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Directive (EU) 2020/2184 establishes a harmonised framework intended to ensure the safety of materials and products that come into contact with water intended for human consumption. To achieve this objective, it introduces a central mechanism: the EUropean Positive Lists (EUPL) . These lists now constitute the single reference for determining which substances may be used in drinking water installations, whether pipes, storage tanks, treatment equipment or any other component of the network. The scope of the EUPL is defined in particular under Article 11(2)(b) and Annex V of the Drinking Water Directive (DWD).   The EUPL: Definition, Role and Scope The EUPL are unique reference lists that group together the substances, compositions or constituents considered safe for use in contact with drinking water. Their function is essential, as they make it possible to exclude any material likely to alter drinking water quality or present a health risk for consumers. Article 10 of the directive indeed requires that only materials, meaning solids, semi-solids, or liquids used for the manufacturing of a product (an item intended to be placed on the market and coming into contact with water intended for human consumption), listed on these registers may be used in installations. This requirement ensures full harmonisation at the European level and ends the differences in practices that previously existed between Member States.   Categories of Materials Covered The EUPL, presented in Commission Implementing Decision (EU) 2024/367, cover four major families of materials: Organic materials  including polymers, resins and monomers used in their manufacture. Cementitious materials , such as mortars or other cement-based components used notably in reservoirs or hydraulic structures. Metallic materials , including authorised alloys such as copper or stainless steel. Enamels, ceramics and other inorganic materials , which are included for applications requiring coated surfaces or specific components. For some of these materials, particularly organic and cementitious ones, the evaluation is based on the calculation of the MTCtap (Maximum Tolerable Concentration at the Tap). This threshold represents the maximum acceptable concentration at the point of use, defined either from ECHA opinions or limits set by the European Commission.   The Inclusion Process The inclusion of a substance in an EUPL is based on a strictly regulated scientific procedure involving a thorough risk assessment, taking into account the potential migration from the material into drinking water under the most unfavourable conditions of use. Conformity tests are then carried out to verify the material’s safety, particularly its impact on organoleptic properties and the microbiological balance of water. When all criteria are deemed satisfactory, the substance may be included in the positive list, following the opinion of ECHA’s Risk Assessment Committee (RAC).   Regulatory Framework and Implementing Decisions The evaluation procedure is defined by Delegated Regulation (EU) 2024/369 , which sets out the information requirements and the modalities for ECHA’s assessment. In parallel, implementing acts establish the test methods used to verify the conformity of substances or compositions. The application rules of Directive (EU) 2020/2184, notably the establishment of the lists and the testing requirements, are detailed in the following implementing decisions, all dated 23 January 2024: Commission Implementing Decision (EU) 2024/367 : Establishes the European positive lists of starting substances, compositions and constituents authorised for use in manufacturing materials or products that come into contact with water intended for human consumption. This document contains the European Positive List. Commission Implementing Decision (EU) 2024/365 : Lays down the application rules of the Directive regarding methodologies for testing and accepting starting substances, compositions and constituents for inclusion in the European positive lists. Commission Implementing Decision (EU) 2024/368 : Its annexes specify that certain cementitious constituents and certain starting substances may be used without being listed in the European Positive List. This exemption depends on their level of migration and/or hazard. Consequently, information (and potentially testing) on these aspects must be obtained to determine whether the substance must be included in the EUPL.   Dynamic Lists Regularly Updated The EUPL are not static. They are subject to periodic review to take account of scientific developments, new toxicological data or technological innovations. The first lists currently include 2,042 starting substances, compositions and constituents. Each listed substance must be reassessed at least every fifteen years. The initial European lists will be drawn up from existing national lists, then reviewed by ECHA to ensure compliance with European requirements. Each entry is associated with an expiration date defined according to the characteristics of the substance and the quality of the initial evaluation. The current deadlines extend to 31 December 2028, 2031, 2034 and 2037 . To remain listed, a renewal or re-evaluation request must be submitted 18 months before the expiration date . Regulatory Procedure: From Notification of Intention to Complete Submission The evaluation process begins with a Notification of Intention (NoI)  submitted via the IUCLID platform. This notification identifies the substance concerned, the associated material category and the type of application (new inclusion, withdrawal or re-evaluation of an already listed substance). The texts provide that NoIs may be submitted from 31 December 2025 . The corresponding complete dossiers must then be submitted within twelve months, meaning that the first inclusion or renewal applications may begin as of 31 December 2026 .   Strategic Importance for Public Health and Sector Stakeholders For operators in the sector, the Directive requires constant vigilance in the selection of materials and the verification of their compliance. They must ensure that the products used are listed, anticipate upcoming revisions, and communicate clearly with users regarding the guarantees offered by this regulatory framework.   Conclusion The European Positive Lists are among the most structuring instruments of Directive (EU) 2020/2184. They ensure a high level of health protection by precisely defining which substances are authorised in drinking water installations. Their implementation is based on robust scientific assessment, regular updates and active cooperation between authorities, manufacturers and operators. For more information, please visit the ECHA website ( DWD processes – ECHA ) or contact us.   References: Directive (EU) 2020/2184: Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast), OJ L 435 , 23.12.2020, pp. 1–62 . Available on: http://data.europa.eu/eli/dir/2020/2184/oj  (accessed on 01/12/2025). Commission Implementing Decision (EU) 2024/367:  Commission Implementing Decision (EU) 2024/367 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184, OJ L 2024/367, 23.04.2024. Available at: http://data.europa.eu/eli/dec_impl/2024/367/oj (accessed on 01/12/2025). ECHA : European Chemicals Agency, Drinking water directive  [online]. Available on: https://echa.europa.eu/water  (accessed on 01/12/2025) .

Understanding REACH Authorisation: A Control Mechanism for the Most Hazardous Substances Introduction The REACH Regulation (EC No 1907/2006) aims to ensure a high level of protection for human health and the environment from the risks posed by chemical substances. Among its four main pillars, Registration, Evaluation, Authorisation and Restriction, the Authorisation process is often the most complex for non-specialists to understand. Yet it plays a critical role in managing the most hazardous substances on the European market. This article explains what REACH Authorisation is, why it exists, who is affected, how an Authorisation dossier is built, and how we support our clients throughout the process. ation est d’expliquer ce qu’est l’autorisation REACH, pourquoi elle existe, qui est concerné, et comment se constitue un dossier d’autorisation et enfin comment nous accompagnons nos clients. Why is Authorisation required? Certain chemical substances present severe hazards: carcinogenic, mutagenic, or toxic to reproduction (CMR); persistent, bioaccumulative and toxic (PBT); or endocrine disruptors. These substances are identified as Substances of Very High Concern (SVHCs) . Once an SVHC is added to Annex XIV of REACH  (the “Authorisation List”), its use is prohibited after a specified sunset date , unless a specific Authorisation is granted for defined uses. The REACH Authorisation process therefore aims to: Control risks associated with the use of these substances. Encourage substitution with safer alternatives. Allow continued use when no technically or economically feasible alternative is available. Who is concerned? The following companies may require an Authorisation: Users of a substance listed in Annex XIV. Importers or suppliers placing the substance on the market for a specific use. It is essential to note that Authorisation is use-specific , not substance-specific: a company may apply for Authorisation for one defined use, even if other uses of the same substance are banned. When should an Authorisation be submitted? It is strongly recommended to submit the application before the Latest Application Date (LAD)  for each substance. If the authorities take longer to assess the dossier, the applicant may continue using the substance beyond the sunset date while awaiting the decision. Once granted, the Authorisation allows continued use of the substance beyond the sunset date under the conditions specified. Steps of the Authorisation Process: The Authorisation workflow includes: Identification of the substance as an SVHC. Inclusion in Annex XIV. Preparation and submission of the Authorisation dossier. Evaluation by ECHA (Risk Assessment Committee – RAC, and Socio-economic Analysis Committee – SEAC). Final decision by the European Commission. Building a REACH Authorisation Dossier A REACH Authorisation dossier is a highly technical and regulatory submission. It must demonstrate that risks are adequately controlled (for threshold substances) or minimised as far as possible (for non-threshold substances such as CMRs), and that no suitable alternatives exist. The dossier includes: Justification for the Application The applicant must explain why Authorisation is needed by defining: The precise uses of the substance, including technical context, operational constraints, and sector-specific details. The quantities involved. Chemical Safety Report (CSR) This report assesses human health and/or environmental risks associated with the use of the substance. It includes: Exposure scenarios describing risk management measures and operational conditions. Risk characterisation comparing exposure levels with “safe” limits (usually derived by RAC experts). Analysis of Alternatives The applicant must demonstrate: That alternatives have been investigated. Why they are not technically or economically viable. That alternatives would reduce risks to humans and/or the environment. It is now strongly recommended to include a Substitution Plan , describing timelines, milestones, organisational structure, and reporting mechanisms related to the future switch to alternatives. Socio-economic Analysis (SEA) This analysis generally compares: The societal benefits (not only company benefits) of continuing to use the substance,vs. The human health/environmental costs of discontinuing its use. Submission and Follow-up The dossier is submitted via ECHA’s portal. Fees apply depending on company size. The evaluation period is not legally fixed and may range from 18 months to 3 years based on our experience. Once Authorisation is granted, companies must: Comply with the conditions described in their dossier, plus any additional conditions set by EU authorities. Prepare a review report  when the Authorisation expires (typically after 4, 7, or 12 years), justifying why substitution could not be completed within the initial timeframe. Key Points for Non-Experts REACH Authorisation is not automatic  and must be justified. It concerns the most hazardous substances . The dossier is highly technical and often requires collaboration across the supply chain. How CEHTRA Supports You At CEHTRA, our experts assist clients with all stages of the Authorisation process: Definition of the use(s) Project management Preparation of all dossier components: CSR, Analysis of Alternatives, Substitution Plan, SEA Dossier submission Defence and responses to ECHA committees Our clients have consistently obtained the full durations requested, even for complex cases. Our experts are also active members of NeRSAP  (Network of Experts in Socio-economic Analysis and Analysis of Alternatives under REACH), ensuring they remain aligned with regulatory expectations and can engage informally with authorities when needed. Finally, these dossiers are complex and time-consuming. From experience, drafting all components typically requires 6 to 15 months , depending on team availability. For any additional questions, feel free to contact our experts.

What is an endocrine disruptor? In the European Union, an endocrine disruptor is defined as a substance that interferes with the hormonal system and may have harmful effects on humans and wildlife. These substances can be of synthetic or natural origin and may impact reproduction, growth, and development. In Europe, endocrine disruptors are assessed under various regulations, particularly those related to pesticides and biocides. The EFSA and l’ ECHA , as well as the l’ OCDE , have published guidance to help identify these substances. The criteria for identifying a substance as an endocrine disruptor are as follows: Endocrine activity : the substance must have endocrine activity. Adverse health effect : it must cause a harmful effect on health. Plausible biological link : there must be a plausible biological link between the endocrine activity and the adverse effect. Regulatory framework: Key milestones  2018 : assessing endocrine disruption potential became mandatory for plant protection products and biocides. April 20, 2023 : entry into force of new classifications under the CLP regulation, introducing the following categories: ED HH  (endocrine disruption for human health), Categories 1 and 2 ED ENV  (endocrine disruption for the environment), Categories 1 and 2 Upcoming or pending regulations:   Update of the Cosmetics Regulation to include the evaluation of endocrine disruptors. Upcoming REACH revisions: identification of endocrine disruptors starting at the lowest tonnage band (from 1 tonne/year). How CEHTRA can support you? In this demanding regulatory context, CEHTRA offers solid expertise and tailored services to support companies in the evaluation of endocrine disruptors.   Key services provided: Critical review of existing data: Review of available regulatory data Targeted bibliographic research and analysis Generation of new, specific data when needed: Tailored testing strategies (in vitro, in vivo) In silico screening (predictive modeling) Monitoring of specific ED-related studies Data compilation in line with the regulatory context: Robust synthesis of studies EFSA table and identification of levels of evidence Determination of classification according to CLP criteria Detailed reports for specific substances or formulations Expert statements (position papers) on ED potential for humans and/or the environment Added value: In silico screening by QSAR experts Use of digital tools to optimize analysis and related costs Tailored services for various sectors (biocides, cosmetics, plant protection products, chemicals, etc.) An experienced in-house team of ecotoxicologists and toxicologists Digital tools ED Pedia : CEHTRA also offers ED Pedia, an interactive tool that allows you to: Instantly check, via CAS number, whether a substance is likely to be an endocrine disruptor Access relevant documentation Download a PDF report of the results Request a CEHTRA expert’s opinion if needed ED Pedia relies on official substance evaluation lists to determine the level of concern regarding a substance’s ED potential. Anticipating regulatory changes Regulation is evolving rapidly: new CLP classifications have already been introduced, and further regulatory changes regarding cosmetics and REACH are expected in the coming months. CEHTRA helps you anticipate and adapt to these developments to ensure your products remain compliant while minimizing risks. Contact Julien Leghait , Head of the Endocrine Disruptors Service , or visit the dedicated page for more information.

CEHTRA provides regulatory, toxicology and risk assessment expertise for the chemical, biocides, PPP, cosmetics, pharma, food industries, ... Your partner in regulatory compliance and product safety Simplify your regulatory compliance with our expertise and innovative tools. Our sectors Contact us Nos programmes Recognized expertise in Regulatory Affairs and Risk Assessment For over 25 years, CEHTRA has been supporting chemical industry players across key strategic sectors. We assist manufacturers, formulators, distributors, and importers in areas including industrial chemicals (REACH), biocides (BPR), plant protection products (PPP), cosmetics, pharmaceuticals, and food products, including novel foods & supplements, as well as packaging, and other sectors related to health, environmental protection, and product safety. Thanks to our multidisciplinary expertise in toxicology, ecotoxicology, risk assessment and international regulations, we offer tailor-made solutions adapted to the specific requirements of each market, both within and outside Europe. Contact an Expert Our Areas of Expertise biocides Explore chemicals Explore cosmetics Explore food Explore packaging Explore pharmaceuticals Explore plant protection Explore all Explore Digital Solutions for Regulatory Affairs & Toxicology Your performance, our smart solutions. REACH Authorisation: Process, Requirements and Key Insights The REACH Regulation (EC No 1907/2006) aims to ensure a high level of protection for human health and the environment from the risks posed by chemical substances. Among its four main pillars, Registration, Evaluation, Authorisation and Restriction, the Authorisation process is often the most complex for non-specialists to understand. Yet it plays a critical role in managing the most hazardous substances on the European market. REACH AUTHORISATION Directive (EU) 2020/2184: Revision of Drinking Water Quality Standards in EU The Directive (EU) 2020/2184, adopted on December 16, 2020, marks a pivotal change in the management of drinking water across EU. It replaces the 1998 directive and aims to ensure universal access to safe and high-quality drinking water while enhancing transparency, monitoring, and risk management. This legislation has significant implications for water suppliers, industries dealing with materials in contact with water, as well as consultants and other stakeholders in the sec NEWS Proposed European Restriction on Octocrylene (CAS 6197-30-4): Scientific and Regulatory Issues Octocrylene is a widely used ultraviolet (UV) filter in cosmetic products, particularly sunscreens, designed to absorb UVB and part of the UVA spectrum, thereby protecting the skin against the harmful effects of sunlight. Currently, octocrylene is authorised in cosmetic products at a maximum concentration of 9% in accordance with Annex VI of the European Cosmetics Regulation... COSMETICS 1 2 3 4 5 Need guidance? Speak with our specialists Select a sector:* First name:* Last name:* Company or Organization:* Email:* How can we help you? Submit

COSMETICK : l’outil digital tout-en-un pour l’évaluation toxicologique et la sécurité des produits cosmétiques. Profils toxicologiques, éco-toxicologiques, calculs de marges de sécurité (MoS) et préparation du RSPC (CPSR) en quelques clics. COSMETICK: the digital tool for cosmetic compliance and safety Access toxicological and eco-toxicological profiles, assess formula safety, and speed up your time-to-market — all in one online solution. Discover Book a demo Simplify your cosmetic compliance with COSMETICK The cosmetics industry faces strict regulatory requirements — especially in Europe under Regulation (EC) No. 1223/2009 , which mandates a Cosmetic Product Safety Report supported by reliable toxicological profiles. COSMETICK is your all-in-one digital solution to streamline, automate, and secure your product safety compliance process. Designed for toxicologists, safety assessors, and formulators , COSMETICK supports you from formulation to market launch. The platform provides robust toxicological and eco-toxicological profiles and enables automated formula safety assessments . With advanced customization features, assessors can input their own data and easily finalize their safety conclusions. Improve efficiency, reduce error risk, and ensure product safety with confidence. Test the substance profile search Key features of COSMETICK: your toxicological assessment tool for cosmetic products Complete toxicological and eco-toxicological profiles Characterization of effects based on a bibliographic synthesis classified by toxicological endpoint Identification of no-effect doses (for irritation, sensitization, systemic toxicity) Identification of alerts using colored icons for fast, clear reading. Evaluation of cosmetic formulas Simplified formula entry and choice of product type Clear, intuitive display to facilitate decision-making (safety margin, alerts, etc.) Automatic export of a pre-filled report for customization A dynamic platform Customization of toxicological data On-line profile request in just a few clicks Regular database updates Monthly newsletter to keep up with regulatory news View all features They chose COSMETICK: Discover their feedback. "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." Select the formula that fits your requirements. Access to toxicological profiles Eco-toxicological profiles Customization with confidential data Export toxicological profiles and reports Updates & regulatory newsletter Advanced Details Basic Details Need help? Here are the answers to your questions. What are the different COSMETICK licences available? COSMETICK offers two license levels tailored to your cosmetic ingredient toxicological evaluation needs: BASIC License : Provides simple and quick access to toxicological profiles of substances. ADVANCED License : Offers full access to all platform features, including the generation of toxicological pre-assessments. Each license is available in two options: Unlimited Access : Perfect for frequent use or multiple users. On-Demand Access : Flexible and cost-effective for occasional use. Need help choosing the best plan for your needs? Contact our team at cosmetick@cehtra.com . What to do if an ingredient is missing from the COSMETICK database ? Can’t find a toxicological profile in our COSMETICK database? No worries! Simply submit a request through our online form . Your request will be reviewed and, once approved, the profile will be added to the database. You can track the progress of your request directly online. We’ll notify you by email as soon as the new profile is available. Does COSMETICK generate a Cosmetic Safety Report? The report provided by COSMETICK is a pre-assessment that includes all essential data to support risk evaluation, such as: Exposure analysis based on your product’s formulation Calculation of Margins of Safety (MoS) for each ingredient Assessment of impurities , including CMR substances (Carcinogenic, Mutagenic, or Reprotoxic) Skin tolerance rationale Option to incorporate your own data (test results, specifications, etc.) This c ustomizable document helps streamline the final preparation of the Cosmetic Safety Report (Part B of the CPSR). Contact Book a demo

CEHTRA experts assess your cosmetic products and ingredients and prepare your Cosmetic Products Safety Report (CPSR) and Product Information File (PIF). Cosmetick database is a powerful toxicological tool that anticipates risk, based on regulatory updates and toxicological data evolutions. Our expert ecotoxicologists can also be consulted to recommend eco-conceptions design for your formulations. Cosmetic products and ingredients: ensure their safety Personalized support for your cosmetic products and ingredients: regulatory compliance, pre-assessment, testing strategy, and toxicological report Our sevices Request support Simplify Cosmetic Compliance Across Europe and Beyond CEHTRA supports companies in the cosmetic industry (start-ups, SMEs, and international groups) in the safety evaluation and regulatory compliance of their products at both the European and international levels . Our experts work across a wide range of products (skincare, hygiene, fragrances, etc.), relying on comprehensive and regularly updated toxicological data, as well as alternative methods (QSAR, read-across, structural alerts) to address data gaps. Committed to a more sustainable cosmetics industry, we provide ecotoxicology services through our COSMETICK tool, a digital solution that delivers ecotoxicological profiles and alerts on environmental risks. Contact our experts Our key services in cosmetic product safety and regulatory compliance Ancre 1 Cosmetic products Pre-assessments Safety reports Ingredients under development Testing strategies In silico approaches Complementary data Intended uses Digital solutions COSMETICK Database of toxicological and ecotoxicological profiles Cosmetic formulation evaluation Data customization, alerts, and monitoring Explore COSMETICK Ingredients & raw materials Toxicological profiles Ecotoxicological profiles Identification of safe concentration levels for cosmetic uses Support for toxicological and ecotoxicological issues Tailored training Endocrine disruptor potential analysis Literature search and bibliographic review In vitro testing: analysis and guidance Data gap management through alternative methods (read-across, in silico approaches) via Simply Predict Looking for guidance on cosmetics? Find it here. What are the main regulatory obligations for placing a cosmetic product on the European market? In Europe, cosmetics must comply with Regulation (EC) No 1223/2009. This requires the preparation of a Product Information File (PIF), which includes a Cosmetic Product Safety Report (CPSR) authored by a toxicologist, the appointment of a Responsible Person (RP), product notification on the European CPNP portal, and compliant labelling. CEHTRA supports its clients at every stage to ensure a smooth and secure market entry. How can the safety of cosmetic ingredients be assessed? Each ingredient must be evaluated for its toxicological and ecotoxicological properties, maximum authorised concentrations, impurities, and potential interactions. CEHTRA’s experts carry out in-depth assessments including literature reviews, analysis of existing data, and the application of alternative methods to ensure the safety of formulations and their regulatory compliance. What are the risks of non-compliance with cosmetic requirements? A non-compliant product may be withdrawn from the market, expose consumers to health risks, result in regulatory sanctions, and damage brand reputation. Authorities can require rapid corrective actions or ban its commercialisation. CEHTRA helps companies anticipate these risks through strong regulatory expertise and tailored compliance strategies. Explore additional resources Can’t find your answer? Submit a request Enhance your regulatory strategy with our complementary services Flex+ Outsource your human resources with complete peace of mind: we find, recruit and manage your profiles, whether for one-off assignments or long-term projects. 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. Endocrine disruptors. The assessment of endocrine disruptors, with rigor and method. Flex + Your projects are moving forward. We provide the resources. Haut de page