K-REACH, South Korea’s REACH-like chemical regulation system, has backed off in order to make registration of chemicals easier for the South Korean market.The K-REACH updates are focused on reducing data requirements and making it easier for co-registrants to work together.
Secondary data is acceptable.
Registrants can use publicly available data from a “credible” organization instead of doing their own testing. This means that information from the ECHA website, journal articles, and public reports of testing can be provided instead of a complete dossier including test data.
One of the goals of REACH is to promote data-sharing that will allow safety of substances to be established with less animal testing. Instead of requiring each company to perform safety tests, REACH 2018 encourages multiple companies to co-register when they’re working with the same substances. A company which has already performed tests can share the information — and the cost of the information — with other companies. This reduces redundant testing, reduces the total amount of animal testing required, and helps with the cost of necessary tests.
K-REACH is taking this a step further by allowing dossiers to include the results of testing by other companies or organizations, under three conditions.
- First, the information must be publicly available. The contact information for researchers or test result owners must be available, so that the data can be reviewed and questioned if necessary.
- Second, the data must come from a credible organization.
- Third, the company using the secondary data must have the right to use the information. If testing data is available online, for example, the company using that data must have permission to use the data. Consent for use of data from journal articles must be obtained from the author or publisher who owns the rights to the data.
As long as these conditions are met, the registrants do not have to provide full test results.
A larger role for The National Institute of Environment
The National Institute of Environment’s Minister of the Environment will have a larger role in the K-REACH approval process. For example, the Minister will prioritize substances being registered, so that substances of higher concern can be handled sooner than substances that are not a source of concern.
The Minister of the Environment will also arbitrate disagreements among co-registrants.
This greater government involvement may be more practical for South Korea than for the European Union, where multiple member states could complicate increased government involvement. However, Korea has also found it more difficult to sort out co-registration issues, according to Chemical Watch, because collaboration among the companies involved is a newer concept in Korea than in the EU.
According to ChemLinkedPro, only 315 of a necessary 510 priority existing chemicals (PECs) have been registered so far under K-REACH. There has also been some opposition from business leaders in South Korea.
Whatever the motivation, the changes in K-REACH should make it easier for companies intending to trade in South Korea to complete their registrations by the deadline.