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and comments to:
SMS +358 45 7396 0114 Twitter: #ChemicalsForum
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Petrochemistry,
81.9M Euro
(46%)Processing
industry,
51.6M Euro
(29%)
Fine chemistry,
28.5M Euro
( 16%)
Others,
10.7M Euro
(6%)
Inorganic
Chemistry,
5.3M Euro
(3%)
Petrochemistry
Processing industry
Fine chemistry
Others
Inorganic Chemistry
< Shipment amount ratio of Chemical industries
of Korea (2013) >
Stay active – send your questions
and comments to:
SMS +358 45 7396 0114 Twitter: #ChemicalsForum
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Reporting
≥ 100 ton/y : Jan. 1st 2015 ~
≥ 70 ton/y : Jan. 1st 2017~
≥ 50 ton/y : Jan. 1st 2018~
≥ 20 ton/y : Jan. 1st 2019~
≥ 10 ton/y : Jan. 1st 2020 ~
Risk
Assessment
Phase-in
Substances
( ≥ 1 ton/year)
Hazard
ExaminationRegistration
Designation as
Authorized
Substances
Designation as
phase-in
substances
subject to
Registration
Non-phase-in
Substances
(all)
Designation as
Restricted/
Prohibited
Substances
Designation as
Toxic Substances
Small amount registration
< 1 ton/year : ~ Dec. 31st 2019
< 100 kg/year : Jan. 1st 2020 ~
< Overview of Registration Process >
No Information Registration Criteria Remarks
1
Information of
manufacturer or
importer
○ New chemicals (all)
○ Phase-in substances
subject to registration
(Above 1 ton/year)
- Name, Address & Representative person
2
Chemical substance
identification
information
- Identity information including name, molecular
formula, chemical structure, etc.
3 Use
- Classification system, confirmed use, prohibited
use
4
Classification and
Labelling
- Items of global classification and labelling standard
(i.e. GHS)
5
Physical-chemical
properties - Differentiated according to tonnage (46 Max.)
- Submission of Full data or test summary
6 Hazard Information
7 Safe use guidance - Protective equipment, Emergency measures
8 Risk
○100 ton or more per year
(Gradually strengthened to
10 ton per year)
1) Hazard assessment
2) Exposure evaluation (Exposure scenario /
Exposure prediction),
3) Prepared in priority of safety confirmation
9
Exposure information,
Estimated Volume
< Registration Dossier >
(A) 15 items
1 t/y ≤ volume < 10 t/y
(A + B) 26 items
10 t/y ≤ volume < 100 t/y
(A+B+C) 37 items
100 t/y ≤ volume < 1,000 t/y
(A+B+C+D) 47 items
1,000 t/y ≤ volume
Physico-
chemical
Properties
1) State of substance
2) Solubility in water
3) Melting/freezing point
4) Boiling point
5) Vapor pressure
6) Octanol-water partition
coefficient
7) Density
8) Grain-size analysis
1) Combustible
2) Explosive
3) Corrosive
1)Viscosity
2) Dissociation constant
Hazards to
Human
1) Acuteoraltoxicity
but,acuteinhalation toxicity
when main exposurepathis
deemed toinhalation given
the substance’s
physicochemical
propertiesanduse
2) Reverse mutation
3) Skin irritation/corrosion
4) Skin hypersensitivity
1) Acute dermal toxicity or acute
inhalation toxicity
2) Eye irritation/corrosion
3) In vitro Mammalian
Chromosomal Aberration Test
4) genetic toxicity test w/ test
animals
5) Repeated Dose Toxicity (28days)
6) Reproductive & Developmental
Toxicity screening
1) Additional genotoxicity
(genotoxicity to reproductive
cells, etc.)
1) Repeated-dose toxicity
(90days)
2) Teratogenecity
3) Second-generation
4) Reproductive toxicity
Carcinogenicity
Hazards to
Environ-
ment
1)Fish acute toxicity
2) Easily-biodegradable
3) Acute Toxicity to
daphnia
magna
1) Growth inhibition of Freshwater
algae
2) Hydrolysis according to pH
values
1) Inherent Biodegradability
2) Confirmation of
degradation product
3) Chronic fish toxicity
4) Chronic toxicity to
daphnia magna
5) Acute toxicity to land
plant
6) Acute toxicity to
invertebrates
7) Respiratory inhibition
causedbyactivatedsludge
8) Adsorption & desorption
1) Additional information on
environmental fate &
dynamics
2) Chronic toxicity to land
plant
3) Chronic toxicity to
invertebrates living on land
4) Additional information on
adsorption & desorption
5) Chronic toxicity to benthos
6) Bioaccumulation
< Requried Test Data>
< Overview of product safety management system>
< Timeline of ARECS Implementation>
< ARECs Implementation Organization >
Stay active – send your questions
and comments to:
SMS +358 45 7396 0114 Twitter: #ChemicalsForum
www.helsinkicf.eu/messagewall
< Data trading scheme for joint registration support >
Foreign
(EU)
Domestic
Lead Registrant,
Consortium and etc.
Consortium Proxy
(REACH Centrum etc.)
Negotiation Agency
(KCMA)
Consortium
Representative,
Consulting Agency
Direct
Negotiation
Offer Negotiation
Condition
④
⑥ Provide Information
⑤ Request Information (price ,
etc.)
Exchange of Information
Result
Notification
⑦
Negotiation
Request
①
Result Notification
⑧
Local
Agency
(Support
Negotiation)
<Negotiation Method Ⅱ.
Indirect Negotiation>
Stay active – send your questions
and comments to:
SMS +358 45 7396 0114 Twitter: #ChemicalsForum
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HCF 2016: Jee Yoon Lee

  • 1. Stay active – send your questions and comments to: SMS +358 45 7396 0114 Twitter: #ChemicalsForum www.helsinkicf.eu/messagewall
  • 2. Petrochemistry, 81.9M Euro (46%)Processing industry, 51.6M Euro (29%) Fine chemistry, 28.5M Euro ( 16%) Others, 10.7M Euro (6%) Inorganic Chemistry, 5.3M Euro (3%) Petrochemistry Processing industry Fine chemistry Others Inorganic Chemistry < Shipment amount ratio of Chemical industries of Korea (2013) >
  • 3. Stay active – send your questions and comments to: SMS +358 45 7396 0114 Twitter: #ChemicalsForum www.helsinkicf.eu/messagewall
  • 4. Reporting ≥ 100 ton/y : Jan. 1st 2015 ~ ≥ 70 ton/y : Jan. 1st 2017~ ≥ 50 ton/y : Jan. 1st 2018~ ≥ 20 ton/y : Jan. 1st 2019~ ≥ 10 ton/y : Jan. 1st 2020 ~ Risk Assessment Phase-in Substances ( ≥ 1 ton/year) Hazard ExaminationRegistration Designation as Authorized Substances Designation as phase-in substances subject to Registration Non-phase-in Substances (all) Designation as Restricted/ Prohibited Substances Designation as Toxic Substances Small amount registration < 1 ton/year : ~ Dec. 31st 2019 < 100 kg/year : Jan. 1st 2020 ~ < Overview of Registration Process >
  • 5. No Information Registration Criteria Remarks 1 Information of manufacturer or importer ○ New chemicals (all) ○ Phase-in substances subject to registration (Above 1 ton/year) - Name, Address & Representative person 2 Chemical substance identification information - Identity information including name, molecular formula, chemical structure, etc. 3 Use - Classification system, confirmed use, prohibited use 4 Classification and Labelling - Items of global classification and labelling standard (i.e. GHS) 5 Physical-chemical properties - Differentiated according to tonnage (46 Max.) - Submission of Full data or test summary 6 Hazard Information 7 Safe use guidance - Protective equipment, Emergency measures 8 Risk ○100 ton or more per year (Gradually strengthened to 10 ton per year) 1) Hazard assessment 2) Exposure evaluation (Exposure scenario / Exposure prediction), 3) Prepared in priority of safety confirmation 9 Exposure information, Estimated Volume < Registration Dossier >
  • 6. (A) 15 items 1 t/y ≤ volume < 10 t/y (A + B) 26 items 10 t/y ≤ volume < 100 t/y (A+B+C) 37 items 100 t/y ≤ volume < 1,000 t/y (A+B+C+D) 47 items 1,000 t/y ≤ volume Physico- chemical Properties 1) State of substance 2) Solubility in water 3) Melting/freezing point 4) Boiling point 5) Vapor pressure 6) Octanol-water partition coefficient 7) Density 8) Grain-size analysis 1) Combustible 2) Explosive 3) Corrosive 1)Viscosity 2) Dissociation constant Hazards to Human 1) Acuteoraltoxicity but,acuteinhalation toxicity when main exposurepathis deemed toinhalation given the substance’s physicochemical propertiesanduse 2) Reverse mutation 3) Skin irritation/corrosion 4) Skin hypersensitivity 1) Acute dermal toxicity or acute inhalation toxicity 2) Eye irritation/corrosion 3) In vitro Mammalian Chromosomal Aberration Test 4) genetic toxicity test w/ test animals 5) Repeated Dose Toxicity (28days) 6) Reproductive & Developmental Toxicity screening 1) Additional genotoxicity (genotoxicity to reproductive cells, etc.) 1) Repeated-dose toxicity (90days) 2) Teratogenecity 3) Second-generation 4) Reproductive toxicity Carcinogenicity Hazards to Environ- ment 1)Fish acute toxicity 2) Easily-biodegradable 3) Acute Toxicity to daphnia magna 1) Growth inhibition of Freshwater algae 2) Hydrolysis according to pH values 1) Inherent Biodegradability 2) Confirmation of degradation product 3) Chronic fish toxicity 4) Chronic toxicity to daphnia magna 5) Acute toxicity to land plant 6) Acute toxicity to invertebrates 7) Respiratory inhibition causedbyactivatedsludge 8) Adsorption & desorption 1) Additional information on environmental fate & dynamics 2) Chronic toxicity to land plant 3) Chronic toxicity to invertebrates living on land 4) Additional information on adsorption & desorption 5) Chronic toxicity to benthos 6) Bioaccumulation < Requried Test Data>
  • 7. < Overview of product safety management system>
  • 8. < Timeline of ARECS Implementation>
  • 9. < ARECs Implementation Organization >
  • 10. Stay active – send your questions and comments to: SMS +358 45 7396 0114 Twitter: #ChemicalsForum www.helsinkicf.eu/messagewall
  • 11. < Data trading scheme for joint registration support > Foreign (EU) Domestic Lead Registrant, Consortium and etc. Consortium Proxy (REACH Centrum etc.) Negotiation Agency (KCMA) Consortium Representative, Consulting Agency Direct Negotiation Offer Negotiation Condition ④ ⑥ Provide Information ⑤ Request Information (price , etc.) Exchange of Information Result Notification ⑦ Negotiation Request ① Result Notification ⑧ Local Agency (Support Negotiation) <Negotiation Method Ⅱ. Indirect Negotiation>
  • 12. Stay active – send your questions and comments to: SMS +358 45 7396 0114 Twitter: #ChemicalsForum www.helsinkicf.eu/messagewall