The National Institute of Environmental Research (NIER) in South Korea provides a summary for the Approval application documents based on the updates on disinfectant and preservatives for humidifiers on April 10th, 2023. This is based on the updated classification on product type based on diversified disinfectant and preservatives for humidifiers under the ‘Regulations on the Approval for Consumer Chemical Products Subject to Safety Verification’ on December 12, 2022.
According to the summary, the Approval application documents for the antimicrobial and preservatives for humidifiers remains the same, but some of the Approval application documents for the preservation treatment product for humidifiers can be exempted. The provided summary for the Approval application documents is as below:
| Documents to be submitted Classification |
Data classification | |||||||||||||||
| Origin or development process | Domestic and overseas usage status | Ingredients | Finished products | |||||||||||||
| Structure decision | Physicochemical, biological characteristics | Manufacturing method | Standards and test methods and supporting data | Test results | Standards and reagents | Ingredients and quantity | Manufacturing method | Standards and test methods and supporting data | Test results | Standards and reagents | Container and packaging | |||||
| Existing products | Antimicrobial and preservatives for humidifiers | Dissolving type (structure-disappearing type) | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ |
| Elution type (structure-maintenance type) | ○ | ○ | ○ | ○ | ○ | ○ | ○ | △ | ○ | ○ | ○ | ○ | ○ | ○ | ||
| Other products | 1. Consumer chemical products for humidifiers | ○ | ○ | △ | ○ | ○ | ○ | ○ | △ | ○ | ○ | ○ | ○ | ○ | ○ | |
| 2. Preservation treatment product for humidifiers | △ | ○ | - | - | - | - | - | - | △ | △ | △ | ○ | - | ○ | ||
| Documents to be submitted Classification |
Data classification | |||||||||||||
| Stability | Toxicological data | Effect & efficacy | Absorption, distribution, metabolism, excretion | |||||||||||
| Single dose | Repeated dose | Reproductive development | Genotoxicity | Immunity | Carcinogenicity | Other toxicity (local, neurological, antigenic) | Cell | Environmental hazard | ||||||
| Existing products | antimicrobial and preservatives for humidifiers | Dissolving type (structure-disappearing type) | ○ | ○ | ○ | △ | ○ | △ | △ | ○ | △ | - | ○ | - |
| Elution type (structure-maintenance type) | ○ | ○ | ○ | △ | ○ | △ | △ | ○ | △ | - | ○ | - | ||
| Other products | 1. Consumer chemical products for humidifiers | ○ | ○ | ○ | △ | ○ | △ | △ | ○ | △ | - | ○ | - | |
| 2. Preservation treatment product for humidifiers | ○ | ○ | ○ | △ | ○ | △ | △ | ○ | △ | - | ○ | - | ||
○: Mandatory documents to be submitted
△: Documents that may be exempted
-: Documents that don’t need to be submitted