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La fenêtre de CEHTRA sur le support réglementaire mondial
Carte interactive de CEHTRA
Sélectionnez un pays dans la carte ci-dessous pour voir comment CEHTRA peut vous accompagner
Les emplacements en vert indiquent la présence de bureaux de CEHTRA
Les emplacements en bleu indiquent les services disponibles via les partenaires de confiance de CEHTRA.
Australie
La loi sur les produits chimiques industriels de 2019, administrée par AICIS, est entrée en vigueur le 01 juillet 2020 et réglemente l'importation et la fabrication de produits chimiques industriels en Australie.
CEHTRA fournit les services suivants :
Catégorisation de l'introduction
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Définition de la portée de l'évaluation (Listé / Exempté / Signalé / Évalué)
Expertise scientifique
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Analyse des écarts de données, stratégie d'essai (y compris les alternatives aux essais in vivo)
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Support scientifique
Préparation du dossier
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Soumission et communication avec les autorités par l'intermédiaire d'un partenaire local
Canada
Le règlement canadien sur la déclaration des substances nouvelles (DSN), en vertu de la Loi canadienne sur la protection de l'environnement (LCPE), est un système à plusieurs niveaux dans lequel des tableaux de données spécifiques sont soumis en fonction des volumes annuels, importés ou fabriqués. Les autorités canadiennes évaluent ces informations pour déterminer si une substance présente un risque déraisonnable pour la santé humaine et/ou l'environnement.
Par l'intermédiaire de notre agence situé à Toronto, CEHTRA fournit les services suivants :
Stratégies de notifications des DSN
Services d'agents canadiens
Préparation
dossier DSN
Communication avec les autorités
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Sélection du calendrier de notification
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Analyse des écarts de données
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Stratégies d'essai (dérogations, lecture croisée, QSAR, essais en laboratoire)
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Support scientifique.
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Agir en tant que représentant autorisé pour des clients sans présence commerciale au Canada
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Compiler et soumettre les informations requises sur l'administration, les dangers et l'exposition
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Préparer les arguments de renonciation / de lecture croisée
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Consultation des autorités canadiennes avant et après la notification
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Enquêtes confidentielles sur l'état de l'inventaire de la LIS.
Chine
Les dispositions révisées relatives à l'administration environnementale des nouvelles substances chimiques (ordonnance MEE n° 12) - en vigueur à partir du 1er janvier 2021 - réglementent l'enregistrement des nouvelles substances chimiques.
Par l'intermédiaire de nos partenaires locaux, CEHTRA peut vous aider en vous proposant les services suivants :
Inventaire
Recherche du CEISC
Notification
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Notification R&D
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Notification des enregistrements
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Enregistrement simplifié et régulier
Obligations après notification
Service de représentation
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Rapport annuel, renouvellement de certificat…
Eurasie
Le règlement technique de l'Union économique eurasienne (UEE) sur la sécurité des produits chimiques ТR.No.041/2017, connu sous le nom d'Eurasia-REACH, approuvé le 3 mars 2017, porte sur l'enregistrement, l'évaluation, l'autorisation et la restriction des substances chimiques.
Par l'intermédiaire de nos partenaires locaux, CEHTRA peut vous assister dans les dossiers EAEU.
Service de notification d'inventaire
Fiches de données de sécurité (FDS)
Service de représentant désigné
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Pré nominations tardives
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Préparation et/ou mise à jour des FDS conformément aux normes GOST
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Représentation des entreprises non-eurasiennes
Union Européenne
Par l'intermédiaire de nos agences dans l'UE, CEHTRA peut vous aider avec les services suivants :
Constitution et mise à jour du dossier
Gestion du FEIS
Représentant exclusif
Gestion logistique
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Diriger la stratégie de test des dossiers des déclarants et des co-déclarants
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Communication du Consortium et du FEIS
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Gestion administrative et financière de la LoA
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Représentation d'entreprises non européennes par le biais de notre entité juridique "Only-Representative" (OR) et de UK-REACH
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Obligations en tant qu'importateur, fabricant ou utilisateur en aval (DU) de l'UE, notifications à l'ECHA
India
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
Japan
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
New Zealand
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.
Philippines
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)
South Korea
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
Taiwan
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
Turkey
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
Safety Data Sheets (SDS) & Label
Only representative service
Consortium and SIEF communication, administrative and financial management
Preparation and/or
update of SDS / Label
in Turkish language
Representation of
non-Turkish companies
United Kingdom
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
USA
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
PMN Submissions
PMN Technical Contact Support
Polymer Exemption qualification assessments, Low Volume Exemption applications, R&D/TME/LoREX support
Compilation of PMN Form and supporting documentation in e-PMN/CDX, Sustainable Futures modelling
Pre-Notice Consultation, Post- submission review support including consent orders and other EPA regulatory actions