Search Results
125 results found with an empty search
Articles (27)
- News from the JRC : a first technical proposal for EU-wide, harmonised waste-sorting labels under the PPWR
On 13 January 2026, the European Commission’s Joint Research Centre (JRC) published a new report: “JRC technical proposal on EU harmonised waste sorting labels under the packaging and packaging waste regulation”. ( Available here: JRC Publications Repository - JRC technical proposal on EU harmonised waste sorting labels under the packaging and packaging waste regulation ) More than just a design report The document is a technical blueprint to support the European Commission in developing future, harmonised packaging-sorting instructions, so consumers and producers encounter the same logic across Member States and packaging can circulate smoothly within the Single Market. This timing is important because the Packaging and Packaging Waste Regulation (PPWR) applies from 12 August 2026, and the Commission is expected to use the JRC work as an input when preparing the secondary legislation on labelling. What the JRC report is proposing At its core, the JRC proposes a harmonised system of consumer-facing labels for packaging and waste receptacles (bins), built to work across Europe’s very different collection and sorting systems. The key idea is intuitive: matching labels so the label you see on packaging corresponds to what you should look for on the bin (and vice-versa). The report serves as evidence-based input for the Commission services, especially DG Environment, to support the planned implementation measures of the PPWR (the JRC aims to inform the Commission’s implementing acts mentioned in the PPWR). Built from behavioural evidence, not “designer taste” One of the strongest signals in the report summary is the methodology behind it. The JRC says the proposal is grounded in: extensive desk research empirical evidence from citizen workshops, surveys, and experiments expert stakeholder workshops and consultations That matters, because sorting labels only work if they work in real kitchens, offices, and public spaces under time pressure, in different languages, and with varying levels of recycling knowledge. “Flexible, yet harmonised”: the balancing act The JRC repeatedly frames the challenge as finding the sweet spot between EU-wide harmonisation and practical flexibility for Member States and real-world packaging constraints. In practice, that balancing act shows up in three main design questions: What should the label communicate? The proposed “conceptual approach” focuses on informing consumers about material composition and providing clear sorting instructions, reinforced through matching labels on bins. Determining the Appropriate Level of Label Granularity A single “plastic” label offers simplicity but may be overly broad, especially in systems that differentiate between rigid and flexible plastics or where composite materials create confusion. According to the JRC summary, the proposed approach aims for a level of granularity that defines distinct labels based on both theoretical and practical considerations. External feedback on the JRC work indicates that early prototypes explored a range of material categories and subcategories. For instance, one industry analysis describes an initial prototype with eight material categories, including subcategories like “soft” vs “hard” plastics. What should the label look like across 27 markets? The visual approach aims to ensure the label both stands out and is understood across Member States, while allowing enough flexibility to work on-pack and on bins as you can see on the figure below. However, even before the Commission locks anything in, the labelling conversation is already contentious. Several industry groups have publicly warned that heavy reliance on text and/or colour could recreate fragmentation because text triggers translation needs and can easily drift into national variants. The JRC summary itself acknowledges the reality: the proposal includes compromises, identifies challenges, and flags future work needs given the complex interplay of regulatory requirements, stakeholder preferences, and practical limitations. In other words, this is not presented as a final “perfect” answer, but as a structured, research-backed basis for the Commission to build on. What this means for brands, retailers, and compliance teams If you put packaged goods on the EU market, this is the moment to treat waste-sorting labels as a system change, not a minor artwork update. A few practical implications stand out: Data discipline becomes design discipline. If labels need to reflect material composition reliably, internal packaging specifications (and component-level bills of materials) have to be clean, current, and auditable. Space on-pack will be a constraint. Expect tension between information richness and small-format packaging realities especially if multiple components need instructions. Consistency across SKUs will matter. Harmonisation is partly about consumer learning: the faster people recognise a label family, the better it performs. Conclusion and next step Under the PPWR, 12 August 2026 is a key milestone, as it is the date of general application of the Regulation and the deadline for the Commission to adopt implementing acts specifying harmonised labelling requirements. These implementing acts are adopted in 2026, while the harmonised labelling obligations take effect from 2028. The bottom line: the JRC has now provided a concrete, evidence-backed proposal. For stakeholders, it’s crucial to begin reviewing the proposed direction now, as once the Commission’s act is adopted, the implementation timeline will accelerate rapidly. CEHTRA supports you in implementing these regulations. Contact us today to learn more about how we can help you. References https://www.europen-packaging.eu/news/joint-industry-statement-on-wsl JRC Publications Repository - JRC technical proposal on EU harmonised waste sorting labels under the packaging and packaging waste regulation CEHTRA supports packaging stakeholders in anticipating and complying with the new PPWR requirements, particularly in terms of labeling and waste management. Author: Baptiste REVERDY
- COSMETICK: a toxicological database and a digital cosmetic risk assessment tool
COSMETICK is a toxicological and ecotoxicological profile database, combined with a digital cosmetic risk assessment tool. It is designed to support toxicologists and safety assessors in the preparation of Cosmetic Product Safety Reports (CPSR), as well as in the safety assessment of ingredients, impurities, raw materials and fragrance compounds or fragrance concentrates. COSMETICK enables the structuring, documentation and use of reliable toxicological data, and their direct application in cosmetic risk assessments compliant with European and international regulatory requirements. COSMETICK: a database, a risk assessment tool… or both? Having access to a structured toxicological profile database has become essential for the organisation of any safety assessor’s work. To meet the needs of CEHTRA’s own safety assessors, toxicological profiles were originally structured and written to be directly used in safety assessments. In parallel, and because risk assessment is a core requirement for safety assessors, COSMETICK was designed with CEHTRA toxicologists as a digital tool supporting cosmetic risk assessment for finished products and raw materials . COSMETICK in numbers: a structured toxicological knowledge base As of the end of December 2025, the COSMETICK database included: toxicological profiles for 3,400 ingredients, 800 impurities, 500 fragrance substances, and 1,900 ecotoxicological profiles. The 3,400 raw materials included are either documented by CEHTRA for its users or entered directly and confidentially by the users themselves. Each toxicological profile results from a rigorous and standardised process involving data collection, selection of relevant studies, and synthesis of results for all endpoints required for cosmetic risk assessment. Results are described for nine toxicological endpoints : skin and eye irritation, skin sensitisation, phototoxicity, acute toxicity, sub-chronic or chronic toxicity, reproductive toxicity, endocrine disruption, and carcinogenicity. Dermal and oral absorption data are also documented. Data gaps are clearly identified and visualised through colour-coded icons. The data are derived from numerous recognised scientific sources (SCCS, CIR, ECHA opinions, EFSA, US EPA, etc.), as well as from peer-reviewed scientific literature and in silico approaches . All sources are precisely referenced. Ecotoxicity is documented in accordance with REACH and CLP/GHS requirements , including PBT/vPvB assessment . It covers biodegradability (OECD, BIOWIN), bioaccumulation (BCF, log Kow), and acute and chronic aquatic toxicity (algae, daphnia, fish), complemented by recognised QSAR models (ECOSAR). The analysis follows a weight-of-evidence approach integrating measured data and literature. Profiles are continuously updated based on several criteria: regulatory and toxicological developments, human health concerns identified during user safety assessments, and frequency of profile use. Successive versions are retained for each profile, with documented comparisons between versions, ensuring traceability of updates and methodological consistency . For risk assessment purposes, cosmetic product types and exposure scenarios can be selected from predefined categories in line with standard safety assessment practices. Developed by toxicologists, used in production at CEHTRA COSMETICK was initially developed as an internal tool at CEHTRA for the preparation of Cosmetic Product Safety Reports from 2018 onwards. Designed by and for toxicologists , it was made available online in 2021 under a licensing model: COSMETICK BASIC , providing access to the toxicological profile database, COSMETICK ADVANCED , providing full access to the database and to cosmetic risk assessment functionalities. The coexistence of the internal CEHTRA tool and the online user version ensures that users benefit from all improvements identified by CEHTRA toxicologists for their own daily practice. These improvements stem from practical needs (export formats, colour-coded user-friendly displays, formula duplication) as well as methodological developments (reverse calculation for raw materials, QRA2, results by IFRA categories). As a result, users can be confident that their cosmetic risk assessments incorporate the most up-to-date scientific and methodological approaches that digital automation can support. Data personalisation further ensures that each assessment remains specific to the company’s choices and practices. What does a toxicological profile look like in COSMETICK? A toxicological profile in COSMETICK includes full substance identification (INCI name, synonyms, CAS number), relevant toxicological data, toxicological reference values , colour-coded warnings , and a structured scientific summary. For each endpoint, the profile summarises study results, identifies critical effects, and provides the toxicological reference values used for risk characterisation: LOAEL, NOAEL, NESIL, and non-effect, irritant or sensitising concentrations . The selected Point of Departure (PoD) is justified. Missing data are explicitly identified to help the safety assessor define appropriate follow-up actions. Warnings and signals of concern Colour-coded warnings allow rapid visualisation of critical toxicological concerns and data gaps. They provide a key decision-support tool, enabling the safety assessor to quickly identify potential issues related to a substance, raw material or formulation before assessing the actual risk based on concentration and intended use. Ecotoxicological profiles are also ranked according to increasing levels of concern. Example: a preservative Phenoxyethanol (CAS No. 122-99-6) is authorised as a cosmetic preservative under the European Cosmetic Regulation, up to a maximum concentration of 1% . Based on CEHTRA’s experience over the past four years, it is the most frequently used preservative . Phenoxyethanol has a broad antimicrobial spectrum, effective against Gram-negative bacteria (e.g. Pseudomonas aeruginosa ), Gram-positive bacteria ( Staphylococcus aureus ), and yeasts ( Candida albicans ). Its activity is attributed to inhibition of microbial DNA/RNA synthesis and increased cell membrane permeability. In 2016, the SCCS evaluated systemic effects and concluded that phenoxyethanol is not classified as reprotoxic and is only a rare skin sensitiser , considering it one of the best-tolerated preservatives. Systemic toxic effects were observed only at oral or dermal exposures approximately 200-fold higher than consumer exposure levels from cosmetics. Consequently, the SCCS concluded that phenoxyethanol is safe for all consumers, including children of all ages, when used up to 1%. Although its irritant properties are well established, it remains well tolerated at authorised levels, without inducing skin irritation or sensitisation. Some rare discomfort reactions (stinging, tightness) may occur, particularly in cases of co-exposure with other irritants. This illustrates the importance of the safety assessor’s expertise, which goes beyond bibliographic data to evaluate safety under realistic conditions of use, such as daily facial application. While such discomfort does not represent a major health risk, it is typically undesirable for both consumers and brands. Phenoxyethanol is classified as STOT SE 3 (H335: May cause respiratory irritation) under CLP Regulation No. 1272/2008. Very rare cases of allergy have been reported and must be assessed case-by-case depending on population, skin type and product type. The substance is neither phototoxic nor genotoxic and shows low acute toxicity. Systemic toxicity is characterised by a sub-chronic study identifying a NOAEL of 500 mg/kg bw/day (357 mg/kg bw/day for daily administration), which adequately protects against reproductive effects observed at higher doses (SCCS, 2016; Api et al., 2025). Available receptor binding studies do not suggest endocrine activity. Nevertheless, attention remains warranted pending conclusions from ECHA, which included phenoxyethanol in its Endocrine Disruptor Assessment programme under the Biocidal Products Regulation (assessment ongoing as of 21 August 2025). From ingredient to finished product: risk assessment in practice Example 1: cosmetic product with a risk of skin sensitization The product assessed is a facial sunscreen used daily. It contains the colourant CI 77288. Several cases of allergy have been reported in the literature for various chromium(III) oxides, as highlighted by CORAP in 2022. In the absence of specific skin sensitisation characterisation, and particularly of quantitative data, the risk of sensitisation at 0.1% cannot be excluded. The risk is considered likely, leading to an unfavourable safety conclusion. Example 2: cosmetic product with insufficient MOS In a product intended for infants, caprylyl glycol is used at 0.5%. The associated Margin of Safety is insufficient, indicating a probable risk of systemic toxicity. The NOAEL is derived from a sub-chronic OECD 408 study. At higher doses, developmental effects may occur and are currently under regulatory scrutiny, potentially leading to harmonised reprotoxic classification (ECHA ARN on 1,2-ethanediols and their carbonates, 2021). Thus, although the Margin of Safety based on a robust toxicological reference value is insufficient, additional concerns are flagged by the “Reprotoxicity” and “Irritation” warnings . At the assessed concentration, irritation is not expected, and lower exposure levels would be considered safe and can be readily calculated. COSMETICK and international regulatory requirements COSMETICK toxicological profiles are prepared in accordance with Annex I of the European Cosmetic Regulation (EC) No. 1223/2009 and SCCS recommendations for CPSR preparation. This methodology reflects principles widely recognised at the international level. For example, China’s CSAR regulation requires documented safety justification based on comprehensive toxicological profiles covering all relevant endpoints. Similarly, the US Modernization of Cosmetics Regulation Act (MoCRA) requires safety substantiation based on reliable and relevant toxicological data for each ingredient. COSMETICK fully aligns with this international approach to cosmetic risk assessment . Licences and access to COSMETICK R&D and toxicology teams may limit their needs to consultation of toxicological profiles, available through COSMETICK BASIC . More comprehensive needs — including finished product risk assessment, raw material use evaluation or fragrance concentrate assessment — are addressed through COSMETICK ADVANCED . Confidential raw materials can be integrated, and users may also include their own toxicological data to personalise reference values. References SCCS, Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation , 12th revision Regulation (EC) No 1223/2009 China Cosmetic Supervision and Administration Regulation (CSAR), NMPA US FDA – Modernization of Cosmetics Regulation Act of 2022 (MoCRA) COSMETICK: an established reference for digital cosmetic risk assessment COSMETICK is a reference digital tool for cosmetic risk assessment, combining a structured toxicological and ecotoxicological database, a robust scientific methodology and decision-support functionalities. It is designed to sustainably support toxicologists, safety assessors and R&D teams in an ever-evolving regulatory landscape. Discover how COSMETICK integrates with the regulatory requirements of the cosmetics market. Contact our toxicology experts to discuss your cosmetic risk assessment needs. Author: Clarisse BAVOUX
- CEHTRA 2025 Review: tools, expertise and solutions to anticipate regulatory risks
In 2025, CEHTRA continued its mission to support industrial companies, institutions and regulated stakeholders in a context marked by increasing regulatory complexity and growing challenges related to the protection of human health and the environment. This year was a structuring one for the group, with the launch of new digital tools, the evolution of long-standing services, the strengthening of our expertise and the development of strategic collaborations. CEHTRAWATCH: a global, expert regulatory monitoring platform One of the key highlights of 2025 was the launch of CEHTRAWATCH, a digital solution dedicated to international regulatory monitoring. CEHTRAWATCH enables users to: scan, track and receive alerts on more than 100 regulatory and toxicological lists, cover over 40 countries, receive personalised alerts based on substances or topics of interest, benefit from continuous updates validated by CEHTRA experts. Designed as a decision-support tool, CEHTRAWATCH helps companies save time, anticipate regulatory risks and work with reliable, structured information, while maintaining access to human expertise. RASafe: from Industrial Hygiene to a global Risk Assessment approach Historically focused on supporting chemical industry players through its Industrial Hygiene activity, CEHTRA evolved this offering in 2025 into a transversal service: Risk Assessment & Safety (RASafe). This transformation is based on a clear observation: chemical risk assessment , and particularly exposure assessment , remains a frequently underestimated pillar of regulatory compliance processes. A structured approach built on three complementary pillars RASafe is now organised around three core areas: Toxicological assessment: Hazard identification, data analysis and derivation of relevant reference values. Exposure modelling and estimation: Assessment of occupational and consumer exposure using recognised methodologies and tools. Regulatory support and training: Audits, preparation of technical documents (CSR, SDS…), and training on risk assessment tools and regulatory compliance, particularly under REACH. A transversal mission Through RASafe, CEHTRA supports industrial companies, public bodies and consultants in better understanding, assessing and managing chemical risks, with a central objective: protecting human health and the environment. CEHTRA blog and webinars: making regulation more accessible The year 2025 also marked the launch of the CEHTRA blog, designed as a space for sharing knowledge and educational resources. Each week, new articles are published to: decode regulatory news, explain key texts and obligations, help stakeholders navigate the regulatory landscape. In parallel, several webinars were organised to provide practical insights into current regulatory topics and to encourage direct exchanges with our experts. Acquisition of Prosacon: strengthening and expanding group expertise In 2025, CEHTRA continued its development with the acquisition of Prosacon, expanding the group’s scope of expertise and strengthening its ability to address increasingly transversal regulatory challenges. This acquisition is part of a strategy of controlled growth, aligned with the concrete needs of our clients. Flex+: agile outsourcing of expert resources The launch of Flex+ responds to a need identified in the field: enabling companies to quickly outsource expert resources, while ensuring high-quality deliverables and regulatory compliance. Flex+ offers a flexible approach, adapted to operational constraints and regulatory challenges faced by organisations. together Alliance: collectively addressing ethanol-related challenges in biocides In response to complex regulatory issues related to ethanol in biocidal products, CEHTRA launched the Together Alliance in 2025. This initiative is based on the belief that certain regulatory challenges require a collaborative approach, encouraging knowledge sharing and the development of joint solutions. Digital and artificial intelligence: supporting human expertise During the CEHTRA 2025 General Meeting, all group entities came together to work on issues related to digital transformation and artificial intelligence. The objective is clear: to explore how digital tools and AI can support experts’ daily work, improve process efficiency and enhance the quality of support provided — without ever replacing human expertise. 2025: a structuring year in support of regulatory compliance The year 2025 was marked by the commitment of our teams, the trust of our clients and close collaboration with our partners.Each project carried out this year helped strengthen our ability to support regulated stakeholders facing ever-higher requirements in terms of regulatory compliance, chemical risk management and regulatory monitoring. CEHTRA enters 2026 with the same ambition: to offer useful tools, rigorous expertise and operational support, closely aligned with real-world challenges.
Pages (98)
- REACH compliance : registration of chemicals | CEHTRA
CEHTRA assists you in updating your REACH registration dossiers. CEHTRA advises you for your chemical products: IUCLID studies, only representative (OR), advice on a substance, fragrance (UVBC), joint submission or consortium and data cost sharing. Chemicals regulatory services: REACH compliance and market access Expert guidance for chemicals registration and regulatory compliance. Our services Request support Expert REACH services for chemicals with global support CEHTRA’s consultants have extensive experience in preparing hundreds of REACH registration dossiers for lead registrants and co-registrants. We support chemical manufacturers and distributors with the full spectrum of REACH services, including dossier compilation and updates, IUCLID migration, SIEF and consortium management, testing strategies, Only Representative services, regulatory compliance, risk assessment, and environmental screening. Our multidisciplinary, multilingual teams, with offices across Europe and beyond, ensure regulatory compliance, streamline processes, and help your chemical products reach the market efficiently and safely. Contact our experts Key regulatory services for REACH Key Services REACH dossier compilation & update Compilation and update of REACH registration dossiers Preparation and submission of Lead Registrant and Co-registrant dossiers IUCLID dossier updates (migration, review, and corrective actions) TCC passing for dossiers submitted with older IUCLID 6 versions Full updates for IUCLID 5 dossiers Identification of vulnerabilities and recommended corrective actions Updates on tonnage, new UVCB qualities, and impurity profiles SIEF & consortium management Coordination and communication within SIEF and consortia Administrative and financial management of Letters of Access (LoA) Boundary composition including all SIEF information Facilitating joint testing strategies and dossier updates Only Representative & international compliance Acting as Only Representative (OR) for non-EU companies under REACH UK-REACH representation and regulatory support Guidance for EU importers, manufacturers, and downstream users (DU) Notifications and regulatory submissions to ECHA Testing Strategy & Regulatory Support Development and adaptation of testing strategies for REACH compliance Regulatory and scientific advice for portfolio and registration strategy Assessment of outcomes from new studies Impacts on Classification & Labelling (C&L) Looking for guidance on REACH compliance? Find it here. What is IUCLID and why is it important for REACH? IUCLID is the software used to create and compile information requested for REACH registration dossiers. It ensures that all safety, exposure, and regulatory information is properly documented. Keeping IUCLID dossiers up-to-date is critical for compliance. How can non-EU companies comply with REACH? Non-EU companies can appoint an Only Representative (OR) based in the EU to handle REACH obligations on their behalf. The OR can submit registration dossiers, is the contact point for ECHA communications, and ensure ongoing compliance, allowing international manufacturers and suppliers to legally market their chemicals in the EU. What are Letters of Access (LoA) and why are they needed? Letters of Access are annexes of Joint Submisson Agreements. They allow companies to legally use existing data submitted by the Lead Registrant in their REACH dossier. They help avoid duplicate testing, reduce costs, and ensure compliance with data-sharing obligations. Explore additional resources Can’t find your answer? Submit a request Enhance your regulatory strategy with our complementary services CEHTRA Training. Deepen your knowledge with our expertise. Digital Solutions. Your performance, our digital solutions. Simply Predict. In silico predictions: for faster, smarter decision-making. Flex + Your projects are moving forward. We provide the resources. Endocrine disruptors. The assessment of endocrine disruptors, with rigor and method. Haut de page
- PRIMO - Cloud Platform for Regulatory Compliance | CEHTRA
CEHTRA’s cloud-based regulatory information management platform. Centralize your data, manage projects, and perform Data Gap Analysis (DGA) for smarter worldwide compliance. PRIMO: Your digital solution for worldwide registration management A cloud-based platform by CEHTRA experts to simplify global regulatory compliance through secure data sharing, smart project management, and gap analysis. Access Your Account Book a demo All-in-One Platform for Secure Data, Project Tracking & Gap Analysis PRIMO (Principle Regulatory Information Management Organizer) is a cloud‑based platform specifically designed—by regulatory and IT experts at CEHTRA—to streamline worldwide regulatory compliance. It enables secure data sharing, project planning, and global regulatory gap analysis to support your testing strategies across all markets. Request your access Key features of PRIMO: your regulatory tool for smarter compliance Project Management Track the progress of your projects (Gantt) Budget tracking Assign tasks and follow-up Working documents & Regulatory insights Data Gap Analysis (DGA) Country-specific support for DGA based on country specific requirements Study Monitoring Dashboard Secure data storage & Sharing Secure sharing and storage of your data Easy upload and download of documents Exchange of large files Collaborative access Simultaneous access for both clients and CEHTRA team members. Select the formula that fits your requirements. Client Access* Upload/download documents Create/modify registration dossiers Create Tasks Track work progress (Gantt Chart) Access to country-specific DGA Access to country-specific support for DGA preparation Access to other clients' consultants Read Read / Write ✔ ✔ ✔ ✔ ✔ Read Read / Write Read Read / Write ✔ ✔ Ultimate Basic * CEHTRA offers a free access to PRIMO Basic to all its clients. Need help? Here are the answers to your questions. How do I access PRIMO? If you already have an account, you can log in via primo.cehtra.com . New users can request access or a demo by contacting primo@cehtra.com . Access to PRIMO Basic is free of charge for all CEHTRA clients. Who can benefit from using PRIMO? PRIMO is designed for regulatory affairs teams, R&D departments, project managers, and companies that need to comply with international regulations. Does PRIMO help with worldwide regulatory compliance? Absolutely. PRIMO is built to simplify global compliance by offering country-specific insights, centralized data management, and tools to keep you aligned with evolving regulatory requirements. Contact Book a demo
- Les Fondamentaux - Formations | CEHTRA Training
Apprendre et se tenir à jour sur les principales réglementations de votre secteur (Biocide, Cosmétique, REACH, Protection des plantes,...) The basics Learn and keep up to date on the essentials of the regulations. Our trainings Training > The basics > BIOCIDES COSMETICS ECOTOXICOLOGY FOOD MEDICAL DEVICES PACKAGING PLANT PROTECTION REACH TOXICOLOGY Ancre 1 Biological evaluation of medical devices in accordance with EN ISO 10993-1 from 690€ (HT) Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan View sessions Familiarise yourself with eSDS: obligations, content and compliance from 690€ (HT) Understand the obligations under REACH and the impact/penalties in the event of non-compliance Know how to draw up an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS View sessions How do Biocidal Product Families work? Accelerate your time to market! from 690€ (HT) Addressing the stages of an application for authorisation of a family of biocidal products : - Similarity of composition & grouping of co-formulants - Similarity of uses - Similar level of risk and efficacy Addressing the various points to be taken into account when dividing biocidal product families for current evaluations View sessions Introduction to packaging regulations: understanding and implementing them from 690€ (HT) Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) View sessions Master CHESAR to simplify your REACH assessments from 1035€ (HT) Understand the obligations under REACH How to use CHESAR to carry out a CSA (Chemical Safety Assessment) Be able to generate a CSR (Chemical Safety Report) under CHESAR Comply with ECHA expectations View sessions Master IUCLID and register your substances under REACH from 345€ (HT) How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT View sessions New ISO 10993-17 : 2023 - General and new features from 690€ (HT) Understand the methodology for the toxicological assessment of medical device components in accordance with ISO 10993-17:2023. View sessions Novel Food & Toxicological assessment: Selecting, understanding and interpreting key studies from 690€ (HT) Understand the role of toxicological studies in Novel Food dossiers. Identify the types of relevant studies depending on the nature of the product. Read and interpret key data from study reports. Identify quality and compliance criteria (OECD, GLP). Efficiently manage and communicate with subcontracted laboratories. View sessions PPWR: Overview of the Key Requirements and Anticipating Impacts from 148€ (HT) Gain a comprehensive understanding of the key requirements and deadlines outlined in the PPWR. This training will equip you with the knowledge to identify how each aspect of the regulation affects your company and its operations. By familiarizing yourself with the specific provisions, you will be able to proactively assess potential impacts on various business activities. Ultimately, the goal is to equip you with the knowledge to ensure compliance and mitigate risks associated with the PPWR. View sessions Plant Protection Products: from regulation to registration from 690€ (HT) Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid View sessions Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics from 148€ (HT) Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. View sessions Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment from 690€ (HT) Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification and Risk Assessment. Be able to spot the pitfalls of studies and know how to avoid them View sessions 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. See our certificate 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... +





