KKDIK Registration | Chemical Registration in Turkey

Description
English

 

KKDIK Regulation (Turkish Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals)

"Registration, Evaluation, Authorization and Restriction of Chemicals” (KKDIK) was published by Turkey's Ministry of Environment, Urbanization and Climate Change on June 23, 2017 in the Official Gazette No. 30105. KKDIK entered into force on December 23, 2017. KKDIK has been prepared on the basis of REACH Regulation (EC) No:1907/2006 dated 18/12/2006 and adapted to the Turkish Industry within the frame of compliance with the legislation of the European Union.

On December 23, 2023, Regulation Nr. 32408 on amending the KKDIK Regulation was published. According to this regulation, registration deadlines has been postponed according to the tonnage band and hazard categories of substances, these are detailed on the important dates indicated below.

Registration, Restriction and Authorization are parallel processes within the scope of KKDIK.

 

Registration within the scope of KKDIK is realized in two steps respectively; Pre-Registration Process and Registration Process. EU REACH registration will not be applicable in Turkey for substances to be registered under KKDIK. Therefore, these substances should be registered within the scope of KKDIK.

Pre-Registration Process, which is the first step, entered into force on 23 December 2017 and will continue until the period specified in the procedures and principles to be published by the Ministry. Registration Process entered into force after the completion of the initial 3-year period for pre-registration.

 

We can summarize important dates for these processes as follows;

23 December 2017: Pre-Registration provisions entered into force for the substances which falls in the scope of KKDIK.

01 January 2021- After: The Registration Process started for the substances which are evaluated within the scope of KKDIK. However, there are important dates that need to be mentioned for this period. These dates and their importance are as follows;

  • 01 January 2021: The Registration Process started for the substances that are evaluated within the scope of KKDIK. Pre-Registered substances can be manufactured or imported between these dates while their Registration Process continue. The substances, which are not Pre-Registered, can be manufactured or imported in condition of completion of the Registration.
  • 31 December 2026: Registration process must be completed for substances that meet the following criteria:  
    • Substances manufactured or imported over 1000+ tons per year,
    • Substances manufactured or imported in quantities of 100 tons or more per year and which are classified as Aquatic Acute 1 and/or Aquatic Chronic 1 (H400/H410) hazard category,
    • Substances manufactured or imported in quantities of 1 ton or more per year and classified under carcinogenicity, mutagenicity and/or reproductive toxicity Category 1A or 1B.
  • 31 December 2028: Registration process must be completed for substances manufactured or imported in quantities of 100 tons or more per year.
  • 31 December 2030: Registration process must be completed for substances manufactured or imported in quantities of 1 ton or more per year.
  • 31 December 2030 and After: The substances, which are within the scope of KKDIK, can be manufactured or imported in condition of completion of the Registration as of this date and/or related registration deadlines indicated above.

 

Restriction Provisions entered into forced on the date 23 December 2017. Currently, all Restriction Provisions indicated in Annex 17 of KKDIK Regulation are active.

 

REGISTRATION PROCESS OF KKDIK

Pre-Registration (Pre-SIEF) and Registration within the scope of KKDIK

The process which is defined as Pre-Registration Process on REACH to prepare for the Registration Process, is called Pre-Substance Information Exchange Forum (pre-SIEF) in the KKDIK Regulation.

Some of the relevant Articles for Pre-Registration, that are mentioned as Pre-Substance Information Exchange Forum (pre-SIEF) in the KKDIK Regulation, are specified as follows;

 

Transitional Provision

TRANSITIONAL ARTICLE 1- (1) All registrants, shall send a pre-SIEF including below mentioned information to the Ministry through Chemicals Registration System in the website of Ministry until 31/12/2020:

a) substance identity according to Annex-6;

b) Role in the supply chain

Entry into Force

ARTICLE 66- (1) ç) All other provisions will enter into force 6 months later the date of its publication on the Official Gazette.

Regulation Nr. 32408 on Amending the Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (KKDIK)

ARTICLE 6 -The phrase "until 31/12/2020" in the provisional Article 1 of the same Regulation (KKDIK Regulation) has been amended as "until the periods specified in the procedures and principles to be published by the Ministry".

As stated in KKDIK Regulation, it is obligatory to submit Pre-SIEF (Pre-Registration) for chemical substances with registration obligation under the scope of KKDIK. This obligation came into force as of December 23, 2017.

There is a Pre-Registration / Registration obligation for substances manufactured or imported in 1 ton or more per year in their own form, in mixtures or in an article.

All actors, who will register the substances, also will submit a Pre-SIEF which will contain the following information through Chemical Registration System (or KKS tool) under Integrated Environmental Information System of the Ministry;

a) Substance identity according to Annex-6;

b) Role in the supply chain

Substances Which Are Exempted from The Registration Provisions Under The KKDIK

The substances in the groups listed below are the most summarized form of the substances exempted from registration by KKDIK. It should be noted that there are some details about these exemptions.

Substances not included in the following lists are obliged to fulfill their Registration and Pre-Registration obligations under the KKDIK in case they are imported or manufactured at 1 ton or more.

Substances which are out of Scope for KKDIK are: Since the substances in this group are not covered by KKDIK, they do not have Registration or Pre-Registration obligations.

  • Radioactive substances and mixtures, Substances subject to customs supervision on their own or in a mixture or in an article (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), Non-isolated intermediates, Wastes (evaluated Bylaw on Waste Management and Radioactive Waste Management), Substances and mixtures which are manufactured or imported for the purpose of defense, Substance in the form of transport (by rail, road, inland waterway, sea or air).

The Substances, which are out of Scope for Registration Process of KKDIK: The substances in this group are exempted from Registration and Pre-Registration obligations, even though they are covered by the KKDIK Regulation.

  • Food and feeding stuffs, Medicinal products (both for Human Use and Veterinary), KKDIK ANNEX-4 substances, KKDIK ANNEX-5 substances, Substances (on their own or in mixtures or in articles) which have been registered previously and which are recovered, Re-imported substance which is the same with the exported substance that have been registered previously, Polymers

Substances Regarded as Being Registered: The active ingredients of the following product groups are considered to be registered under the KKDIK. For this reason, they do not need to be registered.

  • Biocidal Product Active Substances, Plant Protection Product Active Substances

 

As CHEMLEG, Our Services within the scope of KKDIK include;

  • Acting as an Only Representative for all process of KKDIK
  • Determination of substances within the scope of KKDIK
  • Determination of roles and responsibilities within the scope of KKDIK
  • Managing the entire process for substances within the scope of KKDIK
  • Submission of Pre-Registration (Pre-SIEF)
  • Compiling substance-based inventory for your products imported to Turkey,
  • Management of Pre-Registration Process for the substances evaluated within the scope of KKDIK
  • Tracking of Pre-SIEF and SIEF member activities
  • Tracking of consortium activities
  • Preparation and compilation of registration dossiers under KKDIK
  • Submission of the registration dossier to KKS system by chemical assessment experts
  • Conducting Inventory for the substances under Annex 17 (Restricted Substance List)
  • Conducting Inventory for the substances having Pre-Registration obligation.

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