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  • CEHTRA - Your Specialities Our Expertise | Regulatory Affairs | France

    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 Simply Predict 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) ​

  • PRISM | CEHTRA

    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

  • Regulatory expertise - Plant Protection and Health | CEHTRA

    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 3 Oct. 2024 Plant Protection Products: from regulation to registration en savoir plus s'inscrire 7-8 Oct. 2024 Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment en savoir plus s'inscrire Media Flyers Media Related Sectors Simply Predict Haut de page

  • Dedicated Support (Régie) | CEHTRA

    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

  • CEHTRA Media | CEHTRA

    Menu Welcome to CEHTRA Media All our latest updates at your fingertips! Latest News Videos Podcasts Publi- cations Jobs Offers Social Media Voices of CEHTRA Videos | Media Videos ​ Featured video: ​ In our latest video, Estelle introduces the key services for our clients in the Plant Protection sector. To learn more, click here . Click here for more videos back to menu Podcasts - Media Podcasts ​ Featured Podcast: Sandra MARTINEZ BOSCH introduces PRISTINE - CEHTRA’s digital tool designed to simplify the project management of Biocides Click here for more podcasts back to menu Latest News | Media Voice of CEHTRA | Media Latest News ​ Featured News: ​ Our toxicologist Maurine Duplàa delivered an engaging and insightful lecture at the #SkinSensitization training organized by ALTERTOX and acCELLerate. The training focused on Non-Animal Methods (NAMs) and toxicology, with participants benefiting from Maurine's expertise in the field. Click here for more news back to menu Voice of CEHTRA ​ Featured Voice: ​ Sara LOZANO GARCIA Environmental Modeller Consultant Click here for more videos back to menu Publications | Media Publications ​ Featured Publication: ​ Biocides | Framework Guidance: Analysis of alternatives to biocidal active substances Click here for more publications back to menu Job offers | Media Latest Jobs announcements: ​ Registration and Regulatory A ff airs Manager (M/F) ​ Homologation Enginee r (M/F) ​ Expert and BU manager in pharma/tox (M/F) ​ Corporate Lawyer (M/F) Job offers Have passion for biodiversity and environment? Broaden your horizons and enrich your career with CEHTRA. ​ Check out out latest job offers! Click here for more info back to menu Social Media | Media Social Media ​ We keep our LinkedIn followers up to date with the latest announcements and regularly upload new videos and podcasts on our Youtube channel ​ Follow us on LinkedIn and subscribe to our Youtube channel to miss out any updates. Follow us on Linkedin Subscribe to our Youtube channel back to menu

  • ED Pedia | CEHTRA

    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?

  • Trainings | CEHTRA Training

    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 All our courses can be adapted for people with disabilities. 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... +

  • Cosmetic Product Safety Report (CPSR) | CEHTRA

    CPSR If you're a cosmetics manufacturer looking to sell your products in the European Union, it's important to understand the requirements for a Cosmetic Product Safety Report (CPSR). A CPSR ensures that your product is safe for consumers and helps to protect public health. Contact a qualified person, such as a toxicologist, to help you prepare a CPSR and ensure that your product complies with the Cosmetics Regulation (EC) No 1223/2009. Don't risk fines or legal consequences - prioritize the safety of your customers with a thorough CPSR. Clarisse BAVOUX Head of Cosmetics clarisse.bavoux@cehtra.com Send us a message and we will answer you quickly. E-mail Company Your message Send Thank you for your submission! 1 \ What is a CPSR? A Cosmetic Product Safety Report (CPSR) is a document that presents the conclusion on the safety of a cosmetic product and the rationale used by the safety assessor. The report is required in the European Union under the Cosmetics Regulation (EC) No 1223/2009. The purpose of the CPSR is to consider the expected use, list the useful information, from literature or obtained on the product, and quantify any potential risk, if identified, to demonstrate that it can be used without any risk. 2 \ What does a CPSR include? A CPSR typically includes the following information: ​ Part A: gathering information on the presentation of the product, its indications, its expected stability, compatibility with the pack, efficient preservation, information on traces, and tolerance results. ​ Part B: presenting the conclusion, any warning if needed, the rationale to conclude on the different risks induced by the product, and the signature of the qualified safety assessor. ​ An important part of the Safety Report is generally included in Annexes: the toxicological profiles, which must be provided for all ingredients. 3 \ Who prepares a CPSR? A CPSR must be prepared by a qualified person, a safety assessor, such as a toxicologist, who has the necessary diplomas and expertise to assess the safety of cosmetic products. The qualified person may be employed by the cosmetic product manufacturer or by a third-party company that specializes in safety assessments. At CEHTRA, several of our toxicologist can sign the CPSR. 4 \ Why is a CPSR important and what does CEHTRA recommends? A CPSR is important because it ensures that cosmetic products are safe for use by consumers. By identifying potential risks associated with the use of a cosmetic product, the CPSR helps to prevent harm to consumers and to protect public health. CEHTRA recommends a 1rst step before writing this report, in a pre-assessment, before starting any study. ​ In addition, a CPSR is required by law in the European Union. Failure to comply with the requirements of the Cosmetics Regulation (EC) No 1223/2009 can result in fines and other legal consequences. ​ Overall, the CPSR is a crucial component of ensuring the safety of cosmetic products on the market.

  • Plant Protection Products: from regulation to registration

    Plant Protection Products: from regulation to registration En savoir plus Training > Plant Protection Products: from regulation to registration The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid Programme 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 Méthodes mobilisées 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. Public Audience Regulatory Affairs Officer in charge of Products/Active Substances. Prérequis Scientific background. Beginner in regulatory affairs for plant protection products. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 03.10.24 Délais d'accès : 3 mois Estelle Beltran Head of Plant Protection Products ​ 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… +

  • Our Values | CEHTRA

    Our Values Enhance diversity and active listening. ​ Recognize caring and gratitude as essential conditions for collective intelligence. ​ Take initiatives to develop the collective intelligence of our regulatory community. " Working in a team with diverse points of view helps me to broaden my vision about things and allows me to take into account the elements that I wouldn’t have thought through otherwise." ​ Julien LEGHAIT CEHTRA France Collective Intelligence Customer Focus Listen to our clients in order to meet and go beyond their expectations. ​ Demonstrate responsiveness and flexibility to build long-term partnerships with our clients. ​ Accompany our clients’ development through our services. " Working in a domain where regulatory requirements are continuously evolving, it is my passion to pass the experience and knowledge I have gained so far to our clients. This allows developing regulatory strategies that are optimised to address to specific client needs and further strengthen the collaboration with them." ​ Annekathrin FAUPEL CEHTRA Germany Develop creative and ground-breaking digital tools to make life easier for our clients and our teams. Follow up on regulatory developments in order to anticipate the evolution of our clients’ needs. Be open-minded and inventive in addressing the questions we are asked. " Working within a company that welcomes evolution and progressiveness actively encourages us to develop improvements in our day to day working practices, to the benefit of both colleagues and clients." ​ Melanie HARPER CEHTRA United Kingdom Innovation Commitment Commit responsibly to the challenges that the planet is facing. ​ Be a reliable partner for our customers, particularly as regards the regulatory compliance and the safety of their products. ​ Commit to developing and maintaining collective expertise. " At CEHTRA, our individual and collective ‘commitment to excellence’ drive us to accomplish the regulatory success desired by our satisfied customers " ​ Pramod KUMAR CEHTRA India Recruit quality people and profiles. ​ Develop the skills of each individual towards scientific, sectorial and managerial expertise. ​ Diversify skills to provide qualitative and appropriate responses to our stakeholders. " At CEHTRA, we combine our skills on a daily basis to provide technical, scientific, digital and organizational solutions. It is essential to continue to diversify and develop everyone's competences to promote individual development within the company." ​ William BERTRAND CEHTRA Worldwide Competency Transmission Pass on our knowledge with enthusiasm to our colleagues and clients. ​ Detect and develop the talents of our organization. Behave as an active player in tomorrow’s life. " Working in a regulatory domain can be quite challenging, especially when you have to deal with grey zones which are not easy to interpret but here is actually where the magic happens. The discussions and debates that are generated around such topics are very enriching and the knowledge shared between colleagues makes us grow further and allows us to help companies from a 360° approach" ​ Sandra MARTINEZ BOSCH CEHTRA Spain

  • Query Form | CEHTRA

    Query Form If you have questions, feel free to get in touch with our team by filling in the query form below. Select a sector Your name Your email address Company / Organization Your job title Your message Sélectionnez un service Submit Thank you for your message. We will contact you at the earliest possible.

  • Latest News | CEHTRA

    Latest News Welcome to our corporate news page! ​ Here, you can stay up-to-date with the latest news, innovations, and achievements of our company. ​ From product launches and industry insights to events and company culture, we strive to keep you informed on all aspects of our business. Check back often for fresh updates and exciting news! For more updates and announcements, please follow us on LinkedIn Follow us on Linkedin CEHTRA's Expert Insights at Rentrée du DM 2023 ! Learn about CEHTRA's regulatory intelligence and specialized toxicology services in an exclusive interview. Discover how their expertise spans various sectors and integrates regulatory insights. Join us at Rentrée du DM 2022 on Oct 10 & 11 to explore CEHTRA's comprehensive offerings. July 20th, 2023 Join the QuAC Task Force for PT1 and PT2 - Save Time and Resources! Join CEHTRA's QuAC Task Force for PT1 and PT2 dossiers, a practical and cost-efficient solution. Benefit from our expertise in the Biocides sector. Contact Sandra Martinez Bosch ( sandra.martinez.bosch@cehtra.com ) for details and to join now! July 13th, 2023 European Commission's REACH Committee Votes to Restrict Microplastics European Commission's REACH Committee has approved a proposal to restrict the use of microplastics. The proposal is now under review by the European Parliament and Council. If you're unsure about the impact on your business, our experts can assist with regulatory challenges. Contact Stéphane PIERRE at stephane.pierre@cehtra.com . July 11th, 2023 Discover our latest video on Plant Protection at CEHTRA! Estelle Beltran introduces our expertise in the plant protection sector. If you have any questions, feel free to contact us at estelle.beltran@cehtra.com . July 6th, 2023 Webinar: Regulatory Compliance for Recycled Plastics in Food Contact Applications Join us for an informative webinar led by Caroline Opitz from CEHTRA. Learn about the regulations governing recycled plastics in food contact packaging in Europe and the USA. Gain insights into validation processes and ensure compliance. June 29th, 2023

  • CEHTRAcker | CEHTRA

    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

  • Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics

    Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics En savoir plus Training > Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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. Programme 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 Méthodes mobilisées 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. Public Audience Players in the food and cosmetics packaging industry. Prérequis None. Chat Chat 1h30 Location Chat Chat from 140€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 24.09.24 Délais d'accès : 3 mois Caroline Optiz Head of Packaging ​ ​ ​ 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… +

  • Chrome VI Compliance Assessment | CEHTRA

    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

  • Representative Services | CEHTRA

    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

  • Global Chemicals Notification Services | CEHTRA

    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 South Korea Switzerland Taiwan Thailand India Japan Philippines Russia Turkey UK USA Others on application Key Services Value-added Media Flyers Tools CEHTRAcker CEHTRA's window to worldwide regulatory support Media Related Sectors Chemicals (REACH) Industrial Hygiene Simply Predict REACH Authorisation Haut de page

  • Safer cosmetics for tomorrow - Know your regulatory obligations

    Safer cosmetics for tomorrow - Know your regulatory obligations En savoir plus Training > Safer cosmetics for tomorrow - Know your regulatory obligations The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme 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 Méthodes mobilisées 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. Public Audience R&D, Regulatory, Quality, Safety Assessors, Manufacturers, Distributors, Subcontractors, Suppliers, Importers. Prérequis Cosmetics regulatory affairs officer or toxicologist. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne Coming soon Délais d'accès : 3 mois Clarisse Bavoux Head of Cosmetics ​ 2021 « Formation complétement adaptée à mes besoins, Clarisse Bavoux à l'écoute et très clair dans ses explications. Merci pour cette formation qui me sera fort utile au quotidien. » 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… +

  • Brexit | CEHTRA

    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.

  • Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment

    Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment En savoir plus Training > Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Environmental data Reminder of useful physico-chemical parameters Abiotic degradation studies Biotic degradation studies Part 2 - Ecotoxicology Organisms used in regulatory ecotoxicology Ecotoxicology studies: methods Principle of studies: critical parameters Alternative non-experimental methods used in ecotoxicology Part 3 - Regulatory use of data PBT and POP assessment Risk assessment: Principle and derivation of PNECs from ecotoxicology studies Classification SDS Part 4 - Q&A I Assessment of knowledge acquired through a final quiz Méthodes mobilisées 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. Public Audience Scientists and Regulatory Affairs Managers. Prérequis Bac +2. Chat Chat 10h30 Location Chat Chat from 870€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 07.10.24 to 08.10.24 Délais d'accès : 3 mois Blandine Journel Senior Ecotoxicologist ​ 2023 « Une formation de qualité, très bien construite qui m'a permis de rafraichir mes connaissances, certains point ont pu même être mis en pratique/vérifier dès le lendemain sur mes dossiers ! Merci » 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… +

  • Regulatory Ecotoxicology: From appropriate study conduct to environmental risk assessment

    Regulatory Ecotoxicology: From appropriate study conduct to environmental risk assessment Discover Regulatory Ecotoxicology: From appropriate study conduct to environmental risk assessment The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Better understand why studies are carried out, what the results mean and how they can be used for Classification & Labelling and Risk Assessment Be able to spot study pitfalls and know how to avoid them Program Part 1 - Environmental data Reminder of useful physico-chemical parameters Abiotic degradation studies Biotic degradation studies Part 2 - Ecotoxicology Organisms used in regulatory ecotoxicology Ecotoxicology studies: methods Principle of the studies: critical parameters Alternative non-experimental methods used in ecotoxicology Part 3 - Regulatory use of data PBT, POP assessment Risk assessment: Principle and derivation of PNEC from ecotoxicology studies Classification SDS Part 4 - Q&A I Evaluation of knowledge 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 Scientists and Regulatory Affairs Officers. Prerequisites Bac +2. Chat Chat 10.5 Hours Location Chat From 870€ Contact us Online French session Blandine Journel Expert Ecotoxicologist ​ Parole de client « The training was very comprehensive and understandable, including concrete cases to illustrate the concepts discussed. I now have a global vision of the existing ecotoxicological tests and have more insight on the type of tests to be conducted according to the ingredient to be tested. » 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… +

  • Les Fondamentaux - Formations | CEHTRA Training

    THE BASICS Learn and keep up to date on the essentials of the regulations. Discover Training > The basics > Ancre 1 BIOCIDES COSMETICS ECOTOXICOLOGY MEDICAL DEVICES PACKAGING PLANT PROTECTION REACH TOXICOLOGY Biological evaluation of medical devices in accordance with EN ISO 10993-1 from 580€ (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 580€ (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 580€ (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 580€ (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 580€ (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 290€ (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 Plant Protection Products: from regulation to registration from 580€ (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 140€ (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 870€ (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 580€ (HT) Knowing and understanding Cosmetics Regulation 1223/2009 Understand the risk assessment of a cosmetic product Identify areas for improvement in order to comply with regulatory obligations View sessions Toxicology and Classification - the fundamentals of your regulatory success from 1160€ (HT) Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved Optimising interaction between managers and experts View sessions 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… +

  • Candidate form | CEHTRA

    We are recruiting I am applying for the position of Select the position First name Last name E-mail Phone Curriculum Vitae Import file Import a supported file (max. 15 MB) Cover letter (optional) Import file Import a supported file (max. 15 MB) Apply

  • REACH compliance : registration of chemicals | CEHTRA

    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 can you ensure your submission will pass the first submission processing steps in REACH IT. ​ ​ 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 derivation of the cost of the Joint Submission and for each co-registrant. ​ 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 QSARs and others NAMs Expert advice Study monitoring PRIMO tool to optimize management and follow-up of data Trainings 15 Oct. 2024 Master CHESAR to simplify your REACH assessments en savoir plus s'inscrire 22 Oct. 2024 Familiarise yourself with eSDS: obligations, content and compliance en savoir plus s'inscrire Coming soon Master IUCLID and register your substances under REACH en savoir plus s'inscrire Media Related Sectors Global Notifications Industrial Hygiene Simply Predict REACH Authorisation Haut de page

  • Introduction to packaging regulations: understanding and implementing them

    Introduction to packaging regulations: understanding and implementing them En savoir plus Training > Introduction to packaging regulations: understanding and implementing them The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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) Programme 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 Méthodes mobilisées 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. Public Audience Regulatory, Technical and Quality positions. Prérequis None. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 03.12.24 Délais d'accès : 3 mois Caroline Optiz Head of Packaging ​ 2023 « Très intéressantes, cette formation a permis de remettre en place les bases réglementaires au sujet des packagings. » 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… +

  • Pharmaceutical Environmental Risk Assessment (ERA) | CEHTRA

    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 .

  • Regulatory affairs - Packaging compliance | CEHTRA

    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 24 Sept. 2024 Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics en savoir plus s'inscrire 3 Dec. 2024 Introduction to packaging regulations: understanding and implementing them en savoir plus s'inscrire Media Flyers Media Related Sectors Cosmetics Simply Predict Industrial Hygiene Haut de page

  • Biocontrol Diagnosis | CEHTRA

    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

  • Job Offers | CEHTRA

    Job Offers CEHTRA is always looking to recruit new team members that can add strength and depth to our existing staff and contribute to the growth of the company. Would you like to join this friendly yet consciencious and professional group? CEHTRA recruits its consultants on the basis of their broad experience, scientific curiosity, and enthusiasm to take on a challenge. If you are interested, drop us your details via the 'contact us' form. ​ If you think that you have the right attributes, such as scientific competence, innovative mind-set and strong work ethic then send us a copy of your CV: recruitment@cehtra.com ​ Currently, we are looking for Cosmetics Regulatory Affairs Manager (M/F) Contract Specialty Start date Location Permanent Cosmetics ASAP Paris area Read more Apply Data Driven Innovation Accelerator (M/F) Contract Specialty Start date Location CDI - Cadre IA, Science de Données ASAP France (Bordeaux, Paris , Lyon) Read more Apply Ecotoxologist (M/F) Contract Permanent Specialty Ecotoxicology Start date ASAP Location Paris area Read more Apply Endocrine Disruptor Ecotoxicologist Evaluator (M/F) Contract Permanent Specialty Multi-markets Start date ASAP Location France (Bordeaux, Paris , Lyon) Read more Apply Plant Protection Regulatory Affairs Consultant (M/F) Contract Permanent Specialty Plant Protection Start date ASAP Location Bordeaux, Paris, Lyon (full remote possible) Read more Apply Regulatory Consultant REACH/Worldwide (M/F) Contract Permanent Specialty REACH WorldWide Start date ASAP Location France (Bordeaux, Paris , Lyon) Read more Apply

  • PRISM FAQs | CEHTRA

    Predict the future with PRISM A new multi-market regulatory platform for collective intelligence Save the Date: 7th June, 2022 Enter your email address to stay informed! Submit Thanks for for your interest! Hypermind - predictive market Hypermind is a collective forecasting platform created by Emile Servan Schreiber. Read More Collective Intelligence It is now scientifically established that human brains, when assembled, can produce superior intelligence. The IQ of a group emerges not from the IQs of its members, but from their emotional intelligence. It is the quality of the connections that makes the intelligence of the network. Read More Emile Servan Schreiber A doctor in cognitive psychology (Carnegie Mellon), Émile Servan-Schreiber has been a journalist and an artificial intelligence engineer. For the past twenty years, as head of Lumenogic and Hypermind, he has divided his time between research on collective intelligence and its practical applications for companies and governments. Read More Supercollective ​ The diversity theorem tells us that the intelligence of a group is as much a result of the diversity of opinions as of the expertise of each individual. There is no point in being in a group if everyone thinks alike. It is essential to bring together people who see a problem in different ways, even if some are less expert than others. When you are a manager, you must therefore have the humility to seek the opinions of as many people as possible before making decisions. Digital tools make this possible on a very large scale. This is what I call the 'supercollective'. Emile Servan Schreiber Read More The Book Supercollective - The new power of our intelligence Groups have their own intelligence; we have recently learned to measure their IQ. But why are the more feminine groups wiser? How can we invoke the wisdom of a crowd while avoiding the pitfalls of conformity? Why does diversity make us smarter? How does our 'supercollective' intelligence make our companies more successful? How can we use it to revitalise our democracy? And why are American spies so interested in it? Emile Servan-Schreiber provides surprising and stimulating answers to all these questions, based on the latest scientific discoveries and long experience in the field. Read More What is a prediction market? ​ "It is an online betting platform designed to generate reliable forecasts, rather than to enrich a bookmaker. Each fore+F8 it's wrong, his stock is worth nothing." Emile Servan Schreiber Read More What is a probabilistic forecast? Probabilistic forecasting takes a different perspective on anticipating future outcomes. Instead of producing a value as the "best" outcome, probabilistic forecasting involves assigning a "probability" to each possible outcome. In other words, all future events remain possible, they just do not have the same probability. Being a better forecaster A good bettor is someone who is not afraid to change his or her mind, happy to seek out differing points of view, comfortable with the fact that new evidence might lead him or her to abandon what he or she thought. In other words, they are a person with an "actively open mind". Read More ​ What is the difference between a prediction and a survey? When we express a preference, as in a vote or a poll, we only use our emotions and our memory. But when we bet on what will happen (as in a prediction market), we use reason, and the results are more powerful. Read More You don't have to be an expert in the field to answer Various studies have shown that the predictions of generalists far exceed those of experts. Experts who have confined themselves to their specialised field and ignored interdisciplinary knowledge have the worst results. They also tend to be more confident in their - erroneous - predictions than generalists. And their predictions are more definite - which according to probability theory is a bad thing. Read More The challenge - Betting system The most fundamental explanation for the success of the superpredictors is that they have focused on a single objective: predicting the future! What matters is to give the right answer without leaving room for opinions, radical, original or offbeat ideas. Like in a game with rewards. Read More Open ended questions Open-ended questions are ideal for soliciting everyone's creativity. They allow ideas to be generated and selected. Read More Close ended questions Closed-ended questions allow you to predict by choosing an answer from among different options. Read More Why fill in the prediction of others? - Bayesian truth serum The Bayesian truth serum is a scoring system invented at MIT (Prelec, 2004) to elicit truthful and informed responses from respondents. The method requires respondents to provide not only their own answers, but also to estimate the answers of others. Take the example of the question what is the capital of Pennsylvania. Some people will answer Harrisburg while others will answer Philadelphia. This person will have more weight. Read More Diversity of opinion ​ We must trust the intelligence of each person on their own ground. Diversity is the engine of collective intelligence. It is essential to bring together people who see a problem in different ways, even if some are less expert than others. This is why PRISM is an open platform. We believe it is important to have everyone's opinion, from a toxicology student to a regulatory expert. Read More Predicting the future with reliable data ​ Studies conducted over the past 20 years show that prediction markets are more reliable than traditional methods (surveys, experts, data) in 75% of cases, with up to 30% more accuracy. Read More Finding alternative solutions Through collective intelligence, PRISM explores alternative ways of overcoming or circumventing an obstacle by generating innovative ideas or alternative solutions. Becoming an opinion leader PRISM helps to organise and optimise the Collective Intelligence of our regulatory business community, for better decision making and more innovation to responsibly engage with the challenges facing our planet. CIA prediction After each US election, the CIA publishes a report making predictions about the world situation for the next twenty years. Read More Le Point and Hypermind create the Supercollective Institute Who will be elected president of the French republic in 2022? Read More

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