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Top of the page BIOCIDES Description Description Contact Key Services Value-added Trainings Consortia Media Among others, are yo u required to: ​ Deal with an Active Substance dossier (new or renewal)? Submit a single product or BPF dossier? Apply for Article 95 List inclusion or for Technical Equivalence or for any request related to BPR? ​ 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 pr eservatives? Pest control (Rodenticides, Insecticides, Repellents, ...) ? Antifouling products? ​ Entrust your dossi er into experi enced hands! Contact 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 Value-added Services Key Services Biocidal Product Single Product Biocide Products Family EU R&D Notifications Active Substance New active substance Renewal of Active Substances approval Annex I inclusion Article 95 Listing Dossier Preparation Testing strategy Study Monitoring Alternatives to in vivo testing Consortia Management Consortia 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. Media Videos Flyers Consortia QuAC (Biocides) Trainings Coming soon How do Biocidal Product Families work? Accelerate your time to market! en savoir plus s'inscrire 6-7 June. 2024 Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment en savoir plus s'inscrire Trainings Value-added Services Assessment of ED properties Negotiations with Authorities Risk Assessment and Modelling Technical Equivalence Data Sharing Negotiations Consortia Media Haut de page

SFPP3 and CEHTRAPACK Modeling Tools New! Control Substance Migration with SFPP3 and CEHTRAPACK Modeling Tools Meet our packaging expert Are you looking to assess the risk associated with migration of substances from your packaging to its contents? Our migration simulation tools, through calculation or mathematical modeling, enable this evaluation. Our tools provide the following capabilities: ​ Analysis of material/substance transfers from packaging components to contents. ​ Modeling via the SFPP3 tool to estimate contaminant diffusion based on their chemical structure (molecular weight, concentration known or unknown in the material). ​ Evaluation based on phenomena involved in food contamination by materials (substance diffusion in packaging material and substance partitioning between material and food). ​ Diffusion coefficients of substances simulated based on the Piringer model. ​ Estimation of substance concentration in food over time. ​ Method recognized by regulatory authorities for market control. Interested to know more? Please fill out the form below and we will get back to you as soon as pos sible. Contact us First name Last name E-mail Phone number Company Message Send

Top of the page CHEMICALS (REACH) Description Contact Key Services REACH dossier Value-added Trainings Media 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. Description Contact Meet our experts Mathieu ROLLAND Head of REACH mathieu.rolland@cehtra.com Brigitte CASENAVE Senior Chemist brigitte.casenave@cehtra.com Key Services Key Services Dossier compilation & update Lead registrant and co -registrant dossiers testing strategy SIEF Management Only Representative Supply-chain management Consortium and SIEF communication, administrative and financial management of LoA Representation of non-EU companies through our Only-Representative (OR) Legal Entity and UK-REACH 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 TCC passing for dossiers submitted in older versions of IUCLID 6 Full update for IUCLID 5 dossiers Listing vulnerabilities and corrective actions Expert advice to tackle them Boundary composition including all SIEF information Outcomes associated to new studies CSR with CHESAR New UVCB qualities New impurity profile Impact for C&L 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: Companies to update their dossier within or without the CEFIC Action Plan ​ Lead Registrants for preparing the dossier updates and associated costs taking other SIEF members into consideration. ​ Co-registrants when supply-chain and/or composition has been modified. Chemicals (REACH) - Dossier update Value-added Services Trainings 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 Trainings 4 June. 2024 Master CHESAR to simplify your REACH assessments en savoir plus s'inscrire 18 June. 2024 Familiarise yourself with eSDS: obligations, content and compliance en savoir plus s'inscrire Coming soon Master IUCLID and register your substances under REACH en savoir plus s'inscrire Media Related Sectors Global Notifications Industrial Hygiene REACH Authorisation Haut de page

THE BASICS Learn and keep up to date on the essentials of the regulations. Discover Training > The basics > Ancre 1 BIOCIDES COSMETICS ECOTOXICOLOGY MEDICAL DEVICES PACKAGING PLANT PROTECTION REACH TOXICOLOGY Biological evaluation of medical devices in accordance with EN ISO 10993-1 from 580€ (HT) Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan View sessions Familiarise yourself with eSDS: obligations, content and compliance from 580€ (HT) Understand the obligations under REACH and the impact/penalties in the event of non-compliance Know how to draw up an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS View sessions How do Biocidal Product Families work? Accelerate your time to market! from 580€ (HT) Addressing the stages of an application for authorisation of a family of biocidal products : - Similarity of composition & grouping of co-formulants - Similarity of uses - Similar level of risk and efficacy Addressing the various points to be taken into account when dividing biocidal product families for current evaluations View sessions Introduction to packaging regulations: understanding and implementing them from 580€ (HT) Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) View sessions Master CHESAR to simplify your REACH assessments from 580€ (HT) Understand the obligations under REACH How to use CHESAR to carry out a CSA (Chemical Safety Assessment) Be able to generate a CSR (Chemical Safety Report) under CHESAR Comply with ECHA expectations View sessions Master IUCLID and register your substances under REACH from 290€ (HT) How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT View sessions Plant Protection Products: from regulation to registration from 580€ (HT) Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid View sessions Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics from 140€ (HT) Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. View sessions Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment from 870€ (HT) Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification and Risk Assessment. Be able to spot the pitfalls of studies and know how to avoid them View sessions Safer cosmetics for tomorrow - Know your regulatory obligations from 580€ (HT) Knowing and understanding Cosmetics Regulation 1223/2009 Understand the risk assessment of a cosmetic product Identify areas for improvement in order to comply with regulatory obligations View sessions Toxicology and Classification - the fundamentals of your regulatory success from 1160€ (HT) Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved Optimising interaction between managers and experts View sessions 2023 « Formation très claire avec formatrice très agréable. Les exemples concrets ont permis de mettre en lumière la complexité des packagings et d'obtenir des informations sur la composition. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

Familiarise yourself with SDSe: obligations, content and compliance Discover Familiarise yourself with SDSe: obligations, content and compliance The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Know the obligations under REACH and the impacts/sanctions in case of non-compliance Know how to construct an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Know the methods of compliance in case of discrepancies between the downstream uses and the exposure scenarios covered by the eSDS Program Part 1 - Actors in the supply chain Part 2 - Obligation under REACH for eSDS producers Part 3 - Main steps in the construction of the CSA/CSR Part 4 - Construction of an extended safety data sheet Part 5 - Steps when receiving a supplier SDS: compliance objective Part 6 - Impacts/sanctions in case of non-compliance Part 7 - Q&A I Assessment of skills acquired through a final quiz Methodology used The training is delivered through a presentation containing case studies, role plays and continuous interaction with the expert. The support will be given to the trainees. A final quiz will validate the acquired knowledge. For better online learning, our training courses are held in small groups of a minimum of three people up to a maximum capacity of 6 people. Our courses are delivered through synchronous learning. Public Public People working under the REACH Regulation: - QHSE - manufacturers, formulators, chemical manufacturers Prerequisites Knowledge of the REACH Regulation. Knowledge of SDS (sections 1-16). Chat Chat 7 Hours Location Chat From 580€ Contact us Online French session Anna Chelle Expologist and regulatory toxicologist ​ Parole de client « I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

Top of the page Description PLANT PROTECTION Description Contact Key Services Biocontrol Value-added Trainings Media 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. Contact Meet our experts Estelle BELTRAN Head of Plant Protection estelle.beltran@cehtra.com Blandine JOURNEL Expert Ecotoxicologist blandine.journel@cehtra.com Key Services Value-added 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 Biocontrol Diagnostic Fertilizers and Biostimulants Environmental Screening Tailored studies (operator, field) Authorization of formulated products (including North and South America) Trainings Trainings 6 June. 2024 Plant Protection Products: from regulation to registration en savoir plus s'inscrire 6-7 June. 2024 Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment en savoir plus s'inscrire Media Flyers Media Haut de page

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. Conditions Générales d’Utilisation des applications de CEHTRA Mentions légales des applications de CEHTRA

Publications Biocides Cosmetics Pharmaceuticals Biocides Biocides Regulatory Updates March, 2023 Framework Guidance - Analysis of alternatives to biocidal active substances Next February, 2023 ADBAC/BKC in PT2 - Information on Approval Status Next December, 2022 Use of general terms for application frequency Next November, 2022 Update on ECHA Efficacy Guidance Next October, 2022 NEWS on Technical Agreements for Biocides (TAB) Next Cosmetics Information / Toxicological and Regulatory News April, 2022 Publication de l’avis préliminaire du SCCS sur l’alpha-arbutine et la beta-arbutine Next February, 2022 Un rapport met en évidence le manque de conformité des cosmétiques enfants Next January, 2022 Mise à jour de la liste Candidate SVHC Next December, 2021 Parution d’une recommandation scientifique du SCCS sur l’homosalate Next November, 2021 Use of trivial names for active substances in biocidal product label Next Articles March, 2022 Cosmetick, un outil développé par CEHTRA dédié à l’évaluation de la sécurité de vos produits (published in Skinobs) Next June, 2021 Safety Testing of Cosmetic Products: Overview of Established Methods and New Approach Methodologies (NAMs) (published in MDPI) Next September, 2020 What does it take to prepare a solid toxicological dossier for Cosmetic Raw Materials? (published in COSSMA) Next Cosmetics Pharmaceuticals Regulatory Updates October, 2021 Qualification d'impuretés : Modifications de la guideline ICH M7 Next Articles April, 2022 Toxicological approach to define the PDE for your cleaning validation process (published in A3P) Next Pharmaceuticals

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. A CEHTRA designed tool to allow: Sharing and secure storage of data Simultaneous access for client and CEHTRA Project management and planning Global regulatory data gap analysis to assist in designing testing strategies for all markets Project Management ✓ Allows members an overview of the status of their projects ✓ Track the progress of your projects (Gantt) ✓ Assign tasks and follow-up Working Documents ✓ Data Gap Analysis (DGA) ✓ Country-specific support for DGA based on country specific requirements ✓ Study Monitoring Dashboard Data Storage ✓ Secure sharing and storage of your data ✓ Easy upload and download of documents ✓ Exchange of large files Two licence options PRIMO Basic PRIMO Ultimate under development 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 Flyers Access PRIMO Already have a PRIMO account? Click here to access Request a demo today! Drop your queries to: primo@cehtra.com ​ or leave your messages on Let's Chat window below Acknowledgements Our project « Chèque transformation Numérique » has received a grant from the European Union under the FEDER-FSE Aquitaine 2014-2020 operational program.

Top of the page INDUSTRIAL HYGIENE Description Contact Key Services Value-added Trainings Media 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. Click here to learn more... New ! Quickly assess your level of compliance with Chrome VI handling Description Contact Meet our experts Guillaume MOUSSETTE Head of Industrial Hygiene guillaume.moussette@cehtra.com Stephane PIERRE Managing Director of Paris Agency stephane.pierre@cehtra.com Key Services Exposure Scenarios Specific characterisation of the risk linked to the handling of the chemical agent with CHESAR and other tools Chemical safety Reports ​ Refining approaches used in the CSR to guarantee safe use and worker protection On-site audits Ensure compliance with eSDS or authorization / restriction requirements (Operating Conditions and Risk Management Measures) On-site consulting service General Chemical risk management (HSE) 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. Key Services Value-added Value-added Services Exposure and health risks at your working stations Digital dashboard Training modules for specific company needs Trainings Trainings 18 June. 2024 Familiarise yourself with eSDS: obligations, content and compliance en savoir plus s'inscrire Media Flyers Media Related Sectors Chemicals (REACH) Global Notifications REACH Authorisation Haut de page

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 expert 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

Predict the future with PRISM A new multi-market regulatory platform for collective intelligence Save the Date: 7th June, 2022 Enter your email address to stay informed! Submit Thanks for for your interest! Hypermind - predictive market Hypermind is a collective forecasting platform created by Emile Servan Schreiber. Read More Collective Intelligence It is now scientifically established that human brains, when assembled, can produce superior intelligence. The IQ of a group emerges not from the IQs of its members, but from their emotional intelligence. It is the quality of the connections that makes the intelligence of the network. Read More Emile Servan Schreiber A doctor in cognitive psychology (Carnegie Mellon), Émile Servan-Schreiber has been a journalist and an artificial intelligence engineer. For the past twenty years, as head of Lumenogic and Hypermind, he has divided his time between research on collective intelligence and its practical applications for companies and governments. Read More Supercollective ​ The diversity theorem tells us that the intelligence of a group is as much a result of the diversity of opinions as of the expertise of each individual. There is no point in being in a group if everyone thinks alike. It is essential to bring together people who see a problem in different ways, even if some are less expert than others. When you are a manager, you must therefore have the humility to seek the opinions of as many people as possible before making decisions. Digital tools make this possible on a very large scale. This is what I call the 'supercollective'. Emile Servan Schreiber Read More The Book Supercollective - The new power of our intelligence Groups have their own intelligence; we have recently learned to measure their IQ. But why are the more feminine groups wiser? How can we invoke the wisdom of a crowd while avoiding the pitfalls of conformity? Why does diversity make us smarter? How does our 'supercollective' intelligence make our companies more successful? How can we use it to revitalise our democracy? And why are American spies so interested in it? Emile Servan-Schreiber provides surprising and stimulating answers to all these questions, based on the latest scientific discoveries and long experience in the field. Read More What is a prediction market? ​ "It is an online betting platform designed to generate reliable forecasts, rather than to enrich a bookmaker. Each fore+F8 it's wrong, his stock is worth nothing." Emile Servan Schreiber Read More What is a probabilistic forecast? Probabilistic forecasting takes a different perspective on anticipating future outcomes. Instead of producing a value as the "best" outcome, probabilistic forecasting involves assigning a "probability" to each possible outcome. In other words, all future events remain possible, they just do not have the same probability. Being a better forecaster A good bettor is someone who is not afraid to change his or her mind, happy to seek out differing points of view, comfortable with the fact that new evidence might lead him or her to abandon what he or she thought. In other words, they are a person with an "actively open mind". Read More ​ What is the difference between a prediction and a survey? When we express a preference, as in a vote or a poll, we only use our emotions and our memory. But when we bet on what will happen (as in a prediction market), we use reason, and the results are more powerful. Read More You don't have to be an expert in the field to answer Various studies have shown that the predictions of generalists far exceed those of experts. Experts who have confined themselves to their specialised field and ignored interdisciplinary knowledge have the worst results. They also tend to be more confident in their - erroneous - predictions than generalists. And their predictions are more definite - which according to probability theory is a bad thing. Read More The challenge - Betting system The most fundamental explanation for the success of the superpredictors is that they have focused on a single objective: predicting the future! What matters is to give the right answer without leaving room for opinions, radical, original or offbeat ideas. Like in a game with rewards. Read More Open ended questions Open-ended questions are ideal for soliciting everyone's creativity. They allow ideas to be generated and selected. Read More Close ended questions Closed-ended questions allow you to predict by choosing an answer from among different options. Read More Why fill in the prediction of others? - Bayesian truth serum The Bayesian truth serum is a scoring system invented at MIT (Prelec, 2004) to elicit truthful and informed responses from respondents. The method requires respondents to provide not only their own answers, but also to estimate the answers of others. Take the example of the question what is the capital of Pennsylvania. Some people will answer Harrisburg while others will answer Philadelphia. This person will have more weight. Read More Diversity of opinion ​ We must trust the intelligence of each person on their own ground. Diversity is the engine of collective intelligence. It is essential to bring together people who see a problem in different ways, even if some are less expert than others. This is why PRISM is an open platform. We believe it is important to have everyone's opinion, from a toxicology student to a regulatory expert. Read More Predicting the future with reliable data ​ Studies conducted over the past 20 years show that prediction markets are more reliable than traditional methods (surveys, experts, data) in 75% of cases, with up to 30% more accuracy. Read More Finding alternative solutions Through collective intelligence, PRISM explores alternative ways of overcoming or circumventing an obstacle by generating innovative ideas or alternative solutions. Becoming an opinion leader PRISM helps to organise and optimise the Collective Intelligence of our regulatory business community, for better decision making and more innovation to responsibly engage with the challenges facing our planet. CIA prediction After each US election, the CIA publishes a report making predictions about the world situation for the next twenty years. Read More Le Point and Hypermind create the Supercollective Institute Who will be elected president of the French republic in 2022? Read More

Menu Welcome to CEHTRA Media All our latest updates at your fingertips! Latest News Videos Podcasts Publi- cations Jobs Offers Social Media Voices of CEHTRA Videos | Media Videos ​ Featured video: ​ In our latest video, Estelle introduces the key services for our clients in the Plant Protection sector. To learn more, click here . Click here for more videos back to menu Podcasts - Media Podcasts ​ Featured Podcast: Sandra MARTINEZ BOSCH introduces PRISTINE - CEHTRA’s digital tool designed to simplify the project management of Biocides Click here for more podcasts back to menu Latest News | Media Voice of CEHTRA | Media Latest News ​ Featured News: ​ Our toxicologist Maurine Duplàa delivered an engaging and insightful lecture at the #SkinSensitization training organized by ALTERTOX and acCELLerate. The training focused on Non-Animal Methods (NAMs) and toxicology, with participants benefiting from Maurine's expertise in the field. Click here for more news back to menu Voice of CEHTRA ​ Featured Voice: ​ Sara LOZANO GARCIA Environmental Modeller Consultant Click here for more videos back to menu Publications | Media Publications ​ Featured Publication: ​ Biocides | Framework Guidance: Analysis of alternatives to biocidal active substances Click here for more publications back to menu Job offers | Media Latest Jobs announcements: ​ Registration and Regulatory A ff airs Manager (M/F) ​ Homologation Enginee r (M/F) ​ Expert and BU manager in pharma/tox (M/F) ​ Corporate Lawyer (M/F) Job offers Have passion for biodiversity and environment? Broaden your horizons and enrich your career with CEHTRA. ​ Check out out latest job offers! Click here for more info back to menu Social Media | Media Social Media ​ We keep our LinkedIn followers up to date with the latest announcements and regularly upload new videos and podcasts on our Youtube channel ​ Follow us on LinkedIn and subscribe to our Youtube channel to miss out any updates. Follow us on Linkedin Subscribe to our Youtube channel back to menu

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: ​ work from our clients’ site and be integrated into their team (Embedded staff ) 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 Media Videos Flye rs

Biological evaluation of medical devices in accordance with EN ISO 10993-1 En savoir plus Training > Biological evaluation of medical devices in accordance with EN ISO 10993-1 The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Programme Part 1 - Context of the standard in European regulations Part 2 - The fundamental principles of the ISO 10993 series Part 3 - Biological assessment using the methodology of EN ISO 13993-1 Part 4 - Case study to conclude on the conformity of the proposed biological assessment plan Part 5 - Evaluation by questionnaire Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will receive a handout. A final quiz will validate what has been learnt. To enhance online learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience DM players. Quality managers. Functions responsible for compiling technical documentation. Prérequis Knowledge of medical device risk classes, the EU certification process as presented in Regulation 2017/745. General knowledge of issues relating to the biocompatibility of healthcare products. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 17.06.24 Délais d'accès : 3 mois Paul Fernandes Biocompatibility toxicologist ​ ​ « Je suis très satisfaite de cette formation bien adaptée à mon background et qui a bien répondu à mes besoins. Par ailleurs, le format à distance est entièrement satisfaisant, et nombre de stagiaires limité facilite les échanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

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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

Top of the page MEDICAL DEVICES Description Contact Key Services Value-added Trainings Media Patient safety is at the center of our concerns. Speed up your time-to-market is essential to fulfill this goal. Whether you are a legal manufacturer of medical devices, a subcontractor or a supplier, CEHTRA supports you throughout the life cycle of your medical device, from design to post-marketing follow-up, including CE marking. We provide our independence and expertise in biological risk assessment to demonstrate the biological safety of your device. The transversality of our expertise in sectors such as pharmaceuticals, biocides, cosmetics and chemicals (REACH) enables us to provide you with the most detailed support. Our expertise includes the Devices without an intended purpose, the borderline products Description Contact Meet our experts Pierre-Yves JOYEUX Head of Medical Devices sector pierre-yves.joyeux@cehtra.co m Paul FERNANDES Biocompatibility Toxicologist paul.fernandes@cehtra.com Key Services Biological Safety Regulatory Support Quality Management Chemicals (REACH) To guarantee the biocompatibility of materials and substances of medical device To ensure compliance with regulatory requirements throughout the life cycle of medical devices ​ To guarantee regulatory compliance based on regulatory requirements and EN ISO 13485 To ensure that the products that are part of your processes comply with REACh regulations Biological Safety ​ ​ Assessment of the biological risk associated with a product or material Evaluation and testing within a risk management process standard (EN ISO 10993-1:2020) and the MD Regulation Review of predicates, materials, processes and components to inform manufacturer of known and potential biological and toxicological hazards and regulatory implications. Establishment of allowable limits for leachable substances (EN ISO 10993-17) Chemical characterization of medical device materials within a risk management process (EN ISO 10993-18) Recommendation of control measures to reduce risk, whether through testing or by establishing the safety of materials and processes. ​ ​ Regulatory Affairs Support ​ ​ General regulatory support: Need an answer? A problem to assess? Need advice on how to respond to the Notified Body on a biosafety issue? Crisis management support: To help to prepare or develop an effective response before or after receiving an inspection notification from the competent authority, or a warning letter. To help to prepare an effective response to Nonconformity from notified bodies Modification evaluation support: Evaluation of the impact of a modification on the biocompatibility of the material/medical device Mentoring to assist the manufacturer in the characterization of the modification ​ ​ Quality Management ​ ​ Internal audits : Based on Quality management system standard (ISO 13485) & MDR ​ Mentoring: To assist on set up a QMS, we make ourselves available to challenge your system. ​ PRRC ( Person responsible for regulatory compliance ) Possible to externalize this function for specific SMEs manufacturers ​ Chemicals (REACH) ​ ​ Registration of chemical substances to meet the requirements of the REACh regulation Authorization: prohibited substances for which an authorization of use can be set up Monitoring of hazardous substances (SVHC, restricted substances, endocrine disruptors,...) Your tailormade Safety Data Sheets (SDS) Value-added Services Global and transversal approach Data and bibliographic analysis for Biological Safety High level of expertise in toxicology and medical device kept up to date (ISO/EN) Training: Regulatory Affairs, Biological Safety, standardization Independence from labs Benefit/risk Evaluation Trainings 17 June. 2024 Biological evaluation of medical devices in accordance with EN ISO 10993-1 en savoir plus s'inscrire Key Services Value-added Trainings Media Media Flyers Related Sectors Pharmaceuticals Chemicals (REACH) Cosmetics Biocides Haut de page

How likely is it for my substance to be an Endocrine Disruptor ? Enter the CAS number >> Get results >> Download report Try it now! What is ED Pedia? ED Pedia allows any stakeholder of a substance (a) to check instantaneously whether this substance likely has, or not, ED properties, (b) to access instantaneously to the relevant documentation, (c) to download a PDF report on the findings and ( d) if needed, to access CEHTRA expert advice to draw conclusions from the report. Access ED Pedia What is an Endocrine Disruptor? According to the WHO definition 2002, an Endocrine Disruptor (ED) is 'an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse effects in an intact organism, or its progeny, or (sub)populations'. ​ This definition is used to identify Substances of Very High Concern (“SVHC ”) for human health and/or the environment due to their endocrine disrupting properties under the REACh (Registration, Evaluation, Authorization and restriction of Chemicals) legislation (European Parliament and Council of the European Union, 2006). ​ A definition of endocrine disruptors for substances in plant protection and biocidal products was adopted in 2017 at European level (EU Regulations 2017/2100 and 2018/605 ) (European Commission, 2017, 2018). ​ In 2018, a guidance document was published by the European Food Safety Authority (EFSA) for the identification of endocrine disruptors (EFSA, 2018). Several other agencies and public programs also focus on this issue. How does ED Pedia work? ED Pedia searches for CAS Numbers in lists yield from hazard assessment programs that identify potential Endocrine Disruptors, with different levels of concern. For a specific Substance CAS Number, ED Pedia reports for each of the lists whether or not the substance is included. Results, especially those describing the outcome of ED evaluation by the relevant authorities should be taken with care, as CEHTRA – though delivering its best efforts - is not responsible and shall not be held liable for the content of the lists. Media Videos Flyers Useful information for ED Pedia users Terms of use | Legal | Data privacy What is an ED?

Top of the page REACH AUTHORISATION Description Contact Key Services Value-added Trainings Media 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 Description Contact Key Services Key Services Complete Authorisation dossier Drafting the whole dossier in coherence (CSR, AoA, SEA) Advocacy Protect your interest (regulatory watch, supply chain securisation, public consultation...) Conformity Toward the Authorisation or restriction obligation Prioritisation/ Anticipation 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 Value-added Trainings Trainings 4 June. 2024 Master CHESAR to simplify your REACH assessments en savoir plus s'inscrire 18 June. 2024 Familiarise yourself with eSDS: obligations, content and compliance en savoir plus s'inscrire Coming soon Master IUCLID and register your substances under REACH en savoir plus s'inscrire Media Flyers Podcasts Media Related Sectors Chemicals (REACH) Haut de page

Your Specialties, Our Expertise CEHTRA (Consultancy for Environmental & Human Toxicology and Risk Assessment) is a company of social and solidarity economy (entreprise de l’économie sociale et solidaire), the French leader and number 3 worldwide in technical assistance and regulatory, toxicological and ecotoxicological consulting for the sectors related to the chemicals industry. ​ Our ambition: To promote biodiversity by meeting the strategic challenges of our clients. CEHTRA is part of the H2B Group , specialized in testing, inspection and certification related to health and environment issues, on a human scale and with a strategic objective of digital transition. Our headquarters are located near Bordeaux and is present in Europe and worldwide with agencies in France (Bordeaux, Lyon, Paris), Germany, Belgium, Spain, United Kingdom, Canada and India. Key Business Sectors Biocides Chemicals (REACH) Cosmetics Global Chemicals Notification Industrial Hygiene Medical Devices Packaging Pharmaceuticals Plant Protection REACH Authorisation Key Services Dedicated Support (Régie) Endocrine Disruption Poison Centre Notifications Representative S ervices Trainings Digital Tools PRIMO CEHTRAcker COSMETICK ED Pedia Our project « Chèque transformation Numérique » has received a grant from the European Union under the FEDER-FSE Aquitaine 2014-2020 operational program. ​ CEHTRA has received a grant co-funded by Comunidad de Madrid and European Union to boost hiring young talents (Impulso a la contratación en Prácticas de Jóvenes para la Recuperación Económica) ​

OUR EXPERTISE Biocides ​ Are you required to renew an approval of an active substance, to submit a product authorisation 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.

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) Media Flyers

MENTORING Tailor-made training to meet the specific needs of your company. Discover Training > Mentoring > Ancre 1 CEHTRA offers tailor-made training. Together we build a programme directly adapted to your specific needs to best meet the challenges of your company. Our experts cover several sectors: ​ Biocidal products ; Chemicals (REACH) ; REACH authorisation; Cosmetic products ; Plant protection products ; Pharmaceutical products ; Industrial hygiene ; Packaging ; Medical devices; International notifications. Request for tailor-made training Which sector does your request concern? Submit your request Thank you, we will get back to you as soon as possible. What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

Our Values Enhance diversity and active listening. ​ Recognize caring and gratitude as essential conditions for collective intelligence. ​ Take initiatives to develop the collective intelligence of our regulatory community. " Working in a team with diverse points of view helps me to broaden my vision about things and allows me to take into account the elements that I wouldn’t have thought through otherwise." ​ Julien LEGHAIT CEHTRA France Collective Intelligence Customer Focus Listen to our clients in order to meet and go beyond their expectations. ​ Demonstrate responsiveness and flexibility to build long-term partnerships with our clients. ​ Accompany our clients’ development through our services. " Working in a domain where regulatory requirements are continuously evolving, it is my passion to pass the experience and knowledge I have gained so far to our clients. This allows developing regulatory strategies that are optimised to address to specific client needs and further strengthen the collaboration with them." ​ Annekathrin FAUPEL CEHTRA Germany Develop creative and ground-breaking digital tools to make life easier for our clients and our teams. Follow up on regulatory developments in order to anticipate the evolution of our clients’ needs. Be open-minded and inventive in addressing the questions we are asked. " Working within a company that welcomes evolution and progressiveness actively encourages us to develop improvements in our day to day working practices, to the benefit of both colleagues and clients." ​ Melanie HARPER CEHTRA United Kingdom Innovation Commitment Commit responsibly to the challenges that the planet is facing. ​ Be a reliable partner for our customers, particularly as regards the regulatory compliance and the safety of their products. ​ Commit to developing and maintaining collective expertise. " At CEHTRA, our individual and collective ‘commitment to excellence’ drive us to accomplish the regulatory success desired by our satisfied customers " ​ Pramod KUMAR CEHTRA India Recruit quality people and profiles. ​ Develop the skills of each individual towards scientific, sectorial and managerial expertise. ​ Diversify skills to provide qualitative and appropriate responses to our stakeholders. " At CEHTRA, we combine our skills on a daily basis to provide technical, scientific, digital and organizational solutions. It is essential to continue to diversify and develop everyone's competences to promote individual development within the company." ​ William BERTRAND CEHTRA Worldwide Competency Transmission Pass on our knowledge with enthusiasm to our colleagues and clients. ​ Detect and develop the talents of our organization. Behave as an active player in tomorrow’s life. " Working in a regulatory domain can be quite challenging, especially when you have to deal with grey zones which are not easy to interpret but here is actually where the magic happens. The discussions and debates that are generated around such topics are very enriching and the knowledge shared between colleagues makes us grow further and allows us to help companies from a 360° approach" ​ Sandra MARTINEZ BOSCH CEHTRA Spain

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 Submit Thank you for your message. We will contact you at the earliest possible.

Job Offers 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 Cosmetics Regulatory Affairs Manager (M/F) Contract Specialty Start date Location Permanent Cosmetics ASAP Paris area Read more Apply Ecotoxologist (M/F) Contract Permanent Specialty Ecotoxicology Start date ASAP Location Paris area Read more Apply Endocrine Disruptor Toxicologist Evaluator (M/F) Contract Permanent Specialty Multi-markets Start date ASAP Location Bordeaux, Paris , Lyon Read more Apply Human Resources Manager - CDI (M/F) Contract Permanent Specialty Human Resources Start date Mai-Juin Location Bordeaux (Cenon) Read more Apply Marketing and Sales Trainee (M/F) Contract Specialty Start date Location 6 months internship Cosmetic products IT tools ASAP Paris (Saint-Ouen) Read more Apply Physico-chemical Engineer (M/F) Contract Permanent Specialty REACH multi-markets Start date ASAP Location Bordeaux, Paris , Lyon Read more Apply Packaging Regulatory Affairs Manager (M/F) Contract Permanent Specialty Packaging Start date ASAP Location Bordeaux/Paris Read more Apply Plant Protection Regulatory Affairs Consultant (M/F) Contract Permanent Specialty Plant Protection Start date ASAP Location Bordeaux, Paris, Lyon (full remote possible) Read more Apply Regulatory Consultant REACH/Worldwide (M/F) Contract Permanent Specialty REACH WorldWide Start date ASAP Location France (Bordeaux, Paris , Lyon) Read more Apply Sales and Marketing Development Manager (M/F) Contract Specialty Start date Location Permanent Marketing and Sales ASAP Bordeaux, Paris, Lyon Read more Apply

Already a member? Login Wish to create a new account? Register Get started! User Guide | Podcasts | FAQs First Collective Intelligence platform dedicated to the regulatory affairs community for product safety Designed in collaboration with Hypermind , PRISM is a collective intelligence-based platform allowing: a) to predict reliably and with high accurary, the foresights across multiple regulatory sectors including Biocides, Cosmetics, Plant Protection, REACH among others... b) to help industry better understand the impact of any upcoming regulatory changes and allow them to adapt its business strategy accordingly. Why is CEHTRA launching PRISM? ​ CEHTRA is committed in a process to become a social economy company and has already established Collective Intelligence as its primary value. ​ PRISM contributes to organizing and optimizing Collective Intelligence of our business community, better forecasting, better decision making and more innovation to commit responsibly to the challenges that the planet is facing to behave as an active player in tomorrow’s life. Why participate? ​ To access new data and understand the foresights of our community. Whether you are an expert or have limited experience, every prediction counts. Experts tend to place more emphasis on science, while less experienced forecasters tend to better take into account all interference, of whatever nature. This is the very engine of collective intelligence. ​ There are nudges for the best forecasters. Their ranking is also accessible in real time. Finally, we plan to build a panel of "superforecasters". What type of questions are asked? 1. Open questions To generate and select ideas For example : All participants are welcomed to propose ideas for questions. The ideas most likely to succeed are retained. ​ 2. Closed questions To make predictions among different options (optimizing collective forecasts) For example: Multiple choice questions What makes PRISM unique? ​ Unlike other surveys averaging uninformed opinions, PRISM applies sophisticated statistical tools and processes which comply strictly with the collective intelligence principles, grounded in most recent research in cognitive science and behavioral economy Be a part of PRISM to believe it yourself! ​ PRISM User Guide Ready to join? Create your PRISM account User Guide Download PDF (English) Already a forecaster? Login to your PRISM account Watch PRISM video guide PRISM Podcasts Got questions? Get in touch with our team FAQs page - PRISM Podcasts

Top of the page PACKAGING Description Contact Key Services Value-added Trainings Media As a manufacturer, user of packaging or supplier for packaging manufacturing, you are facing regulatory issues? ​ For the safety of your packaging substances & products, our team of expert with over a decade of experience can assist you with : ​ Study of your documentation: declaration of compliance, regulatory statements Compliance of restricted substances thanks to an internal tool using mathematic modeling Monitoring of analysis with external laboratories Evaluation of worldwide regulatory requirements​ for packaging Click here to learn more... New ! Stay Ahead of Substance Migration with SF PP3 and CEHTRAPACK Tools ! Description Contact Meet our expert Caroline Opitz Head of Packaging caroline.opitz@cehtra.com Stephane PIERRE Managing Director of Paris Agency stephane.pierre@cehtra.com Key Services Regulatory / safety watch Customized text list Toxicological and regulatory substance watch Mapping by material / geographical area Regulatory / safety support Collection of supplier data Specifications Declarations of conformity Specific topics Global support Conduct of laboratory tests Multi-market support Food Pharmaceutica Medical Cosmetics Migration modeling Interactions between packaging and contained products: cosmetics and food By calculation By mathematical modeling Risk assessment of various materials : plastics, papers and boards, adhesives, inks, varnishes, metals, glass… Regulatory support on international regulations relative to food contact : EU, USA, Switzerland, China, Mercosur… Editing regulatory specifications and collecting informations from suppliers, documentary diagnosis, help in creation of Declaration of Compliance Compliance of restricted substances thanks to an internal tool using mathematic modeling, advices and monitoring of external lab tests when necessary Pragmatic approach to avoid expensive migration or extraction testsExpertise toxicologique Toxicological expertise Food contact courses We adapt our offer to the customer’s need Key Services Value-added Value-added Services Training offer Regulatory watch Regulatory and toxicological support Dedicated suppor t Packaging data management Migration / release assessment tools Trainings Trainings 18 June. 2024 Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics en savoir plus s'inscrire 14 May. 2024 Introduction to packaging regulations: understanding and implementing them en savoir plus s'inscrire Media Flyers Media Related Sectors Cosmetics Industrial Hygiene Haut de page

Top of the page GLOBAL CHEMICALS NOTIFICATION Description Contact Key Services Value-added Media 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 Mathieu ROLLAND Head of Global Notifications mathieu.rolland@cehtra.com Damien GUYOMAR Toxicologist damien.guyomar@cehtra.com Melanie HARPER Regulatory Affairs Specialist melanie.harper@cehtra.com Description Contact 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 Please click on the highlighted country names to get redirected to their dedicated page on our website Australia Canada China EU countries India Japan Philippines Russia South Korea Switzerland Taiwan Thailand Turkey UK USA Others on application Key Services Value-added Media Flyers Tools CEHTRAcker CEHTRA's window to worldwide regulatory support Media Related Sectors Chemicals (REACH) Industrial Hygiene REACH Authorisation Haut de page