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Turkey KKDIK Registration

Aug 23, 2021
Turkey
REACH

KKDIK was published on June 23, 2017, by the Ministry of Environment and Urbanization of the Turkish Republic and formally came into effect on December 23, 2017. The regulation shares many similarities with EU REACH, thus it is also called Turkey REACH.

KKDIK Regulatory Requirements

Supervision Administration

Turkey's Ministry of Environment and Urbanization (MoEU)

Scope of Registration

  • Substances manufactured in or imported into Turkey in quantities of one tonne or more per year;
  • Substances in mixtures manufactured in or imported into Turkey in quantities of one tonne or more per year;
  • Substances in articles manufactured in or imported into Turkey that are intended to be released under normal or reasonably foreseeable conditions of use and the quantity totals one tonne per year or more.

Who Shall Register

  • Manufacturers and importers of substances (including substances in mixtures) in Turkey; 
  • Manufacturers and importers of articles (intended release) in Turkey; 
  • Non-Turkish manufacturers of substances, mixtures, and articles must perform the registration obligations under KKDIK via an only representative (OR) based in Turkey.

The Implementation of Individual Interim Registration under KKDIK

In March, 2026, Turkey’s Ministry of Environment and Urbanization (MoEU) issued an announcement regarding the KKDIK chemical registration process, introducing significant updates to the procedures, deadlines, and application requirements for individual interim registrations. The announcement clearly stipulates that all substances under KKDIK must complete registration—whether interim or full—by September 30, 2026, to obtain a registration number, regardless of whether a lead registrant (LR) exists or the tonnage level involved. After September 30, 2026, pre-registration numbers will become invalid, and only registration numbers will be recognized. Substances that fail to obtain a valid registration number will not be permitted to enter the Turkish market.

Extension of KKDIK Registration Deadline

On December 23, 2023, Turkey officially announced to extend the KKDIK registration deadlines to 2026, 2028 and 2030 depending on the tonnage band and hazard classification, namely:

(1) Substances meeting the following conditions should be registered before December 31, 2026:

  • Substances manufactured or imported in their own or in a mixture or in goods in an annual amount of 1000 tonnes or more,
  • Substances manufactured or imported in their own form or in a mixture or in goods in an annual amount of 100 tonnes or more, and that are within the Aquatic Acute 1 and Aquatic Chronic 1 (H400, H410) hazard categories according to the Regulation on the Classification, Labelling, and Packaging of Substances and Mixtures,
  • Substances manufactured or imported in their own form or in a mixture or in goods in an annual amount of 1 tonne or more, and that are within the Carcinogenic, Mutagenic, and Reprotoxic Category 1A and 1B hazard categories according to the Regulation on the Classification, Labelling, and Packaging of Substances and Mixtures.

(2) For substances manufactured or imported in their own form or in a mixture or in goods in an annual amount of 100 tonnes or more, the deadline for registration is December 31, 2028;

(3) For substances manufactured or imported in their own form or in a mixture or in goods in an annual amount of 1 tonne or more, the deadline for registration is December 31, 2030.

Pre-registration under KKDIK

Pre-registration can still be submitted before September 30, 2026.

Information Required for Pre-registration

  • Substance information (such as substance name, CAS No., EC No., and substance structure);
  • Enterprise information: Indicate the identity of the enterprise (such as Only Representative, importer, manufacturer).

Full Registration under KKDIK

Registration type

Tonnage band

Data requirements

On-site isolated intermediates under strictly controlled conditions

>= one tonne per year (1t/y)

Existing data only

Transported isolated intermediates under strictly controlled conditions

>=1t/y

Existing data only

>=1000t/y

KKDIK Annex VII

Registration of regular substances

 

>=1t/y

A) 1-10t/y standard registration, all data specified in Annex VII;

B) 1-10t/y, The information on physicochemical properties specified in   Annex VII, for substances that do not meet either of the criteria specified  in Annex 3;

>=10Tt/y

KKDIK Annex VII+VIII

>=100t/y

KKDIK Annex VII+VIII+IX

>=1000t/y

KKDIK Annex VII+VIII+IX+X

Note: for   >=10t/y regular registration, a chemical safety report (CSR) is also needed.

1. Intermediates can be divided into three categories: Non-isolated intermediates, on-site isolated intermediates, and transported isolated intermediates.

Non-isolated intermediates: an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.

On-site isolated intermediate: an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities;

Transported isolated intermediates: an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;

2. The data requirements under Annexes VII, VIII, IX, and X of KKDIK are consistent with those of EU REACH. However, compared to EU REACH, KKDIK introduces the concept of a Chemical Assessment Expert for data review during full registration. When submitting data to the authority, it must be indicated that the relevant data has been reviewed by a Chemical Assessment Expert, a requirement not present in EU REACH.

Ways of Submission

Joint Submission: If a substance is manufactured by multiple manufacturers or imported by multiple importers, registration may be conducted through a joint submission. A lead registrant is selected to submit the registration first, followed by the other registrants.

Individual Submission: A registrant may opt for individual submission if they consider the costs of joint submission unreasonable, if joint submission would lead to the disclosure of information they deem commercially sensitive and likely to cause significant commercial harm, or if they disagree with the lead registrant’s choice of information.

Comparison Between KKDIK and EU REACH Regulations

  • In terms of data review, KKDIK is stricter than EU REACH. KKDIK introduces the concept of a Chemical Assessment Expert, requiring that registration dossiers under KKDIK be prepared by a Chemical Assessment Expert and uploaded to the KKS system. Pre-registration does not require a Chemical Assessment Expert.
  • KKDIK does not establish different pre-registration/registration deadlines based on tonnage or classification.
  • Under KKDIK, dossiers are prepared using the KKS system, whereas under EU REACH, dossiers are prepared using IUCLID files.
  • KKDIK does not distinguish between phase-in substances (existing substances) and non-phase-in substances (new substances).

Our Services

  • KKDIK Regulatory Compliance Consulting and Training;

  • KKDIK OR Service;

  • KKDIK Pre-registration;

  • KKDIK Registration (Full & Interim)

  • Turkey CLP Regulation Regulatory Compliance Consulting and Training;

  • Turkey CLP Regulation OR Service;

  • C&L Notification under Turkey CLP Regulation;

  • Turkish SDS and Labeling Preparation; 

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