Regulatory Services for Chemical Products & Mixtures
in South Korea

Overview

Cleaning and disinfectant products are identified and regulated differently across countries and regions, making it challenging for the industry to place these products in different markets.

Chemicals, both new and existing, in South Korea are regulated by Chemical Control Act (CCA) and Act on the Registration and Evaluations ect. Of chemicals (AREC OR K-REACH). Furthermore, South Korea has completely implemented the GHS for Chemicals and mixtures since 2013. 

Korea Biocidal Regulation (K-BPR) came into force in 2019. Similar to the EU, K-BPR required approval of active substances, authorization of biocidal products, and labeling of treated articles. The treated articles are required to use approved active substances only.

The existing active substances that were marketed in Korea until Dec 31, 2018, are permitted under a grace period of up to ten (10) years; provided the importers/manufacturers have obtained the designation of existing substances from the Ministry of Environment (MoE) through an application process that ended in 2020. The grace period for disinfectant products is three (03) years ending in December 2022.

Biocidal products have a grace period of an additional two (02) years from the completion of the grace period of their active substances.

By the end of the respective grace periods, manufacturers/importers are required to submit a registration dossier with data on hazard, exposure, and efficacy to the MoE.

Consumer products, including household chemicals (cleaning products and detergents), are subject to compliance with product safety and labeling standards which further include testing for safety standards by the laboratories designated by the MoE. Additionally, manufacturers/importers must notify product information to the Korea Environmental Industry & Technology Institute (KEITI) once every three (03) years.

Keeping abreast with the stringent and changing global Regulatory dynamics for chemical products, Freyr can extensively support and provide the end-to-end scientific and chemical Regulatory services in South Korea for placing the entire product portfolio.

Categories

Biocide/ Disinfectant

Detergents

/Cleaning products

General consumer Products

Chemicals

Regulation

K-BPR

CCA; Product safety and labeling standards (KEITI)

Product safety and labeling standards (KEITI)

AREC (K-REACH)

Registration Requirement

Yes

Yes (Notification)

No

Yes

Local representative

Yes

Yes

N/A

Yes

Key data requirements

  Hazard, exposure, risk assessment, and efficacy data

Toxicology requirements, adverse events, or previous technical complaints. Biodegradability, phosphate content, etc.

Safety & compliance evaluations & testing as per National/International Standards.

Hazard, exposure, and risk assessment

Expertise

Freyr Expertise

  • Product classification and Regulatory guidance
  • Regulatory strategies for market access/product launch
  • Develop product notification/registration strategies
  • Regulatory applicability review and interpretation
  • Prepare technical data files (specifications, MSDS, etc.), including registration/notification dossiers
  • Application preparation and submission of relevant introductions and renewals
  • Sustainability and packaging solutions
  • Regulatory intelligence
Freyr Advantages
Advantages

Freyr Advantages

  • Local presence in the market with relevant expertise and experience
  • End-to-end Regulatory consultation
  • Support for region-specific Regulatory complexities
  • A structured and cost-effective approach to ensure compliance in the multi-market scenario
  • Quick turnarounds and faster time-to-market