Differences between EU REACH and KKDIK has long been discussed by the regulatory environment since the regulation was published in June 2017. Although KKDIK is an implementation of EU REACH Regulation in Turkey, and the aim of the Ministry of Environment and Urbanization (MoEU) is to align with the chemicals regulations with the EU, there may still be dissimilitude between the regulation, Annexes and the practical processes when compared with EU REACH regulation.
Annex XVII which lists the Restrictions on manufacturing, placing on the market and the use of certain dangerous substances, mixtures and articles both in EU REACH and KKDIK were identical until 29 November 2019 when the first amendment to KKDIK Regulation was made. According to the amendment, the 67th entry in Annex XVII entered into force restricting the public use of certain cyanide compounds. The restriction also brings some conditions for compliance of those compounds for industrial and professional use with it in terms of labelling requirements in addition to obligations of SEA, Turkish CLP. Distributors and downstream users of these cyanide compounds listed under Entry 67, have the obligation to submit End User Declarations to the manufacturer or the importer, after which these declarations must be submitted to the MoEU.
This amendment to KKDIK diverging from the EU Annex represents the precaution taken by the MoEU as a result of the increasing number of cyanide poisoning incidents in Turkey while the main principles of REACH are still applicable. KKDIK Registration Period will start on 31st December 2020 and gives registrants a 3-year time frame to finalize their registrations. This simply means waiting until the pre-registration deadline to start preparing for registration is not the sensible way, especially if you are planning to be a Lead registrant. “MBDF” which stands for “Substance Information Exchange Forum” in the online MoEU Chemicals Registration System is based on the same principles than in the EU. Once the substances are pre-registered, MBDF communications can be initiated and the need to establish a consortium will be decided amongst the potential registrants. Joint submission of a dossier is possible after the Lead Registrant’s dossier is submitted to the MoEU. Data sharing principles also apply to KKDIK; and potential registrants in Turkey need to review MoEU Guidance on Data Sharing translated from ECHA Guidance Document with adaptations made to reflect the requirements of current regulations in Turkey.
Any exemptions from the obligation to register needs to be decided in the light of Annex IV and the guidance on Annex V exemptions from the obligation to register. However, other sector specific regulations applicable in Turkey and the effect of those regulations to the obligations for compliance with KKDIK must be assessed well.
Multinational corporations with manufacturing facilities around the world may have complex supply chains and various roles according to the definitions in KKDIK (manufacturer, importer etc.) even for the same substance. Moreover, it is highly important to decide on data sharing for regulatory compliance in Turkey for companies who are especially data holders. As the information requirements expressed in Annex VII to X are exactly the same in the EU REACH but required to be presented in a dossier prepared in Turkish language, the purchase of the right to use the sets of data for different volume bands in Turkey becomes extremely important. The costs are under discussion in most of the EU consortia for the moment, especially now that the EU registration deadlines are over and only late/newcomers are requesting Letter of Access.
RGS has been acting as the EU Only Representative for the last 12 years consulting to more than 450 clients all over the world. The team of experts within RGS Group transfers years of 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
Turkey Branch Manager