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title	Standards for Chinese Herbal Medicine Preparations in Major Countries around the World

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1. General projects

Countries around the world are required to conduct general inspections of Chinese materia medica preparations (drying weight loss, ash content, acid-insoluble ash content, water extract, dilute alcohol extract, etc.), TLC identification reaction, HPLC content analysis, etc.

2. Heavy metal limits

item	United States	EU	South Korea	Japan	Hong Kong	Mainland	Taiwan*	WHO
Total heavy metals	<20ppm	<20ppm	<30ppm	<30ppm	-	<20ppm	<100ppm		ADI**
Lead(Pb)	<5ppm	<5ppm	<5ppm	<5ppm	<179mcg/day	<5ppm	-	<10ppm	214ug
Mercury (Hg)	<0.1ppm	<0.1ppm	<0.2ppm	<0.1ppm	<36mcg/day	<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/day	<2.0ppm	-	－	128ug
Copper (Cu)	－	－	－	－	－	<20ppm	－	－

Treatment of influenza, enterovirus, and various viral colds, Chinese medicine is more refined, non-toxic, and effective than Western medicine

＊Taiwan’s Department of Health stipulates that scientific Chinese materia medica produced since 2010/7/1 must meet the new standard: total heavy metals below 30ppm, including 33 commonly used scientific Chinese materials such as Pueraria Decoction, Minor Green-Blue Dragon Decoction and Supplemented Peripatetic Powder. The content of individual heavy metals such as arsenic, cadmium, mercury, and lead in materia medica must also comply with regulations. Arsenic and lead must be below 3 and 10 ppm, and cadmium and mercury must be below 0.5 ppm.

*The European Union, the United States, and Japan have integrated their pharmacopoeia contents and unified specifications.

**ADI: Acceptable Daily Intake (maximum daily intake for adults of 60KG)

3. Toxic substances

item	United States, European Union	South Korea	Hong Kong	Mainland	Taiwan
Total aflatoxins (B1, B2, G1, G2)	<4ppb	-	-	-	<15ppb(Note 1)
Aflatoxin B1	<2ppb	-	-	-	-
Dutohmanspipe Fruit Sour	LC-mass mass must not be detected	-	-	-	HPLC is not allowed to detect (below 4000ppb)
Pyrrolizidine alkaloids ( Common Coltsfoot Flower , climbing groundsel herb , arnebia root , fortune eupatorium herb )	LC-mass mass must not be detected	-	-	-	-
ephedra element	No checkout allowed	-	-	-	-
Sulfur dioxide	General food regulations <30ppm	<30ppb	-	-	<500ppm(Note 2)

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, Yanhusuo, tangerine peel, Milkvetch Root, lotus seed Medicinal materials and their single preparations must be tested for aflatoxin

Note 2: Taiwan’s sulfur dioxide inspection is limited to three medicinal materials: common yam rhizome, ginkgo seed, and lily bulb
4. Microbial limits

item	United States	EU, Japan			South Korea	Taiwan
Microorganisms		General preparations	broken tablet type Must be brewed with boiling water before consumption	broken tablet type Take directly
Aerobic total bacterial count	<10,000	<10,000	<10,000,000	<100,000	<10,000	<10 million
Mold & Yeast	<100	<100	<100,000	<10,000	<100	<10000
Changwei Tao and Gram-negative bacteria	－	<100	－	<1,000	－	－
large intestine bacilli	No checkout allowed	No checkout allowed	<100	No checkout allowed	No checkout allowed	<100
Salmonella	No checkout allowed	No checkout allowed	－	No checkout allowed	No checkout allowed	No checkout allowed
Pseudomonas aeruginosa	No checkout allowed	No checkout allowed	－	－	No checkout allowed	－

Mainland and Hong Kong regions:

Microbiological limit standards for Chinese patent drug in the Pharmacopoeia of the People's Republic of China (unit: individuals/gram or individuals/ml)

dosage form	Item 1	Item 2	Item 3 (specific bacteria)
dosage form	Total bacterial count	Number of mold and yeast	large intestine bacilli	Staphylococcus aureus	Pseudomonas aeruginosa
pill
Does not contain original medicinal materials	1000	100	No checkout allowed
Contains original medicinal materials	30000	100	No checkout allowed
powder	30000	100	No checkout allowed
Oral and external use	30000	100	No checkout allowed	No checkout allowed	No checkout allowed
granule, tablet and capsule
Does not contain original medicinal materials	1000	100	No checkout allowed
Contains original medicinal materials	10000	100	No checkout allowed
lozenge	10000	100	No checkout allowed
Oral and external use	10000	100	No checkout allowed	No checkout allowed	No checkout allowed
soft extract agent	100	100	No checkout allowed
Glue	1000	100	No checkout allowed
syrup, mixture	100	100	No checkout allowed
drop pill	1000	100	No checkout allowed
wine preparation	500	100	No checkout allowed
External use	500	100		No checkout allowed	No checkout allowed
tincture	100	100	No checkout allowed
External use	100	100		No checkout allowed	No checkout allowed
liquid extract agent and extract agent	100	100	No checkout allowed
ointment agent	1000	100		No checkout allowed	No checkout allowed
For burns, ulcers, trauma patients	100	10		No checkout allowed	No checkout allowed
distillate	100	100	No checkout allowed
medicated tea
No sugar	10000	100	No checkout allowed
Sugary	1000	100	No checkout allowed
Liniment	100	100
suppository	10000	100		No checkout allowed	No checkout allowed
For ulcer and bleeding patients	100	10		No checkout allowed	No checkout allowed
Nose drops, aerosol, spray	100	10	No checkout allowed	No checkout allowed	No checkout allowed
Eye drops	100	No checkout allowed		No checkout allowed	No checkout allowed

5. Pesticide residues

A. United States, European Union, Mainland China, Hong Kong, Taiwan

item	United States, European Union	Mainland, 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	Total of both<900
Lindane( γ- Hexachlorocyclohexane)	<600	<600	Total of both<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 are limited to medicinal materials and single preparations of ginseng root, Liquorice Root, Milkvetch Root, and senna leaf.

B. Japanese pesticide residue limit standards

1. Chinese materia medica: (industry standard for pesticide residues in crude drugs)

Applicable scope: Milkvetch Root, Milkwort Root, Liquorice Root, cassia bark, Manchurian Wildginger, Asiatic Cornelian Cherry Fruit, cultivated purple perilla leaf, Chinese Date, Dried Tangerine Peel, loquat leaf, Tree Peony Root Bark

The total amount of BHC≤0.2 mg/kg, the total amount of DDT≤0.2 mg/kg

2. Chinese materia medica preparations: (industry standards for pesticide residues in Kampo and crude drug preparations)

1) Organochlorine pesticides:

Scope of application: Contains Astragalus, Milkwort Root, Liquorice Root, cassia bark, Manchurian Wildginger, Asiatic Cornelian Cherry Fruit, cultivated purple perilla leaf, Chinese Date, Dried Tangerine Peel, loquat leaf, Tree Peony Root Bark, ginseng root, red Kampo and herbal preparations of ginseng and senna leaf

The total amount of BHC≤0.2 mg/kg, the total amount of DDT≤0.2 mg/kg

2) Organophosphorus 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, methionine ≤ 0.2 mg/kg,

Malathion≤1.0 mg/kg

3) Pyrethrin pesticides

Scope of application: Kampo preparations containing Milkwort Root, cultivated purple perilla leaf, Chinese Date, Dried Tangerine Peel and loquat leaf

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

C. Korean Pesticide Residue Limit Standards (Drug Safety Administration Announcement No. 2004-197)

1. All plant-based medicines:

Pesticide name	Licensing standards (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 drugs: (ppm)

1) Napropamide: platycodon root 0.1, white peony root 0.1, astragalus 0.1

2) Dimethyldithiocarbamates: safflower 0.1

3) Difenoconazole: Liquorice Root 0.05

4) Myclobutanil: white peony root 0.1

5) Bifenthrin: Sichuan Lovage Rhizome 0.5, safflower 0.1

6) Cyprodinil: white peony root 0.1

7) Acetamiprid: Astragalus 0.1, safflower 0.1

8) Azocyclotin: Chinese Angelica 0.2

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

10) Ethylenebis-dithiocarbamates: safflower 0.3

11) Iminoctadine: white peony root 0.3, safflower 0.1

12) Imidacloprid: safflower 0.1, astragalus 0.3

13) Thiamethoxam: Astragalus 0.1

14) Carbandazim: white peony root 0.05

15) Chlorfenapyr: Sichuan Qiong 0.05

16) Tebuconazol: Chinese Angelica 1.0

17) Triadimenol: white peony root 0.1

18) Triadimefon: white peony root 0.01

19) Triforine: white peony root 0.1

20) Triflumizole: Astragalus 0.1, white peony root 1.0

21) Fenarimol: Astragalus 0.5

22) Pendimethalin: Chinese Angelica 0.2, dwarf lilyturf root 0.2, Chinese Thorowax Root 0.2, white peony root 0.2, safflower 0.1

23) Fenpropathrin: Chinese Angelica 0.2

24) Fosthiazate: Chinese Thorowax Root 0.02

25) Propineb: white peony root 0.2

26) Pymetrozine: safflower 0.05, astragalus 0.05

27) Fludioxonil: white peony root 0.1

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