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SENASA · Food (SENASA, formerly INAL)

Dietary supplement registration for products exported to Argentina

Dietary supplement registration is the entry of each supplement in the RNPA so it can be sold in Argentina: protein powders, vitamins, minerals, creatine, collagen, probiotics and similar products. It is needed for supplements imported from countries outside Annex III of Decree 35/2025. Since Decree 697/2026 it is granted by SENASA (formerly INAL). A supplement is a food: it cannot have a therapeutic purpose. If it does, it falls under a different framework handled by ANMAT.

Last updated:

Unbranded supplement tubs, capsules and sachets
Supplements
Required by
Código Alimentario Argentino, art. 1381
Agency
SENASA
Estimated timing
30 business days for RNPA registration and for probiotic authorization, according to the duration set by SAGyP Res. 135/2026.
Official fee
$ 303.450
Our fee
Tailored quote
01

Why it is mandatory

The Food Code defines dietary supplements and sets what they may contain and how they are labeled. Registration confirms the product qualifies as a food and not as a medicine, which is the first observation in this category.

The supplement's RNPA is the approval that allows it to be sold and remain on the market, including online. Without registration, a single marketplace listing can trigger a complaint, and SENASA can order a recall.

For brand owners, the formula and doses decide everything. Ingredients or claims that are fine in your home market can block registration in Argentina, so we check them before your buyer orders stock.

What the regulation says

Requirement
«Las autorizaciones de comercialización de los Suplementos Dietarios tendrán una validez de CINCO (5) años. Sin perjuicio de ello, la Autoridad Sanitaria Nacional podrá disponer la prohibición de venta de tales productos cuando razones de orden científico-técnico permitan concluir que su consumo resulta perjudicial para la salud de la población.»

Unofficial translation: “Marketing authorizations for Dietary Supplements shall be valid for FIVE (5) years. Notwithstanding this, the National Health Authority may prohibit the sale of such products when scientific-technical reasons lead to the conclusion that their consumption is harmful to public health.”

Código Alimentario Argentino, Art. 1381
Penalty
«d)Suspensión o cancelación de la autorización de elaboración, comercialización y expendio de los productos en infracción; e)Publicación de la parte resolutiva de la disposición que resuelva la sanción.»

Unofficial translation: “d) Suspension or cancellation of the authorization to manufacture, market and sell the products in violation; e) Publication of the operative part of the decision imposing the penalty.”

Ley 18.284, Art. 9°, incs. d) y e)

Rules that require it

02

Products covered

Supplements we usually classify:

  • Protein powders, mass gainers and amino acids.
  • Vitamins and minerals in capsules, tablets or gummies.
  • Creatine, collagen, caffeine and sports formulas.
  • Supplements with probiotics or prebiotics (require specific authorization).
  • Foods for special medical purposes, which share the RNPA fee.
03

Requirements and documents

In addition to the importer's RNE, for each supplement:

  • Complete qualitative and quantitative formula, with recommended daily dose.
  • Physicochemical and microbiological specifications.
  • Manufacturing process, storage and shelf life.
  • Certificate of free sale from the country of origin.
  • Spanish label without therapeutic claims.
  • Proof of fee payment.

Have some of this already? Upload it and get your quote

04

Official fees and timing

ConceptAmountValidSource
Registration, re-registration or transfer in the RNPA of dietary supplements (IC4000)$ 303.4502026Res. (SAGyP) 135/2026, Anexo
Modifications in the RNPA of dietary supplements, per modification (IC4172)$ 176.7002026Res. (SAGyP) 135/2026, Anexo
Authorization of probiotics, prebiotics and foods with probiotics and/or prebiotics (IC4501)$ 525.0002026Res. (SAGyP) 135/2026, Anexo
Authorization of health claims for advertising (IC4110)$ 373.8002026Res. (SAGyP) 135/2026, Anexo

SENASA fees per product. Each import also pays the authorization or notice, depending on origin. Private laboratory analyses are not official fees and are quoted separately.

Estimated timing

30 business days for RNPA registration and for probiotic authorization, according to the duration set by SAGyP Res. 135/2026.

Depends on: Whether ingredients fit the CAA, whether doses stay within permitted limits and whether the label carries unauthorized claims.

Our fee is quoted in writing for your case: upload your documents below and get a tailored quote.

Already have part of the documents? Upload them and get a quote.

05

How we handle it remotely

  1. Scoping

    We review formula and doses against the CAA to confirm the product is a supplement and not a medicine.

  2. Ingredients

    We flag ingredients not in the CAA or above limits and work out alternatives with you.

  3. Label

    We correct the Spanish label: mandatory statements, dose and permitted claims.

  4. Registration

    We file the RNPA, your importer pays the fee we indicate and we answer observations.

  5. Shipments

    With the RNPA, each operation goes by import authorization or by notice if there is Annex III certification.

06

Risks of not having it

  • A label with therapeutic claims takes the product out of the food category and stalls registration.
  • SENASA analytical verification of the imported batch: sale is not authorized until the result (Decree 2126/71, Annex II, art. 4, as amended by Decree 697/2026).
  • Market withdrawal and destruction at the importer's expense if the product proves unfit or counterfeit (Disp. 537/2025).
  • Sanctions under Law 18.284 for selling unregistered supplements, online channels included.
07

15+ years with Argentine agencies

Dietary supplements carry more fine print than any other food category in Argentina, and we have followed it for more than 15 years. Before filing we check every ingredient against the Food Code: unlisted botanicals, vitamins or minerals above the allowed cap, missing mandatory label statements. We also track the five-year expiry of the authorization so renewal never catches stock on shelves.

08

Frequently asked questions

Is a supplement a food or a medicine in Argentina?

If it complies with the Food Code and has no therapeutic purpose, it is a food and is registered in the RNPA with SENASA. If it claims to cure, treat or prevent disease, or has pharmacological doses, it is no longer a supplement and falls under ANMAT, which keeps its competence over medicines. Classification is settled before stock is bought.

How much does supplement registration cost?

SENASA's fee to register a dietary supplement in the RNPA is ARS 303,450 in 2026 (IC4000, SAGyP Res. 135/2026). If it contains probiotics or prebiotics, the specific authorization of ARS 525,000 (IC4501) is added. Each import's fee comes on top.

Can US supplements enter without an RNPA?

If the supplement has a certificate of free sale from the US authority or another Annex III country, it can be imported with an import notice and no prior RNPA. The prohibitions and maximum limits of the CAA still apply and prevail over the issuing country's conditions, and the label must be in Spanish.

Can imported supplements be sold on Mercado Libre?

Yes, if the product has an RNPA or entered by notice with Annex III certification, and the label complies with the CAA. Listing a supplement without backing exposes the account to takedowns and the product to recall. We leave the registration number and the file ready to answer any complaint.

Does a supplement registered by INAL need to be registered again?

No. Decree 697/2026 recognizes as valid, without re-registration, product registrations that moved from the former INAL to SENASA. Changes to formula, label or registration holder are now filed with SENASA, with a fee of ARS 176,700 per modification under SAGyP Res. 135/2026.

Get a tailored quote for dietary supplements

If you already have experience and want a competitive quote to compare, or to optimize costs and timing, send us your background documents and we quote with priority.

  1. 1Upload your documents and tell us about the product.
  2. 2We review them against the regulation that applies.
  3. 3You receive a written quote and, if something is missing, the exact list.
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    • 15+ years with Argentine agencies
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