Search Results

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 methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023. New ISO 10993-17 : 2023 - General and new features See sessions Contact us Training > The basics > New ISO 10993-17 : 2023 - General and new features Overview Program Audience Trainers Objectives. Understand the methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023. Place Horaire Price Language Access time 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Understand the methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023. Program. ISO 10993-17, BACKGROUND AND CONTEXT OF THE UPDATE Part 1 - Introduction Scope (releasables, raw materials, degradation products, risks covered) Links with other ISO 10993 standards (-1, -18, -9 etc.) - When is it useful and/or essential? ISO 10993-17 (2002) VS ISO 10993-17 (2023) : A NEW APPROACH Part 2 - What's new New terms, definitions and concepts New approaches: taking into account time periods; adapting exposure by weight (previously tolerable intake by weight). Part 3 - Data generation Characterisation according to ISO 10993-18 - Reminder and pre-test considerations AET - (Analytical Evaluation Treshold) - Importance of validating the method Types of data sought for the TRA. Part 4 - Toxicological Risk Assessment Toxicological Screening Limit (TSL) Exposure (EEDmax) Tolerable intake or contact (TI, TIcancer, TCL) Calculation of MOS Part 5 - Conclusion: Endpoint to be assessed Part 6 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a presentation containing case studies and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. DM players responsible for toxicological risk analysis and biocompatibility assessment, quality managers, functions responsible for compiling technical documentation. Prerequisites. General knowledge of issues relating to the biocompatibility of healthcare products, in particular ISO standards 10993-18, -12 and -1. As this is not initial training, knowledge of the previous version of ISO 10993-17: 2002 and basic toxicology concepts is very important (threshold value, exposure dose, systemic vs. local toxicity, NOAEL/LOAEL, etc.). Paul Fernandes Biocompatibility toxicologist What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

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

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 offers comprehensive ERA services to ensure pharmaceutical products meet environmental standards. Minimize environmental impact and maximize compliance with our expert guidance. Environmental Risk Assessment (ERA) ERA assesses environmental risks posed by pharmaceutical products. It minimizes drug impact, identifies risk measures, and ensures proper disposal. CEHTRA provides expert guidance and independent study monitoring for compliance. Blandine JOURNEL Senior Ecotoxicologist, ERA blandine.journel@cehtra.com Stephane PIERRE Head of Pharmaceuticals stephane.pierre@cehtra.com Send us a message and we will answer you quickly. E-mail Company Your message Send Thank you for your submission! EU's Proposal to Strengthen Environmental Risk Assessment (ERA) for Pharmaceutical Products In the EU, an Environmental Risk Assessment (ERA) has been required since 2006 (CPMP/SWP/4447/00, 20061) for any new application for marketing authorization (MA) for a drug, or when there is a potential for a significant increase in environmental concentrations following changes in use of existing MAs (e.g. addition of new indications). Drugs authorized before this date do not currently require an ERA. To achieve the environmental sustainability ambitions of the European Green Deal, the pharmaceutical industry will have to limit the negative impact of its products (and processes) on the environment, biodiversity and human health. Scientific evidence shows that pharmaceutical products are present in the environment as a result of their manufacture, use by patients and inappropriate disposal. The proposal to reform pharmaceutical legislation (Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC) meets a number of commitments on the strategic approach to pharmaceuticals in the environment. It strengthens the ERAof medicinal products to ensure better evaluation and limit the potential negative impacts of medicinal products on the environment and public health. In summary, the EU wishes to strengthen ERA for the marketing of pharmaceutical products by : Strengthening the ERA , by introducing a ground for refusal of marketing authorization when companies fail to provide sufficient evidence for ERA, or if the proposed risk mitigation measures are not sufficient to address the risks. Establish clearer requirements for ERA, including compliance with scientific guidelines, regular ERA updates and post-authorization obligation for additional ERA studies. Extend the scope of ERA to environmental risks arising from antibiotic manufacturing. Extend ERA to all products already on the market and potentially harmful to the environment. (COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS, Reform of the pharmaceutical legislation and measures addressing antimicrobial resistance, 26.4.2023) The aim of an ERA for pharmaceutical products is to : minimize the amount of drug released into the environment through appropriate measures. identify specific risk minimization measures to be undertaken by users. appropriate labeling, to facilitate proper disposal of the drug by patients/healthcare professionals (e.g. ensuring that drugs are disposed of in special containers or returned to pharmacies). The ERA is divided into 3 phases: Phase I: aims to identify the total environmental exposure of pharmaceutical products based on dosage and prevalence of the targeted pathology, and to study their potential for bioaccumulation and persistence in the environment. If specific risks are identified (estimated concentration in the environment greater than 0.01 µg/L, PBT substance or substance of concern), further assessment and a number of studies must be carried out (Phase IIA). Phase IIA: Phase II tests identify the fate of drugs in the environment and their potential effects on representative aquatic and terrestrial organisms, in order to assess whether the risk is acceptable. Phase IIB: If the risk is not considered acceptable, a refined assessment must be carried out (additional studies, modeling of environmental concentrations, risk management measures to be implemented). At CEHTRA, our ecotoxicologists can help you to prepare your ERA dossiers and monitor the studies required We have completed dozens of ERA dossiers in accordance with current guidelines. We are 100% independent of CROs , so we help our customers to carry out only the essential tests . The monitoring of studies by our consultants also ensures that our study reports are as robust as possible .

Quickly find out if your non-food consumer products are affected by GPSR 2023/988. Complete our free 2-minute assessment and, if needed, get personalized guidance from our CEHTRA expert. Are You Concerned by the GPSR (General Product Safety Regulation)? The General Product Safety Regulation (GPSR – EU Regulation 2023/988) has applied since 13 December 2024. Official guidance documents, published in November 2025, help economic operators understand their new and reinforced obligations when placing consumer products on the EU market. The General Product Safety Regulation (GPSR – EU Regulation 2023/988) has applied since 13 December 2024. Official guidance documents, published in November 2025, help economic operators understand their new and reinforced obligations when placing consumer products on the EU market. Why take this GPSR questionnaire? Understand whether the GPSR applies to your products Clarify your position as a manufacturer, importer, distributor or online seller Identify if you are potentially subject to GPSR obligations Avoid misinterpretation of the regulation’s scope This questionnaire is intended for companies operating on the EU market, including manufacturers, brand owners, importers, distributors and e-commerce players. A quick questionnaire to check whether the GPSR applies to your products What is your main sector? Toys/childcare Textiles/accessories Electronics/electrical goods Household/decorative items Scented items / fragrance diffuser Sports/leisure Other Suivant Learn more about the GPSR For a detailed explanation of the GPSR scope, key concepts and practical implications, we invite you to read our dedicated article. Read the article Need further support? If you have specific questions or would like to discuss your situation, you can also reach out to our regulatory experts via the contact form. Request support

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... +

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 Areas: food contact, cosmetics and pharmaceuticals  Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging  Acquire an overview of the regulatory texts applicable to materials  Be familiar with the essential requirements and specific features of this legislation  Understand a container/content risk assessment (LMS) 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, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) 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 - Regulatory requirements for pharmaceutical packaging Part 5 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. 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... +

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."

I 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. Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies See sessions Contact us Training > The basics > Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies Overview Program Audience Trainers Objectives. 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. Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. 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. Program. Part 1 - Introduction – Context and Regulatory Framework The role of toxicological studies in Novel Food assessments EFSA requirements and relevant guidance documents When studies are required (and when they are not) Part 2 - Assessment of Genotoxic Effects Why EFSA emphasizes genotoxicity Standard studies: Ames test, micronucleus assay, chromosomal aberrations Interpretation of results and acceptability criteria Limitations and interpretation caveats Part 3 - Assessment of Systemic Toxicity Subchronic toxicity studies (90 days – OECD Guideline 408) Key concepts: NOAEL, LOAEL, adverse effects, safety margins Parameters monitored: weight, organs, blood, histopathology, etc. How to read a GLP-compliant study report Part 4 - Assessment of Reproductive and Developmental Toxicity When are these studies required? Types of studies (OECD 421/422, prenatal and postnatal development) Common data gaps and EFSA expectations Strategic considerations: justifying absence or planning studies Part 5 - Toxicokinetic Evaluation Is there a need for ADME / toxicokinetic studies? What parameters are evaluated? How do they impact toxicity studies and risk assessment? Part 6 - Oversight and Management of Outsourced Studies Best practices for overseeing subcontracted studies How to select a laboratory (GLP compliance, Novel Food experience) Key points to validate in a study protocol before initiation Communication and deliverables expected for an EFSA dossier Part 7 - Final Session – Q&A and Exchange Addressing participants’ specific questions Sharing experiences and best practices 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. Regulatory Affairs Managers, R&D Project Managers and Quality Managers. Prerequisites. This training course is intended for participants with a basic knowledge of molecular and cellular biology, as well as some understanding of physiology. These prerequisites are essential to ensure a good understanding of the concepts covered, particularly the mechanisms of toxic effects and the interpretation of systemic toxicity data. Marie Liamin Toxicologist - Food safety expert 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... +

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."

Our DNA is international. You can find contact details of all our offices on this page. Our DNA is international Click on the country below for more details North America Europe Asia Canada France Germany Spain India United Kingdom Canada 24 Ivy Lea Crescent Toronto ON M8Y 2B6 Phone: +1 (416) 432-4020 France 126 rue du Landy 93400 Saint-Ouen 15 rue Aristide Briand 33150 Cenon, Bordeaux Phone: +33 (0) 557 77 56 10 8 avenue Leclerc 69007 Lyon Contact - France Germany CEHTRA GmbH Christoph-Probst-Weg 4 20251 Hamburg Phone: +49 ( 0)40 611 35 455 Contact - Germany India CEHTRA Chemical Consultants Pvt. Ltd. B1/A5, Mohan Co-Operative Industrial Estate, New Delhi-110044, INDIA Contact - India Spain Calle Pintor Murillo 29 – oficina bajo A 28100 Alcobendas Madrid Phone: +34 918 429 142 Contact - Spain United Kingdom CEHTRA Limited, Suite 31, 1 Hanley Street, Nottingham NG1 5BL United Kingdom Contact - United Kingdom

CEHTRA helps chemical and life sciences companies ensure regulatory compliance and accelerate global market access. Regulatory Consulting to Support and Strengthen Your Strategy Anticipate. Comply. Accelerate new market access with confidence. Our services Request support Your partner for comprehensive, secure and sustainable compliance At CEHTRA, we support chemical and life sciences companies navigate the complexities of regulations that are constantly evolving. Our multidisciplinary team of regulatory specialists, toxicologists, ecotoxicologists, and scientific experts helps you anticipate regulatory changes, assess impacts on your products, and implement smart & efficient compliance strategies. With over 25 years of experience, a global footprint and dedicated digital tools, CEHTRA guides you from early strategic planning through to dossier submission and post-approval follow-up — ensuring timely, sustainable, and competitive market access. Contact our experts Our Strategic & Regulatory Services Ancre 1 Regulatory Landscape Analysis Assessment of target markets, identification of applicable requirements, and delivery of critical regulatory insights. Evaluation of current and upcoming regulations affecting your product portfolio, including obligations, risks, opportunities, Data Gap Analysis, and priority actions. Analysis of potential regulatory positioning for your products when multiple frameworks apply. Regulatory Impact Assessment Regulatory Watch Continuous monitoring of legislative updates, scientific guidelines, standards, and methodological developments, with compliance roadmaps adjusted as needed. Regulatory Dossier Preparation, Management & Submission Data generation, including the use of alternative methods (QSARs, read-across, in silico modelling) to minimise animal testing where possible. Preparation and development of regulatory dossiers compliant with regional and international requirements. Submission of dossiers and communication with authorities, including local representation when required. Client & Supplier Data Management Collection, verification, secure handling, and continuous updating of essential data to ensure compliance, traceability, and high-quality regulatory dossiers. Looking for advice on regulatory compliance? You'll find it here. What is strategic regulatory consulting? Strategic regulatory consulting involves analyzing the regulatory landscape, assessing compliance risks, and designing efficient strategies to ensure products meet global regulatory requirements. It helps companies reduce delays, manage risks, and optimize market access. Which industries benefit from CEHTRA’s regulatory services? CEHTRA supports a wide range of sectors, including chemicals, biocides, cosmetics, pharmaceuticals, crop protection, and specialty materials. Any company facing complex regulatory requirements can benefit from tailored compliance and strategic advice. How does CEHTRA help with global market access? CEHTRA provides impact assessments, regulatory monitoring, compliance strategies, and dossier submission support for multiple regions worldwide, including Europe, North America, Asia, LATAM, and more. Local representation and guidance ensure smooth, timely, and compliant market entry. Explore additional resources Can’t find your answer? Submit a request

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."

Explore CEHTRA’s values: human-centered expertise, sustainable practices, innovation, and digital solutions driving excellence across all sectors. Our Values at CEHTRA A culture built on scientific excellence and regulatory expertise. Inspired by People, Empowered by Science As an international regulatory consulting firm specialised in chemicals, biocides, cosmetics and other sectors, our culture is shaped by collaboration, innovation, and a strong commitment to scientific integrity. Our commitment to corporate social responsibility (CSR) ensures that every decision considers ethical integrity, societal impact, and environmental sustainability. By leveraging technology, we streamline complex regulatory processes, increase transparency, and empower both our teams and clients to make confident, informed decisions. Our Core Values Driving Regulatory Excellence and Human Connection Discover our values in action and hear directly from our teams how they bring them to life every day across all sectors. Collective / Focus Collective Intelligence Collaboration is at the heart of everything we do. We believe that combining diverse expertise and perspectives leads to smarter, more resilient outcomes in every sector we serve. What this means for clients and teams: Encouraging open dialogue and valuing every team member’s contribution Multi-disciplinary teams collaborating across countries and regulatory areas Sharing knowledge openly to empower colleagues and clients alike Client Focus Our clients’ challenges shape our priorities. We go beyond compliance, focusing on human relationships, understanding the people behind every project, and delivering solutions tailored to their needs. What this means: Actively listening to clients’ constraints and goals Providing solutions that simplify work and accelerate decision-making Building long-term partnerships based on trust, empathy, and transparency " Working in a team with diverse points of view helps me to broaden my vision about things and allows me to take into account the elements that I wouldn’t have thought through otherwise." Julien LEGHAIT " Working in a domain where regulatory requirements are continuously evolving, it is my passion to pass the experience and knowledge I have gained so far to our clients. This allows developing regulatory strategies that are optimised to address to specific client needs and further strengthen the collaboration with them." Annekathrin FAUPEL Innovation / Commitment Innovation Innovation is about improving processes, tools, and experiences for everyone involved. By integrating digital solutions, data-driven methods, and creative thinking, we make regulatory compliance more efficient, transparent, and user-friendly. What this means: Developing technology solutions like CEHTRAWATCH to simplify regulatory workflows Encouraging curiosity, experimentation, and forward-thinking in our teams Applying innovation to enhance usability, efficiency, and impact across all sectors Commitment Commitment reflects our ethical responsibility to people, communities, and the environment. Every decision we make considers societal impact, sustainability, and regulatory integrity. What this means: Acting with integrity and accountability in all projects Supporting public health, environmental safety, and societal well-being Committing to develop and maintain a diverse and collective expertise mix across all sectors " Working within a company that welcomes evolution and progressiveness actively encourages us to develop improvements in our day to day working practices, to the benefit of both colleagues and clients." Melanie HARPER " At CEHTRA, our individual and collective ‘commitment to excellence’ drive us to accomplish the regulatory success desired by our satisfied customers " Pramod KUMAR Competency / Transmission Competency Competency at CEHTRA is built on scientific excellence, regulatory knowledge, and continuous learning. Across every sector, our consultants transform complex regulations into practical guidance that is actionable, accurate, and human-centered. What this means: Translating complex rules into clear, practical solutions Providing mentoring, training, and guidance internally and externally Ensuring that every recommendation reflects deep understanding and human awareness Transmission Sharing knowledge ensures that expertise grows sustainably. We empower colleagues, clients, and partners by transferring skills, insights, and best practices. What this means: Passing on our knowledge with enthusiasm, supporting colleagues and clients to grow their expertise Identifying and nurturing talent within our organization to build strong, capable teams Acting as active contributors to the future, fostering innovation, learning, and long-term success " At CEHTRA, we combine our skills on a daily basis to provide technical, scientific, digital and organizational solutions. It is essential to continue to diversify and develop everyone's competences to promote individual development within the company." William BERTRAND " Working in a regulatory domain can be quite challenging, especially when you have to deal with grey zones which are not easy to interpret but here is actually where the magic happens. The discussions and debates that are generated around such topics are very enriching and the knowledge shared between colleagues makes us grow further and allows us to help companies from a 360° approach" Sandra MARTINEZ BOSCH Join CEHTRA: A Company Driven by Scientific Integrity and Human Values Would you like to work in an organisation where science, innovation and collaboration are key drivers? Explore our career opportunities to learn how CEHTRA fosters professional growth and supports the next generation of regulatory experts. Join Our Team and Shape the Future of Regulatory Science

Flex+ by CEHTRA lets you outsource resources and strengthen your teams with qualified regulatory, toxicology, and compliance experts. Short or long-term assignments, on-site or remote, all backed by CEHTRA’s quality standards. Flex+ by CEHTRA: Externalize your resources with confidence Flex+ provides qualified experts to reinforce your teams in regulatory, safety, and environmental projects. Short- or long-term missions, on-site or remote, all backed by CEHTRA’s quality standards. Our services Discover Flex+ Boost Your Projects with On-Demand Regulatory Experts At CEHTRA, we know that regulatory projects evolve quickly. With Flex+, our flexible staff augmentation and resource outsourcing service, you can strengthen your teams with top regulatory experts without compromising quality or efficiency. Flex+ covers CEHTRA’s full range of services: toxicology, ecotoxicology, regulatory affairs, product stewardship, and compliance. Our experts quickly integrate into your teams to ensure project continuity and regulatory reliability. Contact our experts Why Choose Flex+? Ancre 1 Regulatory experts on demand Call on specialists in chemicals, biocides, cosmetics, pharmaceuticals or other sectors exactly when your project needs them. Time and efficiency savings Our experts integrate seamlessly into your team to help you meet deadlines and regulatory obligations. Full flexibility Scale the duration and level of involvement according to your project requirements, from short-term support to long-term assignments. Cost optimization Avoid long recruitment cycles and benefit from an agile, budget-friendly solution. How Flex+ Works Discover Flex+ 01. Needs assessment We define the skills and mission duration required for your project. 03. Candidate Presentation & Validation You’ll receive a curated shortlist, complete with detailed competencies and fit assessments. 02. Candidate Sourcing & Screening We use our industry network and recruitment tools to find the best candidate profiles. 04. Integration & Continuous Support Flex+ manages HR tasks, integrates experts seamlessly, and ensures ongoing support for successful project delivery.

I 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 Master CHESAR to simplify your REACH assessments See sessions Contact us Training > The basics > Master CHESAR to simplify your REACH assessments Overview Program Audience Trainers Objectives. 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 Place Horaire Price Language Access time Online 10h30 hours from 1035€ (HT) French 2 months Register See sessions Objectives. 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 Program. Part 1 - Obligations under REACH with regard to CSR Part 2 - Definition and construction stages of the CSA Part 3 - Occupational risk assessment Part 4 - Consumer risk assessment Part 5 - Environmental risk assessment Part 6 - Creation of the complete CSR and compliance with ECHA controls Part 7 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. People working on REACH regulations: - Regulatory affairs officer - Toxicologist - Ecotoxicologist - QHSE Prerequisites. Notions on REACH regulations. 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... +

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

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 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

I Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Biological evaluation of medical devices in accordance with EN ISO 10993-1 See sessions Contact us Training > The basics > Biological evaluation of medical devices in accordance with EN ISO 10993-1 Overview Program Audience Trainers Objectives. Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Program. Part 1 - Context of the standard in European regulations Part 2 - The fundamental principles of the ISO 10993 series Part 3 - Biological assessment using the methodology of EN ISO 10993-1 Part 4 - Case study to conclude on the conformity of the proposed biological assessment plan Part 5 - Evaluation by questionnaire Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will receive a handout. A final quiz will validate what has been learnt. To enhance online learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. DM players. Quality managers. Functions responsible for compiling technical documentation. Prerequisites. Knowledge of medical device risk classes, the EU certification process as presented in Regulation 2017/745. General knowledge of issues relating to the biocompatibility of healthcare products. Paul Fernandes Biocompatibility toxicologist 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 and is able to offer Only Representative services under REACH as well as Article 95 Representation under both the EU and UK BPR. With the assistance of locally based partners, we are also in a position to offer representative services in Korea, Russia and Turkey Market Access & Regulatory Representation for Global Suppliers Supporting manufacturers and importers under EU REACH, UK REACH, BPR, K-REACH, KKDIK and global chemical regulations. Our services Request support Only Representative & Global Regulatory Representation Services Representation enables companies to place substances on markets where they do not have a legal presence, ensuring compliance while maintaining commercial flexibility. This approach provides several benefits, including the protection of confidential business information and the ability to supply multiple customers within a country or economic area under a single registration. In the EU, this role is known as the Only Representative (OR), allowing non-EU manufacturers to appoint a qualified entity to fulfill their regulatory obligations under REACH. Similar forms of representation exist in other jurisdictions, supporting international market access and regulatory compliance. CEHTRA operates in both the EU and the UK, offering Only Representative services under REACH as well as Article 95 representation under both the EU and UK Biocidal Product Regulations (BPR). Through strong partnerships with local experts, we also provide representation services in Korea, Russia, and Turkey to support global chemical market expansion. Contact our experts Our Representation Services Ancre 1 EU REACH Only Representative / Article 95 Acting as an OR for non-EU companies to manage REACH obligations, submissions, and compliance across the EU and EEA. K-REACH Representative Assisting manufacturers with representation and compliance under Korea’s K-REACH regulations. SDS & Safety Communication Management Preparing Safety Data Sheets and ensuring proper communication of safety information to authorities and customers. UK REACH Only Representative / Article 95 Providing OR services and regulatory support for UK REACH compliance, including post-Brexit obligations. KKDIK / Turkish Representative Managing regulatory representation and compliance for substances, mixtures, and articles under Turkey’s KKDIK framework. Official Industry & Authority Communication Role Acting as the primary point of contact between companies, regulators, and industry stakeholders for all representation-related matters.

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 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+ 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

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 are the main regulatory obligations for placing a cosmetic product on the European market? In Europe, cosmetics must comply with Regulation (EC) No 1223/2009. This requires the preparation of a Product Information File (PIF), which includes a Cosmetic Product Safety Report (CPSR) authored by a toxicologist, the appointment of a Responsible Person (RP), product notification on the European CPNP portal, and compliant labelling. CEHTRA supports its clients at every stage to ensure a smooth and secure market entry. How can the safety of cosmetic ingredients be assessed? Each ingredient must be evaluated for its toxicological and ecotoxicological properties, maximum authorised concentrations, impurities, and potential interactions. CEHTRA’s experts carry out in-depth assessments including literature reviews, analysis of existing data, and the application of alternative methods to ensure the safety of formulations and their regulatory compliance. What are the risks of non-compliance with cosmetic requirements? A non-compliant product may be withdrawn from the market, expose consumers to health risks, result in regulatory sanctions, and damage brand reputation. Authorities can require rapid corrective actions or ban its commercialisation. CEHTRA helps companies anticipate these risks through strong regulatory expertise and tailored compliance strategies. 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

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

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... +

CEHTRA stands for Consultancy for Environmental & Human Toxicology and Risk Assessment. Since 2001, we provide high quality scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations. Legal This website is hosted by WIX.com Inc. 500 Terry A François Blvd San Francisco, CA 94158, USA CEHTRA - Consultancy for Environmental & Human Toxicology and Risk Assessment CEHTRA Company information CEHTRA SAS 15 rue Aristide Briand 33150 Cenon France Tel: +33 (0) 557 77 56 10 Fax: +33 (0) 557 77 56 20 contact@cehtra.com Reference : CEHTRA SAS Capital social : 16 000 € RCS Bordeaux 434 733 440 TVA FR 24 434 733 440 APE: 7490B SIRET: 434 733 440 00086 Web Hosting :ONLINE SAS B.P. 438 75366 Paris Cedex 08 www.online.net The following terms of use are applicable to the website www.cehtra.com . This website is designed for a French audience and/or people located in France however the terms of use applicable to other countries and regions around the world can vary. Website The website www.cehtra.com is a company presentation site. CEHTRA could never be held responsible for any direct or indirect damages, whatever the cause, origin or nature and consequence, ensued from the consult or use of the website. In particular, CEHTRA accepts no responsibility in case of an interruption or the inability to access the website, bugs, and any other damages arising from the fraudulent actions of third party from the website. Privacy policy - Personal data All personal data collected on the site are treated with the strictest confidentiality. We remind you that you have a right of access, modification, correction and suppression of the data which concern you (art. 34 of the law "Informatique et Libertés" of January 6, 1978). To exercise this right, please contact us. CEHTRA SAS 15 rue Aristide Briand 33150 Cenon France Tel : +33 (0) 557 77 56 10 Fax : +33 (0) 557 77 56 20 contact@cehtra.com READ MORE ABOUT DATA PRIVACY Guarantees and responsibilities CEHTRA endeavors to assure at best that the information at your disposal through the website is accurate and updated. However CEHTRA does not guarantee in any way that the information are accurate, complete and updated. CEHTRA does not insure any tacit or expressed guarantee regarding the whole or a part of the website. Intellectual property and right The website are hosted by the company CEHTRA: biocide-consulting.com cehtra.co.uk cehtra.com cehtra.eu cehtra.fr consulting-reach.com environment-consultancy.com net-reach.eu pesticide-consulting.com reach-chemical-consulting.com reach-expert.com toxicology-consultancy.com The website is an intellectual creation and is under the intellectual property laws. The whole website and each of its components (texts, schemas, software, codes, photos, drawings, logos, brands and models) are the exclusive property of CEHTRA which is the only one empowered to use the relevant intellectual property rights. Guarantees and responsibilities CEHTRA endeavors to assure at best that the information at your disposal through the website is accurate and updated. However CEHTRA does not guarantee in any way that the information are accurate, complete and updated. CEHTRA does not insure any tacit or expressed guarantee regarding the whole or a part of the website. Disputes The previous terms are stated according to the French right and in particular the measures of the law n°2004-575 of the 21st June 2004 for the trust in the digital economy and the lawi n°78-17 of the 6t January 1978 modified by the law n°2004-801 of the 6th August 2004 IT and Freedom. The jurisdictions Sainte Eulalie have the ability to know all the disputes regarding the website. Conditions Générales d’Utilisation des applications de CEHTRA Mentions légales des applications de CEHTRA

Check out latest publications contributed by CEHTRA experts Publications Biocides Cosmetics Pharmaceuticals Biocides Biocides Regulatory Updates March, 2023 Framework Guidance - Analysis of alternatives to biocidal active substances Next February, 2023 ADBAC/BKC in PT2 - Information on Approval Status Next December, 2022 Use of general terms for application frequency Next November, 2022 Update on ECHA Efficacy Guidance Next October, 2022 NEWS on Technical Agreements for Biocides (TAB) Next Cosmetics Information / Toxicological and Regulatory News April, 2022 Publication de l’avis préliminaire du SCCS sur l’alpha-arbutine et la beta-arbutine Next February, 2022 Un rapport met en évidence le manque de conformité des cosmétiques enfants Next January, 2022 Mise à jour de la liste Candidate SVHC Next December, 2021 Parution d’une recommandation scientifique du SCCS sur l’homosalate Next November, 2021 Use of trivial names for active substances in biocidal product label Next Articles March, 2022 Cosmetick, un outil développé par CEHTRA dédié à l’évaluation de la sécurité de vos produits (published in Skinobs) Next June, 2021 Safety Testing of Cosmetic Products: Overview of Established Methods and New Approach Methodologies (NAMs) (published in MDPI) Next September, 2020 What does it take to prepare a solid toxicological dossier for Cosmetic Raw Materials? (published in COSSMA) Next Cosmetics Pharmaceuticals Regulatory Updates October, 2021 Qualification d'impuretés : Modifications de la guideline ICH M7 Next Articles April, 2022 Toxicological approach to define the PDE for your cleaning validation process (published in A3P) Next Pharmaceuticals

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... +