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Overview of "K-REACH"

and its Regulatory Implementation

May , 2016

Wei(William) Zhou
Regulatory Consultant
REACH24H Consulting Group
--Value in Compliance
Purpose of webinar
To help comprehensively understanding on the obligations and
special registration types under K-REACH

To track and analysis the most important updates of chemical


control acts in South Korea besides K-REACH

To provide tips for better compliance with K-REACH to maintain or


even expand your business

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Content

Part 1-Overview main obligations under K-REACH/OSHA/CCA

Part 2- Compliance instructions and Experience sharing

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Part 1 overview main obligations under K-REACH/OSHA/CCA

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Legislation background

Chemical industry reality


Korea is a chemicals importing country, mainly import from Japan, China, the United States,
the European Union countries

Amount of chemicals circulated in South Korea market


44,000 Existing chemicals ;
300 new substances entering market per year;
6800 hazardous chemicals

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Chemical substance management process
Chemical
substance
Priority evaluation
Existing substances authorization
existing substances

Annual report registration Completeness Hazard


Risk assessment
check evaluation

New substances Toxic substances Restricted/prohibite


d substances

Note
3 year grace period for PEC substancesjoint registration for same PEC
Even less than 1 ton/year, registration is required for substances with high hazard to human health and
the environment as designated by MOE through the discussion of relevant ministries
Supply chain communication

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Chemical product management process
Chemical
product
Products contain hazardous
substances Product notification
(above 0.1%&1t/a)

yes Manufacture or
import approval

Designation of risk Safety & labeling


Risk assessment
concerned product standard

no Sale
prohibition/withdraw

Note
Risk concerned product designated by MOE such as products for daily use and use for biocides
Product safety and labeling standard (draft) is still under review by chemical safety evaluation
committee(CSEC)
Application of exemption from product notification when meet the exception conditions

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K-REACH scope
substancenew substance and existing substance

existing substance
chemical substances distributed in the market and announced by the MOE in consulting with the
MOEL before 2 Feb, 1991
chemical substances finished hazard review under TCCA and announced by MOE after 2 Feb,
1991
new substancemeans all chemical substances excluding existing chemical substances
NCIS(National Chemical Information System)
NCIS website http://ncis.nier.go.kr/main/Main.jsp

productmixture and article

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K-REACH exemption scope
Radioactive substances
Pharmaceuticals and quasi-pharmaceutical drugs
Narcotics
Cosmetics and its raw materials
Agrochemicals and its raw ingredients
agrochemicals Fertilizers
Food, food additives, tools, containers and package
Livestock and fish feeds
Ammunitions
Military supplies
Health functional food
Medical devices

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K-REACH Authority
K-REACH obligation Exemption Simplified General registration and Annual report and
registration enquiry notification of
product
Relevant authority KCMA NIER NIER REO
Official process and Review and Review and issue of Enquiry (within 14d) Annual report
period exemption approval registration no. and Before Jun 30
issued within 3d date or further Completeness check and
requirement within Issue of Registration no. Product notification
In case of further 3 ~7days and date or further Review and issue of
consultation with requirement within 30 confirmation notice
NIER, the exemption days from the or further
approval is issued submission date requirement within 7
within 10 days days
Hazard assessment and
issue of assessment
result
within 6 months for new
chemical,
within 1 year for existing
substance subject to
registration

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Obligation and penalty
Article under k-reach Related obligation Penalty
Article 37 and 38 Safety and label standard Imprisonment not exceeding 7 years
- Fine up to 200,000,000 WON.

Article 10, 32 and 38 registrationnotification Imprisonment not exceeding 5 years


- Fine up to 100,000,000 WON.

Article 8,11,18,24,32,38 Annual reportregistration Imprisonment not exceeding 3 years


exemption application - Fine up to 50,000,000 WON.

Article 29,30,35 Chemical information Imprisonment not exceeding 1 years


communicationSDS - Fine up to 30,000,000 WON.

Article 12,15,29,43,44 updatekeep records and Fine up to 10,000,000 WON.


document

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Annual report
Reporting of manufacture (Article 8)
A person who manufacture, import or sell all new chemical and existing chemical
exceeding 1 ton/year shall report its amount and use etc. to the MOE (the local
Environmental agency) annually

substance Legal entity time Data requirement


1 ton/year for manufacture The volume Company information
existing importer during Jan. 1 importer,
chemicals OR on behalf of Dec. 31 of the manufacturer)
New chemicals foreign manufacture previous year
shall be reported OR information
seller Substance information
until Jun 30 of
every year tonnage
Specific use55 types

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Annual report
Exemption from annual report
Directly exemption
Chemical substance imported as incorporated in machines
Chemical substance imported along with machines or devices for commissioning test
Chemical substances in products in solid form, preforming certain
Functions and does not release during normal condition of use
Other chemical substances as listed in the presidential decree that are manufactured or imported for
uses in research, studies, etc.

Annual report update

In case of any changes made by manufacturer, importer or seller, the change shall be reported within
1 month after the change takes place
In case of any changes made in use category, the change shall be reported within 1 month after the
noticed the change

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Registration
Registration (Article 10)
Existing chemicals subject to registration 1 ton/year and new chemicals required to be
registered prior to their manufacture or import
Even less than 1 ton/year, registration is required for substances with high concerns to human
health and the environment as designated by MOE through the discussion of relevant
ministries

substance Legal entity time

Existing substance manufacturer existing chemical subject


subject to registration importer to registration has 3 years
(above 1t/a) and New OR on behalf of foreign transition period
substance (no volume manufacture New substance should be
limit) registered before
manufacture or import

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Registration
Transition period for registration
existing chemical is subject to registration has 3 years from the publication of the priority list
The first PEC list (final) issued in July.1, 2015, containing 510 substances
New substance has no transition period

Public notice of
existing chemical subject to registration

2014 2015 2018.6 2021 2024

First batch & registration Second batch & registration Third batch & registration

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Registration
Data requirement for general registration

Company information Company name, address, name of representative, etc.

Only representative information name, address, contact person, etc.

Chemical identity information Chemical name, molecular formula, chemical structure, CAS No, Purity
(%), etc.

Use information Use category, chemical specific use description, etc.

Classification and labeling Korea GHS

PC/toxicological /environmental and Data requirement based on different tonnage


eco-toxicological data
CSR(chemical safety report) Risk assessment report for registered substance 10 t/a

Guidance on safe use Risk management measures, such as protective equipment

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Registration
Data requirement for general registration

Data requirement 0.1-1t/a 1-10t/a 10-100t/a 100-1000t/a >1000 t/a


(from 2020.1.1 for new
chemical substances)
PC 5 5 7 9 12

Toxicity 2 4 8 11 15

Eco-environment 2 2 5 13 19

In total 9 11 20 33 46

Data source requirement


Local lab designated by MOE and non-Korea OECD-GLP lab for Log Kow/toxicological /environmental
and eco-toxicological data
Accept QASR and read across data with quality
Test plan submission for certain endpoint
Data protection period: 5 years(extendable for 2 times with 5 year per each time)

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Registration
Risk assessment -CSR
tonnage Submission time for CSR

100t/a Jan.1.2015

70t/a Jan.1.2017

50t/a Jan.1.2018

20t/a Jan.1.2019

10t/a Jan.1.2020

CSR information requirement


Overall conclusions/Results of the Risk Assessment, General Substance Information, General Information on
Exposure(Environment Exposure, Effects Assessment, risk characterization, etc.), conclusions/results

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Registration
Exemption for registration
Direct exemption
Chemical substance imported as incorporated in machines
Chemical substance imported along with machines or devices for commissioning test
Chemical substances in products in solid form, preforming certain
Functions and does not release during normal condition of use
Low volume exemption (less than 1 ton/year) for existing substance subject to registration

Application for registration exemption confirmation


Manufactured or imported less than10 ton per year only for export/ to manufacture another chemical
substance of which the whole amount is exported to foreign countries (annually)
Reagents for scientific study, analysis or research only the first time
R&D purpose of (only the first time)
Development of chemicals or products
Improvement or development of process
Testing application scope of chemicals
Pilot product
Non-isolated Intermediates (only the first time)
Isolated intermediate which are not released and are blocked from the exposure (only the first time)
Substances with low concerns announced by ministerial decree(only the first time)
PLC(only the first time)

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Registration
Data requirement for exemption confirmation of registration

registration exemption confirmation Data requirement


type

Manufactured or imported only for Substance name, CAS no/KE no,


export up to 10 ton/year tonnage to be exported;
exporting country
Regents and R&D Substance name, CAS no/KE no, tonnage;
description of use information;
Summary of process improvement/development, application
scope, pilot production;
process flowchart(optional);
CL(if available);
guidance on safe use;
transportation plan, etc.
Surface treated substances Substance name, CAS no/KE no, tonnage;
Process flowchart showing surface treatment
Chemical structure based on chemical and treated chemical
ratio of surface treated and treating substances

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Registration
Registration exemption for PLC
1. Subject of exemption a) When average molecular weight of polymers is not less
from registration/definition of low than10,000 daltons, molecules with molecular weight less than
concern polymer 500 daltons have less than 2% content, and molecules with
molecularweight less than 1000 daltons have less than 5%
content;
b) When average molecular weight of polymers is 1,000-
10,000daltons, molecules with molecular weight less than 500
daltonshave less than 10% content, and molecules with
molecular weightless than 1000 daltons have less than 25%
content
2. Exception of polymer a) Cationic polymer (exception: polymer which is used only
subject to exemption in solid state, and insoluble or not dispersible)
from registration b) Polymer whose number-average molecular weight is less
than10,000 daltons and which contains more than 2% of
monomersthat are new chemical substance, hazardous
chemical substance and specific chemical substance prescribed
by Presidential Decree due to its hazard or risk

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Registration
Simplified registration only for new chemical

Registration type Simplified registration General registration

Tonnage trigger <1t/a(before 2020) 100kg/a~1t/a(after 2020)


<100kg(after 2020)
Process time 3~7d 30d

Risk assessment no no

Data requirement Company information Additionally,


Only representative information (Data requirement as 1-10t general
Importer information registration)
Chemical substance information Physical-chemical data
Use category Hazard data
Simple description of exposure C&L
information Guidance on safe use
No test data requirement

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Registration
Polymer(non PLC) registration-registration for polymer , not monomer

Polymer Data for Polymer properties other Data requirement


registration (for general registration)
0.1-1t/a 1-10t/a 10-100t/a

1-10t/a Number average molecular physical status


weight water solubility
Monomer information melting/freezing point
Remaining monomers(%) boiling point
The content of Mn less than 1,000 vapor pressure
Stability test in acid or alkaline
solution
10-100t/a

100-1000t/a

>1000t/a

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Registration
Biocides registration

Biocides Biocides scope other Data requirement


registration (for general registration)
1-10t/a 10-100t/a 100-1000t/a >1000t/a

0.1-1t/a The use of the substance is the


(from 2020) key factor to classify the
substance to biocide;
1-10t/a
Substance is function as biocides
rather than agriculture use
10-100t/a Such as preservative, detergents

>100t/a

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Registration
Isolated intermediate registration

Isolated intermediate scope Data requirement

Except non-isolated intermediates Registrant information (name, address, contact info)


Substance is completely reaction Substance information (name, CAS no, concentration,
during the production of another molecular formula, impurities and etc)
substance Brief use description
C&L
Physico-Chemical Properties of General data requirement
Healthy toxic and environmental toxic data
Hazardous and Risk Information (if available)
Guidance on safe use (if available)
Other information requested by Ministerial Decree (if available)

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Registration
Joint registration-mandatory
Jonint registration

(1)Appointment of lead registration


Joint submission (2) Cooperation between co-registrants
process Selection and generation of test data submitted
Sharing of data cost (LOA shall be done equally with consideration to the number of
registrants and the tonnage band)
Preparation and submission of submission dossier
(3) Submission by the lead registrant, followed by the submission of each member registrant
(substance basic information, such as chemical name, concentration, ton)
Joint submission data Physico-Chemical Properties
Hazards Data
Test proposals
Risk Information (all joint registrants need to be agreed)
Guidance on safe use (all joint registrants need to be agreed)
To protect business information
Opt-out Joint submission costing more
Causing different C&L from an endpoint

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Registration
Data sharing and inquiry

step registration enquiry process

Step 1 Submission of inquiry application form to the NIER (Applicant information


, chemical information, such as CAS no, use category)
Step 2 Review and formal response from NIER within 14 days
registration status of the chemical inquired
Previous registrants information and registered data
Previous enquired potential registrants
Step 3 Approval from data owners to prepare submission dossier in agreement of cost

Step 4 Submission of dossier to NIER with approval document showing permission from data
owner
Data sharing Physico-chemical data
Hazards data
Data submitted with registration can be used freely after 15 years

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Notification of products
Notification of products containing hazardous chemical substances

Notification conditions (1) Total amount of each hazardous chemical contained in a manufactured or imported
(both 1 and 2) product yearly 1 ton/year
(2) Content of the hazardous chemical contained in a product 0.1%(w/w)
Notification legal entity Manufacture, importer or only representative(OR)

Product definition Product in mixture


Article in which the chemical substance contained in it performs a certain function in
the form of a solid without release during use
Hazardous chemicals Toxic chemical, Chemicals for authorization, Restricted / Prohibited chemicals
(same as MOE and published by MOE)
Information required Notification person information, product information, containing hazardous chemical
for notification substance information(name, %, GHS, function), use of product
Confirmation of A chemical substance to which humans or environment is not exposed where a
exemption from product is normally used;
notification A chemical substance already registered according to article 10 for use of relevant
product

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Management of products of risk concern
Assessment and safe labeling of products of risk concern

Scope of risk products Product with risk to human health and environment and published by MOE through
consultation with relevant Ministries, belong but not limited to:
Household product for general consumer use such as cleansing agent, air freshener,
adhesive, polish, deodorizer, detergent, whitener and softener
Biocidal products such as insecticide, disinfectant, and preservative
15 kind of consumer products has been published in 2015-86 guidance

Risk assessment of risk Minister of Environment will perform Risk Assessments on product
products when categories containing hazardous chemical substances which may
necessary cause harmful damages to human health and environment
Safety labeling for risk MOE have designate and announce safety standards and lebelling standards for risks for
products each product of risk concern after product risk assessment completed
Products management Products not satisfying safety and labelling criteria can not be sold, even withdraw;
Substances in risk concerned products with no safety and labelling criteria can be
requested for registration

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supply chain Communication
Information communication for annual report, registered substances and notified products

Manufacture /importers Downstream user/seller


Substance /products information Name
Possible/restricted uses Substance /products information
Registered information Use/sell tonnages
C&L Specific use information
Containing hazardous chemical Exposure information
substance name and content % Risk management measures
Guidance on safe use

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Only representative
Only representative appointed by overseas manufactures (Article 38, 49-54)
A foreign manufacturer who intends to fulfill obligations is required to appoint OR to fulfill the obligation of the
importer;
Annual reporting, reporting update
Application of registration, etc. Registration update , exemption application, inquiry,
Product notification, exemption application, information communication of hazardous substance in product
Supply chain communication
CBI application

OR notification and legal responsibility

OR notification OR shall notify the nomination or dismissal of Only representative to the local
environmental office with relevant documents

OR legal responsibility Penalty will be imposed to OR for offense, heavy fine and imprison

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Legal entity to comply obligation under K-REACH
Outside of Korea

Non Korea
manufacturer A Foreign
formulator B
Foreign exporter C

In Korea Competent Authority Only RepresentativeOR


customs

Korea importer 1 Korea importer 2

Note:
(1)Article 38 of K-REACH states that Only manufacture and producer can appoint OR for K-REACH.
(2) Either Foreign manufacturer of the substance or Foreign down-steam producer(formulator) can appoint OR for K-
REACH compliance on behalf of the Korean importers of ones own.
(3) Foreign manufacturer can appoint OR and apply for registration on behalf of Korea importers of his foreign down-
steam formulator.
(4) MoE has clearly stated that trade corporations which not involved in manufacture or produce(formulate) of the
substance cannot be entitled to appoint OR for their K-REACH compliance.

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Obligation of substance registration under K-OSHA

Article 40 (Investigation of Harmfulness and Hazardousness of New Chemicals)


(1) An employer who intends to manufacture or import the new chemicals other than
those prescribed by the Presidential Decree shall investigate the harmfulness and
hazardousness of the new chemicals under the conditions prescribed by the Ordinance of
the Ministry of Labor and submit the investigation report to the Minister of Labor in
order to prevent workers' health problems which might be caused by the chemicals,
except in any of the following cases:

Since K-REACH enforcement, all dossier including hazard test studies for KREACH
registration can be used to cover OSHA registration, without the further data
development.

But there is still conflict in required data between two regulations, only regarding
registration of tonnage band 0.1 to 1 t/y.

prior confirmation of exemption from OSHA registration is required for new chemicals with
less than 100kg.

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Conflict K-REACH vs K-OSHA: Registration with 0.1 to 1 t/y

New chemicals is required to be registered according to both K-REACH and Korea OSHA.

Dossier for Registration over 1 t/y under K-REACH can be used to cover Registration under
OSHA
: No further data development

Registration 0.1~1 t/y is critical: need the additional action to comply with OSHA until 2020

Before 2020 K-REACH OSHA


Tonnage < 0.1t/y 0.1t/y ~ 1t/y < 0.1t/y 0.1t/y ~ 1t/y
Required Data Dossier only Only K-REACH Hazard data required
No hazard data registration
-Acute toxicity oral
-AMES
(-Micronucleus Test)

Note: Micronucleus test can be exempted at present, but MOEL might ask for
additional test according to hazard of new chemical.

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How Can Non-Korea exporter comply with K-OSHA?

K-OSHA
When Exporting can be done only after getting the registration notices both from MOE and MOEL.

Who the registration obligators are Korea importers and Korea manufacturers.

How There is no an OR(only representative) conception.

TPR is necessary to proceed with new chemical registration, without disclosing the substance information
(such as chemical name, CAS No, structural formulae, etc.) to the Korea importer.

Every importer should do their own registration under OSHA.

Administrative fee No administrative fee

Penalty (1) A person violates new substance registration under Article 40 shall be published by a fine not exceeding
ten million won;
(2) A person fails to keep and post the Material safety data sheet under Article 41 shall be published by a
fine not exceeding five million won.

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Obligation of written confirmation under CCA

Article 9: Manufacturer or Importer of chemicals shall submit a Witten Confirmation of Details for
Chemical Product to the KCMA prior to manufacture or import after careful self-evaluation whether it
contains any regulated chemical.

Important issues need to be clarified:

Regulated chemicals

Subject to submission

Number of submission for Written confirmation and Letter of confirmation

Procedure

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Regulated chemicals under CCA

Phase-in substance(s) to registration

Non phase-in substance(s)

Toxic substance(s)

Substance(s) subject to authorization

Restricted Substance(s)

Prohibited Substance(s)

substance(s) requiring preparation for accidents

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Part 2 Compliance instructions and Experience sharing

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Substance/ Product information collection and identification
Firstly, Substance/ Product information Collection
Chemical name and each components in the product
CAS no. (if any)
Expected tonnage
Use information in Korea

Secondly, check KECI inventory and confirm the status of Substance


NCIS website http://ncis.nier.go.kr/main/Main.jsp
Confidential inventory check if necessary

Thirdly, confirm the corresponding obligation,


reporting,
registration,
exemption application, etc.
------------------------------------
Note: An impurity or by-product is defined as an unintended constituent present in the
manufactured substance. While it is present in the final substance it was not intentionally added.
It could not be released independently in market and imported by itself.

In this case, Impurities and by-products are not subject to registration and can be directly exemption
from K-REACH.

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Registration exemption confirmation-PLC

Step 1 Checking status: New chemicals & PEC (above 1t/a)

Step 2 Polymer definition and PLC criterion


(refer to page 9)
Step 3 Data preparation and well-organized GPC report
(Any kind of certificate on GPC report is not necessary)
CBI consideration

Step 4 Dossier submission by legal entity (importer or OR)


POA and OR nomination is required in advance

Step 5 KCMA review dossier and issue the confirmation


certification (or require supplementary information )
3-7days for official process

Authority published the template of well-organized GPC report


for assessment (only Korean version available):
a)Name and address of laboratory
b)Name, title, and signature of the person in charge of GPC test
c)Identity information of the tested substance
d)Test condition
e)System correction
f)Testing method
g)Test result

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Joint Registration for PEC under K-REACH

General work flow for Joint registration Cautions when take part in the consortiums

Step 1 Conclusion of agreement The method for identifying the SIP (Substance
Identification Profile) will be decided by each consortium
group of the substances.
Step 2 Select a lead registrant
there is no pre-registration system under K-REACH. So, it
Step 3 Confirm substance sameness is need to spontaneously find consortiums for the
substances and join through SIEF-like IT system.
Step 4 Data sharing
SIEF-like IT system designed by MoE is still under
construction. It is expected to release in early next month.
Step 5 Survey on data availability

Step 6 Analysis data gap Data in EU-REACH could be used for K-REACH registration
if the data quality is high (OECD GLP standard), but
copyright should be clarified first.
Step 7 Generate the additionally required data
Some endpoints could be waived according to the rules
Step 8 Discussion on cost-sharing under K-REACH, after data gap analysis and expert
assessment.
Step 9 Preparation on the submission dossier

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Roadmap on K-REACH Join registration
2015 2016 2017 2018
Contents
9 10 11 12 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q

Segmenting and management for each substance group


(Select the consulting company in charge)

Select the potential leader for each substance group


(Joining K-REACH IT system and leader registrant
application)

Reviewing and concluding the written agreement for


each substance group (Cost sharing method, etc.)

Substance specification and sameness check

Classification and Labelling Review

Data Gap analysis

Data purchase consultation with EU REACH Consortium

Test report generation strategy (data buying or waiving,


etc.)

Prior review carried out for the test report (check for
testing institute, schedule, cost, testing institute capacity)

Test request

Uses survey

Risk assessment report writing

Leader registration dossier creation and submission

Completeness check by NIER and leader registration


completion

Charge for LoA fee and LoA granting

Submit a joint registration dossier

Joint registration completion


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Case Study 1-PLC exemption under K-REACH
Substance X Chemical name ******, CAS *********
Substance information
Tonnage band 1-10 tpa
Importer One

Not list in KECI & meet PLC definition under K-REACH&OSHA


PLC application under K-REACH
Obligation confirmation
Above can cover the OSHA compliance

OR nomination with signed POA(1 week)


K-REACH dossier prepare with full questionnaire (2 week)
Dossier preparation/sub
mit Produce well organized GPC report according to template
K-REACH dossier submit and review1 week

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Case Study 2- new chemical registration under K-REACH and OSHA(0.1-1)

Substance X Chemical name ******, CAS *********


Substance information
Tonnage band 0.1-1 tpa
Importer One
KECI Not list in

Obligation confirmation Not list in KECI


0.1-1registratoin application under K-REACH
Apply registration (0.1-1tpa) under OSHA

OR nomination with signed POA(1 week)


Dossier preparation/sub K-REACH dossier prepare with full questionnaire (2 week)
mit
K-REACH dossier submit and review1 week
Oral acute test in OECD GLP institute (4-6 week)
OSHA dossier submit and review9 week
Issue registration certificate/request supplementary from authority

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Consulting services of K-REACH

Our services

Only Representative Service


New Chemical Substance Checking
Registration Dossiers Preparation and Submission
Lead Registrant
Annual Reporting
Data Sharing
Risk Assessment Report Preparation and Submission
Product Notification
Exemption Application
Training and Consultancy on K-REACH
Korea Safety Data Sheet (SDS) and labeling Preparation
Chemlinked

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Thanks for your listening!

Tel: +86 0571 87007564


/ +86 15167125593
E-mail: zhouwei@reach24h.cn
E-mail:lxt@reach24h.cn

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