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

Already have a PRIMO account? Click here Unlock the power of Cloud Technology to manage your Worldwide Registrations … Introducing A CEHTRA-designed tool dedicated to your regulatory compliance What is PRIMO? PRIMO stands for Principle Regulatory Information Management Organizer . PRIMO has been designed by our regulatory and IT experts to keep you up-to-date with regulatory compliance information for your projects. A CEHTRA designed tool to allow: Sharing and secure storage of data Simultaneous access for client and CEHTRA Project management and planning Global regulatory data gap analysis to assist in designing testing strateries for all markets Project Management ✓ Allows members an overview of the status of their projects ✓ Track the progress of your projects (Gantt) ✓ Assign tasks and follow-up Working Documents ✓ Data Gap Analysis (DGA) ✓ Country-specific support for DGA based on country specific requirements ✓ Study Monitoring Dashboard Data Storage ✓ Secure sharing and storage of your data ✓ Easy upload and download of documents ✓ Exchange of large files Two licence options PRIMO Basic PRIMO Ultimate under development to best suit your needs Basic Ultimate Client Access* Upload/download documents Create/modify registration dossiers Create Tasks Track work progress (Gantt Chart) Access to country-specific DGA Access to country-specific support for DGA preparation Access to other clients' consultants Read-only ✓ Read/write ✓ ✓ ✓ Read-only Read-only ✓ Read/write Read/write ✓ ✓ * CEHTRA offers a free access to PRIMO Basic to all its clients. Media Flyers Access PRIMO Already have a PRIMO account? Click here to access Request a demo today! Drop your queries to: primo@cehtra.com ​ or leave your messages on Let's Chat window below Acknowledgements Our project « Chèque transformation Numérique » has received a grant from the European Union under the FEDER-FSE Aquitaine 2014-2020 operational program.

Top of the page Description PLANT PROTECTION Description Contact Key Services Biocontrol Value-added Trainings Media As a manufacturer or a distributor in the field of agriculture, you want to get your substances approved efficiently and get your Plant Protection Products on the market. From Data Gap Analysis through to the dossier submission to the competent authorities, CEHTRA's team supports you in the necessary steps to meet the current regulatory requirements, for a successful registration. Contact Meet our experts Estelle BELTRAN Head of Plant Protection estelle.beltran@cehtra.com Blandine JOURNEL Expert Ecotoxicologist blandine.journel@cehtra.com Key Services Value-added Key Services Regulatory Dossiers From registration strategy up to the post-submission defense Data Gap Analysis Testing proposal Study monitoring Hazard identification Scientific rationale Risk Assessment Toxicology Consumer Environment Ecotox Modelling and refinement Task Force Management Management support to facilitate joint applications in the EU and abroad Value-added Services Endocrine Disrupting Properties CADDY and IUCLID dossiers Biocontrol Diagnostic Fertilizers and Biostimulants Environmental Screening Tailored studies (operator, field) Authorization of formulated products (including North and South America) Trainings Trainings A venir Produits de Protection des Plantes : de la réglementation à l'homologation en savoir plus s'inscrire 16 Nov. 2023 Toxicologie et Classification - les fondamentaux de vos succès réglementaires en savoir plus s'inscrire 16 Oct. 2023 Ecotoxicologie réglementaire : De la conduite appropriée des études à l'évaluation du risque pour l'environnement en savoir plus s'inscrire Media Flyers Media Haut de page

How likely is it for my substance to be an Endocrine Disruptor ? Enter the CAS number >> Get results >> Download report Try it now! What is ED Pedia? ED Pedia allows any stakeholder of a substance (a) to check instantaneously whether this substance likely has, or not, ED properties, (b) to access instantaneously to the relevant documentation, (c) to download a PDF report on the findings and ( d) if needed, to access CEHTRA expert advice to draw conclusions from the report. Access ED Pedia What is an Endocrine Disruptor? According to the WHO definition 2002, an Endocrine Disruptor (ED) is 'an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse effects in an intact organism, or its progeny, or (sub)populations'. ​ This definition is used to identify Substances of Very High Concern (“SVHC ”) for human health and/or the environment due to their endocrine disrupting properties under the REACh (Registration, Evaluation, Authorization and restriction of Chemicals) legislation (European Parliament and Council of the European Union, 2006). ​ A definition of endocrine disruptors for substances in plant protection and biocidal products was adopted in 2017 at European level (EU Regulations 2017/2100 and 2018/605 ) (European Commission, 2017, 2018). ​ In 2018, a guidance document was published by the European Food Safety Authority (EFSA) for the identification of endocrine disruptors (EFSA, 2018). Several other agencies and public programs also focus on this issue. How does ED Pedia work? ED Pedia searches for CAS Numbers in lists yield from hazard assessment programs that identify potential Endocrine Disruptors, with different levels of concern. For a specific Substance 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 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. Media Videos Flyers Useful information for ED Pedia users Terms of use | Legal | Data privacy What is an ED?

Biocontrol Biocontrol solutions are unmissable alternatives to chemical plant protection products in the context of agriculture evolution towards better mastery of food quality. Biocontrol involves macro-organisms, micro-organisms, semiochemicals (such as pheromones) and substances of natural origin (mineral, animal, plant). CEHTRA prepares regulatory compliance dossiers for biocontrol solutions (excluding macro-organisms), prior to their possible use in Organic Agriculture, and supports manufacturers in the early stages of development of these new solutions. Estelle BELTRAN Head of Plant Protection estelle.beltran@cehtra.com is identified for Biocontrol Diagnostic You are A French SME Developing a new biocontrol product Needing the feasibility of your project CE HTRA provides Preliminary studies of product characterization and efficacy Bibliographic search Data Gap Analysis Laboratory studies and field trials Our coll aboration leads to Keen understanding of substance definition and claim of use State-of the-art of published scientific knowledge Optimised testing strategy Regulatory compliant data

Top of the page INDUSTRIAL HYGIENE Description Contact Key Services Value-added Trainings Media CEHTRA's industrial hygienists have decades of experience working with clients in their industrial sites and manage Environmental, Health and Safety challenges with a well balanced mix of technical expertise and practical experience. CEHTRA's track record in multi-disciplinary risk assessment and modelling applies well to real world situations involving chemical substances: ever since its creation, CEHTRA has designed and conducted EHS audits, and advised management at countless sites in virtually every sector of the chemical industry and services. Click here to learn more... New ! Quickly assess your level of compliance with Chrome VI handling Description Contact Meet our experts Guillaume MOUSSETTE Head of Industrial Hygiene guillaume.moussette@cehtra.com Stephane PIERRE Managing Director of Paris Agency stephane.pierre@cehtra.com Key Services Exposure Scenarios Specific characterisation of the risk linked to the handling of the chemical agent with CHESAR and other tools Chemical safety Reports ​ Refining approaches used in the CSR to guarantee safe use and worker protection On-site audits Ensure compliance with eSDS or authorization / restriction requirements (Operating Conditions and Risk Management Measures) On-site consulting service General Chemical risk management (HSE) Chemical agents are classified according to their hazard level. An inventory of the uses of the chemical agents feeds the exposure assessments via Exposure Scenarios, which enables the characteriation of the risk linked to the handling of the chemical agent. We base our evaluation on the Exposure Scenarios written in the Chemical Safety Report and the Safety Data Sheets that will accompany the chemical agent on the Downstream Users premises. Key Services Value-added Value-added Services Exposure and health risks at your working stations Digital dashboard Training modules for specific company needs Trainings Trainings 25 Oct. 2023 Familiarisez-vous aux FDSe : obligations, contenu et conformité en savoir plus s'inscrire Media Flyers Media Related Sectors Chemicals (REACH) Global Notifications REACH Authorisation Haut de page

EU POISON CENTER NOTIFICATION (PCN) Annex VIII to CLP regulation was released in March 2017 to harmonise the variations between poison centre notifications among members states and the new harmonised system became effective from January 2021 (extended from January 2020). ​ Importers and downstream users placing hazardous mixtures (with a health and/or physical effect classification) on the EU market are to provide specific information on your mixtures to the centralized EU poison centre before placing theses mixture on the market. ​ They will have to: ​ Register a unique formula identifier (UFI), Include the UFI on the label for professional and consumer use, Include the UFI in section 1.1 of the Safety Data Sheet (SDS) for industrial use. Provide and submit to the ECHA harmonised submission portal: ​ The full chemical composition of the mixture Toxicological information of the mixture (SDS Section 11) Product category (according to the new EU product categorization system EUPCS) The safety data sheet and label in the country’s language The UFI (a 16-character alphanumeric code that uniquely identifies a formula (mixture composition) in the EU and can be generated on the UFI generator ECHA created) ​ The obligation lies with EU Legal entity (non-EU supplier of the mixture cannot replace the EU-based duty holder). A duty holder can entrust a third party (e.g. CEHTRA) to complete the PCN on their behalf. ​ Importers and downstream users placing mixtures on the market not already notified under national legislation must comply with Annex VIII of the Regulation from the following dates: ​ Hazardous mixtures for consumer and professional use: January 1, 2021 Hazardous mixtures for industrial use: January 1, 2024. If the mixture is already on the market and already notified to the local poison centre of the Member State, the date of compliance is 1st January 2025. As an Importer or a downstream user placing hazardous mixtures (with a health and/or physical effect classification) on the EU market you need to provide specific information on your mixtures to the centralized EU poison centre before placing these mixtures on the market – known as PCN notification/s. CEHTRA can support as a third party representative to assist in these requirements. Meet our expert Stephane PIERRE stephane.pierre@cehtra.com Key Services Portfolio Review Review Safety data sheets and labels Prepare and submit PCN notification Screen your Portfolio to identify mixtures that require PCN and notification deadlines Full compliance review of SDS and labels Screen for full notification information and generate UFI codes Regulatory support Offer regulatory advice on how best to fulfill obligations Media Flyers Related Sectors Biocides Chemicals (REACH) Plant Protection

Top of the page REACH AUTHORISATION Description Contact Key Services Value-added Trainings Media REACH Authorisation is a European risk management measure which aims to limit human and environmental exposure to substances considered of very high concern. All the users in terms of REACH definition (formulators, importers, downstream users) of one of the Annex XIV substances in Europe must carry out an Authorisation dossier to continue to be able to use the substance in question. CEHTRA's team is experienced and the entire dossier is done in-house, from the exposure estimation to the assessment of socio-economic impacts. Meet our expert Stephane PIERRE Head of REACH Authorisation stephane.pierre@cehtra.com Description Contact Key Services Key Services Complete Authorisation dossier Drafting the whole dossier in coherence (CSR, AoA, SEA) Advocacy Protect your interest (regulatory watch, supply chain securisation, public consultation...) Conformity Toward the Authorisation or restriction obligation Prioritisation/ Anticipation Anticipate the regulatory obligation based on the hazard for your substance portfolio Value-added Services All the dossier parts are performed internally Several dossier submitted with success Member of the NerSAP(Network of REACH SEA and Analysis of Alternatives practitioners) Tox / Ecotox hazard assessment based on SVHC properties Regulatory scoring based on the supporting information Draft the Analysis of Alternatives based on client’s data Value-added Trainings Trainings 11 Oct. 2023 Maîtrisez CHESAR pour simplifier vos évaluations REACH en savoir plus s'inscrire 25 Oct. 2023 Familiarisez-vous aux FDSe : obligations, contenu et conformité en savoir plus s'inscrire A venir Maîtrisez IUCLID et enregistrez vos substances sous REACH en savoir plus s'inscrire Media Flyers Podcasts Media Related Sectors Chemicals (REACH) Haut de page

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

Top of the page PHARMACEUTICALS (Human & Veterinary) Description Contact Key Services Value-added ERA Trainings Media For the safety of your pharmaceutical and veterinary substances & products CEHTRA can assist you with: Safety of your drug substances and drug products: development and regulatory submissions. Safety of your drug production (PDE, OEL/OEB, impurities qualification) Generation of Environmental Risk Assessment (ERA) for your MAA dossier Description Trainings Meet our experts Stephane PIERRE Head of Pharmaceuticals stephane.pierre@cehtra.com Blandine JOURNEL Senior Ecotoxicologist, ERA blandine.journel@cehtra.com Key Services PDE and OEL/OEB Calculations Safety Qualification of Impurities Safety assessment of drug production and workers on site (PDE, OEL/OEB) Safety qualification of impurities in drug substances or products (ICH and VICH guidelines) Preclinical Expertise Development plan, study monitoring, writing regulatory dossiers (CTA, MAA...) Environmental Risk Assessment Entire ERA part of the MAA is covered (dossier preparation, study monitoring, defense with authorities…) Value-added Services Trainings QSAR support using Nexus DEREK and Leadscope Data and bibliographic analysis Toxicologist and Ecotoxicologist team (as well as QSAR expert) Dossier Defense Regulatory Watch Contact Key Services Value-added Related Trainings 10 Oct. 2023 Initiation aux règlementations pour les emballages : les comprendre et les mettre en œuvre en savoir plus s'inscrire Media Videos Flyers Media Related Sectors Biocides Chemicals (REACH) Cosmetics Industrial Hygiene Packaging Haut de page

Top of the page PACKAGING Description Contact Key Services Value-added Trainings Media As a manufacturer, user of packaging or supplier for packaging manufacturing, you are facing regulatory issues? ​ For the safety of your packaging substances & products, our team of expert with over a decade of experience can assist you with : ​ Study of your documentation: declaration of compliance, regulatory statements Compliance of restricted substances thanks to an internal tool using mathematic modeling Monitoring of analysis with external laboratories Evaluation of worldwide regulatory requirements​ for packaging Click here to learn more... New ! Stay Ahead of Substance Migration with SF PP3 and CEHTRAPACK Tools ! Description Contact Meet our expert Caroline Opitz Head of Packaging caroline.opitz@cehtra.com Stephane PIERRE Managing Director of Paris Agency stephane.pierre@cehtra.com Key Services Regulatory / safety watch Customized text list Toxicological and regulatory substance watch Mapping by material / geographical area Regulatory / safety support Collection of supplier data Specifications Declarations of conformity Specific topics Global support Conduct of laboratory tests Multi-market support Food Pharmaceutica Medical Cosmetics Migration modeling Interactions between packaging and contained products: cosmetics and food By calculation By mathematical modeling Risk assessment of various materials : plastics, papers and boards, adhesives, inks, varnishes, metals, glass… Regulatory support on international regulations relative to food contact : EU, USA, Switzerland, China, Mercosur… Editing regulatory specifications and collecting informations from suppliers, documentary diagnosis, help in creation of Declaration of Compliance Compliance of restricted substances thanks to an internal tool using mathematic modeling, advices and monitoring of external lab tests when necessary Pragmatic approach to avoid expensive migration or extraction testsExpertise toxicologique Toxicological expertise Food contact courses We adapt our offer to the customer’s need Key Services Value-added Value-added Services Training offer Regulatory watch Regulatory and toxicological support Dedicated suppor t Packaging data management Migration / release assessment tools Trainings Trainings 10 Oct. 2023 Initiation aux règlementations pour les emballages : les comprendre et les mettre en œuvre en savoir plus s'inscrire 13 Oct. 2023 Des cosmétiques plus sûrs pour demain - Connaissez vos obligations réglementaires en savoir plus s'inscrire Media Flyers Media Related Sectors Cosmetics Industrial Hygiene Haut de page

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

Top of the page MEDICAL DEVICES Description Contact Key Services Value-added Trainings Media Patient safety is at the center of our concerns. Speed up your time-to-market is essential to fulfill this goal. Whether you are a legal manufacturer of medical devices, a subcontractor or a supplier, CEHTRA supports you throughout the life cycle of your medical device, from design to post-marketing follow-up, including CE marking. We provide our independence and expertise in biological risk assessment to demonstrate the biological safety of your device. The transversality of our expertise in sectors such as pharmaceuticals, biocides, cosmetics and chemicals (REACH) enables us to provide you with the most detailed support. Our expertise includes the Devices without an intended purpose, the borderline products Description Contact Meet our experts Pierre-Yves JOYEUX Head of Medical Devices sector pierre-yves.joyeux@cehtra.co m Imen HAMDOUNI Toxicologist imen.hamdouni@cehtra.co m Key Services Biological Safety Regulatory Support Quality Management Chemicals (REACH) To guarantee the biocompatibility of materials and substances of medical device To ensure compliance with regulatory requirements throughout the life cycle of medical devices ​ To guarantee regulatory compliance based on regulatory requirements and EN ISO 13485 To ensure that the products that are part of your processes comply with REACh regulations Biological Safety ​ ​ Assessment of the biological risk associated with a product or material Evaluation and testing within a risk management process standard (EN ISO 10993-1:2020) and the MD Regulation Review of predicates, materials, processes and components to inform manufacturer of known and potential biological and toxicological hazards and regulatory implications. Establishment of allowable limits for leachable substances (EN ISO 10993-17) Chemical characterization of medical device materials within a risk management process (EN ISO 10993-18) Recommendation of control measures to reduce risk, whether through testing or by establishing the safety of materials and processes. ​ ​ Regulatory Affairs Support ​ ​ General regulatory support: Need an answer? A problem to assess? Need advice on how to respond to the Notified Body on a biosafety issue? Crisis management support: To help to prepare or develop an effective response before or after receiving an inspection notification from the competent authority, or a warning letter. To help to prepare an effective response to Nonconformity from notified bodies Modification evaluation support: Evaluation of the impact of a modification on the biocompatibility of the material/medical device Mentoring to assist the manufacturer in the characterization of the modification ​ ​ Quality Management ​ ​ Internal audits : Based on Quality management system standard (ISO 13485) & MDR ​ Mentoring: To assist on set up a QMS, we make ourselves available to challenge your system. ​ PRRC ( Person responsible for regulatory compliance ) Possible to externalize this function for specific SMEs manufacturers ​ Chemicals (REACH) ​ ​ Registration of chemical substances to meet the requirements of the REACh regulation Authorization: prohibited substances for which an authorization of use can be set up Monitoring of hazardous substances (SVHC, restricted substances, endocrine disruptors,...) Your tailormade Safety Data Sheets (SDS) Value-added Services Global and transversal approach Data and bibliographic analysis for Biological Safety High level of expertise in toxicology and medical device kept up to date (ISO/EN) Training: Regulatory Affairs, Biological Safety, standardization Independence from labs Benefit/risk Evaluation Trainings 20 Nov. 2023 Evaluation biologique des dispositifs médicaux selon la norme EN ISO 10993-1 en savoir plus s'inscrire Key Services Value-added Trainings Media Media Flyers Related Sectors Pharmaceuticals Chemicals (REACH) Cosmetics Biocides Haut de page

Top of the page CHEMICALS (REACH) Description Contact Key Services REACH dossier Value-added Trainings Media A solid, highly experienced team focused on helping you meet your compliance deadline. You're in safe hands. A solid REACH dossier will enable you to put your substance on the market serenely. Your product is your priority, you are ours. During REACH Phase 1, 2 & 3 CEHTRA provided high quality technical and regulatory support and obtained extensive experience which can be a real asset to industry faced with the challenge of managing, completing and updating dossiers. ​ Moreover, by implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers. Click here to read more about how CEHTRA experts can assist you with REACH registration dossier updates. Description Contact Meet our experts Mathieu ROLLAND Head of REACH mathieu.rolland@cehtra.com Brigitte CASENAVE Senior Chemist brigitte.casenave@cehtra.com Key Services Key Services Dossier compilation & update Lead registrant and co -registrant dossiers testing strategy SIEF Management Only Representative Supply-chain management Consortium and SIEF communication, administrative and financial management of LoA Representation of non-EU companies through our Only-Representative (OR) Legal Entity and UK-REACH Obligations as EU importer, manufacturer or Downstream-User (DU) Notifications to ECHA CEHTRA's consultants have been involved in the preparation of hundreds of REACH registration dossiers, acting on behalf of either the Lead Registrant or a coregistrant. ​ Industrials have successfully experienced CEHTRA and they continue for reviewing their product portfolio and strategy for REACH registration of substances, adapting testing strategies, expert regulatory and scientific advices. REACH dossier registration updates Implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers. ​ The requirement to update ‘without undue delay’ is in most cases specified as three months and, in more complex cases, up to 12 months. ​ Additionally, Cefic, through its multi-annual Action Plan, provides a framework for REACH registrants to evaluate the safety data in a stepwise manner. IUCLID Migration Dossier Review Lead Registration dossier update Co-registration dossier update TCC passing for dossiers submitted in older versions of IUCLID 6 Full update for IUCLID 5 dossiers Listing vulnerabilities and corrective actions Expert advice to tackle them Boundary composition including all SIEF information Outcomes associated to new studies CSR with CHESAR New UVCB qualities New impurity profile Impact for C&L Tonnage update We have indeed a large amount of experience in the update process: i) IUCLID Migration Services ​ Only by using the Technical Completeness Check (TCC) tool in the latest version of IUCLID (6.5.1.2) can you ensure your submission will pass the first submission processing steps in REACH IT. ​ IUCLID 5.6 and newer files can be imported directly into the latest version of IUCLID (6.5.1.2) however they will most likely fail the latest Technical Completeness Check (TCC) and therefore need updating. Any IUCLID files older that 5.6 will not import into the latest IUCLID directly and would need to be updated in a stepwise process. ​ If you need to make submissions to the UK competent authority after Brexit you will also need to pass the latest TCC check. ​ Our team has good experience with IUCLID migration services. If you have any questions, write to one of our experts or simply drop your query in the chat window below and one of our experts will get back to you. ​ ii) Joint Submission Services ​ CEHTRA experts accompany: Companies to update their dossier within or without the CEFIC Action Plan ​ Lead Registrants for preparing the dossier updates and associated costs taking other SIEF members into consideration. ​ Co-registrants when supply-chain and/or composition has been modified. Chemicals (REACH) - Dossier update Value-added Services Trainings Value-added Services Cost-sharing and data-sharing UVCB registration Alternative testing strategies Expert advice Study monitoring PRIMO tool to optimize management and follow-up of data Trainings 11 Oct. 2023 Maîtrisez CHESAR pour simplifier vos évaluations REACH en savoir plus s'inscrire 25 Oct. 2023 Familiarisez-vous aux FDSe : obligations, contenu et conformité en savoir plus s'inscrire A venir Maîtrisez IUCLID et enregistrez vos substances sous REACH en savoir plus s'inscrire Media Related Sectors Global Notifications Industrial Hygiene REACH Authorisation Haut de page

Top of the page BIOCIDES Description Description Contact Key Services Value-added Trainings Consortia Media Among others, are yo u required to: ​ Deal with an Active Substance dossier (new or renewal)? Submit a single product or BPF dossier? Apply for Article 95 List inclusion or for Technical Equivalence or for any request related to BPR? ​ Our broad experience in supporting active substances and biocidal products is your best guarantee. Among the multiple uses covered by Biocidal Product Regulation (EU) 528/2012 (BPR), which one is yours: ​ Disinfectants? Wood pr eservatives? Pest control (Rodenticides, Insecticides, Repellents, ...) ? Antifouling products? ​ Entrust your dossi er into experi enced hands! Contact Meet our experts Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Cyril DUROU Senior Ecotoxicologist cyril.durou@cehtra.com Annekathrin FAUPEL Senior Regulatory Manager annekathrin.faupel@cehtra.com Key Services Value-added Services Key Services Biocidal Product Single Product Biocide Products Family EU R&D Notifications Active Substance New active substance Renewal of Active Substances approval Annex I inclusion Article 95 Listing Dossier Preparation Testing strategy Study Monitoring Alternatives to in vivo testing Consortia Management Consortia containing specific active substances CEHTRA's consultants has been involved in the preparation of several active substances Annex I inclusion dossiers and submission of biocidal products through the BPR process and under National schemes. ​ Our team has also successfully completed many Biocide Product Registration and Biocide Products Family dossiers from start to finish without counting the numerous projects for regulatory support, Monitoring, Outdoor Operator Exposure Studies, Expert Advice and Position Papers. Media Videos Flyers Consortia QuAC (Biocides) Trainings 3 Oct. 2023 Comment fonctionnent les Familles de Produits Biocides ? Accélérez votre mise sur le marché ! en savoir plus s'inscrire 16 Oct. 2023 Ecotoxicologie réglementaire : De la conduite appropriée des études à l'évaluation du risque pour l'environnement en savoir plus s'inscrire 16 Nov. 2023 Toxicologie et Classification - les fondamentaux de vos succès réglementaires en savoir plus s'inscrire Trainings Value-added Services Assessment of ED properties Negotiations with Authorities Risk Assessment and Modelling Technical Equivalence Data Sharing Negotiations Consortia Media Haut de page

Top of the page COSMETICS Cosmetick Contact Key Services CPSR Ecotoxicology Value-added Trainings Media Our Tools Check out if toxicological and eco-toxicological profiles for your ingredients of interest are covered in Cosmetick! Search profiles Tools Contact Key contacts Clarisse BAVOUX Head of Cosmetics clarisse.bavoux@cehtra.com Marlène BARON Toxicologist marlene.baron@cehtra.com Sandrine MORICHON Regulatory Aff airs Specialist sandrine.morichon@cehtra.com Key Services Cosmetic products & formulations : safety, ecotoxicology, expert advice and regulatory reports Pre-assessment Cosmetic Product Safety Reports (CPSR) Ingredients, Raw Materials : Toxicity, Ecotoxicity and Maximum Doses Toxicological profiles Ecotoxicological profiles Identification of safe concentrations for cosmetic uses Ingredients under development: strategy, dossier (toxicology and ecotoxicology) Support for toxicological and ecotoxicological issues Testing strategy In silico approach Additional data Final dossier Literature search, bibliography In vitro tests: analysis and advice Management of da ta gaps by alternative methods (Read-Across, in silico approach) Key Services CEHTRA has been commissioned by numerous companies including multi-nationals in the cosmetics industry to assist them with cosmetic regulation compliance. ​ CEHTRA evaluates the safety of several types of products (care, hygiene, perfumes...), and new ingredients. Cosmetick includes comprehensive databases allow us to anticipate risks for your products. ​ We can propose complementary approaches in case of data gaps (structural alerts, QSAR, Read-across). Our eco-toxicologists can contribute to the eco-conceptions of your formula. ​ At CEHTRA, we are professional partner of the Cosmetic Valley and provide different training courses on the Fundamentals of the Cosmetic Regulation, webinars on Content / Container Interactions or seminaire in University. Services and Tools in Ecotoxicology ​CEHTRA is committed to the protection of the environment, and offers services and tools in ecotoxicology: ​ COSMETICK is an online software solution offering ecotoxicological profiles and an "Ecotoxicological Alerts" system for ingredients and formulas ​ ECOSCORES can be customised to score and measure the ecotoxicological and environmental footprint of cosmetic products ​ ECOTOXICOLOGICAL EVALUATIONS of ingredients and formulas allow prioritisation of ingredient choices up to the obtaining of Labels such as the EU ECOLABEL (rinsed and non-rinsed cosmetic products) ​ MISSING DATA can be replaced in part by results from alternative methods (Read-Across, in silico approaches) ​ Our ADVICE and REGULATORY support enable us to ensure the compliance of your products and ingredients, manage risks and anticipate regulatory changes. Ecoxotoxicology Key contact Pierre-Yves GOURVES Ecotoxicologist pierre-yves.gourves@cehtra.com Value-added Services In-depth expertise for INCI, impurities and fragrance components, including MOS and QRA Hazard assessment (toxicology and ecotoxicology) Extensive and cross-cutting areas of expertise: from environment to human health, from formulation to packaging Data qualification Monitoring of studies Cosmetick database (toxicological & ecotoxicological profiles, formula analysis) Trainings 10 Oct. 2023 Initiation aux règlementations pour les emballages : les comprendre et les mettre en œuvre en savoir plus s'inscrire 13 Oct. 2023 Des cosmétiques plus sûrs pour demain - Connaissez vos obligations réglementaires en savoir plus s'inscrire Media Flyers Value-added Services Trainings Media Related Sectors Our Partners Packaging Haut de page

REPRESENTATIVE SERVICES Representation allows companies to place a substance on a market in an area where they may not have a legal presence. This has a number of benefits including the protection of confidential information and the ability to supply to numerous customers within a particular country/economic area under one registration. In the EU this role is known as Only Representation (OR) and allows a non-EU manufacturer to appoint an Only Representative to fulfill EU regulatory obligations on their behalf. This form (or similar forms) of representation is also available in a number of other countries. CEHTRA has sites in both the EU and UK 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. Meet our experts Melanie Harper Regulatory Affairs Specialist melanie.harper@cehtra.com Karl Willoughby Regulatory Affairs Specialist karl.willoughby@cehtra.com Key Services EU REACH OR / Article 95 Representation UK REACH OR / Article 95 Representation K-REACH OR (Korea) KKDIK OR (Turkey) CEHTRA can act as "only-representative" and consultant for non-European Union companies who sell, or intend to sell, in the European Union (+ European Economic Area (EEA) countries) substances, preparations (mixtures), or articles which are submitted to REACH regulations. ​ CEHTRA offers an expert service, carried out by personnel with extensive experience in both Only Representative Services and REACH Registration. CEHTRA can act as the EU Representative for a non-EU manufacturer for the purpose of Article 95 listing of the BPR. ​ CEHTRA offers an expert service, carried out by personnel with extensive experience in the area of Biocidal regulation. CEHTRA can also provide advice and assistance with Representative Services required under global regulatory schemes, including OR under UK REACH, should this be required as a result of Brexit. ​ With the assistance of locally based partners, we are able to provide Representative Services in Korea, Turkey, and Russia. Value-added Services Dossier/Substance management SDS preparation Point of Contact for customers Related Sectors Global Chemicals Notification Chemicals (REACH) Media Flyers

ENDOCRINE DISRUPTION The evaluation of substances for Endocrine Disruption (ED) potential has been mandatory since 2018 under the Plant Protection Products and Biocide Products regulations. ​ The year 2023 is a key turning point : ​ New hazard classes for endocrine disruptors according to CLP regulation entered into force on 20 April: - ED H H in Category 1 and Category 2 (Endocrine disruption for human health) - ED ENV in Category 1 and Category 2 (Endocrine disruption for the environment) ​ Also, the update of regulation on Cosmetic Products to take into account ED assessment is awaited in the coming months. ​ In addition, the next update of REACH regulation is expected to include new requirements to identify ED from the lowest tonnage band at the end of the year/beginning of next year. ​ CEHTRA can provide you a balanced and independent ED assessment by experts and can guide you to obtain reliable results using appropriate state-of-the-art tools and methods for your substances of interest. Key Services Optimised assessment of ED properties Generating new data Data compilation for regulatory dossiers Expert statements Existing re gulatory data ​ Targeted bibliographic search ​ QSAR screening Tailored testing strategies (based on in silico , in vitro and/or in vivo studies) ​ Study monitoring of ED specific studies Robust study summaries ​ EFSA table and identification of lines of evidence Reports on ED assessments of specific ingredients or formulations ​ Position papers on the relevance of ED potential of a substance for human health/environment Value-added Services In silico screening by QSAR experts Bespoke services adapted to many domains (biocides, PPP, cosmetics, chemicals…) Experienced in-house (eco)toxicologists Key Contact Interested to know more? Our key contact for Endocrine Disruption services, Julien LEGHAIT will be happy to answer all your queries. You can email him or simply drop your query into the chat window below. Julien LEGHAIT Coordinator of Endocrine Disruption services julien.leghait@cehtra.com Media Videos Flyers Podcasts

DEDICATED SUPPORT (RÉGIE) Combining our high-skilled expertise (toxicology, expology, ecotoxicology, regulatory expertise, product stewardship) with our diverse business sectors (Biocides, Chemicals (REACH), Cosmetics, Global Chemical Notification, Industrial Hygiene, Medical devices, Packaging, Pharmaceuticals, Plant Protection), CEHTRA propose a Dedicated Support by outsourcing its team resources to its clients. In France, this outsourcing contract is known as Régie . Key Services Embedded staff Extended staff Our consultants work from our clients’ site Our consultants work from our offices but exclusively for our client Dedicated Support maximizes flexibility for CEHTRA clients ; the contract can be as short as one month or it could be for a long-term, part time or full time. It can be extended as many times as needed. During this period, one or more of our experienced and trained consultants will either: ​ work from our clients’ site and be integrated into their team (Embedded staff ) work from our offices but exclusively for our client (Extended staff ) ​ Value-added Services Support from CEHTRA experts Maximum flexibility with contract conditions A key advantage of securing Dedicated Support with CEHTRA is the experience and expertise provided by our senior and expert team members whichever the barriers : scientific, regulatory... ​ Depending on the level of expertise required (junior, specialist or senior profile), duration (short or long term, part-time or full-time), we will adapt our pricing that best suits your needs and budget. Key Contact Interested to know more? Our key contact for Dedicated Support, Stephane PIERRE will be happy to answer all your queries. You can either write him an email or simply drop your query into the chat window below. Stephane PIERRE In charge of Dedicated Support / Régie stephane.pierre@cehtra.com Media Videos Flye rs

Your Specialties, Our Expertise CEHTRA (Consultancy for Environmental & Human Toxicology and Risk Assessment) is a company of social and solidarity economy (entreprise de l’économie sociale et solidaire), the French leader and number 3 worldwide in technical assistance and regulatory, toxicological and ecotoxicological consulting for the sectors related to the chemicals industry. ​ Our ambition: To promote biodiversity by meeting the strategic challenges of our clients. CEHTRA is part of the H2B Group , specialized in testing, inspection and certification related to health and environment issues, on a human scale and with a strategic objective of digital transition. Our headquarters are located near Bordeaux and is present in Europe and worldwide with agencies in France (Bordeaux, Lyon, Paris), Germany, Belgium, Spain, United Kingdom, Canada and India. Key Business Sectors Biocides Chemicals (REACH) Cosmetics Global Chemicals Notification Industrial Hygiene Medical Devices Packaging Pharmaceuticals Plant Protection REACH Authorisation Key Services Dedicated Support (Régie) Endocrine Disruption Poison Centre Notifications Representative S ervices Trainings Digital Tools PRIMO CEHTRAcker COSMETICK ED Pedia Our project « Chèque transformation Numérique » has received a grant from the European Union under the FEDER-FSE Aquitaine 2014-2020 operational program. ​ CEHTRA has received a grant co-funded by Comunidad de Madrid and European Union to boost hiring young talents (Impulso a la contratación en Prácticas de Jóvenes para la Recuperación Económica) ​

Already a member? Login Wish to create a new account? Register Get started! User Guide | Podcasts | FAQs First Collective Intelligence platform dedicated to the regulatory affairs community for product safety Designed in collaboration with Hypermind , PRISM is a collective intelligence-based platform allowing: a) to predict reliably and with high accurary, the foresights across multiple regulatory sectors including Biocides, Cosmetics, Plant Protection, REACH among others... b) to help industry better understand the impact of any upcoming regulatory changes and allow them to adapt its business strategy accordingly. Why is CEHTRA launching PRISM? ​ CEHTRA is committed in a process to become a social economy company and has already established Collective Intelligence as its primary value. ​ PRISM contributes to organizing and optimizing Collective Intelligence of our business community, better forecasting, better decision making and more innovation to commit responsibly to the challenges that the planet is facing to behave as an active player in tomorrow’s life. Why participate? ​ To access new data and understand the foresights of our community. Whether you are an expert or have limited experience, every prediction counts. Experts tend to place more emphasis on science, while less experienced forecasters tend to better take into account all interference, of whatever nature. This is the very engine of collective intelligence. ​ There are nudges for the best forecasters. Their ranking is also accessible in real time. Finally, we plan to build a panel of "superforecasters". What type of questions are asked? 1. Open questions To generate and select ideas For example : All participants are welcomed to propose ideas for questions. The ideas most likely to succeed are retained. ​ 2. Closed questions To make predictions among different options (optimizing collective forecasts) For example: Multiple choice questions What makes PRISM unique? ​ Unlike other surveys averaging uninformed opinions, PRISM applies sophisticated statistical tools and processes which comply strictly with the collective intelligence principles, grounded in most recent research in cognitive science and behavioral economy Be a part of PRISM to believe it yourself! ​ PRISM User Guide Ready to join? Create your PRISM account User Guide Download PDF (English) Already a forecaster? Login to your PRISM account Watch PRISM video guide PRISM Podcasts Got questions? Get in touch with our team FAQs page - PRISM Podcasts

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

Maîtrisez IUCLID et enregistrez vos substances sous REACH En savoir plus Training > Maîtrisez IUCLID et enregistrez vos substances sous REACH Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Savoir naviguer et entrer des données dans IUCLID Connaître les principales sections non techniques pour un dossier REACH et savoir les remplir Etre capable de relire les sections techniques d'un dossier REACH Savoir utiliser les différentes fonctionnalités de IUCLID (exports, assistants de validation) Savoir soumettre un dossier dans REACH IT Programme Partie 1 – Introduction à IUCLID 6,5 Partie 2 – Préparation d'un dossier IUCLID: section spécifique de la société, sections techniques, interaction Chesar-IUCLID Partie 3 – Assistant de Validation et plug-ins? IUCLID Partie 4 – Création d'un dossier et soumission sur REACH IT Partie 5 – Q&A I Evaluation des acquis de compétences au travers d'un quizz final Méthodes mobilisées La formation est dispensée autour d'une présentation contenant des études de cas, des mises en situation et une interaction permanente avec l'expert. Le support sera remis aux stagiaires. Un quizz final permettra de valider les acquis. Pour un meilleur apprentissage en ligne, nos formations se déroulent en petit groupe allant d'un minimum de trois personnes jusqu'à une capacité maximale de 6 personnes. Nos formations sont dispensées au travers d'un apprentissage synchrone. Public Audience Tout utilisateur de IUCLID 6 pour préparer et/ou soumettre des dossiers REACH. Prérequis Avoir accès à IUCLID. Connaitre le règlement REACH et ses exigences. Chat Chat 3 heure et demi Location Chat Chat à partir de 290€ (HT) Français S'inscrire Chat Formation disponible sur les sites de Paris, Lyon et Bordeaux. Demande d'information Chat Fiche catalogue En Ligne A venir Nathalie Mayer Toxicologue ​ ​ « Je suis très satisfaite de cette formation bien adaptée à mon background et qui a bien répondu à mes besoins. Par ailleurs, le format à distance est entièrement satisfaisant, et nombre de stagiaires limité facilite les échanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

Produits de Protection des Plantes : de la réglementation à l'homologation En savoir plus Training > Produits de Protection des Plantes : de la réglementation à l'homologation Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Comprendre les procédures réglementaires pour les substances actives et pour les produits Comprendre l'évaluation zonale et les dossiers dRR Appréhender le contenu des dossiers et les pièges à éviter Programme Partie 1 – Le Règlement (CE) N° 1107/2009 Les grandes lignes Les différentes procédures concernées Partie 2 – L’Évaluation zonale Évaluation zonale : zones Nord, Centre et Sud : similitudes et différences Échanges entre le Notifiant et les Autorités Compétentes Partie 3 – Les Exigences - Le Dossier Nouvelles exigences : pour quelles substances ? pour quels produits ? Mise en conformité d’un dossier existant selon les nouvelles obligations règlementaires Partie 4 – Cas pratiques Partie 5 – Q&A I Evaluation des acquis de compétences au travers d'un quizz final Méthodes mobilisées La formation est dispensée autour d'une présentation contenant des études de cas, des mises en situation et une interaction permanente avec l'expert. Le support sera remis aux stagiaires. Un quizz final permettra de valider les acquis. Pour un meilleur apprentissage en ligne, nos formations se déroulent en petit groupe allant d'un minimum de trois personnes jusqu'à une capacité maximale de 6 personnes. Nos formations sont dispensées au travers d'un apprentissage synchrone. Public Audience Chargé des Affaires Règlementaires Responsables Produits/Substances actives. Prérequis Formation scientifique. Débutant en affaires réglementaires des produits phytosanitaires. Chat Chat 7 heures Location Chat Chat à partir de 580€ (HT) Français S'inscrire Chat Formation disponible sur les sites de Paris, Lyon et Bordeaux. Demande d'information Chat Fiche catalogue En Ligne A venir Estelle Beltran Responsable des produits de Protection des Plantes ​ 2020 « Je vais la conseiller à mes proches collaborateurs. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

How do Biocidal Product Families work? Accelerate your time to market! Discover How do Biocidal Product Families work? Accelerate your time to market! The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Understand the regulatory obligations of the different actors involved in authorising the marketing of a biocidal product Program Part 1 - Background to the Biocidal Products Regulation (BPR) Part 2 - Description of the different actors involved in the authorisation of Biocidal products Part 3 - Active substance Part 4 - Biocidal Products Part 5 - Assessment of learning through a final quiz Methodology used The training is delivered through a presentation containing case studies, role plays and continuous interaction with the expert. The support will be given to the trainees. A final quiz will validate the acquired knowledge. For better online learning, our training courses are held in small groups of a minimum of three people up to a maximum capacity of 6 people. Our courses are delivered through synchronous learning. Public Public Anyone concerned with the regulations of biocidal products. Prerequisites None. Chat Chat 7 hours Location Chat From 580€ Contact us Online French session Nathalie Hanon Head of Biocides ​ Parole de client « I am very satisfied with this training course which is well adapted to my background and which 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. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

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

FORMATIONS FONDAMENTAUX Apprenez et restez à jour sur l'essentiel de la réglementation. Découvrir Training > Fondamentaux > Ancre 1 BIOCIDES COSMETIQUES DISPOSITIFS MEDICAUX EMBALLAGES PLANT PROTECTION REACH ECOTOXICOLOGIE Comment fonctionnent les Familles de Produits Biocides ? Accélérez votre mise sur le marché ! à partir de 580€ (HT) Adresser les étapes d'une demande d'autorisation de famille de produits biocides : - Similarity of composition & grouping of co-formulants - Similarity of uses - Similar level of risk and efficacy Adresser les différentes points à prendre en compte lors d'une division des familles de produits biocides pour les évaluations en cours Voir les sessions Des cosmétiques plus sûrs pour demain - Connaissez vos obligations réglementaires à partir de 580€ (HT) Connaître et comprendre le Règlement Cosmétique n°1223/2009 Appréhender l'évaluation de risque d'un produit cosmétique Identifier les points d'amélioration permettant de se conformer aux obligations réglementaires Voir les sessions Ecotoxicologie réglementaire : De la conduite appropriée des études à l'évaluation du risque pour l'environnement à partir de 870€ (HT) Mieux comprendre pourquoi les études sont réalisées, ce que les résultats signifient et comment ils peuvent être utilisés pour les parties Classification & Etiquetage, et évaluation des risques Etre en mesure de repérer les pièges des études et savoir comment les éviter Voir les sessions Evaluation biologique des dispositifs médicaux selon la norme EN ISO 10993-1 à partir de 580€ (HT) Comprendre la méthodologie de l’évaluation biologique suivant la norme EN ISO 10993-1 Evaluer la conformité d’un plan d’évaluation biologique Voir les sessions Familiarisez-vous aux FDSe : obligations, contenu et conformité à partir de 580€ (HT) Connaître les obligations sous REACH et les impacts/sanctions en cas de non-conformité Savoir construire une fiche de données de sécurité étendue En tant qu'utilisateur aval, savoir vérifier sa propre conformité vis-à-vis des FDSe fournisseurs Connaître les méthodes de mise en conformité en cas d'écarts entre les usages avals et les scénarios d'exposition couverts par la FDSe Voir les sessions Initiation aux règlementations pour les emballages : les comprendre et les mettre en œuvre à partir de 580€ (HT) Domaines : contact alimentaire, cosmétiques et pharmaceutiques Connaître les pré-requis règlementaires pour les emballages cosmétiques, contact alimentaire, pharmaceutiques Acquérir une vision globale des textes règlementaires applicables aux matériaux Connaitre les exigences essentielles et les spécificités de ces législations Comprendre une évaluation des risques contenant/contenu (LMS) Voir les sessions Maîtrisez CHESAR pour simplifier vos évaluations REACH à partir de 580€ (HT) Connaître les obligations sous REACH Savoir utiliser CHESAR afin de réaliser un CSA (Chemical Safety Assessment) Savoir générer un CSR (Chemical Safety Report) sous CHESAR Etre en conformité vis-à-vis des attentes de l'ECHA Voir les sessions Maîtrisez IUCLID et enregistrez vos substances sous REACH à partir de 290€ (HT) Savoir naviguer et entrer des données dans IUCLID Connaître les principales sections non techniques pour un dossier REACH et savoir les remplir Etre capable de relire les sections techniques d'un dossier REACH Savoir utiliser les différentes fonctionnalités de IUCLID (exports, assistants de validation) Savoir soumettre un dossier dans REACH IT Voir les sessions Produits de Protection des Plantes : de la réglementation à l'homologation à partir de 580€ (HT) Comprendre les procédures réglementaires pour les substances actives et pour les produits Comprendre l'évaluation zonale et les dossiers dRR Appréhender le contenu des dossiers et les pièges à éviter Voir les sessions Toxicologie et Classification - les fondamentaux de vos succès réglementaires à partir de 1160€ (HT) Comprendre la place de la toxicologie dans la vie des substances selon les réglementations Connaître les principaux tests, leurs difficultés, leurs enjeux Optimiser les interactions Cadres/Experts Voir les sessions 2023 « Formation très claire avec formatrice très agréable. Les exemples concrets ont permis de mettre en lumière la complexité des packagings et d'obtenir des informations sur la composition. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

CEHTRA Training Deepen your knowledge with our expertise. Find the right course for you among our programmes. Discover Nos programmes Our programmes Regular training is essential to keep abreast of regulatory changes. Choose the formula that suits your needs. THE BASICS Learn and keep up to date on the essentials of the regulations. Discover MENTORING Tailor-made training to meet the specific challenges of your company. Discover 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. 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... +

Familiarise yourself with SDSe: obligations, content and compliance Discover Familiarise yourself with SDSe: obligations, content and compliance The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Know the obligations under REACH and the impacts/sanctions in case of non-compliance Know how to construct an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Know the methods of compliance in case of discrepancies between the downstream uses and the exposure scenarios covered by the eSDS Program Part 1 - Actors in the supply chain Part 2 - Obligation under REACH for eSDS producers Part 3 - Main steps in the construction of the CSA/CSR Part 4 - Construction of an extended safety data sheet Part 5 - Steps when receiving a supplier SDS: compliance objective Part 6 - Impacts/sanctions in case of non-compliance Part 7 - Q&A I Assessment of skills acquired through a final quiz Methodology used The training is delivered through a presentation containing case studies, role plays and continuous interaction with the expert. The support will be given to the trainees. A final quiz will validate the acquired knowledge. For better online learning, our training courses are held in small groups of a minimum of three people up to a maximum capacity of 6 people. Our courses are delivered through synchronous learning. Public Public People working under the REACH Regulation: - QHSE - manufacturers, formulators, chemical manufacturers Prerequisites Knowledge of the REACH Regulation. Knowledge of SDS (sections 1-16). Chat Chat 7 Hours Location Chat From 580€ Contact us Online French session Anna Chelle Expologist and regulatory toxicologist ​ Parole de client « 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. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

Evaluation biologique des dispositifs médicaux selon la norme EN ISO 10993-1 En savoir plus Training > Evaluation biologique des dispositifs médicaux selon la norme EN ISO 10993-1 Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Comprendre la méthodologie de l’évaluation biologique suivant la norme EN ISO 10993-1 Evaluer la conformité d’un plan d’évaluation biologique Programme Partie 1 – Contexte de la norme dans la réglementation européenne Partie 2 – Les principes fondamentaux de la série ISO 10993 Partie 3 – L’évaluation biologique suivant la méthodologie de la norme EN ISO 13993-1 Partie 4 – Etude de cas pour conclure sur la conformité du plan d’évaluation biologique proposé Partie 5 – Evaluation par questionnaire Méthodes mobilisées La formation est dispensée autour d'une présentation contenant des études de cas, des mises en situation et une interaction permanente avec l'experte. Le support sera remis aux stagiaires. Un quizz final permettra de valider les acquis. Pour un meilleur apprentissage en ligne, nos formations se déroulent en petit groupe allant d'un minimum de trois personnes jusqu'à une capacité maximale de 6 personnes. Nos formations sont dispensées au travers d'un apprentissage synchrone. Public Audience Acteurs du DM. Responsables qualité. Fonctions en charge de la constitution de la documentation technique. Prérequis Connaissance des classes de risque de dispositifs médicaux, du processus de certification UE tel que présenté dans le Règlement 2017/745. Connaissance générale de la problématique relative à la biocompatibilité des produits de santé. Chat Chat 7 heures Location Chat Chat à partir de 580€ (HT) Français S'inscrire Chat Formation disponible sur les sites de Paris, Lyon et Bordeaux. Demande d'information Chat Fiche catalogue En Ligne 20.11.23 Imen Hamdouni Toxicologue ​ ​ « Je suis très satisfaite de cette formation bien adaptée à mon background et qui a bien répondu à mes besoins. Par ailleurs, le format à distance est entièrement satisfaisant, et nombre de stagiaires limité facilite les échanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +