NEW ARRANGEMENTS ON “1.7 SUPPLIERS” AND “13.1 CHEMICAL SAFETY REPORT” IN KKDIK REGISTRATION DOSSIERS
For your attention
New arrangements have been made in the "1.7 Suppliers" and "13.1 Chemical Safety Report" sections of the registration dossiers within the scope of Regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (KKDIK Regulation).
1.7 Suppliers
In the 1.7 Suppliers section of the registration dossiers, the mandatory section, in which foreign companies represented by the only representatives are obliged to add their importers in Turkey, is no longer mandatory. While it is recommended that only representatives add this information to their registration dossiers, and if the information is not included, it will be adequate to pass the completeness checks performed by the Ministry.
The only representative’s registration dossier must contain all uses of the importers (now downstream users) covered by the registration. In addition, an up-to-date list of customers (importers) within the same supply chain and the tonnage covered for each of the importers, as well as information on obtaining the latest update of the safety data sheet, should be retained and available for the Ministry's audits.
It is recommended that importers seek confirmation from the 'non-Turkish manufacturer' on whether an only representative has been appointed, as well as to obtain a written confirmation from the only representative that the tonnage imported and uses are covered by the registration submitted by the only representative. The importer, where relevant, needs to obtain sufficient information from the 'non-Turkish manufacturer' and/or the only representative in order to fulfill his obligation to compile the safety data sheet. The importer in Turkey should be able to certify which imports are included in the registration to be made by the only representative if requested by the Ministry.
13.1 Chemical Safety Report (CSR)
Since the translation of Chemical Safety Reports, which are required to be submitted in the registration dossiers of chemicals with tonnage bands above 1-10 tpa, is a lengthy process, the option to upload the Chemical Safety Report in English has been introduced for companies (if they wish so).
The registrants that choose to upload the Chemical Safety Report in English must add the Turkish translated version to the registration dossier within 1 (one) year at the latest, starting from the registration deadline, December 31, 2023, in a manner that will include their uses in Turkey, exposure scenarios and risk management measures. In addition, it is still mandatory for all fields in the system in the "Robust Study Summaries" and "Study Summaries" to be submitted in the registration dossier to be filled in Turkish.
In addition, in this announcement of the Ministry, it was emphasized that the registration of all chemicals within the scope of KKDIK Regulation should be completed by 01/01/2024 and that the manufacture and/or import will not be allowed after 01/01/2024 for substances not registered in the Chemical Registration System (KKS).