Under KKDIK, data requirements increase with the annual quantity manufactured or imported — the tonnage band. Accurate tonnage calculation is therefore critical for both cost and timeline.
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.
Correct 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.
Yönetmeliğin resmî tam metni: KKDİK Yönetmeliği — Resmî Gazete.
The band decides the data package
The annual quantity a legal entity manufactures or imports determines the tonnage band, and the band determines which studies are required, what the fee will be and whether a chemical safety report is needed. It is the single variable with the largest effect on registration cost.
How the quantity is calculated
The calculation is per legal entity and per calendar year. Quantities from different suppliers are added together, a substance inside a mixture counts in proportion, and volumes produced for export are included. Looking only at domestic sales gives a misleadingly low figure.
Managing a band change
Track volumes quarterly and set an alert before the next threshold. When a band is about to rise, identify the additional endpoints early, order the studies in time and budget the fee difference. Discovering the change at year end usually means missing a deadline.
Bands and the safety report
Above a defined threshold the chemical safety report becomes mandatory, together with exposure scenarios for every identified use. Below it a technical dossier is enough. Knowing where that line sits before ordering studies prevents both over-testing and under-preparation.
Where hidden volume comes from
Substances arriving inside mixtures, material produced for export and quantities bought from several suppliers are the three sources of volume that regulatory teams most often miss. Reconciling the inventory against customs records once a year usually reveals all three.
Planning Ahead for Higher Tonnage Bands
Because higher tonnage bands demand longer studies, a band change should be planned before it happens rather than after. Track your rolling twelve-month volume and set an internal alert well below the threshold. Firms that treat tonnage bands as a reporting output rather than a planning input usually discover the extra data requirement once production has already crossed the line.