3.159.  Sanitary and phytosanitary policy in Peru is formulated and implemented by three different authorities that operate in their respective spheres of competency (health certification, authorizations, surveillance, control, inspection and sanitary regulation). The National Agrarian Health Service (SENASA), attached to the Ministry of Agriculture and Irrigation (MINAGRI), deals with animal and plant health and the safety of agricultural and livestock food products at the production and primary processing stages; the National Fisheries Health Service (SANIPES), attached to the Ministry of Production (PRODUCE), is the sanitary authority in the fishery and aquaculture sector (primary production, primary processing and processed products); and the Directorate-General of Environmental Health and Food Safety (DIGESA), attached to the Ministry of Health (MINSA), is the health authority responsible for industrially processed foods, except for fishery and aquaculture products. The policies and activities of these three institutions are coordinated by the Standing Multisectoral Commission on Food Safety (COMPIAL), attached to and chaired by MINSA, in which SENASA, DIGESA and SANIPES all participate.[217] The entities in question also have sector-specific policies.[218]

3.160.  The main regulations governing sanitary and phytosanitary policy are the General Law on Agrarian Health, which lays down the legal framework for providing the official animal and plant health services that are essential for the protection of human, animal and plant health[219], along with Legislative Decree No. 1062, the Law on Food Safety[220], and Law No. 26842, the General Health Law (Table 3.11).[221] Several legislative amendments were made during the period under review, including implementation of the Law on strengthening the leadership role of the Health Ministry.[222] In addition, a very important step was taken to simplify procedures, by implementing the Inter‑Agency Collaboration Agreement between MINAGRI, MINSA and SENASA.[223]

3.161.  The preparation of a sanitary and phytosanitary (SPS) measure starts with a risk analysis (questionnaire and on-site visit). If this results in a favourable report, the provisional measure is then drafted with its requirements and notified to the WTO (consultation period). A decision is then issued, and the measure is published as an approved standard in "El Peruano" and notified to the WTO. The SPS measures issued by the three institutions with jurisdiction are based on international standards, guidelines and recommendations drawn up by the competent international organizations, namely, the International Plant Protection Convention (IPPC), the World Organisation for Animal Health (OIE) and the Codex Alimentarius

3.162.  Applications for the various zoosanitary and phytosanitary permits (sanitary or phytosanitary import permit or amendment thereof; inspection report, post-entry quarantine registration, sanitary or phytosanitary export certificate, and sanitary authorization for an export establishment) are processed through the single window for foreign trade (VUCE) by all institutions except for SANIPES

3.163.  SENASA's mission is to manage the Agrarian Health and Agri-Food Safety System for agricultural producers, agents in the agri-food chain, consumers and subnational governments.[224] SENASA's Plant Health Directorate determines the phytosanitary requirements for importation, based on the product, the country of origin and/or provenance and its proposed use, after carrying out a pest risk analysis (PRA).[225] A PRA is performed in the following situations: when a pest entry route is identified; when a plant product is imported from a new country or part thereof; when a previously unimported plant product starts to be imported; or when a pest is identified. In the latter case, the phytosanitary regulations are revised.[226] PRAs can also be performed in response to changes in a country's phytosanitary situation or changes in political boundaries. The studies in question can be based on requests and technical information provided by the national plant protection organizations (NPPOs) of the countries of origin, and importers and exporters, as well as using relevant databases.[227]

3.164.  SENASA issues the Phytosanitary Import Permit (PFI), which authorizes the importation of plants, plant products and other items that are regulated, and is a mandatory requirement before such products may enter Peru.[228] The importer needs the PFI to be able to bring plants, plant products and other regulated items into the country. The document must be issued before official certification in the country of origin and/or source and shipment to Peru, regardless of volume, use or mode of importation. To process a new PFI, a fee is payable equivalent to 1.7% of the official tax unit (UIT); while amendment or duplication of a PFI costs the equivalent of 1.2% of a UIT.[229] Once the original PFI has been obtained, it must be sent to the supplier in the country of origin for cognizance and to obtain the respective phytosanitary certificate from that country's health authority, indicating compliance with the relevant phytosanitary requirements. The PFI is valid for a single shipment and for 90 calendar days from its date of issue. SENASA has defined five phytosanitary risk categories in which plants, plant products and other regulated items are grouped (see below). The phytosanitary requirements are related to the phytosanitary risk categories approved by SENASA

3.165.  The importation into Peru of any plant, plant product or other regulated item is subject to mandatory inspection by SENASA at the health authority's authorized border control points (PCEs).[230] Certain products are also subject to a post-entry quarantine requirement.[231] SENASA established the Post-Entry Quarantine Procedure Manual through General Directive No. 043‑2000‑AG-SENASA-DGSV-DDF. The following are considered materials subject to this procedure: plants and their parts destined for propagation and/or sowing; sexual seed germplasm; biological control entities and organisms that arrive in special culture media or in pest organisms; and plants and parts thereof to be exhibited at conferences or festivals.[232]

3.166.  In the period 2013-18, 272 new phytosanitary import requirements and 86 sanitary import requirements were issued. The agricultural and livestock imports that were suspended in the period 2013-18 are listed in Table 3.12

3.167.  SENASA, as the body responsible for establishing sanitary and phytosanitary import requirements, issued Departmental Resolution (Resolucin Jefatural) No. 0162-2017-MINAGRI-SENASA defining five animal and plant health risk categories in respect of livestock products, depending on their level of processing, proposed use and ability to carry disease pathogens and quarantine pests that pose a risk to agrarian and animal health and public health. The action taken by SENASA depends on the risk category of the product to be imported. The risk categories are: Risk category 1: products and by-products of animal or plant origin that have undergone a process that eliminates the possibility of carriage of pathogens or pests of quarantine importance. SENASA reserves the right to inspect them when it deems it necessary, but they are not subject to mandatory control. Risk category 2: products and by-products of animal or plant origin that have undergone a process that lessens the possibility of carriage of pathogens and pests of quarantine importance. Risk category 3: products and by-products of animal origin that have undergone processing or industrialization, and semi-processed products of plant origin or primary natural products, whose processes do not guarantee the destruction of pathogens and pests of quarantine importance.[233] Risk category 4: primary products of animal origin and seeds, plants or parts thereof intended for propagation, capable of transporting pathogens and pests of quarantine importance. Risk category 5: animals, reproductive material or any other product of animal, plant, or non-plant origin deemed to pose a high risk of introducing pathogens, diseases and pests of quarantine importance

3.168.  The sanitary and phytosanitary risk category listing of agricultural goods that are regulated by SENASA through Departmental Resolution No. 0162-2017-MINAGRI-SENASA, specifies the agricultural or livestock products of risk categories 1 and 2 that do not require a sanitary/phytosanitary import permit to enter Peru.[234]

3.169.  Pursuant to Article 4 of Departmental Resolution No. 0162-2017-MINAGRI-SENASA, agricultural goods entering Peru must satisfy the requirements set out in Table 3.13 according to their risk category. For international transit, agricultural goods classified in risk categories 2 to 4 must have an International Transit Permit and submit to mandatory inspection/verification at the point of entry

3.170.  An important step has been taken to facilitate procedures and trade through the implementation of Agreement No. 0004-2016-MINAGRI-DM, the inter-agency collaboration agreement between MINAGRI, MINSA and SENASA.[235] The objective of this agreement is to establish a relationship of collaboration and mutual support to provide a correct and efficient procedure for importing industrially processed food of animal origin (except for fish and aquaculture products) intended for human consumption, as listed in the Annex to the agreement.[236] The key points of the agreement include: (a) the inclusion of the animal health requirements established by SENASA in the sanitary authorization for industrially processed foods of animal origin destined for human consumption under DIGESA jurisdiction, as listed in the agreement; such requirements must be included in the Single Official Export Certificate issued by the country of origin; and (b) SENASA and DIGESA to conduct joint inspections of imports of the foods covered by the agreement at the points of entry into Peru, establishing a single inspection procedure. SENASA is in charge of the animal health inspection, and DIGESA is responsible for sanitary inspection. The process for implementing the agreement is described in Box 3.2

3.171.  DIGESA uses Ministerial Resolution No. 850-2016, Standards for the Preparation of Ministry of Health Regulatory Documents, as a basis for preparing health regulations and notifying the WTO. During the period under review, DIGESA's health-related notifications to the WTO included the following: Ministerial Resolution No. 372-2016/MINSA, Health Standard establishing the maximum residue limits (MRLs) for veterinary drugs in food for human consumption (G/SPS/N/PER/446), and Ministerial Resolution 1006-2016/MINSA, Health Standard establishing the maximum residue limits (MRLs) for agricultural pesticides in food for human consumption (G/SPS/N/PER/447)

3.172.  The aim of the Law on Food Safety, administered by DIGESA, is to guarantee the safety of food for human consumption using a preventive and comprehensive approach throughout the food chain, also covering animal feed. In order to be sold on the domestic market, processed foods, whether produced locally or imported, require an official document, issued by DIGESA and processed through the VUCE, confirming their inclusion on the Sanitary Register of Food and Beverages for Human Consumption.[237] Imported processed foods also need a certificate of sanitary registration for imported products.[238] In order to export food and beverages under DIGESA jurisdiction, the goods must have been produced in establishments that have obtained sanitary authorization, i.e. establishments that implement the Hazard Analysis and Critical Control Point (HACCP) system.[239] The food or beverages are inspected and analysed for sanitary surveillance purposes. DIGESA also monitors the storage and distribution of food for human consumption to ensure that the products in question are safe and of appropriate quality, and that they meet the relevant sanitary requirements

3.173.  DIGESA's sanitary projects for 2019 include the following: preparation of general principles of food-product traceability along the food chain, for food safety purposes (in collaboration with SANIPES); drafting of a supreme decree to organize and specify certification of the General Principles of Hygiene (PGH) and HACCP for industrially processed foods, which bases the mandatory nature of these sanitary self-control systems on risk; development of sanitary guidelines that specify methods, techniques and procedures for inspection, sampling and analysis for official sanitary certification for the exportation of industrially processed food products intended for human consumption; preparation of a sanitary standard for the production of wine-based alcoholic beverages and by‑products; and development of a sanitary standard for table olives.[240]

3.174.  SENASA's competencies in relation to the safety of primary agricultural food and feedstuffs are regulated by Supreme Decree No. 004-2011-AG approving the Agri-Food Safety Regulations, published on 27 April 2011; and by Supreme Decree No. 006-2016-MINAGRI amending and supplementing the Agri-Food Safety Regulations, published in the Official Journal El Peruano on 4 June 2016. The purpose of these legal instruments is to establish provisions to guarantee the safety of primary agricultural food and feedstuffs, with the aims of protecting human life and health, recognizing and securing the rights and interests of consumers, and promoting the competitiveness of national agriculture. Article 40 of Supreme Decree No. 004-2011-AG establishes requirements for the entry or international transit of primary agricultural food and feedstuffs, which include sanitary certification or its equivalent, issued by the country of origin or by a recognized certification body, and inspection at the border. It also provides that the sanitary and phytosanitary requirements must be the same whether the product is of domestic origin or imported. Article 40A of the Decree provides details of the custody procedure. The products regulated by SENASA's Food Safety Sub-Directorate (SIAG) are listed in Departmental Resolution No. 0162-2017-MINAGRI-SENASA

3.175.  The National Fisheries Health Service (SANIPES) regulates and oversees health and safety services at the national level for fish and aquaculture products and feedstuffs and ingredients thereof of hydrobiological origin that are intended for hydrobiological species, as well as complementary and related services provided by public or private agents related to the fishery and aquaculture sector. SANIPES approves fishery and aquaculture sanitary regulations in conformity with national regulations and international sanitary and phytosanitary measures and standards, including the provisions of the Codex Alimentarius and those of the World Organisation for Animal Health (OIE), within its sphere of competency. It also issues certificates of compliance with sanitary regulations on fishery and aquaculture infrastructures, and the health, safety and traceability of hydrobiological products and veterinary and food products for use in aquaculture. To this end, inspections are carried out to verify compliance with national and international sanitary regulations (if applicable) and those contained in good practice manuals, descriptive reports, hygiene and sanitation manuals and the HACCP plan, among others. SANIPES also applies preventive administrative measures in respect of a danger or risk to public health and/or the health status of the aquatic zones and/or compartments where the hydrobiological resources are located

3.176.  Between January 2013 and April 2019, Peru submitted 350 substantive notifications through SENASA, relating to the adoption of SPS measures (495 including additions). Most of these measures were adopted to protect plant health. Nearly all were regular notifications, with only 10 emergency measures being notified (relating to beef, poultry, eggs, canned fish and ruminants)

3.177.  During the period under review, no trade concerns were raised regarding sanitary or phytosanitary measures adopted by Peru. On the other hand, Peru did raise concerns regarding measures adopted by other Members.[241]

3.130.  The general framework for implementing technical standards and regulations mirrors multilateral rules. During the period under review, significant legal and institutional changes took place, including the repeal of Legislative Decree No. 1030, the Law on National Standardization and Accreditation Systems. This was replaced by Law No. 30224, the Law creating the National Quality System (SNC) and the National Quality Institute (INACAL), of 11 July 2014

3.131.  Following the adoption of the new law, the main institutional change regarding standardization during the period under review was the formation of INACAL in 2014, which Law No. 30224 of 11 July 2014 created along with the SNC and the National Quality Council (CONACAL). INACAL is the SNC's governing body and highest technical and regulatory authority, and is responsible for the latter's operation according to the provisions of the Law. As part of its work, INACAL seeks to promote and enforce the National Quality Policy (PNC) with a view to fostering the development and competitiveness of economic activities and promoting consumer protection. The Institute is specifically responsible for standardization, accreditation and metrology activities, which its founding law requires it to undertake pursuant to both the Agreement on Technical Barriers to Trade and the international conventions and integration agreements on the subject to which Peru is party (see below).[197]

3.132.  Law No. 30224 is governed by the principle of non-obstruction of trade and stipulates that its provisions should not be construed as justifying measures that have the purpose or effect of creating unnecessary barriers to international trade. The Law also guarantees national treatment to imported products and most-favoured-nation (MFN) treatment in the preparation, adoption or application of technical standards. It also provides that public and private entities in stakeholding sectors must be able to participate in the preparation and updating of the PNC, and that the members of the SNC must ensure compliance with transparency procedures pursuant to the international agreements signed by Peru.[198]

3.133.  According to Law No. 30224, the SNC comprises CONACAL and INACAL, along with their technical and standing committees, and the public and private entities that make up the quality infrastructure. The SNC's purpose is to promote and enforce the PNC with a view to the development and competitiveness of economic activities and consumer protection.[199] The Law provides that the SNC will be governed by the principle of harmonization, i.e. its activities must be carried out on the basis of the relevant international guidelines, directives and/or recommendations, or elements thereof, where they exist, with a view to facilitating trade in goods and services. The SNC must also: harmonize sectoral quality policies, as well as those of the different levels of government; steer and coordinate standardization, accreditation, metrology and conformity assessment activities, in accordance with international standards; and promote and facilitate the adoption and certification of quality standards

3.134.  CONOCAL is a coordinating body on quality issues, attached to the Ministry of Production (PRODUCE), consisting of representatives from both the public and the private sectors.[200] Its main functions are to: (a) submit the PNC for approval by the Council of Ministers; (b) promote sectoral quality policies within the PNC framework; (c) monitor PNC implementation; (d) promote and disseminate the development of national standardization, conformity assessment, accreditation and metrology programmes and/or plans; and (e) build consensuses on quality policy.[201]

3.135.  The National Quality Institute (INACAL) is a specialized technical public body, also attached to PRODUCE, with legal status under public law; it has administrative, functional, technical, economic and financial autonomy.[202] The Institute is subject to the regulatory framework, plans and objectives approved by CONACAL. Its main general functions are to: (a) operate the National Quality System pursuant to the provisions of Law No. 30224; (b) prepare the PNC proposal and advocate for it before CONACAL; (c) manage, promote and monitor implementation of the PNC; (d) regulate and rule on standardization, accreditation and metrology issues; (e) administer and manage standardization, metrology and accreditation, with the possibility of delegating specific tasks to SNC members; (f) administer the national information service on technical standards and conformity assessment procedures, as provided for in the Agreement on Technical Barriers to Trade; and (g) represent Peru internationally and participate actively in standardization, metrology and accreditation activities, with the possibility of entering into agreements

3.136.  The legal framework regulating the standardization process in Peru consists of both national legislation and international and supranational regulations (Table 3.10)

3.137.  Standardization activities are the exclusive responsibility of INACAL, in its capacity as governing body, and of the SNC. INACAL is a full member of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC); it also participates in the CODEX Alimentarius. At the regional level, INACAL is a member of the Pan American Standards Commission (COPANT), the Pacific Area Standards Congress (PASC) and the Andean Community (CAN). It also participates in the Sub-Committee on Standards and Conformance (SCSC) in the framework of Asia-Pacific Economic Cooperation (APEC). INACAL's Directorate of Standardization is responsible for standardization activities at the national level, supported by its Standing Committee on Standardization. The Directorate's main function is to promote the development and approval of Peruvian technical standards (NTPs) for all economic sectors. It enjoys technical and functional autonomy, and it adheres to the provisions of the WTO Agreement on Technical Barriers to Trade and international agreements on standardization

3.138.  The Directorate of Standardization has a Standing Committee on Standardization that sets up technical standardization committees (CTNs) tasked with executing the Standardization Programme that results in the preparation of NTPs. The CTNs may be subdivided into technical standardization subcommittees (SCs). [203] The Directorate directs the NTP standardization process, puts standards forward for approval, and manages and coordinates the regional and international harmonization process. It also prepares standardization programmes and updates them on a regular basis, taking into account demands from both the public and the private sectors. It also administers the national enquiry point for technical standards under the Agreement on Technical Barriers to Trade, and issues technical opinions on technical barriers to trade insofar as they relate to technical standardization activities

3.139.  NTPs are the main focus of standardization activities. The process of developing standards within the CTNs or of adopting those standards takes into account the level of protection, the state of the art in the country and the corresponding geographical and climatic conditions. The adoption of standards that could raise those applied by a particular economic agent to the level of a national benchmark is avoided. NTPs are reviewed every five years. Supervised by the Directorate, each CTN prepares work programmes, NTP projects, guidelines and texts related to standardization activities in its sphere of activity, and is also responsible for the revision of NTPs, guidelines and texts on standardization activities that have been in existence for five years or more

3.140.  The standardization process involves the preparation of a technical document known as a "draft technical standard", which recommends that the preparation or revision of an NTP be included in the technical committee's work programme. The draft NTP is also submitted for stakeholder review. This process is announced in the Official Journal El Peruano. A deadline for submitting comments on the draft NTP is set at 60 days from its publication date, after which 30 days are provided for comments to be considered. The NTP must be approved through a resolution published in "El Peruano". The content of NTPs can relate to the following: terminology and definitions; classification; requirements; test methods; sampling and inspection; packaging; labelling; and good practices and management systems. These items are not mutually exclusive, and some NTPs may naturally correspond to more than one category.[204]

3.141.  As at April 2019, INACAL had 157 technical committees. There were also 4,912 NTPs, guidelines and texts on standardization activities[205], of which 1,147 were identical to international standards. Of these, 242 were technical regulations (RTs) and became mandatory as part of an RT.[206]

3.142.  At the CAN level, technical standardization takes place within the framework of the Andean Standardization Network (RAN), the regulations and operating guidelines for which are contained in Resolution 1685. Priority sectors include food, textiles and clothing, leather articles and footwear, and wood and furniture. Technical standards are harmonized at the Community level through the RAN, pursuant to the recommendations of the Code of Good Practice for the Preparation, Adoption and Application of Standards in Annex 3 of the Agreement on Technical Barriers to Trade. Although Andean technical standards (NTAs) are voluntary, they are the main reference both in intra‑community trade and in trade with third countries. Technical standards are harmonized in the Andean technical standardization committees

3.143.  The list of approved NTAs is published periodically by the CAN General Secretariat in the Official Gazette of the Cartagena Agreement. In April 2019, there were 143 NTAs in force.[207] The Andean Standardization Plan (PAN) is prepared on the basis of the member countries' trade policy, and is approved by the members of the RAN and ratified by the Andean Quality Committee (CAC)

3.144.  Mandatory technical regulations (RTs) are drafted by the various central Government ministries in their respective areas of competency. Although there is no general template, ministries should draw on available scientific and technical evidence when preparing draft RTs. In addition, ministries preparing RTs are required to comply with Andean Decision 827, which contains guidelines for the development, adoption and implementation of RTs and conformity assessment procedures, both in CAN member countries and at the Community level. According to Supreme Decree No. 149‑2005-EF, draft RTs must be published in the Official Journal El Peruano or on the websites of the ministries in question, allowing at least 90 calendar days for comments to be received from any interested party. The ministries that prepare RTs must also send them to MINCETUR, which notifies the WTO and CAN, allowing at least 60 days for comments to be received. At least six months must elapse between the publication of the final RT and its entry into force.[208] RTs must be approved by Supreme Decree and countersigned by the MEF, which ensures that the draft RT does not include measures that unnecessarily hinder trade, whether domestic or external. When an RT is approved that is based on, or otherwise refers to, an NTP, INACAL publishes the standard on its website under the heading "List of Technical Standards cited in Mandatory Regulations", indicating the number of the NTP and the RT that makes it mandatory.[209]

3.145.  Peru's legislation also allows for emergency RTs to be issued, and these must be notified within three working days after their publication or entry into effect. They may be adopted without observing the deadline for comments and are issued only when national safety, health or environmental protection issues arise or are likely to do so. Emergency RTs are valid for one year and can be renewed for up to six months. The legislation provides that, if it is in the national interest and if circumstances so warrant, the emergency RT may be converted into a regular one before it expires, after having undergone the approval procedure required of any RT. Only two emergency RTs were issued during the review period

3.146.  In order to confirm compliance with an RT, the products covered by it must be certified by specialized public or private institutions designated by the ministries responsible for the RT in question. The importer and the domestic manufacturer of goods regulated by an RT must apply to the competent ministries for a "Statement of Compliance", which is valid for one year and renewable for further one-year periods. Importers may use this statement for all customs clearance procedures and it must be submitted to the National Supervisory Authority for Customs and Tax Administration (SUNAT) before the goods are absorbed into the domestic economy.[210]

3.147.  Between 2013 and 2018, Peru, through MINCETUR, submitted 64 draft RTs, two addenda to draft RTs, two emergency RTs and eight final RTs. Between January and April 2019, five new notifications were made concerning draft RTs. The products affected by all of these measures are mostly pharmaceuticals, medical devices, health-care products and food and beverages.[211] As at February 2019, there were 128 RTs in force, of which 29 were issued by the Ministry of Agriculture and Irrigation, ten by the Ministry of the Environment, 15 by the Ministry of Energy and Mining, 2 by the Ministry of the Interior, 24 by the Ministry of Health, 14 by the Ministry of Transport and Communications, 15 by PRODUCE, 1 by MINCETUR and 18 by INACAL (metrological standards). Of these, 32 were approved during the period under review (2013-19), 8 of which being the same as international standards and the remainder based on them

3.148.  Peru has notified that MINCETUR is the body designated to serve as the national enquiry point for mandatory technical regulations and conformity assessment procedures, and that INACAL will serve as the national enquiry point for voluntary standards and conformity assessment procedures.[212]

3.149.  Between 2013 and 2018, WTO Members raised three specific trade concerns regarding Peruvian technical regulations in relation to the following: the Act to Promote Healthy Eating among Children and Adolescents (Argentina; Brazil; Canada; Colombia; Costa Rica; Guatemala; the United States; Mexico; Switzerland; and the European Union); the Implementing Regulations of 14 November 2012 for Moratorium on Planting Genetically Engineered Crops (Mexico and the United States); and the Draft Supreme Decree Approving the Regulations Governing the Labelling of Genetically Modified Foods.[213] For its part, Peru raised three concerns, relating to Ecuador's food labelling, a draft reform of Chile's food regulations and a resolution establishing a new regulatory framework for conformity assessment in Ecuador

3.150.  At the Andean Community level, RTs are harmonized through the Andean system of standardization, accreditation, testing, certification, technical regulations and metrology, mainly through the Andean Technical Regulation Plan. RTs are prepared at the national level or, for some products, at the Andean regional level (Andean Technical Regulations). These exist in the areas of cosmetics and domestic and personal hygiene products. In addition, Andean Technical Regulations are being developed on the labelling of clothing and of footwear and leather articles. Decision 827 contains guidelines on the preparation, adoption and application of RTs and conformity assessment procedures in CAN member countries and at the Community level, to prevent them from becoming unnecessary technical barriers to intra-community trade. The Notification and Technical Regulation Information System (SIRT), established by Decision 615, gathers notifications concerning members' RTs. This system provides a free service to inform subscriber users about the draft RTs pertaining to the sector or sectors in which they have an interest. [214]

3.151.  INACAL is responsible for the accreditation of conformity assessment bodies (CABs) in Peru, with its Directorate of Accreditation administering accreditation policy and management. The Directorate enjoys technical and functional autonomy and operates at the national level. INACAL accredits the following CABs subject to compliance with their corresponding ISO/IEC International Technical Standards, which have been adopted as Andean Technical Standards: (a) testing laboratories (NTP‑ISO/IEC 17025); (b) calibration laboratories (NTP-ISO/IEC 17025); (c) clinical laboratories (NTP/ISO 15189); (d) product certification bodies (ISO/IEC 17065); (e) management system certification bodies (NTP-ISO/IEC 17021); (f) certification bodies for persons (NTP‑ISO/IEC 17024); and (g) inspection bodies (NTP-ISO/IEC 17020)

3.152.  After an application for accreditation has been submitted to INACAL, the latter conducts a documentary review and an onsite evaluation of the CAB to be accredited. If non-conformities are identified, they must be corrected. The evaluation report is then forwarded to the Standing Committee on Accreditation for consideration, which, if no other non-conformities are detected, grants accreditation for a three-year period, which may be renewed for four years upon request. Once accreditation has been granted, INACAL evaluates the CAB periodically to verify that the conditions for accreditation are maintained

3.153.  Laboratories or inspection bodies seeking INACAL accreditation must demonstrate technical competency in carrying out testing, calibrations and inspections. Laboratories applying for accreditation for the first time must submit records of their satisfactory participation in at least one "proficiency trial" in each discipline. The report on this participation must not have been issued more than two years before the application for accreditation is made. In the case of follow-up evaluations, at least one participation is required in each sub-discipline within the scope of the accreditation of the laboratory or inspection body in question, over a two-year period. [215]

3.154.  INACAL's Directorate of Accreditation is recognized by two international organizations and a regional one. INACAL has a multilateral recognition agreement with the Inter-American Accreditation Cooperation, which relates to the following: testing laboratories (ISO/IEC 17025); calibration laboratories (ISO/IEC 17025); inspection bodies (ISO/IEC 17020); product certification (ISO/IEC 17065); and certification of quality management systems (ISO/IEC 17021). The multilateral recognition agreement with the International Accreditation Forum covers product certification and quality management systems. The mutual recognition arrangement with the International Laboratory Accreditation Cooperation concerns testing and calibration laboratories and inspection bodies

3.155.  Conformity assessment in Peru is performed by CABs accredited by INACAL, by an accreditation body that has signed a recognition agreement with any of the accredited national institutions, or else by CABs authorized or recognized by the corresponding regulatory authority. For instance, in the case of PRODUCE RTs, conformity is assessed by the CABs authorized by this sector, but certificates from CABs accredited by the national authority of the certifying country are also accepted. Depending on the level of risk associated with the products in question, the regulatory authority may conduct border checks of compliance with the RTs. As at July 2019, Peru had the following conformity assessment bodies: 106 testing laboratories; 2 clinical laboratories; 33 calibration laboratories; 9 product certification bodies; 4 management system accreditation bodies; and 58 inspection bodies. [216]

3.156.  At the Andean Community level, accreditation is performed in the framework of the Andean Network of National Accreditation Bodies, which accredit applicants after evaluating their technical competency to carry out specific conformity assessment activities. There is also an agreement on the recognition of certificates of conformity for regulated products in CAN member countries (Decision 506). The activities of the Andean Network are regulated by JUNAC Resolution 502. Resolution 1885 harmonized the regional requirements to be satisfied by evaluators and technical experts in testing and calibration laboratories that perform accreditation activities under ISO/IEC 17025. Pursuant to Decision 506, since June 2001, CAN member countries have been automatically recognizing and accepting the Certificates of Product Conformity with the Technical Regulations or with the Mandatory Technical Standard of the destination country, issued by the accredited or recognized certification bodies included in a register administered for this purpose by the CAN General Secretariat

3.157.  The INACAL Directorate of Metrology is the technically and functionally autonomous national authority tasked with administering metrology policy and management. The Directorate has custody of and maintains national measurement standards, and provides calibration and verification services, while respecting the subsidiary role of the State. In the field of legal metrology, it evaluates and recognizes authorized bodies called Metrological Verification Units (UVMs), which are tasked with verifying instruments subject to metrological control, such as water, gas and electricity meters; scales; clinical thermometers; and sphygmomanometers. In addition, the Directorate of Metrology prepares Peruvian Metrological Standards (NMPs) on the measurement instruments used in commercial transactions and in the fields of health and safety. These standards usually become RTs and are enforceable through the metrological controls that are established. INACAL is a member of the Inter-American Metrology System (SIM) and the International Organization of Legal Metrology (OIML). It is also an associate member of the General Conference on Weights and Measures (CGPM) and a signatory of the Mutual Recognition Arrangement of the International Committee of Weights and Measures (CIPM MRA)

3.158.  At the Andean Community level, the general objectives of the Andean Metrology Network (RAM) are to harmonize national metrology systems to make member countries' standards and calibration systems traceable at the Andean level. Decision 817 of 2017 establishes special customs treatment for measurement standards and instruments, reference materials and proficiency testing items, to facilitate the entry and circulation of these materials in CAN member countries