Chile Regulatory News

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.

In September, Chile reaffirmed commitments with the Latin American Regulatory Cooperation Forum (LARCF), an association promoting dialogue and information exchange, training initiatives, a...

In September, Chile reaffirmed commitments with the Latin American Regulatory Cooperation Forum (LARCF), an association promoting dialogue and information exchange, training initiatives, and regulatory cooperation through national chemical associations. At a recent meeting, the Chilean authorities demonstrated how the forthcoming notification platform would perform.  

Authorities intend to gradually submit the system to new usability tests; therefore, other testing and showcase sessions will take place until December 2022. Currently, the system can record new substance notifications, including:  

• If the substance is produced or imported  
• Substance information (official and common names, CAS number)  
• Substance hazard class and hazard category  
• Type of use, sector, and product category  
• Imported/manufactured quantity  
• Substance SDS uploads  

The substance notification was created under the new chemical management regulation (Decree 57), published in February 2021. The first notification window is scheduled between February 2024 and August 30, 2024, indicating that non-industrial substances notified after the initial notification period will be handled as “new substances”. Accordingly, an official national chemical inventory will be published by December 31, 2024.  

In Chile, manufacturers and importers shall submit updated information (e.g., tonnage bands) every two years through the notification portal as part of the notification system. In addition, certain substances are required to undergo risk assessment, although the substance list and assessment criteria have until June 30, 2022, to be published. 

 On August 23, 2021, Chile published the official list for the classification of chemical substances through Resolution 777. The list, commonly referred to as “Official List of Substances Classification”, is based on the GHS 7th version.  

Manufacturers exporting chemicals to Chile are recommended to follow up the latest regulatory obligations and start preparing. 

Last update: 2021-11-05

On February 9, 2021, Chile approved its rules for the classification, labeling, and notification of dangerous chemical substances and mixtures (Decree 57) in the official gazette. Decree 57 was ...

On February 9, 2021, Chile approved its rules for the classification, labeling, and notification of dangerous chemical substances and mixtures (Decree 57) in the official gazette. Decree 57 was promulgated in November 2019 and communicated to the WTO on 10 February 2021.

The new legislation targets manufacturers and importers of chemicals and dangerous substances that are not supervised 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 year with the deadline on August 30th.

According to the law, applicants for substances for industrial use have three years to submit their first notification. As for substances for non-industrial use, it allows four years to notify. The recent deadlines are summarized below:

Decree 57 also further outlines the compulsory compliance of GHS in the country, a standard until then has been voluntary. The country has taken a step forward and decided to apply the standard to both industrial and consumer products. 

The GHS standards will phase-in following the periods:

In South America, Chile was the first country to join OECD and the first to implement and mandatory national inventory. It can be expected that other countries in the region will soon follow up and update their chemical agenda. 

Latest update: 2021-03-30

Chile’s Environmental Ministry (MMA) promulgated on February 28, 2022, a Decree establishing collection and recycling goals for batteries and Electrical and Electronic Equipment (EEE). Furthermore...

Chile’s Environmental Ministry (MMA) promulgated on February 28, 2022, a Decree establishing collection and recycling goals for batteries and Electrical and Electronic Equipment (EEE). Furthermore, Decree 207/2022 imposes obligations associated with priority products, batteries and electrical and electronic devices in order to prevent the generation of such waste and promote its reuse or recovery.

All batteries and EEE present in the Chilean market up to 1500 volts direct current or 1000 volts alternating current falls under scope. It is further established batteries and EEE categories and subcategories, which are:

·       Large Devices: EEE with an external dimension greater than 50 centimeters

o   Temperature Exchange Devices.

o   Other Large Devices.

o   Photovoltaic panels.

·       Small Devices: EEE not contained in the Large Devices category

·       Large Batteries: Batteries with a weight greater than 5 kilograms.

·       Small Batteries: Batteries not contained in the Large Batteries category.

Decree 207/2022 also provides limits of hazardous substances in batteries. Chile banned Large Batteries with mercury concentrations greater than 0.1% by weight and Small Batteries with cadmium concentrations greater than 0.01% by weight. Emergency equipment, alarms, and medical devices are exempt from this rule.

The collection goals shall reach a minimum threshold, continuously increasing each year:

Management systems may be individual or collective. Individual management system and collective system composed with a maximum of 20 independent producers must reach indicated goal based on batteries and EEE amounts placed into the market. Larger management systems may meet their targets with any batteries and EEE waste, not necessarily those produced or imported by them.

Interested parties may submit comments within 30 business days, counting from the publication date (March 10). Observations must be sent via the Citizen Consultations Portal.

The document is fully available here.