WHAT IS KKDIK REGISTRATION?
Manufactures and downstream users importing chemicals to the Turkish market must comply with the KKDIK Regulation (Registration, Evaluation, Authorization and Restriction of Chemicals).
If 1 ton and more chemical substances (harmful and harmless) are supplied to the Turkish market annually, KKDIK must complete the records. Otherwise, it cannot import and manufacture chemicals to the Turkish market.
KKDIK Calendar Years
– 3/12/2017 – 31/12/2020: Pre-SIEF (Pre-registration) process.
– 01/01/2021 – 31/12/2023: It is the registration process. Pre-Registered substances can be manufactured, imported or placed on the market within the country in this process. Non-Pre-Registered substances can only be manufactured or imported or placed on the market within the country after the registration process is completed.
– 01/01/2024 and after: Substances not previously registered can only be manufactured or imported or placed on the market within the country after registration has been completed.
What Are Substances Not Covered by KKDIK?
- Waste material mixtures
- Radioactive materials and their mixtures containing radioactive materials;
- Substances and mixtures manufactured or imported for defense purposes. (If the competent authority does not request)
- Substances and mixtures in temporary storage or a free zone or warehouse for re-export purposes or in transit and subject to customs, provided that they are not treated or processed.
- Non-isolated intermediates.
What are the Exempted Substances from KKDIK Regulation?
The provisions in the Second (Registration), Fifth (Downstream User), Sixth (Evaluation) and Seventh (Permission) Sections of this Regulation do not apply to substances manufactured or imported for use in the following products;
- Medicinal products
The provisions of the Second (Registration), Fifth (Downstream User) and Sixth (Evaluation) Part of this regulation do not apply to the following articles:
- a) Substances included in Annex-4,
- b) Substances included in Annex-5,
c) Exported and re-imported to Turkey
Part II (Registration) Part 1 – General Registration Product and process-oriented research and development and section VII (permit) In situ isolated intermediates and carried isolated intermediates not applicable
Part II (registration) and VI (evaluation) provisions do not apply to polymers.
KKDIK Registration Service
KKDIK Registration service starts after Pre-SIEF registration. It is integrated with SIEF Management service. KKDIK registration consists of the following services.
- Preparation of the Technical File
- Determination of information requirements and test studies
- Searching for alternative test methods
- Identifying data gaps and providing information waivers
- Health Hazard assessment (DNEL Calculations)
- Environmental Hazard assessment (PNEC Calculations)
- Physicochemical Hazard assessment (KGR) By Certified Chemical Assessment Specialist
- Establishment of exposure scenarios (KGR) By Certified Chemical Assessment Specialist
- Chemical Safety Assessment
- Chemical Safety Report creation
- Registration Application and follow-up