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Compliance Guidelines | Requirements for Chilean Electronic Cigarettes

Author.

LCS

Source:

Post time:

2025-12-12

On September 8, 2025, the Chilean Ministry of Health issued Resolution No. 1085 to strengthen regulatory requirements for electronic cigarette systems (SEAN), nicotine products (SESN), and their e-liquids before and after their launch; The following is a guide to compliance requirements for electronic cigarettes in Chile.

This article cites relevant reference laws:

Ley 21642: Prohibition of selling electronic cigarettes to minors and nicotine concentration requirements;

Decreto 41, SALUD: Health Warning Standard Requirements for Electronic Cigarette Products;

Resoluci ó n 1085 EXENTA: Electronic cigarette products must complete mandatory information declaration requirements before being sold in the Chilean market.

01 Definition

SEAN system: electronic cigarettes containing nicotine;

SESN system: nicotine free electronic cigarettes;

Electronic e-liquid: a liquid that is heated and atomized through SEAN or SESN systems, regardless of whether it contains nicotine or not.

02 Sales Restrictions

It is strictly prohibited to sell or provide electronic cigarettes to minors under the age of 18, and direct or indirect advertising or promotion of electronic cigarettes is prohibited.

03 Packaging and Labeling

1. Health warning: All packaging must have a black background and white text with Spanish warning.

SEAN and its accessory products have a warning area of ≥ 20%, indicating "Los Sistemas Electror ó nicos de Administraci ó n de Nicotina son potencialmente adictivos" and "Venta exclusiva para mayores de 18 a ñ os";

The warning area for nicotine containing e-liquid should be no less than 20%, indicating "Este l í quido de vapeo es potencialmente adictivo por contener nicotina" and "Venta exclusiva para mayores de 18 a ñ os";

SESN、 The warning area for nicotine free e-liquid and its accessories is ≥ 10%, indicating "Venta exclusiva para mayores de 18 a ñ os".

2. SEAN and SESN must indicate the manufacturer's name, production location, and instructions for assembly, disassembly, and maintenance.

3. Electronic e-liquid must be accompanied by an instruction manual or other explanatory materials, which should include information such as the manufacturer's name, production location, ingredients and their concentrations, usage instructions, storage and preservation methods, charging operations, and contraindications. The label of e-liquid should indicate its components in decreasing concentration order.

4. Electronic e-liquid containing nicotine should indicate its concentration unit and clearly list the contraindications for people allergic to nicotine or nicotine containing products.

5. The packaging should not imply that the product is less harmful than other products, or that it has a positive impact on health or lifestyle, such as awakening the mind, enhancing vitality, promoting recovery, delaying aging, natural environmental protection, etc.

04 Nicotine concentration requirements

Manufacturers must disclose all ingredients and additives. The upper limit of nicotine concentration is 45mg/mL.

05 Manufacturer Declaration Requirements

Manufacturers are required to declare electronic cigarettes and their accessories 6 months prior to product sales, and products that have not completed the declaration cannot be sold in Chile.

1. Importer or domestic manufacturer information: name, registered trademark, address, email, phone number, warehouse address for goods storage, and website URL.

2. Legal representative information: name, registration number, address, email address, telephone number.

3. If the manufacturer is not located within Chile, information about the manufacturer outside Chile must be provided, including company name, address, phone number, country of origin, tax identification number, email, and website.

4. Product type, name, and model, physical product photos, and packaging specifications.

5. Complete ingredient list (in descending order of concentration): IUPAC full name, CAS number, concentration or content, purpose and target; If it contains an intermediate, it should be clearly labeled as an intermediate and its basic composition should be indicated; The main ingredients must be declared, such as nicotine and its salts, ammonium compounds, and moisturizers (such as propylene glycol, glycerol, and triethylene glycol).

06 Equipment Information

The composition, components, accessories, and material types of electronic devices.

2. The chemical type, electrical specifications, and whether the battery is detachable or integrated.

3. The type of metal or material used for the coil or heating resistor, along with the maximum operating temperature reached by the resistor during normal use, and the method or verification method used to determine this temperature.

4. Detailed information of microprocessors or electronic components:

Does the product or device include a charger

If the product or device has wireless connectivity capabilities (such as Bluetooth, WIF, NFC), it is necessary to specify its specific functions, data transmission types, and whether it is associated with mobile applications.

5. Explain and describe the handling methods for the equipment and battery.

6. The original version and Spanish (espa ñ ol) translation of the manual or instruction manual.

In the graphic design of the main packaging, relevant instructions or operation guidelines for assembly, disassembly, and maintenance should also be included.

07 Requirements for e-liquid containers

1. Indicate the total capacity and volume of the packaging in milliliters (ml); Please indicate its expiration date.

2. Final graphic design and labeling: hygiene warning, ingredients, nicotine concentration.

3. Contraindications (using Arial font with minimum font size of 9):

Nicotine containing products: "Producto Contained ICADO en Menores de 18 a ñ os, Embrazo, enfermedades agudas y cr ó nicas, entre ellas enfermedades reflexias, cardiology y cerebrovascular events, al é" rgicos a algunos de sus componentes. Este producto NO es un medicamento y la INTOXICACI ÓN POR NICOTINA ES UNA EMERGENCIA MÉ DICA. En caso de malestar acuda a un centro asistencial o llame a Salud Responde al 6003607777"。

Nicotine free products: "Producto Contained ICADO en Menores de 18 a ñ os, Embrazo, enfermedades agudas y cr ó nicas, entre ellas enfermedades reflexias, cardiology y cerebrovascular events, al é rgicos a algunos de sus componentes. Este producto NO es un medicamento. En caso de malestar acuda a un centro asistencial o llame a Salud Responde al 6003607777"。

4. Electronic cigarette oil containers or packaging must be equipped with opening and closing devices to prevent accidental opening, dumping, and unexpected excessive use of liquids. Adopt "spinning double thread", "spinning internal locking buckle" or other similar devices that comply with child safety standards.

5. Flow control system: using "check valves with flow limiters", "globe valves with built-in counters" or other similar devices.

08 Packaging and Instructions

1. Spanish version: Manufacturer's name, place of production, ingredients and their concentrations, instructions for use, storage methods, storage conditions, loading methods, operating precautions, and contraindications (contraindication requirements are the same as above).

2. Relevant documents issued by the Ministry of Health shall not be used for advertising or printed on product packaging.

Mandatory Report for the Year 2009

After the initial application, the new annual report must be submitted before January 2nd of each year.

If there are no changes, submit a brief explanation report; If there are any changes, complete documents need to be resubmitted.

10 Temporary Transitional Provisions

The authorized product is still valid, but updated information is required:

Authorized products from 2009 to 2016: Updated before January 2, 2026;

2017- Authorized products before the effective date of this law: Updated before January 2, 2027.

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