List for materials and restricted substances in disinfectant
1 Scope
This standard specifies the list of raw material ingredients and application scope of disinfectants applied to different disinfection objects, and also specifies prohibited and restricted substances in the disinfectant formula.
This standard is applicable to disinfectants for drinking water, human, medical instrument, environment and object surface, contaminants, indoor air, central air-condition, swimming pool water, and contaminated water of hospital.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 5749 Standards for drinking water quality
GB/T 19104 Peracetic acid solution
GB/T 19106 Sodium hypochlorite
GB/T 20783 Stable chlorine dioxide solution
HG/T 3779 Dichloroisocyanuric acid sodium salt
Pharmacopoeia of the People's Republic of China (Edition 2015)
Standard for hygiene and safety evaluation of disinfectants and disinfection facilities for drinking water [issued by the Ministry of Health of the People's Republic of China (WEIJIANDUFA [2005] No.336)]
Safety and Technical Standards for Cosmetics (Edition 2015) (issued by the China Food and Drug Administration)
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
disinfectant
preparations used to kill pathogenic microorganisms on a transmission medium to achieve disinfection or sterilization requirements
Note: Disinfectants specified in this standard include not only preparations made of chemical components, biological components and metal ions, but also sodium hypochlorite, ozone gas, ozone water, acidic oxidation potential water, slightly acidic electrolyzed water and chlorine dioxide generated by special generators.
3.2
active ingredient
substances in the disinfectant formula which have killing effect on pathogenic microorganisms
3.3
inert ingredient
substances in the disinfectant formula that have such auxiliary functions as anti-corrosion, skin care, stability, pH adjustment, seasoning, and coloring
3.4
biological active ingredient
substances in the disinfectant formula that uses the extracts of organisms or microorganisms and their products as the active ingredient of the disinfectant
3.5
chemical abstracts service number
registration number formulated for chemical substances by Chemical Abstracts Service
Note: This chemical abstracts service number (CAS No.) is an important tool for retrieving information of chemical substances with multiple names. It is the unique numerical identification number for substances (compounds, polymer materials, biological sequences), mixture or alloy.
3.6
disinfectant for drinking water
disinfectant used to disinfect drinking water and domestic water temporarily for human life in case of public health emergencies
3.7
disinfectant for human
disinfectant used to disinfect hands, human skin and mucous membranes
3.8
disinfectant for medical instrument
disinfectant used to disinfect instruments and articles in contact with human skin, mucous membranes, organs and tissues in medical and health institutions
3.9
disinfectant for environment and object surface
disinfectant used to disinfect the surface of walls, floors, objects, instruments and equipment that are not in direct contact with food and feed in places such as homes, public places, factories, medical and health institutions, and other institutions
3.10
disinfectant for contaminants
disinfectant used to disinfect secretions, excreta, pollutants, medical wastes of patients and suspected patients in medical institutions and infectious diseases foci as well as contaminants and wastes from microbiological laboratories
3.11
disinfectant for indoor air
disinfectant used to disinfect indoor air under unmanned conditions
3.12
disinfectant for central air-condition
disinfectant used to disinfect central air conditioning and ventilation pipes, fan coil units, and condensation systems
3.13
disinfectant for swimming pool water
disinfectant used to disinfect swimming pool water
3.14
disinfectant for contaminated water of hospital
disinfectant used to disinfect contaminated water from medical institutions
4 List of raw materials and application scope of disinfectant
4.1 See Table 1 for the list of active ingredient of disinfectant raw materials and their application scope.
Table 1 List of active ingredients of
disinfectant raw materials and recommended application scope
S.N. English name CAS No. Application scope
1 1,3'-dibromo-5,5'-dimethylhydantoin
(di-bromodimethylhydantoin) 77-48-5 E, C, M, S
2 1,3'-dichloro-5,5'-dimethylhydantoin
(di-chlorodimethylhydantoin) 118-52-5 E, M, S
3 1-bromo-3-chloro-5,5'-dimethylhydantoin
(bromochlorodimethylhydantoin) 16079-88-2 C, E, H, M, S
4 2,2'-dibromo-2-cyanoacetamide 10222-01-2 E
5 2,2'-methylenebis (3,4,6'-trichloro-phenol)
(hexachlorophene) 70-30-4 H
6 2,4,4'-trichloro-2'-hydroxydiphenylether (triclosan) 3380-34-5 E, H, K, M
7 2-aminoimidazole hemisulfate 1450-93-7 E
8 2-methylbenzhydryl chloride 41870-52-4 E, H
9 acetic acid 64-19-7 H
10 acidic electrolyzed oxidizing water — E, H, M
11 benzalkonium bromide 91080-29-4 A, E, H, K, M
12 benzalkonium chloride 8001-54-5/
63449-41-2 A, E, H, K, M
13 enzethonium chloride 121-54-0 A, E, H, K, M
14 benzoic acid 65-85-0 E, H
15 biphenyl-2-ol 90-43-7 E
16 bromine 7726-95-6 E
17 bromochloro-5,5'-dimethylimidazolidine-2,4'-dione 32718-18-6 E
18 calcium hypochlorite 7778-54-3 C, D, E, H, M, S
19 cetrimide 8044-71-1 E, H
20 chlorhexidine diacetate 56-95-1 A, E, H, M
21 chlorhexidine digluconate 18472-51-0 A, E, H, M
22 chlorinated trisodium phosphate 56802-99-4/
11084-85-8 C, E, M
23 chlorine 7782-50-5 D, E, S
24 chlorine dioxide 10049-04-4 A, C, D, H, M, S, W
25 chloroxylenol 88-04-0 E, H, M
26 citric acid 77-92-9 H, M
27 cresol 1319-77-3 E
28 decanoic acid 334-48-5 E, K
29 detergent 6501 68140-00-1 E
30 didecyl dimethylammonium bromide 2390-68-3 A, E, H, K, M
31 didecyl dimethylammonium chloride 7173-51-5 A, E, H, K, M
32 dimethyl dioctylammonium chloride 5538-94-3 A, E, H, K, M
33 dimethyl phenol 95-87-4 H, E
34 dioctyl divinyhriamino glycine phosphate — E
35 dodecyl trimethyl ammonium bromide 1119-94-4 A, E, H, K, M
36 dodecyl dimethyl benzyl ammonium chloride 139-07-1 A, E, H, K, M
37 dodecyl ethyl dimethyl ammonium bromide 7281-04-1 A, E, H, K, M
38 dodecyl trimethyl ammonium chloride 112-00-5 A, E, H, K, M
39 dodecyl dimethyl (2-phenoxyethyl) ammonium bromide / domiphen bromide 538-71-6 A, E, H, K, M
40 ethanol 64-17-5 A, E, H, M
41 formaldehyde 50-00-0 #E, M
42 glutaric dialdehyde 111-30-8 #E, M
43 glyoxal 107-22-2 #E, M
44 Hexamethylenetetramine / Urotropin 100-97-0 A, E, H, K
45 hydrogen peroxide 7722-84-1 A, E, H, M
46 hydropentanedioic acid 110-94-1 E, M
47 Hypochlorous acid 7790-92-3 E, H, M
48 iodine 7553-56-2 E, H, M
49 nonionic acid 112-05-0 E, K
50 octadecyl dimethyl amine oxide — A, E, H, K, M
51 octanoic acid 124-07-2 E, K
52 oligo-[2-(2-ethoxy)-ethoxyethyl]-guanidinium chloride 374572-91-5 E
53 o-Phthalaldehyde 643-79-8 M
54 ozone — A, D, E, S
55 peracetic acid 79-21-0 A, C, E, H, M
56 poly (hexamethylenebiguanide) hydrochloride 32289-58-0 H
57 poly-[2-(2-ethoxy)-ethoxyethyl]-guanidinium — A
58 poly (diallyl dimethyl ammonium chloride) 26062-79-3 A, E, H, K, M
59 polyhexamethyleneguanidine hydrochloride 57028-96-3 A, E, H, K
60 potassium hydrogen peroxymono sulfate sulfate 70693-62-8 E
61 potassium hydrogen persulfate 7727-21-1 E
62 potassium permanganate 7722-64-7 H
63 povidone iodine/polyvinyl pyrrolidone-iodine complex 25655-41-8 E, H, M
64 propan-1-ol 71-23-8 E, H
65 propan-2-ol 67-63-0 E, H
66 quaternary ammonium compounds, (2-((2-((2-carboxyethyl) (2-hydroxyethyl)amino)ethyl)amino)-2-oxoethyl)coco alkyl dimethyl, hydroxides, inner salts 100085-64-1 E
67 quaternary ammonium compounds, alkyl-benzyldimethyl, chlorides, bromides, or hydroxides(alkyl from C8-C22 saturated and unsaturated, such as tallow alkyl, coco alkyl and soya alkyl) Quaternary ammonium compounds A, E, H, K, M
68 quaternary ammonium compounds, benzyl C12-C14 alkyl dimethyl, chlorides 85409-22-9 A, E, H, K, M
69 quaternary ammonium compounds, benzyl C12-C16 alkyl dimethyl, chlorides 68424-85-1 A, E, H, K, M
70 quaternary ammonium compounds, benzyl C12-C18 alkyl dimethyl, salts with 1, 2-benzisothiazol-3(2H)-one 1,1-dioxide(1:1) 68989-01-5 A, E, H, K, M
71 quaternary ammonium compounds, C12-C14 alkyl((ethylphenyl) methyl)dimethyl, chlorides 85409-23-0 A, E, H, K, M
72 quaternary ammonium compounds, di-C8-C10 alkyl dimethyl, chlorides 68424-95-3 A, E, H, K, M
73 quaternary ammonium compounds, dial-kyldimethyl, chlorides, bromides, or methylsulphates (alkyl from C6-C18 saturated and unsaturated, such as tallow alkyl, coco alkyl and soya alkyl) Quaternary ammonium compounds A, E, H, K, M
74 salicylic acid 69-72-7 C, E, H
75 silver 7440-22-4 E, H
76 sodium benzoate 532-32-1 E, H
77 sodium dichloroisocyanurat 2893-78-9 A, C, D, E, H, M, S, W
78 sodium hypochlorite 7681-52-9 C, D, E, H, M, S, W
79 tosyl chloramide sodium 127-65-1 D, E, M
80 trichloroisocyanuric acid 87-90-1 C, D, E, H, M, S, W
81 3,4,4'-trichloro-carbanilid/triclocarban 101-20-2 E, H
82 urea hydrogen peroxide 124-43-6 E
83 zinc undecylenate 557-08-4 H
84 lysozymea 9001-63-2 E, H
85 lysostaphina 9011-93-2 E, H
Note: A represents disinfectant for indoor air; C represents disinfectant for contaminants; D represents disinfectant for drinking water; E represents disinfectant for environment and object surface (#E represents disinfectant for object surface only and not for environment); H represents disinfectant for human; K represents disinfectant for central air-condition; M represents disinfectant for medical instrument; S represents disinfectant for swimming pool water; W represents disinfectant for contaminated water of hospital.
a It represents the biological active ingredient.
4.2 See Table 2 for the list of inert ingredients of disinfectant raw materials and their application scope.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 List of raw materials and application scope of disinfectant
5 Provisions on prohibited substances
6 Provisions on restricted substances
List for materials and restricted substances in disinfectant
1 Scope
This standard specifies the list of raw material ingredients and application scope of disinfectants applied to different disinfection objects, and also specifies prohibited and restricted substances in the disinfectant formula.
This standard is applicable to disinfectants for drinking water, human, medical instrument, environment and object surface, contaminants, indoor air, central air-condition, swimming pool water, and contaminated water of hospital.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 5749 Standards for drinking water quality
GB/T 19104 Peracetic acid solution
GB/T 19106 Sodium hypochlorite
GB/T 20783 Stable chlorine dioxide solution
HG/T 3779 Dichloroisocyanuric acid sodium salt
Pharmacopoeia of the People's Republic of China (Edition 2015)
Standard for hygiene and safety evaluation of disinfectants and disinfection facilities for drinking water [issued by the Ministry of Health of the People's Republic of China (WEIJIANDUFA [2005] No.336)]
Safety and Technical Standards for Cosmetics (Edition 2015) (issued by the China Food and Drug Administration)
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
disinfectant
preparations used to kill pathogenic microorganisms on a transmission medium to achieve disinfection or sterilization requirements
Note: Disinfectants specified in this standard include not only preparations made of chemical components, biological components and metal ions, but also sodium hypochlorite, ozone gas, ozone water, acidic oxidation potential water, slightly acidic electrolyzed water and chlorine dioxide generated by special generators.
3.2
active ingredient
substances in the disinfectant formula which have killing effect on pathogenic microorganisms
3.3
inert ingredient
substances in the disinfectant formula that have such auxiliary functions as anti-corrosion, skin care, stability, pH adjustment, seasoning, and coloring
3.4
biological active ingredient
substances in the disinfectant formula that uses the extracts of organisms or microorganisms and their products as the active ingredient of the disinfectant
3.5
chemical abstracts service number
registration number formulated for chemical substances by Chemical Abstracts Service
Note: This chemical abstracts service number (CAS No.) is an important tool for retrieving information of chemical substances with multiple names. It is the unique numerical identification number for substances (compounds, polymer materials, biological sequences), mixture or alloy.
3.6
disinfectant for drinking water
disinfectant used to disinfect drinking water and domestic water temporarily for human life in case of public health emergencies
3.7
disinfectant for human
disinfectant used to disinfect hands, human skin and mucous membranes
3.8
disinfectant for medical instrument
disinfectant used to disinfect instruments and articles in contact with human skin, mucous membranes, organs and tissues in medical and health institutions
3.9
disinfectant for environment and object surface
disinfectant used to disinfect the surface of walls, floors, objects, instruments and equipment that are not in direct contact with food and feed in places such as homes, public places, factories, medical and health institutions, and other institutions
3.10
disinfectant for contaminants
disinfectant used to disinfect secretions, excreta, pollutants, medical wastes of patients and suspected patients in medical institutions and infectious diseases foci as well as contaminants and wastes from microbiological laboratories
3.11
disinfectant for indoor air
disinfectant used to disinfect indoor air under unmanned conditions
3.12
disinfectant for central air-condition
disinfectant used to disinfect central air conditioning and ventilation pipes, fan coil units, and condensation systems
3.13
disinfectant for swimming pool water
disinfectant used to disinfect swimming pool water
3.14
disinfectant for contaminated water of hospital
disinfectant used to disinfect contaminated water from medical institutions
4 List of raw materials and application scope of disinfectant
4.1 See Table 1 for the list of active ingredient of disinfectant raw materials and their application scope.
Table 1 List of active ingredients of
disinfectant raw materials and recommended application scope
S.N. English name CAS No. Application scope
1 1,3'-dibromo-5,5'-dimethylhydantoin
(di-bromodimethylhydantoin) 77-48-5 E, C, M, S
2 1,3'-dichloro-5,5'-dimethylhydantoin
(di-chlorodimethylhydantoin) 118-52-5 E, M, S
3 1-bromo-3-chloro-5,5'-dimethylhydantoin
(bromochlorodimethylhydantoin) 16079-88-2 C, E, H, M, S
4 2,2'-dibromo-2-cyanoacetamide 10222-01-2 E
5 2,2'-methylenebis (3,4,6'-trichloro-phenol)
(hexachlorophene) 70-30-4 H
6 2,4,4'-trichloro-2'-hydroxydiphenylether (triclosan) 3380-34-5 E, H, K, M
7 2-aminoimidazole hemisulfate 1450-93-7 E
8 2-methylbenzhydryl chloride 41870-52-4 E, H
9 acetic acid 64-19-7 H
10 acidic electrolyzed oxidizing water — E, H, M
11 benzalkonium bromide 91080-29-4 A, E, H, K, M
12 benzalkonium chloride 8001-54-5/
63449-41-2 A, E, H, K, M
13 enzethonium chloride 121-54-0 A, E, H, K, M
14 benzoic acid 65-85-0 E, H
15 biphenyl-2-ol 90-43-7 E
16 bromine 7726-95-6 E
17 bromochloro-5,5'-dimethylimidazolidine-2,4'-dione 32718-18-6 E
18 calcium hypochlorite 7778-54-3 C, D, E, H, M, S
19 cetrimide 8044-71-1 E, H
20 chlorhexidine diacetate 56-95-1 A, E, H, M
21 chlorhexidine digluconate 18472-51-0 A, E, H, M
22 chlorinated trisodium phosphate 56802-99-4/
11084-85-8 C, E, M
23 chlorine 7782-50-5 D, E, S
24 chlorine dioxide 10049-04-4 A, C, D, H, M, S, W
25 chloroxylenol 88-04-0 E, H, M
26 citric acid 77-92-9 H, M
27 cresol 1319-77-3 E
28 decanoic acid 334-48-5 E, K
29 detergent 6501 68140-00-1 E
30 didecyl dimethylammonium bromide 2390-68-3 A, E, H, K, M
31 didecyl dimethylammonium chloride 7173-51-5 A, E, H, K, M
32 dimethyl dioctylammonium chloride 5538-94-3 A, E, H, K, M
33 dimethyl phenol 95-87-4 H, E
34 dioctyl divinyhriamino glycine phosphate — E
35 dodecyl trimethyl ammonium bromide 1119-94-4 A, E, H, K, M
36 dodecyl dimethyl benzyl ammonium chloride 139-07-1 A, E, H, K, M
37 dodecyl ethyl dimethyl ammonium bromide 7281-04-1 A, E, H, K, M
38 dodecyl trimethyl ammonium chloride 112-00-5 A, E, H, K, M
39 dodecyl dimethyl (2-phenoxyethyl) ammonium bromide / domiphen bromide 538-71-6 A, E, H, K, M
40 ethanol 64-17-5 A, E, H, M
41 formaldehyde 50-00-0 #E, M
42 glutaric dialdehyde 111-30-8 #E, M
43 glyoxal 107-22-2 #E, M
44 Hexamethylenetetramine / Urotropin 100-97-0 A, E, H, K
45 hydrogen peroxide 7722-84-1 A, E, H, M
46 hydropentanedioic acid 110-94-1 E, M
47 Hypochlorous acid 7790-92-3 E, H, M
48 iodine 7553-56-2 E, H, M
49 nonionic acid 112-05-0 E, K
50 octadecyl dimethyl amine oxide — A, E, H, K, M
51 octanoic acid 124-07-2 E, K
52 oligo-[2-(2-ethoxy)-ethoxyethyl]-guanidinium chloride 374572-91-5 E
53 o-Phthalaldehyde 643-79-8 M
54 ozone — A, D, E, S
55 peracetic acid 79-21-0 A, C, E, H, M
56 poly (hexamethylenebiguanide) hydrochloride 32289-58-0 H
57 poly-[2-(2-ethoxy)-ethoxyethyl]-guanidinium — A
58 poly (diallyl dimethyl ammonium chloride) 26062-79-3 A, E, H, K, M
59 polyhexamethyleneguanidine hydrochloride 57028-96-3 A, E, H, K
60 potassium hydrogen peroxymono sulfate sulfate 70693-62-8 E
61 potassium hydrogen persulfate 7727-21-1 E
62 potassium permanganate 7722-64-7 H
63 povidone iodine/polyvinyl pyrrolidone-iodine complex 25655-41-8 E, H, M
64 propan-1-ol 71-23-8 E, H
65 propan-2-ol 67-63-0 E, H
66 quaternary ammonium compounds, (2-((2-((2-carboxyethyl) (2-hydroxyethyl)amino)ethyl)amino)-2-oxoethyl)coco alkyl dimethyl, hydroxides, inner salts 100085-64-1 E
67 quaternary ammonium compounds, alkyl-benzyldimethyl, chlorides, bromides, or hydroxides(alkyl from C8-C22 saturated and unsaturated, such as tallow alkyl, coco alkyl and soya alkyl) Quaternary ammonium compounds A, E, H, K, M
68 quaternary ammonium compounds, benzyl C12-C14 alkyl dimethyl, chlorides 85409-22-9 A, E, H, K, M
69 quaternary ammonium compounds, benzyl C12-C16 alkyl dimethyl, chlorides 68424-85-1 A, E, H, K, M
70 quaternary ammonium compounds, benzyl C12-C18 alkyl dimethyl, salts with 1, 2-benzisothiazol-3(2H)-one 1,1-dioxide(1:1) 68989-01-5 A, E, H, K, M
71 quaternary ammonium compounds, C12-C14 alkyl((ethylphenyl) methyl)dimethyl, chlorides 85409-23-0 A, E, H, K, M
72 quaternary ammonium compounds, di-C8-C10 alkyl dimethyl, chlorides 68424-95-3 A, E, H, K, M
73 quaternary ammonium compounds, dial-kyldimethyl, chlorides, bromides, or methylsulphates (alkyl from C6-C18 saturated and unsaturated, such as tallow alkyl, coco alkyl and soya alkyl) Quaternary ammonium compounds A, E, H, K, M
74 salicylic acid 69-72-7 C, E, H
75 silver 7440-22-4 E, H
76 sodium benzoate 532-32-1 E, H
77 sodium dichloroisocyanurat 2893-78-9 A, C, D, E, H, M, S, W
78 sodium hypochlorite 7681-52-9 C, D, E, H, M, S, W
79 tosyl chloramide sodium 127-65-1 D, E, M
80 trichloroisocyanuric acid 87-90-1 C, D, E, H, M, S, W
81 3,4,4'-trichloro-carbanilid/triclocarban 101-20-2 E, H
82 urea hydrogen peroxide 124-43-6 E
83 zinc undecylenate 557-08-4 H
84 lysozymea 9001-63-2 E, H
85 lysostaphina 9011-93-2 E, H
Note: A represents disinfectant for indoor air; C represents disinfectant for contaminants; D represents disinfectant for drinking water; E represents disinfectant for environment and object surface (#E represents disinfectant for object surface only and not for environment); H represents disinfectant for human; K represents disinfectant for central air-condition; M represents disinfectant for medical instrument; S represents disinfectant for swimming pool water; W represents disinfectant for contaminated water of hospital.
a It represents the biological active ingredient.
4.2 See Table 2 for the list of inert ingredients of disinfectant raw materials and their application scope.
Contents of GB 38850-2020/XG1-2020
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 List of raw materials and application scope of disinfectant
5 Provisions on prohibited substances
6 Provisions on restricted substances
