G/TBT/N/KOR/775  
 
11 June 2018  
(18-3576) Page: 1/4 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member: REPUBLIC OF KOREA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible: Chemicals Policy Division, Ministry of Environment  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Chemicals Policy Division, Ministry of Environment,  
Building #6, 11, Doum 6 -ro, Sejong, 330103, Rep. of Korea  
Tel: 82 -44-201-6783  
Fax: 82 -44-201-6786 
E-mail: minaseo@korea.kr  
Website: www.me.go.kr   
3. Notified under Article 2.9. 2 [X], 2.10.1 [   ], 5.6. 2 [  ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Non-phase -
in substance & Phase -in Substance, carcinogenic or mutagenic substance  
5. Title, number of pages and la nguage(s) of the notified document: Revised version 
of the Enforcement Decree of the Act on Registration and Evaluation, etc. of Chemical 
Substances, 64 pages, Korean Revised version of the Enforcement Rules of the Act on 
Registration and Evaluation, etc. of Chemical Substances, 131 pages, Korean  
6. Description of content:  
- Name of Law: Revised version of the Enforcement Decree of the Act on Registration and 
Evaluation, etc. of Chemical Substances  
- Major Contents:  
A. Definition of transported isolated  intermediate (as amended Article 2(1))  
Under the Act on Registration and Evaluation of Chemical Substances, non -isolated and 
on-site isolated intermediates not exposed to consumers are exempted from registration or 
for its registration under REACH. Theref ore, the Ministry of Environment developed a 
definition of transported isolated intermediate as follows "which is generated during 
manufacturing process and transported to other production asked to submit less data than 
other substances. However, transport ed isolated intermediate does not have relevant 
provision in the Act. The EU asks simplified data requirements site, and then used and 
exhausted all", so as to waive some data submission in registration dossier.  
B. Grace period for existing substances (as  amended Article 10)  
For manufacturing or importing existing substance from 10 to 100 ton per year, 
manufacturer or importer should register the substance by 31 December in 2027, and 
register those from one to ten ton per year by 31 December in 2030.  G/TBT/N/KOR/775  
 
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  C. Total amount of substance in the Korea market to be designated as subject to 
registration (as developed Article 10(3))  
For existing substance that a company manufactures or imports less than one ton per 
year, which is exempted from registration, but the tot al amount of the v substances as 
subject to registration after deliberation of the Chemical Substance Evaluation Committee 
in accordance with Article 10(5).  
D. Registration exemption (as amended Article 11)  
When substance is exported as a whole, it is exe mpted from registration regardless of its 
amount. For high molecular compound with less than 10,000 of number average molecular 
weight, it shall be registered when hazardous substance, priority substance or new 
substance remains more than 0.1% in weight ra tio based on unreacted monomer.  
E. Less data requirements for substance registration (as amended Article 13)  
For chemical substance of low concerns, the Ministry of Environment simplifies data 
requirements in order to operate the current registration syst em in more reasonable 
manner. When manufacturer or importer of existing substance notifies the competent 
authorities of the substance or its changed information in accordance with Article 10(3) 
and, as the result, it is revealed that the substance does not  fall under classification and 
labelling of health or environmental hazard, the Ministry of Environment allows to register 
the substance with less data by waiving several data requirements in registration dossier. 
Provided that manufacturer or importer who  notifies the substance or its changed 
information for consumer use, they are not the subject to the waiving of data 
requirements.  
F. New penalty criteria (as developed Article 15(2))  
Fine is imposed lower than 5% of the total sales of the concerned comp any under the law. 
In this case, the total sales is the average annual sales of three consecutive business years 
just before the business year when the company committed the violation.  
G. Concentration -based information provision (as developed in Article 20(2))  
The information on registered or notified substance should be provided regardless of its 
concentration. In addition, the information on unregistered hazardous substance should be 
provided when the hazardous substance is contained more than the mixt ure classification 
criterion in accordance with the ME Public Notice "Regulation on Classification and 
Labelling, etc. of Chemical Substances", even though the hazardous substance does not 
meet its mixture criterion in accordance with the ME Public Notice "Designation of 
Hazardous, Restricted and Banned Substances".  
- Name of Law: Revised version of the Enforcement Rules of the Act on Registration and 
Evaluation, etc. of Chemical Substances  
- Major Contents:  
A. New notification system for existing substance s and their changed information (as 
amended Article 3)  
Manufacturer or importer of existing substance should submit a notification to the Korea 
Environment Corporation (KECO) through the Chemical Substance Data Processing System 
before manufacturing or imp orting the substance. When the tonnage band manufactured 
or imported is changed, manufacturer or importer should submit a notification on the 
changed tonnage band before the changed tonnage band is applied. When other 
information is changed such as classif ication, labelling, intended use and so on, 
manufacturer or importer should submit a notification on the changed information within 
one month after the date when the change occurs.  
B. Registration method (as amended Article 5)  
When existing substance poses low risk concerns, the substance is allowed to submit less 
data (except the case when it does not have classification and labelling on health and 
environmental hazards, and except a person who notifies the substance for consum er use). 
In this case, manufacturer or importer can submit less hazard data that is generally 
applied to the tonnage band from one to ten ton per year, regardless the actual amount 
manufactured or imported. For transported isolated intermediate, its manufa cturer or G/TBT/N/KOR/775  
 
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  importer can submit less hazard data, if appropriate, even to the extent of data 
requirements that are generally applied to the tonnage band from one to ten ton per year 
(when manufactured over 1,000 ton per year).  
C. Notification and notice rega rding new substance (as developed Article 6(2))  
Manufacturer or importer of new substance less than 100kg should submit required 
documents, including a notification on OR appointment and an application for data 
protection, to the National Institute of Envi ronmental Research (NIER) before 
manufacturing or importing the new substance. Then, the NIER gives a notice within seven 
days (or within 14 days in maximum) from the date when the documents are received.  
D. Joint submission method and procedure for joint  registration (as amended Article 17)  
Based on notification of existing substances and their changed information, manufacturers 
and importers of the same substance should form a consortium if it manufactures or 
imports the substance for consumer use. Even though some existing substances have the 
same chemical name or identity, it may be inappropriate to consider them as the same 
substance because their characteristics as high molecular compound are clearly different. 
In this case, separate consortium may be  formed.  
E. Information provision regarding chemical substance (as amended Article 35, and 
developed Article 35(2))  
1) Based on classification and labelling of chemical substance having health and 
environmental hazards, its information such as components a nd contents may not be 
provided if the Ministry of Environment (ME) approves to do so.  
- In this case, "application not to provide information" should be submitted to the Ministry 
of Environment (ME). Then, the ME decides whether it accepts the applicatio n or not based 
on a deliberation of the Information Provision Deliberation Committee (which is newly 
established under Article 7), and informs the applicant of its decision in accordance with 
Article 35(2).  
2) When mixture contains chemical substance with higher risks on human body, including 
carcinogenic, mutagenic and reproductive toxic substances (CMRs) or hazardous 
substances, relevant information should be provided if its concentration is higher than its 
mixture classification criterion in accordance w ith the ME Public Notice "Regulation on 
Classification and Labelling, etc. of Chemical Substances".  
F. Removal of provisions regarding management of risk -concerned products (by abrogating 
Article 43, 44, 47 and 48)  
As the management of household chemical products, including products of risk concerns, is 
transferred to the Consumer Chemical Products and Biocides Safety Act, the Ministry of 
Environment abrogated relevant provisions: including risk assessment method, data 
submission on substances contained in  risk-concerned products that are not designated 
and announced yet, withdrawal order and so on.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: To protect public health from any harms caused by chemical substances of 
risk concerns and enhance safety of chemical substances contained in products (prevention 
of recurrence of humidifier disinfectant case)  
8. Relevant documents:  MoE Public Notice No. 2018 -426, 2018 -427  
9. Proposed date of adoption: 1 January 2019  
Propose d date of entry into force: 1 January 2019  
10. Final date for comments: 60 days from notification  G/TBT/N/KOR/775  
 
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  11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Technical Barriers to Trade(TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93, Isu -ro, Maengdong -myeon, Eumseong -gun, Chungcheongbuk -do, Republic of Korea, 
369-811 
Tel.: (+82) 43 870 5525  
Fax: (+82) 43 870 5682  
E-mail: tbt@kats.go.kr  
Website: http://www.knowtbt.kr  
 
https://members.wto.org/crnattachments/2018/ TBT/KOR/18_2715_00_x.pdf  
https://members.wto.org/crnattachments/2018/TBT/KOR/18_2715_01_x.pdf