Home page/How to prepare a KKDIK technical file?

How to prepare a KKDIK technical file?

KKDIK technical file (IUCLID dossier) is prepared by compiling all scientific and administrative information about the substance in a standard format. The process in general; It includes the steps of definitive determination of the substance identity, collection of existing data, determination of the required data set according to the tonnage band, closing of data gaps through testing, literature or QSAR/reading, creation of physico-chemical, toxicological and ecotoxicological summary records, classification-labeling and, if necessary, addition of the Chemical Safety Report. The file is completed in accordance with MBDF common submission rules and submitted to KKS. The quality of the file is decisive for the acceptance of the record and audit durability.

For questions, contact ONAY Mühendislik.

Backbone of the technical file

KKDIK technical file is a whole that starts from the identity of the substance and extends to the conditions of safe use. The file is established in IUCLID and submitted via KKS. The scope of content expands according to the tonnage band; Above a certain threshold, a chemical safety report is also added.

Sections included in the file

Substance identification: CAS, EC, purity and impurity profile
Physico-chemical properties
Toxicological and ecotoxicological study records
Identified uses and exposure scenarios
Classification and labeling information

Three common mistakes

The first is that studies are added to the file without assessing their reliability. Secondly, the usages are written very generally and the scenarios do not overlap with the field. Third, the file is not updated when the supplier or formulation changes.

Verification before sending

Run software deficiency checks before submitting the file. Empty spaces and contradictions are thus immediately visible. Internal verification takes several hours; An official request for information from the institution takes months.

Official full text of the regulation: KKDIK Regulation - Official Gazette.