INFORMATION ON THE LEAD REGISTRATION DOSSIER WITHIN THE SCOPE OF KKDIK REGULATION

What is Lead Registration Dossier? 

"Lead Registration Dossier" refers to the dossier including the information of the people who undertake responsibilities related to the safety of chemical substances and the relevant documents within the scope of KKDIK (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation. At the same time, the leader registration dossier includes the data set required in KKDIK for the highest tonnage to be registered for the substance. This dossier is submitted by a lead registrant. The lead registrant, as the first person to carry out the registration process, should submit his/her own registration dossier via KKS.  This submission should take place before the other members submit their own registrations.

What are the Contents of the Lead Registration Dossier?

The lead registration dossier first provides the information of the leading company. It includes the information necessary for the identification of the substance (purpose of the substance, chemical identifiers, molecular and structural formula and composition). It includes the classification and labelling of the substance, comprehensive study summaries, information on the CSR if the substance is ≥10 tonne/year, information security and data protection information.

The Lead Registrant submits a registration dossier on behalf of the other registrants via the KKS. This submission must take place before other members submit their own registrations. Other potential registrants in the SIEF may submit their own dossiers after the leader has submitted their dossier.

What are the Steps to Submit a Lead Registration Dossier?

Companies that want to be the leader among the companies in SIEF make their nominations through the KKS system. Companies in MBDF can vote for the candidate by selecting one of the candidate companies from the Lead Candidates page. Then, if there is no objection or problem regarding the selected Lead company, the leader company is determined. The Lead company declares that it is the leader company for the relevant substance through the system.  This Lead company is responsible for the preparation of the leader dossier. The process of submitting the leader registration dossier is as follows:

• Gathering existing information (tests, reports, etc.),
• Organisation and evaluation of all necessary documents and reports,
• Compliance with Annexes 7-8-9-10 information requirements,
• Identification of missing data and completion of missing data,
• Sharing the cost of data,
• Availability to co-registrants on favourable terms.

What are the Advantages of Lead Registration Dossier?

There are many advantages to creating and managing a Lead Registration Dossier:

• Information is gathered at a single point, thus speeding up the process of searching and accessing data.
• All registrants can access the same up-to-date information, reducing information mismatches and contradictions.
• Reduces data errors and contradictions.
• Ensures that only authorised people have access to information and increases data security.

What is the Official Fee for Lead Registration Dossier?    

Detailed information on KKDIK Lead Registration dossier fee is available on the Ministry of Environment, Urbanisation and Climate, Directorate of Revolving Fund web page.