On November 11, 2020, China’s State Administration for Market Regulation (SAMR) and the State Standardization Administration jointly issue the national standard,” GB38598-2020 General Requirement for Label and Instruction Book of Disinfection Products”, which will be mandatorily implemented starting from December 1, 2021.
Currently, the labels and manuals of disinfection products need to comply with the “Management Specification for the Labels and Instruction Books of Disinfection Products”. As a ministerial document issued as early as 2005, the specification has limited enforceability and cannot meet the need for market growth and product surveillance.
To offer greater operability and reference for enterprises and users, GB38598-2020 specifies the labeling and marking requirements for minimum sales package, transport package and use instruction for various types of products including disinfectants, disinfecting apparatus, indicators (of disinfection effect) and sterilized-packed medical instruments, antibacterial/bacteriostat lotions and sanitary products. Compare to the previous ministerial document, the main differences are highlighted as follows:
- Offering separated definitions for new disinfection products, biological indicators and chemical indicators;
- Additional labeling requirements for new disinfection products (subject to premarketing approval). New disinfection products need to place the approval number on product labels and manuals;
- Refined requirements for font size and content statement. The allowable variation range for stable active ingredients (±10% of the nominal content) and unstable active ingredients (±15% of the nominal content);
- For disinfection products included in the “Catalog of Hazardous Chemicals”, the pictograms of transport packages shall comply with “GB191 Packaging-Pictorial Marking for Handling of Goods” and “GB 190 Packing Symbol of Dangerous Goods”. For products with foreseeable harmful effect or danger in case of misuse or incorrect store, it shall be labeled with precautionary statements;
- Annex A of GB 38598 offers many examples of how to correctly place the product name, net content, active ingredient content, strength of germicidal factor, license information, target microorganism, scope application, application method, production date and expiry date, etc.
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