3.100.  Projects under the Standards and Trade Development Facility (STDF) aim to ensure that local products better meet the international standards for food exports, as well as to improve the dissemination of information about these standards. Accordingly, in 2008 Madagascar benefited from a US$20,000 grant to aid its dried beans subsector in meeting international SPS standards

3.101.  According to the TBT Information Management System[119], Madagascar has not made any notification to the WTO regarding its standardization regime or its accreditation and certification procedures. The National Enquiry Point notified in connection with standardization was the Standardization and Regulation Division of the Standardization and Quality Directorate in the Ministry responsible for trade. However, as this unit no longer exists, it is the Quality and Packaging Division (SQC) that performs this function even though there has been no official notification to the WTO. No specific TBT‑related concerns have been raised by WTO Members in regard to Madagascar

3.102.  Law No. 97‑024 of 14 August 1997 still governs the national system of standardization and certification of goods and services.[120] Under this Law, voluntary standards may be made mandatory by decree. The Law makes no mention of imports. No Malagasy standardization body has adopted the Code of Good Practice for the Preparation, Adoption and Application of Standards.[121] The authorities have requested WTO technical assistance for setting up a TBT Committee, for training agents in TBT matters, adopting good regulatory, procedural and notification practices, and adopting the Code

3.103.  The SQC in the Ministry responsible for trade is tasked with preparing, reviewing and disseminating technical regulations (mandatory standards) governing pre‑packaged foods and agricultural products of plant origin. It may write a standard or a part of a standard into a technical regulation, depending on the needs of consumers, domestic industry and importers or exporters. This unit also acts as the Codex Alimentarius contact point. According to the SQC, regulations are drawn up by technical committees comprising all the players concerned with the product to be regulated, including representatives of consumers, manufacturers, exporters, importers or distributors. If necessary, laboratories or research bodies are brought on board. At March 2015, the only mandatory standards concerned: soaps and detergents: Interministerial Order No. 28520/2011 of 30 September 2011; the labelling of pre‑packaged foods: Order No. 1075/2012 of 24 January 2012 (adoption of the Codex standard); the labelling of fortified foods: Order No. 1075/2012 of 24 January 2012; the Malagasy standard for green coffee for marketing: Decree No. 85‑129 of 3 May 1985; the Malagasy standard on vanilla: Interministerial Order No. 4911/99 of 12 May 1999; and the technical regulation on cloves (in preparation)

3.104.  In 2013, the Ministry of Trade and Consumer Affairs consulted stakeholders with a view to updating the technical regulations pertaining to rice, maize, onions, dried beans (including Cape peas) and groundnuts. The aim was to update and harmonize the technical regulations on these products in order to stimulate trade in the Indian Ocean regional market

3.105.  The SQC is also responsible for labelling, packing and packaging. As stated above (Section 3.3.1.1), although the SQC does not undertake either registrations or inspections of imported products and importers, it is present at exportation when the quality and packaging of some export goods are being controlled (Section 3.2.2.3)

3.106.  The Madagascar Bureau of Standards (BNM) was established in 1997 and began operating in 2002 under the technical supervision of the Ministry in charge of industry. It is responsible for the overall management and coordination of standardization issues, including testing, certification and inspection, and the quality assurance of goods and services for the domestic market, and of imports and exports.[122] BNM budget receipts consist of contributions from member enterprises and corporations, loans and grants, government subsidies, and revenue from the various services provided (sales of standards, certification and product approvals). It had been planned to publish the national list of established standards on an official website in 2015. Madagascar has established voluntary standards for construction materials, road safety and urban public transport. A decree on the approval of construction materials was drawn up in 2012, and according to the authorities, this approval was to become operational in the spring of 2015

3.107.  In accordance with the agenda set by its governing board, the BNM develops a preliminary draft standard. It sets up a technical committee for consultation on the chosen criteria. The standards drawn up are either definitive or experimental. The technical committees comprise experts or specialists and representatives of various units of the ministerial departments and public institutions concerned, the private sector (different categories of operator), academic and research institutions, testing laboratories, and consumers' associations concerned by and interested in the standards to be studied. The Malagasy national standard is developed on the basis of the international principles and international standards and principles laid out in the SPS and TBT Agreements. The BNM maintains a directory of some 60 national standards mainly covering food products

3.108.  Madagascar is moving ahead with the harmonization of regional standards and the adoption of international standards (International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC) and the CODEX). These documents may serve the technical committees as source documents

3.109.  The BNM is a correspondent member of the ISO and as such does not take an active part in the technical and policy‑making work of that organization, but benefits from the outcomes of its activities. The BNM has also been affiliated with the IEC since 2005. Madagascar does not participate in the IECEE CB Scheme.[123] The establishment of the BNM National "IEC" Committee was planned for 2015

3.110.  The BNM represents Madagascar at the ISO but has never notified the ISO of its annual work programme. The BNM has announced in connection with this report that these notifications have now been given priority, with a view to improving the operation of the Bureau both nationally and internationally. However, the formulation of a national standardization policy, which has not been done since Madagascar joined the ISO, would first be decided on in the context of preparing the national standardization strategy

3.111.  Madagascar participates in the COMESA Programme on standardization, quality assurance, metrology and testing. This programme aims to harmonize standards and quality assurance programmes within COMESA

3.112.  A decree providing for the introduction of certification was published in September 2014 and in 2015 certification was being put in place by the BNM. Work was under way to identify auditors and train new ones, and product certification was to begin in 2015

3.113.  The use of the metric system is compulsory in Madagascar. The Legal Metrology Division in the Ministry of Trade and Consumer Affairs is responsible for metrology and inspection. Among its domestic activities, it randomly inspects fuel‑measuring instruments to ensure their accuracy. It also represents Madagascar at the International Organization of Legal Metrology and has stated its wish to become an associate member of the International Bureau of Weights and Measures

3.114.  Madagascar imports almost all the medicines and health products consumed in the country. Chemical substances intended for use in public health, as well as cosmetics containing therapeutic substances require a marketing authorization (AMM) issued by the National Registration Commission.[124] The Madagascar Medicinal Products Agency was created in 1998[125] and is responsible for registering, inspecting and controlling the quality of medicines and for testing and control. Its website contains the list of registered products.[126] There were some 2,600 registered products at the end of 2014. Medicines classified as "medium and low‑turnover" (only specialties included in the official publications "Vidal" (France) and "Doroz" (Switzerland)), which pharmaceutical laboratories are reluctant to register given their low import volume, may be imported but are not registered by the Agency

3.115.  Parapharmaceuticals and medical consumables do not require marketing authorization, nor do cosmetics and personal hygiene products not containing therapeutic substances. It could not be determined which body is responsible for testing and assuring the quality of the latter products before their release for consumption

3.116.  The manufacturing laboratory must file an application, the examination of which costs 200 per product for new marketing authorization applications and 140 to 300 for renewals. The application must state, inter alia, the name and address of the manufacturing laboratories holding the marketing authorization in the country of manufacture, the wholesale price excluding tax (PGHT) in foreign currency, the product distribution and supply channel recommended by the laboratory of origin and the method of distribution envisaged (pharmacy, hospital, etc.). The relevant documentation must be attached for any product prequalified by the WHO. For specialties in which the molecule is still protected by a patent, the applicant must submit a dossier to the Malagasy Industrial Property Office (OMAPI) (Section 3.3.6) and deliver to the Agency the receipt attesting to the deposit. Examination of the dossier takes an average of four months

3.117.  Under the new import procedures in place since 2010, only pharmaceutical wholesalers are authorized to import. There are 36 such companies in all of Madagascar, all of them Malagasy companies in which 51% of the shares must belong to the pharmacist in charge. The latter must be Malagasy and must hold a licence issued by the Ministry of Health authorizing them to distribute nationwide

3.118.  To register a product, foreign manufacturers wishing to sell to Madagascar generally turn to a wholesaler to obtain the marketing authorization, which is granted for a period of five years. For the purposes of testing, the Medicines Quality Control Laboratory creates a file for each product and delivers a certificate of analysis. Any batch may undergo a post‑marketing test, whether upon notification or after pharmaceutical inspection

3.119.  Medicines and health products are distributed either through the public health care system or through private pharmacies. The public health care system and private non‑profit institutions are supplied with essential generic medicines (in accordance with a national list) exclusively by the central procurement agency, SALAMA. SALAMA is the country's chief supplier of generic medicines and materials (syringes, compresses, etc.). It purchases its products by international competitive bidding under an exclusivity agreement with the State that runs until 2016.[127] The cost of medicines is not legislated; under a private agreement, wholesalers receive a profit margin of 20% of the PGHT before sale to pharmacies. The pharmacies' margin on sales to patients is 35% of the price of importation (by the SALAMA or by private wholesalers), and 40% in rural areas

3.120.  At the end of 2013 the Madagascar Medical Review reported frequent shortages of medicines.[128] Under the procedures of the Fund for Non‑Stop Supply of Essential Medicines (FANONE), basic health centres are financed entirely by means of a 3% deduction from the 35% sale price increase accorded for medicines. It is therefore the buyers of medicines at public health institutions that finance the health sector's social protection network. Users of private medical facilities (and people not purchasing medicines) therefore do not contribute to the Fund

3.121.  Sustainable natural resource management has been a stated priority of every Malagasy Government since 1999, given the need to preserve the country's exceptional terrestrial, riparian, marine and coastal biodiversity.[129]

3.122.  Environmental protection falls under the Ministry of the Environment, Ecology and Forests (MEEF). Unfortunately, a lack of resources is considerably hampering officials in attaining the goals set by the Ministry, namely: increasing the areas under protection in order to conserve and enhance the biodiversity (Section 4.4); slowing down the degradation of natural resources; developing the environmental reflex at all levels; and strengthening forestry and environmental governance

3.123.  The most acute international trade‑related problems are illegal logging and exportation, especially of rosewood and ebony wood, and illegal exports of animal products such as crocodile skins. The Government's current priorities include registering rosewood and ebony wood in CITES Appendix II, and halting illegal felling and exports. In August 2014, the Government also announced the decision by CITES to lift the moratorium imposed in 2010 on exports of crocodile products from Madagascar. The moratorium was lifted by decision of the CITES Standing Committee in 2014. Several activities have been implemented, such as the reorganization of the non‑industrial subsector; the establishment of new regulations governing the subsector; and research on crocodiles in the wild. A new strategy and a management plan are currently being laid down with the various stakeholders

3.124.  Since 2004, all investment projects requiring public works authorization have been subject to an in‑depth environmental impact study and an environmental management plan or a precise environmental commitment programme, which must be evaluated so as to ensure compatibility with the environment.[130] The National Environment Board is tasked with examining the dossiers

3.125.  Since 2007, regulations intended to protect the ozone layer have been in place for the importation, sale, resale and use of refrigerants, refrigeration equipment and halons. Customs duty was waived in 2010 on equipment for the generation of renewable energies. This was followed in 2011 by a VAT waiver for wind- and water‑powered generators. In October 2014 the Government announced a ban on the production and marketing of plastic bags effective 1 May 2015, imports of such bags being banned as of February 2015

3.78.  It was necessary in March 2015 to draw up an inventory of all standards and technical regulations in force in Madagascar, more particularly those affecting imports and exports, and to publish them officially on the Internet. This effort should be extended to all products potentially affecting human and animal health, safety, etc., such as foodstuffs, para‑pharmaceuticals, tobacco products, cosmetics, products harmful to the environment, medical equipment, etc

3.79.  Such an inventory would pave the way for the introduction, to the extent possible, of common authorization procedures for these products, and this would eliminate the current overlapping of functions mainly as regards the import and export of agrifood products. Such streamlining would boost trade without lessening the protection of domestic and foreign consumers ‑ quite the contrary

3.80.  Apart from the tests carried out by the line ministries concerned (agriculture, livestock, forestry and fisheries), all food products or perishable items (including additives and sweetening matter) are also subject to two other procedures requiring two different laboratory tests

3.81.  A review should be made of national quality control bodies (standardization, certification, inspection, testing, metrology) in order to separate regulatory power more clearly from national certification bodies or those responsible for enforcing standards, and to better circumscribe their respective roles. It is not infrequent today for mandatory standards to be promulgated by some regulatory bodies with no involvement of the Madagascar Bureau of Standards. The review of regulations would, amongst other things, enable all regulatory bodies to work hand‑in‑hand and to rely on the relevant standards when adopting technical regulations

3.82.  Besides, an effort should be made to create or strengthen internal coordination committees and other mechanisms Madagascar has no National TBT Committee (technical barriers to trade), for example in order to properly determine problems or risks associated with a given situation and decide whether government intervention is needed and the type of measure required, as appropriate

3.83.  There is no national accreditation body and no Malagasy entity is currently a member of the International Laboratory Accreditation Cooperation (ILAC).[110] Madagascar nonetheless cooperates with foreign accreditation bodies, in particular the French Accreditation Committee (COFRAC), for the accreditation of official services and/or laboratories, inter alia, so as to ensure that Malagasy products meet the international standards set by some importing countries

3.84.  Madagascar is a member of the three standard‑setting bodies expressly referred to in the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), namely the Codex Alimentarius Commission, the World Organisation for Animal Health (OIE) and the International Plant Protection Convention. According to the authorities, the measures taken in this regard are based on the international standards developed by these three bodies

3.85.  Eleven SPS measures have been notified to the WTO Secretariat since 2007, whereas none had been communicated previously. In particular, Madagascar notified measures taken to combat bee varroasis.[111] The measures taken in 2012 to control the first outbreak of white spot disease in an aquaculture farm are available on the web portal of the National SPS Enquiry Point.[112] No specific SPS‑related trade concern has been reported by the WTO in connection with Madagascar

3.86.  In March 2010, Madagascar designated a new SPS notification authority, the Rural Development Policy Unit. One of the tasks of the SPS Enquiry Point could be to post the relevant Malagasy legislation online on a dedicated website. Table 3.8 contains a list of the main relevant documents. In 2012, the Ministry responsible for livestock and fisheries also endeavoured to draw up an inventory of all regulations on sanitary measures in force for imports; this effort should be extended to all products that could potentially affect human and animal health.[113]

3.87.  Since 2005, the task of the Food Safety and Quality Monitoring Agency (ACSSQDA) has been to ensure that food consumed, distributed, marketed or produced in Madagascar complies with the safety standards. It has a network of seven food control laboratories and delivers certificates of "fitness for consumption" or conformity for every batch of foodstuffs produced or imported, before it is put on the market.[114] The ACSSQDA also conducts analyses and inspections of establishments. The Agency's organization and functioning have been undergirded by the adoption of the new Health Code in 2011 and by Decree No. 2013‑260, which introduced changes in that regard, inter alia: the inclusion in its Board of Directors of three new members from the three ministerial departments concerned (agriculture, livestock and fisheries) and the addition of food quality analysis and control and legal affairs divisions to its structure, and the adoption of new provisions covering detected cases of fraud

3.88.  An Interministerial Task Force was set up in 2013 with EU support in order to buttress Madagascar's food safety system and review the draft Food Law drawn up in 2008 with the support of the FAO.[115] The Task Force brings together the competent health authorities, the Madagascar Bureau of Standards (BNM), the National Codex Alimentarius Committee (in existence since 2005), the Standards and Quality Division in the Ministry responsible for trade, official testing laboratories, and representatives of the agrifood sector, the Chamber of Commerce and Industry and of agricultural producers' organizations

3.89.  SPS control measures for products imported into Madagascar are the responsibility of a number of entities that report to several ministries (agriculture, trade, livestock, higher education with responsibility for nuclear science and technology, fisheries and health), and this suggests that there is scope for streamlining to facilitate trade. More specifically: The Plant Quarantine Division (SQV) in the Ministry of Agriculture controls the importation of live plants, seed and parts of live plants, as well as plant products, soil and growing media, and packaging of plant material. It issues the phytosanitary permit required for importation. The Directorate of Veterinary Services (DSV) in the Ministry of Livestock controls the importation of terrestrial and aquatic animal products (in collaboration with the Ministry responsible for fisheries resources) and genetic materials of animal and plant origin and veterinary inputs for use in livestock farming. It approves importing companies, authorizes the opening of points of sale for veterinary drugs and some avian veterinary vaccines, and delivers health clearances. A Committee for the approval of agro‑pharmaceutical products bringing together different ministerial departments and private entities is tasked with approving all imported phytosanitary products irrespective of their origin. After the requisite tests, the Committee authorizes import for the purposes of marketing the product concerned. The approved products are listed in an official catalogue that is updated annually. The Madagascar Medicinal Product Agency (see below) is responsible for registering, inspecting and controlling the quality of drugs for use in human (but not veterinary) medicine, and for drug testing and control, as well as cosmetics containing therapeutic substances. The ACSSQDA verifies the quality of all food or perishable products, but not of cosmetics and food supplements. The National Institute of Nuclear Science and Technology (INSTN) verifies that all imported products are free of radioactive contamination. If the outcome of the analysis is satisfactory, the Ministry responsible for trade issues a certificate of non‑contamination by radioactivity

3.90.  When imported goods arrive, they must be accompanied by certificates (sanitary and/or phytosanitary) issued by the competent authorities in their country of origin. Before the goods arrive, the importer is required to inform the relevant services in the Ministry responsible for agriculture and/or livestock. Upon arrival of the goods, the border inspection posts first check the documents specifying the content of the import permits issued previously

3.91.  The taking of samples for analysis depends on the degree of risk posed by the imported product. Foodstuffs imported by supermarkets and/or big companies by sea are generally transferred to the capital for customs clearance. In such cases the containers are unpacked by a team comprising the head of the regional veterinary service, an ACSSQDA representative and a trade inspector. Apart from the documentary verification done by the veterinarian, two samples are taken per imported batch for the following purposes: (i) the first is used for microbiological and/or physico‑chemical analyses by the ACSSQDA laboratory; and (ii) the second sample is tested by the INSTN laboratory for non‑contamination by radioactivity

3.92.  Some products must also be quarantined for a period stipulated in the current regulations. If import requirements are not met, the border inspection posts may opt for different measures depending on the cases at hand, i.e. the rejection and/or the destruction of the goods if there is a major risk, or consignment to ports and airports pending completion of the required documentation, in the event of minor risk

3.93.  For foodstuffs of plant origin, control at the border is performed by agents attached to the Ministry responsible for trade. The documents are first checked, and two samples are then taken per imported batch for testing and analysis as described above. 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 control by Customs. Minutes of the unpacking procedure will be drawn up by the team assigned that responsibility and a copy forwarded to the DSV for their records

3.94.  The fact that foodstuffs or perishable items require the taking of at least two samples involving as many entities and departments would suggest that there is room for streamlining without detracting from the quality of the controls. The streamlining of these procedures would be much helped by the creation, at the main ports and airports, of infrastructure and equipment shared by all inspection bodies and adapted to sanitary and phytosanitary inspections, quality control and certification. The authorities stress that this would require substantial multi‑year financial support. Currently, in the event of an SPS alert, the relevant ministries take control measures, which are not communicated electronically to the Customs, but instead by internal mail, and this can be very time‑consuming

3.95.  Following the outbreak of foot‑and‑mouth disease in Europe, Madagascar banned the importation of all live animals and meat and non‑sterilized meat products as of the year 2000, without specifying any origin.[116] Some months later a new order specifically prohibited such imports from South Africa as well.[117] Although the measures regarding South Africa were relaxed somewhat in 2005, no text seems to have abolished these prohibitions for the other countries. Authorization to import processed food products from South Africa was decided by the Malagasy veterinary authorities on 13 May 2014 in the wake of the decision taken by the OIE on the matter. The authorities have indicated that regulatory measures have been taken to authorize imports of animals or products of animal origin from certain EU countries that were affected by foot‑and‑mouth disease but which have now been officially declared disease‑free by the OIE

3.96.  The Plant Health Division (SSV) was set up in 2011 within the Plant Protection Directorate to ensure that exported plant products meet the health requirements of importing countries, and more specifically of the European market, which is the main destination for Madagascar's agricultural exports. This new unit was to become operational in 2015, thanks to support from the EDES programme (see below). Under the regulations in place, it is expected to carry out the health inspection and certification of food products of plant origin destined for export

3.97.  Some companies established in Madagascar and producing food products of animal origin have set up the Hazard Analysis and Critical Control Points (HACCP) system internally.[118] The available information indicates that it is taking a very long time for the competent authorities (DSV or the Fisheries Health Authority (ASH)) to validate the HACCP system set up by agrifood companies. Moreover, the cost of setting up the HACCP system appears to be prohibitive to SMEs and effectively excludes them from international markets. Some establishments working on food products of plant origin are also being requested by their importing clients to install the HACCP system

3.98.  To safeguard access to the EU market, Madagascar has had the benefit of European Union support under the following three programmes: in 2009‑2010, the Better Training for Safer Food in Africa Programme, which was aimed at drawing up a frame of reference for harmonizing the system of inspection of agrifood industries in Africa; in 2011, the Pesticides Initiative Programme assisted private‑sector exporters of fresh fruit and vegetables; and since 2013, the EDES Programme has been targeting the competent authorities, private enterprises and organizations of producers of all agricultural, livestock and fisheries products. EU‑funded regional support programmes are also available for building the capacities of the authorities responsible for SPS matters. These include the Reinforcing Veterinary Governance programme, and the Regional Programme for Plant Protection (PRPV) for the countries members of the Indian Ocean Commission

3.99.  Through the ASH, Madagascar signed a Memorandum of Understanding with China in 2013 laying out the sanitary conditions for access for its fisheries and aquaculture products