ANNOUNCEMENT FROM MOEU CONCERNING WITH REGISTRATION PROCESS, LEAD ELECTION AND KKS

ANNOUNCEMENT ON KKDIK REGISTRATION PROCESS-2 

1) In SIEF queries, the contact information that was entered when sending the pre-SIEF appears. If more than one contact information is to be entered; one of the contact information must be set as default to appear in the SIEF query. For notifications performed in the past:

• If contact information is not filled in, company information will appear on the SIEF query (from EÇBS)
• If a contact person has been entered, even if it is not marked as default, the information of this contact person will appear on SIEF query
• If more than one contact is entered but none of them is marked as default, the system will automatically mark the first entered registration as default and this will appear as contact information in SIEF query for contact information.

 
In this respect, if deemed necessary, you can make your updates from the Submitted Substances Module.

2) When it is decided who will be the Lead Registrant in the SIEFs that are formed, Lead Registrant makes "I am Lead Registrant for the Substance" statement from the SIEF Query section. According to the regulation, one Lead Registrant can be appointed in one SIEF. After making “I am Lead Registrant for the Substance” statement, another Lead Registrant cannot be appointed in the relevant SIEF and Lead Registrant position cannot be given up. After making the lead registrant statement, if any obligation to renounce the lead registrant position or change the lead registrant arises, an official application is made to the Ministry with its justification for an assessment of the situation.

Lead registrant declarations will start on 15/02/2021, statements made before this date will not be considered valid.

3) The Lead Registrant must contact all companies in the SIEF before making “I am Lead Registrant for the Substance” statement. Communication should continue even after the statement is made, and new companies added to SIEF should be included in the process.

4) In the SIEF query of the substances whose lead registrant has been selected; Lead Registrant can be seen by other companies.

5) Registration file of a substance is opened to submission after the Lead Registrant declaration is made (except individual submissions)

6) Those who want to make an individual registration (individual submission), submit their request to make an individual registration to the Ministry officially with its justification. As a result of the Ministry’s evaluation of the justification, if it is found to be appropriate, it opens the authority to send a single registration for the relevant reference substance on a company basis.

Those who make individual registration (individual submission) must also share the data specified in the regulation in the SIEF. If not shared, necessary sanction will be imposed by the relevant organization.

7) All potential registrants, downstream users and third parties who have submitted a pre-SIEF to the Ministry regarding the substance, or registrants who have submitted a registration application before 31/12/2023 for the substance, become participants of the SIEF (KKDIK Regulation, Article 25).

No deletion will be performed for pre-SIEFs that are submitted after 15/02/2021. For the pre-SIEFs that are submitted before 15/02/2021 and need to be deleted, a request for deletion must be made to the Ministry with an official letter along with its justification (requests received by e-mail are not fulfilled).

The text of the announcement can be accessed from the Chemical Registration System (KKS) tab of our Chemicals Help Desk; and also from the link:

https://kimyasallar.csb.gov.tr/kkdik-kayit-surecine-iliskin-duyuru-2/344