Individual provisional registration is when a company temporarily registers the substance in its own name without fully participating in the MBDF joint process. It is a practical option in certain situations.
Generally; It is preferred when MBDF negotiations are prolonged, there is disagreement about data sharing, or the company wants to speed up the process. However, temporary registration does not eliminate the obligation for full registration; It must be completed in accordance with the deadline of September 30, 2026.
ONAY Mühendislik determines the optimal strategy between individual temporary registration and joint registration for your company.
Description of Individual Record
As a rule, registration is made through joint submission; Companies that will register the same substance submit the data together. Individual registration is separated from this joint presentation and the file is submitted independently by the company itself. The legislation positions individual registration as an exceptional means and requires the justification to be clearly stated in the dossier.
Circumstances Justifying Individual Registration
Withdrawal from the joint submission is possible on three main grounds: participation in the joint submission would result in disproportionate costs, disagreement with the classification or evaluation result in the joint file, and situations where it would be necessary to share trade secret information. These justifications need to be supported by concrete data; General statements are not considered sufficient.
Cost Comparison
Individual registration eliminates the access permission fee but leaves the entire data burden to the company. Having the necessary tests done by one's own means in most cases incurs a higher cost than the access permit fee. For this reason, before making a decision, it is essential to find out in the file what works are required and their market price.
Reason for Classification Difference
Situations where the classification in the common file does not accurately reflect your own product is the most legitimate justification for individual registration. A different impurity profile or a different production method may change the hazard profile of the substance. In this case, providing a classification supported by your own data protects both the correct information and the commercial position of your product.
Things to Do Before Decision
The individual registration decision must be made without interrupting communication with the forum. First, the content of the common file and the access permission offer are examined, your own data and needs are clarified, and the cost and duration of the two ways are compared. Individual registration decisions made without this comparison lead to irreversible and costly consequences.
Can the Individual Provisional Registration Decision be Reversed?
It is possible to revert to joint submission after the Individual Provisional Registration decision has been made; However, for this return, access permission negotiations must be held from the beginning, and at that stage the bargaining power will be weakened. It is therefore important that the Individual Provisional Registration preference is not made without reviewing the content of the forum and the offer breakdown.
Related pages
Contact ONAY Mühendislik for your process.
Official full text of the regulation: KKDIK Regulation - Official Gazette.