WHAT SHOULD THE TESTING STRATEGY BE WHEN PREPARING A KKDIK REGISTRATION DOSSIER?

Content addition date : 07-08-2025

KKDIK Regulation - Turkish REACH Regulation (Registration, Evaluation, Authorization of Chemicals) requires that the test strategy applied in preparing the registration dossier be of great importance in terms of both legal compliance and cost-effectiveness. A properly structured test strategy prevents unnecessary testing while also ensuring more reliable results in terms of environmental and human health.

Test requirements in the KKDIK registration process vary depending on the tonnage band and hazard classification of the substance. For example, Annex-7 requirements apply to substances between 1-10 tons/year, while substances of 10 tons or more must also complete the tests covered by Annexes-8, 9, and 10. In this process, it is also mandatory to prepare a Chemical Safety Report (CSR) and create appropriate Safety Data Sheets (SDS).

The first step in developing a testing strategy is to collect and evaluate all available data. At this point, the “Weight of Evidence” (WoE) approach plays a critical role. If the available data is scientifically sufficient and obtained from reliable sources, it may not be necessary to repeat the same test. Additionally, the use of non-testing methods (in silico, QSAR, read-across, in vitro, etc.) is encouraged under KKDIK. These methods are particularly important for reducing animal testing.

Annex-11 allows for exemption from testing under certain conditions. In cases where the test cannot be performed for technical reasons, where existing data is sufficient, or for ethical reasons, it may not be necessary to perform the relevant test. However, this must be scientifically justified.

When determining the testing strategy, the following steps must be taken: analysis of the existing data set on the substance to be registered, evaluation of non-testing methods, planning of mandatory tests in accordance with scientific methods, clarification of data sharing processes, and preparation of a complete registration dossier.

In conclusion, establishing the right testing strategy under KKDIK provides companies with significant advantages not only in terms of legal compliance but also in terms of saving time and money. Prioritizing scientific approaches, evaluating alternative methods, and establishing a registration strategy in a timely manner are the most critical steps in this process.