NEWS LETTER 2022.(VOL.52)

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Chemtopia gives honest consultation to clients

[Newsletter No.52] Selection and Disclosure of Candidate Substances Subject to Authorization and the

The Ministry of Environment designated chemical substances with risk concern as substances subject to authorization and introduced the system for designation and management of substances subject to authorization in 2015 under which any person who wants to manufacture, import or use the relevant substances should get authorization from the Minister of Environment.

ISSUE & FOCUS

I. Candidate substance list and the risk assessment results

According to the Article 19 and 25 of 「Act on Registration and Evaluation, Etc. of Chemical Substances (hereafter referred to as “K-REACH”」, the Minister of Environment shall designate substances subject to intensive Priority control substances and other chemicals with risk concern as substances subject to authorization and make announcement, and the person who wants to manufacture, import, and use a substance subject to authorization shall prepare, submit materials regarding its use, risk and alternative analysis, and get authorization.

The following ten species of chemical substances were selected as candidate substances for the pilot project.
 

Substance name

CAS No.

Status of designation of Priority Control substances

Assigned number

Hazard

Benzo[def]chrysene (Benzo[a]pyrene)

50-32-8

1-2

CMR, PBT

Benz[a]anthracene

56-55-3

2-7

CMR, PBT

Formamide

75-12-7

 1-16

CMR

p-(1,1-dimethylpropyl)phenol

80-46-6

 1-28

Endocrine disorders

Tris(2-chloroethyl) phosphate

115-96-8

 1-67

CMR

Sodium peroxoborate

7632-04-4

  1-125

CMR

Perboric acid, sodium salt

11138-47-9

  1-161

CMR

Sodium Tetraborate, Pentahydrate

12179-04-3

  1-164

CMR

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)

15571-58-1

  1-175

CMR

Trixylyl phosphate

25155-23-1

  1-181

CMR

CMR(Carcinogenicity, Mutagenicity, Reproductive toxicity), PBT(Persistent·Bioaccumulative·Toxic)

 

The authority also provided reviewed summaries of risk supporting the selection of these candidate substances which was performed based on each substance’s hazard, domestic, the volume of domestic distribution, and existing risk assessment performed in Korea and abroad.

Summary files are available as [attachment I], and please be informed that the summaries are written in Korean.

II. Collection of opinion to the authority

 In cases where the risk of handling is high, but alternative substances and technologies are uncertain and strict exposure control is possible, the permission material designation and management system to be manufactured, imported, and used for a certain period of time('15.1.1).

 Amendment of 「Chemical Substance Registration and Evaluation Act Enforcement Decree」 to select and disclose ‘Candidate Substances Subject to Permission (hereinafter referred to as candidate substance for authorization)’ before designation of permitted substances (Enforced on Oct. 15, '22).

 Accordingly, a pilot project was conducted to disclose the summary of the results of the risk review of licensed substances and to specify the procedures and methods of collecting opinions on hazards, uses, and alternatives and technologies for each candidate substance.

Survey Period: January 20, 2022 (Thursday)
Submission method: Email(yuhae@kcma.or.kr)
Contact: External Relations Team, Korea Chemicals Management Association

* Please be informed that all these process shall be done in Korean language.

If there is whom wants to submit an opinion on the candidate list and its review of risk, the one can make a statement of opinion through [attachment II]*. The one shall also submit any opinion regarding collection of opinion such as surveying items, method, submission procedures, etc.

*The [attachment II] is a survey form in Korea. For your understanding, Chemtopia translated in English in [attachment II-1] solely for reading and shall not be used as an actual survey.

In the future, these process will be operated through disclosure of information page in the website of Industrial Support Group where you can search the name and identity number (CAS No.) of a candidate substance for authorization on the relevant menu, inquire the result of risk review, etc., and submit your opinions.

If you have already submitted the statement of opinions, you are going to be informed by the authority institute how to participate in the pilot project.

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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