Home/How to register intermediate substance (KKDIK)?
How to make intermediate KKDIK registration?
Intermediate (intermediate) is a substance used in a chemical process to be converted into another substance. Under KKDIK, registration with reduced data requirements is possible for intermediates produced and used under strictly controlled conditions. However, this convenience is not automatic; The status and controlled conditions must be justified by documentation.
When is intermediate status accepted?
Two conditions are sought together. The first is that the substance is actually used for synthesis and transformed into another substance. Secondly, production and use are carried out in a closed system and under strict control. For example, if the substance is transported by open transfer or worker exposure is not controlled, the status becomes questionable.
How are controlled conditions documented?
- Description of closed system design and technical measures
- Risk management measures in transfer, sampling and cleaning steps
- Ventilation, personal protective equipment and emergency procedures
- Waste and emission control records
- Written controlled condition confirmation from downstream user
What data is requested in the intermediate registration?
The reduced data set includes substance identity, available physico-chemical and toxicological information, as well as exposure and risk management information. New testing is not expected in most cases. However, if the available data is not sufficient to identify the substance, the institution may request additional information. Therefore, it is critical to collect existing literature and supplier data completely while preparing the dossier.
Risk of incorrect status declaration
If the item is not considered an intermediate, the full record dataset is requested. In this case, both the schedule slips and the cost increases. Therefore, it is necessary to make the status decision by examining the production flow. For the technical file setup, you can see our how to prepare a technical file page.
Related pages and source
Official full text of the regulation: KKDIK Regulation - Official Gazette.
For questions, contact ONAY Mühendislik.
Intermediate or downstream?
These two are confused. If a substance is consumed in a reaction and transformed into another substance, it is an intermediate. On the other hand, if the substance remains in the product while retaining its function, for example being used as a solvent or additive, it is not an intermediate. Therefore, the process flow chart is the strongest evidence of the status decision.
Information flow in the supply chain
The manufacturer registering the intermediate must confirm that the customer meets the controlled conditions. This confirmation must be in writing and kept on file. If the customer does not meet the conditions, the status drops. Therefore, we recommend adding a controlled condition clause to contracts. Also see our subuser and GTZ evidence file page for subuser obligations.