South Korea Updates Biocidal Active Substances Subject to Simplified Approval

South Korea Updates Biocide Active Substances Subject to Simplified ApprovalOn February 23, 2021, South Korea announced an amendment to the “List of internationally evaluated biocidal active substances”, a series of substances to be approved through a simplified process with exempted data requirements. Compare to the substances disclosed in September 2020, the total number of active substances increased from 115 to 130 and 24 substances have been excluded due to the absence of evaluation report issued by the US or EU authorities or voluntarily withdrawn/absence of application plan for substance approval.
Since only the European Union and the United States operate the systematic evaluation on biocidal active substances, internationally evaluated substances are limited to those that have been evaluated under the EU BPR and US FIFIRA and issued with valid evaluation reports. In September 2020, the Korean National Institute of Environmental Research requested industries to submit information on internationally evaluated substances, aimed to confirm the substance and scope to be exempted from data submission. Among the 743 substances that prior notified as existing biocidal substances, 142 of them have been approved or registered in the European Union or the United States,of which 115 overlapped with those scheduled to be approved in 2022. The chemical name, CAS number and use type of the substances are disclosed in 3 parts:

  • 105 biocidal active substances subject to government confirmation on data exemption (to be approved in 2022);
  • 10 biocidal active substances subject to government confirmation on data exemption (to be approved in 2022), but may be restricted under Act on the Registration and Evaluation of Chemical Substances of Korean (K-REACH);
  • 3 substances subject to be approved in 2022 but internationally rejected from several use types confirmation.

The amendment this time adjusted the timeline for substance approval, as well as excluded 24 substances recognized as internationally evaluated in 2020:

  • Substances internationally evaluated that subject to be approved in 2021 (117 substances);
  • Substances that subject to subject to government confirmation on data exemption, but may be restricted due to high harmfulness (13 substances);
  • Internationally evaluated substances announced in 2020, but excluded due to absence of evaluation report (5 substances);
  • Internationally evaluated substances announced in 2020, but excluded due to voluntary withdrawal or absence of application plan for substance approval (19 substances).
  • 3 substances subject to be approved in 2022 but internationally rejected from several use types confirmation.

In addition to the hazardous data possibly exempted from data submission, data on the use, exposure, and comprehensive data on safety need to be prepared, notably the component test by each manufacturer. A 3-batch(or more batch) component analysis report (including impurities that are not exempted from submitting data) needs to be prepared in advance, which should be issued from an ISO/IEC 17025 accredited agency within the last 3 years. Depending on the outcome of exemption, the risk assessment report corresponding to the hazardous category would be exempted, but exposure coefficient, exposure scenario cannot be exempted.
In a substance-by-sbustance manner, the institute planned to disclose the information on usable uses in the EU and the US in March 2021, as well as items exempted from data submission and required for additional data submission by June 2021 .

Notification on the ammendment to the list of biocidal substances that have been evaluated internationally(in Korean)

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