Regolamento coreano sulle sostanze chimiche

Corea REACH (K-REACH)

Korea REACH (K-REACH) Compliance Services

Chemical Compliance Expert for South Korea – Korea REACH Registration Services

Il Act on Registration and Evaluation, etc. of Chemicals (K-REACH), enacted as South Korea’s chemical management law, requires registration of chemicals that are manufactured or/and imported into and/or are 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 that 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 to complete shipments smoothly e to avoid any kind of obstructing interruptions to business.

Che cos'è K-REACH (Korea REACH)?

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

Act on Registrazione and Evaluation, etc. of Chemicals came into effect on January 1, 2015 and aims at safe management of chemical substances by requiring registration, evaluation and control of chemicals e 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 to navigate through the requirements e implement workable solutions to manage their obligations in Corea.

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 must take action prior to introducing chemical substances to il market in South Korea, the company must evaluate its obligations.

New Chemical Substance Requirements

New chemical substances that have not been listed on the Korean Existing Chemicals Inventory (KECI) must go through necessary procedures before they are manufactured or/and imported into Korea and put into the domestic market. Depending on annual quantity and related criteria in the relevant legislation, companies must 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) e its/Hers health hazards, the substance(s) may have 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 substances which are imported or manufactured in quantities of 1 ton or above need to be 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

Tipi di registrazione nel quadro di K-REACH

Nuova sostanza

Produttori o importatori di unnuova sostanza chimicanecessità di registrare le sostanze prima difabbricazione o importazione. Per le sostanze inferiori a 100 kg/anno, è richiesta solo la notifica e non è necessario sottoporle alla valutazione dei pericoli.

Sostanza PEC

I produttori o gli importatori di sostanze PEC (Priority Existing Chemicals) devono registrare le sostanze. prima difabbricazione o importazione. La pre-registrazione della sostanza PEC non è possibile in quanto il periodo di transizione è già trascorso.

Sostanza esistente

Per le sostanze esistenti superiore a 1 tonnellata all'anno (TPA) (escluse le sostanze esenti), devono essere registrati entro determinati periodi di tolleranza. Solo le aziende che hanno effettuato la pre-notifica possono avere diritto ai periodi di tolleranza. La scadenza per la registrazione delle sostanze esistenti varia in base alla fascia di tonnellaggio. Dopo la scadenza per ogni fascia di tonnellaggio, le sostanze esistenti all'interno della fascia di tonnellaggio non possono essere preregistrate e devono essere registrate prima di immettere le sostanze in Corea. K-REACH established il phased registration of existing chemical substances by substance category on the basis of the annual amount of a substance e 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

Il same activities, however, need to 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

Processo di registrazione K-REACH

K-REACH Only Representative (OR) Services

Altri regolamenti correlati

K-BPR

La legge sulla gestione della sicurezza dei prodotti chimici di consumo e dei biocidi (nota come K-BPR) riguarda l'immissione sul mercato e l'uso di prodotti chimici di consumo e biocidi pericolosi, con l'obiettivo di proteggere la salute pubblica e l'ambiente da tali sostanze e prodotti. Il K-BPR è entrato in vigore il 1° gennaio 2019 e i suoi recenti emendamenti sono stati promulgati il 24 marzo e il 26 maggio 2020. La sua applicazione inizierà il 1° gennaio 2021.

Legge sui cosmetici

La legge sui cosmetici in Corea del Sud mira a sviluppare l'industria cosmetica e a migliorare la salute pubblica. È in vigore dal 1° luglio 2000 e la recente modifica è entrata in vigore il 7 aprile 2020.

KOSHA & MSDS

La scheda di sicurezza è una parte della legge sulla sicurezza e la salute sul lavoro (KOSHA). Lo scopo di questa legge è quello di mantenere e promuovere la sicurezza e la salute delle persone che forniscono lavoro istituendo stand sulla sicurezza e la salute industriale.

Joint Registration and Data Sharing under K-REACH

Simplify Chemical Export Compliance to South Korea

Many foreign manufacturers want to keep closer control of their chemical export compliance to South Corea e therefore register themselves as Only Representative.

An Only Representative enables a company to keep full control of their compliance strategy e 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 il expertise of K-REACH comes il experience of GPC to support multinational companies in their 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

Processo di registrazione K-REACH

Our Structured Approach for K-REACH Compliance

Step 1 – Substance Assessment

GPC evaluates:

Substance identity
Numero CAS
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 substances that are to be registered are determined by the type of substance, the respective tonnage band and the respective hazard information.

Typical information requirements may include:

Substance Identity Information

Chemical name
Numero CAS
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:

Valutazione dell'esposizione
Caratterizzazione del rischio
Relazione sulla sicurezza chimica (CSR)

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

Chemical Evaluation, Authorization and Restrictions under K-REACH

Chemical substances registered under K-REACH will be 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 on an ongoing basis with all K-REACH-related matters, including changes in substance-related legislation.

K-REACH Exemptions

There are instances where certain substances can be exempted from K-REACH or the regulations can be applies on a more simplified basis depending on il characteristics of the substance e its use.

Potential exemptions may include:

Certain polymers
Research and development substances
Certain intermediates
Other substances meeting regulatory criteria
A substance-specific assessment is required to 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 e 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 to comply con 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 con 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 on the composition of their substance portfolio, their supply chain, their production volumes and their business objectives.

At GPC, we fully understand il specific chemical regulatory requirements for your business and offer expert advice to ensure that your company is compliant with all K-REACH requirements e continues to develop within il global market.

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

If you need assistance con il 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 be happy to assist you con il preparation of il 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 UE REACH requirements. Registrazione, evaluation, risk assessment, and supply chain communication also apply within the scope of the K-REACH act. However, K-REACH is a separate law con 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 or manufactured articles into South Korea can also benefit from an K-REACH Only Representative in order to meet e comply con all of il various South Korean Chemical regulations.

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

Whether a substance has to be registered by KECI, based on the imported volume during a year, hazard classification code e use classification code, etc. A K-REACH regulatory assessment is recommended to clarify il obligations of a substance.

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

UE REACH information may be 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, an Only Representative service and K-REACH dossier preparation e joint registration assistance. GPC will also manage on-going compliance with the K-REACH legislation for you.