The primary purpose of EU REACH-like regulations is to protect the environment and human health from potential or existing harms caused by chemical substances. In line with this objective, over 20,000 chemical substances have been included in the registration process under chemical regulations similar to EU REACH. The information requirements for the registration process are determined based on the tonnage band of the substances manufactured or imported. To meet these requirements, test studies are conducted with the substances, which include animal tests, in vitro tests, and specific calculations. To reduce animal testing and avoid the repetition of these costly tests, Data Sharing is conducted among similar regulations.
General Overview of Registration and Data Sharing Processes
The steps required to complete the joint registration process of a substance under the chemical regulatory system are shown in the flowchart above. The most complex step in this flow is the data-sharing process. Examples that illustrate the detailed nature of the process include substance identity inquiries, communication with data holders, separating data costs, and local expenses. The joint registration process in the registration system is completed for a member who has completed the data-sharing process through the “Letter of Access” provided by the Lead Registrant.
The cost of data sharing for each substance is determined at the beginning of the process. As the number of members wishing to join the joint registration increases, the cost per member decreases proportionally. After a member completes their process, the cost calculation is updated for other members. This approach ensures fair cost-sharing among joint registration members. Thanks to reimbursements, the rights of members who have completed their processes earlier are protected.
In short, Data Sharing Management is defined as the regulations for implementing changes/updates that may occur during and after the data-sharing process of the relevant substance and informing joint registration members about all these aspects.
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