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  • Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment

    Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment En savoir plus Training > Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Environmental data Reminder of useful physico-chemical parameters Abiotic degradation studies Biotic degradation studies Part 2 - Ecotoxicology Organisms used in regulatory ecotoxicology Ecotoxicology studies: methods Principle of studies: critical parameters Alternative non-experimental methods used in ecotoxicology Part 3 - Regulatory use of data PBT and POP assessment Risk assessment: Principle and derivation of PNECs from ecotoxicology studies Classification SDS Part 4 - Q&A I Assessment of knowledge acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. English-language support material will be provided to trainees. A final quiz will validate what has been learnt. To enhance e-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 Scientists and Regulatory Affairs Managers. Prérequis Bac +2. Chat Chat 10h30 Location Chat Chat from 870€ (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 07.10.24 to 08.10.24 Délais d'accès : 3 mois Blandine Journel Senior Ecotoxicologist ​ 2023 « Une formation de qualité, très bien construite qui m'a permis de rafraichir mes connaissances, certains point ont pu même être mis en pratique/vérifier dès le lendemain sur mes dossiers ! Merci » 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… +

  • Safer cosmetics for tomorrow - Know your regulatory obligations

    Safer cosmetics for tomorrow - Know your regulatory obligations En savoir plus Training > Safer cosmetics for tomorrow - Know your regulatory obligations The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Regulatory context for cosmetic products (Europe and other countries) European Cosmetics Regulation n° 1223/2009 - Scope / Borderline products - Cosmetovigilance - Management of updates Part 2 - Cosmetic product safety report - Notion of safety assessment: MoS calculation, local tolerance, etc. - Toxicological profiles of ingredients Part 3 - Specific cases - Baby products, perfumes - In silico Part 4 - Q&A I Assessment of knowledge acquired through a final quiz Méthodes mobilisées The course is based on a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-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 R&D, Regulatory, Quality, Safety Assessors, Manufacturers, Distributors, Subcontractors, Suppliers, Importers. Prérequis Cosmetics regulatory affairs officer or toxicologist. 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 Coming soon Délais d'accès : 3 mois Clarisse Bavoux Head of Cosmetics ​ 2021 « Formation complétement adaptée à mes besoins, Clarisse Bavoux à l'écoute et très clair dans ses explications. Merci pour cette formation qui me sera fort utile au quotidien. » 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… +

  • Introduction to packaging regulations: understanding and implementing them

    Introduction to packaging regulations: understanding and implementing them En savoir plus Training > Introduction to packaging regulations: understanding and implementing them The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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) Programme Part 1 - Regulatory requirements for cosmetic packaging Part 2 - Regulatory requirements for food contact packaging Part 3 - Migration principles (container-content interactions) Part 4 - Regulatory requirements for pharmaceutical packaging Part 5 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-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 Regulatory, Technical and Quality positions. Prérequis None. 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 17.09.24 03.12.24 Délais d'accès : 3 mois Caroline Optiz Head of Packaging ​ 2023 « Très intéressantes, cette formation a permis de remettre en place les bases réglementaires au sujet des packagings. » 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… +

  • Cosmetics - Regulatory and Toxicological Expertise | CEHTRA

    Top of the page COSMETICS Cosmetick Contact Key Services CPSR Ecotoxicology Value-added Trainings Media Our Tools Check out if toxicological and eco-toxicological profiles for your ingredients of interest are covered in Cosmetick! Search profiles Tools Contact Key contacts Clarisse BAVOUX Head of Cosmetics clarisse.bavoux@cehtra.com Marlène BARON Toxicologist marlene.baron@cehtra.com Key Services Cosmetic products & formulations : safety, ecotoxicology, expert advice and regulatory reports Pre-assessment Cosmetic Product Safety Reports (CPSR) Ingredients, Raw Materials : Toxicity, Ecotoxicity and Maximum Doses Toxicological profiles Ecotoxicological profiles Identification of safe concentrations for cosmetic uses Ingredients under development: strategy, dossier (toxicology and ecotoxicology) Support for toxicological and ecotoxicological issues Testing strategy In silico approach Additional data Final dossier Literature search, bibliography In vitro tests: analysis and advice Management of da ta gaps by alternative methods (Read-Across, in silico approach) Key Services 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. Cosmetick includes 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. "COSMETICK Advanced is a very useful tool for any cosmetic products safety assessor : all required data are gathered (very complete toxicological profils but also ecotoxicity data and regulation alerts). The tool can be used to assess the systemic risk of products ingredients and impurities. It also provides local tolerance alerts. It is very easy to use and a great help when you start working on a new project." Ecoxotoxicology Services and Tools in Ecotoxicology ​CEHTRA is committed to the protection of the environment, and offers services and tools in ecotoxicology: ​ COSMETICK is an online software solution offering ecotoxicological profiles and an "Ecotoxicological Alerts" system for ingredients and formulas ​ ECOSCORES can be customised to score and measure the ecotoxicological and environmental footprint of cosmetic products ​ ECOTOXICOLOGICAL EVALUATIONS of ingredients and formulas allow prioritisation of ingredient choices up to the obtaining of Labels such as the EU ECOLABEL (rinsed and non-rinsed cosmetic products) ​ MISSING DATA can be replaced in part by results from alternative methods (Read-Across, in silico approaches) ​ Our ADVICE and REGULATORY support enable us to ensure the compliance of your products and ingredients, manage risks and anticipate regulatory changes. Value-added Services In-depth expertise for INCI, impurities and fragrance components, including MOS and QRA Hazard assessment (toxicology and ecotoxicology) Extensive and cross-cutting areas of expertise: from environment to human health, from formulation to packaging Data qualification Monitoring of studies Cosmetick database (toxicological & ecotoxicological profiles, formula analysis) 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 17 Sept. 2024 Introduction to packaging regulations: understanding and implementing them en savoir plus s'inscrire Media Flyers Value-added Services Trainings Media Related Sectors Packaging Simply Predict Our Partners Haut de page

  • REACH compliance : registration of chemicals | CEHTRA

    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 can you ensure your submission will pass the first submission processing steps in REACH IT. ​ ​ 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 derivation of the cost of the Joint Submission and for each co-registrant. ​ 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 QSARs and others NAMs Expert advice Study monitoring PRIMO tool to optimize management and follow-up of data Trainings 15 Oct. 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 Simply Predict REACH Authorisation Haut de page

  • Master CHESAR to simplify your REACH assessments

    Master CHESAR to simplify your REACH assessments En savoir plus Training > Master CHESAR to simplify your REACH assessments The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Obligations under REACH with regard to CSR Part 2 - Definition and construction stages of the CSA Part 3 - Occupational risk assessment Part 4 - Consumer risk assessment Part 5 - Environmental risk assessment Part 6 - Creation of the complete CSR and compliance with ECHA controls Part 7 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-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 People working on REACH regulations: - Regulatory affairs officer - Toxicologist - Ecotoxicologist - QHSE Prérequis Notions on REACH regulations. 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 15.10.24 Délais d'accès : 3 mois Anna Chelle Expologist and regulatory toxicologist ​ 2022 « Très bien. Informations très utiles. Je vais me servir des slides comme support dans mon travail quotidien. Anna a été très claire et a su répondre à nos questions. Elle s'est également adaptée à nos besoins et s'est concentrée sur les points les plus pertinents pour nous. Un grand merci ! » 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… +

  • Plant Protection Products: from regulation to registration

    Plant Protection Products: from regulation to registration En savoir plus Training > Plant Protection Products: from regulation to registration The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid Programme Part 1 - Regulation (EC) No 1107/2009 The main points The different procedures involved Part 2 - Zonal assessment Zonal assessment: North, Centre and South zones: similarities and differences Exchanges between the Notifier and the Competent Authorities Part 3 - Requirements - The Dossier New requirements: for which substances? for which products? Bringing an existing dossier into line with the new regulatory requirements Part 4 - Case studies Part 5 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-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 Regulatory Affairs Officer in charge of Products/Active Substances. Prérequis Scientific background. Beginner in regulatory affairs for plant protection 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 03.10.24 Délais d'accès : 3 mois Estelle Beltran Head of Plant Protection Products ​ 2020 « Je vais la conseiller à mes proches collaborateurs. » 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… +

  • Regulatory affairs - Packaging compliance | CEHTRA

    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 17 Sept. 2024 Introduction to packaging regulations: understanding and implementing them en savoir plus s'inscrire Media Flyers Media Related Sectors Cosmetics Simply Predict Industrial Hygiene Haut de page

  • Master IUCLID and register your substances under REACH

    Master IUCLID and register your substances under REACH En savoir plus Training > Master IUCLID and register your substances under REACH The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Introduction to IUCLID 6.5 Part 2 - Preparing an IUCLID file: company-specific section, technical sections, Chesar-IUCLID interaction Part 3 - Validation Wizard and plug-ins? IUCLID Part 4 - Dossier creation and submission on REACH IT Part 5 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-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 Any user of IUCLID 6 to prepare and/or submit REACH dossiers. Prérequis Access to IUCLID. Be familiar with the REACH regulation and its requirements. Chat Chat 3h30 Location Chat Chat from 290€ (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 Coming soon Délais d'accès : 3 mois Nathalie Mayer 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… +

  • Familiarise yourself with eSDS: obligations, content and compliance

    Familiarise yourself with eSDS: obligations, content and compliance En savoir plus Training > Familiarise yourself with eSDS: obligations, content and compliance The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Actors in the supply chain Part 2 - Obligation of eSDS producers under REACH Part 3 - Key stages in the construction of the CSA/CSR Part 4 - Construction of an extended safety data sheet Part 5 - Stages on receipt of a supplier SDS: compliance objective Part 6 - Impacts/sanctions in the event of non-compliance Part 7 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-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 People working under the REACH Regulation: - QHSE - manufacturers, formulators, chemical product manufacturers Prérequis Notions on REACH regulations. Notions on SDS (sections 1-16). 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 18.06.24 22.10.24 Délais d'accès : 3 mois Anna Chelle Expologist and regulatory 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… +

  • Medical Devices | Consulting and Regulatory Compliance | CEHTRA

    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 28 Oct. 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 Biocides Cosmetics Simply Predict Chemicals (REACH) Pharmaceuticals Haut de page

  • Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics

    Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics En savoir plus Training > Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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. Programme Part 1 - Regulation 2022/1616/EC - Recycled plastic articles Part 2 - FDA - No Objection Letter (NOL) - recycled plastic articles Part 3 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based on a presentation with role-playing exercises and ongoing interaction with the expert. The support material will be given to the trainees. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 8. Our courses are delivered through synchronous learning. Public Audience Players in the food and cosmetics packaging industry. Prérequis None. Chat Chat 1h30 Location Chat Chat from 140€ (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 18.06.24 24.09.24 Délais d'accès : 3 mois Caroline Optiz Head of Packaging ​ ​ ​ 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… +

  • Biocidal Products - Regulatory Compliance | CEHTRA

    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 7-8 Oct. 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 Related Sectors Simply Predict Haut de page

  • Pharmaceuticals - Regulatory Compliance | CEHTRA

    Top of the page PHARMACEUTICALS (Human & Veterinary) Description Contact Key Services Value-added ERA Trainings Media For the safety and efficacy of both human & veterinary pharmaceuticals, CEHTRA can assist you in: ​ The definition of your preclinical development (development plan) and the drafting of your regulatory dossiers (nonclinical modules) The safety of your CMC activities (PDE, OEL/OEB, qualification of impurities) The Environmental Risk Assessment (ERA) for your MAA dossier Description Meet our experts Stephane PIERRE, PharmD, PhD, ERT Head of Pharmaceuticals, Senior Toxicologist Expert stephane.pierre@cehtra.com Blandine JOURNEL, PhD, ERT Senior Ecotoxico logist Exp ert ​ blandine.journel @cehtra.com Alexandra BONNEFONT, Engineer Deputy Head of Pharmaceuticals, Nonclinical Expert alexandra.bonnefont@cehtra.com Contact Key Services CMC Support Nonclinical sections of Regulatory Dossiers Preclinical Development Environmental Risk Assessment Production Safety PDE Calculation Qualification of Impurities Toxicological Evaluation of Extractable s & Leachables Worker s' Safety OEL/OEB Calculation Authoring CTD, CTA, IND, IMPD, IB, Briefing documents CTD updating Critical review of modules Preclinical Development Plans Study Monitoring Clinical Trial Autorisation : Authoring CTA, IND, IMPD Expertise in Pharmacology, Pharmacokinetics & Toxicology Study Monitoring Authoring the ERA - Phases I & II Interactions with Competent Authorities (EMA, FDA) Key Services To ensure the safety and efficacy of both human & veterinary pharmaceuticals, CEHTRA experts support you in your: ​ CMC activities: PDE (Permitted Daily Exposure) Calculation, OEL/OEB (Occupational Exposure Limit / Occupational Exposure Band) Calculations, Qualification of impurities, Toxicological evaluation of extractables-leachables, In silico assessment (QSAR) ​ ​ Preclinical development plan: Development plan design, Study monitoring (CROs selection, Validation of protocols & study plans, Study follow-up, Discussion of the results, Review of final study reports), Clinical Trial Applications, Gap analysis ​ ​ Regulatory dossiers: Authoring nonclinical sections of CTD, CTA, IND, IMPD, Investigator Brochure (IB), Briefing Documents ; Updating & making a Critical Review of nonclinical modules (2.4 & 2.6, module 4) ; Regulatory Toxicology. ​ ​ Environmental risk assessment: Study monitoring, ERA Drafting (Environmental Risk Assessment, Phase I & Phase II, Module 1.6) & Interactions with competent authorities (EMA, FDA) – Defense of the dossier. ​ CEHTRA expertise allows you to ensure the: ​ Production safety by minimizing the risk of cross-contaminations (residual active substances from API) and impurities (residual solvents, elemental impurities, impurities with mutagenic potential, extractables & leachables,…) ​ Workers’ safety by calculating occupational exposure limits ​ Patient’s safety by designing adequate development plans and performing robust toxicological evaluations based on in silico, in vitro and in vivo data ​ With two main objectives: ​ Safely launch the production of your pharmaceutical product ​ ​ Obtain the Clinical Trial Autorisation and the Marketing Autorisation (MAA) In compliance with: ​ ICH guidelines: ICH Q3A, Q3B, Q3C, ICH M7, VICH GL18, ICH M3(R2), ICH S1A, ICH S1B, ICH S5(R3),… ​ EMA guidelines: Guideline on HBELs 2014, Guideline on control of impurities of pharmacopoeial substances, Guideline on the environmental risk assessment of medicinal products for human use… ​ Thanks to a recognized expert team (pharmacists, ERT toxicologists, engineers…) Meet our Experts in charge of the Régie/Dedicated Support At CEHTRA, we put our experts at your disposal through our Dedicated Support in pharmaceutical sciences called "Régie" Experts supported in-house by a team of senior toxicologists ​ A significant experience with the Dedicated Support: ​ >30 successful « Régies » >10 years of experience with « Régies » >10 on-going « Régies » Maximum flexibility : ​ Contracts ​ Short-term & Long-term Extendables & Renewables Part-time & Full-time ​ ​ Modes ​ Embedded Staff: Our consultants work from our clients’ site Extended Staff: Our consultants work from our offices but exclusively for our client Flexible tariff depending on the expert profile selected (Junior, Specialist, Senior, Expert) For more information, please visit our "Régie" dedicated web page Need information or quotation? Do not hesitate to contact us: Dr Stéphane Pierre, PharmD, PhD, ERT & Head of Pharmaceuticals stephane.pierre@cehtra.com Alexandra Bonnefont, Nonclinical Toxicologist & Deputy Head of Pharmaceuticals alexandra.bonnefont@cehtra.com Meet our Experts in charge of the Régie/Dedicated Support Value-added Added Value Recognized Toxicologists & Ecotoxicologists : Pharmacists, ERT Toxicologists and Engineers with > 20 years of experience A toxicological expertise supported by in silico methods : QSAR models with Nexus, DEREK and Leadscope + 1 dedicated QSAR Expert A demonstrated expertise within the pharmaceutical field: We gained the trust of major groups and small companies Independence from CROs Trainings Related 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 Media Videos Flyers Media Related Sectors Biocides Simply Predict Cosmetics Industrial Hygiene Packaging Haut de page

  • Industrial Hygiene - Advice and Regulatory Support | CEHTRA

    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 Simply Predict REACH Authorisation Haut de page

  • Toxicology and Classification - the fundamentals of your regulatory success

    Toxicology and Classification - the fundamentals of your regulatory success En savoir plus Training > Toxicology and Classification - the fundamentals of your regulatory success The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Regulatory toxicology ? General information Part 2 - ADME (Absorption, Distribution, Metabolism, Excretion): concepts Part 3 - Acute systemic toxicology (oral, cutaneous, inhalation) Part 4 - Local skin and eye tolerance Part 5 - Skin sensitisation Part 6 - Repeated-dose and chronic toxicity Part 7 - Reproductive and developmental toxicity Part 8 - Mutagenicity and genotoxicity - Classification Part 9 - Carcinogenesis Part 10 - Introduction to non-experimental alternative methods used in toxicology Part 11 - Introduction to the determination of Toxicological Reference Values Part 12 - Introduction to human health risk assessment Part 13 - Toxicology described through a regulatory dossier (REACH) - case study Part 14 - Assessment of knowledge through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-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 Employees involved in product safety. Prérequis None. Chat Chat 14 hours Location Chat Chat from 1160€ (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 20.06.24 to 21.06.24 17.10.24 to 18.10.24 Délais d'accès : 3 mois Nathalie Mayer Toxicologist ​ 2022 « Très satisfaite de cette formation qui même si elle ne traite pas du Dispositif médicale, traite le sujet de toxicologie de façon suffisamment large tout en étant accessible. La vision est très globale est c'est ce que je recherchais. » 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… +

  • Les Fondamentaux - Formations | CEHTRA Training

    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… +

  • Regulatory expertise - Plant Protection and Health | CEHTRA

    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 3 Oct. 2024 Plant Protection Products: from regulation to registration en savoir plus s'inscrire 7-8 Oct. 2024 Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment en savoir plus s'inscrire Media Flyers Media Related Sectors Simply Predict Haut de page

  • How do Biocidal Product Families work? Accelerate your time to market!

    How do Biocidal Product Families work? Accelerate your time to market! En savoir plus Training > How do Biocidal Product Families work? Accelerate your time to market! The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Partie 1 - Evaluation de la similarité - Assessment of similarity : - Similarité de la composition et regroupement des coformulants - Similarité des utilisations - Similitude du niveau de risque et d'efficacité Partie 2 - Division des familles de produits biocides pour les évaluations en cours - Splitting of families for on-going applications Partie 3 - 'Best practices' pour les reunions de pré-soumission - Best practices for pre-submission meeting Partie 4 - Evaluation des acquis au travers d'un quizz final Méthodes mobilisées The course is based on a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-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 Anyone concerned by the regulations governing biocidal products. Prérequis Review the GMP guide before the training course (CA-July19-Doc.4.2-Final -Guidance note on GMP concept_rev2). 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 Coming soon Délais d'accès : 3 mois Nathalie Hanon Head of Biocides ​ ​ « 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… +

  • REACH authorisation | Advice and Regulatory Support | CEHTRA

    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 15 Oct. 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) Simply Predict Haut de page

  • Biological evaluation of medical devices in accordance with EN ISO 10993-1

    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 28.10.24 31.03.25 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… +

  • Poison Centre Notifications | CEHTRA

    EU POISON CENTER 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 Stephane PIERRE stephane.pierre@cehtra.com Key Services Portfolio Review Review Safety data sheets and labels Prepare and submit PCN notification 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 Regulatory support Offer regulatory advice on how best to fulfill obligations Media Flyers Related Sectors Biocides Chemicals (REACH) Plant Protection

  • ED Pedia | CEHTRA

    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?

  • Our Values | CEHTRA

    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

  • Latest News | CEHTRA

    Latest News Welcome to our corporate news page! ​ Here, you can stay up-to-date with the latest news, innovations, and achievements of our company. ​ From product launches and industry insights to events and company culture, we strive to keep you informed on all aspects of our business. Check back often for fresh updates and exciting news! For more updates and announcements, please follow us on LinkedIn Follow us on Linkedin CEHTRA's Expert Insights at Rentrée du DM 2023 ! Learn about CEHTRA's regulatory intelligence and specialized toxicology services in an exclusive interview. Discover how their expertise spans various sectors and integrates regulatory insights. Join us at Rentrée du DM 2022 on Oct 10 & 11 to explore CEHTRA's comprehensive offerings. July 20th, 2023 Join the QuAC Task Force for PT1 and PT2 - Save Time and Resources! Join CEHTRA's QuAC Task Force for PT1 and PT2 dossiers, a practical and cost-efficient solution. Benefit from our expertise in the Biocides sector. Contact Sandra Martinez Bosch ( sandra.martinez.bosch@cehtra.com ) for details and to join now! July 13th, 2023 European Commission's REACH Committee Votes to Restrict Microplastics European Commission's REACH Committee has approved a proposal to restrict the use of microplastics. The proposal is now under review by the European Parliament and Council. If you're unsure about the impact on your business, our experts can assist with regulatory challenges. Contact Stéphane PIERRE at stephane.pierre@cehtra.com . July 11th, 2023 Discover our latest video on Plant Protection at CEHTRA! Estelle Beltran introduces our expertise in the plant protection sector. If you have any questions, feel free to contact us at estelle.beltran@cehtra.com . July 6th, 2023 Webinar: Regulatory Compliance for Recycled Plastics in Food Contact Applications Join us for an informative webinar led by Caroline Opitz from CEHTRA. Learn about the regulations governing recycled plastics in food contact packaging in Europe and the USA. Gain insights into validation processes and ensure compliance. June 29th, 2023

  • SFPP3 and CEHTRAPACK modelling tools | CEHTRA

    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

  • 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

  • Toxicology and Classification - the fundamentals of your regulatory success

    Toxicology and Classification - the fundamentals of your regulatory success Discover Toxicology and Classification - the fundamentals of your regulatory success The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Understand the place of toxicology in the life of substances according to the regulations Knowing the main tests, their difficulties, their stakes Optimise the interaction between managers and experts Program Part 1 - Regulatory Toxicology ? General Part 2 - ADME (Absorption, Distribution, Metabolism, Excretion): concepts Part 3 - Acute systemic toxicology (oral, dermal, inhalation) Part 4 - Local skin and eye tolerance Part 5 - Skin Sensitisation Part 6 - Repeat and Chronic Toxicity Part 7 - Reproductive and Developmental Toxicity Part 8 - Mutagenicity and Genotoxicity - Classification Part 9 - Carcinogenesis Part 10 - Introduction to alternative non-experimental methods used in toxicology Part 11 - Introduction to the determination of Toxicological Reference Values Part 12 - Introduction to Human Health Risk Assessment Part 13 - Toxicology described through a regulatory dossier (REACH) - case study Part 14 - Assessment of learning 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 Employees involved in product safety. Prerequisites None. Chat Chat 14 hours Location Chat From 1160€ Contact us Online French session Nathalie Mayer Toxicologist ​ Parole de client « I am very satisfied with this training course which is well adapted to my background and which 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… +

  • Candidate form | CEHTRA

    We are recruiting I am applying for the position of Select the position First name Last name E-mail Phone Curriculum Vitae Import file Import a supported file (max. 15 MB) Cover letter (optional) Import file Import a supported file (max. 15 MB) Apply

  • Mentorat - Formations sur-mesure | CEHTRA Training

    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... +

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