Practices Regarding KKDIK Regulation

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The article dated 05.05.2023, numbered E-21408564-135.99-5831675 and subjected “Practices Regarding KKDIK (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation” sent to TOBB by the General Directorate of Environmental Management of the Ministry of Environment, Urbanisation and Climate Change is forwarded below and it is presented to the information of our members within the framework of the mentioned regulation.

As a result of the evaluation of the problems and solution proposals conveyed to the Ministry by the sector regarding the implementation of the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDİK Regulation) and in order to increase harmonisation with the REACH Regulation No. 1907/2006 in the European Union in practice, the implementation of the following issues regarding the registration processes of chemicals by our Ministry;

  • As it is known, single representatives can add the importer information of the foreign company they represent in Türkiye within the “1.7 Suppliers” section of their registration files, or alternatively they can create their registration files excluding any importer information.

 

  • The registration file for the exclusive representative must include all uses by importers (now sub-users) covered by the registration. The exclusive agent must keep track of an updated record of customers (importers) of the ‘non-Turkish manufacturer’ within the same supply chain, including the quantity covered for each customer. Additionally, they should provide details regarding the most recent update of the safety data sheet in every inspection carried out by the Ministry.

 

 

  • Importers should request confirmation from the ‘non-Turkish manufacturer’ regarding the appointment of a exclusive representative. Moreover, it is highly recommended that they obtain written confirmation from the exclusive agent that the imported tonnage and its utilisation are indeed covered by the registration submitted by said agent. This gives the importer a specific point of contact to report their use if they are recognised as a downstream user, and also confirms that their imports are registered by the exclusive representative.

 

  • The importer should, where relevant, obtain sufficient information from the ‘non-Turkish manufacturer’ and/or exclusive representative to fulfil the obligation to compile the safety data sheet. If the Ministry requests it, the Turkish importer must be able to document which of its imports fall under the registration made by the exclusive representative.

 

 

  • The registration file of the exclusive agent must contain all uses of importers (now sub-users) covered by the registration. The exclusive representative should keep an updated list of customers (importers) of the ‘non-Turkish manufacturer’ within the same supply chain, along with the tonnage covered for each of these customers. Additionally, they should provide information on the supply of the latest updated safety data sheet and submit this information during any inspection by the Ministry.

 

  • As per the industry’s request for translations of Chemical Safety Reports, which are mandatory for chemical registration over 10 tonnes per year, the Chemical Safety Report can also be submitted in English.

 

  • However, registrants who prefer to submit the Chemical Safety Report in English are required to a Turkish translated version to the registration file to include uses in Türkiye, exposure scenarios and risk management measures. On the other hand, all fields in the system regarding the “Comprehensive Study Summaries” and “Study Summaries” to be submitted in the registration file must be filled in Turkish.

 

  • In order for data sharing to function effectively under the KKDİK Regulation, good management practices should be encouraged and the effective functioning of agreements on the sharing of such data should be ensured. For this reason, the Implementing Regulation No. 2016/9 on data sharing in the European Union, which is in parallel with the provisions on chemical registrations in the KKDİK Regulation, has been translated and a “Data Sharing Rules Document” has been prepared in order for registrants to benefit from it in practice, and the existing “Data Sharing Guide” has been updated and will be published on the website of the Chemicals Help Desk.

 

  • The Ministry of Environment, Urbanisation and Climate Change has prepared the said “Data Sharing Rules Document” in the data sharing to be carried out by the companies within the scope of KKDİK, and it is envisaged that the records will be completed as soon as possible by complying with the rules in the updated “Data Sharing Guide” and that the hazardousness of the registered Chemicals will be made available to the public and all parties via KİMVES as soon as possible in order to develop urgent measures to be taken in case of possible natural disasters and other dangerous situations. Detailed information and announcements regarding the above-mentioned issues can be accessed from the website of the Chemicals Help Desk (https://kimyasallar.csb.gov.tr/).