EU REACH and CLP regulations are implemented to enable harmonisation of chemicals regulations with the EU in Turkey by Turkish Ministry of Environment and Urbanisation.
Turkish Competent Authority, MoEU recently announced that there are only days left for the pre-registration deadline for Turkish REACH-like Regulation, KKDIK to end. MoEU also informed companies that the registration module of the Chemicals Registration System; abbreviated as KKS will be ready and active for any entries for registration purposes as of 31/12/2020. KKS has been under construction managed by the IPA Project (Instrument for Pre-Accession Assistance) co-financed by the European Union and Republic of Turkey that started on 1 November 2019.
According to the Transitional Article (2) of KKDIK, substances placed on the Turkish market and meeting the conditions below should be registered during the registration period unless exempted from the obligation to register.
- substances on their own or in mixtures and articles under certain conditions manufactured or imported before 31/12/2023 and
- substances equal to or above 1 tonne/year,
The registration period starts on 31/12/2020 and continues until 31/12/2020 regardless of the tonnage band and hazard classification of the substance.
After the registration deadline 31/12/2023, substances cannot be placed on the market unless registered.
Dossier Submittal Fees
The following procedures are subject to payment according to KKDIK:
- Registration update
- Non-public access information request
- Process and Product Orientated R&D (PPORD) notifications
- Authorisation application
- Review of Authorisations
With only a few days left until the start of registration; a Draft List has been published that includes the fees for registration, registration update, non-public access information request, and process and product orientated R&D (PPORD) notifications. The final list will be published in Ministry of Environment and Urbanization’s circulating capital enterprise unit price list on early 2021. Since the authorisation provisions will enter into force on 31/12/2023, fees for the authorisation process will be determined later.
Manufacturers in Turkey placing products on the EU/EEA market have already registered their substances according to the obligations of EU REACH Regulation and paid their ECHA fees accordingly. Turkish KKDIK Registrations of the same substances compliant with the EU REACH Regulation, will be submitted to MoEU separately and MoEU registration fees will need to be paid. There has been quite a lot of discussions within and outside of Turkey about this duplicate effort needed for the dossier preparation and associated cost for the last few years. Therefore, especially considering the economic conditions the industry is facing in Turkey as a result of the pandemic, MoEU has drafted fees with massive reductions from the initially anticipated numbers which would be identical with the ECHA fee figures but in Turkish currency. The other purpose of the reduced fee structure drafted is to support the companies under the difficult conditions resulting from Covid 19 pandemic. Special reduced fees are defined for SMEs in the Draft List as well. Also, there is a significant cost advantage for companies that will perform joint submission.
KKDIK Fee Structure can be accessed from MoEU website.
Becoming a SIEF Member
Companies submitting pre-registrations to MoEU’s Chemicals Registration System, KKS, do automatically join the corresponding Substance Information Exchange Forum; MBDF. MBDF enables all potential registrants and data holders to interact and prepare for registration. Manufacturers, importers and Only Representatives have to pre-register and join pre-SIEFs for joint registration of their substances through KKS of MoEU. Companies joining the pre-SIEF can reach potential co-registrant’ contact information through KKS. Ministry urges manufacturers, importers and only representatives interested in the registration of the same substance to start communications for data and cost sharing negotiations required for registration.
Substances placed on the market after 2020
If a substance which has not been pre-registered within the given deadline, the KKS system will still allow such companies to pre-register before they place the substance on the Turkish market for the very first time after 2020. However, it is strongly recommended to complete the pre-registrations until the deadline, 31/12/2020, for effective functioning of the joint registration process and also to be on the safe side if annual substance volume may reach or exceed 1 ton threshold anytime.
RGS Group is based in Brussels, Belgium with offices in Istanbul, Turkey. The team of experts within RGS Group transferred years of regulatory experience into practical solutions for non-Turkish companies to comply with Turkish chemicals regulations. Do not hesitate to contact RGS, if you need more details on our services. We can assess your compliance status and build tailor-made solutions for your company.
Dr.Yaprak Yüzak Küçükvar
REACH Global Services Group
Director, Global Regulatory Affairs & Product Stewardship