In response to the rising concerns over chemical products after the “toxic humidifier sterilizer” accident in 2011, South Korea has accelerated the legislative process regarding chemical products. Since the enactment of “Act on the Safety Management for Consumer Chemical Products and Biocides”(hereinafter as “Chemical Product Safety Act”) in 2018, a precautionary management system was established, comprising of conformity verification/approval of consumer chemical products and prior-approval of biocidal active substances and biocidal products, as well as the distribution and follow-up management including display, advertisements, periodic reporting and information disclosure, etc.
The main purpose of South Korea’s Chemical Product Safety Act (K-BPR) regulations is to protect human health and environmental safety and contribute to the development of public safety through the safety control of consumer chemical products, as well as the compliance of active substances, biocidal products and treated-products.
What Products are not covered by K-BPR?
The products listed in the following laws are not covered by K-BPR:
- Health functional foods regulated by the “Law on Health Functional Foods”
- Munitions regulated by the Munitions Management Act and the Defense Business Act
- Pesticides, natural plant protection agents, original agents and pesticide using-equipment regulated by the “Pesticide Management Law”
- Water treatment agents regulated by the Drinking Water Management Act
- Single-ingredient feeds and supplementary feeds regulated by the Feed Management Act
- Substances regulated by the Ship ballast water Management Act
- Food, food additives, utensils, containers, and packaging regulated by the Food Sanitation Law
- Pharmaceuticals, quasi-drugs, animal pharmaceuticals, and quasi-drugs regulated by the Pharmaceutical Affairs Law
- Sanitary products regulated by the Sanitary Products Management Law
- Medical devices regulated by the Medical Device Law
- Cosmetics regulated by the Cosmetics Act
- Organic food, non-edible oil processed products, processed food without pesticide raw materials, organic agricultural and fishery materials, and permitted substances regulated by the “Act on the Management and Support of the Cultivation of Green Agriculture and Fisheries and Organic Foods, etc.”
What Product-types are covered by K-BPR?
The jurisdiction of K-BPR covers consumer chemical products and biocidal products respectively.
Tables 1 and 2 describe the different product types in detail.
Table 1 Product-types of Consumer Chemical Products
|1.Detergent product group||1.Cleaners|
|2.Laundry products group||1.Laundry Detergent|
|3.Coating products group||1.Gloss Coatings|
|2.Special Purpose Coatings|
|4.Adhesive products group||1.Adhesives|
|2.Gap and Crack Fillers|
|5.Air freshener products group||1.Air Fresheners|
|6.Dye and Colorant painting
|2.Colorant Painting Agents|
|7.Auto products group||1.Windshield Washer Fluids For Auto|
|8.Printing and Document Related Products||1.Ink Cartridges And Toners|
|2.Red Seal Ink Pads|
|3.Correction Fluids and Tapes|
|9.Beauty products group||1.Adhesives for Beauty|
|10.Disinfection Products group||1.Disinfectants|
|3. Antibacterial and Disinfectant For Humidifiers|
|4.Sterilization and Disinfectant For Preventing Infectious Diseases|
|5. Other Disinfectants for Quarantine|
|11.Insecticides and Repellents||1.Insect Repellents|
|4.Pesticide for Preventing Infectious Disease Prevention|
|5.Rodenticide for Preventing Infectious Disease Prevention|
|2. Preservative-Treated Filter Product|
|13.Other products group||1.Candle|
|3.Artificial Snow Spray|
|4. Fog Fluid for Performance|
Table 2 Product-types of Biocidal Products
|4.Control of other vertebrates|
|6.Control of other vertebrates|
|8.Preservatives for products|
|10.Fiber and leather preservatives|
|12.Construction material preservatives|
|13.Material and equipment preservatives|
|14.Embalming and taxidermist fluids|
Please note that according to the provisions of K-BPR, different products have different compliance procedures and belong to different management departments. However, at the same time, there are also interlinked areas.
Who should comply with K-BPR?
- Manufactures or importers in Korea
- From January 1, 2021, manufacturers outside Korea could entrust a qualified Korea OR to comply with it.
How to comply with the regulations of consumer chemical products?
Consumer chemical products (or household chemical products) are the chemical products daily used in the living spaces such as homes, offices, and public facilities.
For products already established with safety standards, the importers or manufacturers need to verify the conformity at designated testing/inspection institutes and notify product information to the Korea Environmental Industry & Technology Institute (KEITI) every 3 years.
For products not yet established with safety standards, the importers or manufacturers need to obtain the “approval of consumer chemical products subject to safety verification” from the National Institute of Environmental Research (NIER).
The procedures required for conformity verification and approval of consumer chemical products are summarized as follows:
Figure 1 The compliance procedures for the products already established with safety standards
Figure 2 The compliance procedures for the products not yet established with safety standards
It is important to note that most of the consumer chemical products not yet established with safety standards have a biocidal function and will be regulated as biocidal products after their grace period of deferred approval. Therefore, they need to comply with both the consumer chemical product regulations and biocide regulations within their grace period, as introduced in the next section.
How to comply with the regulations of biocidal products?
It is divided into three major parts: biocidal active substances, biocidal products and treated articles.
Biocidal active substances (AS)
– Definition of AS
Active substance refers to a substance used to eliminate harmful organisms, having the ability to be harmless or to inhibit (remove) harmful organisms by chemicals, natural substances or microorganisms.
– The existing active substance
Existing active substances：The biocidal active substances that put into Korean market before December 13, 2018 are deemed as the existing active substances. The existing active substances need to apply for pre-registration or late pre-registration in order to obtain the grace period of the active substances approval, and then complete the application for the active substances approval within the corresponding grace period.
Pre-registration or Late pre-registration: the company who manufactures or imports biocidal active substances or products in Korea market should firstly apply pre-registration to be included in existing substance list between January 1, 2019 to June 30, 2019 to obtain grace period of active substance. From March 24, 2020, late pre-registration is mandatory before biocidal active substances or products manufactured or imported to Korea. The grace period can be up to 10 years depending on the product type. (Late) pre-registered existing active substances could be put into Korea market without approval during the grace period. Table 3 details the different time limits for different types of biocide products.
Table 3 Existing Active Substance and Grace Period
|Grace Period||Dec 31, 2022||Dec 31, 2024||Dec 31, 2027||Dec 31, 2029|
|PT4.Control of other vertebrates
PT6.Control of other vertebrates
|PT8.Preservatives for products
PT10.Fiber and leather preservatives
|PT12.Construction material preservatives
PT13.Material and equipment preservatives
PT14.Embalming and taxidermist fluids
– New active substances
Substances not included in the list of existing active substances are considered as new active substances. For new active substances, there is no grace period and companies must obtain approval before producing or exporting to Korea market.
– Approval of AS
The AS applicant should apply and submit the required information to NIER via the online system CHEMP. If the completeness checked is satisfied, a notice will be issued to the applicant and the review and approval will proceed. Within 18 months from the date of issuing the notice (excluding data supplementation), NIER will offer the applicant a draft evaluation report for comments, which will further be deliberated by the Management Committee and finally, a notice of AS approval will be issued to the applicant. The procedures required for approval of active substances are summarized as follows:
Figure 3 the compliance procedures for approval of biocidal active substances
Biocidal Product (BP)
– Definition of BP
Biocidal products refer to those products which are composed of more than one active substance or a mixture of active substance, chemical substance, natural substance and microorganism with the main purpose of removing harmful organisms.
– Authorisation of BP
Simliar to the AS approval, BP applications are processed, preliminarily checked by NIER, and deliberated by the Management Committee, but the draft evaluation report will be compiled within 6 months. The procedures required for approval of biocidal products are summarized as follows:
Figure 4 the compliance procedures for authorization of biocidal products
Treated Article (TA)
– Definition of TA
Treated Article or treated-products are those that have additional capabilities to remove harmful organisms, etc. in addition to the main purpose of the product.
– Compliance requirements for TA
According to current developments of regulations, active substances and biocidal products used in the treated article need to be declared and approved before declaring the treated article.
To sum up, both consumer Chemical products and biocidal products need to go through complex evaluation and declaration process. Meanwhile, the continuous improvement and supplement of laws have imposed a certain burden on the declaration of enterprises. Therefore, for the compliance of South Korean Chemical Product Safety Act, different enterprises need to choose the most suitable compliance strategy according to their actual situation and requirements.
To prevent the reoccurrence of “toxic humidifier sterilizer”, the “Act on the Safety Management of Consumer Chemical Products and Biocides” established a statutory plan called “comprehensive management plan for household chemicals and biocides”, which is renewed every five years. The 1st comprehensive management plan was released in early 2021, aimed to strengthen the all-process management in line with the rapid market conditions, particularly the Covid-19 pandemic:
- Quarantine-use disinfectants will be expedited and MoE compiling guidelines and list of products eligible for quarantine purpose;
- A roadmap for microplastic in consumer chemical products will be prepared. It would be mandatory to display the uses of microplastic by 2023 and report the usage and usage history by 2024 and the use of microplastic in certain products will be banned by 2025;
- Online stores and brokerage will be mandatorily required to check whether the product is illegal;
- For product already been placed on the market, the number of inspections will be increased from 1700 in 2020 to 2000 by 2025;
- MoE will increase its support for the industry to prepare dossiers. In addition to the simplified process for internationally evaluated biocidal active substances, an “approval support team” will be formed to offer one-to-one consultation for SMEs and support the entire material preparing process;
- Owing to concerns over unregulated biocidal substances being placed on the market, some life-related products with high human exposure would be recalled after a fact-finding survey.
In addition, a plan strengthening the labeling standard for biocidal treated articles will be prepared to prevent exaggerated advertisement.
|Consumer Chemical Product Subject to Safety Check||Product analysis report
Compliance check of safety standards
Testing arrangement for safety check
Review of the declaration of safety check
|Biocidal active substance, Biocidal products, Treated articles||Only Representative (OR) Service
Data gap analysis and compliance analysis report
Preparation and submission of approval plan reports
Application of approval of active substances
Application of biocidal product authorisation
Regulatory compliance of treated articles
Tests arrangement and monitoring
Review the labelling
K-BPR comprehensive consulting service
Translation of regulatory documents and application materials