New Paradigm of Chemical Control Regulations in

18/06/2012
NEW PARADIGM
OF
CHEMICAL CONTROL REGULATIONS
IN
KOREA
CHEMSPEC EUROPE, BARCELONA
REGULATORY ISSUES CORNER PROGRAMME
JUNE 14, 2012
SPEAKER: AH-REUM, SEO
PROJECT LEADER
CHEMSERVICE ASIA
CONTENTS
A.
B.
C.
D.
E.
F.
G.
Purpose & Background
Overviews from Legal Aspects
Major Arguments
Plan of Authority (MoE)
How companies prepare for K-REACH?
Burden of Industry
Next Steps
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18/06/2012
Chemservice S.A.
Grevenmacher/LUX
ChemCEHTRA
Bordeaux/France
Chemservice Asia
Ltd. Co.
Seoul/Korea
Chemservice Ltd.
Şirket
Chemservice
GmbH
Bodrum/Turkey
Worms/DE
Consortia
Management GmbH
Worms/DE
Chemservice EHNS
GmbH
Worms/DE
ChemAdvocacy
Grevenmacher/LUX
3
► Regulatory Affairs Services
Global Chemical Inventory Listings
REACH & GHS
International Chemical Control Legislation
Global Food Contact Notifications and Petitions
and approval status review
Substance Notifications & Registrations
(incl. Biocides and Pesticides)
Hazard Communication (Label, SDS, Work Instructions)
Regulatory Questionnaire Response
GLP and GMP Consulting
Monitoring of relevant Legislation and Business
Impact Assessment
Training, Product Stewardship, Advocacy Advice
Tariff Code Identification
EH&S Consulting
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Purpose & Background
“Fatal Misuse of Humidifier Disinfectants in Korea”
In Korea, humidifier disinfectants have been put in the water tanks of humidifiers for the
prevention of germs, mold, and/or algae. According to the authorities, as of August 31,
2011, 28 adults, including 13 pregnant women, have been hospitalized because of this
unidentified lung disease similar to acute interstitial pneumonia.
June 14, 2012
ChemSpec Europe, Barcelona
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Purpose & Background
“Asbestosis epidemic near an asbestos mine”
”
In a recent study of the residents of 4 towns in south Chung-Cheong province, where
Asia’s largest asbestos mine was located, over 50 residents among about 200 were
diagnosed with asbestosis.
June 14, 2012
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Purpose & Background
K-REACH:
A. Comes from awareness of importance of Screening Risk Assessment
and Implications for Management of Chemicals in Consumer Products
B. Mainly refers to EU REACH Regulation “to Protect Human Health and
Environment from the risk of the use of chemical substances”
C. Current “Toxic Chemical Management Law” has been pointing out
with some problem
Mainly focus on New chemical substances
Objectivity and Fairness in Assessment by the Authority
D. China, Japan, Taiwan and other countries are adopting REACH-like
legislation.
June 14, 2012
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Overviews from Legal Aspects
Regulations related to Chemical Industry in Korea:
Products
Toxic
Chemicals
Hazardous
Chemicals
Pesticides/
Fertilizers/
Authority
MoE
MoL
MIFAFF
Feed
Food
June 14, 2012
Control Act
Occupational Safety
and Health Act
Agricultural
Chemicals / Fertilizers
Control Act
Pharmaceutical
MoHW
Narcotics
Additives
Toxic Chemicals
/ Feed
Medical
Supplies /
Regulations
Affairs Act / Narcotics
Control Act
MoHW
Food Sanitation Act
ChemSpec Europe, Barcelona
Aims
To Protect Human Health and
Environment from the risk of the
use of chemical substances
To prevent Accident and guarantee
of Labor’s Safety and Health in
Workplace
To ensure a stable supply of quality
goods
To ensure public health through
proper management
To prevent risk from Food and
improve nutrition
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Overviews from Legal Aspects
Regulations related to Chemical Industry in Korea:
Products
Authority
Regulations
Aims
Cosmetics
MoHW
Cosmetic Act
Risk Management of Cosmetics
Explosive,
Dangerous Material
Oxidising and
Flammable
Management Act /
MoPAS
materials /
Gun, Sword and
Gunpowder Control
Gunpowder
Act
High Pressure
High Pressure Gas
Gas
Radio Active
June 14, 2012
MoE
MEST
Safety Control Act
Atomic Energy Act
To ensure public safety and prevent
risk and disaster from those
materials
To prevent risk from high pressure
gas
To use atomic energy and Safety
management
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Overviews from Legal Aspects
Abbreviations (Authority):
MoE
MoL
MIFAFF
MoHW
MoPAS
MEK
MEST
: Ministry of Environment
: Ministry of Labor
: Ministry for Food, Agriculture, Forestry and Fisheries
: Ministry of Health and Welfare
: Ministry of Public Administration and Security
: Ministry of Knowledge Economy
: Ministry of Education, Science and Technology
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Overviews from Legal Aspects
TCCA Mapping:
Chemical Identification
RISK
ASSESSMENT
Restricted or
Prohibited
.
Import Approval
Export Approval
Business License
June 14, 2012
Existing Chemicals
New Chemicals
Hazard Assessment
Hazard Characterization
(New Chemical Notification)
General
Toxic
Observational
Accidental
No Requirement
Import Notification
Business License
Manufacture/
Import
Notification
Prevention Plan
Inspection
Safety Audit
Improvement Order
by Authority (MoE)
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Overviews from Legal Aspects
New Paradigm on Chemical Control Regulation:
A. MoE announced the official draft of “Chemical
Substance and Evaluation Act (so called K-REACH)”
on February 24 2011.
B. Principle of Precautionary Risk Management
C. REACH-like Regulation
Grace Period & Data Requirements
(depending on the Volume band & Hazardous of substance)
Joint Submission Principle
Data sharing on vertebrate animal test
Opt-out
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18/06/2012
Major Arguments
Question:
Answer:
Is K-REACH the amended TCCA?
Not clear yet
Assumptions:
A. Revocation of TCCA , and K-REACH replaces TCCA.
B. K-REACH (Chemical substance Registration and
Evaluation Act) will be part of amended TCCA or;
C. (Most Influential) MoE implements 2 Different Acts.
In view of facts that MoE’s official draft of K-REACH
partially quotes TCCA.
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Major Arguments
Similar Acts are existed:
Regulations
Aims
Authorities
Based on risk assessment and globally regulated
chemicals, the Authority designates specific
Toxic Chemical Control
Act (TCCA)
restricted or prohibited substances on the list. It
affects overall chemical business activities in Korea
MoE
including manufacture, import, use, storage and
transport.
Based on hazardous materials in workplace and
risk assessment, the Authority designates specific
Occupational Safety
and Health Act (OSHA)
restricted or prohibited substances ton the list. It
affects overall chemical business activities in Korea
MoL
including manufacture, import, use, storage and
transport
Quality Control and
Industrial Consumer
Products Safety Act
June 14, 2012
The Authority issues the Safety Certificates for
Articles which contain hazardous materials.
ChemSpec Europe, Barcelona
MEK
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Plan of Authority (MoE)
Schedule:
Registration of New Chemicals
Presidential &
Ministerial
Decree
Priority sub.
For Preregistration
Passage of
Act through
National
Assembly
Dec. 31,
2012
Content Declaration of
Restriction,
Prohibition Substance
Jan. 1,
2014
Jan. 1,
2015
June 14, 2012
2-8 Years Transition Period
for Pre-registered Substance
Jun. 30
2015
Jan. 1,
2017
Jun. 30,
2025
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How companies prepare for K-REACH?
EU REACH, K-REACH and TCCA
Comparison
EU REACH
K-REACH (Expect.)
TCCA
Chemical
Registration
New Chemical Substances
Existing Chemical Substances
①New Chemical Substance
②PACs
※ Based on Volume, Use and
Hazardous
Lowest Volume
1ton/year
0.5ton/year
(80% of Commercial Product)
Data Requirements
Physico-chem. properties: 17
Human toxicity: 20
Eco toxicity: 25
Max. Total: 62
Manufacture/Import
Reports
No requirements.
Physico-chem. properties: 12
Human toxicity: 15
Eco toxicity : 19
Max. Total: 46
Annual Manufacturer/Import
Volume and Uses Reports
Designated Toxic Chemicals
※PACs list updated afterwards.
Authorization
Specific use of SVHC
substances
Specific use of SVHC
substances
Risk Communication
(in Supply Chain)
Obligation to provide SDS for
specific Hazard Materials
Obligation to provide SDS for
specific Hazard Materials
Risk Assessment
CMR, PBT etc.
①CMR, Endocrine disruptors,
PBT, vPvB etc.
②over 100 ton/year
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ChemSpec Europe, Barcelona
New Chemical Substances
0.1tin/year
(0.1~1ton: Simplified
Notification)
Physico-chem. properties: 5
Human toxicity: 9
Eco toxicity: 4
Max. Total: 18
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How companies prepare for K-REACH?
Current TCCA Process
New Chemicals
Hazard
Assessment
Registration
Toxic
Chemicals
Just Focus on New Chemicals
Hazard Assessment (K-REACH: Risk Assessment)
Inventory Check: National Chemical Information System http://ncis.nier.go.kr
TCCA’s Full Notification Test Requirements:
Physico-chemical properties
Acute toxicity data for one rodent species
(oral, dermal, inhalation test), and
Genotoxicity(mutation) data; Ames test data, and in vitro chromosomal
aberration test data, and
Biodegradability test data.
Fish, daphnia and algae toxicity (for full notification only) from 2007
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How companies prepare for K-REACH?
K-REACH Process
Manufacture etc.
Report
PAS List
(Designation &
Public Notice)
Pre-registration
(for 6 months)
Registration
New Chemicals
Application for
Authorization
Toxic
Chemicals
Completeness
Check
Hazard
Assess.
Risk
Assess.
Registration
Inquiry & Data
Sharing
Authorization /
Restricted or
Prohibited List
Consultation
Notification
(for the Specific
Uses)
Banned
Manufacture etc.
Report
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How companies prepare for K-REACH?
K-REACH Data Requirements:
Tier 1
(0.5-5ton/y)
5
4
2
11
Physico-Chem. Properties
Human Toxicity
Environmental Toxicity
Sum Total
Tier 2
(5-50)
7
8
5
20
Tier 3
(50-500)
9
11
13
33
Tier 4
(over 500 ton/y)
12
15
19
46
PACs List Assumption: 2,086 substances
Standard of Prioritization
Hazardous
Volume (Tonnage Band)
CMR or PBT Substances
20 MT –
HPV Substances
20,000 MT CMR or PBT Substances
1 – 20 MT
10 – 20,000 MT
H410 or Toxic Substances
HPV Substances
1,000 – 20,000 MT
H410 or Toxic Substances
1 – 10 MT
HPV Substances
100 – 1,000 MT
Priority #
1
2
3
June 14, 2012
Estimated number of
substances
372
791
923
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Reference: Japan CSCL
Existing Chemicals (some 26,000)
New Chemicals
Chemical Substances already manufactured
when the CSCL was published in 1973
Published Chemicals (some 8,000)
Does not include monitoring chemicals
General Chemicals
Exempted
Chemicals
(some 1,5000)
(7-8,000 estimated)
More than 1 ton
Manufactured /
Imported
Review by the
Persistence
Bio-accumulative Government
Monitoring Chemicals
(vPvB, T is unknown.)
Sufficiently
low
risk concern
More than
1 MT
Less than
1MT
Notification by
Company
Review by the
Government
Intermediates
etc
PLC
Resource: METI
www.meti.go.jp/
Not biodegradable
Not bio-accumulative
Less than 10 t/y
Confirmation
Certain level of risk concern by screening
Priority Assessment Chemicals
Direction of longterm toxicity
investigation
Long-term toxicity to human
or higher trophic predators
Step-wise risk assessment
Direction of long-term toxicity
investigation
Class I Specified Chemicals
Class II Specified Chemicals
Risk to human or eco-system
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How companies prepare for K-REACH?
Japan CSCL – Risk Assessment Procedure
STEP 1. Classification of Exposure
Based on Notified information with regard to Annual quantity of manufacture etc./ use category
STEP 2. Classification of Hazard
Hazardous information collected by the Government and Industries
STEP 3. Prioritization Matrix
Resource: METI
www.meti.go.jp/
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Burden of Industry
Uncertainties:
Systematic Duplication on Registration
TCCA, OSHA etc.
Systematic Duplication on Authorization
Quality Control and Industrial Consumer Products Safety Act
Effectiveness of existing data
EU REACH, OECD HPV etc.
Obligation of Only Representative
Lowest Annual Report Volume
0.5? or 1.0 ton/year?
No Industrial Guidelines
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Nest Steps
Supplementation:
TFT Operation
Developments of Risk Management Factor,
Enforcement ordinances under K-REACH,
Technical Guidelines etc.
IT-Platform Establishment
Agreements among Authorities
Public Forum
to build up local(Korea) risk assessment measure
MoE – MoL – MEK
Authorities – Industries – Other interested parties
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