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Compliance Guidelines - South America | Requirements for Chilean Electronic Cigarettes
Author.
LCS
Source:
Post time:
2026-04-27
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.
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.
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。
1. Manufacturers must disclose all ingredients and additives. The upper limit of nicotine concentration is 45mg/mL.
2. Child safety packaging: Containers must be protected from minors opening or tampering with them
3. Mandatory declaration: All products must be declared to the health bureau before being launched, and sales are not allowed without declaration
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).
6. The laboratory issuing the report must hold the current ISO/IEC 17025 certification.
1. The packaging of SEAN and SESN should include at least the following information in Spanish:
a. Manufacturer name and production address
b. Assembly, disassembly, and maintenance instructions
c. Instructions for use, storage, preservation, loading, and handling
d. Health Warning
2. Electronic nicotine delivery system and accessories:
a. Occupy 20% of the area
b."Los Sistemas Electrónicos de Administración de Nicotina son potencialmente
c.adictivos"The electronic nicotine delivery system has potential addictive properties
d."Venta sólo a mayores de 18 años"Purchase only for individuals aged 18 and above
3. Electronic non nicotine delivery system and accessories:
a. Occupy 10% of the area
b."Venta exclusiva para mayores de 18 años"Purchase only for individuals aged 18 and above
4. The packaging of electronic cigarette e-liquid should include at least the following information in Spanish:
a. Container capacity, e-liquid volume, expiration date
b. Ingredients and their concentrations (sorted in descending order of concentration)
c. Nicotine content (milligrams/milliliter)
d. Contraindications (with fixed text, Arial9)
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.
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.
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