revised labelling standards, improved traceability measures, and phased compliance schedules. Stakeholders are invited to review the draft regulation and provide feedback by December 16, 2024, with SAG publishing responses to comments by January 29, 2025. Read more here.

The Chilean Ministry of the Environment has issued Resolution No. 7595, of December 17, 2024, which officially approves the list of hazardous substances for industrial use notified in 2024. This resol...

The Chilean Ministry of the Environment has issued Resolution No. 7595, of December 17, 2024, which officially approves the list of hazardous substances for industrial use notified in 2024. This resolution, which is in line with Supreme Decree No. 57 of 2019, ensures compliance with regulations on the classification, labeling, and notification of hazardous substances and mixtures.

Key Highlights of Resolution No. 7595

• Promulgation Date: December 17, 2024

• Publication Date: December 30, 2024

• Public Access: The full list of notified hazardous substances is available on the Ministry of the Environment’s official platform: https://plataformasqi.mma.gob.cl.

Background to Supreme Decree No. 57

Supreme Decree No. 57, published on February 9, 2021,  establishes the regulatory framework for the classification, labeling, and notification of hazardous substances and mixtures. According to the decree:

• Manufacturers or importers of hazardous substances, or substances in mixtures exceeding 1 tonne per year, are required to notify the Ministry of the Environment.

• The notification must include relevant safety and classification information in accordance with Title III of the Regulation.

Notification Challenges and Timeline Adjustments

The initial notification deadline for industrial hazardous substances was August 30, 2024. However, due to challenges with the electronic system, Resolution No. 4141 extended the deadline to September 30, 2024 and provided temporary procedures for manufacturers and importers to fulfil their obligations.

Publication of the 2024 Hazardous Substances List

As stipulated by the regulation, the Ministry of the Environment must issue a resolution listing all notified substances by December 31, 2024. Resolution No. 7595 fulfils this requirement by publishing the approved list, ensuring transparency and public access to this important information.

Importance of Compliance

This resolution reinforces Chile’s commitment to chemical safety and ensures the responsible use of hazardous substances in industrial applications. 

The Chilean Government, through the Servicio Agrícola y Ganadero (SAG), has issued Resolution 7525 EXENTA, which establishes an updated list of additives authorized for the manufacture of complete fe...

The Chilean Government, through the Servicio Agrícola y Ganadero (SAG), has issued Resolution 7525 EXENTA, which establishes an updated list of additives authorized for the manufacture of complete feeds, supplements, ingredients, and formulated additives for animals. This new Resolution also repeals Resolution 1.992 EXENTA of 2006. The Resolution, promulgated on November 6, 2024, and published on November 21, 2024, will come into effect on December 22, 2024.

The updated Resolution introduces a revised and comprehensive list of additives authorized for use in animal feed production. This includes supplements, formulated additives, and complete feeds for both productive animals (e.g. those raised for human consumption) and non-productive animals (e.g. domestic pets). The new list reflects the latest scientific advances and international standards. 

Key Features of Resolution 7525 Include

• Focus on Safety and Traceability: The resolution emphasizes the importance of ensuring the safety and traceability of all animal feed products. 

• Alignment with International Standards: The update aligns Chile's regulations with globally recognized frameworks, including Codex Alimentarius and standards set by the European Union, the United States, Mercosur and organizations such as the FAO and FEDIAF (European Pet Food Industry Federation).

Regulatory Requirements for Compliance

• Approval Process: Importers and manufacturers must obtain SAG approval through a Monograph of Production Process for formulated additives.

• Labeling Requirements: All additives must be sold in sealed and labeled packaging in accordance with SAG’s standards.

• Prohibition of Non-Food Grade Additives: The use of technical grade additives or chemicals that do not meet food-grade certification is prohibited.

• Coccidiostats Authorization: Specific additives for preventing coccidiosis in animals are permitted, with additional labeling requirements regarding withdrawal periods.

Exemptions and Nutritional Standards

• Special Diets for Pets: Formulated feeds for dogs and cats with special nutritional needs are exempt from certain additive limits.

• Natural Nutrients: The Resolution takes into account the natural nutrient content of ingredients and ensures that total additive levels comply with safety limits.

Enforcement and Impact on Industry

The resolution outlines strict penalties for non-compliance, including fines and sanctions. The updated list of additives is a significant step toward improving animal feed production standards in Chile.  By integrating scientific advances and global best practices, the new regulation benefits stakeholders across the agricultural and pet food industries, ensuring higher quality and safer products.

For more details, the full text of Resolution 7525 EXENTA is available here (in Spanish).