TURKEY-REACH

TURKEY-REACH

KKDIK (Kimyasalların Kaydı, Değerlendirmesi, İzni ve Kısıtlanması) is Turkey’s version of the EU REACH regulation. It governs the Registration, Evaluation, Authorization and Restriction of Chemicals in Turkey.

Since 23 December 2017, companies manufacturing or importing chemicals into Turkey in quantities of 1 tonne or more per year must comply with KKDIK.

Aims

Global efforts to protect humans and the environment from hazardous effects of the chemicals.

  • To provide a high level of protection of human health and the environment from the use of chemicals.
  • To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.)
  • To allow the free movement of substances on the TURKISH market.
  • To enhance innovation in and the competitiveness of the TURKISH chemicals industry.
  • To promote the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.

REACH
Registration

KKDIK (Kimyasalların Kaydı, Değerlendirmesi, İzni ve Kısıtlanması) requires Turkish manufacturers and importers to register all chemical substances produced or imported in quantities of 1 tonne or more per year. Registration dossiers are submitted through the KKS (Turkish Chemicals Registration System) and must include: Substance identity and analytical data Classification and labelling information Safe use guidelines and Turkish SDSs Study summaries and Chemical Safety Report (CSR) for substances ≥10 tonnes/year The final registration deadline is 31 December 2026. Failure to register results in a ban on manufacturing or import in Turkey.

(OR) Only
Representative Services

Non-Turkish manufacturers must appoint a Turkey-based Only Representative (OR) to comply with KKDIK.

Our OR service handles all regulatory tasks: dossier preparation, data gap analysis, and registration through KKS.

We maintain ongoing communication with the Ministry of Environment, Urbanisation and Climate Change (MoEUCC) to ensure smooth approval.

Pharmegich Healthcare Limited represents more than 200 non-EU companies with successful registrations under KKDIK.

eSDS & SDS

After the REACH and CLP legislations entered into force, the Chemical Safety Data Sheet (SDS) has become the vehicle of communication within the entire supply chain in the EU. The supplier of the substance or preparation must supply and update the SDS in accordance with Annex II of the REACH regulation and taking into consideration the CLP requirements.

In addition, for all the substances where a chemical safety report (CSR) is required, the information in the SDS must be consistent with the CSR and the relevant exposure scenarios (ESs), shall be annexed to the SDS. SDS containing ESs is commonly named as Extended SDS (eSDS). We provides companies REACH & CLP compliant SDSs as well as Extended SDSs.

Legal Guidance
and Consulting

Our regulatory team provides end-to-end consulting for Turkish REACH compliance. We assist with registration strategy, documentation, and regulatory correspondence. Our experts help anticipate evolving Turkish REACH requirements and manage long-term obligations for our clients..

Please contact on js@pharmegichealthcare.com for more information