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[Newsletter No.53] Amendments on List of Priority Controlled-Substances under K-REACH

Date :2022.02.14

NEWS LETTER 2022.(VOL.53)

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Chemtopia gives honest consultation to clients

ISSUE & FOCUS

  • I. Basis of Revision
  • II. Main Contents of Revision
  • III. Domestic Business Status Currently Handing Newly Designated Substance
  • IV. Industry Advice






I. Basis of Revision

The purpose of additional designation of endocrine-disrupting chemicals as the Priority Controlled-Substances (hereinafter, ‘PCS’), in accordance with K-REACH Article 2, Sub-paragraph 10-2 of the Law, and Article 3-2 of the Presidential Decree, is to secure contents, use, exposure information, etc. contained in products and to establish scientific and reasonable management measures on highly hazardous substances that could affect people and environment.

II. Main Contents of Revision

1) Designation of 54 chemicals (162 on specific list) that are confirmed to have hazard of endocrine disorder, PBT, and vPvB corresponding to criteria under Presidential Decree of K-REACH Annex 1-2.

2) Deletion of 4 chemicals in Annex 2 in the current MoE’s Notice for the reason of duplication in prohibited substances’ list, etc.

3) Combination of the current Annex 1 and 2, and putting together chemicals having the same or similar structures or functional groups as one group shown as below specified list of each substance.

 

[Table 1]  Comparison of current and revised content

Category

Current

Revision

Inventory

Annex 1 and Annex 2

Combined to Annex 1

Types

Annex 1: 204 Substances
 (Effective as of July 1st, 2019)

Annex 2: 468 Substances
 (Effective as of July 1st, 2021)

699 Chemicals

Corresponding hydrate/anhydride

N/A

Hydrate/anhydride form in Annex 1 included

Analogues, etc.

N/A

Same number granted

Criteria of Categorization

5 Types

(CMR, EDCs, PBT, STOT, EU SVHC)

6 Types

(CMR, EDCs, PBT, STOT, EU SVHC, vPvB)

III. Domestic Business Status Currently Handing Newly Designated Substance

Category

2014

2016

2018

No. of substance 

42

40

45

No. of companies
 handling the substance

2,151

2,081

2,956

Estimated No. of notification

2,899

2,840

4,208

*Reference: Chemical Statistics Survey in accordance with Article 10 of Chemicals Control Act (hereinafter, CCA) of MoE.

 

As a result of the chemical statistics survey pursuant to Article 10 of the Chemicals Control Act, 45 chemicals (162 in a specific list) of the newly designated PCS are handled in Korea, and a total of 2,956 companies where they handle those chemicals were identified.

 

Of these, 117 out of 162 substances are identified to be non-domestically distributed, and the effect of preemptively inhibiting and evading use of the substance in consumer products is expected.

 

IV. Industry Advice

 

 

à The existing PCS under Appendix 1 and 2 are already in effect, and for newly added PCS from No. 646 to 699 in the amended Appendix 1, the obligation to notify under Article 32 of the K-REACH and the obligation to provide information pursuant to Article 35 of the Act shall apply from January 1st, 2024.

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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