3.131.  Procedures for preparing sanitary and phytosanitary (SPS) measures are stipulated in the 2020 LIC, which repealed the 1992 Federal Law on Metrology and Standardization, as well as specific laws on the subject. Some of these laws were amended during the review period, for example, the Federal Law on Plant Health, the Federal Law on Animal Health and the Law on Health. However, as in the case of the LIC[266], some of the regulations necessary for the implementation of the amendments have not been updated (Table 3.19). The regulatory authorities publish lists of the products subject to animal health requirements, as well as the different requirements, on their websites. The legal basis for these lists are Decisions ("modules"), which are modified to take into account changes in the plant and animal health situation

3.132.  The bodies responsible for drafting and implementing SPS measures remain the same as in 2017 (Table 3.20). The Directorate‑General of Standards of the SE is the national enquiry point designated by Mexico in the framework of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).[267] The national agricultural health, safety and quality policy seeks to maintain and improve agri‑food health and safety conditions, through surveillance systems to reduce the risk of pests being introduced, epidemics and contamination, by controlling and eradicating existing ones, and by adopting good practices in the production and primary processing of products

3.133.  In Mexico, SPS measures are established by means of a NOM. The procedure for preparing NOMs on plant and animal health, fisheries, biosafety and agri‑food safety matters is the same as that used for other NOMs. The objective of these is to prevent, control and combat pests and diseases that affect plant, animal, aquaculture and fishery species. Each unit prepares the preliminary drafts; and the respective subcommittees (which comprise the National Advisory Committee on Agri‑food Standardization (CCNNA) of SADER or the National Advisory Committee on Environmental and Natural Resource Standardization (COMANART) of SERMANAT) carry out the relevant reviews and amendments, respond to comments and approve draft NOMs and, if it is deemed necessary, submit them for consideration to the CCNNA or COMANART. Interested parties may also submit proposals for preliminary drafts of NOMs. In these cases, the CCNNA carries out the appropriate evaluation and submits the preliminary draft for consideration to the subcommittee. The NOMs are reviewed every five years or earlier, in order to update them in line with scientific and technological developments and animal health campaigns. In urgent cases, an emergency NOM can be prepared directly without the need for a preliminary draft or a draft. Emergency NOMs are valid for six months and may be renewed for a further six months

3.134.  According to the authorities, plant and animal health requirements are based on scientific principles and/or international recommendations[268] and, as appropriate, on a risk analysis based on the phytosanitary and/or animal health situation in the geographical areas concerned, as well as of adjoining areas and areas with which there are trade flows

3.135.  In Mexico, phytosanitary, animal health and aquacultural health requirements for imports are published in Decisions and/or NOMs, through the Phytosanitary Requirements Module, the Animal Health Requirements Module and the Aquacultural Health Requirements Module.[269] The requirements for the import of phytosanitary, animal health and aquaculture and fishery goods are available online under the three aforementioned SENASICA Modules.[270] These Modules consist of a catalogue of documents, called phytosanitary, animal health and aquaculture and fisheries requirement sheets, drawn up to prevent the entry of animal, plant and aquaculture and fishery diseases and pests into Mexico.[271] In the event of a plant or animal health emergency that poses a risk to plant or animal health in the country, SENASICA updates or modifies the risk mitigation measures under the relevant Module, which enter into force immediately. In addition, in the event of an animal health emergency, the National Animal Health Emergency Mechanism (DINESA), which tackles diseases and coordinates those involved in order to avoid further damage to livestock and, as the case may be, to public health.[272] Goods subject to phytosanitary or animal health requirements must also come from authorized countries that have sanitary services recognized by SADER.[273]

3.136.  In 2021, Mexico had 74 NOMs relating to animal and plant health in force, 29 of which concerned animal health and aquaculture, 32 plant health, 9 agri‑food safety and 4 forest health.[274] Between 2017 and 2021, Mexico notified 91 (regular) SPS measures to the WTO, of which none were urgent. Products included rice and various fresh fruits, grains, plants and seeds. Mexico also notified amendments to 64 SPS measures that had already been notified. In the same period, six specific trade concerns on measures adopted by Mexico, affecting imports of chilies, shrimps, pork products/swine meat (two instances), hibiscus flowers and casein products were submitted to the SPS Committee.[275]

3.137.  At the point of entry into the country, before customs clearance, importers of agricultural, vegetable, aquaculture and fishery products must demonstrate to the DGIF of SENASICA, or in the case of forestry products the Federal Environmental Protection Agency (PROFEPA) SERMANAT, that the imported goods comply with the requirements indicated under the corresponding Modules.[276] Where import requirements for products of animal or plant origin are not specified in the Modules on animal health or plant health import requirements, or in the case of aquaculture or fishery goods, are not specified in a NOM or in a Decision, SENASICA must be contacted, or, in the case of forestry products, SEMARNAT.[277] To verify compliance with the requirements, a documentary inspection (through the VUCEM) and physical inspection are carried out. Despite the fact that the document review is digital, importers must submit the original documents when the physical inspection is carried out.[278] If the requirements are met, the competent authority issues the relevant verification certificate or record. The interested party may request that this be sent electronically (Table 3.21). In the event of a pest or disease that threatens the health of plants, animals or aquaculture and fishery species, import sanitary certificates may be rescinded and the necessary safety measures will be taken

3.138.  For products that do not require a prior import permit, a sanitary certificate issued by the competent authority in the country of origin must be submitted and the Ministry of Health (SSA) must be notified of the entry and destination of the goods

3.139.  Most goods subject to sanitary regulations also require non‑automatic import licences (prior permits) (Section 3.1.6). Thus, compliance with the phytosanitary and animal health requirements does not exempt the importer from the obligation to obtain the permits required by other Ministries

3.140.  The Interministerial Commission on Biosafety and Genetically Modified Organisms (CIBIOGEM) is responsible for establishing policies on biotechnology safety and the safe use of GMOs.[279] These activities are regulated by the Law on Biosafety of GMOs and its implementing regulations. The importation of GMOs for experimental release into the environment, for pilot programmes or for commercial use, requires a permit issued by SADER and SEMARNAT, after a risk analysis has been conducted (Article 66 of the Law on Biosafety of GMOs). Subsequent imports do not require new permits, provided they concern the same GMO and the same area of release into the environment (Article 58 of the Law on Biosafety of GMOs)

3.141.  The marketing, importing and processing of GMOs intended for human use or consumption require authorization from COFEPRIS of the SSA. This Commission carries out a risk assessment, in accordance with scientific protocols, to determine the safety of GMOs and their products for human consumption. GMOs or products containing GMOs, which are intended for direct human consumption, must bear an explicit reference to GMOs and the label must include their food composition or nutritional properties, where these differ significantly from conventional products. SADER issues NOMs specifying labelling for seeds or other material intended for sowing, cultivation and agricultural production, containing GMOs (Article 101 of the Law on Biosafety of Genetically Modified Organisms)

3.142.  In order to ensure safety in food production processes, Mexico uses NOMs and NMXs that refer to various tools, such as the Hazard Analysis and Critical Control Points (HACCP) system, which specify the minimum requirements for good hygiene practices that must be observed in the production process for foods, beverages or food supplements and their raw materials in order to avoid contamination throughout the process

3.114.  The Federal Law on Metrology and Standardization (LFMN)[247] regulated the national quality system until mid‑2020, when it was repealed and replaced by the Law on Quality Infrastructure (LIC).[248] The drafting of the regulations implementing the LIC has not yet been finalized; therefore the LFMN regulations[249] continue to be used, unless they conflict with the LIC. The purpose of this Law is to set and develop the basis for industrial policy within the National Quality Infrastructure System, through standardization, harmonization, accreditation, conformity assessment and metrology activities, to promote quality in the production of goods and services, with a view to expanding productive capacity, achieving continuous improvement in value chains, promoting international trade and protecting legitimate public interest objectives.[250] In addition to the LIC and the Guide to the structuring and drafting of Standards, there are other laws that also influence standardization procedures.[251]

3.115.  The National Commission for Quality Infrastructure (CNIC) (formerly National Standardization Commission) and the Directorate‑General of Standards (DGN) of the Ministry of the Economy (SE) are responsible for applying the LIC. The SE remains the contact point for the TBT Agreement.[252]

3.116.  The CNIC manages and coordinates standardization, harmonization, conformity assessment and metrology activities; evaluates requests for the establishment of national advisory committees on standardization (responsible for preparing Mexican Official Standards (NOMs)) proposed by ministries (the standardization authorities); and, on an annual basis, reviews, analyses and approves the National Quality Infrastructure Programme (formerly the National Standardization Programme) and its Supplement.[253] In 2021, the SE took over as the permanent chair of the CNIC

3.117.  Mexico issues NOMs (technical regulations) and Mexican Standards (NMXs) (specifications or standards). For technical regulations relating to telecommunications and broadcasting, the Federal Telecommunications Institute (IFT) issues "Technical Provisions" (Disposiciones Técnicas), which, like NOMs, are published in the Official Journal to make them binding

3.118.  There has been no change to the procedure for preparing, issuing and reviewing NOMs since the previous review. In accordance with the LIC, NOMs must be based, in whole or in part, on international standards, except where these are not appropriate or effective in achieving the desired public interest objectives (Chart 3.8). In the event of an emergency that affects the public interest, the competent Standardization Authority may issue the NOM directly and inform the CNIC. Emergency NOMs remain valid for a maximum of six months and may be renewed once for a further six months.[254]

3.119.  The SE has developed a catalogue of NOMs and NMXs in force or rescinded, as well as draft NOMs in public consultation.[255] This catalogue will be part of the new Comprehensive Technology Platform for Quality Infrastructure (PLATIICA), which is being developed by the SE to provide information to the entire National Quality Infrastructure System

3.120.  NOMs must be reviewed by the Standardization Authority within five years of their publication in the Official Journal or their latest amendment. This review must be completed within 60 days of the end of the corresponding five‑year period. The outcome of this review is notified to the CNIC Executive Secretariat. If the Standardization Authority does not review the NOM or notify the review report, the CNIC must conduct this review and could order the rescission of the NOM. In the case of the Technical Provisions, the IFT carries out the review five years after their entry into force

3.121.  Over the period 2017‑21, 212 draft NOMs were published in the Official Journal, of which 84 became NOMs and 1 was rescinded. During the same period, 174 NOMS were published in the Official Journal, of which 20 were based on international standards (16 partially and 4 fully). During 2017‑21, 455 NOMs were reviewed, 81 were amended and 6 removed.[256]

3.122.  During 2017‑21, Mexico notified the WTO Committee on Technical Barriers to Trade of 168 technical regulations relating mainly to the protection of human health and the environment, and consumer protection and information (labelling). In addition, Mexico notified the amendment of 238 previously notified technical regulations.[257] In 2017‑21, on four occasions certain Members posed questions in the TBT Committee about NOMs related to conformity assessment procedures for cheese and curd (HS 0406); measures restricting the sale of food and beverages to children; health‑related advertising; and labelling for pre‑packaged food and non‑alcoholic beverages.[258]

3.123.  NOMs are mandatory for both domestic and imported products. Importers must demonstrate, at the point of entry into the country, that the goods comply with the NOM in question. In the case of NOMs relating to marking and labelling, the importer has several options for checking compliance with NOMs upon customs clearance: (a) submit the goods with the commercial information labels required by the NOM, so that the authorities can verify that they comply with the requirements; (b) submit the goods with the labels required by the NOM and a copy of the "certificate of conformity" issued by an accredited inspection unit. In the case of NOMs issued on the basis of the IFT's Technical Regulations, the provisions of the conformity assessment procedures published in the Official Journal shall be followed, in addition to what, in particular, each of the Technical Provisions may indicate.[259] When imported products do not comply with the requirements of a NOM relating to marking and labelling, the customs authorities shall proceed to detain the goods and set a time limit for the importer to make the necessary corrections. In the event of failure to comply with product safety NOMs, the customs authorities shall proceed to the precautionary seizure of the goods, which may be transferred to the tax authorities.[260]

3.124.  In 2021, imports corresponding to 2,483 tariff lines had to comply with a NOM.[261] The NOMs applied mainly to textile articles, and machinery and mechanical appliances, followed by prepared foodstuffs, chemical products and metals (Chart 3.9). (Number of tariff lines)

3.125.  NMXs or standards are generally voluntary, although they may serve as a reference for the correct application or preparation of a NOM. The procedure for preparing NMXs or standards is very similar to that of NOMs (Chart 3.10). Both NMXs or standards and NOMs must be registered with the National Quality Infrastructure Programme or in the Supplement thereto, and must be based on international standards, except where this is not effective or appropriate. In addition, under no circumstances may NMXs or standards contain specifications, characteristics, values, parameters or requirements that are less stringent than those set out in a NOM

3.126.  NMXs or standards are developed by a national standardization body[262] or by the Standardization Authorities. Pursuant to the LIC, it is the responsibility of the Technical Standardization Committee (CTE) to analyse the draft NMX or standard; if approved, the SE is notified so that it can publish an extract on PLATIICA, and a public consultation is initiated, lasting at least 60 calendar days starting from the calendar day following its publication on the Platform. When the DGN has prepared the NMX or standard proposal, the entire draft is published on PLATIICA. Once the comments have been received, the CTE decides which ones will be included and which ones will not, and informs those who submitted comments that were not included. Once the NMX or standard has been finalized, the SE publishes it on the Platform, which is in the process of being developed.[263]

3.127.  The national standardization body issuing an NMX or standard must review it at least every five years after its publication or latest amendment. The CNIC's Executive Secretariat must be notified of the outcome of the review within 60 days of the end of the corresponding five‑year period. The SE publishes the outcome of the review on the Platform. The CNIC may order the rescission of the standard if it is not reviewed

3.128.  Conformity assessment procedures are prepared by the Standardization Authorities. In accordance with the LIC, these procedures, as with the NOMs, must be based on international standards, except where these are not appropriate or effective in achieving the public interest objectives pursued by the State, and each one that contains the conformity assessment procedure required to determine compliance must be included in the NOMs. The IFT is the authority that issues telecommunications and broadcasting conformity assessment procedures, pursuant to the Federal Telecommunications and Broadcasting Law

3.129.  Conformity assessment is generally carried out by accredited and approved conformity assessment bodies. However, in the absence of adequate infrastructure in the private sector, the Standardization Authorities can carry this out. In order to operate as an accreditation body, authorization from the SE is required, subject to a favourable opinion from the CNIC. An accreditation entity may operate in one or more areas, sectors or branches. Also, only bodies that are accredited with an accreditation entity may operate as conformity assessment bodies. Conformity assessment bodies can operate as: testing, measurement or calibration laboratories; inspection units; or certification bodies. The SE keeps a list of accreditation entities and conformity assessment bodies, which is published on PLATIICA, with the rates and prices charged (Articles 44 and 45 of the LIC). With regard to telecommunications and broadcasting conformity assessment, the IFT has the power to authorize third parties to issue conformity assessment certification, to accredit experts and verification units, and to establish and operate testing laboratories or to authorize third parties to do so. The IFT has issued various provisions on telecommunications and broadcasting conformity assessment.[264]

3.130.  In 2021, Mexico had Mutual Recognition Agreements (MRAs) mainly in the areas of electrical engineering, energy and medical devices, with entities in Belgium; Canada; Denmark; China; the Republic of Korea; Colombia; the United States; Finland; Hong Kong, China; Japan; Norway; Thailand; and the European Union.[265]