Article

South Korea MOE Publishes Detailed Drafts of the Decree and Regulation of the K-BPR

Posted on: June 26, 2018

by June Kang

South Korea emblem - South Korea MOE Publishes Detailed Drafts of the Decree and Regulation of the K-BPR. Learn more from UL.The Safety Control Act of Household Chemical Products and Biocidal Products, recognized as K-BPR, is an Act supported by an enforcement Decree and Regulation. Following the enactment of the Act, promulgated on March 20, 2018, South Korea’s Ministry of Environment (MOE) proposed enactments to the Decree and Regulation on May 30, 2018 to set the details to legally enforce the Act.

These draft enactments detail the approval process and the scope of data required for prior approval of active substances and biocidal products. There are 13 categories of data required, as shown in Table 1 below. The requirements for test data will be detailed through public notifications.  The processing period will take up to 18 months for an active substance and one year for a biocidal product.

[Table 1] Required data for BPR approval

Index No. Biocidal (active) substance Biocidal Product
1 Applicant Applicant
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 draft regulation specifies 15 biocidal product types, as shown in Table 2, that are subject to approval before manufacture or import. 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 currently used and circulated in products.  This will apply to active substances contained in biocidal products circulated in South Korea before December 31, 2018.  This grace period may be adjusted based on the implementation progress.  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 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 of grace period) 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 product surface treatment, Fiber and leather preservatives Construction material preservatives, Materials/equipment preservatives, Embalming or taxidermist fluids, Antifouling agents

When importing products treated with active substances, it is required to use biocidal products that meet criteria set forth in the Decree. Import will be approved if the active substance contained in the product is the same as a product approved in South Korea or if the product is internationally recognized as safe to use.

After the K-BPR takes effect, household chemical products and biocidal products that are currently regulated as risk-concerned products under K-REACH will be regulated under the K-BPR.

To support small and mid-size businesses, MOE will seek a way to allow those businesses to use MOE generated test data when applying for approval.

The public consultation period closed on July 9, 2018.

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References (in Korean only):

KEYWORDS:

South Korea
Ministry of Environment (MOE)
K-BPR
Household Chemical Product
Biocide
Biocidal Substance
Biocidal Product
Risk-Concerned Product