Everyone is checking KKS to see if there is an appointed Lead Registrant for their pre-registered substances. Since there is still a lot of orphan substances, the industry is concerned whether all the co-registrants will meet the deadline.
A lot has changed since KKDIK was first published in 2017; with a system shift from the previous By-Law on Inventory and Control Chemicals to the recent Entegrated Online Environmental System which contains Chemical Registration System (Kimyasal Kayıt Sistemi – KKS), after numerous translated guidance documents, and several system updates, here we are in April 2023 only 9 full months away (less than 188 working days) from the final deadline, 31.12.2023.
UNPREDICTABLE CHANGES MEAN NEW CHALLENGES
The number of Lead registration dossiers submitted to the MoEU is growing as the days pass by. However, it should be noted that, within the system only about 1/6 of the substances have an appointed Lead Registrant.
Besides to this, there happens to be unforeseeable updates of the system. Which means, with dossiers that are submitted in different calendar weeks companies face with a different set of Completeness Check errors. This can be time-consuming for the registrants, as they need to go through the newly requested details one by one. Usually, these errors are not problematic but since the requested data consists details that are not mandatory for EU REACH, it can be hard to get the information that is linked with a document dated several years ago.
Companies should be aware of such issues in order to be prepared for any change. At times, the guidances are updated on a wider scale and the industry is informed on this. Also there is no public list indicating the overall situation within the system.
THERE IS GOOD NEWS AS WELL
The industry is concerned on many things, such as the orphan substances, ambiguous Letter of Access (LoA) procedures and lack of cost transparency.
We will touch base on these topics as well but let us clarify the recent decisions on the path to the registrations. First of all, one of the major topics was the translation of the data. Since time is ticking, and there are not many expert translator offices who are familiar with the regulatory world,Especially when the heavy load of all substances within the KKS is considered this was an enormous problem for the SIEFs and Lead Registrants.
Thanks to the effort of the rooted associations like Istanbul Chemicals and Chemical Products Exporters Association (IKMIB) and Turkish Chemical Manufacturers Association (TKSD), The Ministry decided on granting an additional year window for the companies to resubmit their dossier with the translated information. Here is the case, earlier translation of the Turkish CSRs were mandatory. Now companies are able to use the English documents, submit their dossier (considering all the data sharing mechanism is already clarified) to the Ministry before the deadline, 31.12.2023. In the background, they can work on their translations and update their submittals by 31.12.2024.
As a secondary major change, CKN numbers are no longer required. Earlier, it was a must to have those actors within the dossier as the number was the key to record the Downstream Users (DU) to the related registration dossier.
Since most of the companies are not familiar with the CKN number it was crucial for this request to be not mandatory in order to cover indirect exportations to Turkey. DU’s information section in KKS registration dossier will remain as it is in the registration form, but it will not be mandatory anymore to fill it.
DATA SHARING PROCEDURES IS ONGOING
The most time-consuming process of the whole registration phase is by far the data sharing, which comes with all its diffuculties. Since there is no consortium establishment in Turkey, all the potential co-registrants forming the SIEFs try to find the best way to consitute the data. For each substance the scheme may change, as sometimes the data owner is the European Lead Registrant, and sometimes it is the consortium.
The expending of the data to Turkey is a delicate process and needs to be handled by experts only. Even with knowledge and expertise it takes months to negotiate and go through the legal processes. SIEFs rushing through the processes miss out points on dissemination which can end up with breach of several agreements that are already in place since 2008 for EU REACH purposes.
There has been a recent update on the Guidance on Data Sharing in March. With the recent update of the Ministry, the basic principles and rules regarding data and cost sharing are explained in more detail. The Ministry strongly recommends that companies comply with the KKDIK Regulation and Data Sharing Guidance.
SUPPLY CHAIN COMPLIANCE IS CRUCIAL
In Turkey most of the manufacturers and importers rely on the supply chain to produce their final products and to place them on the market. That is why companies are also getting in touch with their suppliers to understand their intention on KKDIK compliance. Most of the time, such communications take months depending on reaching out to the right person or getting precise feedback on the registration and volumes.
Non-Turkish companies can still appoint an Only Representative based in Turkey to go through pre-registration. It should be noted that, if the non-Turkish suppliers do not prefer to oblige with their obligations then, the registration falls on the shoulder of the Turkish importer(s) which can lead to duplication of sharing the data and confidential business information. It should be noted that, The MoEUCC is accepts EU REACH data as reference.
RGS Group of companies, assists manufacturers over 60 countries to comply with international chemicals legislarions since 2008. With our joined forces with Chemservice Group, we established ChemAdvocay Türkiye (CATR – www.chemadvocacy.com.tr) in April 2021 to solely focus on the coordination of the technical and administrative processes of the SIEF Management with the relevant consortia in the Euor with the Lead Registrants.
Please do not hesitate to contact RGS in case you have any questions on Turkish chemicals regulations, including Classification & Labelling and SDS regulations.
REACH Global Services Group
Tugçe Gizem GÜRLEROGLU
Deputy Director
