Five years after KKDIK publication, manufacturers, distributors, and importers are still struggling to define their obligations, manage SIEF communications and register their chemicals. There are still several hundreds of SIEFs without any Lead Registrant. Many appointed lead registrants have not submitted their dossiers yet.
Companies need to register their chemicals by the deadline of 31st December 2023 to be legally on the market. The first phase of KKDIK was pre-registration. Unlike ECHA, the Turkish Ministry of Environment, Urbanization and Climate Change (MoEUCC) did not split the registrations into different phases based on the tonnage bands. Although it is the last year before the deadline for all chemicals, there are significant number of substances which are still not registered.
A Number of Challenges Remain for Importers, Mixture Manufacturers and Distributors
In parallel to manufacturing companies’ ongoing preparations for registration, mixture manufacturers, importers and distributors are working on their supply chain. They are in communication with their suppliers to ensure their products’ compliance. However, mostly they cannot receive clear responses from the manufacturers whether they will register their chemicals under KKDIK or not.
It should be noted that non-Turkish manufacturers can appoint an Only Representative (OR) in Türkiye to fulfill their registration obligations. If a non-Turkish manufacturer registers a substance by appointing an OR under KKDIK, all the importers in Türkiye can be covered as a Downstream User (DU) under their registration. If the non-Turkish manufacturers do not prefer to fulfill their obligations by appointing an OR, the registration must be carried out by the Turkish importer(s).
Industry is Waiting for The Circular to Be Published to Define Their Roadmap for 2023
MoEUCC held a meeting on 11th October 2022 for “Lead Registrants” and “Only Representatives” to discuss current issues and possible resolutions. MoEUCC announced that they will be publishing a circular covering very important topics; organizations on data sharing, determination of Lead Registrants (LR) and specific deadlines for Lead Dossiers (LD) to be submitted depending on tonnage band, auditing and monitoring processes, defining criteria and authorization of Only Representatives, forwarding downstream user data (including indirect importers) to MoEUCC (KKS section 1.7.) etc. However, it is not published yet.
Once, the tonnage band specific deadlines (before 31st December 2023) for lead dossiers are announced with the Circular, it will be more crucial to plan ahead since the MoEUCC is not planning to postpone the final deadline of 31st December 2023. On the other hand, the industry is still expecting to get an extension of the deadline, especially for co-registration dossier submissions.
Update on MoEUCC Registration Fees
Unlike the ECHA fees, the MoEUCC is preserving the possibility of updating the fees on a yearly basis in relation with the inflation rate. On 30 December 2022, MoEUCC announced the updated KKDIK registration fees for 2023 and integration of the fees in KKS is completed. There is an increase of %45 on the fees when compared to the fees in 2022. Companies may see the updated fees in Turkish Lira (TL) from Turkish Directorate for Revolving Fund Management web site. But one should also keep in mind that with the depreciation of the Turkish Lira the final cost for non-Turkish registrants is not very much impacted with the fee increase of the Ministry.
Turkish SIEF & Consortia Management Activities
Recently, there are increasing levels of enquiries to Lead Registrants & SIEF Facilitators relating to LoA fees and data sharing agreements. Although the registrants do prepare their dossiers in KKS, they cannot submit before getting the right to use their REACH data for KKDIK.
Do not underestimate the significant challenge ahead with regard to data sharing, cost modeling, determination of LoA fees, financial management and legal issues. Since 2008, as RGS Group of companies, we are assisting manufacturers in over 60 countries to comply with international chemicals legislations and we are proud to celebrate our 15th year anniversary in 2023.
We also joined our forces with Chemservice Group to establish ChemAdvocacy Türkiye (CATR) in April 2021 to independently coordinate the administrative and technical processes of the SIEF management with the Lead Registrants, and the relevant consortia in the EU.
Currently, CATR is transposing its EU REACH, K-REACH, UK REACH experience on Consortia Management, Data Management, Financial Management into KKDIK and managing thousands of substances’ LoA&data sharing activities in Türkiye.
If you have any questions on Turkish chemicals regulations, do not hesitate to contact RGS for more details on our services.
REACH Global Services Group
Hilal Sevinc
Deputy Director
www.reach-gs.eu
