Expression of abbreviation KKDIK Regulation is “Registration, Evaluation, Permission and Restriction of Chemicals”. The KKDIK Regulation is harmonized for the Turkish Industry as part of EU harmonization laws in Turkey to EU REACH Regulation.
KKDIK was published by the Ministry of Environment and Urbanisation on 23.06.2017. However, it entered into force on 23.12.2017 except for the dates of some exceptional provisions.
The KKDIK Regulation covers the use, manufacture and market supply of the substances in their own form or in a mixture or in articles.
According to Article 64 of the KKDIK Regulation:
a) The Regulation on Safety Data Sheets for Hazardous Substances and Mixtures, published in the Official Gazette dated 13/12/2014 and numbered 29204,
b) The Regulation on the Inventory and Control of Chemicals, published in the Official Gazette dated 26/12/2008 and numbered 27092 (Repeated),
c) The Regulation on the Restriction and Prohibition of Hazardous Substances and Mixtures, published in the Official Gazette dated 26/12/2008 and numbered 27092 (Repeated),
have been repealed as of the publication date of the KKDIK Regulation.
All potential registrants must submit the pre-MBDF for their substances to the Ministry via the Chemical Registration System (KKS) by 31 October 2025.
For substances that will be manufactured and/or imported for the first time after 31 October 2025, the pre-registrations created by potential registrants must be submitted to the Ministry via KKS within 30 days following their placement on the market.
To regulate the administrative and technical procedures and principles related to the registration, evaluation, permission and restriction of chemicals in order to ensure high level of protection of human health and environment, to encourage alternative methods of assessing the harms of the substances, to increase competition and innovation.
Yes. In this case, the substance has 2 different supply chains. Each represented foreign company is selected, and two different pre-SIEFs and registrations are submitted.
a) Radioactive substances and mixtures within the scope of Safe Transportation of Radioactive Substances Regulation,
b) 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;
c) Non-isolated intermediates;
d) The carriage of hazardous substances and hazardous mixtures by rail, road, inland waterway, sea or air;
e) Wastes within the scope of Waste Management Regulation and Radioactive Waste Management Regulation,
f) Substances and mixtures which are manufactured or imported for the purpose of defence
a) Medicinal products for human or veterinary use within the scope of Bylaw on the Licencing of Medicinal Products for Human Use, Bylaw on the Packaging and Labelling of Medicinal Products for Human Use and Bylaw on Veterinary Medicinal Products,
b) Food within the scope of the Bylaw on Turkish Food Codex,
c) Feeding stuffs within the scope of the Bylaw on Placing on the Market and Use of Feeding Stuffs,
d) Substances included in Annex 4,
e) Substances included in Annex 5,
f) The substance being re-imported is the same as the exported substance,
g) Previously registered recovered substance,
h) Polymers
Substances in cosmetic products have a registration obligation within the scope of KKDIK. However, they have reduced risk assessment requirements under KKDIK.
Active substances in plant protection products and biocidal products are considered registered
Any producer or importer of articles shall submit a registration to the Ministry through Chemicals Registration System on the website of Ministry for any substance contained in those articles, if both the following conditions are met:
- The substance is present in those articles in quantities totalling over one ton per producer or importer per year;
- The substance is intended to be released under normal or foreseeable conditions of use.
For substances manufactured or imported in three consecutive calendar years, the average of the manufacturing or import quantities in the three preceding consecutive calendar years is used as the registration tonnage. For substances not manufactured or imported in three consecutive calendar years, the manufacturing or import quantities of the calendar year containing the highest quantity are used as the registration tonnage.
a) Technical file
(i) Identity of the manufacturer or importer
(ii) Identity of the substance,
(iii) Information on production and use, and, if applicable, exposure categories
(iv) Classification and labeling,
(v) Information on safe use
(vi) Summaries of studies on the intrinsic properties of the substances
(vii) Comprehensive summaries of studies on the intrinsic properties of the substances if necessary
(viii) Information that the above information has been reviewed by a Chemical Assessment Specialist (CAS)
(ix) Further test recommendations if deemed necessary
(x) Exposure information for substances between 1 and 10 tons
(xi) A request specifying which information should be considered confidential, with justification
(b) Chemical Safety Report (>10 tons)
Non-isolated intermediates; There are no obligations under KKDIK for the use of non-isolated intermediates (Article 2(2)(c)).
On-site and transported isolated intermediates; Manufacturers of on-site isolated intermediates in quantities of 1 ton or more annually must prepare a registration dossier unless exempted from registration conditions. However, those who will register on-site isolated intermediates may provide reduced registration information according to Article 17(2) of KKDIK if they declare under strict conditions that the substance is manufactured and used.
Polymers are exempt from registration and evaluation. However, registration of their monomers or other substances contained within is required under the following circumstances:
a) If the polymer consists of monomer units and contains at least 2% by weight of a chemically bound monomer or other substance,
b) If the total amount of the monomer or other substance is one ton or more annually.
Within 20 working days, the manufacturer or importer notifies the Ministry of the need for information. The Ministry allows system access for updates. By filling in the updated tonnage and the required information according to the updated tonnage, an update is made via the system. The Ministry charges a fee for tonnage updates.
a) IUPAC name,
b) If available, the name of the substance in EINECS,
c) Classification and labeling of the substance,
d) Data on physico-chemical properties and movement and behavior between environmental compartments,
e) Toxicological and ecotoxicological information,
f) DNEL or PNEC,
g) Safe use guide,
h) If requested under Annex 9 or Annex 10, analytical methods for the detection of a harmful substance in environmental compartments and for determining human exposure information.
The following information will not be made accessible when the Ministry provides valid justification that its publication would potentially be harmful to the commercial interests of the registrant or any other relevant party:
a) If mandatory for classification and labeling, the purity degree of the substance and the identity of impurities and/or known harmful additives,
b) The total tonnage range in which the substance is registered (1 to 10 tons, 10 to 100 tons, 100 to 1000 tons, or over 1000 tons),
c) Summaries of studies or comprehensive summaries,
d) Information contained in the safety data sheet other than the information listed in the first paragraph,
e) Commercial name(s) of the substance,
f) The IUPAC name of substances classified as harmful under Article 26 of the Regulation on the Classification, Labeling, and Packaging of Substances and Mixtures, used only as one or more of the following:
1. As an intermediate,
2. In scientific research and development,
3. In research and development focused on products and processes.
