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GB 31650-2019 (GB31650-2019)

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BASIC DATA
Standard ID GB 31650-2019 (GB31650-2019)
Description (Translated English) National Food Safety Standard -- Maximum Residue Limits for Veterinary Drugs in Food
Sector / Industry National Standard
Classification of Chinese Standard C53
Classification of International Standard 67.040
Word Count Estimation 64,670
Date of Issue 2019
Date of Implementation 2020-04-01

Standards related to: GB 31650-2019

GB 31650-2019
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
National food safety standard - Maximum residue
limits for veterinary drugs in foods
ISSUED ON: SEPTEMBER 06, 2019
IMPLEMENTED ON: APRIL 01, 2020
Issued by: Ministry of Agriculture and Rural Affairs of PRC;
National Health Commission of PRC;
State Administration for Market Regulation.
Table of Contents
Foreword ... 11 
1 Scope ... 12 
2 Normative references ... 12 
3 Terms and definitions ... 12 
3.1 Veterinary drug residue ... 12 
3.2 Total residue ... 12 
3.3 Acceptable daily intake (ADI) ... 13 
3.4 Maximum residue limit (MRL) ... 13 
3.5 Food-producing animal... 13 
3.6 Fish ... 13 
3.7 Poultry ... 13 
3.8 Animal derived food ... 13 
3.9 Edible Tissues ... 13 
3.10 Skin with fat ... 14 
3.11 Muscle with skin ... 14 
3.12 Byproducts ... 14 
3.13 Edible offal ... 14 
3.14 Muscle ... 14 
3.15 Egg ... 14 
3.16 Milk ... 14 
3.17 All other food-producing species ... 14 
4 Technical requirements ... 15 
4.1 Veterinary drugs with maximum residue limits in animal derived foods that have
been approved ... 15 
4.1.1 Albendazole ... 15 
4.1.2 Amitraz ... 15 
4.1.3 Amoxicillin ... 16 
4.1.4 Ampicillin ... 16 
4.1.5 Amprolium ... 16 
4.1.6 Apramycin ... 17 
4.1.7 Arsanilic acid/Roxarsone ... 17 
4.1.8 Avermectin ... 17 
4.1.9 Avilamycin ... 18 
4.1.10 Azaperone ... 18 
4.1.11 Bacitracin ... 19 
4.1.12 Benzylpenicillin/Procaine benzylpenicillin ... 19 
4.1.13 Betamethasone ... 19 
4.1.14 Carazolol ... 20 
4.1.15 Cefalexin ... 20 
4.1.16 Cefquinome ... 20 
4.1.17 Ceftiofur ... 21 
4.1.18 Clavulanic acid ... 21 
4.1.19 Clopidol ... 21 
4.1.20 Closantel ... 22 
4.1.21 Cloxacillin ... 22 
4.1.22 Colistin ... 22 
4.1.23 Cyfluthrin ... 23 
4.1.24 Cyhalothrin ... 23 
4.1.25 Cypermethrin and alpha-Cypermethrin ... 24 
4.1.26 Cyromazine ... 24 
4.1.27 Danofloxacin ... 24 
4.1.28 Decoquinate ... 25 
4.1.29 Deltamethrin ... 25 
4.1.30 Destomycin A ... 26 
4.1.31 Dexamethasone ... 26 
4.1.32 Diazinon ... 26 
4.1.33 Dichlorvos ... 27 
4.1.34 Diclazuril ... 27 
4.1.35 Dicyclanil ... 27 
4.1.36 Difloxacin ... 28 
4.1.37 Diminazene ... 28 
4.1.38 Dinitolmide ... 29 
4.1.39 Doramectin ... 29 
4.1.40 Doxycycline ... 29 
4.1.41 Enrofloxacin ... 30 
4.1.42 Eprinomectin ... 30 
4.1.43 Erythromycin ... 31 
4.1.44 Ethopabate ... 31 
4.1.45 Febantel/ Fenbendazole/ Oxfendazole ... 32 
4.1.46 Fenthion ... 32 
4.1.47 Fenvalerate ... 32 
4.1.48 Florfenicol ... 33 
4.1.49 Fluazuron ... 33 
4.1.50 Flubendazole ... 34 
4.1.51 Flugestone Acetate ... 34 
4.1.52 Flumequine ... 34 
4.1.53 Flumethrin ... 35 
4.1.54 Fluvalinate ... 35 
4.1.55 Gentamicin ... 36 
4.1.56 Halofuginone ... 36 
4.1.57 Imidocarb ... 36 
4.1.58 Isometamidium... 37 
4.1.59 Ivermectin ... 37 
4.1.60 Kanamycin ... 37 
4.1.61 Kitasamycin ... 38 
4.1.62 Lasalocid ... 38 
4.1.63 Levamisole ... 39 
4.1.64 Lincomycin ... 39 
4.1.65 Maduramicin ammonium ... 39 
4.1.66 Malathion ... 40 
4.1.67 Mebendazole ... 40 
4.1.68 Metamizole ... 40 
4.1.69 Monensin ... 41 
4.1.70 Moxidectin ... 41 
4.1.71 Narasin ... 42 
4.1.72 Neomycin ... 42 
4.1.73 Nicarbazin ... 42 
4.1.74 Nitroxinil ... 43 
4.1.75 Olaquindox ... 43 
4.1.76 Oxacillin ... 43 
4.1.77 Oxibendazole ... 44 
4.1.78 Oxolinic acid ... 44 
4.1.79 Oxytetracycline/Chlortetracycline/Tetracycline ... 45 
4.1.80 Phoxim ... 45 
4.1.81 Piperazine ... 45 
4.1.82 Pirlimycin ... 46 
4.1.83 Propetamphos... 46 
4.1.84 Rafoxanide ... 46 
4.1.85 Robenidine ... 47 
4.1.86 Salinomycin ... 47 
4.1.87 Sarafloxacin ... 47 
4.1.88 Semduramicin ... 48 
4.1.89 Spectinomycin ... 48 
4.1.90 Spiramycin ... 48 
4.1.91 Streptomycin/Dihydrostreptomycin ... 49 
4.1.92 Sulfadimidine ... 49 
4.1.93 Sulfonamides ... 50 
4.1.94 Thiabendazole ... 50 
4.1.95 Thiamphenicol ... 50 
4.1.96 Tiamulin ... 51 
4.1.97 Tilmicosin ... 51 
4.1.98 Toltrazuril... 52 
4.1.99 Trichlorfon ... 52 
4.1.100 Triclabendazole ... 52 
4.1.101 Trimethoprim ... 53 
4.1.102 Tylosin ... 53 
4.1.103 Tylvalosin ... 54 
4.1.104 Virginiamycin ... 54 
4.2 Veterinary drugs that are allowed to be used in food-producing animals, but do
not require a residue limit ... 55 
4.2.1 Acetic Acid ... 55 
4.2.2 Adrenosem ... 55 
4.2.3 Aluminium hydroxide ... 55 
4.2.4 Ammonium chloride ... 55 
4.2.5 Apramycin ... 55 
4.2.6 Artesunate ... 55 
4.2.7 Aspirin ... 55 
4.2.8 Atropine ... 55 
4.2.9 Azamethiphos ... 56 
4.2.10 Benzalkonium bromide ... 56 
4.2.11 Berberine... 56 
4.2.12 Betaine ... 56 
4.2.13 Bismuth subcarbonate ... 56 
4.2.14 Bismuth subnitrate ... 56 
4.2.15 Borax ... 56 
4.2.16 Boric acid and borates ... 56 
4.2.17 Caffeine ... 56 
4.2.18 Calcium borogluconate ... 57 
4.2.19 Calcium carbonate ... 57 
4.2.20 Calcium chloride ... 57 
4.2.21 Calcium gluconate ... 57 
4.2.22 Calcium hydrogen phosphate ... 57 
4.2.23 Calcium hypochlorite ... 57 
4.2.24 Calcium pantothenate ... 57 
4.2.25 Calcium peroxide ... 57 
4.2.26 Calcium phosphate ... 57 
4.2.27 Calcium sulphate ... 57 
4.2.28 Camphor ... 58 
4.2.29 Chlorhexidine ... 58 
4.2.30 Chlorinated lime ... 58 
4.2.31 Chlorite sodium ... 58 
4.2.32 Chlorocresol ... 58 
4.2.33 Choline ... 58 
4.2.34 Citrate ... 58 
4.2.35 Cloprostenol ... 58 
4.2.36 Copper sulfate... 58 
4.2.37 Cortisone ... 59 
4.2.38 Cresol ... 59 
4.2.39 Deciquam ... 59 
4.2.40 Decoquinate ... 59 
4.2.41 Diclazuril ... 59 
4.2.42 Dimercaprol ... 59 
4.2.43 Dimethicone ... 59 
4.2.44 Domiphen ... 59 
4.2.45 Dried yeast ... 59 
4.2.46 Epinephrine ... 60 
4.2.47 Ergometrine maleate ... 60 
4.2.48 Etamsylate ... 60 
4.2.49 Ethanol ... 60 
4.2.50 Ferrous sulphate ... 60 
4.2.51 Flumethrin ... 60 
4.2.52 Fluocinonide ... 60 
4.2.53 Folic acid ... 60 
4.2.54 Follicle stimulating hormone (natural FSH from all species and their
synthetic analogues) ... 61 
4.2.55 Formaldehyde ... 61 
4.2.56 Formic acid ... 61 
4.2.57 Gelatin ... 61 
4.2.58 Glucose ... 61 
4.2.59 Glutaraldehyde... 61 
4.2.60 Glycerol ... 61 
4.2.61 Gonadotrophin releasing hormone ... 61 
4.2.62 Halimide ... 61 
4.2.63 Human chorion gonadotrophin ... 61 
4.2.64 Hydrochloric acid ... 62 
4.2.65 Hydrochlorothiazide ... 62 
4.2.66 Hydrocortisone ... 62 
4.2.67 Hydrogen peroxide ... 62 
4.2.68 Ichthammol ... 62 
4.2.69 Idazoxan ... 62 
4.2.70 Iodine and iodine inorganic compounds including: sodium and potassium-
iodide, sodium and potassium-iodate ... 62 
4.2.71 Iron dextran ... 62 
4.2.72 Kaolin ... 62 
4.2.73 Ketamine ... 63 
4.2.74 Lactasin ... 63 
4.2.75 Lactic acid ... 63 
4.2.76 Lidocaine ... 63 
4.2.77 Luteinising hormone (natural LH from all species and their synthetic
analogues) ... 63 
4.2.78 Magnesium chloride ... 63 
4.2.79 Magnesium oxide ... 63 
4.2.80 Magnesium sulfate ... 63 
4.2.81 Mannitol ... 63 
4.2.82 Medicinal charcoal ... 64 
4.2.83 Menadione ... 64 
4.2.84 Methionine iodine ... 64 
4.2.85 Methylthioninium chloride ... 64 
4.2.86 Naproxen ... 64 
4.2.87 Neostigmine ... 64 
4.2.88 Neutralized eletrolyzed oxidized water ... 64 
4.2.89 Nicotinamide ... 64 
4.2.90 Nicotinic Acid ... 64 
4.2.91 Norepinephrine bitartrate ... 64 
4.2.92 Octicine ... 65 
4.2.93 Oxytocin ... 65 
4.2.94 Paracetamol ... 65 
4.2.95 Paraffin ... 65 
4.2.96 Pepsin ... 65 
4.2.97 Peracetic acid ... 65 
4.2.98 Phenol ... 65 
4.2.99 Polyethylene glycols (molecular weight ranging from 200 to 10000) ... 65 
4.2.100 Polysorbate 80 ... 65 
4.2.101 Posterior pituitary ... 65 
4.2.102 Potassium aluminium sulfate ... 66 
4.2.103 Potassium chloride ... 66 
4.2.104 Potassium permanganate ... 66 
4.2.105 Potassium peroxymonosulphate ... 66 
4.2.106 Potassium sulfate ... 66 
4.2.107 Povidone iodine ... 66 
4.2.108 Pralidoxime iodide ... 66 
4.2.109 Praziquantel (Praziquantel) ... 66 
4.2.110 Procaine ... 66 
4.2.111 Progesterone ... 66 
4.2.112 Pyrantel embonate ... 67 
4.2.113 Recombinant lysostaphin ... 67 
4.2.114 Salicylic acid ... 67 
4.2.115 Scoplamine ... 67 
4.2.116 Serum gonadotrophin ... 67 
4.2.117 Sodium bicarbonate ... 67 
4.2.118 Sodium bromide ... 67 
4.2.119 Sodium chloride ... 67 
4.2.120 Sodium dichloroisocyanurate ... 67 
4.2.121 Sodium dimercaptopropanesulfonate ... 68 
4.2.122 Sodium hydroxide ... 68 
4.2.123 Sodium lactate ... 68 
4.2.124 Sodium nitrite ... 68 
4.2.125 Sodium Perborate ... 68 
4.2.126 Sodium percarbonate ... 68 
4.2.127 Sodium Periodate ... 68 
4.2.128 Sodium pyrosulphite ... 68 
4.2.129 Sodium salicylate ... 68 
4.2.130 Sodium selenite ... 69 
4.2.131 Sodium stearate ... 69 
4.2.132 Sodium sulfate ... 69 
4.2.133 Sodium thiosulphate ... 69 
4.2.134 Soft soap ... 69 
4.2.135 Sorbitan trioleate ... 69 
4.2.136 Sorbitol ... 69 
4.2.137 Strychnine ... 69 
4.2.138 Sulfogaiacol ... 69 
4.2.139 Sulphur ... 70 
4.2.140 Tetracaine ... 70 
4.2.141 Thiopental sodium ... 70 
4.2.142 Vitamin A ... 70 
4.2.143 Vitamin B1 ... 70 
4.2.144 Vitamin B12 ... 70 
4.2.145 Vitamin B2 ... 70 
4.2.146 Vitamin B6 ... 70 
4.2.147 Vitamin C ... 70 
4.2.148 Vitamin D ... 71 
4.2.149 Vitamin E ... 71 
4.2.150 Vitamin K1 ... 71 
4.2.151 Xylazine ... 71 
4.2.152 Xylazole ... 71 
4.2.153 Zinc oxide ... 71 
4.2.154 Zinc sulphate ... 71 
4.3 Veterinary drugs allowed for therapeutic use but not detected in animal food
... 71 
4.3.1 Chlorpromazine... 71 
4.3.2 Diazepam ... 72 
4.3.3 Dimetridazole ... 72 
4.3.4 Estradiol Benzoate ... 72 
4.3.5 Hygromycin B (Hygromycin B) ... 72 
4.3.6 Metronidazole ... 72 
4.3.7 Nadrolone phenylpropionate ... 72 
4.3.8 Testosterone propinate ... 73 
4.3.9 Xylzaine ... 73 
Index of English common names of veterinary drugs ... 74 
Foreword
This standard replaces the relevant part of Announcement No.235 "Maximum
residue limits of veterinary drugs in food-producing animals", of the Ministry of
Agriculture.
Compared with the Announcement No.235 of the Ministry of Agriculture, the
main changes of this standard are as follows:
- ADD the term definitions of "Edible offal" and "All other food-producing
animals";
- ADD 13 kinds of veterinary drugs, including avilamycin, as well as their
residue limits;
- ADD the residue limits of 28 veterinary drugs, including albendazole;
- ADD acceptable daily intake of 15 veterinary drugs, including amoxicillin;
- ADD 73 kinds of veterinary drugs, which are allowed to be used in food-
producing animals, such as acetic acid, BUT do not need to establish
residue limits;
- REVISE the Chinese or English names of 17 veterinary drugs, including
acetyl isovaleryl tylosin;
- REVISE the acceptable daily intake of 9 veterinary drugs, including
apramycin;
- REVISE the residual markers of 15 veterinary drugs, including albendazole;
- REVISE the target tissues and residue limits of 29 veterinary drugs,
including abamectin;
- REVISE the requirements on the use of 23 veterinary drugs, including
amoxicillin;
- DELETE the residue limit of coumaphos;
- DELETE 6 veterinary drugs that are allowed to be used in food-producing
animals, BUT do not need to establish residue limits, such as amprolium;
- The list of prohibited drugs and compounds is no longer included.
National food safety standard - Maximum residue
limits for veterinary drugs in foods
1 Scope
This standard specifies the maximum residue limits of 104 kinds (categories) of
veterinary drugs, such as albendazole, in animal derived foods; specifies 154
veterinary drugs that are allowed to be used in food-producing animals, but do
not require establishing a residue limit, such as acetic acid; specifies 9 kinds of
veterinary drugs that are allowed to be used for therapeutic purposes BUT must
not be detected in food-producing animals, such as chlorpromazine.
This standard applies to animal derived foods, which are related to maximum
residue limits.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) is applicable to this standard.
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1 Veterinary drug residue
Refers to the residue of all drug-related substances, in any edible part of the
animal products, after the drug is used for food-producing animals, including
the original form of the drug or/and its metabolites.
3.2 Total residue
Refers to the original form of the drug or/and the sum of all its metabolites,
in any edible part of the animal product, after the drug is administered to
food-producing animals.
3.3 Acceptable daily intake (ADI)
It refers to the amount of a certain substance, which is ingested from food or
drinking water every day, during a person's life, without obvious harm to his
health. It is calculated on the basis of human body weight; the unit is µg/kg
of body weight.
3.4 Maximum residue limit (MRL)
After the drug is administered to food-producing animals, the maximum
amount/concentration of the veterinary drug residue, which is allowed to
exist on the surface or inside of the food (in terms of fresh weight, expressed
as µg/kg).
3.5 Food-producing animal
All animal species, for human consumption, OR their products, for human
consumption.
3.6 Fish
Refers to aquatic cold-blooded animals, including Pisces, Elasmobranchs,
Cyclostomes, excluding aquatic mammals, invertebrates, amphibians.
However, it shall be noted that this definition can be applied to certain
invertebrates, especially cephalopods.
3.7 Poultry
Domesticated poultry, including chickens, turkeys, ducks, geese, pigeons,
quails.
3.8 Animal derived food
Animal tissues for human consumption AND primary animal products, such
as eggs, milk, honey.
3.9 Edible Tissues
All edible animal tissues, including muscle, fat, liver, kidney and other organs.
3.10 Skin with fat
Edible skin with fat.
3.11 Muscle with skin
Generally, it refers to the muscle tissue, which has skin, of fish.
3.12 Byproducts
All edible tissues, except muscle and fat, including liver, kidney, etc.
3.13 Edible offal
Edible parts, except muscle, fat, liver, kidney.
3.14 Muscle
Refers to muscle tissue only.
3.15 Egg
Shell eggs, which are produced by domestic hens.
3.16 Milk
Milk, which is secreted from normal breasts, through one or more milking,
without additions or extractions. This term can also be used for milk, which
has been processed without changing its composition, OR milk, which has
been standardized for fat content, in accordance with national legislation.
3.17 All other food-producing species
All food-producing species, other than those clearly specified under each
species.
...