3.176.  Paraguay's legislation on the application of sanitary and phytosanitary (SPS) measures comprises several domestic laws and the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). Pursuant to the SPS Agreement, Paraguay has notified the WTO that SENAVE, SENACSA and the MAG are the national enquiry points for sanitary and phytosanitary matters.[164]

3.177.  The following are among the principal regulations governing SPS measures: Law No. 672/24 or Organic Law of the Agricultural Protection and Plant Health Inspection Directorate; Law No. 836/80 on the Health Code; Law No. 123/91 adopting new standards of phytosanitary protection; Law No. 385/94 on seeds and the protection of cultivars and its implementing Regulations; Law No. 2.426/04 establishing SENACSA and its implementing Regulations; Law No. 2.459/04 establishing SENAVE; Law No. 3.742/09 on the control of phytosanitary products for agricultural sanitary use; and Decree No. 6.626/05 establishing the National Technical Committee on Sanitary and Phytosanitary Measures (Table 3.21)

3.178.  Also forming part of Paraguay's regulatory framework for sanitary and phytosanitary matters are the international treaties and conventions signed and ratified, in particular the Convention on the establishment of the Southern Cone Plant Health Committee (COSAVE)[165], the International Convention for the Protection of New Varieties of Plants and the International Plant Protection Convention. Pursuant to COSAVE's recommendations, Paraguay adopted the system for the phytosanitary accreditation of imported plant products (AFIDI).[166]

3.179.  During the review period, a number of laws and standards relating to sanitary and phytosanitary activities were adopted. These include Law No. 4.866/13 amending and supplementing Law No. 2.459/04 establishing SENAVE; Law No. 5.264/14 on promotion of the dairy chain, boosting domestic production and promoting the consumption of dairy products; Decree No. 9.699/12 establishing the National Commission on Agricultural and Forest Biodiversity (CONBIO); Decree No. 1.244/14 establishing the national system for the traceability of plant products and by-products (SITRAVE); and Decree No. 3.966/15 amending and supplementing Decree No. 17.487/97 creating Paraguay's National Codex Alimentarius Committee (CONACAP)

3.180.  The principal authorities for sanitary and phytosanitary matters are SENAVE and SENACSA; relations between them and the Executive are through the MAG

3.181.  SENAVE was set up by Law No. 2.459/04[167], as amended and supplemented by Law No. 4.866/13[168], and started to operate in 2005 as the authority responsible for implementing Law No. 123/91, which adopted new standards of phytosanitary protection, and Law No. 385/94 on seeds and the protection of cultivars, among other legal provisions. SENAVE is also responsible for administering international conventions and agreements signed by Paraguay on plant quality and health, seeds and the protection of new plant varieties and plant species derived from biotechnology

3.182.  SENAVE's responsibilities cover the following areas: (a) plant health: action on plant quarantine, phytosanitary monitoring and protection of agriculture; (b) seeds: keeping the national registers, dealing with the certification and protection of the rights of breeders of new plant varieties; (c) pesticides, fertilizer, soil nutrients and related products: monitor their quality and safety, mainly by controlling inputs and registering companies; (d) quality and safety: ensuring the quality and safety of plant products and by-products, either for export, imported or for domestic consumption, bearing in mind the guidelines and standards of international and national organizations governing the sector. To carry out this task, it verifies the quality and safety of such products and by-products, mostly by certifying quality

3.183.  By drafting what are called "technical regulations" SENAVE develops technical measures to guarantee the quality of plant products and by-products. These regulations lay down the requirements as to quality, packaging and presentation of fresh plant products, including their handling and preparation for appropriate sale on the domestic market and for export. By June 2017, 13 "technical regulations" had been issued, 11 of them during the review period, concerning the following products: potatoes (Resolution No. 468/12); onions (Resolution No. 469/12); bananas (Resolution No. 414/13); bell peppers (Resolution No. 601/13); oranges (Resolution No. 86/14); carrots (Resolution No. 173/14); garlic (Resolution No. 973/14); melons (Resolution No. 1.006/15); pineapples (Resolution No. 507/15); watermelons (Resolution No. 167/15); and strawberries (Resolution No. 167/15)

3.184.  SENACSA was established by Law No. 2.426/04[169] and started to operate in 2005. It is responsible for drafting, regulating, coordinating, implementing and monitoring national animal quality and health policy and administration. Its functions include the following: implementing programmes for the sanitary control, prevention and eradication of animal diseases; diagnosing animal diseases; verifying the quality of vaccines; controlling the safety of products and by‑products of animal origin; registering and approving companies selling veterinary products and animal feed; controlling residues of veterinary medicines, environmental contaminants and pesticides in food of animal origin; and issuing animal health and quality certificates for the import and export of animals, genetic material, products and by-products of animal origin, products and inputs for veterinary use, inter alia. SENACSA and MAG are the authorities implementing the National Plan for Sustainable Development of the Dairy Chain, pursuant to Law No. 5.264/14 on promotion of the dairy chain, boosting of domestic production and promoting the consumption of dairy products

3.185.  The following are some of the legal provisions adopted during the review period in connection with SENACSA and its functions: Resolution No. 2.764/15 authorizing the implementation of the VUI in SENACSA at national level; Resolution No. 3.130/15 amending Articles of Resolution No. 1.290/09 approving good manufacturing practices for veterinary products; Resolution No. 3.845/12 banning the import, distribution, preparation, use or possession of certain active substances; and Resolution No. 1.050/12 banning the import, distribution, preparation, use or possession of clenbuterol, salbutamol, cimaterol or albuterol and other beta‑agonists throughout Paraguay

3.186.  Another institution with responsibility for regulating human health is the MSPBS, through the National Health Monitoring Directorate, INAN[170] and the Directorate of Health Establishments, Related Facilities and Healthcare Technology. The National Health Monitoring Directorate regulates everything to do with medicines for human use, chemicals and reagents for the pharmaceutical and non-pharmaceutical industry, cosmetics and products for household use, as well syringes and needles for human use. INAN's responsibilities concern the regulation of food products and beverages.[171] The Directorate of Health Establishments, Related Facilities and Healthcare Technology has responsibilities with regard to medical, odontological and laboratory appliances, instruments, equipment and devices

3.187.  The National Technical Committee on Sanitary and Phytosanitary Measures[172] and the National Codex Alimentarius Committee (CONACAP)[173] are forums for coordinating and harmonizing the activities of the institutions involved in SPS-related matters. The MSPBS, through INAN, MIC, MAG, MRE, INTN, SENAVE, SENACSA and representatives of the private sector participates in the National Technical Committee on Sanitary and Phytosanitary Measures and in CONACAP

3.188.  Law No. 123/91 adopts new standards of phytosanitary protection and is implemented by SENAVE. It determines phytosanitary responsibilities and obligations concerning disease control and general conditions for the production, transfer, storage and control of entry and exit. On the basis of this Law, SENAVE is required to give authorization for the import, temporary admission, storage in free zones or transit of plant products. Authorization to import leads to the issuing of an AFIDI. For exports, SENAVE issues a phytosanitary certificate for the export of products and by‑products of plant origin

3.189.  SENAVE is responsible for administering Law No. 385/94 on seeds and the protection of cultivars[174] and its implementing Regulations[175], which regulate the production, movement, marketing and quality control of seeds. The purpose of the Law is to guarantee to farmers and users in general the identity and quality of the seed they purchase and to protect the rights of breeders of new cultivars. The Law established the National Register of Commercial Cultivars, the National Register of Protected Cultivars, the National Register of Seed Traders, the National Register of Seed Producers and the National Register of Seed Laboratories. Those seeking to export seeds to Paraguay must have a permanent legal representative listed in the National Register of Seed Traders in Paraguay to act as an importer. Farmers in a personal capacity or in associations may also import seeds in the same way as seed traders listed in the Register

3.190.  SENAVE is responsible for implementing Law No. 3.742/09 on the control of phytosanitary products for agricultural sanitary use[176], which establishes the legal regime for the registration and control of all phytosanitary products for agricultural use as of their entry into Paraguayan territory. The Law also regulates the synthesis, formulation, fractioning, transport, storage, labelling, marketing, advertising, application and elimination of residues and final disposal of empty packages and expired pesticides. Four registration categories have been developed and established for the purpose of implementing the Law: (a) commercial entities, which may be either natural or legal persons engaged in various related activities; (b) professionals, for agronomists, chemists and other professionals who provide advice and/or are responsible for the technical or testing activities of the commercial entities; (c) laboratories, for competent laboratories which analyse, test and/or generate information on phytosanitary products and have been accredited in Paraguay by the ONA; and (d) phytosanitary products, for pesticides

3.191.  Registration of commercial entities, professionals and laboratories is valid for five years and may be renewed. The validity of registration of phytosanitary products depends on their classification, whether experimental, definitive or for export. For a product classified as experimental, registration is for two years, renewable for a further two years, during which it must undergo testing of its efficiency in the field and may not be sold. For products classified as definitive or for export, registration is indefinite, subject to payment of an annual fee

3.192.  During the review period, Decree No. 3.966/15 amending and supplementing Decree No. 17.487/97 was approved, creating the CONACAP

3.193.  Pursuant to Law No. 836/80 on the Health Code, manufacturers, representatives or importers of food products or beverages for sale must first register their products with the MSPBS, which determines whether or not they are fit for consumption and the period of validity of their registration. It is also mandatory to register containers for foodstuffs. Resolution No. 380/11 lays down the criteria and requirements for obtaining and renewing national registration of containers in contact with foodstuffs, which is controlled by INAN

3.194.  Activities involving genetically modified organisms (GMO) are governed by Decree No. 9.699/12, which established CONBIO.[177] This Decree repealed Decree No. 18.481/97 creating the Biosafety Commission (COMBIO), and Decree No. 12.706/08 supplementing and amending Decree No. 18.481/97. The MAG is responsible for starting up CONBIO's operations and for granting authorization for controlled testing, pre-sale release, release for sale and other proposed uses of GMOs for incorporation into agricultural or forestry production, on the basis of the decision taken by CONBIO. The MAG authorizes release for sale of GMOs on the basis of a decision by CONBIO

3.195.  According to the authorities, the new Law meets the need to update the integration, organization and functions of the Commission by incorporating forestry. The main changes are the creation of INFONA and the Paraguayan Agricultural Technology Institute (IPTA) among the institutions composing CONBIO, together with the MAG, MSPBS, MIC, SENACSA, SENAVE, SEAM and the National University of Asuncin (UNA). Another change introduced is the creation of a technical secretariat for the forestry sector, for which INFONA is responsible. Prior to this, there were only two technical secretariats, one for plants (SENAVE) and another for livestock (SENACSA)

3.196.  CONBIO has the following tasks: (a) to evaluate GMOs used in the agricultural and forestry sectors or which it is sought to introduce into Paraguay, and to recommend, where applicable, authorization for their use in Paraguay for the purpose proposed; (b) to advise and decide on matters relating to the introduction, field testing, pre-sale release, release for sale and other proposed uses of GMOs; (c) to help to ensure that natural and legal persons working with GMOs comply with biosafety measures; and (d) to propose biosafety standards, contingency plans in case of accidental release, and biosafety measures in cases of failure to comply with the standards, as well as to give opinions on matters within its competence

3.197.  Paraguay bans the production, import, marketing and use of hormonal substances for the fattening of cattle whose meat and products are for human consumption, and regulates the use of hormones in animal breeding pursuant to Decree No. 3.255/89. SENACSA verifies compliance with this ban, determines the special criteria for registration, sale, use and application of authorized veterinary products and imposes the sanctions applicable for non-compliance with the Decree

3.198.  Promotion and control of organic products are governed by Law No. 3.481/08 on the promotion and control of organic production[178] and its implementing Regulations (Decree No. 4.577/10).[179] The texts designate the authorities for promotion (MAG); accreditation (ONA); and registration, monitoring and control (SENACSA and SENAVE) for this purpose. They also define the procedure for certification and control and the sanctions applicable in cases of failure to comply with the obligations in the Law

3.199.  The MRE is the national authority responsible for notifying sanitary and phytosanitary measures to the WTO[180]; it is a member of CONACAP and the National Technical Committee on Sanitary and Phytosanitary Measures.[181] One of the latter's activities is to make the ENP for notifications to the WTO SPS Committee more efficient

3.200.  During the review period, Paraguay notified only five sanitary and phytosanitary measures to the WTO (four concerning plant health and one animal health), of which two were notifications of emergency measures and three regular measures.[182] Four of these measures affected all Paraguay's trading partners, whereas one of the emergency measures was directed at Brazil in relation to Black Sigatoka disease of bananas.[183]. The second emergency notification concerned the presence of the citrus disease (Huanglongbing (HLB)) in Paraguay.[184] The regular notifications concerned: (a) a draft resolution determining the phytosanitary requirements for importing Nicotiana tabacum (tobacco) from countries outside MERCOSUR; (b) a draft resolution determining the phytosanitary requirements for the entry of kiln-dried sawn timber, sawn timber and logs originating in countries within or outside the region; and (c) the animal health requirements for importing queen bees and apiculture products. The 11 measures adopted by SENAVE in relation to the packaging of vegetables and fruit were notified to the WTO as technical regulations.[185]

3.201.  Although there was only a limited number of notifications to the WTO during the review period, Paraguay has shown progress in their presentation, inasmuch as the previous review showed that the vast majority of measures had been notified after being adopted, whereas during this review period, draft measures were notified, thus giving WTO Members an opportunity to forward comments on the SPS measures planned

3.202.  At the MERCOSUR level, the process of harmonizing SPS measures is taking place through Sub-Working Group No. 8 Agriculture (SGT No. 8) on the basis of the principles, guidelines, criteria and parameters for agreements on the equivalence of sanitary and phytosanitary control systems determined in document RES/GMC/60/99.[186] SGT No. 8 is composed of representatives of each country's regulatory body. During the review period, Paraguay continued to adopt MERCOSUR's harmonized SPS measures

3.150.  In Paraguay, there is no centralized agency for drafting technical regulations. These are prepared and implemented by several authorities, including the MIC, the MSPBS, the MAG and other ministries and regulatory agencies. Although each follows its own procedures, they usually follow those determined in Decree No. 1.765/09 on the format for technical regulations and conformity assessment procedures drawn up within their respective areas of competence. Furthermore, the MIC is responsible for drafting and coordinating policies on technical regulations, which it coordinates with the National Technical Committee on Technical Barriers to Trade, created by Decree No. 1.766/09. This Committee constitutes the forum in which technical regulations are examined and Paraguay's position on technical barriers to trade (TBTs) is decided for the negotiations in which Paraguay takes part at the regional level (LAIA), bi‑regional level (MERCOSUR‑EU) and MERCOSUR's other external relations. The Committee may convene the private sector when an international notification might have an impact on Paraguay's trade

3.151.  The procedure for drafting a technical regulation (RT) usually commences by identifying Paraguay's need to protect a legitimate objective. It may stem from a request by an interested third party or be elaborated ex officio. Pursuant to Decree No. 1.765/09, international standards must be used as the basis for developing RTs unless they are ineffective for achieving the legitimate objectives. Accordingly, most RTs are based on international standards, which may be adopted directly or adapted. In the latter case, Paraguay, through the corresponding government authority, draws up its own RT based on regional or international standards. A draft RT may also be prepared by making an INTN Paraguayan standard mandatory (see below). Whenever an RT is drafted, it must be accompanied by the establishment of a conformity assessment procedure for the product. Once the RT has been prepared, interested parties are consulted. If the measure might affect trade, the draft is notified to the WTO. When an INTN national standard becomes an RT, it is declared mandatory, either by decree or by means of a resolution. With the exception of this case, the INTN does not draft RTs directly, but is usually consulted by government authorities when they are preparing RTs. There is also a (voluntary) guide of good practice for regulation and a risk assessment (ER) and impact (EIR) methodology for RTs. The institutions belonging to the TBT Committee are aware of this guide

3.152.  According to Paraguay's legislation, all draft RTs must be notified. Once they have been notified and published, a period of 60 to 90 days is given in which to receive comments, unless it is essential to approve the RT urgently. The National Information and Notification System (SNIN)[147] deals with the comments received at the international level. Once comments have been received, either internally or from other WTO Members, the draft regulation is reviewed and the competent ministry or body decides whether to adopt the technical regulation, with or without amendment. RTs are adopted in the form of laws, decrees or resolutions, as applicable, and published on SNIN's website and in the Official Journal. For imports, conformity with an RT is checked at the border in accordance with internationally recognized procedures. Domestic products are inspected in situ. Products subject to Paraguayan RTs must be certified by approved and accredited bodies (see below)

3.153.  Paraguay has notified the WTO of two contact points for enquiries relating to RTs. For questions regarding RTs, standards and conformity assessment procedures, the contact point is the SNIN Coordinating Unit, while for notifications to the WTO, information or formal questions from Members regarding TBTs, coordination is through the WTO Reference Centre within the Directorate of Multilateral Economic Organizations in the MRE's Under-Secretariat for Economic Relations and Integration.[148] In 2003, Paraguay notified the WTO that it had accepted the Code of Good Practice annexed to the WTO Agreement on Technical Barriers to Trade.[149]

3.154.  Over the period 2011 to May 2017, Paraguay submitted 73 new notifications on draft RTs, addendums and corrigendums to the WTO Committee on Technical Barriers to Trade. Since it sent in its first notification on RTs in September 2006, Paraguay has submitted 92 new notifications to the WTO.[150] Table 3.20 shows the new RTs adopted over the period 2011 to May 2017

3.155.  The SNIN makes Paraguay's regulations and notifications from other WTO Members in relation to RTs and TBTs available to exporters and the public. SNIN users can participate by sending in their comments on Paraguayan preliminary draft RTs or international notifications pending approval. In order to do this, they must register with the "exporters' early warning service".[151] By May 2017, the SNIN's website reported 124 RTs, including conformity assessment procedures, within Paraguay's regulatory framework.[152] The RTs adopted since the previous review in 2011 concern products such as seeds, cotton, chemicals, service providers, food, meat, automobiles, made‑up articles, footwear, fuel, wire, iron bars, soya beans, live animals, household sanitary products, cables, and salt. The SNIN had over 5,562 international notifications in its database on the same date

3.156.  A large number of RTs adopted by Paraguay are regulations adopted at regional level by the Common Market Group (GMC), MERCOSUR's main executive body, which enacts MERCOSUR technical regulations in the form of resolutions. Within the GMC, Sub‑Working Group No. 3 (SGT No. 3, Technical Regulations and Conformity Assessment), made up of various commissions, prepares draft technical regulations, incorporates comments resulting from the internal consultation process, and submits the final draft to the GMC for approval.[153] The draft regulation is notified to the WTO TBT Committee before adoption by MERCOSUR or incorporation into the internal legal system of member countries.[154] Following approval, the MERCOSUR RT (RTM) has to be incorporated into domestic legislation. During the period 2011‑2016, nine RTMs were harmonized, eight on food and one on metrology

3.157.  The MERCOSUR ECONORMAS project (support for deepening MERCOSUR's economic integration process and sustainable development), carried out between 2010 and 2015 enabled Paraguay to equip three testing laboratories for the metalworking (steel bars (INTN)), electrical goods (especially transformers (Engineering Faculty/National University of Asuncin (FIUNA))) and wood/furniture (parquet and multilaminate flooring) (Faculty of Agricultural Sciences/National University of Asuncin (FCA/UNA)) sectors

3.158.  The drafting and adoption of standards in Paraguay is the responsibility of the INTN, a public, autonomous and decentralized entity with its own legal status and jurisdiction throughout Paraguay. It was set up by Law No. 862/63 and reorganized by Law No. 2.575/05. Relations between the INTN and the Executive are through the MIC, the INTN being the body responsible for improving quality, productivity and certification of the conformity of domestic products with technical standards through its technical bodies: the National Certification Agency (ONC), the National Metrology Agency (ONM), the National Standardization Agency (ONN), the National Inspection Agency (ONI), the Research and Technological Assistance Agency (OIAT) and the Directorate of Regulation.[155] Pursuant to Decree No. 15.552/96, the INTN also acts as the ONC, certifying products, systems and services

3.159.  Paraguayan standards are prepared, adopted or harmonized by the INTN upon request by the private or public sector. The INTN prepares and approves Paraguayan standards through its technical standardization committees (CTN). At May 2017, 64 CTNs had been set up. The procedures followed during this process are based on international guidelines and standards (ISO/IEC). Work is under way to adopt, harmonize and draft standards

3.160.  Requests to draft a standard have to be forwarded to the INTN, which designates the technical committee competent to prepare a draft standard. Once prepared, the draft is put up for public consultation for a period of 60 days, after which it is approved by means of an INTN resolution. As the INTN is a participant in ISONET, standards drawn up are sent to the ISO/IEC Information Centre in Geneva. At May 2017, 804 Paraguayan standards were in force. Since the previous review in 2011, 263 standards have been prepared (198 new standards and 65 revised standards). The majority of INTN standards concern the construction, electricity, dairy produce, wood and textiles sectors

3.161.  The INTN is a member of the MERCOSUR Standardization Association (AMN), the regional non‑governmental institution responsible for harmonizing standards and composed of each member country's standardization agency.[156] Relations between the GMC and the AMN are through SGT No. 3, to which the AMN submits its annual work plan and twice‑yearly progress report, attaching the standards approved. The AMN's activities are conducted through sectoral committees, which represent industry segments in each country. Adoption of MERCOSUR standards as national standards or RTs by each member country is optional. At May 2017, the AMN had adopted 620 MERCOSUR standards.[157]

3.162.  The National Council for Science and Technology (CONACYT) is responsible for framing Paraguay's domestic policies and strategies for science, technology, innovation and quality and also has the task of coordinating the national quality system, which has the following components: standardization, metrology and accreditation, as well as information and notification of technical regulations

3.163.  The Paraguayan National Codex Alimentarius Committee (CONACAP), created by Decree No. 17.487 of 11 June 1997, is composed of representatives of the government and private sectors and analyses, evaluates and makes recommendations to the Government concerning food‑related standards. It advises the Government on harmonizing domestic legislation and regulations on foodstuffs with the standards, guidelines and codes of practice drawn up by the Codex Alimentarius Committee. The INTN acts as the permanent executive secretariat of the CONACAP

3.164.  The INTN, through the ONM, is responsible for the implementation and operation of the national metrology system, pursuant to Law No. 937/82 on metrology and its implementing Decree No. 1.988/99. The ONM is responsible for the implementation and functioning of the National Metrology Laboratory, for keeping national measurement standards, and for drawing up RTs in each specific area of metrology. It also provides the services for controlling measuring instruments used in business, industry and in health services, as well as for monitoring the content of packaged goods. It has the following laboratories accredited by the ONA: mass; calibration of scales; volume and density; pressure; power; dimensions; time and frequency; electricity; and temperature.[158] Paraguay is a member of the International Organization of Legal Metrology (OILM), through the INTN, and of the Inter‑American Metrology System (SIM)

3.165.  The INTN is the national certification agency pursuant to Decree No. 15.552 of 26 November 1996. It has testing/calibration and certification laboratories accredited by the National Accreditation Agency (ONA/CONACYT) and the German Accreditation Agency Deutsche Akkreditierungsstelle‑DAkkS

3.166.  The mechanism and the steps to be taken for the adoption of conformity assessment procedures are similar to those for the adoption of RTs, including a period for public consultation and publication in the Official Journal. A number of government or private bodies are responsible for carrying out these procedures, which are part of technical regulation

3.167.  For the purposes of assessing conformity, certification, inspection at the port of entry and in retail outlets may be used, as well as sampling. Certification is for the most part voluntary and is usually provided by accredited third parties. Products subject to RTs constitute an exception as certification is mandatory. At May 2017, the products subject to mandatory certification included: measuring equipment and instruments; steel bars; electric cables; cement; some fuels (unleaded petrol, aviation fuel, kerosene, gas oil, fuel oil); containers for liquefied petroleum gas (LPG); fire extinguishers; matches; mate[159]; reusable polyethylene plastic bags[160]; cellular devices; incandescent and fluorescent lamps; toys, tyres; and steel rods and bars. Paraguay does not automatically recognize the certification of products or the systems of foreign certification agencies, except in special cases and on a temporary basis

3.168.  Special labelling requirements apply to certain products, for example, wire; packaged foodstuffs; sugar in bags; iron bars; cement; footwear; made‑up articles and textiles; household sanitary products; toys; lubricants; and incandescent and fluorescent lamps. During the review period, a new regulation on labelling the following products was introduced: sugar in bags (Ministerial Resolution No. 46/2016); lubricants (Ministerial Resolution No. 13/16) and household sanitary products (Ministerial Resolution No. 327/13 and Decree No. 10.598/13)

3.169.  Paraguay does not in principle accept as equivalent the technical regulations adopted or the tests conducted by its trading partners. By May 2017, it had not signed any agreement on mutual recognition and had not notified the WTO of any multilateral recognition agreement on conformity assessment

3.170.  Paraguay has an accreditation body, the National Accreditation Agency (ONA), set up in 1998 by Decree No. 20.660 of 20 April 1998. It is currently governed by Law No. 2.279/03 of 26 June 2003 and is part of CONACYT. As an integral part of the national quality system, ONA is the body responsible for directing and managing the national accreditation system and for granting accreditation at the national level to testing and calibration laboratories and agencies that certify products, quality management or environmental management systems, and individuals, as well as other agencies or bodies requiring accreditation or assessment of the competence of their services, according to internationally recognized systems.[161] Accreditation by ONA authorizes these entities to carry out activities in the mandatory as well as the voluntary sphere

3.171.  The ONA keeps a register of institutions, bodies and agencies accredited in Paraguay, as well as a register of assessors and technical experts. In 2011, it became a signatory to the Multilateral Recognition Arrangement of Inter‑American Accreditation Cooperation (IAAC) in respect of testing laboratories, product certification agencies and inspection agencies, and has signed the Mutual Recognition Arrangement with International Laboratory Accreditation Cooperation (ILAC).[162] The ONA represents Paraguay at regional and international accreditation forums and is empowered to sign bilateral or multilateral accreditation recognition agreements

3.172.  Pursuant to Law No. 2.279/03, the Permanent Technical Committee on Accreditation (CTPA), under CONACYT, is responsible for issuing technical rulings which constitute the decision on the concession, extension, reduction, suspension or annulment of accreditation or re‑accreditation

3.173.  According to the provisions in Decree No. 3.900/2010 of 5 February 2010, all conformity assessment bodies providing services to the Government must be accredited by ONA, which has the following accreditation programmes: testing and calibration laboratories (based on NP‑ISO/IEC 17025); product certification (NP guideline ISO/IEC 65); and inspection/verification (NP‑ISO/IEC 17020). Resolution No. 339/2016 established new requirements for the registration of natural and/or legal persons providing sampling services for plant products and by‑products and laboratory testing services. This Resolution also approved the procedure for registration, approval and recognition of Paraguayan and international laboratories

3.174.  Accreditation requires an application to be submitted to ONA, accompanied by supporting documents. An assessment is carried out on the basis of the application, as well as an assessment in situ. To be accredited, applicants must also comply with the reference standard for the sector in which they wish to be accredited, as well as with ONA's policies, regulations and criteria. Once accreditation has been given, the accredited body must undergo periodic evaluations in order to keep it. Laboratories and other entities are accredited in accordance with international standards, notably ISO/IEC 17011, and with the guidelines laid down by ILAC, IAAC, and the International Accreditation Forum (IAF)

3.175.  By May 2017, 48 conformity assessment agencies had been accredited for quality systems; five for product certification; one for certification of persons; as well as 27 testing laboratories, six calibration laboratories and nine inspection agencies, all established in Paraguay.[163]