KKDIK’s 2023 Amendment: What is next for Turkish Pre-registrations, Registrations and SDS?
On 23 December 2023, the long-awaited amendment to the KKDIK (Turkey REACH) Regulation was published.
Here are the key takeaways from the KKDIK Amendment:
The deadlines for Registration were extended by 3, 5 or 7 years (based on the manufacture/import tonnage band and hazard profiles of the substances)
Timelines for other KKDIK requirements
In addition to the new registration deadlines, the KKDIK amendment also indicates several specific timelines for the implementation of other aspects of Turkey REACH.
Dossier evaluation will start from 31 December 2026
The process for determining the Substances of Very High Concern and Substances for Authorisation will start on 31 December 2026
The Inquiry process will be required from 1 January 2031
SIEFs will be operational until 31 December 2032
The authorisation process will start on 31 December 2028
“Principles and Procedures” document
The amendment did not provide clarity on some of the areas which have posed real challenges during the registration period (notably, the lack of Lead Registrants and lengthy data-sharing negotiations). Instead, the amendment states that a “Principles and Procedures” document will be published, addressing the following aspects:
Lead Registrant appointment
Data and cost-sharing
Pre-registration deadlines
From 1 Jan 2024, Safety Data Sheets must be authored according to KKDIK
According to the current regulation, newly authored SDSs must be prepared according to the KKDIK regulation as of 1 January 2024, and SDSs must be written by Chemical Assessment Experts.
The Ministry of Environment and Urbanization and Climate Change (MoEUCC) in Türkiye has officially released the following announcement regarding Safety Data Sheets as follows:
The Regulation on Safety Data Sheets (SDSs) for Hazardous Substances and Mixtures, published in the Official Gazette dated 13.12.2014 and numbered 29204, was repealed by Article 64 of the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK), published in the Official Gazette dated 23.06.2017 and numbered 30105 (Repeated).
Consequently, existing SDSs that were prepared according to the Regulation on Safety Data Sheets for Hazardous Substances and Mixtures and for which there is no requirement for an update, as per the third paragraph of Article 28 of the KKDIK Regulation, shall remain valid. However, once the certificate of the person who prepared the SDS according to the Regulation on Safety Data Sheets for Hazardous Substances and Mixtures has expired, it must be prepared in accordance with the provisions in Section 4 of the KKDIK Regulation by Chemical Assessment Specialists certified under KKDIK.
In the case of any change in the structure of a chemical substance and/or a change in accordance with the third paragraph of Article 28 of the KKDIK Regulation, an updated version must be provided. After 31.12.2023, SDSs shall be prepared according to Annex-2 of the KKDIK Regulation by Chemical Assessment Specialists certified according to Annex-18 of the same regulation, as per Article 27 of the KKDIK Regulation. Additionally, SDSs must be uploaded to the Safety Data Sheet Notification System application in the Integrated Environmental Information System (ECBS).
Link to the official announcement in Turkish Language: (Here)
Do I need to update my SDS?
Any SDS authored from 1 January 2024 must be prepared according to KKDIK. Any SDS authored before this date according to the previous SDS Regulation can still be used, but must be updated to be compliant with KKDIK if one of the following situations occurs:
Once the SDS Specialist’s certificate has expired;
If the structure of a chemical substance changes;
As soon as new information which may affect the risk management measures, or new information on hazards becomes available;
Once an authorisation has been granted or refused;
Once a restriction has been imposed.
What is next?
Manufacturers, importers, distributors, and downstream users must make sure any SDS authored on or after 1 Jan 2024 comply with the KKDİK Regulation and should review if their SDS (prepared according to the previous SDS regulation no. 29204) to check if they need to be updated.
Although the registration deadlines have been postponed, managing time effectively and taking action proactively is important, especially if you are considering being a Lead Registrant (as data-sharing discussions can take time).
Now is the time to prioritise your registration list according to the hazard classification of the substance, and your forecasted tonnages for the next 3 years. Additionally, we recommend you closely follow the developments in Turkey, such as the publication of the “Principles and Procedures” document by the Ministry.
Our in-house Chemical Assessment Specialists can support you in updating or authoring your SDS according to KKDIK. As a trusted KKDIK OR provider to hundreds of companies, we can also provide you with step-by-step assistance to meet the new registration deadlines. Get in touch with our team today. You can also sign up for our Turkey KKDİK: Regulatory Updates and Impact webinar for insight into the KKDİK amendment and its impact on pre-registrations, registrations, SDS and other supply chain obligations.
About Our Expert
Sophie Guinard, Managing Consultant - Regulatory
Sophie leads the development and delivery of chemical notification services globally, including in Asia, the Americas, the Middle East and Russia. Sophie's expertise lies in researching new notification systems, setting up and coordinating new services, delivering training and regulatory auditing.
Sophie holds an MSc in Environmental Science from Lancaster University.