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National Health Commission of China (NHCC) Issued a List of Active Ingredients for Anti-Bacterial Agents (draft for comments)

Abstract: On April 23, the National Health Commission of China (NHCC) issued a list of active ingredients for anti-bacterial agents (draft for comments), solicit opinions from enterprises, institutions and individuals, and publish it at an option after revision.

Background and process

In order to thoroughly implement the China State Council policies about “Delegate power and optimize service”, optimize the supervision mode, improve the efficiency of law enforcement, guide enterprises to standardize production, strengthen the implementation of corporate responsibility, effectively promote the healthy and orderly development of the anti-bacterial market, and effectively protect the health rights and interests of the people. The NHCC organized and analyzed anti-bacterial agent active ingredients of non-plants, studied the substances that are prohibited from adding, and combed the regulatory models of anti-bacterial agents in main countries, such as the United States, Japan, and the European Union, and formulated a list of effective ingredients and inclusion principles in line with Chinese actual conditions. At the same time, NHCC has organized many experts and relevant personnel of the health and health administrative department, the disease control organization, the supervision organization, the National Health Industry Enterprise Management Association Antibacterial Industry Branch and related enterprises to conduct demonstrations and revisions to form the list of active ingredients for antibacterial agents (Consultation Draft).

Main content

(1) Clear management scope. The prescribed range of use is an antibacterial agent and a bacteriostatic agent which are directly used for intact skin and oral mucosa, vaginal mucosa.

(2) Defining terminology. The antibacterial agent directly contact with human skin or mucous membrane (not including for specific parts such as human foot, eyes, nails, ankle, scalp, hair, nasal mucosa, anorectal, etc.), and has a certain bactericidal effect and the killing rate is ≥90%, not the purpose of treating diseases or improving symptoms of skin and mucous membranes. The bacteriostatic agent directly contact with human skin or mucous membrane (not including for specific parts such as human feet, eyes, nails, ankles, scalp, hair, nasal mucosa, anorectal, etc.), and has a certain antibacterial effect and the inhibition rate is ≥50. %, not the purpose of treating diseases or improving symptoms of skin and mucous membranes. The active ingredient is a substance which has a killing or inhibiting action on microorganisms in an antibacterial agent. Prohibited substances are substances that are prohibited from being added in antibacterial agents, including chemical and biological substances.

(3) Limited ingredients and prohibited substances. The first is a list of ingredients, which lists the active ingredients of non-plant resistant antibacterial agents. The second is the list of the banned substances. It is forbidden to add drugs listed in the Pharmacopoeia of the People's Republic of China (2015) (excluding disinfectant and antiseptic drugs) and their raw materials of the same name; prohibit to use microbes, cells, animals or human tissues and body fluids as starting materials; prepared by biological techniques, for the prevention, treatment and diagnosis of human diseases, such as vaccines, blood products, biotechnology drugs, microecological preparations, immunomodulators, diagnostic products, etc. (excluding lysozyme and lysococcus) are prohibited to use; banned substances listed in the "Technical Specifications for Cosmetics Safety" (2015) (excluding iodine); other prohibited substances prescribed by NHCC.

Questions to be explained

(1) The source of the list of active ingredients. US FDA's OTC drug monograph, EU ECHA approved list of active ingredients for human biocides, list of active ingredients of non-pharmaceutical of Labor and Welfare of Japan, Chinese Pharmacopoeia 2, Chinese Pharmacopoeia 4, national standard "disinfectant raw materials" List and Prohibited Substances (reported for approval) and active ingredients in anti-bacterial products sold in China.

(2) The principle of inclusion. The FDA's OTC drug monograph, the list of active ingredients for human biocides approved by the European Union's ECHA, and list of active ingredients of non-pharmaceutical of Labor and Welfare of Japan are all included. The disinfectant and antiseptics in Chinese Pharmacopoeia 2, Chinese Pharmacopoeia 4 are all included, and the disinfectant active ingredients for human skin mucosa are included in the national standard "Disinfectant raw material list and prohibited substances" (reported for approval). However, substances that are clearly harmful to the human body or are not a single active ingredient are excluded from the above six sources.

(3) The conditions for the active ingredients of the anti-bacterial agents in China. Firstly, the products are widely used in China and have been sold for more than three years. Secondly, the active ingredient content can be determined by existing experimental methods. Thirdly, the antibacterial (or antibacterial) effect of the product has a corresponding legal and effective inspection report. The fourthly is the toxicological test report of the active ingredients, including acute oral toxicity test, multiple or one skin irritation test, mucosal irritation test and mutagenic test. Fifthly, the active ingredients have not been banned internationally. The last, the product has instructions for use, enterprise standards, small package products and labels.

Attachment:

List of active ingredients of anti-bacterial agents

编号

中文名称

英文名称

CAS编码

1

1-溴-3-氯-5,5'-二甲基乙内酰脲(溴氯海因)

1-bromo-3-chloro-5,5'-dimethylhydantoin(bromochlorodimethylhydantoin)

16079-88-2

2

2,2'-亚甲基双

(3,4,6-三氯苯酚)

(六氯酚)

2,2'-methylenebis

(3,4,6'-trichloro-phenol)

(hexachlorophene)

70-30-4

3

3-甲基-4-异丙基苯酚

Isopropyl Methyl Phenol

3228-02-2

4

4-氯-3-甲酚

Chlorocresol

59-50-7

5

苯  酚

Phenol

108-95-2

6

二甲基苯酚

dimethyl phenol

95-87-4

7

甲  酚

Cresol

1319-77-3

8

间苯二酚

Resorcin

108-46-3

9

邻苯基苯酚

Biphenyl-2-ol

90-43-7

10

氯二甲苯酚

chloroxylenol

88-04-0

11

麝香草酚

Thymol

89-83-8

12

C8~C10二烷基二甲基氯化铵

quaternary ammonium compounds, di-C8-C10 alkyl dimethyl, chlorides

68424-95-3

13

C12~C14 烷基[(苯乙基)甲基]二甲基氯化铵

quaternary ammonium compounds, C12-C14 alkyl((ethylphenyl) methyl) dimethyl, chlorides

85409-23-0

14

C12~C14 烷基苄基二甲基氯化铵

quaternary ammonium compounds, benzyl C12-C14 alkyl dimethyl, chlorides

85409-22-9

15

C12~C16烷基苄基二甲基氯化铵

quaternary ammonium compounds, benzyl C12-C16 alkyl dimethyl, chlorides

68424-85-1

16

C12~C18 烷基苄基二甲基,1,2-苯并异噻唑-3(2H)-酮,1,1-二氧化物(1:1) 盐化季铵盐化合物

quaternary ammonium compounds, benzyl C12-C18 alkyl dimethyl, salts with 1,2-benzisothiazol -3(2H)-one 1,1-dioxide (1:1)

68989-01-5

17

苯扎氯铵

Benzalkonium chloride

63449-41-2

18

苯扎溴铵

Benzalkonium Bromide

7281-04-1

19

苄索氯铵

Benzethonium chloride

121-54-0

20

二辛基二甲基氯化铵

dimethyl dioctylammonium chloride

5538-94-3

21

甘草酸单铵盐

Ammonium Glycyrrhizate

1407-03-0

22

聚二甲基二烯丙基氯化铵

poly(diallyl dimethyl ammonium chloride)

26062-79-3

23

十二烷基三甲基氯化铵

dodecyl trimethyl ammonium chloride

112-00-5

24

十二烷基三甲基溴化铵

dodecyl trimethyl ammonium bromide

1119-94-4

25

十八烷二甲基氧化铵

octadecyl dimethyl amine oxide

26

双癸基二甲基氯化铵

didecyl dimethylammonium chloride

7173-51-5

27

双癸基二甲基溴化铵

didecyl dimethylammonium bromide

2390-68-3

28

西曲溴铵

cetrimide

8044-71-1

29

度米芬

Domiphen Bromide

538-71-6

30

六亚甲基四胺

(乌洛托品)

Hexamethylenetetramine

Urotropin/Methenamine

100-97-0

31

醋酸氯己定

chlorhexidine  Acetate

56-95-1

32

聚六亚甲基双胍盐酸盐

poly(hexamethylenebiguanide) hydrochloride

32289-58-0

33

葡萄糖酸氯己定

Chlorhexidine Gluconate Solution(Chlorhexidine digluconate)

18472-51-0

34

盐酸聚六亚甲基胍

polyhexamethyleneguanidine hydrochloride

57028-96-3

35

苯甲酸

Benzoic Acid

65-85-0

36

丙  酸

Propionic Acid

79-09-4

37

次氯酸

Hypochlorous acid

7790-92-3

38

甘草酸

Glycyrrhizic Acid

1405-86-3

39

甘草亭酸

Glycyrrhetinic Acid

471-53-4

40

酪氨酸

Tyrosine

60-18-4

41

柠檬酸

citric acid

77-92-9

42

硼  酸

Boric Acid

11113-50-1

43

L-乳酸

L-(+)-lactic acid

79-33-4

44

乳  酸

Lactic Acid

50-21-5

45

山梨酸

Sorbic Acid

22500-92-1

46

十一烯酸

Undecylenic Acid

112-38-9

47

水杨酸

Salicylic Acid

69-72-7

48

辛  酸

Caprylic Acid

124-07-2

49

乙  酸

acetic acid

64-19-7

50

硬脂酰基甘草酸

Stearyl Glycyrrhetinate

13832-70-7

51

苯甲酸钠

Sodium Benzoate

532-32-1

52

次氯酸钙

calcium hypochlorite

7778-54-3

53

次氯酸钠

Active chlorine released from sodium hypochlorite

7681-52-9

54

甘草酸二钾

Dipotassium Glycyrrhizate

68797-35-3

55

高锰酸钾

Potassium Permanganate

7722-64-7

56

焦亚硫酸钠

Sodium Metabisulfite

7681-57-4

57

山梨酸钾

Potassium Sorbate

509-00-01

58

十一烯酸锌

Zinc Undecylenate

557-08-4

59

辛酸钠

Sodium Caprylate

1984-06-1

60

苯甲醇

Benzyl Alcohol

100-51-6

61

三氯叔丁醇

Chlorobutanol

6001-64-5

62

乙  醇

Alcohol (ethyl alcohol)

64-17-5

63

异丙醇

Isopropyl alcohol

67-63-0

64

正丙醇

Propan-1-ol

71-23-8

65

二氯异氰尿酸钠

sodium dichloroisocyanurat

2893-78-9

66

二氧化氯

chlorine dioxide

10049-04-4

67

三氯均二苯脲

(三氯卡班)

3,4,4'-trichloro-carbanilid/triclocarban

101-20-2

68

三氯生

Triclosan

3380-34-5

69

三氯异氰尿酸

trichloroisocyanuric aicde

87-90-1

70

过氧化氢

Hydrogen peroxide

7722-84-1

71

过氧乙酸

Peracetic acid

79-21-0

72

苯甲基氯化物

2-methylbenzhydryl chloride

41870-52-4

73

过氧苯甲酰

Benzoyl Peroxide

94-36-0

74

甲  紫

Methylrosanilinium Chloride

8004-87-3

75

Iodine

7553-56-2

76

聚维酮碘

Povidone Iodine

25655-41-8

77

羟苯苄酯

Benzyl Hydroxybenzoate

94-18-8

78

羟苯丙酯

Propylparaben

94-13-3

79

羟苯丁酯

Butylparaben

94-26-8

80

羟苯甲酯

Methylparaben

99-76-3

81

羟苯乙酯

Ethylparaben

120-47-8

82

羟苯丙酯钠

Sodium Propyl Parahydroxybenzoate

35285-69-9

83

羟苯甲酯钠

Sodium Methyl Parahydroxybenzoate

5026-62-0

84

羟基二氯二苯醚

5-chloro-2-(4-chlorphenoxy)phenol (DCPP)

3380-30-1

85

硫  磺

Sulfur

7704-34-9

86

硫酸羟喹啉

Oxyquinoline Sulfate

134-31-6

87

尿囊素

Allantoin

97-59-6

88

硼  砂

Borax

1303-96-4

89

氧化锌

Zinc Oxide

1314-13-2

90

乳酸依沙吖啶

Ethacridine Lactate

1837-57-6

91

银离子

silver

7440-22-4

92

鱼石脂

Ichthammol

8029-68-3

93

溶菌酶

lysozyme

9001-63-2

94

溶葡萄球菌酶

lysostaphin

9011-93-2

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