European Chemicals Agency is screening substances and evaluating REACH dossiers with the aim to increase the quality of the current dossiers and working on further regulatory actions for the future.
Meanwhile, Turkey is preparing for substance registrations. Turkey is very much dependent on the imports into the country since several formulators and main substance manufacturers as well as article producers are importing chemicals to manufacture new substances and produce formulations, articles. These companies undertake two different roles and accompanying responsibilities according to the Turkish chemical regulations in place. Strong communication channels must be established in the supply chain to maintain full compliance with chemicals regulations today. It is no surprise that the information requests in the supply chain regarding compliance with Turkish REACH-like Regulation, KKDIK triggered by Turkish importers’ requests have increased gradually and progressively. The KKDIK awareness campaigns running in the country with the help of the stakeholders is also motivating the companies for taking actions for compliance.
According to the KKDIK Regulation, any manufacturer or importer of a substance on its own or in a mixture in quantities of one tonne or more per year shall submit a registration dossier to the Ministry of Environment and Urbanisation (MoEU) through Chemicals Registration System called KKS which is accessible from the website of the MoEU. Companies must first pre-register all substances they are placing or planning to place on the Turkish market today and start reviewing long term business plans of the company for the future. By the end of 2023 which is the deadline for registration, all substances in the Turkish market will be KKDIK registered. Safety Data Sheets (SDS) prepared in Turkish language and signed by a certified SDS expert must also be KKDIK Compliant by the end of this date.
Eventually, after pre-registration process, companies end up in a forum called, ön-MBDF which is simply the pre-Substance Information Exchange Forum (pre-SIEF) formed with the inclusion of the pre-registrants for the same substance with typical tasks such as assessment of substance sameness, initiating the data sharing communications and reaching agreement on Classification and Labelling of the substance. Till now there is not much difference compared to the EU REACH SIEF structure. A couple of differences that stand out are; “no tonnage band is required during pre-registration process” and “no SIEF Facilitator functionality (SFF) is yet defined in KKS for pre-registrants”. SFF could make life a little easier for the pre-SIEF members especially for the Turkish manufacturers most of which do not have any REACH experience from the past. Companies often find pre-SIEF activities quite difficult and will wait for a member to initiate the communications.
Discussions in the SIEF may lead to tricky situations in Turkey in terms of confidential business information and infringement of Competition Laws considering all global competitors will eventually exist in the same SIEF. Fingers crossed! For some substances the work in the Turkish SIEF, MBDF led by the industry may run smoothly, whereas for other substances there may be failures observed.
Companies with global presence who already represented their substances in SIEFs and Consortia in the EU know about risks and SIEF management. These companies willing to actively get involved in the SIEF activities through their Only Representatives or local subsidiary offices may act fast in some SIEFs, encouraging other members for the registration preparations. Other SIEFs might still be waiting for a formal start from a member. Waiting for an action is a thread as there is only limited time, only 3 years duration for completion and submissions of substance registrations. Needless to say that the approach of data owners; either the consortia or companies, who may accept or decline to sell the right to refer to the data, already available and acceptable for the use of registrants in Turkey, to parties registering substances is critically important. It may change the whole process for the preparations of the registration dossiers.
RGS celebrates 11 years of Chemicals Regulatory Compliance servicing with several hundreds of clients all over the world. Do not hesitate to contact RGS, if you need compliance with Turkish Chemicals Laws or more details on our services and the status of your substances.
Dr.Yaprak Yüzak Küçükvar
REACH Global Services Group
Turkey Branch Manager