Argentina regulates dietary supplements as food products under the Código Alimentario Argentino (CAA). For companies planning to manufacture, import or commercialise a dietary supplement here, compliance would go beyond “ANMAT approval”. The product and business model decides the regulatory pathway, which can involve establishment of registration, product registration, formulation and labelling compliance, claims assessment and, for imports, specific import procedures.
This blog provides the entire framework for dietary supplement registration and regulation in Argentina.
Regulatory Authority for Dietary Supplements in Argentina
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) has national responsibilities for the control and surveillance of foods. The Instituto Nacional de Alimentos (INAL) (National Institute of Foods) operates within ANMAT’s food-control framework. However, dietary-supplement establishment and product registrations are not simply a single “ANMAT approval”.
ANMAT explains that RNE and RNPA registrations are granted by the competent sanitary authorities. It included jurisdictional authorities and depends on the establishment and product. ANMAT/INAL handles registrations within its area of competence, including relevant imported products.
Applicable Regulations
The National Administration of Drugs, Foods, and Medical Devices (ANMAT) is the principal regulator of dietary supplements in the country. The Argentine Food Code (CAA) covers Article 1381, where its regulations are discussed in detail.
Article 1381 was substantially updated through Resolución Conjunta 3/2020, which replaced the earlier version and introduced updated technical and sanitary requirements.
Companies should also consider other provisions of the CAA and applicable ANMAT requirements governing food establishments, product registration, labelling, advertising, imports and food safety.
RNE vs. RNPA
ANMAT states that establishments producing, processing or fractionating food or dietary supplements must complete the applicable establishment registration before beginning their activities. Product registration is then required before commercialisation. ANMAT also states that an RNE is required for subsequent RNPA registration.
Two registration numbers are particularly important in Argentina’s food regulatory framework.
| Registration | What it covers |
| RNE – Registro Nacional de Establecimientos |
Registration of the establishment and the food-related activities it is authorised to perform
|
| RNPA – Registro Nacional de Productos Alimenticios |
Registration of an individual food product, including dietary supplements
|
What Are Dietary Supplements Under Argentine Regulations?
Suplementos dietarios (Dietary Supplements) are products intended to increase habitual dietary intake of healthy people by supplementing nutrients and/or other ingredients in their diets. These individuals are not in pathological conditions and have basic dietary needs that are unmet or higher than usual.
These supplements may be presented in solid form, i.e., tablets, capsules, pills, granules, powders, or others. It’s also approved in liquid forms like drops, solutions, etc., or other ways in which it can absorb in the gastrointestinal area.
Their composition should contain amino acids, proteins, carbohydrates, lipids, vitamins, fibre, probiotics, minerals, or other nutritional or physiologically beneficial ingredients. Herbal herbs and other ingredients may also be added, provided they comply with the set limits.
Compliance Checklist for Approval
Prior to the dietary supplement registration process in Argentina, companies must check the following:
- Product classification under the CAA
- Valid RNE registration of the importer/company
- RNPA approval before commercialisation
- Spanish-compliant labelling
- Required RNPA/RNE details on labels
- No therapeutic or disease-treatment claims
- Consistency between import and registration documents
Products not registered with RNPA/RNE may be prohibited from import or commercialisation.
Dietary Supplements Registration Process in Argentina
The exact Step-by-Step registration process for these products depends on whether the product is manufactured domestically or imported. However, a standard framework for food registration is given below:
Step 1: Verify Product Classification
Assess whether the product classifies as a dietary supplement according to Article 1381. For that, look into the ingredients, intended use, target population, dosage form, nutrient levels, product presentations, botanical ingredients, and proposed claims.
Step 2: Review Formula Against CAA
The formulation should be assessed against the compositional requirements of Article 1381 and other applicable CAA provisions. Review vitamins and minerals, proteins, lipids, amino acids, fibre, probiotics, carbohydrates, herbs, food additives, maximum permitted levels, and other ingredients with nutrient or physiological roles.
Article 1381 gives details about minimum contribution requirements and Tolerable Upper Intake Levels (ULs) for specific nutrients, vitamins, and minerals. Amino acids and other nitrogenous substances also have to follow specified maximum daily quantities.
Step 3: Obtain RNE Registration
The establishment should register with the competent sanitary authority where an RNE is needed. The RNE identifies the food establishment and the activities it is authorised to conduct. For companies importing dietary supplements, the relevant establishment/deposit and import activities must also be addressed according to the applicable import pathway.
Step 4: Prepare the RNPA Application
The RNPA is the product-level registration. The application requires product information appropriate to the regulatory pathway. For imported products handled through the SIFeGA/INAL framework, ANMAT’s current procedure identifies information including the following:
- Product denomination
- Brand and/or trade name
- Qualitative and quantitative composition
- Product specifications
- Storage conditions
- Shelf life
- Manufacturing process
- Applicable commercialisation/free-sale documentation
- Product label
- Required fee documentation.
What Is SIFeGA?
SIFeGA stands for Sistema de Información Federal para la Gestión del Control de los Alimentos—the Federal Information System for Food Control Management.
It is an electronic system used for food control and registration procedures. Each participating jurisdiction can have its own SIFeGA through which, where applicable, establishment and product sanitary authorisations are managed.
SIFeGA is therefore a regulatory information and processing system. It’s not a regulatory authority.
Step 5: Check Dietary Supplements Labelling Requirements
Article 1381 requires dietary supplements to carry a sales name indicating that the product is a dietary supplement and identifying its characteristic nutrients and presentation form. It should also have the target population included where applicable. The label must also comply with the general food-labelling requirements under Chapter V “Standards for labelling and advertising of food”.
Additional information includes the following:
- Nutritional info with nutrient names
- Ingredients of interest
- Contents of ingredients, RDI covered for each product
- Recommended daily intake
- Lot number
- Expiration date
- Brand name
- Common and scientific names of herbs used
- Instructions for use
Mandatory warnings
Article 1381 requires specific warnings, including the following:
- Do not use it if pregnant, breastfeeding, or in children unless the product is specifically intended for those groups.
- Keep out of reach of children.
- The consumption of dietary supplements does not replace a varied and balanced diet.
- Consult your doctor.
- Consume this product according to the daily intake recommendations established on the label.
- Products containing caffeine have an additional “Contains Caffeine” requirement.
- Products intended for children need “Administered under Adult Supervision”
- Exceeds the Reference Intake by… (indicating the relevant nutrients). Consult your doctor and/or nutritionist” when the vitamin and mineral content exceeds the Reference Intake values established in Table I of Article 1387 of this Code.
- This product is indicated for people who exercise. Its consumption should be under medical supervision.
The label should not portray in any way that it has therapeutic benefits or can treat, cure, or prevent diseases.
Documents Required for Dietary Supplements Registration in Argentina
Although there’s no particular list of documents companies must maintain, a standard framework according to establishment and product registration procedures:
| Establishment Documents | Product Information | Imported Products |
|
|
|
GMP Requirements for Dietary Supplements in Argentina
Article 1381 clearly says that dietary supplements should be manufactured according to Good Manufacturing Practices (GMP). Thus, authorities may request GMP certificates, manufacturing licences, quality control documents, product specifications, and batch traceability information. Any missing or inconsistent manufacturing documents may delay approval.
Dietary Supplement Registration Timelines in Argentina
There is no single official processing time that should be quoted as a universal RNPA approval timeline. The 30 administrative-day period published by ANMAT relates specifically to the initial verification/evaluation stage for a DPS submission, not to all dietary-supplement RNPA applications.
Timelines may increase due to:
- Ingredient-review queries
- Non-compliant claims
- Label deficiencies
- Missing documents
- Botanical or high-risk ingredients
RNPA registrations are typically valid for 5 years.
Dietary Supplement Registration Costs in Argentina
Dietary supplement registration costs in Argentina generally include:
- RNE registration fees
- RNPA registration fees
- Government charges
- Translation and label adaptation expenses
- Apostille/legalisation expenses
Businesses should verify the applicable fee in ANMAT’s current tariff schedule at the time of filing, because the amount can depend on the specific procedure.
Import Regulations for Dietary Supplements in Argentina
Import requirements changed significantly in 2025. Under Decreto 35/2025, Argentina created a simplified import route for certain food products from countries listed in Annex III. The listed jurisdictions include the following:
- Australia
- Canada
- Switzerland
- European Union
- United States
- New Zealand
- Israel
- Japan
- United Kingdom
The framework can also extend to countries covered by qualifying economic-integration or reciprocity agreements. It is subject to the conditions established by the decree.
For qualifying products from the listed countries, importers may use an import notice and sworn declaration route where the applicable conditions are met. The product also has the required authorisation to market, a certificate of free sale or an equivalent document issued by the competent authority of the country of origin.
What if the product is from a country outside Annex III?
ANMAT states that products from countries not covered by Annex III are handled through the applicable SIFeGA process for the RNE and RNPA, followed by an Import permit. This means international companies should determine the import route before assuming that the conventional RNE/RNPA pathway is the only option.
Are Imported Dietary Supplements Subject to Additional Controls?
Yes. ANMAT identifies dietary supplements as Class I imported foods subject to control under its current imported-food surveillance framework. It has also stated that INAL conducts inspections, particularly for higher-risk products, including dietary supplements and foods for special medical purposes, after products enter the country. The objective includes monitoring food safety and preventing misleading or confusing labelling.
Conclusion
Dietary supplements in Argentina are required to meet requirements established by ANMAT and the Argentine Food Code (CAA), including RNE and RNPA registrations, compliant labelling, and restricted Dietary claims.
Artixio assists global supplement companies with ANMAT Dietary Supplement compliance and Argentina market-entry support. Get in touch today at info@artixio.com.
FAQs
How to register a dietary supplement in Argentina?
Dietary supplements in Argentina must obtain:
- RNE (establishment registration)
- RNPA (product registration)
Applications are submitted through SIFeGA by a local Argentine importer or legal entity.
Are therapeutic or disease-treatment claims allowed for supplements in Argentina?
No. The Argentine Dietary Supplement Regulations prohibit therapeutic, disease-treatment, and pharmaceutical-style claims on supplements.
