Controversies over China’s Upcoming Cataloged Management of Disinfectant Ingredients: GB 38850

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Controversies over China’s Upcoming Cataloged Management of Disinfectant Ingredients: GB 38850On April 20, the Chinese Standardization Administration (SAC) released the full contents of 14 national standards for disinfectants, disinfecting instruments, medical electrical equipment including critical care ventilators, of which the most notable one is “GB 388750-2020 Lists of Material and Restricted Substances in Disinfectants”, a mandatory standard without prior consultation, but due to take effect starting from November 1, 2020.

Mandatory National Standards Issued under the SAC Announcement 7 of 2020

No.

Code and Name

Replacement

Effective Date

1

GB 9706.1-2020 Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance
医用电气设备 第1部分:基本安全和基本性能的通用要求

GB 9706.1-2007,
GB9706.15-2008

2023/5/1

2

GB 9706.212-2020 Medical Electrical Equipment—Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators
医用电气设备 第2-12部分:重症护理呼吸机的基本安全和基本性能专用要求

GB 9706.28-2006

2023/5/1

3

GB 9706.237-2020 Medical Electrical Equipment—Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
医用电气设备 第2-37部分:超声诊断和监护设备的基本安全和基本性能专用要求

GB 9706.9-2008

2023/5/1

4

GB 27948-2020 General Requirements for Air Disinfectant
空气消毒剂通用要求

GB 27948-2011

2020/11/1

5

GB 27949-2020 General Requirements of Disinfectant of Medical Instruments
医疗器械消毒剂通用要求

GB/T 27949-2011

2020/11/1

6

GB 27950-2020 General Requirements for Hand Disinfectant
手消毒剂通用要求

GB 27950-2011

2020/11/1

7

GB 27952-2020 General Requirements for Ordinary Objects Surface Disinfectant
普通物体表面消毒剂通用要求

GB 27952-2011

2020/11/1

8

GB 27953-2020 General Requirements on Disinfectant for Infectious Focus
疫源地消毒剂通用要求

GB 27953-2011

2020/11/1

9

GB 27954-2020 General Requirements for Disinfectant of Mucous Membrane
黏膜消毒剂通用要求

GB 27954-2011

2020/11/1

10

GB 27955-2020 Hygienic Requirements for Low-temperature Hydrogen Peroxide Gas Plasma Sterilizer
过氧化氢气体等离子体低温灭菌器卫生要求

GB 27955-2011

2020/11/1

11

GB 28232-2020 Hygienic Requirements for Ozone Disinfector
臭氧消毒器卫生要求

GB 28232-2011

2020/11/1

12

GB 28233-2020 Hygienic Requirements for Sodium Hypochlorite Generator
次氯酸钠发生器卫生要求

GB 28233-2011

2020/11/1

13

GB 28235-2020 Hygienic Requirements for Ultraviolet Appliance of Disinfection
紫外线消毒器卫生要求

GB 28235-2011

2020/11/1

14

GB 38850-2020 List for Materials and Restricted Substances in Disinfectant
消毒剂原料清单及禁限用物质

/

2020/11/1

China has previously developed 10 product standards for disinfectants and disinfecting appliances and the replacement this time elevated the requirements on raw materials, technical indicators, testing methods, usage, product label and manual, which will significantly improve product performance and safety, and play an important role in protecting the environment and human health, particularly when COVID-19 prevention becomes normalized nowadays.

GB 38850 includes 85 active ingredients and 115 inert ingredients as the ingredients allowed for use in disinfectants and specifies explicit criteria and limits for prohibited and restricted substances. However, the inert list becomes the most contentious topic among the industry due to the limited number of substances usable, moreover, the authorities have yet to make clear the transition policy towards the unlisted ingredient used in disinfectants already on the market.

Existing Active Ingredients

In 2013, NHFPC (now known as the NHC) released the “Criteria for Determining Disinfectants and Disinfecting Appliance Using New Ingredient, New Technology and New Mechanism” (hereinafter referred to as “Determining Criteria”), designating all the active ingredients and usage of existing disinfectants. Disinfectants using active ingredients or targeting purposes outside the Determining Criteria are regarded as new disinfectants and subject to review and approval at the national level. Given the fact that no new disinfectant has been approved since 2014, the substance and usage listed in the Determining Criteria have long been deemed by the industry as the permitted active ingredients.

The active ingredients and usages in GB 388750-2020 are almost coincident with those listed in the Determining Criteria, excepting:

  • Hypochlorite is the active ingredient only listed in GB 388750-2020;
  • The active ingredients listed in GB 388750-2020 do not apply to disinfectants used on fruits and vegetables, tableware, and other food contacting tools and equipment. Some speculated that the active ingredients for  these purposes would be compiled into a separate list in the future, but the most authoritative reference nowadays are still the “GB 14930.2-2012 National Food Safety Standard-Disinfectants” and the “List of Ingredients in Food-use Disinfectants (2009 version)”. ;
  • A new use category is particularly included: disinfectants used in the ventilation system of central-air conditioning areas;
  • Minor usage adjustment on triclosan, chlorine dioxide, hydrogen peroxide and other active ingredients.

To an insider, it is very confusing that the criteria for the inclusion and the use scope of certain active ingredients seemed illogical and impractical. For example, Triclosan and Trichlorcarbanilide have already been banned in Europe and the US. Late last year, China NHC consulted on a draft list of active ingredients used in antibacterial/bacteriostatic agents, a category of antimicrobial products with lower efficacy and only used on human body(hand sanitizer, mouthwash and feminine wash with antimicrobial claim instead of disinfection effect), and the 2 substances were not on the draft. The industry once believed that their human body uses would finally be derecognized by Chinese health authorities, but such uses are still maintained in GB 38850. It is worth reminding that GB 38850 will not apply to antimicrobial agents and the eligible ingredients will be compiled into a separate list.

More contentiously, some of the active ingredients permitted for human use are excluded from environmental and surface uses. It would be understandable if such usages were removed for environmental consideration, but 2 well-known substances with greater ecological hazards, triclosan and Nonylphenoxypoly(ethyleneoxy)ethanol are permitted for both human body and environment and surface uses. Another dispute is the possible interference with existing implementing practices. Both Determining Criteria and GB 38850 has not yet permitted the environmental use of Poly (hexamethylenebiguanide) hydrochride (PHMB), but such usage has always been tacitly accepted during the record-filing at the provincial health authorities by numerous manufacturers, the imperative market entry procedure for non-new disinfectants. With the effectiveness of GB 38850 on November 1, a doubt would set in: will these PHMB disinfectants continue to be compliant?

The Inert Ingredients

Of all the disinfectant regulations/standards in China, GB 38850 firstly proposes the definition of “inert ingredient”: Substances contained in a disinfectant formulation and have an auxiliary effect on product performance, such as pH regulators, stabilizers, corrosion-inhibitors, solubilizers, excipients, colorants and fragrance, etc. Compared with the US EPA, who listed over 2000 inerts, it is far from enough that only 115 inert ingredients were included in GB 38850, together with their varying usages limiting to contaminants, drinking water, environment and surface, human, central air-condition, medical instrument and swimming pool water. Although the national standard allows the uses of cosmetic/food colorant and fragrance in all categories of disinfectants except those used on damaged skin and mucous membrane, most of the listed inerts are PH-regulators, stabilizers, corrosion-inhibitors, solubilizers, excipients and only a few of them can help to improve product function and sensory properties. For instance, GB 38850 permits only dozens of common surfactants, which is extremely disproportionate to the technical actuality nowadays.

Prohibited and Restrictive Substances Defined

GB 38850 explicitly prohibited the use of bellow ingredients in disinfectants, by referencing pharmaceutical and cosmetic regulations:

  • Pharmaceuticals, vaccines, serum, toxins, immune stimulants, diagnostic reagent(excluding lysozyme and lysostaphin) listed in the Chinese Pharmacopoeia (Edition 2015, excluding disinfectants and antiseptic);
  • The prohibited substances listed in the “Safety and Technical Standards for Cosmetics(2015 edition, excluding iodine)” in human-use disinfectants.

For skin and mucous membrane disinfectants, several active ingredients have been reiterated with maximum limits, because most of the limits are consolidated from 2 mandatory national standards promulgated in 2011:

Active Ingredient

GB27954-2011
(mucous membrane)

GB 2751-2011
(skin disinfectant)

GB 38850

chlorhexidine gluconate or chlorhexidine acetate

≤5000 mg/L

< 45 g/L

≤45 g/L(skin)
≤5 g/L(mucous membrane)

triclosan

≤ 3500 mg/L

<20 g/L

≤20 g/L(skin)
≤3.5 g/L(mucous membrane)

benzalkonium bromide or benzalkonium chloride

≤ 2000 mg/L

<5 g/L

≤5 g/L(skin)
≤2 g/L(mucous membrane)

povidone iodine solution

≤500 mg/L

/

/

Quality Grading of the Raw Materials

Furthermore, GB 38850 proposes quality requirements towards the raw materials used in certain categories of disinfectants, most of which were already specified in other regulations, national/industrial standards and Chinese Pharmacopoeia, etc. In general, a raw material with inferior quality grade may not be used in certain categories of disinfectants. Of the grading criteria we surveyed, most of the inferior-grade raw materials are exempted from heavy metal and Arsenic limits. That is, a raw material with excessive heavy metal or arsenic contents will be prohibited from disinfectant production. Below table summarized the critical indicators for 4 typical types of disinfectants subject to the quality requirements:

Type of Disinfectant

Grading Criteria(referred standard)

Threshold for inferior grade of active ingredient discouraged from being used

Disinfectant containing sodium hypochlorite

GB/T 19106

heavy metal Pb: 0.001%; As 0.0001%

Disinfectant containing peracetic acid

GB/T 19104

heavy metal Pb: 0.0005%; As 0.0003%

Sodium dichloroisocyanurate disinfectant for drinking water (emergency use)

HG/T 3779

heavy metal Pb:0.001%; As:0.0005%,

Stable chlorine dioxide solution for human, food-related targets, medical instruments and drinking water

GB/T 20783

heavy metal Pb:0.0005%; As:0.0001%,

For the quality grading of active ingredients in disinfectants used on human, food-related targets, medical instrument and drinking water, GB 38850 only pointed out a rough scope for referencing: they shall meet or exceed the quality requirements in the Chinese Pharmacopoeia 2015 Edition (CP 2015), food grade, medical grade and analytical grade specified in other quality standards. A total of 60 active ingredients are permitted for human, medical instrument and drinking water treatment, but only parts of them are included in CP 2015 as disinfectants, antiseptics, or excipients and specified with detailed quality specifications similar to active pharmaceutical ingredients, including test scope, methodology and indicators/limits. Some of the raw materials have been developed with national/industrial standards for food/cosmetic raw material. The quality grading status of the 60 raw materials are summarized as follows:

No.English NameCAS No.Use ScopeStandardization Status
11-bromo-3-chloro-5, 5’-dimethylhydantoin (bromochlorodimethylhydantoin)16079-88-2C, E, H, M, SGB/T 23854-2019(Grading Criteria)
22, 2’-methylenebis (3, 4, 6’-trichloro- phenol) (hexachlorophene)70-30-4H/
32,4, 4’-trichloro-2’-hydroxydiphenylether (triclosan)3380-34-5E, H, K, MQB/T 4947-2016(for cosmetic raw material)
42-methylbenzhydryl chloride41870-52-4E, H/
5Acetic acid64-19-7HGB/T 1628-2008 (industrial grading) GB 1886.10-2015 (food additive standard)
6Acidic electrolyzed oxidizing waterE, H, M/
7Benzalkonium bromide91080-29-4A, E, H, K, MCP 2015 included
8Benzalkonium chloride8001-54-5/63449-41-2A, E, H, K, MCP 2015 included
9Enzethonium chloride121-54-0A, E, H, K, MQB∕T 5106-2017(industrial standard for cosmetic material)
10Benzoic acid65-85-0E, HCP 2015 included
11Calcium hypochlorite7778-54-3C, D, E, H, M, SGB/T 10666-2019
12Cetrimide8044-71-1E, H/
13Chlorhexidine diacetate56-95-1A, E, H, MCP 2015 included
14Chlorhexidine digluconate18472-51-0A, E, H, MCP 2015 included
15Chlorine7782-50-5D, E, S/
16Chlorine dioxide10049-04-4A, C, D, H, M, S, WGB 26366
17Chloroxylenol88-04-0E, H, M 
18Citric acid77-92-9H, MGB/T 8269-2006 GB1886.325-2016(national food safety standard for food additive)
19Didecyl dimethylammonium bromide2390-68-3A, E, H, K, MHG/T 2230-2006(industrial standard for water treatment agent)
20Didecyl dimethylammonium chloride7173-51-5A, E, H, K, M/
21dimethyl dioctylammonium chloride5538-94-3A, E, H, K, M/
22dimethyl phenol95-87-4H, E/
23Dodecyl trimethyl ammonium bromide1119-94-4A, E, H, K, M/
24Dodecyl dimethyl benzyl ammonium chloride139-07-1A, E, H, K, M/
25Dodecyl ethyl dimethyl ammonium bromide1965463A, E, H, K, M/
26Dodecyl trimethyl ammonium chloride112-00-5A, E, H, K, M/
27Dodecyl dimethyl (2-phenoxyethyl) ammonium bromide /domiphen bromide538-71-6A, E, H, K, MCP 2015 included
28ethanol64-17-5A, E, H, MCP 2015 included
29Hexamethylenetetramine/ Urothropin100-97-0A, E, H, KCP 2015 included
30Hydrogen peroxide7722-84-1A, E, H, MCP 2015 included
31Hypochlorous acid7790-92-3E, H, M/
32Iodine7553-56-2E, H, MCP 2015 included
33Octadecyl dimethyl amine oxideA, E, H, K, M/
34OzoneA, D, E, S/
35Peracetic acid79-21-0A, C, E(surface only), H, MGB19104-2008
36Poly ( hexamethylenebiguanide ) hydrochloride32289-58-0H/
37Poly (diallyl dimethyl ammonium chloride)26062-79-3A, E, H, K, MGB/T 33085-2016 (national standard for water treatment agent)
38Polyhexamethyleneguanidine hydrochloride57028-96-3A, E, H, K/
39Potassium permanganate7722-64-7HCP 2015 included
40Povidone iodine/ polyvinyl  pyrrolidone - iodine complex25655-41-8E, H, MCP 2015 included
41Propan-l-ol71-23-8E, H/
42Propan-2-ol67-63-0E, HCP 2015 included
43Quaternary 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 compoundsA, E, H, K, M/
44Quaternary ammonium compounds,benzyl C12-C14 alkyl dimethyl, chlorides85409-22-9A, E, H, K, M/
45Quaternary ammonium compounds,benzyl C12-C16 alkyl dimethyl, chlorides68424-85-1A, E, H, K, M/
46Quaternary ammonium compounds,benzyl C12-C18 alkyl dimethyl» salts with 1,2- benzisothiazol-3(2H)-one 1,1-dioxide (1 5 1)68989-01-5A, E, H, K, M/
47Quaternary ammonium compounds, C12- C14 alkyl((ethylphenyl) methyl) dimethyl, chlorides85409-23-0A, E, H, K, M/
48Quaternary ammonium compounds,di- C8-C10 alkyl dimethyl, chlorides68424-95-3A, E, H, K, M/
49Quaternary 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 compoundsA, E, H, K, M/
50Salicylic acid69-72-7C, E, HCP 2015 included
51Silver7440-22-4E, H/
52Sodium benzoate532-32-1E, HCP 2015 included
53Sodium dichloroisocyanurat2893-78-9A, C, D, E, H, M, S, WHG/T 3779-2005
54Sodium hypochlorite7681-52-9C, D, E, H,  M, S, WGB/T 19106-2013
55Tosyl chloramide sodium127-65-1D, E, M/
56Trichloroisocyanuric aicde87-90-1C, D, E, H, M, S, W/
573,4,4’-trichloro-carbanilid/triclocarban101-20-2E, H/
58Zinc undecylenate557-08-4HCP 2015 included
59Lysozyme9001-63-2E, HGB 1886.575-2016(national standard for food additives) QB/T 5030-2017(industrial standard for disinfectant)
60Lysostaphin9011-93-2E, H/
 A: indoor air;
C: contaminants;
D: drinking water;
E: environment and surface;
H: human;
K: central air-condition;
M: medical instruments;
W: hospital sewage
   

GB 5749 is the national standard for drinking water quality, consisting of regular, non-routine and reference indicators and limits for harmful substances and the impurities in the raw materials used in drinking water disinfectants that carried into drinking water shall not exceed the limits prescribed.

Closing

China’s disinfectant regulation has found a relatively straightforward system for towards existing and new active ingredients: the non-new products (containing existing active ingredients/existing purpose) are tested, evaluated and filed at provincial health authorities in a fixed mode while new active ingredients/new uses are more rigorously reviewed and approved at the national level. The cataloged system was supposed to crack down the unauthorized and excessive use of chemical substances, but the truth of the filing process is that the information on product formula and raw materials are mostly disclosed at limited and varying degrees as the authorities will not necessarily verify the authenticity. The limited availability of the ingredients may lead to a large number of concealment or misstatement by the SMEs while the MLEs would be prohibited from innovations and placed at a greater disadvantage. The industry is calling for transparent criteria for the inclusion of new inert -toxicity and environmental profile, but most urgently, the transition policy for the unlisted inerts in disinfectants already on the market.

Standard and Corporate members may directly click below link to download the English version of GB 38850-2020:

English Translation of GB 38850-2020(for reference only)

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Reference Links

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