South Korea NIER Proposed Minor Refinement on Data Requirements for Biocide Approval

 

South Korean NIER Proposed Minor Refinement on Data Requirements for Biocide ApprovalOn November 1, 2021, the South Korean National Institute of Environmental Research(NIER) invited a 20-day consultation on the amendment to the department rules, “Regulation on the Scope and Method for Preparing Application Data on Biocidal Substance and Product Approvals”.

The current version was published on January 26, 2021, in the form of NEIR Notice 2021-7, which specified all the endpoints of test data and items of general data in the form of mandatory or conditional required data, criteria for exemption, additional test data, acceptance of testing methodology and testing institutes, as well as methods for preparing this data.

Compare to the current regulation, the amendment reinforces the data reliability of component analysis data, by clarifying the qualification of testing institutes:

  • Domestic testing institutes designated by MoE as the testing agency on the physical and chemical properties and hazards of chemical substances;
  • Domestic GLP labs accredited under the Korean pesticide or pharmaceutical regulations, etc;
  • Recognized OECD GLP labs overseas;
  • ISO/IEC 17025 qualified labs;
  • Teratogenicity will be a new compulsory test endpoint for biocidal substance approval.

Applicants of biocidal substances will be required to more specific exposure information on the use scope and user groups. The use scope refers to the space, time, season and use sites, and users will be divided into general consumers, occupational consumers, professional staff and industrial facility users in consideration of the use purpose.The deduction of predicted no-effect concentration will be additionally required during risk assesment process.

Risk assessment should be performed considering all possible exposure groups and those vulnerable to exposure should be given priority and the exposure groups will be adjusted as follows:

NEIR Notice 2021-7

Amending Draft

4.2.1.1. professional user

4.2.1.1.1. worker

4.2.1.1.2. professional staff

4.2.1.2. general user (consumer)

4.2.1.3. direct (primary) or indirect (secondary) exposure

4.2.1.1. worker

4.2.1.1.1. material manufacturing worker

4.2.1.1.2. product production worker

4.2.1.2. user

4.2.1.2.1. professional user

4.2.1.2.1.1. industrial user

4.2.1.2.1.2. professional staff

4.2.1.2.2. general user

4.2.1.2.2.1. professional consumer

4.2.1.2.2.2. general consumer

4.2.1.3. Direct (primary) or indirect (secondary) exposure

    4.2.1.4. Environmental media (water quality, soil, air, etc.)

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