On November 11, 2020, China’s State Administration for Market Regulation (SAMR) and the State Standardization Administration jointly issued the mandatory national standard” GB38598-2020 General Requirement for Label and Instruction Book of Disinfection Products”, expected to take effect on December 1, 2021. This standard will apply not only to disinfectants, disinfecting apparatus, disinfection indicators and antibacterial/bacteriostatic agents that fall under the pre-marketing safety and efficacy evaluation and record-filing process, but also other daily necessities such as contact lenses solutions, wet wipes, hygienic wet wipes, sanitary napkins(pad), diapers, cotton swab/ball, tissues, household paper (excluding toilet paper) and papery tableware.
The drafter and responsible authority, the National Health Commission (NHC) revealed that the standard is the first hygiene standard to passed the deliberation stage by over 140 WTO members. GB38598-2020 is expected to play an important role in reducing trade barriers and ensuring correct and safe uses of disinfection products by both healthcare professionals and general consumers.
Significance and Coverage
All disinfection-related regulations were developed under the national law “Prevention and Treatment of Infectious Diseases” and the ministerial regulation “Administration Measures for Disinfection”. In late 2005, MoH (former NHC) issued a lower level ministerial regulation, “Management Specification for Label and Instruction Book of Disinfection Products” (the “ministerial labeling regulation”), but it gradually become disconnected from the industrial and market changing conditions, especially the decentralized reform of 2013. Now, the arrival of GB38598-2020 has elevated the legal priority of labeling regulations and costs of mishandling: the breach of a national mandatory standard can now be fined up to 50,000 RMB.
Not all products with disinfection functions are regulated as disinfection products in China. For example, boiling sterilizers and alcohol/ iodine cotton ball/swab (carrier disinfectants) commonly used in hospitals are regulated as medical devices. To help industry and users better distinguish disinfection products, GB38598-2020 reiterated the product scope: only products included in the “Catalogue of Disinfection Products”, annex to the “Rules for the Hygiene License for the Production of Disinfection Products (enterprise license applicable only to homemade products)” promulgated in 2009.
The Catalogue classified all disinfection products according to their formulation type, mode of action, use purpose, structuring them into 3 groups and 54 types of products:
Group | Representative products | Number of products |
Disinfectant | powder, tablet, granules, liquid, aerosol and gel disinfectants | 6 |
Disinfecting apparatus | Disinfecting apparatus, disinfection indicators, Packed-sterilized articles with sterilization marking; | 33 |
Sanitary products | antibacterial/bacteriostatic agents, contact lenses solution, wet wipes and hygienic wet wipes, sanitary napkins(pad), diapers, cotton swab/ball, tissues, household paper (excluding toilet paper), gloves/fingerstall, and papery tableware) | 15 |
It is important to note that there is not a full correspondence between the Catalogue and the classification under the “Rules on the Hygiene and Safety Evaluation of Disinfection Products”. Existing Class I and Class II products need to complete the Evaluation and filing process while all products need to comply with labeling requirements:
| Class I | Class II | Class III |
Product Scope | High-level disinfectant/ sterilizing agents, disinfecting/sterilizing apparatuses for medical purpose; Disinfectants for skin and mucous membranes treatment; Biological indicators, and chemical indicators with sterilization effect. | Other disinfectants, disinfecting apparatuses and chemical indicators that do not fall into Category I; Packed-sterilized articles with sterilization marking; antibacterial/bacteriostatic agents. | Hygiene products (wipes, diapers, sanitary napkins, makeup cotton cleaning wipe, paper tableware, contact lenses solution and other hygiene-related products) that do not fall into the category of antimicrobial agents. |
Risk | Relatively High | Moderate | Relatively Low |
Obligation | Pre-marketing hygiene and safety assessment; record filing at the provincial level; Fulfilling of labeling requirements. | Fulfilling of labeling requirements. |
Evaluation validity | Retest every 4 years | Permanent | / |
Structure and Key Changes
GB 38598-2020 consists of 8 chapters of mandatory terms. The first 3 chapters introduce the scope, terms and definitions, and normative reference of other related standards and regulations. Chapter 4 to 7 offer the mandatorily content and prohibited content necessary for a minimum market packaging label, transport packaging label and instruction book for disinfectants, disinfecting apparatus, disinfection indicators and sanitary products. Chapter 8 specifies the requirements for each item of such as nomenclature, language, font size, measuring unit, target microbial organism and expiration date, etc. Finally, some typical examples are compiled in the form of an informative appendix.
For cost and complexity considerations, the minimum market packaging label and the instruction book can be combined, provided that all compulsory contents are correctly placed.
Compared to the ministerial labeling regulation, GB38598-2020 offers more detailed content owing to past monitoring activities. The compulsory items and prohibited information newly added are summarized as follows：
Newly added Information to be Included on packaging labels and in the Instruction Book |
Content | Placement |
Note: S-label of minimum sales packaging or nameplate of disinfection apparatus; T-label for transport packaging I-Instruction Book | S | T | I |
Disinfectants |
Net content | √ | | |
Product specification | √ | √ | √ |
Contact information of the manufacturer | √ | √ | √ |
Storage conditions | √ | | |
Packing specifications | | √ | |
Precautions for storage and transport | | √ | |
Hygiene approval document No.(new products only) | √ | | √ |
Use scope | | | √ |
Disinfecting Apparatus |
Hygiene approval document No. (new products only) | √ | | √ |
Main technical parameters | √ | | |
Main germicidal factor and intensity (only when testing methods are available） | √ | | √ |
Disinfection time, usable area, or volume | √ | | |
Batch number(nameplate), service life of the appliance or major component | √ | | √ |
Packing specifications | | √ | |
Precaution for storage and transport | | √ | |
Mechanism of action (filtration or germicidal, etc.) | | | √ |
Contact information of the manufacturer | | | √ |
Method for assembly and debug and scheme of function keys | | | √ |
Indicator |
Hygiene approval document No. (new products only) | √ | | √ |
Net content | √ | | |
Microbial content (only for biological indicators) | √ | | √ |
Use scope | √ | | |
Batch number and expiration date (or production data and validity period) | √ | | √ |
Storage conditions | √ | | |
Packing specification | | √ | |
Precaution for storage and transport | | √ | |
Product specification | | | √ |
Discoloration explanation (for chemical indicator) | | | √ |
Use scope | | | √ |
Sanitary product |
Net content | √ | | |
Contact information of the manufacturer | √ | √ | √ |
Batch number and expiration date, or production data and validity period. Warranty period for wet wipes, non-disinfecting contact lenses solutions and other sanitary products (disposable products) need to mark the Warranty period and products with disinfection function need to mark the period of validity. Generally it is not necessary to add validity on papery products | √ | √ | √ |
Storage conditions (optionally for other sanitary products) | √ | | |
Active ingredient(s) used in antibacterial/bacteriostatic agents | √ | | |
Contact lenses solutions with a disinfection function need to label the active ingredient and content, as well as the use scope. Wet wipes need to label the product specifications, major raw materials, number of product quality executive standard (enterprise standard or GB15979-2002) Hygienic wet wipes need to label product specifications, name and content of the active ingredients used in the extract liquid, target microbial species and category, and use scope. Sanitary napkins (pad and paper) with antibacterial/bacteriostatic function need to label the target microbial category and product quality executive standard (WS 575-2017) | √ | | |
Disinfection-grade products should be labeled with the words “Disinfection grade”, and disinfection method, as well as the date of disinfection. | | √ | |
Packing specification | | √ | |
Precaution for storage and transport | | √ | |
For antibacterial/bacteriostatic agents used on vaginal mucosa, instruction book should include “shall not be used for STD prevention”; Antibacterial/bacteriostatic agents need to label the product specifications (formulation type) Target microbial category of antibacterial/bacteriostatic agents or contact lenses solutions with a disinfection function. | | | √ |
Newly Added Information Prohibited from Labels and Instruction Book |
Content | Product scope |
Unveracious contents: expression or indication of disease treatment, clinic symptom and disease name (unless the disease was named after a microorganism), names of antibiotics, hormones, anti-fungal medicines, and other prohibited substances. | Disinfectants Disinfecting apparatus Antibacterial/bacteriostatic agents Contact lenses solutions Wet wipes Hygienic wet wipes Other sanitary products |
Description or explanation of disease symptoms How to prevent the recurrence, conducive to wound healing, adjuvant therapy. (for disinfecting apparatus they must also comply with medical device regulations, as the product can have a treatment effect after all necessary human experiments are completed) | Disinfectants Disinfecting apparatus Antibacterial/bacteriostatic agents Contact lenses solutions |
Antibacterial. The word “Antibacterial” shall not appear on the product name | Wet wipes |
Bacteriostatic The word “Bacteriostatic” shall not appear on product name | Hygienic wipes |
Sanitary napkins (pad and paper), diapers and urinal pads must not contain the words “disinfection”, “sterilization”, “degerming”, “leukorrhea-reduction”, “Moistening”, “Anti-inflammation”, “inflammation treatment”, “Spermicide” and “contraceptive” The word “Medicinal” must not appear on product name | Other sanitary products |
Loopholes, Duplications and Prospects
From the consumer’s perspective, there is a considerable overlap between disinfection products and medical supplies, however, not all of them are well overseen and parts of anti-microbial products are still in a legal gray zone.
Disinfecting wet wipes are mushrooming in medical and healthcare facilities and becoming popular among general users, owing to their stronger biocidal efficacy and easy application. Currently, these products are not yet included in the “Catalogue of Disinfection Products” nor in the “Split Catalogue of Medical Device” enforced by the NPMA（National Medical Products Administration）. Domestic producers are not yet covered by the hygiene license and the GB 38598 will not apply to disinfecting wet wipes. The market circulation is ever more dependent on industry self-regulation, a voluntary standard named T/WSJD 001-2019. The latest news show that the ever-increasing uses of disinfecting wet wipes since the Covid-19 pandemic have led to growing concerns among health authorities and this issue is likely to be resolved soon.
On the contrary, contact lenses solutions are also categorized as the Class II medical device that requires product registration process at a provincial level (imported products need to be registered at the national level) and a stringent production licensing system. NHC experts consider the medical device regulation is sufficient to ensure user’s safety and a single labeling regulation would help reduce the burden on enterprises.
As a diverse and confusing product group, it is important to clarify that antibacterial/bacteriostatic agents refer only to skin/mucous membrane contacting products. Therefore，there are a series of antibacterial products which have not yet been overseen by NHC, including antibacterial clothes/fabrics and antibacterial coatings, as well as antibacterial surface treatments (excluding surface-use disinfectants).
Apart from GB 38598-2020, disposable sanitary products also need to comply with another important mandatory standard, GB 17979-2002, which specifies the hygienic requirements, evaluation criteria, testing methods, technical requirements for raw materials and production process, storage, transport and labeling. The standard is being revised and expected to be released soon.
