Search Results

CEHTRA provides regulatory, toxicology and risk assessment expertise for the chemical, biocides, PPP, cosmetics, pharma, food industries, ... Your partner in regulatory compliance and product safety Simplify your regulatory compliance with our expertise and innovative tools. Our sectors Contact us Nos programmes Recognized expertise in Regulatory Affairs and Risk Assessment For over 25 years, CEHTRA has been supporting chemical industry players across key strategic sectors. We assist manufacturers, formulators, distributors, and importers in areas including industrial chemicals (REACH), biocides (BPR), plant protection products (PPP), cosmetics, pharmaceuticals, and food products, including novel foods & supplements, as well as packaging, and other sectors related to health, environmental protection, and product safety. Thanks to our multidisciplinary expertise in toxicology, ecotoxicology, risk assessment and international regulations, we offer tailor-made solutions adapted to the specific requirements of each market, both within and outside Europe. Contact an Expert Our Areas of Expertise biocides Explore chemicals Explore cosmetics Explore food Explore packaging Explore pharmaceuticals Explore plant protection Explore all Explore Digital Solutions for Regulatory Affairs & Toxicology Your performance, our smart solutions. Nitrosamines: understanding carcinogenic risk and control strategies Since the sartans crisis in 2018, the detection of nitrosamines has highlighted systemic gaps in identifying contamination pathways across pharmaceutical supply chains. As impurities belonging to the “cohort of concern” following ICH M7 (R2), nitrosamines present exceptionally high carcinogenic potency. PHARMACEUTICAL PFAS in Drinking Water: Technical Analysis of a New Regulatory Era for Water Utilities Since 12 January 2026, the European Union has reached a major milestone in the protection of public health and water resources. The transition period provided for under Directive (EU) 2020/2184 (recast Drinking Water Directive) has now ended. TOXICOLOGY New Fragrance Allergens: July 2026 Deadline and CPSR Updates for Cosmetic Products The recent amendment to the European Cosmetic Regulation significantly expands the list of fragrance allergens that must be declared on the INCI label (Regulation (EU) No 2023/1545 updating certain entries of Annex III of the EU Cosmetic Regulation). In the original version of Regulation (EC) No 1223/2009, 26 allergens were subject to mandatory labelling. DIGITAL SOLUTIONS 1 2 3 4 5 Need guidance? Speak with our specialists Select a sector:* First name:* Last name:* Company or Organization:* Email:* How can we help you? Submit

Understand the EU Packaging and Packaging Waste Regulation (PPWR) and prepare your business for compliance. CEHTRA supports companies with regulatory expertise, impact assessment and guidance on packaging compliance and sustainability requirements. PPWR - Packaging and Packaging Waste Regulation Supporting companies in understanding and complying with the EU Packaging and Packaging Waste Regulation (PPWR). Contact our PPWR experts What is the PPWR Regulation? The Packaging and Packaging Waste Regulation (PPWR) is a major regulatory initiative introduced by the European Union to reduce packaging waste and strengthen circular economy objectives. The regulation will introduce new obligations related to packaging design, recyclability, labelling, and waste reduction targets, affecting companies placing packaged products on the EU market. As the regulatory framework evolves, companies must anticipate these requirements to ensure compliance and adapt their packaging strategies accordingly. Contact our experts Why the PPWR Matters for Your Business The PPWR regulation will impact a wide range of industries placing packaged products on the European market. Companies may need to review: Packaging design and material choices Labelling and information requirements Responsibilities of economic operators Compliance timelines and regulatory obligations Waste reduction and recyclability targets Understanding these regulatory developments early is essential to anticipatepotential operational and compliance challenges. Who is concerned by the PPWR? The PPWR regulation applies to all companies placing packaged products on the EU market, including manufacturers, importers, distributors and brand owners across sectors such as cosmetics, food, pharmaceuticals and consumer goods. How CEHTRA Supports Your PPWR Compliance CEHTRA works alongside companies to translate regulatory requirements into practical compliance strategies. Our approach focuses on helping businesses: understand the regulatory framework anticipate operational impacts identify potential compliance gaps implement appropriate regulatory strategies By combining regulatory expertise and industry experience, CEHTRA helps companies prepare for upcoming packaging regulations and navigate complex compliance requirements. Discover all our packaging services Prochains webinaires Afin d’aider les entreprises à mieux comprendre les évolutions réglementaires liées au PPWR, CEHTRA organise régulièrement des webinaires dédiés aux réglementations sur les emballages et aux enjeux de conformité. Ces sessions permettent d’explorer les principaux sujets réglementaires et d’échanger directement avec nos experts. PPWR Regulation – Key Requirements and Regulatory Timeline Speaker: Baptiste Reverdy Date: 15 April 2026 French Date: 27 May 2026 English Register to the webinar Register to the webinar Preparing for the PPWR Regulation? The upcoming Packaging and Packaging Waste Regulation (PPWR) will introduce new requirements affecting packaging design, labelling, and compliance responsibilities. CEHTRA experts can help you assess potential impacts and anticipate regulatory obligations. Contact us to discuss how we can support your PPWR compliance strategy. Request support

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

Discover the digital tools developed by CEHTRA to optimise your regulatory procedures and simplify the management of your dossiers. Our digital tools Boost your regulatory performance with our smart, user-friendly solutions. Find your tool Discover our digital solutions and find the tool that fits your regulatory needs. CEHTRAWATCH Simplifying global regulatory compliance with speed and precision. Automated global regulatory watch across 100+ updated lists Customizable monitoring by lists and substances Fast, expert-driven insights in under 30 minutes Discover eD PEDIA Instantly assess endocrine disruption potential and access expert guidance. Instant ED screening Access to curated regulatory & scientific data Downloadable reports & expert support Discover COSMETICK Digital solution for safe, efficient, and compliant cosmetics. Complete toxicological and eco-toxicological profiles Evaluation of cosmetic formulas A dynamic platform Discover PRIMO Unlock the power of cloud technology to manage your worldwide registrations. Secure Data Sharing and Storage Collaborative Project Management Comprehensive Regulatory Data Gap Analysis Discover Smart digital tools for regulatory affairs & compliance. Developed by regulatory experts At CEHTRA, we combine scientific expertise and digital innovation to help you meet increasing regulatory compliance demands with confidence. Our tools are designed to support both routine regulatory tasks and complex compliance challenges, based on real needs identified by our in-house experts. Intuitive interfaces with full support Whether you're managing chemical registrations, conducting risk assessments, or ensuring ongoing regulatory monitoring, our smart solutions help you work more efficiently, reduce errors, and keep your products compliant and safe. Built by scientists, for scientists, CEHTRA’s tools are intuitive, scalable, and ready to boost your performance from day one. Need help? Here are the answers to your questions. Why use digital solutions for regulatory compliance? Digital tools save time, centralize information, reduce human errors, and provide real-time monitoring of regulations, which is essential in a complex and constantly evolving regulatory environment. Who can benefit from CEHTRA’s digital tools? CEHTRA’s digital tools are designed for companies across all sectors, particularly in chemicals, biocides, and cosmetics, that want to simplify regulatory management and improve the efficiency of their internal processes. Are CEHTRA’s digital solutions suitable for both SMEs and large companies? Yes, CEHTRA’s tools are modular and can be used by both SMEs and large companies. They adapt to the specific needs of each organization, offering flexibility, scalability, and ease of use. Contact Don’t see what you need? Ask us

Apprendre et se tenir à jour sur les principales réglementations de votre secteur (Biocide, Cosmétique, REACH, Protection des plantes,...) The basics Learn and keep up to date on the essentials of the regulations. Our trainings Training > The basics > BIOCIDES COSMETICS ECOTOXICOLOGY FOOD MEDICAL DEVICES PACKAGING PLANT PROTECTION REACH TOXICOLOGY Ancre 1 Biological evaluation of medical devices in accordance with EN ISO 10993-1 from 690€ (HT) Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan View sessions Familiarise yourself with eSDS: obligations, content and compliance from 690€ (HT) Understand the obligations under REACH and the impact/penalties in the event of non-compliance Know how to draw up an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS View sessions How do Biocidal Product Families work? Accelerate your time to market! from 690€ (HT) Addressing the stages of an application for authorisation of a family of biocidal products : - Similarity of composition & grouping of co-formulants - Similarity of uses - Similar level of risk and efficacy Addressing the various points to be taken into account when dividing biocidal product families for current evaluations View sessions Introduction to packaging regulations: understanding and implementing them from 690€ (HT) Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) View sessions Master CHESAR to simplify your REACH assessments from 1035€ (HT) Understand the obligations under REACH How to use CHESAR to carry out a CSA (Chemical Safety Assessment) Be able to generate a CSR (Chemical Safety Report) under CHESAR Comply with ECHA expectations View sessions Master IUCLID and register your substances under REACH from 345€ (HT) How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT View sessions New ISO 10993-17 : 2023 - General and new features from 690€ (HT) Understand the methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023. View sessions Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies from 690€ (HT) Understand the role of toxicological studies in Novel Food dossiers. Identify the types of relevant studies depending on the nature of the product. Read and interpret key data from study reports. Identify quality and compliance criteria (OECD, GLP). Efficiently manage and communicate with subcontracted laboratories. View sessions PPWR: Regulatory Requirements, Overview and Expected Impacts. from 148€ (HT) Gain a comprehensive understanding of the key requirements and deadlines outlined in the PPWR. This training will equip you with the knowledge to identify how each aspect of the regulation affects your company and its operations. By familiarizing yourself with the specific provisions, you will be able to proactively assess potential impacts on various business activities. Ultimately, the goal is to equip you with the knowledge to ensure compliance and mitigate risks associated with the PPWR. View sessions Plant Protection Products: from regulation to registration from 690€ (HT) Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid View sessions Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics from 148€ (HT) Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. View sessions Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment from 690€ (HT) Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification and Risk Assessment. Be able to spot the pitfalls of studies and know how to avoid them View sessions 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... +

I How to navigate and enter data in IUCLID  Be familiar with the main non-technical sections of a REACH dossier and know how to complete them  Be able to proofread the technical sections of a REACH dossier  Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT Master IUCLID and register your substances under REACH See sessions Contact us Training > The basics > Master IUCLID and register your substances under REACH Overview Program Audience Trainers Objectives. How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT Place Horaire Price Language Access time Online 3h30 from 345€ (HT) French 2 months Register See sessions Objectives. How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT Program. Part 1 - Introduction to IUCLID 6 Part 2 - Preparing an IUCLID file: company-specific sections, technical sections, Chesar-IUCLID interaction Part 3 - Validation Wizard and plug-ins? IUCLID Part 4 - Dossier creation and submission on REACH IT Part 5 - Q&A I Assessment of skills acquired through a final quiz 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. Download the catalogue Audience. Any user of IUCLID 6 to prepare and/or submit REACH dossiers. Prerequisites. Access to IUCLID. Be familiar with the REACH regulation and its requirements. Damien Guyomar Toxicologist 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... +

I Gain a comprehensive understanding of the key requirements and deadlines outlined in the PPWR. This training will equip you with the knowledge to identify how each aspect of the regulation affects your company and its operations. By familiarizing yourself with the specific provisions, you will be able to proactively assess potential impacts on various business activities. Ultimately, the goal is to equip you with the knowledge to ensure compliance and mitigate risks associated with the PPWR. PPWR: Regulatory Requirements, Overview and Expected Impacts. See sessions Contact us Training > The basics > PPWR: Regulatory Requirements, Overview and Expected Impacts. Overview Program Audience Trainers Objectives. Gain a comprehensive understanding of the key requirements and deadlines outlined in the PPWR. This training will equip you with the knowledge to identify how each aspect of the regulation affects your company and its operations. By familiarizing yourself with the specific provisions, you will be able to proactively assess potential impacts on various business activities. Ultimately, the goal is to equip you with the knowledge to ensure compliance and mitigate risks associated with the PPWR. Place Horaire Price Language Access time Online 1h30 from 148€ (HT) French & English 2 months Register See sessions Objectives. Gain a comprehensive understanding of the key requirements and deadlines outlined in the PPWR. This training will equip you with the knowledge to identify how each aspect of the regulation affects your company and its operations. By familiarizing yourself with the specific provisions, you will be able to proactively assess potential impacts on various business activities. Ultimately, the goal is to equip you with the knowledge to ensure compliance and mitigate risks associated with the PPWR. Program. Part 1 - Overview of the PPWR Regulation: A comprehensive introduction to the PPWR, including its scope and objectives. Part 2 - In-Depth Analysis of Requirements and Key Deadlines: A detailed exploration of the regulation's requirements and the critical timelines for compliance. Part 3 - Labelling and Marking Requirements Under the PPWR: Understanding the specific labelling and marking obligations for products covered by the regulation. Part 4 - Regulatory Timeline and Obligations for Economic Operators: An overview of the key timelines and the specific responsibilities of economic operators under the PPWR. Part 5 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a comprehensive presentation that covers all essential information, timelines, and requirements. Trainees will have the opportunity to ask questions throughout the session, with the trainer providing answers to the best of their ability. Course materials will be provided to all participants for further reference. Download the catalogue Audience. Regulatory, Technical and Quality positions. Prerequisites. None. Baptiste Reverdy Regulatory Affairs Officer – Packaging 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... +

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

COSMETICK : l’outil digital tout-en-un pour l’évaluation toxicologique et la sécurité des produits cosmétiques. Profils toxicologiques, éco-toxicologiques, calculs de marges de sécurité (MoS) et préparation du RSPC (CPSR) en quelques clics. COSMETICK: the digital tool for cosmetic compliance and safety A digital solution dedicated to cosmetic risk assessment, integrating structured cosmetic toxicological profiles, the calculation of Margins of Safety (MOS) , and the preparation of Cosmetic Product Safety Reports (CPSR) to ensure regulatory compliance for cosmetics. Discover Book a demo Simplify your cosmetic regulatory compliance with COSMETICK The cosmetics industry faces strict regulatory requirements — especially in Europe under Regulation (EC) No. 1223/2009 , which mandates a Cosmetic Product Safety Report (CPSR) supported by reliable toxicological profiles. COSMETICK is a toxicological database dedicated to cosmetics, combined with a digital cosmetic safety assessment tool. It provides access to structured cosmetic toxicological profiles, enables exposure assessment, supports the calculation of Margins of Safety (MOS), and generates structured documentation to support the preparation of the Cosmetic Product Safety Report (CPSR) in accordance with the EU Cosmetic Regulation. Developed by regulatory toxicologists, COSMETICK supports cosmetic regulatory compliance through a clear and traceable hazard × exposure methodology. Improve efficiency, reduce error risk, and ensure product safety with confidence. Test the substance profile search Key features of COSMETICK: your toxicological assessment tool for cosmetic products A dedicated toxicological database for cosmetics: comprehensive toxicological and ecotoxicological profiles Characterisation of toxicological effects based on structured bibliographic review by endpoint Identification of no-effect levels (NOAELs and reference values) relevant for Margin of Safety (MOS) calculation Integration of key data required for cosmetic safety assessment and CPSR preparation Visual warning system using colour-coded indicators for rapid and structured interpretation For cosmetic formula safety assessment: Margin of Safety (MOS) calculation and CPSR preparation Simplified formula input with product type selection (leave-on / rinse-off) Automated calculation of Margins of Safety (MOS) based on exposure assessment and toxicological profiles Clear regulatory decision-support interface (MOS values, warnings, alerts) Export of a structured pre-filled document to facilitate preparation of the Cosmetic Product Safety Report (CPSR) A dynamic platform supporting cosmetic regulatory compliance Customisation of cosmetic toxicological profiles according to your assessment needs Online submission of new profile requests in just a few clicks Regular updates of the toxicological database Continuous integration of regulatory developments impacting ingredient safety Monthly newsletter dedicated to cosmetic safety and regulatory compliance updates View all features They chose COSMETICK: Discover their feedback. "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." Select the formula that fits your requirements. Access to toxicological profiles Eco-toxicological profiles Customization with confidential data Export toxicological profiles and assessment reports (pre-CPSR) Updates & regulatory newsletter Advanced Details Basic Details Need help? Here are the answers to your questions. What are the different COSMETICK licences available? COSMETICK offers two license levels tailored to your cosmetic ingredient toxicological assessment needs: • BASIC License: Provides quick and easy access to substance toxicological profiles. • ADVANCED License: Offers full access to all platform features, including the generation of toxicological pre-assessments for the CPSR. Each license is available in two options: • Unlimited Access: Perfect for frequent use or multiple users. • On-Demand Access: Flexible and cost-effective for occasional use. Need help choosing the best plan for your needs? Contact our team at cosmetick@cehtra.com.() What should be done if a toxicological profile is missing from the COSMETICK database? Can’t find a toxicological profile in our COSMETICK database? No worries! • Simply submit a request through our online form. • Your request will be reviewed and, once approved, the profile will be added to the database. • You can track the progress of your request directly online. • We’ll notify you by email as soon as the new profile is available. Does COSMETICK generate a Cosmetic Safety Report (CSR) and safety margins? The report provided by COSMETICK is a pre-assessment that includes all essential data to support risk evaluation, such as: • Exposure analysis based on your product’s formulation • Calculation of Margins of Safety (MoS) for each ingredient • Assessment of impurities, including CMR substances (Carcinogenic, Mutagenic, or Reprotoxic) • Skin tolerance rationale • Option to incorporate your own data (test results, specifications, etc.) This customizable document helps streamline the final preparation of the Cosmetic Safety Report (Part B of the CPSR). Contact Book a demo

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 How do Biocidal Product Families work? Accelerate your time to market! See sessions Contact us Training > The basics > How do Biocidal Product Families work? Accelerate your time to market! Overview Program Audience Trainers Objectives. 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 Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. 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. 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. Download the catalogue 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 Marie Darriet Regulatory Affairs Consultant 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... +

I Understanding regulatory procedures for active substances and products  Understanding zonal assessment and dRR dossiers  Understanding the content of dossiers and the pitfalls to avoid Plant Protection Products: from regulation to registration See sessions Contact us Training > The basics > Plant Protection Products: from regulation to registration Overview Program Audience Trainers Objectives. Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of 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 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. Download the catalogue 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 Steffie Segelle Regulatory Affairs Specialist 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... +

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

Expert CPSR services for cosmetic products. CEHTRA supports CPSR drafting, review, and updates to ensure EU regulatory compliance. CPSR – Cosmetic Product Safety Report The essential safety assessment required before placing cosmetics on the EU market. Request your CPSR quote What is a CPSR? The Cosmetic Product Safety Report (CPSR) is a mandatory regulatory document required to place any cosmetic product on the European Union market, in accordance with Regulation (EC) No 1223/2009. A CPSR is a comprehensive safety assessment carried out by a qualified safety assessor and structured in two parts: Part A – Safety Information: qualitative and quantitative composition, toxicological data of ingredients, exposure assessment, impurity profiles, stability, packaging, and intended or reasonably foreseeable use. Part B – Safety Assessment: overall safety conclusion, warnings and conditions of use, and scientific justification. Contact our experts CEHTRA’s CPSR Expertise Our team of experienced toxicologists and cosmetic safety assessors has a deep knowledge of European and international cosmetic regulations. We provide support for: Preparation of CPSRs for all types of cosmetic products Updating existing CPSRs (formula modifications, new suppliers, packaging changes, regulatory updates) Critical review and auditing of CPSRs prepared by third parties Toxicological assessment of ingredients and impurities Management of regulated substances, including CMRs, nanomaterials, fragrances, and preservatives CPSR Services for All Cosmetic Product Types Our experts assess a wide range of cosmetic products, including: Skincare products (face, body, hair care) Rinse-off and leave-on products Products for children and babies Sunscreens and sun care products Make-up products Personal hygiene products Each CPSR is developed using a science-based, documented, and use-oriented approach, ensuring safe and compliant market access. CPSR and Regulatory Compliance A compliant and up-to-date CPSR is essential to: Place a cosmetic product on the EU market Meet competent authorities’ expectations Secure the liability of the Responsible Person Anticipate regulatory changes CEHTRA also supports you with additional regulatory services, including PIF preparation, CPNP notification, regulatory monitoring, training, and strategic regulatory support. Discover all our cosmetic services Why Choose CEHTRA for Your CPSR? Qualified and recognized safety assessors Strong expertise in EU cosmetic regulatory requirements Pragmatic approach aligned with business and time-to-market constraints Smooth collaboration with R&D, regulatory, and quality teams Strict data confidentiality and traceability Need a CPSR or an Update? Are you planning a new product launch or looking to update an existing CPSR? Our experts are ready to assess your needs and provide tailored support. Contact us to secure the safety and regulatory compliance of your cosmetic products. Request support

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 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.

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 Cosmetics Ecotoxicology Packaging Ecotoxicologist M/F Ecotoxicology CDI, Permanent Saint-Ouen (Paris) ASAP Apply Read more Regulatory Affairs Manager Cosmetic Packaging M/F Packaging CDI, Permanent Saint-Ouen (Paris) ASAP Apply Read more Regulatory Affairs Manager Packaging-PPWR M/F Packaging CDI, Permanent Saint-Ouen (Paris), Lyon, Cenon ASAP Apply Read more Regulatory toxicologist for cosmetic products M/F Cosmetics CDI, Permanent Saint-Ouen (Paris) 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."

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

Latest News Welcome to our corporate news page! Here, you can stay up-to-date with the latest news, innovations, and achievements of our company. From product launches and industry insights to events and company culture, we strive to keep you informed on all aspects of our business. Check back often for fresh updates and exciting news! For more updates and announcements, please follow us on LinkedIn Follow us on Linkedin Join us for a free webinar led by Cyril Durou from CEHTRA. Gain insights into the latest regulatory updates and vigilance measures concerning the Urban Waste Water Treatment Directive. April 02th, 2025 Learn about CEHTRA's regulatory intelligence and specialized toxicology services in an exclusive interview. Discover how their expertise spans various sectors and integrates regulatory insights. Join us at Rentrée du DM 2022 on Oct 10 & 11 to explore CEHTRA's comprehensive offerings. July 20th, 2023 Join CEHTRA's QuAC Task Force for PT1 and PT2 dossiers, a practical and cost-efficient solution. Benefit from our expertise in the Biocides sector. Contact Sandra Martinez Bosch ( sandra.martinez.bosch@cehtra.com ) for details and to join now! July 13th, 2023 European Commission's REACH Committee has approved a proposal to restrict the use of microplastics. The proposal is now under review by the European Parliament and Council. If you're unsure about the impact on your business, our experts can assist with regulatory challenges. Contact Stéphane PIERRE at stephane.pierre@cehtra.com . July 11th, 2023 Estelle Beltran introduces our expertise in the plant protection sector. If you have any questions, feel free to contact us at estelle.beltran@cehtra.com . July 6th, 2023

CEHTRA assists users of Annex XIV substances in achieving regulatory compliance. Our expertise ranges from the complete drafting of your REACH authorisation dossier (CSR, AoA, SEA), to regulatory monitoring and public consultation, to the evaluation of SVHC properties and regulatory anticipation. REACH Authorisation & Restriction: Annex XIV Compliance & Authorisation Dossier Support Expert guidance from exposure assessment to socio-economic impact. Our services Request support Expert REACH services for chemicals with global support CEHTRA’s consultants have extensive expertise in REACH Authorisation and Restriction, having supported numerous companies with Annex XIV applications and regulatory defence strategies. We assist manufacturers, importers, formulators, and downstream users in navigating the complex processes, from exposure assessment and Chemical Safety Reports (CSR) to Analysis of Alternatives (AoA) and Socio-Economic Analysis (SEA). Our multidisciplinary teams combine scientific and regulatory expertise to deliver robust dossiers and defend your interests before ECHA and its committees. With offices across Europe and international reach, CEHTRA ensures regulatory compliance, business continuity, and secure market access for substances subject to authorisation or restriction. Contact our experts Key REACH Authorisation services Key Services Complete authorisation dossier End-to-end drafting and submission of Annex XIV applications (CSR, AoA, SEA). Exposure estimation and use mapping across your supply chain. Data-gap analysis, evidence consolidation, and quality checks for a robust dossier. Advocacy & regulatory defence Regulatory watch, public consultation support and stakeholder engagement. Interaction with ECHA / RAC / SEAC and follow-up to committee opinions. Supply-chain communication and documentation to support continued use. Conformity & compliance Compliance pathways for authorisation or restriction obligations. Post-submission support (clarifications, conditions, corrective actions). Implementation of operational conditions and risk-management measures. Prioritisation & anticipation Portfolio screening vs SVHC / Annex XIV pipeline and deadline planning. Alternatives scoping and substitution roadmap aligned with business needs. Business-continuity planning and risk assessment to avoid disruptions. Looking for guidance on REACH Authorisation compliance? Find it here. What is REACH Authorisation and why is it required? REACH Authorisation is mandatory for substances of very high concern (SVHC) included in Annex XIV of the REACH Regulation. Companies that manufacture, import, or use these substances must obtain authorisation to continue placing them on the EU market. CEHTRA helps you determine whether your substances are affected and provides strategic support to secure compliance and maintain market access. How do you prepare a successful REACH Authorisation dossier? A strong dossier requires several components: a Chemical Safety Report (CSR), an Analysis of Alternatives (AoA), and a Socio-Economic Analysis (SEA). These demonstrate both the safety of continued use and the socio-economic impact of substitution. CEHTRA’s multidisciplinary experts prepare and defend these dossiers, ensuring that your application meets ECHA’s requirements and stands up to committee review. What are the risks of missing REACH Authorisation deadlines? Failure to submit an authorisation application by the regulatory deadline means that the substance can no longer be legally placed on the EU market. This can disrupt supply chains and impact business continuity. CEHTRA supports companies in anticipating obligations, preparing dossiers on time, and defending their applications to avoid costly interruptions. 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

Use CEHTRA's simplified questionnaire to assess your compliance with the REACH regulation's authorisation procedure for Chrome VI and other substances of very high concern (SVHC). Access the list of SVHC in Annex XIV and the safety data sheet. Start now. CHROME VI HANDLING COMPLIANCE New! Assess your compliance level in a few clicks (substances subject to authorisation within the regulation (EC) N°1907/2006 called REACH regulation) start your assessment Where can I find the list of substances subject to authorisation? The objective of the authorisation procedure is to ensure that substances of very high concern (SVHC) are progressively replaced by other less hazardous substances or technologies when suitable economically and technically viable alternatives exist. Where can I find the list of substances subject to authorisation? The substances concerned and subject to authorisation are listed in Annex XIV of the REACH regulation. Please note that this information is available in section 15 of the safety data sheet. The particular case of Ch rome VI Chrome VI is a special case because its use is currently covered, for downstream users (DU), by the holders of the authorisation dossier (list of holders in point 4 of the questionnaire). It is an "upstream" dossier whose registrants have joined together in a consortium: the CETAC sub. Today, this concerns only Chrome VI. What are the obligations related to the handling of a substance subject to authorisation covered by a Third Party (upstream in the supply chain)? When you purchase and handle a substance subject to an "upstream" authorisation dossier, you face several obligations, including: Ensuring that your use of the substance is covered by your supplier Compliance with the conditions of an authorisation granted to an upstream actor in its supply chain (conditions described in the Exposure Scenario attached to the eSDS) Your notification of use to the ECHA (European Chemical Agency) within 3 months after the first delivery What are the consequences of non-compliance? Penal and administrative sanctions (non-exhaustive list) Following a formal notice: Order the payment of a fine of up to €15,000 and a daily penalty of €1,500 Order the cessation of the activities concerned Order a ban on the import, manufacture or placing on the market or a withdrawal from the market of substances, mixtures, articles, products or equipment. If you: Manufacture, import or use, without the corresponding authorisation decision, a substance, as such or contained in a preparation or article, in disregard of Title VII of the REACH Regulation 75000€ fine, up to 2 years in prison If you: Fail to comply with prohibitions or risk reduction measures taken for the protection of health or the environment 75000€ fine, up to 2 years in prison Source: code de l’environnement, articles L. 521–12, L. 521–18 et L. 521–21 To this end, CEHTRA offers a simplified questionnaire to help you quickly assess whether you have little or no risk of non-compliance, or whether you need to implement corrective actions to be defined in more detail. start your assessment

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

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. Endocrine Disruptors (ED): Regulatory Assessment & Strategic Support Expert guidance on EU endocrine disruptor regulations, risk assessment, and strategic compliance solutions. Our services Request support Your partner for safety, compliance, and scientific evaluation of endocrine disruptors Since 2018, the evaluation of endocrine disruption (ED) potential has been a mandatory regulatory requirement for plant protection and biocidal products. In 2023, new hazard classes for ED were introduced under CLP (Regulation (EC) No 1272/2008). Further regulatory requirements are also expected in cosmetic, REACH, and pharmaceutical regulations. Our experts support you in anticipating these regulatory changes and ensuring the compliance of your substances and products across multiple markets. Contact our experts Key Services for Endocrine Disruptors Ancre 1 Critical review of existing data: Review of existing regulatory data Targeted bibliographic search according to ECHA-EFSA guidance Analysis of Toxcast data using our internal digital tool Data generation and tailored testing Tailored testing strategies aligned with OECD guidelines or most recognised protocols Monitoring and interpretation of ED-specific studies (in vitro / in vivo) In silico predictions and (Q)SAR screening Documentation & regulatory dossiers Preparation of ED-relevant sections for PPP and BPR Use of regulatory compliant formats (IUCLID, EFSA table…) Comprehensive documentation for internal strategic purpose or for regulatory submissions Expert statements & defence Independent scientific evaluation of ED properties and CLP classification Support during regulatory interactions with authorities Position papers defending ED assessment and classification Looking for guidance on Endocrine Disruptor assessment? 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. Explore additional resources Can’t find your answer? Submit a request

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

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

I 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. Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics See sessions Contact us Training > The basics > Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics Overview Program Audience Trainers Objectives. 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. Place Horaire Price Language Access time 1h30 from 148€ (HT) French 2 months Register See sessions Objectives. 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. Program. 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. Download the catalogue Audience. Players in the food and cosmetics packaging industry. Prerequisites. None. Caroline Optiz Head of Packaging 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... +

Discover our advanced modeling tools SFPP3 and CEHTRAPACK for controlling substance migration from packaging to contents. Our modeling methods are recognized by regulatory authorities for market control. Contact us to learn more. 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

egulatory support for food and nutraceutical products: safety, compliance, authorizations, and formulation with CEHTRA. Food supplement formulation, safety assessment, and regulatory guidance Supporting your food and nutraceutical products from safety assessment to market authorization. Our services Request support Ensuring safety and compliance for innovative food ingredients Bringing food and nutraceutical products to market requires a firm guarantee of safety for the end consumer. We support industry players at every stage of ingredient and finished product development, whether for human or animal consumption. From scientific safety validation to the preparation of comprehensive regulatory dossiers and applications for innovative ingredients, our expertise helps you streamline and secure your processes. Our multidisciplinary team of toxicologists, chemists, ecotoxicologists, and in silico analysis specialists combines complementary skills to turn your innovations into compliant, reliable products ready to succeed in the market. Contact our experts Key regulatory services for food and nutraceutical products Ancre 1 New products authorisation Comprehensive support for Novel Foods, NDI, and GRAS dossiers. Guidance on the authorization of GMO products and food/feed additives. Preparation and submission of food and feed authorization applications (EU, USA, UK). Management of communications and follow-up with regulatory authorities. Comprehensive safety dossier Preparation of justification dossiers (dose exceedance, absence of labeling, etc.). Safety evaluation of ingredients, substances, additives, and finished products. Expert support on safety topics: endocrine disruption, NAMs, in silico analysis, etc. Support in establishing safety evaluation strategies for raw materials and finished products. Risk Assessment Risk analysis via dietary exposure (contaminants, active substances, bioactive compounds, etc.). Risk assessment for target populations and species. Formulation Support Assistance in formulating finished products. Safety evaluation of candidate ingredients from the early stages of formulation. Preparation of safety reports for selected ingredients. Event, Novel Food training Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies Know more Looking for guidance on food supplements? Find it here. How can innovative food and feed products obtain regulatory approval? Innovative food and feed products must obtain regulatory approval before commercialization, which requires demonstrating their high-quality and safety. This involves developing a robust safety assessment strategy to identify and address all potential risks associated with the consumption of these innovations for the relevant populations or species. Our team of experts supports companies throughout the entire process, from defining the toxicological assessment strategy and preparing dossiers to submission and ongoing communication with authorities, ensuring that innovative products reach the market efficiently and safely. What safety dossiers are required for food supplements? Bringing food and nutraceutical products to market requires ensuring their safety for consumers. Safety dossiers are therefore essential to demonstrate the safety of ingredients, substances, additives, and/or finished nutraceutical products. These dossiers rely on toxicological data or in silico analyses and provide scientific justification when required by regulations (for example, in cases of dose exceedance or absence of labeling). We prepare comprehensive safety dossiers tailored to regulatory requirements to support the successful and compliant introduction of your products to the market. At what stage of product development should safety evaluation begin? Safety evaluation should start as early as possible in the product development process. Early assessments help identify potential safety concerns, guide formulation choices, and ensure alignment with regulatory requirements, saving both time and resources when moving toward market approval. Our team can support you throughout this process to secure a smooth and compliant product development pathway. 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

I 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 Safer cosmetics for tomorrow - Know your regulatory obligations See sessions Contact us Training > The basics > Safer cosmetics for tomorrow - Know your regulatory obligations Overview Program Audience Trainers Objectives. 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 Place Horaire Price Language Access time 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. 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 Program. 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. Download the catalogue Audience. R&D, Regulatory, Quality, Safety Assessors, Manufacturers, Distributors, Subcontractors, Suppliers, Importers. Prerequisites. Cosmetics regulatory affairs officer or toxicologist. Florian Gautier Head of Cosmetics 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... +

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

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