Search Results

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

I Understand the place of toxicology in the life of substances according to the regulations Knowing the main tests, their difficulties, their stakes Optimise the interaction between managers and experts Toxicology and Classification - the fundamentals of your regulatory success Discover Toxicology and Classification - the fundamentals of your regulatory success The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Understand the place of toxicology in the life of substances according to the regulations Knowing the main tests, their difficulties, their stakes Optimise the interaction between managers and experts Program Part 1 - Regulatory Toxicology ? General Part 2 - ADME (Absorption, Distribution, Metabolism, Excretion): concepts Part 3 - Acute systemic toxicology (oral, dermal, inhalation) Part 4 - Local skin and eye tolerance Part 5 - Skin Sensitisation Part 6 - Repeat and Chronic Toxicity Part 7 - Reproductive and Developmental Toxicity Part 8 - Mutagenicity and Genotoxicity - Classification Part 9 - Carcinogenesis Part 10 - Introduction to alternative non-experimental 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 learning through a final quiz Methodology used The training is delivered through a presentation containing case studies, role plays and continuous interaction with the expert. The support will be given to the trainees. A final quiz will validate the acquired knowledge. For better online learning, our training courses are held in small groups of a minimum of three people up to a maximum capacity of 6 people. Our courses are delivered through synchronous learning. Public Public Employees involved in product safety. Prerequisites None. Chat Chat 14 hours Location Chat From 1160€ Contact us Online French session Nathalie Mayer Toxicologist Parole de client « I am very satisfied with this training course which is well adapted to my background and which met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

Discover and learn more about CEHTRA's values 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

Stay one step ahead in the world of biocides with CEHTRAWATCH Biocides, the essential tool for precise regulatory monitoring of your substance portfolio. CEHTRAWATCH Your Essential Digital Tool for R&D and Regulatory Teams Discover BIOCIDES Stay one step ahead in the world of biocides with CEHTRAWATCH Biocides, the essential tool for precise regulatory monitoring of your substance portfolio. Features Anticipate the impact of regulatory changes on your substances, ensuring continuous compliance of your biocidal products. Request a guide Intuitive Navigation Simple and user-friendly interface for efficient management of your substance portfolio. Change History View a detailed table of updates by date, allowing you to maintain full control over the information and its historic. Automated Regulatory Watch Stay informed in real-time with automated notifications. Comprehensive Substance Profile Access detailed profile for each substance, including the Hazard Profile, Status on Regulatory Lists, and Classification. Meet Our Expert Contact our expert to find out about more features of CEHTRAWATCH Biocides but also for a live demo: Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Contact

I Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) Introduction to packaging regulations: understanding and implementing them En savoir plus Training > Introduction to packaging regulations: understanding and implementing them The basics > Ancre 1 Overview 10.06.25 7 hours Online French from 690€ (HT) 2 months Lieu Dates Price Duration Language Access time Would you like to register? 16.09.25 Register Objectives I Skills and Abilities Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) Program Part 1 - Regulatory requirements for cosmetic packaging Part 2 - Regulatory requirements for food contact packaging Part 3 - Migration principles (container-content interactions) Part 4 - Regulatory requirements for pharmaceutical packaging Part 5 - Q&A I Assessment of skills acquired through a final quiz Methods used The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience Regulatory, Technical and Quality positions. Prerequisites None. Request for information Download the catalogue. Download Trainer Caroline Optiz Head of Packaging About CEHTRA For 20 years we have specialised in assisting companies with the marketing of chemical substances and products in France, Europe and beyond. 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 around ten sectors, including REACH, biocides, plant protection products, etc. +

I 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 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… +

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. India’s Chemicals (Management And Safety) Rules India’s Chemicals (Management And Safety) Rules (ICMSR) also referred to as ‘India REACH’ will come into force on the date of their publication in the Official Gazette, expected mid-2021, and will regulate all substances, substances in mixtures, and intermediates that are manufactured, imported or placed on the market in the Indian territory at quantities greater than 1 tonne per year. Regulatory compliance requirements will apply within 18 months of coming into force, and all Indian manufacturers and importers will need to comply. Non-Indian entities who wish to place their chemical products on the market in India will need to appoint an authorised representative (AR) located in India to act on their behalf (similar to EU REACH OR). If your company is currently manufacturing chemicals in India or exporting chemicals to India, ICMSR will affect you. CEHTRA-India registered office in New Delhi is well positioned to act as your AR and service provider and can help you secure the Notification or Registration certificate for your chemicals from India’s Chemical Regulatory Division. The main requirements are: Notification and annual updating All existing and new substances manufactured or imported in India in quantities ≥ 1 tonne per year must be notified to The Chemical Regulatory Division (CRD). Existing substances should be notified within 180 days from the date of commencement of the Initial Notification Period (i.e. commences one year from the date of enforcement of ICMSR Rules). New substances must be notified at least 60 days prior to the date they are placed on the market in India. Notifiers shall update the information submitted annually, no later than 60 days after the end of each calendar year. Registration All priority substances listed in ICMSR Schedule II (currently 750) manufactured or imported (or intended or likely to be released from articles) in India in quantities ≥1 tonne per year will require the submission of a technical dossier within 18 months from the date of their inclusion in Schedule II. Substances manufactured or imported in India in quantities <1 tonne per year may also need to be registered; further details are yet to be published. Substances listed in Schedule II will be subject to authorization and restriction after further assessment. Safety Data Sheet (SDS) All Notifiers of a substance or an intermediate listed in Schedule II or a hazardous chemical will need to maintain and submit an up-to-date SDS in the UN-GHS format and will have to share such SDS with the Downstream User of the substance. Site Safety Report An occupier who has control of an industrial activity in which a hazardous chemical is handled is required to provide the evidence of identification and prevention of accidental hazards within 30 days of commencement of the activity or within 30 days of coming into force of these Rules, whichever is later. Depending on the threshold of quantities of hazardous chemicals, a site safety report or an independent safety audit report may also be required to be submitted within 90-180 days from the date of coming into force of these Rules. Import Notification After completion of notification or registration, importers of priority substances or hazardous chemicals must inform the concerned authority at least 15 days before the import of such substances in quantities greater than the lowest of 1 tonne, the quantity specified in column 3 of Schedule XII and column 3 of Schedule XI. Meet our expert Pramod KUMAR Regulatory Affairs Manager pramod.kumar@cehtra.com Key Services Notification / Registration & update Preparation and update of Notification and Registration dossiers for individual or joint submissions Safety Data Sheets (SDS) Preparation and/or update of SDS in latest UN-GHS format Authorized Representative (AR) service Representation of non-Indian companies through our Indian entity Data Management Arrangement of data on substances already registered with any foreign regulator in other jurisdictions Value-added Services PRIMO tool to optimize management and follow-up of complex worldwide registration projects Experienced data sharing negotiators Scientific and Regulatory expert advice GHS Classification of substances Related Tools Related Sectors Global Chemicals Notification

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… +

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home

There’s Nothing Here... We can’t find the page you’re looking for. Check the URL, or head back home. Go Home