Breaking News! GB 38850-2020 List for Materials and Restricted Substances in Disinfectants Released

On April 9, 2020, the State Administration of Market Regulation and the Standardization Administration issued and approved 14 mandatory national standards. Among them, GB 38850-2020 List for Materials and Restricted Substances in Disinfectant, which was formulated for the first time, has caused great concern and discussion in the industry. It is also the first compulsory standard issued for disinfectant raw materials in China, and is not applicable to antibacterial agents, whose raw material requirements will be separately established and issued, or sanitary products such as wet wipes. Different from the raw material requirements in the sanitation standards of disinfection products in the past, GB 38850-2020 introduces requirements of raw material composition and use range of disinfectants applied to different disinfection objects in a more comprehensive and deliberate way. In addition, substances prohibited and inert substances allowed in the disinfectant formula have been detailed.

1. Main changes in active ingredients of disinfectant raw materials

Compared with the active ingredient list of disinfectant raw materials briefed in Judgment Basis for the Production of Disinfectant and Disinfection Device with New Materials, New Technology and New Sterilization Principles issued by the National Health Commission of the People’s Republic of China in 2013, the raw materials and the range of use in GB 38850-2020 comprises the following changes:

  • Hypochlorous acid was added as a raw material;
  • The range of raw materials for disinfectants that can be applied to fruits and vegetables, tableware and food-contact tools and equipment were not listed in GB 38850-2020;
  • Raw materials for disinfectants used in centralized air conditioning and ventilation systems were added in GB 38850-2020;
  • The range of use of some raw materials, such as triclosan, chlorine dioxide and hydrogen peroxide, was changed.

The differences between the active ingredient lists of the two disinfectants are as follows:

Items

Judgment Basis for the Production of Disinfectant and Disinfection Device with New Materials

GB 38850-2020 List for Materials and Restricted Substances in Disinfectant

Changes

Active ingredients list

84 kinds, including 81 chemical substances, 1 metal ion, and 2 biological substances

85 kinds, including 82 chemical substances, 1 metal ion, and 2 biological substances

1. "Hypochlorous acid (including slightly acidic electrolyzed water)" has been added to GB 38850-2020;

2. In GB 38850-2020, a list of 26 raw materials (including triclosan, benzalkonium chloride, benzalkonium bromide, etc.) that can be used as disinfectants for centralized air conditioning and ventilation systems is detailed for the first time

Limited use range

10 use ranges of disinfectant raw materials:

"A" means disinfectant used to disinfect indoor air

"C" means disinfectant used for pollutants;

"D" means disinfectant used for drinking water;

"E" means disinfectant used to disinfect the environment and the surface of ordinary objects;

"#E" means only disinfectant used for disinfecting the surface of ordinary objects;

"F" means disinfectant used for fruits, vegetables, tableware, and tools and equipment in contact with food;

"H" means disinfectant for human skin, mucous membranes and hands;

"M" means disinfectant for medical devices;

"S" means disinfectant for swimming pool water;

"W" means disinfectant used for sewage in medical and health institutions.

10 use ranges of disinfectant raw materials:

"A" means disinfectant for indoor air;

"C" means disinfectant used for pollutants;

"D" means disinfectant used for drinking water;

"E" means disinfectant for the environment and the surface of objects;

"#E" means only disinfectants used on the surface of objects, not the environment;

"H" means disinfectant for human body;

"K" means disinfectant for centralized air conditioning and ventilation systems

"M" means disinfectant for medical devices;

"S" means disinfectant for swimming pool water;

"W" means disinfectant used for hospital sewage.

1. In GB 38850-2020, the original item "F": the disinfectant used for fruits and vegetables, tableware, and tools and equipment in contact with food, has been deleted;

Item "K": Disinfectant for centralized air conditioning and ventilation systems, has been added;

2. In GB 38850-2020, the range of use of some raw materials has been adjusted, for example, triclosan can be used for the environment; Ozone gas and ozone water can be used for surface disinfection and environmental disinfection; Chlorine dioxide is no longer allowed for the disinfection of the environment and surface.  

2. Requirements for inert ingredients of disinfectant raw materials

The concept of inert ingredients was first proposed in GB 38850-2020, which refers to substances that have the auxiliary functions of anti-corrosion, skin care, stability, pH adjustment, flavoring and coloring in disinfectant formulations. The standard lists 115 kinds of inert raw materials that can be used as disinfectant products for the first time and specifies the range of use of each ingredient.

It should be noted for companies that the inert ingredients used must be within these 115 kinds when producing disinfectant products. In addition, it is necessary to ensure that the range of use of disinfectant products is consistent with the allowable range of inert ingredients contained therein. In addition to damaged skin and mucous membranes, the colorants and fragrances of disinfectants for other purposes can also refer to the relevant requirements of food additives or cosmetics.

3. Requirements for prohibited substances

  • It is forbidden to add medicines and their raw materials of the same name to the disinfectant, human medicinal vaccines, serum or mycocin and their products (except lysozyme and staphylococcus enzyme)
  • It is forbidden to add prohibited substances (except iodine) listed in the Technical Specifications for Cosmetic Safety (2015 version) to disinfectants used for human bodies (hands, skin, mucous membranes)
  • It stipulates the requirements for raw materials in disinfectants using sodium hypochlorite as raw materials and disinfectants using peroxyacetic acid as raw materials, and specifies the content requirements of dioxins in disinfectants using trichlorohydroxydiphenyl ether as raw materials
  • It is forbidden to add industrial raw materials to disinfectant used to disinfect human bodies, medical devices, and drinking water.

4. Requirements for restricted substances

At present, GB38850-2020 only sets quantity limits on the ingredients of some raw materials in skin disinfectants and mucous membrane disinfectant. The following are the changes compared with Skin Disinfectant Sanitary Requirements and General Requirements for Mucosal Disinfectants:

Restricted substances

GB 27954-2011 General Requirements for Mucosal Disinfectants

GB 27951-2011 Skin Disinfectant Sanitary Requirements

GB 38850-2020 List for Materials and Restricted Substances in Disinfectant

Chlorhexidine gluconate or chlorhexidine acetate

Total content of active ingredients≤5000 mg/L

Effective total content<45 g/L;

Content≤45 g/L (Skin disinfectant)

Content≤5 g/L (Mucosal disinfectant)

Trichlorohydroxydiphenyl ether

Total content of active ingredients≤3500 mg/L

Effective total content<20 g/L

Content≤20 g/L (Skin disinfectant)

Content≤3.5 g/L (Mucosal disinfectant)

Benzalkonium bromide or benzalkonium chloride

Total content of active ingredients≤2000 mg/L

Effective total content<5 g/L

Content≤5 g/L (Skin disinfectant)

Content≤2 g/L (Mucosal disinfectant)

Iodophor application solution

Total content of active ingredients≤500 mg/L

None

None

5. Summary

In the process of disinfectant approval and market supervision, it was found that the long-term lack of raw material standards has led to the problem of non-standard raw materials in many disinfectant formulations, which has caused certain harm to the environment, articles and human safety, and is not conducive to standardizing production enterprises. The release of GB 38850-2020 standard will regulate the management of disinfectant raw materials to a certain extent, which is conducive to the healthy development of the disinfection industry and high-quality products. But on the other hand, there is no doubt that this standard will have an impact on the industry for a long time to come. According to the relevant laws and regulations, if the raw materials used in disinfectant products are not within the range of this standard or the raw materials are extracted from plants, administrative approval must be carried out in accordance with the "three new (new materials, new process technology and new sterilization principle)" products before being marketed. Since 2014, no “three new” disinfection products have been approved, indicating that it is very difficult to declare new raw material disinfectants.

Raw materials for disinfectants used in fruits, vegetables, tableware and food-contact tools and equipment are not included in GB 38850 this time. It can be predicted that there may be a separate list of raw materials for food-related disinfectants in the future. It also requires intensive concern in terms of how to manage the disinfectant raw materials used in food and disinfectant products containing such raw materials.

The management requirements for the inert ingredients of disinfectants have never been formally issued before. However, this time GB 38850 listed 115 raw materials of inert ingredients for the first time, which is abrupt for the relevant disinfectant companies. The resulting embarrassment is that: if the inert ingredients used in disinfectant product do not meet the requirements of GB 38850-2020, but have already been filed or are currently being tested for filing, how should the producers proceed with subsequent product production and sales? Should they modify the formula or wait for official immunity? Another issue is how to guarantee the innovation of the product and give full play to the enthusiasm of the industry if only these inert ingredients are allowed. These issues cannot be dealt with simply by applying standards, nor can they be generalized. For law enforcement agencies and related companies, this will be a challenge.

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