1. Introduction
In 2015, South Korea introduced legislation designed to protect human health and the environment
from the impact of chemicals.
The two pieces of legislation introduced were the:
▶ Act on the Registration and Evaluation of Chemicals (K-REACH), which mandates the registration of all
new and existing chemicals marketed or imported into South Korea at ≥1 metric ton per year, requiring
detailed information on their likely hazard to human health and the environment1
▶ Chemicals Control Act (CCA), which focuses on chemical reporting and chemical accident prevention.2
K-REACH and the CCA replaced the existing Toxic Chemical Control Act (TCCA) to provide enhanced
protection against chemical hazards. The drive for enhanced legislation was triggered in response
to an outbreak of toxic lung injury related to inhalation of a disinfectant used to clean humidifiers.
The disinfectant was marketed between 1995 and 2011, and over 150 people are estimated to have been
either definitely or possibly injured as a result of its inhalation.3
The humidifier disinfectant-associated
lung injury resulted in 62 deaths, 3 including young mothers and infants, as well as long-term morbidity
in survivors.4
With an estimated 44,000 chemicals in use in South Korea and about 300 new chemicals marketed
annually,5
registrants and regulators will be kept busy assessing the risk posed to humans, animals
and the environment.
This white paper summarizes the key aspects of K-REACH and provides some ‘top tips’ about registering
a substance to K-REACH.
K-REACH Legislative Development and Goals
K-REACH is the Korean version of the EU regulation for the Registration, Evaluation, Authorization and
Restriction of Chemicals (REACH). K-REACH and REACH share the main goal of cataloguing information
on the hazard of chemicals to support improved risk management in their use. However, while REACH
wants to achieve this by minimizing or avoiding any unnecessary testing on animals,6
K-REACH has no
such goal and in many instances mandates animal testing.5
Although the original K-REACH legislation was brought into effect in 2015, this legislation has now been
revised to impose stricter controls on a broader range of substances (see Table 1).
K-REACH
How to Prepare for K-REACH Legislation

2. Table 1. K-REACH Milestones in the Legislation
2013 K-REACH act passed in law
2015 K-REACH enters into law
2016-17
Consultation on proposed amendments to
strengthen legislation and impose stricter controls
March 2018 K-REACH amendments enter into law
January 1, 2019 Revised K-REACH legislation comes into effect
Related Legislation
Public protection from harm from chemicals is affected through K-REACH and other related legislation
such as the CCA and Consumer Chemical Products and Biocides Safety Act (known as K-BPR). K-BPR
regulates consumer chemical products, biocidal products and biocide-treated articles.7
It is similar to the
EU Biocidal Products Regulation (EU-BPR). Like K-REACH, K-BPR will come into force on January 1, 2019.
The CCA covers the obligations of manufacturers and importers regarding:2
▶ Identification and disclosure of regulated chemical substances
▶ Criteria for storing and handling hazardous chemicals
▶ Labeling of hazardous chemicals
▶ Permissions and declarations required to manufacture, import or use substances or toxic substances
K-BPR requires:7
▶ Identification and disclosure of regulated chemical substances
▶ Criteria for storing and handling hazardous chemicals
▶ Labeling of hazardous chemicals
▶ Permissions and declarations required to manufacture, import or use substances or toxic substances
Together with K-REACH, these regulations provide South Korea’s Ministry of Environment (MoE) with
a comprehensive regulatory platform to enforce a high level or protection against chemical hazards.
The Occupational Safety and Health Act (OSHA), which is overseen by the South Korean Ministry of
Employment and Labor, protects individuals from exposure to hazardous chemicals in the workplace.8
Top tip: Ensure you check the latest regulatory requirements
relevant to your substance, identifying which legislations
are relevant, and your obligations under each of these.

3. Scope of K-REACH
Registration of chemicals manufactured or imported into South Korea under K-REACH is required for:
▶ Any new chemical substance: registration must be obtained before the substance is manufactured
or imported; however, for substances manufactured or imported at <100 kg per year, only notification
is required (see later)
▶ Any existing chemical substance manufactured or imported at ≥1 metric ton per year: deadlines and
information requirements vary with tonnage level (see later)
Unlike REACH, where annual tonnage is calculated as a three-year rolling average and regular
monitoring and updates are required, K-REACH annual tonnage is based on the maximum
manufactured or imported volume in any given year from 2016 to 2018. It is, therefore, essential
to estimate this maximum volume correctly, as it can be difficult to alter the tonnage band,
especially to a higher band, at a later stage in the process.
As with REACH, K-REACH is confined to certain substances, because other substances are regulated
through different legislation (see Table 2).
Under K-REACH, polymers must be registered – this is different from REACH, which only requires
registration of monomers.
Top tip: Check if your substance is in scope and if
it is on the Korean Existing Chemicals List (K-ECL);9
if not, your substance will be considered ‘new’.
Table 2. Scope of K-REACH1
In Scope Out of Scope
▶ Substance on its own – this includes new substances (i.e., those not listed on the Korean
Existing Chemicals List [K-ECL]) and existing substances
▶ Substance in a mixture
▶ Product containing a priority control substance (this used to be referred to as hazardous
chemicals). A product is a mixture or article or a component in a mixture or an article.
If the product contains >0.1% or ≥1 metric ton/year of a priority control substance,
it must be notified to the authorities
▶ The definition of a priority control substance is a substance that is considered hazardous
to any of the following:
-- A substance that causes or threatens to cause cancer, mutation, reproductive
abnormalities or endocrine disorders in humans or animals (CMR)
-- Substances that are highly accumulated in the body and that remain
in the environment for a long time
-- Substances that can damage organs such as lungs, livers and kidneys
if exposed to people
-- Or A substance that can cause serious harm to a person or animal or plant
at or above the same level as the three substances above. Priority control
substances are not classified through hazard evaluation however, substances
can be classed as toxic chemical through hazard evaluation under K-REACH.
▶ Naturally occurring substances
▶ Chemicals subject to other
laws such as cosmetics and
raw materials, pesticides,
pharmaceuticals, medical
devices, fertilizers, etc.

4. K-REACH is a Multi-stage Process
Like REACH, K-REACH is a multistage process with different deadline and information requirements
dictated by the amount of the substance imported or manufactured. Under K REACH, foreign
manufacturers without registered offices in South Korea need to appoint a South Korea-based only
representative (OR) to submit pre-notification and registrations.
* Late pre-notification may be possible in some instances
Table 3. K-REACH Deadlines
Regulation Deadline Date
Registration of 510 designated existing substances ≥1 metric ton/year July 1, 2018
Pre-notification of existing substances manufactured or imported at
volumes ≥1 metric ton/year
January 1, 2019 to
June 30, 2019*
Registration of substances with volume ≥1,000 metric ton/year December 31, 2021
Registration of substances with volume 100–1,000 metric ton/year December 31, 2024
Registration of substances with volume 1–100 metric ton/year December 31, 2030
Top tips: Establish the pre-notification and registration
requirements for your substance, find and contract an OR
if you need one, calculate the maximum tonnage carefully
to identify the information needs for that tonnage band.
Pre-Notification and Notification
All existing substances marketed in or imported into South Korea at ≥1 metric ton/year require
pre-notification. The time window for pre-notification is between January 1 and June 30, 2019.10
The pre-notification information requirements include:
▶ Substance identity information: name and Chemical Abstracts Service (CAS) number
▶ The estimated annual import/manufacture volume band
▶ Classification and labeling according to the Globally Harmonized System of Classification and
Labelling of Chemicals (GHS)
▶ Usage information, which needs to describe usage according to the descriptor system in K-REACH
▶ Legal entity information: name, address and contact information of the Korean legal entity or, in the
case of an OR, the letter of appointment
Pre-notification must be submitted to the Korea Environment Corporation (K-eco).11
Once pre-notification is made, the importer/manufacturer has a ‘grace period’ in which to compile
their K-REACH submission. The grace period is determined by tonnage band – see Table 3.

5. Designated or Priority Existing Chemicals
The MoE identified 510 existing substances for advance registration. The deadline for registration of
these substances was July 1, 2018. To date 340 substances have been registered by lead registrants.
Registration
K-REACH has similar information requirements to REACH, although the use of read-across
and quantitative structure – activity relationship (QSAR) models for waiving some animal
studies is not as widely accepted under K-REACH.
The information needed for registration (in addition to that for pre-notification) includes:12
▶ Test data covering physicochemical properties, toxicology and environmental fate –
the data requirement increases with tonnage band
▶ A risk assessment report, including exposure information and risk management measures
▶ Information on detailed contents
▶ Information on safe usage, such as the handling method and emergency response measures
▶ Regulatory information on the chemical substance concerned
Reduced data requirements, equivalent to those for substances in the 1–10 tonnage band,
are available for products without a GHS classification.
Top tips: Identify all uses for your substance, as this will drive
the exposure scenarios and risk assessment. You may need
to consult downstream users. Conduct a data gap analysis
to identify information you need to source, or the testing
plans you need to carry out.

6. Planning Your Registration
With over ten years of experience in managing substances through regulatory submissions to REACH,
and 20 registrations under K-REACH, Covance has a wealth of experience and insight to share with
companies registering substances in South Korea. The section below provides some insight into what
you need to consider as you start the complex registration journey for your substance.
Find Your Co-Registrants
Like REACH, K-REACH requires a single dossier to be submitted for each substance. This means that,
as in Europe, companies producing chemicals containing the same substance must work together in
a structure called a Chemical Substance Information Communicative Organization (CICO), which is
similar to the EU Substance Information Exchange Forums (SIEFs). The CICO provides a framework,
which enables the effective sharing of data and costs.
To Enable Joint Submission Through a CICO, You Should Follow These Steps:13
▶ Identify potential registrants of the same substance: this can be done through the K-REACH
IT system
▶ Identify a lead registrant: this is usually done at a meeting, where, in addition to identifying
the lead, the general role of all participants is established. At this time, it is also important to
confirm that all potential registrants do have the same substance
▶ Create and sign a contract: this provides the legal framework for the scope of the collaboration
and outlines the financial arrangements
It is Possible to Apply as a Single Registrant if:12
▶ Registration will result in disclosure of confidential business information or trade secrets
that could lead to considerable commercial loss
▶ Greater expense is incurred by submitting data jointly than by submitting data individually
▶ Submission constitutes grounds prescribed by Presidential Decree
As of June 29, 2018, lead registrants had been elected for 350 of the 510 substances identified
as priority existing chemicals.14
Top tips: Characterize your substance in detail, find other
registrants through the K-REACH IT system and consider
how best to engage with them in the CICO. You may
need to consider how important your substance is to you
commercially and if other registrants will prioritize the
substance in the same way. This can influence decisions
regarding who should act as lead registrant.

7. Top tip: Contract data access carefully, checking data quality
(if possible) and ensuring you understand usage limitations.
Identify Possible Data Sources
Given the number of jurisdictions around the world with similar regulatory processes for chemicals,
it may be possible to source missing data from other countries; however, this is not always as
straightforward as it sounds, as it can be difficult to find the data owner and, even for substances that
have been submitted under REACH, the quality of data from the dossier may be poor or the actual
data you need may be missing. This is often not apparent until you have purchased the dossier.
You should also understand that the Chemical Safety Reports (CSRs) required under K-REACH
differ from those for REACH, so evaluation for the Korean-specific situation
is required and EU CSRs are not applicable.
If you wish to purchase data from REACH, you need to submit a letter of access to the data holder.
Often the contracts related to data access limit use to one jurisdiction, so if you have purchased data
used for REACH, you need to purchase it again for K-REACH.

8. Summary
K-REACH is closely aligned with REACH regulation, with similar processes and evaluations although
K-REACH relies more heavily on animal data. The pre-notification period for existing substances imported
or manufactured at ≥1 metric ton/year runs between January 1 and June 30, 2019. After this, submission
deadlines vary by tonnage band. Joint submissions are the norm, with registrants working together in
CICOs – the equivalent to SIEFS in REACH.
It is likely that a number of substances requiring K-REACH registration will have already been registered in
the EU through REACH. REACH dossiers can, therefore, be a data source, although a substantial amount
of rework may be required to align any K-REACH submission with the obligations in the Korean regulation.
Table 4 provides a quick summary of K-REACH features, while Table 5 provides some advice on how to
manage your substance through K-REACH.
Table 4. Summary of Key Facts About K-REACH
Pre-notification for existing substances manufactured or imported at ≥1 metric ton/year is required by June 30, 2019
There are three tonnage bands for existing substances, which have different deadlines for registration
Data requirements for registration increase with increasing tonnage
The registration deadline of 510 priority existing chemicals was July 1, 2018
Joint submission is mandated in most cases, with registrants working together as part of a CICO with a lead registrant
Manufacturers or importers based outside Korea must appoint an OR to submit and manage substance registration
Table 5. Top Tips From Covance on Preparing Your Substance Registration Under K-REACH
▶ Start as early as possible
▶ Ensure you check the latest regulatory requirements relevant to your substance, identifying which legislations are
relevant and your obligations under each of these
▶ Check if your substance is in scope and if it is on the Korean Existing Chemicals List (KECL); if not, your substance will be
considered ‘new’
▶ Establish the pre-notification and registration requirements for your substance
▶ Find and contract an OR if you need one
▶ Calculate the maximum tonnage carefully to identify the information needs for that tonnage band
▶ Identify all uses for your substance, as this will drive the exposure scenarios and risk assessment. You may need to consult
downstream users
▶ Conduct a data gap analysis to identify information you need to source, or the testing plans you need to carry out
▶ Characterize your substance in detail
▶ Find other registrants through the K-REACH IT system and consider how best to engage with them in the CICO.
You may need to consider how important your substance is to you commercially and if other registrants will
prioritize the substance in the same way. This can influence decisions regarding who should act as lead registrant
▶ Contract data access carefully, checking data quality (if possible) and ensuring you understand usage limitations

9. References
1. ChemSafetyPro. How to comply with amended K-REACH regulation 2018.
www.chemsafetypro.com/Topics/Korea/Korea_REACH.html
2. ChemSafetyPro. How to comply with Chemicals Control Act (CCA) in Korea.
www.chemsafetypro.com/Topics/Korea/Introduction_to_Korean_Chemicals_Control_Act.html
3. Paek D, Koh Y, Park DU et al. Nationwide study of humidifier disinfectant lung injury in South Korea,
1994–2011: incidence and dose–response relationships. Ann Am Thorac Soc 2015; 12: 1813–1821.
4. Kim, WY, Hong, SB. Humidifier disinfectant-associated lung injury: six years after the tragic event.
Tuberc Respir Dis 2017; 80(4): 351–357.
5. Ha, S, Seidle, T, Lim, K-M. Act on the Registration and Evaluation of Chemicals (K REACH) and replacement,
reduction or refinement best practices. Environ Health Toxicol 2016; 31: e2016026.
6. ECHA. Animal testing under REACH. https://echa.europa.eu/animal-testing-under-reach
7. ChemSafetyPro. How to comply with consumer chemical products and biocides safety act in South Korea (K-BPR).
www.chemsafetypro.com/Topics/Korea/How_to_Comply_with_Consumer_Chemical_Products_and_Biocides_
Safety_Act_in_South_Korea.html
8. ChemSafetyPro. Overview of chemical regulations in Korea.
www.chemsafetypro.com/Topics/Korea/Overview_of_Chemical_Regulations_in_Korea.html
9. National Chemicals Information Systems (translated). Chemicals Information System. http://ncis.nier.go.kr/main.do
10. ChemSafetyPro. All you need to know about K-REACH pre-notification.
www.chemsafetypro.com/Topics/Korea/All_You_Need_to_Know_About_K REACH_Pre registration.html
11. Korean Environment Corporation (K-eco). Establishment basis. www.keco.or.kr/en/intro/basis/contentsid/2026/index.do
12. ChemSafetyPro. K-REACH registration (2018–2019).
www.chemsafetypro.com/Topics/Korea/Korea_REACH_Registration.html
13. Korean Environment Corporation (K-eco). Hazardous materials management.
www.keco.or.kr/en/core/hazardous_Support/contentsid/3098/index.do
14. CIRS. K-REACH 350 PECs lead registrants have been elected.
www.cirs-reach.com/news-and-articles/k-reach-179-pecs-lead-registrants-have-been-elected.html
Covance has broad expertise in supporting clients through regulatory submissions within REACH
and other global chemical notifications, and can bring the lessons learned from those experiences
to help support clients through K-REACH via its Korean office. To date Covance has registered
approximately 40 priority existing chemicals under K-REACH.
Covance has supported importers and manufacturers through other regulatory registrations.
To discuss your registration, no matter what stage of the process it is at or which jurisdiction
it is within, please contact us.
Covance provides essential research services, models and articles for pharmaceutical, crop protection
and chemical companies, as well as universities, governments and other research organizations.
Learn more about our chemical solutions at www.covance.com/chemical
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