Substance Identity (SID) is the precise definition of a substance and is the foundation of the entire KKDIK process. A wrongly identified substance jeopardises the whole registration.
SID includes CAS/EC number, IUPAC name, molecular structure, purity, impurities and analytical/spectral data. Correct SID determines which MBDF you join, substance sameness and the scope of joint registration.
Incorrect SID leads to the wrong MBDF, separate registration or a rejected dossier. ONAY Mühendislik carries out substance identity and sameness analysis meticulously.
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Contact ONAY Mühendislik for KKDIK and REACH compliance support.
Yönetmeliğin resmî tam metni: KKDİK Yönetmeliği — Resmî Gazete.
What substance identity covers
Substance identity is more than a CAS number. It combines the chemical name, EC and CAS identifiers, the purity range, the impurity profile and any additives or stabilisers. Together these describe the material your company actually places on the market, which is rarely identical to a textbook substance.
Why the forum needs it
Sameness decisions inside the data sharing forum rest entirely on this description. If two members describe their material differently, they cannot share a data set, and both end up paying for studies twice. Providing full analytical data at the enquiry stage is the cheapest way to avoid that outcome.
Where companies get it wrong
The most common gap is relying on a supplier specification sheet instead of the underlying analytical reports. The second is failing to re-check identity after a supplier change, because a different manufacturing route produces a different impurity profile even when the trade name stays the same.
Analytical data you should hold
A defensible substance identity is supported by chromatograms, a purity determination and, for UVCB materials, a description of the source and process. Keep the raw reports rather than a summary sheet, because the forum and the authority both ask for the underlying measurement.
Review it whenever the supply chain moves
Substance identity is not a one-off record. A new supplier, a changed manufacturing route or a different grade can shift the impurity profile enough to affect the sameness decision. Building an annual check into the inventory review keeps the registration aligned with what you actually buy.
Substance Identity Checks Before Joining a Forum
Before you commit to a joint submission, run a substance identity comparison against the lead registrant’s declared profile. Compare CAS and EC numbers, purity ranges, named impurities and the manufacturing route. A substance identity mismatch discovered after you have paid for data access is far more expensive than the analytical work needed to confirm sameness up front.