Ministry of Environment, Urbanization and Climate Change, General Directorate of Environmental Management, Department of Chemicals Management, announced two recent adjustments dated 2 February 2023 regarding the implementation of KKDIK Regulation published in the Official Gazette dated 23 June 2017 and numbered 30105.
NEW ADJUSTMENTS RELATED TO “1.7 SUPPLIERS” AND “13.1 CHEMICAL SAFETY REPORT” SECTIONS IN REGISTRATION DOSSIERS
As it is known, Only Representatives (ORs) are required to add the Turkish importers of the non-resident company they represent to the "1.7 Suppliers" section of their registration dossier.
As a result of the evaluation of the opinions and suggestions from industry federations, associations and various companies by our Ministry, it has been deemed appropriate to remove the aforementioned information requirement from being obligatory.
In this context, although it is recommended that Only Representatives add the aforementioned information to the registration dossiers, there will not be regarded as “missing” in the completeness checks to be carried out by our Ministry in the registration dossiers if they are not added.
The Only Representatives’ registration dossier must contain all uses of the importers (now downstream users) covered by the registration. The only representative must keep an up-to-date list of the customers (importers) of the 'non-Turkish manufacturer' in the same supply chain and the tonnage covered for each of these customers, as well as the information on obtaining the latest update of the safety data sheet and submit the said information during the audits to be carried out by our Ministry.
In this regard, the information in the already published guidance documents such as "Registration Guide", "CRS User Guide" and in the "Frequently Asked Questions (FAQ)" field in the Chemicals Help Desk will be updated as soon as possible.
Some issues that only representatives and importers should pay attention to regarding the registration of chemicals are as follows. Detailed information can be found in the “Registration Guide” on the Chemicals Helpdesk:
Importers should obtain confirmation from the 'non-Turkish manufacturer' whether an only representative has been appointed. In addition, it is highly recommended that they obtain written confirmation from the only representative that the tonnage and usage imported are indeed covered by the registration submitted by the only representative.
This will provide the importer with a point of contact to report their use if they are considered downstream users, and will also give the importer clear documentation that their imports are indeed covered by the registration of the only representative. In addition, the importer is required to obtain sufficient information from the 'non-Turkish manufacturer' and/or the only representative to fulfill the obligation to compile the safety data sheet, where relevant. The importer in Türkiye should be able to document which imports are included in the scope of the registration to be made by the only representative, if requested by our Ministry.
The only representatives’ registration dossier must contain all uses of the importers (now downstream users) covered by the registration. The only representative should keep an up-to-date list of the customers (importers) of the 'non-Turkish manufacturer' within the same supply chain and the tonnage covered for each of these customers, as well as information on obtaining the latest update of the safety data sheet and should submit such information during any inspection to be carried out by our Ministry
13.1 Chemical Safety Report
It has been stated that the Chemical Safety Reports, which are required to be submitted in the registration dossier of chemicals produced or imported 10 tones or more per year, bring additional costs due to the fact that the translation takes a long time and the registration period will be ceased at the end of this year. In this context, the option of uploading the Chemical Safety Report in English has been introduced for those companies that wish to upload them in English.
However, for the registrants who prefer to upload the Chemical Safety Report in English, the Turkish version of the Chemical Safety Report, which includes the use, exposure scenarios and risk management measures in Türkiye must be added to the registration dossier within 1 (one) year from the registration deadline, 31st December 2023, at the latest.
On the other hand, the requirement to fill in all the fields in the system regarding the "Comprehensive Study Summaries" and "Study Summaries" to be submitted in the registration dossier continues as to be in Turkish.
***REGISTER YOUR CHEMICALS UNDER THE KKDIK REGULATION UNTIL 1.1.2024. THE MANUFACTURING AND/OR IMPORTING OF SUBSTANCES THAT ARE NOT REGISTERED IN THE CHEMICAL REGISTRATION SYSTEM WILL NOT BE ALLOWED AFTER 1.1.2024.***
You can download the announcement here