How to Register Polymers under K-REACH

Korea

How to Register Polymers under K-REACH

Little Pro on 2019-04-19

Unlike EU REACH, K-REACH requires the registration of polymer itself. A new polymer substance must be registered prior to its manufacture or import and >=1t/y existing polymer substances must be pre-registered and registered within a given deadline. Some polymers can be exempt from registration if they meet the criterial for the polymer of low concern (PLC). Non-PLCs must be registered as regular substances. In this article, we will summarize how to register polymers under K-REACH with a focus on PLC criteria and reduced data requirements for the registration of non-PLCs.

Polymer of Low Concern (PLC) Criteria under K-REACH

OECD defines polymers of low concern as polymers that are deemed to have insignificant environmental and human health impacts. Examples include polymers with high molecular weight which are less likely to cross biological membranes and do harm. Under K-REACH, polymers of low conern are exempt from (pre-)registration. However, companies must submit applications of confirmation on exemptions (PLC exemptions) to authorites and obtain confirmation that their polymers meet PLC criteria.

The PLC criteria under K-REACH are listed as follows:

Index	Criteria
Scenario 1	Number average molecular weight >1000 Da & < 10000 Da; and Oligomers with molecular weight less than 1,000 Da < 25%; and Oligomers with molecular weight less than 500 Da < 10%; and Non cationic polymer (excluding high molecular compounds which are used only in solid state, and not soluble or dissolved in water); and Content of residual monomers (hazardous substances) in polymer less than 0.1% (* new under amended K-REACH)
Scenario 2	Number average molecular weight > 10000 Da; and Oligomers with molecular weight less than 1,000 Da < 5%; and Oligomers with molecular weight less than 500 Da < 2%; and Non cationic polymer (excluding high molecular compounds which are used only in solid state, and not soluble or dissolved in water);

To apply for PLC exemptions, companies need to submit the following info:

Polymer name and identification number
GPC report & number average molecular weight
Information on monomers and their content
Information on the content of residue monomers.

Registration of Non-polymers of Low Concern (non-PLC)

Non-PLCs must be registered as regular substances according to the table below. A new polymer is defined as a polymer substance that is not listed in Korea Existing Chemicals List.

Substance Type	Obligations
New polymer substance < 100kg/y	Notification prior to manufacture/import (No hazard data requirement)
New polymer substance >= 100kg/y	Registration prior to manufacture/import (Hazard evaluation required)
Existing polymer substance >= 1t/y	Pre-notification between 1 Jan 2019 and 30 Jun 2019 Registration within given grace periods.

Reduced Registration Data Requirements for Non-PLCs

The registration data requirements for non-polymers of low concern (Non-PLCs) can be reduced according to the schedule below.

>=1000t/y polymer: data requirement is the same as 100-1000t/y non-polymer new substances.
100-1000t/y polymer: data requirement is the same as 10-100t/y non-polymer new substances.
10-100t/y polymer: data requirement is the same as 1-10t/y non-polymer new substances.
1-10t/y polymer: data requirement is the same as 0.1-1t/y non-polymer new substances.

K-REACH also offers reduced test data requirements for existing non-PLCs . For example, if an existing polymer substance does not have health hazard and environmental hazard (i.e, not GHS-classified), test data requirements can be reduced to the level of 1-10t/y irrespective of volume bands.

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