KKDİK Registration Services

KKDIK Registration Services

A non-Turkish company cannot register substances under KKDIK Turkish REACH but they can appoint a KKDIK Only Representative (OR) who is legally responsible for ensuring its non-Turkish companies substances are compliant with KKDIK-Turkish REACH Regulation. The appointment of an Only Representative has many advantages for the non-Turkish manufacturer.
KKDIK Turkish REACH regulation compliance of the chemicals and products for continuous sales in Turkey (Chemical Registration, Evaluation, Authorization and Restriction of Chemicals) is mandatory. 
KKDIK promotes the use of existing animal data of good quality, and use of data from alternative, nonanimal tests in order to minimize unnecessary animal testing. Repeating animal testing should only be pursued as a last resort. For example: Data produced in India can be used in EU REACH, and they could also be used in KKDIK registration. There is no difference between EU REACH and KKDIK in terms of test data requirements.
The registration dossier, robust summary & analytical reports summaries have to be submitted in Turkish, however detailed reports can be uploaded in English. The Ministry of Environment and Urbanization (MoEU) could ask that any full study reports that they require for review are sent later on a case-by-case basis, directly from the study owner to the MoEU. Additionally, chemical safety reports have to be in Turkish. And the Chemical Registration System will be completely in Turkish and accessible only to Turkish citizens with an authorized identity number.
Chemicals manufactured in Turkey or imported to Turkey in excess of one ton per year must be registered.
Lisam KKDIK Turkish REACH registration services provide full support for the requirements of KKDIK registration.
We provide a special service for KKDIK registration, pre-registration (pre-SIEF), SIEF participation, actors communication in the supply chain, compiling exposure scenarios, risk assessments, technical dossier preparation, chemical safety assessments (CSA), Turkish REACH chemical safety reports (CSR) including for any stage of companies.
The principle is “one substance, one registration”.
During joint submission process, the lead registrant or KKDIK (Turkish REACH) consortium will do most of the work such as data collection, development of technical dossier and Chemical Safety Report (CSR), and submission of joint registration dossier to CRS.
Other co-registrants only need to pay the lead registrant (LR) or consortium a fee to refer to the joint registration dossier and then prepare the individual part of the registration dossier in Turkey KKS portal.
Regulating administrative and technical procedures and principles for the registration, authorization and restriction of chemicals in order to encourage alternative methods to evaluate the damages to be sought, to keep human health and the environment at a high level, to increase competition and innovation Registration, Evaluation, Authorization and Restriction of chemicals (KKDİK) on June 23, 2017, 30105, KKDIK legislation was published.

Who Should Register?
  • Companies who manufacture or import 1 ton per year or more, on its own, in mixtures or in articles.
  • Manufacturers and importers when a substance is contained in a substance intended for market release under normal or reasonably foreseeable conditions of use, in an amount of one tonne or more per year.
  • Only representatives

Within the scope of the Regulation on KKDIK, we provide services and consultancy regarding Chemical Assessment Specialist (KDU) Trainings, Only Representation, scope identification, pre-registration / registration of substances, preparation of KKDIK-compliant SDS and SDIF and other requirements.

What is the cost of KKDIK registration?
The main components of the registration cost are made up of:
  • Tonnage-based registration fee to be paid to the Ministery of Environment and Urbanization (MoEU)
  • Cost of testing to close data gaps and establish substance identity
  • Access to data via letter of access (LoA) where there is existing information from other registrants. These costs will depend on the amount of existing data that is made available
  • within the MBDF and the relevant tonnage band that registrants need to register within;
  • Fees for consultancy and Only Representation when using third party assistance;
  • Costs for analytical reports, translations, internal overheads etc.
  • Manufacturers and importers when a substance is contained in a substance intended for market release under normal or reasonably foreseeable conditions of use, in an amount of one tonne or more per year.

What are our main KKDIK Turkish REACH registration/pre-registration services?

 
  • lisam Exposure scenarios and risk assessments,
  • lisam KKDIK Chemical Safety Assessment and Chemical Safety Report (certified),
  • lisam Application for KKDIK Turkish REACH registration,
  • lisam Literature review to find available data on related substances.
  • lisam Evaluation of current study reports and rate assessment according to Klimisch criteria,
  • lisam Data migration from IUCLID dossiers to TR-Chemical Registration System,
  • lisam Analyze available data against the KKDIK Turkish REACH requirements to identify key studies and any gaps
  • lisam Develop Derived-No-Effect-Levels (DNELS)
  • lisam Confirm key studies and prepare robust and endpoint summaries for Turkish Chemical Registration System
  • lisam Fill any gaps using scientific strategies that may include the use of:waiver arguments, (Q)SARs and extrapolation, read-across dat, de novo testing ,
  • lisam KKDIK Turkish REACH Authorisation and SVHC Services

Are three or more of your answers yes in the checklist above? Lisam Systems is the solution you are looking for!

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