Koreanische Chemikalienverordnung

Korea REACH (K-REACH)

Korea REACH (K-REACH) Compliance Services

Chemical Compliance Expert for South Korea – Korea REACH Registration Services

Die Act on Registration and Evaluation, etc. of Chemicals (K-REACH), enacted as South Korea’s chemical management law, requires registration of chemicals dass sind manufactured or/and importiert into and/oder sind used on the market in South Korea and manages and uses chemicals safely for human and environmental protection.

Similar to EU REACH, K-REACH requires companies to gather and organize information on the chemical safety of their substances, assess potential risks and ensure dass relevant information is passed on throughout the supply chain.

For companies all over the world exporting chemicals to South Korea, it is crucial to know the K-REACH requirements in order zu complete shipments smoothly und zu avoid any kind of obstructing interruptions to business.

Was ist K-REACH (Korea REACH)?

K-REACH ist short for the Act on Registration and Evaluation, etc. of Chemicals, which ist the major chemical management law in South Korea.

Act auf Anmeldung and Evaluation, etc. of Chemicals came into effect auf January 1, 2015 and aims at safe management of chemical substances by requiring registration, evaluation and control of chemicals und thus protecting human life and health and environmental conservation.

The main objectives of K-REACH are to:

Ensure safe management of chemical substances
Identify and communicate chemical hazards
Evaluate potential risks associated with chemical substances
Promote transparency throughout the chemical supply chain

K-REACH regulates:

Chemical substance registration
Notification requirements
Hazard and risk assessment
Substance evaluation
Authorization and restrictions
Supply chain communication

K-REACH is implemented by:

Ministry of Environment (MoE)
National Institute of Environmental Research (NIER)
Performing scientific evaluation, hazard assessment and reviewing the relevant technical matters.
Korea Environment Corporation (KECO)
Provides administrative and technical support for K-REACH systems.

Our team of experienced K-REACH consultants help organizations zu navigate through the requirements und implement workable solutions zu manage ihre obligations in Südkorea.

K-REACH Registration and Notification Requirements

K-REACH obligations depend on several factors, including:

Substance identity
Chemical inventory status
Annual manufacturing/import volume
Hazard classification
Intended use

In assessing whether a company muss take action prior to introducing chemical substances zu die market in South Korea, the company must evaluate its obligations.

New Chemical Substance Requirements

New chemical substances that haben nicht been listed on the Korean Existing Chemicals Inventory (KECI) muss go through necessary procedures before they are manufactured oder/and imported into Korea and put into the domestic market. Depending on annual quantity and related criteria in the relevant legislation, companies muss file:

Registration, or Notification procedures
Before the substance can be placed on the Korean market.

Existing Chemical Substance Requirements

Depending on the annual volume of the existing chemical substance(s) und its/Hers health hazards, the substance(s) may haben to go through the registration process under K-REACH and companies importing/manufacturing such substance(s) at 1 tonne or above in a year.

Annual import or manufacturing volume
Substance hazard profile
Applicable regulatory requirements
All Stoffe which are imported oder manufactured in quantities of 1 ton oder above need zu sein evaluated by the company regarding the K-REACH registration requirements.

GPC provides Korea REACH Registration Services , including:

Substance inventory verification
Registration obligation assessment
Tonnage evaluation
Regulatory strategy development

Arten der Registrierung unter K-REACH

Neue Substanz

Hersteller oder Importeure einesneue chemische Substanzdie Stoffe registrieren lassen müssen vorHerstellung oder Einfuhr. Für Stoffe, die weniger als 100 kg/Jahr ausmachen, ist nur eine Anmeldung erforderlich und es muss keine Gefahrenbewertung durchgeführt werden.

PEC-Stoff

Hersteller oder Importeure eines PEC-Stoffes (Priority Existing Chemicals) müssen die Stoffe registrieren vorHerstellung oder Einfuhr. Eine Vorregistrierung von PEC-Stoffen ist nicht möglich, da die Übergangsfrist bereits abgelaufen ist.

Vorhandene Substanz

Für Altstoffe über 1 Tonne pro Jahr (TPA) (außer ausgenommene Stoffe), müssen sie registriert werden innerhalb bestimmter Nachfristen. Nur Unternehmen, die eine Voranmeldung vorgenommen haben, können diese Fristen in Anspruch nehmen. Die Frist für die Registrierung von Altstoffen ist je nach Mengenbereich unterschiedlich. Nach Ablauf der Frist für jeden Mengenbereich können Altstoffe innerhalb des Mengenbereichs nicht mehr vorregistriert werden und müssen vor dem Inverkehrbringen der Stoffe in Korea registriert werden. K-REACH established die phased registration of existing chemical substances by substance category auf the basis of the annual amount of a substance und its hazard characteristics and established the respective registration deadline.

Substance Category	Registration Deadline
≥1,000 tonnes/year or CMR substances ≥1 tonne/year	Completed
100–1,000 tonnes/year	31 December 2024
10–100 tonnes/year	31 December 2027
1–10 tonnes/year	31 December 2030

Die same activities, however, need zu be started much earlier by the companies in order to allow for sufficient time for them.

Data assessment
Data gap analysis
Joint registration activities
Testing requirements
Dossier preparation

K-REACH Registrierungsprozess

K-REACH Only Representative (OR) Services

Andere einschlägige Verordnungen

K-BPR

Das Gesetz über das Sicherheitsmanagement von chemischen Konsumgütern und Bioziden (K-BPR) betrifft das Inverkehrbringen und die Verwendung von gefährlichen chemischen Konsumgütern und Biozid-Produkten und soll die öffentliche Gesundheit und die Umwelt vor diesen Chemikalien und Produkten schützen. Das K-BPR ist am 1. Januar 2019 in Kraft getreten, und seine jüngste Änderung wurde am 24. März und 26. Mai 2020 verkündet. Die Durchsetzung wird am 1. Januar 2021 beginnen.

Kosmetisches Gesetz

Das Kosmetikgesetz in Südkorea zielt auf die Entwicklung der Kosmetikindustrie und die Verbesserung der öffentlichen Gesundheit ab. Es ist seit dem 1. Juli 2000 in Kraft, und die jüngste Änderung trat am 7. April 2020 in Kraft.

KOSHA & MSDS

Sicherheitsdatenblätter sind ein Teil des Gesetzes über Sicherheit und Gesundheitsschutz am Arbeitsplatz (KOSHA). Der Zweck dieses Gesetzes ist es, die Sicherheit und Gesundheit von Menschen zu erhalten und zu fördern, die Arbeit durch die Einrichtung von Ständen für Sicherheit und Gesundheitsschutz am Arbeitsplatz.

Joint Registration and Data Sharing under K-REACH

Simplify Chemical Export Compliance to South Korea

Many foreign Hersteller want zu behalten. closer control of ihre chemical export compliance zu South Südkorea und therefore registrieren themselves as Only Representative.

An Only Representative enables a company zu behalten. full control of their compliance strategy und thus avoid relying too much on individual importers.

GPC’s K-REACH Only Representative services include:

Acting as regulatory representative in South Korea
Managing registration obligations
Supporting communication with Korean authorities
Maintaining importer information
Supporting joint registration activities
Protecting confidential business information
Maintaining registration information

With die expertise of K-REACH comes die experience of GPC zu support multinational companies in ihre entire compliance process.

Companies using the same chemical substance already on the market might have to register this in joint registration processes.

Joint registration helps companies:

Reduce unnecessary testing
Share available hazard information
Optimise registration costs
Submit consistent information to Korean authorities

GPC provides K-REACH joint registration support services, including:

Data gap assessment
Existing study evaluation
Consortium communication
Lead registrant coordination
Letter of Access (LoA) evaluation
Registration strategy development

K-REACH Registrierungsprozess

Our Structured Approach for K-REACH Compliance

Step 1 – Substance Assessment

GPC evaluates:

Substance identity
CAS-Nummer
Chemical composition
KECI inventory status
Annual import/manufacturing volume

Step 2 – Regulatory Assessment

Our experts determine:

Whether registration is required
Applicable deadlines
Data requirements
Possible exemptions
Compliance pathway

Step 3 – Data Gap Analysis

We review available information, including:

Toxicological studies
Ecotoxicological data
Physicochemical information
Existing regulatory data

Step 4 – Dossier Preparation and Submission Support

GPC supports:

Technical dossier preparation
Hazard information compilation
Risk assessment documentation
Registration submission activities

Step 5 – Post Registration Compliance Support

Including:

Regulatory updates
Registration maintenance
Changes in substance information
Supply chain communication

K-REACH Registration Data Requirements

Registration requirements for Stoffe dass are to be registered are determined by the type of substance, the respective tonnage band and the respective hazard Informationen.

Typical information requirements may include:

Substance Identity Information

Chemical name
CAS-Nummer
Molecular information
Composition details
Impurity information

Physicochemical Information

Examples include:

Physical state
Melting point
Boiling point
Vapour pressure
Water solubility
Partition coefficient

Toxicological and Ecotoxicological Information

Including:

Acute toxicity
Skin corrosion and irritation
Eye irritation
Sensitisation
Genetic toxicity
Repeated dose toxicity
Aquatic toxicity
Environmental fate information

Risk Assessment Information

For applicable substances:

Bewertung der Exposition
Risikobeschreibung
Stoffsicherheitsbericht (CSR)

As a supporting service for the K-REACH dossier, GPC evaluates die data, prepares the relevant regulatory documents, and assists with the corresponding scientific assessment.

Chemical Evaluation, Authorization and Restrictions under K-REACH

Chemical Stoffe registered under K-REACH will sein evaluated by Korean authorities after registration.

Evaluation may consider:

Hazard properties
Exposure potential
Production/import volume
Risk concerns
Substances identified as posing significant risks may become subject to:
Priority management
Authorization requirements
Restrictions
Prohibition measures

GPC’s K-REACH experts assist companies auf eine ongoing basis with all K-REACH-related matters, including changes in substance-related legislation.

K-REACH Exemptions

There are instances where certain Stoffe kann sein exempted from K-REACH oder the regulations can be applies on a more simplified basis depending on die characteristics of the substance und its use.

Potential exemptions may include:

Certain polymers
Research and development substances
Certain intermediates
Other substances meeting regulatory criteria
A substance-specific assessment ist required zu confirm whether an exemption is granted or not.

As part of our services, GPC’s K-REACH consultants assess possible exemptions for a given substance und recommend appropriate measures to comply with relevant regulations.

K-REACH Consulting Services and Compliance Support by GPC

Comprehensive K-REACH consulting services for global companies zu comply mit chemical regulatory requirements in South Korea by GPC.

Our support includes:

K-REACH Regulatory Assessment Services

Substance applicability review
KECI inventory check
Registration obligation assessment
Compliance strategy development

K-REACH Registration Services

Registration planning
Data gap analysis
Dossier preparation
Testing strategy support
Regulatory submission assistance

K-REACH Only Representative Services

Korean OR appointment
Authority communication
Importer management
Registration maintenance

Ongoing K-REACH Compliance Support

Regulatory monitoring
Registration updates
Supply chain communication
Compliance reviews

Why Choose GPC for K-REACH Compliance?

GPC Chemical Services is a leading chemical regulatory consultant mit experience serving customers worldwide who require specialized chemical compliance services.

Our experts combine:

Global chemical regulatory experience
Scientific and technical expertise
Practical industry knowledge
Experience with REACH-type regulations globally

Efficient strategies for corporate compliance, minimization of risks associated with regulatory non-compliance, and access to the Korean market.

Discuss Your K-REACH Compliance Requirements with Our Experts

Get Tailored Regulatory Support for Your Business Needs

For each company the scope of their K-REACH obligations can vary widely. It depends auf the composition of their substance portfolio, ihre supply chain, ihre production volumes and ihre business objectives.

At GPC, we fully understand die specific chemical regulatory requirements for your business and offer expert advice zu ensure dass your company ist compliant with all K-REACH requirements und continues zu develop within die global market.

Our K-REACH Experts will assess your K-REACH compliance requirements, review your substance portfolio und inform you of all die relevant requirements that apply to you and provide a most effective route for compliance in Korea.

If you need assistance mit die K-REACH registration of a chemical or the services of an Only Representative for foreign manufacturers importing chemicals into South Korea or need a straightforward regulatory assessment of the required measures for your chemicals or preparation, we will sein happy zu assist you mit die preparation of die required dossiers and to monitor and implement the required measures for you on an ongoing basis.

Contact GPC today to discuss your K-REACH requirements and receive expert regulatory support for successful access to the South Korean market.

Frequently Asked Questions About K-REACH

1. Is K-REACH similar to EU REACH?

Yes, K-REACH resembles EU REACH requirements. Anmeldung, evaluation, risk assessment, and supply chain communication also apply within the scope of the K-REACH act. However, K-REACH is a separate law mit different requirements and procedures than those in force within EU REACH.

2. Does a foreign manufacturer need a K-REACH Only Representative?

Companies from all over the world that are exporting chemicals oder manufactured articles into South Korea kann also benefit from an K-REACH Only Representative in order zu meet und comply mit all of die various South Korean Chemical regulations.

3. How do I know if my substance requires K-REACH registration?

Whether a substance has zu sein registered by KECI, based auf the imported volume during a year, hazard classification code und verwenden. classification code, etc. A K-REACH regulatory assessment is recommended to clarify die obligations of a substance.

4. Can EU REACH registration be used for K-REACH?

EU REACH Informationen may sein of value in a K-REACH registration, however, information required for compliance with EU REACH does not automatically fulfill K-REACH requirements.

5. How can GPC support K-REACH compliance?

Complete K-REACH consulting services for chemical importers including a regulatory assessment and compliance advice, a K-REACH registration, eine Only Representative service and K-REACH dossier preparation und joint registration assistance. GPC will also manage on-going compliance with the K-REACH legislation for you.