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Korea REACH

AREC ("Act on the Registration and Evaluation of Chemical Substances") has been in force since January 1, 2015, and the revised version since January 1, 2019. This is also referred to as K-REACH.

New chemicals with a volume of ≥0.1ton/year and existing chemicals ≥1 ton/year must be registered under K-REACH in order to authorize manufacture, import, use and sale. Domestic manufacturers or importers are obliged to register and foreign manufacturer could appoint an Only Representative (OR) to fulfill their legal obligation.

 

Data requirements

Physico-chemical Properties

 

Test Method OECD TG

0.1-1 t/a

1-10 t/a

10-100 t/a

100-1,000 t/a

>1,000 t/a

Physical state

 

X

X

X

X

X

Water solubility

105

X

X

X

X

X

Melting/freezing   point

102

X

X

X

X

X

Boiling point

103

X

X

X

X

X

Vapor pressure

104

X

X

X

X

X

Partition coefficient n-octanol/water

117, 107, 123

 

x

x

x

x

Relative density

109

 

X

X

X

X

Granulometry

110

 

X

X

X

X

Flammability

 

   

X

X

X

Explosive property

 

   

X

X

X

Oxidizing property

 

   

X

X

X

Viscosity

114

     

O

O

Dissociation costant

112

     

O

O

 

Toxicology

 

Test Method OECD TG

0.1-1 t/a

1-10 t/a

10-100 t/a

100-1,000 t/a

>1,000 t/a

Acute oral toxicity*)

423

x

x

x

x

x

Acute dermal toxicity (or inhalation) *)

402, 403

   

x (O)

x (O)

x (O)

Skin corrosion/irritation*)

404
IVT

 

x

x

x

x

Eye corrosion/irritation*)

405
IVT

   

x

x

x

Skin sensitization*)

406/429
IVT

 

x

x

x

x

Ames test

471

x

x

x

x

x

In vitro chromosome aberration

473/487

   

x

x

x

In vitro gene mammalian or
in vivo chromosome aberration*)

476, 474/475

   

x

x

x

Additional mutation test (germ cell mutagenicity etc.) *)

       

O

O

Repeated toxicity (28 days) *)

407/410/412

   

x

x

x

Repeated toxicity (90 days) *)

408/409, 411, 413

       

O

Carcinogenicity*)

451/453

       

O

Screening for reproductive/development toxicity*)

421/422

   

O

O

O

Pre‐natal developmental toxicity study*)

414

       

O

Two‐generation reproductive toxicity*)

416

       

O

 

Ecotoxicology

 

Test Method OECD TG

0.1-1 t/a

1-10 t/a

10-100 t/a

100-1,000 t/a

>1,000 t/a

Short-term fish toxicity

203

x

x

x

x

x

Short-term daphnid toxicity

202

 

x

x

x

x

Algae growth inhibition

201

   

x

x

x

Long-term fish toxicity

210/212/215

     

O

O

Long-term daphnid toxicity

211

     

O

O

Short-term toxicity to plants*)

227

     

O

O

Long-term toxicity testing on plants*)

         

O

Short-term   toxicity to invertebrates (earthworm)

207

     

O

O

Long-term toxicity testing on invertebrates (earthworm)

222

       

O

Long-term toxicity to sediment organisms

218/219

       

O

Activated sludge respiration inhibition test

209

     

O

O

Ready biodegradability

301/310

x

x

x

x

x

Hydrolysis as a function of pH

111

   

x

x

x

Inherent biodegradability

302

     

O

O

Identification of degradation products

       

O

O

Bioconcentration*)

305

       

O

Adsorption/desorption screening test

106/121

     

O

O

Additional adsorption/desorption screening

         

O

Fate and behavior in the environment

         

O

x: GLP study required

X: non-GLP study sufficient

O: can be replaced by test plan

*): subcontracted study

IVT: in vitro alternative available

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