Selling cosmetics in Argentina: what ANMAT requires from your importer
To sell cosmetics, perfumes and personal care products in Argentina, your Argentine importer needs three things before ANMAT: a licensed establishment, a registered product and an import notice filed within 48 hours after customs clearance. Since ANMAT Disposition 4033/2025 there is no prior authorization per shipment: control happens afterwards, in the market. The same route covers dental-use oral hygiene products and disposable hygiene products.
- Required by
- Disp. (ANMAT) 4033/2025
- Agency
- ANMAT
- Estimated timing
- Import notice: within 48 hours after customs clearance. Company license and product registration: [COMPLETAR].
- Official fee
- $ 7.088.400
- Our fee
- Tailored quote
Why it is mandatory
Disposition 4033/2025 removed ANMAT from authorizing each import but kept the sector's health rules (art. 2). Under Resolution 155/98, cosmetics may only be sold if they are registered, imported by a licensed establishment and handled under the technical direction of a registered university professional. That is what allows your product to be sold and stay on shelves, in pharmacies and on marketplaces.
Control moved downstream. ANMAT receives the notice for each shipment, cross-checks data and inspects the market: it can visit the warehouse, request the product file and order recalls. A shipment that cleared customs without issues is not covered if the product was not registered or the label differs from what was approved.
What the regulation says
«Los establecimientos que efectúen las importaciones de los productos detallados en el artículo 1° de la presente medida, deberán presentar, dentro de las 48 (cuarenta y ocho) horas de nacionalizados los productos, el “Aviso de importación” (en carácter de declaración jurada) a través de la plataforma TAD.»Unofficial translation: “Establishments importing the products listed in Article 1 of this measure must file, within 48 (forty-eight) hours after the products are cleared for consumption, the “Import Notice” (as a sworn statement) through the TAD platform.”
«Las actividades mencionadas en el artículo 1º sólo podrán ser realizadas con productos registrados en la ADMINISTRACION NACIONAL DE MEDICAMENTOS, ALIMENTOS Y TECNOLOGIA MEDICA, elaborados o importados por establecimientos habilitados por la misma, que cuenten con la Dirección Técnica de un Profesional Universitario debidamente matriculado (…)»Unofficial translation: “The activities referred to in Article 1 may only be carried out with products registered with the NATIONAL ADMINISTRATION OF DRUGS, FOOD AND MEDICAL TECHNOLOGY, manufactured or imported by establishments licensed by it, under the Technical Direction of a duly registered university professional (…)”
«Unifícanse las sanciones pecuniarias a aplicar a las infracciones cometidas contra las normas sanitarias identificadas en el Anexo I, (…) sin perjuicio de la aplicación de las restantes sanciones administrativas que cupieren y de las denuncias penales que se formularen cuando así correspondiere. (…) En caso de reincidencia, (…) la sanción podrá establecerse en hasta el décuplo del valor impuesto a la infracción anterior.»Unofficial translation: “The monetary penalties applicable to violations of the health regulations listed in Annex I are hereby unified (…) without prejudice to any other administrative sanctions that may apply and to criminal complaints filed where appropriate. (…) In case of repeat offense, (…) the penalty may be set at up to ten times the amount imposed for the previous violation.”
Rules that require it
- Disp. (ANMAT) 4033/2025: ANMAT stops authorizing imports of cosmetics, oral hygiene and disposable hygiene products; 48-hour import notice through TAD.
- Res. (ex MSyAS) 155/98: Cosmetics, personal hygiene and perfumes: only registered products, from licensed establishments, under a technical director.
- Disp. (ANMAT) 345/2006: Definition of grade 1 and grade 2 products and list of grade 2 products (Annex III).
- Dec. 892/2025 y Disp. (ANMAT) 236/2026: Sworn-statement registration of products authorized in reference countries.
- Disp. (ANMAT) 2978/2026: Fee schedule; Annex III sets the fees for cosmetics, personal hygiene, perfumes and oral hygiene.
Products covered
It covers products imported for sale or free distribution (Disp. 4033/2025, art. 1). Within cosmetics, ANMAT uses two grades (ANMAT Disp. 345/2006, Annex I):
- Grade 1: products with basic properties that do not need efficacy proof. For example, toilet soaps, shampoos and conditioners without special claims, moisturizers, make-up and perfumes.
- Grade 2: products with specific claims that require safety or efficacy proof. Annex III of Disp. 345/2006 lists them: sunscreens, antiperspirants, chemical depilatories, hair dyes and bleaches, children's products, anti-acne, anti-wrinkle, chemical exfoliants, skin lighteners, insect repellents and tooth whiteners, among others.
- Personal care and perfumes: colognes, deodorants, bath and hair products, skin care and make-up, classified by grade in the same way.
- Dental-use oral hygiene: toothpastes, mouthwashes and oral care products, with their own registration fee.
- Disposable hygiene products: for external use (diapers, wipes, personal pads) and for intravaginal use.
- No ANMAT involvement at import (art. 3): samples for trade shows or commercial demonstrations, samples for testing laboratories, donations and raw materials for the cosmetics industry.
Requirements and documents
The route has three steps, in this order:
- 1. Licensed establishment: the Argentine company registered with ANMAT as a cosmetics importer, with a warehouse and a technical director (a registered university professional).
- 2. Registered product: standard registration (form R-155) or, if the product is already sold in Australia, EFTA, the European Union, the United States, Israel, Japan or the United Kingdom, a sworn-statement filing backed by a certificate of free sale. See ANMAT market placement notice.
- 3. Import notice: a sworn statement filed through TAD within 48 hours after customs clearance (art. 4), shipment by shipment.
- For standard registration (R-155): product data (name, brand, origin), holder with a legal address in Argentina, manufacturing site and its licenses, technical director, qualitative and quantitative formula in INCI nomenclature, technical specifications (physicochemical and microbiological), label artwork and, for imports, a certificate of free sale from the country of origin.
- For grade 2 products: stability studies and safety tests (for example, skin and eye irritation) plus support for the claim on the label: a sunscreen has to back its protection factor.
- Spanish labels that meet the category rules, show the Argentine holder and registration number, and match what was registered.
- A file per product and per shipment, available for inspection.
Official fees and timing
| Concept | Amount | Valid | Source |
|---|---|---|---|
| License as importer of cosmetics, personal hygiene products, perfumes and oral hygiene products | $ 7.088.400 | 2026 | Disp. ANMAT 2978/2026, Anexo III |
| Registration of an imported cosmetic, personal hygiene product or perfume: grade 1 / grade 2 | $ 1.501.800 / $ 2.511.000 | 2026 | Disp. ANMAT 2978/2026, Anexo III |
| Registration of a dental-use oral hygiene product | $ 1.255.800 | 2026 | Disp. ANMAT 2978/2026, Anexo III |
| Appointment of a technical director, per position | $ 655.200 | 2026 | Disp. ANMAT 2978/2026, Anexo III |
| Import notice (Disp. 4033/2025) | [COMPLETAR] | [COMPLETAR] | Disp. ANMAT 4033/2025, art. 4 |
Official ANMAT fees in Argentine pesos. The license is paid once per company; registration, once per product, and it varies by grade. Legalizations, apostilles, translations, lab tests and private certifications are not official fees and are quoted separately.
Estimated timing
Import notice: within 48 hours after customs clearance. Company license and product registration: [COMPLETAR].
Depends on: Whether the importer is already licensed, the product grade (grade 2 needs tests and claim support), whether it qualifies for the sworn-statement route from a reference country, and how fast the manufacturer delivers formula, certificates and labels.
Our fee is quoted in writing for your case: upload your documents below and get a tailored quote.
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How we handle it remotely
Portfolio map
You send the product list. We classify each item by subcategory and grade, and flag which can go by sworn statement and which need standard registration.
Importer license
If your Argentine buyer is not licensed, we file the establishment registration and technical director appointment. If it is, we check the license covers what you will ship.
Formula, tests and label
We request the INCI formula, the certificate of free sale and, for grade 2, the test reports. We adapt the label to Spanish before filing.
Product registration
We file each product and return the registration number for labels and listings.
Shipment notice and file
We coordinate the clearance date with the customs broker, file the notice through TAD within 48 hours and keep the file ready for ANMAT.
Risks of not having it
- Selling an unregistered product, or one imported by an unlicensed company: proceedings, sales ban and market recall, with fines unified by Decree 341/92.
- An import notice filed late or not at all: a breach that ANMAT can detect in post-market control.
- Labels that differ from what was registered, lack mandatory Spanish information or carry grade 2 claims (such as an SPF) on a product registered as grade 1.
- Formula or supplier changes without updating the registration: the product that arrives is no longer the approved one.
15+ years with Argentine agencies
After more than 15 years in regulatory filings, we watched Disposition 4033/2025 remove shipment-by-shipment import authorization for cosmetics. The foundation stayed: a licensed establishment, a technical director and registered products. Files get stuck on formulas without percentage breakdowns, expired free sale certificates or labels that differ from what was registered. We review the full portfolio before the first shipment, so every 48-hour notice is backed.
Frequently asked questions
Does ANMAT authorize each cosmetics import?
No. Since Disposition 4033/2025, ANMAT no longer authorizes imports of cosmetics, oral hygiene or disposable hygiene products. Your importer still needs a license, each product must be registered, and an import notice must be filed through TAD within 48 hours after clearance. Without those three, the products cannot be sold.
Is my product grade 1 or grade 2?
It depends on what it claims. Basic functions such as cleansing, fragrancing or moisturizing are grade 1. Specific claims that need proof, such as sun protection, antiperspirant action, anti-acne effect or hair dye, are grade 2. ANMAT Disposition 345/2006 lists grade 2 products. The grade changes the documents and the fee.
Can I sell my cosmetics in Argentina without a local importer?
No. Registration and the import notice are filed by a licensed Argentine establishment that acts as the product holder. You can work with your distributor if it is licensed, or with a licensed importer that holds the registrations for your brand.
How much does registration cost?
The importer license costs ARS 7,088,400. Each product pays ARS 1,501,800 if grade 1 or ARS 2,511,000 if grade 2, and ARS 1,255,800 for dental-use oral hygiene (ANMAT Disp. 2978/2026, Annex III). Private costs for documents and tests are added on top.
What if we change the formula or the packaging?
Registration covers a specific formula and label. If ingredients, the concentration of an active or the label text change, the registration has to be reviewed before importing the modified product. Unupdated changes are a common reason for findings in post-market inspections.
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