What is KKDIK Regulation?
On June 23, 2017 the Turkish Ministry of Environment and Urbanization (MoEU) published KKDIK Regulation which is quite similar EU REACH regulation. The purpose is to regulate the administrative and technical procedures and principles regarding to the safe use of chemicals in the Turkey market. By this mean, it is aimed to ensure a high level of protection of human health and the environment.
KKDIK is an acronym in the Turkish language for Registration, Evaluation, Authorization and Restriction of Chemicals.
KKDIK – TURKREACH replaces three existing regulations:
- The Inventory and Control of Chemicals (CICR was immediately replaced by KKDIK regulation on June 23, 2017).
- The Restrictions Relating to the Production, Supply to the Market and Use of Certain Hazardous Materials, Products and Goods; (repealed on December 23, 2017).
- The Preparation and Distribution of Safety Data Sheets for Hazardous Materials and Products; (will be replaced from December 31, 2023)
Regulatory Scope of kkdik regulation
KKDIK covers manufacturing, placing on the market or use of the substances on their own, in a mixture or in an article and placing the mixtures on the market equal to or more than 1 tonne a year. As a scope it is similar to EU REACH.
Being not covered by KKDIK Regulation;
- Radioactive substances and mixtures
- Substances, on their own, in a mixture or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re- exportation, or in transit;
- Non-isolated intermediates
- Carriage of hazardous substances and hazardous mixtures by rail, road, inland waterway, sea or air
- Substances and mixtures which are manufactured or imported for the purpose of defense
Being exempted from Registration;
- Veterinary Products
- Medicinal Products
- Exported Substances in Articles 27-28
- Re-Imported Substances
- Cosmetics and Medical Devices
- Foods and Feeding Stuffs
- PPORD (Product and Process Oriented Research and Development)
Being assumed as registered substance;
- Active substances for use in Biocidal Products (as biocidal products and their active ingredients are covered by Biocidal Products Regulation (BPR))
- Active substances for use in Plant Protection Products (as the plant protection products and their active ingredients are covered by Directive on Procedures and Principles of Plant Protection Products.
There are 2 steps in the registration process of KKDIK which are Pre-registration ( Pre- SIEF ) and Registration. The pre-registration started from December 23rd, 2017 on. So if the Pre-Registration is completed by December 31st, 2020, chemical substances can be manufactured in Turkey or imported into the country until December 31st, 2023 which is the deadline of the registration period. After December 31st, 2023 substances which have not been registered under KKDIK (Turkey REACH) cannot be manufactured in Turkey or imported into the country.
KKDIK – TURKREACH requires to register all substances manufactured or imported into Turkey in volumes greater than or equal to 1 ton per year.
Who can register?
Only Representative (OR) for non-Turkey manufacturers
June 23rd, 2017 KKDIK Publication
3/12/2017 – 31/12/2020: Pre-SIEF (Pre-registration) period.
01/01/2021 – 31/12/2023: It is the registration period.
01/01/2024 and after: No market access for unregistered substances.
KKDIK SIEF – Joint Submission
SIEF = Substance Identification Exchange Forum
SIEF participants should include all relevant actors submitting information to the Agency on the same substance for;
- cost sharing and data sharing
- prevent unnecessary animal testing and reduce costs
- joint submission of the same substance
Different companies who want to register the same substance might construct a joint registration file in the SIEF and submit the registration dossier together.
KKDIK Turkey REACH registration requirements differs from EU REACH
- There is no separation of deadlines depending on the tonnage bands or the classification of the substances.
- All the registrations for substances ≥1 mta have to be submitted in 3 years period (31.12.2020 – 31.12.2023)
- Companies that are exporting chemicals (and articles that are containing some certain chemicals) can appoint an OR and submit the registrations through the OR by which & then their importers will become downstream users. (Article 9)
- A certified Chemical Safety Assessor is needed to compile the dossier and to prepare the Chemical Safety Assessment Report.
- SDS Compilers who are certified in accordance with 29204 (existing SDS Regulation) can compile SDS till 31.12.2023 in accordance with 29204 should be prepared and signed by a certified expert in Turkey
- Only Representative Service
- Third Party Services
- Scope Identification
- Pre-registration & Registration of substances
- C&L Notification
- Chemical Safety Assessment (CSA)
- Chemical Safety Report (CSR)
- Safety Data Sheets – Preperation, Translation, Compilation, Registration – Label Preperation
- SIEF Management
- Consortium Management and Consortium Supporting Service
- Outsourced Support to the Regulatory Teams of Companies.
- Regulatory Trainings