3.82.  The main legislative measures with respect to sanitary and phytosanitary (SPS) requirements are contained in Administrative Regulation No. 40/2004. The Municipal Affairs Bureau of Macao (Instituto para os Assuntos Municipais, IAM) is responsible for formulating and implementing SPS regulations and measures and is the SPS enquiry point for the WTO.[121]

3.83.  Macao, China maintains a list of products by HS heading subject to SPS inspection (SPS Table), which is reviewed periodically, and at least when there is a change in HS nomenclature. The list was most recently amended on 1 January 2017[122], mainly to reflect the adoption of the 2017 HS nomenclature. Products subject to inspection include most plants, flowers, fruit and vegetables, animals, fish, animal products, ice cream, and sugar cane (Table 3.15). These products are listed in Annex III to Chief Executive Decision No. 487/2016, of 28 December 2016

3.84.  The importation of the products listed above requires an import licence, an import declaration, and a valid sanitary certificate(s) issued by the competent authorities of the exporting country/region. The importer must also be registered in the IAM's Import Registry. Importers of these products must apply electronically or in person to the IAM for SPS inspection at least one working day prior to the arrival of the goods at the border. The IAM checks the SPS documentation, and its laboratory or a subcontracted laboratory may conduct random laboratory samplings of the goods to be imported, at the border. In some cases, there are additional requirements, for instance, as stated before, importers of species of animals and plants listed in the CITES must obtain import licences from the DSE before requesting an IAM SPS inspection. Inspections are subject to the payment of a fee, as stipulated in Chief Executive Decision No. 268/2003 of 1 December 2003, which varies according to the product (e.g. MOP 10.0 for certain ornamental plants with roots, MOP 3.0 for certain bulbs and tubers, and MOP 0.3 for eggs); fees did not change during the review period.[123] The authorities noted that the inspection fees are adjusted based on the needs and situation of Macao, China

3.85.  Control measures for pests and diseases follow China's AQSIQ Catalogue of Quarantine of Imported Organisms Contaminated with Pest and Disease. Under the CEPA, Macao, China signed two cooperation agreements with China concerning SPS issues: the Cooperation Arrangement on Inspection, Quarantines, and Food Safety, in 2004; and the Cooperation Arrangement on Inspections and Quarantines, in 2010. Moreover, under the CEPA Agreement on Trade in Goods, signed by China and Macao, China on 12 December 2018, Chapter 6 outlines the cooperation on SPS measures between the two sides. Both authorities agreed to strengthen cooperation on SPS, and to ensure transparency with respect to SPS measures and legislation

3.86.  During the review period, Macao, China made 14 notifications to the SPS Committee, including one correction.[124] Most of them related to food standards (see below). Of particular significance, is the notification of the Food Safety Law.[125] The notifications that followed correspond, to a large extent, to requirements under the Law, e.g. related to the content of pathogenic microorganisms

3.87.  Law No. 5/2013, the Food Safety Law, is to protect public health and safety by regulating food safety supervision and management, risk prevention, control and countermeasures, and incident management. The Law is applicable to food production, and the use of food additives and food-related products in commercial foodstuffs. According to the Law, food safety means having access to foodstuffs that are neither toxic nor harmful, have nutritive value, and do not cause "acute, sub-acute or chronic damage to human health".[126] The Law gives the IAM authority with respect to food safety, and establishes the obligation of public or private entities to provide assistance. In accordance with the Law, the IAM is responsible for: (i) coordinating food safety supervision and management; (ii) submitting proposals for the formulation of food safety policies; (iii) inspecting the premises or establishments where the production and marketing of foodstuffs is carried out; (iv) collecting samples, and examining and analysing the safety of foodstuffs; (v) monitoring and assessing food safety risks; (vi) preparing emergency plans for food security incidents; (vii) investigating and treating food security incidents; and (viii) implementing preventive and control measures, among others

3.88.  The Food Safety Law elaborates the establishment of food safety standards, risk monitoring, risk assessment, and prevention and control measures. It also contains a penalty system, including criminal liability and administrative penalties. The supervisory staff of the IAM enjoys public authority powers in the performance of its duties and may request the police authorities to provide the necessary support, in particular for search purposes or when it finds situations of opposition or resistance to the exercise of its duties

3.89.  The Law mandates that the production and marketing of foodstuffs, and the use of food additives and food-related products must satisfy food safety criteria, covering the following aspects: (i) standards for maximum levels of pathogenic microorganisms, pesticide residues, residues of veterinary medicinal products, heavy metals, radioactive substances, and substances harmful to human health contained in foodstuffs; (ii) types of food additives, their scope, and the limits of their use; (iii) requirements relating to the nutritional ingredients of foodstuffs intended exclusively for infants and children or other specific groups of persons; (iv) hygiene requirements in the production and marketing of foodstuffs; and (v) quality requirements related to food safety

3.90.  Chief Executive Writ of Instruction No. 245/2014 prohibits the importation, exportation or re‑exportation of plant products that contain phytosanitary harmful organisms, as included in its appended list.[127]

3.91.  Since 2013, Macao, China has published 11 food safety standards, notified to the WTO as SPS measures. Among these, Administrative Regulation No. 6/2014 (List of prohibited substances for use in food) prohibits the use of certain substances during animal husbandry or food production, and in the circulation of foodstuffs. The Regulation is applicable to the entire food supply chain.[128] Administrative Regulation No. 16/2014 (Maximum limits of radionuclides in foodstuffs) establishes the maximum permitted levels of radionuclides in food after a nuclear or radiological emergency. Maximum limits are defined for two separate categories "infant food" and "other foods". The Regulation applies to all stages of the food business (Table 3.16)

3.92.  As at June 2020, Macao China, maintained two active SPS measures which had the effect of prohibiting imports (Table 3.17). These measures are deemed to be temporary, although they have been in place for several years. These measures were notified to the WTO. Macao, China does not have an automatic mechanism of revision of SPS measures. The authorities noted that these measures are reviewed as needed and to ensure compliance with international standards. In the case of the measure applied on BSE-related products, in February 2014, Chief Executive Decision No. 27/2014 removed the prohibition of importing meat and meat products from the United Kingdom, which was applied under Chief Executive Decision No. 341/2007.[129] Chief Executive Decision No. 27/2014 also repealed Decision No. 25/GM/96.[130]

3.93.  In February 2019, the prohibition to import poultry products from avian-flu-affected Asian countries, contained in Chief Executive Decision No. 7/2004, was removed by Chief Executive Decision No. 16/2019.[131]

3.70.  As mentioned in the last Review, Macao, China does not have an integrated regime for standardization, accreditation and certification in different sectors of activities. Consequently, there is no official standardization body. Macao, China does not establish its own standards but adopts prevailing international standards and technical requirements. The Macao Economic Bureau (Direco dos Servios de Economia, DSE) is Macao, China's National Enquiry Point for the TBT Agreement

3.71.  There are no specific procedures to develop technical regulations. However, when a product becomes subject to a licensing requirement, the corresponding standard becomes mandatory and, therefore, it becomes a technical regulation. According to the authorities, these technical regulations are always based on international standards, as Macao, China does not develop its own standards, but resorts to adopting international or overseas standards, where appropriate. In addition, Macao, China recognized a series of product safety standards from China and overseas under Administrative Regulation No. 17/2008. During the review period, Macao, China made 12 notifications to the WTO under the TBT Agreement, all in September 2019 (Table 3.13).[113] They refer to vehicle emissions, used motor vehicles, pollutants in gasoline, pharmaceuticals, tobacco products, heaters, packaging, lights, and domestic appliances. All these technical regulations were in place at the date they were notified; some of them had been in force for several years. In this respect, the authorities mentioned that this was due to human resource constraints, and that they would make an effort to fulfil their notification obligations in a timely manner. They also noted that, during the review period, a number of international standards were implemented with a view to supplementing the relevant laws and enhancing regulatory efforts. The recognized safety standards apply to all related products, both imported and locally produced

3.72.  During the period under review, two technical regulations were issued or revised in order to better regulate the import registration of pharmaceutical products. In 2013, Health Bureau Decision No. 10/SS/2013 on maximum limits of heavy metals and toxic elements in traditional medicinal products was enacted.[114] This Decision is a revision of a technical regulation previously imposed in 2003. The second, Health Bureau Decision No. 04/SS/2016, was adopted in 2016 to stipulate an additional documentation and assessment requirement for the import registration of pharmaceutical products containing new chemical entities.[115] The Health Bureau also issued a technical regulation with respect to the labelling of medicines.[116]

3.73.  Apart from those notified, technical regulations also apply to imports of goods, such as radiocommunication equipment, products used in civil engineering, and pressure-reduction stations. Overseas testing results are accepted as a useful reference for licensing purposes. Technical regulations (compulsory standards) for radio-telecommunication equipment are based on ITU standards, and imports are subject to licensing, to ensure that technical regulations are met. Test results and certificates issued by the manufacturers or other authorities are accepted as a reference for licensing purposes. Radiocommunication equipment, such as conventional radio telephones and pagers, must pass type-approval tests.[117] Type-approval certificates are issued by the Macao Post and Telecommunications Bureau. There are two technical standards for type-approval tests, which are mainly derived from European Telecommunications Standards Institute (ETSI) standards

3.74.  Macao, China also applies technical regulations (compulsory standards) for gas emissions of newly imported automotive vehicles (including motorcycles), in accordance with Administrative Regulations No. 1/2012 and No. 1/2008. According to Annexes I and II of Administrative Regulations No. 1/2012 and No. 1/2008, the compulsory standards applied for the importation of automotive vehicles are based on standards implemented in the United States, the European Union, Japan, and China.[118]

3.75.  Compulsory standards are also applied to imports of engineering equipment, which additionally require an import licence to ensure compliance with the technical standards applicable, namely the Macao Codes for Civil Engineering Activities. The Codes were prepared by the Civil Engineering Laboratory of Macau, following, according to the authorities, an in-depth analysis of the corresponding codes and standards used in China, the European Union, the United States, and Hong Kong, China. These codes and standards are now part of the legal framework governing civil engineering activities in Macao, China

3.76.  Technical regulations also exist for pressure-reduction stations, as per Administrative Regulation No. 21/2016 on Technical Regulation of the Pressure Reduction Stations to be Installed in Combustible Gas Transportation and Distribution Pipelines, which governs the design, installation, operation and inspection of pressure-regulating systems (PRSs) fitted in gas transmission and distribution systems. The authorities noted that this Regulation includes aspects such as the definition of the type of PRS, the safety distance to the PRS, and the protection of PRSs, among other issues. Chief Executive Decision No. 61/2014, of 20 March 2014, which superseded Chief Executive Decisions No. 191/2008 and No. 439/2009, updated the list of safety requirements for luminaries, and electrical appliances.[119]

3.77.  Since 2013, Macao, China has adopted 11 food safety standards (Section 3.3.3)

3.78.  Macao, China does not have an overall conformity assessment structure for standardization, accreditation or certification. It does not participate in international agreements or bilateral arrangements (including mutual recognition agreements (MRAs)) in the area of standards, testing, and certification. The authorities noted that, despite this and notwithstanding the small number of technical regulations in place, there has been an increasing interest from producers and service providers to meet international standards. In this respect, the trend of seeking voluntary management system certification, such as ISO 9001 and ISO 14001, by local enterprises or organizations continued to increase during the review period. The Macao Productivity and Technology Transfer Centre (CPTTM), a non-profit association jointly established by the Government and the private sector, is the ISO correspondent member. According to available data, by the end of 2018, the number of ISO 9001 and ISO 14001 certificates amounted to 215 (compared with 7 in 1996) and 73 (up from 3 in 1999), respectively. There were certifications in other areas, too. For example, at least 21 local enterprises or organizations were certified under the ISO 22000 Food Safety Management System, as at December 2018; at least 6 were certified under ISO/IEC 20000 IT Service Management; at least 12 under ISO/IEC 27001 Information Security Management; and at least 2 under ISO 50001 Energy Management System. The services sector, the engineering/construction sector, and the manufacturing sector are the top three sectors using ISO management system certifications

3.79.  In 2018, the Industrial Association of Macau and the CPTTM co-launched the Macao Product Quality Certification Scheme, a voluntary scheme aiming to encourage local enterprises to adopt product quality certification as a means to enhance customer confidence and market competitiveness, thereby supporting the development of the industrial sector

3.80.  In the absence of an official standards or accreditation body, Macao, China does not have a laboratory accreditation scheme. Macao, China laboratories must seek accreditation from bodies in Mainland China, Hong Kong, China, and abroad. The authorities noted that, as in the case of ISO management system certification, a number of local laboratories took the initiative to seek recognized accreditation from the China National Accreditation Service for Conformity Assessment (CNAS), the Hong Kong Accreditation Service, or other overseas accreditation bodies, such as the Portuguese Institute of Accreditation, or the National Association of Testing Authorities of Australia (NATA). In 2020, there were nine accredited laboratories in Macao, China, from bodies in Australia; China; Hong Kong, China; and Portugal (Table 3.14)

3.81.  Food labelling is regulated under Decree-Law No. 50/92/M, as amended, Decree-Law No. 56/94/M, and Administrative Regulation No. 7/2004. Chief Executive Decision No. 556/2009, of 11 January 2010 contains a list of generic food additive names that are used for labelling. The packaging and labelling of medicines and traditional Chinese medicines is regulated by Technical Instructions No. 3/2005 and No. 4/2005 of the Macao Health Bureau, which were notified to the WTO in September 2019.[120] Pharmaceutical products and traditional Chinese medicines that enter Macao, China must have received prior approval from the Health Bureau. There are currently no eco‑labelling initiatives, or labelling requirements on genetically modified organisms. The authorities noted that they have no plans in this respect. There is no automatic mechanism of revision of TBT measures. Macao, China noted that the authorities responsible for technical regulations review the TBT measures in place to assess whether they are in line with international standards and practice, and in response to specific needs