Welcome to CEHTRAcker

CEHTRA's window to worldwide regulatory support

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CEHTRAcker Interactive Map

Select a country in the map below to see how CEHTRA can accompany you

Locations in green indicate presence of CEHTRA offices

Locations in blue indicate services available via CEHTRA's trusted partners

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Australia

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The Industrial Chemicals Act 2019, administered by AICIS, came into effect on 01 July 2020 and regulates the importation and manufacture of industrial chemicals in Australia.

 

CEHTRA provides the following services:

Categorization of introduction

Definition of the scope of assessment (Listed / Exempted / Reported / Assessed)

Scientific expertise

Data Gap analysis, Testing strategy (incl. alternatives to in vivo testing), Scientific support

Dossier preparation

Submission and communication with authorities thought a local partner

 
 
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Canada

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Canada’s New Substances Notification (NSN) Regulations, under the Canadian Environmental Protection Act (CEPA), are a tiered system whereby specific data schedules are submitted based on annual volumes, imported or manufactured. The Canadian Authorities evaluate this information to determine if a substance presents an unreasonable risk to human health and/or the environment.

 

Through our office located in Toronto, CEHTRA provides the following services:

NSN Notification Strategies

Notification schedule selection, Datagap analysis, Testing strategies (waivers, read-across, QSAR, laboratory testing), Scientific support

Canadian Agent Services

Acting as authorized representative for clients without a business presence in Canada

NSN Dossier Preparation

Compiling and submitting required administrative, hazard, and exposure information, Preparing waiver/read-across arguments

Communication with Authorities

Pre- and post- notification consultation with the Canadian Authorities, Confidential DSL Inventory status inquiries

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China

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The revised Provisions on the Environmental Administration of New Chemical Substances (MEE Order No. 12) - effective from January 1, 2021 – regulates new chemical substance registration.

 

Through our local partners, CEHTRA can assist you with the following services:

Inventory

IECSC search

Notification

R&D notification, Record notification, Simplified and Regular Registration

Post-notification Obligations

Representative service

Annual Report, Certificate Renewal…

 
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Eurasia

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The Technical Regulation of Eurasian Economic Union (EAEU) on Safety of Chemical Products ТR.No.041/2017, known as Eurasia-REACH, approved on March 3rd 2017, deals with the Registration, Evaluation, Authorization, and Restriction of Chemical substances.

Through our local partners, CEHTRA can assist you with EAEU dossiers.

Inventory Notification Service

Late pre-nomination

Safety Data Sheets (SDS)

Preparation and/or update of SDS according to the GOST standards

Nominated representative service

Representation of

non-Eurasian companies

 
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European Union

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Through our offices in the EU, CEHTRA can assist you with the following services:

Dossier compilation & update

Lead registrant and co-registrant dossiers testing strategy

SIEF

Management

Consortium and SIEF communication, administrative and financial management of LoA

Only Representative

Representation of non-EU companies through our Only-Representative (OR) Legal Entity and UK-REACH

Supply-chain management 

Obligations as EU importer, manufacturer or Downstream-User (DU), notifications to ECHA

 
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India

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India’s Chemicals (Management And Safety) Rules (ICMSR) also referred to as ‘India REACH’ will come into force on the date of their publication in the Official Gazette, expected mid-2021, and will regulate all substances, substances in mixtures, and intermediates that are manufactured, imported or placed on the market in the Indian territory at quantities greater than 1 tonne per year.

 

Through our office located in New Delhi, CEHTRA provides the following services:

Notification/ Registration   & update

Safety Data Sheets (SDS)

Authorized Representative (AR) service

Data Management

Preparation and update of Notification and Registration dossiers for individual or joint submissions

Preparation and/or update

of SDS in latest

 UN-GHS format

Representation of non-Indian companies through our Indian entity

Arrangement of data on substances already registered with any foreign regulator in other jurisdictions

 
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Japan

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The Chemical Substances Control Law – referred to as CSCL – was firstly enacted in 1973 in Japan to prevent environmental pollution by chemical substances that pose a risk to human health or the environment. CSCL controls both new and existing substances.

The Industrial Safety and Health Law – ISHL - was firstly enacted in 1972 to protect the safety and health of workers in workplaces in Japan. IHSL designates substances that are prohibited to manufacture or import, substances requiring permission and chemical substances requiring safety data sheets and labels. ISHL also controls new substances and requires manufacturers and importers to notify them to the Japanese Ministry of Labor and Welfare (MHLW) prior to production and importation.

 

Through our local partners, CEHTRA can assist you with the following services:

CSCL notification

Standard (full) notification, Low volume notification (LVN), Small volume exemption (SVE), polymer…

ISHL notification

Standard notification,

Low volume notification

Safety Data Sheets (SDS)

& Label

Preparation and/or update of SDS / Label under Japanese standards

 
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New Zealand

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Pesticides, household chemicals and other dangerous goods and substances are regulated by the EPA (Environmental Protection Authority) under the Hazardous Substances and New Organisms Act 1996. All hazardous substances require approval in New Zealand prior to use. Depending on the substance and hazard classification, an approval may take the form of an Individual Approval or a Group Standard Approval.

 

CEHTRA provides the following services:

NZ GHS

Assistance with the classification according to NZ GHS 7

Expertise

Providing guidance on the most appropriate approval route

Registration support

Preparation of paperwork required for approval, including where necessary submission and communication with authorities.

 
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Philippines

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The Pre-Manufacturing and Pre-Importation Notification, known as PMPIN, aims to screen harmful substances before they enter the Philippine market.

CEHTRA provides the following services:

Dossier preparation

Abbreviated or Detailed PMPIN

Dossier submission

Through a local partner (Abbreviated or Detailed PMPIN / SQI / PCL / CCO / Polymer)

 
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South Korea

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The Act on Registration and Evaluation, etc. of Chemical Substances – referred to as “ARECs” or “K-REACH” - was implemented on January 1, 2015 by the Ministry of Environment (MOE) with the aim. of protecting public health and the environment by the registration of chemical substances.

The Occupational Safety and Health Act - referred to as “OSHA” - is regulated by Ministry of Employment and Labor (MOEL), with the purpose of OSHA to maintain and promote the safety and health of workers by preventing industrial accidents and creating a comfortable working environment through establishing standards on occupational safety and health and clarifying where the responsibility lies.

Through our local partners, CEHTRA can assist you with the following services:

K-REACH registration

KECL inventory search, registration dossiers, communication with MOE/NIER

K-REACH OR

Representation of

non-Korean companies

OSHA New Chemical

MOEL’s inventory search, dossier preparation, communication with MOEL

OSHA GHS

GHS classification and preparation of GHS MSDS & Label

 
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Taiwan

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Chemical regulation in Taiwan is covered by the EPA’s Regulation of New and Existing Chemical Substances Registration (Dec 11, 2014 - amended 2019) and the MOL’s Regulation of

new chemical substances registration (Jan 1, 2015).

Through our local partners, CEHTRA can assist you with the following services:

Expertise

Identification of regulatory obligations

Registration

Small Quantity, Simplified and Standard Registration

CBI application

Post-submission Obligations

Annual Reporting

 
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Turkey

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The regulation Kimyasallarin Kaydi Degerlendirmesi Izni ve Kisitlamasi, known as KKDIK, published on 23rd June 2017 deals with the Registration, Evaluation, Authorization, and Restriction of Chemical substances.

 

Through our local certified partners, CEHTRA can assist you with KKDIK dossiers.

Dossier preparation

Preparation of registration dossiers for individual

or joint submissions

SIEF management

Consortium and SIEF communication, administrative and financial management

Safety Data Sheets (SDS) & Label

Preparation and/or

update of SDS / Label

in Turkish language

Only representative service

Representation of

non-Turkish companies

 
 
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United Kingdom

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The Brexit transition deadline of 31 December 2020 is fast approaching and it is vital that companies ensure that they remain compliant beyond this date. CEHTRA team remains available to answer any queries you may have to ensure you are compliant with the new regulatory framework which will apply from 1st January 2021.

Through our offices located in the UK and the EU, CEHTRA can assist you with the following services:

UK REACH Registration and OR

UK REACH

OR

Consortium Management

 
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USA

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The Lautenberg Chemical Safety Act (LCSA) was signed into law in 2016 to modernize the Toxic Substances Control Act (TSCA). New chemicals are still registered under the Premanufacture Notice (PMN) rules, but now the EPA conducts a risk-based review and must make an affirmative safety determination before they can be imported or manufactured. The LCSA empowers the EPA to request more up-front test data and information to characterize hazards, uses, releases, exposure scenarios, etc., meaning that more knowledge and effort is required to achieve a successful registration than ever.

 

CEHTRA provides the following services:

US PMN Strategies

TSCA Inventory List status, Datagap analysis/Data quality check, CA chemical name and CAS RN assignment/proof assurance.

LCSA Exemption Support

Polymer Exemption qualification assessments, Low Volume Exemption applications, R&D/TME/LoREX support

PMN Submissions

Compilation of PMN Form and supporting documentation in e-PMN/CDX, Sustainable Futures modelling

PMN Technical Contact Support

Pre-Notice Consultation, Post- submission review support including consent orders and other EPA regulatory actions