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South Korea - Regulation

The Ministry of Environment of Korea (MoE) published the Act on Registration and Evaluation, etc of Chemical Substances (known as K-REACH) on January 1, 2015. 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.

Under K-REACH, manufacturers or importers of a new chemical substance need to register the substances prior to manufacture or import. For substances less than 100 Kg/year, it only requires notification and does not need to go through hazard evaluation. 

Manufacturers or importers of a Priority Existing Chemicals (PEC) substance need to register the substances prior to manufacture or import. Pre-registration of PEC substances is not possible as the transition period has already passed.

Existing substances above 1 Tonne Per Annum (TPA) must be registered within given grace periods. Only companies that carried out pre-notification can be entitled to the grace periods. The grace periods vary based on tonnage band. After the grace periods for each tonnage band, existing substances within that tonnage band cannot be pre-registered, and they should be registered prior to placing the substances in Korea.

In addition to K-REACH, GPC Korea also provides following services: 

K-BPR

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.  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.

Cosmetic Act

The Cosmetic Act in South Korea aims to develop the cosmetics industry and improve public health. It has been enforced since July 1, 2000, and the recent amendment came into force on April 7, 2020.

KOSHA & MSDS

MSDS is one part of Occupational Safety and Health Act (KOSHA). The purpose of this Act is to maintain and promote the safety and health of people providing labour by establishing stands on industrial safety and health.

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

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

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