KKDIK

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KKDIK

The purpose of KKDIK (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation, which entered into force on 23/12/2017 by the Ministry of Environment and Urbanization, is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances while enhancing competitiveness and innovation.

 

Any manufacturer or importer of a substance in quantities of one tons or more per year shall submit a registration for this substance to the Ministry through Chemicals Registration System in the website of Ministry until 31/12/2023.

On this purpose, we provide consultancy services to determine the responsibilities of your company within the scope of KKDIK and to take the necessary actions in this process.
When do the KKDIK registrations start ?

The registration process has started on 01/01/2021 and will continue until 31/12/2023

Did the KKDIK pre-registration process end?

No, it is planned to continue until the end of the registration period

How will the registrations continue after 31/12/2023?

Substances to be manufactured or to be imported in quantities of one tonne or more per year for the first time after 31/12/2023 must also be registered in the same way before the production/importation.

KKDIK (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation is the harmonized version of the EU REACH regulation for Turkish Industry, aiming to protect both human health and our environment from the negative effects of chemicals at the highest level.

Pre-Registration and Registration Services

  • Preliminary examination to determine registration obligations
  • Pre-registration (Pre-MBDF) via KKS (Chemical Registration System)
  • Determination of the role in the consortium created separately for each substance (leader / member /individual)
  • Carrying out the consortium activities
  • Determining information requirements for the registration process
  • Collecting information requirements for the registration process
  • Preparation of a technical dossier
  • Risk Assessment and Chemical Safety Assessment
  • Permanent Consultancy
  • “Only Representative” Services
  • “Third Party Representative” Services
  • Information Update for the Ministry and consortium after registration

What is KKDIK?

KKDIK (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation is the harmonized version of the EU REACH regulation for Turkish Industry, aiming to protect both human health and our environment from the negative effects of chemicals at the highest level

What is MBDF?

MBDF is a platform for data owners to share their data / studies on the substance.

When do the KKDIK registrations start ?

The registration process has started on 01/01/2021 and will continue until 31/12/2023.

Did the KKDIK pre-registration process end?

No, it is planned to continue until the end of the registration period.

How will the registrations continue after 31/12/2023?

Substances to be manufactured or to be imported in quantities of one tonne or more per year for the first time after 31/12/2023 must also be registered in the same way before the production/importation.

Which information must be evaluated by a Chemical Assessment Expert?

  • Information on manufacture and usage
  • Classification and labeling of the substance
  • Summary report about the information requirements defined in Annexes 6 to 10
  • Chemical Safety Report

Where will the fee information be announced?

It is published every year on the website of the Ministry.

Where will the pre-registrations/registration be made?

Pre-MBDF and other registration can be done electronically from the Chemical Registration System (KKS) module at http://online.cevre.gov.tr/.

Do registration requirements change according to tonnage?

The volume of the substance will also determine the information required to be submitted in the registration dossier. According to the KKDIK, the 4 tonnage bands are classifed as 1 to 10 tonnes per year, 10 to 100 tonnes, 100 to 1000 tonnes, and 1000 tonnes and above.

Who are the actors in the registration obligations?

  • Article producers and importers located in Turkey containing one ton or more per year in their own form or in a mixture.
  • Article producers and importers located in Turkey (if the articles contain more than one ton of substance per year or the substance is designed to release under normal or predictable conditions)
  • “Sole Representatives” established in Turkey and appointed by the manufacturer, formulator or article producer located outside of Turkey in order to fulfill the registration obligations of the importers.

Do manufacturers and importers who produce less than 1 ton per year have any responsibilities?

  • Preparing and providing safety data sheets (SDS) to downstream users and distributors
  • Complying with the restrictions as specified in Annex 17
  • Applying for permission for the products listed in Annex 14
  • Act as a data owner in Materials Information Exchange Forms (MBDF)

Who is the Sole Representative (SR)?

The sole or only representative is a person with a legal entitiy in Turkey who represents a company residing outside of Turkey in order to carry out the necessary registration process.

Who can appoint a third party representative?

A company based in Turkey can appoint a third party representative to carry out transactions related to KKDIK.

What are the responsibilities of a registrant?

  1. Preparation of a technical dossier having all relevant and available information together with other corsortium members
  2. Preparation of the Chemical Safety Assessment (KGD) and a Chemical Safety Report (KGR) for substances manufactured or imported in quantities of 10 tons or more per year per registrant

What are the responsibilities of the consortium lead registrant?

  • Collecting the desired data according to the highest tonnage band within the joint presentation
    Guiding other members of the consortium

    What are the responsibilities of other members of the joint presentation?

      • During the process, you will need to confirm that you are a member of the Joint Presentation created by the Leader in the KKS.
      • Collecting the desired data according to the highest tonnage band within the joint presentation

    What are the responsibilities of those who will register individually?

    1. Notifying to the Ministry of individual registration request in detail
      Fulfilling all Registration obligations as individually

    What sections should the registration dossier consist of?

    • Technical dossier
    • KGR (If 10 tons or more per year)

    What information should be included in the technical dossier?

    1. Manufacturer / Importer Identity
    2. Determination of the Substance
    3. Information on manufacture and usage of the substance
    4. Classification and labeling of the substance
    5. Guidelines for safe use
    6. Study summaries of information on the intrinsic properties of the substance
    7. Comprehensive study summaries, if required
    8. Notification that the Chemical Safety Report (KGR) has been reviewed by an Chemical Assessment Expert

    What is the scope of the Chemical Safety Report (KGR)?

    1. It is the certification of the Chemical Safety Assessment (KGD).
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