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K-REACH - Act on Registration and Evaluation of Chemical Substances, Sout

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Jun 18, 2019 Nadine He

Tags : South Korea Korea REACH

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CONTENTS Last Updated: 2019-06-30

What is K-REACH

Management Framework for What is K-REACH

Substances and Products

Who is affected The Act on Registration and Evaluation of Chemicals of Korea (a.k.a “K-REACH”) was passed on Apr 30th

History and revised several times. It is regarded as the first REACH-style chemical regulation adopted in an Asian
K-REACH manages new chemical substances, existing chemical substances and downstream products by
How to comply
prescribing the requirements for registration, hazard evaluation and risk assessment.
Existing Chemical Substances: Pre-
registrtaion and Registration
The revised K-REACH legislation is a significant deviation from the regulatory mechanisms outlined in th
New Chemical Substances: version. The amendments came into effect on Jan 1st, 2019, which sets out a plan of registering existing
Notification and Registration substances over 1 ton per year in the next 12 years. 
K-REACH: Data Submission
This webpage is designed to assist non-Korean companies, particularly SMEs, in identifying their obligat
K-REACH: Hazard Evaluation &
Risk Assessment the revised K-REACH so they can take the necessary steps to ensure compliance with this regulation.

K-REACH: Joint Submission

K-REACH: Information Management Framework for Substances and Products

Communication

K-REACH: Product Management The chart below is a conceptual representation of the K-REACH framework. Chemicals and products (mix

News articles) are regulated differently as illustrated. 

Expert Articles & Ebooks

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Fig. 1 - Framework of K-REACH (Act on Registration and Evaluation of Chemical Substance, South K

1. Pre-registration of existing chemical substances (≥1 ton per year) before 30 Jun 2019 is necessary to b
for the phase-in registration grace period.

2. 510 PECs that have been published on 1 Jul 2015 are subject to joint registration before 30 June 2018
not eligible for pre-registration/late pre-registration and are not subject to the phase-in registration gra
PECs (≥ 1 t/a) should be registered immediately before manufacture/import.

3. For new chemical substances<100kg/y, they only require notification rather than registration. 

4. K-REACH will allow the Ministry of the Environment (MoE) to perform hazard evaluation and risk asses
According to the results of hazard evaluation, MoE will designate toxic chemical substances. Based on th
evaluation and risk assessment, MoE will impose production and importing requirements necessitating s
undergo authorization, restriction or prohibition.

5. Notification of products containing priority management substances (including hydrates) is required b

manufacture or importation if the priority management substance contained in the product exceed 1 to
0.1% weight ratio threshold.

Who is affected

Korean manufacturers or importers have legal obligations to comply with K-REACH. Foreign manufactur
appoint an Only Representative (OR) to fulfill relevant obligations under K-REACH. 

Manufactures, importers and ORs will be responsible for

· Pre-registration

· Registration

· Information communication with downstream users and sellers

· Products Notification

· Other activities

Importers in South Korea may turn to their non-Korean suppliers and request information that they may
fulfill their regulatory obligations. As for information exchange, a two-way communication mechanism is
to involve
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History

Fig. 2 - History of K-REACH (Act on Registration and Evaluation of Chemical Substances, South Ko

South Korea has been working on its own “REACH-style” regulation for the registration and evaluation o
chemicals since 2011. The final version of K-REACH was passed by the National Assembly on 30 April 20
came into force on 1 Jan 2015.

Since its notification to the WTO on 9 March 2011 (G/TBT/N/KOR/305), the draft proposal has been revis
times focusing on the registration, evaluation, authorization and restriction of new chemicals and existin
chemicals that are manufactured in or imported to South Korea.

The latest amendments to K-REACH were promulgated by the president on 20 Mar 2018 as Law No. 155
is a significant deviation from the regulatory mechanisms outlined in the previous version. The revised K
(effective on 1 Jan) is almost identical to EU REACH . Amendments regarding reduction of vertebrate ani
testing during generation of registration data were incorporated into the revised version of K-REACH as
15584 on 17 Apr 2018. The new requirements came into force on 1 Jan 2019 as well as the other amend

How to comply
Existing Chemical Substances: Pre-registrtaion and Registration

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Fig. 3 - E-translation: Act on Registration and Evaluation of Chemical Substances, South Korea (Act No.
Oct 16th 2018)

All existing chemical substances manufactured or imported at ≥ 1 ton per year are subject to pre-registr
before 30 Jun 2019. The manufacture/import volume can be determined based on the records in year 20
2018. Late pre-registration is applicable to chemicals manufactured or imported over 1 tone/year for the
time after the deadline and before the corresponding phase-in registration deadline.

Pre-registration before 30 Jun 2019 is necessary to be eligible for the phase-in registration grace period
registration of existing chemicals should be complied with based on tonnage band by 2030. However, d
CMR substances with a volume over 1 ton per year should be registered as a priority by 2021. The phase
deadlines will be set based on tonnage band, as below

· >1000 t/y; or designated CMRs (364 substances) above 1 t/y: by 2021

· 100-1000 t/y: by 2024

· 10-100 t/y: by 2027

· 1-10 t/y: by 2030

However, for the 510 PECs that were published on 1 Jul 2015, they were subject to joint registration befo
2018. They are not eligible for pre-registration/late pre-registration and are not subject to the phase-in
grace period. PECs (≥ 1 t/a) should be registered immediately before manufacture/import.

New Chemical Substances: Notification and Registration

The Korea Existing Chemicals Inventory (KECI) contains more than 44,000 chemicals that were domestica
circulated in South Korea prior to Feb 2, 1991 or those published by MoE after hazard evaluation under
Feb 2, 1991. Those not listed in the KECI are regarded as new chemical substances subject to new chemi
registration.

All new chemical substances regardless of tonnge are required to be registered. However, for new chem
substances<100kg/y, they only require notification rather than registration.  In addition, registration und
OSHA shoulod also be complied with as before for new substances ≥0.1t/y. 

K-REACH: Data Submission

K-REACH adopts levels of tonnage band with higher tonnage bands requiring more data submission. Th
information below is required for data submission,

1. Company information (Name, address and representative of the manufacturer or the importer etc.)

2. Chemical identification information (chemical name, molecular formula and chemical structure etc.)

3. Use information

4. Classification and labeling


5. Physicochemical properties

6. Toxicological information

7. Risk assessment
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8. Guidance on safe use (including personal protective devices and measures for explosion, fire or leak)

9. Other information

*For new chemical<100kg/y, only very simple information is required to submit, including manufacturer/
information, chemical name and identity, uses, classification and labelling, etc. Before 2020, for new chem
1t/y, only one test data (acute oral toxicity) should be submitted. 

Table1. Number of Testing Items under K-REACH

0.1-1 t/y
(for new
Data requirement 1-10 t/y 10-100 t/y 100-1,000 t/y >1,0
chemical only
from 2020)

Physical and  
5 8 11 13 13
Chemical Properties

Human Health
2 4 10 11 15
Hazards

Environmental
2 3 5 13 19
Hazards

Total 9 15 26 37 47

Testing Data requirements

Table 2. Physiochemical Testing Items under K-REACH

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0.1-1 t/y
Required (for new
1-10 t/y 10-100 t/y 100-1,000 t/y >
Tests chemical only
from 2020)

Physical state √ √ √ √ √

Water solubility √ √ √ √ √

Melting/freezin
√ √ √ √ √
g point

Boiling point √ √ √ √ √

Vapor pressure √ √ √ √ √

Partition
coefficient n- √ √ √ √
octanol/water

Physicochemic
Relative
al   Properties √ √ √ √
density
Testing

Granulometry √ √ √ √

Flammability √ √ √

Explosive
√ √ √
property

Oxidizing
√ √ √
property

Viscosity O O

Dissociation
O O
costant

Table3. Toxicological Testing Items under K-REACH

0.1-1 t/y
Testing
Required (for new
Method OECD 1-10 t/y 10-100 t/y 10
Tests chemical only
TG
from 2020)

Acute oral
420/423/425 √ √ √ √
toxicity

Acute dermal

toxicity (or 402, 403 √ (O) √(

inhalation)

Skin
corrosion/irrita 404 √ √ √
tion

Eye
corrosion/irrita 405 √ √
tion
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Skin  
406/429 √ √ √
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406/429 √ √ √
sensitization

Ames test 471 √ √ √ √

In vitro  
chromosome 473/487 √ √
aberration

In vitro gene
mammalian or
in vivo 476, 474/475 √ √
chromosome
Toxicology   aberration
Properties
Testing Additional  
mutation
test(germ cell O
mutagenicity
etc.)

Repeated
toxicity (28 407/410/412 √ √
days)

Repeated
408/409, 411,
toxicity (90
413
days)

Carcinogenicity 451/453

Screening for
reproductive/d
421/422 O O
evelopment
toxicity

Pre-natal
developmental 414
toxicity study

Two-
generation
416
reproductive
toxicity

Table4. Eco-toxicological Testing Items under K-REACH

0.1-1 t/y
Testing
Required (for new
Method OECD 1-10 t/y 10-100 t/y 10
Tests chemical only
TG
from 2020)

Short-term fish
203 √ √ √ √
toxicity

Short-term
daphnid toxicit 202 √ √ √
y

Algae growth
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√
inhibition

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Long-term fish
210/212/215 O
toxicity

Long-term
daphnid 211 O
toxicity

Short-term
toxicity to 299/227 O
plants

Long-term
toxicity testing
on plants

Short-term  
toxicity to
207 O
invertebrates
(earthworm)

Long-term
toxicity testing
on 222
invertebrates
(earthworm)

Long-term
Ecotoxicology  
toxicity to
Properties 218/219
sediment
Testing
organisms

Activated
sludge
209 O
respiration
inhibition test

Ready
biodegradabilit 301/310 √ √ √ √
y

Hydrolysis as a
111 √ √
function of pH

Inherent
biodegradabilit 302 O
y

Identification
of degradation O
products

Bioconcentrati
305
on

Adsorption/des
orption 106/121 O
screening test

Additional
adsorption/des
orption
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Fate and
behavior in the
environment

Note: “O”means that the testing plan can be submitted instead of the complete testing report

Vertebrate animal testing

Amendments regarding reduction of vertebrate animal testing during generation of registration data ha
passed and incorporated into the revised version of K-REACH as Law No. 15584 on 17 Apr 2018. The new
requirements came into force on 1 Jan 2019. The authority will develop and adopt alternative tests to m
use of vertebrate animals (newly added Article 4 Paragraph 5 of K-REACH). In addition, industry also nee
prioritize alternative animal testing during data generation (newly added Article 5 Paragraph 5). The vert
animal testing minimizing principle is adopted as a new Article 16-2 during chemical registration, hazard
evaluation and risk assessment. As stipulated in Revised Article 17, any person who intends to apply for
registration shall confirm in advance if there is existing vertebrate animal test data. For more deatils, plea
see ChemLinked news. 

K-REACH: Hazard Evaluation & Risk Assessment

Fig. 4 - Hazard Evaluation & Risk Assessment of K-REACH (Act on Registration and Evaluation of Ch
Substances, South Korea)

The MoE will conduct hazard evaluation on the registered substances. MoE may require additional data
registrant if deemed necessary for hazard evaluation. The toxic chemical substances will be designated b
the hazard evaluation outcome, which is consistent with the criteria under the previous TCCA. The inform
such as the chemical name, hazard properties will be disclosed to the public for reference after hazard e
Generic names can be used for publication if data protection applies. However, once it is designated as t
chemical, the generic name cannot be adopted.

Risk assessment is required for substances manufactured or imported for 10 tons or more per year, or w
result of hazard evaluation implies the necessity of further risk assessment. Based on the hazard evaluati
assessment, MoE will designate the substances subject to authorization, restriction or prohibition. Gener

SVHC such as CMRs and PBTs will be designated for authorization with specific sunset date. Only those a
before the deadline can continue to be circulated on the market after the sunset date. However, the stat
chemicals for authorization is subject to change due to the possible development of new technology or
substituted chemicals, etc.
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The chemicals manufactured or imported at 100 ton per year will require risk assessment requirement fr
2015. For those between 10 ton and 100 ton per year, there are 4 corresponding extended deadlines,

· 100 ton/year: Jan 1, 2015

· 70 ton/year: Jan 1, 2017

· 50 ton/year: Jan 1, 2018

· 20 ton/year: Jan 1, 2019

· 10 ton/year: Jan 1, 2020

K-REACH: Joint Submission

Joint submission of registration dossiers on the same chemicals is an obligation under K-REACH with the
reducing the burden on the industry and avoiding duplicate generation of test data. The individual subm
could be applicable in special cases if approved by MoE in advance.

A pre-set institution like the Substance Information Exchange Forum (SIEF) is established for chemical in
exchange. The SIEF is a borrowed concept from EU REACH, like EU REACH the co-registrants will be requ
purchase distinct endpoint data from the lead registrant (LR) and use them in their own separate dossier

Opt-out is possible when:

1. Exposure of Confidential Business Information (CBI) causes commercial damage

2. Joint submission requires higher cost than individual submission

3. Other causes listed in Presidential Decree

4.“Confirmation of Individual Submission” from MoE in advance

Data sharing:

1.    Permission to use for the registration from data owner is required

2.    The period of data compensation under K-REACH is 15 years, after which the data is available to be

3.    Enquiry of existing available data can be made to MoE

K-REACH: Information Communication

Fig. 5 - Information Communication of K-REACH (Act on Registration and Evaluation of Chemical Sub
South Korea)
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K-REACH adopts a two-way communication mechanism under which the suppliers should provide chem
information to recipients, and vice versa. The manufacturer and importer of registered substances or mix
containing registered substances should provide registration No., chemical name, hazard & risk informa
use information to the downstream user and seller. Downstream users and sellers should also provide its
manufacturer or importer the use, exposure, volume of use or sale, safe use information etc. upon reque
changes occur, the updates should be informed to upperstream and downstream parties within one mo

K-REACH: Product Management

Under K-REACH, the definition of a "product" covers both mixtures and articles for consumer use. Nnoti
products containing priority management substances (including hydrates) is required before manufactu
importation if

· The content of a priority management substance exceeds 0.1 % w/w; and

· The total import weight of the priority management substance in products is over one tonne per year.

In total 672 substances have been designated for priority management in Dec 2018, of which 204 substa
be effective from Jul 1st, 2019 and the other 468 substances effective from Jul 1st, 2021. Manufacturers
importers have legal obligations to notify the authority the name, use, content, hazards, simple exposure
information, etc. of the priority management substance. However, the notification is not required if the s
has been registered under K-REACH.

News

· Please click here to see a list of news about K-REACH.

Expert Articles & Ebooks

1. Nadine He, 24 Apr 2019, "K-REACH Only Representative Transfer Issues: Can I Change My OR?"

2. Nadine He, 21 Oct 2018, "K-REACH Pre-registration: Concise Overview of Critical Checkpoints"

3. Nadine He, 9 Jan 2018, "K-REACH Enforcement Decree Amendments"

4. Nadine He, 1 Dec 2015, " K-REACH Notification of Products Containing Hazardous Chemical Substanc

5. Nadine He, 20 Mar 2015, "Registration Exemption under K-REACH"

6. William Chou, 30 Dec 2014, "How K-REACH Will Affect the Flavors and Fragrances Industry"

7. Nadine He, 10 Apr 2014, "Polymer Registration under K-REACH: Scope, Data Requirements & Exempt
Chemlinked

8. Nadine He, 19 Nov 2013, "K-REACH: A Comparative Analysis With EU-REACH and China REACH", Chem

9. Sanghee Park, 3 May 2013, "K-REACH Adopted in the National Assembly and Starts from 1 Jan 2015",

Chemtopia

10. Eun-suk Park, 24 Sep 2013, "Chemical Registration Challenges in South Korea", Nam&Nam

11. "South Korea's National Assembly Aadopts K-REACH". LawBC. 17 May 2013.
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12. "Korean Legislature Adopts K-REACH". 3E Company. 6 June 2013.

Tags : South Korea Korea REACH

Nadine He
ChemLinked Editor

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