1/18

Korea Chemicals Management Association

Jae-sung, Kim

2/18

CONTENTS

Introduction of K-REACH

Related works for K-REACH implementation

Ⅰ

Ⅱ

3/18

Introduction of K-REACH Ⅰ

4/18

1. Reformed TCCA System

Chemical Registration

Chemical Evaluation

Designation of Toxic Substance

Management of Toxic Substance

Chemical Containing Product Management

Management Stage 2015.1.1 ~ ~ 2014.12.31

Act on Registration and Evaluation etc. of

Chemical Substance

(K-REACH)

Chemicals Control Act

(CCA)

Toxic Chemicals Control Act

(TCCA)

Chemicals Safety

Registration &

Evaluation

5/18

2. Comparison of TCCA & K-REACH

TCCA`

K-REACH

New Chemicals

Registration Toxicity

Examination Hazardous substances

Existing Chemicals (Substance subject

to registration) Registration

Hazard Examination

Risk Assessment

New Chemicals

Authorized substance

Hazardous substances

Restricted/

Prohibited substance

6/18

3. K-REACH Flowchart

Substance subject to

registration

(above 1ton)

New Chemicals

Existing chemicals

(above1ton)

Hazardous substance

Authorized substance

Restricted/Prohibited

substance

Chemical Substance

Reporting on manufacture

Registration Risk Assessment Hazard

Examination

Registration → Examination/Assessment → designation of hazardous chemicals

7/18

Designation of risk concerned product→ Assessment →

Management standard

Mixture Product (0.1% & above 1 ton)

Products

Notification

Designation of risk concerned product

Safety·Labelling standard

Sale prohibition /Recall measures

Non-compliance

Not announced prodcucts

Risk Assessment

Manufacture/Import approval

3. K-REACH Flowchart

8/18

4. Changes During K-REACH Introduction

Main Scheme MOE Proposal private member’s Proposal Final version

Reporting (manufacture etc.)

Both new and existing chemicals in 1 ton or more (yearly basis)

Reporting every 2 yr Manufacturer &

importer

All new and existing chemicals in 1 ton or more (yearly basis)

Every year

Manufacturer, importer, seller, user

All new and existing chemicals in 1 ton or more (yearly basis)

Every year Manufacturer, importer,

seller

Registration Both new and existing

chemicals in 1 ton or more (yearly basis)

All new and existing chemicals

All new and existing chemicals in 1 ton or more (yearly basis)

Submission of risk assessment

Both new and existing chemicals in 100 tons or more (yearly basis)

Both new and existing chemicals in 10 tons or more (yearly basis)

Both new and existing chemicals in 100 tons (yearly basis)

* gradually tighten up to 10 tons until Year 2020)

Information provision - Information provided by

downstream user and product sellers

Only upon requests from manufacturers/importers

High Risk Concerned products

-

Product reporting, hazard examination etc.

Article is exempted

Penalty - No set value

* Certain amount paid in a ratio of company’s sales

Default

9/18

5. Registration procedure

Distinction between completeness check (Registration) and

quality check (Examination)

< Examination period : 60 days >

<30 days>

< Low volume 3-7 days >

Manufacture

Import

Possible

Current system K-REACH system

Examination result

Registration

Examination

Registration completeness

check

Manufacture

Import

Possible

10/18

6. Registration data

Information on chemical identity, hazard and risk etc.

Information Registration criteria Remarks

1 Information of manufacturer or importer

-New chemical -Existing chemical (1 ton or more per year)

- Name, address, representative person

2 Chemical substance Identification information

-Identity information including name, molecular formula, chemical structure etc.

3 Use - Use classification system, known use, prohibited use

4 Classification and Labeling - GHS

5 Physico-chemical properties - Differentiation according to tonnage (46 max.) - Full data or examination plan 6 Hazard information

7 Guidance on safe use -protective equipment, emergency measures

8 Risk information 100 ton or more per year - Hazard assessment - Exposure scenario - Safety confirmation

9 Exposure, estimated volume

11/18

Pre announ-cement

Target substance

Substance subject to registration ≥ 1 ton/year

reporting

Regist-

ration

15.1.1 (enforcement)

17.1.1 16.1.1

Risk Ass. ≥ 70 ton/yr

≥ 100 ton/yr ≥ 50 ton/yr

≥ 20 ton/yr

≥ 10 ton/yr

19.1.1 18.1.1 20.1.1 14.1.1

Grace period [3yrs]

New chemicals

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

New chemicals < 1 ton/year < 100㎏/year

Grace period [3yrs] Grace period [3yrs]

7. K-REACH implementation schedule

21.1.1 24.1.1

12/18

Classification TCCA K-REACH REACH

Registration target New chemicals

Existing chemicals subject to

registration New chemicals

Existing chemicals New chemicals

Reporting of annual quantity

X O X

Registrant Manufacturer,

importer

Manufacturer, importer,

Only representative

Manufacturer, importer,

Only representative

Quantity requiring registration

0.1~1T >1T

1~10T 10~100T

100~1000T >1000T

1~10T 10~100T

100~1000T >1000T

Processing time 60 days 30 days 1~2 weeks

Standard for chemical evaluation

hazards risks risks

Listing on existing chemical inventory

After 3 years X X

Product control X O O

<Reference>

13/18

Related works for K-REACH implementation

Ⅱ

14/18

(Purpose) Consultation system for domestic and foreign industries to

support implementation of K-REACH

(Online) Korean/English Homepage (www.chemnavi.or.kr) (2014.8)

(Offline) Experts available for consultation with domestic and

overseas companies (2014.4)

1. Help desk operation by MOE

15/18

(Purpose) To identify potential operational problems of joint registration system and develop industry support measures for K-REACH settlement

(Period) 2014.8~2015.7 (1 year)

(Subject) 7 substances that are to be included in the 1st priority list of existing chemicals subject to registration1

(Content) From consortium formation to actual registration

Consortium

formation

Registration

Preparation

Registration

Application

Registration

Completion

• Substance

identification

• Representative

selection

• Dossier

preparation

• Cost sharing

• Registration

dossier

submission

• Submission of

required

additional data

2. Joint-Registration Pilot Project by MOE

Chemical Substance (CAS No.) Chemical Substance (CAS No.)

Diisocyanatomethylbenzene (26471-62-5) Hydrogen bromide (10035-10-6)

Benzoyl peroxide (94-36-0) 2,4-Diisocyanatotoluene (584-84-9)

4,4'-Methylenedianiline (101-77-9) (Butoxymethyl)oxirane (2426-08-6)

Trichloroethylene (79-01-6) -

16/18

(Purpose) To identify potential registrants beforehand, and provide support in preparing for joint registration (Similar to EU REACH의 SIEF)

(Period) 2014.8~2014.12 (4 months)

(User) Korean manufacturer/importer, Only Representative, owner

(Content) Room per substance, group e-mail/SMS, data exchange forum etc.

Room per substance

(registrants of same

substance to know each

other)

E-mail, SMS

(communication between

joint registrants)

Data exchange forum

(communication

between data owner and

purchaser)

Help Desk Homepage

3. Establishment of Joint-registration support system

17/18

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 of same 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)

4. Joint-registration Support by KCMA

KRC-IT

(KCMA)

Potential

Registrant

Identification on

potential registrants

Consortium

formation

Joint-registration

preparation

Consulting

agency

Expert group Technical

consul-

tation

- Communication

Platform

- LoA Shop

- Document

library

18/18