INFORMATION ON THE REGISTRATION PROCESS WITHIN THE SCOPE OF THE KKDIK REGULATION

What is KKDIK?
KKDIK (Registration, Evaluation, Authorization and Restriction of Chemicals) Regulation was enforced by Republic of Türkiye, Ministry of Environment, Urbanization and Climate Change on 23 June 2017.

The purpose of this regulation is to protect human beings, other living beings and the environment from chemicals, to encourage alternative methods for the evaluation of the hazards of substances, to increase competition and innovation n the market and to take chemaicals under control. In this way, it is ensured that safe and sustainable products are placed on the market.

What are the Chemicals to be Evaluated within the scope of KKDIK Regulation?
Within the scope of KKDIK, chemicals are grouped in three categories. These groups are briefly defined below:

•    Substance: The chemical element and the compounds formed by this chemical element are defined as substances. The production of these substances can be carried out by natural or unnatural means. Within the scope of KKDİK Regulation, the substance itself is evaluated as well as the impurities that occur during the production of the substance and are not added to the production for a specific purpose are also considered as substances. Solvents that can be separated from the substance are outside the scope of this regulation.
•    Mixture: It is a substance made by combining two or more different substances in such a way that their chemical properties do not change. Within the scope of KKDİK Regulation, not the mixture itself, but the substances that make up the mixture are evaluated.
•    Articles are objects that are given a special shape, surface and design during production to determine their function rather than their chemical structure.

Who are the Parties under KKDIK Regulation?
Within the scope of KKDIK, the roles of the responsible parties should be well defined. These roles are briefly defined below;

•    Manufacturer; is a natural or legal person resident in Turkey who manufactures the substance in Turkey.
•    Importer; is a natural or legal person resident in Turkey who supplies the substance from abroad to Turkey in order to supply it to the market.
•    Only Representative is a natural or legal person resident in Turkey appointed by the manufacturer, formulator or article manufacturer located outside Turkey to fulfil the importer obligations within the scope of KKDIK by mutual agreement.
•    Downstream user is a real or legal person resident in Turkey who uses a substance in its own form or in a mixture during its industrial and professional activities and who is not a distributor or consumer, different from the manufacturer and importer. According to this definition, a company producing a mixture is a downstream user of the substances used to create the mixture.
•    Manufacturer of an article is a natural or legal person resident in Turkey who manufactures the articles or provides the formation of the articles.

What is Dossier Registration of Substance under KKDIK Regulation?
Within the scope of the KKDIK Regulation, which aims to protect living health and the environment in the manufacture, import and use of chemicals, companies operating in Turkey and manufacturing or importing more than 1 tonne of chemicals per year are required to register the chemicals they manufacture or import from the Chemical Registration System (KKS) module of the Integrated Environmental Information System. Registration dossiers are inspected and approved by the Ministry of Environment, Urbanisation and Climate Change.

Who can Register a Dossier within the scope of KKDIK Regulation?
Pursuant to the KKDIK Regulation, those who are obliged to register KKDIK dossier are briefly defined below;

•    Manufacturers and importers who produce one tonne or more of a substance per year, either on its own or in a mixture
•    Manufacturer or importer of monomers and other substances in the polymer (Polymers need not be registered; however, monomers and other chemicals in the polymer must be registered if the necessary conditions are met. These conditions are that the polymer contains 2% or more by weight of the monomer substance (s) or other substance (s) in the form of monomer units and chemically bonded and the total amount of monomer substance (s) or other substance (s) is one tonne or more per year).
•    The manufacturer or importer of substances contained in the articles that cause intentional release

According to KKDIK Regulation, these persons are obliged to register for chemicals. It is not possible to manufacture or place on the market substances for which no registration application has been made.

What is the Content of the Technical Dossier Prepared under KKDIK Regulation?
In order to apply for registration under the KKDIK Regulation, a technical dossier for the relevant substance must be created and submitted to the Ministry for approval. The information that should be included in the technical file is briefly summarised below.

•    Registration company information
•    General information about the substance
•    Information about the stages of production and use of substances
•    Information on classification and labelling of substances
•    Guidance on the safe use of the substance
•    Study summaries and comprehensive study records of the information obtained from Annex-7 and Annex-11 of the KKDIK Regulation depending on the registration tonnage of the substance
•    Chemical Safety Report (CSR) if the registered tonnage of the substance is 10 tonnes or more

How is the Technical Dossier Content Control Performed by the Ministry within the Scope of KKDIK Regulation?
The Ministry checks the completeness of the registration applications made through the KKS module. However, during this check, the accuracy, quality or adequacy of the data submitted is not evaluated. The purpose of this completeness check is to request this information from the applicant if there is a deficiency in the dossier. The Ministry checks the completeness of the technical dossier of the substance within 21 working days. If there is a deficiency revealed in the completeness check, the registrant must complete the requested deficiencies by the date set by the Ministry.

How to Update the Registration Dossier by the Registrant under KKDIK Regulation?
Updates can be made to the technical dossiers submitted to the Ministry of Environment, Urbanisation and Climate Change in case of developments regarding the registrant companies or substances. Situations requiring updates are briefly stated below.

•    Company name or address change
•    Change of substance composition
•    Change in the quantity of manufactured or imported material
•    Newly defined areas of use

What are the Responsibilities of the Registrants under the KKDİK Regulation in case they stop Manufacturing and Importing?
If a registration has been made for a substance, there is an obligation to update the registration (Article 22) and to keep the information (Article 32). This means that registrants that cease manufacturing or importing a substance must inform the Ministry of the new total tonnage (in this case 0 tonnes/year) manufactured or imported.

In addition, the registrant must keep all available information it needs to fulfil its duties under the KKDIK Regulation for at least 10 years from the latest date on which the substance was manufactured, imported, supplied or used (alone or in a mixture). In this context, even if the registrant has terminated manufacturing and importation, if it is still supplying and using the substance, the period of 'at least 10 years' does not start.