Cap. 132 sub. leg. AF

Harmful Substances in Food Regulations(Cap. 132, section 55(1)) [27 May 1983](Format changes—E.R. 2 of 2012) 1. Citation and commencement (1) These regulations may be cited as the Harmful Substances in Food Regulations. (2) Regulation 3 insofar as it applies to item 2 in Schedule 1 came into effect on 1 January 1985. (E.R. 2 of 2012) 2. Interpretation In these regulations, unless the context otherwise requires—air transhipment cargo (航空轉運貨物) has the meaning assigned to it in section 2 of the Import and Export Ordinance (Cap. 60); (29 of 2000 s. 5)air transit cargo (航空過境貨物) means any article in transit that is both imported and consigned for export in an aircraft; (29 of 2000 s. 5)article in transit (過境物品) has the meaning assigned to it in section 2 of the Import and Export Ordinance (Cap. 60); (29 of 2000 s. 5)cargo transhipment area of Hong Kong International Airport (機場貨物轉運區) has the meaning assigned to it in section 2 of the Import and Export Ordinance (Cap. 60); (29 of 2000 s. 5) condensed milk (煉奶) means milk which has been condensed by the evaporation of a portion of its water content, whether or not sugar has been added, and includes— (a) any such milk made from skimmed milk or partly skimmed milk; and (b) evaporated milk; (L.N. 173 of 2011) dried milk (奶粉) means milk which has been concentrated in the form of solid or powder by removal of water, whether or not it has been sweetened, modified or compounded, and includes any such milk made from skimmed milk or partly skimmed milk; (L.N. 173 of 2011)fatty acid (脂肪酸) means any carboxylic acid obtained by the hydrolysis of oil or fat, and includes any such acid existing in a free state in oil or fat;fish (魚) does not include live fish other than shell fish; (L.N. 173 of 1986)follow-up formula (較大嬰兒及幼兒配方產品) has the meaning given by regulation 2(1) of the Food and Drugs (Composition and Labelling) Regulations (Cap. 132 sub. leg. W); (L.N. 86 of 2021)food animal (食用動物) means an animal or bird commonly kept for the purpose of providing food for human consumption; (L.N. 148 of 2001)infant formula (嬰兒配方產品) has the meaning given by regulation 2(1) of the Food and Drugs (Composition and Labelling) Regulations (Cap. 132 sub. leg. W); (L.N. 86 of 2021)low erucic acid rapeseed oil (低芥酸菜籽油) means any vegetable oil produced from low erucic acid oil-bearing seeds of varieties derived from the Brassica napus L., Brassica rapa L. and Brassica juncea L., species; (L.N. 86 of 2021) meat (肉類) means the flesh or other edible part (including blood) of— (L.N. 148 of 2001) (a) any animal; or (b) any bird, intended for human consumption; (L.N. 173 of 1986) milk (奶類) means cows milk, buffaloes milk and goats milk, and includes cream, separated milk and milk beverage, but does not include dried milk, condensed milk or reconstituted milk; (L.N. 215 of 2008 and L.N. 253 of 2008)milk beverage (奶類飲品) means any beverage resulting from combining liquid milk fat with other solids derived from milk, whether exclusive of any food additive or otherwise; (L.N. 215 of 2008 and L.N. 253 of 2008)oil or fat (油或脂肪) means oil or fat derived from any animal, bird, fish or plant but does not include any essential oil;partially hydrogenated oil (部分氫化油) means any oil or fat that has undergone the process of hydrogenation but is not fully saturated as a result of that process; (L.N. 86 of 2021)peanut (花生) means groundnut or the seed of Arachis hypogaea L.;peanut products (花生產品) includes oil of peanut or any product containing peanut as its ingredient;reconstituted milk (再造奶) means products resulting from the recombining with water of milk constituents, namely, milk fat and other solids derived from milk exclusive of any other substance, and includes the products resulting from the melting of frozen concentrated milk; (L.N. 173 of 2011)sell (售賣) includes offer, or expose for sale or have in possession for sale; (L.N. 173 of 2011)skimmed milk (脫脂奶) includes separated milk and machine skimmed milk. (L.N. 173 of 2011)(L.N. 67 of 1985; L.N. 331 of 1987; L.N. 148 of 2001; E.R. 2 of 2012) 3. Prohibition of import and sale of food containing certain substances in excessive concentrations A person must not import, consign, deliver, manufacture or sell, for human consumption, any food of a description specified in Column D of Schedule 1 which contains any substance specified opposite thereto in Column B, or the description of such substance in Column C, in greater concentration than is specified opposite thereto in Column E.(L.N. 148 of 2001; L.N. 173 of 2011; E.R. 2 of 2012) 3A. Prohibition of import and sale of certain food or oil etc. containing prohibited substances (L.N. 173 of 2011; L.N. 86 of 2021)(1) A person must not import, sell or consign or deliver for sale for human consumption, any fish, meat, milk, dried milk, condensed milk or reconstituted milk which contains any substance specified in Schedule 2. (L.N. 86 of 2021)(2) A person must not import for human consumption any oil or fat or a mixture of oil and fat containing partially hydrogenated oil. (L.N. 86 of 2021)(3) A person must not sell, or consign or deliver for sale, for human consumption any food (including any oil or fat or a mixture of oil and fat) containing partially hydrogenated oil. (L.N. 86 of 2021)(L.N. 148 of 2001; L.N. 230 of 2001; L.N. 173 of 2011; E.R. 2 of 2012) 3B. Application to air transit or air transhipment cargo (1) Regulations 3 and 3A do not apply in relation to the import of any food referred to in those regulations that is air transit cargo or air transhipment cargo; but if at any time between its being brought into and taken out of Hong Kong such food is removed from the cargo transhipment area of Hong Kong International Airport then, for the purposes of regulations 3 and 3A— (L.N. 86 of 2021)(a) the food is deemed to be imported at the time of such removal; and(b) the person who brought the food, or caused it to be brought, into Hong Kong as air transit cargo or air transhipment cargo is deemed to be the person who imports the food at the time of its removal,and, except to that extent, those regulations have effect as if this paragraph had not been enacted. (L.N. 86 of 2021)(2) In proceedings against a person for an offence under regulation 5, being proceedings—(a) in relation to the import of any food referred to in regulation 3 or 3A that is air transit cargo or air transhipment cargo; and (L.N. 86 of 2021)(b) in which it is necessary for the prosecution to prove that, at any time between its being brought into and taken out of Hong Kong, the food was removed from the cargo transhipment area of Hong Kong International Airport,it is a defence for the person to show that he took all reasonable steps and exercised reasonable diligence to avoid such removal occurring.(3) Where in any proceedings the defence provided by paragraph (2) involves an allegation that the commission of the offence was due to—(a) the act or default of another person; or(b) reliance on information given by another person,the defendant is not, without the leave of the court, entitled to rely on the defence unless, not less than 10 days before the hearing of the proceedings, he has served a notice in writing on the prosecutor giving all particulars of—(i) the person who committed the act or default or gave the information; and(ii) the act, default or information,of which he is aware at the time he serves the notice.(4) A person is not entitled to rely on the defence provided by paragraph (2) by reason of his reliance on information supplied by another person, unless he shows that it was reasonable in all the circumstances for him to have relied on the information, having regard in particular to—(a) the steps which he took, and those which might reasonably have been taken, for the purpose of verifying the information; and(b) whether he had any reason to disbelieve the information.(29 of 2000 s. 5) 4. Amendment of Schedule 1 The Director of Food and Environmental Hygiene may, by notice published in the Gazette, amend the concentrations specified in Column E of Schedule 1.(L.N. 67 of 1985; L.N. 173 of 1986; L.N. 85 of 1990; 78 of 1999 s. 7; L.N. 148 of 2001; E.R. 2 of 2012) 5. Offence and penalties Any person who contravenes regulation 3 or 3A commits an offence and is liable to a fine at level 5 and to imprisonment for 6 months. (L.N. 173 of 1986; L.N. 331 of 1987; L.N. 177 of 1996) 6. Name in which proceedings may be brought Without prejudice to the provisions of any other enactment relating to the prosecution of criminal offences and without prejudice to the powers of the Secretary for Justice in relation to the prosecutions of criminal offences, prosecutions for an offence under any of the provisions of these regulations may be brought in the name of the Director of Food and Environmental Hygiene.(L.N. 362 of 1997; 78 of 1999 s. 7) Schedule 1 [regs. 3 & 4]Maximum Concentration of Certain Substances Present in Specified Foods A B C D E Item Substance Description of substance Description of food Maximum concentration 1. Aflatoxin B1 Infant formula and follow-up formula other than formula manufactured from milk proteins 0.1 microgram per kilogram of the food.(Note 1) Any other food intended to be consumed principally by persons under the age of 36 months other than infant formula and follow-up formula manufactured from milk proteins 0.1 microgram per kilogram of the food.(Note 2) (L.N. 86 of 2021) 1A. Aflatoxin M1 Infant formula and follow-up formula intended to be consumed principally by persons under the age of 12 months 0.025 microgram per kilogram of the food.(Note 1) Any other milk or dried milk 0.5 microgram per kilogram of the food.(Note 1) (L.N. 86 of 2021) 1B. Aflatoxins, total Sum of aflatoxins B1, B2, G1 and G2 Non-ready-to-eat almonds, Brazil nuts, hazelnuts, peanuts and pistachios 15 micrograms per kilogram of the food. Non-ready-to-eat peanut products and products of almonds, Brazil nuts, hazelnuts and pistachios 15 micrograms per kilogram of the food. Spices 15 micrograms per kilogram of the food. Any other food 10 micrograms per kilogram of the food. (L.N. 86 of 2021) 2. Amoxycillin Muscle, liver and kidney of all food animals 50 micrograms per kilogram of the food. Milk 4 micrograms per kilogram of the food. 3. Ampicillin Muscle, liver and kidney of all food animals 50 micrograms per kilogram of the food. Milk 4 micrograms per kilogram of the food. 4. Bacitracin Muscle, liver and kidney of bovine, porcine and poultry 500 micrograms per kilogram of the food. Milk 500 micrograms per kilogram of the food. 4A. Benzo[a]pyrene Oil or fat or any mixture of oil and fat 5 micrograms per kilogram of the food. Infant formula and follow-up formula intended to be consumed principally by persons under the age of 12 months 1 microgram per kilogram of the food. (L.N. 86 of 2021) 5. Benzylpenicillin Muscle, liver and kidney of all food animals 50 micrograms per kilogram of the food. Milk 4 micrograms per kilogram of the food. 6. Carbadox Quinoxaline-2-carboxylic acid Muscle of porcine 5 micrograms per kilogram of the food. Liver of porcine 30 micrograms per kilogram of the food. 7. Ceftiofur Desfuroylceftiofur Muscle of bovine and porcine 1 000 micrograms per kilogram of the food. Liver of bovine and porcine 2 000 micrograms per kilogram of the food. Kidney of bovine and porcine 6 000 micrograms per kilogram of the food. Milk 100 micrograms per kilogram of the food. 8. Chlortetracycline Sum of the parent drug and its 4-epimers Muscle of all food animals 100 micrograms per kilogram of the food. Liver of all food animals 300 micrograms per kilogram of the food. Kidney of all food animals 600 micrograms per kilogram of the food. Milk 100 micrograms per kilogram of the food. 9. Cloxacillin Muscle, liver and kidney of all food animals 300 micrograms per kilogram of the food. Milk 30 micrograms per kilogram of the food. 10. Colistin Muscle and liver of bovine, porcine and poultry 150 micrograms per kilogram of the food. Kidney of bovine, porcine and poultry 200 micrograms per kilogram of the food. Milk 50 micrograms per kilogram of the food. 11. Danofloxacin Muscle of bovine and poultry 200 micrograms per kilogram of the food. Muscle of porcine 100 micrograms per kilogram of the food. Liver of bovine and poultry 400 micrograms per kilogram of the food. Liver of porcine 50 micrograms per kilogram of the food. Kidney of bovine and poultry 400 micrograms per kilogram of the food. Kidney of porcine 200 micrograms per kilogram of the food. 11A. Deoxynivalenol Cereal-based foods intended to be consumed principally by persons under the age of 36 months 200 micrograms per kilogram of the food.(Note 2) (L.N. 86 of 2021) 12. Dicloxacillin Muscle, liver and kidney of all food animals 300 micrograms per kilogram of the food. Milk 30 micrograms per kilogram of the food. 13. Dihydro-streptomycin Sum of dihydrostrepto-mycin and streptomycin Muscle and liver of bovine, porcine and poultry 500 micrograms per kilogram of the food. Kidney of bovine, porcine and poultry 1 000 micrograms per kilogram of the food. Milk 200 micrograms per kilogram of the food. 14. Dimetridazole Muscle, liver and kidney of porcine and poultry 5 micrograms per kilogram of the food. 15. Doxycycline Muscle of bovine, porcine and poultry 100 micrograms per kilogram of the food. Liver of bovine, porcine and poultry 300 micrograms per kilogram of the food. Kidney of bovine, porcine and poultry 600 micrograms per kilogram of the food. 16. Enrofloxacin Sum of enrofloxacin and ciprofloxacin Muscle of bovine, porcine and poultry 100 micrograms per kilogram of the food. Liver of bovine 300 micrograms per kilogram of the food. Liver of porcine and poultry 200 micrograms per kilogram of the food. Kidney of bovine 200 micrograms per kilogram of the food. Kidney of porcine and poultry 300 micrograms per kilogram of the food. Milk 100 micrograms per kilogram of the food. 17. Erucic acid The fatty acid cis-docos-13-enoic acid Low erucic acid rapeseed oil 2 per centum by weight of its fatty acid content. Any other oil or fat or any mixture of oil and fat 5 per centum by weight of its fatty acid content. Any food to which oil or fat or a mixture of oil and fat has been added 5 per centum by weight of its fatty acid content of all the oils and fats in the food. (L.N. 86 of 2021) 18. Erythromycin Muscle, liver and kidney of bovine, porcine and poultry 400 micrograms per kilogram of the food. Milk 40 micrograms per kilogram of the food. 19. Flumequine Muscle and liver of bovine, porcine and poultry 500 micrograms per kilogram of the food. Kidney of bovine, porcine and poultry 3 000 micrograms per kilogram of the food. 20. Furaltadone Muscle of porcine and poultry 0 microgram per kilogram of the food. 21. Furazolidone Muscle, liver and kidney of bovine, porcine and poultry 0 microgram per kilogram of the food. 22. Gentamicin Muscle of bovine, porcine and poultry 100 micrograms per kilogram of the food. Liver of bovine and porcine 2 000 micrograms per kilogram of the food. Kidney of bovine and porcine 5 000 micrograms per kilogram of the food. Liver and kidney of poultry 100 micrograms per kilogram of the food. Milk 200 micrograms per kilogram of the food. 22A. Glycidyl fatty acid esters Glycidyl fatty acid esters expressed as glycidol Powdered infant formula and powdered follow-up formula intended to be consumed principally by persons under the age of 12 months 50 micrograms per kilogram of the food. Liquid infant formula and liquid follow-up formula intended to be consumed principally by persons under the age of 12 months 6 micrograms per kilogram of the food. (L.N. 86 of 2021) 23. Ivermectin 22, 23-Dihydro-avermectin B1a (H2B1a) Liver of bovine 100 micrograms per kilogram of the food. Liver of porcine 15 micrograms per kilogram of the food. 24. Josamycin Muscle and liver of poultry 200 micrograms per kilogram of the food. Kidney of poultry 400 micrograms per kilogram of the food. 25. Kitasamycin Muscle, liver and kidney of porcine and poultry 200 micrograms per kilogram of the food. 26. Lincomycin Muscle of bovine, porcine and poultry 100 micrograms per kilogram of the food. Liver of bovine, porcine and poultry 500 micrograms per kilogram of the food. Kidney of bovine, porcine and poultry 1 500 micrograms per kilogram of the food. Milk 150 micrograms per kilogram of the food. 26A. Malachite green Sum of malachite green and leucomalachite green Any food (including live fish, live reptiles and live poultry) 0 microgram per kilogram of the food. (L.N. 137 of 2005) 26B. Melamine Liquid infant formula and liquid follow-up formula intended to be consumed principally by persons under the age of 12 months 0.15 milligram per kilogram of the food. Milk other than liquid infant formula and liquid follow-up formula intended to be consumed principally by persons under the age of 12 months 1 milligram per kilogram of the food. Any other food intended to be consumed principally by persons under the age of 36 months 1 milligram per kilogram of the food. Any food intended to be consumed principally by pregnant or lactating women 1 milligram per kilogram of the food. Any other food 2.5 milligrams per kilogram of the food. (L.N. 86 of 2021) 27. Metronidazole Muscle, liver and kidney of porcine and poultry 0 microgram per kilogram of the food. 28. Neomycin Muscle and liver of bovine, porcine and poultry 500 micrograms per kilogram of the food. Kidney of bovine, porcine and poultry 10 000 micrograms per kilogram of the food. Milk 500 micrograms per kilogram of the food. 29. Oxolinic acid Muscle of bovine, porcine and poultry 100 micrograms per kilogram of the food. Liver and kidney of bovine, porcine and poultry 150 micrograms per kilogram of the food. 30. Oxytetracycline Sum of parent drug and its 4-epimer Muscle of all food animals 100 micrograms per kilogram of the food. Liver of all food animals 300 micrograms per kilogram of the food. Kidney of all food animals 600 micrograms per kilogram of the food. Milk 100 micrograms per kilogram of the food. 30A. Patulin Apple juice and other beverages to which apple juice has been added 50 micrograms per kilogram of the food.(Note 1) (L.N. 86 of 2021) 31. Sarafloxacin Muscle of poultry 10 micrograms per kilogram of the food. Liver and kidney of poultry 80 micrograms per kilogram of the food. 32. Spectinomycin Muscle of bovine, porcine and poultry 500 micrograms per kilogram of the food. Liver of bovine, porcine and poultry 2 000 micrograms per kilogram of the food. Kidney of bovine, porcine and poultry 5 000 micrograms per kilogram of the food. Milk 200 micrograms per kilogram of the food. 33. Streptomycin Sum of dihydro-streptomycin and streptomycin Muscle and liver of bovine, porcine and poultry 500 micrograms per kilogram of the food. Kidney of bovine, porcine and poultry 1 000 micrograms per kilogram of the food. Milk 200 micrograms per kilogram of the food. 34. Sulfonamides Sum of all substances belonging to the sulfonamide group Muscle, liver and kidney of all food animals 100 micrograms per kilogram of the food. Milk 100 micrograms per kilogram of the food. 35. Tetracycline Sum of parent drug and its 4-epimer Muscle of all food animals 100 micrograms per kilogram of the food. Liver of all food animals 300 micrograms per kilogram of the food. Kidney of all food animals 600 micrograms per kilogram of the food. Milk 100 micrograms per kilogram of the food. 36. Tiamulin Sum of metabolites that may be hydrolysed to 8-alpha-hydroxymutilin Muscle of porcine and poultry 100 micrograms per kilogram of the food. Liver of porcine 500 micrograms per kilogram of the food. Liver of poultry 1 000 micrograms per kilogram of the food. 37. Trimethoprim Muscle, liver and kidney of bovine, porcine and poultry 50 micrograms per kilogram of the food. Milk 50 micrograms per kilogram of the food. 38. Tylosin Muscle, liver and kidney of bovine, porcine and poultry 200 micrograms per kilogram of the food. Milk 50 micrograms per kilogram of the food. 39. Virginiamycin Muscle of porcine 100 micrograms per kilogram of the food. Liver of porcine 300 micrograms per kilogram of the food. Kidney of porcine 400 micrograms per kilogram of the food. 40. 3-monochloropropane-1,2-diol Solid condiments containing acid hydrolysed vegetable proteins 1 milligram per kilogram of the food. Any other condiments containing acid hydrolysed vegetable proteins 0.4 milligram per kilogram of the food. (L.N. 86 of 2021) Note 1: The maximum concentration applies to the food that is, or is reconstituted to be, ready for consumption. Note 2: The maximum concentration applies to the dry matter of the food. (Schedule 1 replaced L.N. 148 of 2001. L.N. 86 of 2021) Schedule 2 [reg. 3A]Prohibited Substances 1. Dienoestrol ((E,E)-4,4’-(diethylideneethylene) diphenol) including salts and esters thereof. 2. Diethylstilboestrol ((E)-αβ-diethylstilbene-4,4’-diol) including salts and esters thereof. 3. Hexoestrol (meso-4,4’-(1,2-diethylethylene) diphenol) including salts and esters thereof. 4. Avoparcin. (L.N. 148 of 2001) 5. Clenbuterol. (L.N. 148 of 2001) 6. Chloramphenicol. (L.N. 148 of 2001) 7. Salbutamol. (L.N. 148 of 2001)(L.N. 173 of 1986)