‣ for potential registrants to create similar dossiers in Turkish . Some EU consortia have already calculated the cost of usage rights for the REACH dataset for KKDIK compliance . Many companies are working to determine a methodology for data transfer between EU registrants and potential Turkish registrants , with the legal and practical issues to be managed . The benefits of establishing a Turkish consortium or managing the process through the MBDF as experienced in REACH is being discussed by potential Turkish registrants and global manufacturers through their ORs .
Registration fees
On 4 January , the MoEU , as the Turkish competent authority , officially published its final registration fees . These confirm , without changes , the draft quotation already made last October . The following procedures are subject to payment according to the regulation :
• Registration
• Registration update
• Confidentiality request for information
• Process & product-orientated R & D ( PPORD ) notifications
• Authorisation application
• Review of authorisations
Considering the economic condition the industry is facing in Turkey as a result of the pandemic , the MoEU fees represent a massive reduction compared to ECHA fees , as well as what was initially announced by the MoEU . Special reduced fees are defined for SMEs in the registration fees list . There is a significant cost advantage for companies that perform joint submission in line with the EU ’ s approach for REACH registration fees . The lowest fee is determined as TL50 for joint registration of a substance in 1-10 tonnes / year band for micro-sized enterprises . The highest is TL 15,000 for single submission of a substance of over 1,000 tonnes / year by a large enterprise .
Unlike ECHA , the MoEU is preserving the possibility of updating these fees on a yearly basis in relation with the inflation rate . Independently , LoA fees will be determined after data sharing modalities are set among the data owners and co-registrants in the SIEF environment . Thus , LRs are encouraged to register as early as possible to enable co-registrants to proceed with their registration in time .
Other issues
The obligation for CSRs to be prepared by certified experts , who must go through a tough , 64-hour training course and also take an examination , is one of the eye-catching differences in KKDIK . Although this led to many discussions in the regulatory environment for various reasons , the intention is to increase the quality of the dossiers . Annex XVIII of KKDIK sets out the rules of certification and details on becoming a certified body as well as qualifications of the candidates eligible to become a Chemical Safety Expert ( KDU ). Registration dossier submission is made by the legal entity that manufactures or imports the substance to be registered , or by the OR that acts on behalf of the manufacturer . A KDU fluent in Turkish is clearly needed in the preparation of the dossier . Companies have different distribution channels for the supply
Dr Yaprak Yüzak Küçükvar
of products for each region . There are different factors influencing the registration coverage in a supply chain . Whether substances are to be registered via an OR or via the Turkish subsidiary of the global players must be decided with care . Indirect exports , toll manufacturing channels , different manufacturing sites of a global company , warehouses in the distribution channels and many other factors may carry an importance during decision-making for compliance . The inventory of substances may take a long while to finalise , as many communications are needed within the company .
Final thoughts
KKDIK ( pre- ) registrations and SEA notifications for hazardous substances or polymers are both managed under KKS . The MoEU amended the SEA regulation to bring it in line with the EU ’ s CLP regulation and the latest ATP by the end of 2020 . The pre-registration and classification and labelling notification are linked to each other . If notification is required , the initial step is to pre-register the substance under KKS . It is also planned that candidate list of substances for very high concern will be published for consultation in 2021 . Therefore , companies who have obligations for KKDIK and SEA must be dedicated to follow MoEU announcements closely . The registration journey has already started on the 1 January and three years is a short period compared to the ten-year registration period we had for EU REACH . Prepare now . •
DIRECTOR , GLOBAL REGULATORY AFFAIRS & PRODUCT STEWARDSHIP
64 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981