Ah-Reum Seo of Chemservice Asia introduces the forthcoming chemicals regulation for South Korea

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1 Environment & Regulations The best strategy to implement K-REACH Ah-Reum Seo of Chemservice Asia introduces the forthcoming chemicals regulation for South Korea Most existing chemicals on the market have never been fully assessed under South Korea s current Toxic Chemical Control Act (TCCA) of The Korea Centres for Disease Control & Prevention (KCDC) reported on 31 August 2011 that the unidentified fatal lung disease found in Korea might have been caused by chemical disinfectants used with household humidifiers. Chemicals in household products have remained a grey area of chemical management in Korea, because many of them are registered as existing chemicals and used without any type of chemical risk assessment. 1 All this convinced the Ministry of the Environment (MOE) to adopt the Act of the Registration & Evaluation of Chemical Substances, generally referred to as K-REACH, which enters into force as of 1 January The stated purposes of K-REACH are to: 1. Define the issues associated with the registration of chemical substances, the evaluation and assessment of hazards and risks of chemical substances and products containing chemical substances and the designation of hazardous chemical substances 2. To protect public health and the environment by generating and using information on chemical substances This paper introduces the core elements of K-REACH in parallel with the comparison of experiences from EU REACH and other legislation, with the aim of enabling the reader to undertake a sophisticated strategy for K- REACH implementation. K-REACH outline Under K-REACH, any business operator in Korea who manufactures, imports, uses or sells a chemical substance for commercial purposes shall actively generate, share and use the information on hazards and risks of the chemical substance being manufactured or imported (Figure 1 and Table 1).

2 Figure 1 - K-REACH outline Unlike EU REACH, only selected and published existing chemicals by the MOE are subject to registration under K-REACH. Based on the circulated amount and hazard ad exposure information of an existing chemical substance, the MOE will announce the priority assessment chemical (PAC) substances list every three years. The total number of existing chemical substances subject to registration will be approximately 2,500 and the first batch will be available in October A grace period of three years is given to the PAC list substances from the date of publication of the list. Table 1 - Major five requirements applied to raw materials under K-REACH In addition, polymers also have to be registered under K-REACH. The definition of (general) polymers here is the same as the OECD definition, which allows the 2% rule. For the registration of a polymer to be within K-REACH s compliance requirements, data about the polymer s characteristics are required, as well as about its toxicity data based on its volume band.

3 Annual reporting is another new requirement under K-REACH. By comparison with the Japanese Chemical Substance Control Act (CSCL), sellers of existing chemical substances at 1 tonne/year and sellers of all new chemical substances regardless of the tonnage band are also obligatory to report its amount and use to the MOE by the end of April every year. There are other differences between K-REACH and the CSCL in terms of applicants and use categories. In terms of the contents to be reported and exemptions from annual reporting, there is no difference between the two regulations (Table 2). Table 2 - Annual Reporting requirements of K-REACH & CSCL In terms of generating registration data, a higher volume requires more data, much the same as with EU REACH (Table 3). Registration data shall be jointly submitted though a designated lead registrant, but individual submission may be allowed if there is a possibility of disclosure the confidential business information that may cause significant commercial loss and if joint submission costs more than individual submission. Registration data that has been registered for more than 15 years may be used without consent of the owner. The MOE shall inform previous registration of the same chemical substance to a person who intends to file a registration if he/she asks. Under K-REACH, only a Korean legal person can apply all of the prescribed obligations. Therefore, overseas manufacturers and producers may appoint an only representative (OR) who is qualified under an MOE decree to perform the legal activities on behalf of the current or potential importer of the chemical substance or the product. An OR shall be approved by the MOE if he or she has actual experience in regulatory affairs for at least three years.

4 Table 3 - Physical-chemical property, toxicological & eco-toxicological studies required under K-REACH & TCCA Strategy for implementation Until 2015, the TCCA and K-REACH are both options. Unlike EU REACH, K-REACH does not initiate the use of substance information exchange forums (SIEFs) and will not use IUCLID as the reporting system. Thus, industry is currently without any advice on how to start cooperation for a joint registration and a dossier generation. Fortunately, the Korean authorities will accept TCCA notifications until 31 October Notifying a new chemical substance before that date under the TCCA will be advantageous because data requirements and thus, the costs will be reduced compared with K-REACH. Since there is only short time until October 2014, meeting this deadline is unlikely if new studies have to be conducted for a chemical substance. Thus, the first step of using both options, TCCA and K-REACH, should be a detailed substance assessment and data analysis. Depending on the outcome of the assessment, TCCA notification of the relevant new chemical substances should then start immediately in order to save costs. As of 2015, all registration will be under K-REACH. Through substance screening and evaluation and consortia participation, intelligence will be gathered to make an estimate of the costs for registration. Depending on the costs of the registration in relation to the business opportunity in Korea, a registration should then be considered. Purchasing a letter of access from an EU REACH consortium rather than generating new test studies is also possible. Therefore, a company that intends to enter into Korean market needs to take a flexible approach to

5 adapting its business priorities. Depending on the priority of the substance of concern, the activities and costs in the legal process will differ. References 1. Lee et al., Environ. Sci. Technol. 2012, 46, Contact: Ah-Reum So Chemservice Asia Website: