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K-REACH was finally passed by the National Assembly on 30 Apr 2013 as Law No.11789 (K-REACH Chempedia) and came into force on 1 Jan 2015. So far, almost all the related support documentation have been published by South Korea's Ministry of Environment (MoE), the National Institute of Environmental Research (NIER) and the Korea Chemicals Management Association (KCMA) to facilitate the smooth implementation of K-REACH.
The K-REACH subordinate statutes, the Presidential Decree (also known as the Enforcement Decree) and the Ministerial Decree (also known as the Enforcement Rules) which detail the management of chemicals and downstream products, and specify and elucidate the registration requirements and any possible registration exemptions, etc. were officially published on 9 Dec and 24 Dec 2014 respectively.
In addition, the MoE published another three regulations on South Korea’s Official Gazette, including:
MoE Announcement No.2014-240 Designation Standards of Test institutions and the Management Rules (2014.12.30)
MoE Announcement No.2014-241 Measures for the Compilation of Data Protection Application and the Follow-up Management (2014.12.30)
MoE Announcement No.2014-242 Regulation on Fees for Examination and Safety Inspection of Hazardous Chemical Substance Handling Facilities (2014.12.31)
Meanwhile, on the 31st of December NIER published seven regulations relating to K-REACH, including:
NIER Announcement No.2014-44 Measures for Registration Dossier Preparation and Hazard Evaluation
NIER Announcement No.2014-45 Classification and Labeling Requirements of Chemicals
NIER Announcement No.2014-46 Guidelines for the Testing Methods of Chemicals
NIER Announcement No.2014-47 Usage Permission for Hazard Evaluation Results and Cost
NIER Announcement No.2014-48 Measures for the Risk Assessment of Chemicals
NIER Announcement No.2014-49 Measures for the Compilation of Chemical Information
NIER Announcement No.2014-50 Measures for the Risk Assessment of Risk Concerned Products
To help companies better comply with K-REACH, the KCMA developed 4 non-mandatory guidance documents, which will be updated based on actual industry practices.
Guidance on Chemical Identification (2015.1.6)
Guidance on Data and Cost Sharing (2015.1.7)
Guidance on Notification of Hazardous Chemicals in Products (2015.1.9)
Guidance on Registration (draft, public consultation: 2015.1.27-2015.2.2)
In addition to the regulations and guidance documents, two batches of Q&A collections relating to K-REACH implementation have also been published. The first Q&A document covers registration, exemptions, usage and the IT system, etc. The second Q&A document is mainly for registration of reagents used for scientific study, analysis or research even though they are applicable to registration application, small volume registration, registration via OR appointment, etc.
More recent developments have seen the release of the draft version of the Designation of Risk Concerned Products and the Safety and Labeling Standards which is open for public consultation until the 17th of Feb 2015. A public hearing for the Guidelines for Disclosure of Chemical Information will be held on 6 Feb 2015.
