What Changed
- FEHD received five health food applications over the past three years that could not obtain official recommendation because they contained Chinese medicine ingredients outside Cap. 132.
- DH issued one recommendation for a registered pharmaceutical product and three for proprietary Chinese medicines under GACC Order No. 280 over the past three years.
- The HKSAR Government confirmed it has not compiled official statistics on the market size of health food products.
On October 21, 2026, the Secretary for Environment and Ecology, Mr Tse Chin-wan, provided a written response to Legislative Council Question 14 (LCQ14) raised by the Hon Shiu Ka-fai. The exchange highlights significant regulatory challenges encountered by Hong Kong health food manufacturers seeking to export products to Mainland China. Specifically, local producers face operational difficulties under the Mainland's General Administration of Customs (GACC) Order No. 280, which requires official recommendations from local competent authorities prior to registration. Due to distinct statutory definitions across Hong Kong ordinances, certain health food products fall outside the regulatory remits of both the Food and Environmental Hygiene Department (FEHD) and the Department of Health (DH), leaving manufacturers unable to secure necessary export recommendations.
Under Decree No. 280 of the General Administration of Customs of the People's Republic of China, titled the "Administrative Provisions of the Customs of the People's Republic of China on Registration of Overseas Manufacturers for Export of Food to China" (the Provisions), overseas production enterprises of food listed in the Mainland's import catalogue must complete an official recommendation process. To register and gain market access, applicants must submit an audit and inspection report—covering raw material origins, production premise layout, equipment, and storage facilities—alongside a formal recommendation letter issued by the competent authority in their home jurisdiction. In the Hong Kong Special Administrative Region (HKSAR), the GACC recognizes three entities as competent authorities: the Food and Environmental Hygiene Department (FEHD), the Department of Health (DH), and the Agriculture, Fisheries and Conservation Department (AFCD).
Unlike jurisdictions with a unified regulatory definition for health foods, Hong Kong regulates health products through a multi-pronged approach based on ingredients, health claims, directions for use, dosage, and packaging. Key statutes governing these products include:
- Public Health and Municipal Services Ordinance (PHMSO) (Cap. 132): Regulates general food safety and standards. Under section 2, "food" includes ingredients used in food preparation, but explicitly excludes medicine as defined under the Pharmacy and Poisons Ordinance (PPO) (Cap. 138) and Chinese herbal medicine or proprietary Chinese medicine as defined under the Chinese Medicine Ordinance (CMO) (Cap. 549).
- Pharmacy and Poisons Ordinance (PPO) (Cap. 138): Regulates pharmaceutical products, requiring registration and licensing for local manufacturing.
- Chinese Medicine Ordinance (CMO) (Cap. 549): Regulates proprietary Chinese medicines and herbal ingredients, establishing safety, quality, and efficacy criteria.
- Undesirable Medical Advertisements Ordinance (UMAO) (Cap. 231): Regulates health claims, including specific restrictions governing six groups of health claims made for orally consumed products.
The interaction between these ordinances creates a jurisdictional dilemma for health food products that combine general food vehicles with active medicinal or Chinese herbal ingredients. If a health product contains Chinese medicine ingredients listed under Cap. 549, FEHD determines that the item is not "general food" under Cap. 132 and rejects processing for a recommendation under food safety protocols. Conversely, if the product is not classified or formally registered as a "pharmaceutical product" under Cap. 138 or a "proprietary Chinese medicine" under Cap. 549—due to failing to meet those specific statutory definitions or registration standards—the Department of Health cannot process or issue a recommendation letter under pharmaceutical or Chinese medicine regulatory channels. Consequently, manufacturers of unclassified health food items find themselves unable to obtain official endorsement from either authority.
Official data provided in the reply illustrates the impact of this jurisdictional boundary over the preceding three-year period:
- FEHD Approvals: The FEHD successfully made seven recommendations for food product registration applications under the Provisions. None of these approved cases involved products bearing health claims.
- FEHD Rejections and Referrals: The FEHD received five applications for health food products that failed to secure recommendations. Because these products contained Chinese medicine ingredients under Cap. 549, they fell outside the PHMSO (Cap. 132) food definition. Although referred to the DH, they could not obtain recommendations because they were not registered pharmaceutical products or proprietary Chinese medicines.
- DH Recommendations: The DH issued one recommendation letter for a Hong Kong-manufactured product registered as a pharmaceutical product under Cap. 138, and three recommendation letters for products registered as proprietary Chinese medicines under Cap. 549.
- Market Size Data: The HKSAR Government confirmed that it has not compiled official market size or annual growth statistics for local health food products over the past five years.
To support Hong Kong's role as a food trade hub, as outlined in the First Five-Year Plan for Economic and Social Development of the Hong Kong Special Administrative Region (2026-2030), the HKSAR Government continues discussions with Mainland authorities regarding trade facilitation. Existing arrangements permit meat and dairy exports (established last year) and grant expedited customs clearance—releasing goods upon sampling without waiting for lab test results—for specific food groups, including beverages, pastries, confectionery, tea, select noodle products, and condiments. However, these measures apply only to items fully meeting standard food definitions and safety criteria under Cap. 132.
Frequently Asked Questions
Q1: Which Hong Kong departments are authorized to issue recommendation letters for Mainland export under GACC Decree No. 280?
The GACC recognizes the Food and Environmental Hygiene Department (FEHD), the Department of Health (DH), and the Agriculture, Fisheries and Conservation Department (AFCD) as competent authorities in Hong Kong to issue recommendations within their respective regulatory scopes.
Q2: Why are some health food products unable to obtain export recommendations from the FEHD?
The FEHD issues recommendations under the Public Health and Municipal Services Ordinance (Cap. 132). Under Cap. 132, "food" excludes products containing medicine regulated under Cap. 138 or Chinese herbal and proprietary medicines regulated under Cap. 549. If a health food contains Chinese medicine ingredients, FEHD cannot treat it as general food.
Q3: Can the Department of Health issue export recommendations for health foods that FEHD rejects?
The Department of Health can only issue recommendations for products that are formally registered as "pharmaceutical products" under Cap. 138 or "proprietary Chinese medicines" under Cap. 549. If a health food product does not meet the legal criteria for these specific registrations, DH cannot issue a recommendation letter.
Q4: What customs clearance facilitation measures are currently available for Hong Kong food products entering the Mainland?
Certain Hong Kong food products (including beverages, pastries, confectionery, tea, specified noodle products, and condiments) enjoy customs facilitation where goods tested at customs are released immediately without waiting for test results. Meat and dairy exports have also been permitted since last year.
Who May Be Affected
Hong Kong health food manufacturers, exporters, local pharmaceutical and Chinese medicine businesses, and trade compliance professionals.
Cross-Border Context
Applies to Hong Kong enterprises seeking to export food, health products, pharmaceuticals, and proprietary Chinese medicines to Mainland China under GACC Decree No. 280.
What to check next
- Monitor future Legislative Council discussions or policy proposals regarding the classification and export registration pathways for health food products in Hong Kong.
This article provides general information and does not constitute legal advice. Consult the official text and obtain advice appropriate to your circumstances where needed.