How to Comply with Amended K-REACH Regulation 2019

Korea

How to Comply with Amended K-REACH Regulation 2019

Little Pro on 2015-12-31

The amended Act on Registration and Evaluation, etc of Chemical Substances in South Korea (also known as K-REACH) was promulgated in March 2018 and will come into force on 1 Jan 2019. In this article we will give you an overview of the amended K-REACH regulation and summarize what the main changes are. We will also compare it with EU REACH regulation. [Last update: 17 Sept 2018].

Main Requirements of Amended K-REACH

Under amended K-REACH, 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 ("registration") according to the following requirement:

New substances must be registered prior to manufacture or import. <100kg/y new substances only require notification and do not need to go through hazard evaluation.
All >=1t/y existing chemical substances (excluding exempt substances) must be registered within given grace periods.
To benefit from the grace periods for existing substances, manufacturers and importers of >=1t/y existing chemical substances must notify their company info, substance name, volume, classification and use info to the MoE in advance ("pre-notification").

Foreign manufacturers who export chemical substances to Korea may appoint a Korea-based only representative to submit pre-notification or registrations.

In addition, producers and importers of products containing priority control substances need to report their products to the Ministry of Environment.

The picture below gives you an overview of amended K-REACH.

Amended K-REACH Overview

Important notes:

The difference between registration and notification is that registration requires submission of hazard data. Notification only involves submission of some administrative info.
Like EU REACH, K-REACH also restricts the use of certain hazardous chemical substances in consumer products and articles. [Read more...]
If you manufacture chemicals or import chemicals, you not only need to comply with K-REACH, but also need to comply with Chemicals Control Act (CCA).

To understand the impact of Korea REACH regulation on your business, you only need to:

Check if your products are within the scope of K-REACH;
Identity your obligations under K-REACH;

Scope of K-REACH

Within Scope	Substance on its own - new substance(1) & existing substances; Substance in a mixture; and Product (2) containing priority control substance;
Out of Scope	Naturally occurring substances; Chemicals subject to other laws: cosmetics and raw materials, pesticides, pharmaceuticals, medical devices, fertilizer, etc;

1.'New substance' is a substance that is not listed on Korean Existing Chemicals List(KECL). More info about KECLcan be found here.

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.

K-REACH Registration

Under K-REACH, new substances must be registered prior to manufacture or import. >1t/y existing substances must be registered within the deadlines listed below.

First 510 existing substances >=1t/y: 1 July 2018
>=1000t/y and CMR substances >=1t/y: 31 Dec 2021
100-1000t/y: 31 Dec 2024
1-100t/y: 31 Dec 2030

Some substances and uses (i.e, R&D substance, export-only use, polymer of low concern) are exempt from full registration. However, you need to apply for confirmation on exemption.

Product Notification and Priority Control Substance

'Product' is a unique concept under K-REACH. A product means a mixture or an article used by consumers or a component of the mixture or the article that may expose consumers to chemical substances. Manufacturers and importers of products containing >0.1% and >=1t/y priority control substances shall submit product notification to the MoE.

How to Understand Priority Control Substance and Product Notification Requirement.

Old K-REACH vs Amended K-REACH

Items	Old K-REACH	Amended K-REACH
Annual report	Required	Revoked
<100kg/y new substances	Require registration	Require notification
Pre-notification	No requirement	Required for >=1t/y existing substances
Registration	Required for new subsances and designated >=1t/y existing substances	Required for new subsances and all >=1t/y existing substances
Management of consumer chemical product and biocides	Covered by K-REACH	Transferred to Consumer Chemical Products and Biocides Act
Product notification	Notification of products containing designated hazardous substances	Notification of products containing designated "priority control substances".

Industry's Obligations under Amended K-REACH

Obligation	Target	Who/When
Pre-notification	>=1t/y existing substances	Who: M/I/OR When: within 6 months pre-notification window period or before manufacturing or import starts.
Registration	New substance: <100kg/y new substance only requires notification. >=1t/y existing substances	Who: M/I/OR New substance: No grace period. Existing substance: Within grace period provided that a pre-notification has been submitted.
Product Notification	Products containing more than 1t/y priority control substance (>0.1% in content)	Who: M/I/seller Deadline: to be determined.

How to Comply with Amended K-REACH - for Foreign Companies

Items	What to Do
Regulatory Check and Pre-notification	Draw up a list of non-exempt substances exported to Korea including its use & volume; Check KECI and determine if each substance is a new substance or not. Determine which substances require pre-notification and registration
Registration	Decide who will do pre-notification or registration : M/I/OR; Determine the right type of registration: confirmation on exemption, simplified, or general registration
Product Notification	Identify if your product requires notification; Determine who will do product notification: M/I/OR
Restriction/Authorisation	Check if your product contains any restricted substances or substances requiring authorization (i.e, Formaldehyde). Comply with provisions on restriction or authorization.

Comparison between EU REACH and K-REACH

Items	EU REACH	K-REACH
Registration Target	New substance(>=1t/y); Existing substance(>=1t/y)	New substance; Existing substance(>=1t/y);
Tonnage Band	EU: 1-10t,10-100t,100-1000t,1000t+	Korea: <1t/y (for new substances only),1-10t,10-100t,100-1000t,1000t+
Polymer	EU: Registration of monomer	Korea: Registration of polymer itself
Only Representative	EU: Yes	Korea: Yes
Pre-registration of Existing Substances	EU: Pre-registration	Korea: Pre-notification
SVHC notification	EU: SVHC notification	Korea: Product notification
Restriction/authorisation	EU: Restriction/authorisation	Korea: Restriction/authorisation

References

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