The Backstory
For nearly seven years we’ve been hearing of an impending regulation in Turkey which would require registration, evaluation, authorization and restriction of chemical substances, much like the existing chemical regulatory framework in the EU, referred to by the acronym of REACH. On June 23, 2017 Turkey made these plans a reality by publishing their new REACH-like regulation—referred to as KKDIK (“KKDIK” are the first letters of REACH written in Turkish) —in the Official Gazette.
What’s Changing
A key feature of both EU REACH and Turkey’s KKDIK is “no data, no market.” In other words, manufacturers and importers must develop technical dossiers, and in some cases chemical safety reports, to demonstrate that their chemical substances pose minimal risk to human health or the environment—those that do not meet this criterion may eventually proceed from “evaluation,” to “authorization” (permission required to manufacture/import for some specified period of time until the substance is phased out), and/or “restriction” (either on all or some uses of the substance). And again—data is key. In fact, manufacturers and importers in the EU marketplace often spends hundreds of thousands of USD generating data on their substances’ physical, chemical and toxicological properties, in support of REACH. Understandably, the introduction of KKDIK, which becomes enforceable on December 23, 2017, has been met with mixed reactions.
Implications
If you’re a manufacturer or importer of chemicals in the Turkish market—whether they be pure substances, contained within a mixture, or embedded within an article—the time to begin planning for and assessing your KKDIK obligations is now. From determining your data requirements; to coordinating testing both internally and externally (and in the proper order, based on study length); from garnishing financial support from those in control of the budget; to creation of the technical dossier and supporting analytical reports; and tracking of substance volumes, tonnage bands and supply routes; along with performing chemical safety assessments and developing exposure scenarios and risk management measures—REACH and KKDIK compliance are massive undertakings whose required time, resources and complexity should not be underestimated. Anticipating these additional regulatory burdens, planning accordingly and budgeting for the additional resources needed, are all wise strategies to ensure the continuity of your operation in Turkey for years to come. Global Safety Management is happy to help you navigate the complexities.
