Chile Regulatory News

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.

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. 

Since February 13, 2022, single-use plastics products have faced a ban in Chile. Law 21.368 was published in August 2021 and aims to fight back the indiscriminate use of single-use plastics in diffe...

Since February 13, 2022, single-use plastics products have faced a ban in Chile. Law 21.368 was published in August 2021 and aims to fight back the indiscriminate use of single-use plastics in different forms.

The single-use plastic restriction is only the start of an increasing effort to promote recycling and drive the country towards Circular Economy concepts. The recently published legislation also limits the generation of related disposable products, regulates plastics, and impose additional rules that will progressively enter into force.

In this respect, food retail establishments are forbidden to use and distribute single-use use products, such as glasses, cups, cutlery, chopsticks, stirs, mugs, straws, plates, goblets, boxes or food containers with foodstuff, trays, and sachets to be used in the business.

When consumers request a "to-go" meal, disposable products must be made of materials other than plastics, or be certified plastics in accordance with the Ministry of Environment certification guideline. The Ministry has 18 months to announce the regulation.

Beverage merchants must comply with a minimum percentage of recycled material when referring to the composition of plastic bottles, as well as offering returnable bottles scheme to consumers. The minimum recycled plastic content in bottles is to be successively implemented, not being less than 15% in 2025; 25% in 2030; 50% in 2040; 60% in 2050; and reaching 70% in 2060. In addition, manufacturers and importers are in charge of implementing awareness programs to promote recycling and the ecological impacts it may cause.

Any business that does not comply with the provisions is subjected to fines.

On January 21, 2022, Chile published the determination decision to start the elaboration of a decree to regulate the instrument intended to prevent waste generation and promote waste recovery.The futu...

On January 21, 2022, Chile published the determination decision to start the elaboration of a decree to regulate the instrument intended to prevent waste generation and promote waste recovery.

The future Decree will focus on household products, especially food, personal hygiene, and cleaning products. The labeling of the articles above must display the information on the components, composition, and instructions for recycling.

It also foresees the creation of a voluntary certification program for household packing when meeting specific recyclability criteria. The Decree will be closely related to Decree 12/2020, responsible for setting Chile's packing collection and recovery goals.

To obtain the recyclability seal, manufacturers must observe:

• that at least 80% of the weight of the container is made of technically recyclable materials;
• that the materials can be separated from the rest of the container; and
•       that there is currently demand from the recycling industry for these materials.

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