CRAD BLOG

NEW ERA OF KKDIK - REGISTRATION PHASE AND ACTIONS TO TAKE

As you well know the KKDİK (In other words Turkish REACH) had entered a new era as of 1.1.2021. There had been a 3-year period for pre-registration of the substances placed on the market by way of manufacturing or import before 31.12.2020.

Please bear in mind that the pre-registration will continue till 31.12.2023 for the substances imported into Turkey after 31.12.2020. Even though a pre-registration seems to be possible even in December 2023 in theory; in practice the deadline for pre-registration should be considered as September 2023 at the latest so that you can still achieve a successful registration to be submitted as a co-registrant before the registration deadline 31.12.2023. 

Now let's have an interactive view for the activities to be considered for a successful registration under the scope of KKDİK. 

As experienced under the scope of EU REACH the main aim of the pre-registration activity is to form the SIEF of the substance to be registered and to initiate the communication and cooperation between the potential registrants of the substance. This is what needs to be initiated (or at least expected to start) as of January 2021. It would be the best to define the further steps in a step wise approach. 

1) Do you have any substance that you are in the intention of nominating yourself as a Lead Registrant (LR)? 

That is the first point that you need to decide and inform the pre-SIEF members to obtain the general approval and initiate the dossier compilation work. As most would recall this activity caused many ambiguities and communication mess back in 2009 for the EU REACH. For KKDİK we again (unfortunately) expect such a mess with a smaller of size when compared to REACH. There had been cases where such communication started even before 31.12.2020 which indeed was not a correct and compliant strategy. 

We expect; the mutual agreements of the members within the EU REACH consortiums / EU REACH SIEF’s would play a critical role in this respect to prevent a mess of communication and conflicts. General expectation is; the EU LR of the dossier is the most suitable candidate to be LR for KKDİK as they do have/hold most of the data and the experience in the dossier compilation of the particular substance. With the assumption of Turkish SIEF to be a mirror reflection of the EU SIEF, prior discussion and decisions of the EU SIEF members would minimise the conflicts for identification of the LR for the KKDİK registration. 

For sure there might be exemptions such as EU LR not interested in taking a LR in Turkey based on the market volume or having other KKDİK SIEF members (such as local manufacturers with higher volume or more influence on the market. 

Also, the LR candidates who will be represented by an OR needs to decide and inform their OR if they agree with disclosure of their LE name for the SIEF communication. 

With a lesson learnt from the EU REACH; Industry may act reluctantly to accept the OR being accepted as an OR if the background of the company who the OR is acting on behalf of is not disclosed. This might seem reasonable as they would rely on the LR to have their co registration on time with the required data. So; disclosure of the company represented can be required for the cases to act as LR candidate which would be easier for the SIEF members to be convinced. 


2) Determination & Identification of your role with in the SIEF for the registration period.

Even though it is not obliged per the legal text the role, identification in the SIEF activities which were previously determined as below per the EU REACH and the generally accepted principles set forth by the EU Chemical Industry Stakeholders: 

•    Lead 
•    Involved / Active
•    Passive
•    Dormant


These definitions will sound familiar to the regulatory experts of the chemical industry with EU REACH experience as they are sourced from the CEFIC guidance on SIEF and other several subjects under the EU REACH. As there were no other Local initiative specific to KKDİK it would be the best to follow the available support that had been created with EU REACH experience, with thanks to CEFIC which have worked well since then.  
    

3) Tonnages: 

Starting to collect tonnage information to decide your registration tonnage band.This process might be easy for direct exports. But as understood from the questions we had received many industry stakeholders have the need to cover the indirect exports of the substances to Turkey which are further formulated by the DU’s out of Turkey. Thus, this can be complicated than expected and will totally depend on the strategic business decision of your company. For the indirect supply chain, you can cover the volume based on your wish and identification. Please note that the OR will have obligations to have a traceable record of these volumes and the covered importers in Turkey. Thus, the companies who do not have the intention of taking a LR needs to start to collect and/or organise how this data will be collected in coordination with DU’s and OR so that they can determine the tonnage thresholds they need to cover till to the submission date of their choice. 

In this respect for sure there will be many pre-registrants which are in the intention of being covered by their suppliers KKDİK registration for the substances that they had pre-registered to be on the safe side. This also needs to be communicated up and down the supply chain if your supplier of substances is in the intention of covering your exports to Turkey with in their KKDİK registration tonnage band. 

4) Uses:

Communication of uses is another critical point to be covered while taking steps towards registration.It had been a challenge during REACH implementation in the EU for the DU’s to define their uses within the given Use Coding structure. In most cases the registrants identified the generally known uses and informed this to the DU’s along with the acknowledgement that if there is another r specific use the DU should cover on their own. 

For KKDİK, the period for registration being 3 years only which the clock had already started ticking it would be either impossible or challenging to identify if there is specific uses of the Turkish importers in Turkey. Taking the COVID-19 conditions and the lack of experience in the Chemical Industry DU’s in Turkey it would not be possible to compile this information within such condition and time period. Due to that our expectation and advice is; to cover the same uses identified and covered for the EU REACH registration for KKDİK as well. For sure there might be exceptional cases, but this would be the pragmatic way for a seamless registration strategy. 



5)  After the above listed steps being covered by you in cooperation with your OR the pre-SIEF communication should be initiated. When the LR is identified the data transfer and the dossier compilation should start along with the submission. 
 
We as your OR; will soon circulate the ‘’Registrant Questionnaires’’ to cover and identify the above-mentioned steps to determine your needs and take the relevant actions as referred. 


CRAD Team 
 

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