South Korean government published a list of 115 chemical substances where a simplified approval process is applicable. These 115 substances are active biocidal substances that were already approved under the EU BPR (Biocidal Product Regulation) and the US Fifra (Federal Insecticide, Fungicide, and Rodenticide Act). They are used as disinfectants, algicides, repellents, rodenticides, and insecticides (Product group 1).
Although a substance is on the list, if a substance is considered to be high risk and toxic, or there are risks the approval is not renewed under the EU BPR then the South Korean government will not approve the substance. Of these 115 substances, ten substances have the possibility of non-approval:
- formaldehyde; formalin for use as a disinfectant;
- coumatetralyl for use as a rodenticide;
- boric acid for use as a disinfectant or insecticide;
- polyhexamethylene biguanide hydrochloride; PHMB for use as a disinfectant;
- brodifacoum; 4-hydroxy-3-(3-(4'-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin for use as a rodenticide; and
- flocoumafen for use as rodenticides or insecticide.
By 16 October 2020, applicants are required to submit a substance identity report (SID), product, and exposure information. Even after submitting this information to the government, applicants must submit full dossiers by December 2022. The dossiers include SID reports that are issued by an ISO/IEC 17025 accredited body, less than three-years-old, and produced with three batches in triplicate. It is emphasized that most EU data are more than three-years-old since they are produced, so applicants shall review and generate new SID reports accordingly.
To get K-BPR approvals, applicants should analyze specific data requirements under K-BPR, which might be different from the EU or US dossiers. For instance, in the case of bioaccumulation study on fish, the bioconcentration factor (BCF) value in the EU is above 2,000 whereas in South Korea, 500.
Affected stakeholders and implications
Those who manufacture or import biocidal active substances should submit approval dossiers on time. The grace period of the first product group (Disinfectants, algicide, repellents, rodenticides, and insecticides) ends by December 2022. It is recommended to submit all dossiers by August 2021, considering the time taken for the dossier evaluation. The South Korean government will publish a list of additional test data that has to be submitted in June 2021.
Last update: 10/22/2020
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