Overview of Consumer Chemical Products and Biocides Regulations in South Korea    

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.

South Korean Biocide Regulations:
Act on the Safety Management of Consumer Chemical Products and Biocides
History
20 Mar 2018First enacted as Act 15511
24 Mar 2020Partially revised  as Act 17103
26 May 2020Partially revised as Act 17326
18 May 2021Partially revised as Act 18170
Main supporting regulations in force
1 Jan 2021Precedential Decree 31323
1 Jan 2021MoE Ordinance 901
5 Jun 2020MoE Notice 2020-117
1 Feb 2019MoE Ordinance 1381
26 Jan 2021NIER Notice 2021-6
26 Jan 2021NIER notice 2021-7
1 Feb 2019MoE Notice 2019-37
1 Jan 2019MoE Notice 2018-242
25 Jun 2021NIER Notice 2021-32

Contents

1. Scope and Major Obligations

Under the Chemical Products Safety Act, the use scenarios and exposed groups were expanded to “ordinary living space including office and public-use facilities, or multi-use facility, etc.” and “people and/or environment”. If a risk is identified and through field investigation and risk assessment, a product would be designated as the “consumer chemical product subject to safety verification” and its manufacturers or importers need to obtain conformity verification or approval depending on the availability of the safety standard officially released.

Biocides have a relatively clear-cut scope consisting of 4 categories and 15 product types, but subject to diverse processes, timeframes, and data requirements due to their roles in supply chains, grace period granted and product function claims.

Major Obligations of Consumer Chemical Products and Biocides in South Korea

Consumer chemical products subject to safety verification

  • Conformity verification and reporting
  • Approval
  • Fulfillment of safety and labeling standards

Biocide

  • Notification of existing biocidal substances deferred from substance approval
  • Biocidal active substance approval
  • Biocidal product approval
  • Safety and labeling standards for biocidal treated articles

Distribution and follow-up management

  • Restrictions on display and advertisement
  • Recording and reporting

 

2. Consumer Chemical Products Subject to Safety Verification

Apart from chemical products transferred from risk-concerned products previously regulated under the “Act on Registration and Evaluation of Chemical Substances” (K-REACH), other products capable of causing chemical exposure to people or the environment are evaluated through field investigation and risk assessment. All risk-concerned products and newly identified products are announced under the MoE notice, “Designation of Consumer Chemical Products Subject to Safety Verification and Safety and Labeling Standards”.
Safety and labeling standards offer product definition and a set of requirements on prohibited and restricted substances for different products (formulation type), container, packaging, and the uses of children-protective packaging, as well as the mandatory information displayed on product labels.
By May 2021, a total of 13 groups and 39 consumer chemical products have been designated, of which 31 have been established with safety and labeling standards.

Group

Product

Detergent products

cleansers

Removers

laundry products

Laundry detergents

Bleaching agents

Fabric softeners

coating products

Gloss coatings

Special purpose coatings

Anti-rust additives

Ironing auxiliaries

Adhesive products

Adhesives

Gap and crack fillers

Air freshener products

Air fresheners

Deodorizing agents

Dye and colorant painting products

Dye agents

Colorant painting agents

Auto products

Windshield washer fluids for automobiles

Engine antifreezes

Printing and office supplies

Ink cartridges and toners

Red seal ink pads

Correction fluids and taps

Beauty products

Adhesive for beauty

Tattoo inks

Disinfection products

Disinfectants

Algicides

Antibacterial/disinfectants for humidifier

Sterilant/disinfectants for infectious disease prevention

Other disinfectant for quarantine use

Pest control products

Insect repellents

Health-use pest control, prevention, and attractant pesticides

Health-use insect repellents

Pesticides for infectious disease prevention

Rodenticide for infectious disease prevention

Preservatives and preservative-treated products

Wood preservatives

Preservative-treated products

Others

Candles

Dehumidifying agents

Artificial snow spray

Fog fluid for performance

Household chemical products for humidifiers

For products already established with safety standards, the importers or manufacturers need to verify the conformity at designated testing/inspection institutes and notiify 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 and documents required for conformity verification and approval of consumer chemical products are summarized as follows:

Procedures and Documents Required for the Safety Verification of Consumer Chemical Products in South Korea

Fig1.-Procedures for conformity verification and notification of consumer chemical products already established with safety standards

Fig2.-Procedures for approval of consumer chemial products not yet established with safety standards

Documents required

Conformity verification:

  • Application form;
  • Documents on product information such as product photos and instructions;
  • Documents on the composition, mixing ratio of chemical substances used;
  • Copy of certificate of company/business registration;
  • Copy of confirmation results(renewal)

Notification:

  • Report of conformity verification;
  • Copy of confirmation results;
  • Documents on product information such as product photos and instructions;
  • Documents on the composition, mixing ratio of chemical substances used

Application form

General information on the applicant

Product information (product name, item, formulation, etc.)

Data on chemical substances that perform the main function of the product

-Identification information of chemical substances: name, molecular formula, structural formula, etc.
-Use of chemical substances
-Classification and labeling information;
-Physical and chemical properties
-Hazards of chemical substances
-Risk information including exposure information such as exposure route and exposure type of chemical substances

Product data

-Effect/Efficacy
-Hazards of the product
-Standards and methods of test and inspection related to the component analysis of the product
-Data on safe use (safety of the product, emergency measures in case of explosion, fire, leakage, and protective gear, etc.)

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.

3. Biocide Management

Fig3.-Approval of Biocidal Active Sustance and Biocidal Products in South Korea

Products with the main purpose of removing or deterring the action of harmful organisms are defined as biocidal products(BPs) and treated articles(TAs) are products that have been treated with, or intentionally incorporating one or more BP for harmful organism removal, which is aside from its primary function. Anyone who intends to manufacture or import biocidal active substances(ASs) and biocidal products must obtain prior approval from MoE and only approved biocidal products can be used for treated articles.

For active substances used in biocidal products or treated articles which were placed on the South Korean market before December 31, 2018, transitional measures can be applied after the notification process and publicly announced as “Existing Active Substance Subject to Grace Period for Deferred Approval”. Such AS can be manufactured or imported without AS approval within the grace period and corresponding BP approval exemption can be extended to 2 years after the grace period of AS(s) approval.

Before the manufacture or import of an existing AS, the manufacturers or importers need to notify to NIER and a grace period will be granted depending on biocidal product type and hazard level. Being different from EU biocide regulation, South Korea has only 15 biocidal product types. In addition, microbial organisms and in-situ generated AS can be imported or manufactured without AS approval until December 31, 2029.

Dec 31, 2022

Dec 31, 2024

Dec 31, 2027

Dec 31, 2029

  1. Disinfectants
  2. Algaecides
  3. Rodenticides
  4. Insecticides
  5. Repellents
  1. Control of other vertebrates
  2. Control of other invertebrates
  3. Wood preservatives
  1. Preservatives for products
  2. Film preservatives
  3. Fiber and leather preservatives
  1. Construction material preservatives
  2. Material and equipment preservatives
  3. Embalming and taxidermist fluids
  4. Antifouling products

 

 For ASs that have not yet been designated and publicly announced as “Existing Active Substance Subject to Grace Period” or delisted as existing AS, the manufacture and import activities shall be suspended immediately. Furthermore, an application plan for AS approval shall be submitted within one year from the date when the AS is designated, which includes a detailed schedule, preparation method and expected date of applying AS approval. For those who failed to submit the plan, the AS approval application or required information is deemed difficult to be submitted within the granted grace period, MoE may prohibit the manufacturing or import of existing AS.

3.1 Approval of Biocidal Active Substance

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 one year from the date of issuing the notice (excluding data supplementation), NEIR 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.

A data package usually consists of 7 parts:

No.

Information

Details

1

identification of the manufacturer/importer

-Company name, address, the contact information of the applicant

2

Identity of Active Substance

-Name and identity information including molecular, formula, chemical composition, etc.

3

Biocidal product type

-Type(s) of biocidal product that eh active substance can be used

4

Information of the Active Substance

- Physic-chemical properties and biological features

- Exposure information (i.e., use, major exposure route, exposure type, etc.)

- Hazards and risks on human, animal, and the environment

- Efficacy and effect

- Classification and labeling

5

Documents certifying the AS is subject to less- strict approval criteria

 

6

Raw materials & AS Manufacturing process

-Raw materials and manufacturing process of the AS

- Precautions for handling, and disposal method of the AS

- Information about uses and regulations on AS in Korea and other countries

- Confirmation of individual submission;

-Supporting documents such as a copy of entrusting agreement (in case of OEM);

7Data on representative BP 

8

Comprehensive safety data

-Comprehensive data about the safety of the AS, including risk assessment

If the purpose and use of an AS are limited enough so that the exposure to human or the environment is insignificant, or an AS is necessary for public and environmental health as the risk of other AS is not low enough to substitute the AS, it can be approved under less-strict approval criteria.

The validity of AS approval varies from 5 to 10 years depending on the approval criteria applied and hazard profile

Validity of AS Approval

Condition

10 years

General AS

7 Years

- AS subject to less-strict AS approval criteria

- AS with respiratory sensitization;

- AS with more than two properties of the followings: persistence, bioaccumulation, or toxicity.

5 years

- AS that falls under all the above conditions for 7-year validity

 

3.2 Approval of Biocidal Product

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 and BP can also be approved under similar less-strict criteria if it for industrial purposes only, or the BP is necessary for public and environmental health as there is no other low-risk alternative, but manufacturer/importer should comply with manufacturing/storage standard and attach supporting documents in BP application materials:

Data Requirements for BP Approval

No.

Information

Details

1

identification of the manufacturer/importer

-Company name, address, the contact information of the applicant

2

Identity of Biocidal Product

- Product name, BP type

3

Information on substances in BP

- Components, mixing ratio, intended purpose and use of all substances in BP

- Name and address of AS supplier

- Name, intended purpose and use of such nanomaterial(s) in case of intentionally incorporated/added nanomaterials.

4

Information on BP

- Physic-chemical properties and biological features

- Exposure information (i.e., use, major exposure route, exposure type, etc.)

- Hazards and risks on human, animal, and the environment

- Efficacy and effect

- Classification and labeling

5

Documents justifying less- strict approval criteria

Document proving that the application falls into one of the following conditions:

-There is reliable information proved that the use and exposure of the BP or AS (s) have an insignificant impact on human, animal and the environment;

-It is proved by scientific evidence that it is unnecessary to submit such data;

-When relevant data has been submitted for the registration under Article 10 of K-REACH;

6

Raw materials & AS Manufacturing process

-Raw materials and manufacturing process of BP

- Raw materials and manufacture processing of BP

- Precautions for handling, and disposal method of BP

- Information about uses and regulations on BP in Korea and other countries

- Documents certifying the use of safety container or package that meets quality control standards

- Current status and plan for complying with manufacturing/storage facility standards

-Supporting documents such as a copy of entrusting agreement (in case of OEM);

7

Comprehensive safety data

-Comprehensive safety report on BP, including risk assessment

The validity of BP approval varies from 3 to 10 years, depending on the approval criteria for both BP and AS(s):

Validity of BP Approval

Condition

10 years

General BP

5 Years

- BP was approved under less-strict BP approval criteria

-One or more AS in the BP was approved under less-strict AS approval criteria;

3 years

- BP that falls under all the above conditions for 5-year validity

3.3 Me-too Approval and Waived Data Requirements

Manufacturers/importers of generic ASs/BPs can prove equivalence/ similarity to an already approved AS or BP (referenced AS/BP) with fewer data requirements but an additional data use consent from the data owner. Once the equivalence/similarity was recognized by the Management Committee, generic ASs/BPs will be deemed to obtain AS/BP approval and has the same validity as its referenced AS/BP. If the referenced AS/BP altered significant matters such as chemical composition, risk information, efficacy, etc., and obtained an amendment to AS/BP approval from MoE, the equivalence/similarity should be recognized again.

To effectively use the test data generated overseas, ASs already evaluated and approved in the EU and the US and issued with evaluation reports are selected and publicly announced as “internationally evaluated biocidal active substances”, which will be approved through a simplified process with exempted data requirements. Currently, NIER is carefully analyzing notified existing ASs, their product types approved under EU BPR and US FIFIRA and availability of test data, and releasing exemption criteria for each AS batch-wise. By the middle of June 2021, 130 disinfectants, insecticides, rodenticides, and preservatives have been issued with the criteria and most physic-chemical, biological, toxicity and environmental tests would be exempted.

A BP can also be approved with fewer data requirements if all the following conditions are met:

  1. All ASs used in the BP are publicly announced to have low risk;
  2. BP contains no intensively controlled substance, nanomaterial, or hazardous/risky persistent pollutant;
  3. BP has sufficient effect and efficacy, including but not limited to destroying harmful organisms;
  4. No Personal Protective Equipment (PPE) requirements for handlers or applicators

3.4 Biocidal Treated Articles (TA)

The efficacy/effect claim, the purpose of biocidal treatment and biocidal function of a TA complexly determine different manufacturer/importer obligations including safety standard and labeling standard TA, information record, archiving and disclosure, as well as evidence of biocidal efficacy if necessary.

 

TA with no efficacy/effect claim

TA with efficacy claim

TA with no biocidal function

TA with biocidal function

purpose of biocidal treatment

General product protection

General product protection

Collateral product protection

Auxiliary function of the TA

claim

Has no TA-related claim

Efficacy/effect related to the production of general products

The efficacy/effect of product protection was incidentally generated such a deodorization and insect repelling

The biocidal efficacy/effect on other objects other than the main function of the TA

Typical Example

Coolant

dishcloth, toothbrush

clothing, sleeping bag

Handle knob

Obligation

Safety Standard for TA

BPS used in TAs have been approved and used within the scope.

BPs used in imported TAs shall satisfy criteria similar with already-approved BP

Similar criteria:

AS(s) used or an approved BP type;

AS is publicly announced;

The intended use of the AS was publicly recognized by other government or the safety of the BP used in TA was recognized or approved by other government (EU or US)

Information disclosure

Provide BP information to TA buyers upon request

Record and Archive

Record the information on names and usage of BP used and keep the information for 10 years

Labeling Standard for TA

/

Indicate that the TA has been treated with BP;

Indicate the names and functions of all ASs in BP;

In case of BP intentionally added with nanomaterial, indicate that BP used contains nanomaterial;

Hazard information and precautions for handling BP used in TA;

Efficacy evidence

/

/

/

Keep the evidence of efficacy/effect claim, or else the manufacturer/importer would be punished for unfair labeling and advertising following the “Act on Fair Labeling and Advertising”

4. Main Laws and Regulations

Code

Title

Effective Date/Last Update

Act 17326

Act on the Safety Management of Consumer Chemical Products and Biocides (Overarching Regulation)

2021.1.1

Precedential Decree 31323

Enforcement Decree of the Act on the Safety Management of Consumer Chemical Products and Biocides

2021.1.1

MoE Ordinance 901

Enforcement Regulations of the Act on the Safety Management of Consumer Chemical Products and Biocides

2021.1.1

NIER Notice 2021-6

Regulation on the Criteria, Scope and Data Preparing for the Determination of AS Equivalence and BP Similarity

2021.1.26

MoE Notice 2021-50

Regulation on the Procedure and Fee Collection of Government Offered Data for the Application of AS Approval

2021.3.9

NIER Notification 2021-7

Regulation on the Scope and Preparing Method of Application Data for AS and BP Approval

2021.1.26

MoE Notice 2019-37

Regulation on the Safety Containers and Packaging for Biocidal Products

2019.2.1

MoE Notice 2018-242

Regulation on the Labeling of Biocidal Products

2019.1.1

NIER Notification 2018-70

Regulation on the Subjects and Method for the Risk Assessment of Consumer Chemical Products

2019.1.1

MoE Notice 2020-117

Designation of Consumer Chemical Products Subject to Safety Verification and Safety and Labeling Standard

2020.6.5

MoE Ordinance 1381

Regulation on the Operation of Consumer Chemical Product and Biocide Management Committee

2019.2.1

MOE Notice 2020-291

Detailed Standard for Calculating Fines

2021.1.1

NIER Notification 2018-73

Regulation on the Testing Methods of Biocides

2019.1.1

NIER Notification 2021-5

Regulation on the Designation of Testing and Inspection Institutes for Consumer Chemicals and Biocides

2021.1.19

MoE Notice 2020-290

Regulation on the Reward for Reporting against Irregularities in Consumer Chemical Products and Biocides

2021.1.1

NIER Notification 2021-2

Regulation on the Approval of Consumer Chemical Subject to Safety Verification

2021.1.7

NIER Notification 2021-12

Regulation on the Standard and Methods for Testing and Inspection of Consumer Chemical Products Subject to Safety Verification

2021.1.29

NIER Notification 2021-8

Criteria for the Approval of Biocidal Active Substances and Biocidal Products

2021.1.26

NIER Notification 2021-11

Designation of Existing Biocidal Active Substances Subject to Deferred Approval

2021.1.26

MoE Notice 2018-244

Regulation on the Application and Issuing of English Certification for Consumer Chemical Products Subject to Safety Verification and Biocides

2019.1.1

NIER notification 2021-10

Low-risk Biocidal Active Substances

2021.1.26

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.

6. AgroPortal Resources

NEWs: