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A panel discussion on substance information exchange forum (SIEF) management under REACH-like regulations including K-REACH and Taiwan REACH was delivered during the Chemical Regulatory Annual Conference 2019 held by REACH24H in Xi’an on September 2nd, 2019. Professionals, including Ms. Catherine Cornu from the European Chemicals Agency (ECHA), Mr. HwoKyung Lee from the Korea Testing & Research Institute (KTR) and Ms. Cheish Yahui Ni from the Environmental Resource International Co., Ltd.(ERI) introduced ongoing efforts made by regulatory authorities and shared their insights.
The discussion kicked off with a question on what registrants should do if the EU REACH data owners are reluctant to share data for use in K-REACH or Taiwan REACH. According to Ms. Cornu, data sharing under EU REACH is mandatory. If the registrants refuse to share data or the price is set unfairly, a dispute can be sent to ECHA for arbitration, however this stipulation only applies to EU-REACH and there are no mandatory provisions relating to cross regional data sharing. Data submitted more than 12 years ago can be used free of charge for later EU REACH registration but is not free for any other applications. ECHA has aided at the beginning of K-REACH implementation to pass messages to data owners through its REACH-IT system, encouraging them to share data to minimize animal testing.
Although as Ms. Cornu indicated, ECHA made great efforts to facilitate K-REACH, communicating with EU consortiums to purchase data has not been easy. Mr. Lee introduced South Korea’s finished registration of 510 priority existing chemicals registration (166 PECs opted out), which represented industry’s first exposure to K-REACH’s joint registration mechanism during which many issues were encountered. One major criticism leveled at regulators by industry is that supports from authorities to obtain EU REACH data have been inadequate. Problems are further compounded by the fact that the current data submission software used in both Taiwan and Korea are not compatible with EU’S IUCLID software. Ms. Cornu emphasized that not only ECHA, but also Taiwan EPA and Korea MoE, the authorities actually don’t own the data. What they can help is still limited.
For Taiwan REACH, joint submission is not a mandatory obligation as in EU REACH and K-REACH. Ms. Cornu and Mr. Lee agreed that it is the most significant difference among the three regulations. EU REACH requires mandatory joint registration of chemical substances without exemption. K-REACH offers opt-out exemptions from joint registration under certain conditions. Taiwan’s regulation gives the industry freedom to choose the way to register their substances.
Industry representatives expressed their concern whether there is enough time and a feasible method to contact other potential registrants to do a joint registration under Taiwan REACH and K-REACCH. Ms. Ni introduced Taiwan’s “SIEF like” platform (CL news). However its function is limited to finding co-registrants (name and contact info disclosed). Some potential registrants raised concerns that SMEs make up a big part of Taiwan’s chemical industry and are thus likely to seek joint registration to mitigate against compliance costs. However, larger enterprises may favor individual submission and few co-registrants as competitors. According to Ms. Ni, Taiwan EPA is reluctant to intervene too much, and intends to allow market forces and the mutual benefits of joint registration to motivate industry to use the facility and reduce repetition of testing. The management of consortiums will be administrated by industry. Obviously, it would be a big challenge for potential registrants when there is inadequate infrastructure in place to support LR election, consortium communication etc.
Mr. Lee then introduced the Chemical Substance Information Communicative Organization (CICO, a.k.a Korea SIEF) for K-REACH. The CICO is not ready yet and is expected to open 2 weeks later. It would be more like a REACH SIEF. However, it’s very interesting that all active members should have a meeting to vote for a lead registrant (LR) face to face. Considering the fact that all existing chemicals at or above one tonne per year should be jointly registered, the registrants, especially big companies handling a large volume of chemicals will inevitably be very busy going forward.
