KKDIK (Turkey REACH)
What is KKDIK?
On June 23rd, 2017, the Ministry of Environment and Urbanization (MoEU) of Turkey published its KKDIK regulation which is very similar to EU REACH regulation, aiming to regulate the safe use of chemicals in the Turkey market to ensure sound protection for human health and the environment. KKDIK is an acronym in Turkish for Registration, Evaluation, Authorization and Restriction of Chemicals.
The KKDIK regulation came into force on December 23rd, 2017. It replaces the following three existing laws:
• Regulation on the Inventory and Control of Chemicals, No.27092 (starting from June 23rd, 2017),
• Regulation on the Restrictions Relating to the Production, Supply to the Market and Use of Certain Hazardous Materials, Products and Goods, No.27092 (starting from December 23rd, 2017).
• Regulation on the Preparation and Distribution of Safety Datasheets for Hazardous Materials and Products, No.29204 (starting from December 31st, 2023)
Similar to EU REACH regulation, chemical substances on their own or in mixtures or intended to release in articles, manufactured in or imported to Turkey in quantities equal to or more than 1 tonne a year must be registered with the MoEU. Additionally, companies should fulfill obligations of Evaluation, Authorization and Restriction and safety data sheet (SDS) as well.
Being exempted from KKDIK Regulation
• Radioactive substances
• Substances subject to customs supervision
• Substances for use in national defense
• Non-isolated intermediates
• Carriage of hazardous substances by rail, road, inlandwaterway, sea or air
Being deemed as registered substance
• Active substances for use in Biocidal Products
• Active substances for use in Plant Protection Products
Being exempted from registration
• Foods or feeding stuffs
• Medicinal products
• Substances included in Annex IV
• Substances included in Annex V
• Registered substances from the recovery process
• Registered substances being re-imported
• Polymers (monomers and other reactants need to be registered)
• PPORD substances (PPORD notification)
KKDIK registration includes two stages, namely Pre-SIEF (Pre-registration) and Registration. Pre-registrations and Registrations are submitted online through the KKS tool. The pre-registration started from December 23rd, 2017 and all pre-registrations should be submitted before December 31st, 2020. The Registration Period will start on December 31st, 2020, and if the Pre-Registration has been completed by December 31st, 2020, chemical substances can be manufactured in Turkey or imported into the country until December 31st, 2023. After December 31st, 2023, substances which have not been registered under KKDIK cannot be manufactured in Turkey or imported into the country with a volume equal to or above 1 tonnage per year.
• Only certified Chemical Assessment Experts described in KKDIK Annex XVIII can compile the dossier, CSR as well as SDS/eSDS.
• No distinction between phase-in and non-phase-in substances. Both existing and new substances could be pre-registered and registered.
• The registration deadline under KKDIK is unrelated to any tonnage band.
• Data required for registration are exactly the same as those required in EU REACH(Annex VII/VIII/IX/X).
• EU REACH data is acceptable for KKDIK registration, but new usage right is required.
Other Obligations under KKDIK
|• Authority: proposed by MoEU
• Duties: Dossier evaluation and substance evaluation
• Results: Decision on whether to require more information and evaluation; substance may be included in authorization or restriction list
|• Candidate list of Authorization: SVHC
• Authorization List: Annex XIV
• Results: Substances included in Annex XIV cannot be manufactured, imported or used unless any authorization has been granted
• Annex XIV will be published after December 31st, 2023
|• Restriction List: Annex XVII
• Results: Must comply with restrictions for substances stated in Annex XVII
• Provides effective dates for entries of restrictions
Related Turkish Regulations and Obligations
|SDS Regulation||SEA (CLP) Regulation|
|SDS regulation (No.29204) is to be replaced by KKDIK Annex II on December 31st, 2023. Between December 23rd, 2017 and December 31st, 2023, both of the two regulations are in force.
• Standard 16-section SDS
• Must be prepared in Turkish
• Should be prepared and signed by a certified expert in Turkey
• A copy of SDS should be submitted to MoEU
|C&L (Classification & Labelling) Notification
For substances which are classified as hazardous ones, manufacturers or importers have to submit C&L Notification to the Turkish competent authority to form the C&L inventory
• Non-Turkish manufacturers can appoint an OR to complete the C&L Notification
• For substances placed on the market after June 1st, 2015, the competent authority should be notified at least within one month after such substances are placed on the Turkish market for the first time
• Submit through KKS tool
• Only Representative Service
• Pre-registration Service
• KKDIK Registration Service
• SIEF Management
• Testing Supervision
• Safety Data Sheet (SDS) and Label Preparation
• C&L Notification
• KKDIK Compliance Analysis
• Consortium Supporting Service