On April 29, 2024, the State Administration for Market Regulation (SAMR) and the Standardization Administration of China (SAC) officially approved 34 mandatory national standards and one amendment to an existing mandatory national standard, including the Amendment to GB 38598-2020: General Requirements for Labels and Instructions of Disinfection Products. This amendment is scheduled to take effect on May 1, 2025.
The amendment revises and supplements certain provisions of the current standard, with the aim of further regulating the labeling and instruction requirements for disinfection products. It is intended to enhance product safety and strengthen compliance management across the industry.
Amendment Content (English Version)
Clause "7.1 h)"
Original Text:
h) For antibacterial (or bacteriostatic) agents, the label shall indicate the active ingredients and their concentrations, as well as the intended use (for products intended for the genital mucosa, the label shall also state: “Not to be used for the prevention of sexually transmitted diseases during sexual activity”).
Revised Text:
h) For antibacterial (or bacteriostatic) agents, the label shall indicate the active ingredients and their concentrations, the intended use, and warning statements. The warning shall read: “This product is not a drug and does not have therapeutic, nursing, or health care functions. For products intended for the genital mucosa, the label shall also state: ‘Not to be used for the prevention of sexually transmitted diseases during sexual activity.’” The warning text shall be in bold font or in a font size larger than that used for the “Instructions for Use” and general precautions.
Clause 8.1 b)
Original text:
b) The height of Chinese characters, minority language characters, numbers, and letters shall be greater than 1.8 mm;
Revised text:
b) The height of Chinese characters, minority language characters, numbers, and letters shall be greater than or equal to 1.8 mm;
Clause 8.3 c)
Original text:
c) The brand name shall be in the format of “××牌”. The use of trademarks shall comply with relevant national regulations and shall not exaggerate product functions or mislead consumers;
Revised text:
c) The brand name shall be in the format of “××牌”. The use of trademarks shall comply with relevant national regulations and shall not exaggerate product functions or mislead consumers, such as: using homophones or graphics that imply disease treatment, nursing, or health care effects.
Important Notice
For products manufactured or imported between the implementation date of this standard (December 1, 2021) and the effective date of this amendment (May 1, 2025), their labels and instruction manuals may continue to be used and the products may be sold until the end of their indicated shelf life, provided they comply with the original provisions of the standard at the time.
Products manufactured or imported on or after May 1, 2025 must comply with the requirements set forth in this amendment.
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