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South Korea - Regulation

The Act on Registration and Evaluation, etc of Chemical Substances (known as K-REACH) aims to protect public health and the environment. This is achieved by four procedures, namely notification or registration, evaluation, authorization, and restriction of chemicals. K-REACH has been enforced since January 1, 2015 and the recent amendment has come into force on January 1, 2019.

 

Relevant documents are uploaded in the right side bar 'Downloadable Content'. 

  • The Act on Registration, Evaluation, etc. of Chemicals (Korean and English)
  • A Guide on the Act on Registration, Evaluation, etc. of Chemicals (Korean)
  • A Guide on the Amendment of the Act on Registration, Evaluation, etc. of Chemicals on January 1, 2019 (Korean/English)

Under K-REACH, any person who intends to manufacture or import a new chemical substance or at least one ton per year of an existing chemical substance shall register the chemical substance ("registration") according to the following requirement:

  • New substances must be registered prior to manufacture or import. Below 100kg per year (<100kg/y) new substances only require notification and do not need to go through hazard evaluation
  • All over 1 ton per year (>=1t/y) existing chemical substances (excluding exempt substances) must be registered within given grace periods
  • To benefit from the grace periods for existing substances, manufacturers and importers of >=1t/y existing chemical substances must pre-register their company info, substance name, volume, classification and use info to the Ministry of Environment in advance ("pre-registration")

Foreign manufacturers who export chemical substances to South Korea may appoint a Korea-based Only Representative to submit pre-registration or registrations.

Besides, producers and importers of products containing priority control substances need to report their products to the Ministry of Environment. 

Within Scope
  • Substance on its own – New Substances(1) and Existing Substances
  • Substance in a mixture
  • Product(2) containing priority control substance
Out of Scope
  • Naturally occurring substance
  • Chemicals subject to other laws: cosmetics and raw materials, pesticides, pharmaceuticals, medical devices, fertilizer, etc.

(1) ‘New Substance’ is a substance that is not listed on Korean Existing Chemicals List (KECL)

(2) ‘Product’ is a mixture, or an article used by consumers or a component of the mixture or the article that may expose consumers to chemical substances

Ony Representative (OR) is an intermediary, and is mandatory for companies based outside of South Korea wishing to register the substance they export to South Korea. Foreign companies may appoint Korea-based ORs to fulfil relevant obligations under K-REACH. 

As an OR, GPC Korea offers:  

  • General consultancy and training
  • Substance identification
  • Application for exemption substance confirmation from Ministry of Environment
  • K-REACH registration
  • Risk assessment report
  • Test monitoring/translation of study reports
  • Preparation of Korean SDS and label
  • Regulatory update monitoring

K-REACH pre-registration start from 1 Jan 2019 and end on 30 June 2019. It is required all >=1t/y existing chemical substances manufactured in or imported to South Korea. Only those pre-registered existing substances can benefit from registration grace periods, during which one can manufacture or import those pre-registered substances without full registrations. 

 

1. Scope

K-REACH pre-registration is only required for >=1t/y existing chemical substances. New chemical substances do not require pre-registration and they must be registered before manufacture or import. 

 

2. Object

A Korean manufacturer or importer of >=1t/y existing substances shall submit pre-notifications to the Ministry of Environment. This should be done between 1 Jan 2019 and 30 Jun 2019. Foreign manufacturers or formulators can appoint Korea-based Only Representatives (OR) to submit pre-registrations. Downstream users and foreign traders cannot submit pre-registrations.

Late pre-registration is possible for existing substances exceeding 1t/y for the first time after 30 June 2019. At least, 12 months before the relevant grace period deadline for registration.

 

3. Information requirements

Required information for K-REACH pre-registration is as follows: 

  • Substance identity information: name, CAS no. 
  • Estimated annual import/manufacture volume band
  • GHS classification and labelling
  • Use information (using K-REACH use descriptor system to describe uses)
  • Legal entity information: name, address, contact info of Korean legal entity
  • In case of using OR: OR appointment letter

It should be noted that one applicant shall update their pre-registrations within one month if there are changes with:

  • Annual volume
  • GHS classification and labelling
  • Uses
  • Importer information

According to the article 10 of amended K-REACH regulation, any person who intends to manufacture or import a new chemical substance or at least one ton per year of an existing chemical substance shall register the chemical substance before he or she manufactures or imports the substance. 

 

1. Scope

K-REACH registration is required for >=1t/y existing chemical substance and >=100kg/y new chemical substances. To find out if a substance is an existing substance or not, you shall search Korea Existing Chemicals List first. 

Substance type Obligations

New substance

< 100kg/y

  • Notification prior to manufacture/import (No hazard data requirement)

New substance

>= 100kg/y

  • Registration prior to manufacture/import (Hazard evaluation required)

Existing substance

>= 1t/y

  • Pre-registration between 1 Jan 2019 and 30 Jun 2019
  • Registration within given grace periods

 

2. Object

Only Korean manufacturers and importer are obligated to register chemical substances under K-REACH. Foreign manufacturers may appoint Korea-based Only Representatives to submit chemical registrations on their behalf. 

 

3. Deadline

Substance type Registration deadline
510 designated existing substances 1 July 2018
  • >=1000t/y existing substances
  • >=1t/y designated CMR substances 
31 December 2021
100-1000t/y existing substances 31 December 2024
10-100t/y existing substances 31 December 2027
1-10t/y existing substances 31 December 2030

 

4. Information requirements

Required information for K-REACH registration is as follows: 

  • Legal entity information: name, address, contact info of Korean legal entity
  • Substance identity information: name, CAS no. 
  • GHS classification/labelling
  • Use information (using standard use descriptor)
  • Test data: physico-chemical properties, toxicology and enviromental data
  • Risk assessment report including exposure info and risk management measures
  • Information on contents, etc. in case containing hazardous substance
  • Safe use information such as handling method and emergency response measures

Similar to SIEF in EU-REACH, CICO (Chemicals substance Information Communicative Organization) includes a group of potential registrants of one substance. The role of each participant is to strive for an efficient registration and communication process for the substance of concern.

The following information needs to be submitted jointly by all registrants of the same substance. 

  • Substance identification information
  • GHS classification and labelling
  • Test data: phsico-chemical properties
  • Test data: toxicology data
  • Test data: enviromental hazard

 

1. CICO position 

Position Role Advantages Disadvantages
Lead Registrant As a consortium leader, have same role of being active member  ● Might have more power in decision making than active member
● Profits incurred from selling LoA to passive members and non-members
● Unpredictable pre-investment cost for data purchase/produce
● Need time and cost to set up a consortium
Active member As a member of the consortium, engages in every  decision-making and have the ownership of the data needed for the registration ●  Profits incurred from selling LoA to passive members and non-members
Passive member As a member of the consortium, has limited right in decision-making
But do not have the ownership of the data thus only can purchase Letter of Access (LoA)
● No need of pre-investment in terms of cost and time
● LoA price is predictable
● Buying LoA is costly
● Need to pay additional costs in case there is no data prepared by the consortium
● Obtain less compensation from selling LoA to non-members

 

 ITEMS

EU REACH

K-REACH

Registration target

  • New substance (>=1t/y)
  • Existing substance (>=1t/y)
  • New substance (>=100kg/y)
  • Existing substance (>=1t/y)

Registration tonnage band

  • 1-10t
  • 10-100t
  • 100-1000t
  • 1000t+
  • <1t for new substance 
  • 1-10t 
  • 10-100t
  • 100-1000t
  • 1000t+

Polymer

Regisration of Monomer

Registration of Polymer itslef

Only Representative

Yes

Yes

Pre-registration of existing substances

Pre-Registration

Pre-Notification

Substances of Very High Concern (SVHC) Notification

SVHC Notification

Product Notification

Restriction / Authorization

Restriction / Authorization

Restriction / Authorization

Request for Quote

The Consumer Chemical Products and Biocide Safety Management Law (known as K-BPR) concerns the placing on the market and use of hazardous consumer chemical and biocidal products, which aims to protect public health and environment from these chemicals and products. This is achieved by assessment or notification of consumer chemical products’ risk, authorization of biocidal chemical substances and products and determination of biocidal chemical used products. K-BPR was taken into force on January 1, 2019, and its recent amendment was promulgated on March 24, and May 26, 2020. Its enforcement will start on January 1, 2021.

1. Consumer chemical product

Ministry of Environment (MoE) designated consumer chemical products that have a potential to expose hazardous chemicals to human and environments while its use at the home, office, and public facilities (“consumer chemical product subject to safety confirmation”). The consumer chemical products are categorized into two, of which requires either approval or notification.

 

1) Notification of consumer chemical products subject to safety confirmation

Any person who intends to manufacture or import a consumer chemical product that is subject to notification needs a product safety confirmation from concerned research institutes and notifies the confirmation results to Korea Environmental Industry & Technology Institute (KEITI) no later than 30 days since its confirmation.

 

2) Approval of consumer chemical products subject to safety confirmation

Any person who intends to manufacture or import a consumer chemical product that is subject to approval shall gain approval from MoE. It includes sterilizing materials such as anti-bacterial disinfectant for humidifiers, for preventing infectious diseases and other disinfection purposes, as well as insecticides, rodenticides, and hygiene repellents.

 

2. Biocides (Biocidal substance, biocidal product, biocidal treated product)

Any person who intends to manufacture or import biocides shall gain approval from MoE. Biocides under K-BPR refer to biocidal substances, biocidal products, biocidal treated products.

 

1) Biocidal substance

Biocidal substance refers to the chemical, natural material and microorganism to remove or control harmful organisms like pests and bacteria and make them harmless.

* Existing Biocidal Substance

Existing Biocidal Substance refers to a biocidal active substance included in biocidal products, which has placed on the market before December 31, 2018. By December 31, 2019, the list of 741 existing biocidal substances has been confirmed and varying substances have different grace periods.

* Biocidal substance other than the Existing Biocidal Substance 

Any person who intends to manufacture and import biocidal substances requires approval from MoE. It applies to all biocidal substances except designated substances that have fewer risks, substances are used for research purposes and are subject to other laws.

 

2) Biocidal product

Biocidal product is defined as an article mainly used to remove harmful organisms, which is,

  • comprised of more than one biocidal chemical substance, or a mixture of biocidal chemical substance and non-biocidal chemical substance, a natural substance, and microorganism
  • made of a chemical substance or a mixture of a chemical substance, natural substance, and microorganism

Any person who intends to manufacture and import biocidal products requires approval from MoE. Once a product is approved to be manufactured or imported, safety labelling for products concerned shall be stated.

Within scope
  • Consumer chemical product (1)
  • Biocidal substance (2)
  • Biocidal product (3)
  • Biocidal treated product (4)
Out of scope
  • Consumer chemical products and biocidal chemicals used for research and experiments and non-sale
  • Chemicals subject to other laws: health functional food, military supplies, agricultural chemicals, pharmaceuticals, cosmetics, food additives etc. 

(1) ‘Consumer chemical product’ is defined as an article that has a potential of chemical exposure to human and environment while its use at the home, office, and public facilities etc.

(2) 'Biocidal substance’ refers to a chemical, natural material and microorganism to remove or control harmful organisms like pests and bacteria and make them harmless

(3)  ‘Biocidal product’ is an article mainly used to remove harmful organisms, which is 

  • comprised of more than one biocidal chemical substance, or a mixture of biocidal chemical substance and non-biocidal chemical substance, a natural substance, and microorganism
  • made of a chemical substance or a mixture of a chemical substance, natural substance, and microorganism

(4) ‘Biocidal treated product’ refers to a product that uses biocidal products during the production process, but its main purpose is not to remove harmful organisms

As per the recent amendment of K-BPR on March 24, 2020, the concept of Only Representative (OR) is included in the law, which will take into force on January 1, 2021.  OR is an intermediary appointed by a foreign manufacturer based outside of South Korea to get an approval of consumer chemical products, biocidal substances, and biocidal products so that such chemicals and products can be imported in South Korea.

During the grace periods, any person who intends to manufacture or import biocides can continue to manufacture and import the biocides without approval from MoE once he or she submits an Existing Biocidal Substance notification to MoE. By December 31, 2020, for those companies who had reported their Existing Biocidal Substances, an approval plan (simplified version of approval application) shall be submitted in National Institute of Environmental Research (NIER).

Biocides approval process begins with submitting approval application. Once the authority initiates the assessment, a notice informing approval assessment initiated will be sent to the applicant. In six months from the date of the notice, approval assessemnt result will come out and might require more information from the applicant. After going through committee deliberation, the approval application is finally approved and will be notified to the applicant. This process is described in the picture below. 

For biocides use approval, then necessary documents are as follows.

 

1. Biocidal substance

  • An approval application form that includes applicant and biocides information (e.g. product name, material type etc.)

  • Chemical substance identification and chemical processing procedure
  • Chemical substance information (e.g. physicochemical properties, exposure, and safety information, labelling)
  • MSDS and Risk assessment

 

2. Biocidal product

  • An approval application form that includes applicant and biocides information (e.g. product name, material type etc.)

  • Active substance information
  • Biocidal product information (e.g. physicochemical properties, exposure, and safety information, labelling)
  • MSDS and Risk assessment
  • Product processing procedure and processing and storage methods/plans

Each biocides use approval has expiration period.

 

1. Biocidal substance

Expiration period Criteria
10 years
  • Biocidal substance
7 years
  • A biocidal substance that its approval criteria are eased (1)
  • A biocidal substance that affects respiratory organs
  • A biocidal substance that is persistent, accumulative, or toxic (having more than two features) 
5 years
  • When a substance has all features mentioned above

(1) Approval criteria for a biocidal substance are eased when 

  • the biocidal substance has little potential to be exposed to human or environment due to its purpose and use is limited 
  • the biocidal substance is needed due to lack of substitutable substance that has little risks

 

2. Biocidal product

Expiration periods Criteria
10 years
  • Biocidal product
5 years
  • A biocidal product that its approval criteria are eased (1)
  • A biocidal product that contains a biocidal substance having eased approval criteria
3 years
  • When a product has all feature mentioned above

(1) Approval criteria for a biocidal product are eased when

  • the biocidal product used for an industrial purpose
  • the biocidal product is needed due to lack of substitutable product that has little risks

Request for Quote

In developing the cosmetics industry and improving public health, the Act regulate matters concerning the manufacture, sale, import, and export, etc of cosmetics. The Cosmetic Act has been enforced since July 1, 2000, and the recent amendment came into force on April 7, 2020.

 

Relevant documents are uploaded in the right-side bar ‘Downloadable Content’.

  • Cosmetic Act (Korean and English)

According to the Cosmetic Act, cosmetics include two main categories: functional cosmetics and general cosmetics. Some articles in the Cosmetic Act particularly applies to functional cosmetics. For instance, a person or company who is involved in the sale of a functional cosmetic should process examinations of the safety and effectiveness of each product and report it to MFDS (Ministry of Food and Drug Safety).

1) Functional cosmetics: As determined by ordinance of the Prime Minister, these cosmetics include the following:

  • Cosmetics that help whiten skin
  • Cosmetics that help smoothen or improve skin wrinkles
  • Cosmetics that help tan skin
  • Cosmetics that help protect skin from ultraviolet rays
  • Cosmetics that help change hair colour
  • Cosmetics that help remove body hair
  • Cosmetics that help alleviate alopecia
  • Cosmetics that help alleviate acneiform skin
  • Cosmetics that help alleviate urtication from atopic skin
  • Cosmetics that help thin redlines from stretchmarks

 

2) General cosmetics: These include all cosmetics excluding functional cosmetics.

 1. Main requirement for manufacturers and manufacturer-seller

 

Manufacturer

Manufacturer-Seller

Definition

Manufacturing all or part of the cosmetics*

(*This excludes manufacturing secondary packaging or labelling)

Distributing or selling manufactured or imported cosmetics, or offering or supplying cosmetics to import agency business

Main requirement

-Follow manufacturer-seller’s request and guidance ∙ supervision based on quality control standard

-Prepare and keep documents including manufacturing control standards, product standards, manufacturing control records and quality control records

-Manage hygiene of manufacturing plants, facilities and equipment

-Inspect facilities and equipment regularly to maintain and keep it, in order not to disturb operation

-Do not place any object that might cause harm and ensure there is no release or leakage of harmful substances

-Follow quality control standards

-Follow safety control standards

-Keep product standards and quality control records received from manufacturers

-Prepare and keep import control records attached to imported cosmetics

-Distribute products after thorough quality inspection by serial number

 

*** Anyone who violates these matters shall be fined up to 2 million KRW.

 

2. Contents to be stated on primary or secondary packages

  • Name of the cosmetic
  • Tradename and address of the business operator
  • All ingredients used in manufacturing the relevant cosmetic
  • Volume or weight of contents
  • Manufacturing serial number
  • Use-by date or best before date after opening
  • Price
  • The word “Functional cosmetic” or functional cosmetic logo (only for functional cosmetics)
  • Cautions for use
  • Other matters prescribed by ordinance of the Prime Minister

*** Anyone who violates these matters shall be fined up to 2 million KRW.

3. Prohibition of false labelling and advertising

  • Labelling or advertising that might mislead consumers to think the cosmetics are medicines
  • Labelling or advertising that might mislead consumers to think general cosmetic as functional cosmetic, or labelling or advertising that is different from the examination result of safety and efficacy of functional cosmetic
  • Labelling or advertising that might mislead consumers to think any cosmetic other than a natural or organic cosmetic as a natural or organic cosmetic
  • Other labelling or advertising that might mislead or deceive consumers

***Anyone who violates these matters shall either be sentenced up to one year imprisonment or fined up to 10 million KRW.

 

Source: MFDS (Ministry of Food and Drug Safety)

Request for Quote

A person who intends to manufacture or import any chemical substance or a mixture, which falls under the classification standards for hazards and dangers of chemical substances, physical factors, etc. that cause health impairments to employees, shall prepare material safety data sheets and submit them to the Minister of Employment and Labor.

* Overseas manufactures can appoint an Only Representative (OR) to prepare and provide MSDS, as well as to apply Approval for Non-Disclosure.

* Process

Substances subject to prepare MSDS: a chemical substance or mixture that causes health disorders to employees

Exception:

  1. a chemical substance or mixture that is specified in 15 other Acts.
  2. a chemical substance or mixture provided mainly to general consumers for daily life
  3. a chemical substance or mixture with low toxicity and explosiveness risk
  4. a chemical substance or mixture for R&D

* 16 categories:

     1) Information about the chemical product and company

     2) Hazard and risk assessment

     3) Name and content of ingredients

     4) First Aid Measures

     5) How to deal with explosions and fires

     6) Measures for leakage accidents

     7) Handling and storage

     8) Exposure prevention and personal protection

     9) Physicochemical properties

     10) Stability and Reactivity

     11) Toxicological information

     12) Environmental Impact

     13) Disposal precautions

     14) Information required for transportation

     15) Legal Regulatory Status

     16) Other notes

 

* Deadline:

1) Existing MSDS (have been imported and provided MSDS before Jan 16th, 2021)

  • A grace period based on tonnage band

Deadline

Tonnage band

Jan 16th, 2022

Over 1000 tpa

Jan 16th, 2023

100-1000 tpa

Jan 16th, 2024

10-100 tpa

Jan 16th, 2025

1-10 tpa

Jan 16th, 2026

Below 1 tpa

 

2) New MSDS (newly imported after Jan 16th, 2021)

  • No grace period
  • Need to submit MSDS prior to manufacture or import

If a manufacturer or importer wants to write the alternative information (alternative name and alternative content) in MSDS instead of the name and content of the hazardous ingredients that are trade secrets, the person can apply Approval for Non-Disclosure.

Request for Quote

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