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[Newsletter No.39] K-REACH Administrative Notice on CMR substance and Priority control substance

Date :2019.03.26

NEWS LETTER 2019.(VOL.39)

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[Newsletter No.39] K-REACH Administrative Notice on CMR substance and Priority control substance Prior to the enforcement of amended K REACH in 2019, an administrative notice was announced for "CMR substances", as a subject to registration by 2021 and "Priority control substances" as a subject to product notification, being contained in manufactured or imported products. The final substance lists would be published within this year after reflecting the industry's opinions on the lists

ISSUE & FOCUS

I. CMR substances
II. Priority Control Substance
III. Industry Advice

I. CMR substances

1. CMR substances

: Ministry of Environment Notice No. 2018-761

Any existing chemical substances which have Carcinogenicity, Mutagenicity and toxicity for Reproduction are or are of concern to human or animal shall be designated as the CMR substance and they shall be registered by 2021. 544 CMR substance and its hydrates were pre-announced as the subject to registration by 2021. This CMR substance list was sorted out from the references of foreign carcinogenic substance list such as IARC, NTP, EPA, etc.

Any person who manufactures or imports 1 ton or above per year of the CMR substance or its hydrates shall do pre-notification by end of June 2019. And, the registration of those substances must be completed by 2021, which is equivalent to the registration deadline of regular substances exceeding 1,000 ton/year.

II. Priority Control Substance

2. Priority Control Substance
: Ministry of Environment Notice No. 2018-748

According to the amended K-REACH, a chemical substance which has a high risk of concern, shall be designated as priority control substance in order to notify them prior to product manufacture or import

- Substances which cause or may cause cancer, mutation and reproductive toxicity or having endocrine disrupting properties to human or animal (CMR & EDC)

- Substances such as those having persistent, bioaccumulative, and toxic properties (PBT)

- Substances which may cause adverse effects to human organs such as the lung, liver and kidneys etc. by long term or repeated exposure (STOT)

- Substances which give probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances.

Any person who manufactures or imports priority control substance contained in products shall notify to the MoE prior to manufacture or import if the case meets following both criteria:

1. The content of individual priority control substance per product shall exceed 0.1% weight by weight (w/w).
2. Total quantity of each priority control substance of each product shall exceed 1 ton per year.

The 785 priority control substances (Annex1) have been published to be implemented in 1st April 2019 and an additional 410 substances (Annex 2) would be implemented two years later, which is April 1st, 2021.

III. Industry Advice

3. Industry Advice

There was a collecting public opinion on the lists of CMR and Priority control substance until November 1st, 2018. Since the finalized lists will be announced by end of this year, please be aware of following deadlines:
1. Enforcement date of pre-notification of CMR substances to register: January 1st, 2019
2. Enforcement date of product notification of priority control substance: 1st list in Annex 1, by April 1st, 2019 and 2nd list in Annex 2 by April 1st, 2021.

In order to fulfill the obligations within the deadline and for follow-up,

1) Check whether CMR substances are included in your product or substance list and if so, proceed to pre-notification
Once the pre-notification of 1 ton or over existing chemical substance has to be done by end of June 2019, it requires checking above and preparing registration soon, because their rgistration deadline is 2021.

2) Be prepared and proceed to product notification if your product includes priority control substances exceeding threshold.
Any party manufacturing or importing a product that contains in priority control substance above threshold shall submit the “Notification of product containing priority control substance”,before manufacturing or importing the product with a relevant use instruction of the product, a picture, etc., within a period from the next day of verifying that the cumulative gross volume for each priority control substance contained in the products is 1 ton or over per year.

3) Communicate with consumers who use yourproduct containing priority control substance.
Supplier of priority control substance contained in product shall provide a consumer sufficient information of the product upon consumer’s request as in below within 45 days as free of charge: Product name, name and content of priority control substance being contained in products, available use, restricted use, safe use instruction and condition to use, exposure measure, handling precaution, etc.

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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