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, Regulation on Classification, Labeling, and Notification of Hazardous Chemicals and Mixtures on February 9, 2021, which formally implements GHS labelling for chemical products, however some products such as cosmetics, pharmaceuticals, and food additives are excluded from the GHS requirement.
The new legislation targets manufacturers and importers of chemicals and dangerous substances that are not regulated by other regulations. 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.
Decree 57 also outlines the compulsory compliance of GHS in the country, a standard until then has been voluntary.
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).
Feb-12-2024
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.
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