Ana sayfa/Tonnage Bands and Data Requirements under KKDIK
Tonnage Bands and Data Requirements under KKDIK
Under KKDIK (Turkey REACH), data requirements increase with the annual manufactured or imported quantity, i.e. the tonnage band. In general, the 1-10 tonne band requires basic physico-chemical and limited toxicological data; the 10-100 tonne band adds broader toxicological and ecotoxicological data plus a Chemical Safety Report; and the 100-1000 and 1000+ tonne bands require more comprehensive, often long-term studies. Accurate tonnage planning avoids unnecessary testing costs and clarifies the final registration timeline. ONAY Mühendislik manages tonnage planning and monitoring.
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Contact ONAY Mühendislik for KKDIK and REACH compliance support.
How tonnage bands work
The annual quantity a legal entity manufactures or imports determines the tonnage band, and the band determines the data package, the fee and whether a chemical safety report is needed. It is the single variable with the greatest influence on registration cost.
Calculating the volume
The calculation is made per legal entity and per calendar year. Quantities from different suppliers are added together, and a substance contained in a mixture counts in proportion. Volumes produced for export are included as well, so domestic sales alone give a misleading picture.
Data requirements by band
- Lower bands: physicochemical data and limited toxicological information
- Middle bands: repeated dose and additional environmental endpoints
- Higher bands: reproductive toxicity and long-term environmental studies
- Above the threshold: a chemical safety report with exposure scenarios
Managing a band change
Track volumes quarterly and set an early warning before the next threshold. When a band is about to rise, identify the additional endpoints, order the studies in time and budget the fee difference. Discovering the change at year end usually means missing a deadline.
Related pages
Official source: KKDIK Regulation — Turkish Official Gazette.
Volumes hide in the supply chain
Quantity data usually sits with purchasing and logistics rather than with the regulatory team. By the time the annual total is visible, a threshold may already have been crossed. A quarterly tonnage report closes that gap and gives enough warning to order studies in time.