Home/Provisional Registration for 6 Substances in the 10–100 Ton Band: Completed in 8 Weeks
Provisional Registration for 6 Articles in the 10–100 Ton Band: Completed in 8 Weeks
This text has been prepared as a representative case; Company, product and substance information has been anonymized.
Case summary
A company importing special chemical raw materials to Turkey wanted to start the KKDIK registration process for its six substances in the annual 10–100 tons band. However, in some of the articles, the Leader Registrar had not yet been determined, and in some articles, common registration conditions and data access fees had not been clarified.
In order to avoid interruption of imports, the appropriate registration method was evaluated separately for each item. As a result of the work carried out by ONAY Mühendislik, the Individual Temporary Registration File for six items was prepared within eight weeks and submitted via KKS.
Initial status
The following was determined in the examination carried out at the beginning of the project:
- Import data kept on a product basis is not converted to an item basis
- CAS and EC information are not compatible with each other in some Safety Data Sheets
- The amounts of substances in the mixture are not reflected in the annual tonnage calculations
- There were deficiencies in the composition information received from suppliers.
- Joint registration and Lead Registrar processes have not yet been finalized for some items
- It is not clear for which substances the company must register
ONAY Mühendislik take?
The first stage reviewed import records for the previous three years alongside product lists and safety data sheets. Substances within products were identified by their CAS and EC numbers to create a substance-level KKDİK inventory.
For each substance, the company's role, annual tonnage, area of use and possible registration exemptions were evaluated separately. For the six substances included in the registration:
- Substance identity and composition information confirmed
- Reference substance records to be used in KKS were created
- Available physicochemical, toxicological and ecotoxicological information was reviewed
- Literature research and technical justification were carried out for titles for which data were not available
- Individual Provisional Registration Files prepared
- KKS data entries and quality checks completed
- Reference process for ministerial fees followed
When preparing the provisional registration dossiers, we also documented the data and work needed for future full registration.
8-week project calendar
| Period | Work in progress |
|---|---|
| 1–2. week | Creation of product and item inventory |
| 3. week | Tonnage, scope and exemption considerations |
| 4–6. week | Technical data review and file preparation |
| 7. week | KKS data entries and quality control |
| 8. week | Submission of files and completion of the registration process |
Result
At the end of the project, the company:
- Completed the Individual Temporary Registration process for six items
- Converted product-based import data into item-based KKDIK inventory
- Clarified the items within and outside the scope of registration
- Predetermined the data and budget he would need during the full registration phase
- Significantly reduced regulatory risks for imports and supply continuity
This case shows that the provisional registration process is not just about entering basic information into the KKS; correct substance identification, tonnage calculation, exemption analysis and technical data evaluation show that they must be carried out together.
ONAY Mühendislik manages KKDIK Individual Temporary Registration projects holistically, from inventory work to KKS file submission.
Other project examples: ONAY Mühendislik case studies — lead registration, temporary registration, Only Representative and UFI–PCN projects.