Regulations & EHS&S
Advice for K-REACH 25th January 2019
By Matthieu Duchemin, Head of Expert Consultant Group and Asia-Pacific Regulatory Services at Envigo
Matthieu Duchemin, Head of Expert Consultant Group and Asia-Pacific Regulatory Services at Envigo, provides 12 insightful ti
Two key pieces of legislation are:
Act on the Registration and Evaluation of Chemicals (K-REACH), which mandates the registration of all new and existing chemicals marketed or imported into South Korea at ≥1 tonne per year, requiring detailed information on their likely hazard to human health and the environment
Chemicals Control Act (CCA), which focuses on chemical reporting and chemical accident prevention.
As with REACH, K-REACH is confined to certain substances, because other substances are regulated through different legislation. Unlike REACH, where annual tonnage is calculated as a 3-year rolling average and regular monitoring and updates are required, K-REACH annual tonnage is based on the maximum manufactured or imported volume in any given year from 2016 to 2018.
Like REACH, K-REACH is a multistage process with different deadline and information requirements dictated by the amount of the substance imported or manufactured. Under K-REACH, foreign manufacturers without registered offices in South Korea need to appoint a South Korea-based only representative (OR) to submit pre-notification and registrations.
- Pre-notification for existing substances manufactured or imported at ≥1 tonne/year is required by 30th June 2019.
- There are three tonnage bands for existing substances, which have different deadlines for registration.
- Data requirements for registration increase with increasing tonnage.
- The registration deadline of 510 priority existing chemicals was 1st July 1 2018.
- Joint submission is mandated in most cases, with registrants working together as part of a CICO with a lead registrant.
- Manufacturers or importers based outside Korea must appoint an OR to submit and manage substance registration.
Designated or priority existing chemicals
K-REACH has similar information requirements to REACH, although the use of read-across and quantitative structure–activity relationship (QSAR) models for waiving some animal studies is not as widely accepted under K-REACH.
Planning your registration
Like REACH, K-REACH requires a single dossier to be submitted for each substance. This means that companies producing chemicals containing the same substance must work together in a structure called a Chemical substance Information Communicative Organization (CICO), which is similar to the EU Substance Information Exchange Forums (SIEFs). The CICO enables the effective sharing of data and costs.
K-REACH is closely aligned with REACH, although K-REACH relies more heavily on animal data. The pre-notification period for existing substances imported or manufactured at ≥1 tonne/year runs between 1st January and 30th June 2019. After this, submissions deadlines vary by tonnage band. Joint submissions are the norm, with registrants working together in CICOs – the equivalent to SIEFS in REACH.
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