The Korean REACHA1) State of substance2) Solubility in water
3) Melting/freezing point
Physicochemical 4) Boiling pointProperties
5) Vapor pressure6) Octanol-water partition coefficient7) Density8) Grain-size analysis
1) Acute oral toxicity
but, acute inhalation toxicity when main
exposure path is deemed to inhalation givenHazards tothe substance’s physicochemical properties
Humanand use2) Reverse mutation
3) Skin irritation/corrosion
4) Skin hypersensitivity

Hazards toEnvironment

1)Fish acute toxicity
2) Easily-biodegradable
3) Acute Toxicity to daphnia magnaB1) CombustibleCD

1)Viscosity

2) Explosive2) Dissociation constant3) Corrosive

1) Acute dermal toxicity or acute inhalation toxicity
2) Eye irritation/corrosion3) In vitro Mammalian Chromosomal Aberration Test
4) genetic toxicity test w/ test animals
5) Repeated Dose Toxicity (28days)
6) Reproductive& Developmental Toxicity screening

1)1) Additional genotoxicity
2)(genotoxicity to reproductive cells, etc.) 3)
4)

1)
2)

1) Inherent Biodegradability2)Confirmation of degradation product3) Chronic fish toxicity4) Chronic toxicity to daphnia magna
5) Acute toxicity to land plant6)Acute toxicity to invertebrates7)Respiratory inhibition caused byactivated sludge8) Adsorption & desorption

Growth inhibition of Freshwater algae
Hydrolysis according to pH values

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Repeated-dose toxicity (90days)
Teratogenecity
Second-generation reproductive toxicity
Carcinogenicity

1)Additional information on environmental
fate & dynamics
2) Chronic toxicity to land plant
3)Chronic toxicity to invertebrates living onland
4) Additional information on adsorption& desorption5) Chronic toxicity to benthos6) Bioaccumulation

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The Korean REACH
Exceptions for Polymer

Exceptions for BiocidePolymer

BiocideTest items

1≤ T <10 ton

Tests for 10≤ T <100 ton substance1≤ T <10 ton
10≤ T <100 ton

Tests for 100≤ T <1000 ton substance100≤ T

Tests for ≥ 1000 ton substance10≤ T <100 ton

0.1≤ T <1 ton(Required from Jan. 1,2020)

Tests for 1≤ T <10 ton substance

Test items
1) Appearance2) Water solubility3) Meting point/Freezing point
4) Boiling point
5) Vapor pressure1) Acute oral toxicity
2) Ames3) Acute fish toxicity
4) Ready biodegradation100≤ T <1000 ton
Tests for 1≤ T <10 ton substance1000≤ T ton
Tests for 10≤ T <100 ton substance※ Polymer data should be submitted additionally1) Mn & molecular weight distribution2) Monomers information (chemical name, CAS No., %)3) Residue of monomers (%)4) Percentage of Mn < 1,000
5) Acid/base stability

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The Korean REACH∙ QSAR , read-across (structural similarity)∙ If test infra is not built, test must take long time

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19The Korean REACH“ALL” Non-phase-in chemicals should be registered, even in very small quantities
 Simplified registration for less than 1ton/yr (0.1 ton, '20)

 Additional data can be ordered at a time of hazard examination and risk assessment

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The Korean REACH
Exemption

1

2

3

Can be exempted, but to be confirmed

Most of the exempted substances are:1.

Chemicals for scientific testing2.

Chemicals for R&D

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The Korean REACH
 Hazard Examination
 Hazard Evaluation
 Risk Assessment
Designation
Classification

Criteria for Designation

NoteToxicSubstances
Authorization/
Restricted/
Prohibited
Substances
Management : pursuant to the Chemicals Control Act (enforced in Jan 1, 2015)

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The Korean REACH

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The Korean REACH

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The Korean REACH

Protection of Confidential Business Information :- Pursuant to 『Unfair Competition Prevention and Trade Secret Protection Act』
- Component, content, etc.
- Submitter must claim the information as confidential business information

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The Korean REACH

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The Korean REACH

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The Korean REACH

Potential Products of Risk Concern → (Risk Assessment) → Products of Risk Concern, Safety/Labeling Standards

Risk Assessment

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The Korean REACH

Risk Assessment → Safety/Labeling Standards for each product category- (Safety Standards) Prohibited substances, Content-restricted substances, Obligatory Labeling substances※ Substances of high risk, such as humidifier sterilizer substances(PHMG, PGH), or carcinogens are prohibited substances- (Labeling Standards) Content and toxicity information is specified on the surface of the packaging for Hazardous

Chemical Substances under AREC, or internationally accepted CMRs, etcProhibition of sales/import for the products failing the standards- Health and environmental risk → Retrieval, Ban on sales, Disposal of products- Emergency measures to prevent expanded damages

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The Korean REACH

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The Korean REACH
Revision of Enforcement Rules
개요
Purpose : To address challenges businesses face when implementing the law
Details of Revision
 Eased burden of confirmation on registration exemption for chemical reagents (annual → `first time only) Only Representative (OR)Simplification of procedure, when OR is changed(submit written dismissal & appointment
respectively → submit integrated one) Enhancement of notification form (e.g. name of chemical substance can be replaced with name ofproduct) Deletion of Duplicated Items in the Form imported quantity in the forms of report, registration, etc.
 exposure data in application form for small-volume registration
 Improvement of the way how a representative is appointed for joint registration (majority → autonomous
appointment), etc.

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