Argentine
Profil du MembreParticipation aux discussions sur les préoccupations commerciales SPS et OTC
Lien vers Renseignements par membre sur le site web de l'OMC
AUTORITÉ NATIONALE RESPONSABLE DES NOTIFICATIONS SPS
Nom/Organisme | Coordonnées |
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Secretaría de Bioeconomía Dirección Nacional de Cooperación y Articulación Internacional Correo electrónico: sps-argentina@magyp.gob.ar Tel: +(5411) 4349-1671 Paseo Colón 982, Piso 2, Oficina 203 Buenos Aires, CP 1063 Buenos Aires 1063 |
POINT(S) D'INFORMATION SPS
Nom/Organisme | Coordonnées |
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Servicio Nacional de Sanidad y Calidad Agroalimentaria
Coordinación de Relaciones Internacionales Paseo Colón 367 - 5° piso 1063 - Buenos Aires |
Arborescence des codes du SH associés aux notifications SPS
Participation aux discussions sur les préoccupations commerciales SPS
Reconnaissance de l'équivalence
Documents du comité SPS
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Suppléments
Examens des politiques commerciales
3.227. As is the case with the technical regulations, a number of institutions are involved in the development of sanitary and phytosanitary measures within their area of expertise. SENASA, a decentralized body under the Ministry of Agriculture, Livestock and Fisheries (MAGyP), is responsible for implementing national policy on animal and plant health and quality, and on the quality and safety of food, and for ensuring compliance with the law.[434] The National Drugs, Food and Medical Technology Administration (ANMAT) is responsible for regulations governing procedures for the registration of medical products, while the National Grape-Growing and Wine Production Institute (INV) is tasked with developing sanitary measures for grape-growing and wine production. The National Seed Institute (INASE) is responsible for introducing measures related to seeds. The National Food Control System (SNCA), composed of SENASA, ANMAT and the National Food Commission (CONAL), was created by Decree No. 815/99 to ensure that the entities which make up the SNCA enforce the Argentine Food Code (see below) throughout the country
3.228. SENASA has three technical national directorates in charge of implementing sanitary and phytosanitary measures: the National Plant Protection Directorate (DNPV), the National Animal Health Directorate (DNSA) and the National Food Quality and Safety Directorate (DNICA). The functions of the DNPV include developing and proposing phytosanitary regulations governing forestry production and the import, export, processing, storage, packing, transport and marketing of plants and their products and by-products, so as to preserve the country's phytosanitary status and help protect public health. The DNSA is responsible for formulating animal health legislation to safeguard the production, import, export, international transit and welfare of livestock and the identification, traceability, transport and marketing of animals and their reproductive material. The DNSA is also responsible for proposing and implementing technical and administrative rules concerning the registration of veterinary products and the listing, authorization, control and certification of plants to be processed, fractionated and stored. The DNICA drafts, amends and updates regulations relating to hygiene, safety and quality of raw materials that affect the trade of products, by-products and derivatives of animal and plant origin and animal feed, at the national and international level
3.229. CONAL is tasked with proposing updates to the Argentine Food Code, using international standards and MERCOSUR agreements as a benchmark. It also recommends uniform deadlines, requirements and procedures for conducting inspections and authorizing establishments and products, as well as for processing, preparing, storing, fractionating and marketing them throughout Argentina. In addition, it maintains the Single National Register of Products and Establishments. Another of its functions is to facilitate the establishment of cooperation mechanisms between public and private organizations to ensure the effective sanitary control of foods
3.230. The Argentine Food Code (Law No. 18.284 of 1969 (as amended)) sets out the underlying legal framework for the development of sanitary and phytosanitary measures in Argentina and establishes the rules to be followed when producing, marketing, importing and exporting food for human consumption in order to protect the health of the consumer. The Code is also the framework law governing the SNCA.[435] Moreover, there is a series of legal instruments that regulates aspects of plant and animal health, including products, by-products and derivatives of animal and/or plant origin, agrochemical products, animal imports and propagation material (Table 3.38)
3.231. Some of the main legal provisions related to sanitary and phytosanitary measures adopted during the review period include: (i) SENASA Resolution No. 76/2019, which removes the register of importers and exporters of animals, plants, reproductive and/or propagation material, products, by‑products and/or derivatives of animal or plant origin or goods containing ingredients of animal and/or plant origin among their components; (ii) SENASA Resolution No. 369/13, which creates the Traceability System for Phytosanitary and Veterinary Products, whereby all veterinary product transactions in the commercial chain throughout Argentina, including national and imported products, and the various types of retail premises selling such products are recorded. The system requires a seller and a buyer; (iii) SENASA Resolution No. 125/2014, which makes it mandatory for those who intend to engage in the export, import or international transit of products and by-products of plant origin to comply with the requirements established in bilateral agreements signed by the DNPV; and (iv) DNPV Order No. 4/2013, which creates SENASA's National Phytosanitary Register of Propagation, Micropropagation and/or Breeding Material Operators
3.232. Only authorized imports of products and by-products of plant or animal origin or regulated food items that meet all the relevant sanitary, phytosanitary, zoosanitary and/or safety requirements in each instance are permitted to enter the country. In order to obtain authorization, the importer must complete all the necessary formalities, including the registration of each product and/or operator, the authorization of the establishment/plant of origin and approval of the audits at origin, where appropriate (Table 3.39)
3.233. By its Resolution No. 76/2019 of 30 January 2019, SENASA removed its register of exporters and/or importers of animals, plants, reproductive or breeding material, products, by-products and/or those derived from animals or plants, or goods that contain ingredients of animal and/or plant origin among their components, created by SENASA Resolution No. 492 of 6 November 2001. Where required by current health regulations, SENASA will obtain information from the Register of Importers and Exporters of AFIP's Directorate-General of Customs (DGA) and the Single Register of Operators in the Food Processing Chain, created by Resolution No. 21-APN-MA of 23 February 2017 of the former Ministry of Agro-Industry
3.234. A number of products are subject to sanitary/phytosanitary controls when imported or exported; these controls are carried out by SENASA, ANMAT and the INV, depending on the product.[436] For example, all shipments of products and by-products of grains for export or re-export must be subject to phytosanitary and quality controls by SENASA.[437]
3.235. The issuing of an import authorization may require a risk analysis, depending on the product and the sanitary situation in the country of origin of the goods. For example, when importing a plant product, SENASA, through the Directorate of Foreign Plant Trade (DCEV), a department under the DNPV, may order an audit of the entire sanitary system of origin or an audit of the production chain for the goods intended for import specifically. Moreover, should SENASA or the DCEV and DNPV consider it necessary, the authority responsible for phytosanitary matters in the country of origin and/or provenance must provide guarantees for its national control system, which must have systems for auditing the entire production and marketing chain for plant products. The importation of plant products within ANMAT's jurisdiction that might involve a phytosanitary risk requires authorization and/or inspection from SENASA. In general, imported products of animal or plant origin, whether or not packaged for direct sale to the public, are controlled by SENASA, with the exception of edible oils which are the responsibility of ANMAT
3.236. Imports of plants or parts thereof, whether in their natural state or processed to some degree, wood, products and derivatives of plant origin or goods and/or inputs containing components of plant origin believed to pose a phytosanitary risk require, in addition to the authorization issued by SENASA, a Phytosanitary Import Authorization (AFIDI), also issued by SENASA (DCEV). Products of plant origin that have undergone industrial or technological processing and are therefore believed not to be directly affected by crop pests do not require an AFIDI; however, they are inspected upon entering Argentina.[438] The AFIDI is the document indicating the phytosanitary requirements that must be met by products of plant origin. SENASA assesses AFIDI applications on a case-by-case basis. The document is valid for two months in the case of imports for consumption, and nine months for imports for propagation and growth media. It may be used for multiple shipments during these periods. The AFIDI must be processed via the management system for imported plant products (SIGPV_IMPO) and must be accompanied by a SENASA import certificate, following a physical and documentary verification of the goods in accordance with the phytosanitary requirements for import as set out in the AFIDI. The importer must be registered in the DGA's Register of Importers and Exporters. In the case of seeds, an import application authorized by INASE should also be presented. A flora certificate is required for live specimens, products and by-products of wild flora.[439] Where the goods are placed in wood packaging, a sworn declaration of wood packaging and wood for carriage and stowage must be presented in accordance with SENASA Resolution No. 614/2015
3.237. Imports of plants, cuttings, buds and bulbs, which are considered to be products of greater phytosanitary risk, are to be quarantined upon entry. Products of plant and animal origin imported for the first time may be subject, if SENASA deems it necessary, to a prior inspection at origin
3.238. The details of the phytosanitary policy are developed through the DCEV, which has the authority to establish the phytosanitary requirements for import after consulting the DNPV's various agencies, where necessary. Pest risk analyses are used to determine phytosanitary requirements. The country of origin of the goods is informed of the requirements and may make remarks and comments. Any changes deemed necessary and appropriate in the light of these remarks are made and the exporting country is notified for final confirmation or further comment. Once confirmation is received or the comments have been evaluated, the DCVE prepares the definitive import requirement and notifies the WTO
3.239. The DNSA sets animal health standards based on the recommendations of the World Organisation for Animal Health (OIE) and on the latest scientific information available. Some animal health standards are defined at the MERCOSUR level by the Animal Health Commission and the Plant Health Commission of Working Subgroup (SGT) No. 8 on agriculture and the Food Commission of SGT No. 3 on technical regulations and conformity assessment. These standards are issued in the form of resolutions of the MERCOSUR Common Market Group, which are then incorporated into Argentine law
3.240. Importing live animals and genetic material requires authorization from SENASA, which is based on a technical evaluation. This authorization must be obtained before the animals or genetic material are shipped from the exporting country and is valid for 30 days from the date of approval.[440]
3.241. The DNICA is responsible for designing food product legislation. SENASA has the authority to suspend the import of food products if their entry involves a proven risk for human, animal or plant health. In the event of a recurrence, the complete suspension of the import authorization for a specific origin may be ordered. Moreover, SENASA has the power to change the specific import requirements to align them with the international reference standard. The WTO should be notified of such changes
3.242. The development of sanitary and phytosanitary measures follows an established procedure. Annex II of SENASA Resolution No. 401/2010 contains a manual of legislative techniques and procedures for developing standards,[441] and SENASA Resolution No. 712/2016 sets out the procedure for SENASA to follow when handling draft legislation. Annex I of the Resolution establishes requirements for the various stages of the development process of a new SENASA standard, namely authorization to create and/or amend a new standard, the drafting of the legislative proposal, the internal consultation process, consultation with related sectors, legal analysis, public consultation and the preparation of the final draft
3.243. During the period under review, a significant change was introduced which placed limits on the possible duration of sanitary or phytosanitary measures for the first time. Annex I, Article 3, of Ministry of Agro-Industry Resolution No. 381/2017 provides that all standards of the former Ministry of Agro-Industry and its decentralized agencies (including SENASA) imposing obligations on citizens and issued after the entry into force of the Resolution should expressly set a period of validity not exceeding four years, which may be extended once by a reasoned decision of the competent authority with the rank of under-secretary or higher
3.244. Between 1 January 2013 and 31 December 2020, Argentina submitted 99 SPS notifications (including addenda and corrigenda) to the WTO, of which three were notified as emergency measures.[442] During this period, no other WTO Members expressed any new trade concerns regarding the sanitary and phytosanitary measures adopted by Argentina. Since the creation of the WTO in 1995, seven such concerns have been raised regarding the measures taken by the country, but none of them were during the review period.[443]
POINT(S) D'INFORMATION OTC
Nom/Organisme | Coordonnées |
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Secretaría de Industria y Comercio Dirección Nacional de Reglamentos Técnicos Área de Obstáculos Técnicos al Comercio Avda. Julio A. Roca N° 651 Of. 416 (C1067ABB) Buenos Aires Argentina | Courrier électronique: focalotc@produccion.gob.ar Téléphone: +(54 11) 4349 4037 / 4067 Site Web: http://www.puntofocal.gob.ar |
Participation aux discussions sur les préoccupations commerciales OTC
Communication(s) concernant la mise en œuvre
29/08/2003 | |
20/04/1999 | |
11/02/1999 | |
04/09/1996 |
Accord entre les Membres
Acceptation du Code de pratique
Chargement en cours..
IRAM - INSTITUTO ARGENTINO DE NORMALIZACIÓN | G/TBT/CS/N/75 |
Documents du comité OTC
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Examens des politiques commerciales
3.195. Punto Focal Argentina, the country's focal point for the WTO Agreement on Technical Barriers to Trade (TBT Agreement) and point of contact for notification of the WTO,[412] is managed by the National Technical Regulation Directorate (DNRT) under the authority of the Under-Secretariat for Domestic Market Policies within the MDP's Secretariat of Domestic Trade. The legal framework for the national standards, quality and certification system in Argentina consists of the TBT Agreement, incorporated into national legislation by Law No. 24.425 of 7 December 1994, and a series of domestic laws, regulations and standards. One of the main regulations in force is Decree No. 1.066/2018, which relaunched the National Quality System (SNC) (see below), and specified the functions to be performed within the SNC by national agencies responsible for regulating volunteer activity, accrediting conformity assessment bodies, defining metrics and coordinating technical regulators
3.196. The procedures followed to develop technical standards, regulations and other provisions are specified in Decrees Nos. 333/1985 and 1.172/2003, as supplemented during the period under review by Decrees Nos. 561/2016, 1.063/2016, and 733/2018, aimed at streamlining and facilitating the formalities required to develop such provisions (Table 3.36)
3.197. A series of other laws, decrees and resolutions establish standards and technical regulations, both general, such as Decree No. 733/2018 for the simplification of formalities, and specific in scope, such as the Law on Seeds and Phytogenetic Creations, the Argentine Food Code, and technical regulations applicable to wine and medications. Technical regulations formulated by MERCOSUR, within the framework of the Common Market Group, have also been incorporated into Argentine law by national instruments
3.198. Various institutions participate in formulating technical regulatory provisions, including the MDP's Secretariat of Domestic Trade, the Secretariat of the Environment and Sustainable Development, SENASA, ANMAT and INV (see below).[413]
3.199. Since the last review in 2013, the authorities have introduced a series of legislative and regulatory changes. In November 2018, Decree No. 1.066/2018 relaunched the former National Standards, Quality and Certification System, originally created in 1994 (Article 1 of Decree No. 1.474/94 and amendments thereto). Under a new name, the National Quality System (SNC), the system is composed as follows: (a) Level 1 consists of: (i) the National Quality Council (CNC), responsible for coordinating policies on quality assurance, standardization and certification, and (ii) the Advisory Committee, a consultative body;[414] (b) Level 2: (i) the National Institute of Industrial Technology(INTI), a decentralized agency within the MDP, responsible for formulating, maintaining and disseminating national measurement standards; (ii) the Argentine Standards and Certification Institute, responsible for issuing and updating national standards; (iii) the Technical Regulators Commission (CRT), an inter-ministerial committee for coordination among regulatory agencies with respect to the TBT Agreement and the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and ensuring adherence to good regulatory practices; (iv) the Argentine Accreditation Agency (OAA), responsible for accrediting certification bodies for quality assurance systems, products, services and processes, as well as conformity assessment bodies; (c) Level 3: (i) certification bodies (accredited by the OAA) for quality assurance systems, products, services and processes, as well as testing and calibration laboratories; (ii) quality systems auditors certified by the OAA
3.200. To simplify the regulations and make the information more transparent, the Simplified Agricultural Information System (SISA) was established to replace the registration and information systems for the production and marketing of seeds and grains.[415] Administrative Decision No. 311/2018 created the Directorate of Chemical Substances and Products, under the authority of the Secretariat of Environmental Control and Monitoring, primarily responsible for proposing and implementing action and management tools in respect of chemical substances and products, consistent with the international environmental protection commitments undertaken by Argentina. Decree No. 1.066/2018 created the CRT as the body responsible for cooperation among the various regulators, with the aim of standardizing internal processes and improving efficiency and transparency
3.201. Decree No. 504/2019, Official Journal of 23 July 2019, designated the Secretariat of the Environment and Sustainable Development as implementing authority of the Basel, Rotterdam, Stockholm and Minamata Conventions. Within the Secretariat, the Decree created the Interministerial Bureau on Chemical Substances and Products to coordinate activities among the various government units concerned with chemical substances
3.202. The National Quality System (SNC) regulates standardization and conformity assessment activities in Argentina, within a strictly voluntary framework. The SNC is governed by the National Quality Council (CNC), composed of representatives of various government divisions and of the standardization and accreditation bodies. The Council is assisted by an advisory committee, composed of representatives of the sectors concerned. Two bodies are responsible for managing technical matters in the SNC: the Argentine Standards and Certification Institute; and the OAA.[416]
3.203. In implementing the national quality assurance policy, the CNC is responsible for defining the strategic guidelines, ensuring coordination among SNC members and drafting annual quality plans on the implementation of the national quality assurance policy, to guide the activities of public and private institutions concerned with different aspects of quality. The plans are generally aimed at promoting competitiveness and protecting consumers. For example, the stated objective of the 2019 Annual Quality Plan was to promote quality in the production of goods and services and thereby strengthen exports through added-value products; to open up domestic and international market access for Argentine products and to encourage more complex and diverse production.[417]
3.204. The body responsible for developing national standards is the Argentine Standards and Certification Institute (IRAM), a private non-profit institution.[418] As the national standardization agency operating under the authority of the SNC, IRAM develops, studies and publishes Argentine standards in all fields.[419] IRAM is the only state-recognized standards and certification body in Argentina and represents the country in international standardization processes. IRAM is a member of the International Organization for Standardization (ISO), and, through the Argentine Electrotechnical Committee, of the International Electrotechnical Commission (IEC). It also participates in the Pan American Standards Commission (COPANT) and the MERCOSUR Standardization Association (AMN). IRAM has been a signatory of the Code of Good Practice for Standardization since 1996
3.205. According to the authorities during this review, the procedures followed by IRAM to develop voluntary standards are based on the principles of openness, transparency, consensus, relevance, coherence and capacity development, all fully consistent with the principles of the WTO TBT Agreement. The procedures followed in studying standards were always in line with the relevant ISO/IEC directives and always sought to apply ISO and IEC international standards.[420] IRAM also advises national, provincial and municipal public agencies, at their request, on standardization matters
3.206. The process of developing standards involves more than 250 technical standards bodies (committees, subcommittees, commissions and working groups), with the participation of various organizations representing producers, consumers, academia, and the scientific and public sector. The process starts with the preparation of a project developed by consensus within one of the IRAM technical bodies, which is submitted for public discussion during a period of between 60 and 180 days (with exceptions). The project is then revised to reflect any input received during the public consultation phase, submitted for approval to the General Committee on Standards, and finally remitted to IRAM senior managers for application as a standard
3.207. IRAM standards apply to multiple sectors of the economy, including food; environment; fuel; construction; energy efficiency; electrical engineering; energy; quality control; mechanics; metallurgy and steelmaking; mining; chemicals; social responsibility; health; security; and information technology. According to information from IRAM, the Institute's quality policy is aimed at developing standards that benefit society and contribute to national sustainability.[421] The standards published by IRAM can be reviewed at the request of interested parties, including the public sector, applying the same methodology as for the initial study. There is no established timetable for periodic review of the standards or confirmation of their continuing validity. As of 2021, IRAM has more than 9,000 approved standards
3.208. The development and review of mandatory technical regulations in Argentina is the responsibility of each ministry or regulatory agency. Each institution thus has its own provisions covering how technical regulations in its particular field are prepared and revised, and, where necessary, establishes mandatory requisites for goods marketed in the country, whether produced locally or in other countries. According to the authorities, the regulations are intended to ensure product safety and set clear standards for particular aspects of product quality and information, without unduly encumbering trade. Technical regulations in Argentina generally continue to be based on MERCOSUR standards and the standards and recommendations of such international organizations as the ISO, COPANT, the Codex Alimentarius Commission, the International Organization of Legal Metrology (OIML) and the IEC
3.209. The agencies engaged in establishing technical regulations include the following: the National Directorate of Technical Regulations (DNRT) under the authority of the Under-Secretariat for Domestic Market Policies within the MDP's Secretariat of Domestic Trade (SCI); the Secretariat for Industry, the Knowledge Economy and Foreign Trade Management; the Secretariat of the Environment and Sustainable Development; INV; SENASA; the National Food Commission (CONAL); ANMAT; the National Gas Regulatory Authority (ENARGAS); the National Entity for Communications (ENACOM); the Secretariat of Food, Bioeconomy and Regional Development; the Secretariat of Quality Health Care; and the Ministry of Transport. All of these agencies coordinate their work within the framework of the CRT, which has become a coordination forum for implementation of the TBT Agreement in Argentina. The DNRT was created by MDP Administrative Decision No. 1.080/2020 and assigned primary responsibility for developing, monitoring and implementing technical regulations and procedures for conformity assessment within the framework of the TBT Agreement; and for developing policies linked to improving the quality and technical conformity of goods and services, in order to enhance competitiveness
3.210. Resolution No. 299/2018, in force during part of the period under review, outlined the process for developing and reviewing technical regulations and conformity assessment procedures in the former Ministry of Production. The Resolution provided for technical regulations to be proposed ex officio or at the request of a department of the Ministry, another national government body, or a natural or legal person. If the request was accepted, a pre-feasibility analysis was initiated. Resolution No. 299/2018 was revoked by MDP Resolution No. 70/2021 as part of a reorganization of government agencies and functions. As of 2021, these functions are performed by the DNRT, which conducts a detailed analysis of product scope, technical requirements and standards, and proposed implementation plan; performs the conformity assessment procedure; and elicits the opinions of public and private actors. It can also seek a technical endorsement from INTI and/or consult with qualified specialists and specialized technical agencies. The DNRT also notifies the WTO Secretariat of the proposed technical regulation for Members' comments. Argentina's notifications of the WTO are published on the country's focal point website. Once the procedures for developing a technical regulation and conducting conformity assessments have been finalized, the DNRT recommends them to the competent authority, which decides whether or not to adopt and apply them and publishes its decision in the Official Journal
3.211. The DNRT monitors implementation of the technical regulations it has adopted, assesses their impact and takes measures as necessary to improve quality and technical conformity. The DNRT is authorized to review current technical regulations or conformity assessment procedures and propose new ones or adjustments as necessary based on the findings of monitoring and impact evaluation process. This procedure is ad hoc with no pre-established timeframe for the review. The technical regulations of government agencies are generally reviewed ex officio, or at the request, if technically justified, of natural or legal persons, but with no set timeframe for that review. It is up to the agency responsible for implementing the regulation to review it, as and when it deems fit. According to the authorities, such reviews have tended to focus on updating the parameters required of particular products, the procedure for demonstrating conformity, or the overall scope of the regulation. Technical regulations are generally amended or revoked on the basis of changes in technology or international standards
3.212. Between 1 January 2013 and 31 December 2020, Argentina presented 360 notifications to the WTO Technical Barriers to Trade Committee. Of these, 129 were ordinary notifications, including 118 concerning draft technical regulations.[422] Argentina's technical regulations raised no concerns in practice among its trading partners during the period under review.[423]
3.213. The accreditation of bodies for the certification of quality systems, products, services and processes, and of testing and calibration laboratories, is the responsibility of the OAA, a civil, economically-sustainable entity established within the SNC in 1995 to perform the functions set forth in National Executive Decree No. 1.474/94.[424] The OAA, composed of representatives of producers, consumers and the technology sector, is the SNC's only accreditation body and conducts all accreditation activities. It accredits testing and calibration laboratories; clinical laboratories; providers of aptitude tests; inspection bodies; and system certification bodies for quality control, environmental management, workplace health and safety management, hazard analysis and critical control points, food safety management, products and persons.[425]
3.214. Argentina recognizes foreign certification bodies and laboratories, if accredited by their national accreditation agencies, in countries where reciprocity agreements to such effect are in place. Signature of such an agreement facilitates but does not automatically guarantee recognition. The OAA represents Argentina in the International Accreditation Forum (IAF), the International Laboratory Accreditation Cooperation (ILAC) and the Inter-American Accreditation Cooperation (IAAC), in which capacity it has been a signatory of the multilateral recognition arrangements (MLAs) concluded by those organizations
3.215. The OAA is also the National Monitoring Authority for good laboratory practices within the framework of the Organisation for Economic Co-operation and Development (OECD). In that role it monitors conformity with good laboratory practices applicable to the non-clinical study of pesticides, biocides and industrial chemical products as required for purposes of registration or marketing permits under the OECD Mutual Acceptance of Data (MAD) Agreement. The OAA can also conduct, if necessary, any other monitoring in accordance with good laboratory practices, or any other activity subject to its mandate as defined by regulatory authorities or requested by the interested parties.[426] The OAA is also responsible for conducting any accreditation activity introduced into international practice or defined by regulatory authorities
3.216. In the context of this review, the authorities indicated that the accreditation of third-party conformity assessment bodies is not a requirement for all technical regulations implemented at the national level; determining whether this is necessary depends on the analysis undertaken during the particular drafting process. They also clarified that OAA regulations on the accreditation of certification bodies and laboratories are consistent with those of the international standardization organizations as contained in the ISO/IEC standards (adopted as IRAM standards). For example, among other conditions, the entities concerned must adhere to ISO/IEC guidelines for their activity in order to be accredited.[427]
3.217. The aim of the Calidad Argentina plan is to promote accreditation as, , according to the authorities, there is currently a shortage of laboratories accredited with the OAA.[428] In September 2019, as part of this plan, a new line of credit was introduced, on preferential terms, to finance the OAA accreditation of laboratories and certification and inspection bodies registered as MSMEs. This financing, provided by FONDEP, is intended for laboratories and certification and inspection bodies holding valid MSME certificates. Loans of up to ARS 300,000 per beneficiary are provided within the framework of the Argentina Exporta programme
3.218. According to information from the OAA, as of June 2021 there were 189 accredited testing laboratories; 26 calibration laboratories; 12 clinical laboratories; 7 certification bodies for quality control systems; 7 certification bodies for environmental management systems; 25 certification bodies for products; 3 certification bodies for persons; 3 certification bodies for food safety management systems; 2 certification bodies for hazard analysis and critical control points; 1 certification body for workplace health and safety management systems; 17 inspection bodies; and 5 providers of aptitude testing.[429] As of the same date, 21 bodies were recognized as being in compliance with the OECD Principles of Good Laboratory Practice.[430]
3.219. As of June 2021, 48 certification bodies, mostly private, had been accredited by the OAA for quality control systems (7 bodies); environmental management systems (7); products (25); persons (3); food safety management systems (3); hazard analysis and critical control points (2); and workplace health and safety management systems (1)
3.220. The main legal framework for the technical regulations of the Secretariat of Domestic Trade (SCI) consists of Law No. 24.240, on Consumer Protection, and Decree No. 274/2019 of 17 April 2019, on Fair Trade, from which the cross-cutting and specific technical regulations are derived. Decree No. 274/2019 makes the SCI the implementing authority, responsible for establishing safety requirements for products or services not specifically regulated by other laws
3.221. The certification bodies assigned to systems (for quality control, products, services and processes), as well as the inspection bodies and testing and calibration laboratories for the conformity assessment of technical regulations within the SCI's purview, must meet the requirements established in SCI Resolution No. 344/2021 of 9 April 2021, (which revoked Resolution No. 262/2019 and established specific conformity assessment systems for the technical bodies). The Resolution empowers the SCI, as the implementing authority, to define and modify the conformity assessment systems applicable to the technical bodies for each of the technical regulations within its purview; to recognize technical bodies as qualified to deal with those technical regulations and to periodically review that recognition. An annex to the Resolution establishes a series of requisites which, depending on the system assigned for the technical regulation in question, may or may not include accreditation with the OAA, in accordance with ISO/IEC series 1700 standards. The technical bodies must have legal personality and qualified personnel in the country. They must also assume civil, commercial, administrative and criminal liability for their recognized functions and maintain civil liability insurance coverage commensurate with the risks of their activity, and no less than 400 times the adjustable minimum living wage (SMVM) in the case of certification bodies; 150 times the SMVM for testing laboratories; and 100 times the SMVM for inspection bodies
3.222. All technical bodies must meet the requirements established in Resolution No. 344/2021 but that alone does not qualify them to deal with a particular technical regulation. To obtain that qualification an interested technical body must apply for recognition from the SCI, using the TAD Platform, and submit documentation demonstrating fulfilment of the previously established requisites according to the conformity assessment scheme for that regulation. The SCI examines the application and documentation, and if necessary, directs the body to rectify defects in the documentation within 45 days. Applications and recognition must refer to a particular certification regime and product category. To maintain recognition under the various conformity assessment systems, technical bodies must issue documents attesting to the conformity assessment findings based on verifiable information or data
3.223. The Under-Secretariat for Domestic Market Policies, under the authority of the SCI, as implementing authority for SCI Resolution No. 344/2021, is authorized to enter into agreements with the OAA for the purpose of establishing guidelines for the development of technical body accreditation schemes and applying conditions beyond those indicated in ISO/IEC 17011. It can also record in the technical regulations the acceptance of testing reports issued by foreign-based technical bodies accredited with an accreditation agency that has signed multilateral recognition arrangements to which the OAA is a party
3.224. To administer the certification of products covered by technical regulations, mandatory certification systems have been established by means of regularly revised resolutions, specifying the certification system to be used and the symbols and labels that products must display (Table 3.37).[431] All certification bodies and laboratories contributing to the certification of conformity and related testing protocols under mandatory certification systems for products and services regulated by the SCI must meet the requisites established in Resolution No. 344/2021. According to the legislation, marketers of products and services subject to mandatory certification systems must furnish the SCI with authenticated copies of certificates of conformity issued by recognized certification bodies, prior to any marketing.[432]
3.225. The certification body for INTI is one of the entities assigned to certify products (on a voluntary and regulated basis) as well as processes and persons. INTI is Argentina's only public sector certification body and provides its endorsement as an independent third party to certify that products, processes and persons meet applicable standards and technical specifications.[433]
3.226. For products subject to mandatory certification, each of the resolutions and updates thereof must specify the technical regulations and standards to be met for certification, and the procedure to follow to obtain that certification. For example, in the particular case of textiles and footwear, a Sworn Declaration of Product Composition (DJCP) (textile products, clothing and footwear), is required prior to marketing, together with verification of the labelling and market samples. The certification process unfolds in four phases: (a) phase 1: certification request; (b) phase 2: conformity assessment; (c) phase 3: issuance of certificate/seal of conformity; and (d) phase 4: oversight or monitoring. For the certification of regulated products, the recognized certification bodies issue a conformity certificate. This document, as well as a seal of conformity, can also be issued in the case of voluntary certification. Where certification is mandatory, the applicant must be legally domiciled in Argentina