All You Need to Know About K-REACH Pre-notification

Little Pro on 2018-09-17

K-REACH pre-notification will start from 1 Jan 2019 and end on 30 June 2019. It is required for all >=1t/y existing chemical substances manufactured in or imported to Korea. Only those pre-notified existing substances can benefit from registration grace periods, during which one can manufacture or import those pre-notified substances without full registrations. In this article, we will summarize everything you need to know about the K-REACH pre-registration: scope, exemptions, who, when and info requirements.

K-REACH Pre-notification Scope

K-REACH pre-notification is only required for >=1t/y existing chemical substances. New chemical substances do not require pre-notification and they must be registered prior to manufacture or import. 

For mixtures, you need to know the identity of each substance in them and calculate the total volume of each substance in all mixtures. To find out if a substance is an existing substance or not, you shall search KECL first.

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K-REACH Pre-notification Exemption

Many >=1t/y existing substances qualify pre-registration exemptions. Please refer to the table below.

Exemption Description and Examples
Substances controlled by other regulations
  • Radioactive substances
  • Pharmaceutical products and quasi-drugs
  • Narcotics
  • Cosmetics and raw materials for cosmetics
  • Pesticides and active ingredients for pesticides
  • Fertilizers
  • Food, food additive, device and container/packages
  • Feeds
  • Gunpowder and military supplies
  • Health functional foods
  • Medical devices
  • Hygiene goods (i.e, food detergent)
  • Active substance and biocidal product under K-BPR
The first list of 510 PECS
  • Their grace periods have expired.
  • They must be registered pior to manufacture or import.
Substances exempt from registration (confirmation not required)
  • Chemical substance imported as already equipped machinery
  • Chemical substance imported together with relevant machineries or equipment for the purpose of trial operation
  • Chemical substances in articles with not intended release
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.
Substances annouced by MOE as exempt from registration due to their concerns
  • 44 exempt substances: glucose, etc.

Note: For >=1t/y existing substances which qualify for confirmation on exemptions, manufacturers or importers do not submit pre-notifications only if confirmation on exemption certificates have been obtained.

K-REACH Pre-notification: Who and When

A Korean manufacturer or importer of >=1t/y existing substances shall submit pre-notifications to Korea Environment Corp (KECO). This should be done between 1 Jan 2019 and 30 Jun 2019. Foreign manufacturers or formulators can appoint Korea-based only representatives to submit pre-notifications. Downstream users and foreign traders cannot submit pre-notifications.

Late pre-notification is also possible for existing substances exceeding 1t/y for the first time after 30 June 2019. 

How Is Annual Volume Determined?

It is based on the maximum manufacture or import volume in any given year from 2016 to 2018. It is not based on 3-year-average (like EU REACH).

K-REACH Pre-notification: Information Requirements

The following info is required for K-REACH pre-notification:

  • Substance identity info: name, CAS no. 
  • Estimated annual import/manufacture volume band
  • GHS classification and labelling
  • Use info (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

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

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

How to Comply with K-REACH Pre-notification Requirement

You shall firstly make an inventory of substances manufactured in or imported into Korea, determine if they are new substances or not and determine if they are exempt from K-REACH pre-notifications. Secondly, you shall make a final list of >=1t/y non-exempt exsting substances and gather their uses and classification & labelling. Finally, you shall submit pre-notifications on time. You can do it by yourself or use a consultant. 

Our next article will be "Everything you need to know about K-REACH registrations". Please subscribe to our newsletter to read more.

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 Tags: Topics - KoreaREACH-like Regulation and Registration