Request a DemoArgentina is a key and dynamic player within MERCOSUR—the South American trade bloc comprising Argentina, Brazil, Paraguay, and Uruguay—which collectively works to harmonize cosmetic regulations among its member states. Through a combination of MERCOSUR resolutions and national legislation, Argentina enforces a comprehensive regulatory framework that ensures the safety and quality of cosmetic products. This framework encompasses all stages of a product's lifecycle, including classification, labelling, market authorization, and post-market surveillance. A thorough understanding of these requirements is essential for companies seeking compliance and success in the Argentine market.
Part 1 Regulatory Framework and the Competent Authority
1.1 Main Regulations
| Type | Regulation | Description |
|---|---|---|
| Overarching | This regulation sets the framework for overseeing cosmetic products, requiring all responsible parties to ensure product safety and compliance with applicable regulations. | |
Market authorization | This regulation governs the authorization of companies involved in the production, packaging, storage, and/or importation of cosmetic products. | |
This regulation implements an electronic management system for the automatic admission process of Grade I cosmetic products. | ||
Instruction Manual for the Registration of Grade II Cosmetic Products | This guideline outlines the process for registering Grade II cosmetic products, and modifying existing registrations. | |
This regulation defines updated technical standards for cosmetic products. | ||
This regulation prescribes technical guidelines for good manufacturing practices in cosmetic products. | ||
This regulation establishes standardized labelling requirements for cosmetic products. | ||
This regulation lays down provisions for advertisements distributed through various media channels that directly target consumers. | ||
Ingredient | This regulation lists substances prohibited for use in cosmetic products. | |
This regulation sets out substances restricted for use in cosmetic products. | ||
This regulation specifies colorants permitted for use in cosmetic products. | ||
This regulation stipulates preservatives permitted for use in cosmetic products. | ||
This regulation identifies ultraviolet filters permitted for use in cosmetic products. | ||
Post-market Surveillance | This regulation creates a national Cosmetovigilance program to monitor the safety and efficacy of cosmetic products. | |
This regulation mandates cosmetic companies to implement recall systems for cosmetic products in cases of safety or quality concerns. |
1.2 Competent Authority
The National Administration of Drugs, Food and Medical Devices (ANMAT) serves as Argentina's competent authority for cosmetic products. Its mandates include ensuring the quality, safety, and efficacy of these products, as well as monitoring adverse events associated with their use. It oversees the entire product lifecycle—from production and importation to storage and commercialization—as well as the substances used in product formulation.
Beyond its core regulatory duties, ANMAT promotes the advancement of regulatory science through research and development programs, as well as maintains active collaboration with academic, scientific, and international organizations.
Part 2 Cosmetic Compliance Requirements
2.1 Definition
In Argentina, cosmetic products are broadly defined to include personal hygiene products, cosmetics, and perfumes. As established by Resolution No. 155/1998, these products are preparations composed of natural or synthetic substances, or their mixtures, designed primarily or exclusively to cleanse, perfume, alter appearance, correct body orders, and/or protect or maintain the applied areas in good condition. The designated areas of application include external parts of the human body—such as the skin, hair, nails, lips, and external genitals—as well as the teeth and the mucous membranes of the oral cavity.
2.2 Classification
Order No. 8067/2024, adopted to incorporate MERCOSUR GMC Resolution No. 18/2023 into Argentine domestic law, classifies cosmetic products as Grade I and Grade II based on their formulation, application sites, target users, and potential for adverse effects from improper use. Detailed descriptions and examples of each grade are provided below.
Product Classification | Description | Product Types (Non-exhaustive) |
|---|---|---|
Grade 1 | Cosmetic products that are subject to a lower level of health surveillance due to their application areas, target users, formulation, and/or the health impacts of their declared use purposes. |
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Grade 2 | Cosmetic products that are subject to a higher level of health surveillance due to their application areas, target users, formulation, and/or the health impacts of their declared use purposes. |
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2.3 Market Authorization
Entering the Argentine cosmetics market involves a two-tiered authorization process: companies shall be licensed for activities such as production, packaging, storage, and/or importation, while cosmetic products shall satisfy entry conditions aligned with their classification.
2.3.1 Authorization for Company Operation
Under Order No. 346/2006, cosmetic companies engaged in production, packaging, repackaging, storage, and/or importation shall apply for operational authorization from ANMAT, supported by the required documentation listed below:
1) Completed application form;
2) Architectural plans, and a description of premises and facilities;
3) Proof of fee payment;
4) Accreditation or registration proof of the designated technical manager;
5) Details on the capacity of the quality control laboratory, whether it is managed internally by the company or contracted to an external provider;
6) A signed declaration identifying the company's legal representative;
7) Other documents required by the authority.
Regarding the "quality control laboratory" mentioned in item "5)", Order No. 346/2006 clarifies that quality control falls exclusively under the responsibility of companies that formulate, manufacture, package, and repackage products. Accordingly, these companies shall maintain their own quality control laboratory. Importers, on the other hand, shall either operate an in-house laboratory, or engage an external one, to ensure the quality of the products they place on the market.
2.3.2 Authorization for Cosmetic Products
Argentina imposes distinct market entry requirements on cosmetic products according to their classification. Grade I products follow an automatic electronic admission process, while Grade II products are subject to a more stringent registration procedure. The following sections outline key requirements for each category.
1) Grade I Cosmetic Products
Before being placed on the market, Grade I products shall complete the automatic admission process through ANMAT's Electronic Management System. To access this system, companies are required to obtain a username and a personal access code, which are issued by ANMAT's IT Department upon request.
Once access is granted, companies shall submit an admission request containing essential product details, including the product's identification, formula, shelf life, quality control measures, stability data, usage instructions, label artwork, manufacturer, and marketing authorization holder. For imported products, companies shall provide information on the country of origin, along with supporting documents such as a certificate of free sale, and a letter of authorization.
2) Grade II Cosmetic Products
To register a Grade II product, companies shall complete and submit the "Form R-155" to ANMAT. Preparing this form requires the compilation of key product information, including details of the product registration holder, manufacturer, importer, product identification, qualitative formula, technical specifications, and labelling.
Form R-155 also specifies the supporting documentation required to substantiate the information provided. All such documents shall be attached to the form at the time of filing. Additional pages provided at a later stage will not be accepted for inclusion in the product file.
The required supporting documentation includes:
Microbiological specifications;
Test reports on safety evaluations (e.g., skin irritation, ocular irritation, phototoxicity);
Label artwork;
Legalized original formula (for imported products only);
Legalized certificate of free sale (for imported products only);
Letter of authorization (if applicable);
Authorization contract (if applicable).
2.4 Ingredients
Among MERCOSUR members, Argentina enforces comparatively stricter controls on cosmetic ingredients. While adhering regional technical documents issued by MERCOSUR, it further strengthens its regulatory framework by implementing national restrictions aligned with international practices.
2.4.1 Alignment with MERCOSUR Documents
MERCOSUR has issued eight resolutions governing the use of cosmetic ingredients, which serve as the foundation for ingredient management across member states. In Argentina, the following national orders have been adopted to align with these resolutions:
No. | Ingredient Category | Argentine Regulation | Corresponding MERCOSUR Resolution |
|---|---|---|---|
1 | Prohibited substances | Order No. 6433/2015 | MERCOSUR GMC Resolution No. 62/2014 |
Order No. 7885/2022 | MERCOSUR GMC Resolution No. 37/2020 | ||
2 | Restricted substances | Order No. 6365/2012 | MERCOSUR GMC Resolution No. 24/2011 |
Order No. 7885/2022 | MERCOSUR GMC Resolution No. 37/2020 | ||
3 | Permitted colorants | Order No. 1608/2013 | MERCOSUR GMC Resolution No. 16/2012 |
4 | Permitted preservatives | Order No. 2709/2022 | MERCOSUR GMC Resolution No. 35/2020 |
5 | Permitted UV filters | Order No. 2384/2018 | MERCOSUR GMC Resolution No. 44/2015 |
Order No. 7810/2022 | MERCOSUR GMC Resolution No. 14/2021 |
To promote the safe use of cosmetic ingredients, MERCOSUR periodically revises its resolutions for the ingredient categories listed above. These updates are then reflected in Argentina's domestic regulations through corresponding orders.
2.4.2 Alignment with International Standards
Beyond MERCOSUR alignment, Argentina also enforces additional restrictions on certain cosmetic ingredients by referencing international regulations, such as those issued by EU and U.S. Examples of such restrictions include:
Order No. 5978/2023: This Order prohibits the use of 6-Amino-m-cresol (CAS No. 2835-98-5), 1,2,4-Trihydroxybenzene (CAS No. 533-73-3), and 2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid (CAS No. 117907-43-4) in cosmetic products, with reference to Commission Regulation (EU) 2020/1683;
Order No. 7078/2019: This Order bans the use of methyl methacrylate (CAS No. 80-62-6) in cosmetic products, referencing a U.S. report identifying this ingredient as the one most frequently linked to adverse events in nail care products reported to the U.S. Food and Drug Administration;
Order No. 249/2017: This Order limits the use of hydroquinone (CAS No. 123-31-9), p-hydroxyanisol (CAS No. 150-76-5), and benzoyl peroxide (CAS No. 94-36-0) to professional applications within artificial nail systems, reflecting corresponding restrictions adopted by EU.
2.5 Labelling and Advertising
2.5.1 Cosmetic labelling
1) General Requirements
Labelling is essential to inform consumers about a product's composition, intended use, and efficacy, thereby reducing misuse. In Argentina, cosmetic labels shall be clear, truthful, and free from content that could mislead or confuse consumers, imply therapeutic effects, claim insect elimination or protection, and suggest disinfectant properties or complete microorganism elimination. To support informed choices, cosmetic products are required to bear the following information on the packaging:
No. | Required Information | Type of Packaging |
|---|---|---|
1 | Product name, and product group (if not implied in the name) | Primary and secondary |
2 | Brand | Primary and secondary |
3 | Product authorization details | Secondary |
4 | Batch number | Primary |
5 | Shelf life | Secondary |
6 | Content | Secondary |
7 | Country of origin | Secondary |
8 | Details of the marketing authorization holder | Secondary |
9 | Customer service contact information | Secondary |
10 | Directions for use (if applicable) | Primary or secondary |
11 | Warnings and use restrictions (if applicable) | Primary and secondary |
12 | List of ingredients (following INCI nomenclature) | Secondary |
Notes: Except for the ingredient list, product name, and brand, all mandatory labelling information shall be clearly presented in Spanish. The ingredient list shall be labeled following the INCI nomenclature. | ||
2) Specific Requirements
In addition to the general requirements stated above, Argentina mandates the inclusion of warnings and use restrictions on labels for 14 designated product groups. Different wording with the same meaning is permitted. Examples can be found in the table below.
No. | Product Group | Required Warnings and Use Restrictions on Labels |
|---|---|---|
1 | Aerosols | a) "Flammable. Do not spray close to fire"; b) "Do not puncture or incinerate"; c) "Do not expose to sunlight or temperatures exceeding 50°C"; d) "Protect eyes during application"; e) "Keep out of the reach of children"; f) "Avoid direct inhalation of this product"; g) Indicate the recommended minimum application distance. |
2 | Antiperspirant products | a) "Apply only to the specified areas"; b) "Do not use on irritated or damaged skin"; c) "Discontinue use immediately if irritation and/or itching occurs at the application site". |
3 | Neutralizers, as well as hair perming and straightening products | a) "Do not use on irritated or damaged scalp"; b) "Keep out of the reach of children"; c) "Apply this preparation only for its intended purpose. Avoid any other applications, as it is dangerous". |
4 | Oral hygiene products intended for sensitive teeth | a) "Discontinue use of the product and consult your dentist if dental sensitivity persists for more than four weeks"; b) "Avoid ingestion of the product". |
5 | Toothpastes and mouthwashes with fluoride | a) Specify the name of the fluorine compound used and its concentration in ppm (parts per million); b) Indicate the method of use, if necessary; c) "Do not use in children under 6 years of age" (for mouthwashes only). |
2.5.2 Cosmetic Advertising
Order No. No. 4059/2025 governs public advertising of a broad range of products, including cosmetics. It sets out overarching principles to govern advertising practices for regulated products, mandating that only products authorized by ANMAT can be advertised, and that all promotional content be accurate, objective, non-misleading, and grounded in approved information. It also emphasizes the use of accessible language in advertising, and assigns accountability to the marketing authorization holder for ensuring regulatory compliance across all advertising channels.
Built upon these principles, Order No. No. 4059/2025 further specifies two sets of detailed obligations: elements that shall appear in public advertising, and practices that are expressly prohibited.
Obligation Type | Illustrative Examples |
|---|---|
Required elements in public advertising | a) Advertisements shall present the product's authorized identification details, and display the product label as approved; b) Scientific and technical references included in any advertisement shall be made accessible to ANMAT, and provided in Spanish; c) Where one or more professionals (e.g., physician, dentist, or pharmacist) are shown to endorse the product, their license number shall be disclosed; d) Advertisements can include a phone number or website to address consumer inquiries, provided the information is accurate and compliant. |
Prohibited practices in public advertising | a) Advertisements shall not contain false, exaggerated, or ambiguous information that could mislead consumers and influences their purchasing decisions; b) Products shall not be advertised with efficacies or uses not authorized by ANMAT; c) Phrases such as "Approved by ANMAT" and the ANMAT logo are not allowed in advertising; d) Advertisements shall avoid making unsubstantiated claims regarding safety, efficacy, or expert recommendations. |
2.6 Post-market Surveillance
2.6.1 Cosmetovigilance System
To harmonize national practices with MERCOSUR GMC Resolution No. 19/2005, Argentina enacted Order No. 339/2006 to incorporate regional Cosmetovigilance requirements into its national legal framework. This regulation stipulates that cosmetic manufacturers and importers operating in Argentina shall develop and maintain a Cosmetovigilance system aimed at monitoring product safety and responding to adverse events, as part of their broader quality assurance obligations.
A compliant Cosmetovigilance system shall facilitate the structured collection and recording of reports on product-related issues, including adverse events and quality complaints. Companies are required to evaluate each report and, where a potential health risk is identified, notify ANMAT without delay. This ensures a focused response to credible safety concerns.
2.6.2 Product Recall System
In parallel with Cosmetovigilance requirements, Argentina requires cosmetic manufacturers and importers to maintain a standardized and regularly updated product recall system, enabling swift action to address products found to be non-compliant or potentially hazardous, as mandated by Order No. 1402/2008.
This regulation differentiates between voluntary recalls initiated by companies and those mandated by ANMAT. It categorizes recalls into three risk classes—Class I (serious injury or death), Class II (temporary reversible harm), and Class III (no health consequences)—which define the scope and rigor of recall verification. For voluntary recalls, companies shall implement robust verification procedures to ensure removal throughout the entire distribution chain, from primary distributors to consumers. In ANMAT-ordered recalls, the authority oversees the recall's effectiveness, performs selective audits, and may issue public warnings, especially for Class I and some Class II cases.
A product recall is formally closed only when ANMAT verifies that the responsible company has fully implemented the recall in accordance with its classification. If product destruction is involved, the company shall obtain prior written authorization from ANMAT, and maintain proper records of the process.
