INFORMATION ON THE CO-REGISTRATION DOSSIER WITHIN THE SCOPE OF KKDIK REGULATION

What is a Co-Registration Dossier?

A co-registration dossier is a dossier prepared by a group of chemical substance manufacturers or importers in order to register the same chemical substance. The dossier contains the information necessary for the safe use of the chemical and is submitted to the Ministry of Environment, Urbanisation and Climate Change. The co-registration dossier is an important document under the KKDIK (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation and aims to ensure compliance with the safe management of chemicals.

What are the Contents of the Co-Registration Dossier?

•  Additional information based on the information in the lead dossier
• Company specific production and usage information
• Exposure scenarios and risk management measures
• Internal security and utilisation procedures

How to Prepare a Co-Registration Dossier?

Each company prepares its own co-dossier. This dossier is supported by the co- information found in the lead dossier and includes additional company-specific  usage and additional information. The dossier is completed by submission to the Ministry of Environment, Urbanisation and Climate Change.

What is the Preparation Process of Co-Registration Dossier?

• Formation of Consortium: Companies manufacturing or importing the same chemical substance come together to form a consortium. 
• Determination of the Leader Company: A leader company is selected among the consortium members. This company is responsible for the preparation of the leader dossier. 
• Preparation of the Leader Dossier: The lead company prepares the lead dossier by collecting all necessary information. 
• Data Sharing: The information contained in the leader dossier is shared with the consortium members. 
• Preparation of Co-Dossiers: Each company prepares its own co-dossier by using the information in the leader dossier and adds additional company-specific information.
• Submission of Dossiers: Both the lead dossier and the co-dossiers are submitted to the relevant authorities (Ministry of Environment and Urbanisation). 

What are the Advantages of Co-Registration Dossier?

•    Cost Effectiveness: Thanks to data sharing and co-operation, testing costs and repetitive studies are reduced. 
•    Data Quality: More comprehensive and reliable data is collected with the contribution of all companies.
•    Compliance and Safety: Safe use of chemical substances is ensured and legal compliance is increased. The co-registration dossier encourages co-operation in chemical substance management and reduces costs while increasing safety.

What is the Official Fee Co-Registration Dossier?

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