3.100.  The number of food samples taken rose during the review period from 9,633 in 2016 to 18,433 in 2023 (Table 3.17), including a significant number of samples taken from imported products. During the period under review, there was also a rise in the number of fitness for consumption and conformity certificates issued.[207] Source: Information provided by the authorities

3.101.  In 2017, Law No 2017‑048[208] was adopted to strengthen health controls on foodstuffs placed on the local market and those intended for markets overseas. It provides for a National Health Risk Assessment Agency (DNER). The agency is responsible for analysing the risks associated with food and foodstuffs produced in and imported into Madagascar. Under the legislation the agency is independent and risk assessment must be based on the available scientific evidence and conducted in an independent, objective and transparent manner. However, the legislation has little to say on how the agency should operate

3.102.  Several ministerial bodies (agriculture, trade, livestock, higher education with responsibility for nuclear science and technology, fisheries and health) have a role in the SPS food risk control chain for Madagascar's imports and exports. As Table 3.18 indicates, the plethora of actors points to a need to streamline and harmonize in order to increase trade facilitation. In that regard, the authorities indicate that the national trade facilitation committee, supported by UNCTAD, is working to implement a "Business Process Analysis" on trade facilitation that will map, analyse and issue recommendations on simplified import and export procedures at each stage with the various stakeholders. Source: Law No. 2017‑048 governing the safety of foodstuffs and animal feed

3.103.  When imported goods arrive in Madagascar, they must be accompanied by (sanitary and/or phytosanitary) certificates issued by the competent authorities in their country of origin. Before the goods arrive, the importer must inform the relevant services at the Ministry responsible for agriculture and/or livestock. If import requirements are not met, the border inspection posts may take various measures depending on the cases at hand, i.e. reject and/or destroy the goods if there is a major risk, or consign the goods to ports or airports pending completion of the required documentation, in the event of minor risk

3.104.  Border control of foodstuffs of plant origin upon arrival of consignments at border checkpoints is governed by Decree No. 2018‑592[209] and is carried out by Ministry of Agriculture and Livestock health inspectors. The control procedure remains the same: first, documents are verified, then two samples are taken for testing and analysis from each imported batch. If the outcome of the checks is satisfactory, the border control posts issue a visa or a release order and the goods proceed to a second stage of controls led by the Customs service. The importation of live animals or fish is still governed by Law No. 2006‑030 on livestock farming in Madagascar.[210]

3.105.  These procedures highlight the need to streamline and harmonize controls due to the double sampling of food or perishable goods at importation, involving several entities and departments. As at the last review, we would again point to the need for the main ports and airports to have shared infrastructure and equipment suitable for conducting sanitary and phytosanitary inspections, quality controls and certification procedures. It would also be important to establish an electronically interconnected SPS alert system with links to the various ministries involved. Currently, in the event of an SPS alert, the relevant ministries take control measures, but those measures are forwarded to Customs by internal mail rather than electronically, and this can be very time‑consuming

3.106.  The certification of the Hazard Analysis and Critical Control Points (HACCP) system has become a strategic objective for Madagascar in order for the country to better meet international requirements and improve the competitiveness of Malagasy products on global markets. Specialist businesses or bodies such as Bureau Veritas, CODAL, CERTVALUE, SGS, GCL, AFNOR, QHSE and Groupe SOCOTEC Madagascar are involved in HACCP certification in Madagascar.[211]

3.107.  Since its last review, Madagascar has benefited from EU assistance programmes aimed at strengthening and maintaining its access to the EU market. In 2017, Madagascar received support from the European Union under the "Fit for Market" programme to enhance the competitiveness and sustainability of the horticultural sector.[212] Information and training sessions were held for exporting companies and competent authorities on the need to comply with the new requirements of Regulation (EU) 2016/2031.[213]

3.108.  Following negotiations between the Malagasy Ministry of Trade and the EU, in February 2024 the EU raised the acceptable MRL of nicotine per kilo of vanilla to 0.3 mg/kg, which is favourable to Malagasy exporters.[214] In February 2023 the EU adopted a measure that temporarily introduced more stringent official controls and emergency measures on the entry of black‑eyed peas into its territory from Madagascar. This was due to a high risk of contamination from pesticide residues.[215]

3.109.  In 2021, Madagascar was a recipient under a three‑year programme (2021‑24) delivered by China that aimed to assist eight African countries to align with [its] SPS regulations in order to increase their exports of agri‑food products to China.[216] In 2018, Madagascar was the subject of STDF‑funded STDF/PPG/575 project on the implementation of standards and trade development. The purpose of the project was to enable relevant public and private sector stakeholders to prioritize SPS investments for market access in export‑oriented value chains using the STDF P‑IMA[217] framework

3.95.  Madagascar is a member of the Codex Alimentarius Commission, the World Organization for Animal Health (WOAH) and the International Plant Protection Convention (IPPC), which are standard‑setting bodies designated in the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). The SPS measures taken by Madagascar are based on the international standards developed by these three bodies. National SPS legislation has developed since the last review (Table 3.15). In 2017, Madagascar adopted a Phytosanitary Strategy Plan (PSPM) for the period 2018‑28, which is based on sector‑specific national papers, the IPPC and the Comprehensive Africa Agriculture Development Programme (CAADP) of the African Union.[203]

3.96.  Decree No. 2018‑544 of 2018 detailing the organization of the Ministry of Agriculture and Livestock provides for the Plant Protection Directorate (DPV) to be responsible for coordinating and supporting technical activities in pursuit of the Ministry's policy on phytosanitary protection. As the competent authority nationwide in sanitary and phytosanitary matters, the DPV includes: · the Plant Inspection and Quarantine Division (SIQV) · the Phytopharmacology, Pesticide and Fertilizer Control Service (SPCPE); and · the Phytosanitary, Plant Health and Pest Control Service (SPSSLR) which falls under the Directorate‑General of Agriculture at the Ministry of Agriculture and Livestock

3.97.  Over the period 2015‑24, Madagascar submitted 44 notifications of SPS measures to the Secretariat of the WTO, compared to 11 in 2015 (Table 3.16). These notifications cover measures taken in respect of control of origin, the licensing of establishments engaged in activities, the conditions for the designation of processing laboratories and maximum residue limits (MRLs) for pesticides in foodstuffs. In 2018, Madagascar notified prevention measures against highly pathogenic avian influenza rampant in countries, zones or compartments declared infected following official notifications and reports by countries of the World Organization for Animal Health (WOAH).[204] No specific SPS‑related trade concern has been reported at the WTO in connection with Madagascar. Source: National Assembly and FAO. Viewed at: https://assemblee‑nationale.mg/; and https://www.fao.org/faolex/opendata/fr/. Source: WTO, ePing. Viewed at: https://eping.wto.org/

3.98.  Following the adoption of the "ePhyto" project by the national trade facilitation committee in 2021, the phytosanitary certificates required for international trade in plants and plant products can be obtained digitally (Section 3.2.1). Consumer health protection is the responsibility of the Food Safety and Quality Monitoring Agency (ACSQDA) established in 2013 by Decree No 2013‑260 and falls under the technical and administrative supervision of the Ministry responsible for health.[205] Its activities are governed by the Public Health Code of 2011 (Law No 2011‑002 of 15 July 2011) as amended in 2022.[206]

3.99.  The ACSQDA works with a network of six food control laboratories and delivers certificates of "fitness for consumption" or conformity for every batch of locally produced or imported foodstuffs, before they are placed on the local market. However, it still does not have an official website describing its activities, nor is it referred to on the official Internet portal of the Ministry of Health

3.83.  As the last report noted, the Madagascar Standards Bureau (BNM) is the body responsible for implementing national policy on standardization and quality. Law 97‑024 of 14 August 1997 governing standards‑related and certification‑related activities in Madagascar has remained unchanged since 2015.[182] The authorities indicate that the national standardization strategy announced in 2015 is still undergoing validation. The BNM is affiliated to regional and international standard‑setting bodies.[183] Under the framework of the International Electrotechnical Commission (IEC), Madagascar established the National Electronic Committee, known as NEC Madagascar[184], in 2017; since its inception, the NEC has adopted 53 IEC Standards and in so doing attained "Affiliate Plus" status in January 2024.[185] The standardization process has not undergone any significant change since the last review and still consists of eight fundamental stages.[186]

3.84.  The BNM is the depositary and manager of the national conformity mark, the "NMG"; it also provides NMG Halal certification and conformity assessment for other marks such as the "Malagasy ny Antsika" label of the Industrial Trade Union of Madagascar (SIM). BNM approval consists in certification of a product prior to marketing; the approval is a mandatory pre‑requisite for securing sales authorization or eligibility for an incentive. In 2024, 203 standards were developed in various sectors mainly in agri‑food (96), electrical and electronic equipment (56), buildings and public works (15), chemical engineering (19), transport (8), manufacturing (3), medicines and medical devices (1), tourism (1), environment (3), and testing and conformity assessment (1).[187] The authorities indicate that all the standards developed at the BNM are voluntary: making the standards obligatory is a matter for the relevant ministries. In 2024 the BNM had a list of three groups of certified products, mainly relating to flours for infant use, fortified biscuit flours and Halal foods. Approvals relate mainly to imports of solar kits and latex male condoms.[188]

3.85.  The work of drafting, revising and disseminating technical regulations (mandatory standards) and regulations on agricultural products of plant origin, as well as conducting quality control of pre‑export products, are the responsibility of the Quality and Packaging Division (SQC), a body attached to the Ministry of Industry and Trade (MICC). The SQC is responsible for the official (mandatory) inspection comprising control, labelling, packaging and wrapping of agricultural products of plant origin for export. The SQC is the competent authority with responsibility for TBT matters, and receives the notifications from the TBT Committee. Since 2015, Madagascar has not made any notifications to the WTO regarding its standardization regime or its accreditation and certification procedures

3.86.  The authorities state that most technical regulations are adopted in response to requests from operators in the relevant sector (planters or farmers, collectors, exporters and the public sector for agricultural export products). The SQC is present when the quality and packaging of certain export goods are undergoing controls but has no role in import operations. It is responsible for issuing the CCCO (Section 3.2.1), an electronic procedure performed via the MIDAC module. Six products from Madagascar are currently subject to the CCCO at export: vanilla, cloves, lychees, coffee, cocoa and cowpeas (black‑eyed peas); the CCCO is not mandatory for other agricultural products of plant origin intended for export

3.87.  The Legal Metrology Division (SML) is the body with responsibility for legal metrology in Madagascar.[189] It is a member of the International Organization of Legal Metrology (OIML) and the SADCMEL, the branch of the SADC that deals with legal metrology. The SML has undertaken to achieve two major objectives but has not laid down a precise timetable in that regard. It has undertaken to implement and maintain a quality management system that complies with ISO 17:025 and ISO 9001:2000. It provides testing and calibration for clients in conformity with international (OIML) standards. The authorities indicate that during the period 2015‑24, the SML verified 71,461 measuring instruments in Madagascar

3.88.  Madagascar, which is fairly rich in biodiversity with around 80% endemic species, has prioritized the regulation and management of compliance with environmental standards governed by a Law of 2015 containing the Malagasy environmental charter. The charter makes an environmental impact assessment (EIA) compulsory for any investment project, whether public or private, that may harm the environment.[190] The Decree on environmentally compliant investment (MECIE) lays down the rules and procedures that apply in that respect together with the role of the stakeholders involved. The National Environment Board (ONE) has responsibility for implementing the MECIE Decree and as such acts as a one‑stop shop for the process. Since 2019, draft revisions to the MECIE Decree have been initiated and are still pending.[191]

3.89.  The job of the ONE is on the one hand to categorize investment projects into projects that require either an EIA (and are subject to an environmental permit issued by the ONE) or a PREE (environmental commitment programme issued by the sectoral ministries), and on the other hand to lead the evaluation of EIA files by coordinating the ad hoc technical assessment committee with a view to delivery of the environmental permit. The total number of permits issued by the ONE since its establishment (1998‑2024) is 1,093, of which 932 relate to EIAs and 161 to compliance (MEC). Since the last review in 2015, the ONE has issued 485 permits: 32 for 2024 compared to 37 in 2023 and 86 in 2015. The sectors that received the highest numbers of permits were mining (32%), manufacturing (20%), infrastructure (7%) and biodiversity (7%).[192] The authorities indicate, without providing a list, that the marketing of certain products may sometimes be subject to prior receipt of environmental documents (environmental plan (PE) or PREE)

3.90.  As part of the Environmental Information System (SIE), ONE has set up an environmental dashboard, a tool to monitor the state of the environment and how it develops; it allows for better decision‑making at all levels and supports environmental assessment. In 2018 Madagascar adopted a decree (Decree No. 2018‑1145) prohibiting the storage, abandonment and introduction into its territory of waste, hazardous waste and hazardous substances from abroad, and regulating the export thereof.[193]

3.91.  Responsibility for regulating the medicines market in Madagascar lies with the Madagascar Medicinal Products Agency (AMM).[194] The AMM has a Medicines Quality Control Laboratory (LNCQM) that has consisted solely of a physical chemistry unit for over 15 years and has not yet received WHO pre‑qualification.[195]

3.92.  Despite its abundant biodiveristy, which includes various medicinal plants, Madagascar continues to import virtually all drugs and health products, and the sector had a trade deficit of USD 146.2 million in 2019.[196] The official AMM website indicates that around only 2,900 products were registered at end‑June 2024. One study shows that undernotification is linked to lack of awareness among professionals of pharmacovigilance and the cumbersome administrative burden it entails.[197] Before being marketed or issued, even free of charge, any drug for human use or any like product defined in the Public Health Code, whether manufactured locally or imported, must have marketing authorization, which is now delivered electronically[198] and is valid for a renewable five‑year period

3.93.  The most recent procedural handbook for drug registration in Madagascar dates back to 2016.[199] The AMM has a tariff schedule governed by Order No. 24364/2004 for the acts it promulgates.[200] To obtain market authorization, manufacturing laboratories must pay a processing fee, which for a new application for drugs from abroad is EUR 200, and for locally manufactured drugs is MGA 164,000. The processing fee for renewal applications ranges between EUR 140 and EUR 300 depending on the foreign product categories and are up to MGA 160,000 for products of domestic origin. The time taken to process new market authorizations is around four months, and for renewals or amendments it is around two months

3.94.  Import procedures still stipulate that only wholesalers are authorized to import pharmaceutical products. In 2024, 36 private wholesalers and one public procurement centre (SALAMA) were registered.[201] Order No. 26.704/2022‑MSANP requires at least 51% of the shares of private distribution entities to belong to pharmacists.[202]