What's CCA?
South Korea’s Chemicals Control Act passed national assembly in May of 2013 and came into force on 1 Jan 2015, the same enforcement date as K-REACH. CCA and K-REACH replaced the previous Toxic Chemicals Control Act (TCCA) to address the basic management of industrial chemicals and chemical products in South Korea. The registration and evaluation of new and existing substances are now regulated under K-REACH. CCA regulatory provisions mainly focus on the control of the whole process from market access, distribution, handling to disposal of chemicals.
Management Framework
Fig. 1 - Framework of South Korea’s Chemicals Control Act
Prohibited substances: In principle, no one can handle prohibited substances, however, for those manufactured, imported or sold for use in experiment, testing and research, handling is provisionally permitted provided permission is obtained.
Substances subject to authorization: Any person who intends to manufacture, import or use these substances should obtain permission in advance.
Restricted substances: Any person who intends to import restricted substances should pay attention to the restricted usages and apply for permission in advance.
Toxic substances: Any person who intends to import toxic substances should notify the type and usage information.
Who Needs to Comply with CCA?
Business operators involved in the manufacture, import, sale, storage, logistics and downstream use of hazardous chemicals should comply with CCA requirements.
Hazardous chemical substances defined under CCA include toxic substances, substances subject to authorization, restricted substances, prohibited substances and accident precaution chemicals.
History
5 Apr 2013 CCA drafted
7 May 2013 CCA passed by national assembly
4 Jun 2013 CCA published as Law No. 11862
7 Apr 2014 CCA’s subordinate statutes drafted
9 Dec 2014 CCA’s Enforcement Decree published as Presidential Decree No. 25836
24 Dec 2014 CCA’s Enforcement Rules published as MoE Decree No. 583
1 Jan 2015 CCA came into effect
20 Jan 2015 CCA partially revised and published as Law No.13035, implemented on 21 Jul 2015.
Main Contents of CCA Regulation
The CCA regulation contains 7 chapters as well as an addendua:
Ⅰ General provisions (Article 1-8)
Ⅱ Statistical survey and information disclosure of chemical substances (Article 9-12)
Ⅲ Safety management of hazardous chemical substances
Section 1. Hazardous chemical handling criteria (Article 13-22)
Section 2. Installation and operation of hazardous chemical handling facilities (Article 23-26)
Ⅳ Business operators of hazardous chemical substances
Section 1. Identification of business types and business permit for hazardous chemical substances (Article 27-30)
Section 2. Management of business operators of hazardous chemical substances (Article 31-38)
Ⅴ Preparation for and countermeasures against chemical accidents
Section 1. Designation of accident precaution chemicals (Article 39-42)
Section 2. Countermeasures against chemical accidents (Article 43-47)
Ⅵ Supplementary provisions (Article 48-56)
Ⅶ Penalty (Article 57-64)
How to Comply
Written Confirmation of Chemical Product Specifications
According to the Article 9 of CCA, manufacturers or Importers of chemicals shall submit a “Written Confirmation of Details for Chemical Product” to the KCMA prior to manufacture or import after careful self-evaluation whether it contains any regulated chemical of the followings:
1. Phase-in substances to registration (PEC substances required to register under K-REACH)
2. Non phase-in substances (New chemical substances required to register under K-REACH)
3. Toxic substances
4. Substances subject to authorization
5. Restricted substances
6. Prohibited substances
7. Accident precaution chemicals
Below are the documents required for “Written Confirmation”:
Table of ingredients: specifying name, CAS No. content, etc. of chemical substances contained in the product.
Relevant document, such Letter of Confirmation (LOC)
For the submission of “Written Confirmation”, the followings are some basic rules:
One submission for one product (a chemical or a preparation/mixture)
A re-submission is required if any change is made to the composition.
Separate “Written Confirmation” is required for same product imported from different countries.
It should be noted that persons who intend to manufacture/ import PEC substances are required to submit chemical confirmation within 6 months (namely 31 Dec 2015) from the date of PEC list officially published. This requirement was specified on July 1, 2015, as the issuance of the PEC list.
Follow-up Registration/Permission Management
If any of the 7 kinds of regulated chemical is contained, the manufacturer or importer should perform the following additional tasks after submitting the “Written Conformation”.
Type of regulated chemical | Requirements | Competent authority | Regulation | Processing period |
PEC substances | Registration ≥1t/y | NIER | K-REACH | 30 days |
New chemical substances | Registration <1t/y (2015-2019); <100kg/y (from 2020) | NIER | K-REACH | 3 days; 7 days if necessary for further discussion |
Registration ≥1t/y | NIER | K-REACH | 30 days | |
Registration exemption | KCMA | K-REACH | 3 days; 10 days if necessary for further discussion | |
Toxic substances | Notification of import | Regional environmental office | CCA
| Immediately |
Permission for business | Regional environmental office | CCA | 15 days | |
Substances subject to authorization | Permission for manufacture, import and use | Regional environmental office
| CCA | 20 days |
Restricted substances
| Permission for import | Regional environmental office
| CCA | About 15 days |
Permission for business | CCA | 15 days | ||
Approval of export | CCA | About 15 days | ||
Prohibited substances | Permission for manufacture, import and sale | Regional environmental office
| CCA | About 30 days |
Approval of export | Regional environmental office | CCA | About 15 days | |
Accident precaution chemicals | Permission for business | Regional environmental office | CCA | 15 days |
Off-site Impact Analysis
Under CCA, all enterprises intending to install and operate handling facilities for hazardous chemicals shall prepare an off-site impact analysis report that evaluates the impact of potential chemical accidents on the surrounding environment and population.
Risk Management Plan
So far there are 69 accident precaution chemicals with designated usage level thresholds in the Annex 10 of CCA’s Enforcement Rules.
CCA requires that any person who handles accident precaution chemicals, once this threshold is exceeded, should prepare and submit the risk management plan every five years. In addition, as accident precaution measures, the contents of the risk management plan will be notified to local residents at least once a year.
The risk management plan should include the following information:
1. List of accident precaution chemicals and their corresponding hazard information
2. List of handling facilities for accident precaution chemicals, as well as their current status
3. Engineering safety information of handling facilities of accident precaution chemicals, operation process, etc.
4. Information of responsible person and relevant staff for the operation of accident precaution chemicals
5. Education, training and self-inspection plans for accident precaution
6. Emergency contact information in case an accident occurs, etc.
7. Potential leakage, exposure pathway, as well as a contingency plan in case an accident occurs
8. Confirmation of the scope of impact on surrounding residents, environment, etc. in case an accident occurs
9. Evacuation plan in case an accident occurs
10. Measures and plans for recovery or to minimize/eliminate the damage caused by chemical accidents
11. Others relating to safety management of accident precaution chemicals
Permission for Business
The MoE will issue a business permit for hazardous chemical substances (except for prohibited substances and substances subject to authorization) when the handling equipment and technical manpower are shown to meet the necessary standards.
The business permit will cover manufacturing, sale, warehousing, logistics, and downstream uses. The business operators are required to submit the following corresponding materials:
1. An off-site impact analysis report for the installation and operation of handling facilities for hazardous chemicals
2. Inspection results for the insulation and operation of handling facilities for hazardous chemicals
3. A risk management plan for accident precaution chemicals
4. A list specifying the handling facilities and technical manpower
News
14 Aug 2015 Written Confirmation Exemption Criteria under South Korea’s Chemical Control Act
13 May 2015 950 Substances to Be Added into Korea’s Existing Chemical Inventory
27 Nov 2014 Korea Publishes Draft Toxic, Restricted and Prohibited Substances Lists
14 Nov 2014 19 Dec 2014: Deadline for Korea New Chemical Registration Exemption Application under TCCA
29 Oct 2014 Korea Updates Toxic Chemical Substance and GHS Classification Lists
17 Oct 2014 22 Oct 2014: Deadline for Korea New Chemical Registration under TCCA
29 Aug 2014 South Korea: Toxic Chemical Substance List Updated with GHS Classification
21 May 2014 South Korea Makes Changes to Substance Inventories
28 Mar 2014 South Korea Updated Substance Inventories
28 Feb 2014 TCCA and K-REACH Transitional Issues
7 Jan 2014 South Korea Updates Toxic Substance List and GHS Classification List
17 Jun 2013 South Korea Adopts Amendment of TCCA
Expert Articles & Ebook
1. Nadine He, 20 Mar 2015, "Registration Exemption under K-REACH"
2. William Chou, 30 Dec 2014, "How K-REACH Will Affect the Flavors and Fragrances Industry"
3. Nadine He, 10 Apr 2014, "Polymer Registration under K-REACH: Scope, Data Requirements & Exemptions" , Chemlinked
4. Nadine He, 19 Nov 2013, "K-REACH: A Comparative Analysis With EU-REACH and China REACH", Chemlinked
5. Sanghee Park, 3 May 2013, "K-REACH Adopted in the National Assembly and Starts from 1 Jan 2015", Chemtopia
6. Eun-suk Park, 24 Sep 2013, "Chemical Registration Challenges in Korea", Nam&Nam