News About Turkish REACH (KKDIK)

KKDIK (Turkish REACH) Regulation Overview

The KKDIK Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals) was published on 23 June 2017 by the Ministry of Environment and Urbanization of the Republic of Turkey and came into effect on 23 December 2017.

KKDIK aligns closely with the EU REACH Regulation (EC 1907/2006), reflecting Turkey's ongoing efforts to harmonize national legislation with EU standards as part of its EU candidacy process.

Purpose of KKDIK

The purpose of KKDIK, as outlined in Article 1, is:

  • To ensure a high level of protection for human health and the environment.
  • To establish procedures for the registration, evaluation, authorization, and restriction of chemical substances.
  • To provide technical guidelines for compliance.
  • To encourage alternative methods for hazard evaluation, reducing the reliance on animal testing.

Scope of KKDIK Registration

KKDIK applies to substances that are:

  1. Manufactured or imported in Turkey in quantities ≥ 1 tonne/year.
  2. Substances in mixtures: Part of a formulation with annual quantities ≥ 1 tonne/year.
  3. Substances in articles: Intended for release under normal or foreseeable use, totaling ≥ 1 tonne/year.

These obligations fall on:

  • Manufacturers (Turkey-based).
  • Importers of chemicals into Turkey.
  • Downstream users in Turkey.
  • Only Representatives (ORs) appointed by non-Turkey manufacturers.

Replacement of Previous Regulations

KKDIK replaced the following earlier chemical regulations in Turkey:

  1. Regulation on the Inventory and Control of Chemicals (No. 27092) – replaced on 23 June 2017.
  2. Regulation on Restrictions Relating to Hazardous Materials, Products, and Goods (No. 27092) – replaced on 23 December 2017.
  3. Regulation on Safety Datasheets for Hazardous Materials (No. 29204) – replaced on 31 December 2023.

Updated KKDIK Registration Phases

1. Registration Deadlines

KKDIK registration now follows an updated, tiered approach based on annual tonnage and hazard classification:

  • 31 December 2026:

    • Substances ≥ 1,000 tonnes/year.
    • Substances ≥ 100 tonnes/year classified as:
      • Aquatic Acute 1 (H400) or Aquatic Chronic 1 (H410).
    • Substances ≥ 1 tonne/year classified as CMR (Category 1A or 1B).

  • 31 December 2028:

    • Substances ≥ 100 tonnes/year.

  • 31 December 2030:

    • Substances ≥ 1 tonne/year.

2. Pre-Registration Phase

The pre-registration phase allows companies to prepare and participate in Substance Information Exchange Forums (SIEFs) to share testing data and avoid duplicative efforts.

  • The timeline and detailed guidelines for the pre-registration phase will be published in the upcoming Procedures and Principles document by the Ministry of Environment, Urbanization, and Climate Change.

3. Joint Registration

Joint registration is mandatory to reduce costs and testing. Key elements include:

  • Lead Registrant: One company coordinates and submits the full dossier.
  • Data Sharing: All registrants collaborate to share existing test data and related costs.

Key Requirements for KKDIK Registration

Registrants must prepare and submit a dossier containing:

  1. Substance Identification: Identity, composition, and purity.
  2. Hazard Classification: GHS-compliant classification and labeling.
  3. Physicochemical Data: Melting/boiling points, solubility, etc.
  4. Toxicological and Ecotoxicological Data: Health and environmental impact assessments.
  5. Chemical Safety Report (CSR): Required for substances ≥ 10 tonnes/year to outline risk management measures and exposure scenarios.

Only Representative (OR) for Non-Turkey Entities

Non-Turkey manufacturers must appoint an Only Representative (OR) based in Turkey to:

  • Fulfill all KKDIK obligations on their behalf.
  • Serve as the liaison with Turkish authorities.
  • Assist with registration, data sharing, and compliance.

Penalties for Non-Compliance

Failure to comply with KKDIK can result in:

  1. Market Bans: Substances not registered cannot be legally imported or manufactured.
  2. Fines: Financial penalties may be imposed for non-compliance.
  3. Loss of Business: Companies risk losing access to the Turkish market.

How to Prepare for KKDIK Compliance

To ensure full compliance:

  1. Identify Your Substances: Review substances manufactured, imported, or used at the 1-tonne/year threshold.
  2. Engage with SIEFs: Collaborate for data sharing and joint registration.
  3. Appoint an OR: Non-Turkey entities must appoint a qualified Only Representative.
  4. Monitor Updates: Stay informed about the Ministry's Procedures and Principles publication for pre-registration guidance.

Need Expert Support? Contact Us!

Our team of experienced consultants provides:

  • Only Representative Services for non-Turkey companies.
  • Registration and Compliance Support: Preparation and submission of dossiers.
  • Regulatory Monitoring: Staying ahead of Turkey’s evolving chemical legislation.

Contact us today to ensure seamless compliance with KKDIK!