3.57.  There has been little change to Malawi's SPS regime during the period under review; the legislation in force remains outdated and a range of capacity weaknesses are yet to be addressed.[57] Sanitary and phytosanitary protection in Malawi involves several entities; a National SPS Coordinating Committee is chaired by the Ministry of Agriculture, Irrigation and Water Development (MAIWD). The MAIWD remains in charge of animal health and plant protection; it shares responsibilities for food safety with the Ministry of Health and the MBS. The Ministry of Environmental Affairs (MEA) and the Pesticides Control Board regulate the importation, marketing and use of pesticides, including biological agents, in Malawi. Likewise, the Pharmacy, Medicines and Poisons Board controls the marketing and importation of all pharmaceutical products and poisons in the country

3.58.  Malawi maintains three SPS enquiry points: the MBS (food safety); the Department of Animal Health at the MAIWD (animal health), and the Department of Agricultural Research Services at the MAIWD (plant health). The MoIT continues to serve as Malawi's SPS notification authority; one notification was made to the WTO SPS Committee during the review period.[58] Malawi is a member of the Codex Alimentarius, the World Organisation for Animal Health (OIE), and the International Plant Protection Convention (IPPC). The MBS is the national contact point for the Codex Alimentarius Commission; it also controls and certifies certain foodstuffs. In principle, Malawi's SPS measures are based on relevant IPPC, Codex, or OIE standards, guidelines, or recommendations; trading partners affected by an SPS measure are informed by Malawi through peer-to-peer contacts

3.59.  Malawi maintains import prohibitions for: meat and poultry treated with growth hormones; grapes, apples, peaches, plums, pears, citrus, bananas, pumpkins, gourds, and strawberries from countries outside Africa, the European Union, and North America; Irish potato (except from southern African countries); flower bulbs for propagation (except from Southern Africa, the Netherlands, Germany, the United Kingdom, Israel, North America, Australia, and New Zealand); seeds for sowing tea (except from sub-Saharan African countries); tobacco leaves (except from Africa); rubber seeds from tropical America; and passion fruit from Australia and New Zealand. According to the authorities, efforts are being made to transition to situational imposition of bans based on the phytosanitary situation in the country of origin. While a general import ban on genetically modified organisms (GMO) remains in place, importation for experimental purposes may be authorized by the MEA; during the period under review the MEA has granted authorizations for GMO cotton and cowpea seed

3.60.  A system of trade permits, often involving more than one competent authority, remains in place for a range of agricultural goods, including for the purposes of cross-border trade (section 3.1.6). Import permits for live animals, animal products, plants, plant products, and fertilizers (valid for four weeks) are issued by the competent departments of the MAIWD. Typically, the permits specify the total quantity and value of a particular product that can be traded. The import permit and a sanitary or phytosanitary certificate issued by the exporting country are required when the goods reach Malawi's borders for the purposes of documentary checks, but these do not replace conformity control by the MBS (section 3.1.8). Malawi lacks the administrative capacity to introduce a risk management scheme for the purpose of granting import permits. The authorization and control procedure is the same for all imports irrespective of the country of origin (including COMESA/SADC member States). Imports of live animals are subject to a 28-day quarantine before entering Malawi, unless they are originating from a disease-free country

3.61.  The Pesticides Control Board authorizes, keeps a register, and carries out the testing and certification of pesticides imported or produced in Malawi; in the absence of national technical regulations, its conformity assessments are based on International Plant Protection Convention (IPPC) guidelines. Malawi applies the harmonized application form for pesticide registrations, developed by the Southern and East African Regulatory Committee for Harmonization (SEARCH); agrochemicals registered in at least three SEARCH countries would normally receive automatic registration in Malawi.[59] The Pharmacy, Medicines and Poisons Board is responsible for registering and licensing medicines, poisons (except pesticides), and pharmacy businesses; it has the authority to issue compulsory licences for the manufacture of pharmaceuticals in Malawi

3.62.  Malawi has an optional SPS control scheme for the certification of exports. Nevertheless, for lack of internationally accredited facilities, Malawian exporters tend to opt for the conformity assessment and certification services of private companies, most of which are based abroad

3.46.  The Malawi Bureau of Standards (MBS), a statutory organization established in 1972, remains in charge of standards development, conformity assessment and metrology services in Malawi. It represents Malawi in standardization activities at the regional level, including in the framework of COMESA, SADC, the African Organization for Standardization, and the Intra-Africa Metrology System. The MBS is a member of the International Organization for Standardization (ISO), and an affiliated member of the International Electrotechnical Commission (IEC), the International Organization of Legal Metrology, and the Codex Alimentarius Commission

3.47.  The MBS serves, inter alia, as the national TBT enquiry point on standards and conformity assessment, whereas the Ministry of Industry and Trade is Malawi's TBT notification authority.[50] Malawi has neither made any TBT notifications nor been the object of any TBT-related specific trade concerns since its last review

3.48.  In January 2014, Malawi adopted a National Quality Policy (NQP) with a view to improving the national quality infrastructure comprising standardization, testing, certification, metrology and accreditation; an implementation strategy has also been elaborated. According to the authorities, the Malawi Bureau of Standards Act of 2012, which still lacks subsidiary legislation (implementing regulations), may require an amendment in light of the NQP

3.49.  Standards development is a demand-driven process that commences with the submission of a proposal to the MBS by any interested party and a review of its relevance to the national economy by the New Work Item Approval Committee (NWIAC). As from 2014, NWIAC is also responsible for determining whether the proposal should lead to the adoption of a standard or a technical regulation, in order to facilitate the future draft's timely circulation for public comments. The MBS formulates national standards in all fields of interest; it is a signatory to the WTO Code of Good Practice for the Preparation, Adoption and Application of Standards.[51] Some 43 technical committees, with broad stakeholder representation, consider the adequacy of international norms or the need for Malawi to develop its own standards. Following approval of the draft as a Malawi standard by the MBS Board, a general declaration is published in the Government Gazette; a standard may be declared mandatory by a separately published Order of the Minister responsible for trade, which would prescribe the date for its enforcement as a technical regulation

3.50.  In 2015, Malawi had 1,058 national standards including 662 technical regulations; the corresponding figures for 2009 were 690 and 644. Regionally harmonized standards include 79 at COMESA level and 24 at SADC level. Information on the number of standards and technical regulations based on international standards was not made available. In principle, Malawian standards are to be reviewed every five years; the authorities acknowledge that this time frame has not been respected in most cases

3.51.  There is no independent accreditation body in Malawi.[52] The MBS retains sole responsibility for the testing and certification, for quality assurance purposes, of goods and services subject to technical regulations in Malawi. To this end, it carries out periodic inspections on the domestic market and, under the so-called Import Quality Monitoring Scheme (IQMS), the compulsory testing of all consignments of similar goods entering Malawi.[53] In principle, the MBS issues an annual import certificate, thereby waiving the import quality monitoring fees for the next 12 months, if four consecutive consignments of the same product from the same manufacturer are found to be compliant.[54] The number of import consignments inspected under the IQMS has registered a steady upward trend, increasing from 2,259 in 2010 to 4,537 in 2014; during the same period, the number of annual import certificates granted by the MBS fluctuated somewhat, with a peak of 67 in 2012 and a low of 26 in 2014 (Chart 3.5)

3.52.  Malawi does not recognize certificates and test reports from certification bodies accredited overseas, including those from the SADC/COMESA region. According to the authorities, compulsory testing and certification at destination is a means of controlling for possible product deterioration during transportation to Malawi. For lack of international accreditation of its facilities, the certificates and test reports issued by the MBS under its Export Quality Certification Scheme are generally not accepted in foreign markets, except for some African and Asian countries. As a result, both imports and exports continue to face significant additional costs

3.53.  A recent assessment of Malawi's quality infrastructure has found scope for rebalancing surveillance efforts at the border and on the domestic market through a more targeted approach to addressing consumer safety concerns. The study has recommended, inter alia, accepting conformity assessment results from regional partners and accredited certification bodies; introducing risk analysis in the IQMS; and publishing conformity assessment-related costs and time frames.[55]

3.54.  The activities of the MBS are funded by revenue from a standards development "cess levy" on certain imports, testing fees and the sale of standards; there is no regular allocation from the state budget towards its day-to-day operations.[56] The cess levy is applied on some 91 broadly defined product categories at the rate of 0.2% of the landed cost of imports. In addition, imports covered by the IQMS are subject to a fee for mandatory inspection and testing, amounting to 0.65% of the f.o.b. value (with a minimum payable of MK 15,000 and a maximum of MK 400,000). Domestically produced goods are subject to inspection fees whenever MBS officers visit producers' premises; details on the mechanism for their calculation were not made available

3.55.  In addition to the MBS, a number of other public entities are involved in inspection, testing and certification activities, some acting as regulatory authorities. For instance, the Censorship Board is responsible for inspection, testing and certification of all supports with audiovisual content for suitability for public consumption in Malawi. The MBS interacts, on an ad hoc basis, with the relevant public institutions when developing standards in their respective areas of competence; no overarching policy is in place to coordinate their activities. According to the authorities, most of these institutions have serious capacity problems primarily due to financial difficulties

3.56.  A technical regulation stipulates labelling requirements for pre-packaged food intended for sale in Malawi. Pre-packaged food products must be labelled in English or Chichewa, and clearly show the expiry date and ingredients. In addition, baby food must have calorie content information