KOREA-REACH

KOREA-REACH

K-REACH (Act on the Registration and Evaluation of Chemicals) is South Korea’s chemical regulation, modeled after the EU REACH system.
It aims to protect human health and the environment by regulating the manufacture, import, and use of chemical substances in Korea.

K-REACH came into effect on 1 January 2015 and was significantly amended in 2019.

Aims

Global efforts to protect humans and the environment from hazardous effects of the chemicals.

  • To provide a high level of protection of human health and the environment from the use of chemicals.
  • To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.)
  • To allow the free movement of substances on the KOREAN market.
  • To enhance innovation in and the competitiveness of the KOREAN chemicals industry.
  • To promote the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.

REACH
Registration

K-REACH (Act on the Registration and Evaluation of Chemicals) requires all manufacturers and importers in South Korea to register chemical substances produced or imported in quantities of 1 tonne or more per year.
The regulation aims to protect human health and the environment while encouraging responsible chemical management.

Registration dossiers are submitted to the Ministry of Environment (MoE) and include substance identity, hazard assessment, and Chemical Safety Report (CSR) for substances ≥10 tonnes/year.

Key registration deadlines depend on production volume: 31 Dec 2021: ≥1,000 tonnes/year 31 Dec 2024: ≥100 tonnes/year 31 Dec 2027: ≥10 tonnes/year 31 Dec 2030: ≥1 tonne/year

(OR) Only
Representative Services

Non-Korean manufacturers exporting to South Korea must appoint a Korea-based Only Representative (OR) to fulfill regulatory requirements.

We act as your OR, preparing registration dossiers, managing substance data, and coordinating with the National Institute of Environmental Research (NIER) and the Ministry of Environment (MoE).

Our service ensures your substances remain legally on the Korean market, without interruption to trade.

eSDS & SDS

After the REACH and CLP legislations entered into force, the Chemical Safety Data Sheet (SDS) has become the vehicle of communication within the entire supply chain in the EU. The supplier of the substance or preparation must supply and update the SDS in accordance with Annex II of the REACH regulation and taking into consideration the CLP requirements.

In addition, for all the substances where a chemical safety report (CSR) is required, the information in the SDS must be consistent with the CSR and the relevant exposure scenarios (ESs), shall be annexed to the SDS. SDS containing ESs is commonly named as Extended SDS (eSDS). We provides companies REACH & CLP compliant SDSs as well as Extended SDSs.

Legal Guidance
and Consulting

We provide continuous consulting and regulatory assistance under K-REACH, including dossier reviews, communication with authorities and compliance updates. Our legal experts help companies anticipate policy changes, handle data sharing, and maintain complete regulatory records.

Please contact on js@pharmegichealthcare.com for more information