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Consortium forming and other associated activities have been scaled up considerably to support PEC joint registration under K-REACH. South Korea’s authority has already prioritized the first batch of 510 substances needing registration (CL news) and issued an announcement to schedule the lead registrant (LR) election deadline (CL news) for these substances. There has also been considerable industry activity concerning identification of LRs and follow-up communications with co-registrants as well as discussion and debate about certain controversies arising from the enforcement of K-REACH.
According to Mr. Peaksoo Park from KNCPC, at REACH24H’s Chemical Regulatory Annual Conference (CRAC 2015) which concluded in Hangzhou on Nov 3rd, although a three-year grace period is granted for registration (finishing on 30 Jun of 2018), South Korea’s MoE still intends to accelerate LR election to push potential registrants to join the Joint Registration Information System. Thus the announcement urging potential registrants to join the system and finish the LR election by 14 Dec 2015 is now a legal requirement. LRs for some substances, potentially some of the 136 PECs administrated by Korean Petrochemical Industry Association (KPIA) may be determined accordingly in a short time.
KPIA is composed of 25 member companies and will administrate the registration of 136 PECs, almost 27% of the total PECs. Some substances still only have one or two potential registrants, and not all the KPIA members want to be a LR, according to Dr. Won-Kwen Kuk from Korea Conformity Laboratories (KCL). The petrochemical joint registration consortium will be enlarged to involve non-member companies of KPIA and currently 5 Korean consulting companies are serving as consultants to aid in joint registration.
It is expected that the elected-LRs for the 136 PECs shall be limited to KPIA member companies however the absolute voting advantages of these potential LRs has proven to be a contentious topic. The situation poses an interesting catch-22 for companies sitting on the fence as with the approaching deadlines they will be forced to join a consortium, after which debating LR selection maybe futile.
So far, even Korea’s domestic manufacturers and importers are procrastinating in an attempt to wait for any further changes to the system. Most of them are SMEs without dedicated regulatory compliance staff or without any KREACH data of their own. Non-Korean manufacturers have an extra requirement to contend with in that they must firstly designate an OR to communicate through the online system and check whether or not a consortium is present for a particular substance and whether or not an LR has already been selected. The upcoming deadline seems to only apply to one situation in which many potential registrants are present and someone is willing to be LR. However, in other cases the deadline may be invalid:
(1) There is no one willing to be LR before deadline
(2) There is a foreign company whose operational activities are in the highest tonnage band and with a significant amount of data joins the system later than the deadline.
In EU REACH, there is no such deadline set and LR election is totally a voluntary and self-managed act.
Apart from the controversial deadline for LR election, the Joint Registration Information System made by Korea authority is not as open and transparent as in the EU. Obviously, joining the system is not the same as participation within the Substance Information Exchange Forum (SIEF) under EU REACH. For EU REACH, SIEF is comprised of all relevant stakeholders for the given substance, including EU’s manufacturers, importers or ORs that have already undertaken pre-registration/post pre-registration, downstream users or any data holders who could share data with potential registrants. However, K-REACH’s Joint Registration Information System is only limited to the potential registrants based in Korea or ORs representing non-Korean manufacturers. To join, corresponding verification documents should be submitted (CL news). For EU REACH, SIEF can be a channel for all SIEF members, even for those with the sole intention of remaining updated on the latest progress in joint registration, while in K-REACH joining SIEF is a very serious business decision only undertaken for registration purposes. You cannot get any information unless you make your decision to register and join the Substance Information Exchange System.
