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Ensure the safety of your cosmetic products with CEHTRA's expert Cosmetic Product Safety Report (CPSR) services. Our qualified toxicologists can assess the safety of your product and provide thorough guidance on the CPSR process. Contact us today for a consultation. 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.

CEHTRA is an international leader in technical and regulatory support with regard to the safety of chemical products. Our focus is on scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations: from portfolio strategy to notification of chemicals and OUR EXPERTISE Biocides Are you required to renew an approval of an active substance, to submit a product authorisation or BPF dossier, to apply for Article 95 List inclusion or for Technical Equivalence? Chemicals (REACH) A solid, highly experienced team focussed on helping you meet your compliance deadline. Cosmetics Demonstrate the safety of both your finished products and ingredients. Get the packaging safety tested. Shorten the time to market. Global Chemicals Notification Our internal tools designed to provide you the best worldwide, personalized and optimized strategy for a minimum cost. Industrial Hygiene 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. Packaging Experienced, quality support in managing complex and constantly evolving regulation on packaging. Pharmaceuticals For the safety of your pharmaceutical substances & products we can assist you in the development of your new drugs, safety of your drug production and generation of environmental risk assessment. Plant Protection 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. REACH Authorisation REACH Authorisation is an European risk management measure which aims to limit human and environmental exposure to substances considered of very high concern.

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

Explore career opportunities at CEHTRA, including roles for ecotoxicologists, toxicologists, physico-chemical experts and regulatory consultants. Join our international team committed to chemical safety and apply today. Join our team at CEHTRA Explore exciting job opportunities at CEHTRA for toxicologists, ecotoxicologists, regulatory affairs experts, engineers, and more — across 10 key sectors including REACH, biocides, cosmetics, and beyond. Filter by sector BIOCIDES Regulatory Affairs Manager - Biocides (M/F) BIOCIDES CDI, Permanent Germany, Belgium, France, Sapin, Remote ASAP Apply Read more Careers at CEHTRA: What our team says Julien LEGHAIT "Working in a team with diverse points of view helps me to broaden my vision about things and allows me to take into account the elements that I wouldn’t have thought through otherwise."

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

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

CEHTRA stands for Consultancy for Environmental & Human Toxicology and Risk Assessment. Since 2001, we provide high quality scientific and innovative solutions ensuring regulatory compliance of chemicals to international obligations. Data Privacy GDPR is the General Data Protection Regulation, a sweeping legislation passed by the EU and enforceable as of May 25, 2018. GDPR maintains that data protection is a fundamental human right and it is the responsibility of any company that controls and processes data to protect that right. At some point over the past few years we have been in contact with you, either as part of a scientific and regulatory forum or in another capacity. You already know that we do not send out emails which are not tailored towards your specific needs or are not of mutual interest. We will not bombard you with endless e-mails that are of little interest to you, but every-so-often, there may be something that we think may be of interest to you for your business. Your data: We collect only the data that is strictly necessary. This means your contact details. They are only used for communicating with you regarding business related matters. Your data remains confidential: We promise to never transmit, share or reveal our personal data with any other entity, business or organisation for whatever means, in full compliance with the General Data Protection Regulation (GDPR) of 2018. Your rights to access: In full compliance with the French CNIL , you may at anytime access the your data in order to modify or update them by simply contacting us at: CEHTRA SAS 15 rue Aristide Briand Cenon, Bordeaux France contact@cehtra.com Your right to be forgotten: Your personal data is kept for a maximum of 5 years. You may at anytime request that your details be deleted. Your data is secure: CEHTRA does everything that is possible to ensure that your data is safe. he data service provider OVH ensures that the site respects the legal requirements as described namely the General Data Protection Regulation (GDPR) of 2018.

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

Our experts assess the endocrine disrupting properties of your substances and their potential classification. Our optimized strategies and data compilation ensure compliance with regulatory requirements and anticipate future regulatory changes. Flex+ by CEHTRA: Externalize your resources with confidence Flex+ provides qualified experts to reinforce your teams in regulatory, safety, and environmental projects. Short- or long-term missions, on-site or remote, all backed by CEHTRA’s quality standards. Our services Discover Flex+ Areas of expertise Flex+ covers CEHTRA’s full range of services: toxicology, ecotoxicology, regulatory affairs, product stewardship, and compliance. Our experts quickly integrate into your teams to ensure project continuity and regulatory reliability. Contact our experts Key Services Ancre 1 Interim or temporary support Fast response to workload peaks or staff replacements. Dedicated project teams Multi-profile teams supervised by CEHTRA experts. Technical & regulatory assistance IUCLID/EFSA dossiers, risk assessment, SDS/CLP compliance. Knowledge transfer & follow-up Smooth integration, reporting, and ongoing technical suppo Why choose Flex+ Flex+ offers rapid access to experienced profiles who can immediately adapt to your operational needs. Each mission is supervised by CEHTRA specialists to ensure technical excellence and alignment with regulatory expectations. All assignments are conducted under strict confidentiality and quality frameworks, guaranteeing reliable results. Flexible durations and mission formats allow you to scale your resources easily, according to your project’s pace and priorities. Discover Flex+ Looking for flexible regulatory support? Find it here. What is an endocrine disruptor (ED)? An Endocrine Disruptor (ED) is a substance or a mixture that alters one or more functions of the endocrine system and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations. Why is ED assessment required under EU regulations? Since 2018, ED assessment has been mandatory under the Plant Protection Products Regulation and Biocidal Products Regulation. In 2023, new hazard classes for endocrine disruptors were added to CLP Regulation. Updates to REACH Regulation, cosmetic and pharmaceutical legislations are expected to extend these requirements further — making ED evaluation essential for market access and compliance in the EU. Is there an official list of endocrine disruptors in the EU? There is currently no single, definitive EU list of all endocrine disruptors. However, several regulatory lists and databases identify or flag substances with suspected or proven ED properties: The ED assessment list published by European Chemicals Agency (ECHA) The list of approved and non-approved active substances under Plant Protection Products Regulation and Biocidal Products Regulation The Candidate List of Substances of Very High Concern (SVHC) under REACH Regulation In France, the Annex I of AGEC law lists substances identified as potential ED These lists are updated regularly, and companies should monitor them closely to anticipate regulatory impacts on their substances or products. CEHTRA has designed a digital tool to detect the presence of substances in those and many other lists of suspected or proven ED. Such data must be interpreted with caution and reviewed by an expert that CEHTRA can provide. Discover Flex+ Can’t find your answer? Submit a request

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

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 08.04.24 to 09.04.24 06.06.24 to 07.06.24 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… +

Master CHESAR to simplify your REACH assessments En savoir plus Training > Master CHESAR to simplify your REACH assessments The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Obligations under REACH with regard to CSR Part 2 - Definition and construction stages of the CSA Part 3 - Occupational risk assessment Part 4 - Consumer risk assessment Part 5 - Environmental risk assessment Part 6 - Creation of the complete CSR and compliance with ECHA controls Part 7 - Q&A I Assessment of skills acquired through a final quiz 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 People working on REACH regulations: - Regulatory affairs officer - Toxicologist - Ecotoxicologist - QHSE Prérequis Notions on REACH regulations. 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 04.06.24 08.10.24 Délais d'accès : 3 mois Anna Chelle Expologist and regulatory toxicologist ​ 2022 « Très bien. Informations très utiles. Je vais me servir des slides comme support dans mon travail quotidien. Anna a été très claire et a su répondre à nos questions. Elle s'est également adaptée à nos besoins et s'est concentrée sur les points les plus pertinents pour nous. Un grand 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… +

Safer cosmetics for tomorrow - Know your regulatory obligations En savoir plus Training > Safer cosmetics for tomorrow - Know your regulatory obligations Fondamentaux > 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… +

Plant Protection Products: from regulation to registration En savoir plus Training > Plant Protection Products: from regulation to registration Fondamentaux > 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 06.06.24 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… +

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 Fondamentaux > 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 19.03.24 18.06.24 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… +

Introduction to packaging regulations: understanding and implementing them En savoir plus Training > Introduction to packaging regulations: understanding and implementing them Fondamentaux > 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 26.03.24 14.05.24 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… +

Toxicology and Classification - the fundamentals of your regulatory success En savoir plus Training > Toxicology and Classification - the fundamentals of your regulatory success Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Regulatory toxicology ? General information Part 2 - ADME (Absorption, Distribution, Metabolism, Excretion): concepts Part 3 - Acute systemic toxicology (oral, cutaneous, inhalation) Part 4 - Local skin and eye tolerance Part 5 - Skin sensitisation Part 6 - Repeated-dose and chronic toxicity Part 7 - Reproductive and developmental toxicity Part 8 - Mutagenicity and genotoxicity - Classification Part 9 - Carcinogenesis Part 10 - Introduction to non-experimental alternative methods used in toxicology Part 11 - Introduction to the determination of Toxicological Reference Values Part 12 - Introduction to human health risk assessment Part 13 - Toxicology described through a regulatory dossier (REACH) - case study Part 14 - Assessment of knowledge 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 Employees involved in product safety. Prérequis None. Chat Chat 14 hours Location Chat Chat from 1160€ (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 20.06.24 to 21.06.24 17.10.24 to 18.10.24 Délais d'accès : 3 mois Nathalie Mayer Toxicologist ​ 2022 « Très satisfaite de cette formation qui même si elle ne traite pas du Dispositif médicale, traite le sujet de toxicologie de façon suffisamment large tout en étant accessible. La vision est très globale est c'est ce que je recherchais. » 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… +

Biological evaluation of medical devices in accordance with EN ISO 10993-1 En savoir plus Training > Biological evaluation of medical devices in accordance with EN ISO 10993-1 Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Programme Part 1 - Context of the standard in European regulations Part 2 - The fundamental principles of the ISO 10993 series Part 3 - Biological assessment using the methodology of EN ISO 13993-1 Part 4 - Case study to conclude on the conformity of the proposed biological assessment plan Part 5 - Evaluation by questionnaire Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will receive a handout. A final quiz will validate what has been learnt. To enhance online learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience DM players. Quality managers. Functions responsible for compiling technical documentation. Prérequis Knowledge of medical device risk classes, the EU certification process as presented in Regulation 2017/745. General knowledge of issues relating to the biocompatibility of healthcare products. 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 Imen Hamdouni Toxicologist ​ ​ « 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… +

Familiarise yourself with eSDS: obligations, content and compliance En savoir plus Training > Familiarise yourself with eSDS: obligations, content and compliance Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Actors in the supply chain Part 2 - Obligation of eSDS producers under REACH Part 3 - Key stages in the construction of the CSA/CSR Part 4 - Construction of an extended safety data sheet Part 5 - Stages on receipt of a supplier SDS: compliance objective Part 6 - Impacts/sanctions in the event of non-compliance Part 7 - Q&A I Assessment of skills acquired through a final quiz 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 People working under the REACH Regulation: - QHSE - manufacturers, formulators, chemical product manufacturers Prérequis Notions on REACH regulations. Notions on SDS (sections 1-16). 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 18.06.24 22.10.24 Délais d'accès : 3 mois Anna Chelle Expologist and regulatory toxicologist ​ ​ « 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… +

How do Biocidal Product Families work? Accelerate your time to market! En savoir plus Training > How do Biocidal Product Families work? Accelerate your time to market! Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Partie 1 - Evaluation de la similarité - Assessment of similarity : - Similarité de la composition et regroupement des coformulants - Similarité des utilisations - Similitude du niveau de risque et d'efficacité Partie 2 - Division des familles de produits biocides pour les évaluations en cours - Splitting of families for on-going applications Partie 3 - 'Best practices' pour les reunions de pré-soumission - Best practices for pre-submission meeting Partie 4 - Evaluation des acquis au travers d'un quizz final 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 Anyone concerned by the regulations governing biocidal products. Prérequis Review the GMP guide before the training course (CA-July19-Doc.4.2-Final -Guidance note on GMP concept_rev2). 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 Nathalie Hanon Head of Biocides ​ ​ « 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… +

Master IUCLID and register your substances under REACH En savoir plus Training > Master IUCLID and register your substances under REACH Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes 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 Programme Part 1 - Introduction to IUCLID 6.5 Part 2 - Preparing an IUCLID file: company-specific section, technical sections, Chesar-IUCLID interaction Part 3 - Validation Wizard and plug-ins? IUCLID Part 4 - Dossier creation and submission on REACH IT Part 5 - Q&A I Assessment of skills acquired through a final quiz 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 Any user of IUCLID 6 to prepare and/or submit REACH dossiers. Prérequis Access to IUCLID. Be familiar with the REACH regulation and its requirements. Chat Chat 3h30 Location Chat Chat from 290€ (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 Nathalie Mayer Toxicologist ​ ​ « 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… +

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