Argentina introduces new tobacco product regulations: shifting from "comprehensive ban" to "conditional access"

On April 30, 2026, the Argentine Ministry of Health officially signed Resolution 549/226 and released it on May 4. The new regulations officially abolish the 2011 ban on electronic cigarettes and the 2023 comprehensive ban on heated tobacco, establish a registration, sales, and regulatory framework for new tobacco and nicotine products, and shift the Argentine market from a "comprehensive ban" to "conditional access".

1. Category of regulated products

a) Electronic Cigarette Equipment (DCE)

b) Soluciones L í quidas (e-liquid)

c) Heating Tobacco Equipment (DPTC)

d) Heating cigarette sticks (Sticks)

e) Nicotine bag (BN)

2. Core requirements of the product

a) Electronic Cigarette Equipment (DCE)

 Prohibition of disposable electronic cigarettes

The battery must comply with UL8139 standard

Not allowed to 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<20 mg/mL

Oil storage capacity ≤ 2 mL

 Tobacco flavor only (no seasoning allowed)

Prohibited substances: sweeteners such as sugar, lactose, maltose, etc; Vitamins, minerals, caffeine, taurine, etc

Restricted substances: Diethylene glycol, ethylene glycol, carbonyl compounds such as diacetyl, formaldehyde, etc; Heavy metals such as lead, cadmium, mercury, etc

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 ≤ 5 mg/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 ≤ 8 mg/bag

Limited to menthol and tobacco flavors only

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

3. General requirements for packaging

Child anti opening: Mandatory requirements for e-liquid containers and nicotine bag packaging

Warning message area: 50% on the front and 50% on the back, with black text on a white background

Mandatory labeling: "Este producto NO ha sido avalado para dejar de fumar" (This product is not approved for smoking cessation)

Prohibited content: claims of harm reduction, patterns that attract minors, and labeling as' tobacco free '

Registration number: must be indicated on the packaging

4. Registration requirements

• Application channel: TAD online platform

Registration fee: equivalent to the retail price of 2000 packs (20 cigarettes per pack) of the highest commercial value cigarettes in Argentina

Approval deadline: Notify the registration number within 5 working days after all materials are complete

Registration validity period: 5 years (can be renewed for free)

• Bill of Materials:

Proof of applicant's identity and legal representative

Product formula (sworn declaration, including ingredient concentration and toxicological data)

Analysis report on composition and emissions under normal usage conditions (issued by a recognized laboratory)

At least one listing approval certificate from a reference country regulatory agency (US/EU/Japan/Canada, etc.)

Product description and manual

Manufacturer's Certificate of Quality Assurance (COA)

Distribution Plan

Responsibility Statement

 Label sample

Additional information for various products (see regulations for device size, battery type, nicotine content, etc.)

5. Obligations after registration

Batch analysis reports should be kept for at least 5 years

Report information changes within 30 days

Cooperate to provide sales data and consumer group information

Accept on-site inspection

6. Prohibited Marketing Practices

Prohibit any form of inducing minors to consume

Prohibit misleading advertising or unauthorized advertising by health authorities

Prohibit claiming that the product has reduced harm, is safer, or similar statements

Prohibit the use of statements such as' no tobacco 'that may mislead consumers

7. Consequences of Violations

False oath declaration: registration cancellation+legal sanctions

Unregistered sales: Import/distribution/sale prohibited, products may be delisted

8. Opportunities and Challenges

The new tobacco market in Argentina has officially opened up, and compliant products can be legally sold, which is a new opportunity for domestic manufacturers.

At the same time, product flavor restrictions, product type restrictions (such as banning disposable electronic cigarettes), and requirements for prohibited and restricted substances also pose new compliance challenges.

If you need to learn more about regulatory details and compliance plans, please feel free to contact us. We will be dedicated to providing you with detailed compliance plans and high-quality testing and certification services.

Contact phone number: 0755-28506411

e-mail address: service@element-testing.com

URL: http://www.element-testing.com