GBF under KKDİK: who prepares it, who is responsible?

KKDİK and the place of the GBF

KKDİK (Kimyasalların Kaydı, Değerlendirilmesi, İzni ve Kısıtlanması Hakkında Yönetmelik, the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals) is the Turkish counterpart of the EU REACH Regulation (EC) No 1907/2006, often called "Turkish REACH". It was published in Official Gazette No. 30105 of 23/06/2017. The obligations concerning the GBF are in Article 27 of the regulation, and how the form is to be prepared is set out in Annex 2. Classification and labelling rules are in a separate regulation, the SEA Regulation (the Turkish counterpart of the EU CLP Regulation).

The transition period ended at the end of 2023: the option to prepare GBFs under the old SDS regulation, published in Official Gazette No. 29204 of 13/12/2014, ran until 31/12/2023. Since 1 January 2024 the only basis is KKDİK Annex 2.

Who prepares the GBF?

Since 1 January 2024 the GBF is prepared by a chemical assessment expert (KDU) certified by the Ministry. The authority of the former "GBF preparer" certificates ended on 31/12/2023. Companies handle this work either with a KDU on staff or with a consultancy that offers KDU services.

Annex 2 also requires the preparer to be a "competent person who shall take into account the specific needs of the user audience", and requires the supplier to ensure that this person receives appropriate training, including refresher training (Annex 2, 0.2.3).

Who is responsible, and when must it be provided?

The obligation to deliver the GBF to the recipient lies with the supplier. Everyone in the supply chain who passes the product to the next link (manufacturer, importer, distributor, downstream user) carries this obligation towards their own recipient. A GBF is provided in the following main cases:

• the substance or mixture is classified as hazardous under the SEA Regulation,
• the substance is PBT (persistent, bioaccumulative, toxic) or vPvB (very persistent, very bioaccumulative),
• the substance is on the candidate list prepared for substances subject to authorisation.

For some mixtures that are not classified as hazardous, a GBF must also be provided on the recipient's request if they contain certain hazardous components above a threshold.

• When: with the product, in practice with the first delivery at the latest. KKDİK does not state an explicit deadline; its EU counterpart, REACH Article 31/8, says "at the latest on the date on which the substance/mixture is first supplied".
• How: free of charge, on paper or electronically (KKDİK Article 27/8).
• Language: Turkish.

When is an update mandatory?

The GBF is updated when new information that may affect risk management, or new information on hazards, becomes available, when an authorisation is granted or refused, or when a restriction is imposed. The updated form is sent free of charge to all recipients who received the product within the previous 12 months (Article 27/9 and 27/10). What changed in the revision is stated in Section 16, and the version information on the first page (Annex 2, 0.2.5).

In practice, the most common triggers for an update are a change in a component's harmonised classification, a change in the formulation, new toxicological data, and a new GBF received from the supplier.

How do the KKDİK registration deadlines affect the GBF?

An amendment published in Official Gazette No. 32408 of 23/12/2023 staggered the registration deadlines for substances by tonnage and hazard:

Why this matters for the GBF: for substances subject to registration, the information in the GBF must be consistent with the information in the registration dossier and, where one exists, the Chemical Safety Report; if the report is completed, the relevant exposure scenarios are annexed to the GBF (Annex 2, 0.1.2). So as registrations progress, existing GBFs also need to be reviewed.

Practical notes for distributors and importers

• Translating the foreign supplier's English SDS is not enough on its own: the form must follow the KKDİK Annex 2 structure, be in Turkish and be prepared by a KDU.
• If you sell the same product under a different packaging or brand name, the identification and supplier details in Section 1 must be adapted to you.
• Keep a record of which version you gave to which customer and when; only with this record can you meet the 12-month update obligation.

Sources

• KKDİK Regulation (23/06/2017, Official Gazette No. 30105), Article 27 and Annex 2.
• Regulation amending the KKDİK Regulation (23/12/2023, Official Gazette No. 32408) — announcement of the Directorate General of Environmental Management.
• Regulation on Safety Data Sheets for Hazardous Substances and Mixtures (13/12/2014, Official Gazette No. 29204) — until 31/12/2023.
• Ministry of Environment, Urbanisation and Climate Change of the Republic of Türkiye — Chemicals Helpdesk.