Korea to tighten safety standards for disinfection and sterilization products 
In early March 2021, the Ministry of Environment (MOE) of South Korea issued a draft amendment of the Designation of Consumer Chemical Products Subject to Safety Check and Relevant Safety and Labeling Standards (hereinafter the “draft amendment”), which is a subordinate regulation of the Consumer Chemical Products and Biocides Safety Act. In the draft amendment, MOE states that the amendment is needed due to the COVID-19 pandemic situation, in which more and more disinfection and sterilization products are used, requiring stricter safety standards and more products to be regulated. The major provisions of the draft amendment are as follows:
- Newly introduces safety and labeling standards for electrolysis-type sterilizers (electrolytic water sterilizers)
Electrolytic water sterilizers are devices that disinfect water with chlorine, such as hypochlorous acid (HOCl), which is produced by electrolysis of tap water and salt in the device. The draft amendment stipulates content standards for substances that can be used in these devices, such as benzene (allowable maximum content: 5mg/kg), as well as information mandated to be displayed on such sterilizers, such as precautions during use.
- Mandates submission of materials that evidence the efficacy or effectiveness of sterilizer / disinfectant when presenting the effects or effectiveness on the product labeling or advertisement
If efficacy or effectiveness of biocides used in sterilizer / disinfectant products are going to be displayed on product labels or advertisement, evidencing materials of the efficacy or effectiveness must be submitted in the notification of the products. The draft amendment stipulates the scope and the format of the evidence documentation to be submitted.
- Reinforces the existing safety standards
Considering the increased use of sterilizers and disinfectants, the draft amendment stipulates chemical substances allowed for use in biocidal products and the relevant content standards by product type. For example, the permissible maximum content for formaldehyde in spray products is 40mg/kg.
- Newly introduces permissible limits for microorganisms
In order to prevent deterioration or damage to sterilizer and disinfectant products, permissible limits for microorganisms contained are newly established.
- Adds new items to the scope of the regulation and strengthens safety standards
Lubricants are newly designated as consumer chemicals subject to safety confirmation, and the relevant safety and labeling standards are stipulated. Additionally, benzalkonium chloride (BZK) and sodium dichloroisocyanurate (NaDCC) are designated as prohibited substances in spray and fragrance products.
- Revises existing labeling requirements
To prevent damage from misuse of detergents and disinfectants, indication of precautionary statements for use is newly mandated. For items that are discharged into sewage systems, such as cleaners, laundry detergents and bleach, containing fluorescent whitening agents, the name of every fluorescent whitening agent must be displayed/labeled.
The MOE conducted a public consultation on this draft amendment until March 28, 2021. However, it has not promulgated as of April 18, 2021.
The draft amendment of the Designation of Consumer Chemical Products Subject to Safety Check and Relevant Safety and Labeling Standards can be viewed at:
https://www.epeople.go.kr/nep/thk/elecPbl/elecPblntcDetail.npaid
If the above link is not accessible, please visit:
https://www.epeople.go.kr/cmmn/idea/redirect.do?ideaRegNo=1AE-2103-0000241
