| title | Standards for Chinese Herbal Medicine Preparations in Major Countries around the World |
|---|
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 |
－ |
－ | |
＊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 |
broken tablet type | |||
|
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) | ||
|
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 | |
|
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