KKDİK – 2017 Draft

Melih Babayiğit / General Director - Crad

The most significant development in chemical legislation in our recent history was the publication and implementation of the REACH regulation prepared by the European Union Commission in 2006. Both because we are a candidate country and because our largest export market is the EU, this regulation has directly concerned our chemical industry. With the impact created by the EU REACH regulation, other countries and economic zones around the world began to successively implement similar regulations. In the recent past, the USA followed with TSCA, South Korea with K-REACH, and China with Chinese REACH. In addition to our candidate country status for the EU and our acquis harmonization process, the Ministry of Environment and Urbanization of the Republic of Turkey also prepared, some time ago, the Draft Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals, which we can abbreviate as KKDİK. Due to various technical and political reasons, the regulation that had been pending in draft form since 2015 was resubmitted to industry stakeholders in January 2017 to obtain feedback on the latest amendments made to it. On the one hand, I wanted to briefly address in my article the changes contained in this latest draft, and on the other hand, the effects of the regulation as a whole on our industry prior to its publication. First of all, I should note that KKDİK, as it is based on the REACH regulation within the framework of acquis harmonization, is quite similar in its general structure to the REACH regulation.

The main theme of the regulation is that all industry members producing chemical substances at a rate of 1 ton or more per year and importing them either independently or within a mixture must compile and submit the data requested by the relevant authority regarding that substance.

Through the data to be compiled in this way, it will be possible to identify previously unknown harmful properties of chemicals, and both the measures to be taken regarding safe use and the decisions on restrictions or prohibitions to be taken can be based on more sound and current data. According to the latest published draft, there is only one article that will enter into force upon publication of the regulation in the Official Gazette. That is the article repealing Regulation No. 27092, referred to as the KEK regulation, on the Inventory and Control of Chemicals. All other articles will enter into force 6 months following their publication, while other provisions regarding restrictions and registration are subject to a process extending until 2025. The publication of the regulation during 2017 is an expectation shared by everyone. Since the regulation was initially prepared in 2014, subsequently amended according to feedback received several times and resubmitted for consultation, any further delay would necessitate further amendments due to the domino effect of interdependent implementation dates. Furthermore, any further delay in publication would risk KKDİK, the regulation referred to as Turkish REACH and which has been the focus of interest in both domestic and global chemical industry for a considerable time, losing the attention and consideration it deserves.  

Addressing critical dates with respect to the current draft:

From the end of the 6th month following publication until 31 December 2019, preliminary MSDS notification will be made for substances currently produced and imported in quantities exceeding 1 ton. Between 1 January 2020 and 31 December 2022, a registration process will take place for substances for which preliminary MSDS notification has been made. From 31 December 2022 onwards, if a substance is to be produced or imported in quantities exceeding 1 ton, it cannot be placed on the market without being registered. Safety Data Sheets will be prepared in accordance with the KKDİK regulation from 31 December 2022 onwards. The provisions relating to Annex 17 on restrictions will enter into force on 6 months following publication, 31/12/2018, 31/12/2019, and 31/12/2021 respectively, as details are provided in the regulation. One of the most important changes made in this draft is the removal of the article below, which relates to new entrepreneurs beginning new chemical substance production or importation, following the process presented in REACH Regulation as late pre-registration and in the KKDİK regulation as preliminary MSDS.

Old Draft KKDİK Regulation Temporary Article 2:

Those who did not send preliminary MSDS by 31/12/2018 cannot place their substances on the market without registering them from that date onwards. As can be understood from this deleted article, a new entrepreneur who missed the preliminary MSDS notification deadline would not be able to place products on the market without registration. With the deletion of this article, entrepreneurs who missed the preliminary MSDS process are now able to place their products on the market until the final registration deadline. Beyond these matters, of course, is the main theme of the KKDİK regulation: how to obtain the data on which Substance Data Files and Chemical Safety Assessment will be based. In this respect, given that the relevant data has already been compiled by SIEFs under the EU REACH regulation and collected by ECHA, recreating them would be neither economically viable nor would provide any benefit in terms of time and labor expended.

In summary, there is clearly no point in reinventing the wheel. For this reason, the general expectation is that the data already compiled under the current EU REACH regulation will be made available for use by global manufacturers already holding access letters for an additional fee, and domestic manufacturers likewise will be able to benefit from this data through the same additional fee mechanism to create joint registration files.

Of course, we should not forget the requirement that summaries of studies and chemical safety assessment reports must be translated into Turkish by a certified Chemical Safety Assessment expert. From the perspective of importers, whereas many importers register the same substance individually, global manufacturers designating a single representative for all importers domiciled in Turkey to conduct registration through will likewise be both economically and practically easier. One should consider that importers of various scales, particularly those of SME size, will find it quite difficult to secure both the budget and trained personnel for this matter. Just as our chemical industry exporting to the EU region had to meet REACH compliance requests from their customers there in order to be able to send goods to them, global chemical manufacturers exporting their products to our country will likewise have to assist their customers and meet their demands regarding KKDİK compliance in order to sell their products to Turkey. Of course, I should also emphasize that one needs to be informed and demanding in this regard.