For intermediates, KKDIK allows registration with reduced data requirements when produced and used under strictly controlled conditions. The key to this advantage is accurate documentation of 'controlled conditions'.
Controlled conditions; It indicates that the substance has been handled in closed systems with strict technical and procedural measures and that exposure has been minimized. If these conditions cannot be sufficiently justified, the full registration data set may be requested.
ONAY Mühendislik performs conformity assessment and filing of intermediate status and controlled conditions.
Intermediary Description
An intermediate is a substance that is produced and consumed to be converted into another substance. This definition is based on whether the substance has undergone chemical transformation, not just on location in the production flow. Substances that are used as solvents, catalysts or processing aids and do not undergo chemical transformation are not considered intermediates; these are subject to full registration obligations.
Meaning of Controlled Conditions
The reduced registration obligation for intermediates is based on the substance being used under strictly controlled conditions. These conditions; It includes keeping the substance in a closed system by technical means, minimizing release through process control and automation, handling only by trained personnel, and controlling waste and cleaning processes.
Documentation of the Declaration
When declaring that controlled conditions are provided, this must be supported by concrete evidence. Process flow diagram, closed system design, ventilation measurement results and personnel training records constitute this evidence set. When a controlled condition declaration is made and the field application does not comply with it, the reduced registration right loses its validity.
Intermediates Transported to Site
If the intermediate is being transported to another site, written confirmation from the buyer is required that controlled conditions are maintained during transport and at the receiving site. For shipments made without this confirmation, the sending party cannot rely on the reduced registration obligation. It is recommended that confirmation be obtained on a product-by-product basis and by date.
Evidence Required in the Audit
In the audit, the accuracy of the intermediate substance declaration is checked in two aspects: whether the substance is actually consumed and transformed into another substance and whether controlled conditions are actually applied. Reaction efficiency and mass balance records answer the first question, and field observation and measurement records answer the second question. Both sets of records must be available.
Field Verification of Intermediate Registration Statement
The controlled condition declaration provided within the scope of the Intermediary Registration must correspond exactly to the field application. The process flow diagram, closed system design and ventilation measurements are evidence of this verification. If an Intermediary Registration declaration is made and the conditions are not actually met, the reduced registration right loses its validity.
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Official full text of the regulation: KKDIK Regulation - Official Gazette.