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 and its implementing Resolution 777/2021, Regulation on Classification, Labeling, and Notification of Hazardous Chemicals and Mixtures on February 9, 2021, which formally implements GHS labelling for chemical products.
The new legislation targets chemical substances and hazardous mixtures, of MINSAL-MMA. It considers the development of a system for the notification of substances and their prioritization to implement risk assessment to a selection of them, subsequent to their manufacture and/or importation. 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. On December 2024 it is predicted the Authority will publish the chemical inventory and the second notification deadline will be on the 30th of August 2026.
Decree 57 also outlines the compulsory compliance of GHS in the country, a standard until then has been voluntary.
Jun-26-2024
On 27 May 2024, the Chilean Agriculture and Livestock Service (SAG) published a draft regulation that establishes the conditions and requirements for authorising the importation and use of pesticide samples. This draft, which aims to improve processes for research and development in the agricultural sector, reflects the SAG's commitment to improving the efficiency and safety of pesticide evaluation. If adopted the resolution will repeal Resolution No. 92 of 2002. It is open for comments until 24 July 2024.
Streamlined Process for Innovation
The new regulations propose a structured framework for the management of pesticide samples, which is crucial for innovation in pest control solutions. By providing clear guidelines, the SAG aims to facilitate scientific research and product development, while ensuring that safety and environmental standards are maintained. The regulations specify the documentation required for importing samples, including detailed information on chemical composition, intended use and safety data sheets. This transparency is expected to streamline the approval process and reduce the administrative burdens for researchers and companies.
Ensuring Safety and Compliance
Safety is the core of the proposed regulation. The draft requires strict safety measures to be followed during the handling, storage, and application of pesticide samples. These measures include proper labelling, safe storage conditions and protocols for emergency situations. Additionally, the regulations emphasise the importance of complying with international safety standards, bringing Chile's practices in line with global best practice.
To ensure thorough oversight, the SAG will require detailed reporting from companies that import and use pesticide samples. These reports must include data on the use, efficacy and any observed environmental or health impacts. This information will be essential for ongoing monitoring and assessment to ensure that the use of these samples does not pose undue risks.
Facilitating Research and Development
One of the main objectives of the new regulations is to support research and development in the agricultural sector. By simplifying the process of obtaining and using pesticide samples, the SAG hopes to encourage innovation and the development of more effective and safer pest control solutions. The regulations will make it easier for researchers to conduct field trials and laboratory experiments accelerating the discovery of new products and practises that can improve agricultural productivity and sustainability.
The draft regulations also include provisions for the import of pesticide samples for educational purposes. Universities and research institutions will have easier access to these samples, supporting academic research and the training of future scientists. This educational component is seen as an important part of fostering a culture of innovation and scientific inquiry within Chile's agricultural sector.
Public Consultation and Feedback
The SAG has opened the draft regulations for public consultation, inviting feedback from stakeholders including farmers, researchers, industry representatives and environmental groups. This inclusive approach aims to gather diverse perspectives and ensure that the final regulations are robust, practical and widely accepted.
Stakeholders are encouraged to review the draft and provide input on various aspects such as documentation requirements, security measures and reporting protocols. The SAG will carefully consider this feedback before finalizing the regulations, with the aim of creating a regulatory framework that supports innovation while protecting public health and the environment.
The consultation is open for comments until 24 July 2024.
Conclusion
The proposed regulations for the import and use of pesticide samples represent a significant step forward for Chile's agricultural sector. By establishing clear guidelines and robust safety measures, the SAG aims to facilitate research and development, support innovation, and ensure the safe and effective use of pesticides. The public consultation process underscores the importance of stakeholder engagement in shaping policies that will impact the future of agriculture in Chile.
For more details, please see the draft resolution (in Spanish) here.
Feb-20-2024
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:
Amended Articles |
New Final Clause |
Article 7 |
Experiments on live animals that are intended to carry out research, manufacturing, or marketing activities of cosmetics, hygiene, or personal odorization products are prohibited.
|
Article 13 |
Infringements of the provisions of the final paragraph of Article 7 will be punished by 291 bis of the Penal Code.
|
A subsection of Article 291 |
The same penalties of the preceding paragraphs shall apply if the acts of mistreatment, cruelty, and experimentation, or unnecessary suffering with live animals are executed to develop research activities, manufacture, or commercialization of cosmetic, hygiene or personal odorization products. |
An exception to the prohibition on animal testing is made if the following conditions are met:
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.
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.
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).
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