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On 26 Nov 2014, South Korea’s National Institute of Environmental Research (NIER) issued 7 drafts for the pending implementation of K-REACH. The drafts concerning classification & labeling, dossier compilation, hazard & risk assessment, adopted testing methods, etc. will be subject to a period of public consultation due by 16 Dec 2014. A brief introduction for each draft is provided as below:
1. Classification and Labeling Requirements of Chemicals
Drafted according to Article 14 of K-REACH, Article 18 Paragraph 5 of K-REACH Enforcement Rules, Article 16 Paragraph 1 of CCA and Article 12 Paragraph 2 of CCA Enforcement Rules
Chemical substance classification and labeling standards are specified in this document. For more details, please refer to the 4 attachments
Attachment 1: Cutoff value & bridging
Attachment 2: classification & labeling elements (pictogram, signal word, H code, P code)
Attachment 3: Codification of hazard/precautionary statements, Classification and labeling summary tables
Attachment 4: GHS classification list of toxic chemical substances
2. Measures for Registration Dossier Compilation and Hazard Evaluation
Drafted according to Article 14 and 18 of K-REACH, and Article 18, 32 of K-REACH Enforcement Rules
This document provides guidance on registration dossier compilation for general substances, polymers and biocides. In addition, it provides the methods for hazard evaluation. The exemption conditions of testing items are specified as Attachment 2 for reference.
3. Guidelines for the Testing Methods of Chemicals
Drafted according to Article 14 Paragraph 1 of K-REACH, and Article 18 Paragraph 11 of K-REACH Enforcement Rules
Registration of substances required to submit physico-chemical, toxicological and eco-toxicological data accordingly. This document encompasses 5 aspects to guide the generation of qualified testing data for K-REACH registration, including:
General Rules
Physical-Chemical Properties (20 testing methods)
Effects on Biotic Systems (13 testing methods)
Physical-Chemical Properties (12 testing methods)
Health Effects (26 testing methods)
4. Usage Permission for Hazard Evaluation Results and Cost Sharing
Drafted according to Article 19 of K-REACH, and Article 36 Paragraph 6 of K-REACH Enforcement Rules
Any person who intends to use the result of hazard evaluation (conducted by MoE) for the purpose of registration or hazard examination of chemical substance in other countries should obtain an approval from the MoE. The approval application should be submitted to NIER. The details on obtaining approval and how much it will cost, are prescribed in this document.
5. Measures for the Risk Assessment of Chemicals
Drafted according to Article 24 of K-REACH, and Article 41 Paragraph 6 of K-REACH Enforcement Rules
Risk assessment is required for substances manufactured or imported in volumes of 10 tons or more per year, or when the result of hazard evaluation necessitates further risk assessment. This document specifies criteria for designation of substances for risk assessment based on amount, usage, hazard information, concerns to human health/environment.
6. Measures for the Compilation of Chemical Information
Drafted according to Article 29, 30 and 35 of K-REACH, and Article 45 Paragraph 3, Article 47 Paragraph 4 and Article 55 Paragraph 4 of K-REACH Enforcement Rules
The manufacturers and importers of registered substances or mixtures containing registered substances should provide registration No., chemical name, hazard & risk information, safe use information to the downstream users and sellers. The information should be included in MSDS. In addition, the manufacturers and importers of products containing hazardous chemicals should provide information to the transferees/consumers accordingly. The compilation and supply of safety information on registered chemical substances and products containing hazardous chemicals should be complied with according to NIER’s document.
7. Measures for the Risk Assessment of Risk Concerned Products
Drafted according to Article 33 Paragraph 7 of K-REACH, and Article 53 Paragraph 5 of K-REACH Enforcement Rules
The MoE will conduct risk assessment for risk concerned product in order to prevent the risks to the human health and environment which may occur due to the hazardous chemical substance contained in products. This document specifies which objects require risk assessment and the methods for risk assessment.
