켐토피아 뉴스레터

NEWS LETTER 2019.(VOL.44)

Chemtopia thinks ahead of clients

Chemtopia gives honest consultation to clients

[Newsletter No. 44] New chemical substances registered under K-REACH, how to comply with ISHL?

Dear precious client,

In accordance with the promulgation of the partial amendment of [Enforcement Rule of ISHL] on 31st January 2019, submission of the investigation report on hazardous • risk of new chemical substance (hereinafter investigation report) would be considered as to have submitted for the new chemical substances registered in accordance with [Regulations of Act on Registration Evaluation Etc. of Chemicals] (hereinafter K-REACH).

ISSUE & FOCUS

I. New chemical substances registered in accordance with K-REACH
II. 「Enforcement rule of ISHL」 and its related legislations
III. Countermeasures from the industry

I. New chemical substances registered in accordance with K-REACH

New chemical substances registered to MoE in accordance with 「K-REACH」 Article 10 is treated as to have submitted the investigation report to MoEL.

Despite the amendment of the enforcement, any person who intends to manufacture or import 100kg or more or less than 1 ton of a new chemical, an investigation report has to be submitted by 31st December 2019.

II. 「Enforcement rule of ISHL」 and its related legislations

○ Enforcement rule of ISHL

Article 86 (Submission of investigation report on hazardous • risk of new chemical substances)

① According to ISHL, Article 40, Paragraph 1, any person who intends to manufacture or import new chemicals (hereinafter, “new chemical manufacturer etc”) shall submit required information in accordance with the 4 of Appendix 11 attached to the form No.18 of investigation report on hazardous • risk of new chemical substances (hereinafter “investigation report”) 30days before the date of manufacture or import (if an annual manufacture or import quantity is 100kg or more or less than 1ton: 14 days before) to MoEL. However, which particular new chemical substance is registered to MoE in accordance with K-REACH, Article 10, the investigation report will be considered as to have submitted to MoEL.

Addendum, Article 2 (An exception for submission of investigation report on hazardous • risk of new chemical substance report)

Despite the amendment of the enforcement the Article 86, Paragraph 1, new chemical manufacturer etc who intends to manufacture or import new chemicals 100kg or more or less than 1 ton shall submit the investigation report on hazardous • risk of new chemical substance to MoEL by 31st December 2019.

III. Countermeasures from the industry

○ Target subject for the investigation report under 「ISHL」

Each of the target subjects below must comply with the duties beside.

Target subject	Applicability to submit the investigation report
New chemicals registered for below 0.1 ton under K-REACH	N/A
New chemicals registered for 0.1 or more and below 1ton under K-REACH	Submit investigation report by 31st December 2019
Existing chemicals received an exemption by corresponding 2% polymer rule under K-REACH	After checking the exemption criteria under ISHL, if the conditions are not met, submit investigation report.
Chemical substances exempt from registration or notification under K-REACH	N/A

Chemtopia Co., Ltd. provides corresponding services to comply with amended and legislated regulations :

· Chemical registration service including Pre-registration, OR service, Read-across or QSAR approach, CSR preparation, Data sharing and negotiation
· Chemical inventory for regulatory tracking
· Support of regulatory monitoring and volume tracking with chemical management system
· Provision of domestic and foreign chemical regulatory database
· MSDS and label authoring system
· Test arranging & its monitoring with domestic and foreign test institutes

This newsletter is available in Korean, English, and Japanese

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