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K-REACH Registration

By Little Pro on 2015-12-31 Views:  Update:2017-01-18

According to the article 10 of K-REACH, any person who intends to manufacture or import a new chemical substance or at least one ton per year of a designated existing chemical substance subject to registration shall register the chemical substance before he/she manufactures or imports. This article has been updated according to the latest K-REACH presidential decree published in the end of 2014.

K-REACH Registration - An Overview

Obligation Target Who/When
Registration
  • New substance;
  • Designated existing substance(>=1t/y);and
  • <1t/y existing substance if required by MoE.
  • Who: M/I/Only Representative
  • New substance: No grace period.
  • Designated Existing substance: 3 years grace period since its publication.

 

The following information is required. Hazard data requirement increases with tonnage band.

  • Legal entity information;
  • Information on the identification of the chemical substance;
  • Uses;
  • Classification and labelling;
  • Physical and chemical properties;
  • Hazard data(toxicology and eco-toxicology data);
  • Risks assessment report including exposure scenarios(for >=10t/y substance);
  • Guidance on safe uses;
  • Other data prescribed by Ordinance of the Ministry of Environment.

K-REACH Registration Exemptions

There are two types of exemptions from registration under K-REACH. One type does not require prior confirmation while the other one requires companies to apply for the prior Confirmation of Registration Exemption.

Exemptions not requiring confirmation.
  • A chemical substance imported as contained in machinery;
  • A chemical substance imported along with machinery or equipment for a test run;
  • A chemical substance in a product in solid state with specific shape for a certain function and not discharged during its use;
Exemptions requiring Confirmation of Registration Exemption.(*)
  • Substances manufactured, imported or used to be entirely exported if the volume is <=10t/y;
  • Reagents used for scientific testing or chemical research (Shall apply for exemption annually);
  • Substances used for R&D purpose;
  • Polymer of low concern (PLCs);
  • Surface-treated substances;
  • Non-isolated intermediates & some isolated intermediates manufactured or used under strictly controlled conditions;

Reduced Data Requirements for Intermediates and non-PLCs

For onsite isolated intermediates and polymers that do not qualify for confirmation of registration exemptions, K-REACH also offers reduced data requirements. For intermediates, only physio-chemical data is required. For 100-1000t/y new polymer, data requirement is the same as 1-10t/y regular new substances.

Registration of Designated Existing Substances

Not all existing substances require registration under K-REACH. The MoE will designate certain existing substances subject to registration based on their hazards and volume. A grace period of 3 years will be given to those designated existing substances once they are published.

The first list of 510 designated existing substances subject to registration is published on 1 July 2015. Substances on the list shall be registered before 1 July 2018 if they are in amounts exceeding one tonne per year. Joint submission for those substances are mandatory. If you wish to find out who is the lead registrant for the designated existing chemical substances, please click the links below. 

Risk Assessment

Risk assessment report is required for substances manufactured or imported with a volume of at least 10t/y and substances deemed as one requiring risk assessment based on the result of hazard assessment. However, risk assessment report does not always need to be submitted with a registration dossier together. Grace periods are given according to the following schedule.

Tonnage band Required date
>=100t/y
  • Since 1 Jan 2015
70-100t/y
  • Since 1 Jan 2017
50-70t/y
  • Since 1 Jan 2018
20-50t/y
  • Since 1 Jan 2019
10-20t/y
  • Since 1 Jan 2020

 

Simplified Registration for Small Volume of New Substances

Before 2020
  • Applicable to all <1t/y new substances;
  • Required info: legal entity, substance identity, identified uses and exposure info;
  • Hazard data not required;
After 2020
  • Only applicable to <0.1t/y new substances;
  • Additional hazard data required for 0.1-1t/y new substances: acute toxicity, AMES, acute toxicity study on fish, and biodegradability.

 

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.

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.

Korea Reference & Resource

 

 Tags: Topics - KoreaREACH-like Regulation and Registration

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