With the pre-registration deadline for KKDIK quickly approaching on the 31st of December 2020, we at CIRS are busy monitoring the latest updates and preparing you to fulfil all the necessary obligations. Completion of the pre-registration obligation provides you with a grace period for registration until the end of 2023 after which all chemical substances manufactured/imported to Turkey in one ton/year must be fully registered.
To make this process easier for you, we have gathered all the most frequently asked questions from our practical experience to-date with the KKDIK regulation.
- If pre-registration is completed within C&L notification, then why should a foreign enterprise do the pre-registration themselves and not through a TR-importer?
If a TR-importer does C&L notification, they select the role of ‘importer’. The pre-registration will also have been completed under an importer. This may result in the following scenarios (a) higher cost for registration (b) the TR-importer may not do the registration and choose a supplier which has registered their substance with an OR (c) If the TR-importer does the registration, then they can buy the substance from any supplier they want as they will have the registration number. The result is an overall loss of commercial power in Turkey
- How is the pre-registration/registration of a polymer processed according to the KKDIK regulation?
Article 4 (hh) of KKDIK: Polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units, distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units and comprising of the following:
1) A simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and
2) Less than a simple weight majority of molecules of the same molecular weight
According to the KKDIK regulation, polymers are themselves exempt from registration. In the same way as EU REACH, it is the monomer unit and any other substances which are present in 1 ton/year or greater which require pre-registration/registration.
- For C&L notification of chemicals delivered in mixtures, does each individual substance require notification?
The way a mixture is classified is if the mixture contains a substance which is classified as hazardous and it is above the appropriate concentration limit (varies depending on the substance in question), then the mixture is classified as hazardous. If a mixture meets hazardous criteria, then C&L notification is required. Classification is the same as EU REACH.
- Is it possible to transfer completed pre-registrations?
Currently, the online platform for submitting pre-registration/registration dossiers is updating. This is the KKS tool (IUCLID and REACH-IT hybrid). This may take some time to complete. The OR transfer function will be available after the update is complete.
- According to KKDIK, all substances manufactured/imported into Turkey in 1 ton/year should be pre-registered. If my substance is less than 1 ton/year can it still be pre-registered?
Yes, it is still possible to pre-register substances which are less than 1 ton/year. This will also cover future business if annual tonnages rise to the 1 ton/year mark or above in the period of three years. If pre-registration is not completed before Dec. 31st 2020 and tonnages rise above the 1 ton/year threshold, then full registration will be required which will be far costlier.
- Is there a system of reporting dispatches into Turkey after pre-registration is completed?
Currently, there is not such a system in place for reporting dispatches
- When dealing with a mixture, if a raw material is pre-registered under the supplier, can the pre-registration be used by the formulator of the mixture?
This is the decision of the supplier who obtained the pre-registration number and whether he grants access to the formulator to use the pre-registration number.
- Who may register in the case of a multinational company/group companies?
This depends on whether each company within the same parent company are defined as ‘registrant’ according to Article 4(ü) of the KKDIK regulation. If multiple companies are under the same legal entity, then just one company needs to act as the registrant. In the case of a separate legal entity, such as a sister company, they should also register.
- How are alloys registered?
According to the KKDIK regulation, alloys are treated in the same way as mixtures. Therefore, each individual substance i.e. each metallic substance must be registered individually.
- If the tonnage band is expected to increase in the future, can the higher tonnage band be registered under instead?
Companies may register under higher tonnage bands if they expect their annual tonnage to increase. The higher registration fee must also be paid. Furthermore, the registration dossier must include all the required information for the higher tonnage band as data requirements differ between tonnage bands.
- If a company is importing a mixture to Turkey, how can they find out if the individual components have already been registered in Turkey by the supplier, if the supplier is refuses to share the information?
The options are to (a) Contact the formulator where the supplier is not the same entity as the formulator. The formulator may be more willing to share the composition information. (b) Take analytical measurements to determine the composition of the mixture or (c) Find an alternative supplier of the same substance who is willing to share the information
- Our substance only has a CAS No. and no EC No. is available, can we process pre-registration only with CAS No.?
Yes, there is no problem to process pre-registration without EC No.
- We are a distributor located outside Turkey, can we appoint an OR and process pre-registration?
No. It’s same as EU REACH. Only foreign manufacturers can appoint an OR and process pre-registration.
- Is there a definition of “new chemical” in the KKDIK regulation?
No. The regulation is only about the substance. There is no specific definition of Existing Chemical and New Chemical. CIRS suggests companies to process pre-registration of all their substances.
- If the manufacturer completes the pre-registration, can the local importer take C&L notification with this pre-registration No.?
No, if the importer processes C&L Notification, they have to firstly complete pre-registration by themselves.
- Our product contains a raw material which has not been reacted. The tonnage of this raw material is more than 1 ton/year. Are we still required to process pre-registration of this raw material?
It’s similar as EU REACH. If the raw material is not residual on purpose, it can be regarded as an impurity and pre-registration will not be required.
- We are a Turkish legal entity which owns several factories in different sites, how shall we process the pre-registration?
According to KKDIK regulation, registrant shall be the natural or legal person in Turkey. If the company has one individual legal entity which own different factories, and the factories have no individual legal entity, only one pre-registration is enough, and all factories will be covered.
If you have any further questions, please do not hesitate to contact us:
Julie Harrington, Regulatory Affairs Consultant
+353 0 87 197 2618