KKDIK Turkish REACH
KKDIK (Turkish REACH) is the Turkish Regulation on Chemicals Registration, Evaluation, Auhtorisation and Restriction and published on the 23th of June, 2017 from the Turkish Ministry of Environment and Urbanization (MoEU). KKDIK Turkish REACH was published on 23 Jun 2017 by Ministry of Environment and Urbanization of Turkish Republic and formally came into force on December 23, 2017.
KKDIK or Turkey REACH came into effect on 23 December 2017. Substances manufactured in Turkey or imported into Turkey in volumes above 1 t/y have to be registered by manufacturers, importers or an Only Representative. Substances on the market needed to be preregistered by 31 December 2020. Pre registration is possible until end of the registration phase on 31 December 2023 for those substances introduced for the first time after 31 December 2020.
The purpose of the KKDIK pre registration is to find potential co registrants and form a MBDF (Substance Information Exchange Forum similar to SIEF). The registration platform KKS (hybrid REACH IT & IUCLID) is open as of 1 January 2021. Direct transfer of EU REACH dossiers into KKS is not possible; translations into Turkish will be required. There will be 4 volume bands based on the tonnage (1 10 t/y, 10 100 t/y, 100 1000 t/y and above 1000 t/y), however, all can be registered any time until 31 December 2023. KKDIK includes an additional annex compared to EU REACH specifying that registrations can only be submitted by a Turkish certified risk assessor. The same requirement exists for the responsible person to create Safety Data Sheets. The KKDIK Turkish REACH regulation have many common similarities with EU REACH so it is also called Turkish REACH in practice.
The Turkish Regulation on Classification & Labelling of Substances and Mixtures SEA Regulation is currently aligned with EU CLP legislation up to the 13th ATP to CLP. The newly added Article 44a requires submission of mixture composition and hazard properties to the National Poison Information Centre for classified mixtures before placing on the market. This will enter into force on 1 January 2025.
Turkish REACH, KKDIK regulation came into force from 23 December, 2017 and KKDİK Turkish REACH is harmonized closely with the EU-REACH provisions and articles. KKDIK requires companies to submit pre-register (pre-SIEF) and register substances on their own, in mixtures or in articles placed, manufactured or imported into Turkey with volumes equal or above 1 tone per annum. Substances, preparations ("mixtures") and articles are subject to different provisions under KKDIK Turkish REACH. Meanwhile, non-Turkish companies and Turkish companies have different obligations.
As well as the certain degree of expertise on the applicable chemical safety and transportation regulations, one more key element is required to ensure the regulatory compliance of Safety Data Sheets (SDS) in Turkey. In accordance with the Regulation OG 13.12.2014 – 29204, SDS authors need to be certified after completing a training course and passing the examination held by the Turkish Standards Institution (TSE) or the Turkish Accreditation Agency (TÜRKAK). The certification information then is presented in Section 16 of SDSs. Along with the submission of the SDS to the online system of the Turkish Ministry of Environment and Urbanization (MoEU), these extra steps provide accountability over the hazard communication process. Our team are all chemists with SDS Author (TÜRKAK) and Dangerous Goods Safety Adviser (UK & TR authorities) certifications and have years of experience managing compliancy requirements of various branches of the chemical industry.
KKDIK Turkish REACH Pre-Registration and Registration Obligations
- All substances on their own, in mixtures or in articles which were manufactured and placed, imported into Turkey with volumes equal to or above 1 tone per year, are required to get notified by 31 December, 2020 and registered by 31 December, 2023.
- All manufacturers, importers, formulators, only representatives must notify their substances indentity and role in the supply chain through Chemical Registration System of MoEU. Companies who have already done Classification-Labelling Notification (SEA) will be able to transfer this information to the notification portal of the MoEU.
- The registration process is carried out by submitting a substance registration dossier to the Ministry and Environment and will begin after 31 December,2020 (deadline of pre-SIEF) and will end on the December 31,2023.
- From 1 January 2024, substances must finish KKDIK registration before they will be manufactured in or imported into Turkey.
- When we compare KKDIK with REACH-EU, the data review under KKDIK Turkish REACH is much stricter and more conservative than that under REACH EU. Under KKDIK Turkish REACH, the registration dossiers must be prepared, signed and uploaded to CRS (KKS) system by the certified “Chemical Assessment Specialist”. But, for submission KKDIK Pre-SIEF of the substances, the “Chemical Assessment Specialist” is not an obligation.
- Companies must comply with restriction conditions set out in Annex 17 (Article 66 of KKDIK Turkish REACH regulation).
- Applications for authorisation can be submitted from the Chemical Registration System (KKS) Portal and will be assessed by the MoEU and MoEU will inform on its decision within 10 months.
- The list of substances to be added to Annex 14 will be determined by the Ministry of Environemnt, in accordance with the REACH-EU Regulation, and will be published on MoEU website.
- Under KKDIK Turkish REACH there are not specific deadlines for different tonnage bands more than 1 tone per year and like in REACH-EU, companies located outside Turkey should appoint a legal Only Representative (OR) in Turkey for pre-SIEF and registration purposes.
- The KKDIK registration period is between 1 January 2021 and 31 Decemeber 2023. Manufacturers, importers, formulators or only representatives who have sent pre-SIEF submissions for their substances before 31 Dec. 2020 can use the pre-SIEF number for manufacturing or importing during the period. However, companies that have not completed pre-registration before 31 December 2020 must complete registration otherwise they will not allowed to manufacture or import during the grace period.
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