Sunday, April 19, 2015

[Polymer] Registration of Polymer under K-REACH

A new polymer which does not satisfy polymer exemption conditions under K-REACH shall be registered like new substance. However, required test data for a polymer are less than those for a substance. Please refer to the following table for data requirements in accordance with tonnage bands.
Volume of
manufacture and import
Data requirements
0.1 ~ 1ton/yr
- Physicochemical properties (state of substance, water solubility, melting/freezing point, boiling point, vapor pressure)
- GPC data
- Stability in acidic and alkaline conditions
1 ~ 10ton/yr
10 ~ 100ton/yr
- Data requirements of ,
- Acute oral toxicity (Acute inhalation toxicity shall be needed in case the main exposure pathway is considered as inhalation)
- Ames test
- Acute fish toxicity
- Ready biodegradability
100 ~ 1000ton/yr
- Data requirements of
- Physicochemical properties (octanol/water partition coefficient, density, granulometry)
- Skin irritation/corrosiveness
- Skin sensitization
- Acute daphnia toxicity
Over 1000ton/yr
- Data requirements of
- Physicochemical properties (flammability, explosive properties, oxidizing properties)
- Acute dermal toxicity or acute inhalation toxicity
- Eye irritation/corrosiveness
- In vitro chromosome aberration using mammalian culture cell
- Genetic toxicity
- 28days repeated dose toxicity
- Reproductive and developmental toxicity: screening
* can be substituted with test protocol
- Freshwater algae growth inhibition
- pH hydrolysis

* Polymer compounds with 1,000Mn<10,000 whose monomers, which are new chemicals, hazardous chemicals and chemicals with hazard and risk or announced by MoE, exceed 2%weight shall be registered, but if content of residual monomer is less than 0.1%, only physicochemical test data are required.

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