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  • COSMETICK | CEHTRA

    Already have a COSMETICK account? Click here How about giving a digital touch to the safety evaluation of your cosmetic products? A CEHTRA-designed tool dedicated to your cosmetics safety assessment Introducing A CEHTRA-designed tool dedicated to your cosmetics safety assessment What is COSMETICK? The concept of COSMETICK was born from the collaboration between software developers and toxicologists to faciliate the evaluation of the safety of cosmetic products, in the context of toxicological profiling. ​ COSMETICK allows its users to: a) Access to hundreds of toxicological profiles and composition of raw materials b) Identify toxicological alerts and reference values such as NOAELs c) Consult dozens of literature and regulatory sources of information d) Find their CEHTRA projects and results of Margins of safety (when evaluated by CEHTRA experts) ​ Databases INCI, impurities and Raw Materials ✓ Toxicological profiles of ingredients and impurities ✓ Warnings and toxicological values ✓ Export of the profiles CEHTRAPEDIA ✓ Link to each substance with reference data (Annexes of the Cosmetic Regulation, CLP, IARC…) ✓ Regular updates Cosmetic projects For the products evaluated by CEHTRA: ✓ Calculation of Margins of Safety (MOS) for ingredients, ✓ Calculation for impurities ✓ Conclusions ✓ Analysis of the impact of toxicological changes ​ For the products evaluated by the user: ✓ Simplified creation of projects ✓ Table of results (MOS ingredients, calculation impurities) ✓ Export of the evaluation ✓ Analysis of the impact of toxicological changes Two licence options COSMETICK Basic COSMETICK Advanced to best suit your needs Basic Advanced Toxicological profiles for ingredients and impurities : read-only Raw Materials: composition in case of access to confidential data Toxicological profiles for ingredients and impurities : modification (confidential data) and export of a Word document CEHTRAPEDIA: consultation for the ingredients and existing substances CEHTRAPEDIA: consultation for any substance Creation of a cosmetic project (formula) Export of a Word document for a toxicological assessment Analysis of the impact of toxicological changes on a previous report ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ Downloads Coming soon Access COSMETICK Already have a COSMETICK account? Click here to access Have questions about COSMETICK? Drop your queries to: contact@cehtra.com ​ or leave your messages on Let's Chat window below

  • PRIMO | CEHTRA

    Already have a PRIMO account? Click here Unlock the power of Cloud Technology to manage your Worldwide Registrations … Introducing A CEHTRA-designed tool dedicated to your regulatory compliance What is PRIMO? PRIMO stands for Principle Regulatory Information Management Organizer . PRIMO has been designed by our regulatory and IT experts to keep you up-to-date with regulatory compliance information for your projects. With its state-of-the-art cloud technology, PRIMO allows its users to: a) both share and store their data securely, b) prepare their worldwide registration dossiers and c) make project management easier by giving simultaneous access to all team members, external collaborators and consultants. Data Storage ✓ Secure sharing and storage of your data ✓ Easy document upload and download Working Documents ✓ Instant access for anyone, anytime, anywhere ✓ Data Gap Analysis (DGA) ✓ Country-specific support for DGA ✓ Monitoring follow-up Project Management ✓ Track work progress in real-time ✓ Project budget at your fingertips Two licence options PRIMO Basic PRIMO Ultimate to best suit your needs Basic Ultimate Client Access* Upload/download documents Create/modify registration dossiers Create Tasks Track work progress (Gantt Chart) Access to country-specific DGA Access to country-specific support for DGA preparation Access to other clients' consultants Read-only ✓ Read/write ✓ ✓ ✓ Read-only Read-only ✓ Read/write Read/write ✓ ✓ * CEHTRA offers a free access to PRIMO Basic to all its clients. Media PRIMO advert Access PRIMO Already have a PRIMO account? Click here to access Have questions about PRIMO? Drop your queries to: contact@cehtra.com ​ or leave your messages on Let's Chat window below Latest Announcements Please visit this page regularly for all future updates on PRIMO

  • Locations | CEHTRA

    Our DNA is international ​ Click on the country below for more details North America Europe Asia Canada Belgium France Germany Luxembourg Spain India United Kingdom Belgium 134 rue Saint Germain 1410 Waterloo ​ Phone: +32 (0) 235 161 44 Canada 24 Ivy Lea Crescent Toronto ON M8Y 2B6 ​ Phone: +1 (416) 432-4020 France 15 rue Aristide Briand 33150 Cenon, Bordeaux ​ Phone: +33 (0) 557 77 56 10 4 avenue Laurent Cély Hall A, 4ème étage 92600 Asnières sur Seine ​ Phone: +33 (0) 1 76 27 56 09 8 avenue Leclerc 69007 LYON ​ Phone: +33 (0)4 74 94 37 44 Germany Heisterbusch 3c 21682 Stade ​ Phone: +49 (0) 4141 545 60 69 India TC15/1764, Forest Office Lane (B51) Vazhuthacaud, Trivandrum - 695014 ​ Phone: +91 (0)471 406 1870 Spain Calle Pintor Murillo 29 – oficina bajo A 28100 Alcobendas Madrid ​ Phone: +34 918 429 142 United Kingdom CEHTRA Limited, Suite 31 1 Hanley Street Nottingham, NG1 5BL ​ Phone: +44 (0) 115 950 9857

  • Poison Centre Notifications | CEHTRA

    EU Poison Centre Notification (PCN) Annex VIII to CLP regulation was released in March 2017 to harmonise the variations between poison centre notifications among members states and the new harmonised system became effective from January 2021 (extended from January 2020). ​ Importers and downstream users placing hazardous mixtures (with a health and/or physical effect classification) on the EU market are to provide specific information on your mixtures to the centralized EU poison centre before placing theses mixture on the market. ​ They will have to: ​ Register a unique formula identifier (UFI), Include the UFI on the label for professional and consumer use, Include the UFI in section 1.1 of the Safety Data Sheet (SDS) for industrial use. Provide and submit to the ECHA harmonised submission portal: ​ The full chemical composition of the mixture Toxicological information of the mixture (SDS Section 11) Product category (according to the new EU product categorization system EUPCS) The safety data sheet and label in the country’s language The UFI (a 16-character alphanumeric code that uniquely identifies a formula (mixture composition) in the EU and can be generated on the UFI generator ECHA created) ​ The obligation lies with EU Legal entity (non-EU supplier of the mixture cannot replace the EU-based duty holder). A duty holder can entrust a third party (e.g. CEHTRA) to complete the PCN on their behalf. ​ Importers and downstream users placing mixtures on the market not already notified under national legislation must comply with Annex VIII of the Regulation from the following dates: Hazardous mixtures for consumer and professional use: January 1, 2021 Hazardous mixtures for industrial use: January 1, 2024. If the mixture is already on the market and already notified to the local poison centre of the Member State, the date of compliance is 1st January 2025. As an Importer or a downstream user placing hazardous mixtures (with a health and/or physical effect classification) on the EU market you need to provide specific information on your mixtures to the centralized EU poison centre before placing these mixtures on the market – known as PCN notification/s. CEHTRA can support as a third party representative to assist in these requirements. Meet our expert Sarah HENLY sarah.henly@cehtra.com Key Services Portfolio Review Review Safety data sheets and labels Prepare and submit PCN notification Regulatory support Screen your Portfolio to identify mixtures that require PCN and notification deadlines Full compliance review of SDS and labels Screen for full notification information and generate UFI codes Offer regulatory advice on how best to fulfill obligations Downloads PCN flyer - EN Related Sectors Biocides Chemicals (REACH) Plant Protection

  • Our Values | CEHTRA

    Top of Page Biodiversity & Environment Diversity Team spirit Digital future Career paths Trust & Leadership Collaborative mindset Our values Passion for Biodiversity and Environment safety are our driving forces Diversity is at the core of our work culture

  • Global Chemicals Notification | CEHTRA

    Global Chemicals Notification When it comes to chemical regulatory compliance, there is no ‘one method fits all’ approach. Here at CEHTRA we have developed our own internal tools designed to provide you the best worldwide, customized, and optimized strategy for a minimum cost. Our expert practitioners have collectively decades of experience and using our PRIMO tool are able to identify the most up to date regulatory requirements for the designated target countries. We prepare the Master dossier on which all other submissions are based. When required, our partners, chosen for their geographic proximity, language, and culture have the skills to prepare your local submission dossiers. Meet our experts Sarah HENLY Head of Global Notifications sarah.henly@cehtra.com Damien GUYOMAR Toxicologist damien.guyomar@cehtra.com Melanie HARPER Regulatory Affairs Specialist melanie.harper@cehtra.com Key Services Global Registration Strategies Registration schemes adapted to your needs Scientific Expertise Data Gap analysis, Testing strategy (incl. alternatives to in vivo testing), Scientific support Testing Programme Monitor testing adapted to local requirements Registration Dossiers Preparation of Country-compliant dossiers & communication with authorities Value-added Services PRIMO tool to optimize management and follow-up of complex worldwide registration projects Scientific and Regulatory expert advices Only Representative services Countries covered EU countries UK Russia Turkey Switzerland USA Canada China Australia Thailand South Korea Japan Philippines Taiwan Others on application India Please click on the highlighted country names to get redirected to their dedicated page on our website Downloads Global Chemicals Notification Flyer - EN Tools CEHTRAcker CEHTRA's window to worldwide regulatory support Related Sectors Chemicals (REACH) Industrial Hygiene REACH Authorisation

  • Brexit | CEHTRA

    Brexit Follwing the UK's departure from the European Union, CEHTRA team remains available to answer any queries you may have to ensure you are compliant with the new regulatory framework which applies from 1st January 2021. We have addressed some key information related to four of key business sectors (REACH, Biocides, Plant Protection and Cosmetics) on this page to keep you informed how CEHTRA experts can accompany you with the new regulatory framework. Key Contacts Biocides Annekathrin FAUPEL Regulatory Affairs Specialist annekathrin.faupel@cehtra.com REACH Plant Protection Melanie HARPER Regulatory Affairs Specialist melanie.harper@cehtra.com Philippe ADRIAN Head of Plant Protection philippe.adrian@cehtra.com REACH UK REACH Registration and OR UK REACH OR Consortium Management Support for negotiation with data holders for access Communications with UK regulatory authorities Biocides Plant Protection Great Britain (England, Scotland and Wales) will establish independent pesticides regulatory rules on 1 January 2021. Therefore please make sure that your current UK products are authorised under the new rules. ​ According to CRD, the new laws to ensure the safe use of plant protection products will be similar to existing laws including compliance with regulations for Maximum Residue Levels (MRLs). ​ Current product authorisations and MRLs will still be valid in the Great Britain from 1 January 2021. The Health and Safety Executive (HSE) will continue to operate as the UK’s regulator. In addition, under the terms of the Northern Ireland Protocol, the EU pesticides rules will continue to apply in Northern Ireland after 1 January 2021. ​ CEHTRA will continue to support its clients for their UK products. REACH UK REACH Registration UK REACH OR Consortium Management Support for negotiation with data holders for access Communications with UK regulatory authorities Biocides UK BPR OR (Article 95) UK BPR Registration UK BPR Authorisation From 1 January 2021, Great Britain (England, Scotland and Wales) will put in place a regulatory framework for biocidal products. It will be similar to EU framework (EU BPR), but both will operate independently of each other. ​ All applications will be submitted to HSE as regulating authority Biocidal product authorizations and active substance approvals that are valid in GB will remain valid until their normal expiry date. The authorization will need to be transferred to a company based in UK. The authorization holder of biocidal actives and products will need to be established in the UK by 1st January 2022. Respective data might have to be resubmitted to HSE. These data will be the same data or other information that you previously submitted to ECHA or other competent authorities. Biocidal product or active substance applications still under evaluation after 31st December 2020 will be continued by HSE where possible to grant the authorization. Information supporting the original application has to be resubmitted for enabling HSE to complete the evaluation within 90 or 180 days depending on your situation. ​ A UK article 95 list for approved a.s. suppliers will be established similar to the EU Article 95 list. To stay on the UK Article 95 list you will have to comply with the according requirements within 2 years’ time. Plant Protection Great Britain (England, Scotland and Wales) will establish independent pesticides regulatory rules on 1 January 2021. Therefore please make sure that your current UK products are authorised under the new rules. ​ According to CRD, the new laws to ensure the safe use of plant protection products will be similar to existing laws including compliance with regulations for Maximum Residue Levels (MRLs). ​ Current product authorisations and MRLs will still be valid in the Great Britain from 1 January 2021. The Health and Safety Executive (HSE) will continue to operate as the UK’s regulator. In addition, under the terms of the Northern Ireland Protocol, the EU pesticides rules will continue to apply in Northern Ireland after 1 January 2021. ​ CEHTRA will continue to support its clients for their UK products. Cosmetic products Great Britain (England, Scotland and Wales) establishes independent regulatory rules for cosmetic products placed on the British market from January 1, 2021. The regulation remains very close to the Cosmetic Regulations (with a PIF, a safety report, a notification). The Responsible Person must be in Great Britain. By default, the importer is this RP. It is recommended to identify a RP who will be able to assume all the responsibilities for the safety of the product. ​ A notification will also have to be made on the UK portal. ​ These steps are valid for new products as well as for existing products entering Great Britain. CEHTRA can assist cosmetics manufacturers in these procedures.

  • Cosmetics | CEHTRA

    Cosmetics Demonstrate the safety of both your finished products and ingredients. Get the packaging safety tested. Shorten the time to market. The current regulation for the cosmetics industry requires safety assessment to be performed by a qualified Safety Assessor, with a relevant expertise in Toxicology. Cosmetics Combining our years of expertise, information from our databases and access to state-of-the-art digital tools, we aim at demonstrating safety and compliance for cosmetic products in CPSR and PIF documents. During the R&D phase, before launching the product on the market and later, we anticipate concerns, validate safe uses and manage easy updates. Meet our experts Clarisse BAVOUX Head of Cosmetics clarisse.bavoux@cehtra.com Marlène BARON Toxicologist marlene.baron@cehtra.com Coraline BELIN Regulatory Toxicologist coraline.belin@cehtra.com Key Services CPSR comprehensive evaluation Raw Materials: toxicity and maximal doses Ingredients under development: strategy, dossier Support for toxicological and eco-toxicological issues Pre-assessment and final Cosmetic Product Safety Report Toxicological Profiles and identification of safe concentrations for cosmetic uses Strategy for tests, in silico approach, complementary data and final dossier Literature search, use of existing data, in vitro tests and support for in silico approaches CEHTRA has been commissioned by numerous companies including multi-nationals in the cosmetics industry to assist them with cosmetic regulation compliance. ​ CEHTRA evaluates the safety of several types of products (care, hygiene, perfumes...), and new ingredients. CEHTRA’s comprehensive databases allow us to anticipate risks for your products. ​ ​ We can propose complementary approaches in case of data gaps (structural alerts, QSAR, Read-across). Our eco-toxicologists can contribute to the eco-conceptions of your formula. ​ ​ At CEHTRA, we are professional partner of the Cosmetic Valley and provide different training courses on the Fundamentals of the Cosmetic Regulation, webinars on Content / Container Interactions or seminaire in University. Value-added services In-depth expertise for INCIs, impurities and perfume components, including MOS and QRA In-house rich database Digital analysis of the impact of changes to manage the need of updates Review of Product Information files Responsibility of the Responsible Person for your products (through written mandate) International regulatory compliance Our tools Interested to know more about COSMETICK? Please contact our cosmetic experts Downloads Cosmetics Flyer - EN Our Partners Related Sectors Packaging

  • CEHTRA - Your Specialities Our Expertise | Consultancy based in France

    Your Specialties, Our Expertise CEHTRA stands for Consultancy for Environmental & Human Toxicology and Risk Assessment ​ Since 2001, we provide high quality scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations. ​ You are committed to the safety of your products. We are committed to high quality regulatory services at optimized costs. Key business sectors Biocides Chemicals (REACH) Cosmetics Global Chemicals Notification Packaging Industrial Hygiene Medical Devices Pharmaceuticals Plant Protection REACH Authorisation Key services Dedicated Support (Régie) Representative Services Poison Centre Notifications Trainings Digital tools PRIMO CEHTRAcker COSMETICK Consortia 1bCoF (Biocides) QuAC (Biocides) Latest News NewsA title NewsB time NewsB title NewsC time NewsC title NewsD time NewsD title NewsGC title CCCC Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Ertuei. NewsGD title DDDDD Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. NewsGB title BBBBB Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. NewsGA title AAAAA Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Click here for more news NewsA time

  • ICMSR | CEHTRA

    India’s Chemicals (Management And Safety) Rules 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. Regulatory compliance requirements will apply within 18 months of coming into force, and all Indian manufacturers and importers will need to comply. Non-Indian entities who wish to place their chemical products on the market in India will need to appoint an authorised representative (AR) located in India to act on their behalf (similar to EU REACH OR). ​ If your company is currently manufacturing chemicals in India or exporting chemicals to India, ICMSR will affect you. CEHTRA-India registered office in New Delhi is well positioned to act as your AR and service provider and can help you secure the Notification or Registration certificate for your chemicals from India’s Chemical Regulatory Division. The main requirements are: Notification and annual updating All existing and new substances manufactured or imported in India in quantities ≥ 1 tonne per year must be notified to The Chemical Regulatory Division (CRD). Existing substances should be notified within 180 days from the date of commencement of the Initial Notification Period (i.e. commences one year from the date of enforcement of ICMSR Rules). New substances must be notified at least 60 days prior to the date they are placed on the market in India. Notifiers shall update the information submitted annually, no later than 60 days after the end of each calendar year. ​ Registration ​ All priority substances listed in ICMSR Schedule II (currently 750) manufactured or imported (or intended or likely to be released from articles) in India in quantities ≥1 tonne per year will require the submission of a technical dossier within 18 months from the date of their inclusion in Schedule II. Substances manufactured or imported in India in quantities <1 tonne per year may also need to be registered; further details are yet to be published. Substances listed in Schedule II will be subject to authorization and restriction after further assessment. ​ Safety Data Sheet (SDS) All Notifiers of a substance or an intermediate listed in Schedule II or a hazardous chemical will need to maintain and submit an up-to-date SDS in the UN-GHS format and will have to share such SDS with the Downstream User of the substance. ​ Site Safety Report ​ An occupier who has control of an industrial activity in which a hazardous chemical is handled is required to provide the evidence of identification and prevention of accidental hazards within 30 days of commencement of the activity or within 30 days of coming into force of these Rules, whichever is later. Depending on the threshold of quantities of hazardous chemicals, a site safety report or an independent safety audit report may also be required to be submitted within 90-180 days from the date of coming into force of these Rules. ​ Import Notification ​ After completion of notification or registration, importers of priority substances or hazardous chemicals must inform the concerned authority at least 15 days before the import of such substances in quantities greater than the lowest of 1 tonne, the quantity specified in column 3 of Schedule XII and column 3 of Schedule XI. Meet our experts Sarah HENLY Regulatory Affairs Manager sarah.henly@cehtra.com Pramod KUMAR Regulatory Affairs Manager pramod.kumar@cehtra.com Key Services Notification/ Registration & update Preparation and update of Notification and Registration dossiers for individual or joint submissions Safety Data Sheets (SDS) Preparation and/or update of SDS in latest UN-GHS format Authorized Representative (AR) service Representation of non-Indian companies through our Indian entity Data Management Arrangement of data on substances already registered with any foreign regulator in other jurisdictions Value-added Services PRIMO tool to optimize management and follow-up of complex worldwide registration projects Experienced data sharing negotiators Scientific and Regulatory expert advice GHS Classification of substances Related tools Related Sectors Global Chemicals Notification

  • Representative services | CEHTRA

    Representative Services Representation allows companies to place a substance on a market in an area where they may not have a legal presence. This has a number of benefits including the protection of confidential information and the ability to supply to numerous customers within a particular country/economic area under one registration. In the EU this role is known as Only Representation (OR) and allows a non-EU manufacturer to appoint an Only Representative to fulfill EU regulatory obligations on their behalf. This form (or similar forms) of representation is also available in a number of other countries. CEHTRA has sites in both the EU and UK and is able to offer Only Representative services under REACH as well as Article 95 Representation under both the EU and UK BPR. With the assistance of locally based partners, we are also in a position to offer representative services in Korea, Russia and Turkey. Meet our experts Melanie Harper Regulatory Affairs Specialist melanie.harper@cehtra.com Karl Willoughby Regulatory Affairs Specialist karl.willoughby@cehtra.com Key Services EU REACH OR/ Article 95 Representation UK REACH OR/ Article 95 Representation K-REACH OR (Korea) KKDIK OR (Turkey) CEHTRA can act as "only-representative" and consultant for non-European Union companies who sell, or intend to sell, in the European Union (+ European Economic Area (EEA) countries) substances, preparations (mixtures), or articles which are submitted to REACH regulations. ​ CEHTRA offers an expert service, carried out by personnel with extensive experience in both Only Representative Services and REACH Registration. CEHTRA can act as the EU Representative for a non-EU manufacturer for the purpose of Article 95 listing of the BPR. ​ CEHTRA offers an expert service, carried out by personnel with extensive experience in the area of Biocidal regulation. CEHTRA can also provide advice and assistance with Representative Services required under global regulatory schemes, including OR under UK REACH, should this be required as a result of Brexit. ​ With the assistance of locally based partners, we are able to provide Representative Services in Korea, Turkey, and Russia. Value-added Services Dossier/Substance management SDS preparation Point of Contact for customers Related Sectors Global Chemicals Notification Chemicals (REACH) Key Contacts Melanie Harper Regulatory Affairs Specialist melanie.harper@cehtra.com Karl Willoughby Regulatory Affairs Specialist karl.willoughby@cehtra.com

  • Dedicated Support (Régie) | CEHTRA

    Dedicated Support (Régie) Combining our high-skilled expertise (toxicology, expology, ecotoxicology, regulatory expertise, product stewardship) with our diverse business sectors (Biocides, Chemicals (REACH), Cosmetics, Global Chemical Notification, Industrial Hygiene, Medical devices, Packaging, Pharmaceuticals, Plant Protection), CEHTRA propose a Dedicated Support by outsourcing its team resources to its clients. In France, this outsourcing contract is known as Régie . Key Services Embedded staff Extended staff Our consultants work from our clients’ site Our consultants work from our offices but exclusively for our client Dedicated Support maximizes flexibility for CEHTRA clients ; the contract can be as short as one month or it could be for a long-term, part time or full time. It can be extended as many times as needed. During this period, one or more of our experienced and trained consultants will either: ​ a) work from our clients’ site and be integrated into their team (Embedded staff ) b) work from our offices but exclusively for our client (Extended staff ) ​ Value-added Services Support from CEHTRA experts Maximum flexibility with contract conditions ​ A key advantage of securing Dedicated Support with CEHTRA is the experience and expertise provided by our senior and expert team members whichever the barriers : scientific, regulatory... ​ Depending on the level of expertise required (junior, specialist or senior profile), duration (short or long term, part-time or full-time), we will adapt our pricing that best suits your needs and budget. Key Contact Interested to know more? Our key contact for Dedicated Support, Stephane PIERRE will be happy to answer all your queries. You can either write him an email or simply drop your query into the chat window below. Stephane PIERRE In charge of Dedicated Support / Régie stephane.pierre@cehtra.com

  • Job Openings | CEHTRA

    Job openings CEHTRA is always looking to recruit new team members that can add strength and depth to our existing staff and contribute to the growth of the company. Would you like to join this friendly yet consciencious and professional group? CEHTRA recruits its consultants on the basis of their broad experience, scientific curiosity, and enthusiasm to take on a challenge. If you are interested, drop us your details via the 'contact us' form. ​ If you think that you have the right attributes, such as scientific competence, innovative mind-set and strong work ethic then send us a copy of your CV: recruitment@cehtra.com ​ Currently, we are looking for Medical Device Senior Regulatory Consultant Market Leader - Packaging Market leader - Industrial Hygiene Expert in modeling chemical exposure / Senior Industrial Hygienist Contract Specialty Start date Location CDI Industrial Hygiene ASAP France ​ Contract Specialty Start date Location CDI Medical Devices ASAP Lyon / Bordeaux Contract Specialty Start date Location CDI Packaging ASAP Lyon / Bordeaux / Paris

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  • Internships | CEHTRA

    Internships CEHTRA is always looking to recruit new interns that can add strength and depth to our existing staff and contribute to the growth of the company. Would you like to join this friendly yet consciencious and professional group? ​ If you think that you have the right attributes, such as scientific competence, innovative mind-set and strong work ethic then send us a copy of your CV: recruitment@cehtra.com

  • 1bCoF | CEHTRA

    Imagine whe n Co-formulants’ knowledge is powered with digital technology Introducing First reliable Co-formulants tool that belongs to Biocides community What is 1b CoF ? It’s a concept , a tool and a vision designed for Biocides community by its experts. 1bCoF is the first consortium with a digital touch where Biocides experts and companies can reliably and securely contribute, share and access valuable information on co-formulants. With it’s easy to use interface, information remains at your fingertips and accessible anywhere, anytime. Why 1b CoF ? It provides one reliable source of harmonized data across the biocides industry to minimize the regulatory risk of new products, optimize their time-to-market and shield their brands . ​ It saves costs, time and resources by allowing a shared access to existing co-formulants data. ​ It shares costs to compile data with one reliable and harmonized platform for co-formulants for all your R&D and Regulatory needs. ​ It brings additional support from biocides experts to help you with regulatory compliance at optimized costs . Downloads 1bCoF advert Key Contacts Nathalie HANON General Manager & industry expert nathalie.hanon@cehtra.com Cyril DUROU Technical Manager & Deputy General Manager cyril.durou@cehtra.com Annekathrin FAUPEL Germany Coordinator & Deputy Technical Manager annekathrin.faupel@cehtra.com Nathanaëlle DANGLADES Data Manager nathanaelle.danglades @cehtra.com Latest Announcements The schedule for next 1b CoF webinars will be available soon. Please visit this page regularly for all future updates.

  • Upcoming Events | CEHTRA

    Upcoming Events This page will be regularly updated with events and conferences attended by CEHTRA experts. We also have an exhibition booth at some selected events which are excellent occasions to meet and discuss with our team. CEHTRA is the Gold Sponsor for Congrès Biocides 2020 5 / 6 / 2020 Posted on: CEHTRA is the Gold Sponsor for the upcoming Congrès Biocides 2020 to be held in Lyon, France on the 14th and 15th October. For more information, click below to visit the congress website. Click here for more information CEHTRA is a Silver Sponsor for Le Congrès Parfums & Cosmétiques Posted on: 5 / 6 / 2020 CEHTRA is a Silver Sponsor for Le Congrès Parfums & Cosmétiques 2020 being held on the 4th and 5th November in Chartres, France. For more information, click below to visit the congress website. Click here for more information News C Title Posted on: News C date Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Click here for more information

  • Packaging | CEHTRA

    Packaging Experienced, quality support in managing the complex and constantly evolving regulation on food and food packaging . Our food contact materials and packaging team has over a decade of hands-on experience providing worldwide regulatory support, can help you to ensure the safety of your products and can help you prepare and update your dossiers. Meet our expert Francois RENON Head of Packaging francois.renon@cehtra.com Key Services Food contact and packaging regulatory support FCS risk assessments Declaration of compliance Cosmetic Packaging: ICC Worldwide support to be compliant with the requirements of the food contact and packaging regulations Risk assessments of food contact substances to be compliant with the regulation For all the actors of the chain value (from the starting substances suppliers to the manufacturer of the final article) Risk assessment of the interactions between the container and the content of cosmetic products Risk Assessment of articles made from plastics, glass, paper & board, coatings, metals... Including recycled, biobased and biodegradable materials Pragmatic approach to avoid expensive migration or extraction tests Regulatory Support on worldwide food contact regulations including the EU Member States, Switzerland, USA, China, MERCOSUR... Toxicological Expertise Risk assessment of food contaminants Value-added services Data management for cosmetic packaging Support on enviromental legislation on packaging External resources Regulatory Watch Training support for the risk assessment of cosmetic packaging Training support for recycled packaging Downloads Packaging Flyer - EN Key Contacts Francois RENON Head of Packaging francois.renon@cehtra.com Related Sectors Cosmetics Industrial Hygiene

  • Sectors | CEHTRA

    Biocides Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Introduction in 5 lines. Meet our experts Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Cyril DUROU Senior Ecotoxicologist cyril.durou@cehtra.com Annekathrin FAUPEL Biocodes Regulatory Affairs annekathrin.faupel@cehtra.com Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Text line 1 Key Services Text text 3 lines max Text text Text to explain Key service 1 (4 lines max) text Text text 3 lines max Text text Text to explain Key service 1 (4 lines max) text Text text 3 lines max Text text Text to explain Key service 1 (4 lines max) text Text text 3 lines max Text text Text to explain Key service 1 (4 lines max) text Bullet point 1 Bullet point 1 Bullet point 1 Bullet point 1 Bullet point 1 Bullet point 2 Bullet point 2 Bullet point 2 Bullet point 2 Bullet point 2 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 4 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 4 Bullet point 5 Bullet point 3 Bullet point 3 Bullet point 3 Bullet point 5 Other Services Text text text text Text text text text Text text text text Text text text text Text text text text Text text text text Text text text text Text text text text text text text text text text text text text text text text text ​ ​ Text text text text Text text text text text text text text text text text text text text text text text ​ ​ Text text text text Text text text text text text text text text text text text text text text text text ​ ​ Text text text text Text text text text text text text text text text text text text text text text text Biocides Brochure - EN Biocides Brochure - FR Key Contacts Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Cyril DUROU Senior Ecotoxicologist cyril.durou@cehtra.com Annekathrin FAUPEL Biocodes Regulatory Affairs annekathrin.faupel@cehtra.com Relevant sectors and services Chemicals (REACH) Plant Protection

  • Key Contacts | CEHTRA

    Key Contacts Section 1: Key Business Sectors Sector Contact person Job title Email address Biocides Biocides Biocides Nathalie HANON Cyril DUROU Annekathrin FAUPEL Head of Biocides Senior Ecotoxicologist Senior Regulatory Manager Chemicals (REACH) Chemicals (REACH) Chemicals (REACH) Mathieu ROLLAND Aurelie SEVESTRE Brigitte CASENAVE Head of Chemicals (REACH) Senior Toxicologist Senior Chemist Cosmetics Clarisse BAVOUX Head of Cosmetics Global Notifications Global Notifications Global Notifications Aurelie SEVESTRE Damien GUYOMAR Melanie HARPER Head of Global Notifications Toxicologist Regualtory Affairs Specialist Industrial Hygiene Charles ALARCON Head of Industrial Hygiene nathalie.hanon@cehtra.com cyril.durou@cehtra.com annekathrin.faupel@cehtra.com mathieu.rolland@cehtra.com aurelie.sevestre@cehtra.com brigitte.casenave@cehtra.com clarisse.bavoux@cehtra.com aurelie.sevestre@cehtra.com damien.guyomar@cehtra.com melanie.harper@cehtra.com charles.alarcon@cehtra.com Packaging Francois RENON Head of Packaging francois.renon@cehtra.com Pharmaceuticals Pharmaceuticals Pharmaecuticals Stephane PIERRE Maryse CORROLLER Blandine JOURNEL Head of Pharmaceuticals Expert Toxicologist Senior Ecotoxicologist stephane.pierre@cehtra.com maryse.corroller@cehtra.com blandine.journel@cehtra.com Plant Protection Plant Protection Plant Protection Philippe ADRIAN Estelle BELTRAN Blandine JOURNEL Head of Plant Protection philippe.adrian@cehtra.com Expert Environmental Consultant estelle.beltran@cehtra.com Senior Ecotoxicologist blandine.journel@cehtra.com REACH Authorisation Stephane PIERRE Head of REACH Authorisation stephane.pierre@cehtra.com Medical Devices Gaëlle REGUER Head of Medical Devices gaelle.reguer@cehtra.com Section 2: Our International contact points ​ Country France France France Contact person Cyril DUROU Sarah TERRADOT Stephane PIERRE Agency Cenon agency Lyon agency Paris agency Belgium Philippe ADRIAN Brussels agency Canada Jason NUGENT Toronto agency India India Pramod KUMAR Kaleeswaran SAMPATH New Delhi agency Trivandrum agency Germany Annekathrin FAUPEL Stade agency Spain Nathalie HANON Madrid agency United Kingdom Peter JENKINSON Nottingham agency Email address cyril.durou@cehtra.com sarah.terradot@cehtra.com stephane.pierre@cehtra.com philippe.adrian@cehtra.com jason.nugent@cehtra.com pramod.kumar@cehtra.com kaleeswaran.sampath@cehtra.com annekathrin.faupel@cehtra.com nathalie.hanon@cehtra.com peter.jenkinson@cehtra.com

  • Data Privacy | CEHTRA

    Data Privacy GDPR is the General Data Protection Regulation, a sweeping legislation passed by the EU and enforceable as of May 25, 2018. GDPR maintains that data protection is a fundamental human right and it is the responsibility of any company that controls and processes data to protect that right. At some point over the past few years we have been in contact with you, either as part of a scientific and regulatory forum or in another capacity. You already know that we do not send out emails which are not tailored towards your specific needs or are not of mutual interest. We will not bombard you with endless e-mails that are of little interest to you, but every-so-often, there may be something that we think may be of interest to you for your business. ​ Your data: We collect only the data that is strictly necessary. This means your contact details. They are only used for communicating with you regarding business related matters. ​ Your data remains confidential: We promise to never transmit, share or reveal our personal data with any other entity, business or organisation for whatever means, in full compliance with the General Data Protection Regulation (GDPR) of 2018. ​ Your rights to access: In full compliance with the French CNIL , you may at anytime access the your data in order to modify or update them by simply contacting us at: CEHTRA SAS 15 rue Aristide Briand Cenon, Bordeaux France contact@cehtra.com ​ Your right to be forgotten: Your personal data is kept for a maximum of 5 years. You may at anytime request that your details be deleted. ​ Your data is secure: CEHTRA does everything that is possible to ensure that your data is safe. he data service provider OVH ensures that the site respects the legal requirements as described namely the General Data Protection Regulation (GDPR) of 2018. ​

  • Industrial Hygiene | CEHTRA

    Industrial Hygiene CEHTRA's industrial hygienists have decades of experience working with clients in their industrial sites and manage Environmental, Health and Safety challenges with a well balanced mix of technical expertise and practical experience. CEHTRA's track record in multi-disciplinary risk assessment and modelling applies well to real world situations involving chemical substances: ever since its creation, CEHTRA has designed and conducted EHS audits, and advised management at countless sites in virtually every sector of the chemical industry and services. Meet our experts Stephane PIERRE stephane.pierre@cehtra.com Key Services Exposure Scenarios Characterisation of the risk linked to the handling of the chemical agent Risk Management Measures Ensure compliance with eSDS requirements (Operating Conditions and Technical Measures) Safety Data Sheets Safety information on substances and mixtures from manufacture to use Chemical Safety Reports Refining approaches used in the CSR to guarantee safe use and worker protection Chemical agents are classified according to their hazard level. An inventory of the uses of the chemical agents feeds the exposure assessments via Exposure Scenarios, which enables the characteriation of the risk linked to the handling of the chemical agent. We base our evaluation on the Exposure Scenarios written in the Chemical Safety Report and the Safety Data Sheets that will accompany the chemical agent on the Downstream Users premises. Value-added services Advice on exposure and health risks Exposure scenarios using CHESAR and other tools Training modules for specific company needs Interpreting risk data Transport of Dangerous Goods by road (ADR2015) Defining right strategies for monitoring campaigns Downloads Industrial Hygiene Flyer - EN Key Contact Stephane PIERRE stephane.pierre@cehtra.com Related Sectors Chemicals (REACH) Global Notifications REACH Authorisation

  • REACH Authorisation | CEHTRA

    REACH Authorisation REACH Authorisation is a European risk management measure which aims to limit human and environmental exposure to substances considered of very high concern. All the users in terms of REACH definition (formulators, importers, downstream users) of one of the Annex XIV substances in Europe must carry out an Authorisation dossier to continue to be able to use the substance in question. CEHTRA's team is experienced and the entire dossier is done in-house, from the exposure estimation to the assessment of socio-economic impacts. Meet our expert Stephane PIERRE Head of REACH Authorisation stephane.pierre@cehtra.com Key Services Complete Authorisation dossier Advocacy Conformity Prioritisation/ Anticipation Drafting the whole dossier in coherence (CSR, AoA, SEA) Protect your interest (regulatory watch, supply chain securisation, public consultation...) Toward the Authorisation or restriction obligation Anticipate the regulatory obligation based on the hazard for your substance portfolio Value-added Services All the dossier parts are performed internally Several dossier submitted with success Member of the NerSAP(Network of REACH SEA and Analysis of Alternatives practitioners) Tox / Ecotox hazard assessment based on SVHC properties Regulatory scoring based on the supporting information Draft the Analysis of Alternatives based on client’s data Downloads REACH Authorisation Flyer - EN Key Contact Stephane PIERRE Head of REACH Authorisation stephane.pierre@cehtra.com Related Sectors Chemicals (REACH)

  • Trainings | CEHTRA

    Trainings Trainings ​ Please note that this page is currently being updated. In the meanwhile, limited information has been made available for the current trainings. If you have any urgent queries, please send an email to training@cehtra.com You choose what you want to learn and when. Regular training is essential to keep up-to-date with the changing regulations. You can come to us or we can come to you. Unique Tariff Price per participant: 1,100€ / day (excluding VAT) The price includes the training materials and lunch. ​ You choose when, You choose where Upon request, our courses can be customized to your specific requirements. ​ How to register? Pre-registration form to be sent to training@cehtra.com ​ ​ Training 1 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 2 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 3 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 4 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat Training 5 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 6 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 7 Duration: 1.5 days Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.​ Training 8 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 9 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 10 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 11 Duration: 1.5 days Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 12 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 13 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 14 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 15 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 16 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 17 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 18 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 19 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 20 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 21 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 22 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 23 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Training 24 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​ Training 25 Duration: 1 day Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. ​

  • Careers | CEHTRA

    Job openings Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. ​ Internships Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. Introduction in 3 lines. ​

  • CEHTRAcker | CEHTRA

    Welcome to CEHTRA cker CEHTRA's window to worldwide regulatory support This page is not adapted for smartphone screens. Please access it on your computer. 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 Australia 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 Go back to the interactive map Canada 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 Go back to the interactive map China 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… Go back to the interactive map Eurasia 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 Go back to the interactive map European Union ​ 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 Click here to be redirected to our page dedicated to EU REACH Go back to the interactive map 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 Click here to be redirected to our page dedicated to ICMSR Go back to the interactive map 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 Go back to the interactive map 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. Go back to the interactive map 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) Go back to the interactive map 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 Go back to the interactive map 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 Go back to the interactive map 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 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 Go back to the interactive map 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 Click here to get redirected to our page dedicated to Brexit Go back to the interactive map 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 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 Go back to the interactive map

  • Plant Protection | CEHTRA

    Plant Protection As a manufacturer or a distributor in the field of agriculture, you want to get your substances approved efficiently and get your Plant Protection Products on the market. From Data Gap Analysis through to the dossier submission to the competent authorities, CEHTRA's team supports you in the necessary steps to meet the current regulatory requirements, for a successful registration. Meet our experts Philippe ADRIAN Head of Plant Protection philippe.adrian@cehtra.com Estelle BELTRAN Expert Environmental Consultant estelle.beltran@cehtra.com Blandine JOURNEL Senior Ecotoxicologist blandine.journel@cehtra.com Key Services Regulatory Dossiers From registration strategy up to the post-submission defense Data Gap Analysis Testing proposal, study monitoring, hazard identification, scientific rationale Risk Assessment Toxicology, Consumer, Environment, Ecotox, modelling and refinement Task Force Management Management support to facilitate joint applications in the EU and abroad Value-added services Endocrine Disrupting Properties CADDY and IUCLID dossiers Tailored studies (operator, field) for regulatory compliance Fertilizers and Biostimulants Environmental Screening Authorization of formulated products (including North and South America) Downloads Plant Protection Flyer - EN Key Contacts Philippe ADRIAN Head of Plant Protection philippe.adrian@cehtra.com Estelle BELTRAN Expert Environmental Consultant estelle.beltran@cehtra.com Blandine JOURNEL Senior Ecotoxicologist blandine.journel@cehtra.com Related Sectors Trainings

  • News & Events | CEHTRA

    Latest News Stay informed about all our latest announcements across all our business sectors. This page will be updated regularly. To help you find the most relevant news, we have introduced a filter below. Select the markets that interests you. Filter news for sectors that interests you - - - - - - - - - - All (Default) Biocides Global Notifications Pharmaceuticals Chemicals (REACH) Industrial Hygiene Plant Protection Cosmetics Packaging REACH Authorisation - News 1 Date 1 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 2 Posted on: Date 2 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 3 Posted on: Date 3 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 4 Date 4 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 5 Posted on: Date 5 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 6 Posted on: Date 6 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 7 Date 7 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 8 Posted on: Date 8 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 9 Posted on: Date 9 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 10 Date 10 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 11 Posted on: Date 11 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 12 Posted on: Date 12 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 13 Date 13 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 14 Posted on: Date 14 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 15 Posted on: Date 15 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 16 Date 16 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 17 Posted on: Date 17 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 18 Posted on: Date 18 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 19 Date 19 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 20 Posted on: Date 20 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 21 Posted on: Date 21 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 22 Date 22 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 23 Posted on: Date 23 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. 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  • Chemicals (REACH) | CEHTRA

    Chemicals (REACH) A solid, highly experienced team focused on helping you meet your compliance deadline. You're in safe hands. A solid REACH dossier will enable you to put your substance on the market serenely. Your product is your priority, you are ours. During REACH Phase 1, 2 & 3 CEHTRA provided high quality technical and regulatory support and obtained extensive experience which can be a real asset to industry faced with the challenge of managing, completing and updating dossiers. ​ Moreover, by implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers. Click here to read more about how CEHTRA experts can assist you with REACH registration dossier updates. Meet our experts Mathieu ROLLAND Head of REACH mathieu.rolland@cehtra.com Brigitte CASENAVE Senior Chemist brigitte.casenave@cehtra.com Key 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 CEHTRA's consultants have been involved in the preparation of hundreds of REACH registration dossiers, acting on behalf of either the Lead Registrant or a coregistrant. ​ Industrials have successfully experienced CEHTRA and they continue for reviewing their product portfolio and strategy for REACH registration of substances, adapting testing strategies, expert regulatory and scientific advices. REACH dossier registration updates Implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers. ​ The requirement to update ‘without undue delay’ is in most cases specified as three months and, in more complex cases, up to 12 months. ​ Additionally, Cefic, through its multi-annual Action Plan, provides a framework for REACH registrants to evaluate the safety data in a stepwise manner. IUCLID Migration Dossier Review Lead Registration dossier update Co-registration dossier update Full update for IUCLID 5 dossiers and TCC passing for dossiers submitted in older versions of IUCLID 6 ​ Listing vulnerabilities and corrective actions and expert advice to tackle them a) Boundary composition including all SIEF information b) Outcomes associated to new studies c) CSR with CHESAR a) New UVCB qualities b) New impurity profile c) Impact for C&L d) Tonnage update We have indeed a large amount of experience in the update process: i) IUCLID Migration Services ​ ​ Only by using the Technical Completeness Check (TCC) tool in the latest version of IUCLID (6.5.1.2) can you ensure your submission will pass the first submission processing steps in REACH IT. ​ IUCLID 5.6 and newer files can be imported directly into the latest version of IUCLID (6.5.1.2) however they will most likely fail the latest Technical Completeness Check (TCC) and therefore need updating. Any IUCLID files older that 5.6 will not import into the latest IUCLID directly and would need to be updated in a stepwise process. ​ If you need to make submissions to the UK competent authority after Brexit you will also need to pass the latest TCC check. ​ Our team has good experience with IUCLID migration services. If you have any questions, write to one of our experts or simply drop your query in the chat window below and one of our experts will get back to you. ​ ​ ii) Joint Submission Services ​ ​ CEHTRA experts accompany: a) Companies to update their dossier within or without the CEFIC Action Plan ​ b) Lead Registrants for preparing the dossier updates and associated costs taking other SIEF members into consideration. ​ c) Co-registrants when supply-chain and/or composition has been modified. Value-added services Cost-sharing and data-sharing UVCB registration Alternative testing strategies Expert advice Study monitoring PRIMO tool to optimize management and follow-up of data Downloads REACH Flyer - EN Key Contacts Mathieu ROLLAND Head of REACH mathieu.rolland@cehtra.com Brigitte CASANAVE Senior Chemist brigitte.casanave@cehtra.com Related Sectors Global Notifications Industrial Hygiene REACH Authorisation

  • Company Profile | CEHTRA

    Company Profile CEHTRA is an international leader in technical and regulatory support with regard to the safety of chemical products. Our focus is on scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations: from portfolio strategy to notification of chemicals and from human exposure to site audits. CEHTRA consultants provide high quality regulatory services to companies such as yours committed to the safety of their products at optimized costs. ​ CEHTRA differentiates itself by responding to the strategic challenges of its clients by: ​ A wide range of services including outsourcing (known as "Regie" in France), industrial hygiene and consortia management on one hand, and tools for digital disruption to save time and costs on the other. ​ Alternative regulatory strategies to accelerate the time to market of products thanks to industrial and international expertise recognized for almost 20 years. ​ An innovative blend of proven scientific and digital solutions: endocrine disruption, QSAR and Read-Across support, Data and Management tools such as CEHTRAPEDIA, PRIMO etc. ​ Our Vision ​ Today's safe chemicals are a key to tomorrow's sustainable future. ​ Combining our scientific expertise and years of consulting experience, we remain committed to our clients to ensure safety of their chemicals, thus contributing to the global efforts to protect biodiversity for a safer future. ​ The three key aspects defining CEHTRA's vision are: Client Backing Scientific Expertise Biodiversity Protection

  • Latest News | CEHTRA

    Latest News Stay informed about all our latest announcements across all our business sectors. This page will be updated regularly. News 1 Date 1 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 2 Posted on: Date 2 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 3 Posted on: Date 3 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 4 Date 4 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 5 Posted on: Date 5 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 6 Posted on: Date 6 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 7 Date 7 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 8 Posted on: Date 8 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 9 Posted on: Date 9 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 10 Date 10 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 11 Posted on: Date 11 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 12 Posted on: Date 12 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 13 Date 13 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 14 Posted on: Date 14 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 15 Posted on: Date 15 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 16 Date 16 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 17 Posted on: Date 17 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 18 Posted on: Date 18 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 19 Date 19 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 20 Posted on: Date 20 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 21 Posted on: Date 21 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 22 Date 22 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 23 Posted on: Date 23 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 24 Posted on: Date 24 Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. News 25 Date 25 Posted on: Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.

  • Biocides | CEHTRA

    Biocides Are you required to renew an approval of an active substance, to submit a product authorization or BPF dossier, to apply for Article 95 List inclusion or for Technical Equivalance? Our broad experience in supporting active substances and biocidal products is your best guarantee. Among the multiple uses covered by Biocidal Product Regulation (EU) 528/2012 (BPR), which one is yours: Disinfectants? Wood preservatives? Rodenticides? Insecticides? ​ Entrust your dossier into experienced hands! ​ Meet our experts Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Cyril DUROU Senior Ecotoxicologist cyril.durou@cehtra.com Annekathrin FAUPEL Senior Regulatory Manager annekathrin.faupel@cehtra.com Key Services Product Authorization Biocides Product Family Single Product EU R&D Notifications Active Substance Active Substances Annex I inclusion Article 95 Listing Dossier Preparation Testing strategy Study Monitoring Alternatives to animal testing Consortium Management Biocide Product Family Consortium containing specific active substances CEHTRA's consultants has been involved in the preparation of several active substances Annex I inclusion dossiers and submission of biocidal products through the BPR process and under National schemes. ​ Our team has also successfully completed many Biocide Product Registration and Biocide Products Family dossiers from start to finish without counting the numerous projects for regulatory support, Monitoring, Outdoor Operator Exposure Studies, Expert Advice and Position Papers. Value-added Services Assessment of ED properties Negotiations with Authorities Worldwide Compliance Risk Assessment and Modelling Technical Equivalance Data Sharing Negotiations Downloads Biocides Flyer - EN Tools Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Cyril DUROU Senior Ecotoxicologist cyril.durou@cehtra.com Annekathrin FAUPEL Senior Regulatory Manager annekathrin.faupel@cehtra.com Related Sectors Trainings

  • News | CEHTRA

    Latest News Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Events Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text Text text text

  • Our Expertise | CEHTRA

    Our Expertise Biocides Are you required to renew an approval of an active substance, to submit a product authorization or BPF dossier, to apply for Article 95 List inclusion or for Technical Equivalence? Chemicals (REACH) A solid, highly experienced team focussed on helping you meet your compliance deadline. ​ Cosmetics Demonstrate the safety of both your finished products and ingredients. Get the packaging safety tested. Shorten the time to market ​ Global Chemicals Notification Our internal tools designed to provide you the best worldwide, personalized and optimized strategy for a minimum cost. ​ Industrial Hygiene CEHTRA's industrial hygienists have decades of experience working with clients in their industrial sites and manage Environmental, Health and Safety challenges with a well balanced mix of technical expertise and practical experience. ​ Packaging Experienced, quality support in managing complex and constantly evolving regulation on packaging. ​ Pharmaceuticals For the safety of your pharmaceutical substances & products we can assist you in the development of your new drugs, safety of your drug production and generation of environmental risk assessment. ​ Plant Protection As a manufacturer or a distributor in the field of agriculture, you want to get your substances approved efficiently and get your Plant Protection Products on the market. ​ REACH Authorisation REACH Authorisation is an European risk management measure which aims to limit human and environmental exposure to substances considered of very high concern. Our Expertise Biocides Are you required to renew an approval of an active substance, to submit a product authorization or BPF dossier, to apply for Article 95 List inclusion or for Technical Equivalence? Chemicals (REACH) A solid, highly experienced team focussed on helping you meet your compliance deadline. ​ Cosmetics Demonstrate the safety of both your finished products and ingredients. Get the packaging safety tested. Shorten the time to market ​ Global Chemicals Notification Our internal tools designed to provide you the best worldwide, personalized and optimized strategy for a minimum cost. ​ Industrial Hygiene CEHTRA's industrial hygienists have decades of experience working with clients in their industrial sites and manage Environmental, Health and Safety challenges with a well balanced mix of technical expertise and practical experience. ​ Packaging Experienced, quality support in managing complex and constantly evolving regulation on packaging. ​ Pharmaceuticals For the safety of your pharmaceutical substances & products we can assist you in the development of your new drugs, safety of your drug production and generation of environmental risk assessment. ​ Plant Protection As a manufacturer or a distributor in the field of agriculture, you want to get your substances approved efficiently and get your Plant Protection Products on the market. ​ REACH Authorisation REACH Authorisation is an European risk management measure which aims to limit human and environmental exposure to substances considered of very high concern.

  • Query Form | CEHTRA

    Query Form If you have questions, feel free to get in touch with our team by filling in the query form below. Select a sector Your name Your email address Company / Organization Your job title Your message Sélectionnez un service General Query Biocides Cosmetics Chemicals (REACH) Global Notifications Industrial Hygiene Packaging Pharmaceuticals Plant Protection REACH Authorization arrow&v Submit Thank you for your message. We will contact you at the earliest possible.

  • Medical Devices | CEHTRA

    Medical Devices As a legal manufacturer of Medical Devices or as a Supplier for Medical Device manufacturing, you may have to face unexpected challenges in applying the new quality and regulatory requirements. With over 20 years of combined experience, our passionate team has extensive knowledge in all aspects that will help you succeed in your market access strategy. As your secure and reliable partner, CEHTRA can provide a comprehensive service as well as a tailor-made solution to answer your questions. We apply a tailored benefit/risk approach relevant to your product categorization and class. Our expertise includes the Devices without an intended purpose, the borderline products, the combination products containing blood derivative, animal tissue, ancillary medicinal substance. Meet our expert Gaëlle REGUER Head of Medical Devices gaelle.reguer@cehtra.com Imen HAMDOUNI Toxicologist imen.hamdouni@cehtra.com Key Services Regulatory Affairs Support Quality System Support Quality System Support Manufacturing process-focused to ensure Business Performance through the whole lifecycle of technical files, from initiation to MDR/IVDR remediation to ensure Regulatory compliance based on the ISO 13485 requirements to ensure Patient / User-oriented Safety and Performance of the Medical Devices to ensure consistent Quality of Products which are made available to the market Regulatory Affairs support to ensure Business Performance through the whole lifecycle of Products technical files, from Design initiation to MDR/IVDR remediation Strategic approach of new markets Implementation of new requirements: EU MDR & IVDR: Technical files: compliance with multiple requirements Risk Management file: whole lifecycle, process approaches Standard management: technical watch, implementation in the compliance to the Essential Requirements / General Safety and Performance Requirements Medical Device - Vigilance Management ​ ​ Quality support to ensure Regulatory compliance based on the ISO 13485 Standard requirements ISO 13485, ISO 17025, FDA 21 CFR part 820, RCD 16 Audits: Internal & Suppliers/CMO/CRO Process: Creation, implementation, maintenance & reporting, risk-based approach Documentation: implementation, improvement for clarity & simplification CAPA: management at department levels Audit / inspections: technical support ​ ​ Product-focused to ensure user-oriented Safety and Performance of the Medical Devices Preclinical Affairs: Risk assessment and control, toxicological risk assessment with skilled toxicologists Clinical Affairs: Clinical Evaluation Plan and Reports, Clinical evaluation of PMS & PSUR Clinical Trials, PMCF studies: Regulatory support for Clinical Trials Design transfer: From Product Specifications to Manufacturing Process ​ Manufacturing Process-focused to ensure consistent Quality of Products on the market Qualification & Validation strategies consistent with production requirements, training and documentation Qualification : Equipment & Software / process validation & verification Risk based approach Qualification & Validation Output for Quality Assurance Documentation: implementation, improvement for clarity & simplification for regulatory purpose Value-added Services Holistic and transversal approach Data and bibliographic analysis for Biological Safety & Clinical Safety and Performance Training : Regulatory Affairs, Biological Safety Expert review of Technical Files Responsible Person for Regulatory Compliance Benefit/risk Evaluation Downloads Medical Devices Flyer - EN Key Contact Gaëlle REGUER Head of Medical Devices gaelle.reguer@cehtra.com Imen HAMDOUNI Toxicologist imen.hamdouni@cehtra.com Related Sectors Trainings

  • Legal | CEHTRA

    Legal This website is hosted by WIX.com Inc. 500 Terry A François Blvd San Francisco, CA 94158, USA ​ ​ CEHTRA - Consultancy for Environmental & Human Toxicology and Risk Assessment ​ CEHTRA Company information CEHTRA SAS 15 rue Aristide Briand 33150 Cenon France Tel: +33 (0) 557 77 56 10 Fax: +33 (0) 557 77 56 20 contact@cehtra.com Reference : CEHTRA SAS Capital social : 16 000 € RCS Bordeaux 434 733 440 TVA FR 24 434 733 440 APE: 7490B SIRET: 434 733 440 00086 Web Hosting :ONLINE SAS B.P. 438 75366 Paris Cedex 08 www.online.net The following terms of use are applicable to the website www.cehtra.com . This website is designed for a French audience and/or people located in France however the terms of use applicable to other countries and regions around the world can vary. Website ​ The website www.cehtra.com is a company presentation site. ​ CEHTRA could never be held responsible for any direct or indirect damages, whatever the cause, origin or nature and consequence, ensued from the consult or use of the website. In particular, CEHTRA accepts no responsibility in case of an interruption or the inability to access the website, bugs, and any other damages arising from the fraudulent actions of third party from the website. Privacy policy - Personal data ​ All personal data collected on the site are treated with the strictest confidentiality. We remind you that you have a right of access, modification, correction and suppression of the data which concern you (art. 34 of the law "Informatique et Libertés" of January 6, 1978). To exercise this right, please contact us. CEHTRA SAS 15 rue Aristide Briand 33150 Cenon France Tel : +33 (0) 557 77 56 10 Fax : +33 (0) 557 77 56 20 contact@cehtra.com READ MORE ABOUT DATA PRIVACY Guarantees and responsibilities ​ CEHTRA endeavors to assure at best that the information at your disposal through the website is accurate and updated. However CEHTRA does not guarantee in any way that the information are accurate, complete and updated. CEHTRA does not insure any tacit or expressed guarantee regarding the whole or a part of the website. Intellectual property and right ​ The website are hosted by the company CEHTRA: ​ biocide-consulting.com cehtra.co.uk cehtra.com cehtra.eu cehtra.fr consulting-reach.com environment-consultancy.com net-reach.eu pesticide-consulting.com reach-chemical-consulting.com reach-expert.com toxicology-consultancy.com ​ The website is an intellectual creation and is under the intellectual property laws. The whole website and each of its components (texts, schemas, software, codes, photos, drawings, logos, brands and models) are the exclusive property of CEHTRA which is the only one empowered to use the relevant intellectual property rights. ​ ​ ​ Guarantees and responsibilities ​ CEHTRA endeavors to assure at best that the information at your disposal through the website is accurate and updated. However CEHTRA does not guarantee in any way that the information are accurate, complete and updated. CEHTRA does not insure any tacit or expressed guarantee regarding the whole or a part of the website. Disputes ​ The previous terms are stated according to the French right and in particular the measures of the law n°2004-575 of the 21st June 2004 for the trust in the digital economy and the lawi n°78-17 of the 6t January 1978 modified by the law n°2004-801 of the 6th August 2004 IT and Freedom. The jurisdictions Sainte Eulalie have the ability to know all the disputes regarding the website.

  • Pharmaceuticals | CEHTRA

    Pharmaceuticals (Human & Veterinary) For the safety of your pharmaceutical and veterinary substances & products CEHTRA can assist you with: Safety of your drug substances and drug products: development and regulatory submissions. Safety of your drug production (PDE, OEL/OEB, impurities qualification) Generation of Environmental Risk Assessment (ERA) for your MAA dossier ​ ​ Meet our experts Stephane PIERRE Head of Pharmaceuticals stephane.pierre@cehtra.com Maryse CORROLLER Expert Toxicologist maryse.corroller@cehtra.com Blandine JOURNEL Senior Ecotoxicologist, ERA blandine.journel@cehtra.com Key Services PDE and OEL/OEB Calculations Safety assessment of drug production and workers on site (PDE, OEL/OEB) Safety Qualification of Impurities Safety qualification of impurities in drug substances or products (ICH and VICH guidelines) Preclinical Expertise Development plan, study monitoring, writing regulatory dossiers (CTA, MAA...) Environmental Risk Assessment Entire ERA part of the MAA is covered (dossier preparation, study monitoring, defense with authorities…) Value-added services Trainings QSAR support using Nexus DEREK and Leadscope Data and bibliographic analysis Toxicologist and Ecotoxicologist team (as well as QSAR expert) Dossier Defense Regulatory Watch Downloads Pharmaceuticals Flyer - EN Key Contacts Stephane PIERRE Head of Pharmaceuticals stephane.pierre@cehtra.com Maryse CORROLLER Expert Toxicologist maryse.corroller@cehtra.com Blandine JOURNEL Senior Ecotoxicologist, ERA blandine.journel@cehtra.com Related Sectors Cosmetics Biocides Chemicals (REACH) Industrial Hygiene Packaging