3.84.  The Food and Environmental Hygiene Department (FEHD), through the Centre for Food Safety (CFS), and the Food and Health Bureau (FHB) are the authorities responsible for food safety and related issues. The Agriculture, Fisheries and Conservation Department (AFCD) is the competent authority for animal health and plant protection. The TID is HKC's enquiry point under the WTO Agreement on SPS.[161] This institutional set-up has remained basically unchanged since HKC's last TPR

3.85.  From January 2014 to December 2017, HKC submitted six SPS notifications to the WTO: four referred to new measures (including an emergency measure) and two were addenda to previously notified measures. The notifications covered food for human consumption, edible fats and oils of animal origin, and horses from specified countries.[162] All four new measures were based on international standards, and the authorities considered them to be in conformity with those standards. A comment period of at least 60 days was generally provided in the notifications. No specific trade concerns have been raised in the WTO SPS Committee regarding SPS measures applied by HKC during the review period

3.86.  HKC participates in meetings of the Codex Alimentarius Commission, the World Organization for Animal Health (OIE) and the Commission on Phytosanitary Measures of the International Plant Protection Convention (IPPC) under the auspices of Mainland China

3.87.  The Public Health and Municipal Services Ordinance (Cap. 132, Part V) and its subsidiary regulations, and the Food Safety Ordinance (Cap. 612) are the main laws governing food safety.[163] The Public Health and Municipal Services Ordinance regulates the protection of food purchasers, offences in connection with the sale of unfit and adulterated food, composition and labelling of food, food hygiene, and seizure and destruction of unfit food. The Food Safety Ordinance, passed in 2012, introduced new safety control measures, including a requirement for food importers and distributors to register with the FEHD and to keep transaction records in order to enhance food traceability. The Food Safety Ordinance also empowers the Director of the FEHD to issue Food Safety Orders to control, prohibit or recall imports or the supply of any food on public health grounds

3.88.  Food importers are responsible for ensuring that food products comply with all applicable laws and requirements. A prior import licence and/or a written permission from the FEHD is required for the importation of high-risk items such as frozen confections, milk and milk beverages, game, meat, poultry and eggs. Imports of these products are allowed only if they come from sources duly recognized by the FEHD: sources for frozen confections, milk and milk beverages are recognized on a manufacturing plant basis, while game, meat and poultry sources are country-specific. Under the Imported Game, Meat, Poultry and Eggs Regulations (Cap. 132AK), imports of these products require a health certificate issued by a competent body in the exporting country. Failure to submit the health certificate or the prior written permission upon entry into HKC is considered an offence liable, on conviction, to a fine of HK$50,000 and to imprisonment for six months.[164] Imports of meat and poultry transhipped through HKC in sealed refrigerated containers do not require a transhipment certificate, provided the seals remain intact during transport

3.89.  Following OIE guidelines and notifications, the Centre for Food Safety may temporarily suspend imports of poultry meat and poultry products (including eggs) for human consumption from areas where avian influenza in poultry is reported. In such cases, HKC will inform the Consulate-General and the competent authorities of the exporting countries/places concerned, and issue press releases. As at June 2018, 22 areas were subject to temporary import suspension, in most cases of a limited scope and duration.[165]

3.90.  Import controls and requirements on food products are imposed for public health reasons, and are based on risk assessment. The CFS conducts reviews and analysis of food-related hazards to public health, using the risk analysis framework established by international food safety authorities and best available scientific evidence. The CFS also runs a food surveillance programme, under which the Centre's inspectors take samples of food at import, wholesale and retail levels for microbiological, chemical and radiation testing. The results are published monthly.[166]

3.91.  During the review period, amendments were made to the Food and Drugs (Composition and Labelling) Regulations (Cap. 132W). The amendments, based on Codex standards, became effective in March 2014, December 2015 and June 2016, and provided for, respectively: (i) the reduction of fees on small volume exemption applications submitted by electronic means; (ii) changes to the nutritional composition and labelling of infant formulae[167]; and (iii) changes to the nutritional labelling of follow-up formulae and pre-packaged food for infants and young children.[168]

3.92.  Also during the period under review, HKC started implementation of the Pesticides Residues in Food Regulation (Cap. 132CM), which came into effect in August 2014.[169] The Regulation sets out a list of pesticide maximum residue limits in food products, mostly based on the standards of the Codex Alimentarius Commission and the standards of some major food exporting economies. Imports or sales of food containing a pesticide not included on the list are not permitted unless it is demonstrated that consumption of such food is not dangerous or prejudicial to health, on the basis of a risk assessment conducted by the CFS

3.93.  In June 2017, the authorities proposed amendments to the Food Adulteration (Metallic Contamination) Regulations in order to update them and better prevent the adverse health effects posed by metallic contaminants in food. Basically, the proposed amendments would provide for the establishment of specific maximum levels targeting individual foods or food groups in accordance with the Codex principles and modern international regulatory trends in this area.[170]

3.94.  The AFCD is responsible for enforcing SPS controls on imports of live animals and plants. Under the Public Health (Animals and Birds) Ordinance (Cap. 139), a special permit from the AFCD is required for imports (including transhipment) of live animals and poultry, except for imports of non-CITES animals and poultry from Mainland China, which are regulated in separate legislation.[171] On arrival, animals must be accompanied by a valid animal health certificate issued by the competent veterinary authority of the exporting country. Inspection procedures at the border/boundary, and quarantine restrictions, apply, in order to prevent the introduction of animal diseases into HKC

3.95.  The Plant (Importation and Pest Control) Ordinance (Cap. 207), also enforced by the AFCD, regulates the importation of plants and parts thereof.[172] The Ordinance draws on the principles and procedures of the IPPC and the Plant Protection Agreement for the Asia Pacific Region.[173] Imports of plants are subject to a Plant Import Licence (PIL) and must be accompanied by a valid phytosanitary certificate issued by the competent authority in the country/place of origin. Imports of cut flowers; fruit and vegetables for consumption; grains, pulses, seeds and spices for consumption or industrial use; timber and timber products; dried tobacco; and plants and soil from Mainland China are exempted from these requirements. Certain plants (specified in the First Schedule of the Ordinance) are subject to fumigation requirements and/or quarantine conditions

3.96.  The Genetically Modified Organisms (Control of Release) Ordinance (Cap. 607) regulates the release into the environment and the transboundary movement of genetically modified organisms (GMOs).[174] No one is allowed to release a GMO into the environment or import a GMO intended to be released into the environment unless the GMO has been approved by the AFCD or is exempted from approval.[175] This requirement does not apply to GMOs in transit or transhipment, or if the GMO is a pharmaceutical product for human use. Exports of GMOs intended for release into the environment are not permitted, unless an export notification is submitted to the competent authority, and/or approval of the competent authority of the place of destination is obtained according to the legal or regulatory requirements of that place, and copies thereof are sent to the Director of the AFCD.[176]

3.97.  Any person wishing to release a GMO into the environment or import a GMO for the same purpose must submit an approval application in a specified form and a risk assessment report on the possible adverse biosafety effect of the GMO. In addition, importers must provide information, inter alia, on the regulatory status of the GMO in the place from which it is to be imported.[177] The authorities have indicated that no applications for either release or import for release have been submitted since the Ordinance (Cap. 607) came into effect

3.98.  Imports of GMOs (whether for release into the environment; contained use; direct consumption as food or feed; or processing) must be accompanied by the documents prescribed in the Regulations, containing information such as the GMO's common and scientific names, its new or modified traits and characteristics, and the contact details of the exporter and importer.[178] The documentation requirements do not apply to import shipments of GMOs for contained use or for processing that are unintentionally mixed with other living organisms, where the quantity of the GMOs in the total quantity of living organisms in the lot does not exceed the prescribed percentage, which is currently set at 5%.[179] The AFCD carries out random sampling on shipments to verify compliance with the restrictions on the import and export of GMOs intended for release into the environment and the documentation requirements

3.74.  HKC has no central body for the development of standards or comprehensive legal framework regulating this area. Instead, different regulatory agencies issue their own standards and technical requirements, using international or overseas standards as a reference or aligning domestic standards with international standards where appropriate. The authorities state that their policy is to avoid situations where the setting of standards would dictate market development or become a means of protecting certain sectors of the industry.[152] The Product Standards Information Bureau (PSIB) of the ITC is HKC's enquiry and notification point for the purposes of the WTO Technical Barriers to Trade (TBT) Agreement.[153]

3.75.  Since its last Review, HKC has submitted seven notifications to the TBT Committee.[154] Two concerned technical regulations (formula products and food for infants; and edible fats and oils and "waste cooking oils"); four referred to conformity assessment procedures (voluntary water‑efficiency labelling on flow controllers and water closets, and energy labelling on various types of electrical appliances); and one was an addendum about the promulgation of a voluntary marketing and quality code (formula milk and food products for infants), whose draft had been notified in 2012. A comment period of at least 60 days was generally provided in the notifications, with proposed dates for adoption and entry into force set well after the expiry of the comment period. No specific trade concerns have been raised in the WTO TBT Committee concerning standards or technical regulations applied by HKC during the period under review

3.76.  Technical regulations (i.e. mandatory standards) currently in force include products such as motor vehicles, ocean-going vessels, household electrical appliances, portable air compressors, boilers and pressure vessels, building materials, toys and children's products, consumer goods, food, firefighting equipment, lifts and escalators, and telecommunications apparatus and equipment, among others. These technical regulations are applied on environmental, safety and health grounds (Table A3.3)

3.77.  The competent regulatory agencies are in charge of setting their respective conformity assessment procedures in accordance with relevant legislation. Importers are responsible for ensuring that products meet applicable technical regulations and standards; generally, mandatory product certification is not required. The C&ED is responsible for ensuring that consumer goods comply with safety requirements at the border/boundary

3.78.  The Hong Kong Accreditation Service (HKAS), under the ITC, provides accreditation services to laboratories, certification bodies, and inspection bodies. The HKAS system comprises three accreditation schemes: the Hong Kong Laboratory Accreditation Scheme (HOKLAS), the Hong Kong Certification Body Accreditation Scheme (HKCAS), and the Hong Kong Inspection Body Accreditation Scheme (HKIAS). In April 2018, there were 273 organizations accredited under these schemes: 227 laboratories; 25 certification bodies; and 21 inspection bodies.[155]

3.79.  The HKAS is a member of the International Accreditation Forum (IAF), the International Laboratory Accreditation Cooperation (ILAC), the Pacific Accreditation Cooperation (PAC), and the Asia Pacific Laboratory Accreditation Cooperation (APLAC). It is also a signatory to the multilateral mutually recognition agreement (MRAs) administered by these organizations. Since January 2014, the HKAS has expanded the scope of its MRAs to cover energy management system certification, food safety management system certification, greenhouse gas validation and verification, and proficiency testing providers. As of April 2018, the HKAS had concluded MRAs with over 90 economies worldwide.[156]

3.80.  With the aim of turning HKC into a regional testing and certification hub, the Government and the Hong Kong Council for Testing and Certification (HKCTC) have put in place a number of measures to foster the development of this industry, which the authorities consider has a clear competitive advantage and growth potential.[157] For example, in February 2016, the "nil waiver fee" was introduced to facilitate the operation of testing and calibration laboratories in industrial buildings. This means that owners of industrial premises can apply to the Lands Department for a waiver of lease conditions in order to accommodate testing and calibration laboratories, and successful applicants are exempted from the payment of the corresponding waiver fee.[158] Testing and certification bodies and services are also eligible to apply under the recently established funding schemes: the Technology Voucher Programme and the Professional Services Advancement Support Scheme (Table A3.2)

3.81.  HKC's labelling requirements concern mainly food products, certain household electrical appliances, Chinese herbal medicines, proprietary Chinese medicines and pharmaceutical products. Pharmaceutical products are, for example, required to have indications of the name of the pharmaceutical product, the name and quantity of each active ingredient, the name and address of the manufacturer, the product registration number, the batch number, the expiry date, the dosage, and the route and frequency of administration on the label

3.82.  Food labelling requirements are administered by the Centre for Food Safety (CFS) under the FEHD, and are stipulated in Schedule 3 of the Food and Drugs (Composition and Labelling) Regulations (Cap. 132W). Pre-packaged food labels must contain the following information in either Chinese or English or in both: the name of the food; the list of ingredients, including any allergens and additives[159]; an indication of the "use by" or "best before" date; a statement of special conditions for storage or instructions for use; the name and address of the manufacturer or packer; and the count, weight or volume of food. Regular inspections are conducted and random food samples tested to verify the labelled content. Offenders are liable to a maximum fine of HK$50,000 and six months' imprisonment.[160] Genetically-modified (GM) food is not subject to labelling requirements, rather a voluntary "positive labelling" approach is used, whereby any food product containing 5% or more of an individual GM ingredient should be labelled as GM food. The authorities do not recommend negative labelling (i.e. "GM free"), as they consider this might mislead consumers

3.83.  The Mandatory Energy Efficiency Labelling Scheme is administered by the Electrical and Mechanical Services Department, and requires local manufacturers or importers of the prescribed products to submit specified information and documents for the assignment of reference numbers. Local manufacturers or importers are required to attach energy labels in the prescribed format specified in the Energy Efficiency (Labelling of Products) Ordinance (Cap. 598) before supplying these products in HKC. Local suppliers (including wholesalers and retailers) are not allowed to supply any specified product which has not been assigned a reference number and does not bear energy labels. Some types of household electrical appliances are subject to energy-efficiency labelling in order to inform consumers' choice