You can click the link below to access the KKDIK Regulation:
KKDIK Regulation No 30105 (Repeated) (Turkey REACH)
What Is the KKDIK Regulation?
KKDIK stands for the “Registration, Evaluation, Authorisation and Restriction of Chemicals.” It is a regulation intended to ensure a high level of protection of human health and the environment.
The Regulation was published by the Ministry of Environment, Urbanisation and Climate Change of the Republic of Türkiye on 23 June 2017. It covers the manufacture, placing on the market and use of chemical substances in Türkiye, whether on their own, in mixtures or in articles.
The Relationship Between KKDIK and REACH
KKDIK and REACH are two regulations that serve the same purpose. KKDIK is Türkiye’s national chemicals regulation, closely modelled as a national adaptation of REACH. The main similarities between them can be summarised as follows:
- Both regulations rely on the European Union’s EINECS and ELINCS databases for the identification and classification of substances.
- The “No data, no market” principle under REACH also applies to KKDIK. Accordingly, substances manufactured or imported in quantities of one tonne or more per year, whether on their own, in mixtures or in articles with an intended release, must be registered through the Chemicals Registration System before they may be manufactured or imported.
- Both regulatory frameworks promote data sharing between registrants of the same substance to avoid unnecessary animal testing and reduce costs. Under both regulations, a Substance Information Exchange Forum (SIEF) is established to prevent the duplication of tests involving animals.
- The requirements and standard rules relating to Safety Data Sheets under REACH also apply under KKDIK.
I Have a REACH Registration. Do I Also Need to Register Under KKDIK?
Compliance with REACH or registrations submitted to ECHA are not, on their own, sufficient for compliance with KKDIK. KKDIK is an independent Turkish legislation enacted directly under national law.
All notifications, registrations and administrative procedures within the scope of the Regulation must be carried out under the authority of the Ministry of Environment, Urbanisation and Climate Change of the Republic of Türkiye, rather than ECHA, and through the Ministry’s national Chemicals Registration System (KKS).
Furthermore, the legal obligations under KKDIK apply only to natural or legal persons established in Türkiye. Therefore, REACH registrations are not sufficient for manufacturers established outside Türkiye that wish to place their chemicals on the Turkish market. Such manufacturers must appoint an Only Representative established in Türkiye in order to fulfil the relevant obligations under KKDIK. Cases of non-compliance with the Regulation are subject to the administrative and criminal penalties prescribed under Turkish law.
KKDIK Regulation Requirements
- Registration obligations: In accordance with the “No data, no market” principle, substances subject to the Regulation may not be manufactured or placed on the market unless they have been registered. Accordingly, manufacturers or importers of substances in quantities of one tonne or more per year, whether on their own or in mixtures, must submit a registration application through the Ministry’s Chemicals Registration System (KKS).
- Technical dossier: During the registration process, a technical dossier must be prepared containing information such as the identity of the manufacturer or importer, substance identity, manufacture and uses, classification and labelling, and guidance on safe use. The relevant dossier information must be reviewed by a certified Chemical Assessment Expert (KDU), as required under KKDIK.
- Chemical safety assessment: A chemical safety assessment must be performed, and a Chemical Safety Report (CSR) must be prepared for substances subject to registration in quantities of 10 tonnes or more per year.
- Safety Data Sheets (SDSs): Suppliers placing on the market substances or mixtures that are classified as hazardous, meet the PBT or vPvB criteria, or contain substances included in the Candidate List must also provide recipients with a Safety Data Sheet in Turkish.
- Data sharing and joint submission: Registrants of the same substance must comply with the applicable data-sharing and joint-submission requirements. These provisions are intended to avoid unnecessary animal testing and ensure that data-sharing costs are determined in a fair, transparent and non-discriminatory manner.
- Record keeping: Information relating to a substance or mixture must be kept available for at least 10 years following the date on which it was last manufactured, imported or used.
Need Support?
Chemleg can support you throughout every stage of your KKDIK compliance process. Our main services include:
- Product Stewardship
- TR REACH (KKDIK) Registration
- Only Representation
- KKDIK Authorisation and Restriction
- IUCLID and KKS Dossier Support
- SDS and eSDS
- Chemical Assessment Expert Training
- Data-Sharing Management
You can arrange a consultation with our experts by completing the form below.
