Registration Exemption under K-REACH

The Act on Registration and Evaluation of Chemicals in Korea (a.k.a K-REACH) has been effective since 1 Jan 2015. Chemical registration is the most significant regulatory obligation for industry to comply with; however, there are also many registration exemption conditions. Under some conditions, the chemical substances are directly exempt from registration, while under other conditions the registrant needs to supply additional confirmation of registration exemption from the Korea Chemical Management Association (KCMA) in advance of production or import.

1. Registration Exemption Conditions

1.1 Direct exemption without any application:

First of all, we should make it clear that K-REACH does not apply to chemical substance falls under one of the following items, which means they have no compliance obligation under K-REACH.

• Radioactive substances

• Pharmaceutical products and quasi-pharmaceutical drugs

• Narcotics

• Cosmetics and raw materials for cosmetics

• Pesticides and active ingredients for pesticides

• Fertilizers

• Food, food additives, devices, containers and package

• Feeds

• Gunpowder

• Military supplies

• Health functional foods

• Medical devices

In addition, for existing chemical substances subject to registration (i.e. priority evaluation chemical substances, PECs) or new chemical substances, if any of the following conditions apply, registrants are exempt from corresponding registration obligation under K-REACH:

• Chemical substance imported which are incorporated in machines

• Chemical substance imported along with machines or devices for trial run

• Chemical substances in products in solid form, preforming certain functions and are not released during normal use

• Low volume exemption (less than 1 ton/year) for PECs

Note: Low volume exemption (less than 1 ton/year) is inapplicable to new chemical substances.

Under these conditions chemicals are automatically exempt from registration without any application. However, for the conditions listed below, registration exemption confirmation should be obtained in advance.

1.2 Indirect exemption needing application for registration exemption confirmation

① Manufactured or imported less than 10 ton per year only for export

② Manufactured or imported less than 10 ton per year to manufacture another chemical substance, of which the whole amount is exported

③ Reagents for scientific study, analysis or research

④ R&D purpose of

1. Development of chemicals or products

2. Improvement or development of process

3. Testing application scope of chemicals in places of business

4. Pilot production

⑤ PLC

1. Polymers with Mn more than 10,000 Daltons & oligomer content less than 2% below 500 and less than 5% below 1,000

2. Polymers with Mn in a range 1,000-10,000 Daltons & oligomer content less than 10% below 500 and less than 25% below 1,000

Exception case: There are two cases that are inapplicable to PLC exemption above

1. Cationic polymer (excluding cationic polymer which is neither water soluble nor dispersible in water, and is only to be used in the solid phase)

2. Polymer with Mn less than 10,000 Daltons, which contains more than 2% of monomers that are new chemical substance, hazardous chemical substance or specific chemical substance prescribed by Presidential Decree due to its hazard or risk

⑥ Surface treated substances

⑦ Non-isolated Intermediates

⑧ Isolated intermediate which are not released and are blocked from exposure through technical methods

2. Frequency of Exemption Application

For those exemption conditions listed above (①~⑧)which still require confirmation of registration exemption in advance, the application frequency varies. 

3. Data Requirements for Exemption Application

The Korea Chemicals Management Association (KCMA) is assigned as the competent authority for review of the registration exemption application. The application will be processed within 3 days. In case of further consultation with NIER, the exemption approval can be issued within 10 days. In addition to the application form, a copy of document as specified below should be submitted. The data requirements vary for each condition.