KKDIK, widely known in the EU as the Turkish REACH-like Regulation was published on the 23rd of June 2017 after final opinions of the stakeholders and Turkish Chemicals Manufacturers are considered by the Ministry of Environment and Urbanisation (MOEU) early in the year.
The regulation is basically a translation of REACH Regulation and an output of an EU Implementation Project for the purpose of aligning Turkish chemicals regulatory management to that of the European Union. Despite the fact that EU and Turkey relations with regard to the EU membership are on hold, several Ministries are continuously working on aligning the regulations with the EU as global harmonisation is popular amongst regulatory environment, especially within the frame of EU-Turkey Customs Union.
The Turkish By-Law on Inventory and Control of Chemicals of 2011 is repealed on the same date, 23 June 2017 while By-Law on Restriction of Manufacturing, Placing on the Market and Use of Certain Hazardous Substances, Preparations and Articles will be repealed 6 months after KKDIK publication date. The Regulation enables companies to adopt their Safety Data Sheets according to KKDIK requirements via providing a long transition period. The current Regulation on Preparation of Safety Data Sheets for dangerous substances and mixtures will be in force until 31 December 2023 which is the deadline for companies to submit registration dossier to MOEU regardless of the hazard classification and the volume of the substances put into the Turkish market. In addition to that a three year time frame is given for companies to submit registrations between 31/12/2020 – 31/12/2023 and database system called “Chemicals Registration System” abbreviated as KKS in Turkish is readily available on the MOEU website for making pre-registrations for the time being. The same database system is already being used since 2015 to make SEA notifications which is Classification and Labelling Notifications in Turkey. Keeping in mind Turkey adopted CLP Regulation earlier, the SEA notifications for hazardous substances in the market are already completed before 2015 deadline. MOEU system that will be used for (pre)-registrations is representing an old version of IUCLID regarding the data fields and structure. The system can be defined as a hybrid of IUCLID and REACH-IT through which online created dossiers can be submitted to MOEU directly. However, it is anticipated that KKS will be under construction in the upcoming months or years to cope with the changes in REACH and IUCLID in the recent years.
European Chemicals Agency (ECHA) had published several guidance documents, factsheets, and updates since 2008. Guidance on Registration is the only guidance document published by the MOEU for the time being. However, Ministry is working on other guidance documents as well. A newly published guideline; “The documents and programmes that the Chemical Safety Assessor Training and Certifying Bodies must deliver to the MOEU” is for companies planning to become a certifying body in Turkey. The document summarises the conditions and all necessary requirements regarding certification. It was already known from the Draft KKDIK documents that Chemical Safety Reports will be prepared and signed by Certified Risk Assessors established in Turkey. The requirements and procedures for qualifying to apply for a certificate and getting authorised as a certified body are already explained in Annex XIIX of the Regulation. Another important document published at an earlier stage of KKDIK before many guidance documents is “The Fact Sheet on Toll Manufacturer under KKDIK”. The roles of companies are clarified in this document.
The data requirements for compliance to KKDIK is almost the same as in EU REACH. Many experts in the regulatory business believe that it is a wise decision to share the data used in EU REACH registrations and agree that this eventually increases the regulatory value of the data. The terms Substance Information Exchange Forum, Consortium, Lead Registrant, Joint Submission, are all translated into Turkish in KKDIK regulation. EU consortia probably will start thinking about giving the right to use the data for compliance purposes to KKDIK in Turkey after finalising 2018 registrations which is keeping everybody busy at this point in time.
REACH Regulation Article 8 which defines the term Only Representative (OR) and the obligations of an OR in short are translated into Turkish in Article 9 of KKDIK Regulation. The section relating to OR role in the Guidance on Registration is also identical to ECHA guidance document as well. Companies located outside of Turkey putting chemicals into the Turkish market must appoint an Only Representative to comply with the KKDIK obligations unless they have subsidiary with qualified staff to take on the workload in Turkey. Otherwise, appointing a trustworthy OR seems to be the safest way for compliance likewise in EU REACH Regulation.
Please contact RGS, if you are not compliant with Turkish Chemicals Regulations or need more details on our services and the status of your substances.
Dr. Yaprak Yüzak Küçükvar
RGS Turkey Branch Manager