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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. REACH Authorisation: Process, Requirements and Key Insights The REACH Regulation (EC No 1907/2006) aims to ensure a high level of protection for human health and the environment from the risks posed by chemical substances. Among its four main pillars, Registration, Evaluation, Authorisation and Restriction, the Authorisation process is often the most complex for non-specialists to understand. Yet it plays a critical role in managing the most hazardous substances on the European market. REACH AUTHORISATION Directive (EU) 2020/2184: Revision of Drinking Water Quality Standards in EU The Directive (EU) 2020/2184, adopted on December 16, 2020, marks a pivotal change in the management of drinking water across EU. It replaces the 1998 directive and aims to ensure universal access to safe and high-quality drinking water while enhancing transparency, monitoring, and risk management. This legislation has significant implications for water suppliers, industries dealing with materials in contact with water, as well as consultants and other stakeholders in the sec NEWS Proposed European Restriction on Octocrylene (CAS 6197-30-4): Scientific and Regulatory Issues Octocrylene is a widely used ultraviolet (UV) filter in cosmetic products, particularly sunscreens, designed to absorb UVB and part of the UVA spectrum, thereby protecting the skin against the harmful effects of sunlight. Currently, octocrylene is authorised in cosmetic products at a maximum concentration of 9% in accordance with Annex VI of the European Cosmetics Regulation... COSMETICS 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

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 Access toxicological and eco-toxicological profiles, assess formula safety, and speed up your time-to-market — all in one online solution. Discover Book a demo Simplify your cosmetic 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 supported by reliable toxicological profiles. COSMETICK is your all-in-one digital solution to streamline, automate, and secure your product safety compliance process. Designed for toxicologists, safety assessors, and formulators , COSMETICK supports you from formulation to market launch. The platform provides robust toxicological and eco-toxicological profiles and enables automated formula safety assessments . With advanced customization features, assessors can input their own data and easily finalize their safety conclusions. 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 Complete toxicological and eco-toxicological profiles Characterization of effects based on a bibliographic synthesis classified by toxicological endpoint Identification of no-effect doses (for irritation, sensitization, systemic toxicity) Identification of alerts using colored icons for fast, clear reading. Evaluation of cosmetic formulas Simplified formula entry and choice of product type Clear, intuitive display to facilitate decision-making (safety margin, alerts, etc.) Automatic export of a pre-filled report for customization A dynamic platform Customization of toxicological data On-line profile request in just a few clicks Regular database updates Monthly newsletter to keep up with regulatory news View all features They chose COSMETICK: Discover their feedback. "COSMETICK Advanced is a very useful tool for any cosmetic products safety assessor : all required data are gathered (very complete toxicological profils but also ecotoxicity data and regulation alerts). The tool can be used to assess the systemic risk of products ingredients and impurities. It also provides local tolerance alerts. It is very easy to use and a great help when you start working on a new project." Select the formula that fits your requirements. Access to toxicological profiles Eco-toxicological profiles Customization with confidential data Export toxicological profiles and reports Updates & regulatory newsletter Advanced Details Basic Details Need help? Here are the answers to your questions. What are the different COSMETICK licences available? COSMETICK offers two license levels tailored to your cosmetic ingredient toxicological evaluation needs: BASIC License : Provides simple and quick access to toxicological profiles of substances. ADVANCED License : Offers full access to all platform features, including the generation of toxicological pre-assessments. Each license is available in two options: Unlimited Access : Perfect for frequent use or multiple users. On-Demand Access : Flexible and cost-effective for occasional use. Need help choosing the best plan for your needs? Contact our team at cosmetick@cehtra.com . What to do if an ingredient is missing from the COSMETICK database ? Can’t find a toxicological profile in our COSMETICK database? No worries! Simply submit a request through our online form . Your request will be reviewed and, once approved, the profile will be added to the database. You can track the progress of your request directly online. We’ll notify you by email as soon as the new profile is available. Does COSMETICK generate a Cosmetic Safety Report? The report provided by COSMETICK is a pre-assessment that includes all essential data to support risk evaluation, such as: Exposure analysis based on your product’s formulation Calculation of Margins of Safety (MoS) for each ingredient Assessment of impurities , including CMR substances (Carcinogenic, Mutagenic, or Reprotoxic) Skin tolerance rationale Option to incorporate your own data (test results, specifications, etc.) This c ustomizable document helps streamline the final preparation of the Cosmetic Safety Report (Part B of the CPSR). Contact Book a demo

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 Personalized support for your cosmetic products and ingredients: regulatory compliance, pre-assessment, testing strategy, and toxicological report Our sevices Request support Simplify Cosmetic Compliance Across Europe and Beyond CEHTRA supports companies in the cosmetic industry (start-ups, SMEs, and international groups) in the safety evaluation and regulatory compliance of their products at both the European and international levels . Our experts work across a wide range of products (skincare, hygiene, fragrances, etc.), relying on comprehensive and regularly updated toxicological data, as well as alternative methods (QSAR, read-across, structural alerts) to address data gaps. Committed to a more sustainable cosmetics industry, we provide ecotoxicology services through our COSMETICK tool, a digital solution that delivers ecotoxicological profiles and alerts on environmental risks. Contact our experts Our key services in cosmetic product safety and regulatory compliance Ancre 1 Cosmetic products Pre-assessments Safety reports Ingredients under development Testing strategies In silico approaches Complementary data Intended uses Digital solutions COSMETICK Database of toxicological and ecotoxicological profiles Cosmetic formulation evaluation Data customization, alerts, and monitoring Explore COSMETICK Ingredients & raw materials Toxicological profiles Ecotoxicological profiles Identification of safe concentration levels for cosmetic uses Support for toxicological and ecotoxicological issues Tailored training Endocrine disruptor potential analysis Literature search and bibliographic review In vitro testing: analysis and guidance Data gap management through alternative methods (read-across, in silico approaches) via Simply Predict Looking for guidance on cosmetics? Find it here. What are the main regulatory obligations for placing a cosmetic product on the European market? In Europe, cosmetics must comply with Regulation (EC) No 1223/2009. This requires the preparation of a Product Information File (PIF), which includes a Cosmetic Product Safety Report (CPSR) authored by a toxicologist, the appointment of a Responsible Person (RP), product notification on the European CPNP portal, and compliant labelling. CEHTRA supports its clients at every stage to ensure a smooth and secure market entry. How can the safety of cosmetic ingredients be assessed? Each ingredient must be evaluated for its toxicological and ecotoxicological properties, maximum authorised concentrations, impurities, and potential interactions. CEHTRA’s experts carry out in-depth assessments including literature reviews, analysis of existing data, and the application of alternative methods to ensure the safety of formulations and their regulatory compliance. What are the risks of non-compliance with cosmetic requirements? A non-compliant product may be withdrawn from the market, expose consumers to health risks, result in regulatory sanctions, and damage brand reputation. Authorities can require rapid corrective actions or ban its commercialisation. CEHTRA helps companies anticipate these risks through strong regulatory expertise and tailored compliance strategies. Explore additional resources Can’t find your answer? Submit a request Enhance your regulatory strategy with our complementary services Flex+ Outsource your human resources with complete peace of mind: we find, recruit and manage your profiles, whether for one-off assignments or long-term projects. CEHTRA Training. Deepen your knowledge with our expertise. Digital Solutions. Your performance, our digital solutions. Simply Predict. In silico predictions: for faster, smarter decision-making. Endocrine disruptors. The assessment of endocrine disruptors, with rigor and method. Flex + Your projects are moving forward. We provide the resources. Haut de page

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

CEHTRA and is able to offer Only Representative services under REACH as well as Article 95 Representation under both the EU and UK BPR. With the assistance of locally based partners, we are also in a position to offer representative services in Korea, Russia and Turkey Market Access & Regulatory Representation for Global Suppliers Supporting manufacturers and importers under EU REACH, UK REACH, BPR, K-REACH, KKDIK and global chemical regulations. Our services Request support Only Representative & Global Regulatory Representation Services Representation enables companies to place substances on markets where they do not have a legal presence, ensuring compliance while maintaining commercial flexibility. This approach provides several benefits, including the protection of confidential business information and the ability to supply multiple customers within a country or economic area under a single registration. In the EU, this role is known as the Only Representative (OR), allowing non-EU manufacturers to appoint a qualified entity to fulfill their regulatory obligations under REACH. Similar forms of representation exist in other jurisdictions, supporting international market access and regulatory compliance. CEHTRA operates in both the EU and the UK, offering Only Representative services under REACH as well as Article 95 representation under both the EU and UK Biocidal Product Regulations (BPR). Through strong partnerships with local experts, we also provide representation services in Korea, Russia, and Turkey to support global chemical market expansion. Contact our experts Our Representation Services Ancre 1 EU REACH Only Representative / Article 95 Acting as an OR for non-EU companies to manage REACH obligations, submissions, and compliance across the EU and EEA. K-REACH Representative Assisting manufacturers with representation and compliance under Korea’s K-REACH regulations. SDS & Safety Communication Management Preparing Safety Data Sheets and ensuring proper communication of safety information to authorities and customers. UK REACH Only Representative / Article 95 Providing OR services and regulatory support for UK REACH compliance, including post-Brexit obligations. KKDIK / Turkish Representative Managing regulatory representation and compliance for substances, mixtures, and articles under Turkey’s KKDIK framework. Official Industry & Authority Communication Role Acting as the primary point of contact between companies, regulators, and industry stakeholders for all representation-related matters.

CEHTRA ensures the compliance of your product dossiers and families of biocidal products (BPR) and active substances. Our expertise includes risk assessment, technical equivalence, biocidal consortiums as well as the evaluation of ED properties and substances of concern (SoCs). The skilled partner for regulatory guidance in complex EU regulation for biocides CEHTRA provides expert support to help you achieve successful biocidal product and active substance compliance. Our services Request support A commitment to expert regulatory support for biocidal products and active substances: CEHTRA offers extensive expertise in the field of biocidal products and active substances according to the Biocidal Products Regulation (EU) 528/2012 (BPR). Our dedicated team has been involved in preparation of multiple active substances dossiers (Annex I inclusions), numerous submission of biocidal products through the BPR process (Union and National Authorisations), as well as product applications following national schemes (transitional regime). Whether your products are disinfectants, wood preservatives, pest control products (rodenticides, insecticides, repellents), or antifouling products, CEHTRA offers end-to-end regulatory support: from dossier preparation until authorisation. We aim for continuous regulatory monitoring and providing tailored strategic advice to our clients . CEHTRA’s exceptional multilingual, multidisciplinary team offers specialised guidance and helps companies achieve complete regulatory compliance across jurisdictions. Contact our experts Key Services Key regulatory services for biocidal products and active substance Active Substance New active substance Renewal Annex I inclusion Article 95 Listing Technical Equivalence Biocidal Product Single Product and Biocidal product families (BPF) Union/National/Simplified authorisations Same biocidal product EU R&D Notifications Group of Interest Unique approach Optimised Strategy Reduction of costs and resources Explore our consortia Related Services Testing strategy Study Monitoring Alternatives to in vivo testing Outsourcing services Flex+ Digital solution: CEHTRAWATCH Explore how we make complex regulatory landscapes clearer and easier to navigate. Discover 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 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 Course, Introduction to Packaging Regulations Introduction to packaging regulations: understanding and implementing them Know more Training, Recycled Plastics Regulations 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

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 have published a guidance and OECD has edited a guideline to help identify these substances. The criteria for identifying a substance as an endocrine disruptor are as follows: Endocrine activity: the substance must have endocrine activity. Adverse health effect: it must produce an adverse health effect. 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 Contact Try ED Pedia

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 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 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

I Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Biological evaluation of medical devices in accordance with EN ISO 10993-1 See sessions Contact us Training > The basics > Biological evaluation of medical devices in accordance with EN ISO 10993-1 Overview Program Audience Trainers Objectives. Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Program. Part 1 - Context of the standard in European regulations Part 2 - The fundamental principles of the ISO 10993 series Part 3 - Biological assessment using the methodology of EN ISO 10993-1 Part 4 - Case study to conclude on the conformity of the proposed biological assessment plan Part 5 - Evaluation by questionnaire Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will receive a handout. A final quiz will validate what has been learnt. To enhance online learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. DM players. Quality managers. Functions responsible for compiling technical documentation. Prerequisites. Knowledge of medical device risk classes, the EU certification process as presented in Regulation 2017/745. General knowledge of issues relating to the biocompatibility of healthcare products. Paul Fernandes Biocompatibility toxicologist What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I Understand the role of toxicological studies in Novel Food dossiers. Identify the types of relevant studies depending on the nature of the product. Read and interpret key data from study reports. Identify quality and compliance criteria (OECD, GLP). Efficiently manage and communicate with subcontracted laboratories. Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies See sessions Contact us Training > The basics > Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies Overview Program Audience Trainers Objectives. Understand the role of toxicological studies in Novel Food dossiers. Identify the types of relevant studies depending on the nature of the product. Read and interpret key data from study reports. Identify quality and compliance criteria (OECD, GLP). Efficiently manage and communicate with subcontracted laboratories. Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Understand the role of toxicological studies in Novel Food dossiers. Identify the types of relevant studies depending on the nature of the product. Read and interpret key data from study reports. Identify quality and compliance criteria (OECD, GLP). Efficiently manage and communicate with subcontracted laboratories. Program. Part 1 - Introduction – Context and Regulatory Framework The role of toxicological studies in Novel Food assessments EFSA requirements and relevant guidance documents When studies are required (and when they are not) Part 2 - Assessment of Genotoxic Effects Why EFSA emphasizes genotoxicity Standard studies: Ames test, micronucleus assay, chromosomal aberrations Interpretation of results and acceptability criteria Limitations and interpretation caveats Part 3 - Assessment of Systemic Toxicity Subchronic toxicity studies (90 days – OECD Guideline 408) Key concepts: NOAEL, LOAEL, adverse effects, safety margins Parameters monitored: weight, organs, blood, histopathology, etc. How to read a GLP-compliant study report Part 4 - Assessment of Reproductive and Developmental Toxicity When are these studies required? Types of studies (OECD 421/422, prenatal and postnatal development) Common data gaps and EFSA expectations Strategic considerations: justifying absence or planning studies Part 5 - Toxicokinetic Evaluation Is there a need for ADME / toxicokinetic studies? What parameters are evaluated? How do they impact toxicity studies and risk assessment? Part 6 - Oversight and Management of Outsourced Studies Best practices for overseeing subcontracted studies How to select a laboratory (GLP compliance, Novel Food experience) Key points to validate in a study protocol before initiation Communication and deliverables expected for an EFSA dossier Part 7 - Final Session – Q&A and Exchange Addressing participants’ specific questions Sharing experiences and best practices Methods used. The course is based on a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. Regulatory Affairs Managers, R&D Project Managers and Quality Managers. Prerequisites. This training course is intended for participants with a basic knowledge of molecular and cellular biology, as well as some understanding of physiology. These prerequisites are essential to ensure a good understanding of the concepts covered, particularly the mechanisms of toxic effects and the interpretation of systemic toxicity data. Marie Liamin Toxicologist - Food safety expert What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I How to navigate and enter data in IUCLID  Be familiar with the main non-technical sections of a REACH dossier and know how to complete them  Be able to proofread the technical sections of a REACH dossier  Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT Master IUCLID and register your substances under REACH See sessions Contact us Training > The basics > Master IUCLID and register your substances under REACH Overview Program Audience Trainers Objectives. How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT Place Horaire Price Language Access time Online 3h30 from 345€ (HT) French 2 months Register See sessions Objectives. How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT Program. Part 1 - Introduction to IUCLID 6 Part 2 - Preparing an IUCLID file: company-specific sections, technical sections, Chesar-IUCLID interaction Part 3 - Validation Wizard and plug-ins? IUCLID Part 4 - Dossier creation and submission on REACH IT Part 5 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. Any user of IUCLID 6 to prepare and/or submit REACH dossiers. Prerequisites. Access to IUCLID. Be familiar with the REACH regulation and its requirements. What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved  Optimising interaction between managers and experts Toxicology and Classification - the fundamentals of your regulatory success See sessions Contact us Training > The basics > Toxicology and Classification - the fundamentals of your regulatory success Overview Program Audience Trainers Objectives. Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved Optimising interaction between managers and experts Place Horaire Price Language Access time Online 14 hours from 1380€ (HT) French 2 months Register See sessions Objectives. Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved Optimising interaction between managers and experts Program. Part 1- Regulatory toxicology ? General information Part 2 - ADME (Absorption, Distribution, Metabolism, Excretion): concepts Part 3 - Acute systemic toxicology (oral, cutaneous, inhalation) Part 4 - Local skin and eye tolerance Part 5 - Skin sensitisation Part 6 - Repeated-dose and chronic toxicity Part 7 - Reproductive and developmental toxicity Part 8 - Mutagenicity and genotoxicity - Classification Part 9 - Carcinogenesis Part 10 - Introduction to non-experimental alternative methods used in toxicology Part 11 - Introduction to the determination of Toxicological Reference Values Part 12 - Introduction to human health risk assessment Part 13 - Assessment of knowledge through a final quiz Methods used. The course is based around an interactive presentation with ongoing engagement between the trainees and the expert. Trainees will be provided with the course materials. A final quiz will validate the knowledge acquired. To enhance e-learning, our courses are run in small groups, ranging from a minimum of three people to a maximum of six. Our courses are delivered through synchronous learning. Download the catalogue Audience. Employees involved in product safety. Prerequisites. None. Maurine Duplaa Toxicologist Marlène Baron Toxicologist What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

Apprendre et se tenir à jour sur les principales réglementations de votre secteur (Biocide, Cosmétique, REACH, Protection des plantes,...) The basics Learn and keep up to date on the essentials of the regulations. Our trainings Training > The basics > BIOCIDES COSMETICS ECOTOXICOLOGY FOOD MEDICAL DEVICES PACKAGING PLANT PROTECTION REACH TOXICOLOGY Ancre 1 Biological evaluation of medical devices in accordance with EN ISO 10993-1 from 690€ (HT) Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan View sessions Familiarise yourself with eSDS: obligations, content and compliance from 690€ (HT) Understand the obligations under REACH and the impact/penalties in the event of non-compliance Know how to draw up an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS View sessions How do Biocidal Product Families work? Accelerate your time to market! from 690€ (HT) Addressing the stages of an application for authorisation of a family of biocidal products : - Similarity of composition & grouping of co-formulants - Similarity of uses - Similar level of risk and efficacy Addressing the various points to be taken into account when dividing biocidal product families for current evaluations View sessions Introduction to packaging regulations: understanding and implementing them from 690€ (HT) Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) View sessions Master CHESAR to simplify your REACH assessments from 1035€ (HT) Understand the obligations under REACH How to use CHESAR to carry out a CSA (Chemical Safety Assessment) Be able to generate a CSR (Chemical Safety Report) under CHESAR Comply with ECHA expectations View sessions Master IUCLID and register your substances under REACH from 345€ (HT) How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT View sessions New ISO 10993-17 : 2023 - General and new features from 690€ (HT) Understand the methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023. View sessions Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies from 690€ (HT) Understand the role of toxicological studies in Novel Food dossiers. Identify the types of relevant studies depending on the nature of the product. Read and interpret key data from study reports. Identify quality and compliance criteria (OECD, GLP). Efficiently manage and communicate with subcontracted laboratories. View sessions Plant Protection Products: from regulation to registration from 690€ (HT) Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid View sessions Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics from 148€ (HT) Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. View sessions Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment from 690€ (HT) Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification and Risk Assessment. Be able to spot the pitfalls of studies and know how to avoid them View sessions Safer cosmetics for tomorrow - Know your regulatory obligations from 690€ (HT) Knowing and understanding Cosmetics Regulation 1223/2009 Understand the risk assessment of a cosmetic product Identify areas for improvement in order to comply with regulatory obligations View sessions What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I Addressing the stages of an application for authorisation of a family of biocidal products :  - Similarity of composition & grouping of co-formulants  - Similarity of uses  - Similar level of risk and efficacy  Addressing the various points to be taken into account when dividing biocidal product families for current evaluations How do Biocidal Product Families work? Accelerate your time to market! See sessions Contact us Training > The basics > How do Biocidal Product Families work? Accelerate your time to market! Overview Program Audience Trainers Objectives. Addressing the stages of an application for authorisation of a family of biocidal products : - Similarity of composition & grouping of co-formulants - Similarity of uses - Similar level of risk and efficacy Addressing the various points to be taken into account when dividing biocidal product families for current evaluations Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Addressing the stages of an application for authorisation of a family of biocidal products : - Similarity of composition & grouping of co-formulants - Similarity of uses - Similar level of risk and efficacy Addressing the various points to be taken into account when dividing biocidal product families for current evaluations Program. Partie 1 - Evaluation de la similarité - Assessment of similarity : - Similarité de la composition et regroupement des coformulants - Similarité des utilisations - Similitude du niveau de risque et d'efficacité Partie 2 - Division des familles de produits biocides pour les évaluations en cours - Splitting of families for on-going applications Partie 3 - 'Best practices' pour les reunions de pré-soumission - Best practices for pre-submission meeting Partie 4 - Evaluation des acquis au travers d'un quizz final Methods used. The course is based on a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. Anyone concerned by the regulations governing biocidal products. Prerequisites. Review the GMP guide before the training course (CA-July19-Doc.4.2-Final -Guidance note on GMP concept_rev2). Nathalie Hanon Head of Biocides Marie Darriet Regulatory Affairs Consultant What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I Areas: food contact, cosmetics and pharmaceuticals  Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging  Acquire an overview of the regulatory texts applicable to materials  Be familiar with the essential requirements and specific features of this legislation  Understand a container/content risk assessment (LMS) Introduction to packaging regulations: understanding and implementing them See sessions Contact us Training > The basics > Introduction to packaging regulations: understanding and implementing them Overview Program Audience Trainers Objectives. Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) Program. Part 1 - Regulatory requirements for cosmetic packaging Part 2 - Regulatory requirements for food contact packaging Part 3 - Migration principles (container-content interactions) Part 4 - Regulatory requirements for pharmaceutical packaging Part 5 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. Regulatory, Technical and Quality positions. Prerequisites. None. Caroline Optiz Head of Packaging What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

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

I Understanding regulatory procedures for active substances and products  Understanding zonal assessment and dRR dossiers  Understanding the content of dossiers and the pitfalls to avoid Plant Protection Products: from regulation to registration See sessions Contact us Training > The basics > Plant Protection Products: from regulation to registration Overview Program Audience Trainers Objectives. Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid Program. Part 1 - Regulation (EC) No 1107/2009 The main points The different procedures involved Part 2 - Zonal assessment Zonal assessment: North, Centre and South zones: similarities and differences Exchanges between the Notifier and the Competent Authorities Part 3 - Requirements - The Dossier New requirements: for which substances? for which products? Bringing an existing dossier into line with the new regulatory requirements Part 4 - Case studies Part 5 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. Regulatory Affairs Officer in charge of Products/Active Substances. Prerequisites. Scientific background. Beginner in regulatory affairs for plant protection products. Estelle Beltran Head of Plant Protection Products Steffie Segelle Regulatory Affairs Specialist What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I Understand the obligations under REACH How to use CHESAR to carry out a CSA (Chemical Safety Assessment)  Be able to generate a CSR (Chemical Safety Report) under CHESAR  Comply with ECHA expectations Master CHESAR to simplify your REACH assessments See sessions Contact us Training > The basics > Master CHESAR to simplify your REACH assessments Overview Program Audience Trainers Objectives. Understand the obligations under REACH How to use CHESAR to carry out a CSA (Chemical Safety Assessment) Be able to generate a CSR (Chemical Safety Report) under CHESAR Comply with ECHA expectations Place Horaire Price Language Access time Online 10h30 hours from 1035€ (HT) French 2 months Register See sessions Objectives. Understand the obligations under REACH How to use CHESAR to carry out a CSA (Chemical Safety Assessment) Be able to generate a CSR (Chemical Safety Report) under CHESAR Comply with ECHA expectations Program. Part 1 - Obligations under REACH with regard to CSR Part 2 - Definition and construction stages of the CSA Part 3 - Occupational risk assessment Part 4 - Consumer risk assessment Part 5 - Environmental risk assessment Part 6 - Creation of the complete CSR and compliance with ECHA controls Part 7 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. People working on REACH regulations: - Regulatory affairs officer - Toxicologist - Ecotoxicologist - QHSE Prerequisites. Notions on REACH regulations. Anna Chelle Expologist and regulatory toxicologist What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification and Risk Assessment.  Be able to spot the pitfalls of studies and know how to avoid them Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment See sessions Contact us Training > The basics > Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment Overview Program Audience Trainers Objectives. Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification and Risk Assessment. Be able to spot the pitfalls of studies and know how to avoid them Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification and Risk Assessment. Be able to spot the pitfalls of studies and know how to avoid them Program. Part 1 – Environmental data Review of useful physico-chemical parameters Study of abiotic degradation Study of biotic degradation Bioaccumulation Part 2 – Ecotoxicity Organisms used in regulatory ecotoxicology Ecotoxicity studies: methods Study principles: critical parameters Non-experimental alternative methods used in ecotoxicology Part 3 – Regulatory use of data PBT, POP, PMT evaluation Risk assessment: Principle and Derivation of PNECs from ecotoxicity studies Classification SDS (Safety Data Sheets) Part 4 – Q&A | Knowledge assessment through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. English-language support material will be provided to trainees. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. Scientists and Regulatory Affairs Managers. Prerequisites. Bac +2. Blandine Journel Senior Ecotoxicologist What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs  Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics See sessions Contact us Training > The basics > Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics Overview Program Audience Trainers Objectives. Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. Place Horaire Price Language Access time 1h30 from 148€ (HT) French 2 months Register See sessions Objectives. Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. Program. Part 1 - Regulation 2022/1616/EC - Recycled plastic articles Part 2 - FDA - No Objection Letter (NOL) - recycled plastic articles Part 3 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based on a presentation with role-playing exercises and ongoing interaction with the expert. The support material will be given to the trainees. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 8. Our courses are delivered through synchronous learning. Download the catalogue Audience. Players in the food and cosmetics packaging industry. Prerequisites. None. Caroline Optiz Head of Packaging What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I Knowing and understanding Cosmetics Regulation 1223/2009  Understand the risk assessment of a cosmetic product  Identify areas for improvement in order to comply with regulatory obligations Safer cosmetics for tomorrow - Know your regulatory obligations See sessions Contact us Training > The basics > Safer cosmetics for tomorrow - Know your regulatory obligations Overview Program Audience Trainers Objectives. Knowing and understanding Cosmetics Regulation 1223/2009 Understand the risk assessment of a cosmetic product Identify areas for improvement in order to comply with regulatory obligations Place Horaire Price Language Access time 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Knowing and understanding Cosmetics Regulation 1223/2009 Understand the risk assessment of a cosmetic product Identify areas for improvement in order to comply with regulatory obligations Program. Part 1 - Regulatory context for cosmetic products (Europe and other countries) European Cosmetics Regulation n° 1223/2009 - Scope / Borderline products - Cosmetovigilance - Management of updates Part 2 - Cosmetic product safety report - Notion of safety assessment: MoS calculation, local tolerance, etc. - Toxicological profiles of ingredients Part 3 - Specific cases - Baby products, perfumes - In silico Part 4 - Q&A I Assessment of knowledge acquired through a final quiz Methods used. The course is based on a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. R&D, Regulatory, Quality, Safety Assessors, Manufacturers, Distributors, Subcontractors, Suppliers, Importers. Prerequisites. Cosmetics regulatory affairs officer or toxicologist. Florian Gautier Head of Cosmetics What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

I Understand the obligations under REACH and the impact/penalties in the event of non-compliance  Know how to draw up an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs  Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS Familiarise yourself with eSDS: obligations, content and compliance See sessions Contact us Training > The basics > Familiarise yourself with eSDS: obligations, content and compliance Overview Program Audience Trainers Objectives. Understand the obligations under REACH and the impact/penalties in the event of non-compliance Know how to draw up an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS Place Horaire Price Language Access time Online 7 hours from 690€ (HT) French 2 months Register See sessions Objectives. Understand the obligations under REACH and the impact/penalties in the event of non-compliance Know how to draw up an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS Program. Part 1 - Actors in the supply chain Part 2 - Obligation of eSDS producers under REACH Part 3 - Key stages in the construction of the CSA/CSR Part 4 - Construction of an extended safety data sheet Part 5 - Stages on receipt of a supplier SDS: compliance objective Part 6 - Impacts/sanctions in the event of non-compliance Part 7 - Q&A I Assessment of skills acquired through a final quiz Methods used. The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Download the catalogue Audience. People working under the REACH Regulation: - QHSE - manufacturers, formulators, chemical product manufacturers Prerequisites. Notions on REACH regulations. Notions on SDS (sections 1-16). Anna Chelle Expologist and regulatory toxicologist What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. See our certificate About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

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... +

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

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