3.79.  The responsibility for enforcement of SPS-related legislation primarily rests with the Ministry of Agriculture and Food Industries (MAFI) through the Department of Fisheries (fish and fish products), the Department of Veterinary Services (animals and animal products), and the DOA (plants, plant products, and regulated articles) regarding various SPS issues. The Ministry of Health (MOH), through its Food Safety and Quality Division, is responsible for food safety matters. At the entry points, the MAQIS is a one-stop institution providing integrated services with respect to quarantine and certification of imports and exports, whether animals, carcasses, fish, agricultural produce, plants, soils, or microorganisms. MAQIS also inspects and enforces regulations that cover food and related matters

3.80.  Malaysia's legal framework for SPS issues remains the same as in recent Reviews and includes the Food Act 1983 and Food Regulations 1985; the Food Hygiene Regulations 2009; the Food Irradiation Regulations 2011; the Animal Act 1953 (Act 647); the Animals Ordinance, 1962 (Sabah No. 16 of 1962) for Sabah; the Veterinary Public Health Ordinance, 1999, Cap. 32 for Sarawak; the Fisheries Act 1985 and Fish Marketing Regulations 2010; the Biosafety Act 2007; the Plant Quarantine Act 1976 and Plant Quarantine Regulations 1981; and the Malaysian Quarantine and Inspection Services Act 2011. The main changes since 2018 concern amendments to the Food Regulations 1985. Effective 1 April 2021, Malaysia revised the importation requirements for certain cereals, grain products, and oil seeds for processing. Henceforth, an import permit from MAQIS as well as a phytosanitary certificate issued by the national plant protection organization in the exporting country is mandatory for consignments from all countries

3.81.  Requirements pertaining to halal products are specified under Section 29 of the Trade Description Act 2011 (Act 730), the Halal Food – Production, Preparation, Handling and Storage – General Guidelines (MS 1500:2009), and the Malaysian Protocol for the Halal Meat and Poultry Production

3.82.  The Under Secretary of the International Division of MAFI serves as Malaysia's enquiry point and notification authority under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures. The 13 notifications provided to the WTO SPS Committee between February 2018 and August 2021 addressed the changes mentioned above and, except for grains, the MOH's Food Safety and Quality Division was identified as the responsible authority. One new specific trade concern was raised by the Russian Federation in the Committee (ID 491), and two previously raised issues resurfaced.[164]

3.83.  Malaysia is a member of the key international standard setting bodies in the SPS area, i.e. the Codex Alimentarius Commission (since 1971), the World Organisation for Animal Health (WOAH), and the International Plant Protection Convention. According to the authorities, Malaysia takes into account guidelines issued by these institutions in the conduct of risk assessment. Regarding bovine spongiform encephalopathy (BSE), Malaysia's surveillance and monitoring systems are based on WOAH standards. Malaysia is a country without an official BSE risk status, and imports of beef are only allowed from countries of negligible risk or controlled risk. Should an outbreak of avian influenza be notified to WOAH, the Department of Veterinary Services will suspend imports from the affected countries and resume importation in accordance with Articles 10.4.3 and 10.4.19 of the WOAH Terrestrial Animal Health Code 2021

3.71.  The Department of Standards Malaysia (JSM) is Malaysia's national standardization and accreditation body, established under the Standards of Malaysia Act 1996 (Act 549) as amended. The Act also set up a Standards and Accreditation Council to advise the Senior Minister of International Trade and Industry on relevant matters. MSAC is guided by inputs from 26 National Standards Committees (NSCs) and the National Accreditation Committee. The NSCs are sectoral standards committees set up by JSM to carry out the technical work related to standardization in each specific industrial sector. JSM represents Malaysia in regional and international activities related to standardization and accreditation

3.72.  Malaysian standards (MS) are in principle voluntary unless they have been made mandatory by the relevant domestic regulators. Of the 4,804 MS developed across 25 sectors as of 1 June 2022, 2,032 of them (42.3%) were identical to international standards and a further 210 MS were modified versions of international standards.[156] Per December 2021, 496 MS had been made mandatory by the regulators, notably by the Energy Commission, the Construction Industry Development Board (CIDB), the National Water Services Commission, the Federal Agricultural Marketing Authority, and the Fire and Rescue Department of Malaysia.[157] The mandatory standards pertained to agriculture, chemicals, building and construction, petroleum and gas, medical devices and healthcare facilities, electrical and electronic equipment, food and food products, palm oil and related products, and quality and environmental management

3.73.  The national standards development strategy has evolved from a numbers-based to a needs‑based model. Moreover, obsolete MS have been withdrawn, and priority is accorded to the development of indigenous standards while promoting direct use of international standards. These factors taken together have contributed to a downward trend in the overall number of MS

3.74.  The Fourth Schedule of the Customs (Prohibition of Imports) Order 2017 addresses the conformity of imports with MS or any other approved standard, as stipulated in the respective technical regulations of regulatory bodies. Part I covers cement, cement products, and plastic flushing cisterns equipped mechanisms. Imports require a certificate of approval (COA) or a letter of exemption, issued by or on behalf of the Chief Executive of the CIDB.[158] Two items were added to Part I in 2022, i.e. recovered paper and paper board, and waste and scrap of metal. Imports require a COA pursuant to the guidelines for importation and inspection of wastepaper and metal scrap.[159]

3.75.  Part II of the Fourth Schedule lists products subject to TBT requirements (Table A3.5). Several amendments were issued during the review period, notably adding certain steel products (bars and rods), and motor vehicle accessories (child seats, rear view mirrors, and safety glass).[160] Moreover, imports of motor vehicles require a letter of approval issued by the Road Transport Department, and the vehicles must satisfy E-Mark and MS mark requirements.[161] Part II requirements do not apply to FCZs

3.76.  JSM is the sole accreditation body, offering accreditation schemes for (i) certification bodies; (ii) laboratories; (iii) inspection bodies; (iv) good laboratory practice compliance (based on OECD principles); (v) proficiency testing providers; (vi) primary healthcare laboratories; and (vii) validation and verification bodies. By August 2022, JSM had accredited 169 certification bodies under 17 different programmes, 824 active laboratories, and 23 Malaysian inspection bodies.[162]

3.77.  JSM is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) and the International Accreditation Forum Multilateral Recognition Arrangement (IAF MLA). It is also a full adherent to the OECD Mutual Acceptance Data in the Assessment of Chemicals. At the regional level, JSM is a signatory to the Asia Pacific Accreditation Cooperation Mutual Recognition Arrangement (APAC MRA). Following its successful APAC peer evaluation in 2020, JSM enlarged its MRA scopes to include proficiency testing providers and certification of persons in 2021. Malaysia is a signatory to five sectoral ASEAN MRAs, covering electrical and electronic equipment; GMP inspection of manufacturers for medicinal products; inspection and certification systems on food hygiene for prepared foodstuff products; a bio‑equivalence study report on generic medicinal products; and type approval of automotive products. Malaysia has also entered into recognition agreements with the United States regarding the 2020 APEC-TEL MRA for Conformity Assessment of Telecommunications Equipment (EMC Testing) and the US-EPA Toxic Substances Control Act (TSCA) Title VI for Formaldehyde Testing

3.78.  Malaysia notifies proposed technical regulations to the WTO Committee on Technical Barriers to Trade (TBT Committee) on a regular basis. The 38 notifications submitted between March 2018 and January 2022 covered a wide range of products, including communications equipment, electronic goods, food and beverages, pharmaceuticals, wastepaper and metal scrap products, wood, medical devices, motor vehicles, and pre-packaged products. One specific trade concern relating to measures maintained by Malaysia was raised in the TBT Committee in March 2022.[163]