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Regulatory Standards for Chinese Medicinal Preparations in Major Countries Worldwide

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2007/8/23

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1. General Items

All countries must conduct general inspections on Chinese medicinals preparations (including loss on drying, ash content, acid-insoluble ash, water extract, dilute alcohol extract, etc.), TLC identification reactions, and HPLC content analysis.

2. Heavy Metal Limits

Item	USA	EU	South Korea	Japan	Hong Kong	Mainland China	Taiwan*	WHO
Total Heavy Metals	<20ppm	<20ppm	<30ppm	<30ppm	-	<20ppm	<100ppm		ADI**
Lead (Pb)	<5ppm	<5ppm	<5ppm	<5ppm	<179mcg/天	<5ppm	-	<10ppm	214ug
Mercury (Hg)	<0.1ppm	<0.1ppm	<0.2ppm	<0.1ppm	<36mcg/天	<0.2ppm	-	-	43ug
Cadmium (Cd)	<0.2ppm	<0.2ppm	<0.3ppm	<0.2ppm	<3500mcg/dose	<0.3ppm	-	<0.3ppm	60ug
Arsenic (As)	<1.0ppm	<1.0ppm	<3.0ppm	<3ppm	<1500mcg/天	<2.0ppm	－	－	128ug
Copper (Cu)	－	－	－	－	－	<20ppm	－	－

＊The Taiwan Department of Health stipulates that scientific Chinese medicinals produced after July 1, 2010, must meet new standards: total heavy metals below 30ppm, including 33 commonly used scientific Chinese medicinals such as Pueraria Decoction, Minor Green-Blue Dragon Decoction, and Supplemented Peripatetic Powder, with individual heavy metal contents of arsenic, cadmium, mercury, and lead also required to meet regulations, with arsenic and lead below 3 and 10ppm, and cadmium and mercury below 0.5ppm.

＊The European Union, the United States, and Japan have integrated their pharmacopoeia contents, unifying specifications to be more consistent.

**ADI: Acceptable Daily Intake (maximum daily intake for a 60KG adult)

III. Toxic Substances

Item	USA, EU	Korea	Hong Kong	Mainland China	Taiwan
Total Aflatoxins (B1, B2, G1, G2)	<4ppb	-	-	-	<15ppb(註一)
Aflatoxin B1	<2ppb	-	-	-	-
Dutohmanspipe Fruit Acid	LC-mass mass Not detectable	-	-	-	HPLC Not detectable (below 4000ppb)
Pyrrolizidine alkaloids (Coltsfoot Flower, climbing groundsel herb, Arnebia, Fortune Eupatorium)	LC-mass mass Not detectable	-	-	-	-
Ephedrine	Not detectable	-	-	-	－
Sulfur Dioxide	General Food Regulations <30ppm	<30ppb	－	－	<500ppm(註二)

Note 1: Chinese Star Anise, Chinese Date, Areca Peel, Glossy Privet Fruit, Fennel, Hawthorn Fruit, Asiatic Cornelian Cherry Fruit, Barbary Wolfberry Fruit, Pepper Fruit, Koji, Corydalis Tuber, Tangerine Peel, Astragalus Root, Lotus Seed medicinal materials and their single-formulation preparations must be tested for aflatoxins.

Note 2: In Taiwan, sulfur dioxide testing is limited to Chinese Yam, Ginkgo Seed, and Lily Bulb among medicinal materials.
4. Microbial Limits

Item	USA	EU, Japan			Korea	Taiwan
Microorganisms		General Preparations	Crushed Tablet Type Must be brewed with boiling water before consumption	Crushed Tablet Type Direct Consumption
Aerobic Total Plate Count	<10,000	<10,000	<10,000,000	<100,000	<10,000	<10 million
Mold & Yeast	<100	<100	<100,000	<10,000	<100	<10000
Gastrointestinal Tract & Gram-Negative Bacteria	－	<100	－	<1,000	－	－
Large Intestine Bacillus	Not Detected	Not Detected	<100	Not Detected	Not Detected	<100
Salmonella	Not detected	Not detected	－	Not detected	Not detected	Not detected
Pseudomonas aeruginosa	Not detected	Not detected	－	－	Not detected	－

Mainland and Hong Kong regions:

Microbial limit standards of the Chinese Pharmacopoeia for Chinese patent drugs (unit: CFU/g or CFU/mL)

Dosage form	Item 1	Item 2	Item 3 (Specific bacteria)
Dosage form	Total bacterial count	Mold and yeast count	Escherichia coli	Staphylococcus aureus	Pseudomonas aeruginosa
Pill
Without original medicinal materials	1000	100	Not detected
Containing raw medicinal materials	30000	100	Not detectable
powder	30000	100	Not detectable
Oral and external use	30000	100	Not detectable	Not detectable	Not detectable
granule, tablet, and capsule
Not containing raw medicinal materials	1000	100	Not detectable
Contains raw medicinal materials	10000	100	Not detectable
lozenge	10000	100	Not detectable
Oral and topical use	10000	100	Not detectable	Not detectable	Not detectable
Soft extract preparation	100	100	Not detectable
Gel preparation	1000	100	Not detectable
Syrup preparations, mixtures	100	100	Not detectable
drop pill dose	1000	100	not detectable
wine preparation	500	100	not detectable
external use	500	100		not detectable	not detectable
tincture	100	100	not detectable
For external use	100	100		Not detectable	Not detectable
liquid extract and extract	100	100	Not detectable
ointment	1000	100		Not detectable	Not detectable
For burns, ulcers, and wounds	100	10		Not detectable	Not detectable
distillate	100	100	Not detectable
medicated tea
Sugar-free	10000	100	Not detectable
Contains sugar	1000	100	Not detectable
Liniment	100	100
Suppository	10000	100		Not detectable	Not detectable
For ulcers, bleeding	100	10		Not detectable	Not detectable
Nasal drops, aerosol, spray	100	10	Not detectable	Not detectable	Not detectable
Eye drops	100	Not detectable		Not detectable	Not detectable

V. Pesticide Residues

A. USA, EU, Mainland China, Hong Kong, Taiwan

Item	USA, EU	Mainland China, Hong Kong	Taiwan
Alachlor	<20
Aldrin & Dieldrin	<50	<50	-
Azinphos-methyl	<1000
Bromopropylate	<3000
Chlordane (sum of cis,trans and xythlordane)	<50	<50
Chlorfenvinphos	<500
Chlorpyrifos	<200
CHlorpyrifos-methyl	<100
DDT(sum of DDT, DDE and TDE)	<1000	<1000	<1000
Deltamethrin	<500
Diazinon	<500
Dichlorvos	<1000
Dithiocarbamates	<2000
Endosulfan(sum of isomers & Endosulfan sulphate)	<3000
Endrin	<50	<50
Ethion	<2000
Fenitrothion	<500
Fenvalerate	<1500
Fonofos	<50
Heptachlor (sum of Heptachlor and Heptachlorepoxide)	<50	<50
Hexachlorobenzene	<100	<100
Hexachlorocyclohexane isomers (other than γ)	<300	<300	The total of both is <900
Lindane( γ- Hexachlorocyclohexane)	<600	<600	The total of both is <900
Malathion	<1000
Methidathion	<200
Parathion	<500
Parathion-methyl	<200
Permethrin	<1000
Phosalone	<100
Piperonyl butoxide	<3000
Pirimiphos-methyl	<4000
Pyrethrins (sum of)	<3000
Quintozene	<1000	<1000	<1000

Note: Taiwan's pesticide residue limits apply only to Ginseng, Liquorice Root, Astragalus Root, and Senna Leaf in raw materials and single-ingredient preparations.

B. Japan's Pesticide Residue Limits

1. Chinese Medicinals (Raw Materials): (Industry Standards for Pesticide Residues in Herbal Medicines)

Scope of Application: Astragalus Root, Milkwort Root, Liquorice Root, Cassia Bark, Asarum, Asiatic Cornelian Cherry Fruit, Cultivated Purple Perilla Leaf, Chinese Date, Dried Tangerine Peel, Loquat Leaf, Peony Bark

Total BHC ≤ 0.2 mg/kg, Total DDT ≤ 0.2 mg/kg

2. Chinese Medicinals (Preparations): (Industry Standards for Pesticide Residues in Kampo and Herbal Preparations)

1) Organochlorine Pesticides:

Scope of Application: Kampo and herbal preparations containing Astragalus Root, Milkwort Root, Liquorice Root, Cassia Bark, Asarum, Asiatic Cornelian Cherry Fruit, Cultivated Purple Perilla Leaf, Chinese Date, Dried Tangerine Peel, Loquat Leaf, Peony Bark, Ginseng, Red Ginseng, Senna Leaf

Total BHC ≤ 0.2 mg/kg, Total DDT ≤ 0.2 mg/kg

2) Organophosphate Pesticides:

Scope of Application: Kampo preparations containing Milkwort Root, Asiatic Cornelian Cherry Fruit, Cultivated Purple Perilla Leaf, and Dried Tangerine Peel

Parathion ≤ 0.5 mg/kg, Methyl Parathion ≤ 0.2 mg/kg, Methidathion ≤ 0.2 mg/kg,

Malathion ≤ 1.0 mg/kg

3) Pyrethroid Pesticides

Scope of Application: Kampo preparations containing Milkwort Root, Cultivated Purple Perilla Leaf, Chinese Date, Dried Tangerine Peel, and Loquat Leaf

Fenvalerate ≤ 1.5 mg/kg, Cypermethrin ≤ 1.0 mg/kg

C. South Korea's Pesticide Residue Limits (Ministry of Food and Drug Safety Announcement No. 2004-197)

1. All Herbal Medicines:

Pesticide Name	Permissible Limit (ppm)
Total BHC (sum of α, β, γ, and δ-BHC)	0.2
Total DDT (sum of p, p'-DDD, p, p'-DDE, o, p'-DDT, and p, p'-DDT)	0.1
Aldrin	0.01
Endrin	0.01
Dieldrin	0.01
Methoxychlor	1.0
Cypermethrin	0.5
Endosulfan (sum of α,β-endosulfan and endosulfan sulfate)	0.2
Chinomethionat	0.3
Captan	2.0
Quintozene, PCNB	0.1
Chlorothalonil	0.1
Chloropyrifos	0.5
Tolylfluanid	1.0
Procymidone	0.1

2. Individual Pesticides: (ppm)

1) Napropamide: Platycodon Root 0.1, Peony Root 0.1, Astragalus 0.1

2) Dimethyldithiocarbamates: Carthamus 0.1

3) Difenoconazole: Liquorice Root 0.05

4) Myclobutanil: Peony Root 0.1

5) Bifenthrin: Sichuan Lovage Rhizome 0.5, Carthamus 0.1

6) Cyprodinil: Peony Root 0.1

7) Acetamiprid: Astragalus 0.1, Carthamus 0.1

8) Azocyclotin: Chinese Angelica 0.2

9) Azoxystrobin: Liquorice Root 0.05, Chinese Angelica 0.1, Astragalus 0.1

10) Ethylenebis-dithiocarbamates: Carthamus 0.3

11) Iminoctadine: Peony Root 0.3, Carthamus 0.1

12) Imidacloprid: Carthamus 0.1, Astragalus 0.3

13) Thiamethoxam: Astragalus 0.1

14) Carbandazim: Peony Root 0.05

15) Chlorfenapyr: Chuanxiong 0.05

16) Tebuconazol: Chinese Angelica 1.0

17) Triadimenol: Peony Root 0.1

18) Triadimefon: Peony Root 0.01

19) Triforine: Peony Root 0.1

20) Triflumizole: Astragalus 0.1, Peony Root 1.0

21) Fenarimol: Astragalus 0.5

22) Pendimethalin: Chinese Angelica 0.2, Ophiopogon Tuber 0.2, Bupleurum 0.2, Peony Root 0.2, Carthamus 0.1

23) Fenpropathrin: Chinese Angelica 0.2

24) Fosthiazate: Bupleurum 0.02

25) Propineb: Peony Root 0.2

26) Pymetrozine: Carthamus 0.05, Astragalus 0.05

27) Fludioxonil: Peony Root 0.1

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