3.100.  To ensure the health of animals and humans, the competent authority, in response to the existence of infectious animal diseases or a global epidemic, may announce quarantine measures, including the prohibition to import, transit, or tranship. In this instance, the competent authority coordinates with other agencies to implement the necessary measures to prevent and control the sanitary situation

3.101.  Importers of goods subject to animal quarantine must submit the following documents, in electronic or paper format, to the import/export animal quarantine authority, to apply for quarantine inspection: original veterinary certificate; bill of lading or sea waybill/air waybill; photocopies of import or customs declaration; and any other relevant documents required by the import/export animal quarantine authority.[230] For animals for which the quarantine requirements have not been determined, the importer, prior to importation, must apply for the issuance of an individual quarantine requirement from the competent authority and for quarantine inspection with the import/export animal quarantine authorities

3.102.  The import/export animal quarantine authority specifies the ports of entry, transit, or transhipments and areas/places of inspection. The packaging of quarantine products cannot be opened, moved, or handled in a way that may spread infectious animal diseases. The quarantine authority may also inspect vehicles, vessels, or aircraft before goods are un/loaded for import (export). The results of the inspection are notified to the importers (exporters). If animals are found to be sick, infected, or contaminated, and a risk of transmission of infectious animal diseases exists, precautionary measures as deemed necessary are taken, including immediate disposal

3.103.  Domestic and imported products sold, including online, are subject to quarantine requirements and must have a warning label indicating the animal health inspection or quarantine requirements.[231]

3.104.  The BAPHIQ updates, when necessary, the list of individual quarantine requirements of prohibited plants and plant products by origin.[232] Requirements are based on international standards, guidelines, or recommendations, and scientific evidence, and are changed accordingly.[233] Moreover, for plants or plant products prohibited by origin, the prohibition also applies if they are unloaded and transhipped through a territory included in the list. Imports of regulated plants and plant products require a phytosanitary certificate issued by the plant quarantine authority at origin.[234]

3.105.  To monitor and prevent the entrance and dissemination of plant diseases and pests, the BAPHIQ may publicly notify the types and scope of specific plant diseases and pests, and establish a monitoring or surveying programme accordingly; and, if deemed necessary, take emergency control measures, such as restricting or prohibiting the cultivation of susceptible plants or destroy those already cultivated; order the owner to kill the relevant pests; and/or establish quarantine inspection stations. In this context, plant protection/quarantine officers are empowered to enter farms, warehouses, vessels, vehicles, or aircraft to inspect plants and plant products and their packaging.[235]

3.106.  The FDA, the competent authority governing food safety and sanitation in Chinese Taipei, sets food sanitary requirements based on the principle of risk assessment, as well as on scientific evidence and existing international standards. The FDA has a risk assessment and advisory system, as well as a food sanitation and safety monitoring system. If during monitoring an incidence is found that may be harmful to food sanitation and safety, an inspection is conducted, an alert is issued, and other necessary measures are implemented

3.107.  Chinese Taipei's regulations regarding food safety are vast and detailed. The Act Governing Food Safety and Sanitation is a general piece of legislation, and specific regulations have been enacted to implement it.[236] In many instances, these are product specific. In addition to setting food‑related sanitary requirements, the FDA sets standards for pesticides[237], veterinary drugs[238], food additives residue limits[239], and labelling of food products. Regulations seem to apply both to locally produced foods and to imports and exports. For instance, in 2022, the FDA indicated that food exporters had to comply with local regulations as well as at destination.[240]

3.108.  Inspection requirements for imported food products are amended as necessary, to ensure compliance with the sanitation and safety requirements. In this context, the FDA and the Customs Administration have set up a customs notification platform for food imports that do not require import inspection, which is updated on a quarterly basis, based on the FDA's inspection results. Other food imports may be required to undergo systematic inspection. In general, food products require a three‑tier sanitary control: at origin, upon arrival, and post‑market surveillance.[241] Some food products, such as meat, fish, eggs, and dairy products, require stricter sanitary controls at origin (for instance, an audit of the food safety management conditions of the production chain). In addition, during the period under review, an onsite inspection fee was introduced.[242]

3.109.  Upon arrival, imported products may be subject to different types of inspection: batch‑by‑batch inspection, reinforced or regular randomly selected batch inspection, batch‑by‑batch verification, or oversight inspection.[243] The type of inspection is determined by factors such as publicly available information about product safety, scientific evidence, and nonconforming records. Nevertheless, due to the nature or inspection time‑frame, food importers may apply for prior release of the imported goods and store them at a specific location.[244] In addition, preferential inspection measures (i.e. the minimum inspection rate of regular randomly selected batch inspection) apply to importers with "Excellent Industry" status

3.110.  During 2018‑23 (June), Chinese Taipei made 161 regular notifications to the WTO SPS Committee. Most of them (101) were related to food safety or to protect human health, 32 to protect plant health, and 26 to protect animal health. Two of the regular notifications were temporary measures taken as a result of the COVID‑19 pandemic; they related to alternative methods to submit food safety and sanitation certificates, and original veterinary and phytosanitary certificates. Five notifications indicated that emergency measures were taken, four of which were taken for plant protection and one for animal protection. Fifty‑six of the measures notified by Chinese Taipei were not based on international standards. Four specific trade concerns were raised in relation to the measures adopted by Chinese Taipei regarding new procedures for the recognition of infectious animal disease‑free status of a trading partner; import restrictions on poultry and beef; phytosanitary risk assessment procedure on imports of fresh vegetables and fruits; and general import restrictions due to bovine spongiform encephalitis (BSE). This last concern has been raised since 2004 and was last raised in 2020.[245]

3.97.  The regulatory framework to formulate and implement sanitary and phytosanitary (SPS) measures has not changed significantly since the previous Review. Several laws and regulations still regulate plant and animal health and food safety (Table 3.11). The main pieces of legislation to govern measures to prevent the introduction of pests or diseases and ensure food sanitation, safety and, quality, and protect public health are the Plant Protection and Quarantine Act; Statute for the Prevention and Control of Infectious Animal Diseases; and the Act Governing Food Safety and Sanitation. Source: Compiled by the WTO Secretariat based on information provided by the authorities and online information

3.98.  The main institution responsible for developing and implementing SPS measures also remains unchanged since 2018. The Ministry of Health and Welfare (MOHW), through its implementing agency the Food and Drug Administration (FDA), continues to deal with issues related to food safety and sanitation and is responsible for, inter alia, ensuring quality and safety of food, medical products, and cosmetics; SPS inspection and certification procedures; and food labelling. The BAPHIQ, under the COA, safeguards and ensures the quality and safety of imports of agricultural products; manages quarantine services to prevent and control animal and plant diseases and pests; and is the WTO enquiry point/notification authority for SPS issues. Other agencies such as the BSMI, under the MOEA, and the Customs Administration are also involved in the procedures to set and/or implement SPS measures

3.99.  Chinese Taipei sets and amends SPS measures according to international standards, guidelines, or recommendations, and scientific evidence.[228] If the epidemic situation changes or a new epidemic pest of quarantine significance occurs, which poses a risk to the production of crops and animal health, the COA amends the list of products subject to SPS measures and import inspection, as required.[229]

3.86.  The main legislation regulating standardization, metrology, and consumer safety in Chinese Taipei did not change substantially during the period under review[205]; however, the subsidiary legislation is often updated as required in response to industry and consumer needs, and technological developments. For instance, there are 7 regulations and 12 directives relating to standardization, 117 directives governing the different regulated products and procedures, and 25 regulations setting issues such as the use of certification marks, recognition of testing laboratories, and exemptions from inspection.[206] In the case of metrology, the Act dates from 2009 and has not changed; nevertheless, there are 14 regulations and 33 directives that deal with verification and type approval related to weights and measuring instruments.[207]

3.87.  The Bureau of Standards, Metrology and Inspection (BSMI), under the MOEA, is the competent authority to enforce the Standards, Commodity Inspection, and Weights and Measures Acts. It continues to be responsible for standardization, metrology, and consumer product safety. It is also the WTO enquiry point/notification authority for TBT issues

3.88.  The BSMI sets an annual work programme, which includes Chinese Taipei's standards (CNS) that are to be drafted and revised according to the needs of manufacturers, consumers, and other users, with a view to applying consistent standards to Chinese Taipei's products, procedures, and services.[208] The work programme is published on a monthly basis in the BSMI Standards Gazette. In its 2022 work plan, the BSMI emphasized areas related to green energy technologies, environmental protection, energy saving, smart machinery, and products to assist in scientific and technological development

3.89.  Within the BSMI, the Standards Division is responsible for the development and compilation of CNS. Standards are set in accordance with the Standards Act and applicable regulations and are developed considering the interests of consumer and industry, and international practices.[209] Use of standards is voluntary unless referenced in a technical regulation as being mandatory. Technical regulations are the basis to carry out inspection, certification, accreditation, recognition, or other conformity assessment activities. When a need for establishing a technical regulation arises, suitable existing local and international standards are reviewed for referencing in the technical regulation

3.90.  Procedures to develop standards do not seem to have changed substantially since the last Review in 2018. The procedure is as follows: submitting a proposal[210]; drafting; soliciting comments; review; determination; and approval and promulgation.[211] In general, it takes about six months to complete the process; however, if the proposal is complex or onsite investigation or testing is required, eight or more months may be needed.[212] International standards are used, fully or partially, as a basis for drafting CNS. The BSMI may also adopt related international standards or Chinese Taipei's group standards that already exist when these are technically appropriate and applicable.[213] According to information provided by the authorities, the equivalency rate between CNS and international standards is high (Table 3.10). Standards are reviewed every five years after adoption or earlier if required. Copies of CNS may be purchased online or onsite; CNS that have English translations are marked with an asterisk in the CNS Catalogue

3.91.  The BSMI continues to provide voluntary certification and testing services.[214] The BSMI implements two voluntary product certification programmes: the CNS Mark Certification (CNS Mark) System, which is granted to products that comply with relevant CNS; and the Voluntary Product Certification (VPC) System, which is used mainly for products with emerging technology and for innovative products. The main difference between the two systems is that the VPC System can be used to certify products that comply with relevant international standards where CNSs have not yet been developed.[215]

3.92.  Overseas manufacturers may apply to obtain a CNS Mark Certificate. To obtain a CNS Mark, a company needs to have its quality management system assessed and products tested to assess compliance with CNS standards. Assessment of the company's quality management system is done by certification bodies recognized by the BSMI. Testing can be done by the BSMI or testing laboratories recognized by the BSMI.[216] Once permission to use the CNS Mark has been granted, the BSMI will, inter alia, conduct follow‑up visits to factories for quality control, inspect products in the market, and revise compliance. In cases of non-compliance, the CNS Mark registered manufacturers are required to take corrective measures.[217]

3.93.  Products subject to technical regulations must be inspected as per the Commodity Inspection Act and its regulations before they are imported or placed on the market.[218] The BSMI oversees inspection and testing; it maintains four kinds of pre‑market inspection schemes: batch‑by‑batch inspection, monitoring inspection, registration of product certification (RPC), and declaration of conformity (DoC). For batch-by-batch inspection and monitoring inspection, manufacturers or importers must apply to the BSMI for inspection before products are shipped out of the production premises or when they arrive at destination. Testing can be done by the BSMI, its commissioned organizations, or testing laboratories recognized by the BSMI.[219] The Commodity Inspection Mark shall be affixed before products are placed on the market.[220] The BSMI also undertakes post‑market surveillance based on a risk assessment system to ensure the safety of regulated products. The BSMI adopts an annual plan to undertake market surveillance and identify products of high risk, and specifies principles for conducting surveillance activities, including market checks, sampling tests, special projects, and monitoring of products sold online.[221] Importers or manufacturers of certain products may apply for exemption from inspection under certain conditions.[222]

3.94.  The number of products that require mandatory inspection by the BSMI increased from 1,224 in 2018 to 1,356 in 2022. During 2018‑22, 165 items were added, and 33 items were removed from the List of Regulated Products. According to the authorities, all of the added products were notified to the WTO TBT Committee. Most of the products that are regulated are mechanical products, electrical and electronics products, and textiles.[223]

3.95.  To facilitate conformity assessment procedures for the industry and trading partners, Chinese Taipei has several mutual recognition arrangements (MRAs); these mainly cover electrical and electronic products. Some MRAs only cover the recognition of test reports, while others are more comprehensive, with recognition extending to certificates. Testing laboratories or certification bodies are designated under different MRAs, which allow products for export to the other contracting party to be tested locally

3.96.  During 2018‑23 (June), Chinese Taipei made 213 regular notifications to the WTO TBT Committee, most of which were notified as technical regulations or/and conformity assessment procedures.[224] The measures notified related mainly to measures to protect human health and safety. Four notifications were related to temporary measures taken because of the COVID‑19 pandemic; one of them was of an urgent nature.[225] The urgent measure related to draft amendments to the Regulations for the Inspection and Examination of Imported Medical Devices.[226] During the review period, one specific trade concern was raised at the Committee about the draft of the Organic Agriculture Act.[227]