Yordas Group

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K-REACH Registration: Are you compliant?

Kaying Tam

Read Time: 3 minutes

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.