Normativa coreana sobre productos químicos

Corea REACH (K-REACH)

Korea REACH (K-REACH) Compliance Services

Chemical Compliance Expert for South Korea – Korea REACH Registration Services

En Act on Registration and Evaluation, etc. of Chemicals (K-REACH), enacted as South Korea’s chemical management law, requires registration of chemicals que son manufactured or/and importado into and/o son 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 que 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 en order a complete shipments smoothly y a avoid any kind of obstructing interruptions to business.

¿Qué es K-REACH (Korea REACH)?

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

Act en Inscripción and Evaluation, etc. of Chemicals came into effect en January 1, 2015 and aims at safe management of chemical substances by requiring registration, evaluation and control of chemicals y 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 a navigate through the requirements y implement workable solutions a manage su obligations en 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 debe take action prior to introducing chemical substances a el market in South Korea, the company must evaluate its obligations.

New Chemical Substance Requirements

New chemical substances that tienen no been listed on the Korean Existing Chemicals Inventory (KECI) debe go through necessary procedures before they are manufactured o/and imported into Korea and put into the domestic market. Depending on annual quantity and related criteria in the relevant legislation, companies debe 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) y its/Hers health hazards, the substance(s) may tienen 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 sustancias which are imported o manufactured en quantities of 1 ton o above need a ser 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

Tipos de registro en el marco de K-REACH

Nueva sustancia

Fabricantes o importadores de una nueva sustancia química necesidad de registrar las sustancias antes defabricación o importación. Para sustancias de menos de 100 Kg/año, sólo se requiere notificación y no es necesario pasar por la evaluación de peligros.

Sustancia PEC

Los fabricantes o importadores de sustancias PEC (sustancias químicas existentes con carácter prioritario) deben registrar las sustancias antes defabricación o importación. El prerregistro de sustancias PEC no es posible porque ya ha transcurrido el periodo transitorio.

Sustancia existente

Para las sustancias existentes superior a 1 tonelada al año (TPA) (excluidas las sustancias exentas), deben estar registradas dentro de los periodos de gracia establecidos. Sólo las empresas que hayan efectuado una notificación previa podrán acogerse a los periodos de gracia. La fecha límite para el registro de sustancias existentes varía en función de la banda de tonelaje. Después de la fecha límite para cada banda de tonelaje, las sustancias existentes dentro de la banda de tonelaje no pueden ser pre-registradas, y deben ser registradas antes de colocar las sustancias en Corea. K-REACH established el phased registration of existing chemical substances by substance category en the basis of the annual amount of a substance y 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

En same activities, however, need a 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

Proceso de inscripción en K-REACH

K-REACH Only Representative (OR) Services

Otras normativas relacionadas

K-BPR

La Ley de Gestión de la Seguridad de los Productos Químicos de Consumo y Biocidas (conocida como K-BPR) se refiere a la comercialización y el uso de productos químicos de consumo y biocidas peligrosos, cuyo objetivo es proteger la salud pública y el medio ambiente de estas sustancias químicas y productos. La K-BPR entró en vigor el 1 de enero de 2019, y su reciente enmienda fue promulgada el 24 de marzo y el 26 de mayo de 2020. Su aplicación comenzará el 1 de enero de 2021.

Ley de cosméticos

La Ley de Cosméticos de Corea del Sur tiene por objeto desarrollar la industria cosmética y mejorar la salud pública. Se aplica desde el 1 de julio de 2000, y su reciente modificación entró en vigor el 7 de abril de 2020.

KOSHA & MSDS

Las FDS forman parte de la Ley de Seguridad y Salud en el Trabajo (KOSHA). El objetivo de esta Ley es mantener y promover la seguridad y la salud de las personas que prestan trabajo estableciendo tribunas sobre seguridad y salud en el trabajo.

Joint Registration and Data Sharing under K-REACH

Simplify Chemical Export Compliance to South Korea

Many foreign fabricantes want a guarda closer control of su chemical export compliance a South Corea y therefore regístrese en themselves as Only Representative.

An Only Representative enables a company a guarda full control of their compliance strategy y 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 el expertise of K-REACH comes el experience of GPC a support multinational companies en su 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

Proceso de inscripción en K-REACH

Our Structured Approach for K-REACH Compliance

Step 1 – Substance Assessment

GPC evaluates:

Substance identity
Número 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 sustancias que are to be registered are determined by the type of substance, the respective tonnage band and the respective hazard información.

Typical information requirements may include:

Substance Identity Information

Chemical name
Número 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:

Evaluación de la exposición
Caracterización del riesgo
Informe sobre la seguridad química

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

Chemical Evaluation, Authorization and Restrictions under K-REACH

Chemical sustancias registered under K-REACH will ser 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 en un ongoing basis with all K-REACH-related matters, including changes en substance-related legislation.

K-REACH Exemptions

There are instances where certain sustancias puede ser exempted from K-REACH o the regulations can be applies on a more simplified basis depending on el characteristics of the substance y its use.

Potential exemptions may include:

Certain polymers
Research and development substances
Certain intermediates
Other substances meeting regulatory criteria
A substance-specific assessment es required a 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 y 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 a 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 en the composition of their substance portfolio, su supply chain, su production volumes and su business objectives.

At GPC, we fully understand el specific chemical regulatory requirements for your business and offer expert advice a ensure que your company es compliant with all K-REACH requirements y continues a develop within el global market.

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

If you need assistance con el 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 ser happy a assist you con el preparation of el 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. Inscripción, 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 o manufactured articles into South Korea puede also benefit from an K-REACH Only Representative en order a meet y comply con all of el various South Korean Chemical regulations.

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

Whether a substance has a ser registered by KECI, based en the imported volume during a year, hazard classification code y utilisar classification code, etc. A K-REACH regulatory assessment is recommended to clarify el obligations of a substance.

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

EU REACH información may ser 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, un Only Representative service and K-REACH dossier preparation y joint registration assistance. GPC will also manage on-going compliance with the K-REACH legislation for you.