K-REACH Polymers

In Korea polymers are not generally exempt from K-REACH. They are divided into two groups: PLCs (Polymers of Low Concern) need an exemption dossier and non-PLCs need a full dossier according to K-REACH requirements.

LAUS can support you with studies for the characterization of your polymer and for dossier endpoints.

Characterization for all Polymers

All polymers have to be characterized in order to determine whether they are PLCs or non-PLCs.

Polymer Characteristics:
- Number average molecular weight and molecular weight distribution
- Monomer composition information: monomer name and content (%) and content of residual monomers (%)
- Content of MW 1,000 or less(%)
- Stability in acidic and alkaline condition

PLCs can be described according to the following criteria:

- Polymers Mn ≥ 10,000
Mw < 1,000: < 5%
Mw < 500: < 2%

- Polymers Mn ≥ 1,000 ∼ < 10,000
Mw < 1,000: < 25%
Mw < 500: < 10%

Mn: number average molar mass determined by GPC

Mw: mass average molar mass determined by GPC

Excluded from PLCs are:

Cationic polymers (except cases used only in its solid state, as polymers not dissolved or dispersed in water）
Polymers Mn < 10,000, if 2 % of monomers/reactants are a “New chemical substance” or a “Chemical substances designated by MOE”

For all polymers basic physico-chemical properties have to be determined:

	Test Method OECD TG	All polymers
Physical state		X
Water solubility	105	X
Melting/freezing point	102	X
Boiling point	103	W
Vapor pressure	104	W

Data Requirements for non-PLCs (non- “Polymers of Low Concern”)

Physico-chemical Properties

	Test Method OECD TG	1-10 t/a	10-100 t/a	100-1,000 t/a	>1,000 t/a
Partition coefficient n-octanol/water	117, 107, 123			W	W
Relative density	109			X	X
Granulometry	110			X	X
Flammability					W
Explosive property					W
Oxidizing property					W

Toxicology

	Test Method OECD TG	1-10 t/a	10-100 t/a	100-1,000 t/a	>1,000 t/a
Acute oral toxicity toxicity (or inhalation) *)	423 (403)		x	x	x
Acute dermal toxicity (or inhalation) *)	402, 403				x
Skin corrosion/irritation*)	404 IVT			x	x
Eye corrosion/irritation*)	405 IVT				x
Skin sensitization*)	406/429 IVT			x	x
Ames test	471		x	x	x
In vitro chromosome aberration	473/487				x
In vivo gene mutation*)					x
Repeated toxicity (28 days) *)	407/410/412				x
Screening for reproductive/development toxicity*)	421/422				x

Ecotoxicology

	Test Method OECD TG	1-10 t/a	10-100 t/a	100-1,000 t/a	>1,000 t/a
Short-term fish toxicity	203		x	X	X
Short-term daphnid toxicity	202			X	X
Algae growth inhibition	201				X
Ready biodegradability	301/310		W	W	W
Hydrolysis as a function of pH	111				W