chemical control system in korea june, 2005. order of presentation 1.chemical control system in...

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


Products Legislation Authorities

Explosive, Oxidizing & Dangerous Substance Ministry of Government Flammable Products Control Law Administration and Home Affairs

Gunpowder Gun, Sword and Ministry of GovernmentGunpowder Control Administration and Law Home Affairs

High-Pressured High-Pressured Gas Ministry of Commerce,Gas Safety Control Law Industry and Energy

Ozone Layer Depleting Law Related to Manufac- Ministry of Commerce,Substances(CFC, etc) ture Control of Specific Industry and Energy

Materials for the Purposeof Protecting Ozone Layer

Pesticides Agricultural Chemicals Ministry of AgricultureControl Law

2


Products Legislation Authorities

Hazardous Chemicals Toxic Chemicals Ministry of Environment(Industrial use) Control Law

Industrial Safety Ministry of Laborand Health Law

Pharmaceutical Pharmaceutical Affairs Ministry of HealthProducts Law and Welfare

Cosmetics Cosmetic Law Ministry of Healthand Welfare

Food Additives Food Sanitation Law Ministry of Healthand Welfare

Radioactive Atomic Energy Law Ministry of ScienceSubstances 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 nature4


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


Chemicals

Notification

Safety Test

General Chemical

s

ToxicChemicals

New Chemicals Existing Chemicals

ObservationalChemicals

Prohibition,Restriction

in use

Review for New and Existing Chemicals

6

Total ’91~’95

’96 ’97 ’98 ’99 ’00 ’01 ’02 ’03

Number 2,696 568 168 235 244 218

314 328 300 321

RESULT

Toxic 106 41 16 7 11 4 7 5 8 7

Observa-tional

6 - - - 2 - - 2 1 1

General 2,584 527 152 228 231 214

307 321 291 313

2.Toxic Chemical Control Law (TCCL) Number of Notified New Chemicals

7


　　　　　　　　　　　　

Total

’88~’95

’96 ’97 ’98 ’99 ’00 ’01 ’02 ’03

Tested 951 245 44 499 37 40 35 20 16 15RESULT

Toxic 438 25 8 381 5 9 6 1 1 2Observa-tional

8 - - - 6 - - 1 1 -

General 505 220 36 118 26 31 29 18 14 13

Number of Reviewed Existing Chemicals

8


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


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


New Chemical Notification & Review * From Jan. 1, 2006, only by TCCL (Ministry of Environment)

NIER

Chemical ExaminationCommittee

Related Ministries

Result ofReview

Public Notice

Notifier

Review

Request of Restriction on Manufacture/ Import

Notice

11


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


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


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


Data Requirement for Notification * From 2006, will be expanded step by step (First year, ecotoxicity data)

* Listed on at least Two Other Foreign Inventories Before 1991** Meet the Definition of OECD Polymer

Types Basic Data Set

One of following setsSimplified - Acute oral test + Ames test;Notification* - Acute oral test + Chromosomal aberration test; or

- Biodegradability (for biodegradable chemicals)

Polymer Molecular weight, Characteristics, Stability data Notification**

Full Acute oral test + Ames test + Notification Chromosomal aberration test + Biodegradability test

15


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


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


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


Custom Clearance

Are the Products Contain Toxic Chemicals?Are the Products Contain Toxic Chemicals?

Submission of Component Information(KCMA) Submission of Component Information(KCMA)

Are the Chemicals Excluded from TCCL?Are the Chemicals Excluded from TCCL?

Is Annual Volume (manufacture/ import) 100kg or less?

Is Annual Volume (manufacture/ import) 100kg or less?

Are all components listed in the Existing Chemicals List?

Are all components listed in the Existing Chemicals List?

New Chemical NotificationNew Chemical Notification

NO

NO

NO

NO

Yes

Go to Relevant Law

Notice of Toxic Chemicals

Custom Clearance

Low Volume Exemption

Yes

Yes

Yes

(1) By Components Certificate (2) By Self-Certification Form

19

(From Jan. 1, 2006, Component Certificate would not be required)


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


Product Name

Chemical name CAS No. % Abitol 72-63-9

1,3-Propanediol 504-63-2 HCl* 7647-01-0 8%

An Example of Component Certificate

Signature

NamePosition

* 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


TRI (implemented Since 1999)

* Reported by Feb. of next year

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)

22


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

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

Hazard Review Procedure of New Chemicals (From 2006, this process will not be enforced)

MOL

Industrial ChemicalsResearch Center

Related Ministries

Result ofReview

Public Notice

Notifier

Hazard ReviewRequest of Restriction on Manufacture/Import

Notice


27


MSDS

Business Owner

• Responsibility of MSDS Preparation, and Placement at workplace

• Also when transferring subject chemicals

29


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


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

Hazard Mark

Product name

…Substance

…Substance …Substance

Toxicity Handling precautions

Hazard Mark

Hazard Mark

32


ISHL

Hazard Pictogram

Product name

…Substance

…Substance …Substance

Toxicity Handling precautions

HazardPictogram

Hazard Pictogram

33

[Warning Label in accordance with Article 41 of ISHL]

As for other details, refer to the MSDS

Pictogram of Hazard• EU type• Yellow or Orange Color Background


34

Explosives Oxidative

Corrosive

Hazardous to Environment

HarmfulIrritantsensitization

Extremely flammableHighly flammableFlammableWater prohibition

Highly Toxic ToxicCarcinogenicMutagenicReprotoxin

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

chemical control system in korea june, 2005. order of presentation 1.chemical control system in...

Documents

chemical control system

chemical laws6

toxic chemicals control

artificial chemical

gassafety control lawindustry

high physicochemical

human health

accident protection