Chile Regulatory News

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.

The "Waste Management, Extended Producer Responsibility and Recycling Promotion" Bill No 20.920, popularly known as "The Bill" or "REP Bill," emphasizes waste generation reduction and recycling promot...

The "Waste Management, Extended Producer Responsibility and Recycling Promotion" Bill No 20.920, popularly known as "The Bill" or "REP Bill," emphasizes waste generation reduction and recycling promotion. It holds importers and producers financially responsible for properly managing the waste produced by goods sold on the domestic market. The goals of the Bill are to reduce waste creation and increase garbage reuse by up to 30%. By internalizing the costs and unfavorable externalities related to waste management.  

Moreover, another bill called the Bill of Natural Resources and Environment which aims to ensure that waste producers do not escape their responsibility for their waste. The Bill establishes the concept of "Extended Producer Responsibility (EPR)," which requires importers and producers of specific goods designated as "priority products" to plan and finance the collection and treatment of the waste using a management system. 

Even though the Extended Producer Responsibility Act has been in effect since the middle of 2016, there are some provisions that, to be enforced, call for a competent authority to issue Supreme Decrees outlining the instruments intended to prevent waste production and advance its valuation. 

In 2022 the environment ministry of Chile released its biennial regulatory program, which includes plans to increase extended producer responsibility and put a special emphasis on information availability. There is no deadline for the government to disclose its Risk Assessment Resolution on the agenda. A period of 18 months was set forth by Supreme Decree 57/2021 on 9 February 2021 for the country to pass the resolution. 

The priority products covered by any supreme decree that establishes recollection objectives must be mentioned by it. This includes the classifications or subcategories it enforces, the recall objectives, the related duties, the producers it binds, and the limitations placed on an individual or collective management systems. 

Every two years manufacturers and importers of dangerous substances have to notify the environmental authority. The first notification deadline due on February 2024.  Any manufacturer or importer...

Every two years manufacturers and importers of dangerous substances have to notify the environmental authority. The first notification deadline due on February 2024. 

Any manufacturer or importer of a substance as such and any importer of a dangerous substance contained in quantities equal to or greater than one tone per year (TPA) must notify the environmental authority in the Substance Notification System, through the Single Window of the Environmental Authority portal. As it is stated in art 294 of Decree 57, the notification must be made every two years, with a deadline of 30 August, considering what was manufactured and imported in the previous two calendar years.   

However, the first notification must be made until February 2024, for substances for industrial use and in the fourth year for substances for non-industrial use. The information to be provided should include elements such as: 

• name, address, telephone, and email address  

• name of the substance and number of the American Chemical Society  

• hazard classification(s) of the substance indicating the class and category of hazard 

• amount of substance manufactured or imported per year expressed in mass ranges 

• intended uses.  

In the case of substances contained in mixtures, the corresponding use of the mixture must be indicated.   

Once the notification has been made, the Ministry of the Environment will issue a Resolution with all the notified substances, until 31 December of that same year. This is part of a current new regulation that the Chilean government is implementing, and its process is ruled by Title VI of Decree 57 which is the result of the country’s commitments as an OECD party. These harmonized labelling and classification of chemicals are obligations that Chile is complying with to facilitate international trade and protect human health and the environment.  

Chile approved the uniformized Regulation on Classification, Labelling and Notification of Hazardous Chemicals and Mixtures by Decree 57 on 26 November 2019. In publishing Decree 57 Chile formally accepts the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals. Under article 270 of Decree 57, the supplier of a hazardous substance or mixture must provide its recipient with a Safety Data Sheet (SDS). Title V of this Decree describes its requirements and obligations, as well as specifies what information must be included in each section of the registration.   

The Chilean Ministry of Health opened, on 22 August, 2022, a consultation on proposed amendments to the Chilean Food Health Code. The proposals would completely modify Title III of the Code – which ...

The Chilean Ministry of Health opened, on 22 August, 2022, a consultation on proposed amendments to the Chilean Food Health Code. The proposals would completely modify Title III of the Code – which regulates food additives – by eliminating 15 of its 30 articles, and replacing a further 14 articles. Only one article – on the definition of food additives – would be left untouched. 

In addition to the Codex Alimentarius, the new rules establish regulations in the EU (EFSA specifications) and the US (Food Chemical Codex and FDA specifications) as secondary options to assess the identity and purity of food additives.  

Furthermore, the Chilean authorities would establish a technical norm listing allowed food additives and their authorized uses, use conditions, and limits. The Ministry of Health has already drafted this technical list, on which comments can also be submitted during the consultation period. 

Finally, the rules also address the labelling obligations for food additives. 

The drafts are open for consultation until November 30, 2022. They can be accessed on the Ministry’s website. 
 

In 2019, Chile adopted Supreme Decree 57 (DS/57), on the Classification, Labelling and Notification of Chemical Substances. DS/57 seeks to comprehensively implement the UN GHS in Chile, as well as int...

In 2019, Chile adopted Supreme Decree 57 (DS/57), on the Classification, Labelling and Notification of Chemical Substances. DS/57 seeks to comprehensively implement the UN GHS in Chile, as well as introduce several other chemicals management instruments, such as a register of substances placed in the market. 

Now, Chilean authorities are adapting pieces of legislation preceding DS/57 to align them to the Decree’s requirements. This is because, while DS/57 introduces unified legislation on the GHS, previous regulation had already introduced aspects of it in a more piecemeal manner (leading ot inconsistencies in the regulatory framework). 

Decree 60 of the Ministry of Health, published in August 17, introduces changes to Supreme Decree 43 of 2015, establishing regulations for the storage of hazardous substances. Until these modifications, SDSs required under Supreme Decree 43 had to be in accordance with a standard on the topic approved by the Chilean Institute for Standardization (Chilean Norm 2245). As per the changes introduced, SDSs will now have to follow the indications set in DS/57. 

Regarding the transport of dangerous goods, Decree 40 of the Ministry of Transport has introduced the same clarification on the format of SDSs. Moreover, it also requires packaging labelling to be in accordance with the provisions of DS/57 (until now, such labelling was governed by Chilean Norm 2190). 

The changes highlight how Chilean authorities are advancing towards comprehensive and unified chemicals management in the country. In addition to implementing the UN GHS, DS/57 also introduces notification and obligations, starting in August 2024. To learn more about the obligations introduced by DS/57, you can re-watch our webinar on it.
 

The Chilean Ministry of Environment published on May 10, 2022, Resolution 240/2022 to better identify products that fall under packing materials and further indicate the corresponding categories. The ...

The Chilean Ministry of Environment published on May 10, 2022, Resolution 240/2022 to better identify products that fall under packing materials and further indicate the corresponding categories. The provision is aligned with the Decree 12/2020 that entered into force in 2021.

In turn, Decree 12/2020 introduced recycling, recollection, and other obligations to manufacturers of containers and packing materials. Decree 12/2020 defines containers and packing as those materials used to contain, protect, handle, facilitate consumption, store, preserve, transport, or improve the product presentation. In case an article comes integrated or attached to the product, it is also considered a packing element. The same applies to goods aimed at informing consumers.

Resolution 240/2022 brings an extensive list identifying those products treated as packing materials and hence subject to goals imposed by the regulations. The list divides the packing material according to their use categories, i.e., food, cleaning products, personal care products, health, horticulture, tools, clothes and shoes, and home, among others, and contains more than 145 examples. Furthermore, the regulation also brings criteria to further classify the materials into residential and non-residential.

As Chile publishes regulations to implement extended producer responsibility, businesses must be attentive to changes and new obligations to come.