HCF 2016: Jee Yoon Lee
-
Upload
chemicals-forum-association -
Category
Presentations & Public Speaking
-
view
343 -
download
0
Transcript of HCF 2016: Jee Yoon Lee
Stay active – send your questions
and comments to:
SMS +358 45 7396 0114 Twitter: #ChemicalsForum
www.helsinkicf.eu/messagewall
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
www.helsinkicf.eu/messagewall
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
1Information of
manufacturer or
importer
○ New chemicals (all)
○ Phase-in substances
subject to registration
(Above 1 ton/year)
- Name, Address & Representative person
2Chemical substance
identification
information
- Identity information including name, molecular
formula, chemical structure, etc.
3 Use- Classification system, confirmed use, prohibited
use
4Classification and
Labelling
- Items of global classification and labelling standard
(i.e. GHS)
5Physical-chemical
properties - Differentiated according to tonnage (46 Max.)
- Submission of Full data or test summary6 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
9Exposure 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) Acute oral toxicity
but, acute inhalation toxicity
when main exposure path is
deemed to inhalation given
the substance’s
physicochemical
properties and use
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
caused by activated sludge
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>
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 AgencyDirect
Negotiation
Offer Negotiation Condition
④
⑥ Provide Information
⑤ Request Information (price , etc.)
Exchange of Information
Result Notification
⑦
NegotiationRequest
①
Result Notification
⑧
Local Agency
(Support Negotiation)
<Negotiation MethodⅡ. Indirect Negotiation>