3.111.  The regulatory framework concerning sanitary and phytosanitary (SPS) measures remained broadly unchanged during the review period. The main pieces of legislation remain the Food and Drug Act; the Food, Drugs and Related Products (Registration, etc.) Act; the Animal Disease (Control) Act; and the Agriculture (Control of Importation) Act

3.112.  NAFDAC is the competent authority for food safety. Under the Federal Ministry of Agriculture and Food Security, the Department of Veterinary and Pest Control Services (DVPCS) is the competent authority for animal health and the fisheries department for fish and fisheries products. The Nigeria Agricultural Quarantine Service (NAQS) is the competent authority for plant health. These four institutions are also the relevant national enquiry points. The FMITI is the SPS notification authority, and Nigeria submitted 14 SPS notifications (including 1 correction and 1 addendum) between January 2017 and August 2024, all but one of them in May 2018. Nigeria is a member of the World Organisation for Animal Health (WOAH, formerly OIE) and Codex Alimentarius, and is a contracting party to the IPPC

3.113.  NAFDAC regulates food, drugs, cosmetics, medical devices, bottled water, and chemicals and detergents (the "regulated products"). It controls the manufacturing, distribution (including advertisement), sale, and use (e.g. of medical devices) of these products as well as their import or export (including large quantities for personal use).[266] NAFDAC provides access to relevant regulations on its website.[267]

3.114.  Regulated products need to be registered with NAFDAC prior to being manufactured and being put on the market, imported, or exported in a complex process, with registration certificates valid for five years.[268] This process includes additional NAFDAC approval for the production or importation (an import licence) of a sample prior to registration, and has been reported in the past to be burdensome and discriminate against foreign producers.[269] A webtool allows users to identify relevant permits and documents that need to be attached to an import consignment.[270] NAFDAC maintains publicly accessible lists of all registered products – one for drugs and one for all other products

3.115.  Since 2016, product registration can be done online on the NAPAMS portal, and its use has been mandatory since 2023. All previously registered products with physical NAFDAC certificates were required to use the system at the time of certificate renewal, but were also able to "digitize" existing certificates earlier.Error! Hyperlink reference not valid. Registration includes uploading documents such as company registration, the trademark registration, packaging information to be displayed, and product certificates or the NAFDAC certificate in case of renewal. The NAFDAC website provides detailed information including guidelines and an e-application user manual, and also indicates that the registration of food products should not take more than 90 days from submission (120 days for drugs).[271]

3.116.  In addition, a company registering a product needs to book an appointment for the inspection of production premises to confirm compliance with good manufacturing practices (GMP) and send relevant documentation electronically or in hard copy to NAFDAC. According to the authorities, product samples are taken during inspection

3.117.  The complex process to register imported products includes the submission of a notarized contract manufacturing agreement, a notarized certificate of manufacture and free sale (a confirmation that the company is authorized to produce such goods), a laboratory certificate of analysis (for a specific batch number), the good's trademark registration in Nigeria, the "label or artwork" for the product, and an invitation from the manufacturer to inspect its premises regarding GMP.[272] Notarizations can only be completed by a notary from the Nigerian Bar Association. Once the product is generally approved, NAFDAC issues an import licence for the product sample to undergo laboratory analysis for conformity with requirements, inspects the manufacturing premises in the exporting country for GMP, and issues the registration document when all requirements are satisfied. Each NAFDAC registration certificate for imported products is valid for five years. Since 2019, NAFDAC registration certificates have been only provisional until inspection of the first two import consignments.[273] Fees for the registration of products are significantly higher for imported products due to the higher costs resulting from the inspection of production premises abroad.[274]

3.118.  For imports from China and India, a particular system is in place. In each, NAFDAC has approved four Pre-Shipment Inspection and Testing Agents to coordinate document verification, inspection, and product analysis activities for NAFDAC with samples tested by the agents in NAFDAC-approved laboratories there. Following the issue of a Clean Report of Inspection and Analysis, the registration process continues as for exporters from other Members.[275]

3.119.  For narcotics and similar controlled substances, NAFDAC also issues additional import licences. It also issues health certificates for the export of packaged and semi-processed meat products. Exports of NAFDAC-regulated products also need to demonstrate conformity with requirements both in Nigeria and the export destination. According to the authorities, requirements in the importing market are used in case of incompatibility between them and Nigerian requirements

3.120.  The import of animals and animal products requires an import permit from the DVPCS for each shipment.[276] To obtain an import permit, a shipment requires a veterinary certificate issued in the exporting country. As indicated in the previous Review, the authorities maintain that requirements are based on international standards of the WOAH. At the border, the NAQS inspects shipments of animals and animal products, verifies veterinary certificates, and enforces quarantine requirements.[277] The DVPCS undertakes domestic surveillance for animal diseases and for exports issues mandatory international veterinary certificates

3.121.  The import of beef, pork, mutton, and chicken meat remains on the import prohibition list but, as with other such goods, a waiver can be granted (Section 3.1.5). During the review period, Nigeria's import restrictions on meat, pork, poultry, milk and dairy products, genetic material, and live cattle were the subject of a specific trade concern at the WTO.[278] The review of these restrictions was highlighted at the time of the previous Review but did not lead to any changes, according to the authorities

3.122.  Imports of fish are subject to an import permit issued by the NAQS and can only be done by limited liability companies.[279] The NAQS inspects shipments of aquatic resources at the border, verifies SPS certificates, and enforces quarantine requirements. The NAQS also issues health certificates for the export of fish and fishery products

3.123.  The import of all plant materials (including for consumption) is subject to import permits issued by the NAQS after a risk analysis, as well as a phytosanitary certificate issued in the country of export.[280] The NAQS reviews documentation of shipments at the border, while it inspects all shipments (using sampling or full inspection) either at the border or at the premises of the importer in case of a sealed container, before the shipment is released. Where required, shipments are moved to quarantine at the importer's expense until final release, disposal, or re-shipment. The NAQS also plays a role in ensuring that plant exports meet IPPC requirements and inspects all exports. The Federal Produce Inspection Service also intervenes in the import and exports of agricultural produce

3.124.  According to the National Biosafety Management Agency (NBMA) Act, 2015, the NBMA regulates the use of genetically modified organisms in Nigeria and approves their use. As at June 2024, three cotton, cow-pea, and maize GMOs had been approved for cultivation. The use of GMO grains for food, feed, and processing is also regulated, while GMOs in consumer and food products must be indicated on the label.[281]

3.100.  All products subject to an NIS and made in Nigeria must obtain MANCAP certification before being put on the market or exported. The authorities indicate that if a foreign technical regulation is incompatible with an NIS, that foreign technical regulation would be assessed for exports. A division under the Product Certification Directorate at SON is tasked with issuing such certificates, which are valid for three years and must be attached to the final products, following testing and evaluation.[260] Tests have to be undertaken at the SON laboratory, which in 2021 was ISO 17025 accredited for some additional food-related test parameters such as iodine and vitamin A. It was already previously accredited for parameters such as those for moisture, heavy metals, and microbiological tests, and the authorities indicated their confidence in the accuracy of other tests. However, producers are not allowed to submit test results from other accredited laboratories. Following certification, surveillance inspections can be carried out to confirm continued compliance

3.101.  Importers of products subject to an NIS or an adopted ISO, IEC, or harmonized ECOWAS standard must provide a "product certificate" to submit "e-form M" via the authorized dealer bank prior to importation (Section 3.1), as well as a SONCAP certificate at the time of customs clearance. The related conformity assessment process was raised as a specific trade concern in the TBT Committee twice in 2021.[261] To obtain a product certificate, a sample must be tested at the country of origin prior to exportation by one of six authorized conformity assessment bodies (CABs).[262] To obtain a SONCAP certificate, the CABs have to confirm conformity of an individual shipment with the test result of the sample and seal the consignment before issuing the SONCAP certificate, which includes relevant shipment information. Under the SONCAP scheme, the six CABs can use test results from an ISO 17025 International Accreditation Forum (IAF)-accredited laboratory

3.102.  As a result, a SONCAP certificate is valid for one shipment only. Administrative fees to be applied by the six CABs are set by the National Agency for Food and Drug Administration and Control (NAFDAC) at between USD 500 and USD 2,000 for the product certificate (depending on its validity) and USD 350 for the issuance of a SONCAP certificate. SON can also issue SONCAP import permits to "bona fide" manufacturers for the importation of raw materials and manufacturing equipment, allowing such regulated products to undergo conformity assessment in Nigeria. Between 2020 and 2023, SON issued around 17,000 such import permits each year, according to the authorities

3.103.  In addition to product conformity with adopted standards in Nigeria, all imported products have to be registered with SON at a cost in a separate process. Once registered, SON issues a product registration logo to be affixed to the product prior to marketing

3.104.  SON also operates a market surveillance system that includes (announced and unannounced) inspections at production premises in Nigeria, market surveys, responses to complaints received, and inspections at ports. No data were available regarding the number of instances that SON found non-compliant domestically produced goods or imported goods subject to NISs that were on the market. SON indicated that it was planning to address this data gap. On average, it initiated 10 to 15 investigations per year. The Federal Competition and Consumer Protection Commission (FCCPC) also undertakes market surveillance, can test products for conformity with NISs, and order their withdrawal from the market.[263] Information provided to the Secretariat did not clarify how SON and FCCPC collaborate in this regard

3.105.  SON also manages a number of voluntary quality schemes. These include an NIS mark of quality (for "excellent product performance" and consistently meeting NISs), a Nigerian Quality Award Scheme for products meeting certain criteria agreed between the producer and the SON Governing Council, or product type certification of exports that can include certificates of conformity with commercial contracts

3.106.  As spelled out in the NQP, the Nigerian National Accreditation System (NiNAS) set up in 2019 is Nigeria's sole national accreditation body. NiNAS is a full Member of the African Accreditation Cooperation (AFRAC) and an associate member of the International Laboratory Accreditation Cooperation (ILAC).[264] To participate in the AFRAC MRA, a peer evaluation took place in June 2024 with results expected later this year. As at June 2024, there were 26 active testing laboratories, 3 active medical testing laboratories, 6 active calibration laboratories, 2 active inspection bodies, and 6 management and personal certification bodies accredited by NiNAS.[265] Other laboratories, such as the SON laboratory, might instead be accredited by foreign certification bodies. There are no NiNAS-accredited product certification bodies yet

3.107.  The National Metrology Institute under SON is in charge of scientific and industrial metrology in Nigeria. It is a member of the ECOWAS accreditation body and the intra-African metrology system (AFRIMETS), and according to the authorities ISO 17025-accreditation is ongoing. The department of weights and measures under the FMITI undertakes market surveillance regarding legal metrology

3.108.  SON is a member of ISO and the IEC and maintains a number of association agreements

3.109.  All products marketed need to be labelled in English, using metric units and containing information regarding the country of origin, date of manufacture, batch number, and relevant NIS standards. The Pre-Packaged Food (Labelling) Regulations, 2022 replaced two earlier regulations, while labelling requirements for pharmaceuticals are spelled out in NAFDAC's Drug and Related Product Labelling Regulations, 2021

3.110.  There are no regulations concerning the marketing of organic foods

3.95.  During the review period, the regulatory framework concerning standards and technical regulations remained largely unchanged, with the Standards Organization of Nigeria Act, 2015 the main piece of legislation.[256] The authorities indicate that the Act is being amended. The National Quality Policy (NQP) under preparation at the time of the previous Review was adopted in 2021. It aims to strengthen the national accreditation and metrology systems and better define the roles of various institutions in developing standards and in administering technical regulations.[257]

3.96.  While Nigeria's regulatory framework legally distinguishes between standards and technical regulations, effectively all national standards are mandatory as a result of two certification schemes (see below). Together with the complex and costly conformity assessment procedures, the framework discourages imports and market entry

3.97.  The national standards body remains the Standards Organization of Nigeria (SON), which is also the enquiry point for TBT issues. SON is an organization under the general supervision of the FMITI and funded by its own funds (fees and penalties), aid, and federal budget allocations. It is governed by the Nigerian Standards Council (NSC), which includes a chairperson, the Director General, and representatives of several federal ministries and industry associations, all of which are appointed by the President upon recommendation by the Minister of Industry, Trade and Investment. The FMITI is the national notification authority. During the review period, Nigeria submitted to the WTO only 4 TBT notifications in 2018 (relating to chicken and tea) and another 10 in 2020 (relating to vehicles). Nigeria has not submitted any updates to its 1996 notification regarding the administration and implementation of the TBT Agreement

3.98.  Nigerian Industrial Standards (NISs) are developed in standing technical committees, mandated to have broad participation from regulators, consumers, researchers, experts, and the private sector.[258] However, there seems to be room for broader participation as one of the NQP's specific objectives is to improve stakeholder participation in standard development. Once developed, standards are adopted by the NSC and published online in the SON library.[259] As a result of the two certification schemes, all NISs are effectively technical regulations, i.e. they are mandatory for concerned products. Between 2017 and June 2024, around 280 new NISs were adopted. According to the authorities, in mid-2024, there were 1,929 NISs in place, including 908 original NISs and 869 NISs adopted from the ISO and the IEC

3.99.  Goods covered by NISs and being put on the market have to prove conformity with the relevant NIS. Domestically produced goods are subject to the Mandatory Conformity Assessment Programme (MANCAP), while imported products must prove conformity at the time of import under the SON Conformity Assessment Programme (SONCAP)