Early in 2025, the Turkish Ministry of Environment and Urbanization released the Draft Implementation Rules to increase adherence to the country’s KKDIK chemical laws. These regulations, which seek to improve chemical lifecycle management and simplify industry compliance, provide clarification on important procedures such as pre-registration, Lead Registrant (LR) determination, and transitional periods. These are the key points.

1. Pre-registration Deadlines

Substances produced/imported at >1t must be pre-registered via the Chemical Registration System (KKS) by June 30, 2025, and join MBDF.

For substances first produced/imported after June 30, 2025:

• 100-1000t/year: Pre-register by December 31, 2027.

• 1-100t/year: Pre-register by December 31, 2029.

2. Lead Registrant (LR) Determination

• By September 30, 2025, LR must be established for drugs launched prior to December 31, 2030.

• To engage with MBDF regarding tonnage ranges and data gap analysis, LRs who have not yet submitted registration dossiers must obtain at least 70% of MBDF members’ agreement.

• Under the new regulations, LRs that were confirmed prior to the implementation of these rules but without filed dossiers must be re-confirmed.

3. Transitional Registration

• By December 31, 2025, LR must submit the statistics specified in Annex 1. By June 30, 2026, member companies must turn in their registration dossiers to the Ministry of Industry and Technology.

• This does not apply to businesses that finish full registration by December 31, 2025. 

• Statutory fees must be paid for transitional registration.

4. Safety Data Sheets (SDS)

Suppliers must upload their SDS to the designated SDS management system after preparing them in accordance with Turkish requirements.
Please take note that the final version of this document will be modified in response to industry input; it is presently a consultation draft. To prevent fines, market prohibitions, and business interruptions, companies should make clear their pre-registration and transitional compliance requirements.

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