Argentina's comprehensive regulatory interpretation of new tobacco products
Date：2026-05-09 10:08:10 Classification
：【Statute】 Visits：
On April 30, 2026, Argentina completed the regulatory transformation of new tobacco products from a comprehensive ban to comprehensive regulation through the Ministry of Health Resolution 549/226 and its annex "Requirements for Registration, Sale, and Inspection of Tobacco and Nicotine Products". The core of the new regulations is to establish the "Tobacco and Nicotine Product Registration System (RNPTN)", and all related products intended for sale in the Argentine market must complete registration.
1、 Regulatory scope and product classification
The new regulations will explicitly include the following five types of products in the regulatory scope:
Electronic cigarette devices: devices and accessories powered by batteries that generate aerosols by heating liquids.
Liquid solution for electronic cigarettes: used for electronic cigarette devices and nicotine containing liquids.
Heating tobacco product device: a battery driven device and its accessories for heating specially made cigarettes to produce aerosols.
Cigarette: a special cigarette designed for heating tobacco products.
Nicotine bag: a small bag containing nicotine, placed between the gums and lips, that does not burn or produce aerosols.
The regulations also stipulate that any electronic or mechanical device recognized by health authorities as a substitute for tobacco or nicotine consumption experience, even if it does not fully meet the above definition, will be subject to equivalent regulation, except for medical products approved by the Argentine National Agency for Medicines, Food and Medical Technology (ANMAT).
2、 Core requirements for product registration
Importers or manufacturers are required to submit registration applications through the Remote Programming Platform (TAD), with an application fee equivalent to the final consumer sales value (in pesos) of the highest value 2000 packs (20 cigarettes per pack) of cigarettes in the Argentine market. The application materials mainly include:
Subject qualification documents: documents that prove the legal status of the applicant and legal representative.
Product formula and toxicological data: A copy of the product formula declared under oath (translated into Spanish and notarized/certified if necessary) must be provided, including the concentration and toxicological data of each ingredient.
Laboratory Analysis Certificate: issued by a certified laboratory, an analysis certificate (to be translated and legalized) regarding the components generated during the normal use of the product. Imported products also need to specify the methods for measuring nicotine and restricted ingredient concentrations.
Overseas approval certificate: If the product has been approved in a specific reference country, corresponding proof documents (legalization/certification required) must be provided.
Product Description and Safety Statement: Includes an overall product description, photos with and without packaging, instructions for use, and a safety opening mechanism design statement to prevent minors from coming into contact and to prevent formula tampering.
Quality Control Certificate: Manufacturer's quality control certificate for each product (imported products need to be translated and legalized). Domestic products need to be submitted after the first batch is completed.
Distribution Plan: A distribution plan for the product to be registered.
Quality and Safety Responsibility Statement: A sworn declaration by the manufacturer and/or importer that they are responsible for the quality and safety of the product after it is launched.
Declaration of Packaging and Labeling Compliance: A declaration of compliance with graphic standards and health warning labeling resolutions, and submission of labeling and advertising plans for products to be registered.
3、 Additional specific requirements for different types of products
1. General requirements for packaging
·Child anti opening: Mandatory requirements for e-liquid containers and nicotine bag packaging
·Warning area: 50% on the front and 50% on the back, with black text on a white background
·Mandatory annotation: "Este producto NO ha sido avalado para dejar de fumar"
·Prohibited content: claims of harm reduction, patterns that attract minors, and labeling as' tobacco free '
·Registration number: must be marked on the packaging
2. Core requirements of the product
a、 Electronic Cigarette Equipment (DCE)
·Prohibition of disposable electronic cigarettes
·The battery must comply with UL8139 standard
·Cannot have entertainment functions (games, music, etc.)
·Must be accompanied by an instruction manual
·Must have packaging and cannot be sold naked
b、 e-liquid
·Nicotine must be sourced from tobacco (synthetic nicotine is prohibited)
·Nicotine concentration<20mg/mL
·Oil storage capacity ≤ 2mL
·Tobacco flavor only (no seasoning allowed)
·E-liquid must not contain:
i) Ingredients that are carcinogenic (Class 1 or 2), mutagenic (Class 1 or 2), or reproductive toxic (Class 1), except nicotine;
Ii) Components classified as respiratory sensitizers; Diethylene glycol or ethylene glycol;
Iii) For example: fructose, lactose, maltose, sucrose, acesulfame potassium, aspartame, sodium saccharin, steviol glycosides; Vitamins and minerals; Radioactive material; Long chain nipagin ester; Triclosan; Phenoxyethanol; Preservatives that may release formaldehyde;
·The concentration of the following substances in e-liquid shall not exceed the prescribed values: diacetyl (22 mg/L), formaldehyde (22 mg/L), acrolein (22 mg/L), acetaldehyde (200 mg/L), lead Pb (10 mg/L), arsenic As (3 mg/L), cadmium Cd (1 mg/L), mercury Hg (1 mg/L), antimony Sb (5 mg/L);
C、 Heating Tobacco Equipment (DPTC)
·Equipment temperature ≤ 400 ° C
·Must be accompanied by an instruction manual
·Equipment size, battery type, and compatible accessories must be declared
d、 Heating cigarette sticks (Sticks)
·Tobacco flavor only
·Nicotine ≤ 5mg/tube
·Must declare filter composition, tobacco variety, and emission data
e、 Nicotine bag (BN)
·Nicotine must be sourced from tobacco (synthetic nicotine is prohibited)
·Nicotine ≤ 8mg/bag
·Only available for menthol and tobacco flavors
·Prohibited substances: menthone, methyl eugenol, safrole, coumarin, NNN, etc
·Prohibit vitamins, minerals, caffeine, taurine, etc
·The ingredients must be of food grade or pharmaceutical grade purity
4、 Compliance Points and Suggestions
1. Systematic preparation: Registration application involves multiple stages such as regulatory consultation, product testing, document preparation, and compliance (translation, certification), making it a systematic project.
2. Supply chain control: Enterprises need to have strong control over the supply chain to accurately provide formulas and toxicology data, and may require toxicology experts to evaluate and support.
3. Partner selection: It is crucial to find reliable laboratories familiar with Argentine regulations and international testing standards related to tobacco products as partners.
4. Full chain management: Argentina's new regulations have established a full chain management system with product registration as the core, covering pre admission testing, production process control, and post market supervision.
This regulation marks the beginning of a standardized management phase for the new tobacco market in Argentina. Enterprises need to fully understand and strictly comply with the above requirements in order to complete product registration and enter the market legally.
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