Preparation of Safety Data Sheets Within the Scope of the KKDİK Regulation

Transition from SDS Regulation to KKDIK

For many years, the preparation of Safety Data Sheets (SDS) in Türkiye was governed by the Regulation on Safety Data Sheets for Hazardous Substances and Mixtures, published in the Official Gazette dated 26 December 2008 and numbered 27092. This regulation was largely based on the EU REACH Regulation (EC) No 1907/2006 and applied to chemical manufacturers, importers, and distributors.

However, with the publication of the Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (KKDIK) in the Official Gazette dated 23 June 2017 (No. 30105), the former SDS regulation was repealed, introducing major changes to the SDS preparation process in Türkiye.

When Did the Old SDS Regulation Become Invalid?

The previous SDS regulation was officially repealed as of 31 December 2023.
As of 1 January 2024, all SDS preparation and distribution activities in Türkiye must fully comply with the provisions of the KKDIK Regulation.

Mandatory SDS Requirements under the KKDIK Regulation

The obligations related to SDS preparation are detailed in the Fourth Section – Supply Chain Communication (Articles 27–32) of the KKDIK Regulation.

📘 Article 27 – Obligation to Provide a Safety Data Sheet

SDS must be supplied when:

A substance or mixture is classified as hazardous.
A non-classified substance meets specific criteria (e.g., PBT, vPvB, endocrine disruptor, CMR).
The downstream user explicitly requests the SDS.

The SDS must be provided free of charge to recipients.

📘 Article 28 – SDS Content Requirements

SDS must be prepared in accordance with the format specified in Annex-2 of the KKDIK Regulation.
The information must be accurate, up-to-date, and scientifically valid.
The SDS must be provided in Turkish and technically aligned with KKDIK.

📘 Article 29 – Inclusion of Exposure Scenarios (e-SDS)

If a substance is placed on the market in quantities ≥10 tonnes/year,
And if a Chemical Safety Report (CSR) is required,
The SDS must include exposure scenarios as an annex.

This is known as the extended SDS (e-SDS) format.

📘 Article 30 – Communication Along the Supply Chain

Manufacturers, importers, and downstream users must forward relevant information up and down the supply chain when there are changes to the SDS or risk management measures.
The SDS must be updated if new hazards or risk-related information becomes available.

📘 Article 31 – Updating the SDS

If new hazard data becomes available,
If restriction/authorization conditions change,
Or upon acceptance of a registration dossier,

The SDS must be updated within 12 months and redistributed to the entire supply chain.

📘 Article 32 – Record Keeping and Access

All SDS-related information must be kept for at least 10 years, even after the substance or mixture is withdrawn from the market.
The SDS must be made available to the authorities and recipients upon request.

Substances Outside the Scope of SDS Obligation under KKDIK

According to the Turkish KKDIK Regulation (Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals), not all substances require a Safety Data Sheet (SDS). Below are the substance categories that are explicitly exempt from SDS requirements:

1. Radioactive Substances

Substances classified as radioactive fall under the scope of the Turkish Atomic Energy Authority Law No. 2690, dated August 9, 1983.
Therefore, they are excluded from KKDIK and SDS preparation is not required for such substances.

2. Substances Under Customs Supervision

Chemical substances temporarily under customs control and not placed on the market (e.g., goods in transit) are not subject to SDS requirements under KKDIK.

3. Substances Used for Research and Development (R&D)

Substances used exclusively for scientific research or product development may be temporarily exempt from registration and SDS obligations.
However, this exemption depends on the quantity used and duration of use and must be monitored under restricted conditions.

4. Waste

Wastes are governed by the Waste Management Regulation published in the Official Gazette dated March 14, 1991 (No. 20814).
They are not considered substances or mixtures under KKDIK and thus do not require an SDS.

5. Final Products Intended for Human or Animal Health

KKDIK does not apply to finished products intended for human or animal health that fall under separate regulatory frameworks, such as:

Pharmaceuticals (for human or veterinary use)
Medical devices
Veterinary products
Plant protection products
Biocidal products (Note: some ingredients may still require SDS if supplied separately.)

6. Food and Feed Substances

Food and feed products fall under Food Safety Regulations and are therefore outside the scope of KKDIK.
An SDS is not required for these products. However, additives or processing aids used in their production may still require an SDS.

7. Non-Hazardous Substances

As per KKDIK Article 27, an SDS is only mandatory for substances:

Classified as hazardous, or
Meeting specific criteria such as PBT, vPvB, CMR, or endocrine-disrupting properties.

For non-hazardous and non-classified substances, SDS preparation is optional, not mandatory.

📌 Note: Cases Where SDS Preparation Is Recommended Despite Being Out of Scope

In certain cases, even though a substance, mixture, or article may fall outside the scope of KKDIK, the preparation of a Safety Data Sheet (SDS) is still recommended due to practical or commercial requirements:

For cosmetic products and cleaning products, an SDS may be requested by customers during market placement, especially in B2B transactions.
Companies engaged in export to markets such as the EU, UK, or the US often prepare SDSs to meet foreign regulatory or buyer requirements.
SDSs are frequently needed for supply chain transparency, sustainability documentation, product safety, and compliance with digital certification systems such as UseSafe.
Logistics and transportation companies may request SDSs for classification and handling purposes, especially for international shipping.
Even for non-hazardous substances, mixtures, or articles, SDS preparation may be advisable if:
- Requested by official authorities for alignment with other sectoral regulations,
- Needed for communication of product safety in the supply chain, or
- Demanded by consumers or end users for transparency or internal safety assessments.

KKDIK Annex-2 – Structure and Content of Safety Data Sheets

Annex-2 of the KKDIK Regulation (Türkiye’s Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals) defines the mandatory structure and content requirements for Safety Data Sheets (SDS). This annex is based on Annex II of the EU REACH Regulation (EC No. 1907/2006) and has been fully harmonized with recent updates.

As of January 1, 2024, all SDSs in Türkiye must comply with this structure to be considered valid.

The 16 Mandatory Sections of the SDS (as per KKDIK Annex-2)

The following 16 main headings must be fully included in a SDS document:

Section	Title
1	Identification of the substance/mixture and of the company/undertaking
2	Hazards identification
3	Composition/information on ingredients
4	First-aid measures
5	Firefighting measures
6	Accidental release measures
7	Handling and storage
8	Exposure controls/personal protection
9	Physical and chemical properties
10	Stability and reactivity
11	Toxicological information
12	Ecological information
13	Disposal considerations
14	Transport information
15	Regulatory information
16	Other information

However;

The safety data sheet (SDS) shall be prepared in Turkish.
The safety data sheet shall be prepared in a format similar to that provided in Annex-2 of the KKDIK Regulation.
The standard headings and the corresponding subheadings, as set out in Annex-2 of KKDIK, shall be presented in the same order and without any changes to their names or numbering.
If it is necessary to use more than one page in the preparation of the safety data sheet:
- The same format shall be used on each page;
- The information required under Section I of the SDS shall appear on every page;
- Each page shall indicate both the current page number and the total number of pages.
The information required under Section II of the SDS shall be completed in accordance with the explanations provided in Annex-2 of the KKDIK Regulation.
In cases where certain information required in the SDS cannot be obtained, headings and subheadings shall not be omitted or left blank. Instead, a clear justification for the absence of data shall be provided using expressions such as “not applicable”, “no data available”, or “no specific provision”.
The safety data sheet shall be provided free of charge, either in written form or in electronic format.
Suppliers shall promptly update the safety data sheet for their substance or mixture in the following cases:
- When new information is obtained that may affect risk management measures or indicates new hazards;
- When the substance or mixture becomes subject to restrictions or prohibitions.
The updated SDS shall be provided free of charge, in written or electronic form, to all former recipients who were supplied with the substance or mixture within the previous 12 months, as of the date of the update.

Why Is It Mandatory to Prepare an Annex-2 Compliant SDS?

Article 28 of the KKDIK Regulation explicitly requires that the content of the Safety Data Sheet (SDS) be prepared in full compliance with Annex-2.

This structured format ensures that the recipient of the SDS obtains accurate and reliable information for all stages of the substance’s lifecycle—safe use, transport, and disposal.
Effective information transfer throughout the supply chain (as required by Article 30) is only possible through the consistent use of this standardized format.
Annex-2 of KKDIK serves as the legally recognized technical template for SDSs in Türkiye. A complete and compliant SDS not only ensures regulatory alignment, but also guarantees safe manufacturing, responsible marketing, and downstream communication across the supply chain.

At Doruksistem, with over 20 years of experience in regulatory compliance, we provide your company with the most accurate, up-to-date, and Annex-2-compliant SDS content, tailored to your products and industry needs.

Key EU Updates to Consider in SDS Preparation (Latest 2023/2024 Version)

In parallel with the 2021/2022 EU revisions, Safety Data Sheets (SDS) are expected to be updated to include the following new requirements:

UFI (Unique Formula Identifier) and PCN (Poison Centre Notification) information for products placed on the EU market
Explicit declaration of nanoform substances, where applicable
Identification and disclosure of substances with endocrine-disrupting properties
Cross-referencing of exposure scenarios and integration with extended SDS (e-SDS) formats
Alignment of SDS content with the conclusions of the Chemical Safety Assessment (CSA)

Safety Data Sheets and Chemical Assessment Specialists

A Chemical Assessment Specialist (CAS) — in Turkish, Kimyasal Değerlendirme Uzmanı (KDU) — is a person who has successfully completed an accredited training program and obtained certification in accordance with the KKDIK Regulation, as authorized by the Ministry of Environment, Urbanization and Climate Change.

According to Articles 27 and 28 of KKDIK and related provisions:

“The Safety Data Sheet must be prepared or verified by a certified Chemical Assessment Specialist.”

In line with this provision, as of January 1, 2024, only SDSs prepared or checked by certified Chemical Assessment Specialists (KDU) are considered legally valid in Türkiye.

SDSs must be prepared by individuals who have:

Completed the training specified in Annex-18 of the KKDIK Regulation, and
Been certified by a personnel certification body accredited for Chemical Assessment Specialist qualification.

For imported substances and mixtures, the importer is responsible for having the SDSs prepared by persons holding the same qualifications.

The supplier must upload the SDS for the substance or mixture placed on the Turkish market via the designated software system provided on the official website of the Ministry.

The information to be included in the SDS must be presented under the following standard headings, and the responsibility for providing accurate and complete information lies with the natural or legal person responsible for placing the hazardous substance or mixture on the market.

Under the KKDIK Regulation, Safety Data Sheets (SDS) may only be prepared by certified Chemical Assessment Specialists (CAS) (Kimyasal Değerlendirme Uzmanları – KDU).

The requirements for training, qualification examination, certification of Chemical Assessment Specialists, as well as the accreditation criteria for certification bodies, are regulated as follows:

Training and Training Institutions

The training duration shall be at least 64 hours and must cover the topics listed in Part Two of Annex-18 of the KKDIK Regulation.
A single training day shall not exceed 8 hours, and a maximum of 2 hours of break time is permitted per day.
Training must be delivered by experts who meet the criteria specified in Part Four of Annex-18.
Each training session may include no more than 30 participants.
Trainings must be conducted in adequate and appropriate facilities, allowing for the implementation of practical exercises.
Training venues must offer suitable thermal comfort conditions and adequate lighting.
Training tools and equipment must be in line with current technological standards.
The training institution shall submit its training program, prepared in accordance with Part Two and Part Four of Annex-18, to the General Directorate of Environmental Management of the Ministry of Environment and Urbanization for approval.
Upon receiving the Ministry’s approval, the training institution may start delivering at least 64 hours of face-to-face training on the topics in Part Two of Annex-18 to candidates intending to take the Chemical Assessment Specialist qualification exam.
Each training institution is subject to at least one annual observation by the Ministry’s personnel from the General Directorate of Environmental Management.
If any non-conformities with the above-mentioned training conditions are detected during such observation (as per subparagraph (h) of Annex-18), the training institution shall suspend its training activities until the issue is resolved.
If the non-conformity is not corrected within 12 months, the Ministry shall revoke the training institution’s approval certificate.

Qualification Examination

The qualification exam shall consist of two sections: multiple-choice and essay-type questions.
The subjects and scoring system of the exam are defined in Part Five of Annex-18 of KKDIK.
The exam duration is 180 minutes.
Candidates may take the qualification exam if they have received training in accordance with Paragraph 1 of Part One of Annex-18 and meet the conditions outlined in Part Three, without prejudice to Paragraph (c) of Heading 4 of Part One.
Candidates who fail to score at least 70 points in the exam are allowed to retake the exam up to two more times within one year, without being required to undergo additional training.

Certification Body

The certification body shall submit its certification program, prepared in accordance with Parts Three and Five of Annex-18, to the Ministry.
After obtaining the Ministry’s approval, it shall apply to the Turkish Accreditation Agency (TÜRKAK) for accreditation to certify personnel under ISO 17024, specifically in the field of chemical assessment.
Upon accreditation, the body may begin certifying personnel in chemical assessment.
The certification body must notify the Ministry in writing, within one month of certification, of each certified individual’s contact details, certificate number, and date of issuance.
The Ministry publishes the list of certification bodies accredited by TÜRKAK on its official website.

Qualification Certificate

Candidates who score 70 points or higher in the certification exam are granted the Chemical Assessment Specialist Qualification Certificate.
The validity period of the certificate is five (5) years.
Individuals wishing to renew their certificate may retake the exam without any training requirement, either within the validity period or up to two years after its expiration.
As per subparagraph (c) of Annex-18, certificates of individuals who successfully complete a new qualification exam shall be revoked and reissued with a new certificate number.
Individuals who can prove at least 10 years of experience in chemical management at the Ministry may be certified by the certification body without taking the exam, provided the certification body assumes full responsibility for these certifications.

You can access the KKDIK Regulation and its related annexes concerning Safety Data Sheets (SDS) through the links below:

Safety Data Sheets (SDS) Under KKDIK and Doruksistem’s Expertise

The Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (KKDIK), one of the most comprehensive frameworks in Türkiye’s chemical management legislation, entered into force on June 23, 2017. With this regulation, a major transformation was introduced regarding Safety Data Sheets (SDS).

As of January 1, 2024, only SDSs that are:

Prepared in Turkish
Fully aligned with Annex-2 of KKDIK, and
Signed by a certified Chemical Assessment Specialist (KDU)

are considered legally valid in Türkiye. SDSs and GBFs prepared under the former regulation are no longer valid after this date.

At Doruksistem, we continue to bring our local and international expertise — gained from preparing over 100,000 Safety Data Sheets (SDS) to date — into full alignment with the latest regulatory requirements to support manufacturers and suppliers.

Preparing an SDS Is Not Enough — It Must Be Done Correctly

At Doruksistem, we provide services with Ministry-approved Chemical Assessment Specialists (KDU) who are highly experienced in preparing SDSs that fully comply with KKDIK. Every SDS we prepare:

Follows the 16-section structure defined in KKDIK Annex-2,
Includes complete information such as hazard classifications, labeling elements, exposure scenarios, UFI codes, and PCN notifications,
Meets e-SDS (extended SDS) requirements where applicable,
Ensures both upstream and downstream information flow across the supply chain,
Is audit-ready, sustainable, and digitally traceable.

Why Doruksistem Stands Out

📌 In-house team of certified Chemical Assessment Specialists (KDU)
📌 Integrated approach to KKDIK, EU REACH, CLP, MoCRA, and SEA regulations
📌 Sector-specific expertise in cosmetics, paints, textiles, non-food products, cleaning agents, and packaging
📌 End-to-end traceability through our UseSafe Digital Certification & Product Passport System
📌 Document compliance checks for e-export and customs processes
📌 Integration with msds.net.tr, enabling secure access to your SDSs — prepared and signed by certified KDUs — along with automatically generated PDF links and QR codes
➤ These can be used across occupational safety, warehousing, supply chain communication, customs declarations, digital messaging, product web pages, and even invoices.

Safety Data Sheets (SDS)

Preparation of SDSs within the Scope of KKDİK Regulation