Systematization for Registration and
Evaluation of Chemical Substances

Nov. 2014
Ministry of Environment
Chemical Management Division

1 Background and Progress
2 Main Regulations
3 Follow-up Implementations
4 Future Plan

1
Background and Progress

1. Background and Progress마스터 제목 스타일 편집

Global Status: Chemicals

마스터 텍스트 스타일을 편집합니다

At a global level,

둘째 수준
셋째 수준
넷째 수준
다섯째 수준

8.8 million chemicals developed
120,000 chemicals
commercially distributed

2,000 new chemicals registered per year
44

1. Background and Progress마스터 제목 스타일 편집마스터 텍스트 스타일을 편집합니다
둘째 수준
셋째 수준
넷째 수준
다섯째 수준

• Essential for modern times, but hazardous to human health andenvironment ☞ Precautionary measures needed

551. Background and Progress마스터 제목 스타일 편집

DDT(1939~1973)마스터 텍스트 스타일을 편집합니다
✓ Substance of Miracles (1939)둘째수준 pest eradication, etc- Malaria
prevention,

셋째 (P.H.Muller)수준- A developer
won Nobel prize(1948)넷째 수준✓ Adverse다섯째effects
수준on Ecosystem(e.g. red-tailed robin, trout, etc)
- Rachel Carson, Silent Spring (1962)- Prohibition of use in U.S. (1973)✓ Still used for prevention of Malaria
and typhus in several countries
661. Background and Progress마스터 제목 스타일 편집

Damage from thalidomide (1957~1961)마스터 텍스트 ✓
스타일을
편집합니다
Morning sickness inhibitor

둘째수준- No adverse effects from animal testing
셋째 수준

넷째 수준
✓ 12,000
infants with birth defects다섯째 수준

from 50 countries- 4 years spent to identify causes※ U.S. was the only country without damages(Sales not authorized based on toxicity analysis data)✓ Reused for chemotherapy- 2.5 billion dollars earned per year

77

1. Background and Progress마스터 제목 스타일 편집

Damage from humidifier disinfectant (2011~2013)마스터 텍스트
스타일을편집합니다✓Carpetantibacterial agents, etc(‘97)
둘째+ 수준
- Water
PGH / PHMG (0.01%)- Reused
humidifier disinfectant agents
셋째as수준

넷째 수준✓Unidentified
lung damage다섯째 수준

(e.g. acute respiratory failure)- Frequently occurred in the pregnant,infant/babies✓Suspected cases (April,14)- Of 361 patients examined, 27 confirmed
to have lung damage; 41 with high possibility;
8
42 with low possibility8

1. Background and Progress마스터 제목 스타일 편집

Chemicals,difficult to know …
마스터 텍스트 스타일을 편집합니다
Especially, their 셋째
HAZARD!!
수준둘째 수준

If we use them well,넷째If수준
we use them wrong다섯째 수준

99

1. Background and Progress마스터 제목 스타일 편집

Introduction of EU REACH (June‘07)마스터 텍스트 스타일을 편집합니다둘째 수준
Protect public health and the environment셋째 수준- Secure chemical substance information
before market release 넷째 수준다섯째 수준

Strength competitiveness of EU chemical industry- Armed with the latest technology and service -Obtain human∙physical resources- developed IT system, established ECHA 10101. Background and Progress마스터 제목 스타일 편집

EU,
U.S,
Japan,
마스터텍스트스타일을 China…
편집합니다
둘째 수준

No Data

셋째 수준
넷째 수준
다섯째 수준

No Market !!
.....Global Standard
1111

1. Background and Progress마스터 제목 스타일 편집

Needs for Korea Act on Registration and Evaluation, etc
of Chemical Substances마스터 텍스트 스타일을 편집합니다

1
2
3

Protect human health and the environment둘째 수준from unknown chemicals
셋째 수준
넷째 수준
Obtain chemical safety data다섯째 수준

Promote occupational safety management
Chemical accident of humidifier disinfectant
Prevention of repeated chemical accident⇒ Needs for advancing
chemical registration and evaluation system
12121. Background and Progress마스터 제목 스타일 편집
Develop a system for securing advanced chemical information

Definition of
the Korea Act

EU REACH(introduced in June‘07) "No Data, No Market“

management
based on 綠色化學마스터 Chemical
텍스트
스타일을
편집합니다
Expect for developing eco-friendly substances and risk management methods둘째 수준

Annual reporting; registration prior to manufacture / import; information provision셋째 수준

Extended to existing chemicals (prior public notice, grace period for registration)넷째 수준다섯째Institute수준 of Environmental Research
Hazard assessment by National

Examination/evaluation of registered substances, designation of hazardous substances

Details

Safety management of household chemical products and biocide
Declaration of product containing hazardous chemicals, Safety standard
labeling for risk-concerned product, etc

Current Status‘11.4.

‘12.9.

‘13.5.

‘13.8‘14.2~4Legislation ofLegislation ·ChemicalPublicChemicalaccident of
noticeaccident in announcement of the subordinate laws
Korea
Act
humidifier
Gu-midisinfectant
Issue•Formation/operation of consultative body among stakeholders① Exemptionfromregistration* The original law unchanged if its opinion violates the intent of the lawof R&Dsubstance-Prolong grace period for registration of small-medium enterprises,
not subject to confirmation of exemption of R&D substances below 1 ton ② Registrationof small
volume new chemicals‘14.6.

Present

Regulatory
examination
completed

Ongoing review
by Legislative
OfficeDraftsubordinatelaw
Maintain the current law (exemption); add safetymeasure(submissionofmanagementplan,etc)
13
Small volume to be registered, simplify submission data,
13
shortenregistrationperiod,etc

2AOverview of the Act

2A. Overview of the Act

마스터
제목
스타일
편집
(Chemical substance)
Registration → Evaluation/Assessment → Designation of hazardous chemicals

마스터 텍스트 스타일을 편집합니다
둘째 수준
셋째 수준
넷째 수준
다섯째 수준

15
15

2A. Overview of the Act마스터 제목 스타일 편집(Chemical substance)
Designation of Risk concerned product → Evaluation → Management standard마스터 텍스트 스타일을 편집합니다
둘째 수준
셋째 수준
넷째 수준
다섯째 수준
Enforcement Date: 2015.1.1
Risk data submission criteria to be strenghened
Date2015.1.1

2017.1.1

2018.1.1

2019.1.1

2020.1.1

Criteria

100t/year

70t/year

50t/year

20t/year

10t/year16
16

2A. Overview of the Act마스터 제목 스타일 편집
Reporting : All new chemicals = existing chemicals ≥ 1ton/year

Reporting마스터 텍스트 스타일을 편집합니다
Grace period [3year]
Grace period [3year]

Grace period [3year]둘째 수준

Substance subject to registration ≥ 1ton/year

Regist셋째 수준

ration[Low quantity] New Chemicals < 1ton/year< 100㎏/year넷째 수준[General Registration]
New Chemicals
다섯째 수준

Risk[Manufacture/Import]≥ 100t/yr

Data
Product
Reporting

Preannounceme
ntof
Substance

14.1.115.1.1(Enforcement)≥ 70t/yr ≥ 50t/yr ≥ 20 t/yr ≥ 10 t/yr

Reporting hazard chemical substance contained in products > Total 1ton/year

16.1.1

17.1.118.1.119.1.120.1.117
17

마스터 제목 스타일 편집마스터 텍스트 스타일을 편집합니다

2B
둘째 수준

셋째 수준

넷째 수준
다섯째 수준

Main Contents18

2B-1. Reporting of
Manufacture etc.

2B-1-1. Meaning of Reporting System마스터 제목 스타일 편집

Meaning of Reporting① Understanding in advance of an obligator of joint submission , Fundamental data for designation of existingchemicals subject to registration마스터 텍스트 스타일을 편집합니다

② Understanding status of obligator’s performance , Use of substance after registration, Confirm the fact of volume
changeReporting Method

둘째 수준
셋째 수준

- Report the status of chemicals of the preceding year by June 30 of the following year넷째 수준
- A person responsible for reporting the manufacture, importingand sellingof chemicals etc. of chemicals ⇒ Except다섯째수준Obligator of Reportfor users in business, sales to consumers

Contents of Reporting- ① Report Company Name, ② Name of the chemical substance, Identity number, ③ Quantity of manufacture,use/sales, ④ Detailed use- In case of seller, Product name, Buyer, If report composition elements, ②, ③, ④ can be omitted

Exemption of Reporting- Low effectiveness of existing chemical substance in terms of risk
* Since reporting is to understand the status of registration performance, except existing chemical substancewhich have no possibility to be applicable to registration(Notification)
20
20

마스터 제목 스타일 편집마스터 텍스트 스타일을 편집합니다
둘째 수준
셋째 수준

넷째 수준
2B-2. Registrationof다섯째 수준
Chemical Substance21

2B-2-1. Registration Procedure마스터 제목 스타일 편집

Division of Registration and Evaluation Procedure (Similar to EU)마스터 텍스트 스타일을 편집합니다

Division between Review procedure of submission data( Registration) and Review of contents(Evaluation)

둘째 수준
셋째 수준
넷째 수준
다섯째 수준

22
22

2B-2-2. Substance subject to registration마스터 제목 스타일 편집
Designation System of Existing Chemicals Subject to Registration마스터 텍스트 스타일을 편집합니다

Every 3 years Designation and Announcement of Existing Chemicals Subject to Registration둘째 수준- Result of Report and Statistical survey, Consideration of domestic/overseas data regarding hazard &risk

셋째 수준
Grant 3 year Registration Grace period넷째 수준수준
- 3 year registration grace period referring to EU다섯째
REACH registration period* REACH Fermentation('07.6) after First : ‘10.12(3yr6mth), Second : ‘13.5(6yr), Third : ‘18.5(11yr)

Prior notice for Designation- Prior notice schedule(‘14yr) before enforcement23
23

2B-2-3. Substance subject to registration마스터 제목 스타일 편집

Chemical Substance subject to registration by type

ImpuritiesㆍBy-productfrom registration마스터 텍스트except
스타일을
편집합니다

둘째 수준
- Fill in the application registration(Similar
to EU)
셋째 수준 purpose or Non-commercial value* Impurities : By chance or Unintended, Non-commercial
to other chemical substances넷째 수준다섯째 수준

Different types of intermediates- Non-isolated: Exemption / Isolated: Registration* Intermediate : A substance that is manufactured for and consumed in or used forchemical processing in order to be transformed into another substance.

Low concern Polymer is exempted from registration- Exceptions: Cationic polymer, etc.

2424

2B-2-4. Substance subject to registration마스터 제목 스타일 편집
Registration of Small Quantity New chemical Substance마스터 텍스트 스타일을 편집합니다

Simplification of Registration Below 1 ton/year('20yr 0.1t)

둘째 수준- Submission Data : Business information, Use, Identification information, Purpose셋째 수준of Use related to exposure information넷째 수준다섯째 수준

- Period : Notification within 3 days after registration(If necessary additional review:7 days)- In case of concerning of consumer exposure and exceeding accumulation ofsmall quantity standard, submit additional data25
25

2B-2-5. Exemption of Chemical Registration

마스터
제목
스타일
편집
Exemption of Chemical Registration① Chemicals in imported machineries마스터 텍스트 스타일을 편집합니다

② Chemicals in imported machineries devices for test-run

둘째 수준③ Chemicals contained in solid form product that is not released during use

Chemicals subject to Registration셋째
Exemption
수준 Confirmation넷째 수준다섯째 수준

1. Chemicals that are intended for manufacture or import for scientific experiment, analysis such as reagents(Annual Basis)

2. For the purpose of research and development (R&D plan Basis)
3. Low concern polymers (For the first time)
4. Chemically surface-treated chemicals that are intended for manufacture/import in which both the substances subject tosurface-treating agent are not new chemicals or existing chemicals subject to registration (For the first time)
5. Chemicals such as manufactured or imported in amounts that are no more 10 tons for the purpose of exporting theentire quantity abroad (Annual Basis)
6. Chemicals such as manufactured or imported in amounts that are no more 10 tons for the purpose of exporting theentire quantity abroad to manufacture other chemicals (Annual Basis)
7. Non-isolated intermediate and isolated materials of certain condition (For the first time)26
26

2B-2-6. Chemicals subject to Registration Exemption
Confirmation마스터 제목 스타일 편집

Chemicals for Experiment analysis, Research and Development마스터 텍스트 스타일을 편집합니다

Regulation of Chemicals subject to Registration Exemption Confirmation(Same as current hazard regulation)

둘째 수준
셋째 수준

- Process development, Reagent, Demonstration manufacture before product, For test etc. Materialization넷째 수준다섯째 수준
Permit transfer out of a place of business, Reinforce of Safety- Submission of proof data for research and development, safety plan, post processing plan etc.

2727

2B-2-7. Data apply for Registration마스터 제목 스타일 편집

Specific Data apply for Registration (Similar to EU)

Materialization of Data of identification information, use, classification, labelling, characteristic, Hazard,마스터 텍스트 스타일을 편집합니다

Risk,etc

Information

둘째 수준

Registration Criteria

Remarks셋째수준- Name,Address & Representative person

1

Information of manufacturer
or importer2

Chemical substanceidentification information

3

Use○ New chemicals

4Classification and Labeling○ Existing chemicals subject toregistration- International classification, Materialization of GHS items

5

Physical-chemical properties

6

Hazard Information- Differentiation according to tonnage(46 Max.)- Submission of Full data or test summary

7

Safe use guidance- Protective equipment, Emergency measures

8

Risk

9

Exposure information,
Estimated Volume(Above 1 ton/year)○100 ton or more per year
(Gradually strengthened)- Identity수준
information including name, molecular formula, chemical넷째structure etc.
다섯째 수준
- Use classification system, known use, prohibited use- 1) Hazard assessment, 2) Exposure assessment(Exposure
scenario / Exposure prediction), 3) Safety confirmation28
28

2B-2-8. Data apply for Registration마스터 제목 스타일 편집
Submission of testing date (Differential according to annual manufacturing import volume)

1ton above~10ton below : Max 14 items (A)10ton above~100ton below : Max 25 items (A+B)
100ton above~1,000ton below : Max 36items (A+B+C)
1,000ton above : Max 46 items (A+B+C+D)

Will announce test exemption
criteria by typeEx) When result of Bacterial
Reverse Mutation Test andchromosome aberration test isnegative, accept gene mutation test
instead of animal test마스터 텍스트 스타일을 편집합니다
둘째 수준

Type
Physicochemical
properties

Toxicology
properties
testing

Ecotoxicology
property
testing

A

B

셋째 수준

1) State of the substance,2) water solubility1) Flammability3) melting/freezing point, 4) boiling point
2) Explosiveness5) vapour pressure, 6)Partition coefficient3) Oxidising propperties
n-octanol/water
7) Relative density , 8) Granulometry
1) Acute toxicity by oral route or Acutetoxicity by inhalation
2) Eye irritation/corrosion
1) Acute oral toxicity, if exposure path3) in vitro Mammalian Chromosome
determines to be inhalation, acute
Aberration Test
inhalation toxicity4) in vivo Mammalian Cell Gene Mutation
2) Bacterial Reverse Mutation Test
Test3)Skin irritation/corrosion
5) Repeated Dose 28-day Oral Toxicity4)Skin sensitisation
Study in Rodents
6) Reproduction/Developmental Toxicity
Screening Test

CD넷째1) Viscosity수준2) Dissociation constant다섯째 수준

1) short-term toxicity testing on fish2) Ready Biodegradability
3)
short-term
toxicity
testing
invertebrates1) Alga growth inhibition teston 2) Hydrolysis as a Function of pH

1) Additional Mutagenetic toxicity(Germ cell mutagenicity tests)

1) Inherent biodegradability test
2) Informationofdecomposition
products
3) Chronic toxicity test in fish4) Daphnia magna Reproduction Test
5) Terrestrial Plants, Growth Test
6) Earthworm, Acute Toxicity Tests
7) Activated Sludge, Respiration
Inhibition Test
8) Adsorption/Desorption screening

1) Subchronic oral toxicity test (90 days)
2) Teratogenicity
3) Two-Generation Reproduction Toxicity
Study4) Carcinogenicity

1) Additional information of environmental fateand distribution2) Terrestrial Plants Reproduction Test
3) Earthworm Reproduction Test
4) Additional information of Absorption/
Desorption screening5) Sediment-Water Chronomid Toxicity
6) Bioconcentration: Flow-through Fish Test
7) Additional information of decomposition
products

2929

2B-2-9. Data apply for Registration마스터 제목 스타일 편집
Rationalization of Registration data (Similar to EU)마스터 텍스트 스타일을 편집합니다

Acknowledgment of 非Test data(QSAR, read-across) and test plan substitute

Omit test, in case of experiment execution Impossibility and no possible damages that may둘째 수준

cause exposure to human body or the environment셋째 수준

Current
No exception fortest data넷째 수준
K-REACH다섯째 수준
Test data can be omitted⇒ Small quantity⇒Dramatically expansion of non-Test data
∙ QSAR , read-across(Structure Similarity)⇒ In case of impossibility of technical test
⇒ In case of non-exposure to human, environment⇒ Acknowledgment of Test plan substitute∙ No structure of test base, Long-time required

30
30마스터 제목 스타일 편집마스터 텍스트 스타일을 편집합니다
둘째 수준
셋째 수준
넷째 수준
다섯째 수준

2B-3. Evaluation, Assessment
And
Designation of Hazardous
Chemicals31

2B-3-1. Evaluation, Assessment System마스터 제목 스타일 편집

Hazard Evaluation : Notification of Result of Registered hazardous chemicals- Review of test data submitted by manufacturer and Property data마스터 텍스트 스타일을 편집합니다

- Additional data can be required for submission regarding consumer hazardous chemical
substance and Biocide둘째 수준◇ Grounds for additional date can be ordered for submission- As a result of review of propriety and reliability, require revision, supplement셋째 수준- Concerns about exposure to human body and environment based on use and exposure
information넷째 수준- Small quantity of existing chemicals which were manufactured, imported accumulation다섯째 수준
amount isexceed 1 ton- Possibility of designation as hazardous chemical substance- Biocide, Products containing hazardous chemical substance- In case of need of test data specialty

Hazard Assessment : Government self-assessment of Internationalorganization evaluation substance and entire quantity export substance etc.

Risk Evaluation : Implement of evaluation and Notification of result based on
the result of hazard examination- Selection of evaluation substance, Preparation of hazard assessment report32
32

2B-3-2. Designation of Hazardous substances마스터 제목 스타일 편집

Designation : Evaluation· Assessment Result, Hazardous Substance, Authorized
Substance, Restricted Substance, Prohibited SubstanceCriteria
Remarks
마스터Designation텍스트스타일을 편집합니다

Category
Hazardous○ Hazard examination Result- Possible damage to
Ecotoxicology substance

human

body·

- Name, Classification, whether
substance is a hazard substancethechemical둘째 수준

Mutation· Bio accumulative etc.
셋째-- Carcinogenic·
수준Classification,
Name,
Authorized use, Grace period
Authorized

Restricted/
Prohibited○ Hazard examination + Risk evaluation result- Risk-concerned substance○ Hazard examination + Risk evaluation result- Admitted risk substanceetc.
넷째- prior수준
notice + Acceptance of an opinion procedure- Prepare risk evaluation plan,socio-economic
다섯째수준
analysis plan(If needed)- International organization, International agreementetc.
- Name, Classification, prohibited use- Prior notice + Acceptance of an opinion procedure-Prepare risk evaluation plan, socio-economic analysis
plan(If necessary)

Management : According to「Chemical Control Act('15.1.1 Enforcement)」- Strengthen business authorization and standard use management of handling33
facilities etc.
33

2B-3-3. Designation of Risk-posing substances마스터 텍스트 스타일을 편집합니다

Prohibited
Restricted
Authorized

Toxic substance according to TCCA

Toxic

마스터
제목
스타일 편집
Designationof toxic
substance* Current status of designation of toxic substance according to harmful regulation(May 2014) :둘째 수준

687 chemicals included in Benzene, Toluene, Sodium peroxide etc.
⇒ regard as toxic substances according to K-REACH(Additional clause Article 2)셋째 수준

Supplement to correspond with UN GHS

넷째 수준* GHS : Globally Harmonized System of Classification and Labelling of Chemicals
다섯째 수준

- Repeated exposure toxicity, Mutagenicity, Carcinogenicity, reproductive toxicity(Health Hazard)- Aquatic acute ecotoxicity, Aquatic chronic ecotoxicity (Environment Hazard) establishment or
improvement* Repeated exposure toxicity requires additional aquatic ecology toxicity item about algae, a water flea,
exclusion of specific exposure period* Maintain Acute oral · Dermal and Inhalation toxicity · Skin corrosion etc. which is coincident
with GHS* Low item of toxicity level(Eye damage etc.) and No reflection of items which is not standard of GHS(Aquatic34
plant growth inhibition test, etc.)34

2B-3-4. Designation of Hazardous Chemical
Substances

마스터
제목
스타일
편집
Designation of Authorized Chemicals

Significance: In case of Restriction·prohibition of Manufacture·Import·Use, will cause chaos in industry마스터 텍스트 스타일을 편집합니다

* Restricted‧Prohibited Chemicals : Prohibition of manufacture, import, use as a special or all use둘째 수준* Current status of designation of restricted·prohibited substances(‘14.5mth) :Handling prohibited substances(60 DDT, PCBs, Current asbestos etc. substances), Handling셋째 수준

restricted substances넷째 수준(12 Malachite green, Nonylphenol etc. substances)다섯째 수준
⇒ In spite of high hazardous chemicals, If industry’s cost burden is higher than benefit of national healthcare for a certain period, It is allowed to manufacture, import, use for a certain period⇒ Proper management of high risk concerned substances, Induce development of substitute substancegradually◇ EU REACH :- Development promotion of substitute substance, For the purpose of gradual market liquidation of risk-posing
substances- Designation of 134 authorized candidate substances(‘13.12),
35- Currently Designation of Musk xylene, MDA, HBCDD, DEHP, BBP, DBP etc.31 as authorized object substance (‘14.6)

35

2B-3-5. Designation of Hazardous Chemical
Substances마스터 제목 스타일 편집

Authorization Grace Period : Manufacture, Import, Use without authorization* Considering the use, manufacture and usage cycle of the relevant chemical subject toauthorization마스터 텍스트 스타일을 편집합니다
둘째 수준

Criteria of designation of chemicals subject to Authorization : Similar to EU REACH셋째 수준

Category

EU REACH Criteria

K-REACH넷째 수준다섯째 수준

Cancer“Directive 67/548/EEC”Carciogenic Category1/2 Substance

Table4. 1, Ga mok

Mutation“Directive 67/548/EEC”Mutagenic Category1/2 Substance

Table4. 1, Na mok“ Directive
Substance

Table4. 1, Da mok

Reproductive toxicity

67/548/EEC”Reproduction

Endocrine system
Endocrine Disruptor
disorderResidual-prone/LivingorganismAnnex 1 PBT Substanceaccumulatise/Toxicity
High residual-prone/Highliving organism
Annex 13 vPvB substanceaccumulatise

toxicity

Category1/2

Table4. 1, Ra mok

Table4. 2

Table4. 3

3636

마스터 제목 스타일 편집마스터 텍스트 스타일을 편집합니다
둘째 수준
셋째 수준
넷째 수준
다섯째 수준

2B-4.Chemical Substances ∙Mixtures Information offering37

2B-4-2. Chemical substances ∙Preparation
Information offering마스터 제목 스타일 편집

Registered chemical substances, Contained mixtures Information offering : Substance·mixtures
Transferor ⇒ Transferee마스터 텍스트 스타일을 편집합니다

- Registration Number, Name, Hazard·Risk Information, Safety use information etc.

둘째 수준

(In case of occurrence of change item : within 1 month)수준- In case of repeated transfer: At the first time 셋째of transfer
넷째of 수준
-「Occupational Safety and Health Act.」Acceptanceinformation for MSDS다섯째 수준
Bilateral Information Offering : Provide within 1 month from the date of opposite party’s request- Downstream user·Seller⇒ Manufacturer·Importer : Use, Exposure information, Volume of usage ·sale, safety use etc.
- Manufaturer· Importer⇒ Sub-user·Seller : Use, Characteristic, manufacture·import quantity,
Safety use information etc.
Notification by Minister of Environment : If modification to the information, notification to registeredperson.

38
38

2B-4-3. Specific contents of Information
Offering마스터 제목 스타일 편집“Chemical Substance Safety Information” Offering마스터 텍스트 스타일을 편집합니다

Name, Hazard, Limited Use, Precaution etc. Mainly offer chemical substance safety
information etc.

둘째 수준

- Component, Content etc. Except for business confidential information, Quantity of
manufacture·Import·sale can be omitted셋째 수준Content넷째 수준다섯째 수준
- Offering Registration content relevant to classification, Labeling, Hazard etc.

Period- Offering according to simplified form before transfer or concurrently

3939마스터 제목 스타일 편집마스터 텍스트 스타일을 편집합니다
둘째 수준
셋째 수준
넷째 수준
다섯째 수준

2B-5. Chemical ProductManagement40

2B-5-1. Reporting of Products Containing
Hazardous Chemical Substances마스터 제목 스타일 편집

Reporting Requirements마스터 텍스트 스타일을 편집합니다

(Total quantity criteria) Product production and Importer base, total quantity exceeds 1ton peryear by chemical substance둘째 수준(Content criteria) Weight ratio of products containing chemical substance: Exceed 0.1%
(Similar to EU REACH)셋째 수준(Preparation product) Except for product in Article 2, 15ho, na mok넷째 수준다섯째 수준

Weight ratio(0.1%)※ Article 2.15. “Product“ mean goods that are ultimately used by consumers or parts or components of such goods,
and which fall under the following with the possibility of exposing consumers to chemical substances.
Ga. Products consisting of preparation
Na. Products where chemical substances are not released during use, but perform a certain function
while in the form of a certain solid form.

(For consumer) For consumer product subject to report, Except for industrial product4141

2B-5-3. Risk-Posing Products마스터 제목 스타일 편집

Risk-posing products : Concerns about posing risk to people’s health or the environment, Announcement of
Ministry of Environment마스터 텍스트 스타일을 편집합니다

① Products such as cleaners, air fresheners, adhesives, polishes, odor removers, synthetic detergents ,bleach,fabric softners, etc., used by the general consumer primarily for household use둘째 수준② Biocide such as insect repellents, disinfectants, preservatives, etc.

셋째 수준

Risk Evaluation : Evaluation risk-posing products for each type넷째 수준
-Enforcement of government self risk evaluation without submitting
producer· importer’s hazard data
- If necessary, require data submission, Collect sample

다섯째 수준

- In case of incident of domestic/overseas hazardous concern, Emergency enforcement, Determine whether
hazardous or not<Method of hazard examination of products containing hazardous chemical substances>plan- Basic plan should be established every 2 years by President of National Institute of Environmental Research

Object- International regulation product, Detection products containing hazardous chemical substance

Evaluation
Method-Confirmation of product containing hazardous chemicals → Computation of exposure allowable tolerance →Evaluation of degree of exposure→Risk etc. process4242

2B-5-4. Risk-posing Products마스터 제목 스타일 편집

Safety• Labeling Standards : According to risk evaluation, announce the safety and labeling standards regarding
risk for each type
- Registration• Examination•Evaluation of chemicals(⇒ Hazard∙Risk Information), Set the standard by making

마스터 텍스트 스타일을 편집합니다

use of status of product reporting etc, synthetically둘째 수준- Designation of unserviceable hazardous chemical substance or Set the safety standard such as volume ofcontent yield of water evapotranspiration etc. of product containing hazardous chemical substance(including
container packaging)

셋째 수준

넷째 수준
Prohibition of Sales, etc. : No selling or presenting as a importof products다섯째수준unsuitable according to the safety andlabeling standards- A person Intending to produce or import risk-posing products that do not have safety or labeling standards shallsubmit data by preclearance of the Minister of Environment
Withdraw Order, etc. If products doesn’t meet the standard, risk concerned product whose standard are notnotified:- Possible damages to health or the environment → Collect, Withdraw, Prohibition of Sales, Scrapping, Order totake a improvement • correct- Order to take emergency measures to prevent spread of damage

4343마스터 제목 스타일 편집마스터 텍스트 스타일을 편집합니다

3A
둘째 수준

셋째 수준

넷째 수준
다섯째 수준

System Implementation
44

3A. System Implementation마스터 제목 스타일 편집

Selection of Existing Chemical Substance subject to Registration

Overview마스터 텍스트 스타일을 편집합니다
Designation. Announcement considering ①Domestic volume, ②Hazard․ Risk among existingchemical substances
K-REACH

둘째 수준

셋째 수준

Article 9

Persons jointly submitting registration application data are all in agreement, they may jointly submit
test data in 3 years of grace period넷째 수준다섯째 수준
Future Direction
Pre-announcement 518 substances
Official announcement after gathering the opinions in 2016
Will review the criteria to select substance for notification after 3 yrs
45
45

3A. System Implementation마스터 제목 스타일 편집Transfer of control of household use
chemical productsHousehold product

BiocideProduct underOverview
Quality마스터 텍스트 스타일을 편집합니다
Transfer of control for household product(‘12.11)

management andindustrial safety law(8)cleaners, air
freshners,
adhesives,
polishes, odor
remover, synthetic
detergents,
bleach, fabricsoftners

Uncontrolled product(7)둘째 수준Reflect applicable provision(Chapter
6) 수준
셋째

넷째 수준
Apply Product under Quality management and industrial safety law 다섯째 수준
before the announcement of safety standard

Discussing the time of transfer

rustinhibitor,
antifogging
agent,
colorant‧decoloring
agent, dyefor tatoo

Insectrepellents,
disinfectants,
preservatives

Future Direction
Develop Safety․ Labeling standards(Regulation) this year based on hazard assessment(Safety standard) use ban substance & set of substance content, reinforcement of substance standard(Labeling standard) Labeling of hazardous substance contents, Review of duty of indication partly all ingredient

Negative method regulation(Exception : positive regulatory scheme for biocidal ingredientRoutine checkup, Reinforcement of market monitoring etc. construct of follow-up system
Arranging follow-up guideline such as watchdog and operation of accident investigation center46
46

3A. System Implementation마스터 제목 스타일 편집

Compositionof Evaluation Committee

Overview마스터 텍스트 스타일을 편집합니다
Established to deliberate on K-REACH main system(Article7)둘째 수준(Matters of deliberation) formation of the basic plan, designation of existing chemical subject to registration,
designation of chemicals subject to restricted and prohibited, safety and labeling standards of risk-posing products셋째 수준Composition of Specialized Committee넷째 수준다섯째 수준

①Risk Evaluation Committee, ②Governing Committee for risk-posing products, ③Social Economy Analysis
Committee

Future Direction
Composition of Evaluation Committee(Within 30 people) and Specialized Committee by
field(Within 10 people) in a year
(Evaluation Committee) Equal ratio of expertise and experience in the fields of chemistry ,environment, health, toxicity,
economy and policy(Specialized Committee by Field) organized with private member
After enforcement, management of evaluation committee according to appointment47
47

마스터 제목 스타일 편집마스터 텍스트 스타일을 편집합니다

3B
둘째 수준

셋째 수준

넷째 수준
다섯째 수준

Establishing Management Basis48

3B. Establishing Management Basis마스터 제목 스타일 편집

Securement of Management Manpower

Overview마스터 텍스트 스타일을 편집합니다

Necessary to increase personnel for Evaluation and Assessment at the
National Institute of Environment Research personnel(currently 4
people)

둘째 수준

셋째 수준

Increase of Registration Substance(330substances/yr→About 2thousand substances/yr),
Increase of test data submission items(16→46items), Implementation of New System(hazard넷째 수준evaluation etc.)다섯째 수준

New chemical substance(0.1ton →all), Existing chemical substance(Regulated →1ton/year)

Future Direction
Until ’15 year-end 30~40people(including temporary position) level manpower
securement
Additional securement of manpower according to transfer of Life chemicals
management
49
49

3B. Establishing Management Basis마스터 제목 스타일 편집

Securement of Management Manpower

Overview
Type
Physicochemical
properties마스터 텍스트 스타일을 편집합니다A

B

C

1) State of the substance,2) water solubility1) Flammability3) melting/freezing point, 4) boiling point
2) Explosiveness5) vapour pressure, 6)Partition
3) Oxidising propperties
coefficient n-octanol/water
7) Relative density , 8) Granulometry
1) Acute toxicity by oral route or Acutetoxicity by inhalation
2) Eye irritation/corrosion
1) Acute oral toxicity, if exposure path3) in vitro Mammalian Chromosome
determines to be inhalation, acute
Aberration Test
inhalation toxicity4) in vivo Mammalian Cell Gene
2) Bacterial Reverse Mutation Test
Mutation Test
3)Skin irritation/corrosion
5) Repeated Dose 28-day Oral Toxicity4)Skin sensitisation
Study in Rodents
6)
Reproduction/Developmental
Toxicity Screening Test

D

둘째 수준

1) Viscosity
2) Dissociation constant셋째 수준

Toxicology
properties
testing넷째 수준1) Additional Mutagenetic toxicity다섯째수준 tests)(Germ cell mutagenicity

1) short-term toxicity testing on fish
Ecotoxicolog
1) Alga growth inhibition test2) Ready Biodegradabilityyproperty3) short-term toxicity testing on 2) Hydrolysis as a Function of pH
testing
invertebrates1) Inherent biodegradability test
2) Information of decomposition
products
3) Chronic toxicity test in fish4) Daphnia magna Reproduction
Test5) Terrestrial Plants, Growth Test
6) Earthworm, Acute Toxicity Tests
7) Activated Sludge, Respiration
Inhibition Test
8)
Adsorption/Desorption
screening1) Subchronic oral toxicity test (90days) 2) Teratogenicity
3)
Two-Generation
Reproduction
Toxicity Study
4) Carcinogenicity

1) Additional information of environmental
fate and distribution2) Terrestrial Plants Reproduction Test
3) Earthworm Reproduction Test
4) Additional information of
Absorption/ Desorption screening5) Sediment-Water Chronomid
Toxicity
6) Bioconcentration: Flow-through Fish
Test7) Additional information of decomposition
products

50※1t∼10t: 14 items(A), 10t∼100t: 25items(A+B), 100t∼1,000t: 36items(A+B+C), 1,000 t above: 46items(A+B+C+D)

50

3B. Establishing Management Basis마스터 제목 스타일 편집Completion of Evaluation System마스터 텍스트 스타일을 편집합니다
Overview
둘째 수준

Requiring specific Testing data preparation method regarding test items(Max.46)
according to K-REACH셋째 수준

Currently announce testing methods of 33 testing items according to hazard regulation넷째 수준
Promotion of hazard evaluation core-technology development business(‘12.3 ~‘14.12)
다섯째 수준
Arranging evaluation skill of hazardous item, Korea environment behavior model, Consumer
exposure coefficient and evaluation model, Workshop exposure evaluation etc. related manual

Future Direction
OECD test guideline reference, Total Test Method Supplementation· Organization
Arrangement of testing method and data preparation method regarding the rest of 13 items

Announcement of Hazard data preparation method, Preparation of related technicalmanual“Joint Registration demonstration project” pilot written & applicability evaluation schedule

51
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3B. Establishing Management Basis마스터 제목 스타일 편집

Establishment· Operation of IT System

Overview마스터 텍스트 스타일을 편집합니다
To support performance. operation of the entire process system(K-REACH Article 39)둘째 수준①Development of report preparation system, ②Development of registration
evaluation system ③Portal system, ④Development of product registration
evaluation system

셋째 수준

넷째 수준
◇ Current status of IT system related to EU REACH- Consisting of REACH-IT, IUCLID5, ECHA Portal etc. 다섯째 수준- Development from ’07, launched in June ’08 and ’09 Completed(20.5 billion KRW during 3 yrs)
Future Direction
Chemical Substance information processing system
Open(‘14.12), Completion of Establishment(’15yr)’14yr Establishment of Basic System(2.5billion KRW), ’15yr Budget 2.8billion KRW)
Consideration of Integration of existing SYSTEM(NCIS) and System of
Chemical Substance Management
For convenience of Civil compliant, NCIS system operates separately,
Integration until ’15yr

52
52

3B. Establishing Management Basis마스터 제목 스타일 편집

Establishment of GLP test base

Overview마스터 텍스트 스타일을 편집합니다

Currently, Minister of Environment designates GLP testing Institution : 15둘째 수준

K-FDA(Medicine and Medical supplies Field 19)and Rural Development Administration(Agricultural pesticide Field 16)셋째 수준◇ GLP(Good Laboratory Practice) : Good laboratory operational standard- Standards regarding operating system, manpower, facilities etc., which are to be equipped as
testing institution to secure reliability of all kinds of chemical substance’s toxicity testing넷째 수준다섯째 수준
Undesignated item(12) among testing items required by K-REACH

30 items out of 46 testing items required by K-REACH, Invertebrate chronic toxicity, Plant acutetoxicity etc, 12 items are not designated.

Future Direction
Forwarding domestic testing basis establishment &Business of manpower training continually
Testing basis establishment : Environment damage field test. Evaluation skill, Testing facilities management
guideline, Testing item field, Construction facilities, Equipment standardization etc.(Annually 15 Million)
Training of Professional manpower : Environment damage field(19 items), GLP Institutional related

Utilize the test plan submission(Article14 3)53
53마스터 제목 스타일 편집마스터 텍스트 스타일을 편집합니다

3C
둘째 수준

셋째 수준

넷째 수준
다섯째 수준

Cooperation & Support of
Stakeholders

54

3C. Cooperation & Support of Interested
parties마스터 제목 스타일 편집

Support of Small and Medium Enterprises

Overview마스터 텍스트 스타일을 편집합니다
Legal system of small and medium enterprise's Implementation capacity is the outcome of the settlement system둘째 수준Domestic distribution by SMEs 26%(110 million tons/470 million tons),
number of SMEs 96%(15,905companies/16,547companies)셋째 수준

Launched “industry support group”(‘14.4)

넷째 수준다섯째 수준

To increase capacity of SME’s chemical safety management”(‘14.6.25, Minister’s meeting)Future Direction
K-REACH First in line(~’17yr) small and medium enterprises supporting business propulsion◇ ’15yr Support budget(Submission of National Assembly)- (Test data support) Small and medium-sized enterprises chemical substanceregistration‧ hazard evaluation
support(28Milliom)* offer national test data after produce‧ secure → foreign test data purchasing cost savings- (1:1 consulting expert support) small and medium-sized enterprises the whole system implementation procedures
support(20Million)* Confirmation of chemical substance, Preparation of registration data, Registration procedure etc. support- (Hazard evaluation support) Small and medium-sized enterprises hazard evaluation system implementation consulting(20Million)* Hazard evaluation report preparation support → Writing ability Enhancement and cost savings

55
55

3C. Cooperation & Support of Interested
parties마스터 제목 스타일 편집

Development of Green Chemistry Technology

Overview마스터 텍스트 스타일을 편집합니다

New paradigm“Green Chemistry”

둘째 수준▣ 12 Principals, Anatas & Warner(3) Less HazardousChemicalsSyntheses(4) DesigningSaferChemicals(5) Safer Solventsand Auxillaries넷째 수준(10) Designfor Degradation(11) Real-timeanalysis for PollutionPrevention
다섯째 수준
(12) InherentlySaferChemistryfor AccidentPrevention

셋째 수준

Main Function of Green Chemical Center is to develop technology in relation to risk evaluation of chemical substances andreduction and prevention of risks posed by main function of chemical substances(Article40)

Future Direction
Business promotion of Hazardous chemical substance reduction technology development
Select the project for pre-research project for joint planning project with related government(‘14.8)▣ Main Technology① Development of substitute substance and production of prototype regarding domestic/overseas chemical substanceregulation object substance② Use of hazardous chemical substances․ Emission reduction process development and substantiation

56
56

3C. Cooperation & Support of Interested
parties마스터 제목 스타일 편집

Establishment of communication system of chemical product risk information

Overview마스터 텍스트 스타일을 편집합니다

To increase public reliability for K-REACH, needs sound communication between
government and society둘째 수준

ECHA "Communication Strategy"(Goal : involve, cooperate, consult, inform)

셋째 수준
넷째 수준
다섯째 수준

MFDS “Communication
advisory committee”(regularmeeting with media, NGO,
experts)

Needs of cooperation measure between Government and civil organization

Future Direction
Inducing participation in the system of K-REACH
Composition of Evaluation Committee, Participation in establishing basic plan, Monitoring related
to risk-posing product safety, Cooperation of monitoring system

Vitalization of Communication regarding chemical product safety management
Review regular meeting & holding workshop among interested parties- Share hazardous chemical product information, Discussion of consumer problem presentation
items

57
57

4. Future Plan마스터 제목 스타일 편집of K-REACH IT마스터 텍스트 스타일을 Development
편집합니다Announce lower statute(‘14.11),
Following notification(’14.11~)

system, Secure personnel,둘째 수준establish test infrastructure
셋째 수준
넷째 수준
다섯째 수준

Online helpdesk, Guidance, Pilot
for joint registration
Perform supporting projectEvaluation committee,
Workshop for stakeholders, etc.

after enforcement
58
58

4. Future Plan마스터 제목 스타일 편집

Public health protection
K-REACH&Type
yourtext here.
Strengthen industrial
competitiveness Type your text here.

마스터 텍스트 스타일을 편집합니다
Type your text here.
둘째 수준Type your text here.
Type your text here. 셋째 수준
Typ
넷째 수준
Information
다섯째sharing
수준:Induce to develop
alternatives to reduce useof hazardous chemicals

Apply to safety use of chemical insociety as a whole
Authorization·restriction·probihited :Restrict manufacture, import and use ofchemicals
Registration·Evaluation(All new chemicals including existing chemicals
59
59

4. Future Plan마스터 제목 스타일 편집

Sustainable growth of Chemistry Industry
through realization Green Chemistry마스터 텍스트 스타일을 편집합니다
둘째 수준Management of chemical substance safety
information
Settlement of public concern and enhance of셋째 수준

Promotion of higher value-added chemistry넷째 수준
industry viable다섯째 수준

Innovation of eco-friendly management system

corporate image- Foster chemical substanceinformation manager- Expansion of R&D investment- Consultant etc. Service industry- Advancement of hazardous substancesubstitute technology- Expansion of Domestic test capacity- Promotion of developing chemicals
with cutting-edge technology
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60

Thank you