Ana sayfa/What is substance sameness?
What is substance sameness?
Substance sameness determines whether substances manufactured or imported by different companies are considered the same substance under the identity rules. It governs which MBDF you join and the scope of joint registration. Incorrect sameness assessment can lead to the wrong MBDF or separate registration.
Related pages
Contact ONAY Mühendislik for KKDIK and REACH support.
What substance sameness means in practice
Substance sameness decides whether two companies are registering the same substance. Without that decision a joint registration cannot be built and study data cannot be shared. The assessment looks at the main constituent, the impurity profile and any additives or stabilisers.
What evidence is needed
- Analytical data: chromatograms, spectra and purity determination
- Percentages of the main constituent and impurities
- Summary of the manufacturing route and raw materials
- Additive and stabiliser information
- Source and process description for UVCB substances
Why the trade name is not enough
Two suppliers may sell a product under the same commercial name yet manufacture it differently. Different routes produce different impurities, and impurities drive the sameness decision. For that reason each new supplier should trigger a fresh analytical comparison.
The cost of getting it wrong
Treating different substances as identical produces a dossier that does not describe your material, and the registration may be rejected. Treating identical substances as different pushes you into an individual registration with extra testing and higher fees. The decision should therefore rest on laboratory data, not on assumptions.
Related pages
Official source: KKDIK Regulation — Turkish Official Gazette.
Who runs the assessment
In a joint registration the lead registrant usually coordinates the sameness work, but each member supplies data for its own material. Agreeing a common analytical protocol at the start matters, because results from different methods cannot be compared and the discussion then drags on for months.