K-REACH Amendments Approved to Accelerate New Chemical Registration

South Korea’s MoE approved the amendments on K-REACH Enforcement Rules to simplify and accelerate new chemical registration and approvals of exemptions for R&D purposes. However, only new chemical substances affected by the Japan’s trade dispute are eligible for the favorable measures. The measures will apply until Dec 31st, 2021.

The trade war between Japan and South Korea has been steadily escalating. In response to the urgent requests from South Korea’s government to minimize industry losses during this difficult time, the Ministry of Environment (MoE) approved on Sep 16th by MoE Decree No.824 the amended K-REACH Enforcement Rules to include temporary measures to ease new chemical localization and promote R&D.

However, the measures will only apply to key new chemicals that may suffer supply shortage or delays in manufacturing caused by the trade war ("supply risk response substances"). Enterprises should apply to the Ministry of Trade, Industry and Energy (MOTIE) for approval to be qualified for the favorable measures.

The temporary measures were proposed on Aug 26th by MoE Notice No.2019-631 for public comments until Sep 2nd, 2019. The amendments mainly focus on the following two aspects.

A: Expansion of acceptable test plan endpoints for registration of new chemical substances

For K-REACH registration, the testing plan can be submitted instead of the complete testing report for some endpoints including physicochemical properties (max. 2 endpoints), toxicological (max. 7 endpoints) and eco-toxicological (max. 14 endpoints) data. To support the rapid time-to-market of new chemicals, MoE proposed that all hazard endpoints (47 items) are acceptable. However, the registrants should still submit the test data if they do have some. It would be a temporary measure only applicable before the end of 2021.

B: Omission of some data required for confirmation application of registration exemption

Under the current regulatory framework, new substances for R&D use require pre-application for confirmation of registration exemption before manufacture/import. However, for this case, MoE plans to omit some data required to be submitted during the application. Only post-treatment plan and the treatment results will still be required, and all the other sections required for the chemical safety management plan can be omitted. Similar to the other preferential measures, this measure will end on Dec 31st, 2021.

In addition, the K-REACH Enforcement Decree is under revision. The amendments focus on the omission of some data required for registration of new chemcials (below 1 ton per year) that meeting criteria of "supply risk response substances". The public consultation period will end on Oct 28th, 2019.