Article

South Korea – Prior Approval for Active Biocidal Substances and Biocidal Products is Mandatory under K-BPR

Posted on: February 14, 2019

by June Kang

South Korea enacted the Safety Control Act on Household Chemical Products and Biocidal Products, also known as K-BPR or Chemical Products Safety Control Act, in March of 2018.  The MOE enacted the Decree and Regulation of the Act on December 24, 2018 and December 28, 2018, respectively, to establish the details necessary to legally enforce K-BPR.  K-BPR took effect shortly thereafter on January 1, 2019.

The Decree and Regulation of K-BPR specify the approval process for biocidal active substances and biocidal products.  The processing period takes up to 18 months for an active biocidal substance and one year for a biocidal product.

The 13 categories of required data remained unchanged from the proposal and are finalized as shown in Table 1 below.  The detailed requirements for test data were published through public notifications.

[Table 1] Required data for BPR approval

Index No. Biocidal (active) substance Biocidal Product
1 Applicant information Applicant information
2 Identity of the active substance (Molecular formula, chemical composition and others) Identity of the biocidal product (product name, product type, standard usage, expiration date and others)
3 Physical chemical and biological property (including physical hazards) Physical, chemical and biological property (including physical hazards and pharmaceutical property)
4 Classification and labelling Classification, labelling and packaging
5 Intended uses and exposure (including biocidal product type) Intended uses and exposure (including biocidal product type)
6 Production process Production process
7 Effectiveness and efficacy against target organisms Effectiveness and efficacy against target organisms
8 Health hazard Health hazard (including irritation, sensitization, corrosion and acute toxicity only)
9 Environmental hazard Environmental hazard
10 Measures to protect humans, animals and the environment Measures to protect humans, animals and the environment
11 Domestic and international usage and regulatory information Domestic and international usage and regulatory information
12 Comprehensive data on safety (including risk assessments) Comprehensive data on safety (including risk assessments)
13 Data on representative example products in which the biocidal substance is used Data verifying that the applicant complies with manufacture/storage standards.

 

The finalized regulation specifies 15 biocidal product types, as shown in Table 2, that are subject to approval before manufacture or import.  These finalized product types have also remained unchanged from the proposal.  It is strictly prohibited to use active substances in a manner other than the approved product type and use.

[Table 2] Biocides product types

Group Product Type
Disinfectants 1.     Disinfectants
2.     Algaecide
Pest control 3.     Rodenticides
4.     Control of other vertebrates
5.     Insecticides
6.     Control of other non-vertebrates
7.     Repellents
Preservatives 8.     Preservative for products
9.     Preservative for product surface treatment
10.   Fiber and leather preservatives
11.   Wood preservatives
12.   Construction material preservatives
13.   Materials/equipment preservatives (Preservatives for liquid-cooling and processing systems and working or cutting fluid preservatives)
14.   Embalming or taxidermist fluids
Others 15.   Antifouling agents

 

A grace period will be granted for active substances used and circulated in products in South Korea before December 31, 2018 and notified to MOE by June 30, 2019.  This grace period may be adjusted based on the implementation progress.  Based on these notifications, a list of biocidal active substances for which the grace period benefit applies is scheduled to be announced on December 31, 2019.

The scheduled grace period for the different product types are shown in Table 3.  A person manufacturing or importing a biocidal product containing one or more active substances must obtain approval from MOE before the applicable grace period ends in order to be able to continue to manufacture or import.

[Table 3] Scheduled grace period for biocidal products

Group 1 Group 2 Group 3 Group 4
Grace period (End date) 3 years
(Dec. 31, 2022)
5 years
(Dec. 31, 2024)
8 years
(Dec. 31, 2027)
10 years
(Dec. 31, 2029)
Product type Disinfectants

Algaecide

Rodenticides

Insecticides

Repellents

Wood preservatives

Control of other vertebrates

Control of other non-vertebrates

Preservative for products

Preservative for product surface treatment

Fiber and leather preservatives

Construction material preservatives

Materials/equipment preservatives

Embalming or taxidermist fluids

Antifouling agents

 

With K-BPR in effect, household chemical products and biocidal products that were regulated as risk-concerned products under K-REACH are now regulated under K-BPR.  The detailed regulation on household chemical products and biocidal products is expected to be published in February 2019.

References (in Korean only):

[MOE Press Release] Prior Approval System for Biocides and Mandatory Registration System for Chemicals substances circulated in Korea, announced on December 28, 2018: [보도자료] 살생물제 사전승인, 국내 유통물질 등록 제도 시행 (2018년 12 월 28일자 보도)

The Decree of the Safety Control Act of Household Chemical Products and Biocidal Products enacted on December 24, 2018 as Presidential Decree No. 29412: 생활화학제품 및 살생물제 안전관리에 관한 법률 시행령 [대통령령 제29412호, 2018. 12. 24., 제정]

The enactment draft of the Regulation of the Safety Control Act of Household Chemical Products and Biocidal Products enacted on December 28, 2018 as MOE Ordinance No. 794: 생활화학제품 및 살생물제 안전관리에 관한 법률 시행규칙 [환경부령 제794호, 2018. 12. 28., 제정]

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Keywords:

South Korea

Ministry of Environment (MOE)

K-BPR

Household Chemical Product

Biocide

Biocidal Substance

Biocidal Product

Risk-Concerned Product


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