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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 Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 14 hours Location Chat Chat from 1160€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 17.10.24 to 18.10.24 Chat Catalogue Access time: 3 months Public Audience Employees involved in product safety. Prerequisites None. 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. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

New ISO 10993-17 : 2023 - General and new features En savoir plus Training > New ISO 10993-17 : 2023 - General and new features The basics > Ancre 1 Overview Objectives I Skills and Abilities Understand the methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023. Programme ISO 10993-17, BACKGROUND AND CONTEXT OF THE UPDATE Part 1 - Introduction Scope (releasables, raw materials, degradation products, risks covered) Links with other ISO 10993 standards (-1, -18, -9 etc.) - When is it useful and/or essential? ISO 10993-17 (2002) VS ISO 10993-17 (2023) : A NEW APPROACH Part 2 - What's new New terms, definitions and concepts New approaches: taking into account time periods; adapting exposure by weight (previously tolerable intake by weight). Part 3 - Data generation Characterisation according to ISO 10993-18 - Reminder and pre-test considerations AET - (Analytical Evaluation Treshold) - Importance of validating the method Types of data sought for the TRA. Part 4 - Toxicological Risk Assessment Toxicological Screening Limit (TSL) Exposure (EEDmax) Tolerable intake or contact (TI, TIcancer, TCL) Calculation of MOS Part 5 - Conclusion: Endpoint to be assessed Part 6 - Q&A I Assessment of skills acquired through a final quiz Methods used The course is based around a presentation containing case studies 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. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 30.09.24 03.02.25 Chat Catalogue Access time: 3 months Public Audience DM players responsible for toxicological risk analysis and biocompatibility assessment, quality managers, functions responsible for compiling technical documentation. Prerequisites General knowledge of issues relating to the biocompatibility of healthcare products, in particular ISO standards 10993-18, -12 and -1. As this is not initial training, knowledge of the previous version of ISO 10993-17: 2002 and basic toxicology concepts is very important (threshold value, exposure dose, systemic vs. local toxicity, NOAEL/LOAEL, etc.). Paul Fernandes Biocompatibility toxicologist ​ ​ ​ La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

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 Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 10h30 Location Chat Chat from 870€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 07.10.24 to 08.10.24 Chat Catalogue Access time: 3 months Public Audience Scientists and Regulatory Affairs Managers. Prerequisites Bac +2. 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. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

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 Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 29.10.24 Chat Catalogue Access time: 3 months Public Audience People working under the REACH Regulation: - QHSE - manufacturers, formulators, chemical product manufacturers Prerequisites Notions on REACH regulations. Notions on SDS (sections 1-16). 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. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

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 Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 03.12.24 Chat Catalogue Access time: 3 months Public Audience Regulatory, Technical and Quality positions. Prerequisites None. 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. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

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 Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online Coming soon Chat Catalogue Access time: 3 months Public Audience R&D, Regulatory, Quality, Safety Assessors, Manufacturers, Distributors, Subcontractors, Suppliers, Importers. Prerequisites Cosmetics regulatory affairs officer or toxicologist. 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. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

Master CHESAR to simplify your REACH assessments En savoir plus Training > Master CHESAR to simplify your REACH assessments The basics > Ancre 1 Overview Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 10h30 hours Location Chat Chat from 8700€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 15.10.24 to 16.10.24 Chat Catalogue Access time: 3 months Public Audience People working on REACH regulations: - Regulatory affairs officer - Toxicologist - Ecotoxicologist - QHSE Prerequisites Notions on REACH regulations. 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. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

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 Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 28.10.24 31.03.25 Chat Catalogue Access time: 3 months Public Audience DM players. Quality managers. Functions responsible for compiling technical documentation. Prerequisites 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. 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. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

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 Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 19.11.24 Chat Catalogue Access time: 3 months Public Audience Anyone concerned by the regulations governing biocidal products. Prerequisites Review the GMP guide before the training course (CA-July19-Doc.4.2-Final -Guidance note on GMP concept_rev2). 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. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

Plant Protection Products: from regulation to registration En savoir plus Training > Plant Protection Products: from regulation to registration The basics > Ancre 1 Overview Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 03.10.24 Chat Catalogue Access time: 3 months Public Audience Regulatory Affairs Officer in charge of Products/Active Substances. Prerequisites Scientific background. Beginner in regulatory affairs for plant protection products. 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. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

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 Objectives I Skills and Abilities 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 Methods used 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. Chat Chat 1h30 Location Chat Chat from 140€ (HT) French Register Chat It is possible to schedule the training in face-to-face mode on request. Request for information Online 24.09.24 Chat Catalogue Access time: 3 months Public Audience Players in the food and cosmetics packaging industry. Prerequisites None. Caroline Optiz Head of Packaging ​ ​ ​ La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

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 Simply Predict 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) ​

How do Biocidal Product Families work? Accelerate your time to market! Discover How do Biocidal Product Families work? Accelerate your time to market! The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Understand the regulatory obligations of the different actors involved in authorising the marketing of a biocidal product Program Part 1 - Background to the Biocidal Products Regulation (BPR) Part 2 - Description of the different actors involved in the authorisation of Biocidal products Part 3 - Active substance Part 4 - Biocidal Products Part 5 - 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 Anyone concerned with the regulations of biocidal products. Prerequisites None. Chat Chat 7 hours Location Chat From 580€ Contact us Online French session Nathalie Hanon Head of Biocides ​ 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… +

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 24 Sept. 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

CEHTRA Training Deepen your knowledge with our expertise. Find the right course for you among our programmes. Discover Nos programmes Our programmes Regular training is essential to keep abreast of regulatory changes. Choose the formula that suits your needs. THE BASICS Learn and keep up to date on the essentials of the regulations. Discover MENTORING Tailor-made training to meet the specific challenges of your company. Discover All our courses can be adapted for people with disabilities. 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... +

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 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

Regulatory Ecotoxicology: From appropriate study conduct to environmental risk assessment Discover Regulatory Ecotoxicology: From appropriate study conduct to environmental risk assessment The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Better understand why studies are carried out, what the results mean and how they can be used for Classification & Labelling and Risk Assessment Be able to spot study pitfalls and know how to avoid them Program 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 the studies: critical parameters Alternative non-experimental methods used in ecotoxicology Part 3 - Regulatory use of data PBT, POP assessment Risk assessment: Principle and derivation of PNEC from ecotoxicology studies Classification SDS Part 4 - Q&A I Evaluation of knowledge 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 Scientists and Regulatory Affairs Officers. Prerequisites Bac +2. Chat Chat 10.5 Hours Location Chat From 870€ Contact us Online French session Blandine Journel Expert Ecotoxicologist ​ Parole de client « The training was very comprehensive and understandable, including concrete cases to illustrate the concepts discussed. I now have a global vision of the existing ecotoxicological tests and have more insight on the type of tests to be conducted according to the ingredient to be tested. » 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… +

Master IUCLID and register your substances under REACH Discover Master IUCLID and register your substances under REACH The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities How to navigate and enter data in IUCLID Know the main non-technical sections for a REACH dossier and how to fill them in Be able to review the technical sections of a REACH dossier Know how to use the different functionalities of IUCLID (exports, validation wizards) Know how to submit a dossier in REACH IT Program 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 acquired skills 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 Any user of IUCLID 6 to prepare and/or submit REACH dossiers. Prerequisites Know the REACH regulation and its requirements. Chat Chat 3.5 Hours Location Chat From 290€ Contact us Online French session Nathalie Mayer 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… +

Plant Protection Products: from regulation to registration Discover Plant Protection Products: from regulation to registration The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Understand the regulatory procedures for active substances and for products Understand zonal evaluation and dRR dossiers Understand the content of the dossiers and the pitfalls to avoid Program Part 1 - Regulation (EC) No 1107/2009 The main points The different procedures involved Part 2 - Zonal assessment Zonal evaluation: North, Central and South zones: similarities and differences Exchanges between the Notifier and the Competent Authorities Part 3 - The Requirements - The Dossier New requirements: for which substances? for which products? Bringing an existing dossier into line with the new regulatory obligations Part 4 - Case studies Part 5 - Q&A I Assessment of acquired skills 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 Regulatory Affairs Officer responsible for products/active substances. Prerequisites Scientific background. Beginner in regulatory affairs for plant protection products. Chat Chat 7 Hours Location Chat From 580€ Contact us Online French session Estelle Beltran Head of Plant Protection ​ Parole de client « I will recommend it to my close colleagues. » 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… +

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

CPSR If you're a cosmetics manufacturer looking to sell your products in the European Union, it's important to understand the requirements for a Cosmetic Product Safety Report (CPSR). A CPSR ensures that your product is safe for consumers and helps to protect public health. Contact a qualified person, such as a toxicologist, to help you prepare a CPSR and ensure that your product complies with the Cosmetics Regulation (EC) No 1223/2009. Don't risk fines or legal consequences - prioritize the safety of your customers with a thorough CPSR. Clarisse BAVOUX Head of Cosmetics clarisse.bavoux@cehtra.com Send us a message and we will answer you quickly. E-mail Company Your message Send Thank you for your submission! 1 \ What is a CPSR? A Cosmetic Product Safety Report (CPSR) is a document that presents the conclusion on the safety of a cosmetic product and the rationale used by the safety assessor. The report is required in the European Union under the Cosmetics Regulation (EC) No 1223/2009. The purpose of the CPSR is to consider the expected use, list the useful information, from literature or obtained on the product, and quantify any potential risk, if identified, to demonstrate that it can be used without any risk. 2 \ What does a CPSR include? A CPSR typically includes the following information: ​ Part A: gathering information on the presentation of the product, its indications, its expected stability, compatibility with the pack, efficient preservation, information on traces, and tolerance results. ​ Part B: presenting the conclusion, any warning if needed, the rationale to conclude on the different risks induced by the product, and the signature of the qualified safety assessor. ​ An important part of the Safety Report is generally included in Annexes: the toxicological profiles, which must be provided for all ingredients. 3 \ Who prepares a CPSR? A CPSR must be prepared by a qualified person, a safety assessor, such as a toxicologist, who has the necessary diplomas and expertise to assess the safety of cosmetic products. The qualified person may be employed by the cosmetic product manufacturer or by a third-party company that specializes in safety assessments. At CEHTRA, several of our toxicologist can sign the CPSR. 4 \ Why is a CPSR important and what does CEHTRA recommends? A CPSR is important because it ensures that cosmetic products are safe for use by consumers. By identifying potential risks associated with the use of a cosmetic product, the CPSR helps to prevent harm to consumers and to protect public health. CEHTRA recommends a 1rst step before writing this report, in a pre-assessment, before starting any study. ​ In addition, a CPSR is required by law in the European Union. Failure to comply with the requirements of the Cosmetics Regulation (EC) No 1223/2009 can result in fines and other legal consequences. ​ Overall, the CPSR is a crucial component of ensuring the safety of cosmetic products on the market.

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

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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 24 Sept. 2024 Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics en savoir plus s'inscrire 3 Dec. 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

Top of the page FOOD PRODUCTS Description Contact Key Services Value-added Trainings Your food and nutraceutical products must comply with strict safety and regulatory requirements. We offer our expertise to assist you in the following subjects: Authorization applications for your innovative ingredients Safety evaluation of your products (ingredients, substances, finished products) Preparation of safety and regulatory dossiers Formulation of your future products Description Contact Meet our expert Marie LIAMIN Food Products Market Manager marie.liamin@cehtra.com Stephane PIERRE Managing Director of Paris Agency stephane.pierre@cehtra.com Key Services Key Services New products authorisation Novel Food/NDI GMO Food improvement agents Safety dossiers Ingredients Substances Finished products Regulatory dossiers Absence of labelling information Dose exceeded Functional ingredients Justification dossier Formulation Ingredient efficacy Ingredient safety Proposed formulas Evaluation of Product Safety: ingredients, substances, additives, finished nutraceuticals and food supplements Analysis of safety data for innovative ingredients and support in the preparation and submission of authorization applications (EU, USA, UK) Management of exchanges with authorities Preparation of safety dossiers Preparation of regulatory dossiers for the market introduction of nutraceutical products (justification for dose exceedance, justification for absence of labeling mention, DADFMS dossier, etc.) Support in safety evaluation strategy for ingredients and finished products Team of toxicologists, in silico analysis experts, chemists, and ecotoxicologists Customized offer to meet client needs Value-added Services Global support Exchanges with the authorities Regulatory and toxicology watch Team of toxicologists, experts in in silico analysis, chemists and ecotoxicologists Study monitoring Value-added Trainings Trainings 24 Sept. 2024 Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics en savoir plus s'inscrire 3 Dec. 2024 Introduction to packaging regulations: understanding and implementing them en savoir plus s'inscrire Related Sectors Packaging Cosmetics Simply Predict Haut de page

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... +

Safer cosmetics for tomorrow - Know your regulatory obligations Discover Safer cosmetics for tomorrow - Know your regulatory obligations The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Know and understand the Cosmetic Regulation n°1223/2009 Understand the risk assessment of a cosmetic product Identify the points of improvement to comply with regulatory obligations Program Part 1 - Regulatory context of cosmetic products (Europe and other countries) European Cosmetic Regulation n° 1223/2009 - Scope of application / Borderline products - Cosmetovigilance - Management of updates Part 2 - Cosmetic Product Safety Report Cosmetic product safety report - Concept of safety assessment: MoS calculation, local tolerance... - Toxicological profiles on ingredients Part 3 - Specific cases - Baby products, perfumes - In silico Part 4 - Q&A I Assessment of knowledge 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 R&D, Regulatory, Quality, Safety assessor, Manufacturers, Distributors, Subcontractors, Suppliers, Importers. Prerequisites Cosmetic regulatory officer or toxicologist. Chat Chat 7 hours Location Chat From 580€ Contact us Online French session Clarisse Bavoux Head of Cosmetics ​ Parole de client « I am very satisfied with this training course which is well adapted to my background and which met my needs. Clarisse Bavoux is very clear in her explanations, the presentation is well structured and the references are provided, which is very useful to work on after the training. » 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… +

ENDOCRINE DISRUPTION The evaluation of substances for Endocrine Disruption (ED) potential has been mandatory since 2018 under the Plant Protection Products and Biocide Products regulations. ​ The year 2023 is a key turning point : ​ New hazard classes for endocrine disruptors according to CLP regulation entered into force on 20 April: - ED H H in Category 1 and Category 2 (Endocrine disruption for human health) - ED ENV in Category 1 and Category 2 (Endocrine disruption for the environment) ​ Also, the update of regulation on Cosmetic Products to take into account ED assessment is awaited in the coming months. ​ In addition, the next update of REACH regulation is expected to include new requirements to identify ED from the lowest tonnage band. ​ Anticipation and adaptation to these regulatory changes are strongly recommended. ​ CEHTRA can provide you a balanced and independent ED assessment by experts and can guide you to obtain reliable results using appropriate state-of-the-art tools and methods for your substances of interest. Key Services Optimised assessment of ED properties Generating new data Data compilation for regulatory dossiers Expert statements Existing re gulatory data ​ Targeted bibliographic search ​ QSAR screening Tailored testing strategies (based on in silico , in vitro and/or in vivo studies) ​ Study monitoring of ED specific studies Robust study summaries ​ EFSA table and identification of lines of evidence Reports on ED assessments of specific ingredients or formulations ​ Position papers on the relevance of ED potential of a substance for human health/environment Value-added Services In silico screening by QSAR experts Bespoke services adapted to many domains (biocides, PPP, cosmetics, chemicals…) Experienced in-house (eco)toxicologists Key Contact Interested to know more? Our key contact for Endocrine Disruption services, Julien LEGHAIT will be happy to answer all your queries. You can email him or simply drop your query into the chat window below. Julien LEGHAIT Coordinator of Endocrine Disruption services julien.leghait@cehtra.com Media Videos Flyers Podcasts Related Sectors Simply Predict

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