KKDIK Regulation The registration schedule for substances covered by the scope of the regulation has been determined gradually according to tonnage and classification as follows.

• For substances manufactured or imported in quantities of 1000 tons or more per year: December 31, 2026
• For substances manufactured or imported in quantities of 100 tons or more per year and classified as Aquatic Acute 1 and/or Aquatic Chronic 1 (H400, H410) hazard categories under the SEA Regulation, the deadline is December 31, 2026.
• For substances manufactured or imported in quantities of 1 ton or more per year and classified as carcinogenic, mutagenic, and/or toxic to the reproductive system in hazard categories 1A or 1B under the SEA Regulation, December 31, 2026
• For substances not covered by the above conditions,

o For substances manufactured or imported in quantities of 100 tons or more per year, December 31, 2028

o For substances manufactured or imported at an annual rate of 1 ton or more: December 31, 2030

Temporary Registration

• If the lead company is unable to fulfill its obligations regarding full registration, it shall submit the data specified in Annex 1 of the Procedures and Principles to the Ministry by March 31, 2026, to obtain temporary registration.

Following the lead company’s temporary registration, member companies shall submit their member registration entries to the Ministry via the Chemical Registration System (KKS) by 30/09/2026.

• Companies that are not included in the joint registration group related to Article and will submit their registration files separately shall, if they are unable to fulfill their obligations regarding full registration, submit a temporary registration to the Ministry by March 31, 2026, by submitting the data specified in Annex 1 of the Procedures and Principles via the Chemical Registration System (KKS).

Substances whose registration has not been completed by the specified registration deadline may not be manufactured or imported until the registration process is completed.

These companies are not directly liable under the KKDIK Regulation. However, they may appoint an Only Representative, who is a natural or legal person established in Turkey, to fulfill the obligations of their importers. In the event that an Only Representative is not appointed, the registration of the substance must be carried out by the importing companies.

Manufacturers, mixture or article producers, and formulator companies outside Turkey can appoint an Only Representative.

Companies that only buy and sell or act as sales agents (traders) cannot appoint an Only Representative.

Manufacturing: Production or extraction of the substance in its natural state

Manufacturer: A natural or legal person established in Turkey who manufactures the substance in Turkey

Import: Physical entry into the Turkish customs territory

Importer: The natural or legal person established in Turkey responsible for importation

Producer of article : The natural or legal person established in Turkey who produces or assembles the article

Formulator: The mixture producer within the scope of the KKDIK Regulation

Institutions must confirm that they are the ‘registrant’ as defined in Article 4(ü) of the KKDIK Regulation.

Organizations may open “branches” that are separate from the company headquarters or head office and do not have legal personality. In such cases, the company headquarters established in Turkey, which has legal personality and must comply with the provisions of KKDİK, is responsible. Branches do not register.

Companies affiliated with the main headquarters may be the “registrant” under KKDİK if they have separate legal personality from the parent company.

Substances manufactured in quantities of 1 ton or more per year must be registered regardless of whether they are exported abroad.

Since substances exceeding 1 ton per year are subject to registration, substances imported or manufactured in quantities below 1 ton may not be registered.

Importers or manufacturers must comply with the relevant obligations of the regulation regarding the substance’s use, restrictions, authorization, provisions in the safety data sheet, etc., as well as their position in the supply chain, regardless of the quantity.

In biocidal and plant protection products, only substances used as “active substances” are exempt from quantity registration.

However, other uses of the substance in quantities of 1 ton or more for purposes other than this are not exempt from registration and must be registered.

The amount of the substance used in medical products for human and animal health under the Regulation on Packaging Information, Instructions for Use, and Tracking of Human Medical Products and the Regulation on Veterinary Medical Products is exempt from KKDIK Regulation registration.

However, other uses of the substance falling under the KKDIK Regulation in quantities of 1 ton or more are subject to registration.

If the substance does not perform its primary function when released, but only performs an accessory function, then the release of the substance from the article is considered if intended.

For example, in scented children’s toys, the substances that give off the scent release to perform their auxiliary function of providing the scent.

Substances that meet the criteria in Article 47 of the KKDIK Regulation are designated as substances of very high concern.

According to Article 8(2) of the KKDIK Regulation, notification is required for substances of very high concern in articles if the following conditions are met:

1) The substance is included in the candidate list of substances subject to authorization

2) The concentration of the substance in the articles is greater than 0.1% by weight,

3) The total quantity of the substance in the articles (i.e., articles containing more than 0.1% by weight of a “substance of very high concern”) exceeds 1 ton per year per manufacturer or importer,

4) The substance has not been previously registered for this specific use

The KKDIK Regulation also applies to substances found in nature as defined in Article 4(h).

However, certain substances listed in Annex 5, such as minerals, ores, ore concentrates, raw and processed natural gas, crude oil, and coal, etc., are exempt from registration unless they have been chemically modified.

According to Article 2(5)(a) of the KKDIK Regulation, substances listed in Annex 4 are exempt from registration.

A modified substance derived from a substance is exempt from registration if it has an EINECS entry corresponding to the substance listed in Annex 4.

Yes. These substances are subject to registration.

Yes, these substances are covered by the regulation.

Regardless of particle size, they must be evaluated according to the provisions of the KKDIK Regulation in terms of human health and environmental characteristics.

The KKDIK Regulation defines alloys as ‘mixtures’.

It is the elements that make up the alloy, not the alloy itself, that must be registered.

Components that are not important in terms of the alloy’s properties (i.e., those that are part of a substance within the mixture) are considered impurities, and there is no need to register the substances that constitute these impurities.

Polymers are not registered as substances. However, they cannot be considered outside the scope of the regulation.

According to Article 7(3), monomers and other chemicals contained in a polymer that has not been previously registered by an actor in the supply chain must be registered if both of the following conditions are met:

• The polymer contains 2% or more by weight of monomer substance(s) or monomer units and other substances that have formed chemical bonds (i.e., free or unbound monomers will not be considered when checking whether this condition is met);
• The total quantity of the monomer substance(s) or other substance(s) is one ton or more per year.

According to Article 7(2) of the KKDIK Regulation, the reduced registration requirements applied to on-site isolated intermediates and transported isolated intermediates do not apply to monomers.

The purpose of the SIEF is to facilitate the sharing of information required for registration in order to prevent duplication of work among potential registrants of the same substance.

Another purpose is to reach agreement on the classification and labeling information for the substance.

The SIEF also serves as a platform for data owners to share their data and studies related to the substance. In addition, if the existing information is not sufficient for registration, the SIEF jointly determines the work that needs to be done.

No. Only substances covered by SEA Regulation Article 41 require an SEA Classification & Labeling Notification.

A SEA Classification & Labeling notification is made for polymers classified as hazardous and above the concentration limit values specified in the SEA Regulation, or polymers that cause the mixture to be classified as hazardous. 

Safety Data Sheets (SDS) are prepared in accordance with the Regulation on Safety Data Sheets for Hazardous Substances and Mixtures, published in the Official Gazette dated 13/12/2014 and numbered 29204, or the KKDIK Regulation, until 31/12/2023.

After December 31, 2023, MSDSs will be prepared solely in accordance with the KKDIK Regulation.

Labels for hazardous substances and mixtures manufactured/imported in Turkey must be prepared in Turkish.

However, suppliers may use languages other than Turkish on their labels, provided that the same details are included in all languages used.

Safety Data Sheets (SDS) are prepared in accordance with the Regulation on Safety Data Sheets for Hazardous Substances and Mixtures, published in the Official Gazette dated 13/12/2014 and numbered 29204, or the KKDIK Regulation, until 31/12/2023.

After December 31, 2023, MSDSs will be prepared solely in accordance with the KKDIK Regulation.