What is KKDIK Individual Provisional Registration (ITR)?

Individual Provisional Registration (ITR) is an alternative registration pathway that allows manufacturers and importers to submit a temporary individual registration dossier when participation in a joint submission is not feasible.

This mechanism is particularly relevant in cases where:

• No Lead Registrant has been appointed,

• The Lead dossier has not been submitted,

• Access to data via Letter of Access (LoA) is unavailable, delayed, or commercially unviable,

• The Substance Information Exchange Forum (SIEF) is inactive or non-functional.

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Regulatory Context

Following the Ministry’s announcement dated 6 March 2026, all substances manufactured or imported into Türkiye at ≥1 ton/year must have either:

• A Temporary Registration (Individual or Joint), or

• A Full Registration

by 30 September 2026.

After this deadline:

• Substances without a valid registration number cannot be legally manufactured or placed on the Turkish market.

• Compliance checks will focus on the existence of a valid registration number in the KKS (Kimyasal Kayıt Sistemi).

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Key Characteristics of ITR

• No LoA requirement: Registration can proceed independently of consortium data access.

• Data gaps allowed: Missing data can be justified in accordance with Annex-1 principles.

• Standalone submission: Not dependent on Lead Registrant activity.

• Deferred completeness: The dossier can be updated later during the transition to full registration.

• Regulatory safeguard: Ensures business continuity despite SIEF failures.

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Strategic Positioning

ITR is not a replacement for full registration — it is a risk mitigation instrument.

You use ITR when:

• Waiting for joint registration exposes you to non-compliance risk, or

• The cost/time uncertainty of LoA is unacceptable.

You do not use ITR when:

• A functioning joint submission exists with a viable Lead and reasonable LoA conditions.

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Strategic Positioning

ITR is not a replacement for full registration — it is a risk mitigation instrument.

You use ITR when:

• Waiting for joint registration exposes you to non-compliance risk, or

• The cost/time uncertainty of LoA is unacceptable.

You do not use ITR when:

• A functioning joint submission exists with a viable Lead and reasonable LoA conditions.