IMPORTANT - KKDİK NEWS UPDATE- PRINCIPLES AND PROVISIONS ARE PUBLISHED!

Content addition date : 13-08-2025

We wish to inform you that after a long period of silence since Jan 2024 Ministry of Environment, Urbanization and Climate Change of Republic of Turkiye who is the enforcing Competent Authority for KKDİK published the ‘’Principles & Provisions of implementing KKDİK''. 

The publication has the following headings:
► Registration
► Substance Information Exchange Forum
► One Substance One Registration Principle
► Determination of Lead Registrants  
► Joint Registration Group
► Temporary Registration
► Completion of the Registration Process
► Chemicals Science Group
► Chemicals Advisory Group
► Updating the Registration Dossier
► Safety Data Sheets 

Most of the above are containing principles similar to the REACH such as ‘’one substance One registration’’ principle of EU REACH. 

With in this initial news circulation, we prefer to focus on the critical Articles of the Principles & Provisions which impose some critical dates and conditions that may have an impact on your KKDİK registration strategy. Thus, not all articles will be expressed thoroughly in this initial e-mail alert. 

We also tried our best to have some brief executive comments of ours regarding these critical points from the Principles & Provisions.  Please find below the critical articles with our comments. 

Also, you can use the links below to view the publication from the Ministry Helpdesk web site as well as the Turkish original of the Principles & Provisions: 

• Link: Ministry Helpdesk web site
• Link: Turkish original of the Principles & Provisions
• Link: Un official English translation of Principles & Provisions: 

Critical Articles imposing new conditions and dates: 
Article 6 
(1)    All potential registrants of the substances that are importer or manufactured above 1 mta before the date 31.10.2025 should submit a pre-registration before 31.10.2025. 
(2)    Any substances that are manufactured or imported above 1 mta after 31.10.2025 should submit a pre-registration within 30 days from the first date of placing on the market. 

CRAD Comments: Till today there were no deadline mentioned on the legal text for pre-registrations. This article imposes a deadline for pre-registrations. Also please note that the term ‘’Placing on the market’’ is used here. From our perspective it should be ‘’manufactured or imported’’ . However, import means placing on the market but conflicts may arise for manufactured substances that are not placed on the market.) 

Article 8 – Determination of Lead Registrants
(1)    The Lead Registrants of the substances that are placed on the market before the publication of this ‘’procedures and principles’’ should be determined before 31.12.2025. The Lead Registrants of the substances that are placed on the market after the publication of this ‘’procedures and principles’’ should be determined within 6 months from the date of placing on the market. 

CRAD Comments:  The given date as 31.12.2025 means there are 141 days left for the substances on the market to determine a LR for which a LR is not yet assigned. Also considering 30 days voting period this drops to 111 days right from today. That seems to be unachievable. Considering the authority who paused the Submission system for 19 months, now asking the industry to handle the LR determination with a rush after causing all stakeholders to lose precious 19 months before the approaching first deadline, a flexibility should been considered such as determining this date as 30.06.2026. 

Also, it covers all substance at all tonnage bands. An applicable deadline wise separation would be more supportive for the industry. Especially for the niche and fine Chemicals for which even the volume of their largest manufacturers are below 100 mta ( or maximum export tonnages to Turkiye is below 100 mta) who have a registration deadline of 31.12.2030 (such as precious metals, fragrance, pigments, flavours) there is no reason or logic to rush to being obliged to determine a Lead Registrant 5 years a head of the applicable deadline. Considering the fast-changing conditions and innovation in chemistry, it is even absolute if these substances or its manufacturers will still be active as of 2029-2030.     

(2)    Voluntary initiative is the primary essential for determination of Lead Registrant. Unless no SIEF member takes such voluntary initiative, then Ministry, in consultation with TOBB (The Union of Chambers and Commodity Exchanges of Türkiye) starts a determination initiative based on criteria such as tonnage band, company size, data ownership.
 
CRAD Comments:  Gives some references about the criteria to be considered for LR determination and to be interpreted as to provide positive motivation and requesting companies for taking initiative and responsibility. Gives no expression of ‘’Forcing a company to be LR as a Legal Obligation’’ which is neither logical, nor legally possible.   
   
(3)    Lead Candidate announces their intention to SIEF members with reasoning via the KKS. After this communication all SIEF members should respond in 30 days either accepting or objecting. SIEF members who did not respond within this period are deemed as accepted and all these records should be kept. With the condition that the LR candidate have the “absolute majority” (including the no responses as an acceptance) in the SIEF then they are assigned as LR.  If the LR candidate cannot achieve the “absolute majority” in the SIEF then they communicate the situation with SIEF members and withdraws from the LR Candidacy. And the procedure starts from the beginning. 

(4)    The LR of a substance for which the Registration dossier is not yet submitted, SIEF communication including the Tonnage band, Data gap status and the presumed conditions of the SIEF agreement should be conducted. If these conditions are accepted by the “absolute majority” the LR can proceed with the registration.  

(5)    Unless the LR achieves “absolute majority”, the procedure to determine a new LR starts. 
 

(6)    If a LR of a submitted registration dossier cannot continue the LR role, LR communicates the situation to SIEF members and applies to Authority in a formal written format. After the assessment by the Authority, Authority enables a new voting for new LR with in the SIEF. Former LR is obliged to hand over the data without any prejudice to the Confidentiality, Data ownership and Cost Sharing principles within 30 days after the new LR being approved by the Authority.  

(7)    For the substances for which the Registration dossier was not yet submitted but there is a LR yet assigned before the publication of this ’’procedures and principles’’ the LR determination can be re-conducted only if required. 

CRAD Comments:  There seems to be some ambiguity between Prg 4 and 7 conflicting each other as both references the same cluster. There are some hundred substances for which the LR was assigned long time ago and the dossier was ready for submission since a year but was not submitted just due to the closure of KKS for submissions. It would be much clearer and more supportive to give a term of 2 months after the submission system of KKS being back in action for the compiled dossiers to be submitted for which the LR conducted the communication including the principles and content specified in this  ’’procedures and principles’’. 
The KKS system has an inbuilt voting system which records only the acceptance, if the objections would also be recorded it would be more transparent to the SIEF members and the authority to view the status and achievement of “absolute majority”.

Temporary Registration 
Article 10  

(1) If the LR is unable to fulfil its obligations regarding complete registration, they shall submit  Temporary registration by submitting the data specified in Annex 1 of this ‘’Procedures and Principles’’ to the Ministry before 31.03.2026. Following the Temporary Registration of the LR, other member companies shall submit their joint registration to the Ministry via the KKS before 30.09.2026.

(2) Companies who are not part of the co-registration group referred to in Article 2 and will submit their individual registration dossiers separately under the second paragraph of Article 6 and who were unable to fulfil their obligations regarding complete registration, shall submit the data specified in Annex 1 of these Procedures and Principles to the Ministry via the KKS by 31.03.2026 to complete their Temporary registration.

(3) The entry of the data listed in Annex 1 of this Procedures and Principles to KKS shall be conducted by a Chemical Assessment Specialist (KDU), and the relevant KDU's certification of competence shall be attached. 

(4) The provisions of the Regulation regarding registration fees listed in the Ministry's List of official fees shall apply for the Temporary registration process.

(5) The provisions of the first, second, third, and fourth paragraphs of this article shall not apply to companies that are able to submit a complete registration dossier by 31.03.2026. 

CRAD Comments:  By Article 10 of the Procedures and Principles the authority wishes to give some flexibility for the substances where there is a conflict or a challenge regarding obtaining the data required for full registration. In a mean to prevent a market shortage of substances for which a data is not made available by the EU SIEF or Consortia or in the conditions of financial conflicts the Authority gives an option to submit a Temporary registration for a limited period of time. Based on our experience this scenario can be applicable to very rare substances for which the Data owner have no interest in the Turkish Market and resisting to provide data for KKDİK purposes. For sure the condition and reasoning for not achieving the full registration dossier will be questioned by the Authority.  

However, 31.3.2026 is considerably an early date to give up seeking data as there is still 9 months for the first deadline. Considering the smaller tonnage bands with 2028 & 2030 deadline, why a LR should give up years before the applicable registration deadline? It would be much better if this date only be applied to the substances that are subject to 31.12.2026 deadline. And there might be further dates for the future deadlines that are 9 months before the applicable deadline. 

Completion of the registration process
ARTICLE 11-

(1) Companies that have completed the tonnage band-based information requirements specified in the KKDİK Regulation that are necessary for the complete registration dossier by the deadlines specified in the 2nd provisional article of the Regulation (the article which specifies the new deadlines published as of Dec 2023) ;
a) Companies that have submitted their individual registration dossier separately under the scope of 2nd paragraph of Article 7,
b) Lead Registrants who have submitted their registration dossier.
c) Co-registrants of joint registration groups whose LR has submitted a complete registration dossier, 
are deemed as completed their registration.

(2) If potential registrants are unable to obtain the necessary data for the full registration dossier or access such data from publicly available, non-copyrighted global data sources, the LR in the joint registration shall notify the Ministry of the relevant circumstances, along with a detailed justification, by submitting a request for an extension via KKS. If the registration dossier is an individual registration per the 2nd Paragraph of Article 7, the individual registrant company shall notify the Ministry via KKS.

(3) The Ministry shall evaluate the justification specified in the second paragraph and notify the relevant party of its decision regarding the request for an extension.

(4) If the Ministry requests additional information within the additional period granted, such requests shall be fulfilled within the period specified by the Ministry. If the additional information cannot be provided within the specified period, an extension shall be requested from the Ministry, stating the reasons.
The additional time granted by the Ministry under the third paragraph shall not exceed two years from the final registration date specified for the relevant tonnage range of the substance. If the data cannot be provided by the end of the additional time, the Ministry shall approve or reject the registration for the relevant substance after the Chemical Advisory Group has evaluated the reasons provided.

CRAD Comments:  By Article 11 (similar to Article 10) of the Procedures and Principles the authority wishes to give some flexibility for the substances where there is data gap and lack of data to complete the registration based on a solid reason. 

Updating the Registration Dossier
Article 15 –

(1) In cases where registrations made under the Regulation are required to be updated in accordance with Article 22(1) of the Regulation, the existing registrations shall be updated within three (3) months from the date on which the need for update arises. If there is a circumstance preventing the update within this period, the situation shall be notified to the Ministry in writing with detailed justification, and an extension request shall be submitted to the Ministry.

(2)  Where the Ministry has taken a decision to update, in accordance with Article 22(2) of the Regulation, the registrant shall carry out the update including the information required by the decision within the period specified in the decision.

(3)  Updates to registrations made prior to the publication of these Procedures and Principles may be carried out until the final registration deadlines specified in the Regulation.

CRAD Comments:  This article gives clear terms for the updates to the dossiers which were subject to date assignment of the Authority in the Legal Text. 

Article 16 – Safety Data Sheets

(1)  Safety Data Sheets prepared in accordance with Article 27(1) of the KKDİK Regulation shall be uploaded by the supplier to the Ministry’s dedicated SDS portal within ECBS.

(2)  In accordance with the Regulation and Annex-2, under Section 16 of the SDS, the contact details of the Certified Chemical Assessment Specialist (KDU) and the date and number of the KDU qualification certificate shall be provided.

(3) Training and certification processes for KDUs shall be carried out under the coordination of the Ministry.

CRAD Comments:  Again, these were the details that were skipped on the KKDİK legal text. Thes conditions were the inheritance from the former SDS regulation and now implemented and integrated into KKDİK and Annex II principles regarding the SDS. Based on this provision  the compiler of the SDS should be stated on Sec 16 along with contact information and certification details. Also, the SDS should be uploaded to the e-CBS system as a soft pdf copy.  

As noted, above are the critical articles imposing new conditions and dates of implementation. As we rushed to inform our clients at the earliest regarding the conditions that may have an impact on their registration strategy, we skipped the ‘’sentence by sentence interpretation of the procedures and principles for this instance. 

We as CRAD are at your service for your further questions and to re-design your registration strategy in the case of a need.  

Yours sincerely
CRAD KKDİK Team