What is Turk Reach?
In June 2017, the Government of Turkey published in the Official Gazette the Registration, Evaluation, Authorization, and Restriction of Chemicals regulation, also called KKDIK (Turk REACH), which is the Turkish abbreviation of REACH. The Ministry of Environment and Urbanization (MoEU) is the responsible body for the enforcement and implementation of KKDIK (Turk REACH).
Turk REACH requires companies importing into or manufacturing in Turkey to register all chemical substances whether pure or in mixture with an annual production or importation volume of more than one ton. The KKDIK (Turk REACH) regulation includes foreign chemical exporters to Turkey as well as Turkish exporters who use chemicals in their formulations and/or products, with some exceptions. KKDIK (Turk REACH) is very similar to the EU REACH regulation, with some differences. For example, KKDIK (Turk REACH) does not separate pre-registration and registration deadlines depending on the classification of the substance or the annual tonnage band, and the Chemical Safety Report that is to be submitted during the registration period should be prepared and signed by a local Certified Chemical Safety Expert.
Exporters of chemical products to Turkey can register their products in Turkish through their subsidiary, distributor, or appointed representative (“only representative”) to fulfill KKDIK (Turk REACH) obligations. This regulation came into force in January 2021. It is possible to pre-register chemical substances until February 31, 2020. All chemical substances should be registered by December 2023. After December 31, 2023, chemical substances, both pure and in mixtures or in articles that are equal to, or above, one metric ton per year, cannot be manufactured or placed on the market if they are not registered in accordance with the relevant KKDIK (Turk REACH) provisions.
The Turkish Chemical Manufacturers Association recommends that companies register in the Turk REACH pre-registration phase. Pre-registration will enable the regulators as well as other manufacturers and importers to see the list of companies that will register the same product in the system. Companies that pre-register the same product can contact each other and share the registration fee.
The new Turkish regulation (KKDIK) requires companies to pre-register and register substances that are manufactured or placed on the Turkish market either on their own, or in mixtures, or in articles with an intended release that is equal to, or above, 1 metric ton per annum.
Companies exporting chemicals to Turkey can appoint an Only Representative (OR) to submit the KKDIK registration and the CLP notification on their behalf.
KKDIK does not set separate pre-registration and registration deadlines depending on the classification of the substance or the annual tonnage band.
After 31 Dec 2023, substances either on their own, in mixtures, or in articles that are equal to, or above, 1 metric ton per annum, cannot be manufactured or placed on the market if they are not registered in accordance with the relevant provisions of KKDIK.
KKDIK (Turkish REACH) Key Points
Unless otherwise specified in KKDIK (Turkish REACH), the manufacturer or importer who manufactures or imports the substance in its own form or in the mixture one or more tonnes per year applies for registration to the Ministry of Environment through the Chemical Registration System on the website of the Ministry.
KKDIK (Turkish REACH) is based upon the principle that manufacturers, importers, and downstream users should ensure that they do not adversely affect human health or the environment in processes such as manufacturing, placing on the market, and utilizing chemicals.
According to KKDIK (Turkish REACH), the responsibility of managing the risks of the substances belongs to the real or legal persons who manufacture, import, market, or use these substances within the framework of their professional activities.
Produced in Turkey or imported into the country, registrations of chemical substances within the scope of the KKDIK regulation (Turkish REACH) will be submitted through the Ministry of Environment and Urbanization's online Chemical Registration System (CRS).
All registrants shall send a pre-SIEF including the below-mentioned information to the Ministry through the Chemicals Registration System on the website of the Ministry until 31/12/2020 : (pre-registration deadline)
a) substance identity according to Annex-6; b) Role in the supply chain
All registrations will be completed between 01 January 2021-31 December 2023.
KKDIK applies to all chemical substances on their own or in preparations as well as in articles. However, the regulation does not cover the following substances and mixtures.
Radioactive substances and mixtures;
Goods, mixtures or articles in transit and goods in free-zone for re-export;
Transport of dangerous substances and mixtures by various modes;
Substances manufactured or imported for defense purposes;
Food and feeds;
Turkish Chemical Regulation Services
Intertek global experts can assist you step-by-step with complying with the Turkish REACH (KKDIK) Regulation. Our regulatory services include:
Although KKDIK is almost a copy-paste of the EU REACH Regulation, there are unavoidably slight differences as a result of the timing of Turkey introducing KKDIK. For instance, the Turkish CLP Regulation known as SEA was put into force before KKDIK Regulation, which is differing from the situation in the EU. KKDIK is also foreseeing a pre-registration process and a Substance Information Exchange Forum called MBDF, very similar to SIEF formation. However, the striking difference between EU REACH and KKDIK is that the pre-registration tonnage band will not trigger the deadline for registration. The registration period or the deadline for registration will be the same for all substances pre-registered and a 3 years' time frame is envisaged for the registration period. One of the important additional requirements of KKDIK, when compared with EU REACH, is that Chemical Safety Report should be prepared and signed by a local Certified Risk Assessor. Similar requirements are in place under the SDS Regulation of Turkey. SDSs have to be prepared in Turkish and signed by a certified Turkish expert. More details about the requirements for the qualified persons to issue the Chemical Safety Report, certification criteria, and Certifying Bodies will be available in Annex XIIX of KKDIK.
There is plenty of regulatory compliance burden involved for local and international companies that are putting chemicals on the Turkish market either as an importer, distributor, or manufacturer. The scope of Article 8 of the EU REACH remains identical in Article 9 of the Turkish KKDIK regulation, and the responsibilities of an Only Representative (OR) are similar in KKDIK. Manufacturers located outside of Turkey, putting products on the national market must appoint an OR to comply with the regulatory obligations. It is inevitable for companies established outside of Turkey to appoint an Only Representative, or even those manufacturing locally in Turkey to appoint a Trustee, that is specialized and technically skilled at consulting and supplying trustee services to comply with the regulation. In this context, when technical, legal, and legislative obligations are taken into consideration, the decision on this long-term cooperation based on mutual trust is very critical.
KKDIK: PRE-REGISTRATION AND REGISTRATION OBLIGATIONS
All substances (on their own, in mixtures, or in articles) manufactured in Turkey or imported into Turkey with volumes equal to or above 1 tone per year, are required to get pre-registered by 31 December 2020 and registered by 31 December 2023.
All registrants (Manufacturers, Importers, Formulators, Only Representatives) will need to notify their substances identity and role in the supply chain through the Ministry’s Chemical Registration System Portal. Companies that have already done Classification-Inventory 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 MoEU and will begin right after the notification deadline (31 December 2020) and will end on the 31st of December 2023.
Under KKDIK there are no specific deadlines for tonnage bands above 1 tone per year and like in EU REACH, companies located outside of Turkey can appoint an Only Representative (OR) in Turkey for notification and registration purposes.
KKDIK: OBLIGATIONS RELATED TO ARTICLES
a) Producers and importers are required to notify the MoEU of the substances listed on the Candidate list (same as in EU REACH) which are present in their articles if both following conditions are met:
b) Producers and importers are required to notify and register the substances intended to be released from their articles in quantities equal to or above 1 tone per year.
KKDIK: APPLICATION FOR AUTHORISATION
The list of substances to be added to Annex XIV will be determined by the MoEU, in accordance with the REACH Regulation, and will be published on Ministry’s website.
Applications for authorization can be submitted via the Ministry’s Chemical Registration System Portal and will be assessed by the MoEU. The Ministry will inform on its decision within 10 months.
Companies must comply with Restriction conditions set out in Annex XVII (Article 66 of KKDIK regulation).
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