Matthieu Duchemin, Head of Expert Consultant Group and Asia-Pacific Regulatory Services at Envigo, provides 12 insightful tips for preparing your substance registration under the changing regulations of K-REACH.
K-REACH is the South Korean version of the EU regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). With an estimated 44,000 chemicals in use in South Korea and about 300 new chemicals marketed annually, registrants and regulators assess the risk posed to humans, animals and the environment. This legislation is intended to impose stricter controls on a broader range of substances, effective 1st January 2019.
Here are 12 insightful tips on preparing your substance registration under the changing regulations of K-REACH.
K-REACH legislative development and goals
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.
K-REACH and REACH share the main goal of cataloguing information on the hazards of chemicals to support improved risk management in their use. K-REACH and the CCA replaced the existing Toxic Chemical Control Act (TCCA) to provide enhanced protection against chemical hazards. The drive for enhanced legislation was triggered in response to an outbreak of toxic lung injury related to inhalation of a disinfectant used to clean humidifiers.
Tip 1 Start as early as possible.
Tip 2 Ensure you check the latest regulatory requirements relevant to your substance, identifying which legislations are relevant and your obligations under each of these.
Scope of K-REACH
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.
Tip 3 Check if your substance is in scope and if it is on the Korean Existing Chemicals List (KECL); if not, your substance will be considered ‘new’.
A multistage process
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.
Tip 4 Establish the pre-notification and registration requirements for your substance.
Tip 5 Find and contract an OR if you need one.
Tip 6 Calculate the maximum tonnage carefully to identify the information needs for that tonnage band.
- 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.
Tip 7 Identify all uses for your substance, as this will drive the exposure scenarios and risk assessment. You may need to consult downstream users.
Tip 8 Conduct a data gap analysis to identify information you need to source, or the testing plans you need to carry out.
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.
Tip 9 Characterize your substance in detail.
Tip 10 Find other registrants through the K-REACH IT system and consider how best to engage with them in the CICO. You may need to consider how important your substance is to you commercially and if other registrants will prioritize the substance in the same way.
Tip 11 This can influence decisions regarding who should act as lead registrant.
Tip 12 Contract data access carefully, checking data quality (if possible) and ensuring you understand usage limitations.
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.
It is likely that a number of substances requiring K-REACH registration will have already been registered in the EU through REACH. REACH dossiers can, therefore, be a data source, although a substantial amount of rework may be required to align any K-REACH submission with the obligations in the Korean regulation. Getting your product through K-REACH requires long-term planning, insight into the regulatory requirement and a constant focus on reaching your end goal.
Matthieu Duchemin, Head of Expert Consultant Group and Asia-Pacific Regulatory Services at Envigo, Woolley Road, Alconbury, Huntingdon, Cambridgeshire, PE28 4HS, UK
T: +44 (0) 1480 892000