Interpretation for KKDIK (Turk-REACH) Regulation

KKDIK (Turkish-REACH) Regulation Overview

The KKDIK Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals), also known as Turkish REACH, was:

  • Published on 23 June 2017 by the Ministry of Environment and Urbanization (MoEU) of the Republic of Turkey.
  • Came into effect on 23 December 2017.

This regulation mirrors the EU REACH Regulation (EC No. 1907/2006) in structure, intent, and process, ensuring that manufacturers, importers, and suppliers manage chemical safety effectively within Turkey.


Scope of KKDIK (Turkish-REACH) Registration

The KKDIK regulation applies to:

  1. Substances

    • Any chemical substance manufactured in or imported into Turkey in quantities of 1 ton or more per year.
  2. Substances in Mixtures

    • Substances that are part of a mixture, where the total quantity manufactured or imported reaches 1 ton or more per year.
  3. Substances in Articles

    • Substances contained in articles manufactured or imported into Turkey with intentional release during normal or reasonably foreseeable use.
    • The total annual quantity of the released substance must be 1 ton or more per year.

Note:
The intentional release from articles refers to scenarios like fragrances from air fresheners, inks from printer cartridges, or chemicals in cleaning wipes.


Who Must Complete KKDIK Registration?

1. Turkey-Based Manufacturers and Importers

  • Manufacturers and importers of substances, mixtures, or articles located in Turkey are obligated to comply with the KKDIK registration requirements.

2. Non-Turkey Manufacturers

  • Non-Turkey manufacturers exporting substances, mixtures, or articles to Turkey must:
    • Appoint a KKDIK Only Representative (OR) based in Turkey.
    • The OR will take responsibility for fulfilling the registration and communication obligations under KKDIK.
  • This helps non-Turkey companies continue business in Turkey without burdening their local customers with registration obligations.

Key Point:
The Only Representative (OR) acts on behalf of non-Turkey manufacturers to ensure compliance and serve as the point of contact for regulatory bodies.


KKDIK (Turkish-REACH) Registration Process and Timelines

The KKDIK registration is divided into two main phases:

Step 1: Pre-Registration (Deadline Passed)

  • The pre-registration phase (similar to the EU REACH pre-SIEF process) allowed companies to:
    • Submit basic information about substances.
    • Participate in Substance Information Exchange Forums (SIEFs) to avoid duplicate testing and share data with other registrants.
    • Prepare for the formal registration phase.

Pre-registration Deadline:
Companies had until 31 December 2020 to submit pre-registration information.


Step 2: Registration

Following pre-registration, companies must submit full registration dossiers by the regulatory deadline.

Registration Requirements:

For substances that meet the 1 ton/year threshold, the registration dossier must include:

  1. Identification of the Substance:

    • Chemical identity, structure, composition, and impurities.
  2. Hazard Classification and Labeling:

    • GHS-compliant classification and labeling details.
  3. Physicochemical Properties:

    • Physical and chemical characteristics such as melting point, boiling point, solubility, etc.
  4. Toxicological and Ecotoxicological Data:

    • Health and environmental impact studies to assess risks.
  5. Exposure Scenarios and Risk Management Measures:

    • Information on how the substance is used and controlled during its lifecycle.
  6. Chemical Safety Report (CSR):

    • Mandatory for substances ≥10 tons/year. It includes detailed exposure and risk assessment for workers, consumers, and the environment.

Registration Deadline:

  • The final registration deadline under KKDIK is 31 December 2023.
  • Companies must ensure that all substances manufactured or imported at 1 ton/year or more are fully registered before this date.

Data Sharing and Consortia

KKDIK encourages data sharing to reduce costs and unnecessary testing on animals.

  • Joint Submission: Companies manufacturing or importing the same substance are required to share relevant test data and submit a joint registration dossier.
  • Lead Registrant: One company (often a major stakeholder) acts as the Lead Registrant to compile and submit the dossier on behalf of other co-registrants.
  • SIEF (Substance Information Exchange Forum): Registrants collaborate in SIEFs to share information and testing costs.

Benefits of Joint Registration:

  • Cost-effective approach.
  • Avoids duplication of efforts and testing.

Role of Only Representatives (OR)

Non-Turkey manufacturers rely on Only Representatives (OR) to fulfill KKDIK obligations.

  • Responsibilities of ORs:
    • Register substances on behalf of the non-Turkey entity.
    • Maintain communication with the Turkish Ministry of Environment and Urbanization.
    • Support local importers by ensuring compliance with KKDIK.

Consequences of Non-Compliance

Failure to comply with KKDIK requirements can result in:

  1. Import/Manufacturing Bans: Substances not registered cannot be legally imported or manufactured in Turkey.
  2. Fines and Penalties: Regulatory authorities may impose financial penalties.
  3. Loss of Market Access: Companies risk losing access to the Turkish market.

Next Steps for Companies

  1. Review Substances:

    • Identify substances manufactured, imported, or included in articles that meet the 1 ton/year threshold.
  2. Appoint an OR (if needed):

    • Non-Turkey companies must appoint a KKDIK OR to manage registration.
  3. Participate in Joint Registration:

    • Collaborate with other registrants to share costs and data.
  4. Prepare and Submit Dossiers:

    • Develop comprehensive registration dossiers in line with KKDIK requirements.