- Chemical substance, natural substance, or microbe used to remove, render harmless, or inhibit any harmful organism
- Those who wish to manufacture or import active substance for biocidal products or biocide-treated article must receive an approval from the Ministry of Environment
- New active substance : before release to the market
- Existing active substance : before the deadline of approval deferment period
- Manufacture, import, sales, and distribution of active substance that has not received the approval of the Ministry of Environment are prohibited
Active Substance
Active Substance
Approval Deferment of Existing Active Substance
A person who intends to manufacture or import an active substance contained in any biocidal product or treated article distributed in the Republic of Korea prior to December 31, 2018 may manufacture or import an existing active substance without obtaining approval of that substance in the case where such substance is designated and publicly notified as the existing active substance eligible for approval deferment; such substance can be manufactured and imported during the deferment period without an approval
| Deferment Period | Until 12/31/2022 | Until 12/31/2024 | Until 12/31/2027 | Until 12/31/2029 |
|---|---|---|---|---|
| Active Substance (Product Type) | Disinfectants | Preservative for wood | Preservative for product | Preservative for construction material |
| Algaecide | Remover for other vertebrates | Preservative for product surface treatment | Material and equipment preservative | |
| Rodenticide | Remover for other invertebrates | Preservative for fabric and leather | Preservative for corpse and stuffed specimen | |
| Insecticide | No content | No content | Antifouling chemical for ships and underwater facilities | |
| Repellent | No content | No content | No content | |
| Products and Treated Products |
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Approval Procedure of Active Substance
- Application for approval, assessment, approval, etc. are based on the Chemical Product Management System (CHEMP)
- It takes 18 months from the application for approval to the notification of approval
- Preparation of “Biocidal Active substance Dossier” (BAD)
- Hazard confirmation data (test data, non-test data, general data)
- Application for approval of active substance
- Response to the National Institute of Environmental Research through modification and supplementation
Active Substance Approval Tasks
- Preparation of active substance approval data
- Analysis of components and tests on effect/efficacy considering the purpose of active substance
- Tests on physical/chemical/biological properties and hazard to human body/environment of active substance
- Hazard assessment of active substance
Flowchart of Active Substance Approval
- Mfr./Importer
- Prep → File for application
- File for application → Reception
- Receive notification of start → Draft(Within 1 year)
- View draft → Draft(Submit opinion within 30 days of end of viewing period(+30-day ext. possible))
- Receive notification of approval
- NIER
- Reception → Assessment
- Assessment → Receive notification of start(Notify start within 30 days), Assessment → Draft
- Draft → View draft(Over 30 days)
- Screening → Completion(Within 30 days (+30-day ext.possible))
- Completion → Receive notification of approval