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 2018	First enacted as Act 15511
24 Mar 2020	Partially revised  as Act 17103
26 May 2020	Partially revised as Act 17326
18 May 2021	Partially revised as Act 18170
Main supporting regulations in force
1 Jan 2021	Precedential Decree 31323
1 Jan 2021	MoE Ordinance 901
5 Jun 2020	MoE Notice 2020-117
1 Feb 2019	MoE Ordinance 1381
26 Jan 2021	NIER Notice 2021-6
26 Jan 2021	NIER notice 2021-7
1 Feb 2019	MoE Notice 2019-37
1 Jan 2019	MoE Notice 2018-242
25 Jun 2021	NIER Notice 2021-32

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

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.

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

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

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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.

 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:

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

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:

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

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.

4. Main Laws and Regulations

5. Future Trends

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：

• K-BPR: South Korea Delists over 100 Existing Biocidal Active Substances

• K-BPR: NIER Clarifies Approval and Notification Requirements for Chlorine Dioxide Disinfectors