WHILE TALKING WHETHER THE DEADLINE WILL BE EXTENDED…
As the KKDIK registration deadline of 31/12/2023 is getting closer and closer, Turkish Competent Authority (Ministry of Environment, Climate, and Urbanization (MoECC)) continues to meet the experts within the sector on presentations and events regarding the progresses on the Turkish Chemicals Regulations. Although no official statement has been issued, MoEUCC has voiced their intentions through these meetings and webinars where they clearly declared that registration deadline will not be delayed. Quite the contrary, the Ministry has strongly pushing for the lead registrations to be completed by the end of 2022.
Therefore, Lead Registrants are currently rushing to submit their dossiers on time. When a Lead Registrant submits its registration dossier, all other MBDF (SIEF) members are notified automatically. Companies approved by the Lead Registrant can consequently send their own joint submission dossiers.
MoEUCC, is also communicating the latest developments in the registration processes to the chemical industry, and recently announced some updates on the Chemical Registration System (KKS), especially with regard to subjects of concern of the industry.
One of them is regarding registration fee payment procedure. Until June the registration fees payment were carried out by a physical cash deposit to one pre-defined bank of Turkey. However, as of June, an online payment procedure has been established.
Another subject of interest for all potential registrants was related to the language criteria. The MoEUCC recently announced that the Full Study Reports and other reports can be uploaded to the system in English, provided that all fields in the system for “Robust Study Summaries” and “Study Summaries”, are duly entered into the Chemical Registration System, and are filled in Turkish.
NEW GUIDANCES REGARDING CSR PREPARATION ON KKS
Seven new guidance have been released on Ministry website to assist companies in fulfilling their obligations regarding the creation of a Chemical Safety Report and information requirements.
Additionally, the Ministry has published a “Guidance on the Preparation of PPORD Dossiers”.
These manuals comprise publications that describe the information requirements for substance properties, exposure, usage, and risk management measures, as well as chemical safety assessment, as defined by the KKDIK Regulation. In addition to a number of fundamental KKDIK procedures, the appropriate publications are defining specific scientific and/or technological approaches that should be implemented by the industry or approved institutions within the scope of KKDIK.
TURKISH C&L INVENTORY IS NOW AVAILABLE ON KIMVES SECTION IMPLEMENTED TO THE CHEMICALS HELP DESK
According to the By-Law on Classification, Labelling and Packaging of Substances and Mixtures (SEA Regulation), hazardous substances (alone or used in a mixture) which are exported to the Turkish market must be notified. The Chemicals Help Desk, where it is possible to access many guidelines and information regarding the regulations, is kept up to date by the Ministry. Classification and labelling notifications of hazardous substances submitted to the Ministry’s online KKS system by the manufacturer/importer of the substances are now available online under KIMVES section of the Chemicals Help Desk website. It has been stated that the notifications being published on this area are based on company declarations. The Ministry does not accept any legal responsibility regarding the use of the information contained therein.
CHEMICAL SAFETY ASSESSMENT THROUGH CSARS
According to the KKDIK Regulation, a Chemical Safety Assessment (CSA) shall be performed by companies placing substances on the Turkish Market in quantities greater than 10 tons per year and a Chemical Safety Report should be completed and included in the Registration Dossier. There is a Chemical Safety Assessment and Reporting System (CSARS, with Turkish acronym – KGDRS) integrated into Chemical Registration System – KKS (Turkish acronym) which enables preparing the CSR (KGR with Turkish acronym). In order for the CSR sections 8-10 (Exposure Assessment and Risk Characterization) to be fully formed through the CSARS system; substance determinants, molecular weight, physical state, vapor pressure, Partition Coefficient-Log Kow, water solubility, biodegradability, PNEC and DNEL information must be entered to the registration dossier. Also, the ‘’3.5. Usage and Exposure Information’’ parts of the registration dossier is essential to be completed for the creation of CSR parts 9-10 in full. In case of this information is missing in the registration dossiers, parts 9-10 of the CSR cannot be automatically generated by the system.
RGS Group based in Brussels, Belgium with subsidiary in Istanbul, Turkey is representing global companies located in over 55 countries as a local Only representative through its Turkish presence. As a leading company, RGS also transfers 14 years of regulatory experience predominantly in EU REACH experience to its operations in Turkey. Do not hesitate to contact RGS, if you need compliance with Turkish Chemicals Regulations or more details on our services.
REACH Global Services Group
Pınar Ozgun Yavas
Deputy Director
www.reach-gs.eu
