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Top of the page COSMETICS Cosmetick Contact Key Services CPSR Ecotoxicology Value-added Trainings Media Our Tools Check out if toxicological and eco-toxicological profiles for your ingredients of interest are covered in Cosmetick! Search profiles Tools Contact Key contacts Clarisse BAVOUX Head of Cosmetics clarisse.bavoux@cehtra.com Marlène BARON Toxicologist marlene.baron@cehtra.com Key Services Cosmetic products & formulations : safety, ecotoxicology, expert advice and regulatory reports Pre-assessment Cosmetic Product Safety Reports (CPSR) Ingredients, Raw Materials : Toxicity, Ecotoxicity and Maximum Doses Toxicological profiles Ecotoxicological profiles Identification of safe concentrations for cosmetic uses Ingredients under development: strategy, dossier (toxicology and ecotoxicology) Support for toxicological and ecotoxicological issues Testing strategy In silico approach Additional data Final dossier Literature search, bibliography In vitro tests: analysis and advice Management of da ta gaps by alternative methods (Read-Across, in silico approach) Key Services CEHTRA has been commissioned by numerous companies including multi-nationals in the cosmetics industry to assist them with cosmetic regulation compliance. ​ CEHTRA evaluates the safety of several types of products (care, hygiene, perfumes...), and new ingredients. Cosmetick includes comprehensive databases allow us to anticipate risks for your products. ​ We can propose complementary approaches in case of data gaps (structural alerts, QSAR, Read-across). Our eco-toxicologists can contribute to the eco-conceptions of your formula. ​ At CEHTRA, we are professional partner of the Cosmetic Valley and provide different training courses on the Fundamentals of the Cosmetic Regulation, webinars on Content / Container Interactions or seminaire in University. "COSMETICK Advanced is a very useful tool for any cosmetic products safety assessor : all required data are gathered (very complete toxicological profils but also ecotoxicity data and regulation alerts). The tool can be used to assess the systemic risk of products ingredients and impurities. It also provides local tolerance alerts. It is very easy to use and a great help when you start working on a new project." Ecoxotoxicology Services and Tools in Ecotoxicology ​CEHTRA is committed to the protection of the environment, and offers services and tools in ecotoxicology: ​ COSMETICK is an online software solution offering ecotoxicological profiles and an "Ecotoxicological Alerts" system for ingredients and formulas ​ ECOSCORES can be customised to score and measure the ecotoxicological and environmental footprint of cosmetic products ​ ECOTOXICOLOGICAL EVALUATIONS of ingredients and formulas allow prioritisation of ingredient choices up to the obtaining of Labels such as the EU ECOLABEL (rinsed and non-rinsed cosmetic products) ​ MISSING DATA can be replaced in part by results from alternative methods (Read-Across, in silico approaches) ​ Our ADVICE and REGULATORY support enable us to ensure the compliance of your products and ingredients, manage risks and anticipate regulatory changes. Key contact Pierre-Yves GOURVES Ecotoxicologist pierre-yves.gourves@cehtra.com Value-added Services In-depth expertise for INCI, impurities and fragrance components, including MOS and QRA Hazard assessment (toxicology and ecotoxicology) Extensive and cross-cutting areas of expertise: from environment to human health, from formulation to packaging Data qualification Monitoring of studies Cosmetick database (toxicological & ecotoxicological profiles, formula analysis) Trainings 18 June. 2024 Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics en savoir plus s'inscrire 14 May. 2024 Introduction to packaging regulations: understanding and implementing them en savoir plus s'inscrire Media Flyers Value-added Services Trainings Media Related Sectors Our Partners Packaging Haut de page

Job Offers CEHTRA is always looking to recruit new team members that can add strength and depth to our existing staff and contribute to the growth of the company. Would you like to join this friendly yet consciencious and professional group? CEHTRA recruits its consultants on the basis of their broad experience, scientific curiosity, and enthusiasm to take on a challenge. If you are interested, drop us your details via the 'contact us' form. ​ If you think that you have the right attributes, such as scientific competence, innovative mind-set and strong work ethic then send us a copy of your CV: recruitment@cehtra.com ​ Currently, we are looking for Cosmetics Regulatory Affairs Manager (M/F) Contract Specialty Start date Location Permanent Cosmetics ASAP Paris area Read more Apply Ecotoxologist (M/F) Contract Permanent Specialty Ecotoxicology Start date ASAP Location Paris area Read more Apply Endocrine Disruptor Toxicologist Evaluator (M/F) Contract Permanent Specialty Multi-markets Start date ASAP Location Bordeaux, Paris , Lyon Read more Apply Endocrine Disruptor Ecotoxicologist Evaluator (M/F) Contract Permanent Specialty Multi-markets Start date ASAP Location France (Bordeaux, Paris , Lyon) Read more Apply Marketing and Sales Trainee (M/F) Contract Specialty Start date Location 6 months internship Cosmetic products IT tools ASAP Paris (Saint-Ouen) Read more Apply Physico-chemical Engineer (M/F) Contract Permanent Specialty REACH multi-markets Start date ASAP Location Bordeaux, Paris , Lyon Read more Apply Packaging Regulatory Affairs Manager (M/F) Contract Permanent Specialty Packaging Start date ASAP Location Bordeaux/Paris Read more Apply Plant Protection Regulatory Affairs Consultant (M/F) Contract Permanent Specialty Plant Protection Start date ASAP Location Bordeaux, Paris, Lyon (full remote possible) Read more Apply Regulatory Consultant REACH/Worldwide (M/F) Contract Permanent Specialty REACH WorldWide Start date ASAP Location France (Bordeaux, Paris , Lyon) Read more Apply Sales and Marketing Development Manager (M/F) Contract Specialty Start date Location Permanent Marketing and Sales ASAP Bordeaux, Paris, Lyon Read more Apply

Top of the page PHARMACEUTICALS (Human & Veterinary) Description Contact Key Services Value-added ERA Trainings Media For the safety and efficacy of both human & veterinary pharmaceuticals, CEHTRA can assist you in: ​ The definition of your preclinical development (development plan) and the drafting of your regulatory dossiers (nonclinical modules) The safety of your CMC activities (PDE, OEL/OEB, qualification of impurities) The Environmental Risk Assessment (ERA) for your MAA dossier Description Meet our experts Stephane PIERRE, PharmD, PhD, ERT Head of Pharmaceuticals, Senior Toxicologist Expert stephane.pierre@cehtra.com Blandine JOURNEL, PhD, ERT Senior Ecotoxico logist Exp ert ​ blandine.journel @cehtra.com Alexandra BONNEFONT, Engineer Deputy Head of Pharmaceuticals, Nonclinical Expert alexandra.bonnefont@cehtra.com Contact Key Services CMC Support Nonclinical sections of Regulatory Dossiers Preclinical Development Environmental Risk Assessment Production Safety PDE Calculation Qualification of Impurities Toxicological Evaluation of Extractable s & Leachables Worker s' Safety OEL/OEB Calculation Authoring CTD, CTA, IND, IMPD, IB, Briefing documents CTD updating Critical review of modules Preclinical Development Plans Study Monitoring Clinical Trial Autorisation : Authoring CTA, IND, IMPD Expertise in Pharmacology, Pharmacokinetics & Toxicology Study Monitoring Authoring the ERA - Phases I & II Interactions with Competent Authorities (EMA, FDA) Key Services To ensure the safety and efficacy of both human & veterinary pharmaceuticals, CEHTRA experts support you in your: ​ CMC activities: PDE (Permitted Daily Exposure) Calculation, OEL/OEB (Occupational Exposure Limit / Occupational Exposure Band) Calculations, Qualification of impurities, Toxicological evaluation of extractables-leachables, In silico assessment (QSAR) ​ ​ Preclinical development plan: Development plan design, Study monitoring (CROs selection, Validation of protocols & study plans, Study follow-up, Discussion of the results, Review of final study reports), Clinical Trial Applications, Gap analysis ​ ​ Regulatory dossiers: Authoring nonclinical sections of CTD, CTA, IND, IMPD, Investigator Brochure (IB), Briefing Documents ; Updating & making a Critical Review of nonclinical modules (2.4 & 2.6, module 4) ; Regulatory Toxicology. ​ ​ Environmental risk assessment: Study monitoring, ERA Drafting (Environmental Risk Assessment, Phase I & Phase II, Module 1.6) & Interactions with competent authorities (EMA, FDA) – Defense of the dossier. ​ CEHTRA expertise allows you to ensure the: ​ Production safety by minimizing the risk of cross-contaminations (residual active substances from API) and impurities (residual solvents, elemental impurities, impurities with mutagenic potential, extractables & leachables,…) ​ Workers’ safety by calculating occupational exposure limits ​ Patient’s safety by designing adequate development plans and performing robust toxicological evaluations based on in silico, in vitro and in vivo data ​ With two main objectives: ​ Safely launch the production of your pharmaceutical product ​ ​ Obtain the Clinical Trial Autorisation and the Marketing Autorisation (MAA) In compliance with: ​ ICH guidelines: ICH Q3A, Q3B, Q3C, ICH M7, VICH GL18, ICH M3(R2), ICH S1A, ICH S1B, ICH S5(R3),… ​ EMA guidelines: Guideline on HBELs 2014, Guideline on control of impurities of pharmacopoeial substances, Guideline on the environmental risk assessment of medicinal products for human use… ​ Thanks to a recognized expert team (pharmacists, ERT toxicologists, engineers…) Meet our Experts in charge of the Régie/Dedicated Support At CEHTRA, we put our experts at your disposal through our Dedicated Support in pharmaceutical sciences called "Régie" Experts supported in-house by a team of senior toxicologists ​ A significant experience with the Dedicated Support: ​ >30 successful « Régies » >10 years of experience with « Régies » >10 on-going « Régies » Maximum flexibility : ​ Contracts ​ Short-term & Long-term Extendables & Renewables Part-time & Full-time ​ ​ Modes ​ Embedded Staff: Our consultants work from our clients’ site Extended Staff: Our consultants work from our offices but exclusively for our client Flexible tariff depending on the expert profile selected (Junior, Specialist, Senior, Expert) For more information, please visit our "Régie" dedicated web page Need information or quotation? Do not hesitate to contact us: Dr Stéphane Pierre, PharmD, PhD, ERT & Head of Pharmaceuticals stephane.pierre@cehtra.com Alexandra Bonnefont, Nonclinical Toxicologist & Deputy Head of Pharmaceuticals alexandra.bonnefont@cehtra.com Meet our Experts in charge of the Régie/Dedicated Support Value-added Added Value Recognized Toxicologists & Ecotoxicologists : Pharmacists, ERT Toxicologists and Engineers with > 20 years of experience A toxicological expertise supported by in silico methods : QSAR models with Nexus, DEREK and Leadscope + 1 dedicated QSAR Expert A demonstrated expertise within the pharmaceutical field: We gained the trust of major groups and small companies Independence from CROs Trainings Related Trainings 18 June. 2024 Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics en savoir plus s'inscrire Media Videos Flyers Media Related Sectors Biocides Chemicals (REACH) Cosmetics Industrial Hygiene Packaging Haut de page

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

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. ​

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

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! The basics > 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… +

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

Toxicology and Classification - the fundamentals of your regulatory success En savoir plus Training > Toxicology and Classification - the fundamentals of your regulatory success The basics > 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… +

TRAINING THE BASICS Learn and stay up to date on the essentials of the regulations. Discover Training > The basics > Ancre 1 BIOCIDES COSMETICS PACKAGING PLANT PROTECTION REACH ECOTOXICOLOGY Toxicology and Classification - the fundamentals of your regulatory success From 1160€ 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 more information Plant Protection Products: from regulation to registration From 580€ Understand the regulatory procedures for active substances and for products Understand zonal evaluation and dRR dossiers Understand the content of the dossiers and the pitfalls to avoid more information Master IUCLID and register your substances under REACH From 290€ How to navigate and enter data in IUCLID Know the main non-technical sections for a REACH dossier and how to fill them in Be able to review the technical sections of a REACH dossier Know how to use the different functionalities of IUCLID (exports, validation wizards) Know how to submit a dossier in REACH IT more information Master CHESAR to simplify your REACH evaluations From 580€ Know the obligations under REACH Know how to use CHESAR to perform a CSA (Chemical Safety Assessment) Know how to generate a CSR (Chemical Safety Report) under CHESAR To be in compliance with ECHA expectations more information Familiarise yourself with SDSe: obligations, content and compliance From 580€ Know the obligations under REACH and the impacts/sanctions in case of non-compliance Know how to construct an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Know the methods of compliance in case of discrepancies between the downstream uses and the exposure scenarios covered by the eSDS more information Regulatory Ecotoxicology: From appropriate study conduct to environmental risk assessment From 870€ 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 more information Safer cosmetics for tomorrow - Know your regulatory obligations From 580€ Know and understand the Cosmetic Regulation n°1223/2009 Understand the risk assessment of a cosmetic product Identify the points of improvement to comply with regulatory obligations more information How do Biocidal Product Families work? Accelerate your time to market! From 580€ Understand the regulatory obligations of the different actors involved in authorising the marketing of a biocidal product more information Parole de client « 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… +

Safer cosmetics for tomorrow - Know your regulatory obligations En savoir plus Training > Safer cosmetics for tomorrow - Know your regulatory obligations The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes Knowing and understanding Cosmetics Regulation 1223/2009 Understand the risk assessment of a cosmetic product Identify areas for improvement in order to comply with regulatory obligations Programme Part 1 - Regulatory context for cosmetic products (Europe and other countries) European Cosmetics Regulation n° 1223/2009 - Scope / Borderline products - Cosmetovigilance - Management of updates Part 2 - Cosmetic product safety report - Notion of safety assessment: MoS calculation, local tolerance, etc. - Toxicological profiles of ingredients Part 3 - Specific cases - Baby products, perfumes - In silico Part 4 - Q&A I Assessment of knowledge acquired through a final quiz Méthodes mobilisées The course is based on a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience R&D, Regulatory, Quality, Safety Assessors, Manufacturers, Distributors, Subcontractors, Suppliers, Importers. Prérequis Cosmetics regulatory affairs officer or toxicologist. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne Coming soon Délais d'accès : 3 mois Clarisse Bavoux Head of Cosmetics ​ 2021 « Formation complétement adaptée à mes besoins, Clarisse Bavoux à l'écoute et très clair dans ses explications. Merci pour cette formation qui me sera fort utile au quotidien. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

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

Safer cosmetics for tomorrow - Know your regulatory obligations Discover Safer cosmetics for tomorrow - Know your regulatory obligations The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Know and understand the Cosmetic Regulation n°1223/2009 Understand the risk assessment of a cosmetic product Identify the points of improvement to comply with regulatory obligations Program Part 1 - Regulatory context of cosmetic products (Europe and other countries) European Cosmetic Regulation n° 1223/2009 - Scope of application / Borderline products - Cosmetovigilance - Management of updates Part 2 - Cosmetic Product Safety Report Cosmetic product safety report - Concept of safety assessment: MoS calculation, local tolerance... - Toxicological profiles on ingredients Part 3 - Specific cases - Baby products, perfumes - In silico Part 4 - Q&A I Assessment 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 R&D, Regulatory, Quality, Safety assessor, Manufacturers, Distributors, Subcontractors, Suppliers, Importers. Prerequisites Cosmetic regulatory officer or toxicologist. Chat Chat 7 hours Location Chat From 580€ Contact us Online French session Clarisse Bavoux Head of Cosmetics ​ Parole de client « I am very satisfied with this training course which is well adapted to my background and which met my needs. Clarisse Bavoux is very clear in her explanations, the presentation is well structured and the references are provided, which is very useful to work on after the training. » 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 The basics > 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… +

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.

Introduction to packaging regulations: understanding and implementing them En savoir plus Training > Introduction to packaging regulations: understanding and implementing them The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) Programme Part 1 - Regulatory requirements for cosmetic packaging Part 2 - Regulatory requirements for food contact packaging Part 3 - Migration principles (container-content interactions) Part 4 - Regulatory requirements for pharmaceutical packaging Part 5 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience Regulatory, Technical and Quality positions. Prérequis None. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 14.05.24 17.09.24 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… +

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 06.06.24 to 07.06.24 07.10.24 to 08.10.24 Délais d'accès : 3 mois Blandine Journel Senior Ecotoxicologist ​ 2023 « Une formation de qualité, très bien construite qui m'a permis de rafraichir mes connaissances, certains point ont pu même être mis en pratique/vérifier dès le lendemain sur mes dossiers ! Merci » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

Master IUCLID and register your substances under REACH Discover Master IUCLID and register your substances under REACH The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities How to navigate and enter data in IUCLID Know the main non-technical sections for a REACH dossier and how to fill them in Be able to review the technical sections of a REACH dossier Know how to use the different functionalities of IUCLID (exports, validation wizards) Know how to submit a dossier in REACH IT Program 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 acquired skills 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 Any user of IUCLID 6 to prepare and/or submit REACH dossiers. Prerequisites Know the REACH regulation and its requirements. Chat Chat 3.5 Hours Location Chat From 290€ Contact us Online French session Nathalie Mayer Toxicologist ​ Parole de client « I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

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… +

Plant Protection Products: from regulation to registration En savoir plus Training > Plant Protection Products: from regulation to registration The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid Programme Part 1 - Regulation (EC) No 1107/2009 The main points The different procedures involved Part 2 - Zonal assessment Zonal assessment: North, Centre and South zones: similarities and differences Exchanges between the Notifier and the Competent Authorities Part 3 - Requirements - The Dossier New requirements: for which substances? for which products? Bringing an existing dossier into line with the new regulatory requirements Part 4 - Case studies Part 5 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience Regulatory Affairs Officer in charge of Products/Active Substances. Prérequis Scientific background. Beginner in regulatory affairs for plant protection products. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 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 The basics > Ancre 1 Overview Objectifs I Compétences et Aptitudes Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. Programme Part 1 - Regulation 2022/1616/EC - Recycled plastic articles Part 2 - FDA - No Objection Letter (NOL) - recycled plastic articles Part 3 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based on a presentation with role-playing exercises and ongoing interaction with the expert. The support material will be given to the trainees. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 8. Our courses are delivered through synchronous learning. Public Audience Players in the food and cosmetics packaging industry. Prérequis None. Chat Chat 1h30 Location Chat Chat from 140€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 18.06.24 24.09.24 Délais d'accès : 3 mois Caroline Optiz Head of Packaging ​ ​ ​ La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

Plant Protection Products: from regulation to registration Discover Plant Protection Products: from regulation to registration The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Understand the regulatory procedures for active substances and for products Understand zonal evaluation and dRR dossiers Understand the content of the dossiers and the pitfalls to avoid Program Part 1 - Regulation (EC) No 1107/2009 The main points The different procedures involved Part 2 - Zonal assessment Zonal evaluation: North, Central and South zones: similarities and differences Exchanges between the Notifier and the Competent Authorities Part 3 - The Requirements - The Dossier New requirements: for which substances? for which products? Bringing an existing dossier into line with the new regulatory obligations Part 4 - Case studies Part 5 - Q&A I Assessment of acquired skills 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 Regulatory Affairs Officer responsible for products/active substances. Prerequisites Scientific background. Beginner in regulatory affairs for plant protection products. Chat Chat 7 Hours Location Chat From 580€ Contact us Online French session Estelle Beltran Head of Plant Protection ​ Parole de client « I will recommend it to my close colleagues. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

Regulatory Ecotoxicology: From appropriate study conduct to environmental risk assessment 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… +

Master CHESAR to simplify your REACH evaluations Discover Master CHESAR to simplify your REACH evaluations The basics > Ancre 1 Training > Overview Objectives I Skills and Abilities Know the obligations under REACH Know how to use CHESAR to perform a CSA (Chemical Safety Assessment) Know how to generate a CSR (Chemical Safety Report) under CHESAR To be in compliance with ECHA expectations Program Part 1 - Obligation under REACH towards CSR Part 2 - Definition and construction steps of the CSA Part 3 - Occupational risk assessment Part 4 - Consumer risk assessment Part 5 - Environmental risk assessment Part 6 - Creation of the full CSR and compliance with ECHA controls Part 7 - Q&A I Assessment of competence acquisition through a final quiz Methodology used The training is delivered through a presentation containing case studies, role plays and continuous interaction with the expert. The support will be given to the trainees. A final quiz will validate the acquired knowledge. For better online learning, our training courses are held in small groups of a minimum of three people up to a maximum capacity of 6 people. Our courses are delivered through synchronous learning. Public Public People working in the framework of the REACH Regulation: - Regulatory Affairs Officer - Toxicologist - Ecotoxicologist - QHSE Prerequisites Notions on the REACH Regulation. Chat Chat 7 Hours Location Chat From 580€ Contact us Online French session Anna Chelle Expologist and regulatory toxicologist ​ Parole de client « Very good. Very useful information. I will use the slides in my daily work. Anna was very clear and answered our questions. She also adapted to our needs and focused on the most relevant points for us. Many thanks. » 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… +

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.

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

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 .

CEHTRA Training Deepen your knowledge with our expertise. Find the right course for you among our programmes. Discover Nos programmes Our programmes Regular training is essential to keep abreast of regulatory changes. Choose the formula that suits your needs. THE BASICS Learn and keep up to date on the essentials of the regulations. Discover MENTORING Tailor-made training to meet the specific challenges of your company. Discover All our courses can be adapted for people with disabilities. What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

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.