Transcript PowerPoint 프레젠테이션

Chemical Control System
in Korea
June, 2005
Order of Presentation
1.Chemical Control System in Korea
2.Toxic Chemicals Control Law
3.Industrial Safety and Health Law
4.Label under TCCL & ISHL
5.Other Chemical Laws
6. International Harmonization
1
1.Chemical Control System in Korea
Products
Legislation
Authorities
Explosive, Oxidizing &
Flammable Products
Dangerous Substance
Control Law
Ministry of Government
Administration and
Home Affairs
Gunpowder
Gun, Sword and
Gunpowder Control
Law
Ministry of Government
Administration and
Home Affairs
High-Pressured
Gas
High-Pressured Gas
Safety Control Law
Ministry of Commerce,
Industry and Energy
Ozone Layer Depleting
Substances(CFC, etc)
Law Related to Manufacture Control of Specific
Materials for the Purpose
of Protecting Ozone Layer
Ministry of Commerce,
Industry and Energy
Pesticides
Agricultural Chemicals
Control Law
Ministry of Agriculture
2
1.Chemical Control System in Korea
Products
Hazardous Chemicals
(Industrial use)
Legislation
Authorities
Toxic Chemicals
Control Law
Ministry of Environment
Industrial Safety
and Health Law
Ministry of Labor
Pharmaceutical
Products
Pharmaceutical Affairs
Law
Ministry of Health
and Welfare
Cosmetics
Cosmetic Law
Ministry of Health
and Welfare
Food Additives
Food Sanitation Law
Ministry of Health
and Welfare
Radioactive
Substances
Atomic Energy Law
Ministry of Science
and Technology
3
2.Toxic Chemical Control Law (TCCL)
Status of Law



Feb. 2, 1990 legislated
Dec. 31, 1996 wholly amended
Dec. 31, 2004 wholly amended *
* Will be enforced from Jan. 1, 2006
* Enforcement Decree will be published on June or July this year
Purpose & Definition of TCCL


Prevention of harm to human health and the environment
Definition of Chemical Substances:
 a substance created by artificial chemical reaction on elements or
compounds
 substances extracted and purified from materials in nature
4
2.Toxic Chemical Control Law (TCCL)
Major Administration System






New Chemical Notification
Special Review of Existing Chemicals
by test and literature review
Control of Hazardous Chemicals
Control of Endocrine disrupter (Observational Chemicals)
Survey of Amount in Circulation
Survey of Toxic Release Amount (TRI)
5
2.Toxic Chemical Control Law (TCCL)
Review for New and Existing Chemicals
Chemicals
New Chemicals
Existing Chemicals
Notification
General
Chemicals
Safety Test
Observational
Chemicals
Toxic
Chemicals
Prohibition,
Restriction in
use
6
2.Toxic Chemical Control Law (TCCL)
Number of Notified New Chemicals
Total
’91~
’95
’96
’97
’98
2,696
568
168
235
244 218 314 328 300 321
Toxic
106
41
16
7
11
4
7
5
8
7
Observational
6
-
-
-
2
-
-
2
1
1
General
2,584
527
152
228
Number
R
E
S
U
L
T
’99 ’00 ’01 ’02
’03
231 214 307 321 291 313
7
2.Toxic Chemical Control Law (TCCL)
Number of Reviewed Existing Chemicals
Total
’88~
’95
’96
’97
’98
’99
’00
’01
’02
’03
951
245
44
499
37
40
35
20
16
15
Toxic
438
25
8
381
5
9
6
1
1
2
Observational
8
-
-
-
6
-
-
1
1
-
General
505
220
36
118
26
31
29
18
14
13
Tested
R
E
S
U
L
T
8
2.Toxic Chemical Control Law (TCCL)
Definition of Hazardous Chemical Substances
• Restricted/Prohibited Chemicals: severely harmful to human health
(4/55)
and the environment
* Business permit required
• Toxic Chemicals: harmful to human health and the environment
(548)
* Manufacturer registration, import report required
• Observational Chemicals: likely to be harmful to human health and the
(18)
environment
* annual report required/additional data may be required
• Accident Protection Chemicals: Chemicals with concern of accident
(from 2006)
* Large volume, high Physico-chemical hazard, high acute toxicity
9
2.Toxic Chemical Control Law (TCCL)
Existing Chemicals List (ECL)
Definition
• List of chemicals that have been manufactured
domestically or imported before the enforcement
date of Feb. 2, 1991.
Structure
• In an alphabetical order (IUPAC or CA Index Name)
• CAS No. Index
• Confidential part + Non-confidential part
• 36,000 Chemicals are listed
Can be searched by CAS Surveyer (CD-Rom); Chem list & STN(On-line)
10
2.Toxic Chemical Control Law (TCCL)
New Chemical Notification & Review
* From Jan. 1, 2006, only by TCCL (Ministry of Environment)
Public Notice
Notice
Notifier
NIER
Result of
Review
Review
Chemical
Examination
Committee
Request of Restriction
on Manufacture/ Import
Related
Ministries
11
2.Toxic Chemical Control Law (TCCL)
New Chemical Notification
- Chemicals Exempt from TCCL
(Chemicals controlled under other relevant laws)
• Radioactive Substances
• Pharmaceutical Products, Quasi-Pharmaceutical Products and
Cosmetics
• Narcotics
• Psychopharmaceuticals
• Agricultural Chemicals (Formulation only)
• Fertilizers
• Food and Food Additives
• Feeds
• Gunpowder
• Toxic Gases Defined under the High-Pressured Gas Safety Control
Law
12
2.Toxic Chemical Control Law (TCCL)
New Chemicals Notification
- Chemicals Excluded from Toxicity Review
• Toxic Chemicals
• Observational Chemicals
• Chemicals already Notified to the MOE as new chemical
• Other Substances to be Designated by Presidential
Decree
13
2.Toxic Chemical Control Law (TCCL)
New Chemicals Not Subject to Notification
• 100 kg or less per year
• R & D Chemicals
• Chemicals enclosed in machinery
• Articles in solid state
• Some natural chemicals
•
Chemicals accepted and announced by the Head of NIER as
having been manufactured domestically or imported into
Korea before Feb. 2, 1991
Review Period: 45 days
14
2.Toxic Chemical Control Law (TCCL)
Data Requirement for Notification
* From 2006, will be expanded step by step (First year, ecotoxicity data)
Types
Simplified
Notification*
Basic Data Set
One of following sets
- Acute oral test + Ames test;
- Acute oral test + Chromosomal aberration test; or
- Biodegradability (for biodegradable chemicals)
Polymer
Molecular weight, Characteristics, Stability data
Notification**
Full
Notification
Acute oral test + Ames test +
Chromosomal aberration test + Biodegradability test
* Listed on at least Two Other Foreign Inventories Before 1991
** Meet the Definition of OECD Polymer
15
2.Toxic Chemical Control Law (TCCL)
Required Information for Notification
• Notice Form
 Chemical Identity (name, structure, CAS No)
 Physico-chemical properties
 Information on Impurities (identity and percentage)
 Estimated volume per year for three years
• Information regarding exposure and its amount to
Environment
• Toxicity Data (except for polymer)*
 GLP Data from July 1, 1997
* Non-GLP for polymer
16
2.Toxic Chemical Control Law (TCCL)
Protection of Confidential Information
(adopted in June 1992)
– Items to be claimed : Chemical identities, testing data
– Items to be denied
: Notifier, MSDS & any data
already disclosed to the public
– Protection Period
: five(5) years
* Extension of five years upon request.
– Supporting Data
: Generic name
Reasons for confidentiality claim
17
2.Toxic Chemical Control Law (TCCL)
Report of Volume of Circulated Chemicals
Future plan : per 4 years
Result of 1999 Survey
Use : 234.1 million ton (29,283 Chemicals)
 Domestic manufactured 181.2 million ton (3,480
Chemicals)
 Imported : 42.2 million ton
Not open to public
18
2.Toxic Chemical Control Law (TCCL)
Custom Clearance
Are the Chemicals Excluded from TCCL?
Go to Relevant Law
Yes
NO
(1) By Components Certificate
(2) By Self-Certification Form
Submission of Component Information(KCMA)
(From Jan. 1, 2006, Component Certificate would not be required)
Are the Products Contain Toxic Chemicals?
NO
Notice of Toxic Chemicals
Yes
Are all components listed
in the Existing Chemicals List?
NO
Is Annual Volume (manufacture
/ import) 100kg or less?
Yes
Yes
Custom Clearance
Low Volume Exemption
NO
New Chemical Notification
19
2.Toxic Chemical Control Law (TCCL)
Confirmation Certificate for Customs Clearance
* This process will be changed in next year
– Issued from Korea Chemicals Management Association (KCMA)
– Application for Issuance of Confirmation Certificate to KCMA
• Submission of Component Certificate prepared by foreign
exporter
• Self-Certification for confidentiality
Self-Certification for full confidentiality Claim.
* This process will be changed in next year
– Preparation of “Self-Certification of Chemical Substance” form
in English form by exporter
• Send to importer
• Importer -- KCMA with Korean form prepared by importer.
20
2.Toxic Chemical Control Law (TCCL)
An Example of Component Certificate
Product Name
Chemical name
Abitol
1,3-Propanediol
HCl*
CAS No.
72-63-9
504-63-2
7647-01-0
%
8%
Signature
Name
Position
* A Product containing HCl
Content of 10% or more is Classified as Toxic Chemical
** Even in the Case When New Chemicals Are
Included, the Chemical Content Must be Indicated
21
2.Toxic Chemical Control Law (TCCL)
TRI (implemented Since 1999)
Chemicals
Business Type
1999
80
Petroleum Refinery; Chemical Companies
(100 or more employees)
2000
80
23 Business Types
(100 or more employees)
2001
160
23 Business Types
(50 or more employees)
2002
240
28 Business Types
(50 or more employees)
* Reported by Feb. of next year
22
2.Toxic Chemical Control Law (TCCL)
International Harmonization
• PIC enforced under TCCL (from Feb.24, 2004)
• Consideration on introduction of GHS
Future Plan
From Jan. 1, 2006, amended TCCL will be in effect.
Major Change
• Submission of new chemical notification -- Only to
MOE(National Institute of Environmental Research)
• Data requirement for new chemical notification will be
expanded
• Change of classification system of hazardous chemicals
* new: Accident Protection Chemicals
• Change of customs clearance procedure
* Self-Certificate only (proposed)
23
3.Industrial Safety & Health Law (ISHL)
Purpose
To protect from hazardous facts (hazardous ray, chemicals, noise,
etc.)
For Chemicals
• Prohibition or Restriction of highly hazardous chemicals
• TWA
• Report of Hazard Review Result (began enforcing 2/1/1991)
* will be deleted from next year
• MSDS (began enforcing 7/1/1996)
• Labeling
• Monitoring of hazardous chemicals at workplace
24
3.Industrial Safety & Health Law (ISHL)
Existing Chemicals
• Existing Chemicals List (8,000)
• Chemicals listed under other laws prior to 6/30/1991
* Including chemicals that have either received or are
in the process of applying for authorization and
approval of manufacture, import and use
• Combined with TCCL’s List in Dec. 1996
25
3.Industrial Safety & Health Law (ISHL)
Hazard Review Procedure of New Chemicals
(From 2006, this process will not be enforced)
Notice
Notifier
Public Notice
MOL
Hazard
Result of
Review
Review
Industrial
Chemicals
Research Center
Request of Restriction
on Manufacture/Import
Related
Ministries
27
3.Industrial Safety & Health Law (ISHL)
MSDS
Business Owner
• Responsibility of MSDS Preparation, and
Placement at workplace
• Also when transferring subject chemicals
29
3.Industrial Safety & Health Law (ISHL)
Contents of MSDS (16 headings)
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Chemical Product and Company Information
Components, Contents and Related Information
Hazardous Dangerous Property
First Aid Measures
Prevention Measures for Explosion Fire
Spill Response Measures
Handling and Storage Procedures
Exposure Prevention Measures / Personal Protective Equipment
Physical & Chemical Properties
Stability and Reactivity
Toxicological Information
Effects on the Environment
Precautions for Disposal
Transport Information
Regulatory Information
Other Information
30
3.Industrial Safety & Health Law (ISHL)
Standard for Preparing and Keeping the MSDS on File Etc.
(Public Notice 1997-27, MOL)
• IMDG Code and DGR Code : apply only until the business place for
first use
• Exceptions from MSDS filing requirement
 Less than 1% of Hazardous Chemicals Content (0.1% for
carcinogens)
 Solid Consumer Products (Except where carcinogenic chemicals
are included)
 Exceptions from MSDS Translation Requirement: R&D reagents
• Accept Foreign Languages for Experimental or Laboratory Chemicals
• Accept EU's Orange Background Color as Hazard Symbol
• Specific Standards of Classification of Hazardous Chemicals
• Itemizing Size of Warning Labels for Solid Consumer Products
Which Contain Carcinogenic Chemicals
31
4. Label under TCCL & ISHL
TCCL: Only for Toxic Chemicals
Product name
Hazard
Mark
Hazard
Mark
Hazard
Mark
…Substance
…Substance
…Substance
 Toxicity
 Handling precautions
32
4. Label under TCCL & ISHL
ISHL
[Warning Label in accordance with Article 41 of ISHL]
Product name
Hazard
Pictogram
Hazard
Pictogram
Hazard
Pictogram
…Substance
…Substance
…Substance
 Toxicity
 Handling precautions
As for other details, refer to the MSDS
33
4. Label under TCCL & ISHL
Pictogram of Hazard
• EU type
• Yellow or Orange Color Background
Explosives
Harmful
Irritant
sensitization
Oxidative
Corrosive
Extremely
flammable
Highly
flammable
Flammable
Water
prohibition
Hazardous to
Environment
Highly Toxic
Toxic
Carcinogenic
Mutagenic
Reprotoxin
34
5. Other Chemicals Laws
The Law Regulating Manufacture of Specific
Substances to protect Ozone Layer
Regulated Chemicals
– Specific chemicals
– Article containing specific chemicals
Permission for Manufacturer & Importer
Approval of amount
Seller : Sales plan (including usage, user)
35
5. Other Chemicals Laws
Laws Related to Manufacture and Import / Export
regulations of specific chemical Substances for the
purpose of restricting chemical weapons
Chemical Weapon : prohibited for all activities
Specific Chemicals
– Schedule 1 : permitted for Manufacture, Import/Export
– Schedule 2 : imported only from member countries
– Schedule 3 & Single Chemicals : reporting requirement only for
manufacturer
Reporting requirement
– Annual list (result of last year and plan of this year)
36
6. Intenational Harmonization
Stockholm Convention: adopted in May 17, 2004
PIC: adopted under TCCL in Feb. 24, 2004
GHS: 2004. 6. Task force was organized
(Inter-government committee & working group)
• Translation of Text book by task force
• Now distributed for public comment by relevant authorities
37
6. Intenational Harmonization
Stockholm Convention: adopted in May 17, 2004
PIC: adopted under TCCL in Feb. 24, 2004
GHS: 2004. 6. Task force was organized
(Inter-government committee & working group)
• Translation of Text book by task force
• Now distributed for public comment by relevant authorities
38