Korea

Differences between EU REACH Pre-registration and K-REACH Pre-registration

Little Pro on 2019-05-17 Views:  Update:2019-05-17

From 1 July 2019, >=1t/y existing chemical substances cannot be manufactured/imported/used in Korea unless they have been pre-registered under K-REACH. In this article, we will summarize the main differences between EU REACH pre-registration and K-REACH pre-registration to help you comply with the K-REACH pre-registration requirement.

Volume Calculation

Under K-REACH, volume trigger 1t/y is based on the maximum volume manufactured or imported in any given year from 2016 to 2018. Under EU REACH, the volume trigger is based on the average volume of three consecutive years.

Polymer

For a polymer, you calculate the estimated quantity of monomers contained and pre-register the monomers under EU REACH. Under K-REACH, you need to pre-register the polymer substance itself. For polymers which meet the criteria for polymer of low concern, it is recommended that you directly apply for confirmation on registration exemption to avoid full registration in the future.

Read more:How to Register Polymers under K-REACH

Raw Materials for Cosmetic Use

Under K-REACH, raw materials for cosmetics use are fully exempt from K-REACH pre-registration and registration. Under EU REACH, they are not.

Fertilizers

Under K-REACH, fertilizers are fully exempt from K-REACH pre-registration and registration. Under EU REACH, they are not.

Non-isolated Intermediates

Under both K-REACH and EU REACH, non-isolated intermediates are exempt from pre-registration/registration. However, under K-REACH, you also need to apply for confirmation on exemptions for non-isolated intermediates (very unwise requirement). Otherwise, the non-isolated intermediates are not exempt.

Priority Existing Chemical Substances (PECs)

For substances on the first list of 510 priority existing chemical substances subject to K-REACH registration, their pre-registration under K-REACH is forbidden since their grace periods have expired in July 2018. There is no such limitation under EU REACH.

Info Requirement

For EU REACH pre-registration, you only need to provide substance identification, legal entity info and estimated tonnage band. Under K-REACH, you need to provide for more info for pre-registration (see below):

  • Substance identity info: name, CAS no.
  • Estimated annual import/manufacture volume band
  • GHS classification and labelling
  • Identified uses (using K-REACH use descriptor system to describe uses)
  • Legal entity info: name, address, contact info of Korean legal entity
  • In case of using OR: OR appointment letter and names of importers

It should be noted that one applicant shall update their pre-registration within one month if there are changes with:

  • Annual volume
  • GHS classification and labelling
  • Uses
  • Contact info or change of OR

Recommendation?

There are many existing chemicals substances which qualify for exemptions from pre-registration/registrations (see table below). You shall apply for confirmation on exemptions first rather than submit pre-registrations since pre-registration is a only a temperary thing. 

Substances exempt from registration (application of confirmation on exemption required)
  • Chemical substance imported/manufactured for export-only use, including substance imported/manufactured to make export-only products.
  • Chemical reagents
  • Substances for R&D use
  • Surface treated substances
  • Non-isolated intermediates 
  • Isolated intermediates (which can be technically blocked from leakage or exposure)
  • Polymer of low concern.

References

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 Tags: Topics - KoreaREACH-like Regulation and Registration

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