૶ Act on Registration and Evaluation, etc. of
Chemical substance(K-REACH)૷
: Current Status
2014.12

Korea Chemicals Management Association
Kim, JaesungϨOverview

ϩ

Main ContentsϪCurrent Status㻞1. Reformed TCCA System~ 2014.12.31

Management Stage

2015.1.1 ~Chemical Registration

Chemical Evaluation
Toxic Chemicals
Control Act(TCCA)

Designation of Hazardous
Substance

Act on Registration and
Evaluation etc. of Chemical
Substance(K-REACH)
Registration &Evaluation & Designation

Management of Hazardous
Substance
Hazardous Chemical Containing
Product Management

Chemicals Control Act(CCA)
Chemicals Safety2. K-REACH Flowchart _ Chemical SubstanceØ Registration → Examination/Assessment → designation of hazardous chemicals
Chemical Substance

Existing
chemicals(above1ton):
Manufacturer/Import
er/Seller

Reporting on
manufacture, etc

New Chemicals

Substance subject toregistration(above 1ton):
Manufacturer/Importer

Registration

Manufacture·import volume less than 1 ton per year, designation
if great damage on health·environment is suspected1) 100 ton or more
2) If risk assessment isrequired following
hazard examination

Completenesscheck

HazardExamination

Toxic
substance

Risk Assessment

Authorized
substance

Restricted/Prohibited
substance2. K-REACH Flowchart _ Products
Ø Products containing hazardous chemical substances → Notification
Ø Designation of risk concerned product → Risk assessment → Management standard

Products

Mixture Product(0.1% & above 1 ton)

Notification

Not announced products

Designation of risk
concerned productRisk Assessment

Announce safety·labellingstandards

Manufacture/Importapproval

Non-compliance

Sale prohibition/Recall measures3. K-REACH implementation schedule

reporting

Reporting : all new chemicals, 1 ton or more existing chemicals

Grace period [3yrs]

Grace period [3yrs]

Grace period [3yrs]

Substance subject to registration ≥ 1 ton/year
RegistPre announcement
Targetsubstance

rationRisk Ass.

14.1.1

New chemicals < 1 ton/year< 100໎/year

New chemicals≥ 100 ton/yr

15.1.1 16.1.1(enforcement)≥ 70
ton/yr

17.1.1≥ 50
ton/yr

18.1.1≥ 20
ton/yr

19.1.120.1.1≥ 10 ton/yr

21.1.124.1.11. ReportingØ Purpose : Identification of obliged registrants in advance, confirmation of any changes after registration etc.
- Encourage joint-submission* Similar to EU REACH “Pre-registration”
Ø Reporting : Anyone who manufactures, imports or sells new chemicals and 1 ton or more existing chemicals
annuallyØ Required information: Use and Tonnage of chemical substances- Any changes (i.e. use) need to be notified
Ø Obligator of Report- A person responsible for reporting the manufacture, importing and selling of chemicals etc,. of chemicals э
Except for users in business, sales to consumers
Ø Contents of Reporting- ①Report Company Name, ②Name of the chemical substance, Identity number, ③Quantity of manufacture,use/sales, ④Detailed use- In case of seller, Product name, Buyer, If report composition elements, ②, ③, ④ can be omitted< Substances exempted from reporting >- Chemicals in imported machineries- Chemicals in imported machinery devices for test-run- Chemicals contained in solid form product that is not released during use- Manufactured/imported substances for the purpose of research and studies- Substances for test, Non isolated intermediates- Low effectiveness of existing chemical substance in terms of risk , etc.
* Since reporting is to understand the status of registration performance, except existing chemical substance which have no possibility
to be applicable to registration(Notification)

2. Registration of Chemical substanceTarget : Manufacturer or importer of all new chemicals & existing chemicals (above1ton/yr).
- Although less than 1ton, registration obligation applies to substance that have high risk concern to humanhealth and the environment.

Existing chemical subject to registration- Every 3 years Designation and Announcement of Existing Chemicals Subject to Registration* Result of Report and Statistical survey, Consideration of domestic/overseas data regarding hazard &risk- Target : 518 chemical substances(Pre-announcement, 14.10.31)[Toxic chemicals(318), Observational chemicals(45), Restricted chemicals(4), PRTR(42), Substances requiring preparation for
accidents(12), CMR(33), Aquatic environment(45), Etc(19)]- Grace period : manufacture/import possible for 3 years from notification date
- Joint submission : same chemical substances are subject to joint submission- Data sharing : under consent from owner who have previously submitted data
- Test data selected/produced : one test data of each test items2. Registration of Chemical substance
Exemption of Chemical Registration
ཛ Chemicals in imported machineries
ཛྷ Chemicals in imported machinery devices for test-run
ཝ Chemicals contained in solid form product that is not released during use

Requires “Confirmation of Registration Exemption” from the KCMA
£ Manufactured/imported chemicals for the purpose of chemical reagent for scientific experiment, analysis or research (yearly)ཛྷ Manufactured/imported chemicals for the purpose of R&D (R&D unit)ཝ Low concern polymers (first time)ཞ Chemically surface-treated substances which both base substance and surface-treating substance do not fall into new chemicals
or substances subject to registration (first time)§ Chemicals manufactured or imported 10 tons or less per year for the purpose of export only (yearly)¨ Chemicals manufactured or imported 10 tons or less per year for the purpose of manufacturing other only export chemicals(yearly)© Non-isolated intermediate and isolated materials of certain condition (first time)2. Registration of Chemical substancev Registration procedure

Joint
submission

Individual
submission

Submit of leadregistrant

Individual
submission
confirmation

Request modify/supplement

Individual
submission

Completeness
review

Notice forthe results

modify/supplementv Notice for the results
Date
Low volume newchemicals

within 3 days[less then 1ton/y(15~19), less then 0.1ton/y(20~)]
within 7 days(If necessary additional review)
within 30 days(from the application of registration)

Generalregistration

within 3 months from an expiration date of grace period(in case of an application submitted by a person
who manufactures/imports a priority existing chemical substance during the period of 2 month prior to
an expiration date of grace period)2. Registration of Chemical substancev Procedure and Method of Joint Data Submission

Form ofConsultative
group

Election of
Lead
Registrant

Preparation ofRegistration

Leadregistrant
registration

Individual
registration

Ø Procedure : After completing registration of Lead Registrant, member registrants should apply for registrationby preparing their own required documents. Other information needs to be submitted by all registrants
individually.
Ø Election of Lead Registrant :“Agreement among parties” → “Election by the majority decision”
Ø Responsibility of Lead Registrant- Tasks for the selection/production of test data for submission- Tasks concerning the share of cost for registration data submission- Other tasks regarding joint preparation and data submission
Ø Share of cost : “Agreement among parties” → “equally shared based on the numbers of people need to submit

the data and manufacturing/import volume”

2. Registration of Chemical substancev Joint Submission Data
1. Classification and Labeling of chemical substance
2. Physico-chemical properties of chemical substance
3. Hazard information of chemical substance
4. Test plan
5. In case all members of joint submission agree• Risk of chemical substance• Data regarding the guidance of safe use

v Individual submission
1. In case that it is anticipated to cause significant commercial damages due to the disclosure ofconfidential business information
2. In case that it costs more if submitted jointly than individually
3. In case chemical classifications of substance are different for the same toxicity studies to besubmitted
4. In case that individuals disagree with the lead registrant on the selection of test data for the same test
item to be submitted jointly3. Data apply for Registrationv Specific Data apply for Registration
Information

Registration Criteria

Remarks

3

Information of manufacturer orimporter
Chemical substanceidentification information
Use

4

Classification and Labeling5

Physical-chemical properties

6

Hazard Information

7

Risk

- 1) Hazard assessment, 2) Exposure assessment(Exposure scenario / Exposure
prediction), 3) Safety confirmation

8

Safe use guidance- Protective equipment, Emergency measures

9

Exposure information,
Estimated Volume

1
2- Name, Address & Representative person- Identity information including name, molecular formula, chemical structureetc.
- Use classification system, known use, prohibited use- New chemicals- Existing chemicals subject toregistration(Above 1 ton/year)- International classification, Materialization of GHS items- Differentiation according to tonnage(47 Max.)- Submission of Full data or test summaryu Hazardous data(general registration)
Category1≤ - <10t

10≤ - <100t100≤ - <1,000t≥ 1,000t

0.1≤ - <1t(From 2020.1.1)

Physico-chemical properties

8

11

13(2)

13(2)

5

Toxicology properties

4

10(1)

11(2)

15(6)

2

Ecotoxicology properties

3

5

13(8)

19(14)

2

Total

15

26(1)

37(12)

47(22)

9* Number in the bracket shows the number of test that can be replaced with test plan

3. Data apply for Registrationv Exceptions for biocide
Manufacture• import volume

Toxicity data1≤ - <10t

Test data of 10-100 t for general registration

10≤ - <100t

Test data of 100-1000t for general registration≥ 100t

Test data over 1000t for general registration

0.1≤ - <1t(From 2020.1.1)

Test data of 1-10t for general registrationv Exceptions for polymer
Manufacture• import volume

Toxicity data1≤ - <10t

Physico-chemical properties of 0.1-1t test data for general registration

10≤ - <100t

Test data of 0.1-1 t for general registration100≤ - <1,000t

Test data of 1-10 t for general registration≥ 1,000t

Test data of 10-100 t for general registration

0.1≤ - <1t(From2020.1.1)

Physico-chemical properties of 0.1-1t test data for general registration3. Data apply for Registrationv Standard of Hazard data•

Level of data – any one of the following- The whole testing data describing test result without modification of process & procedure etc., which is performed to produce
Physico-chemical properties, hazard information of chemical substance- Testing summary which is descripting sufficient information like purpose, method, result and conclusion sufficient
information to perform of evaluation regarding testing result by minimizing the whole testing data•

Test data produced by designated domestic testing Institute or foreign testing Institute following GLP standard- 1 item for physico-chemical properties, 15 items for Toxicology properties, 14 items for Ecotoxicology properties- When submitting Foreign testing Institute Implementation testing date, GLP certificate or document required for the verificationof following GLP standard

v Submission of test plan
- (Applicant) Preparation &submission of test plan - name of test data, name of testing institute, test method, test schedule,
expected submission date of test data
- (National Institute of Environment Research) Review the completeness and notify the result - submission due date, test
condition/ method, supplement request- (Applicant) Test execution and submission of test data – Submission due date can be extended if test data cannot be submitted
by the due date due to the force majeure reason of domestic testing institute- If test data is not submitted by the due date, it will considered as not registered3. Data apply for Registrationv Submission of Risk data••

Phased reinforcement of submission standard
Category≥ 100t

≥ 70t

≥ 50t

≥ 20t

≥ 10t

Enforcement date2015.1.1

2017.1.1

2018.1.1

2019.1.1

2020.1.1

Items for data preparation

1. Chemical substance identification information & Physico
chemical properties
2. Confirmed use in manufacture & in the supply chain
3. Hazard assessment for human health
4. Physico-chemical risk assessment

5. Hazard assessment for the environment
6. Assessment of persistent and bioaccumulative
7. Exposure assessment
8. Confirmation of safetyv Data related to guidance for safety use
1. Handling measures(Storage method, handling precautionsetc.)
2. Fire fighting measures(fire extinguish method, fireextinguishing agent, fire extinguishing equipment)
3. Control measures for leakage(Control chemicals, equipment,
control method etc.)

4. Protective equipment, disposal method etc.
5. Regulation information according to relevant legislation
6. Other safety use guidance such as emergency measures3. Data apply for Registrationv Isolated Materials
1. Information of manufacturer• Importer – company name, address, president
2. Chemical identification information – chemical name, molecular formula/structure, identity no., product name, purity(%),
name/content of impurity/byproduct3. Main use – Classified use, explanation of specific use, inapplicable use
4. Classification & Labeling
5. Physico-chemical properties
6. Others- Submission of hazard data, exposure data, risk data, safety use data if possess themv Cases when data for registration can be omitted•

Corresponding test data among Physico-chemical properties, hazard data, data submission can be omitted for the cases below

1. Chemicals manufactured/imported below 10 tons per year and can be judged of hazard to human health & environment
through result from QSAR internationally recognized Quantitative structure activity relationship program
2. Chemicals can be judged of hazard to human health & environment through result from internationally qualified andrecognized in vitro test
3. Chemicals can be judged of hazard to human health & environment as similarly structured chemicals
4. Chemicals which is not possible to be tested technically4. Evaluation, Assessment Systemu Hazard Evaluation : Notification of Result of Registered hazardous chemicals- Review of test data submitted by manufacturer and Property data
- Additional data can be required for submission regarding consumer hazardous chemical substance and Biocideü Grounds fo r addit io nal dat e can be o rdered for submission- As a result of review o f pro priet y and reliabilit y, require revisio n, supplement- Co ncerns abo ut exposure t o human bo dy and enviro nment based o n use and expo sure infor mat io n
- Small quant it y o f exist ing chemica ls which wer e manu fact ured, impo rt ed accumu lat io n amo u nt isexceed 1 t o n- Po ssibil it y o f designat io n as hazardo us chemical subst ance
- Biocide, Product s co nt aining hazardo us chemical subst ance
- In case of need o f t est dat a specialt yu Hazard Assessment : Government self-assessment of International organization evaluation substance and entire
quantity export substance etc.
u Risk Evaluation : Implement of evaluation and Notification of result based on the result of hazard examination- Selection of evaluation substance, Preparation of hazard assessment report5. Designation of Hazardous substancesuDesignation : Evaluation· Assessment Result, Hazardous Substance, Authorized Substance, Restricted Substance,
Prohibited SubstanceCategory

Designation Criteria
̺ Hazard examination Result

Hazardous- Possible damage to human body·Ecotoxicology
substance

Remarks- Name, Classification, whether the chemical substance isa hazard substance- Carcinogenic· Mutation· Bio accumulative etc.

̺ Hazard examination + Risk evaluation result
Authorized- Risk-concerned substance- Name, Classification, Authorized use, Grace period etc.
- prior notice + Acceptance of an opinion procedure- Prepare risk evaluation plan, socio-economic analysis
plan- International organization, International agreement etc.

Restricted/

̺ Hazard examination + Risk evaluation result

Prohibited- Admitted risk substance- Name, Classification, prohibited use- Prior notice + Acceptance of an opinion procedure- Prepare risk evaluation plan, socio-economic analysis
plan(If necessary)u Management : According to૶Chemical Control Act('15.1.1 Enforcement)૷



6. Information provision

Ø Registered chemical substances, Contained mixtures Information offering : Substance·mixtures Transferor э Transferee- Registration Number, Name, Hazard·Risk Information, Safety use information etc.
(In case of occurrence of change item : within 1 month)- In case of repeated transfer: At the first time of transfer-ࠕOccupational Safety and Health Act.ࠖAcceptance of information for MSDSØ Bilateral Information Offering : Provide within 1 month from the date of opposite party’s request
purpose of use, information on exposure, use & sales volume, safe use etc.

Manufacturer/importer

Downstream
users/sellers
use, properties, manufactured & imported volume, safe use etc.

э Component, Content etc. Except for business confidential information, Quantity of manufacture·Import·sale can be omitted

Ø Notification by Minister of Environment : If modification to the information, notification to registered person.

7. Products Management
Ø Notification of Mixture Products- (Total quantity criteria) Product production and Importer base, total quantity exceeds 1ton per year bychemical substance- (Content criteria) Weight ratio of products containing chemical substance: Exceed 0.1% (Similar to EU REACH)- (For consumer) For consumer product subject to report, Except for industrial productØ Risk Concerned Products : Concerns about posing risk to people’s health or the environment, Announcement of
Ministry of Environment- Products such as cleaners, air fresheners, adhesives, polishes, odor removers, synthetic detergents, bleach, fabricsofteners, etc., used by the general consumer primarily for household use- Biocide such as insect repellents, disinfectants, preservatives, etc.

Ø Risk Evaluation : Evaluation risk-posing products for each type
- Enforcement of government self risk evaluation without submitting producer· importer’s hazard data
- If necessary, require data submission, Collect sample- In case of incident of domestic/overseas hazardous concern, Emergency enforcement, Determine whether hazardous
or not

7. Product Management
Ø Safety·Labelling Criteria : announcement on product specific Safety & Labelling criteria in accordance toassessment result- chemicals banned in Risk Concerned Products, threshold level of content, migration and evaporation etc. (including
container/packaging)Ø Prohibition of Sales, etc. : No selling or presenting as a import of products unsuitable according to the safety andlabeling standards- A person intending to produce or import risk-posing products that do not have safety or labeling standards shallsubmit data by preclearance of the Minister of Environment
Ø Withdraw Order, etc. If products doesn’t meet the standard, risk concerned product whose standard are not notified:- Possible damages to health or the environment → Collect, Withdraw, Prohibition of Sales, Scrapping, Order to take aimprovement·correct- Order to take emergency measures to prevent spread of damage

8. Activities of appointee
Activities of appointee by overseas manufacturer and producer
1. Reporting of the use, quantity, etc. of chemical substances under Article 8
2. Application for registration under Article 10(3)3. Notification under Article 32
4. Modification Report under Article 8(3)5. Application for Exemption of Chemical Registration under Article 11(2)6. Modification Registration, Modification Report of Chemicals under Article 12
7. Confirmation of Individual Submission under Article 15(1)8. Inquiry of Chemical Registration under Article 16(2)9. Confirmation of consent to use of Vertebrate Animal Testing Data under Article 17(2)10. Provision of Information on Chemical Substances under Article 29
11. Provision of Information under Article 30(2)12. Application for Exemption of Chemical Notification under Article 32(3)13. Provision of Information on product containing a hazardous substance under Article 35
14. Submission of data for approval of manufacture. Import of risk-posing products that do not have safety orlabeling standards under Article 36(2)15. Application for data protection under Article 459. Future Plan

Announce lower statute(‘14.11),
Following notification(’14.12~)

Online helpdesk, Guidance, Pilot forjoint registration

Development of K-REACH IT
system, Secure personnel, establish
test infrastructure

Evaluation committee, Workshop
for stakeholders, etc

Perform supporting project after
enforcement1. Pilot project§ Pilot project on 7 substances
No.

Substance name

CAS No.

No. of companies

No. of domestic
manufacturers

26471-62-5

7

2

1

Diisocyanatomethylbenzene(TDI)

2

Benzoyl peroxide

94-36-0

10-3

Hydrogen bromide

10035-10-6

10

-

4

p-xylene

106-42-3

118

5

1-Chloro- 2,3-epoxypropane(Epichlorohydrin)

106-89-8

7

2

6

Trichloroethylene

79-01-6

9-

7

Hydrogen chloride

7647-01-0

108

Ø (Content) From consortium formation to actual registration
Consortium
formation• Substanceidentification• Representative
selection

Registration
Preparation

Registration
Application

Registration
Completion• Dossier preparation• Cost sharing• Registration dossier
submission• Submission ofrequired additional
data



2. Development of GuidanceDevelopment of 4 dossiers for K-REACH Guidance

Confirmationof Substance nameandidentification

Dataexchangeand costsharing

Registration• Confirmation standard
system• Basic principle of dataexchange• Inquiry procedure• Data sharing standard• Protection of business
confidentiality, etc• Registrant obligation• Registration application
procedure• Preparing Registration
dossier , etc• Confirmation and naming• Substance identification
confirmation standard• Examples, etc

Notification• Notification obligation• Notification procedureand method• Examples, etc3. Help desk operation by MoE
Ø (Purpose) Consultation system for domestic and foreign industries to support implementationof K-REACH
Ø (Online) Homepage (www.chemnavi.or.kr) (2014.8)
Ø (Offline) Experts available for consultation with domestic companies (2014.4)

3. Establishment of Joint-registration support system

Ø (Purpose) To identify potential registrants beforehand, and provide support inpreparing for joint registration (Similar to EU REACH_SIEF)
Ø (Period) ~2015.3
Ø (User) Korean manufacturer/importer, Only RepresentativeØ (Content) Room per substance(registrants of same substance to know each other),group e-mail/SMS(communication between joint registrants)4. Joint-registration Support by KCMA
Ø Installation of Joint-registration Center (K-REACH Center; KRC), support in formation/operation of potential
registrants consortium- Potential registrants who wants jointly register needs to join KRC. Through KRC-IT, potential registrants ofsame substance are identified and consortium is formed.
- KRC will support joint registration through mutual cooperation and dividing function among consulting
agency and experts from relevant field (chemistry/toxicity/ legal/ tax)

Potential
Registrant

KRC-IT(KCMA)-Communication
Platform- LoA Shop
- Document
library

Identification on
potential registrants

Consulting
agencyConsortium
formation

Joint-registration
preparation

Technical
consultation

Expert groupKorea Chemicals Management Association