CIRS Group
Medical Devices
C&K Testing
Carbon Neutrality

Exemption Information Requirement under K-REACH

from CIRS by

The revised edition of K-REACH was published and came into force on 30 Oct this year. In order to help enterprises comply with K-REACH, the attention on the following points should be paid.

1. It was required that enterprise should apply for the exemption every year when manufacturing or importing reagents for scientific study, analysis or research. Now it is revised that the exemption application will only be required at the first importation or manufacture.

2. When applying for the exemption for research & development, the required documents have been revised from 4 items down to 2 items. The “2 items” refer to “substance general terms” and “safety management plan”. After the revision, the “post-management plan” and “transferring plan” will not be required any more.

The substance exemption under K-REACH includes 2 types, one type can be exempted directly, the other type needs to file exemption application to the officials. Only after the approval of the application can the substance be exempted.

1. Substance that can be directly exempted: substance contained in the imported device; substance contained in the article that will not be released during use; existing substance with an amount less than 1 ton per year.

2. Substance that needs exemption application: reagents for scientific study, analysis or research; substance for product development; polymer of low concern.

For the above mentioned two types of substances, the exemption application will only be required at the first importation or manufacture.

CIRS advises that enterprises should first judge whether the products fall into the above mentioned criteria that can be exempted under K-REACH to reduce cost. It is also advised that enterprises appoint qualified OR to deal with the exemption application in order to avoid unnecessary problems.

Should you have any question regarding to K-REACH, please do not hesitate to contact us at


We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.