12
Stay active send your questions and comments to: SMS +358 45 7396 0114 Twitter: #ChemicalsForum www.helsinkicf.eu/messagewall

HCF 2016: Jee Yoon Lee

Embed Size (px)

Citation preview

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>

< 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 AgencyDirect

Negotiation

Offer Negotiation Condition

⑥ Provide Information

⑤ Request Information (price , etc.)

Exchange of Information

Result Notification

NegotiationRequest

Result Notification

Local Agency

(Support Negotiation)

<Negotiation MethodⅡ. Indirect Negotiation>

Stay active – send your questions

and comments to:

SMS +358 45 7396 0114 Twitter: #ChemicalsForum

www.helsinkicf.eu/messagewall