Chemical Watch reports that some data-sharing agreements in the EU are being amended to allow companies in South Korea to use EU data to register chemicals, under the country's chemicals registration Act, Deirdre Lawler of Dr Knoell Consult said at Chemical Watch's Enforcement Summit in Brussels, last week.
Like under REACH, South Korea's Act on the Registration and Evaluation of Chemicals (K-REACH) requires registrants to jointly submit registrations, unless they qualify for an opt out. Although test data can be submitted in English, the dossiers must be written in Korean.
Using REACH data to register substances in South Korea is fast becoming a hot topic as, in theory, it should save time and money and reduce the need for animal testing.
It is on the agenda in the bi-annual discussions between the European Commission and the South Korean authorities, Miguel Aguado-Monsonet of the Commission’s industry directorate (DG GROW) told delegates. But there has “not been much advance on this”, he added, although the Commission “is trying to make global thinking apply”.
One challenge, said Ms Lawler, is that some EU data may not be accepted by Korean authorities because of differences between REACH and K-REACH data requirements, such as good laboratory practice (GLP) certification and local testing methods.
Consultancy KTR, meanwhile, has told Chemical Watch the data the National Institute of Environmental Research (Nier) requests is often inconsistent. For some substances, it will accept robust study summaries from the EU but, at other times, it said, it demands the full report.
Jean-Philippe Montfort of law firm Mayer Brown pointed out at Chemical Watch's Asia Summit in Singapore in September that, while some companies that have joined REACH Siefs also produce or import the substance in South Korea, others in the group do not. The latter, he said, are more reluctant to consider global access, as it would require a review of most EU consortium/Sief agreements and letters of access (LoAs).
Implementing global data sharing would create positive “spillover effects”, as data developed under one regime may create a need for an update in another, he added. This would affect all companies, regardless of whether they have a presence elsewhere.
Some REACH registrants have voiced concern that, if they share data with the South Korean authorities, it may leak into the public domain and, thus, lose its financial value.