Officials from South Korea’s Ministry of Environment have met with EU companies to discuss some of the difficulties which have emerged over data sharing with South Korean companies.Meeting in the fringes of a workshop, organised by the Korea Institute for Science and Technology (KIST) in Cologne, ministry officials told the companies it is encouraging Korean firms to share EU data where possible – but the high cost is seen as a barrier.
They asked the European company representatives how much progress they think is being made, what difficulties they face and how things could move forward.
Willi Muenninghoff of ReachCentrum, a major EU consortia management consultancy, told the meeting that Korean companies expected price negotiations to begin immediately whereas, in practice, several steps have to happen first. This situation, he said, has not been easy to explain to Korean consultancies and lead registrants.
Consortia have to change their own agreements which restrict data use to EU REACH purposes, and this can take up to six months. Then a decision has to be reached by consortium members on which data would be shared, followed by an assessment of who the owners are – which could well be third parties. Only then, he explained, could price negotiations begin.
He also told the meeting that, until the first six to eight months of last year, it had been unclear to EU companies what the K-REACH data requirements were. It is now understood that most data in REACH dossiers generated by Qsars, read-across and weight of evidence approaches can also be used in K-REACH registration dossiers. Being able to use robust study summaries, rather than full study reports, has simplified matters greatly.
Another challenge, he said, had been finding out who was in charge of data negotiations in South Korea. In some cases, several parties had asked for the same data, while consultancy firms used by South Korean lead registrants had sometimes changed without the company being made aware.
According to ReachCentrum, when comparing the cost of testing with that of buying data from EU consortia, South Korean companies shouldn’t underestimate the additional work they might face, after an assessment of the dossier by Korea’s National Institute of Environmental Research (Nier), if they don’t use data that is already available and used in the EU for all endpoints.
The consultancy has, however, noticed better communication with South Korean companies since last year, as their understanding of the process improves.
Mr Muenninghoff said ReachCentrum is dealing with 93 of the 510 priority existing chemicals that must be registered by June 2018, and that these are managed by 44 different EU consortia.
Fourteen out of the 93 chemicals still have no lead registrant. As of 24 April, registration proposals have been submitted for 21 of them, with a further 25-30 expected in May or June.
At the meeting, Carol Pettit from the Cobalt REACH Association said that, it had been approached by different consultants with different enquiries, for the same substances.
Echoing ReachCentrum, she said Korean companies thought EU data costs are high compared to local testing costs, but that they needed to realise that because of ongoing testing and changing substance data, it will become more cost effective to buy the data from EU consortia rather than doing their own testing.
There are also potential licensing problems, said Ms Pettit. The consortium’s Licence to Use agreement allows the use of the EU data for K-REACH registrations, but not for sublicensing. This might become a problem should the Korean government want to access the data itself, to review the studies. Meanwhile, the consortium is also preparing a summary note which describes their approach to grouping and read-across for cobalt substances.
In concluding the meeting, the ministry officials noted that data-sharing negotiations are ultimately a matter for the Korean companies involved.
However, as time is running out for the companies, the ministry hopes EU businesses can make increased efforts to accelerate negotiations.