South Korea Reach Regulation for Various Sectors

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. 

(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. 

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

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