The increasing demand for organic, safe, and cruelty-free cosmetics has promoted the production and sale of cosmetic products in Argentina. These cosmetic products are regulated by the ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), which is the main regulatory authority in Argentina. Argentina serves as a good scope for the development of domestic and foreign cosmetic products.
Now, let’s look deeper into the aspects of cosmetic products in Argentina.
Definition Of Cosmetics By ANMAT
In Argentina, cosmetic, personal hygiene, and perfume products are defined under Resolution 155/98. They are preparations. They are made from natural or synthetic substances or even mixtures thereof. Consumers use these products on external parts of the human body. This includes the skin, hair system, nails, lips, external genital organs, teeth, and oral mucous membranes. They cleanse, perfume, change appearance, protect or maintain these areas in good condition, and/or correct body odors. Cosmetic products may not claim therapeutic activity.
Cosmetics Classification by ANMAT
Cosmetic, personal hygiene, and perfume products in Argentina are classified as Grade I or Grade II under the MERCOSUR Technical Regulation. It was incorporated into Argentina through ANMAT Disposition 8067/2024. This Disposition incorporated MERCOSUR GMC Resolution 18/23 and repealed ANMAT Disposition 345/2006, which had previously incorporated GMC Resolution 07/05.
Grade I products require a lower initial degree of sanitary surveillance. It is based on their area of application, intended population, particular formulation characteristics, or the health impact of their claimed purpose of use. Grade II products require a higher degree of sanitary surveillance based on the same classification criteria.
| Category | Current regulatory distinction | Examples |
| Grade I | Products requiring a lower degree of sanitary surveillance based on their area of application, intended population, formulation characteristics, and/or claimed purpose of use. |
Shampoo, conventional conditioner, lipstick without photoprotective purpose, facial/body makeup without photoprotective purpose
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| Grade II | Products that need a higher degree of sanitary surveillance. It is based on their area of application, intended population, formulation characteristics, and/or claimed purpose of use. |
|
Regulatory Parties In Argentina
The regulatory authority and framework of Argentina’s cosmetic industry are as follows:
Ministry of Health and ANMAT
Argentina’s Ministry of Health and ANMAT are responsible for the national regulatory framework. They apply their rules to personal hygiene and cosmetic and perfume products. Resolution 155/98 establishes the national framework for the import, export, manufacture, packaging, and storage of these products. ANMAT implements and enforces the requirements.
MERCOSUR
Argentina incorporates MERCOSUR technical regulations into its national regulatory framework. The current framework for cosmetic classification is MERCOSUR GMC Resolution 18/23. It is incorporated into Argentina by ANMAT Disposition 8067/2024. It replaced the previous GMC Resolution 07/05 framework.
Restrictions on Cosmetic Ingredients
Argentina’s cosmetic ingredient requirements are also updated through the MERCOSUR framework. ANMAT Disposition 2820/2026 incorporated MERCOSUR GMC Resolution 27/25 into Argentina’s national framework. The resolution modifies the technical regulation that concerns substances not frequently used in cosmetics.
Disposition 2820/2026 also added substances to the existing ANMAT list of prohibited ingredients. Products already regularized were given 60 days from publication of the disposition to comply with the new requirements.
Cosmetics Registration and Admission Process in Argentina
The regulatory process for cosmetics in Argentina depends on the product’s classification. It also considers whether the company is manufacturing or importing the product. The current classification of cosmetics into Grade I and Grade II follows MERCOSUR GMC Resolution 18/23. It is incorporated into Argentina by ANMAT Disposition 8067/2024.
Before a company carries out manufacturing, packaging, fractionation, conditioning, or import activities for cosmetics, the establishment must be authorized by ANMAT. Under Disposición ANMAT 7939/2025, establishments covered by the regulation can obtain authorization through the submission of a Declaración Jurada (DDJJ) de habilitación through ANMAT’s digital platform. The submission generates a file number and enables the declared activities at the declared plants or facilities, subject to subsequent verification by ANMAT.
The declaration is made for the relevant product category and identifies the establishment, activities, facilities, and, where required, the technical director. The applicant must have, among other things, documentation demonstrating legal possession of the premises, municipal authorization of the building or equivalent documentation, an appropriately qualified and currently registered technical director, a quality management system, and the required quality-control arrangements.
1. Grade I Cosmetic Products
Grade I products are cosmetics with basic or elementary properties. For them, the initial verification of specific characteristics is not required. For products falling within the Grade I framework, ANMAT’s electronic admission procedure established under Disposición 959/2012 remains relevant to product admission. However, the classification of the product must now be determined under MERCOSUR GMC Resolution 18/23 as incorporated by Disposición 8067/2024.
The admission must be completed before the product is marketed and may be submitted by a duly authorized manufacturer or importer. In particular, the Grade I automatic-admission criteria include the following:
- The product must not contain prohibited substances
- It must not contain certain restricted substances that would make it a Grade II product unless the formulation still permits Grade I classification
- It must not contain sunscreen filters whose function is protection of the skin against harmful solar radiation
- Don’t make therapeutic claims
- No use of names or indications that could mislead or confuse consumers with regard to its origin, composition, purpose, or safety
- Its labeling must meet the rules that apply
The information submitted through the electronic system is made under declaration of responsibility. ANMAT may subsequently observe the filing for non-compliance. Where ANMAT raises an observation, the manufacturer or importer must make the requested modifications within the period established by the procedure.
2. Grade II Cosmetic Products
Grade II products require a higher degree of sanitary surveillance. Their classification must be established under GMC Resolution 18/23 as incorporated by ANMAT Disposition 8067/2024. The product information, safety and/or efficacy information, labeling, composition, and other technical documentation required for the product must be submitted through the corresponding ANMAT procedure. It shouldn’t be treated under the Grade I automatic-admission route.
What Happens After Product Admission?
For Grade I products admitted through the electronic system, the holder/manufacturer/importer remains responsible for the truthfulness of the information submitted and for the product’s sanitary suitability. ANMAT can observe the admission for regulatory non-compliance. Modifications to admitted products are handled through the established electronic system. The regulation specifically recognizes modifications for matters like denomination, brand, formula, manufacturers, packers, importers, quality-control laboratory, labelling, and origin.
The current framework also places continuing responsibility on the manufacturer. The importer has to make sure of the product quality, safety, and efficacy and adhere to the applicable Good Manufacturing Practices. Disposición 7939/2025 clearly says that manufacturers and importers have an active post-marketing role in collecting and evaluating information that concerns the use of their products. That’ll help identify, prevent, or mitigate risks.
Documents Required for Establishment Authorization in Argentina
For establishment authorization under the current 2025 framework, ANMAT expressly identifies documentation mentioned below:
- Corporate/statutory documentation appropriate to the applicant
- Evidence of legal possession of the premises
- Municipal authorization of the building or equivalent competent-authority documentation
- Details and professional credentials/registration of the technical director
- Quality-management-system documentation
- Arrangements with quality-control laboratories where testing is outsourced
- Functional plan of the establishment
- Proof of payment of the applicable fee
Import and Market Placement of Foreign Cosmetic Products in Argentina
ANMAT Disposition 236/2026, since 2026, covers imported cosmetic, personal hygiene, and perfume products. The disposition covers foreign-origin cosmetics that satisfy the formulation, labeling, quality, safety, and efficacy requirements of the nation.
Sanitary authorization is required for companies that wish to import and market foreign products. The products must be authorized and registered with ANMAT. The registration and authorization process is implemented through a Declaración Jurada (DDJJ) called the Aviso de Puesta en el Mercado.
ANMAT’s current transitional procedure requires the company to submit the Aviso de Puesta en el Mercado together with the documentation specified by Disposition 236/2026. ANMAT states that this submission mechanism is transitional until the digital platform provided for under Disposition 236/2026 becomes operational.
Labelling Of Cosmetic Products in Argentina
The MERCOSUR Technical Regulation on Labelling for Personal Hygiene Products, Cosmetics, and Perfumes (GMC Resolution 48/21) applies to cosmetic, personal hygiene, and perfume products. ANMAT Disposition 7809/2022 is the one through which it has been incorporated into Argentina. The regulation provides information about compulsory things to add, rules for primary and secondary packaging, what language to use, warnings and restrictions of use, and specific requirements for some product categories.
Transparency and truthfulness are needed for labels that are mandatory. Information that’s added should prevent inappropriate use. Provide the details in the language of the MERCOSUR State Party where the product is marketed. Exceptions are elements like INCI ingredient nomenclature, names, and trademarks.
Key requirements include the ones mentioned below:
- Identity of the product in the language of the state where the product is going to be sold.
- Statement providing net quantity in metric units of measurement.
- Any warnings or cautions.
- Name and address of the manufacturer or distributor.
- Directions given for the use of the product.
- Ingredient list ( using INCI ).
- Other mandatory information prescribed by the regulation
A product having both primary and secondary packaging should have the information on the respective packaging. In case of no secondary package, the required information must appear on the primary package. For small primary containers, certain directions, warnings or restrictions may be provided through an accompanying leaflet/material or the inside of the secondary package, subject to the prescribed cross-reference on the package.
Claims and Prohibited Representations
The labels on cosmetic products should not have names, trademarks, images, electronic links, or statements that mislead or confuse consumers about the product’s properties, origin, composition, allowed purpose of use, or safety. The regulations also ban therapeutic claims. The MERCOSUR labelling regulation specifically restricts representations involving the prevention or treatment of diseases or therapeutic conditions and certain claims relating to disinfection, complete elimination of microorganisms, insects or other medicinal-type effects.
Conclusion
Argentina’s cosmetics framework is based on ANMAT’s national requirements together with harmonized MERCOSUR technical regulations. Companies should address more than product admission alone. Classification, establishment authorization, formulation and prohibited substances, labelling, import requirements and post-market responsibilities all form part of the regulatory pathway.
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FAQs
How are cosmetics classified in Argentina?
Cosmetic, personal hygiene, and perfume products are classified as Grade I or Grade II under MERCOSUR GMC Resolution 18/23. Grade I products require a lower initial degree of sanitary surveillance. Grade II products require a higher degree based on their area of application, intended population, particular formulation characteristics, and/or claimed purpose of use.
Who regulates cosmetics in Argentina?
In Argentina, ANMAT—National Administration of Drugs, Food, and Medical Technology—handles the regulation of cosmetics through Resolution MS and AS No. 155 of 1998 and subsequent ANMAT and MERCOSUR regulations.
What is Argentina’s ANMAT harmonised with?
Argentina incorporates MERCOSUR technical regulations into its national cosmetics framework. The current cosmetic classification framework is based on MERCOSUR GMC Resolution 18/23, incorporated by ANMAT Disposition 8067/2024.
What is the electronic admission process for Grade I cosmetic products in Argentina?
Grade I products may be admitted through ANMAT’s electronic admission procedure established under Disposition 959/2012. The product must first meet the Grade I classification criteria under the current MERCOSUR GMC Resolution 18/23 framework, incorporated by Disposition 8067/2024.
