Food and Agricultural Import Regulations and Standards

An Expert's View about Agriculture and Animal Husbandry in Argentina

Posted on: 23 Jan 2012

This report provides information on regulations and standards for importing U.S. food and beverages into Argentina.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 12/23/2011 GAIN Report Number: Argentina Food and Agricultural Import Regulations and Standards - Narrative FAIRS Country Report Approved By: Brooke Markley Prepared By: Maria Julia Balbi, Mariana Prosperi, Andrea Yankelevich, and Ken Joseph Report Highlights: This report provides information on regulations and standards for importing U.S. food and beverages into Argentina. In general, Argentina has potential for increased imports of agricultural products, although unexpected changes in import procedures may require additional efforts to ensure that export operations are feasible. ARGENTINA: FOOD AND AGRICULTURAL IMPORT REGULATIONS AND STANDARDS (FAIRS) This report was prepared by the Office of Agricultural Affairs of the USDA/Foreign Agricultural Service in Buenos Aires, Argentina, for U.S. exporters of domestic food and agricultural products. While every possible care was taken in the preparation of this report, information provided may not be completely accurate either because policies have changed since its preparation, or because clear and consistent information about these policies was not available. It is highly recommended that U.S. exporters verify the full set of import requirements with their foreign customers, who are normally best equipped to research such matters with local authorities, before any goods are shipped. FINAL IMPORT APPROVAL OF ANY PRODUCT IS SUBJECT TO THE IMPORTING COUNTRY’S RULES AND REGULATIONS AS INTERPRETED BY BORDER OFFICIALS AT THE TIME OF PRODUCT ENTRY. Section I. Food Laws: The Argentine Food Code (Código Alimentario Argentino – CAA) is the technical rule created by Law §18284 passed in 1969 and put into force by Decree §2126 in 1971 that regulates locally produced and imported food products. The CAA’s main goal is to protect public health and the good faith in commercial transactions of food products within the National territory of Argentina. The CAA incorporates standards agreed upon within the Southern Cone Common Market (Mercosur) framework, which in turn are influenced by standards from: 1) the European Union; 2) the Codex Alimentarius (Codex); and 3) the U.S. Food and Drug Administration (FDA). The CAA is permanently updated by joint resolutions from the Ministry of Health and the Ministry of Agriculture. Decree §815 of 1999 set the bases for the creation of the National Food Inspection System (Sistema Nacional de Control de Alimentos - SNCA). The SNCA guarantees the enforcement of the CAA. Also, Decree §815 created the National Food Commission (CONAL) which functions as an advisory body that provides support and monitoring to the SNCA. The SNCA and CONAL’s members are the Ministry of Health and the Ministry of Agriculture. Food regulatory agencies at provincial level are invited to participate in CONAL. CONAL’s Secretariat is located at the Ministry of Health. Also, the Advisory Committee to the CONAL composed by members of the industry and consumers organizations is a mandatory non- binding consultancy body created by Decree 815. There are three government agencies that have the authority to enforce the CAA in Argentina: A. Within the Ministry of Agriculture: The National Animal and Plant Health and Food Safety Service (Servicio Nacional de Sanidad y Calidad Agroalimentaria - SENASA) that handles those food products under the annexes I and II of Decree §815. That is, fresh, chilled, or frozen products and by-products of animal, plant and seafood origin. It also handles canned products containing over 60% animal origin and food preparations containing over 80% animal origin. The National Wine Institute (Instituto Nacional de Vitivinicultura - INV) exercises control over wine and wine products during their production, manufacturing, and marketing stages. B. Within the Ministry of Health: The National Food Institute (Instituto Nacional de Alimentos - INAL) which depends on the National Drug and Medical Technology Administration (ANMAT), regulates consumer-ready food products, health supplements, and both alcoholic and non-alcoholic beverages, with the exception of wine. SENASA and INAL sometimes have overlapping responsibilities. FAS recommends that exporters rely on their importers to get their products registered with the appropriate organization. Decree §1812 of September, 1992, regulates imports of processed foods and beverages (except wine). The main articles of the Decree established the following: As per articles 2 and 3 consumer-ready food products and ingredients are controlled by SENASA (CCA), which inspects all shipments before customs approves their release to the domestic market. Articles 5 and 6 state that consumer-ready food products that have proven stability and were registered in the CAA will be tested and inspected by INAL (CCA) only after customs have released them to the domestic market. A certificate of stability will be issued by INAL when the importer has proved to INAL, at the time of registering the product, that the product has been manufactured, packed up, and transported in accordance with the Argentine regulations. Then, INAL will issue a certificate of stability which will authorize the importer to release the shipment from customs without the need of inspection. Article 7 states that either when the importer of a consumer-ready product is unable to show a certificate of stability or when the food product has suffered an evident damage, INAL has the right to inspect and test the shipment before it is released from customs. Article 8 states that when there are reasons to presume a risk for human, animal or plant health because of the introduction of food products to the country; the three above-mentioned agencies (SENASA, INAL, and INV) have the right to perform inspections to the shipments previous to entry of the product into Argentina provided that the importer is informed about this procedure. Article 10 states that for all those food products that require previous inspection, the CCA has 14 days to issue the free sale certificate. Article 11 states that customs will automatically release the consumer-ready food products that can show a stability certificate. In the case of those products where a previous inspection is required, customs will need authorization from the CCA in order to free the shipments. Article 12 states that if an authorization from the CCA is not submitted, customs may allow the importers to convey their shipment to their warehouse. In this case, the product cannot be marketed until the correspondent certificates are submitted to customs. The importer has 14 days to hand out the required paperwork to the customs office. Article 13 states that a representative sample from every shipment will be taken by a customs official before leaving the harbor area. Article 14 establishes that, when a case as stated in Art. 12 occur, and the importer does not submit the authorization from CCA in the term foreseen by Art. 10 (14 days) due to his own fault, customs and CCA will destroy or re-export the shipment and the importer will be liable to a fine, expenses and penal charges. Article 18 states that in the case of imported consumer-ready foods, the CAA requirements are considered to be met when the products come from the following countries/regions: Australia, Austria, Canada, Switzerland, Israel, U.S.A, Japan, Norway, New Zealand, E.U., Sweden and Countries with specific food safety agreements with Argentina. In all of these cases, the food products should have been manufactured under the same controls as those products destined for human consumption in the domestic market of the country of origin. As per Resolution §876/97, consumer-ready food products from Mercosur countries do not need to go through the registration process. The importer just has to submit an oath declaration with the following attachments: free sale / fit for human consumption certificate issued by the sanitary/food safety authority of the country of origin, numeric identification if applicable, original labels, lot number/s, weight, for those that are not the manufacturers of the food product being imported, a certificate signed by the manufacturer which states to be aware of the present export to Argentina. Section II. Labeling Requirements: A. General Requirements Products imported through SENASA (fresh, chilled, or frozen products and by-products of animal, plant and seafood origin): A label must be affixed to the packaging of the imported products. It must include the following information in Spanish: 1. Importer’s name and address 2. Country of origin 3. Establishment of origin 4. Ingredient declaration 5. Temperature range for maintenance requirements 6. Minimum durability Products imported through INAL (consumer-ready foods, and alcoholic and non-alcoholic beverages, except wine): Imported processed foods from the United States can come in their original package. There is no need to translate the labels. The only special requirement is a sticker label affixed to the retail package (no matter the size/volume) containing the following data in Spanish: 1. Name and brand of the product 2. Identification of origin 3. Composition: ingredients and additives in decreasing order of weight 4. Net weight or measure 5. Lot number 6. Expiration date 7. Exporter’s name and address 8. Importer’s name and address 9. Importer’s National Register of Establishment number (RNE) 10. National Register of Food Product number (RNPA) 11. Storage, preparation and usage instructions when needed 12. Nutritional information Products imported through INV (wine): A sticker label should be affixed to each imported bottle of wine, containing the following information in Spanish: 1. Brand 2. Legal identification of the product (wine) 3. Alcoholic grade 4. Net content 5. Country of origin 6. Acronym and analysis number (granted by the INV) 7. Color 8. Sugar content (if more than 6 milligrams per liter of sugar) 9. Importer’s name, address and INV registration number 10. Other components other than wine 11. Warning statements (“beber con moderación” “Prohibida su venta a menores de 18 años”) All the mandatory statements must be printed in the labels with readable fonts and clear colors whose contrast is easily identified by costumers. The legal identification of the product, alcoholic grade, net content, and country of origin may be printed in more than one label only if they are in the same visual camp. Therefore they can be read without having to turn the bottle around. The font size must be larger than 1.5 millimeter and 3 millimeters for alcoholic grade and net content. Organic Products According to Decree §206/2001, imported products labeled as "organic" must come from a country whose organic standards have been evaluated by SENASA and found to be equivalent to the Argentine regulations on organic production. Otherwise, they must be certified by any of the Argentine certifying agencies approved by SENASA prior to export. Biotech Products There are no labeling requirements for biotech foods in Argentina. Argentina does not have a national regulatory system for biotech foods, and none is likely in the near term. Most Argentine legislators believe that the national interest is not served by mandatory labeling legislation. B. Requirements specific to nutritional labeling: A nutritional fact panel is required in Argentina for imported and domestic food products. Joint Resolution 40/2004-SPRRS and 298/2004-SAGPyA (Article 235 Fifth of CAA), regulates nutrient content claims according to the following term equivalence: Absolute Nutrient Content and/or Energy Value: Light, lite, low Very low … Free, No…, Without …, Zero … No … added High…, Rich… Source… Comparative Nutrient Content Light…, Lite …, Reduced …, Less than … Increased …, More than … In 2011, evaluation and labeling of prebiotics were included in the CAA by Joint Resolution 229- SPRel, and 731/2011- SAGyP (Article 1390, BO 32279 of CAA). By joint resolution §57/10-§548/10, in Chapter 5, Article 235 was added to the CAA on October 06, 2010 and will enter into force once CONAL reviews it and makes recommendations for its implementation. This resolution regulates all allergenic substances and others that are capable to produce adverse reactions in susceptible people which are listed below must be declared following the list of ingredients on the label if they or some of their byproducts (traces) are present in the food as ingredients or as part of the ingredients: 1. Cereals with gluten 2. Crustaceans and products 3. Table egg and products 4. Fish and products 5. Peanuts and products 6. Soybeans and products 7. Milk and products 8. Nuts 9. Sulfur Dioxide and Sulfites 10. Tartrazine This information must be presented in contrasting colors to allow visibility and with the following legend: “Contains:..” followed by the name of the substance and/or “Traces of…” according to the list above. Statements/warnings legends suggesting that the food product may contain a possible allergenic substance are not allowed. Section III. Packaging and Container Regulations: Argentina does not officially have any special packaging or container size requirements or preferences. It is a marketing issue where the consumer determines what type of package/container he/she prefers. In addition, there are no official municipal waste disposal laws or product recycling regulations that affect imported products. Section IV. Food Additives Regulations: Argentina uses a positive list of food additives. Article 2 of Decree §2092 of October 1991, states the following: "... all foods, condiments, beverages, or their raw material and food additives which are manufactured, fractioned, preserved, transported, sold, or exposed, must comply with the CAA requirements. When one of those is imported, the CAA requirements will be applied. The GOA also considers products from countries which have food controls comparable to those of Argentina, or when they use the Codex Alimentarius (FAO/OMS) standards, to be in compliance with Argentine standards." All additives used must be included in the Mercosur positive list of food additives. If the additive in question does not appear on that list, its registration can be requested to INAL. This list varies by product and can be obtained from an importer. Section V. Pesticides and Other Contaminants: SENASA’s resolution 256/03 establishes the Maximum Residue Limits (MRLs) for products that are traded in the country. The mechanism to set them is as follows: a chemical company that applies for a pesticide to be released in the Argentine market must carry out a two-year study in three different agro- ecological areas of Argentina. The sampling method to be used in these cases is the one that is approved by FAO. Argentina uses the Tolerated Daily Intake (Ingesta Diaria Admisible - in Spanish) suggested by the Codex Alimentarius for the Latin American Region 14 as a reference. The required listed number is generally lower than that suggested by the Codex but higher than that suggested by the EU. If SENASA has doubts about whether the MRL established by the research is right or not, then they use the Codex number. The current MRL list is the annex of resolution §256/03. It can be accessed on the Internet at and then by typing the number of the resolution on the search field. Section VI. Other Regulations and Requirements: Before the product is shipped, it must undergo a "pre-shipment inspection" in the country of origin, carried out by an international certification company appointed by the GOA. The GOA’s objective is to compare the merchandise shipped with the price paid for it in order to avoid under-billing. These companies have offices in all major U.S. ports. (Note: This procedure only applies to the agricultural and food products included in the following HTS Chapters: 1, 2, 5, 7, 12, 13, 14, and 23). Health supplements that contain certain ingredients should have a "warning" sign and specific language determined on a case-by-case basis. INAL regulates this requirement according to the CAA. U.S. bar codes can remain on the package, and most retailers make use of them. Enriched Flour: By Argentine Law §25.630 and its Decree §569/2003, all flour-based products must have been manufactured with enriched flour. The required nutrients are as follows: Nutrient Quantity (mg/Kg) Iron 30 Folic Acid 2.2 Thiamin (Vitamin B1) 6.3 Riboflavin (Vitamin B2) 1.3 Niacin 13.0 Diet products that require either more or less of the amounts indicated above are exempted together with those products deemed as organic/ecological/biological by Law §25127. Labels must show the content of each nutrient and the legend “Enriched Flour Law §25630 - Harina Enriquecida Ley N° 25630”. Section VII. Other Specific Standards: Product samples with no commercial value (under US$100) do not pay import duties. Regular mail should be used. Post recommends exporters coordinate with their importers/agents on this matter. Section VIII. Copyright and/or Trademark Laws: Argentina has not adhered to the Geneva Pact. Therefore, brands and trademarks have to be registered in Argentina to ensure brand property. Post recommends that any U.S. company that will launch products in the Argentine market should register them. The cost is approximately US$300 per brand. Section IX. Import Procedures: Products imported through SENASA (fresh, chilled, or frozen products and by-products of animal and seafood origin): (SENASA Resolution §816/02 - available in English upon request). An import permit is required to import products and by-products of animal origin into Argentina. The permit is obtained from SENASA and should be requested by an importer who has already been registered at SENASA and who has registered the facility intending to export to Argentina. The application for the permit must state the following: 1. Type of product 2. Country of origin 3. Name of meat establishment 4. Official meat establishment number 5. Address of meat establishment 6. Essay describing the manufacturing process of the product (endorsed –signed and sealed - by the government of the country of origin) 7. Essay on the packaging type listing the materials that will be used. In addition, the packaging must be approved by the appropriate official authority at the country of origin. The certificate should state that the packaging is approved to be in contact with edible products (this primarily applies to canned products) 8. Two copies of the original product label to be imported This permit includes the registration numbers of the importer and product. After the permit is granted and within five (5) days prior to arrival of the product at the Argentine port of entry, the importer must advise SENASA of the arrival of the shipment. During the following fifteen (15) days, the importation must be completed. Only with a strong justification can this time period be extended. U.S. products and by-products of animal origin can only be imported from U.S. plants approved by the United States Department of Agriculture and the Food and Drug Administration, and must be accompanied by an official health certificate. While SENASA accepts products from any FSIS/FDA- approved facility, it reserves the right to prior inspection and approval of the establishments of origin by SENASA, when deemed necessary. All U.S. meat plants exporting products and by-products of animal origin to Argentina may be audited by SENASA. On January 22, 2002, SENASA Resolution §117 was implemented. This new resolution defines the methodology to be followed for risk assessment of importation of live animals, their reproductive material, and products and by-products of animal origin as related to Bovine Spongiform Encephalopathy (BSE) occurrence. Before the BSE case of December 23, 2003 in the state of Washington, the U.S. product most affected by this resolution was sweetbreads, which were barred from importation into Argentina in January 2002. After the BSE case of December 23, 2003, all imports of live animal products and by-products of ruminant origin were temporarily suspended. USDA and SENASA are working jointly to overcome this issue. In June 2006, the Secretariat of Agriculture of Argentina issued Resolution §315/2006 which Article 1 states that Argentina will adopt the OIE’s Terrestrial Animal Code recommendations, Article which does not apply restrictions or conditions related to BSE for the following products: dairy products, bovine semen and embryos, hides and furs (except for the head), gelatin and collagen from hide and fur (except for the head), tallow, and bi-calcium phosphate. As of December 2011, the resolution still has yet to be implemented. Processed meat products: The same data apply to processed products such as ham, sausages, canned products, etc. In this case, a full description of the product composition in Spanish is required (i.e. percentage of each of its major ingredients, approved by the official sanitary service). Fresh, chilled and frozen pork and lamb meat: The United States does not have an agreed upon protocol with Argentina for the importation of these meats. However, market access for fresh, chilled and frozen pork was requested in April 2011. Dairy products: On December 16, 2010, Argentina published in the official bulletin 137/2010 and 941/2010, Law 18.284 which exempts fatty acid limits in milk. Article 1º: Include in article 155 tris of the Argentine Food Code, drafted as: “ Article 155 tris: the fatty acids from industrial production content can’t be over of: 2% total fat in vegetal oils and margarines designated to direct consumption, and 5% total fat in other type of food. These limits don’t apply to ruminants’ fat, including milk fat.” Products imported through SENASA (products of plant origin): In order to obtain a USDA Phytosanitary Certificate required for all plant products entering into Argentina (which should be signed by an Animal and Plant Health Inspection Service/APHIS official inspector, not by an APHIS state inspector), the exporter will need to submit an import certificate (AFIDI) to APHIS. This AFIDI can only be obtained from SENASA by the importer in Argentina. The AFIDI will explain in detail all the necessary requirements needed before the product can be exported. Upon arrival in Argentina, SENASA will hold the product at the port of entry for inspection and to verify that it meets all the requirements stated in the AFIDI. SENASA will then issue an import certificate for customs to release the product. The AFIDI must state the following: 1. Name of product 2. Destination 3. Origin 4. Phytosanitary (health) certificates including additional declarations (for specific information on this certificate, please contact the APHIS Office in Buenos Aires, Juramento 2089, 1428 Buenos Aires, Argentina, phone: 54-11-4706-3819; fax: 54-11-4706- 0593; e-mail: Also with plant materials, SENASA only accepts products from APHIS-approved facilities, and it reserves the right to prior inspection and approval of the establishments of origin by a SENASA official, when deemed necessary. Products imported through INAL (processed foods, and alcoholic and non-alcoholic beverages, except wine): Product and importer registration is required prior to importing a product into Argentina. The product must be registered by an importer who has already completed the registration process at INAL. If the product has no problems, its registration should be ready in less than thirty (30) days. The requirements to register imported processed foods are listed below: A. A new importer must apply only once for a National Register of Establishment (RNE). The requirements are as follows: 1. Letter addressed to the Minister of Public Health 2. Registration form 3. Customs registration form 4. Tax Office (DGI) registration form 5. Municipal authorization for the warehouse (cold chambers, for frozen products) 6. Approval of partnership of the company 7. Payment of fee B. In order to register the product, the importer along with his RNE must apply for a National Register of Food Product number (RNPA). The requirements are the following: 1. Letter addressed to the Minister of Public Health announcing intention to register 2. Application form 3. Flow chart and monograph of the product manufacturing process, its shelf-life, product specifications, shipping and storage requirements, quality controls, and packaging type 4. List of ingredients and additives 5. Original label and three copies 6. Supplementary label with the data stated under "Section II. Labeling Requirements" 7. Certificate of free sale and fit for human consumption issued by the sanitary authority of the country (or state) of origin 8. Payment of fee C. Once the RNPA has been issued and the product is in the port, the importer needs to obtain a Certificate of Free Circulation (Certificado de Libre Circulación) at INAL. The requirements are listed below: 1. Letter requesting a Certificate of Free Circulation for the product/s 2. Shipment information 3. Copy of the invoice 4. Bill of lading 5. Copy of the RNE 6. Copy of the RNPA 7. Manufacturing date and shelf life 8. Certificate of Free Sale / Fit for Human Consumption certificate / Certificate of Analysis, issued by the Health / Agriculture Department of the country (or state, or county) of origin 9. Certificate of aging (for alcoholic beverages, except for wine) Once the importer has an RNPA, he does not need to apply for a new one every time he imports the product. However, he must request a Certificate of Free Circulation for each shipment. Since April 2010, some importers of consumer-ready products have reported delays in receiving Certificates of Free Circulation. On February 15, 2011, the Secretariat of Interior Commerce issued resolution 45/2011 which bumped the number of products to that will require a non-automatic import license from 400 to 600. This included a range of products from luxury cars to farm equipment. It is important that importers check the non-automatic import license requirements for their products. In the case of health supplements, items (A), (B), and (C) mentioned above also apply with slight differences. Instead of the RNE, importing establishments need to obtain from INAL a National Register of Establishment of Health Supplements number (RNESD). And instead of the RNPA, a National Register of Health Supplements number (RNSD) is needed. The requirements are as follows: 1. Request register authorization at INAL 2. Each presentation must be signed by the owner of the product, the local legal representative, and technical director of the local establishment 3. Certificate of Free Sale from the country of origin, issued by the national or state sanitary authority, and stamped by the Argentine Consulate. 4. Analysis of the product for verification that it complies with the CAA standards 5. The Argentine importer must have a technical director who will be responsible for: the genuine origin of the product, the legitimacy of the document, the shelf life of the product, the quality control of the shipment, the correct labeling, and the appropriate "warning" literature on each package or promotional material, when required Products imported through INV (wine): 1. The importer must be registered in the INV. 2. Import permit issued by the INV (form 1825-O. y M.) 3. The import permit form must come accompanied by a certificate issued by the appropriate official authority of the country of origin, stating its analytical specifications. 4. The product must comply with the limits of analytical composition required by the INV for similar locally manufactured products. 5. The importer must submit an import for domestic consumption document (form OM -1993 SIM) 6. A sticker must be affixed to each bottle (see Section II. Labeling Requirements). Once the product arrives at the warehouse, the importer must request an analysis and shipment control by the INV. If the analysis is correct, the INV issues a Certificate of Free Circulation. Then, the product is ready to be marketed. The following is information that U.S. wineries must provide to the Argentine importer: 1. Certificate of Country of Origin 2. Certificate of Free Sale and Fit for Human Consumption 3. Certificate from the Wine Institute analysis of the product Appendix I. Government Regulatory Agency Contacts: Servicio Nacional de Sanidad y Calidad Agroalimentaria (SENASA) Avda. Paseo Colón 367, piso 5 1063 Buenos Aires, Argentina Tel: (54-11) 4121-5353 Fax: (54-11) 4121-5153 Instituto Nacional de Alimentos (INAL) Estados Unidos 25 1101 Buenos Aires, Argentina Tel: (54-11) 4342-5674; 4340-0800 (ext. 3538) Fax: (54-11) 4331-6418 Instituto Nacional de Vitivinicultura (INV) San Martín 430 5500 Mendoza, Argentina Tel: (54-261) 4496358; 4496359 Fax: (54-261) 4496306 Appendix II. Other Import Specialist Contacts: Argentina has only one official laboratory for products of animal origin, which is owned by SENASA. However, there are several other laboratories approved by SENASA and the Food Safety Inspection Service (FSIS), U.S. Department of Agriculture. List of approved laboratories may be obtained through the FAS Buenos Aires office, as follows: Office of Agricultural Affairs U.S. Embassy, Buenos Aires Avda. Colombia 4300, C1425GMN Buenos Aires, Argentina Phone: 54-11-5777-4627, Fax: 54-11-5777-4216 E-mail: / Homepage:
Posted: 23 January 2012

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