EU manufacturers registered their substances via their in-house expert departments, or outsourced these services from an EU-based consultant company during implementing EU-#REACH process. In parallel, non-EU manufacturers exporting to Europe had to appoint an #OnlyRepresentative, a legal entity based in the EU.
Now it is time for all chemical manufactures of the world exporting to Turkey to implement the same practice by appointing a trustworthy local Only Representative, unless they own a Turkish legal entity able to coop locally with REACH-like administrative and technical regulation. Indeed, Turkish Law REACH “#KKDIK” is adopted in 23rd June 2017 and the deadline for pre-registrations are 31st December 2020. In comparison with other similar legislations around the world (i.e. Korea), #TurkishREACH bears a characteristic of a regulatory approximation within the on-going accession negotiations process with the EU. This is the reason why KKDIK is nearly a copy-paste in Turkish language of the Regulation (EC) No 1907/2006, only with some minor changes that are necessary for Turkish manufacturers to fully comply with this costly, time consuming and sophisticated piece of legislation.
Therefore, non-Turkish manufacturers exporting to Turkey find themselves within a familiar regulatory environment, but would also need to adapt to some national specifications to be closely followed through the #MoEU declarations and publications… in Turkish language!
Nevertheless, Article 8 of the EU REACH is identical in the Turkish KKDIK version as Article 9 and the “Guidance on Registration” of the MoEU shows similar obligations with regard to the Only Representative (OR) definition.
KKDIK Article 9 provides the framework of the important role of Only Representatives in the regulation. Since this is the only Article in the KKDIK Regulation, it leaves plenty of room for many misunderstandings and misinterpretation on obligations of Only Representatives. This means also that similar lack of information and insufficient definition of the roles and duties of an OR in the EU regulation is reflected in the KKDIK as well.
The role of an Only Representative is extremely important, because his actions for each substance of his client reflect on all stakeholders in the supply chain, #SIEF, TR authorities.
Taking into account the complexety of the KKDIK regulation, with no central access point that can give high quality information on Only Representatives issues, is raising strong concern among many non-TR Companies and their TR customers.
The shortcoming of the OR role and definition within REACH had motivated the ORs in the EU to gather and to establish the Only Representative Organisation (ORO) in 2008. Since then #ORO worked very hard to solve and implement the “OR Best Practices Guide” for the implementation issues faced by over 30 ORs. Within this experience background ORO members represent today more than 2,325 Non-EU manufacturers over the world, handling over 14,000 substances and covering directly or indirectly about 50,000 importers/Downstream Users in the EU/EEA.
Doruksistem is an Associated Member of ORO works under the principles of OR Best Practices Guide. #DORUKSISTEM had already pre-registered substances of lots of manufacturers from all over the world since KKDIK launched in 2017. As of today, DORUKSISTEM had prepared nearly 45000 SDSs, notified more than 2500 substances during CICR notifications (Chemicals Inventory and Control Regulation -CICR) and nearly 1200 C&L Registrations are completed for more than 250 manufacturers locally and globally.
Therefore, DORUKSISTEM is currently one of the most well organized experienced and scientific based knowledge REACH-related consultancy company being able to handle with the Turkish REACH Law KKDIK Regulation. DORUKSISTEM is also working as an approved R&D company under the umbrella of TUBITAK (The Scientific and Technological Research Council of Turkey) in #TUBITAK MAM Technology Free Zone in Kocaeli.
Through its experienced multilingual expert team of scientists, chemical engineers and environmentalists, DORUKSISTEM is able to offer a well-established professional IT-system, monitoring substance volumes and establishing the link between volumes and downstream user (DU) information, achieving the information under strictly confidential systems, defining the responsibilities regarding SDSs, and representing the manufacturers not only at SIEF’s and consortia’s, but also vis-à-vis the public authorities during likely inspections. Besides these technical infrastructure and human resources proficiencies, an OR also needs good communication skills and a thorough professional integrity to accomplish such mission on behalf of its customers. Likewise the EU REACH process, it will also be a long term business relationship within KKDIK and therefore it is an important decision for a manufacturer located outside of Turkey to assign the right OR. Not every OR is able to contribute actively in the scientific communication or in dossier preparation. Doruksistem is the oldest consultancy company in the Chemicals regulatory compliance area. With it’s extreme experience since 2005 Doruksistem became the most trusted OR in Turkey.
It is evident that working with qualified Turkish speaking technical experts who are fluent in English ( Even in French, German,Italian and Bulgarian) with very good communication and experienced consultancy skills is the key for KKDIK compliance when exporting chemicals to Turkey. Likewise in KEK (CICR) and SEA (Turkish CLP) regulations in Turkey, the online system does not resemble to ECHA REACH-IT by which an OR can open new accounts for each client of their own. The MoEU system does not support opening several accounts and the procedures for changing an Only Representative is not clear for the time being and MoEU has not announced any changes or construction to the online system either. This makes the decision even more critical for companies as OR change procedures remains as a grey area.
DORUKSISTEM recommends manufacturers to take an intelligent judicious decision when appointing their Turkish OR.
Please contact DORUKSISTEM if you are not compliant with Turkish Chemicals Control Laws or need more details on DORUKSISTEM’s services and the status of your substances.
www.doruksistem.com.tr
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