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켐토피아 뉴스레터

NEWS LETTER 2019.(VOL.48)

Chemtopia thinks ahead of clients

Chemtopia gives honest consultation to clients

[Chemtopia Newsletter No. 48] Follow-up measures after pre-registration As of June 30th, 2019, deadline of K-REACH pre-registration for existing (phase-in) chemical substances has passed, and related issues and requirements to be prepared for clients are as follows:

ISSUE & FOCUS

I. Supplementation of pre-registration and late pre-registration

1.   Supplementation of pre-registration

   -  Available to supplement insufficient information other than substance names among submitted information.

   -  Available to submit accompanying documents for notification in writing when UVCB or intermediates was
          pre-registered or when pre-registration was made by product names owing to non-disclosure of trade
          secrets.

   -  Supplementation period: Monday, July 8th to Friday, July 19th , 2019

 

2.   Late pre-registration

   -  Late pre-registration is permitted without deadline when volume of 1 ton or above is newly manufactured or
          imported after the deadline of pre-registration.

 

  Q. What should we do if we missed the pre-registration period or overseas manufacturers delayed providing
  chemical substance information?

  A. The best way is filing a late pre-registration as soon as possible, even if you are late.

  Q. We manufactured or imported more than 1 ton of chemicals in the past in 2015, for example, and we haven’t
  filed a pre-registration because we don’t manufacture or import them now. However, can we file a late pre-
  registration if we are planning to resume our business again in Korea?

  A. Yes, you can.

 

II. Notification of pre-registration completion to supply chains and change of pre-registration

1.  Supplementation of pre-registration

   -  While a receipt number (ex. K1903-******) is issued as a result of pre-registration, you are not obliged to
          deliver the number, itself to supply chains.

   -  Instead, you or your Only Representative (OR) have to inform of ‘completion of pre-registration’, including
          the fact of OR appointment, if any overseas manufacturer or producer appoints an OR. 

 

2.   Change of pre-registration

   -  File a change of pre-registration within 1 month after change.

          •    Change in manufactured or imported tonnage band;

          •    Change in company name, address and contact number of manufacturer or importer;

          •    Change in importers’ list of relevant chemical substances where only representative is appointed by
                overseas manufacturer or producer;

   -  File a change of pre-registration within 1 month after recognition of change.

          •    Change in the classification and labelling of chemical substances;

          •    When any new consumer use is identified.

III. Establishment of registration strategy

1.   Joining CICO (SIEF in Korea)

   -  Available to join CICO of corresponding substance after pre-registration of the substance (Expected in
          August).

   -  Decide upon participation types for joint registration within the CICO: Lead registrant, Active, Passive
          participant.

 

2.   Considerations for decision of registration

    As such registration involves expenses, make sure to consider the followings and make final decisions on
    registration.

   -  Be prepared in advance for K-REACH compliance as foreign companies. For domestically supplied
          substances, domestic companies consider changing supply model to domestic procurement as an option by
          comparing supply by importation if they are not sure for foreign supplier’s compliance.

   -  Change of suppliers into whom are likely to comply K-REACH registration among vendors;

   -  Comparison of business profits and registration expenses on each chemical substance;

   -  Profitability from preemption of the market by early registration.

 

3.   Determination of point of time for registration of low tonnage bands

    While a high tonnage band of more than 1,000 tons should be registered by 2021, the point of registration time
    for lower tonnage bands (less than 1,000 tons) shall be determined by following consideration.

   -  Consider early registration if a company owns data;

   -  When market preemption is expected by early registration;

   -  When any importer or manufacturer of more than 1,000 tons within the CICO runs for lead registrant and
           any disadvantage in cost sharing is expected by the lead registrant, early registration shall be considered,
           nevertheless, a registrant is in low tonnage band;

   -  When reduction of dossier or consulting expenses is expected due to the buying power resulting from large
          number of participants despite low tonnage band registration.


For chemical substances with 1,000 tons or more, limited and short time is allowed, approximately two years is left by end of 2021. Therefore, it is advisable to prepare for registration in timely manner.

 

  English version of K-REACH and K-BPR is on sale. It includes not only Act, Decree and Rule, but
  also Appendix and Attached Form. From Appendix, you will get the information about detailed registration exemption
 confirmation, etc. And, with Attached Forms, which are the application forms, you will get practical knowledge about what
  you actually prepare for dossier. Please contact us, if you are interested.

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

1203~6 Daerung post tower 7th, 48, Digital-ro No. 33,
Guro-Gu, SEOUL, 08377, KOREA

TEL : +82-2-826-9100, FAX : +82-2-877-0674

COPYRIGHT(C) 2019 CHEMTOPIA. ALL RIGHTS RESERVED.

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