Home page/KKDIK Regulation Imprint, Sections and Annexes
KKDIK Regulation Imprint, Sections and Annexes
KKDIK Regulation, fully known as the Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals, is the basic legislation regulating the placing of chemicals on the market in Turkey. It was published in the Official Gazette dated 23 June 2017 and numbered 30105. It is Türkiye's adaptation of the REACH Regulation in the European Union and is based on the same principle: no data, no market.
KKDIK Regulation imprint
- Full name: Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals
- Publication: 23 June 2017, Official Gazette number 30105 (duplicate)
- Competent institution: Ministry of Environment, Urbanization and Climate Change
- System: Chemical Registration System (KKS)
- EU equivalent: REACH Regulation (1907/2006)
What parts does the Regulation consist of?
KKDIK Regulation consists of twelve parts. Knowing which obligation is regulated where makes it easier to navigate to the right article when preparing a file.
- General Topics — purpose, scope, basis and definitions
- Registration of Substances — registration obligation, tonnage thresholds, dossier content
- Sharing Data and Avoiding Unnecessary Testing — MBDF, joint registration, access letter
- Information Within the Supply Chain — safety data sheet and information flow
- Downstream Users — terms of use and verification obligation
- Evaluation — file and item evaluation
- Permit — substances subject to authorization and application
- Restriction of Certain Harmful Substances, Mixtures and Articles
- Fees — registration and application fees
- Information — access to information and privacy
- Audit and Sanction
- Miscellaneous and Final Provisions — transitional provisions and schedule
Who is bound by the KKDIK Regulation?
Obligation varies depending on the company's role. The manufacturer producing in Turkey records that he produces, and the importer records that he imports. Manufacturers outside Türkiye cannot register directly; It appoints a sole representative resident in Turkey. The downstream user does not register but must verify that his use is covered in the supplier's file.
Registration threshold and tonnage
The registration obligation starts with a threshold of 1 tonne per year per legal entity. The amount is calculated based on the calendar year total; Quantities from different suppliers are added together and counted in proportion to the share of the substance in the mixture. As Tonnage band increases, the requested data set expands, and above a certain threshold, chemical safety report becomes mandatory.
Inspection and enforcement
The eleventh part of the Regulation regulates inspection and enforcement. Unregistered production or import may result in administrative fines as well as suspension of supply of the substance to the market. The first document requested in an audit is usually the item inventory, tonnage records and registration evidence.
Related pages
- What is KKDIK? Registration and Tonnage Guide
- KKDIK Registration Calendar and Deadlines
- KKDIK Administrative Fines
- KKDIK Glossary of Terms
- KKDIK Consulting Services
Official full text of the regulation: KKDIK Regulation — Official Gazette, 23.06.2017 / 30105 (duplicate).
Contact ONAY Mühendislik for your obligations under the Regulation.
Annexes of KKDIK Regulation: From Annex-1 to Annex-18
The KKDİK Regulation contains eighteen annexes. Its articles establish the framework, while the annexes set out the practical requirements: the data required in registration dossiers, exempt substances and restricted uses. The annexes largely correspond to those of EU REACH. Annex 18 is specific to Türkiye and has no equivalent in EU REACH.
| Appendix | Title | What does it do in practice? |
|---|---|---|
| Annex-1 | General provisions for the evaluation of substances and preparation of chemical safety reports | Provides the skeleton of the chemical safety report. Every record over 10 tons/year is processed according to this annex. |
| Annex-2 | Requirements for the preparation of safety data sheets | Here is the 16-chapter structure of the GBF; The primary basis of the SDS preparer. |
| Annex-3 | Criteria for substances registered between 1–10 tonnes | Determines which item will require the full data set in low tonnage. |
| Annex-4 | Substances exempt from registration obligation | The first stop of the exemption check; Substances such as water, nitrogen and glucose are here. |
| Annex-5 | Exemptions from registration obligation | Exemptions based on situation and not on substance basis: unprocessed substances found in nature, by-products. |
| Annex-6 | Information requirements referred to in clause 11 | The core of each registration file: registrant ID, substance identification, manufacturing and use information. |
| Annex-7 | Standard information requirements for substances of 1 tonne and above | Data set of the lowest tonnage band: physico-chemical properties and main toxicity/ecotoxicity. |
| Annex-8 | Standard information requirements for substances of 10 tonnes and above | is added above Annex-7; In this band, a chemical safety report is also mandatory. |
| Annex-9 | Standard information requirements for substances of 100 tonnes and above | Long-term toxicity and environmental fate studies come into play and a test recommendation is made. |
| Annex-10 | Standard information requirements for substances of 1,000 tonnes and above | The most comprehensive data set; The band with the highest cost and time. |
| Annex-11 | General rules for adapting standard test regimes | Way to present data without testing: read-across, QSAR, weight of evidence, reasons for skipping tests. |
| Annex-12 | Substance evaluation and chemical safety report preparation by downstream users | If your use is not in the supplier's exposure scenario, the downstream user report is prepared according to this annex. |
| Annex-13 | Criteria for the determination of PBT and vPvB substances | Thresholds for the assessment of persistent, bioaccumulative, toxic; Technical gate of the SVHC route. |
| Annex-14 | List of substances subject to authorization | The substance on the list cannot be placed on the market without permission. Corresponding to EU REACH Annex XIV. |
| Annex-15 | Files | Content of the files to be submitted to the Ministry during the restriction and permit processes. |
| Annex-16 | Socio-economic analysis | Framework of the social benefit argument of use in the permit application. |
| Annex-17 | Restrictions on the manufacture, placing on the market and use of certain harmful substances, mixtures and articles | The most frequently asked attachment. Restriction list: certain uses are prohibited or conditional if the substance is here. It is the equivalent of EU REACH Annex XVII and is regularly updated. |
| Annex-18 | Conditions for obtaining Chemical Evaluation Specialist qualification certificate | Turkey-specific annex. Determines who can approve the registration file: A person without an KDU certificate cannot sign the file. There is no such obligation in EU REACH. |
Which supplement comes into play at which tonnage?
The only thing that determines the size of the log file is the tonnage band. Bands are cumulative: the upper band includes the data of the band below it.
| Annual amount (per legal entity) | Mandatory data attachment | Chemical safety report |
|---|---|---|
| 1 – 10 tons | Annex-6 + Annex-7 | Not required |
| 10 – 100 tons | Annex-6 + Annex-7 + Annex-8 | Required |
| 100 – 1,000 tons | Annex-6 + Annex-7 + Annex-8 + Annex-9 | Required |
| 1,000 tons and above | Annex-6 + Annex-7 + Annex-8 + Annex-9 + Annex-10 | Required |
The threshold is1 tonne per year per legal person. If two different companies import the same substance in 0.6 tons each, there is no registration obligation; arises if a single company imports 1.1 tons. When the tonnage calculation is made incorrectly, there is a risk of unnecessary costs or incomplete records — you can check your situation with our liability test and see the cost from the 2026 duty tariff.
Evaluation, permission and restriction: three other columns
KKDIK is not just about registration. Here are our detailed guides for the other three pillars in the code's name:
- KKDIK dossier evaluation — compliance check, test offer review, 30-day right to comment
- KKDIK substance evaluation — prioritization criteria and request for additional information
- KKDIK permit process and Annex-14 — substances of high concern, permit application, substitution plan
- KKDIK restriction and Annex-17 — prohibited and conditional substances, scope of substance in goods
Whole legislation
KKDIK does not stand alone; SEA works in conjunction with the safety data sheet and UFI/PCN. See how the four connect and what obligations arise based on your role on one page: Türkiye chemical regulations map.
If you have a Exemption claim, first verify the scope: KKDIK excluded substances — which exemption removes what in waste, transit, intermediates, polymers and cosmetics.