As the KKDIK registration deadline of 31/12/2023 is getting closer and closer, companies are going through an important period for compliance with KKDIK. 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.
Currently companies have already started to communicate within the MBDF’s of their substances, lead registrant appointments were mostly determined. Joint submission of a dossier is possible after the Lead Registrant’s dossier is submitted to the MoEU. Therefore Lead Registrants are rushing to submit registration dossiers on time. The Ministry performs a completeness check within 3 weeks when registration dossier is submitted. Also when the Lead Registrant submit registration dossier, all other MBDF members are notified automatically. Companies approved by the Lead Registrant send joint submission dossiers.
Turkish Competent Authority, MoEU recently announced that full evaluation and approval process of the first registration dossier was accomplished on July 1st using new KKS. They also declared that 70 full registration dossiers have been submitted and evaluations are being done by the Ministry.
Establishing a Consortium under KKDIK
Through REACH experience, it is possible to predict that establishing a Consortia is a very effective way for cooperation of potential registrants of a substance or group of substances to fulfil the KKDIK requirements in time. As the data sets for KKDIK registrations already exists in the control of EU Consortia, Consortia members want to share the right to use the data to comply with regulations in Turkey. Therefore most of the KKDIK Lead Registrant companies are also the members of the relevant Consortium in EU.
On the other hand the provision and sharing of data between competitors require a high degree of administration and confidentiality. In order to best manage this process, Turkish Competent Authority, MoEU require the formation of MBDFs / consortia by chemical companies which manufacture or distribute the same substances. Usually they commission an external MBDF or Consortium manager to act as their independent trustee.
For this purpose ChemAdvocacy Turkey (CATR) was established in April 2020 as a partnership between Chemservice Group and RGS Group as an independent secretariat and trustee of choice to KKDIK consortia, granting a smooth and professional process to fulfil the registration obligations while keeping confidentiality amongst all parties.
The MoEU’s project on CSA and improvements
The MoEU’s EU-financed project entitled as “Technical Assistance to Conduct Chemical Safety Assessments under the scope of REACH Regulation” will be finalised on 31/10/2021. Within the scope of project activities, two dissemination seminars were held in October 2021 with Covid measures in Istanbul and Izmir.
KKS was under construction managed by this project that started on 1 November 2019. During dissemination seminars, the Ministry announced the following developments;
- Inquiry Management module was developed and integrated to KKS. This module is being used successfully to receive notifications, monitor and response in a systematic and practical manner. It will ensure visible system maintenance and support sustainability.
- Integrating the Chemical Safety Assessment and Reporting (CSA&R) Tool to KKS is finished. CSA&R tool is more user friendly compared to the reference tool of ECHA. In the ECHA system, chemical data is taken and uploaded into a separate tool. In KKS, since the CSA system will work in an integrated manner, there is no need to export the data or to enter data into a separate tool again. Therefore, CSA can be made with this new tool integrated into the KKS by using the data entered to KKS system. CSA&R tool will be active after 31/10/2021.
- Comprehensive studies were accomplished to update the KKS to latest IUCLID format.
- 6 short guidance video scenarios were prepared and are being finalized. The ready ones are already published on Chemical Help Desk.
RGS was established in 2008 in Brussels provides global consultancy services to companies operating in the chemicals and cosmetics sectors within the scope of the EU REACH and Turkish KKDIK regulations. As RGS Group of Companies, including RGS-Turkey subsidiary, we have been carefully providing since 2008 our professional consultancy services in the implementation of EU REACH and Turkish KKDIK/SEA regulations to more than 1.100 manufacturers in over 55 countries.
Do not hesitate to contact RGS, if you need compliance with Turkish Chemicals Regulations or more details on our services.
REACH Global Services Group
Pınar Ozgun Yavas