Ⅳ

Legislation and Amendment ofChemicals Management Act

1. TCCA
2. Act on Registration and Evaluation, etc. of
Chemical Substances (K-REACH)
3. Chemicals Control Act (CCA)

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1-1. Current Toxic Chemicals Control Act
 History of TCCA
History

Main Contents

Poison and Toxin oriented management(1963~1990, Act on Poisons and Toxins)
Beginning of full-scale chemicals
management policy(1990~1996, Toxic Chemicals Control Act)

Acute toxic substance based regulation
to prevent poisoning accidents

Setting up basis of advanced chemicals
management(1996~2005, OECD accession)

Joining of OECD in 1996, introduction ofadvanced system such as GLP, TRI etc.

Policy shift to advanced chemicals
management(2006~, Receptor oriented precautionary
management)
Separation of toxicity evaluation and risk
assessment(`expected in 2nd half of 2013)

Restricted · Banned substancedesignation(Proceeding risk assessment based
scientific regulation)

Systematic management including
examination of toxicity etc.

Legislating Act on Chemicals Evaluation
and Registration etc.
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1-2. Purpose of TCCA and Contents
 Purpose- Enable all people to live in a healthy and comfortableenvironment by properly controlling toxic chemicals

 TCCA Exemption

 Atomic Energy Act (radioactive substance) Pharmaceutical Affairs Act(Medicines and non pharmaceuticaldrugs)
 Act on the Control of Narcotics (Narcotics)
 Cosmetics Act (Cosmetics)
 Agrochemicals Control Act (Technical ingredients andagrochemicals) Fertilizer Act (Fertilizers)
 Food Sanitation Act (Food and food additives)
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1-2. Purpose of TCCA and Contents
 Main Content- Confirmation of chemical manufacture, import, toxicity
examination of new chemicals, risk assessment- Investigation of circulation and TRI- Toxic Chemicals Safety Management* Toxic chemicals: Import report, Business registration, facility
inspection, Toxic chemicals labeling etc.
* Restricted·Banned substance: Import·Business approval* Accident Precaution chemicals: comply regulation standard,
self-prevention plan, accident report and effect analysis

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1-3. Classification / Management System
under TCCA
Existing Chemicals

New Chemicals

Safety Test

Toxicity Examination

Risk Assessment

Restricted.
Prohibited(72)Import Permission
Business Permission

General Chemicals(42,874)

toxic
substance(652)

Observational
Chemicals(83)

Manufacture.
Import.
Use

Importnotification
Businessregistration

Manufacture.
Importnotification

Export Approval

Regular·Frequent inspection
Safety test, improvement order

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Accident Precaution
Chemials(69)
Establishment of
Self-preventionplan1-4. Reformed TCCA System~ 2014.12.31

Management Stage

2015.1.1 ~Chemical Registration

Act on Registrationand Evaluation etc. of
Chemical Substance(K-REACH)

Chemical Evaluation
Toxic Chemicals
Control Act(TCCA)

Designation of Toxic
Substance

Registration &Evaluation

Management of Toxic
Substance

ChemicalsControl Act(CCA)

Chemical Containing
Product Management

Chemicals Safety

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2-1. Comparison of TCCA & KK-REACHTCCA`

New Chemicals

Registration

Toxicity
Examination

Toxic
chemicals

Risk
Assessment

Approved or
Restricted
Bannedsubstance

K-REACH

Existing Chemicals(Substance subject toregistration)

Registration

HazardExamination

NewChemicals
Toxic
Chemicals

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2-2. Instigating Enactment Procedure of
K-REACH
National Assembly
member’s version
Pilot project by MoE·MCI
submitted(2012.03~2013.02)(2013.04.8)

Draft actdeveloped by MoE(2010.12)

Opinion gathering(2011.02~)

Submission to
National Assembly(2012.09.28)

Promulgation(2013.5.22)

National Assembly
Approval(2013.4.30)

MoE·MCI Pilot Project (2012)

Implementation andSupport Measures for
Stakeholders’ Forum
Guidance
Industry
confirmation- Registration Evaluation - Opinion gathering among - awareness,of test data accessibility
draft guidance(survey)
relevant Ministries
development (4 in total)
gathering among - Professional training- Consortium per substance, - Opinion
education, support forindustry, government,
cost calculation sharing
test cost according to
NGO
etc.
·

·

company size

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2-3. Changes During KK-REACH Introduction
Main Scheme

MOE Proposal
Both new and existingchemicals in 1 ton ormore (yearly basis)
Reporting(manufacture etc.) Reporting every 2 yr
Manufacturer &importerBoth new and existing
Registration
chemicals in 1 ton ormore (yearly basis)

private member’s Proposal
All new and existingchemicals in 1 ton or more
(yearly basis)
Every year
Manufacturer, importer,
seller, user
All new and existingchemicals

Both new and existing Both new and existing
Submission of risk chemicals
in 100 tons chemicals in 10 tons orassessment
or more (yearly basis) more (yearly basis)
Information
provision
High Risk
Concerned
products-

Penalty--

Information provided bydownstream user andproduct sellers
Product reporting,hazard examination etc.
No set value* Certain amount paid in aratio of company’s sales
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Final version
All new and existingchemicals in 1 ton ormore (yearly basis)
Every year
Manufacturer, importer,
sellerAll new and existingchemicals in 1 ton ormore (yearly basis)
Both new and existingchemicals in 100 tons
(yearly basis)* gradually tighten up to
10 tons until Year 2020)
Only upon requests frommanufacturers/importers
Article is exempted
Default

2-4. KK-REACH Flowchart<Chemical substance & mixture >Existing chemical substances(1 ton or more/year)
Existing substances
subjected for registration
Reporting(manufacturing etc.)

Registration

Designation of
toxic
chemicals
Hazardexamination

Designation ofsubstances thatare authorizedRisk
assessment
Designation ofsubstances that are
restricted/banned.

New
Chemicals<Product>
Reporting high risk
concerned product(Solid product exempted)

Product that isconcerned ofhazardousness

Risk
assessment

Safety/labelingstandard
Distribution-management(i.e. a ban on selling, recall)

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2-5. KK-REACH content (Reporting) Purpose : Identification of obliged registrants in advance,
confirmation of any changes after registration etc.
- Encourage joint-submission- Similar to EU REACH “Pre-registration”
 Reporting : Anyone who manufactures, imports or sells new chemicals
and 1 ton or more existing chemicals annually Required information: Use and Tonnage of chemical substances- Any changes (i.e. use) need to be notified< Substances exempted from reporting >① Chemicals in imported machineries② Chemicals in imported machinery devices for test-run③ Chemicals contained in solid form product that is not released during use④ Manufactured/imported substances for the purpose of research and studies⑤ Others chemicals listed in Presidential Decree etc.
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2-5. KK-REACH content (Subject to Registration)
 Existing Chemical Substances- Designation and Notification of existing chemical substances subject toRegistration- Chemicals manufactured or imported 1 ton or more annually are subject to registerprior to manufacture or import- Allow manufacturing & importing without registration given a grace period* Existing chemicals :① All substances domestically circulated since Feb.2.1991 (37,021 types)② Substances that have been examined for its hazardousness and published by the MoE
in according to 「TSCA」 since Feb 2 1991 (assumed 6,878 as of Dec.2012) Subject to registration even its volume less than 1 ton per year

- Designation and Notification of chemical substances subject to Registration
if recognized to cause serious damage to public health and environment All New chemicals< Substances exempted from reporting >① Chemicals in imported machineries② Chemicals in imported machinery devices for test-run③ Chemicals contained in solid form product that is not released during use④ Chemicals manufactured 10 tons or less per year for the purpose of export only,
and those chemicals listed in Presidential Decree (requires “Confirmation ofRegistration Exemption” from the Minister of Environment)
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2-5. KK-REACH content (Registration data) Information of chemicals, hazard examination and risk assessment etc.

- Submit a risk assessment including Exposure Scenario for chemical substances
manufactured and imported 100 tons or more per year.
* Submission date of risk assessment data
100 tons(‘15) → 70 tons (‘17)→ 2018 : 50 tons → 2019 : 20 tons → 2020 : 10 tons
Information
1

2

Registration criteria

Information of manufacturer or- Name, address, representativeperson

importer
Chemical substance Identification- Name, identification information

information

3

Use

4

Classification and Labeling5

Physico-chemical properties

6

Hazard information

Remarks(i.e.
-New chemical substancemolecular

formulaandchemicalstructure)

Existingchemicalsubstance-(1 ton or more per year)-protective equipment, emergency
7

Guidance on safe use

measures in a case of explosion,
fire and leakage- New & existing

8

Risk

(100 tons or more per year)* gradually phase-in

9

Test plan (substitution acceptable)

10

Confidentiality data (upon request)- details to be specified insubordinatelegislation- exposure

scenario

describing

overallhandling measures, exposure control andmanagement- May submit relevant references used in
the registrationas a replacement- K-REACH Article 45 (Data protection)

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2-5. KK-REACH content (Registration)
 Registration confirmation : check if subject to registration or

exemption
 Data preparation:- new chemical substances: prior to the legislation enforcement- existing chemical substances: in time with registration grace period* only accept hazardous data produced by GLP or government approved
testing laboratories

 Joint-submission : Manufacturer or importers registering same

substances subject to registration
 Data sharing : under consent from owner who have previously
submitted data Foreign manufacturers & producer (overseas) : shall appoint anappropriate person in Korea who fulfills the requirement specified
in the Ministerial Decree; and the person will act on behalf tocomplete required duties
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2-5. KK-REACH content (Hazard Examination &Risk Assessment) Hazard : Notification of hazard examination result to theregistrants- Review testing data and references submitted by companies* MOE will directly conduct hazard assessment for substances
identified by international organizations.
t Risk : Risk Assessment based on the result of hazard
examination, and notification of the result- Risk assessment of chemicals manufactured or imported
10 tons or more per year
Tonnage
100 or more ton/year
70 or more ton/year
50 or more ton/year
20 or more ton/year
10 or more ton/year

Submission date of risk information
1st Jan. 2015
1st Jan. 2017
1st Jan. 2018
1st Jan. 2019
1st Jan. 2020
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2-5. KK-REACH content (Designation ofHazardous Chemicals Substances) Designation of chemicals through Examination & evaluation result→ toxic substance, authorization substance, prohibited/restricted
substance
Classification
Toxic
substance
Authorized
substance
Restricted/
Bannedsubstance

Designation standard
Remarks○ Result of hazard examination- substances recognized as toxic - Notification of name, toxic
to human body and ecology
status etc.
based on the result of
hazardous examination○ Result of hazard examination & - Carcinogenesis, mutation,risk assessment
biological concentration etc.
- Substances concerned to be- Notification of name, use,hazardous
suspended term of permission
banned/restricted by○ Result of hazard examination & - SubstancesInternational institutes andrisk assessment
international treaty- Substances identified as- Announcement of name,hazardous
expected date etc.
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2-5. KK-REACH content (Designation ofHazardous Chemicals Substances) removal from designation list when substitute substancesdeveloped; or new technology is commercialized; or there is
no identified hazard
 Management : 「Act of Chemical Substance Management)」(enforcement Jan. 01. 2015)- Permit for business, a standard on facility of handling, control
purposes of use etc.

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2-5. KK-REACH content (Information provision)
 Manufacturer to provide information on Registered substance &mixture to downstream user (Manufacturer/Importer ⇒ User)- Registration number, name, hazardous & risk information,safe use etc. (any changes to be informed within 1month ) Information provision within the supply chain:

Manufacturer/importer

purpose of use, information on exposure,use & sales volume, safe use etc.
(on request for notification and registration
obligation)use, properties, manufactured & imported
volume, safe use etc.

Downstream
users/sellers

 MoE to notify any changes on the information to the registrant
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2-5. KK-REACH content (Notification of ProductContaining Hazardous Substance ) Products : Any final products or parts which may expose chemical
substance to the consumers
 Subject to Notification : In case chemical substances exceed
one tons per year in total contained in products- Name, volume, hazardous information, purpose of use in the
product◇ Exemption from notification : hazard chemical substance is not released
during use, and performs specific function in a solid form.
◇ Confirmation on the exemption : release of hazardous chemical substanceis controlled and the use of chemical substance in the product is alreadyregistered.

 Provision of information : Manufacturer/Importer ⇒ Customer- name, use, condition- Provide safe use information of the product upon request ofcustomers
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2-5. KK-REACH content (HighHigh-Risk Concerned
Product ) Risk concerned product : Published by the MoE as it isconcerned to pose risks to public health or environment* Household products such as detergent, air freshener, adhesives,
synthetic detergents, bleaches etc.
* Biocides such as non-agricultural insecticide, disinfectants,
preservatives etc.

 Risk Assessment : Category specific evaluation of risk

concerned product Safety & Labeling criteria : chemicals banned, threshold level ofcontent, migration and evaporation etc.

 Circulation management : selling & importing of products which
fail to meet criteria are banned, or recalled back- If Safety & Labeling criteria are not published, they must geta prior approval authorized by the Minster of Environment
before being used or imported.
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2-5. KK-REACH content (Time of Enforcement &Interim Measures) Enforcement date : Jan.01.2015- Different active dates for provision of risk information

 Interim Measures- Person who have already received hazard examination under“Korea Toxic Chemicals Control Act”
⇒ classified as “completed” for Registration and Hazard
examination- Violation prior to legislation enforcement⇒ subject to administrative disposition, penalty/fine may becharged under “Korea Toxic Chemical Control Act”

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2-6. Legislation schedule of KK-REACH
Subordinate law
 Instigating Enactment Procedure (Jan.2014~)
 Enforcement of “K-REACH” (Jan.1.2015)
 Implementation measures- Develop technical guidance and standard (2013-2014)- Develop and distribute brochure for industry about K-REACH- Develop a tool for “K-REACH”, conduct national education- Give an advance notice regarding existing substances that are
subjected to registration

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3-1. Chemicals Control Act (Background)Frequent chemical
accidents

Facility Deterioration

After hydrofluoric acidaccident in Gumi ( 12.09.27)
series of chemical
accidents occurrence

Industrial complex
installation before 90 s
Facility deterioration
Concern for possibility oflarge scale chemical
accident in future
’

‘

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3-2. Chemicals Control Act (amendments)
 Amendment for chemical accident prevention, preparedness
and response

Classification

Facility
Management

BeforeAmendment- Toxic chemicals business
Register (local government)- Restricted substance, Banned
substance business approvalsystem(MoE)- Hazardous Chemicals(Toxic chemicals,
Restricted substance, Banned
substance, accident precaution
chemicals) Business approval (MoE)- No registration or approval for
accident precaution chemicals- Business approval after submissionof off-site consequence analysis, andconfirmation of facility safety
management inspection result- Business operator of precaution
chemicals submits risk managementplan- Regular and frequent inspection,
safety inspection management(MoE)- Regular and frequent inspection,
safety inspection management (local
government)

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3-2. Chemicals Control Act (amendments)
구분Classification

Before기존

Amendment변경- Toxic chemicals import notificationand management(local government)- Toxic chemicals import notificationand management (MoE)- Management of approved substance(MoE)- Submission of Toxic Chemicals
transport Plan and confirmation
notification (MoE)- Investigation of chemicals every 4
years (MoE)- Investigation of chemicals every 2
years (MoE)- Classification and Labeling for toxic
chemicals(MoE)- Classification and Labeling for toxic
chemicals(MoE)No relevant regulation- OEM Notification (MoE)- Contractor guidance and inspection(MoE)

ChemicalsManagement

OEM
Management

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3-2. Chemicals Control Act (amendments)
Classification
SafetyEducationandTraining

Penalty

Information
DisclosuresystemBeforeAmendment- Toxic substance manager education(MoE)- Toxic chemicals manager, user,transporter, contractor education(MoE)- Fine up to 300 million(local government)- Fine up to 5% of annual income (MoE)- If a business faces 3 times
suspension in 2 years period,
business license cancelled (MoE)- Announcement to regional community
on self prevention plan of accident
precaution chemicals (MoE)- Annual announcement to regional
community on risk management planof accident precaution chemicals
(MoE)

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3-2. Chemicals Control Act (amendments)
Classification
ChemicalAccidents
Preparedness

ResponsetoChemicalAccidents

BeforeAmendment- Notification if any risk concerned tohuman health or environment (MoE)- Immediate notification on every
chemical accidents (MoE)- Management and designation of
special regulation area forchemical accident prevention (MoE)- Research on effects after accidents(MoE)- Dispatch field control coordinator to
accident site (MoE)- Research on cause of accident, resident
health and effect on environment (MoE )- Command measures including recovery,
removal, etc. to person responsible forthe cause of the accident (MoE)

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Ⅴ

Domestic Industry Action Plan
1. K-REACH
2. Chemicals Control Act

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1-1. Industry Participation in Legislating
K-REACH Subordinate Law
 Background- Dissatisfaction of industries regarding K-REACH, promulgated on ‘13.5.22* Increase in burden on industries with all new chemicals becoming
subject to registration* Increase in interest of R&D substance exemption

 Participation in Working Group for legislation of subordinate law- MoE formed WG consisting of chemical industry organization, experts,
NGOs, relevant GOs- In process of draft subordinate law development through WG discussion- Discussion on draft legislation in WG with opinions of chemical industries
as the basis

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1-2. Progress of Discussion on main Issuesof K-REACH
Issue 1 : Registration Exemption of R&D substance< Content >Not defined as
exempted under the act,
concern on new productdevelopment
diminishing< Review direction inconsortium >Similar to current TCCA,
exemption scope to be
included in theenforcement decree<Note>
In case of foreign policies, exemption given under strict condition such as
restriction on manufactured/imported volume or notification/exemption
registration process, expert implementation etc.

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1-2. Progress of Discussion on main Issuesof K-REACH
Issue 2 : Low Volume New Chemicals Registration< Content >All new chemicals
subject to registration,
strict standard leading
to burden on
registration cost andtime consuming< Review direction inconsortium >Regulate as subject tosimplified registration,
minimize requested
information, shorten
registration notifying
period<Note>
In case of foreign policies, different level of registration(notification)
standard and information request according to possessing information

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1-2. Progress of Discussion on main Issuesof K-REACH
Issue 3 : CBI related concerns<Content>
Information provisionobligation including
use, exposure
information, use/sales
volume leading to CBIconcerns<Review direction inconsortium>
Submitted information to
be concealed on requestof information protection<Note>
In case of similar foreign policies, CBI is protected, safety information
including name/hazard/health effect is disclosed

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1-3. Support for KK-REACH implementation
Preparation
 Education, advertisement for industries’ better implementation on
K-REACH enacting from 2015
- MoE and KCMA conducting education on K-REACH implementation
measures for industries- Additional education appropriated for SME

 Development of detailed K-REACH guide line

- MoE and KCMA developing guid lines on areas needed in
implementing K-REACH including reporting, registration, risk
assessment etc.
- Improvement and modification in guidance through pilot project whenneeded Education and training for managers on new policy
implementation- Technical education on new policy including risk assessment,
ecotoxicology test, etc.
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1-4. KCMA Industry Support Plan IT based consortium Formation and Operation- Preparation of joint registration and advanced communication among
domestic and international companies- Provide support on toxicity, legal affairs and administration by forming
an expert group- Match making substance data holder and data user

 Toxicity data Trading System- Network building with domestic and international data possessor isunder plan to be operated in later 2014
- Through toxicity with domestic and purchase among domestic andoverseas chemical industries, we aim to reduce registration costby the means of price fairness

 K-REACH help desk setup (2014.7 www.kreach.or.kr)- KCAM help desk to be setup to provide K-REACH implementation support
for domestic and international companies- Policy Q&A and consulting in Korean and English
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2-1. Participation in legislating Subordinate
Law of CCA
 Background- Dissatisfaction of industries regarding revised Chemicals
Control Act promulgated on 2013.06.04* Excessive fines, indefinite notification period Participation in WG for legislation of subordinate law- MoE formed WG consisting of chemical industry
organization, experts, NGOs, and relevant GOs- In process of draft subordinate law development throughWG discussion- Discussion on draft legislation in WG with opinion ofchemical industries as the basis

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2-2. Progress of Discussion on main Issuesof CCA
Issue 1 : Excessive Fines<Industry Concern>- Fine up to 5% ofannual income uponoccurrence ofchemical accident- Fine imposed forsimple errors,
uncontrollable
condition, natural
disasters, slightviolation of regulation<Communication through WG>- Fine imposedconsidering condition,
not on occurrence
discretely- Encouraging andeducating for vulluntarycompliance* Preventive effort,
measurement order
implementation considered<Note>
intentional, duplicative, gross negligence, incompliance to measurement
order face fine equivalent to business suspension (business operator
selectable)

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2-2. Progress of Discussion on main Issuesof CCA
Issue 2 : Off-site Consenquence Analysis< Industry Concern >Excessive cost due topreparation of analysis< Communication through WG >- Evaluation of cost benefit ofanalysis preparation,differentiation in preparation
items according to business size

Issue 3 : Unclear regulation of “immediate”notification
on chemical accident occurrence< Communication through WG >- Immediate notification principle- Exemption from responsibility
granted if notification is delayed
due to emergency measures orin difficult situation< Industry Concern >Unintended violation
due to unclear definitionof “immediate”

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2-3. Support for CCA Implementation
Preparation
 Education, advertisement for industries better implementation on’

CCA enacting from2015- MoE and KCMA conducting education on CCA implementation
measures for industries- Additional education appropriated for SME- Technical education on new policy including Off-site
Consequence Analysis, Risk Management Plan, etc.

 Development of detailed CCA guide line
- MoE and KCMA developing guide line on areas needed in
implementing CCA including facility safety management, safety
management of hazardous substances etc.

 Education and training for managers on new policy
implementation- Safety Management check on chemicals used and facilities- Direction / Guidance for new policy compliance52/54

2-5. CCA Subordinate Law Legislation
Schedule
2013.6.4(Promulgation)~2013.11

2013. 122014. First quarterof the year

2014. Second
quarter of the year

2014. Third
quarter of theFormation of government-industry WG, discussion on
Criteria of fine imposement

Legislation detailed of subordinate law (draft) including
administrative measures and fine, etc.

Pre-announcement of Subordinate law(draft) legislation

Regulatory review, Ministry of Legislation review

State Council deliberation and promulgation

year

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