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Explore career opportunities at CEHTRA, including roles for ecotoxicologists, toxicologists, physico-chemical experts and regulatory consultants. Join our international team committed to chemical safety and apply today. Join our team at CEHTRA Explore exciting job opportunities at CEHTRA for toxicologists, ecotoxicologists, regulatory affairs experts, engineers, and more — across 10 key sectors including REACH, biocides, cosmetics, and beyond. Filter by sector Cosmetics Ecotoxicology Packaging Sales Fragrance Development Engineer M/F Packaging, Cosmetics CDD, Fixed-term contract Saint-Ouen (Paris) ASAP Apply Read more Sales Assistant M/F Customer Acquisition - Work-Study Program Sales Work-study program, Alternance Lyon, Bordeaux ASAP Apply Read more Perfume Technician in a Laboratory M/F Packaging CDD, Fixed-term contract Saint-Ouen (Paris) ASAP Apply Read more Ecotoxicologist M/F Ecotoxicology CDI, Permanent Saint-Ouen (Paris) ASAP Apply Read more Regulatory Affairs Manager Cosmetic Packaging M/F Packaging CDI, Permanent Saint-Ouen (Paris) ASAP Apply Read more Regulatory Affairs Manager Packaging-PPWR M/F Packaging CDI, Permanent Saint-Ouen (Paris), Lyon, Cenon ASAP Apply Read more Regulatory toxicologist for cosmetic products M/F Cosmetics CDI, Permanent Saint-Ouen (Paris) ASAP Apply Read more Careers at CEHTRA: What our team says Julien LEGHAIT "Working in a team with diverse points of view helps me to broaden my vision about things and allows me to take into account the elements that I wouldn’t have thought through otherwise."

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. Mentoring Tailor-made training to meet the specific needs of your company. Contact us Training > Mentoring > Tailor-made regulatory training with CEHTRA: Build skills that match your industry challenges At CEHTRA, we understand that every company faces unique regulatory challenges. That’s why we offer customised training programmes, built with you and for you, to meet your specific needs and support your teams effectively. Whether you're navigating new regulations, onboarding staff, or developing in-house expertise, our tailor-made sessions ensure your teams gain the right knowledge at the right time. Tell us about your training goals A fully personalised approach You choose the topics, technical level, language, format (on-site, remote or hybrid), and duration. We design a targeted training programme based on your industry, regulatory priorities, and learning goals. You work directly with a CEHTRA expert to fine-tune the content to your real-life business challenges. Our Areas of expertise Cosmetics. Packaging. Pharmaceutics. Toxicology. Food. Chemicals REACH. Ecotoxicology. Biocides. Medical devices. Plant Protection. 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... +

ED Pedia lets you instantly screen substances by CAS number, access regulatory insights, download PDF reports, and get expert guidance. ED Pedia: Your tool to identify Endocrine Disruptors (EDs) Check CAS numbers instantly, access ED regulatory data, download reports, and get expert guidance. Access ED Pedia Try ED Pedia Endocrine Disruptor screening tool for chemical substances With ED Pedia, CEHTRA offers a fast and reliable solution to identify potential endocrine disruptors (EDs) by CAS number. Users can explore regulatory data, download comprehensive reports, and consult experts, making chemical substance assessment simpler, faster, and fully traceable. Search by CAS Number Key features of ED Pedia: your digital tool to identify endocrine disruptors Instant CAS number screening Check if a substance is listed as a potential endocrine disruptor. Access to regulatory data Explore official hazard assessment lists and classification levels. Downloadable PDF reports Keep a clear, traceable record of your findings. Expert guidance from CEHTRA Access CEHTRA expert advice to interpret results and draw reliable conclusions when needed. Need help? Here are the answers to your questions. What is an Endocrine Disruptor? In the European Union, an endocrine disruptor is defined as a substance that interferes with the hormonal system, potentially causing adverse effects on humans and wildlife. These substances can be synthetic or natural and can affect reproduction, growth and development. In Europe, endocrine disruptors are assessed through various regulations, including those relating to pesticides and biocides and they can be classified according to CLP. EFSA and ECHA (https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5311)have published a guidance and OECD (https://www.oecd.org/content/dam/oecd/en/publications/reports/2018/09/revised-guidance-document-150-on-standardised-test-guidelines-for-evaluating-chemicals-for-endocrine-disruption_g1g938a4/9789264304741-en.pdf)has edited a guideline to help identify these substances. The criteria for identifying a substance as an endocrine disruptor are as follows: 1. Endocrine activity: the substance must have endocrine activity. 2. Adverse health effect: it must produce an adverse health effect. 3. Plausible biological link: there must be a plausible biological link between the endocrine activity and the adverse effect. How to identify Endocrine Disruptors by CAS Number with ED Pedia ED Pedia searches for CAS Numbers in lists from hazard assessment programs that identify potential Endocrine Disruptors, with different levels of concern. For a specific CAS Number, ED Pedia reports for each of the lists whether or not the substance is included. Results, especially those describing the outcome of ED evaluation other than by the relevant authorities should be taken with care, as CEHTRA – though delivering its best efforts - is not responsible and shall not be held liable for the content of the lists. How can I check if a substance is an Endocrine Disruptor? The easiest way to check if a substance may have endocrine-disrupting (ED) properties is by searching its CAS number in official regulatory lists. ED Pedia allows you to instantly screen substances against hazard assessment programs, download a PDF report, and access expert guidance to interpret the results. This helps stakeholders save time, ensure compliance, and make reliable decisions. If you need help in the interpretation of the results given by the tool, don’t hesitate to contact our expert: Julien Leghait (https://www.cehtra.com/contact) Contact Try ED Pedia

Explore CEHTRA’s webinars, conferences and regulatory events. Access expert insights on toxicology, chemical regulations and industry trends, live or on demand. CEHTRA Webinars, Conferences & Regulatory Events Restez informé des dernières évolutions, orientations et ressources en matière de réglementation des produits chimiques. All events Questions Toxicologists Asked About Cosmetic Safety Assessment – COSMETICK Webinar During our COSMETICK webinar on cosmetic safety assessment, toxicologists raised key questions on endocrine disruption, Margin of Safety (MOS), and toxicological data gaps. Mar 19 4 min read

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 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

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 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

Stay up-to-date with regulatory and toxicological changes. CEHTRAWATCH is an online platform, verified by experts, no software installation needed. CEHTRA WATCH: regulatory and toxicological monitoring for chemical substances Stay compliant with real-time alerts and customized regulatory and toxicological tracking, substance by substance. Discover Book a demo Targeted monitoring based on your substance portfolio CEHTRA WATCH is a regulatory and toxicological monitoring tool for chemical substances, designed to track regulatory changes, regulatory lists (SVHC, CLP…) and scientific data impacting your substances. Monitor only the updates that matter to your substances and relevant lists, with a platform developed by CEHTRA’s regulatory and toxicological experts. → Save time for regulatory, toxicology and R&D teams → Quickly identify changes that may impact your business Explore the lists The challenge Regulatory and toxicological updates are numerous. But not all of them affect your substances. T eams must monitor regulatory news , scientific opinions and updates across multiple lists published by various authorities. The challenge is not only accessing information, but determining whether a change actually impacts your substance portfolio. CEHTRA WATCH enables both one-off screening and continuous monitoring of regulatory and toxicological changes. Regulatory and toxicological monitoring focused on your substances Unlike general regulatory monitoring tools, CEHTRA WATCH provides portfolio-based monitoring. With CEHTRA WATCH, you can instantly analyze a single substance or an entire portfolio: import your list of substances (CAS numbers or names) track their presence across regulatory and toxicological lists automatically receive notifications when your substances are impacted This allows you to avoid: manually monitoring multiple lists reviewing irrelevant information missing critical regulatory or toxicological updates Monitoring key regulatory and toxicological lists CEHTRA WATCH monitors updates across more than 130 regulatory and toxicological lists, focusing only on information relevant to your substance portfolio. The platform enables: SVHC monitoring (intentions and Candidate List) CLP classification tracking and CLH intentions monitoring of regulatory processes (Assessment of Regulatory Needs, CORAP…) monitoring of toxicological data and scientific publications (IARC, NTP, RIFM…) monitoring of toxicological reference values (ATSDR, ANSES, Prop 65…) Covered lists include European regulations (CLP, REACH, Cosmetics Regulation), as well as key national and international lists. All updates are automatically filtered based on your substance portfolio, ensuring that only relevant changes are highlighted. Significant time savings for regulatory and toxicology teams Instead of manually monitoring dozens of lists: CEHTRA WATCH identifies relevant regulatory and toxicological changes compares list versions over time alerts you directly when your substances are affected Teams can focus their expertise on impact assessment, rather than information gathering. A digital platform supported by CEHTRA expertise CEHTRA WATCH has been developed by CEHTRA’s scientific and regulatory experts. Updates integrated into the platform are selected and validated for industrial relevance. The platform complements the expertise of your internal teams and CEHTRA consultants by facilitating the identification of regulatory and toxicological changes. How CEHTRA WATCH works 1. Instant screening of a substance For a given substance, instantly access its presence across multiple regulatory and toxicological lists. → quick identification of existing classifications and statuses 2. Portfolio screening Upload a list of substances (CAS numbers or names) and obtain a consolidated view of their regulatory and toxicological status. → prioritization of substances to monitor 3. Continuous monitoring Receive notifications when your substances are impacted by regulatory or toxicological updates. → early detection of changes impacting your activities Need help? Here are the answers to your questions. How does CEHTRA WATCH save time compared to manual regulatory monitoring? CEHTRA WATCH 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 CEHTRA WATCH help reduce compliance risks? Regulatory and toxicological changes can directly impact the use of substances. CEHTRA WATCH 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? CEHTRA WATCH 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 CEHTRA WATCH replace regulatory or toxicological expertise? No. CEHTRA WATCH 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. Contact Book a demo

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

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

Welcome to CEHTRA's window to the worldwide regulatory support. Welcome to CEHTRA cker CEHTRA's window to worldwide regulatory support CEHTRAcker Map CEHTRAcker Interactive Map Select a country in the map below to see how CEHTRA can accompany you Locations in green indicate presence of CEHTRA offices Locations in blue indicate services available via CEHTRA's trusted partners Australia The Industrial Chemicals Act 2019, administered by AICIS, came into effect on 01 July 2020 and regulates the importation and manufacture of industrial chemicals in Australia. CEHTRA provides the following services: Categorization of introduction Definition of the scope of assessment (Listed / Exempted / Reported / Assessed) Scientific expertise Data Gap analysis, Testing strategy (incl. alternatives to in vivo testing), Scientific support Dossier preparation Submission and communication with authorities thought a local partner Go back to the interactive map CEHTRAcker Austalia CEHTRAcker Canada Canada Canada’s New Substances Notification (NSN) Regulations, under the Canadian Environmental Protection Act (CEPA), are a tiered system whereby specific data schedules are submitted based on annual volumes, imported or manufactured. The Canadian Authorities evaluate this information to determine if a substance presents an unreasonable risk to human health and/or the environment. Through our office located in Toronto, CEHTRA provides the following services: NSN Notification Strategies Canadian Agent Services NSN Dossier Preparation Communication with Authorities Notification schedule selection, Datagap analysis, Testing strategies (waivers, read-across, QSAR, laboratory testing), Scientific support Acting as authorized representative for clients without a business presence in Canada Compiling and submitting required administrative, hazard, and exposure information, Preparing waiver/read-across arguments Pre- and post- notification consultation with the Canadian Authorities, Confidential DSL Inventory status inquiries Go back to the interactive map China The revised Provisions on the Environmental Administration of New Chemical Substances (MEE Order No. 12) - effective from January 1, 2021 – regulates new chemical substance registration. Through our local partners, CEHTRA can assist you with the following services: Inventory IECSC search Notification R&D notification, Record notification, Simplified and Regular Registration Post-notification Obligations Representative service Annual Report, Certificate Renewal… Go back to the interactive map CEHTRAcker China Eurasia The Technical Regulation of Eurasian Economic Union (EAEU) on Safety of Chemical Products ТR.No.041/2017, known as Eurasia-REACH, approved on March 3rd 2017, deals with the Registration, Evaluation, Authorization, and Restriction of Chemical substances. Through our local partners, CEHTRA can assist you with EAEU dossiers. Inventory Notification Service Safety Data Sheets (SDS) Nominated representative service Late pre-nomination Preparation and/or update of SDS according to the GOST standards Representation of non-Eurasian companies Go back to the interactive map CEHTRAcker Eurasia European Union Through our offices in the EU, CEHTRA can assist you with the following services: Dossier compilation & update SIEF Management Only Representative Supply-chain management Lead registrant and co-registrant dossiers testing strategy Consortium and SIEF communication, administrative and financial management of LoA Representation of non-EU companies through our Only-Representative (OR) Legal Entity and UK-REACH Obligations as EU importer, manufacturer or Downstream-User (DU), notifications to ECHA Click here to be redirected to our page dedicated to EU REACH Go back to the interactive map CEHTRAcker EU India 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. Through our office located in New Delhi, CEHTRA provides the following services: Notification/ Registration & update Safety Data Sheets (SDS) Authorized Representative (AR) service Data Management Preparation and update of Notification and Registration dossiers for individual or joint submissions Preparation and/or update of SDS in latest UN-GHS format Representation of non-Indian companies through our Indian entity Arrangement of data on substances already registered with any foreign regulator in other jurisdictions Click here to be redirected to our page dedicated to ICMSR Go back to the interactive map CEHTRAcker India Japan The Chemical Substances Control Law – referred to as CSCL – was firstly enacted in 1973 in Japan to prevent environmental pollution by chemical substances that pose a risk to human health or the environment. CSCL controls both new and existing substances. The Industrial Safety and Health Law – ISHL - was firstly enacted in 1972 to protect the safety and health of workers in workplaces in Japan. IHSL designates substances that are prohibited to manufacture or import, substances requiring permission and chemical substances requiring safety data sheets and labels. ISHL also controls new substances and requires manufacturers and importers to notify them to the Japanese Ministry of Labor and Welfare (MHLW) prior to production and importation. Through our local partners, CEHTRA can assist you with the following services: CSCL notification Standard (full) notification, Low volume notification (LVN), Small volume exemption (SVE), polymer… ISHL notification Standard notification, Low volume notification Safety Data Sheets (SDS) & Label Preparation and/or update of SDS / Label under Japanese standards Go back to the interactive map CEHTRAcker Japan New Zealand Pesticides, household chemicals and other dangerous goods and substances are regulated by the EPA (Environmental Protection Authority) under the Hazardous Substances and New Organisms Act 1996. All hazardous substances require approval in New Zealand prior to use. Depending on the substance and hazard classification, an approval may take the form of an Individual Approval or a Group Standard Approval. CEHTRA provides the following services: NZ GHS Assistance with the classification according to NZ GHS 7 Expertise Providing guidance on the most appropriate approval route Registration support Preparation of paperwork required for approval, including where necessary submission and communication with authorities. Go back to the interactive map CEHTRAcker New Zealand Philippines The Pre-Manufacturing and Pre-Importation Notification, known as PMPIN, aims to screen harmful substances before they enter the Philippine market. CEHTRA provides the following services: Dossier preparation Abbreviated or Detailed PMPIN Dossier submission Through a local partner (Abbreviated or Detailed PMPIN / SQI / PCL / CCO / Polymer) Go back to the interactive map CEHTRAcker Philippines South Korea The Act on Registration and Evaluation, etc. of Chemical Substances – referred to as “ARECs” or “K-REACH” - was implemented on January 1, 2015 by the Ministry of Environment (MOE) with the aim. of protecting public health and the environment by the registration of chemical substances. The Occupational Safety and Health Act - referred to as “OSHA” - is regulated by Ministry of Employment and Labor (MOEL), with the purpose of OSHA to maintain and promote the safety and health of workers by preventing industrial accidents and creating a comfortable working environment through establishing standards on occupational safety and health and clarifying where the responsibility lies. Through our local partners, CEHTRA can assist you with the following services: K-REACH registration KECL inventory search, registration dossiers, communication with MOE/NIER K-REACH OR Representation of non-Korean companies OSHA New Chemical MOEL’s inventory search, dossier preparation, communication with MOEL OSHA GHS GHS classification and preparation of GHS MSDS & Label Go back to the interactive map CEHTRAcker South Korea Taiwan Chemical regulation in Taiwan is covered by the EPA’s Regulation of New and Existing Chemical Substances Registration (Dec 11, 2014 - amended 2019) and the MOL’s Regulation of new chemical substances registration (Jan 1, 2015). Through our local partners, CEHTRA can assist you with the following services: Expertise Identification of regulatory obligations Registration Small Quantity, Simplified and Standard Registration CBI application Post-submission Obligations Annual Reporting Go back to the interactive map CEHTRAcker Taiwan Turkey The regulation Kimyasallarin Kaydi Degerlendirmesi Izni ve Kisitlamasi, known as KKDIK, published on 23rd June 2017 deals with the Registration, Evaluation, Authorization, and Restriction of Chemical substances. Through our local certified partners, CEHTRA can assist you with KKDIK dossiers. Dossier preparation Preparation of registration dossiers for individual or joint submissions SIEF management Safety Data Sheets (SDS) & Label Only representative service Consortium and SIEF communication, administrative and financial management Preparation and/or update of SDS / Label in Turkish language Representation of non-Turkish companies Go back to the interactive map CEHTRAcker Turkey CEHTRAcker UK United Kingdom The Brexit transition deadline of 31 December 2020 is fast approaching and it is vital that companies ensure that they remain compliant beyond this date. CEHTRA team remains available to answer any queries you may have to ensure you are compliant with the new regulatory framework which will apply from 1st January 2021. Through our offices located in the UK and the EU, CEHTRA can assist you with the following services: UK REACH Registration and OR UK REACH OR Consortium Management Click here to get redirected to our page dedicated to Brexit Go back to the interactive map CEHTRAcker USA USA The Lautenberg Chemical Safety Act (LCSA) was signed into law in 2016 to modernize the Toxic Substances Control Act (TSCA). New chemicals are still registered under the Premanufacture Notice (PMN) rules, but now the EPA conducts a risk-based review and must make an affirmative safety determination before they can be imported or manufactured. The LCSA empowers the EPA to request more up-front test data and information to characterize hazards, uses, releases, exposure scenarios, etc., meaning that more knowledge and effort is required to achieve a successful registration than ever. CEHTRA provides the following services: US PMN Strategies TSCA Inventory List status, Datagap analysis/Data quality check, CA chemical name and CAS RN assignment/proof assurance. LCSA Exemption Support PMN Submissions PMN Technical Contact Support Polymer Exemption qualification assessments, Low Volume Exemption applications, R&D/TME/LoREX support Compilation of PMN Form and supporting documentation in e-PMN/CDX, Sustainable Futures modelling Pre-Notice Consultation, Post- submission review support including consent orders and other EPA regulatory actions Go back to the interactive map

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 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

COSMETICK : l’outil digital tout-en-un pour l’évaluation toxicologique et la sécurité des produits cosmétiques. Profils toxicologiques, éco-toxicologiques, calculs de marges de sécurité (MoS) et préparation du RSPC (CPSR) en quelques clics. COSMETICK: the digital tool for cosmetic compliance and safety A digital solution dedicated to cosmetic risk assessment, integrating structured cosmetic toxicological profiles, the calculation of Margins of Safety (MOS) , and the preparation of Cosmetic Product Safety Reports (CPSR) to ensure regulatory compliance for cosmetics. Discover Book a demo Simplify your cosmetic regulatory compliance with COSMETICK The cosmetics industry faces strict regulatory requirements — especially in Europe under Regulation (EC) No. 1223/2009 , which mandates a Cosmetic Product Safety Report (CPSR) supported by reliable toxicological profiles. COSMETICK is a toxicological database dedicated to cosmetics, combined with a digital cosmetic safety assessment tool. It provides access to structured cosmetic toxicological profiles, enables exposure assessment, supports the calculation of Margins of Safety (MOS), and generates structured documentation to support the preparation of the Cosmetic Product Safety Report (CPSR) in accordance with the EU Cosmetic Regulation. Developed by regulatory toxicologists, COSMETICK supports cosmetic regulatory compliance through a clear and traceable hazard × exposure methodology. Improve efficiency, reduce error risk, and ensure product safety with confidence. Test the substance profile search Key features of COSMETICK: your toxicological assessment tool for cosmetic products A dedicated toxicological database for cosmetics: comprehensive toxicological and ecotoxicological profiles Characterisation of toxicological effects based on structured bibliographic review by endpoint Identification of no-effect levels (NOAELs and reference values) relevant for Margin of Safety (MOS) calculation Integration of key data required for cosmetic safety assessment and CPSR preparation Visual warning system using colour-coded indicators for rapid and structured interpretation For cosmetic formula safety assessment: Margin of Safety (MOS) calculation and CPSR preparation Simplified formula input with product type selection (leave-on / rinse-off) Automated calculation of Margins of Safety (MOS) based on exposure assessment and toxicological profiles Clear regulatory decision-support interface (MOS values, warnings, alerts) Export of a structured pre-filled document to facilitate preparation of the Cosmetic Product Safety Report (CPSR) A dynamic platform supporting cosmetic regulatory compliance Customisation of cosmetic toxicological profiles according to your assessment needs Online submission of new profile requests in just a few clicks Regular updates of the toxicological database Continuous integration of regulatory developments impacting ingredient safety Monthly newsletter dedicated to cosmetic safety and regulatory compliance updates View all features Why users rely on COSMETICK 🧪 Data Reliable profiles ⚖️ Decision Consistent assessments ⚡ Efficiency Faster workflows Select the formula that fits your requirements. Access to toxicological profiles Eco-toxicological profiles Customization with confidential data Export toxicological profiles and assessment reports (pre-CPSR) Updates & regulatory newsletter Advanced Details Basic Details They trust us. Need help? Here are the answers to your questions. What are the different COSMETICK licences 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.(mailto: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 Safety Report (CSR) and safety margins? 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. Contact Book a demo

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

CEHTRA provides regulatory, toxicology and risk assessment expertise for the chemical, biocides, PPP, cosmetics, pharma, food industries, ... Your partner in regulatory compliance and product safety Simplify your regulatory compliance with our expertise and innovative tools. Our sectors Contact us Nos programmes Recognized expertise in Regulatory Affairs and Risk Assessment For over 25 years, CEHTRA has been supporting chemical industry players across key strategic sectors. We assist manufacturers, formulators, distributors, and importers in areas including industrial chemicals (REACH), biocides (BPR), plant protection products (PPP), cosmetics, pharmaceuticals, and food products, including novel foods & supplements, as well as packaging, and other sectors related to health, environmental protection, and product safety. Thanks to our multidisciplinary expertise in toxicology, ecotoxicology, risk assessment and international regulations, we offer tailor-made solutions adapted to the specific requirements of each market, both within and outside Europe. Contact an Expert Our Areas of Expertise biocides Explore chemicals Explore cosmetics Explore food Explore packaging Explore pharmaceuticals Explore plant protection Explore all Explore Digital Solutions for Regulatory Affairs & Toxicology Your performance, our smart solutions. BPR Water Treatment Guidance: ECHA/EFSA Requirements for Drinking Water In August 2023, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) jointly published a landmark guidance document on the impact of water treatment processes on residues of active substances in water abstracted for drinking water production (EFSA Journal, doi: 10.2903/j.efsa.2023.8194). BIOCIDES Draft 24th ATP to CLP: Substances Industry Should Start Monitoring Now The draft 24th Adaptation to Technical Progress (ATP) to the CLP Regulation (EC) No 1272/2008 proposes a significant number of new harmonised classifications that could affect chemical substance portfolios across several industrial sectors. DIGITAL SOLUTIONS Regulatory Convergence between the Drinking Water Directive (EU 2020/2184) and the Biocidal Products Regulation (BPR) The sanitary safety of drinking water in the EU is primarily based on an increasing synergy between two legislative pillars: Directive (EU) 2020/2184 (Drinking Water Directive), which constitutes a revision of the pre-existing Directive 98/83/EC, and Regulation (EU) No 528/2012 (BPR). TOXICOLOGY 1 2 3 4 5 Need guidance? Speak with our specialists Select a sector:* First name:* Last name:* Company or Organization:* Email:* How can we help you? Submit

egulatory support for food and nutraceutical products: safety, compliance, authorizations, and formulation with CEHTRA. Food supplement formulation, safety assessment, and regulatory guidance Supporting your food and nutraceutical products from safety assessment to market authorization. Our services Request support Ensuring safety and compliance for innovative food ingredients Bringing food and nutraceutical products to market requires a firm guarantee of safety for the end consumer. We support industry players at every stage of ingredient and finished product development, whether for human or animal consumption. From scientific safety validation to the preparation of comprehensive regulatory dossiers and applications for innovative ingredients, our expertise helps you streamline and secure your processes. Our multidisciplinary team of toxicologists, chemists, ecotoxicologists, and in silico analysis specialists combines complementary skills to turn your innovations into compliant, reliable products ready to succeed in the market. Contact our experts Key regulatory services for food and nutraceutical products Ancre 1 New products authorisation Comprehensive support for Novel Foods, NDI, and GRAS dossiers. Guidance on the authorization of GMO products and food/feed additives. Preparation and submission of food and feed authorization applications (EU, USA, UK). Management of communications and follow-up with regulatory authorities. Comprehensive safety dossier Preparation of justification dossiers (dose exceedance, absence of labeling, etc.). Safety evaluation of ingredients, substances, additives, and finished products. Expert support on safety topics: endocrine disruption, NAMs, in silico analysis, etc. Support in establishing safety evaluation strategies for raw materials and finished products. Risk Assessment Risk analysis via dietary exposure (contaminants, active substances, bioactive compounds, etc.). Risk assessment for target populations and species. Formulation Support Assistance in formulating finished products. Safety evaluation of candidate ingredients from the early stages of formulation. Preparation of safety reports for selected ingredients. Event, Novel Food training Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies Know more Looking for guidance on food supplements? Find it here. How can innovative food and feed products obtain regulatory approval? Innovative food and feed products must obtain regulatory approval before commercialization, which requires demonstrating their high-quality and safety. This involves developing a robust safety assessment strategy to identify and address all potential risks associated with the consumption of these innovations for the relevant populations or species. Our team of experts supports companies throughout the entire process, from defining the toxicological assessment strategy and preparing dossiers to submission and ongoing communication with authorities, ensuring that innovative products reach the market efficiently and safely. What safety dossiers are required for food supplements? Bringing food and nutraceutical products to market requires ensuring their safety for consumers. Safety dossiers are therefore essential to demonstrate the safety of ingredients, substances, additives, and/or finished nutraceutical products. These dossiers rely on toxicological data or in silico analyses and provide scientific justification when required by regulations (for example, in cases of dose exceedance or absence of labeling). We prepare comprehensive safety dossiers tailored to regulatory requirements to support the successful and compliant introduction of your products to the market. At what stage of product development should safety evaluation begin? Safety evaluation should start as early as possible in the product development process. Early assessments help identify potential safety concerns, guide formulation choices, and ensure alignment with regulatory requirements, saving both time and resources when moving toward market approval. Our team can support you throughout this process to secure a smooth and compliant product development pathway. Explore additional resources Can’t find your answer? Submit a request Enhance your regulatory strategy with our complementary services CEHTRA Training. Deepen your knowledge with our expertise. Digital Solutions. Your performance, our digital solutions. Simply Predict. In silico predictions: for faster, smarter decision-making. Flex + Your projects are moving forward. We provide the resources. Endocrine disruptors. The assessment of endocrine disruptors, with rigor and method. Haut de page

CEHTRA ensures the regulatory compliance of your packaging. Our experts can assist you with your declarations of conformity and with the risk assessment of your products. Our offer extends to laboratory testing, migration modeling and toxicological expertise. Packaging regulatory compliance and safety expertise for global markets Helping you ensure safe and compliant packaging, worldwide. Our services Request support Comprehensive regulatory services for safe and compliant packaging Ensuring the safety and compliance of packaging materials is a major challenge for industries such as food, cosmetics, pharmaceuticals and medical devices. Our team of experts supports manufacturers, suppliers and users of packaging with tailored regulatory and toxicological services. From tracking international packaging regulations and restricted substances to staying ahead with safety and environmental watch, migration modeling, supplier data collection and laboratory testing, we help ensure your packaging materials meet global compliance requirements. With over a decade of experience in packaging safety, we provide practical and cost-effective solutions to secure your products and protect consumers. Contact our experts Key regulatory services for packaging materials Ancre 1 Regulatory, Safety & Environmental Watch (Europe, USA, China) Monitoring packaging regulations Tracking restricted substances and toxicological risks Surveillance of new recycling technologies Continuous follow-up of evolving environmental regulations Regulatory and compliance support Collection and assessment of supplier data for packaging compliance Drafting and review of specifications and regulatory documentation Preparation and verification of declarations of conformity (DoC) Guidance on specific regulatory topics and global compliance support Coordination and follow-up of laboratory testing Migration modeling and risk assessment Evaluation of interactions between packaging and contained products (food and cosmetics) Migration and extraction studies through calculation and mathematical modeling Predictive modeling to reduce unnecessary and costly laboratory tests Multi-market expertise Packaging regulatory support for the food secto Expertise in cosmetics packaging and product interactions Compliance services for environmental regulations Packaging Regulations Webinars and Training Keeping up with evolving packaging regulations is essential for companies placing products on the market. Our webinars and training sessions help professionals understand key regulatory requirements, anticipate upcoming changes, and ensure compliance across their packaging portfolios. Led by regulatory experts, these sessions cover topics such as EU packaging legislation, Extended Producer Responsibility (EPR), eco-design requirements, and labeling obligations, providing practical insights to support effective regulatory strategies Free PPWR Webinar: Understanding the Packaging and Packaging Waste Regulation Know more Introduction to packaging regulations:understanding and implementing them Know more Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics Know more Looking for guidance on packaging compliance? Find it here. How can I ensure packaging safety and compliance with international regulations? Ensuring packaging safety starts with understanding global regulatory requirements. Our experts help review declarations of compliance, draft specifications, and monitor regulations across EU, USA, China, Switzerland, and Mercosur. By combining document assessment, supplier data collection, and risk evaluation, we provide practical guidance to keep your packaging materials safe and compliant worldwide. How can I ensure packaging safety for food contact materials? Ensuring the safety of food contact packaging requires compliance with specific regulations and careful material assessment. Our experts evaluate substances, perform risk assessments, and monitor interactions between packaging and food. We also guide you through documentation, declarations of compliance, and migration modeling to guarantee that your packaging is safe, compliant, and suitable for food applications. What does the new PPWR regulation mean for packaging compliance? The Packaging and Packaging Waste Regulation (PPWR) sets strict requirements for packaging design, recyclability, and material safety across the EU. Our experts help manufacturers and suppliers understand PPWR obligations, assess packaging safety, and implement compliant solutions. We provide guidance on restricted substances, documentation, and material selection to ensure your packaging meets regulatory requirements while supporting sustainability goals. 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 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 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.(mailto: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 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

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 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? Find it here. 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

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."

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."

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."

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."

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."

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."