ChemCon Asia, the leading chemical regulatory conference with its unique focus on the Asia-Pacific area was initiated on 9 Sep, 2013 in Seoul, Korea.
With the conference venue located in the gangnam district of Seoul and the K-REACH Act being released on Apr 30 this year, there is no doubt that the progress of this EU-REACH style regulation with the ambition to manage the overall chemicals, covering both new and existing chemicals in South Korea fell into the spotlight of the pre-conference morning seminar.
8 major types of compliance activities are summarized in the presentation of Mr. In-Mok Hwang from Korea Ministry of Environment (MOE), namely:
1. Annual reporting
2. Registration, Joint submission
3. Hazard examination and Risk Assessment, designate substances as toxic, authorized and prohibited
4. Communication with supply chain
5. Notification of products
6. High Risk Concerned Products
7. Appointment of Only Representative (optional)
The diagram below depicts the overall K-REACH management scheme, shared by Mr Hwang.
K-REACH, compared with its precedent TCCA, comes with more demanding registration data requirements. In terms of the data requirements, unlike its China counterpart, there is no specific requirement for local data (maintained principle from TCCA), and non-real test data would be readily acceptable, including QSAR and read-across. These might serve as a great relief for the industry stakeholders facing the registration obligation.
Besides all new chemical substances, priority environmental chemicals (PECs) which are screened out of the existing chemicals, will be subject to registration under K-REACH if exceeding 1 ton/year threshold. Staggered grace period would be allowed for different list of PECs, i.e. 2, 5, 8 years for 1st, 2nd, 3rd PECs, respectively, from the publication date of the substances.
K-REACH will operate on the basis of the grandfather inventory, the Korea Existing Chemical Inventory (KECI), in identifying the new and existing chemicals. According to Ms Ami Fukuroi from the Korea Testing & Research Institute, the priority list of 2,086 substances has been drafted. Since Korea has been conducting circulation survey every two years, the government has been well informed of the chemicals on the market and has very specific idea of the screening criteria for priority substances (total tonnage circulating in the market and hazardous/risk characteristics are two major factors).
Unlike the mechanism adopted in EU REACH and China NCSN (a.k.a. China REACH), Korean MOE will take the responsibility to conduct the hazard evaluation and risk assessment of the registered substances and the follow-up designation of substances for authorization, restriction and ban. Nevertheless, the risk information needs to be submitted by the industry and submitted before the various deadlines determined by tonnage band of the chemicals manufactured or imported.
Table 1. Deadline of Risk Information Submission
|tonnage band||Deadline of Risk Information Submission|