Expert CPSR services for cosmetic products. CEHTRA supports CPSR drafting, review, and updates to ensure EU regulatory compliance. India CDSCO Medical Device Regulatory Support Expert regulatory support for CDSCO registration, import licenses, Authorized Indian Agent coordination, technical documentation, and post-approval compliance. Start Your CDSCO Approval Process Accelerate your medical device market access in India Entering the Indian medical device market requires strict compliance with the Medical Device Rules (MDR) 2017 and regulations governed by the Central Drugs Standard Control Organization (CDSCO) . At CEHTRA, we provide end-to-end regulatory consulting services to help medical device manufacturers, importers, and Authorized Indian Agents achieve fast, compliant, and efficient market access in India. With deep regulatory expertise and hands-on experience in CDSCO submissions, we support companies at every stage of the approval process from classification to post-market compliance. Contact our experts Why CDSCO Regulatory Support is Essential CEHTRA supports companies navigating the CDSCO regulatory framework with a structured, compliant, and efficient approach. We help clients: Obtain CDSCO import licenses and registrations Comply with medical device rules (MDR) 2017 Prepare complete regulatory dossiers Manage CDSCO queries and deficiency responses Ensure post-approval regulatory compliance Access regulatory intelligence and updates Accelerate medical device market entry in India Medical Devices we support We provide regulatory support for a wide range of medical devices and healthcare technologies, including: Class A, B, C & D Medical Devices Sterile and non-sterile medical devices Imported medical devices In Vitro Diagnostic Devices (IVDs) Diagnostic technologies Healthcare equipment and technologies Supporting your market access strategy in India Whether you are preparing your first CDSCO application or expanding an existing product portfolio, CEHTRA provides the regulatory expertise required to support your business objectives and ensure long-term compliance in India. We simplify the CDSCO regulatory process through expert guidance, structured documentation support, and end-to-end regulatory management. Discover the approval process CDSCO medical device approval process in India Navigate each stage of the CDSCO approval process with confidence. CEHTRA provides expert regulatory support from device classification to post-approval compliance, helping you achieve efficient and compliant market access in India. step 1 – device classification (a, b, c, d) Medical devices are classified based on risk level: Class A – low risk Class B – low to moderate risk Class C – moderate to high risk Class D – high risk The classification determines the regulatory pathway, documentation requirements, review process, and applicable fees. step 2 – regulatory strategy assessment Once classification is confirmed, the appropriate regulatory pathway is defined, including licensing requirements, submission strategy, and documentation expectations. A clear regulatory strategy helps reduce delays, avoid compliance risks, and ensure smoother CDSCO approval in India. step 3 – appointment of an authorized Indian agent For imported medical devices, foreign manufacturers must appoint an authorized Indian agent to represent them before CDSCO and manage regulatory communications. step 4 – regulatory documentation preparation We support the preparation and review of all required regulatory and technical documentation, including: device master file (DMF) plant master file (PMF) ISO 13485 certification labelling information free sale certificate (FSC) on-site quality documentation other CDSCO-required supporting documents step 5 – SUGAM portal submission Applications are prepared and submitted through the CDSCO SUGAM portal by the applicant or authorized Indian agent, including all regulatory documents and required fees. step 6 – CDSCO review and query management CDSCO reviews the application for compliance with applicable regulations and may request clarifications or additional documentation during the review process. CEHTRA supports full query resolution and deficiency response management. step 7 – grant of CDSCO license Upon successful review, CDSCO issues the relevant license, allowing the medical device to be legally imported, manufactured, and marketed in India. step 8 – post-approval regulatory compliance After approval, companies must maintain ongoing compliance, including: product changes and updates license maintenance and variations documentation updates post-market regulatory obligations Ready to enter the indian medical device market? CEHTRA’s goal is simple: help clients reduce regulatory complexity and achieve successful commercialization in the Indian market. We provide reliable, efficient, and compliance-focused regulatory support tailored to your business needs across every stage of the CDSCO approval process. CDSCO medical device approval FAQs How does CEHTRAWATCH save time compared to manual regulatory monitoring? CEHTRAWATCH enables targeted regulatory and toxicological monitoring based on your substance portfolio. After importing your substance list, the platform automatically tracks their presence across multiple regulatory and toxicological lists. Relevant updates are identified and displayed in your dashboard or via alerts. Regulatory and toxicology teams no longer need to manually search multiple sources and can focus on impact analysis for their products and activities. How does CEHTRAWATCH help reduce compliance risks? Regulatory and toxicological changes can directly impact the use of substances. CEHTRAWATCH allows you to quickly identify whether a substance in your portfolio appears or evolves in a regulatory or toxicological list. Updates are integrated into the platform and changes between versions are highlighted. This targeted monitoring helps teams detect early changes that may affect compliance or risk assessment. Which regulatory and toxicological lists are monitored? CEHTRAWATCH monitors a wide range of regulatory and toxicological lists relevant to the chemical industry, including: European regulations (CLP, REACH, Cosmetics Regulation) SVHC and CLH intentions key national lists toxicological monographs (IARC, NTP…) toxicological reference values All updates are filtered based on your substance portfolio to ensure relevance. Does CEHTRAWATCH replace regulatory or toxicological expertise? No. CEHTRAWATCH does not replace human expertise. The platform facilitates the identification of relevant regulatory and toxicological changes, but impact assessment remains the responsibility of experts. It is designed as a complement to internal teams and CEHTRA consultants. Request support

I 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 Familiarise yourself with eSDS: obligations, content and compliance See sessions Contact us Training > The basics > Familiarise yourself with eSDS: obligations, content and compliance Overview Program Audience Trainers Objectives. 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 Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. 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 Program. Part 1 - Actors in the supply chain Part 2 - Obligation of eSDS producers under REACH Part 3 - Key stages in the construction of the CSA/CSR Part 4 - Construction of an extended safety data sheet Part 5 - Stages on receipt of a supplier SDS: compliance objective Part 6 - Impacts/sanctions in the event of non-compliance Part 7 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. People working under the REACH Regulation: - QHSE - manufacturers, formulators, chemical product manufacturers Prerequisites. Notions on REACH regulations. Notions on SDS (sections 1-16). Anna Chelle Expologist and regulatory toxicologist 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 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 Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment See sessions Contact us Training > The basics > Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment Overview Program Audience Trainers Objectives. 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 Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. 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 Program. Part 1 - Environmental data Review of useful physicochemical parameters Degradation study Bioaccumulation Part 2 - Ecotoxicity Organisms used in regulatory ecotoxicology Ecotoxicity studies: methods Principle of studies: critical parameters Alternative non-experimental methods used in ecotoxicology Part 3 - Regulatory use of data PBT, PMT assessment Risk assessment: Principle and derivation of PNECs from ecotoxicity studies Classification Part 4 - Q&A I Assessment of learning through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. English-language support material will be provided to trainees. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. Scientists and Regulatory Affairs Managers. Prerequisites. Bac +2. Blandine Journel Senior Ecotoxicologist 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 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... +

CEHTRA experts assess your cosmetic products and ingredients and prepare your Cosmetic Products Safety Report (CPSR) and Product Information File (PIF). Cosmetick database is a powerful toxicological tool that anticipates risk, based on regulatory updates and toxicological data evolutions. Our expert ecotoxicologists can also be consulted to recommend eco-conceptions design for your formulations. Cosmetic products and ingredients: ensure their safety Bespoke support for your cosmetic products and ingredients: regulatory compliance, pre-assessment, testing strategy, and toxicological reports Our sevices Request support Simplify Cosmetic Compliance Across Europe and Beyond CEHTRA assists cosmetic industry companies (start-ups, SMEs, and international groups) with product safety evaluations and regulatory compliance of their products and ingredients at European and global levels. Our experts assess a wide range of products (skincare, hygiene, fragrances, etc.), relying on COSMETICK, our database containing several thousand of toxicological profiles, fed with literature data, alternative methods results, and in silico predictions (QSAR, read-across) to address data gaps. Committed to a more sustainable cosmetics industry, we also provide ecotoxicology services for the assessment of environmental impact of products and ingredients. Contact our experts Our key services in cosmetic product safety and regulatory compliance Ancre 1 Cosmetic products Pre-assessments Cosmetic Product Safety Reports (CPSR) Contact our experts Cosmetic ingredients Safety assessment toxicological profiling and data gap analysis identification of safe concentrations of use Testing strategies according to NGRA principles In silico approaches NAMs testing programs Authorization dossiers SCCS, CIR submissions INCI names application New cosmetic ingredient registration or notification (CSAR) COSMETICK: digital tool for safety and compliance More than 4000 toxicological and ecotoxicological profiles Cosmetic formulations evaluation, MoS calculations Customization of data and alerts Confidential data management Explore COSMETICK Support for toxicological and ecotoxicological issues Bespoke training Endocrine disruptor potential analysis Literature search and bibliographic review Data gap management with digital methods (read-across, in silico approaches) by Simply Predict Discover Simply Predict service Looking for guidance on cosmetics? Find it here. What COSMETICK licence options are available? COSMETICK offers two licence levels designed for professionals involved in cosmetic safety assessment and cosmetic regulatory compliance: BASIC Licence Provides access to the COSMETICKtoxicological database, including structured cosmetic toxicological profiles required for CPSR preparation. ADVANCED Licence Provides full platform access, including the toxicological database, formula evaluation features, automatedMargin of Safety (MOS)calculation, and structured documentation to support CPSR preparation. Each licence is available under two access models: Unlimited access – suitable for teams conducting regular safety assessments On-demand access – flexible solution for occasional toxicological evaluations Need guidance selecting the most appropriate solution for your cosmetic risk assessment needs? Contact us at cosmetick@cehtra.com. What if an ingredient is not available in the COSMETICK toxicological database? If a cosmetic toxicological profile is not available in the COSMETICK toxicological database, you may submit a request directly via the online form. Each request is reviewed by regulatory toxicologists to ensure that the newly developed profile meets scientific and regulatory standards applicable to cosmetic safety assessment and CPSR preparation. Once validated, the profile is added to the toxicological database. You can track the progress of your request online and will receive an email notification when it becomes available. Does COSMETICK generate a Cosmetic Product Safety Report (CPSR)? COSMETICK produces a structured pre-assessment containing the key elements required for preparation of the Cosmetic Product Safety Report (CPSR), in accordance with Annex I of Regulation (EC) No 1223/2009. This pre-assessment includes: Exposure assessment based on the product formulation Calculation of the Margin of Safety (MOS) for each ingredient Evaluation of impurities, including CMR substances (carcinogenic, mutagenic or reprotoxic) Identification of relevant toxicological warnings Justification of skin tolerance Integration of user-specific data (test results, specifications, supplier information) The generated document supports preparation of Part B of the CPSR, which must be reviewed and validated by a qualified safety assessor in accordance with Article 10 of the EU Cosmetic Regulation. Explore additional resources Can’t find your answer? Submit a request Enhance your regulatory strategy with our complementary services Flex+ Outsource your human resources with complete peace of mind: we find, recruit and manage your profiles, whether for one-off assignments or long-term projects. 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. Endocrine disruptors. The assessment of endocrine disruptors, with rigor and method. Flex + Your projects are moving forward. We provide the resources. Haut de page

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

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.

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 PACKAGING PLANT PROTECTION REACH TOXICOLOGY Ancre 1 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 and cosmetics Understand the regulatory prerequisites for cosmetic and food contact 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 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 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 Safer cosmetics for tomorrow - Know your regulatory obligations from 690€ (HT) Knowing and understanding Cosmetics Regulation 1223/2009 Understand the risk assessment of a cosmetic product Identify areas for improvement in order to comply with regulatory obligations View sessions Toxicology and Classification - the fundamentals of your regulatory success from 1380€ (HT) Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved Optimising interaction between managers and experts View sessions 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... +

Join CEHTRA, a leading regulatory affairs and toxicology consulting firm. Apply online easily through our application form Careers in Regulatory Affairs, Toxicology & Chemical Safety Join CEHTRA, a leading regulatory affairs and toxicology consulting firm. Apply online easily through our application form – no CV upload required. Apply to CEHTRA Would you like to join a recognized consulting firm in regulatory affairs, toxicology and chemical risk assessment? CEHTRA regularly recruits scientific, regulatory and support profiles in France and internationally. Why join CEHTRA? For over 20 years, CEHTRA has been supporting industrial clients in sectors such as: Chemicals Cosmetics Biocides Pharmaceuticals Medical devices Food & feed What we offer: High-level scientific and regulatory projects Recognised European expertise A collaborative and people-focused environment Career development opportunities within a growing international group I am applying for the position of: First name* Last name* Phone* E‑mail* Curriculum Vitae* Import a file Cover Letter (optional) Import a file Apply 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."

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

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

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

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

Join H2B as a Digital Marketing Apprentice in Saint-Ouen or Lyon and support SEO, content, UX and web projects in health, climate and the environment. Digital Marketing Internship (Work-Study Program) Paris, Lyon ASAP Return to all positions Apply Purpose To increase the visibility and appeal of the H2B Group's subsidiaries through an effective digital strategy. Key Responsibilities Website Management and Optimization (UX) Update and manage websites built on WordPress and PrestaShop. Optimize the user experience (UX), navigation, and content. Publish and integrate web content (pages, articles, news). SEO, Digital Visibility, and Business Development Contribute to improving organic search engine optimization (SEO/GEO). Conduct keyword research and identify opportunities for increased visibility. Track digital performance using Google Analytics 4 and SEO tools. Create content for social media and blogs to boost visibility and generate leads. Participate in digital marketing initiatives that support business development. Education Bachelor's and Master's degree programs in digital marketing, communications, or e-commerce Hard Skills CANVA WORDPRESS PRESTASHOP GA4 Experience Previous experience in digital marketing is preferred Soft skills Writing Skills Curiosity Attention to Detail Communication Team Spirit Independence Benefits Why join CEHTRA? High profit-sharing based on economic and climate objectives Additional leave (JNT/RTT) 100% employer-covered health insurance Remote work: 2 days per week Seniority bonus Meal vouchers covered at 60% Sustainable mobility allowance Employee savings plan with employer contribution Works council (CSE) ticketing benefits Sports: challenges and discounted rates Unlimited tea and coffee CEHTRA is a leading European consultancy in regulatory, toxicological, and ecotoxicological sciences, committed to climate action and biodiversity protection. Our mission is to prevent toxicological risks to human health while addressing key challenges such as nanoparticles, endocrine disruptors, and PFAS. Part of the H2B Group, a fast-growing group focused on emerging environmental and health risks, CEHTRA offers diverse and rewarding career paths in both technical expertise and project management. With offices in Bordeaux, Lyon, Paris, Germany, Spain, the UK, Canada, and India, CEHTRA operates across high-growth sectors including chemicals, cosmetics, biocides, pharmaceuticals, food, plant protection, packaging, and medical devices.

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... +

CEHTRA ensures the safety and conformity of your substances and plant protection products. Our experts help you to meet regulatory requirements: approval and authorisation dossiers, data gap analysis, toxicological and environmental risk assessments, and endocrine disrupting (ED) properties. Expert regulatory support for Plant Protection Products We guide you through every step, from active substance strategy to product authorization. Our services Request support Bringing your Plant Protection Products safely to market At CEHTRA, we understand the challenges you face in navigating complex regulatory landscapes for plant protection products. Our experts provide end-to-end support from identifying data gaps to dossier submission and defense ensuring compliance with European and national requirements. With a tailored strategy and strong scientific expertise, we help you achieve successful approvals and accelerate your market access. Contact our experts Key regulatory services for Plant Protection Products Regulatory strategy & Dossier preparation Data gap analysis (DGA, DMT) and study design Dossier preparation (CADDY, IUCLID formats) Submission to European and national authorities Scientific argumentation and post-submission defense Risk assessment & Scientific expertise Human health (toxicology, operator, consumer exposure) Environmental fate and behaviour Ecotoxicology and ecosystem impact Modelling and refinement for tailored risk assessments Task Force & Project management Coordination of multi-company dossiers at EU level Strategic partnerships for active substance approval Study monitoring and follow-up with laboratories Regulatory support in Europe and worldwide Added-Value Services Endocrine Disruptor Biocontrol, fertilizers, and biostimulants expertise Customized field and operator studies Preliminary risk assessments (PRA) Looking for guidance on plant protection compliance? Find it here. How can I get my Plant Protection Product (PPP) authorized in Member States of the EU ? The active substance contained in your PPP must first be approved at EU level. Once it is approved, you can apply for product authorization in the Member States, following zonal application or mutual recognition. CEHTRA supports manufacturers, formulators and distributors throughout the EU approval and national authorization processes of Regulation (EC) No 1107/2009. We guide you from initial regulatory strategy to dossier preparation, submission, and post-submission defense. Our experts ensure your products meet EU regulations efficiently, helping you bring them to market with confidence. What are the benefits of biostimulants for crops and how can they be put on the market? Biostimulants can enhance crop growth, improve nutrient efficiency, and increase tolerance to abiotic stress, and they may be put on the market at European level with Regulation (EU) 2019/1009 or at national level following Member States’ specific requirements. Our experts support you from safety assessment to dossier preparation and submission, ensuring your biostimulant comply with regulations and reach the market successfully. What is Preliminary Risk Assessment (PRA) of Plant Protection Products and why is it crucial for your projects? Preliminary Risk Assessment (PRA) includes environmental screening, identifying in advance the potential risks to groundwater and to the ecosystem, that are associated with the use of Plant Protection Products (PPPs). This PRA is based on conditions of uses and effects on non-target organisms (NTO), and allows manufacturers and distributors optimising their field efficacy testing strategy, as well as adjusting ahead the Good Agricultural Practices so as to secure the environmental safety of their products’ uses. Explore additional resources Can’t find your answer? Submit a request Enhance your regulatory strategy with our complementary services CEHTRA Training. Deepen your knowledge with our expertise. Digital Solutions. Your performance, our digital solutions. Simply Predict. In silico predictions: for faster, smarter decision-making. Flex + Your projects are moving forward. We provide the resources. Endocrine disruptors. The assessment of endocrine disruptors, with rigor and method. Haut de page

CEHTRA 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

India’s Chemicals (Management And Safety) Rules (ICMSR) also referred to as ‘India REACH’ will come into force on the date of their publication in the Official Gazette, expected mid-2021. ICMSR (India REACH) Services: Notifications, Registration & Representation Expert guidance to navigate India’s chemical regulations and ensure full compliance. Our services Request support India’s Chemicals (Management And Safety) Rules India’s Chemicals (Management And Safety) Rules (ICMSR) also referred to as ‘India REACH’ will come into force on the date of their publication in the Official Gazette, expected mid-2021, and will regulate all substances, substances in mixtures, and intermediates that are manufactured, imported or placed on the market in the Indian territory at quantities greater than 1 tonne per year. Regulatory compliance requirements will apply within 18 months of coming into force, and all Indian manufacturers and importers will need to comply. Non-Indian entities who wish to place their chemical products on the market in India will need to appoint an authorised representative (AR) located in India to act on their behalf (similar to EU REACH OR). If your company is currently manufacturing chemicals in India or exporting chemicals to India, ICMSR will affect you. CEHTRA-India registered office in New Delhi is well positioned to act as your AR and service provider and can help you secure the Notification or Registration certificate for your chemicals from India’s Chemical Regulatory Division. Contact our experts Key Services Key regulatory services for biocidal products and active substance Notification / Registration & update Preparation and update of Notification and Registration dossiers for individual or joint submission Authorized Representative (AR) service Representation of non-Indian companies through our Indian entity Safety Data Sheets (SDS) Preparation and/or update of SDS in latest UN-GHS format Data Management Arrangement of data on substances already registered with any foreign regulator in other jurisdictions Need help navigating India REACH? Find answers here. What is ICMSR (India REACH) and how does it affect chemical manufacturers and importers in India? ICMSR, or India Chemicals (Management and Safety) Rules, also known as India REACH, regulates all chemical substances, mixtures, and intermediates manufactured, imported, or sold in India in quantities ≥1 tonne per year. All Indian manufacturers and importers must comply with ICMSR to legally operate in the Indian chemical market. Non-compliance can result in penalties and restricted market access. How can non-Indian companies export chemicals to India under ICMSR regulations? Non-Indian companies wishing to sell chemical products in India must appoint an Authorised Representative (AR) based in India. The AR acts on behalf of the foreign company for notification, registration, and compliance with ICMSR, similar to the EU REACH OR system. CEHTRA-India can serve as your AR and guide your company through the entire compliance process. Comment suivre l’évolution des réglementations ? Notification: All substances ≥1 tonne/year must be notified to India’s Chemical Regulatory Division (CRD), with annual updates. Registration: Priority substances listed in Schedule II require a technical dossier within 18 months of inclusion. Safety Data Sheet (SDS): Up-to-date UN-GHS SDS must be maintained and shared with downstream users. Site Safety Report: Facilities handling hazardous chemicals must submit safety reports or audits depending on chemical quantities. Explore additional resources Can’t find your answer? Submit a request

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

CEHTRA helps manufacturers implement the PPWR through its regulatory expertise: training, packaging assessments, regulatory interpretation, supplier data collection, roadmap development, and compliance action plans. PPWR - Packaging and Packaging Waste Regulation Supporting companies in understanding and complying with the EU Packaging and Packaging Waste Regulation (PPWR). Attend the Free PPWR Webinar 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 Register for the Free PPWR Webinar: Understanding the Packaging and Packaging Waste Regulation Join our webinar dedicated to the Packaging and Packaging Waste Regulation (PPWR) and gain a clear overview of this new European regulation on packaging. Know more PPWR Webinar Objectives During this webinar, our experts will cover: the key provisions of the PPWR regulation the implementation timeline and deadlines the new obligations for companies impacts on packaging design and management the first steps to anticipate for regulatory compliance This session will help participants better understand the implications of the PPWR and identify the actions required to anticipate upcoming regulatory changes. Date: 18 June 2026 10:00 - 11:00 French Register to the webinar Date: 18 June 2026 14:00 - 15:00 English Register to the webinar Speaker Introduction Anaïs Coinet and Loriane De Franceschi support companies in understanding and implementing European packaging regulations (PPWR). They will share their expertise to anticipate legal obligations, optimize packaging design and strategy, and ensure compliance with PPWR requirements. Participants will gain practical guidance and concrete examples to prepare their packaging strategies in line with PPWR requirements. Preparing for the PPWR Regulation? Section À propos. Chaque site a une histoire et les utilisateurs veulent découvrir la vôtre. 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

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

CEHTRA assists you in updating your REACH registration dossiers. CEHTRA advises you for your chemical products: IUCLID studies, only representative (OR), advice on a substance, fragrance (UVBC), joint submission or consortium and data cost sharing. Chemicals regulatory services: REACH compliance and market access Expert guidance for chemicals registration and regulatory compliance. Our services Request support Expert REACH services for chemicals with global support CEHTRA’s consultants have extensive experience in preparing hundreds of REACH registration dossiers for lead registrants and co-registrants. We support chemical manufacturers and distributors with the full spectrum of REACH services, including dossier compilation and updates, IUCLID migration, SIEF and consortium management, testing strategies, Only Representative services, regulatory compliance, risk assessment, and environmental screening. Our multidisciplinary, multilingual teams, with offices across Europe and beyond, ensure regulatory compliance, streamline processes, and help your chemical products reach the market efficiently and safely. Contact our experts Key regulatory services for REACH Key Services REACH dossier compilation & update Compilation and update of REACH registration dossiers Preparation and submission of Lead Registrant and Co-registrant dossiers IUCLID dossier updates (migration, review, and corrective actions) TCC passing for dossiers submitted with older IUCLID 6 versions Full updates for IUCLID 5 dossiers Identification of vulnerabilities and recommended corrective actions Updates on tonnage, new UVCB qualities, and impurity profiles SIEF & consortium management Coordination and communication within SIEF and consortia Administrative and financial management of Letters of Access (LoA) Boundary composition including all SIEF information Facilitating joint testing strategies and dossier updates Only Representative & international compliance Acting as Only Representative (OR) for non-EU companies under REACH UK-REACH representation and regulatory support Guidance for EU importers, manufacturers, and downstream users (DU) Notifications and regulatory submissions to ECHA Testing Strategy & Regulatory Support Development and adaptation of testing strategies for REACH compliance Regulatory and scientific advice for portfolio and registration strategy Assessment of outcomes from new studies Impacts on Classification & Labelling (C&L) Looking for guidance on REACH compliance? Hier finden Sie es. What is IUCLID and why is it important for REACH? IUCLID is the software used to create and compile information requested for REACH registration dossiers. It ensures that all safety, exposure, and regulatory information is properly documented. Keeping IUCLID dossiers up-to-date is critical for compliance. How can non-EU companies comply with REACH? Non-EU companies can appoint an Only Representative (OR) based in the EU to handle REACH obligations on their behalf. The OR can submit registration dossiers, is the contact point for ECHA communications, and ensure ongoing compliance, allowing international manufacturers and suppliers to legally market their chemicals in the EU. What are Letters of Access (LoA) and why are they needed? Letters of Access are annexes of Joint Submisson Agreements. They allow companies to legally use existing data submitted by the Lead Registrant in their REACH dossier. They help avoid duplicate testing, reduce costs, and ensure compliance with data-sharing obligations. 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 Areas: food contact and cosmetics Understand the regulatory prerequisites for cosmetic and food contact 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) Introduction to packaging regulations: understanding and implementing them See sessions Contact us Training > The basics > Introduction to packaging regulations: understanding and implementing them Overview Program Audience Trainers Objectives. Areas: food contact and cosmetics Understand the regulatory prerequisites for cosmetic and food contact 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) Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Areas: food contact and cosmetics Understand the regulatory prerequisites for cosmetic and food contact 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) Program. Part 1 - Regulatory requirements for cosmetic packaging Part 2 - Regulatory requirements for food contact packaging Part 3 - Migration principles (container-content interactions) Part 4 - 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, Technical and Quality positions. 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... +

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

CEHTRA offers customized and cost-effective Global Chemicals Notification services to ensure regulatory compliance for chemicals in various countries. Our experts use PRIMO and provide scientific expertise, testing programs, and country-compliant dossier preparation. Top of the page GLOBAL CHEMICALS NOTIFICATION Description Contact Key Services Value-added Media When it comes to chemical regulatory compliance, there is no ‘one method fits all’ approach. Here at CEHTRA we have developed our own internal tools designed to provide you the best worldwide, customized, and optimized strategy for a minimum cost. Our expert practitioners have collectively decades of experience and using our PRIMO tool are able to identify the most up to date regulatory requirements for the designated target countries. We prepare the Master dossier on which all other submissions are based. When required, our partners, chosen for their geographic proximity, language, and culture have the skills to prepare your local submission dossiers. Meet our experts Mathieu ROLLAND Head of Global Notifications mathieu.rolland@cehtra.com Damien GUYOMAR Toxicologist damien.guyomar@cehtra.com Melanie HARPER Regulatory Affairs Specialist melanie.harper@cehtra.com Description Contact Key Services Global Registration Strategies Registration schemes adapted to your needs Scientific Expertise Data Gap analysis Testing strategy (incl. alternatives to in vivo testing) Scientific support Testing Programme Monitor testing adapted to local requirements Registration Dossiers Preparation of Country-compliant dossiers Communication with authorities Value-added Services PRIMO tool to optimize management and follow-up of complex worldwide registration projects Scientific and Regulatory expert advices Only Representative services Countries Covered Please click on the highlighted country names to get redirected to their dedicated page on our website Australia Canada China EU countries India Japan Philippines Russia South Korea Switzerland Taiwan Thailand Turkey UK USA Others on application Key Services Value-added Media Flyers Tools CEHTRAcker CEHTRA's window to worldwide regulatory support Media Related Sectors Chemicals (REACH) Industrial Hygiene Simply Predict REACH Authorisation Haut de page

I Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved  Optimising interaction between managers and experts Toxicology and Classification - the fundamentals of your regulatory success See sessions Contact us Training > The basics > Toxicology and Classification - the fundamentals of your regulatory success Overview Program Audience Trainers Objectives. Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved Optimising interaction between managers and experts Place Horaire Price Language Access time Online 14 hours from 1380€ (HT) French 2 months Register See sessions Objectives. Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved Optimising interaction between managers and experts Program. Part 1- Regulatory toxicology ? General information Part 2 - ADME (Absorption, Distribution, Metabolism, Excretion): concepts Part 3 - Acute systemic toxicology (oral, cutaneous, inhalation) Part 4 - Local skin and eye tolerance Part 5 - Skin sensitisation Part 6 - Repeated-dose and chronic toxicity Part 7 - Reproductive and developmental toxicity Part 8 - Mutagenicity and genotoxicity - Classification Part 9 - Carcinogenesis Part 10 - Introduction to non-experimental alternative methods used in toxicology Part 11 - Introduction to the determination of Toxicological Reference Values Part 12 - Introduction to human health risk assessment Part 13 - Assessment of knowledge through a final quiz Methods used. The course is based around an interactive presentation with ongoing engagement between the trainees and the expert. Trainees will be provided with the course materials. A final quiz will validate the knowledge acquired. To enhance e-learning, our courses are run in small groups, ranging from a minimum of three people to a maximum of six. Our courses are delivered through synchronous learning. Download the catalogue Audience. Employees involved in product safety. Prerequisites. None. Maurine Duplaa Toxicologist Marlène Baron 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... +

CEHTRA ensures the safety of your pharmaceutical substances and products (human and veterinary). Our experts assist you in your regulatory submissions: PDE, OEL/OEB, qualification of impurities, preclinical expertise (CTA...), environmental risk assessments (ERA) for MAA dossiers. Pharmaceutical & Veterinary Product Compliance and Safety Services From molecule to market: secure your pharmaceutical development with toxicology expertise. Our services Request support Comprehensive solutions for Human & Veterinary Pharmaceuticals At CEHTRA, we support pharmaceutical companies in ensuring the safety of their human and veterinary medicines. Our multidisciplinary team of pharmacists, toxicologists, and engineers provides expert guidance across CMC activities, preclinical development, regulatory dossier preparation, and Environmental Risk Assessment. From calculating PDE and OEL/OEB limits to designing preclinical development plans and authoring critical documents, we help you navigate complex regulations and accelerate your path to Clinical Trial Authorisation (CTA) and Marketing Authorisation (MAA). Contact our experts Key pharmaceutical services to ensure safety and compliance Ancre 1 CMC Support PDE (Permitted Daily Exposure) c alculation OEL/OEB (Occupational Exposure Limit / Occupational Exposure Band) c alculations Qualification of impurities Toxicological evaluation of extractables-leachables In silico assessment (QSAR) Preclinical development Development plan design Study monitoring (CROs selection Validation of protocols & study plans Study follow-up Discussion of the results Review of final study reports) Clinical Trial Applications Gap analysis Pre-clinical dossiers Authoring nonclinical sections of CTD, CTA, IND, IMPD, Investigator Brochure (IB), Briefing Documents Updating & making a Critical Review of nonclinical modules (2.4 & 2.6, module 4) Environmental Risk Assessment Study monitoring ERA Drafting (Environmental Risk Assessment, Phase I & Phase II, Module 1.6) Interactions with competent authorities (EMA, FDA) – Defense of the dossier Looking for guidance on pharmaceuticals? Find it here. How do you ensure both patient and worker safety in pharmaceutical production? CEHTRA evaluates production safety, occupational exposure limits, toxicology of impurities, and environmental risk assessments, helping you comply with ICH and EMA guidelines while protecting patients, staff, and the environment. What are best practices for preclinical development and CMC in pharmaceuticals? Our experts guide you through preclinical development planning, CRO selection, study monitoring, PDE and OEL/OEB calculations, and qualification of impurities, ensuring your development process is safe, efficient, and fully compliant. How to comply with regulatory requirements for human and veterinary medicines? CEHTRA supports your regulatory submissions (CTD, CTA, IND, IMPD, Investigator Brochures) and liaises with EMA and FDA, ensuring your products meet all compliance standards while accelerating market access. 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

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

CEHTRA ensures the compliance of your product dossiers and families of biocidal products (BPR) and active substances. Our expertise includes risk assessment, technical equivalence, biocidal consortiums as well as the evaluation of ED properties and substances of concern (SoCs). The skilled partner for regulatory guidance in complex EU regulation for biocides CEHTRA provides expert support to help you achieve successful biocidal product and active substance compliance. Our services Request support A commitment to expert regulatory support for biocidal products and active substances: CEHTRA offers extensive expertise in the field of biocidal products and active substances according to the Biocidal Products Regulation (EU) 528/2012 (BPR). Our dedicated team has been involved in preparation of multiple active substances dossiers (Annex I inclusions), numerous submission of biocidal products through the BPR process (Union and National Authorisations), as well as product applications following national schemes (transitional regime). Whether your products are disinfectants, wood preservatives, pest control products (rodenticides, insecticides, repellents), or antifouling products, CEHTRA offers end-to-end regulatory support: from dossier preparation until authorisation. We aim for continuous regulatory monitoring and providing tailored strategic advice to our clients . CEHTRA’s exceptional multilingual, multidisciplinary team offers specialised guidance and helps companies achieve complete regulatory compliance across jurisdictions. Contact our experts Key Services Key regulatory services for biocidal products and active substance New active substance Renewal Annex I inclusion Article 95 Listing Technical Equivalence Biocidal Product Single Product and Biocidal product families (BPF) Union/National/Simplified authorisations Same biocidal product EU R&D Notifications Group of Interest Unique approach Optimised Strategy Reduction of costs and resources Explore our consortia Related Services Testing strategy Study Monitoring Alternatives to in vivo testing Outsourcing services Flex+ Active Substance Digital solution: CEHTRAWATCH Explore how we make complex regulatory landscapes clearer and easier to navigate. Discover together – a collaborative alliance for biocides Supporting companies with flexible, confidential and cost-efficient regulatory solutions. Discover Looking for guidance on biocides? Find it here. How can a substance qualify for use as an active substance for biocides in EU? A substance can only be used for this if certain conditions are met: The substance must be assessed and formally approved based on a scientific evaluation performed by European Chemicals Agency (ECHA) and the EU Member States. An active substance dossier includes comprehensive data on the substance’s identity, physicochemical properties, (eco-))toxicological profile, environmental fate, and intended uses. The assessment must demonstrate that the substance is effective for the intended biocidal purpose and no unacceptable risks to human health, animal health, or the environment are found. Once approved, the substance is included in the Union list of approved active substances, published by ECHA. Only after these steps can a substance be eligible for use in the EU. CEHTRA’s expert team have a proven track record of preparing and submitting active substance dossiers (new approvals, renewals, Annex I inclusions, etc.) and supporting companies until successful approval is established. How do I place a biocidal product or a biocidal product family on the market in the EU? To place a biocidal product or a biocidal product family (BPF) on the market in the EU, companies must prepare and submit a comprehensive dossier according to the criteria set by the Biocidal Products Regulation (BPR). These dossiers typically include data on physicochemical properties, efficacy, (eco-)toxicological hazard profiles and risk assessments. The submission can be made through national schemes or via the EU central authorisation process (ie. BPR procedure), dependent on the EU status. With deep expertise and knowledge in the BPR framework, CEHTRA can assist in the entire process from dossier preparation, designing testing strategies, and managing the dossier until the successful authorization reached, allowing market access for biocidal products in EU and national markets. What is the Biocidal Products Regulation (BPR, EU 528/2012) and who needs to comply with it? The main goal of the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) is to ensure a high level of protection for humans, animals, and the environment, by harmonizing the process via an EU-procedure that allows improving the functioning of the market for biocidal products such as disinfectants, wood preservatives, pest control products, and antifouling products. To sell these products within EU, companies must meet strict BPR requirements. Approval of active substances used in the products and biocidal product authorisations are mandatory before going to the market. The complexity of EU requirements for biocidal products, including active substances used in these products, requires a dedicated understanding of the Regulation (EU) 528/2012. At CEHTRA, our experienced regulatory team is able to guide you in selecting the right steps towards full BPR compliance. 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

Regular training is essential to keep up-to-date with the changing regulations.You choose what you want to learn and when. You can come to us or we can come to you. CEHTRA Training Deepen your knowledge with our expertise. Find the right course for you among our programmes. Our trainings Contact us Nos programmes Our training programmes Regular training is essential to keep abreast of regulatory changes. Choose the formula that suits your needs. All our courses can be adapted for people with disabilities. the basics Learn and keep up to date on the essentials of the regulations. Discover mentoring Tailor-made training to meet the specific challenges of your company. Contact us What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +