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K-REACH Registration Eased for 1 Ton
and Separate K-OSHA Reporting Back |
Effective January 1, 2025, the amended Act on the Registration and Evaluation of Chemical Substances (K-REACH) changes the threshold for new substance notification from 100 kg/year to less than 1 ton per year. Accordingly, entities manufacturing or importing less than 1 ton of new substances annually are now required to notify these substances, instead of registering them.
Until 2024, companies that completed registration of new substances in the 0.1–1 tonnage band under Article 10 of K-REACH were deemed to have fulfilled their obligation to submit the Hazard and Danger Assessment Report for New Substances (K-OSHA) under Article 108 of the Occupational Safety and Health Act (K-OSHA), administered by the Ministry of Employment and Labor (MoEL).[1][2] However, as this tonnage band is now subject to notification rather than registration, the K-OSHA reporting must now be prepared and submitted separately, along with the relevant test data.
Nevertheless, the exemption from K-OSHA reporting for substances imported in quantities below 100 kg remains in effect—if a K-REACH notification has been submitted for less than 1 ton, the K-OSHA exemption is still considered to have been granted for quantities below 100 kg.[2] |
Legislation | Annual Volume(Ton) | By2024 | 2025 | MoE1) (K-REACH) | 0.1-1 | Registration of New Substances | Notification of New Substances | MoEL2) (K-OSHA) | Deemd submisson of K-OSHA Report; No further action required | K-OSHA Report must be submitted | Table 1. Comparison of Changes in MoEL Submission for 0.1–1 Ton per Year (Effective January 1st, 2025) Note : 1) Ministry of Environment 2) Ministry of Employment and Labor
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2. Important Note for Foreign Companies and ORs |
(1) The Only Representative system is not recognized for K-OSHA Reporting [3]. The legal obligation to report lies with the manufacturer or domestic importer.
(2) If multiple domestic importers exist for the same substance, each importer must submit their own K-OSHA report to remain compliant depending on their individual importing volume.
For example, if an OR has notified 250 kg under K-REACH, and the volume is split between two importers (200 kg for Importer A and 50 kg for Importer B), Importer A must submit the K-OSHA report, whereas Importer B is exempt, as the imported quantity is less than 100 kg.
Type | Case 1: Importer handles 0.1–1 ton/year | Case 2: Importer handles <0.1 ton/year | When OR notifies <1 ton/year under K-REACH | K-OSHA reporting required | K-OSHA reporting not required | When OR registered ≥1 ton/year under K-REACH | K-OSHA reporting not required | Table 2. Reporting obligations for importers (K-REACH Notification by OR) |
3. Industry Recommendation |
(1) Check compliance with K-REACH and K-OSHA obligation
Review all manufactured and imported new substances in the 0.1–1 ton/year. Ensure that K-OSHA reporting is submitted for all applicable substances. Identify any notifications submitted since 2025 that are missing the K-OSHA report.
(2) Verify if the substance is listed in both K-REACH and K-OSHA's existing chemical
K-REACH and K-OSHA maintain separate existing substance lists, and no unified public search system is currently available for K-OSHA. External consultation may be necessary to verify K-OSHA listing. A general indicator: if a substance has a “KE-XXXXX” identifier, it is likely on the K-OSHA existing substance list. Substances with numbers like “20XX-X-XXX” or "9X-X-XXX” without a “KE-” prefix should be reviewed carefully.
(3) Confirm if the substance is among published new substances under K-OSHA
Since 2018, K-OSHA has periodically published lists of reported new substances and their applicable tonnage thresholds. Substances on this list are exempt from reporting up to the published threshold.
(4) For any substance imported as a finished consumer product
If an imported item is a final consumer product in its ready-to-use form (e.g., laundry detergent, deodorant, etc.), it falls outside the scope of K-OSHA and is therefore not subject to the reporting requirement.
We are happy to assist you with your regulatory compliance needs. Our services include: Reviewing substance inventory status under K-REACH and K-OSHA Preparing and submitting K-REACH notification and K-OSHA hazard and danger assessment reports Assessing confidentiality and data sharing strategies when an importer(s) is involved in K-OSHA reporting
| Note : [1] Occupational Safety and Health Act, Article 108(1): Manufacturers or importers of new chemical substances must assess their hazards and dangers and submit an assessment report to the Minister of Employment and Labor, as prescribed by Ordinance. [2] Enforcement Rule of the Occupational Safety and Health Act, Article 147(1): Where a new chemical substance has been registered under Article 10 of K-REACH, submission of the hazard and danger assessment report to the Ministry of Employment and Labor is deemed to have been completed; this equivalency, however, does not apply in cases of notification. [3] The OR system is only applicable under certain K-OSHA provisions, such as MSDS reporting. It does not apply to hazard and danger assessment reports under Article 108. | | For more information, please contact us: ☎ Inquiry: +82-(0)2-826-9100 (Main line), chemtopia@chemtopia.net |
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