In line with recent global developments, chemicals management in South Korea is currently undergoing a major overhaul. Following its adoption by the National Assembly of the Republic of Korea in April 2013, the Act on the Registration and Evaluation of Chemicals has taken effect in January 2015. The Act, which has consequently been dubbed Korea REACH or K-REACH, is designed to closely mirror the European Union’s regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) of 2006, adopting many of the same concepts – including pre-registration, registration, evaluation, authorisation and restriction of chemical substances.
The purpose of K-REACH is to protect public health and the environment through the registration of chemical substances, the screening of hazardous chemical substances, hazard and risk assessments of products containing chemical and hazardous substances as well as sharing information on chemical substances. As such, it will eventually overhaul the Toxic Chemicals Control Act (TCCA) of 1991, regulating both new and existing substances under a single system. It is complemented by the Chemicals Control Act (CCA), which focuses on the control of hazardous substances and the response to chemical accidents. Similar to REACH, foreign manufacturers exporting chemical substances or products containing hazardous chemical substances into South Korea may appoint an “Only Representative” to fulfil relevant obligations under K-REACH.
Under K-REACH, manufacturers, importers and sellers are required to annually report information about so-called “new substances” and “existing substances” to the South Korean Ministry of Environment. The “existing substances”, which need to be reported only if manufactured, imported or sold in quantities of more than one ton per year, are chemicals which have been domestically commercialized prior to February 2, 1991 and have been designated and published in the Korea Existing Chemicals Inventory (KECI). The KECI, which is issued by the South Korean Ministry of Environment and the South Korean Ministry of Labour, currently includes more than 43,000 chemical substances. The “new substances”, whose quantities and uses always have to be reported to the Ministry of Environment under K-REACH, are defined as substances that have not been placed on the Korean market before February 2, 1991 or that have not undergone the examination of toxicity under the provisions of the TCCA after February 2, 1991. The first reporting deadline for K-REACH will apply mid-2016, requiring manufacturers, importers, sellers and Only Representatives to have substance inventories and solid substance-volume-tracking processes in place.
Concerning the registration of substances, K-REACH distinguishes between new substances – which shall be registered prior to production or importation – and so-called “designated existing substances” that are manufactured, imported or sold in quantities of more than one ton per year. These need to be registered within a grace period of maximum eight years. The first tranche of 510 designated existing substances that have been selected for registration under K-REACH were included in the amended Priority Existing Chemicals (PEC) list released on July 1, 2015. The registration deadline for this first tranche of designated existing substances is in June 2018. To identify potential registration obligations, substance inventories need to be checked against the KECI as well as a multitude of existing exemptions, which may partially need to be certified by the Korean Chemicals Manufacturer Association (KCMA).
As K-REACH requires the joint submission of registration dossiers, the registration of the substances included in the PEC list involves cooperation in so-called Chemical substance Information Communicative Organizations (CICO), which are equivalent to the European Substance Information Exchange Forums (SIEF) and which can be joined via the Chemical Substance Information Processing System. For each CICO with its leading, active and dormant members, lead registrants can nominate themselves and get elected by the CICO members. Up to now, lead registrants for about 150 out of 510 PECs have been elected in two rounds. Since processes and tools are still evolving, the registration of designated existing substances has taken a slow start. Up until now, however, the formation of CICO Leadership Teams seems to be the approach favoured by the industry, as opposed to the formation of consortia, which require significant human and financial resources. This is also due to the fact that many PECs have already been assessed and registered in the European Union and that the process of dossier compilation under K-REACH is very similar to the REACH process, with equal definitions of substance identity.
Within the compilation of new substance dossiers, collection of data from EU-registered substances has previously proved to be a challenge as no standard data sharing agreement was in place under K-REACH, a situation which is currently improving. Following the compilation and submission of registration dossiers for new substances under the leniency program in late 2015, the first feedback obtained from dossier evaluations by the National Institute of Environmental Research (NIER) provided an understanding of the extent and form of data expected to be submitted, partially filling the gap of lacking guidance documents as well as the lack of official English translations thereof. Even though the NIER seems to follow a responsive way of interaction with the registrants, the information obtained remains verbal and can provide a somewhat uncertain basis for industry decisions, such as the development of a registration strategy.
Up to this point, it can be concluded that there is a need for standardized CICO and data sharing templates as well as more sharing of best practice cases needed by NIER, especially for dossier preparation. However, ERM will use the lessons learned thus far to support clients in efficiently compiling registration dossiers and to support continuity of supply chains.