KKDIK Lead Dossier Registration

As you know, the KKDIK (Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals) is a crucial regulation that organizes the registration and evaluation process of substances to ensure their safe use throughout all stages from production to disposal in Turkey. One of the required chemical registration processes under this regulation is the “KKDIK lead dossier registration”.

This article will answer frequently asked questions about KKDIK Lead Dossier Registration.

What is a Lead Dossier?

A lead dossier is the main registration dossier submitted to the Turkish Ministry on behalf of the manufacturers or importers of a substance in a joint registration by the lead registrant. This dossier, which contains all necessary information about the substance, is prepared by the lead registrant in the registration process. Other registrants access this dossier to complete their registration dossiers.

What is Included in the KKDIK Lead Dossier?

The lead dossier includes the following information:

• Substance description and identification information
• Classification
• Usage information
• Physico-chemical properties
• Toxicological information
• Ecotoxicological information
• Safety usage guide
• Chemical safety report

 

The lead dossier facilitates the fulfillment of registration obligations for companies manufacturing or importing the same substance and makes data sharing much simpler.

How is the KKDIK Lead Dossier Registered?

The following steps are followed for KKDIK lead dossier registration:

1. Creation of the Substance
   Information Exchange Forum (SIEF) First, registrants need to create a SIEF, which is a forum that enables data sharing and the creation of a common dossier among companies registering the same substance.

2. Selection of Lead Registrant
   A lead registrant is selected from among the SIEF members. This person is responsible for leading the other registrants in the registration process and preparing and submitting the lead dossier.

3. Preparation of Technical Dossier
   The lead registrant is also the company that prepares the technical dossier of the substance. The technical dossier includes details such as the chemical identity, properties, and toxicological and ecotoxicological information of the substance.

4. Data Sharing and Cost Allocation
   After the lead dossier preparation is completed, other registrants use this dossier to complete their registration processes. During this stage, data sharing and fair distribution of costs are required.

5. Submission and Fees
   Once the lead dossier is prepared and all data is collected, the lead registrant submits the application and pays the related registration fees. These fees vary according to the amount of the chemical substance manufactured or imported.

6. Ministry Review and Completeness
   Check After the registration application is completed, the Ministry conducts a completeness check. If there are any deficiencies, the lead registrant is asked for additional information. The completeness check is completed within three weeks from the application date.

7. Completion of Registration
   Once the Ministry approves the completion of the registration process, a registration number is provided to the lead registrant. Other registrants submit their registration dossiers to the Ministry after the lead registrant completes the registration process.

 

The chemical substance can be legally marketed with the registration number. In cases where necessary, the lead registrant and other registrants may need to update their registration information. Changes in substance composition, changes in manufactured or imported quantities, and the addition of new uses are examples of such updates.

The KKDIK Lead Dossier Registration process facilitates the safe and effective management of chemical substances. By doing so, compliance with the KKDIK Regulation is also ensured. However, to avoid rejection of the application at the end of the registration process, it is recommended that companies complete the process with professional support. Thus, legal penalties are avoided, and compliance with the regulation is guaranteed.

For our services related to the KKDIK Regulation, click here.