KKDIK Compliance and Turkey REACH Regulations

Overview of KKDIK

KKDIK, widely known as Turkey REACH, is the primary regulatory framework for the registration, evaluation, authorization, and restriction of chemicals in Turkey. This regulation is administered by the Ministry of Environment, Urbanization and Climate Change (MoEUCC) and aims to ensure a high level of protection for human health and the environment.

Under KKDIK, all chemical substances manufactured in or imported into Turkey in quantities of one metric ton or more per year must be registered through the Chemical Registration System (KKS). This requirement covers substances on their own, in mixtures, or those intended to be released from articles.

Exemptions from KKDIK

Not all substances fall under the scope of registration. Certain categories are exempt from KKDIK requirements due to their nature or being governed by other specific legislations:

• Full Exemptions

Radioactive substances, substances under customs supervision, non-isolated intermediates, and waste.

• Partial Exemptions

Substances used in medicinal products (human or veterinary), food, and feeding stuffs (including additives and flavorings) are exempt from the registration part of KKDIK.

• Polymers

Polymers themselves are exempt from registration; however, the constituent monomers and other chemically bound substances must be registered if they meet the volume threshold.

KKDIK Registration Types

The registration process in Turkey is categorized by the role of the entity and the status of the substance in the market:

• Interim Registration

This is a critical phase for substances already on the market. It allows companies to submit a preliminary set of data to the MoEUCC to maintain market access while moving toward full registration.

• Full Registration

This involves the submission of a comprehensive technical dossier. For substances exceeding 10 tons per year, a Chemical Safety Report (CSR) is also required.

• Joint Registration

To reduce costs and avoid animal testing, companies registering the same substance are required to submit their information jointly through the "one substance, one registration" principle.

Other Core Obligations under Turkey REACH

Compliance with KKDIK involves more than just the initial registration. Companies must adhere to several other major requirements:

• Only Representative (OR) Appointment

Non-Turkish manufacturers must appoint a Turkish-based OR to manage their KKDIK obligations and serve as the legal link with the MoEUCC.

• Safety Data Sheet (SDS) Management

All hazardous substances must be accompanied by an SDS in Turkish, authored by a certified chemical safety expert.

• SEA (CLP) Notification

Companies must notify the MoEUCC of the classification and labeling of hazardous substances according to the SEA Regulation.

• Information Communication

Suppliers are obligated to pass safety information down the supply chain to ensure safe handling and use.

Other Major Chemical Regulations in Turkey

In addition to KKDIK, businesses must be aware of other key Turkish regulations that impact chemical compliance:

• SEA Regulation

The Turkish equivalent of the EU CLP, focusing on the Classification, Labeling, and Packaging of substances and mixtures.

• GBF Regulation

This regulation sets the specific standards and certification requirements for the experts who prepare Safety Data Sheets in Turkey.

• Substances Subject to Registration

This refers to the specific list of chemicals that have been identified as requiring mandatory monitoring and registration based on their tonnage and hazard profile under Turkish law.

Proregulations' KKDIK Services

Our team provides specialized support to ensure your business meets all Turkish chemical regulatory requirements:

• OR services
  Acting as the professional OR for non-Turkish companies to manage all technical communication with the MoEUCC.
• Interim registration support
  Managing the interim submission process to ensure your substances maintain legal access to the Turkish market.
• Technical dossier and CSR preparation
  Assisting in data collection, gap analysis, and the creation of Chemical Safety Reports.
• Turkish SDS authoring
  Providing compliant SDS services authored by certified specialists in the Turkish language.
• Consortium and SIEF management
  Representing your interests within Substance Information Exchange Forums (SIEFs) to coordinate data sharing.

If you need to ensure your chemical products are fully compliant with Turkey's KKDIK regulation or require an Only Representative, please contact us.