[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
① 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
② 1 ~ 10ton/yr
③ 10 ~ 100ton/yr	- Data requirements of ①, ② - 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
④ 100 ~ 1000ton/yr	- Data requirements of ③ - Physicochemical properties (octanol/water partition coefficient, density, granulometry) - Skin irritation/corrosiveness - Skin sensitization - Acute daphnia toxicity
⑤ Over 1000ton/yr	- Data requirements of ④ - 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 1,000≤Mn<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.

It is likely ; Deregulation in the required data for KOSHA registration.

▪ With regards to KOSHA registration with tonnage band of ‘over 0.1t/y’, the hazard studies which required to submit would be reduced from three(3) end points at present to one(1) end point.

 For the substance registration under KOSHA, it is required in principle to submit the 3 end points of toxicity(acute toxicity test-oral / inhalation, Ames test, and micronucleus test), even though micronucleus test is usually waived. But Korea Ministry of Employment and Labor(MoEL) has a plan to substitute those requirement with only the acute toxicity test. Also other genotoxicity studies like Ames test, micronucleus test could be ordered to submit by MoEL for the chemical substance that is expected to cause harmful risk to the health like mutagenicity.

▪ In addition, MoEL has a plan to shorten the duration for examination of registration dossier with tonnage band of ‘over 0.1t/y’ from 45 days at present to 14 days, i.e. MoEL will respond to each application of substance registration within 14 days.

▪ Expected schedule by MoEL

- 2015.4 : Preparation for amendment of the enforcement rule

- 2015.5 : Legislative notice

- 2015.7 : Review for regulatory and legislative purpose

- 2015.9 : Enactment and enforcement.

Registration of new chemical substance ; K-REACH vs KOSHA

▪ For the new chemical substance, which is defined as not-listed substance onto Korea Inventory of Existing Chemical Substance, it should comply with registration under both K-REACH and KOSHA, since K-REACH has come into enforcement as of January 1 2015.

▪ With the tonnage band of ‘over 1t/y’ before beginning of 2020, the dossier for K-REACH registration can be also submitted to MoEL for KOSHA registration without further hazard data development.

▪ However, be noted that there is conflict in the required hazard data for registration between K-REACH and KOSHA, only regarding registration with tonnage band of ‘0.1 to 1t/y’

▪ please refer to the comparison in the table for the details

Before 2020	K-REACH (MoE)		KOSHA (MoEL)
Tonnage	< 0.1t/y	01t/y~1t/y	< 0.1t/y	0.1t/y <
Required Data	Basic Information Only “No Hazard Data”		Exempted from registration		Basic Information + “Hazard Data1” Required

▪ Unlike K-REACH, because KOSHA does not have the legal definition of ‘Representative’(similar concept to Only Representative in EU REACH), the registration under KOSHA should be conducted by the name of Korea importer. Nevertheless KOSHA registration could be completed via the authorized 3^rd Party by the overseas manufacturer, without risk to disclose the worthy information of the substance(CBI) to Korea importers. 

How to register intermediates under K-REACH

▪ Intermediate means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance.

-          Non-isolated intermediate : an intermediate that is not intentionally removed from the equipment in which the synthesis takes place, during synthesis.

-          Isolated intermediate : other intermediate that is not falling in definition of Non-isolated intermediate.

▪ K-REACH compliance subject to Non-isolated intermediate

-          Exempted from the obligation of ‘Annual Reporting’

-          Exempted from the obligation of ‘Registration’, but prior confirmation of the registration exemption shall be required (just once at first time)

▪ K-REACH compliance subject to Isolated intermediate

-          Only “isolated intermediate which blocked from release or exposure by functional method” can be exempted from the obligation of ‘Registration’ but prior confirmation of the registration exemption shall be required (just once at first time)

-          Other isolated intermediates are subject to Registration. But, the submission of hazard data,  risk and exposure assessment, or safe use guidance could be exempted.

▪ According to consultation with the competent Korea Government, the authority is most likely to only consider ‘On-site, Isolated intermediate’ as ‘Isolated intermediate’ which defined under K-REACH. This means that in adverse ‘Transport, Isolated intermediate’ is considered as ‘Substance’. Therefore ‘Isolated intermediate’ imported into Korea should comply with K-REACH obligation as ‘Substance’, not as ‘Isolated intermediate’, even though the same substance is considered as ‘Isolated intermediate’ in the relevant regulations of other countries, like EU-REACH.

[Polymer] Comparison of Polymer Exemption Conditions between K-REACH and KOSHA

There are considerable differences in polymer exemption conditions between K-REACH and KOSHA. Therefore, if business entity intends to get confirmation of polymer exemption, they should consider exemption conditions of both K-REACH and KOSHA. If a new polymer satisfies exemption conditions under K-REACH but does not satisfy those under KOSHA, and vice versa, business entity should proceed registration or apply for confirmation of exemption from registration under K-REACH and KOSHA respectively. However, if a new polymer satisfies exemption conditions under both K-REACH and KOSHA, business entity has only to apply for confirmation of exemption from registration under K-REACH, which covers counterpart under KOSHA. Please refer to the following table for details.

K-REACH

KOSHA

Ø  Polymer compounds with Mn≥10,000 whose molecular content of MW<1,000 is less than 5% and that of MW<500 is less than 2% Ø  Polymer compounds with 1,000≤Mn<10,000 whose molecular content of MW<1,000 is less than 25% and that of MW<500 is less than 10% (Exception: polymer compounds whose monomers, which are new chemicals, hazardous chemicals and chemicals with hazard and risk or announced by MoE, exceed 2%weight) Ø  Exception: Cationic polymer compounds (excluding polymer compounds only used in solid form and not dissolved or dispersed in water)

Ø  Polymer compounds, whose Mn≥1,000, which  do not make cation, whose monomers are neither new chemicals, prohibited substances, substances subject to permission nor hazardous substances subject to control and which satisfy one of the following two conditions -       If insoluble in water or organic solvent, polymer compounds should not contain any metal, except sodium, magnesium, potassium or calcium -       If soluble in water or organic solvent, molecular content of MW<1,000 in polymer compounds should be less than 1%. If polymer compounds’ Mn<10,000, the monomers should not include double bond between carbons, triple bond between carbons, double bond between carbon and nitrogen, triple bond between carbon and nitrogen, aziridine group, epoxy group, sulfonic acid group, hydrazine group, phenolic hydroxyl group, or fluorine group