Argentina Food Regulations

For most prepackaged foods, Argentina's food regulatory framework is relatively straightforward, with the Argentine Food Code (Código Alimentario Argentino or CAA) serving as a dominant regulation, which is comprehensive and regularly updated. As a member of MERCOSUR (Common Market of the South), regional standards are not directly applicable in Argentina. Instead, Argentina mainly incorporates these standards into CAA to make these regulations effective.

Part 1 Competent Authority

The two primary competent authorities overseeing food products in Argentina are :

• The National Administration of Medicines, Food and Medical Technology (ANMAT) under the Ministry of Health

• The Secretary of Agriculture, Livestock and Fisheries (SAGyP), under the Ministry of Economy.

Specifically, ANMAT is mainly responsible for supervising most packaged food, while SAGyP oversees agricultural food and its derivatives. Additionally, there are other agencies worth noting, such as the National Food Commission (CONAL). The members of CONAL are from different ministries, such as the Ministry of Health and SAGyP. One of the important responsibilities for CONAL is to review and approve amendments to the CAA.

The following table details the responsibilities of key ministries and subordinate agencies:

Part 2 Main Regulations

The Argentine Food Code (CAA) is the primary federal legal framework for food safety in Argentina, enacted by Law 18284 in 1969. This constantly updated technical regulation establishes hygienic-sanitary, bromatological, and commercial identification provisions applicable to individuals, legal entities, establishments, and products within its scope, including imported products.

The CAA comprises over 1400 articles divided into 22 chapters. These chapters cover general conditions for food factories and trade, food conservation and treatment, utensil use, container and wrapper standards, food labeling and advertising, and specifications for various food types, beverages, additives, etc. Chapters are regularly updated through joint resolutions of the Ministry of Health and SAGyP, with the CAA having been supplemented or modified by 454 standards to date. Key supplementary regulations amending CAA include:

• Decree 2126/1971: Approves the ordered text and the regulations of Law 18284

• Decree 815/1999: Establishes the National Food Control System to ensure CAA compliance

• Resolution 241/2011: Creates the Federal Food Control Program (PFCA)

• Provision 2873/2012: Sets requirements for probiotic use

• Provision No. 1675/2014: Implemented the registration of establishments covered by the Argentine Food Code in the National Registry of Establishments (RNE) through SIFeGA, under the National Food Institute (INAL)

• Provision No. 8403/2015: Implemented the registration of food products, including foods for specific medical purposes, in the National Registry of Food Products (RNPA) through SIFeGA, under the National Food Institute (INAL)

• Provision 10873/2017: Creates the "Comprehensive Plan for the Inspection of Establishments, Food Products and Materials in Contact with Food"

• Decree 35/2025: revises Decree 2126/1971

• Provision 537/2025: Establishes the procedure for obtaining the Authorization or Import Notice under the National Food Institute (INAL), covering the National Establishment Registry (RNE), the National Registry of Food Products (RNPA), and the authorization of food contact containers and utensils

In addition to the CAA, other general and product-specific regulations must be followed, such as:

• Law 24240/1993: Provides the rules for consumption protection

• Decree 4238/1968: Stipulates regulations on the inspection of products and by-products and derivatives of animal origin

• Decree 1812/1992: Stipulates regulations for the inspection of products, by-products, and derivatives of animal origin

• Law 14878/1959 General Wine Law

• Law 25163/1999: Sets general rules for the designation and presentation of wines and spirits of vinous origin from Argentina, including indication of origin and geography

• Law 27233/2015 Animal and Plant Health

• Notices for prohibited products or advertising activities

• Other regulations issued by SENARA regarding agriculture products

• …

Part 3 Market Access Approval

According to the CAA, all foods, condiments, beverages, their raw materials, and food additives manufactured, packaged, preserved, transported, sold, or displayed must meet the Argentine Food Code's requirements. These requirements also apply to imported products.

On January 20, 2025, Argentina implemented modifications to the CAA through Decree 35/2025, aiming to simplify and streamline import procedures for food products. This decree stipulates that CAA requirements are considered satisfied for imported food products and/or packaging with certification issued by countries listed in Annex III of the decree (Australia, Canada, Switzerland, EU, US, New Zealand, Israel, Japan, UK, and countries with Economic Integration Treaties or Reciprocity Agreements in force regarding hygienic-sanitary matters) or when states use "Codex Alimentarius" (FAO/WHO) standards.

In another word, food products for which CAA requirement are considered satisfied are exempt from certain administrative procedures required by the CAA, e.g., procedures outlined in Articles 1416 bis (Sanitary authorization of enterprises), 1416 tris (Sanitary authorization of food products), 1416 quarter, and 1416 fifth of the Argentine Food Code (Sanitary authorization of food contact container and appliance). These products only require completion of an import sworn declaration, and the Authority may not impose additional requirements.

One thing worth noticing is that, even though CAA requirements are considered satisfied, the labeling of such products must comply with current regulations (Chapter V of the CAA) for allergens and general labeling. Moreover, these changes currently apply only to the prepackaged products regulated by INAL. They do not apply to agri-products regulated by SENASA.

Imported products not falling under the aforementioned exemptions must demonstrate compliance with the provisions established in the Argentine Food Code and pay attention to the following steps.

3.1 Registration requirements

• National Registry of Establishments (RNE) (Sanitary Authorization of Enterprises for Most Prepackaged Foods)

As per the CAA, the installation and operation of food manufacturers and sellers, as well as those producing packaging and materials in contact with food, must be authorized by the health authority corresponding to their place of production, processing, packaging, storage, preservation, or sale. For import operations involving processed products, importers must be registered with the corresponding authority. ANMAT Regulation No. 1675/14, Article 17, establishes that RNE registrations are valid for a maximum of five (5) years and may be renewed.

To fulfill this requirement, stakeholders must use ANMAT's Federal Information System for Food Control Management (SIFeGA). SIFeGA is designed to manage procedures outlined in the CAA under INAL's jurisdiction, including RNE and RNPA registration (introduced in the next point), laboratory tests, and other procedures.

To obtain the RNE registration, the following information must be provided:

• Importer data: company name, CUIT (Taxpayer Identification Number), address, company bylaws (if applicable), DGA (Customs General Directorate) registration.

• Establishment's CUIT (deposit) and address, municipal authorization, schematic plan of the establishment.

• Proof of electronic payment of the corresponding fee with code.

Once the sworn declaration is submitted, an RNE number will be obtained. Further details can be found in Chapter XXI Procedures of the CAA. Procedure to use this SIFeGA system can be found here.

• National Registry of Food Products (RNPA) (Sanitary Authorization for Most Prepackaged Foods)

This registration signifies the health authorization granted by the authority for all food products, allowing their marketing, circulation, and sale throughout the national territory. For imported foods, importers must complete the RNPA registration with the authority. INAL registers imported packaged products ready for consumption, raw materials, additives, processing aids, dietary supplements, and foods for specific medical purposes. RNPA registrations are valid for a maximum of five (5) years and may be renewed.

To register a food product, the interested party must:

• Possess the corresponding RNE registration granted by a competent health authority.

• Ensure the scope of the RNE authorization includes the "importer" activity.

• Verify that the scope of the RNE authorization associated with the RNPA corresponds to the product's category, condition, and attribute.

• Use the SIFeGA system to apply for the RNPA.

To obtain the RNPA registration, the following information must be completed:

1. Enterprise information: Identification of the business name and subsidiary information of the processing establishment of origin and other participating establishments for imported products.

2. Product information:

   - Name, brand and product category

   - Qualitative and quantitative composition of ingredients and additives

   - Labeling, with the mandatory information and any additional information, if applicable.

   - Specifications: physical-chemical, microbiological, and other specific requirements established in the regulations

3. Storage conditions

4. Type of packaging, material, net contents, and drained water of the consumer unit.

5. Shelf life of the consumer unit under declared storage conditions, supported by relevant documentation.

6. Description of the manufacturing method, including operations and processes until the final product is obtained.

7. Document proving suitability, for imported products.

8. Other specific requirements

9. Proof of electronic payment of the corresponding fee with code.

Once the information is loaded, an RNPA number will be obtained. Details can be found at Chapter XXI Procedures of CAA.

• Product Registration for Non-Specified Processed Food

As per Article 3 of the CAA, any processed food not defined by this Code, including foods for Special Diets, may only be registered after acceptance by the national health authority. For evaluation, certificates and monographs must be submitted. The authority will authorize them provided their raw materials, ingredients, additives (in permitted proportions), food contact materials, processing processes, and food safety meet the Code's requirements.

Needed documents include:

• Preliminary report justifying the evaluation request within the framework of Article 3 of the Argentine Food Code.

• Certificate of RNE.

• The complete qualitative-quantitative formula of the product: full name of all ingredients, including additives with their corresponding INS number, in percentage form and in decreasing order of weight.

• The product manufacturing process with different operations and processes until the final product is obtained.

• Conservation conditions, mode of use, or preparation must be indicated.

• Physical-chemical and microbiological specifications of the product.

• International regulatory background and/or evidence of commercialization in national or foreign markets for the product.

• Product label or draft sign in accordance with regulations.

Read more here.

• Country and Enterprise Registration for Animal Products

All applications for the import of products and by-products of animal origin from a new facility in a country exporting to Argentina will be subject to prior inspection by SENASA, when deemed necessary. Individuals or legal entities interested in evaluating the possibility of importing a product, by-product, or derivative with animal components must submit an application to SENASA.

During the application, the following information must be provided:

• Descriptive monograph of the product stating: identification of the manufacturer, official number of the establishment, animal species, brand and product name and designation according to regulatory, technical legislation (including operating flow), list of ingredients (including additives and processing aids, quantifying if use is limited by current legislation), decreasing percentage composition, durability and/or expiration period, conservation and transport conditions, thermal penetration studies in sterilized or thermoprocessed products, and any other treatment and/or process the product undergoes.

• Original copies of the product monograph must be submitted as an affidavit, signed by a professional responsible for the exporting company and endorsed by the Official Health Service of the exporting country.

• Original label of the product to be imported.

• Draft supplementary label, which must include importer data, country of origin and/or provenance, name of the production facility, Official Establishment Number Manufacturer, ingredient declaration, maintenance temperature range, and minimal durability.

Applications must be submitted via the TAD platform. Read the application procedures here.

For animal products from a new country, their exporting countries will be evaluated by SENASA first. Read details regarding rules of procedure relating to audits of countries exporting goods of animal, plant and by-product origin to the Argentine Republic here.

• Registration with INV for Wine Imports

Importers shall submit the application via TAD platform. Needed documents can be found here.

3.2 Import Authorization for Processed Foods

As per Decree 35/2025, importers of food products certified by any of the countries identified in Annex III of Decree 35/2025 must complete an affidavit for such operation during the importation (which requires information regarding the importer, warehouse, the product, label and destination). This affidavit must attach documents such as "marketing authorization" or "certificate of free sale of the product" or a similar document approved by the competent Health Authority of the exporting countries.

For other importers, they must complete an "import authorization" application. This application manages registration in the National Registries of Establishments (R.N.E.), Foodstuffs (R.N.P.A.), Packaging Establishments (R.N.E.E.), and Containers and Food Utensils in Contact with Food (R.N.P.E.), as well as the Declaration of Nutritional Seals and Warnings. In these cases, the authority will conduct an analytical verification of the hygienic-sanitary and bromatological conditions of the product upon arrival in the country. Circulation, marketing, and sale will not be authorized until the verification results are available.

To complete this import authorization application, enterprises must to fill a form and then provides the following documentation:

• Copy of invoice (or multiple invoices contained in a single document).

• Bill of lading / waybill / air waybill.

• Proof of payment of the corresponding current tariff, processed through ANMAT's Electronic Payment System (or multiple tariffs corresponding to different products, compiled in a single document).

Applications shall be submitted via the TAD platform. Application guidelines can be read here.

3.3 Inspection Requirements

To enhance food safety supervision, Argentina has established a Federal Food Control Program (PFCA) within ANMAT. The general objectives of PFCA include strengthening surveillance, auditing, and regulatory actions, as well as improving responses to food incidents. Read details for PFCA here.

Within the framework of PFCA, Argentina created a "Comprehensive Plan for the Inspection of Establishments, Food Products and Materials in Contact with Food." This plan includes actions for controlling chemical and microbiological contaminants, nutritional composition factors, quality, and labeling in food and food contact materials, including imported food. The Directorate of Inspection, Surveillance and Risk Management (DFVyGR) of the INAL is responsible for coordinating the execution of actions derived from this plan.

The Comprehensive Plan applies to three cases:

1. Food processing establishments.

2. Food products and materials in contact with food entering the country.

3. Food products and materials in contact with food marketed within the country.

All imports are subject to documentary and analytical control.

• Documentary inspection

The documentary inspection begins upon submission of the import authorization. An electronic file is generated to facilitate communication with the regulated party during the inspection process.

• Analytical audit

Annually, a list of foods and food contact materials subject to analytical control is established, grouped into classes based on their risk. Notwithstanding this list, unlisted products may also be subject to analytical inspection based on information received from health alerts, product rejections, and first admissions.

The list of foods subject to control for 2025 includes:

Whenever products requiring entry authorization are subject to analytical inspection, the relevant file will be notified of the sampling and submission method to the National Reference Laboratory of INAL.

Analytical audits may include:

1. Laboratory analysis and labeling evaluation.

2. Lab tests only.

3. Labeling evaluation only.

Laboratory analysis verifies compliance with existing legislation specifications. If the interested party fails to send samples to the National Reference Laboratory within the specified period, or if deviations are found during verification at the establishment, the firm will be subject to reinforced monitoring frequency (analytical inspection of each shipment entering the country from that firm). Read more here.

Additionally, Argentina has a National Plan for Residue Control and Hygiene in Food (CREHA), which detects residues and contaminants exceeding established values in animal foods intended for human consumption. Sampling plans apply to domestic consumption, export, and import. The CREHA Animal Plan 2025 provides detailed monitoring of animal products, substances subject to analysis, analysis methods, etc. Read more here.

Part 4 Product Standards

The CAA not only provides general requirements for food compliance but also details product standards for specific food categories. Generally, such chapters will provide definitions, specifications, allowed additives, contaminant levels, and analysis methods regarding a specific food category.

Details can be checked by reading the following chapters:

• Chapter III (Articles: 155 to 183) – foodstuffs

• Chapter IV (Articles: 184 to 219) – packaging and FCMs

• Chapter V (Articles: 220 to 246) - standards for the labeling and advertising of food

• Chapter VI (Articles: 247 to 519) - meat and related foods

• Chapter VII (Articles: 520 to 552) - fatty foods, edible oils

• Chapter VIII (Articles: 553 to 642) - dairy foods

• Chapter IX (Articles: 643 to 766) - farinaceous foods - cereals, flours and derivatives

• Chapter X (Articles: 767 to 818) – confectionery products

• Chapter XI (Articles: 819 to 981) - plant foods

• Chapter XII (Articles: 982 to 1079) – waters, non-alcoholic beverage, etc.

• Chapter XIII (Articles: 1080 to 1107) - fermented beverages (beer, cider and wine)

• Chapter XIV (Articles: 1108 to 1136) – alcoholic beverages (distilled spirit, liquor, etc.)

• Chapter XV (Articles: 1137 to 1198) - stimulating or fruitive products (e.g., coffee, etc.)

• Chapter XVI (Articles: 1199 to 1338) – auxiliary components (spices, essences, etc.)

• Chapter XVII (Articles: 1339 to 1390) - dietary foods

• Chapter XVIII (Articles: 1391 to 1406) - food additives

• Chapter XIX (Articles: 1407 to 1412) - flours, concentrates, isolates and protein derivatives

For example, Chapter XVII for dietary foods outlines requirements for dietary supplements (Article 1381). As per the CAA, dietary supplements are products intended to increase normal dietary intake by supplementing nutrients and/or other ingredients in the diet of healthy individuals who, while not in pathological conditions, have unmet or greater than usual basic dietary needs. They must be administered orally and can be in solid (tablets, capsules, granules, powders, or other) or liquid (drops, solution, or other) forms, or other forms suitable for gastrointestinal absorption. All must be manufactured following GMP requirements. Requirements for permitted vitamins and minerals, probiotics, labeling, and warning information can be found in Article 1381.

For agricultural products, regulations issued by SENASA must be followed.

Part 5 Food Ingredient/Additive

Enterprises can find the legal basis for the use of food ingredients, including additives, in the CAA.

The following table summarizes content regarding ingredients and additives:

As per the CAA, a food additive refers to any ingredient intentionally added to food, without nutritional purpose, to modify its physical, chemical, biological, or sensory characteristics during manufacturing, processing, preparation, treatment, packaging, conditioning, storage, transportation, or handling. The additive itself or its derivatives may become a component of said food. This definition does not include contaminants or nutrients incorporated into food to maintain or improve its nutritional properties.

Fundamental principles regarding the use of food additives are:

• The safety of additives is paramount. Before authorizing an additive, it must undergo appropriate toxicological evaluation, considering cumulative, synergistic, or protective effects.

• Food additives should be monitored and re-evaluated when necessary if usage conditions change, and kept current with emerging scientific information.

• The use of additives should be limited to specific foods, under specific conditions, and at the minimum level necessary to achieve the desired effect.

• Technological justification for an additive is only valid when it provides technological advantages not achievable through more appropriate manufacturing operations or greater hygienic/operational precautions.

• The use of additives is justified for technological, health, nutritional, or psychosensory reasons, provided that: authorized additives are used in concentrations such that their daily intake does not exceed permitted values, and they meet purity requirements established by FAO-WHO or the FOOD CHEMICAL CODEX STAN 100.

If an additive is not on this list, an application for registration must be submitted to CONAL. Read the application procedure and involved system here.

• Application for the Authorization of Probiotics and Prebiotics

Argentina does not have specific regulations for novel foods, but enterprises may use them after obtaining the RNPA number for their food. However, Argentina has established a Probiotics and Prebiotics Evaluation Committee and stipulated an approval procedure for new probiotics and prebiotics.

Main documentation required:

• RNE certificate.

• Application letter addressed to the Probiotics and Prebiotics Evaluation Committee, indicating the purpose of the application and applicant's details.

• The complete qualitative-quantitative formula of the product: full name of all ingredients, including additives with their corresponding INS No., in percentage form and in decreasing order of weight.

• Approved or proposed sign adjusted to current regulations.

• Dossier or Evaluation Protocol specifying information and evidence in accordance with the current regulatory framework (CAA, Chapter XVII, arts. 1389 and 1390, as appropriate to the ingredient), with all points developed in an orderly and complete manner.

• Evidence in a foreign language must be translated into Spanish, as established by Law No. 19,549 and Decree No. 1759/72 and its amendments.

Read more here.

Part 6 Labeling and Claim

Requirements regarding labeling and claims can be found in Chapter V of the CAA. Key information is summarized below:

6.1 General Principle

Packaged foods must not be described or presented with labels that:

• Use words, signs, names, symbols, emblems, illustrations, or other graphic representations that may render information false, incorrect, or insufficient, or that may mislead, confuse, or deceive the consumer regarding the true nature, composition, origin, type, quality, quantity, shelf life, performance, or method of use of the food.

• Attribute effects or properties that the food does not possess or cannot be demonstrated.

• Highlight the presence or absence of components that are intrinsic or typical of foods of the same nature, except in cases provided for in specific MERCOSUR Technical Regulations.

• Highlight, in certain types of processed foods, the presence of components added as ingredients to all foods with similar processing technology.

• Highlight qualities that may be misleading regarding the real or supposed therapeutic properties that some components or ingredients have or may have when consumed in quantities other than those found in the food or when consumed in pharmaceutical form.

• Indicate that the food has medicinal or therapeutic properties.

• Recommend its consumption for reasons of stimulating action, improving health, preventing disease, or having curative effects.

6.2 Mandatory Labeling Items

Chapter V details mandatory labeling items for most prepackaged foods:

• Sales name of the food.

• List of ingredients (including the labeling of 8 types of allergens: certain cereals, crustaceans, egg, fish, peanut, soy, milk, and certain dried fruit. Read the whole list here).

• Net contents.

• Identification of place of origin (including name of the enterprise, place of origin, registration numbers obtained from the authority).

• Name or business name and address of the importer, for imported foods.

• Batch identification.

• Best-by date.

• Preparation and instructions for use of the food, where applicable.

Nutrition labeling is not applicable to certain products, such as alcoholic products, but it is applicable for most prepackaged food. When labeled, it is necessary to provide values for:

• Carbohydrate.

• Protein.

• Total fat.

• Saturated fat.

• Trans fat.

• Dietary fiber.

• Sodium.

6.3 Claims

Claims in Argentina include the following types:

• Nutrient content claim (e.g., “zero”, “0”).

• Comparative content claim (a type of nutrition claim).

• Health claims.

Health claims in Argentina can be further categorized into three types:

• Functional claims for nutrients: Describes the nutrient's physiological role in growth, development, and normal body functions. E.g., "Nutrient X (naming a physiological role of nutrient X in the body with respect to the maintenance of health and the promotion of normal growth and development). Food Y is a source of / high in nutrient X".

• Declaration of other functions: Describes specific beneficial effects, in the context of a total diet, of consuming a food or its components on the normal biological functions or activities of the organism. Such statements relate to a positive contribution to health or to the improvement or modification of a function or the preservation of health. E.g.: "Substance A (naming the effects of substance A on the improvement or modification of a physiological function or biological activity associated with health). Food Y contains X grams (or the corresponding unit) of substance A".

• Disease risk reduction statement: Relates the consumption of a food or food component, in the context of the total diet, to the reduction of the risk of a disease or health-related condition. Risk reduction means significantly altering an important risk factor or factors for a chronic disease or health-related condition. These statements should not be interpreted by the consumer as cautionary statements, using appropriate language and references to other risk factors. Examples: "A healthy diet rich in nutrient X can reduce the risk factor for disease D. Food Y is high in nutrient X". "A healthy diet low in nutrient A may reduce the risk factor for disease D. Food X has a low amount of nutrient A".

To use such health claims, enterprises need to submit applications to the authority, as Argentina currently lacks a comprehensive framework for health claims. Therefore, health claims require individual approval. Currently, Argentina has only 28 authorized health claims. Read more here.

The following documents are needed for the application of health claims:

• General information of the applicant.

• Nature of the statement, indicating the category to which it belongs.

• Drafting of the declaration to be used in Spanish, consistent with the overall nutritional composition of the food within the framework of a healthy diet.

• Indication of whether trademark and confidentiality data are included, if applicable.

• Food or food component to which the declaration refers.

• Description of the production process, indicating the type of safety assurance system applied.

• Description of the relationship between the food/component and the declared effect: Description of the benefit and rational basis of the declaration.

• Specific conditions of use, indicating the target population, quantity of food or component, and consumption pattern required to obtain the declared benefit, with substantiation, especially whether that amount can reasonably be consumed as part of a balanced diet.

• If necessary, indication of the population group that should avoid consuming/using the food/component for which the declaration is made, with corresponding justification.

• Indication of the probable health risk if the food/component is consumed in excess.

• Other restrictions on use, if applicable.

• Characterization of the food or food component responsible for the health effects, including centesimal composition and content of all nutrients and food components for which the declaration is made.

• Analytical method for the identification and quantification of the component in the food matrix.

• Studies conducted on the food or food component under production conditions: batch-to-batch variability, results and conclusions of stability studies (mentioning analytical procedures), and conclusions regarding storage conditions and shelf life.

• Information on the component justifying its availability for human use and its relationship to the proposed statement, where applicable.

• Information on any factor that may affect the absorption or use of the component in the body.

• Data demonstrating that the component reaches the target site in the organism or is involved in the declared effect when absorption is not required.

• Complete copy of scientific, human, and other studies ("in vivo", "in vitro", and "ex vivo") supporting the statement, including updated favorable and unfavorable evidence. These must be in Spanish or translated by a public translator.

• General summary of the scientific information.

• Documentation proving that the health property claim has been recognized by the scientific community and/or accepted by Regulatory Agencies.

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