On March 8, 2021, the South Korean Ministry of Environment issued the Announcement 2021-139, a draft amendment to the “MoE Notification 2020-117 Designation of Consumer Chemical Products Subject to Safety Verification and Safety and Label Standards”. The biocide part represents the largest changes, namely the abolishment of air-use disinfectants, the establishment of microbial contamination limits and clarification on eligible main substances and limits, as well as the mandatory efficacy test data required for products with biocidal substance claim. A new product category, lubricants will be newly designated as consumer chemical products based on the actual condition investigation and risk assessment. As a result of the respiratory toxicity data recently produced in Korea, Benzalkonium Chloride and Sodium Dichloroisocyanurate will be added to the list of universally prohibited substances in spray-type products.
The safety verification system was established under the “Act on Consumer Chemical Products and Biocides Safety”, notable the safety verification on consumer chemicals and notification, pre-approval of active substance and biocidal products. Of all the 13 groups of 39 consumer chemical products designated for safety verification, 3 groups overlap with biocides.
Category (Notification 2020-117)
Category (Announcement 2021-139)
Special Purpose Coating Agent
Special Purpose Coating Agent
Gap and crack fillers
Air freshener products
Dye and Colorant painting products
Colorant painting agents
Windshield washer fluids for automobiles
Engine antifreezing agent
Printing and Document Related Products
Ink cartridges and toners
Red seal ink pads
Correction fluids and tapes
Adhesives for beauty
Antibacterial agent and disinfectant for humidifier*
Sterilization and disinfectant for preventing infectious diseases*
Other disinfectants for quarantine*
Antibacterial and disinfectant for humidifiers*
Quarantine sterilization and disinfectant for the prevention of infectious diseases*
Insect repellent products
Prevention, attracting insecticide for health use*
Repellent for health use*
Prevention insecticide for infectious diseases*
Rodenticide for infectious diseases*
pesticide for preventing infectious disease prevention*
Rodenticide for infectious disease prevention*
Preservative products, Preservative-treated products
Preservative-treated filter product
Artificial snow spray
Fog fluid for performance
Household chemical products for humidifiers*
* Products not yet established with safety standards that need to obtain premarketing approval from the MoE.
Apart from substances approved under biocide management system and notified existing substances within the approval grace period, the safety standard specified dozens of main substances allow for use in disinfectants, algicide and insect repellents. The amending draft increases the substances and refines allowable limits in different use categories and formulation types.
Consumer-use disinfectants have definite use categories and scopes and disinfectants for other uses need to comply with the biocide regulation. In this amendment, air disinfection purpose has been removed from the “special purpose” category and “electrolytic sterilizer purpose” was newly added.
General objects: furniture, glass, wood, plastic, metal, fiber, etc.;
For drainage pipes, for removing mold, for closed spaces (where people cannot enter, such as refrigerators and shoe racks, and detailed purpose must be stated together)
Children's products (only for products intended for use by children under 13 years)
Toothbrush and tongue cleaner sterilization
For electrolytic sterilizer
Multi-purpose, wet mop cleaner, toilet water tank (Limited to products that generate sterilized water from chlorine ions through an electrolysis device)
The draft adds Ethylene oxide and Acrylic acid as prohibited in all formulations and 6 substances have been newly established with content limits in general-use disinfectants. A microbial contaminant limit of 500/g (mL) viable cell count was proposed for special-purpose disinfectants. In case of a product indicating the effect or efficacy of the biocidal substance used, additional efficacy data needs to be submitted.
The newly proposed product category, lubricants, refer to oil film foaming chemicals used for vehicle, musical instrument, leisure goods, tool, and metal. These products have been established with 5 prohibited substances, 6 restricted substances and 8 substances to be controlled during the manufacturing process. Also, the amending draft requires a biodegradation test on fabric softeners that emission into water system and add more allowable preservative substances for remover and laundry detergent.
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