K-REACH:
How to reach it?
Sookie Hong
3E Company
September 29, 2015
Content: K-REACH
• Regulatory Landscape
• Requirements in Details
- Exclusions/Exemptions
- Report, Registration, and Notification
- Data for hazard evaluation or risk assessment
- K-REACH and GHS
• Draft Amendments
• Regulatory Timelines and Forecast
• Conclusion
Korea REACH
• “K-REACH” (Act on Registration and Evaluation of
substances (aka “AREC”) – Ministry of Environment
(MoE))
TCCA à
K-REACH
CCA
- Risk assessment/preventive - Hazardous substances
control (pre-market) management (licensing,
- Designation of hazardous inspection)
substances (toxic, banned, - Response to emergency/chemical
restricted) accidents
– New chemical notification under TCCA removed
– Hazard testing under TCCA transferred to K-REACH
3
Chemical Lists Designated by K-REACH
Toxic
Banned
K-REACH will
Restricted designate
PEC
Exception:
“Accident-prone” (only CCA)
Permissible “Observational” repealed
4
K-REACH Legal Framework
• Act on Registration and Evaluation of substances (“AREC”)
‐ Presidential Decree stipulates:
Grace period of existing chemical registration
Exempted substances for R&D (i.e. reagents, non-isolated
intermediate, low-risk polymer, etc.)
‐ Ministerial Decree specifies:
Required documents for registration exemption application, required
test data, hazard assessment methods, content of risk communication,
etc.
‐ Guidance and Notices provides:
Product notification, data and cost sharing, chemical “confirmation”
requirement, classification/labeling, registration dossier, testing method,
data protection, etc.
5
K-REACH Overview
Hazard
Evaluation and
Registration /
No pre- chemical
registration Annual designation
Reporting
(i.e. toxic
substances)
Authorization/
Restriction
Risk Risk
Communication (banned, Assessment
restricted,
permissible)
6
K-REACH: Requirements (1)
Requirements Act of K-REACH (May 22, 2013)
Reporting (Art. 8)
• Importers, Manufacturers, and Sellers (excluding users)
Requirement • Quantity AND Use Report
• All new substances and ≥ 1 ton/year for existing
substances
• Every year
Registration (Art. 9 - 17)
• Importers, Manufacturers
• All new substances
• ≥ 1 ton/year for designated existing substances
• < 1 ton if considered hazardous to human health or
environment
Risk Assessment (Art. 24)
• ≥ 100 ton/year initially
• ≥ 10 ton/year after year 5 (i.e., 2020)
7
K-REACH: Requirements (2)
Requirements Act of K-REACH (May 22, 2013)
Risk Communication (SDS, (Art. 29 - 30)
chemical properties, use, exposure • End user and seller ómanufacturer and
scenario, and safe use guidelines, importer
quantity of use/sale, etc.)
(Optional for downstream user “upon request
by manufacturer or importer” (Art .30))
Product Notification (Art. 32 - 37)
• Report of hazardous substances in products
exceeding 1 ton/year
• Product risk assessment/safety standard
• Product sale ban/recall
8
K-REACH Key Points
• Effective from January 1, 2015
• Only Representatives (“OR” policy)
‐ Foreign companies need to appoint a representative
for reporting, registration, notification, etc.
‐ Eligibility of representatives
§ Korean citizenship holder
Or
§ A person or business entity who has an address
in Korea
9
CBI under K-REACH
• Period of data protection: 15 years
• Not eligible for CBI:
‐ Chemical common name, trade name, and product
name
‐ Chemical or product use
‐ Safe use information of chemical or product (i.e.
precautionary statements for handling, disposal, etc.)
‐ Accident response
‐ Physico-chemical properties
‐ Hazards/Risk information
10
Out of Scope
• Radioactive substances
• *Pharmaceutical and quasi-pharmaceutical
• Narcotics
• *Cosmetics and related raw materials
• *Agricultural substances and their active ingredients
• Fertilizers
• Food and food additives
• Animal feeds
• Gun powder and military supplies
• Health supplements
• Medical devices
*: Precursors used to manufacture active ingredients are subject to K-REACH
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Existing vs. New Chemical Substances
• “Existing” chemical substances
‐ Chemical substances distributed for commercial purposes
domestically before February 2, 1991 and announced by the
MOE on December 23, 1996
‐ Chemical substances for which the hazard evaluation has
been completed under the Toxic substances Control Law
after February 2, 1991 and was published by the MOE
à Basically it is listed in KECI (Korea Existing Chemical
Inventory)
• “New” chemical substances
‐ Not listed in KECI
12
Annual Reporting
• Subject: ALL new substances regardless of
quantity and existing substances manufactured,
imported, or sold ≥ 1 t/y
• Who? Manufacturer, importer, and seller
- Seller who sells substances for industrial use
• What? Quantity and use
- 55 Use categories designated by the MoE
• For 2015 reporting, deadline is by June 30, 2016
13
Exemptions of Reporting
a) Existing substances below 1 ton/yr (manufacture,
import, sale)
b) Imported substances equipped in machinery
c) Imported substances contained in experimental
machinery or equipment
d) Substances contained in finished article and not
released during its use
e) PPORD
f) Reagents
g) Non-isolated intermediates
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Additional Exemptions from Reporting
K-REACH Quiz
• Mixture scenario
B: A: New
Existing chem
chem 0.1t
0.7t
C:
Existing
chem 2t Answer:
A and C
Which one(s) are subject to annual reporting? 16
Registration (1)
• All new substances regardless quantity and
“designated existing substances” 1 ton or more
per year
• Who? Manufacturer, Importer
• Registration for new substances must be done
prior to manufacture or import à no grace
period
• Process time:
- 3-7 days for substances < 1 t/y
- 30 days for substances ≥ 1 t/y
17
Registration (2)
• “Designated existing substances subject to
registration” (aka “PEC” (Priority Evaluation
Chemicals)) will be issued by MoE every 3 years
based on the criteria of total quantity in commerce
and hazard/risk concerns. Grace period for
registration: 3 years from announcement
à First batch PEC with 510 substances published
(July 1, 2015)
18
Registration (3)
• What to submit:
‐ Information of importer, manufacturer, or representative
‐ Chemical identity/information (name, CAS, molecular formula,
structure, impurities/by-products, estimated quantities of import
or manufacture)
‐ Intended use
‐ Classification and labeling à GHS
‐ Physio-chemical properties
‐ Hazard information
‐ Risk information including exposure scenario (only imported or
manufactured 10 tons or more per year)
‐ Guidance of safe use
‐ Others… (CBI application, etc.)
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Exemptions of Registration
a) Imported substances equipped in machinery
b) Imported substances contained in experimental
machinery or equipment
c) Substances contained in finished article and not
released during its use
d) *Substances manufacture domestically or imported ≤
10 ton/yr to export for military purpose
e) *Reagents for R&D
f) Surface treated substances
g) Non-isolated intermediates
h) PLC (cationic polymers are subject to registration)
*“Confirmation of Registration Exemption” must be submitted every year. (for
now)
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Existing substances will not be selected as PEC
• Impurities and by-products
• Minerals, ores, ore concentrates, cement clinker, crude oil, coal
• Natural gas, liquefied petroleum gas, natural gas condensate
• Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal
oil, animal waxes
• Fatty acids from C6 to C24 and their potassium, sodium, calcium
and magnesium salts
• Glycerol
• Process gases and components thereof
• Coke, magnesium oxides
• Glass, ceramic frits
• Compost and biogas
• Hydrogen and oxygen
Types of Registration
Low volume Low volume
Standard
(before 2020) (after 2020)
• All new and • New < 1 t/y • New < 100
designated • No hazard data kg/y
substances ≥ 1 submission • No hazard data
t/y; high risk (but exposure submission
concerned < 1 information for (but exposure
t/y use is required) information for
• Hazard data, use is required)
physico-
chemical, etc.
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Data Submission (1)
• Mandatory Joint-submission for PEC
The justifiable reasons for individual submission:
‐ Compromised trade secret that may cause damage to business
‐ If joint submission is more costly than individual submission
‐ Classification and labeling from same testing category are different among
registrants
à “Confirmation of Individual Submission” from the KCMA required
• Sharing vertebrate animal test data for new substances
A person must obtain the prior approval from the owner of the data that had
been submitted for registration (Act Art. 16 - 17)
Exception: no consent is needed if the data which 15 years have passed since
its use for registration
à If refused by the owner, the data submission can be waived with a
“Confirmation” from KCMA
• Industry can check with the NIER if existing data available
23
Data Submission (2)
• Test proposal showing test information and schedules
may be accepted in lieu of testing data of physico-
chemical, toxicity, and eco-toxicity (like EU REACH) à
Only if testing data proven as unavailable.
• MoE only accepts data generated from locally certified
labs (GLP) or internationally qualified labs (OECD)
(except physico-chemical data)
• Some data submission during registration maybe
waived
‐ QSAR for substances imported or manufactured below 10
ton per year
- Isolated intermediates
- New substances with low volume (1 t until 1/1/2020)
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Hazard Review/Risk Assessment
• NIER will conduct hazard review on registered substances:
- new substances within 6 months
- PEC within 1 year
à Designate and publish toxic chemical
substances
• Additional data for risk assessment are required for registration; gradual
reduction of quantity :
≥ 100 ton/yr by Jan. 1, 2015;
≥ 70 ton/yr by Jan. 1, 2017;
≥ 50 ton/yr by Jan. 1, 2018;
≥ 20 ton/yr by Jan. 1, 2019;
≥ 10 ton/yr by Jan. 1, 2020
à Start counting the date of registration certificate received, NOT the date of
registration submission.
à Designate and publish banned, restricted, and permissible chemical
substances
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Authorization/Restriction
• Authorization - Designation of “Permissible” substances
‐ Results of hazard evaluation and risk assessment that demonstrate high risk
‐ Substances with high risk of CMR, endocrine disruptors
‐ PBT, vPvB
‐ Other substances with similar high risks
‐ Must have a permit to manufacture, import, or use
• Restriction - Designation of “Restricted / Banned”
‐ Results of hazard evaluation and risk assessment that demonstrate high risk
‐ Designated by international institutes as high risk
- Substances that have been removed from Permissible list
‐ Banned (all usage) or restricted (partial usage) from
manufacture, import, sell/store, transport, or use
26
Product Control (1)
• Safety management for “Risk concerned
products”
1) Household products – cleansers, adhesives, deodorizers, air
fresheners, bleaching agents, detergents, fabric softener, etc.
2) Biocide products – preservatives, disinfectants, insecticides, etc.
‐ Product Notification prior to manufacture or import:
exceeding 1 ton/yr per “hazardous substance” containing 0.1
% in product
‐ Substance name, concentration, use in product, hazard properties
‐ Exceptions: chemical substances not released from
product during its use, substances in finished
articles, etc.
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Product Control (2)
• Hazardous Substances here means:
‐ K-REACH designated ones: Toxic, permissible, restricted, or
banned substances
• “Exemption from Notification” can be granted to:
‐ Release of hazardous substance in product is controlled
‐ Hazardous substance in the product already registered for the respective
use
• Risk assessment requirement per product category
• MoE will publish safety standard, labeling, packaging, and safety
information for consumers
• Safety, labeling criteria will include hazardous substances that are
not allowed in risk-concerned product, concentration limit,
migration, evaporation, etc.
• For product that fails to meet safety standard, MoE can ban or
recall
28
Post-Registration (1)
All records below must be kept for 5 years
• Chemical information
• Annual Report (including exemption application)
- Registrants’ information change à within 1 month
- Change in Use à within 1 month
• Chemical registration (including exemption
application)
- Change in annual volume à within 1 month
- Change in risk/hazard info à within 6 months
29
Post-Registration (2)
• Notification of risk-concerned product that
contains hazardous substances (including
exemption application)
• Risk communication
• CBI information
30
What to submit where?
Importer,
Manufacturer, Registration,
(Seller), Existing testing data
OR inquiry
Annual reporting,
Product notification Local MoE
Chemical identification,
Exemption application,
Applying for individual
registration for PEC, etc.
EU vs. K-REACH
EU REACH K-REACH
Pre-registration Yes No
Annual reporting No Yes
Existing chemical All existing substances 1 Only PEC 1 ton or more
registration ton or more
Joint registration Mandatory Mandatory (for PEC)
Registration types Standard; Intermediate Standard; Low volume
Use only; PPORD
Hazard evaluation /risk Industry Government (MoE)
assessment
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K-REACH facts that may interest you... (1)
• Nano materials are subject to hazard evaluation under K-
REACH
• Testing data that was used for registration with ECHA is
acceptable for K-REACH registration (but QSAR or Read-
across from EU REACH may not be acceptable)
• Non-GLP testing data for physio-chemical properties
other than Pow are acceptable
• New substances approved of LVE (100 kg) under TCCA
are considered as exempted for K-REACH registration
• K-REACH does not grant “expedited” registration
process for new substances even if they have been used
by OECD member countries
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K-REACH facts that may interest you... (2)
• “Unknown” chemical substances are not allowed
– must obtain information from suppliers
• For registration, use category per chemical
substance must be specified – must obtain
information from suppliers
• Registration Fee
‐ Discounted fee for SME (up to 80%)
‐ 100,000 KRW for new substances
‐ 200,000 KRW for PEC
‐ Other fees: exemption application (50,000 KRW);
product notification (50,000 KRW)
MoE vs. MoEL: data submission
Before K-REACH: one-time submission
TCCA (MoE) – ISHL (MoEL) Hazard Testing
TCCA Hazard Testing
ISHL Hazard Testing
MoE (NIER) MoEL
After K-REACH: separate submission
MoE K-REACH Hazard
(NIER) Evaluation
MoEL ISHL Hazard Testing
K-REACH and GHS
1) During registration, GHS hazard classification and
labeling (pictograms, H and P codes) information are
required
2) Risk communication – SDS may be utilized
Classification/Labeling
‐ MoE adopted UN 3rd Rev. by including hazard class “Hazardous to
Ozone Layer” (NIER No. 2014-45)
Safety Data Sheet (SDS)
‐ MoEL is a ruling authority on the format
‐ Updated SDS standard including K-REACH information (e.g. Sec 15)
is pending
Draft amendments/latest notice
1) Draft - Ministerial Decree amendment proposal
(MoE No. 2015-540)
• Simplifying documentation for R&D application
• Reagents for R&D application
• Selecting a lead registrant for joint registration
• Simplifying a representative change
2) Final - Exemptions from “Chemical Identification”
requirement (MoE 2015-162)
• Published on September 1, 2015
• Exempted existing substances from annual reporting also
exempted from chemical identification obligation
What Is Coming Up
• 510 PEC substances must be notified (“Chemical
identification”) to KCMA by January 2016 (within 6
months since published date)
• Annual report for 2015 due by June 30, 2016
• 510 PEC substances to be jointly registered by June
2018 (3 years since the published date)
• Risk assessment data ≥ 100 ton/yr until Dec. 2016; ≥
70 from Jan. to Dec. 2017; ≥ 50 from Jan. to Dec.
2018…
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Thank you for your attention!
경청해주셔서 감사합니다!
