Polymer Registration under K-REACH: Scope, Data Requirements & Exemptions

Polymer registration is of crucial concern for the chemical industry. Under K-REACH, only polymers designated as priority substances or new chemical substances require registration. Unlike EU REACH, polymers will be individually registered instead of monomer registration.

1. Polymer Registration Scope

All new polymers are required to be registered, regardless of tonnage, if not listed in the Korea Existing Chemicals Inventory (KECL) by 1 Jan 2015 ( K-REACH implementation date).          

When polymers are designated by MoE as priority substances, and are manufactured or imported in volumes greater than 1 tonne per year, they are subject to existing chemical registration.

So far, the priority list subject to existing chemical registration under K-REACH hasn’t been issued yet. The whole list is categorized in to priority 1, 2 and 3 chemical substances which will be issued every three years with a three-year grace period for each category. Although the industry is anxious to know whether their existing substances are subject to registration, the government is holding off issuing the first batch until Oct 2014, and will cover less than 500 substances. However, based on the designation criteria, potential registrants can by estimating the total trading amount of their substances in Korea, with the consideration of the substances’ hazard information, make an inference on the potential of their substances being listed. The criteria are specified as below. The registration of polymer under K-REACH only applies to those included in the PECs list, which would cover the polymers subject to authorization and restriction under EU REACH. It seems most of the companies involved in the manufacture or import of polymers under K-REACH can feel relieved.

Table 1. Criteria for designation of priority substances subject to registration

2. Polymer Registration Data

No low-volume exemptions will be granted for new chemical substance registration under K-REACH. The 0.1 tonne per year threshold stipulated under TCCA which currently governs Korea’s new chemical substances will not apply to K-REACH. However, K-REACH has set 1 tonne per year as a threshold for new chemical substances subject to simplified registration. The tonnage threshold will be reduced to 0.1 tonne after 2020. So if the polymer belongs to new chemical substance and is in quantities less than 1 t/y (2015.1.1~2019.12.31) or less than 0.1 t/y since 2020 under K-REACH then simplified registration can be applied for.

Table 2. Simplified Registration

Note: simplified registration is only granted for new chemical substances.

After 1 Jan 2020 new polymers manufactured or imported in a range of 0.1 to 1 tonne per year will no longer benefit from the simplified registration, and should additionally submit testing data generated for 5 physiochemical items. The processing period will be extended to 30 days, same as the general registration corresponds to 4 tonnage bands (1-10, 10-100, 100-1000, above 1000 t/y).

In addition, the existing polymers selected from the KECL as priority substances, if manufactured or imported above 1 ton per year should submit corresponding testing data according to the 4 tonnage bands. The detailed data requirements are specified as below.

Table 3. Testing Data Requirements of Polymer Registration

There is currently no existing chemical registration obligations in Korea. TCCA governs the new chemical registration and for the polymers belonging to new chemical substances, the data requirements under TCCA are simplified and are almost the same as that required for the tonnage band of 0.1 to 1 t/y (since 2020) under K-REACH. Obviously, polymer registration will be tightened under K-REACH. It is more efficient to register the polymer under TCCA and thus obtain exemption from K-REACH if your polymer is new and circulated in Korea with high tonnage band.

For testing data acceptance under K-REACH, in principle, physicochemical properties do not require GLP except for LogKow. Other toxicological and eco-toxicological data should comply with GLP protocols.

Data used for EU REACH registration, generated in compliance with OECD GLP protocol, is acceptable under K-REACH. However, monomers require registration under EU REACH while K-REACH requires registration of the whole polymer. Thus, the data cannot be used universally. As for the data generated from read-across approach based on the monomer’s data, the authority’s attitude is conservative. Due to the great difference of the nature of monomer and polymer, we predict a low acceptance of such data.

3. Polymer Registration Exemption

Seen from the comparison table below, polymer exemption criteria under K-REACH are not identical to those under TCCA. Some polymers exempt from TCCA may not meet the exemption criteria under K-REACH and will require registration after 2015. For such cases, in consideration of the fact that the Confirmation of Exemption obtained under TCCA is still valid under K-REACH, it is recommended to complete new polymer exemption application from the Korean Chemical Management Association (KCMA) under TCCA.

Table 4. Polymer exemption criteria under TCCA vs K-REACH

The table below summarizes the data required for polymer registration exemption. Under TCCA, the data requirements differ for different exemption cases. For K-REACH, those applying for Chemical Registration Exemption Confirmation should submit all the listed data.

Table 5. Data requirements of exemption application for polymer registration