Korea

K-REACH Registration (2018-2019)

Little Pro on 2015-12-31 Views:  Update:2018-10-17

According to the article 10 of amended K-REACH regulation, any person who intends to manufacture or import a new chemical substance or at least one ton per year of an existing chemical substance shall register the chemical substance before he or she manufactures or imports the substance. Penalty is high for those who fail to comply with K-REACH registration obligations. In this article, we have summarized everything you need to know about the new K-REACH registration rules: scope, exemptions, info requirements, joint submission and reduced data requirements.

K-REACH Registration Scope

K-REACH registration is required for >=1t/y existing chemical substances and new chemical substances. 

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

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.

Note: Even if a substance is not subject to K-REACH registration based on the small volume of an individual company, the substance may require registration if its total volume in Korea exceeds the following thresholds and it has been designed/annouced as substances subject to registration by authorities (i.e, MOE). 

  • The total volume of a new substance >=1t/y
  • The total volume of an existing substance >=10t/y

K-REACH Registration Exemption

Many >=1t/y existing substances and new substances qualify for registration exemptions. Some exemptions only require self-judgements while other exemptions require the application of confirmation on exemptions. More info can be found in the table below.

Exemption Description and Examples
Substances controlled by other laws and regulations  (confirmation not required)
  • 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
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 no 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(PLC).
Substances annouced by MOE as exempt from registration due to their concerns
  • i.e, water, 
  • The list has not been published yet.

Who Can Register

Only Korean manufacturers and importers are obligated to register chemical substances under K-REACH. Foreign manufacturers may appoint Korea-based only representatives to submit chemical registrations on their behalf.

K-REACH Registration Deadline

New substances must be notified/registered prior to manufacture or import. >=1t/y existing substances must be pre-notified between 1 Jan 2019 and 30 June 2019 and get fully registered within the following registration deadlines.

Substance Type Registration Deadlines
  • 1 July 2018
  • >=1000t/y existing substances
  • >=1t/y CMR substances (to be annouced)
  • 31 Dec 2021
  • 100-1000t/y existing substances
  • 31 Dec 2024
  • 10-100t/y existing substances
  • 31 Dec 2027
  • 1-10t/y existing substances
  • 31 Dec 2030

K-REACH Pre-notification

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.

Read more about K-REACH Pre-notification

K-REACH Registration Info Requirements

The following info needs to be submitted for K-REACH registrations. Test data requirement is very similar to EU REACH and it increases with tonnage band. Testing proposal is also accepted for high tier studies.

  • Legal entity info
  • Trade name and chemical anme
  • Substance identification and notification number
  • GHS classification/labelling
  • Use information (using standard use descriptor)
  • Test data: physico-chemical properties, toxicology and enviromental data
  • Risk assessment report including exposure info and risk management measures
  • Information on contents, etc. in case containing hazardous substance
  • Safe use information such as handling method and emergency response measures.
  • Regulatory information on chemical substance concerned

Joint Submission

Joint submission of existing substance registration is mandatory under K-REACH. Opt-out is possible when:

  • Where the disclosure of trade secrets of the enterprise is expected to cause considerable commercial loss;
  • Where more expenses are incurred in submitting data jointly than submitting data individually;
  • Where submission constitutes grounds prescribed by Presidential Decree.

The following info needs to be submitted jointly by all registrants of the same substance. Joint submission of chemical safety report is optional. 

  • Substance identification info
  • GHS classification and labelling
  • Test data: phsico-chemical properties
  • Test data: toxicology data
  • Test data: enviromental hazard.

Reduced Test Data Requirements

K-REACH also offers reduced test data requirements for some special substances. For example, if an existing chemical 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.  Like EU REACH, transported isolated intermediates also qualify for test data exemptions. In addition, a polymer that does not meet PLC criteria also qualifies for some test data exemption (i.e, long-term toxicity data waived). More info can be found in Presidential Decree. 

Note:  Low volume registration for 0.1-1t/y new substances will expire on 31 Dec 2019. After 31 Dec 2019, standard registration applies to 0.1-1t/y new substances.

Provision of Information after Registration

Any person who transfers a chemical substance registered or a mixture containing such chemical substance shall prepare and provide information such as the registration number and name of the relevant chemical substance, information on hazards and risks, and safe uses, to any person who acquires the chemical substance. Such information is usually communicated via SDSs.

K-REACH Registration vs EU REACH Registration

There are 2 big differences between K-REACH registration and EU REACH registration. Firstly, K-REACH registration is also required for <1t/y new substances. Secondly, K-REACH requires the registration of polymer itself, not its monomers.

Read More

How to Comply with Amended K-REACH Regulation

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 Tags: Topics - KoreaREACH-like Regulation and Registration

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