The Korean REACH
Overview & Regulatory Implementation

Yukyung KIM
Ministry of Environment, KOREA
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The Korean REACH

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The Korean REACH

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The Korean REACH
Toxic
Chemicals Act(enacted in 1992)∙Leak of hydrofluoric acid in Gumi,∙ Lack of chemical info.
∙ No system for transferring
chemical info.
∙ Household chemicals inconsumer product (e.g. humidifier(K-REACH)
disinfectant)Continuous occurrences of chemical accident

Registration &Chemicals

Evaluation ofControl Act

Chemical Substances

Promulgation of K-REACH
enactment on May 22, 2013

Promulgation of revised CCA on Jun.
4, 2013

Enforced on Jan. 1, 2015
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The Korean REACH<Toxic Chemicals Control Act >Manufacturer ∙ Importer(around100 companies)

Toxic SubstanceNon-phase-in substance(more than 0.1 ton)

> 0.1 ton

HazardReview

Application

Substances according to internationalorganization and conventions
Data for Registration Application
Additional Data
- Substance properties & hazards data
(at least 7, maximum 16)
Confirmation ofManufacturer ∙ Importer
Exemption(around 2000 companies)

Restricted ∙Prohibited Substance<K-REACH>
Manufacturer ∙ Importer(around 3000 companies)

Manufacturer ∙ Importer ∙ Seller

Designation of Substances
subject to Registration

Phase-in Substance(more than 1 ton)reportNon-phase-in Substance(all)

Hazardous
Substance

registration

Data for Registration
Data on Status
Application
Quo- Substance properties & Hazards data
(at least 14, maximum 46)- Risk data based on exposure scenario

Yukyung KIM

HazardReview

Risk
Assessment

Additional Data

Additional Data

Substance subject
to Permission

Restricted ∙ProhibitedSubstance

5The Korean REACH<K-REACH>

Chemical Substance
Manufacturer ∙Importer ∙ Seller

Manufacturer ∙ Importer

Data onStatusquoSubstancesubject toPermission

Registration

HazardReviewRisk
Assessment

Data for
Registration
Application

Addition
al Data

Addition
al Data

ReportNon-phase-in
Substance
(all)

Toxic
Substance

Designation of
Substance
Subject toRegistration

Phase-in
Substance(over 1 ton peryear)

Restricted∙
Prohibited
Substance

Mixture Product(over 1ton ofcontained
hazardoussubstance)

Product of Risk
Concerns(Household
ChemicalProducts)

NotificationProhibition ofHandling[Principle)

Off-siteBusiness
Impact+ Permissi
Assessment
on

SafetyLabeling
Standard

Written Offsite Impact
Assessment
Written Risk
Control Plan

Prohibition of sales /withdrawal

Yukyung KIM• standards for installation,
placement, management•Regular inspection by handlingfacility•Safety diagnosis, self-diagnosis•notification of subcontract•hazardous substance manager•safety training and education
programOn-siteResponse

ImpactInvestig
ation
Order

Nonconformity
Order

Business

Obligation of Business
Operator

ChemicalAccident

Status data on
containedhazardous
substance

Risk
Assessment by Gov.

Installer ∙ Operator ofHandling Facilities

Permission onmanufacture∙Import∙Use[Principle)

Substancerequiring
preparation foraccidents(Over certainquantities)

Chemical Product<CCA>

Manufacturer ∙Importer ∙ Seller& Person who
keeping, storing andtransferring

Immediate
reportMinimizing
damages/Restoration

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The Korean REACH



Chapter 1 : General provision (Article 1~ 7)

Chapter 2 : Registration of Chemicals (Article 8 ~ 17)

Chapter 3 : Hazard evaluation & Risk assessment (Article 18 ~ 24)Chapter 4 : Designation of authorization chemicals and etc. (Article 25~28)

Chapter 5 : Communicaion on chemicals information (Article 29 ~ 31)

Chapter 6 : Management of risk concerned product (Article 32 ~ 37)Chapter 7 : Supplementary provisions (Article 38 ~ 48)

Chapter 8 : Penalties (Article 49 ~ 54)Addendum (Article 1 ~ Article 7)

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The Korean REACH

 Radioactive substances Medicinal products and quasi-drugs
 Narcotics

 Cosmetics
 Agrochemicals and active ingredient Fertilizer Food and food additives, packaging

 Feed Explosives such as gunpowder Military supplies
 Health functional food Medical appliance

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The Korean REACHPhase-in Chemicals-

Chemicals domestically distributed for commercial purpose prior to February 2, 1991 and publicly announced assuch by the MoE (37,021 substances)-

Chemical substances that has undergone the Hazard examination process after February 2, 1991 under TCCA
and publicly announced as such by the MoE (6,163 substances)-

Most of the chemical substances that has undergone the Hazard examination process between Jan 1, 2012 andDec 31, 2014, but not yet announced as such by MoE(1,277 substances) → to be confirmed and announced
after consultation with the companies

Non-phase-in Chemicals-All chemical substances excluding phase-in chemicals

Phase-in Chemicals subject to Registration-Chemicals designated out of phase-in chemicals based on exposure potential such as circulation volume,
hazards of chemicals, etc., published by MoE

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The Korean REACH

Hazard-properties of chemical substances, including toxicity, which are detrimental to human health or theenvironment→ (1) Hazard Examination: initiated by the registration of companies(2) Hazard Evaluation: initiated by the government (without the registration)

Risk-degree of damage to human health or the environment when exposed to hazardous chemical substances→ Risk Assessment:
10ton/year by 2020)

Ifproduction/import volume ≥ 100ton/year (to be strengthened asor needed by the result of the hazard examination/evaluation

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The Korean REACHIntermediates-Chemical substances that are produced in the process of making some other chemical substances and entirely
consumed within that process.

→ (1) Non-isolated Intermediates: Not intentionally removed or isolated from the production facility☞ exempted from registration(2) Isolated Intermediates: Other than isolated intermediates☞ exempted from registration if leak or exposure is technically blocked

Polymers- Molecules characterized by the sequence of one or more types of monomer units→ Polymers of low risk concern are exempted from registration

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The Korean REACH

Phase-in Chemicals(≥ 1 ton/year)
Designation as phase-inchemicals
subject to Registration

ReportingRegistration

Designation as
Toxic Chemicals

HazardExamination

Non-phase-in
Chemicals (all)Designation as
Authorization
Chemicals
RiskAssessment

If ≥ 100 ton/yearor depending on hazard
examination results

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Designation as
Restricted/Prohibited
Chemicals
Consideringinternational treaty

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The Korean REACH: Non-phase-in substance
Exempted from reporting① Chemicals in imported machineries② Chemicals in imported machinery devices fortest-run③ Chemicals contained in solid form productthat is not released during use④ Manufactured/imported substances for thepurpose of research and studies⑤ Others chemicals listed in Presidential Decree
etc.

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Purpose : To get the health and safety information of chemicals: “ALL” non-phase-in substance◈ Separation of registration and examination procedures (same as EU)

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The Korean REACH

Designated every 3 years :3 years of grace period

1st (2015)

2nd(2018)

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3rd (2021)

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The Korean REACH

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