Korea REACH (K-REACH) is Korea’s REACH-like chemical regulation system. Like other REACH-like systems, K-REACH works to align its goals and systems with EU REACH. Recently, Korea and the EU are beginning to work toward data sharing.
Some data sharing agreements in the EU now allow Korean registrants to use EU REACH data to register substances. Discussions between the European Commission and the South Korean authorities are working toward extending this cooperation further.
Allowing data sharing between REACH and K-REACH is expected to reduce the amount of animal testing needed and to reduce costs overall.
There are still some complications. REACH and K-REACH data requirements are not identical. There are some differences in the two systems’ definitions of good laboratory practices, for example.
Languages can also be an issue. Testing documents can be submitted in English for K-REACH, though the dossiers must be written in Korean. No European languages are currently allowed. This may be a factor in what Chemical Watch reports as inconsistent requests for reports. Sometimes “robust study summaries” are accepted, but sometimes full reports are required in order to use REACH data.
Some companies currently under EU REACH have expressed concern that their data will not be fully secure in K-REACH. There have been no incidents so far to cause these worries, but security is top of mind for many manufacturers now.
It is perhaps not surprising that companies with a presence in both the EU market and the South Korean market are most solidly behind Korea/EU data sharing. Some companies which do not have a presence in both markets hesitate to complicate their compliance situation further.
With data sharing, updates in information from K-REACH could spark updates in the EU, and vice versa. This should, however, be a positive effect.
Increasing the accessibility of data for all registrants has obvious benefits which may outweigh the concerns. Companies will be able to reuse data from REACH registrations in their K-REACH registrations, and vice versa.
The benefit of this ability to re-use data will be greater for companies that have good control of their data from the beginning. Re-using data that is well organized and documented is a different experience from re-using data that exists largely in email threads and physical files.
REACH compliance is a long, complex, expensive process. Using a software solution that keeps all data and communications together and fully accessible makes that data available for future use — so it doesn’t have to be done again. REACH requires companies to keep their dossiers updated, so a good software solution is necessary even if it is used only for REACH2018.
However, if data sharing between REACH and Korea REACH goes through, the ability to re-use data will make your investment in the right software go even further.
We know that EUPHOR will have significant value for you as you work toward REACH 2018 compliance, as well as for other chemical regulation regimes, whether internal, state, national, or global. Contact us to discuss your needs and learn how EUPHOR can make a difference for you.