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Products Compliance Assessement Service

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Korea REACH Substances Compliance Assessement Service

Highlights on Korea REACH
Regulation Links

Korea REACH : The “Act on Registration and Evaluation of Chemicals”

Datase link to existing substances : NCIS List

Brief Summary

The Act on Registration and Evaluation of Chemicals (known either as “Korea REACH”, or “K-REACH”) was passed on 30th April 2013 and revised several time, is regarded as the first EU REACH-like chemical regulation adopted in an Asian country.

The revised K-REACH legislation is a significant deviation from the regulatory mechanisms outlined in the previous version.

The amendments came into effect on 1st January 2019, which sets out a plan of registering existing substances over 1 ton per year.

Similarily to EU REACH in 2008, K-REACH offered the possibility of pre-registration up through 30 June 2019, allowing benefit of the transitional period until 2021, for full registration completion.

Starting 1 July 2019, the full registration process is now required immediately.

K-REACH manages new chemical substances, existing chemical substances and downstream products by prescribing the requirements for:
- Registration of chemical Substances;
- Screening of hazardous chemical substances;
- Hazard and risk assessment of products containing chemical substances and hazardous substances;
- Sharing information of chemical substance.

The Ministry of Environment (MoE) is responsible for the registration and evaluation of chemical substance under this Act.

Based on the hazard evaluation and risk assessment, MoE may impose production and importing requirements necessitating that substances undergo “Authorization”, “Restriction” or “Prohibition” process.

Some measures under K-REACH
K-REACH Exemption Scopes :
  • ¤ Ammunitions
    • • Subject to Act on the Control of Firearms, Swords, Explosives
  • ¤ Biocidal products
    • • Subject to Act on Consumer Chemicals and Biocide Safety
  • ¤ Cosmetics and materials
    • • Subject to Act on Cosmetics
  • ¤ Fertilizers
    • • Subject to Act on Fertilizer Control
  • ¤ Food, food additives, tools, containers and package
    • • Subject to Act on Food Sanitization
  • ¤ Health functional food
    • • Subject to Act on Health Functional Food
  • ¤ Ingredients and agrochemicals
    • • Subject to Act on the Agrochemicals Control
  • ¤ Livestock feeds
    • • Subject to Act on Control of Livestock and Fish Feeds
  • ¤ Medical devices
    • • Subject to Act on Medical Devices
  • ¤ Military supplies
    • • Subject to Act on the Management of Military Supplies
    • • Subject to Act on Defense Acquisition Program
    • • With the exception for commercial goods under Article 3 of the Act on the Management of Military Supplies Narcotics
  • ¤ Narcotics
    • • Subject to Act on Control of Narcotics
  • ¤ Personal care products
    • • Subject to Act on Safety of Personal Care Products
  • ¤ Pharmaceuticals and non-pharmaceutical drugs
    • • Subject to Act on Pharmaceutical Affairs
  • ¤ Radioactive substances
    • • Subject to Act on Atomic Energy
Definition of New Substances :

A new substance is defined as a substance that is not on the following lists:

- Chemical substances which were placed on Korean market before Feb. 2, 1991, and notified by the Ministry of Environment on Dec. 23, 1996; and

- Chemical substances which have undergone the examination of toxicity under the former provisions or the provisions of this Act after February 2, 1991 and were announced by the Minister of Environment.

Access to: The Korean Existing Chemicals List (KECL).

Products Compliance Assessement Service with Regard to K-REACH
Service Pack: Products assessment & Classification
  • ¤ Review and consolidation of the K-REACH regulation at the date of the study (core regulations and amendments)

  • ¤ Classification of the products, in the relevant regulatory categories
  • ¤ Identification of the regulatory requirements and adequate compliance procedures for each item (or item category when relevant)
  • ¤ Identification of mutual compliance requirements with actors up and down the supply chain
  • ¤ Identification of the resulting full set of regulatory obligations, if any
  • ¤ Evaluation of compliance strategies and associated timelines deliverables

  • ¤ Products Assessment Deliverable :
    • • The deliverable for this service pack is a study report detailing the above obligations with relevant regulatory references and compliance deadlines
    • • This report will include, when possible and relevant, qualitative and quantitative evaluations of the necessary compliance undertakings and strategies
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