G/TBT/N/KOR/719  
 
20 June 2017  
(17-3283) 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:  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, Republic of Korea  
Tel: 82 -44-201-6783  
Fax: 82 -44-201-6786 
E-mail: minaseo@korea.kr   
Website: www.me.go.kr   
3. Notifi ed 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, existing subst ance subject to registration, substance subject to authorization, 
restricted and banned substance  
5. Title, number of pages  and language(s)  of the notified document:   
 Revised version of the Enforcement Rules of the Act on Registration and 
Evaluation, etc.  of Chemical Substances (22 pages, in Korean)  
 Revised version of the Enforcement Decree of the Act on Registration and 
Evaluation, etc. of Chemical Substances (15 pages, in Korean)  
6. Description of content:   
Enforcement Rules of the Act on Registration a nd Evaluation, etc. of Chemical Substances  
1. Extended notice period for registration and registration update (Article 6(1)2, Article 
9(3)2 as amended)  
 Currently, the number of registered new substances in small volume (less than one 
ton) amounts to aroun d 10 per day and 2,000 substances per year. However, the 
regulatory authorities only have three days to screen each application for updating 
registration information, which results in technical difficulties and concerns over 
insufficient review. Under the draft amendment, the regulatory authorities extend the 
notice period for registration and registration update up to 10 days (maximum 20 days) 
so as to ensure enough review time and pr udent information management.  
2. Abrogated provision on submission of wri tten contract with testing institute when 
submitting a test plan (Article 14(2)2 is removed)  
 G/TBT/N/KOR/719  
 
- 2 - 
 
   Submitted test plan includes specific test methods, timeline and the date when relevant 
test data will be submitted. Therefore, the draft amendment does not ask a written 
contract that is concluded with testing institute when submitting a test plan.  
3. Enhanced process for test plan review and for informing the result (Article 15(1) & 
Article 15(3) as amended)  
 1) NIER should review test plans within the notice pe riod of registration.  
 2) When the head of NIER decides that a test plan has nothing to modify or 
complement in accordance with Article 15(2), potential registrants submit testing data 
as prescribed in the test plan.  
4. Joint submission of registration do ssier, including risk data (Article 16(2) as amended)  
 Even though not all members of consultative group reach an agreement, some 
members who agree is allowed to submit risk data or safe -use guidance document in a 
joint manner.  
5. Enhanced method and proce dure for joint submission of registration dossier (Article 
17(1) as amended, Article 17(3) as new)  
 When lead registrant is not appointed or when members of consultative group are hard 
to reach an agreement for joint submission of existing substance, joint  submission of 
registration dossier is delayed. In this case, the Minister of Environment may 
recommend an appropriate representative or arrangement for the registration.  
6. Improved procedure of hazard review (Article 23(1) as amended)  
 Of those substanc es registered, the regulatory authorities perform screening on their 
hazard and risk by using the registered information such as intended use, classification 
and labeling, quantity to be manufactured or imported.    
 Then, the regulatory authorities may car ry out hazard review and take necessary 
measures on the substances according to the priority of them when they are suspected 
to have higher hazard or risk.  
7. Expanded scope of those who should follow an order of withdrawal, etc. & Deadline for 
submitting written plan and result of the order (Article 48 as amended)  
 The draft amendment expands the scope of those should follow an order of products 
withdrawal from the market: from producer and importer to business entity who 
manufactures the products by means  of original equipment manufacturing or original 
development manufacturing, main contractor or subcontractor, and seller. In this case, 
the scope of seller is limited to superstore (e.g. department store, large retailer and so 
forth) in accordance with Art icle 2(3) of the Distribution Industry Development Act. This 
is to enhance consumer convenience and make sure that withdrawal measure is 
implemented in a swift manner.  
8. Updated instruction for preparing application of registration exemption confirmation 
(Appendix 5 as revised)  
 1) For chemical substance used for R&D, business entity should submit a result of 
follow -up measure within three months after the R&D period ends, if there is remaining 
quantity of the substance or R&D achievement.  
 2) When changi ng a period taken for R&D, intended quantity manufactured or 
imported, or researcher or developer, the business entity should requ est to update the 
change to the  Korea Environment Corporation with evidence documents.  
Enforcement Decree of the Act on Regist ration and Evaluation, etc. of Chemical Substances  
1. Expanded scope of chemical substances subject to registration exemption (Article 
11(2)2 as amended)  
 Currently, polymer that has number average molecular weight of less than 10,000 
should be registered if it contains more than 2% of monomer that is a new substance. 
Under this draft amendment, polymer can receive confirmation of registration 
exemption if the polymer contains new substance that its information such as hazard 
data was already registered as manufactured or imported over one ton per year and G/TBT/N/KOR/719  
 
- 3 - 
 
  went through hazard review, except the cases when the new substance has risk 
concerns (e.g. designation as hazardous substance).  
2. Expanded waiving of data requirements when submitting substance registrat ion dossier 
(Article 13(6)2 as new)  
 When hazard of chemical substance are known by referring to hazard data that foreign 
governments or international organizations already made available to the public, the 
draft amendment allows waiving of the relevant da ta requirements in registration 
dossier.      
3. Expanded scope of individual data submission when submitting registration dossier of 
existing substances subject to registration (Article 14(3) as new)  
 The draft amendment states that individual submission i s allowed in certain cases 
where the Minister of Environment specifies and announces. For example, when 
potential registrant who wants individual submission agrees to share its individually -
submitted data with others for free, the potential registrant is a llowed for individual 
submission.   
4. Designation & Public Notice of substance subject to authorization, restricted or banned 
substance (Article 19(3) and Article 20(4) as new)  
 Of those substances that foreign government or international organization alr eady 
regulates or decides to regulate, substances having higher risk concerns and sufficient 
data may be designated as substance subject to authorization, restricted or banned 
substance without socioeconomic analysis or risk assessment in accordanc e with t he 
draft amendment.  
5. Additional and updated works that the Minister of Environment assigns or entrusts to 
the head of the National Institute of Environmental Research, the heads of local 
environment offices, the Korea Environment Corporation and the Kore a Chemicals 
Management Association (Article 31(1)7(2), Article 31(4)1(2), and Article 31(4)2(2) as 
new, etc.)  
 1) Head of the National Institute of Environmental Research carries out works related 
to designation and Public Notice of toxic substances.  
 2) Heads of local environment offices receive applications for registration exemption 
confirmation and, if necessary, perform an inspection on relevant place of business.  
 3) The Korea Environment Corporation conducts works related to receiving notifications 
for informing OR appointment or dismissal, and receiving requests on data protection, 
which was entrusted to the Korea Chemicals Management Association before.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
To encour age registration of chemical substances and protect public health from any 
harms caused by chemical substances of risk concerns.  
8. Relevant documents:   
 MoE Public Notice No. 2017 -467 
 MoE Public Notice No. 2017 -466 
9. Proposed date of adoption: 30 Septem ber 2017  
Proposed date of entry into force: 30 September 2017  
10. Final date for comments:  60 days from notification  G/TBT/N/KOR/719  
 
- 4 - 
 
  11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, 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/c rnattachments/2017/TBT/KOR/17_2785_00_x.pdf  
https://members.wto.org/crnattachments/2017/TBT/KOR/17_2785_01_x.pdf