CHINA DISINFECTION PRODUCT LABELLING
China has included the revision of GB 38598-2020 in its 2026 standards plan. GB 38598-2020 remains the current basis for labels and instructions, including those for imported products. This article reviews the requirements by product type, prohibited wording and the information required for imports.
Current requirementsImported productsRevision included in the 2026 standards plan
The National Disease Control and Prevention Administration (NCDPA) has issued its 2026 plan for disease prevention and control standards (国疾控综法规函〔2026〕250号). The plan was issued on 15 October 2026 and published on the NCDPA website on 23 October.
It lists 53 projects in nine categories. Nine concern disinfection: eight revisions and one new standard. Five of the nine are mandatory national standards (GB); four are health-industry standards (WS/T).
Among the nine, project JK20260605 is the revision of General requirements for labels and instructions of disinfection products, revising GB 38598-2020; the lead drafting unit is the Jiangsu Provincial Centre for Health Supervision and Guidance. Three product standards are being revised in the same batch: GB 38456-2020 (antibacterial and bacteriostatic washes), GB 27949-2020 (medical device disinfectants) and GB 27953-2020 (disinfectants for terminal disinfection).
As of publication, no draft for comment has been issued under JK20260605. A standards plan assigns drafting tasks and units; it does not produce a text. From project approval to a draft for comment usually takes more than a year, followed by review, approval and publication. What governs how an imported label is produced today is still GB 38598-2020.
The standard is the mandatory basis for the labels and instructions of disinfection products, and once revised, every product sold in China will be governed by the new text. With the revision just launched, this article reviews the labelling requirements of the current standard.
Scope of GB 38598-2020
GB 38598-2020, General requirements for labels and instructions of disinfection products, is a mandatory national standard in force since 2021. Before it, labels and instructions were governed by the Rules for the Administration of Labels and Instructions of Disinfection Products (卫监督发〔2005〕426号). Those rules have not been repealed and remain in force alongside the standard; the NCDPA has confirmed this in published replies.
Scope. Under clause 1, the standard sets general requirements for labels and instructions, and requirements for the statement of individual items, for disinfectants, disinfection devices, indicators and sanitary products. It applies to disinfection products produced, sold and used within China, and does not apply to export products neither sold nor used in China. The test is where the product is sold, not where it is made.
Definition. Clause 3.1 defines a disinfection product as a disinfectant, disinfection device, indicator or sanitary product listed in the catalogue of production categories. On that definition, a product outside the catalogue is not a disinfection product.
Relationship with other standards. Clause 8.8 sets four requirements for use scope: the object of use must be specific; for a new product it must match the hygiene licence approval; for a product requiring hygiene safety evaluation it must match the evaluation report; for other products it must conform to the relevant standards. The clause names no standards; which one applies depends on product type — medical device disinfectants, for instance, correspond to GB 27949, and antibacterial and bacteriostatic washes to GB 38456.
Role in filing. Filing of a disinfection product is a notification, not an administrative approval. The label and instructions form part of the hygiene safety evaluation report, the technical document in which the responsible entity evaluates the product's hygiene and safety performance. After filing, the provincial regulator checks the product against the version filed.
Current labelling requirements
Information required for the four product types
Disinfectants (chapter 4). The smallest sales package must carry: product name; net content; specification, for tablets; main active ingredient and its content; use scope; production date and expiry date, or batch number and use-by date; manufacturer name, address and contact details, with the production hygiene licence number added for domestic products; storage conditions; and, for imports, the country or region of origin. The leaflet adds the spectrum of microorganisms killed, method of use, precautions, effective period and the standard complied with. A disinfectant used on mucous membranes must state in its use scope "for use only in the diagnosis and treatment of patients in medical institutions" (仅限医疗卫生机构诊疗用).
Disinfection devices (chapter 5). A nameplate takes the place of a label and is fixed to or stuck on the device. It states the product name; main technical parameters; main sterilising factor and its intensity; operating time and the area or volume treated; and the service life of the machine or of its main components. The leaflet must also contain the mechanism of action, the spectrum killed, installation and commissioning instructions, and a diagram of each function key.
Indicators (chapter 6). Beyond the common content — product name, net content, use scope, production date and expiry, manufacturer information, storage conditions and the like — biological indicators state the organism and its count, and chemical indicators and sterilisation packaging state the colour change.
Sanitary products (chapter 7). Beyond the common content: antibacterial and bacteriostatic preparations state the active ingredient and its content and the use scope, and a product for vulvar mucosa must also state "not to be used to prevent venereal disease in sexual intercourse" (不应用于性生活中对性病的预防); contact lens care products state the active ingredient and content where the product has a disinfecting function, and the use scope; wet wipes state specification, main raw materials and the standard complied with; hygienic wipes also state the active ingredient and content in the expressed liquid, and the spectrum killed; disinfection-grade products state the words "disinfection grade" (消毒级) together with the disinfection method and date.
Rules that apply to all products
Language and type size. Chinese in standard characters, in a prominent position on the display or visible surface. Characters must be taller than 1.8 mm. Pinyin, minority scripts and foreign languages may be used alongside, but the foreign text must be smaller than the corresponding Chinese; registered trademarks are excepted.
Product names. Names follow the Rules for Naming Health-Related Products, in the order: trademark or brand name, model for devices, generic name, attribute name. A brand is written in the form "××牌". One product carries one name only, and no false, exaggerated or absolute wording may be used.
Active ingredients. Chemical ingredients are declared by chemical name and content: mg/L, g/L or per cent for liquids; mg or g per tablet, mg/kg or per cent for solids; plant materials by Chinese name with the words 提取液 (extract); biological actives in U/mL, mg/L or g/L. The declared figure is a range — ±10 per cent of the centre value for a stable product, ±15 per cent for an unstable one.
Consistency of stated indications. For the spectrum killed, use scope, method of use and effective period, clauses 8.7 to 8.9 and 8.11 set the same structure: a new product must match its hygiene licence approval; a product requiring hygiene safety evaluation must match its evaluation report, and for the spectrum may additionally rely on a test report; other products must conform to the relevant standards.
Dates, effective period and standard. The effective period must meet clause 8.11, and a disinfectant used repeatedly must also state the in-use period of the working solution. Production date and expiry date, or batch number and use-by date, go on the visible surface of the smallest sales package in year-month-day form (clause 8.12). The standard complied with is either the national standard for the product or an enterprise standard self-declared and published on the national enterprise standards platform; the year may be omitted from the number (clause 8.13).
Instruction. Disinfectants, disinfection devices, indicators, antibacterial and bacteriostatic preparations and contact lens care products must have an instruction inside the smallest sales package. Where the label already carries the full content of the instruction, a separate instruction is not required.
Wording that may not be used
Under clause 8.2, no disinfection product may state or imply a therapeutic effect on disease, state clinical symptoms or the name of a disease — except where the disease name forms part of a microorganism's name — or carry the names of antibiotics, hormones, antifungal drugs or other substances the health authorities prohibit from being added. The specific prohibitions for disinfectants, for devices and for each type of sanitary product are set out in Table 1.
Table 1. Compiled from GB 38598-2020, clauses 4.4, 5.4 and 7.4. The general prohibition in clause 8.2 applies to all products.
| Product type | Wording that may not appear (clause) |
|---|---|
| Disinfectants (4.4) | Anti-inflammatory and anti-infective claims; treating disease, alleviating or relieving clinical symptoms, describing or explaining disease symptoms; preventing venereal disease, spermicidal and contraceptive claims; use on the feet, eyes, nails, armpits, scalp, hair, nasal mucosa or anorectal area; the formulas "× days as one course", "as directed by a physician", "prevents recurrence", "helps wound healing", "adjunct to drug therapy" |
| Disinfection devices (5.4) | Treating disease, alleviating or relieving clinical symptoms; adjunct to drug therapy |
| Antibacterial and bacteriostatic preparations (7.4.1) | Anti-inflammatory and anti-infective claims; treating disease, alleviating or relieving disease symptoms, describing or explaining disease symptoms; preventing venereal disease; suitability for damaged skin, damaged mucous membrane or wounds; "high-efficiency", disinfection, sterilisation, bacteria-removal, spermicidal and contraceptive claims; use on the feet, eyes, nails, armpits, scalp, hair, nasal mucosa or anorectal area; the same formulas as for disinfectants |
| Contact lens care products (7.4.2) | "All-purpose", "high-efficiency", sterilisation and bacteria-removal claims; treating disease, alleviating or relieving disease symptoms; adjunct to drug therapy |
| Wet wipes (7.4.3) | Sterilisation, disinfection, antibacterial, bacteriostatic, bactericidal, bacteria-removal, "medicinal" and "high-efficiency" claims; prevention of venereal disease; treatment of disease; alleviation or relief of disease symptoms; anti-inflammatory and anti-infective claims |
| Hygienic wipes (7.4.4) | Sterilisation, disinfection, bacteriostatic, bacteria-removal, "medicinal" and "high-efficiency" claims; prevention of venereal disease; treatment of disease; alleviation or relief of disease symptoms; anti-inflammatory and anti-infective claims. The product name may not use "antibacterial" |
| Other sanitary products (7.4.5) | On sanitary towels, panty liners, toilet paper, nappies (pads, paper), incontinence pads and nappy pants: disinfection, sterilisation, bacteria-removal, "stopping vaginal discharge", "removing dampness", "moistening", anti-inflammatory and anti-infective claims, spermicidal and contraceptive claims. The product name may not use "medicinal" |
Imported-product requirements under clause 8.15
The labelling requirements specific to imported products sit in clause 8.15. They are detailed and differ from the rest of the standard:
The country or region of origin, expressly including Hong Kong, Macao and Taiwan.
The name and address of the responsible entity in China (在华责任单位, the single entity registered in China for the imported product), consistent with that entity's business licence. The contact details on the pack are the Chinese entity's telephone, not the overseas factory's.
Where the product is contract-manufactured, the name and address of the actual manufacturer.
Annex A.12.3 adds that the overseas manufacturer's name and address must match the authorisation letter held by the responsible entity in China. That letter is itself a filing document, so the two are prepared together.
What this means for imported products
Taken together, GB 38598-2020 works on two levels: chapters 4 to 7 give the labelling lists by product type, and chapter 8 unifies how that information is written. What the standard regulates is, in effect, a relationship of correspondence — what appears on the package and in the leaflet must be consistent with the product itself, with the hygiene licence approval or the hygiene safety evaluation report, and with the product standard complied with.
For imported products, that correspondence rests on clause 8.15: the origin, and the responsible entity in China. Manufactured abroad and answerable in China is the structure the standard sets for imports.
(Compiled from the text of GB 38598-2020, the NCDPA 2026 standards plan and the NCDPA's published replies.)
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For over a decade, REACH24H has tracked regulatory developments in China's disinfection product sector and supported companies with compliance and market access.. Our China disinfectant compliance services bring label management together with product classification, testing and filing support.
Support across the filing process. Product type and compliance analysis, data gap review, dossier preparation and submission.
Label management and testing support. Assistance with labels, test supervision and test report review.
Laboratory collaboration. An established network of accredited testing laboratories supports project delivery.
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