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ChP regulation on heavy metal and pesticide residuce in herb

Nov 26, 2021

last year, the China Pharmacopoeia (ChP) Commission issued the revised opinion draft of the 2020 edition, namely General Rules for the Inspection of Herb and Decoction <0212>; stipulating that all varieties of plant Chinese medicines need to be tested for heavy metals (5 items) and pesticide residues (33 items)


The refers to the limited inspection of the purity, soluble substances, harmful or toxic substances of medicinal materials and decoction pieces, including moisture, ash, impurities, toxic components, heavy metals and harmful elements, sulfur dioxide residues, pesticide residues, aflatoxins, etc.

Chinese herb

Unless otherwise specified, the moisture content of decoction pieces is usually not more than 13%; the impurity of medicine scraps is usually not more than 3%; the sulfur dioxide residue of medicinal materials and decoction pieces (except minerals) must not exceed 150mg/kg; The heavy metal in herb and decoction pieces derived from plants must not be lead Over 5mg/kg, cadmium NMT 1mg/kg, arsenic 2mg/kg, mercury 0.2mg/kg,copper 20 mg/kg; medicinal materials and decoction pieces (plants) banned pesticides,see the table below for details must not be detected, or not exceed the limit of quantification.


NoNameResidue mattersLOQ(mg/kg)
1MethamidophosMethamidophos0.05
2Methyl parathionMethyl parathion0.02
3ParathionParathion0.02
4MonocrotophosMonocrotophos0.03
5PhosphoaminePhosphoamine0.05
6BHCBHC0.1
7DDTDDT0.1
8InsectamidineInsectamidine0.02
9HerbicideHerbicide0.05
10AldrinAldrin+Dieldrin

0.05
11Dieldrin0.05
12FenamiphosThe sum of fenamiphos and its oxygen analogs (sulfone, sulfoxide), expressed as fenamiphos0.02
13MethoxophosMethoxophos0.02
14ThionophosThionophos0.02
15CoumaphosCoumaphos0.05
16PhytophosPhytophos0.02
17TerbuthionThe sum of terbuthion and its oxygen analogues (sulfone, sulfoxide), expressed as terbuthion0.02
18ChlorsulfuronChlorsulfuron0.05
19MethamsulfuronMethamsulfuron0.05
20MetsulfuronMetsulfuron0.05
21PhorateThe sum of phorate and its oxygen analogues (sulfone, sulfoxide), expressed as phorate0.02
22Isofenphos-methylIsofenphos-methyl0.02
23Systemic PhosphorusSystemic Phosphorus0.02
24CarbawayThe sum of carbofuran and 3-hydroxy carbofuran, expressed in carbofuran0.05
25AldicarbThe sum of aldicarb and its oxygen analogues (sulfone, sulfoxide), expressed as aldicarb0.1
26MethophosMethophos0.02
27ClozophosClozophos0.01
28HydrocarbophosHydrocarbophos0.05
29EndosulfanThe sum of α-endosulfan and β-endosulfan and endosulfan sulfate0.05
30FipronilThe sum of fipronil, fipronil, fipronil sulfone and fipronil sulfoxide, expressed as fipronil0.02
31DicofolDicofol (the sum of o,p′-isomer and p,p′-isomer)0.2
32Thiocyclic PhosphateThiocyclic Phosphate0.03
33Thiophos-methylThiophos-methyl0.03


Compare of heavy metal worldwide

Country or organizationPbAsCdHgCu
China5210.220
America520.30.2——
U.K5510.1——
Germany5——0.20.1——
Japan205——————
WHO10——0.3————
ISO10423——

The above table shows that the heavy metal limit standards stipulated in the 2020 edition of the ChP are not lower than the limit standards of foreign pharmacopoeias, and even lead and arsenic limit standards are more stringent than foreign limit standards. Other countries such as the United States, the European Union, Japan and other developed countries and the WHO have not made limit requirements for copper in the heavy metal limit of Chinese herbal medicines.

The limit requirements for the four heavy metal elements of lead, arsenic, cadmium, and mercury are also very different in different countries and regions. China's heavy metal limits for traditional Chinese medicines are within the range of other countries and regions. It can be seen that my country's heavy metal limit standards in Chinese herbal medicines are relatively complete.