K-REACH Registration: Are you compliant?
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According to Article 10 of the K-REACH regulation, any business intending to manufacture or import a new chemical substance (at any quantity) or 1 tonne per year or more of an existing chemical substance is required to register the substance.
This article summarizes the key points you need to know about K-REACH registration including scope, exemptions, deadlines and more.
Registration Scope
K-REACH Registration Exemption
Many >=1t/y existing substances and new substances qualify for registration exemptions. Some of these exemptions require prior confirmation of the exemption with the Korean authorities.
Exemption: Substances controlled by other laws and regulations (confirmation not required)
Examples:
Radioactive substances
Pharmaceutical products
Cosmetics and raw materials for cosmetics
Pesticides and active ingredients for pesticides
Fertilizers
Food, food additive, device and container/packages
Feeds
Health functional foods
Hygiene goods (i.e, food detergent)
Active substances and biocidal products under K-BPR
Exemption: Substances exempt from registration (confirmation not required)
Examples:
Chemical substance imported as part of machinery
Chemical substance imported together with relevant machinery or equipment for the purpose of trial operation
Chemical substances contained in a product perform a certain function in a specific solid form, which does not leak in the process of using the product.
Exemption: Substances designated as “low-risk” substances by the Korean Ministry of Environment (MoE)
Examples:
As specified in Ministry of Environment Notice No. 2018-234:
E.g. impurities, by-products, certain substances occurring in nature
Exemption: registration (application of confirmation on exemption required)
Examples:
Chemical substance imported or manufactured for export-only use (including substance used to make export-only products)
Chemical reagents
Substances for R&D use
Surface treated substances
Non-isolated intermediates
Isolated intermediates (which can be technically blocked from leakage or exposure)
Polymers of low concern (PLC)
Registration Deadlines to Remember
New substances must be registered prior to manufacture or import (at any quantity) unless exempt. >=1t/y existing substances (which have been pre-notified) are to be fully registered within the following registration deadlines:
Only Representatives (OR)
Only Korean manufacturers and importers are obligated to register chemical substances under K-REACH. Foreign manufacturers may appoint Korea-based Only Representatives to submit chemical pre-notifications, notifications and registrations on their behalf.
Be Prepared
Here’s what you need to know to comply with amended K-REACH regulations
Substance Registration
Decide who will submit the registration: manufacturer, importer or OR
Determine the right type of submission: confirmation of exemption, new substance notification, new substance registration, general existing substance registration or designated existing substance registration
Identify the registration deadline that applies based on the substance type
Notification of Priority Controlled Substances
Identify if your product contains Priority Controlled Substances that require notification;
Determine who will do the notification: manufacturer, importer or OR
Restriction/Authorisation
Check if your product contains any restricted substances or substances requiring authorization
Comply with provisions on restriction or authorization
How can Yordas help?
Providing Only Representative services for foreign companies
Clarifying your regulatory obligations under K-REACH
Preparing supporting evidence to justify exemptions
Supporting with analytical testing (including for polymers and polymer of low concern)
Carrying out data sharing discussions and commissioning endpoint testing (and acting as study monitor) where relevant
Submitting notifications and registrations
Support with other Korean regulations (K-OSHA, K-CCA, GHS etc.)
If you wish to discuss any of the points above, or any other aspect of K-REACH compliance, send us a message here.
