K-BPR- Pre-notification and Approval for the First Batch of Existing Active Substances will be Closed Soon - Regulatory News - Chemicals

Recently, South Korea’s Ministry of Environment (MoE) has released a series of deadlines, including the pre-notification deadline, approval deadline as well as the approval application submission deadline for the first batch of existing active substances.

Under the requirements of the Consumer Chemical Products and Biocides Safety Act, any person who intends to manufacture or import active substance for use in biocidal products or treated articles must obtain approval from the Minister of the Environment before manufacturing or importing. But the current regulation does not give clear submission deadlines.

The grace period for the first batch of existing active substances will be closed on 31 December 2022. To ensure normal manufacturing or importing, related enterprises must complete approval before the end of grace period.

However, as it will take MoE at least a year and a half to process substances approvals, related enterprises must submit dossiers in advance so that the approval can be completed in time. If enterprises fail to submit the approval applications plan or other required documents in time, or the submitted documents are unqualified, MoE will remove their substances out of the existing substance list. These substances will be prohibited from manufacturing, importing and selling.

But if enterprises only intend to manufacture or import the existing active substances within the grace period, and will use alternative substances after the grace period expires, related enterprises can submit a statement to continue their manufacturing, importing or selling.

Related Deadlines

Pre-notification: Before 30 Sep. 2021;
Approval: Before the approval application submission deadline;
Approval application (the first batch of existing active substances)

LR/Individual submission: Before 31 Oct. 2021;
Joint submission (AM, PM): Before 31 Dec. 2021;

If manufacturers or importers fail to meet the deadline, they should inform the downstream users of this in time. The validity of active substance approval is set within 5~10 years depending on the properties of the substance and must be re-approved before expiration.

Grace Period for Existing Biocidal Substances

K-BPR,Biocide,Substance,Active,Approval,Pre-notification

Grace period group information for active substance approval
Category	Group 1	Group 2	Group 3	Group 4
Daily Exposure Level	High	Medium	Medium	Low
Biocidal product type	Disinfectant	Wood preservative	Product preservative	Construction material preservatives
	Algaecide	Control of other vertebrate	Product surface preservative	Working or cutting fluid preservatives
	Rodenticide	Control of other invertebrate	Fiber, leather, rubber and polymerized materials preservatives	Embalming and taxidermist fluids
	Insecticide			Antifouling products
	Repellent

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Further Information

K-BPR Consumer Chemical Products and Biocides Safety Act

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