The media wildfire and rampant speculation surrounding the potential costs of K-REACH registration has according to the Korean MoE been grossly exaggerated. The most notable figure bandied by media put the total cost of compliance at a staggering 12 billion USD, a figure estimated based on the total number of companies involved in the circulation of chemicals in Korea approximately 16,000 companies. To allay industry concerns about the cost and time needed for registration, Korea’s Ministry of Environment (MoE) has made some statements to clarify these issues.
K-REACH refers to the Act on Registration and Evaluation of Chemical Substances, which will come into force on 1 Jan 2015. Most notably, K-REACH registration will apply only to new substances and to priority existing chemical substances selected on the basis of circulation volume and hazard, such as those with carcinogenic or reproductive toxicity, estimated to include more than 2,000 substances and concern approximately 3000 Korean companies rather than the total 16,000 companies.
Tonnage banding under K-REACH is divided into four categories with the data requirements for higher volume tonnage bands increasing. The specific data requirements associated with band 1, 2, 3 and 4 require 11, 20, 33 and 46 testing items respectively. Alternative testing strategies are acceptable, such as QSAR, grouping and read-across. There will not be any low-volume exemption for new chemical registration under K-REACH, however low-volume manufacturers and importers may be granted a simplified registration. Estimates made by the MoE, put the total cost of compliance at $645m, a figure which will encompass the entire 8-year grace period for registration of Priority 1, 2 and 3 chemicals.
Considering the limited domestic testing resources for some of the testing items, testing proposal which includes the contents of tests and schedules, etc. can be submitted in lieu of some parts of application dossier. In this case, the registration No. can be obtained in advance which will ease delays caused by congested testing facilities.
So far, there are 16 GLP-certified labs designated by the MoE, 19 designated by the Ministry of Food and Drug Safety and 16 designated by the Rural Development Administration, which should be sufficient to meet the expected testing demands. Some shortfalls have been noted regarding the testing and analysis of potential environmental hazards. To combat this, the MoE and the Ministry of Trade, Industry and Energy (MOTIE) are planning to jointly establish testing institutes (MoE: $1.4m; MOTIE: $1.4m) and promote development of professional expertise in chemicals (MoE: $1m; MOTIE: $2.8m) in 2014. The initiative should greatly increase Korea’s testing capacity and ease the anxiety surrounding potential long term delays and widespread industrial disruption.
MoE has confirmed there will be exemptions for R&D substances though it hasn’t been officially included into K-REACH. For reference, under the current regulatory system the TCCA, R&D substances are already exempted from hazard assessment (Article 9 of TCCA). For priority substances, a maximum 8-year grace period can be granted for priority 3 chemicals allowing business to continue as usual until this deadline is reached.
The clarification regarding cost and delays offered by the MoE has eased many of the misgivings voiced by industry. However, a clear working model specifying how K-REACH will be practically implemented has still to be presented. The forthcoming Presidential Decree and Ministerial Decree hold the promise of finalizing many of the previously unclear details. K-REACH will come into effect on 1 Jan 2015 with the deadline fast approaching it can be assumed that the MoE is hard at work developing the supporting documents, which will flesh out critical aspects of the Act, especially issues concerning cost and time taken for testing.