The European Chemical Industry Council (CEFIC) has raised concerns over the incompatibility of the IT systems of REACH and Turkey’s new REACH-like Regulation KKDIK.
Without a compatible IT tool, European companies could face the laborious task of having to recreate dossiers already submitted under REACH for Turkish registrations.
The Turkish chemical registration system (KKS) has the same structure as REACH-IT, but it does not have the same export and import facilities as IUCLID. “At the moment it does not allow uploading substance files and creates extra work,” CEFIC says.
No official discussions have taken place between European industry and Turkish officials since the publication of KKDIK last June, and no meetings are scheduled in the near future, it says.
At the end of April, the Ministry of Environment and Urbanisation (MoEU) held a meeting, during which representatives from European industry gave verbal opinions to the ministry, CEFIC says. It was attended by about 100 people.
The KKDIK Regulation, which comes into effect on 23 December this year, closely mirrors REACH. However, it requires registrations to be made in Turkish – another major concern for industry with Cefic saying “it would be good to allow summaries in English”.
As Turkey specialises in formulations, its imports of chemicals far exceeds its exports. This means many European companies with exports to Turkey will have to re-register the same substances in Turkish.
CEFIC says European industry is also concerned about access to data and data ownership. “It seems that Turkish regulators believe that they can benefit from the EU REACH data, but the studies are often owned by EU REACH consortia and changes to existing contracts need to be done before the data can be used,” it says.
The MoEU has said it hopes that at least some of the European data will be available for free, by the time KKDIK registrations are due. However, ECHA has poured cold water on this idea.
In May the agency commented that the provision to make data summaries available for free after 12 years only applies to REACH registrations. “If the study summaries are used for other regulatory schemes, the data owner can still be entitled to compensation,” ECHA said.
Single registration window
Another difference between REACH and KKDIK is that the latter sets a single registration deadline for substances in all tonnage bands between 2020 and 2023.
CEFIC says that lumping together high-volume substances, which are usually from data-rich manufacturers, with low-tonnage registrations – which are likely to include many SMEs – “will potentially cause some confusion in the SIEFs[substance information exchange fora] and it will not facilitate communication”.
A further hurdle is KKDIK’s Annex 18, which specifies the qualifications of those who can sign off chemical safety reports (CSRs). CSR authors must receive training and become certified, which makes the process “complicated”, it says.
Companies are also concerned about the availability of third-party vendors that will enable them to meet both the language and the CSR certification requirements. “This is another reason why registration should be prioritised for the highest volumes,” CEFIC adds.