August 14, 2017
The long-awaited Turkey REACH Regulation was published through Official Gazette 30105 (repeated) on June 23, 2017 by the Ministry of Environment and Urbanization (MoEU). The Regulation is known as KKDIK, the acronym in the Turkish language for Registration, Evaluation, Authorization and Restriction of Chemicals. The MoEU is the responsible body for enforcement and implementation of this Regulation.
KKDIK was prepared by taking EU Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) into consideration.
This Regulation will replace three existing Regulations:
- The Inventory and Control of Chemicals (immediately replaced by KKDIK);
- Regulation on Safety Data Sheets for Hazardous Substances and Mixtures (will be replaced by KKDIK on December 31, 2023);
- Regulation on Restrictions for the Manufacture, Marketing and Use of Certain Dangerous Substances & Preparations (will be replaced on December 23, 2017).
Registration and Notification
Upon publication of KKDIK, manufacturers and importers are no longer required to submit notification as required under the Regulation of Inventory and Control of Chemicals. However, starting December 23, 2017, manufacturers and importers need to begin to pre-register substances which are imported in the amount of greater than or equal to 1 metric ton/year, via the Ministry’s Chemical Registration System portal. The Ministry will conduct an evaluation of whether the registration dossiers are complete and follow the requirements; and they will inform the registrant to submit any additional information within 12 months of the Ministry starting the evaluation, for the registrant to meet the compliance requirement.
As in the previous notification system, and like in EU REACH, importers and manufacturers that do not have a legal representative in Turkey can carry out their compliance responsibility under KKDIK through assigning an Only Representative (OR) in Turkey. Annex 18 of KKDIK, which contains qualification requirements for technical experts, requires that notification and registration requirements (and Safety Data Sheet authoring – see below) must be fulfilled by certified Chemical Safety Assessors.
Unlike EU REACH, there are not staggered deadlines for tonnage bands above 1 metric ton/year. The pre-registration deadline is December 31, 2020 and a registration cutoff date of December 31, 2023 is given by the Regulation. This is intended to provide sufficient time for manufacturers and importers to comply with the Regulation.
Safety Data Sheets
On December 31, 2017, the transition period for Safety Data Sheet preparation will begin. During the transition period, an SDS can either be prepared per the Regulation of Safety Data Sheets for Hazardous Substances and Mixtures or per the KKDIK Regulation. The Regulation on Safety Data Sheets for Hazardous Substances and Mixtures will be completely replaced by KKDIK on December 31, 2023.
The requirement for the Safety Data Sheet to be written by a certified Turkish expert still stands under KKDIK. The transition period is intended to provide sufficient time for the Chemical Safety Assessors to acquire the training and certification required for authoring SDSs, as provided in Annex 18 of the KKDIK.
Restriction and Authorization
The Regulation on Restrictions for the Manufacture, Marketing and Use of Certain Dangerous Substances & Preparations, will be repealed by the KKDIK Regulation as of December 23, 2017. Annex 14 & 17 of KKDIK, which closely resemble but are not identical to the EU lists for substances subject to restriction and authorization, will replace this Regulation in regards to restriction and authorization of substances.
Applications for authorization may be submitted through the Ministry’s Chemical Registration System portal, by one or more applicants. The Ministry will perform a Risk Assessment and Socio-economic Analysis of the information and will inform on its decision within 10 months.
More information on KKDIK will be available in the September 1, 2017 release of ChemADVISOR® Navigator.
{ Recommended Action Items }
- Read and understand how Turkey REACH is similar and different to EU REACH;
- Calculate which substances in your inventory may be imported or manufactured in Turkey ≥1 ton/year;
- Determine if the OR you used for obligations in Turkey is certified for KKDIK compliance;
- Plan to initiate pre-registration steps in 2018;
- Plan to transition your Turkey SDSs to the KKDIK requirements by 2023.
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