Search Results

I 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 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… +

I 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 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… +

I 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 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… +

I Understand the regulatory obligations of the different actors involved in authorising the marketing of a biocidal product 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… +

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

I 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 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… +

I 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 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… +

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

CEHTRA provides consulting services for safe and effective medical devices (quality management system (QMS), technical documentation). Among others, our consultants assess biocompatibility (ISO 10993 standards) and toxicological risk and write the biological evaluation report. Medical Devices regulatory services: MDR & IVDR compliance and CE marking Regulatory support for medical devices from safety to CE marking. Our services Request support Expert services with global support CEHTRA’s multidisciplinary consultants combine expertise in toxicology, ecotoxicology, pharmaceuticals, biocides, cosmetics and chemicals to provide independent regulatory and scientific advice for medical devices. Our team supports you in dossier preparation, risk assessments, and regulatory submissions to help your medical devices reach the market safely and efficiently. Contact our experts Key regulatory services for medical devices Ancre 1 Biological Safety & Risk Assessment Biological risk assessment (ISO 10993-1:2020) Biocompatibility evaluation (cytotoxicity, sensitization, irritation, etc.) Toxicological profiles for raw materials & components Endocrine disruptor and chemical safety evaluation (REACH/MDR alignment) Establishment of risk management documentation Regulatory Affairs & CE Marking EU MDR / IVDR dossier preparation and updates Notified Body support and response strategy Clinical Evaluation Reports (CER) and Post-Market Surveillance (PMS) Guidance for importers, manufacturers & authorized representatives Quality Management & ISO 13485 QMS audits and gap analysis (ISO 13485 & MDR) Internal training and mentoring Preparation for regulatory inspections Assistance in implementing corrective actions Chemicals (REACH) for Medical Devices REACH registration of chemical substances in devices Notification of substances of very high concern (SVHC) Assessment of impurities, degradation products & extractables/leachables Toxicological data evaluation for REACH-MDR consistency Looking for guidance on MDR & IVDR compliance? Find it here. What is the difference between MDR and IVDR in the EU? The Medical Devices Regulation (MDR – EU 2017/745) applies to general medical devices, while the In Vitro Diagnostic Regulation (IVDR – EU 2017/746) focuses on diagnostic devices such as reagents and tests used to examine human samples. Both regulations reinforce safety, clinical evidence and post-market surveillance requirements, but the IVDR introduces a more stringent classification system for diagnostics and closer involvement of Notified Bodies. CEHTRA supports companies in identifying the applicable framework and ensuring compliance with both MDR and IVDR obligations. How to prepare for CE marking of a medical device? CE marking demonstrates that a device complies with EU regulatory requirements and can be legally placed on the market. Preparation involves: Defining the intended use and classification of the device. Establishing a Quality Management System (QMS) compliant with ISO 13485. Conducting a biological safety and risk assessment (ISO 10993). Preparing the technical documentation including performance and safety data. Submitting the dossier to a Notified Body (when required). CEHTRA assists manufacturers throughout this process by providing regulatory strategy, dossier preparation, and expert responses to Notified Body questions. What are Clinical Evaluation Reports (CER) and why are they required? A Clinical Evaluation Report (CER) is a mandatory document under MDR that demonstrates the clinical safety and performance of a medical device. It compiles and assesses data from clinical investigations, scientific literature, and post-market experience. CERs are crucial because they provide the evidence required by Notified Bodies to grant CE marking and must be regularly updated throughout the device’s lifecycle. CEHTRA’s consultants support manufacturers in writing and maintaining CERs to ensure robust documentation and smooth regulatory approval. Explore additional resources Can’t find your answer? Submit a request Enhance your regulatory strategy with our complementary services CEHTRA Training. Deepen your knowledge with our expertise. Digital Solutions. Your performance, our digital solutions. Simply Predict. In silico predictions: for faster, smarter decision-making. Flex + Your projects are moving forward. We provide the resources. Endocrine disruptors. The assessment of endocrine disruptors, with rigor and method. Haut de page

CEHTRA is an international leader in regulatory affairs, toxicology, and ecotoxicology, providing scientific expertise to ensure chemical compliance worldwide. Global Experts in Chemical and Environmental Compliance Combining science, digital innovation, and regulatory intelligence to secure a safer future. Our agencies Leading the Way in Chemical Regulatory Expertise CEHTRA is an international leader in technical and regulatory support for the safety of chemical products. With more than 25 years of recognized expertise, we provide scientific and innovative solutions to ensure regulatory compliance worldwide, from portfolio strategy and chemical notifications to human exposure assessments and site audits. Our consultants deliver high-quality, tailored regulatory services that help companies safeguard their products while optimizing costs. Contact our experts What Sets CEHTRA Apart CEHTRA stands out by addressing the strategic regulatory challenges faced by its clients through a unique combination of services, expertise, and innovative tools. Comprehensive Services We offer a wide range of services including outsourcing (known as "Regie" in France), industrial hygiene, and consortia management. At the same time, our digital tools drive efficiency and cost savings, enabling companies to streamline regulatory processes. Alternative Regulatory Strategies Our industrial and international expertise allows us to propose alternative regulatory strategies that accelerate product time-to-market, ensuring compliance without compromising quality or safety. Innovative Scientific & Digital Solutions CEHTRA combines proven scientific approaches with cutting-edge digital solutions. We support endocrine disruption assessments, QSAR and Read-Across evaluations, and provide data and management platforms such as CEHTRAPEDIA and PRIMO, helping clients optimize regulatory workflows and decision-making. Discover digital solutions From Local Roots to a Global Network of Regulatory and Scientific Experts CEHTRA’s growth from its French origins to a truly global presence reflects our commitment to advancing chemical safety through science and collaboration. Today, our team of regulatory affairs specialists, toxicologists, and ecotoxicologists supports clients across Europe, North America, and Asia. By combining regulatory intelligence with deep scientific expertise, we help industries navigate complex chemical regulations with confidence — from REACH and Biocides to Cosmetics, Pharmaceuticals, Food, and other sectors. Our multilingual and multidisciplinary network delivers local insights with global consistency, ensuring regulatory compliance and sustainable growth for our partners worldwide. We have a strong global footprint with offices in three locations in France, Madrid, Hamburg, Frankfurt, Nottingham, New Delhi, and Toronto. This international presence allows us to provide localized support while leveraging global expertise, ensuring compliance with local and international regulations efficiently and confidently. CEHTRA and the H2B Group CEHTRA is part of the H2B Group , which brings together European SMEs and VSEs committed to the prevention of emerging risks related to climate, health, and the environment. Within CEHTRA, two subsidiaries reinforce our range of specialized regulatory services. CAP COMPLIANCE Specializing in regulatory support for medical devices (DM and DMDIV), CAP COMPLIANCE offers tailor-made expert services to ensure the compliance of healthcare products. Their expertise allows clients to navigate complex medical device regulations efficiently and confidently. PROSACON Based in Germany, PROSACON addresses REACH and biocides issues on a European scale, with strong expertise in active substances and chemicals. PROSACON supports clients in achieving regulatory compliance across multiple countries and industries. " 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 Learn About Our Team and Values

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

CEHTRA supports all chemical industry players with expert risk assessment, ensuring safety for professionals, consumers, and the environment. Compliant with REACH & GPSR, we provide reliable, sustainable solutions for responsible innovation. Chemical risk assessment and safety: from innovation project to regulatory framework CEHTRA supports companies in the assessment, modeling, and management of chemical risks in order to protect the health of workers, consumers, and the environment. Our services Request support Your partner in understanding and managing chemical risks: protecting workers, consumers, and the environment. Regardless of your position in the supply chain, protecting workers, consumers, and the environment from chemical risks is a key priority and a shared responsibility. As an expert in chemical risk assessment, CEHTRA supports all players in the chemical industry — fragrances, flavourings, pharmaceuticals, aeronautics, automotive, construction and many others — to meet major health and environmental challenges. Thanks to the expertise of our toxicologists (ERT), ecotoxicologists and chemists, we carry out rigorous assessments based on recognised methodologies and in compliance with European regulations such as REACH and GPSR. This scientific and regulatory approach offers a comprehensive view of each project, combining scientific expertise, field knowledge and regulatory compliance to provide our clients with reliable and sustainable solutions that support responsible innovation. Discover our solutions tailored to your business: Explore Industrial Services Explore Consumers Services Industrials and Professionals: Tailored Chemical Safety and Compliance Solutions Contact our Expert Field Support, Operational and Regulatory Assistance On-site audits Compliance of on-site practices (authorisations, restrictions, strictly controlled conditions, etc.) Compliance of professional activities with extended Safety Data Sheets (eSDS) Preparation of responses to Competent Authorities Submission of data to Authorities (IUCLID, REACH-IT) REACH Regulatory Documentation Chemical Safety Report (CSR, DU CSR) Drafting of extended Safety Data Sheets (eSDS) Training Principles of CSR and Risk Assessment using CHESAR Extended Safety Data Sheets: obligations, content, and compliance Chemical Risk Assessment Toxicological hazard assessment Development of exposure scenarios specific to professional activities Exposure modelling and risk assessment related to workplace operations Software, Models, and Tools* CHESAR Human Health: ECETOC TRA, ART, RISKOFDERM, MEASE, EGRET, CLE OWB Environment: EUSES, SIMPLE TREAT, CLE LET *Developed by sector organisations and recognised and validated by the Competent Authorities. Consumer products: Ensuring safe everyday use Contact our Expert Regulatory Support Regulatory assistance for placing on the market new consumer products. Identification of regulatory requirements related to consumer product safety (REACH, CLP, GPSR, etc.). Software, Models, and Tools* CHESAR Human Health: ECETOC TRA, EGRET, CLE OWB, AISE REACT, CONSEXPO Environnement: EUSES, CLE LET *Developed by sector organisations and recognised and validated by the Competent Authorities. Chemical Risk Assessment Toxicological hazard assessment Evaluation of exposure to substances resulting from contact, migration, or handling of chemical products or articles (e.g. consumer goods such as textiles, sporting goods, fashion accessories, toys, or olfactory decoration items). What’s Included in a Chemical Risk Assessment? Any contact, handling or use of a chemical product or substance may require a risk assessment to ensure the safety of operators, consumers and the environment, as part of an innovation project or regulatory obligations (REACH, GPSR, etc.). Toxicological assessment: assessing the intrinsic capacity of a substance to cause harm and deriving toxicological reference values. Exposure modelling and estimation: assessing the emission process of a chemical substance in contact with humans and the environment, and quantifying their exposure using calculation models. Looking for guidance on chemical risks? Find it here. Who is required to perform a chemical risk assessment, and under which regulatory framework? In the workplace , employers must identify the chemical products used by their employees and assess the risks to their health . This obligation is part of the Single Risk Assessment Document (DUER) required under the French Labour Code . For the placing on the market of chemical substances or articles, manufacturers, importers, and distributors must ensure compliance with European regulations (REACH, CLP, GPSR, etc.) and provide all necessary information, including Safety Data Sheets , exposure scenarios , as well as clear labelling and appropriate instructions for use , to guarantee safe handling and use by both workers and consumers. What are the differences between chemical risks in workplace and those related to consumer products? In the workplace, workers may be regularly exposed over long periods to high concentrations of chemical substances . The implementation of appropriate collective and personal protective equipment (PPE) can help reduce these exposures. Consumers , on the other hand, use consumer products (such as cosmetics, cleaning agents, paints, toys, textiles, etc.) occasionally or repeatedly , which generally contain substances at low concentrations . However, these products concern the general population , including children and vulnerable individuals , and are used without specific protective measures . What should be done when restricted chemical substances exceed the recommended thresholds? Exceeding restriction thresholds requires immediate action : assessing the risk to determine the extent of the non-compliance , securing the manufacturing chain (including substance portfolio management, production processes, and substitution), withdrawing or recalling affected products , and strengthening preventive measures for both workers and consumers . Explore additional resources Can’t find your answer? Submit a request Haut de page

Regular training is essential to keep up-to-date with the changing regulations.You choose what you want to learn and when. You can come to us or we can come to you. CEHTRA Training Deepen your knowledge with our expertise. Find the right course for you among our programmes. Our trainings Contact us Nos programmes Our training programmes Regular training is essential to keep abreast of regulatory changes. Choose the formula that suits your needs. All our courses can be adapted for people with disabilities. 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. Contact us 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. See our certificate 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... +

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. ICMSR (India REACH) Services: Notifications, Registration & Representation Expert guidance to navigate India’s chemical regulations and ensure full compliance. Our services Request support 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. Contact our experts Key Services Key regulatory services for biocidal products and active substance Notification / Registration & update Preparation and update of Notification and Registration dossiers for individual or joint submission Authorized Representative (AR) service Representation of non-Indian companies through our Indian entity Safety Data Sheets (SDS) Preparation and/or update of SDS in latest UN-GHS format Data Management Arrangement of data on substances already registered with any foreign regulator in other jurisdictions Need help navigating India REACH? Find answers here. What is ICMSR (India REACH) and how does it affect chemical manufacturers and importers in India? ICMSR, or India Chemicals (Management and Safety) Rules , also known as India REACH , regulates all chemical substances, mixtures, and intermediates manufactured, imported, or sold in India in quantities ≥1 tonne per year. All Indian manufacturers and importers must comply with ICMSR to legally operate in the Indian chemical market. Non-compliance can result in penalties and restricted market access. How can non-Indian companies export chemicals to India under ICMSR regulations? Non-Indian companies wishing to sell chemical products in India must appoint an Authorised Representative (AR) based in India. The AR acts on behalf of the foreign company for notification, registration, and compliance with ICMSR, similar to the EU REACH OR system. CEHTRA-India can serve as your AR and guide your company through the entire compliance process. Comment suivre l’évolution des réglementations ? Notification: All substances ≥1 tonne/year must be notified to India’s Chemical Regulatory Division (CRD), with annual updates. Registration: Priority substances listed in Schedule II require a technical dossier within 18 months of inclusion. Safety Data Sheet (SDS): Up-to-date UN-GHS SDS must be maintained and shared with downstream users. Site Safety Report: Facilities handling hazardous chemicals must submit safety reports or audits depending on chemical quantities. Explore additional resources Can’t find your answer? Submit a request

Explore CEHTRA’s regulatory expertise across biocides, cosmetics, pharma, REACH, crop protection, and more. Our sectors Explore CEHTRA’s regulatory expertise across biocides, cosmetics, pharma, chemicals, environment, and more sectors. Explore Regulatory support across markets CEHTRA supports companies across a wide range of regulated sectors. From product design to market launch, our multidisciplinary experts offer tailor-made regulatory solutions that combine scientific excellence with strategic vision. biocides Explore chemicals Explore cosmetics Explore food Explore medical devices Explore packaging Explore pharmaceuticals Explore plant protection Explore Need guidance? Speak with our specialists Select a sector:* First name:* Last name:* Company or Organization:* Email:* How can we help you? Submit

Stay one step ahead in the world of biocides with CEHTRAWATCH Biocides, the essential tool for precise regulatory monitoring of your substance portfolio. CEHTRAWATCH Your Essential Digital Tool for R&D and Regulatory Teams Discover BIOCIDES Stay one step ahead in the world of biocides with CEHTRAWATCH Biocides, the essential tool for precise regulatory monitoring of your substance portfolio. Features Anticipate the impact of regulatory changes on your substances, ensuring continuous compliance of your biocidal products. Request a guide Intuitive Navigation Simple and user-friendly interface for efficient management of your substance portfolio. Change History View a detailed table of updates by date, allowing you to maintain full control over the information and its historic. Automated Regulatory Watch Stay informed in real-time with automated notifications. Comprehensive Substance Profile Access detailed profile for each substance, including the Hazard Profile, Status on Regulatory Lists, and Classification. Meet Our Expert Contact our expert to find out about more features of CEHTRAWATCH Biocides but also for a live demo: Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Contact

CEHTRA’s cloud-based regulatory information management platform. Centralize your data, manage projects, and perform Data Gap Analysis (DGA) for smarter worldwide compliance. PRIMO: Your digital solution for worldwide registration management A cloud-based platform by CEHTRA experts to simplify global regulatory compliance through secure data sharing, smart project management, and gap analysis. Access Your Account Book a demo All-in-One Platform for Secure Data, Project Tracking & Gap Analysis PRIMO (Principle Regulatory Information Management Organizer) is a cloud‑based platform specifically designed—by regulatory and IT experts at CEHTRA—to streamline worldwide regulatory compliance. It enables secure data sharing, project planning, and global regulatory gap analysis to support your testing strategies across all markets. Request your access Key features of PRIMO: your regulatory tool for smarter compliance Project Management Track the progress of your projects (Gantt) Budget tracking Assign tasks and follow-up Working documents & Regulatory insights Data Gap Analysis (DGA) Country-specific support for DGA based on country specific requirements Study Monitoring Dashboard Secure data storage & Sharing Secure sharing and storage of your data Easy upload and download of documents Exchange of large files Collaborative access Simultaneous access for both clients and CEHTRA team members. Select the formula that fits your requirements. Client Access* Upload/download documents Create/modify registration dossiers Create Tasks Track work progress (Gantt Chart) Access to country-specific DGA Access to country-specific support for DGA preparation Access to other clients' consultants Read Read / Write ✔ ✔ ✔ ✔ ✔ Read Read / Write Read Read / Write ✔ ✔ Ultimate Basic * CEHTRA offers a free access to PRIMO Basic to all its clients. Need help? Here are the answers to your questions. How do I access PRIMO? If you already have an account, you can log in via primo.cehtra.com . New users can request access or a demo by contacting primo@cehtra.com . Access to PRIMO Basic is free of charge for all CEHTRA clients. Who can benefit from using PRIMO? PRIMO is designed for regulatory affairs teams, R&D departments, project managers, and companies that need to comply with international regulations. Does PRIMO help with worldwide regulatory compliance? Absolutely. PRIMO is built to simplify global compliance by offering country-specific insights, centralized data management, and tools to keep you aligned with evolving regulatory requirements. Contact Book a demo

Ensure the safety of your cosmetic products with CEHTRA's expert Cosmetic Product Safety Report (CPSR) services. Our qualified toxicologists can assess the safety of your product and provide thorough guidance on the CPSR process. Contact us today for a consultation. 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.

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

If you have questions, feel free to get in touch with our team by filling in the query form and our team will get back to you. Talk to our experts Reach out to our experts for strategic regulatory advice across all sectors we serve — including chemicals, biocides, pharmaceuticals, and cosmetics. If you need tailored regulatory advice, technical support, have a general inquiry, or simply want to learn more about our services, don’t hesitate to contact us using the form below. We do our best to respond within one business day. Your inquiry will be handled with care and full confidentiality. Select a sector:* First name:* Last name:* Company or Organization:* Email:* How can we help you? Submit

Explore career opportunities at CEHTRA, including roles for ecotoxicologists, toxicologists, physico-chemical experts and regulatory consultants. Join our international team committed to chemical safety and apply today. Join our team at CEHTRA Explore exciting job opportunities at CEHTRA for toxicologists, ecotoxicologists, regulatory affairs experts, engineers, and more — across 10 key sectors including REACH, biocides, cosmetics, and beyond. Filter by sector BIOCIDES Regulatory Affairs Manager - Biocides (M/F) BIOCIDES CDI, Permanent Germany, Belgium, France, Sapin, Remote ASAP Apply Read more Careers at CEHTRA: What our team says Julien LEGHAIT "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."

Introducing 1bCoF, first reliable Co-formulants tool that belongs to Biocides community. 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.

Explore CEHTRA’s values: human-centered expertise, sustainable practices, innovation, and digital solutions driving excellence across all sectors. Our Values at CEHTRA A culture built on scientific excellence and regulatory expertise. Inspired by People, Empowered by Science As an international regulatory consulting firm specialised in chemicals, biocides, cosmetics and other sectors, our culture is shaped by collaboration, innovation, and a strong commitment to scientific integrity. Our commitment to corporate social responsibility (CSR) ensures that every decision considers ethical integrity, societal impact, and environmental sustainability. By leveraging technology, we streamline complex regulatory processes, increase transparency, and empower both our teams and clients to make confident, informed decisions. Our Core Values Driving Regulatory Excellence and Human Connection Discover our values in action and hear directly from our teams how they bring them to life every day across all sectors. Collective / Focus Collective Intelligence Collaboration is at the heart of everything we do. We believe that combining diverse expertise and perspectives leads to smarter, more resilient outcomes in every sector we serve. What this means for clients and teams: Encouraging open dialogue and valuing every team member’s contribution Multi-disciplinary teams collaborating across countries and regulatory areas Sharing knowledge openly to empower colleagues and clients alike Client Focus Our clients’ challenges shape our priorities. We go beyond compliance, focusing on human relationships, understanding the people behind every project, and delivering solutions tailored to their needs. What this means: Actively listening to clients’ constraints and goals Providing solutions that simplify work and accelerate decision-making Building long-term partnerships based on trust, empathy, and transparency " 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 " 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 Innovation / Commitment Innovation Innovation is about improving processes, tools, and experiences for everyone involved. By integrating digital solutions, data-driven methods, and creative thinking, we make regulatory compliance more efficient, transparent, and user-friendly. What this means: Developing technology solutions like CEHTRAWATCH to simplify regulatory workflows Encouraging curiosity, experimentation, and forward-thinking in our teams Applying innovation to enhance usability, efficiency, and impact across all sectors Commitment Commitment reflects our ethical responsibility to people, communities, and the environment. Every decision we make considers societal impact, sustainability, and regulatory integrity. What this means: Acting with integrity and accountability in all projects Supporting public health, environmental safety, and societal well-being Committing to develop and maintain a diverse and collective expertise mix across all sectors " 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 " At CEHTRA, our individual and collective ‘commitment to excellence’ drive us to accomplish the regulatory success desired by our satisfied customers " Pramod KUMAR Competency / Transmission Competency Competency at CEHTRA is built on scientific excellence, regulatory knowledge, and continuous learning. Across every sector, our consultants transform complex regulations into practical guidance that is actionable, accurate, and human-centered. What this means: Translating complex rules into clear, practical solutions Providing mentoring, training, and guidance internally and externally Ensuring that every recommendation reflects deep understanding and human awareness Transmission Sharing knowledge ensures that expertise grows sustainably. We empower colleagues, clients, and partners by transferring skills, insights, and best practices. What this means: Passing on our knowledge with enthusiasm, supporting colleagues and clients to grow their expertise Identifying and nurturing talent within our organization to build strong, capable teams Acting as active contributors to the future, fostering innovation, learning, and long-term success " 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 " 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 Join CEHTRA: A Company Driven by Scientific Integrity and Human Values Would you like to work in an organisation where science, innovation and collaboration are key drivers? Explore our career opportunities to learn how CEHTRA fosters professional growth and supports the next generation of regulatory experts. Join Our Team and Shape the Future of Regulatory Science

CEHTRA stands for Consultancy for Environmental & Human Toxicology and Risk Assessment. Since 2001, we provide high quality scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations. Data Privacy GDPR is the General Data Protection Regulation, a sweeping legislation passed by the EU and enforceable as of May 25, 2018. GDPR maintains that data protection is a fundamental human right and it is the responsibility of any company that controls and processes data to protect that right. At some point over the past few years we have been in contact with you, either as part of a scientific and regulatory forum or in another capacity. You already know that we do not send out emails which are not tailored towards your specific needs or are not of mutual interest. We will not bombard you with endless e-mails that are of little interest to you, but every-so-often, there may be something that we think may be of interest to you for your business. Your data: We collect only the data that is strictly necessary. This means your contact details. They are only used for communicating with you regarding business related matters. Your data remains confidential: We promise to never transmit, share or reveal our personal data with any other entity, business or organisation for whatever means, in full compliance with the General Data Protection Regulation (GDPR) of 2018. Your rights to access: In full compliance with the French CNIL , you may at anytime access the your data in order to modify or update them by simply contacting us at: CEHTRA SAS 15 rue Aristide Briand Cenon, Bordeaux France contact@cehtra.com Your right to be forgotten: Your personal data is kept for a maximum of 5 years. You may at anytime request that your details be deleted. Your data is secure: CEHTRA does everything that is possible to ensure that your data is safe. he data service provider OVH ensures that the site respects the legal requirements as described namely the General Data Protection Regulation (GDPR) of 2018.

CEHTRA stands for Consultancy for Environmental & Human Toxicology and Risk Assessment. Since 2001, we provide high quality scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations. 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

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 came into effective in January 2021 (extended from January 2020). CEHTRA can support as a third party representative to assist in these requirements. 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

Our experts assess the endocrine disrupting properties of your substances and their potential classification. Our optimized strategies and data compilation ensure compliance with regulatory requirements and anticipate future regulatory changes. Simply Predict Powered by CEHTRA: In silico consulting & training for animal-free safety assessment Simply Predict offers in silico expertise and training to accelerate regulatory compliance and reduce animal testing. Our experts combine AI-based predictions with scientific validation to support smarter, faster, and ethical safety assessment. Our services Discover Simply Predict Fast-track innovation & regulatory compliance Simply Predict supports industries and regulators in adopting New Approach Methodologies (NAMs) and computational toxicology tools. Our mission: combine innovation and regulatory reliability to make non-animal testing a scientific standard. Contact our experts Key Services Ancre 1 QSAR & Read-Across predictions Accurate in silico models to predict physicochemical, toxicological, and ecotoxicological properties. In silico training programs Custom training sessions on QSAR, read-across, and regulatory applications of NAMs. Computational toxicology consulting Strategic support for dossier submissions and regulatory interactions (REACH, BPR, CLP, OECD). Data interpretation & reporting Expert validation and documentation to ensure acceptance by authorities. Why choose Simply Predict Simply Predict combines science, AI, and regulatory expertise to make in silico solutions accessible and reliable. You benefit from predictive accuracy, traceable data, and recognised expertise across multiple regulatory frameworks. Discover Simply Predict Looking for in silico expertise and training? Find it here. What is an endocrine disruptor (ED)? An Endocrine Disruptor (ED) is a substance or a mixture that alters one or more functions of the endocrine system and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations. Why is ED assessment required under EU regulations? Since 2018, ED assessment has been mandatory under the Plant Protection Products Regulation and Biocidal Products Regulation. In 2023, new hazard classes for endocrine disruptors were added to CLP Regulation. Updates to REACH Regulation, cosmetic and pharmaceutical legislations are expected to extend these requirements further — making ED evaluation essential for market access and compliance in the EU. Is there an official list of endocrine disruptors in the EU? There is currently no single, definitive EU list of all endocrine disruptors. However, several regulatory lists and databases identify or flag substances with suspected or proven ED properties: The ED assessment list published by European Chemicals Agency (ECHA) The list of approved and non-approved active substances under Plant Protection Products Regulation and Biocidal Products Regulation The Candidate List of Substances of Very High Concern (SVHC) under REACH Regulation In France, the Annex I of AGEC law lists substances identified as potential ED These lists are updated regularly, and companies should monitor them closely to anticipate regulatory impacts on their substances or products. CEHTRA has designed a digital tool to detect the presence of substances in those and many other lists of suspected or proven ED. Such data must be interpreted with caution and reviewed by an expert that CEHTRA can provide. Discover Simply Predict Can’t find your answer? Submit a request

Stay up-to-date with regulatory and toxicological changes. CEHTRAWATCH is an online platform, verified by experts, no software installation needed. CEHTRAWATCH: Your smart regulatory monitoring tool for chemical substances Stay compliant with real-time alerts and customized regulatory and toxicological tracking, substance by substance. Discover Book a demo Stay ahead of regulatory change — All your updates in one platform Regulations evolve constantly and missing an update can lead to costly dossier delays, compliance risks, and business disruptions. CEHTRAWATCH, CEHTRA’s intelligent regulatory compliance solution, is designed for the chemicals, biocides, pharmaceuticals, cosmetics, food, and packaging industries. It provides real-time global monitoring of regulatory updates, giving regulatory affairs professionals, toxicologists, and compliance managers the tools to save time, reduce risks, and anticipate changes before they impact the business. With CEHTRAWATCH, you can track evolving regulations, secure compliance, and streamline decision-making all on a single digital platform built for regulatory professionals and toxicogists. Explore the lists Key features of CEHTRAWATCH: Your essential regulatory tool for faster, smarter compliance Instant Portfolio Overview Run a T0 scan of your substances in under 30 minutes, get a clear regulatory overview of your portfolio at a glance. Regulatory Coverage Monitor 100+ regulatory and toxicological lists, updated daily. CEHTRAWATCH scans, filters, and delivers the information that matters straight to your dashboard. Smart Alerts & Customization Set your notification frequency, choose the updates that matter most, and access regulatory and toxicological information tailored to each of your substances. Design by expert, made for you. Built by CEHTRA’s team of scientific and regulatory experts to ensure accuracy, reliability, and relevance. Need help? Here are the answers to your questions. How does CEHTRAWATCH save time compared to manual regulatory monitoring? By centralizing 100+ regulatory and toxicological lists in one platform and providing automated alerts, CEHTRAWATCH eliminates the need for manual searches across multiple sources. This saves hours of research and reduces the risk of missing critical updaptes. How does CEHTRAWATCH help reduce compliance risks? By providing automated alerts on regulatory and toxicological changes, CEHTRAWATCH ensures you never miss important updates. All published information is verified by our trusted experts, making this proactive approach safer and helping to protect your company's reputation. Which industries and professionals is CEHTRAWATCH monitoring tool designed for? CEHTRAWATCH is designed for regulatory affairs professionals, toxicologists, compliance managers, and R&D teams who need a reliable regulatory compliance platform to track global chemical regulations. It is particularly valuable for companies in the chemicals, biocides, pharmaceuticals, cosmetics, food, and packaging industries , where staying ahead of regulatory changes is essential for compliance and market access. Is CEHTRAWATCH a regulatory compliance software that requires installation? No, CEHTRAWATCH is an online regulatory compliance platform accessible directly from your browser. Unlike traditional software, it requires no installation, giving you instant access to regulatory and toxicological updates anytime, anywhere. Contact Book a demo

CEHTRA: Your partner for biocontrol solutions. We offer regulatory compliance dossiers and support for manufacturers. From feasibility studies to optimized testing strategies, trust us for top-quality, regulatory-compliant data. Contact us today Biocontrol Biocontrol solutions are unmissable alternatives to chemical plant protection products in the context of agriculture evolution towards better mastery of food quality. Biocontrol involves macro-organisms, micro-organisms, semiochemicals (such as pheromones) and substances of natural origin (mineral, animal, plant). CEHTRA prepares regulatory compliance dossiers for biocontrol solutions (excluding macro-organisms), prior to their possible use in Organic Agriculture, and supports manufacturers in the early stages of development of these new solutions. Estelle BELTRAN Head of Plant Protection estelle.beltran@cehtra.com is identified for Biocontrol Diagnostic You are A French SME Developing a new biocontrol product Needing the feasibility of your project CEHTRA provides Preliminary studies of product characterization and efficacy Bibliographic search Data Gap Analysis Laboratory studies and field trials Our collaboration leads to Keen understanding of substance definition and claim of use State-of the-art of published scientific knowledge Optimised testing strategy Regulatory compliant data

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