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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.

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 (directive 98/83/EC) and aims to ensure universal access to safe and high-quality drinking water while enhancing transparency, monitoring, and risk management. This regulatory text has significant implications for water suppliers, industries manufacturing materials in contact with drinking water, as well as all stakeholders across the sector. In this article, we will explore the key objectives, new requirements, and essential details of this directive to help you understand its impact on water management practices. We will also provide a brief introduction to the positive lists, which we will explore in detail in a next article. The revision of the Drinking Water Directive (DWD) is part of the European Union's strong commitment to protecting public health and the environment by ensuring access to clean and safe drinking water. Originally adopted in 1998 and thoroughly revised in December 2020, the Directive was updated to reflect scientific advances and address emerging pollutants such as endocrine disruptors and microplastics. This revision was also a direct response to the "Right2Water" European Citizens' Initiative, emphasizing citizens' right to access high-quality drinking water. The revised DWD (Directive (EU) 2020/2184) entered into force on January 12, 2021, requiring Member States to transpose its provisions into national legislation by January 2023. Its overarching goal is to ensure that all EU citizens benefit from some of the highest drinking water standards in the world, while promoting sustainable water management and enhancing consumer confidence in tap water.   1. Key Objectives of revised DWD The main objective of this directive is to protect public health while improving the quality of drinking water across the European Union. To achieve this, the directive sets several specific goals: Public Health Protection : Drinking water must be free from chemical and microbiological contaminants that could harm health. Improved Access to Drinking Water : The directive aims to ensure universal access to safe and affordable drinking water. Enhanced Monitoring : It establishes stricter monitoring of water quality and mechanisms for risk assessment. Sustainable Water Management : The directive includes measures to protect water resources against the impacts of climate change and other environmental pressures.   2. New Drinking Water Quality Parameters and the Watch List Mechanism The revised DWD represents a substantial evolution in the EU regulatory framework for drinking water, introducing updated quality parameters and a watch list mechanism to ensure a high level of health protection in light of emerging environmental challenges. In accordance with Article 5 , Member States are required to adopt and comply with the parametric values established in Annex I , which encompass microbiological, chemical, and indicator parameters. This revision integrates the most recent scientific findings and recommendations of the World Health Organization (WHO) , leading to the inclusion of new chemical substances such as Bisphenol A, PFAS (Total and Sum) and Chlorate. These additions reflect growing concerns about endocrine disruptors , pharmaceutical residues , microplastics , and other persistent organic pollutants , thereby reinforcing the long-term safety of drinking water across the European Union. Complementing these static standards, the Directive introduces a dynamic watch list mechanism , established under Article 13 . This tool is used to proactively monitor emerging substances of concern that are not yet subject to mandatory regulatory limits but may pose a risk to human health. The European Commission is mandated to establish and periodically update this list based on scientific evidence and data provided by Member States. The first version of the watch list includes, among others, 17-β-estradiol and nonylphenol, both recognized as endocrine-disrupting chemicals.   3. Risk-Based Approach and Supply System Management The directive strengthens water quality monitoring and requires a complete risk-based approach to water safety  (Article 7). This approach is implemented in line with the Water Safety Plan (WSP) approach developed by the World Health Organization (WHO). Member States must ensure the implementation of this comprehensive risk-based approach. WSPs are proactive risk assessment and risk management approaches  recognized as the most reliable way to manage drinking-water supplies for public health protection. This approach is built on a preventive safety planning approach  and relies on the multiple-barrier approach. The EU risk framework requires three components of assessment: catchment risk (Article 8), supply system risk (Article 9), and domestic distribution system risk (Article 10). Specifically, WSPs, applied through this framework, include: Risk Identification: Water suppliers carrying out the risk assessment of the supply system  must identify the hazards (biological, chemical, physical, or radiological agents) and hazardous events in the supply system. This assessment must take into consideration risks stemming from climate change, leakages and leaking pipes. The identification also covers specific pollutants relevant for the catchment areas. Risk Assessment, Validation, and Management: Once risks are identified, specific strategies must be implemented to mitigate them. This involves systematically determining the risk score  (product of likelihood and severity) and risk level. For existing measures, this requires validating the effectiveness of existing control measures  in controlling the hazardous event. Based on the outcome, control measures  are defined and implemented for the prevention and mitigation of risks identified in the supply system. This also involves implementing a supply-specific operational monitoring program  (article 13) to ensure control measures function as intended. Emergency Procedures and Corrective Actions : The WSP framework includes developing Emergency Response Plans (ERPs) for serious situations that require immediate, extensive action for which there is no standard operating procedure. In the event of non-compliance with parametric values that constitute a potential danger to human health, immediate remedial action (article 14) must be taken, including prohibiting or restricting the water supply.   This approach not only ensures immediate protection but also contributes to the long-term resilience of drinking water supply systems.   4. Materials in Contact with Drinking Water (Articles 10 and 11) A significant innovation introduced by the directive concerns materials in contact with drinking water. To prevent harmful substances from leaching into drinking water, the directive sets minimum requirements for these materials and establishes a harmonized framework across the EU. On April 23, 2024, the European Commission published a comprehensive set of legal acts in the Official Journal of the European Union, including three implementing decisions (EU 2024/365, EU 2024/367, EU 2024/368) and three delegated regulations (EU 2024/369, EU 2024/370, EU 2024/371). These new measures introduce: A Positive List  of authorized starting substances, compositions, and constituents used in materials that encounter drinking water. Testing Methodologies  and harmonized European Positive Lists to ensure consistent safety evaluations. A Procedure for Adding New Substances  to the Positive List (Regulation (EU) 2024/369). Conformity Assessment Procedures and rules for designating assessment bodies (Regulation (EU) 2024/370). Harmonized Specifications for Product Marking , ensuring transparency and traceability (Regulation (EU) 2024/371). These regulations, which came into force on May 15, 2024, will generally apply from December 31, 2026 . They cover materials used in new installations for water abstraction, treatment, storage, and distribution, as well as those used in repair works. Through these measures, the EU has established a unified, science-based approach to ensuring the safety and quality of drinking water from source to tap, further strengthening public health protection and supporting the free movement of compliant materials and products across the internal market.   5. Consumer Information Access A crucial aspect of this directive is transparency. Consumers must be regularly informed about the quality of the water they consume. The results of water quality analyses should be easily accessible and understandable, such as through mobile apps or water bills. Additionally, water suppliers must inform consumers about corrective measures in the event of contamination, potential health risks, and actions taken to ensure water quality. This transparency aims to build consumer trust in tap water, encouraging its use over bottled water.   Conclusion Directive (EU) 2020/2184 represents a major advancement in ensuring high-quality drinking water across the European Union. It imposes new safety standards, strengthens water quality monitoring, and introduces strict requirements for materials used in drinking water infrastructures. Furthermore, it adopts a risk-based approach in line with the Water Safety Plans (WSPs) , supporting proactive risk management. The emphasis on transparency and consumer trust in tap water is also key. In a future article, we will explore in greater detail the European Positive Lists (EUPL) , which play a crucial role in regulating materials in contact with drinking water. Stay tuned! Bibliography 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 19/11/2025). Water safety plan manual : World Health Organization, Water safety plan manual: step-by-step risk management for drinking-water suppliers [online], second edition, 2023, ISBN 978-92-4-006769-1. Available on: https://www.who.int/publications/i/item/9789240067691 (accessed on 19/11/2025).

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 [1]. However, due to increasing environmental concerns, and following a proposal from the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), the European Chemicals Agency (ECHA) launched in 2025 a public consultation concerning a potential restriction on the use of octocrylene in finished cosmetic products. This proposed restriction aims to prohibit octocrylene in cosmetic products at concentrations equal to or greater than 0.001% [2]. The public consultation will open on 24 September 2025  and close on 24 March 2026 . Early comments are encouraged before 23 January 2026 , to allow the Committees to consider feedback during their initial discussions. The final decision on this proposed restriction is expected in 2027, following the opinions of ECHA’s scientific committees and the European Commission [2].   1. Rationale for the Restriction The primary objective of this restriction is to mitigate environmental risks arising from the widespread accumulation of octocrylene in aquatic environments. Although octocrylene is an effective UV filter for skin protection, it poses an environmental hazard due to its persistence and toxicity, particularly in aquatic ecosystems. Indeed, octocrylene is poorly biodegradable and may accumulate in the biological tissues of aquatic organisms [1] .   2. Hazard Characterisation The hazard profile of octocrylene is evaluated based on its ecotoxicological properties, including toxicity, persistence, and bioaccumulation potential. • Persistence and limited biodegradability: Octocrylene is concluded to be persistent (P)  and very persistent (vP)  due to its low biodegradability, according to standard OECD 301 biodegradation tests. It displays high lipophilicity (log Kₒw > 6) and an aromatic structure, both indicators of potential bioaccumulation in biological tissues.Although environmental monitoring data suggest in situ accumulation in living organisms, in vivo fish studies  indicate that octocrylene is neither bioaccumulative (B) nor very bioaccumulative (vB)  under the bioaccumulation criteria of Annex XIII of REACH. Consequently, octocrylene is not classified as very persistent and very bioaccumulative (vPvB)  [1]. • Aquatic toxicity: Octocrylene exhibits high chronic toxicity to aquatic organisms. Tests on Daphnia magna  established a NOEC (No Observed Effect Concentration)  of 2.66 µg/L  for reproduction, indicating significant toxicity even at low concentrations. From this, a PNEC (Predicted No Effect Concentration)  of 0.266 µg/L  for freshwater can be derived [1] .   3. Risk Characterisation The environmental risk assessment combines both the hazard profile of octocrylene and the actual exposure conditions in aquatic environments. The risk is expressed as the ratio between the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC).   Risk Characterisation Ratios (RCR): The RCRs—comparing PEC to PNEC—are used to assess risk under various exposure scenarios. RCR values exceed 1 in most cases. In the scenario related to emissions during bathing in freshwater lakes (ES 12), RCR values are calculated at 744 for freshwater and 7443 for freshwater sediments.For marine coastal waters, the RCR is 109 for water and 1108 for sediments. These values indicate that actual concentrations of octocrylene in the environment far exceed the PNEC of 0.266 µg/L, suggesting an unacceptable environmental risk [1,2]. Emission and dissemination pathways: The main emission routes of octocrylene into the environment include: Direct release during swimming , where up to 50% of the applied amount may be washed off into the water [2]; Indirect release via domestic wastewater , leading to the dissemination of octocrylene into agricultural soils and watercourses, thereby increasing aquatic contamination [1,2]. Such widespread and persistent emissions contribute significantly to aquatic pollution and heighten environmental risk.   4. Proposed Restriction The restriction proposal under public consultation aims to ban the use of octocrylene in finished cosmetic products at concentrations ≥ 0.001% . This measure seeks to reduce emissions of the substance into the environment, mainly by limiting its use in cosmetics, which constitute the primary source of exposure [1,2] .   5. Scientific and Industrial Implications Key strengths of the restriction: Protection of aquatic ecosystems:  Octocrylene is toxic to many aquatic organisms even at low concentrations. Restricting its use would help preserve aquatic ecosystem integrity [1] . Availability of substitutes:  Several next-generation UV filters with more favourable environmental profiles are available as potential alternatives to octocrylene in cosmetic formulations. Precautionary principle:  Reducing exposure to this substance aligns with the REACH Regulation’s objectives to minimise exposure to persistent and toxic chemicals [1] . Limitations and uncertainties: Bioaccumulation uncertainty:  Although persistent, the bioaccumulation potential of octocrylene in aquatic organisms remains insufficiently characterised [1] . Ecological substitutes:  While alternative UV filters exist, their environmental profiles have not yet been fully validated, which may hinder their immediate implementation   [2] .   6. Conclusion Assessments by France and ECHA conclude that the widespread use of octocrylene represents an unacceptable environmental risk under REACH criteria. The key hazard elements, chronic toxicity, persistence, and wide diffusion, justify a preventive regulatory action.The proposed restriction, setting a threshold of 0.001%, represents a strong regulatory measure to protect aquatic ecosystems, while granting industry sufficient time to adapt. Octocrylene exemplifies the balance between environmental protection and human health safety. The European Commission’s final decision will need to ensure a transition towards safe, efficient, and sustainable cosmetic products.   References French Agency for Food, Environmental and Occupational Health & Safety (ANSES). Regulatory Management Option Analysis (RMOA) on Octocrylene.  Report for public consultation, March 2023. Available on the official ANSES website. (2023) European Chemicals Agency (ECHA). Annex XV Restriction Report: Proposal to restrict Octocrylene (CAS 6197-30-4).  Consultation launched on 24 September 2025, closing on 24 March 2026. Accessible via the ECHA website. (2025) To access the full toxicological and ecotoxicological profiles of this substance in COSMETICK To learn more about CEHTRA’s expertise in cosmetics and ingredient safety

The unexpected appearance of N-nitrosamine impurities in medicines marked a major regulatory turning point. These compounds, already known to occur in the environment and food, compelled the global pharmaceutical industry to re-evaluate its manufacturing processes. In response, an unprecedented level of international coordination emerged among major regulatory agencies, including the FDA (United States), EMA (Europe), Anvisa (Brazil), and Health Canada, aiming to assess the extent of the issue and establish mitigation strategies. This event had a profound impact on the reassessment of manufacturing processes, enforcing increased vigilance and stricter controls at all stages of pharmaceutical production—from raw materials to finished products. Toxicological Profile of N-Nitrosamines Structure and Mechanism of Action N-nitrosamines are characterized by a nitroso (-N=O) functional group bound to an amine (>NR₂). Their toxicity relies on a crucial bioactivation mechanism that begins with α-hydroxylation, primarily catalyzed by cytochrome P450 (CYP 450) enzymes. This step leads to the formation of unstable intermediates that subsequently generate reactive diazonium ions. These ions are highly electrophilic and can interact with DNA, causing irreversible genetic damage. Mutagenic and Carcinogenic Properties Due to their ability to alter DNA, N-nitrosamines are classified as mutagenic and genotoxic agents. Their properties also make them potent carcinogens. Extensive studies have shown that 82% of 228 tested nitrosamines were carcinogenic in vivo, underlining their hazardous nature. This high prevalence of carcinogenicity justifies the stringent regulatory measures implemented and the need to minimize their presence in pharmaceutical products. The 2018 Crisis and Its Expansion The N-nitrosamine crisis emerged in 2018, following the unexpected detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in sartan drugs—commonly used for the treatment of hypertension and heart failure. This initial discovery quickly led to a broader investigation, revealing a more systemic issue. Contamination was subsequently identified in other widely prescribed medicines, including ranitidine (an H2 receptor antagonist), nizatidine (another antiulcer drug), and metformin (used to treat type 2 diabetes). The detection of these impurities resulted in large-scale product recalls worldwide, exposing the systemic nature of the problem and highlighting the need for a comprehensive reassessment of manufacturing and quality control processes within the pharmaceutical industry Sources of N-Nitrosamine Contamination Contamination of pharmaceuticals with N-nitrosamines can arise from multiple sources and complex mechanisms throughout the drug lifecycle. Understanding these origins is essential to prevent and mitigate their formation: Formation during synthesis:  Reaction between nitrites and secondary or tertiary amines (or their precursors) under acidic or high-temperature conditions. Reagents or intermediates may themselves be contaminated. Contaminated solvents:  Certain solvents such as Dimethylformamide (DMF) or N-Methyl-2-pyrrolidone (NMP) may degrade into amines or nitrites, leading to N-nitrosamine formation. Recycled materials:  Use of recycled solvents or reagents, if insufficiently purified, can introduce N-nitrosamines or their precursors. Azide degradation:  Azides used in specific syntheses may degrade in the presence of nitrites to form N-nitrosamines. Excipients:  Some excipients may contain tertiary amines (e.g., crospovidone, povidone) or be contaminated with nitrites, promoting in situ formation of N-nitrosamines in the finished product. Active substance degradation:  The active ingredient itself can degrade to generate amines or other precursors of N-nitrosamines. Packaging materials:  Primary packaging materials (e.g., certain plastic films or labels) may release amines or nitrites that react with the drug product. Storage conditions:  Elevated temperature and humidity during storage can accelerate component degradation and N-nitrosamine formation over time. Regulatory Framework and Mitigation Strategies Given the complexity and scale of the N-nitrosamine issue, regulatory agencies have established a structured three-step approach for the pharmaceutical industry: Risk Assessment: The first step involves identifying potential risks of N-nitrosamine formation or contamination across the entire product portfolio. This requires a detailed analysis of synthesis pathways, raw materials, excipients, solvents, and manufacturing and storage conditions. Manufacturers must demonstrate that they have thoroughly evaluated and characterized these risks. Confirmatory Testing: Following risk assessment, robust analytical testing is required to confirm the presence or absence of N-nitrosamines. High-sensitivity methods, such as liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS), are preferred for their precision and ability to detect trace levels of these impurities. Control and Mitigation: If N-nitrosamines are detected, or a significant risk is identified, control and mitigation strategies must be implemented. These may include modifications to synthesis routes, use of alternative raw materials, optimization of storage conditions, or the establishment of strict impurity limits. Dedicated working groups, such as the NISG (Nitrosamine Impurities Steering Group)  and the NITWG (Nitrosamine Impurities Working Group) , have been created to coordinate actions and share best practices globally. Acceptable Intakes of N-Nitrosamines To protect public health, regulatory authorities have defined Acceptable Intake (AI)  limits for N-nitrosamines. The underlying principle is to ensure that the additional lifetime cancer risk remains below 1 in 100,000. Specific AI limits have been established for the most common N-nitrosamines: NDMA (N-nitrosodimethylamine):  96 ng/day NDEA (N-nitrosodiethylamine):  26.5 ng/day For newly identified nitrosamines lacking compound-specific toxicological data, the Carcinogenic Potency Categorization Approach (CPCA)  is applied. This approach classifies nitrosamines into carcinogenic potency categories (PC 1 to PC 5), each associated with corresponding AI limits. In addition, the Less-Than-Lifetime (LTL)  concept allows temporary adjustment of exposure limits for shorter treatment durations, acknowledging that cumulative risk is lower over limited periods. Need assistance ensuring regulatory compliance for your pharmaceutical products?

When a company develops a new ingredient, whether it is a concentrated plant extract, a biotech-derived ferment, a processed algae or a “functional” mushroom, one recurring question always arises: is a Novel Food procedure required before marketing the ingredient within the EU?   This question often emerges when the project is already well advanced: the formulation is nearly finalized, the marketing identity is ready, the first commercial discussions have started… and suddenly, regulatory uncertainty arises. This can cause a serious slowdown, or even block market entry, if the question has not been addressed early on.  The reality is that innovation does not take place solely in the laboratory or through marketing arguments. An essential part of success lies in the regulatory qualification of the ingredient , particularly regarding its possible classification as a Novel Food  under the criteria defined by the European Union.    What “Novel Food” Really Means  The term Novel Food  does not imply a risk or a restriction. It refers to a regulatory concept : a Novel Food is simply a food or ingredient that was not consumed to a significant degree before 15 May 1997  by the European population, or that results from an innovative process  altering its composition or bioavailability.  Since safety cannot be justified through long-term, significant consumption, it must instead be demonstrated through toxicological safety studies .  Therefore, Novel Food status is not a judgment of immediate safety , but rather an invitation to demonstrate safety  in an official dossier, evaluated by EFSA and validated at the European level. Being classified as Novel Food does not mean “impossible to market”, but rather “requires prior authorization”.    A Quick Test to Know if Your Ingredient Falls Within the Novel Food Scope  Here are a few simple points of attention. If several of these statements apply to your ingredient, a Novel Food status analysis is likely necessary.  Your ingredient has not been the subject of documented consumption in Europe before 1997.   You use an innovative process that modifies the concentration, structure, or metabolites of the raw material.   The ingredient is fermented using a strain or a technique that is not part of Europe’s food tradition.   The source comes from a species rarely consumed in the EU (specific microalga, medicinal mushroom, microorganism, cell culture, etc.).   The final chemical profile is no longer comparable to the traditional raw material.  If you identify with one or more  of these cases, a regulatory screening  is recommended before any commercial communication or product launch.    Common, and Often Underestimated, Situations  Many companies believe they fall outside the scope of the Novel Food Regulation because the ingredient exists naturally or is consumed in other parts of the world. However, the reality is quite different.  example, while curcuminoids extracted from Curcuma longa  root  and standardized to 95% curcumin are authorized in Europe for use in food supplements, curcumin itself  is considered a Novel Food.    Regulatory Solutions to Confirm the Status of Your Ingredient  The Novel Food Regulation allows, in cases where an ingredient’s status is unclear, to consult the competent authorities  through a formal consultation procedure  designed to officially determine the status of an ingredient.  This procedure gives an EU Member State the responsibility, based on data provided by the applicant, to decide on the ingredient’s classification. It is an optional procedure , with both advantages and disadvantages  that should be carefully assessed before submission.    What Changes When an Ingredient Is a Novel Food  When an ingredient is considered a Novel Food, the regulatory approach changes. It is no longer simply a matter of verifying compliance with a positive list, but of providing scientific evidence of safety  for European consumers under realistic conditions of use (dose, formulation, target population, cumulative exposure, etc.).  The evaluation covers:  The exact composition, including impurities, possible nanoparticles, solvents, or residues  Technical specifications (natural variability, stability)  Manufacturing processes  Dietary exposure of different population groups  Available toxicological data  The ability to demonstrate absence of risk under intended conditions of use    The Importance of Anticipation  The earlier the status is assessed, the more secure the time-to-market  will be. Conversely, discovering a potential Novel Food issue once formulations are finalized and commercial partners are engaged can lead to multi-year delays,  time needed to compile a dossier, conduct or gather the required studies, submit to the competent authorities, and wait for their evaluation.  This is why more and more companies are integrating a Novel Food regulatory screening  early in the development phase, even before finalizing the product positioning.    CEHTRA, Supporting You to Decide Quickly and Wisely  At CEHTRA , we support project leaders, manufacturers, and start-ups during this critical qualification phase. The goal is not only to prepare a dossier later, but to help you make the right decisions quickly :  Verify whether the ingredient falls under the scope of the Novel Food Regulation  Identify the elements to be documented (consumption history, equivalence, composition, etc.)  Build a realistic and progressive safety assessment strategy  Develop a clear, well-argued, and robust dossier in case of official submission  Our approach aims to secure your innovation without unnecessary obstacles .    In Conclusion  Determining whether an ingredient is a Novel Food is not a mere administrative formality, it is a strategic step  that defines commercial feasibility, cost anticipation, and credibility with partners.  The earlier the verification is carried out, the smoother, more controlled, and transparent the innovation path will be, both internally and with investors, clients, and distributors.  To discuss your specific case or request a Novel Food status assessment, you can contact Marie Liamin , Food Products Market Manager at CEHTRA .

The identification of endocrine disruptors (EDs) has become a major public health and environmental concern worldwide. EDs are chemical substances capable of interfering with the hormonal system, leading to adverse effects on both humans and wildlife. Monitoring and assessing these substances is essential to protect human health, particularly among vulnerable populations such as pregnant women, children, and wild species. To this end, the U.S. Environmental Protection Agency (EPA) has developed ToxCast , a comprehensive database compiling in vitro  biological activity data for hundreds of chemicals, enabling the analysis of their potential endocrine-disrupting effects. What is the ToxCast Database? ToxCast  (short for Toxicity Forecaster ) is a flagship EPA program designed to evaluate the toxicological potential of chemicals. Using a suite of high-throughput in vitro screening (HTS)  assays, ToxCast examines the bioactivity of thousands of chemicals across multiple biological targets. These in vitro  assays measure biological responses, including hormonal activity, on specific receptors, enzymes, and cellular processes involved in endocrine regulation. The main goal of ToxCast is to provide detailed data on chemical substances to predict their potential to interfere with biological systems, particularly endocrine systems in humans and animals. With data on more than 10,000 chemicals , ToxCast has become an invaluable resource for researchers and regulators seeking to identify endocrine disruptors. One of the key advantages of ToxCast lies in its non-animal testing approach , reducing reliance on traditional animal studies. This aligns with the European Union’s “One Health” strategy , Directive 2010/63/EU, and the EU roadmap toward phasing out animal testing, by promoting the use of alternative methods such as in vitro  assays and computational approaches in toxicity assessment. What Does This Update Include? The latest version of the ToxCast database, invitrodb v4.3 , introduces several critical improvements, many of which directly enhance its usefulness in endocrine disruptor evaluation. 1. Enhanced Data Analysis The updated ToxCast release introduces new analytical features that improve the accuracy and reliability of in vitro  screening data interpretation. These enhancements allow researchers to better understand biological effects on hormone receptors and other key mechanisms underlying endocrine function. Improved analytical tools now integrate additional parameters, making it easier to compare data across substances. For example, chemical effects on hormonal receptors can be assessed faster and more precisely, allowing for early detection of substances potentially disrupting endocrine pathways . 2. Updated Software Tools The software tools used to process ToxCast data have also been upgraded. Widely used R packages , such as tcpl and tcplFit2, have been enhanced to provide improved data handling, smoother workflow management, and more advanced visualization capabilities. The tcplFit2 package, for instance, now offers more accurate dose–response curve fitting , enabling more reliable estimation of effect concentrations. This is essential for assessing risks associated with low-dose exposures to EDs, which are frequently encountered in real-world environmental settings. 3. Expanded Chemical Coverage The update also expands ToxCast’s chemical coverage, now encompassing over 10,000 evaluated substances . This broader dataset supports a more comprehensive toxicological assessment, including for lesser-known or emerging substances that may pose endocrine-related risks. CEHTRA’s Digital Tool: Supporting ED Identification One of the major advances in applying ToxCast data is CEHTRA’s digital tool , designed to facilitate rapid access and interpretation of information from the ToxCast database. 1. Instant Substance Check Through a CAS number search , CEHTRA’s tool allows instant verification of a chemical’s regulatory status and its inclusion in lists of potential or confirmed endocrine disruptors. By entering a single CAS number, users can access detailed information about a substance’s status, potential toxicity, and regulatory evaluation history. This feature represents a significant time-saver , offering quick and reliable access to critical regulatory and toxicological data. 2. Integrated ToxCast Data Analysis Beyond regulatory status, the CEHTRA tool also enables direct analysis of ToxCast data  for the queried substances. It streamlines the exploration of in vitro  high-throughput screening results to assess bioactivity on endocrine-relevant biological targets. In just a few clicks, users can visualize the full spectrum of a substance’s biological effects on hormone receptors, enzymes, and related cellular pathways. By simplifying the use of complex datasets, CEHTRA’s tool empowers users to draw scientifically robust conclusions on endocrine activity , supporting both regulatory assessments and research efforts. This functionality is particularly valuable for ED studies, where data heterogeneity often poses analytical challenges. Conclusion The latest ToxCast database update  marks a major step forward in the evaluation of endocrine disruptors. With expanded chemical coverage, improved analytical methods, and enhanced data management, this update provides a stronger foundation for assessing the potential hazards of chemical substances. CEHTRA’s digital tool complements this progress by offering an intuitive platform to access and analyze ToxCast data efficiently. Together, these innovations enable faster, more reliable identification of endocrine-disrupting substances, strengthening the capacity of regulatory and industrial stakeholders to protect public health and the environment . Need expert support for your endocrine disruptor assessments?

PFAS at the Heart of Regulatory Concerns Per- and polyfluoroalkyl substances (PFAS) are receiving increasing attention from European authorities due to their persistence, bioaccumulation, and toxicity. In this context, the Plant Protection Products (PPP)  sector is now under closer scrutiny following the publication of the ECHA Annex XV restriction report . According to this report, active substances used in PPPs, biocidal products, and medicinal products differ chemically from other PFAS subgroups  due to the presence of one or more CF₃ groups , a key molecular signature for understanding their environmental behavior . Key Figures from ECHA and the EU Pesticide Database While the PPP sector represents only 2% of total PFAS sales  within the EU, it remains a major regulatory focus . Based on data from the European Pesticide Database , 89 molecules  contain at least one CF₃ group: 57  have already expired and are no longer in use 1  is currently under evaluation for first approval 25  are undergoing renewal procedures 6  are scheduled for future renewal In addition, Annex A (v2 – 2023)  lists 47 PFAS-based active substances  used in PPPs (non-exhaustive list), all requiring further assessment and regular updates . Trifluoroacetic Acid (TFA): A Key Regulatory Issue Trifluoroacetic acid (TFA)  can form in soil, water, and plants from the degradation of molecules containing CF₃ groups. Persistent and toxicologically relevant, TFA has now come under close examination by European authorities. Some active substances in PPPs degrade into TFA, potentially impacting renewal timelines or leading to stricter re-evaluations. What to Expect in 2025: EFSA Task Force Dedicated to TFA The European Food Safety Authority (EFSA) has established a dedicated working group to revise the toxicological reference values for TFA. Two initial meetings took place in November 2024 and February 2025, focusing on: Reviewing TFA data submitted by EU notifiers (in vivo and in vitro studies) Proposing updated reference values Coordinating with ECHA’s Risk Assessment Committee (RAC) and the German competent authority Additional meetings are planned throughout 2025, with an official EFSA statement expected by year-end, which could reshape evaluation and renewal strategies across the sector. CEHTRA’s Support CEHTRA’s experts assist companies in ensuring regulatory compliance regarding PFAS, helping them to: Interpret ECHA reports and data, Assess degradation pathways, including those leading to TFA, Anticipate regulatory impacts on their active substances and product portfolios Contact our Plant Protection expert, Estelle Beltran , for a tailored assessment and proactive strategy ahead of upcoming regulatory changes.   Coming Next This article opens a dedicated series on PFAS regulatory developments in plant protection and biocidal products.With every EFSA/ECHA meeting or key regulatory milestone (2025–2026), CEHTRA will publish a concise and actionable update to help industry stakeholders stay informed and compliant.

At CEHTRA, we believe that scientific expertise alone is not enough. What truly makes a difference is the way it is put at the service of clients, teams… and, more broadly, society as a whole. Since day one, our teams have shared a strong conviction: no effective regulatory strategy can be built without a human, collaborative and responsible vision . Collective intelligence at the core of our support CEHTRA brings together an international and multidisciplinary team , fluent in English, French, German and Spanish , with professional backgrounds spanning industry, regulatory authorities, laboratories and consultancy . This diversity is our strength. It allows us to approach each dossier with a 360° perspective , anticipate regulatory developments and design strategies tailored to each market. “Working with different perspectives broadens our vision and pushes us to consider aspects we might not have identified on our own.” Client-focused support, from the first exchange to regulatory success At CEHTRA, one project means one dedicated point of contact . We believe in human, responsive and flexible support , where active listening is just as important as technical expertise.Our mission is not only to respond to regulatory obligations, it is to provide clear, actionable and reassuring solutions at every stage of the process . “Sharing our experience to build trust and co-develop effective strategies is what drives us every day.” Innovation and continuous improvement The regulatory landscape evolves quickly, very quickly . This is why we actively foster a culture of continuous improvement : new digital tools, optimized internal workflows, and open knowledge-sharing across teams and countries.At CEHTRA, innovation is not a statement, it is a daily practice serving our clients. A responsible and sustainable commitment Independent and part of the Social and Solidarity Economy (SSE) , CEHTRA operates with a strong environmental conscience.Our teams are 100% trained on climate impact awareness , and we actively work to reduce our carbon footprint by rethinking our ways of working, traveling and producing materials. More than a regulatory service provider, we aim to be a trusted partner committed to ethical and responsible collaboration . Choosing CEHTRA means choosing: Recognized scientific and regulatory expertise Human, tailored and attentive client support An engaged, multicultural and collaborative team A responsible vision of regulatory compliance, built for the future 📩 I nterested in discussing your regulatory challenges?

In today’s fast-paced regulatory environment, staying ahead of changes in chemical and product regulations is more important than ever. Companies need a reliable, easy-to-use solution to track updates, ensure compliance, and mitigate risk. That’s where Cehtrawatch , our innovative digital regulatory monitoring tool , comes in. Streamline your regulatory compliance Cehtrawatch is designed to simplify compliance management. Whether you manage chemical substances, industrial products, or complex portfolios, our platform provides an intuitive interface that allows you to monitor regulatory changes in real time. With automated alerts  and a comprehensive overview of all relevant updates, your team can focus on decision-making instead of manual tracking. Key features of CEHTRAWATCH - your digital regulatory monitoring tool Instant Portfolio Overview : Run a T0 scan of your substances in under 30 minutes, get a clear regulatory overview of your portfolio at a glance. Real-time regulatory alerts : Keep track of updates to regulatory and toxicological lists without constant manual checks. Change history tracking : Review updates over time to understand regulatory trends and prepare for upcoming requirements. User-friendly dashboard : Navigate complex regulatory data easily with a clean, intuitive interface. Customizable reporting : Generate reports tailored to your organization’s needs for internal tracking or regulatory submissions. Why choose CEHTRAWATCH? With the growing complexity of global regulations, relying on manual tracking or fragmented tools is no longer viable. Cehtrawatch  empowers companies to: Reduce compliance risk and avoid potential fines Stay ahead of changes in regulatory and toxicological lists, with all updates carefully controlled by regulatory experts Save time with automated monitoring and reporting Make informed decisions backed by accurate, up-to-date regulatory data Ensure your business stays compliant effortlessly Access the platform instantly online — no installation or software required Get started today With CEHTRAWATCH, regulatory watch becomes simpler, faster, and more reliable. Whether you are in cosmetics, chemicals, pharmaceuticals, or other industries, this tool is designed to give you clarity and control.  For more information or to schedule a demo of Cehtrawatch, please contact our key representative, Sara Lozano , who will be happy to guide you through the platform.

n-Hexane (CAS No. 110-54-3) is a volatile aliphatic hydrocarbon derived from petroleum distillation. Used as a solvent, it plays a key role in several sectors:  Food industry : extraction of vegetable oils (soy, rapeseed, sunflower), flavors, and proteins.  Cosmetics and perfumery : obtaining absolutes, essential oils, and pure plant extracts.  Its popularity is based on its efficiency, high yield, and low cost. However, this solvent requires strict purification to limit residues and protect exposed workers ( ANSES ).   Long largely unknown to the general public, its use is now attracting attention. The press ( Le Point ) recently highlighted that it could indirectly be present in certain food products. Once metabolized, n-hexane is converted into 2,5-hexanedione, a molecule capable of accumulating in the brain and causing neurological effects ( Fiche toxicologique n°113 - Edition Juin 2025).    The ECHA Proposal: Toward Inclusion on the SVHC List  In February 2025, Slovenia proposed to ECHA (European Chemicals Agency) that n-hexane be classified as a Substance of Very High Concern (SVHC) due to its neurotoxicity. The public consultation, opened in August 2025, will close on October 16, 2025.  This classification is based on Article 57(f) of the REACH Regulation (EC No. 1907/2006). The candidate SVHC list already includes over 240 concerning substances (carcinogens, reproductive toxins, endocrine disruptors, etc.). Inclusion triggers information obligations and can lead to authorizations or usage restrictions.    Implications for the Cosmetic and Food Industries, and for Consumers  Transparency and labeling: obligation to inform when a product contains more than 0.1%.  Search for alternatives : adoption of safer processes (supercritical CO₂, “green” solvents).  Costs and reformulations : adaptation of processes, investments, and potential increase in final product price.  Health and public perception : better protection and transparency for consumers, but possible increased concern reported by media.  Regulatory pressure and certifications : organic certifications and certain markets will likely require its absence, accelerating the transition to other techniques.  This trend is already encouraging the development of solvent-free processes, such as the EcoXtract®  approach.    Consideration in Cosmetic Products  In cosmetics, n-hexane may remain as trace  residues after ingredient extraction. At these levels, the risks are considered negligible for consumers. European Cosmetic Regulation No. 1223/2009 requires safety assessors to check for these impurities in their reports.    Classified as CMR (Repro cat.2, H361f) , n-hexane is prohibited as an ingredient  in cosmetic products. As in the pharmaceutical sector (ICH Q3C (R8)), it is only tolerated as a residual impurity  at strictly limited concentrations. Its neurotoxic effects, severe at high doses, are known and controlled through exposure thresholds. Therefore, the presence of traces does not pose a danger to the end user.    Ensuring Safety and Anticipating Regulatory Changes  For manufacturers, having a detailed toxicological profile  of each substance is essential to secure formulations and anticipate regulatory developments. Potential inclusion of n-hexane on the SVHC list would mark an important step and could accelerate the transition to more sustainable alternatives.  In the context of cosmetic regulations, having a detailed toxicological profile helps professionals anticipate and secure their formulations.  ➡️ To explore the complete profile of this substance, visit our dedicated page: 👉  https://www.cehtra.com/cosmetick    And check out the associated LinkedIn post  for a concise overview.

A Floral Aldehyde Under Regulatory Scrutiny HOMONOPAL, also known as Pinoacetaldehyde, is a synthetic aromatic aldehyde commonly used in fragrance compositions. Its CAS number is 33885-51-7. Known for its green, floral, and slightly aldehydic scent, this compound imparts freshness and lift to perfume accords, particularly in fine fragrances, personal care products, and cleaning formulations. Industries Impacted HOMONOPAL is used across a wide range of sectors: Cosmetics and personal care, including perfumes, shampoos, lotions Household cleaning agents Industrial fragrance applications Its broad application stems from both its olfactory profile and its performance in complex fragrance matrices. New Regulatory Developments from ECHA In April 2025, the European Chemicals Agency (ECHA) published a new Assessment of Regulatory Needs  (ARN)  for Pinoacetaldehyde. This document significantly shifts the regulatory landscape for this fragrance ingredient, highlighting serious human health and environmental concerns. ECHA concludes the substance presents: Known or potential hazard for reproductive toxicity Known or potential hazard for skin sensitisation Known or potential hazard for aquatic toxicity Based on this assessment, ECHA outlines the following regulatory actions: "Harmonised classification as Reprotoxic category 1B." "Potential restriction: Harmonised classification as Repr. 1B would lead to generic restriction of the substance(s) in consumer mixtures by means of restriction entry 30." "The harmonised classification as Repr. 1B may trigger regulatory action under the Cosmetic Products Regulation and render the substance unacceptable as a co-formulant in biocidal products." The assessment also notes that HOMONOPAL is widely used in professional settings, often with low levels of operational controls and risk management: “Restriction of professional uses is preferred over authorisation as it is considered to be more efficient and effective to introduce controls at the level of placing on the market rather than at the level of uses.” "Frequent exposures with a long duration" are also highlighted, particularly concerning for vulnerable worker populations. Implications for the Cosmetics Industry The harmonised classification as Reprotoxic Category 1B  has direct implications for cosmetic uses. Under the Cosmetic Products Regulation (EC) No 1223/2009, substances classified as Repr. 1B are generally prohibited unless explicitly exempted by the European Commission. In practical terms, this could mean: Prohibition of HOMONOPAL in consumer cosmetics Reformulation pressures on fragrance suppliers Loss of functionality in certain perfume accords If the restriction under Annex XVII, entry 30 of REACH is adopted, it will also mean a generic restriction in consumer mixtures, including many non-cosmetic fragrance applications. Conclusion The regulatory future of HOMONOPAL is now at a critical juncture. While still legally used today, the proposed harmonised classification and restrictions may lead to its complete phase-out in consumer products, including cosmetics. Formulators, regulatory teams, and risk assessors should begin preparing substitution strategies and consider the toxicological profile of alternatives. This case exemplifies the increasing scrutiny on fragrance ingredients and the importance of proactively managing substances with potential reproductive and environmental hazards. Link to the ECHA assessment

When it comes to nutrition, dietary supplements, or innovative ingredients, the word “ natural ”  immediately inspires trust. But is a natural ingredient always safe for consumption? Spoiler alert : not necessarily. And this is precisely what scientists and food safety experts strive to demonstrate—with evidence to back it up. Natural does not mean harmless The misconception is persistent: what comes from nature cannot cause harm. Yet nature is full of active, powerful substances… sometimes toxic. Some well-known examples include: Certain plants, such as belladonna or foxglove, can cause severe poisoning. Essential oils, which are very popular, may contain molecules with neurotoxic or irritating effects that can present a risk if not used appropriately. Beyond the intrinsic composition of natural products, external contamination (heavy metals, hydrocarbons, bacterial toxins, microbes…) can also render natural substances unfit for consumption. In short: natural ≠ harmless. And this is something that national health authorities and EFSA (European Food Safety Authority) regularly remind us of through their scientific evaluation What determines the safety of a natural ingredient The safety assessment of an ingredient derived from natural products does not depend solely on its origin. It is based on several factors, including: Chemical composition : extraction, concentration, presence of secondary metabolites… Parts used : composition can vary greatly between a plant’s root, leaves, or fruit. Dose of exposure : “the dose makes the poison,” as Paracelsus once said. Mode of consumption : ingestion, skin application, inhalation… Consumer profile : healthy adult? pregnant woman? child? A plant extract used for centuries in herbal tea can become problematic if concentrated in a dietary supplement or given to a vulnerable population. An essential safety evaluation In Europe, food ingredients without a significant history of consumption prior to 15 May 1997 are considered Novel Food . This means they must undergo an authorization request to the European Commission. The aim of this request is to demonstrate the safety of the Novel Food under the intended conditions of use. These often complex dossiers must provide scientific evidence, frequently supported by toxicological data, of their safety. Even outside the Novel Food framework, all food products, including those already authorized, must be free of risk for consumers. It is the responsibility of manufacturers and/or market operators to ensure this absence of risk, by keeping up to date with regulatory and toxicological developments concerning the ingredients they use. CEHTRA supports you in securing your natural ingredients At CEHTRA, we support industries, start-ups, and project leaders through these complex steps of assessing the safety of their products. We offer: Analysis of available toxicological data on your product ingredients Identification of regulatory status (Novel Food or not) Preparation of a solid safety dossier Integration of digital tools to anticipate potential issues Our specialized team helps you secure innovation without slowing down your ambitions. The goal? To launch your ingredient in full compliance, with a clear, transparent, and reassuring message for your clients and partners. Contact Marie Liamin , Food Products Market Leader, or visit the dedicated page for more information.

1. Known Uses  Glabridine is an isoflavonoid (isoflavane) extracted from Glycyrrhiza glabra  (licorice root). It is widely used in cosmetics for its skin-lightening and anti-tyrosinase activity, as well as for its antioxidant and anti-inflammatory properties. It is mainly found in skincare products, anti-aging creams, and sunscreens. 📖 J Lui, 2025 ScienceDirect   2. Mechanism of Action of Glabridine   Glabridine inhibits tyrosinase, a key enzyme in melanin synthesis responsible for skin pigmentation. It acts as a reversible, non-competitive inhibitor, meaning it effectively reduces tyrosinase activity without directly binding to its active site. This inhibition occurs through a multi-phase kinetic process, suggesting the formation of a stable glabridine-tyrosinase complex. 📖 J Chen, 2016 PubMed   3. Toxicological and Regulatory Concerns   Available scientific data show efficacy in tyrosinase inhibition, but systemic toxicity studies remain limited. Points of caution include:  The potential estrogenic activity of certain isoflavones, an endocrine-disrupting effect observed in some tests, particularly in vitro, cannot be excluded (CIR Glycyrrhiza Glabra  (Licorice), 2008) CIR Reports   Limited data on systemic toxicity and reproductive toxicity (EFSA, 2011) EFSA Journal   Our view:  Such effects and “data gaps” warrant further research.  In the context of cosmetic regulations, having a detailed toxicological profile helps professionals anticipate and secure their formulations.  To explore the complete profile of glabridine, visit our dedicated page:  https://www.cehtra.com/cosmetick    📢 And check out the associated LinkedIn post for a concise overview : https://lnkd.in/p/eSj7GxE5

In the recent meeting of Coordination Group (CG-54), a proposal of the Austrian Member State was discussed which has been raised in a CG e-consultation, concerning information on the use frequency of products (“Number and timing of application”) for use in PT 1, PT2 and PT4 given by the applicants in SPC and PAR for BPR product authorization. Austrian authorities are experiencing that applicants often use quite general terms for application frequency for professional and nonprofessional use, such as “as required” or “daily use”, etc. It has been proposed that these general terms must not be accepted any longer by the Member States, as the application frequency, e.g., expressed in number of applications per day, determines how often the product is applied and is a crucial input parameter especially for human exposure assessment. The maximum or typical number of applications per day must be stated in SPC and DRA/PAR authorised use to reflect realistic worst-case assumptions. This proposal has been agreed at CG-54 meeting in November 2022 by consensus: For product authorisation, the use frequency must be given in SPC and PAR according to the guidance and Annex VI, point (33) of the BPR and the term ‘as required’ (or similar terms, e.g. ‘daily use’) for determination of application frequency shall be no more accepted by the member states for the application frequency without further justification. Details of application frequency are relevant input parameters for human and environmental exposure and risk assessment. Therefore, the (maximum or typical) number of applications per day must be stated in SPC and DRA/PAR authorised use. Examples are given as follows: Example 1 , hand disinfectants used in the medical sector: Nurses or hospital/medical staff should use hand disinfectants as often as necessary. However, in the case of hand disinfectants, a “maximal or typical” number of applications per day should be indicated in SPC and PAR authorised uses. This number should correspond to the safe number of applications determined by the exposure scenario (reverse reference scenario). Example 2 , surface disinfection products: no clear use frequency can be set. Therefore, a “maximal or typical” number of applications per day should be indicated in SPC and PAR authorised uses. This number should correspond to the safe number of applications determined by the exposure scenario ( reverse reference scenario , chapter 3.2.5.5). Example 3 , automated dosing: In certain situations, “as required” can mean “adding the product intermittently to the system, in order to maintain a system concentration within certain defined limits”. In such cases, the term “as required” might be acceptable. However, typical and/or maximal amount of product needed for application should be given. This conclusion might generally be applied to all PTs. Sources: CG-54_e-c Use of the term as required for the application frequency_vf.pdf ECHA Guidance on the Biocidal Products Regulation Volume III Human Health - Assessment & Evaluation (Parts B+C), Version 4.0, December 2017, chapter 3.2.5.5 Reverse reference scenarios

On 2nd of December 2021, the ECHA Biocidal Products Committee (BPC) recommended the approval of ABDAC/BKC and adopted the BPC opinion for PT2 by simple majority. Two Member States (Germany and Finland) raised their concerns about unacceptable risk for environment, mainly for the soil compartment. As the concerns could not be solved at the 76th meeting of the Standing Committee of Biocidal products (SCBP) on 24th June 2022, ECHA organized a dedicated meeting with the eCA, the concerned Member States and the Commission services on 23rd August 2022 to resolve the reservations of the concerned Member States. It became clear during the 77th meeting of the SCBP that further discussions and assessment are needed to be able to clarify whether the exposure of the active substance to soil compartment is resulting in an acceptable risk or not. Therefore, ECHA is requested to revise its opinion on ADBAC/BKC for PT2 considering the information available in the application for approval of the active substance, discussions and arguments expressed during the various expert and regulatory meetings (BPC Environment Working Group, BPC plenary, the Standing Committee meeting, and the ad-hoc meeting of 23 August 2022), as well as the additional arguments that may be put forward during the additional discussions it will organise. ECHA is requested to provide a revised assessment report and a revised opinion. As the opinion shall be adopted by 30th June 2023 at the latest, the approval of ADBAC/BKC for PT2 can be expected in July 2025. Sources: Mandate requesting ECHA opinions under Article 75(1)(g) of the BPR "Re-assessing the risk on the environment (soil compartment) posed by ADBAC/BKC from use in biocidal products of PT2"

ECHA developed in 2022 a recommended (i.e. not mandatory) framework guidance to applicants for approval of biocidal active substances but also to Member State Competent Authorities (MSCAs) on how to perform an analysis of alternatives (AoA) to active substances being candidate for substitution (CfS) according to Art. 10(1) of the Biocidal Products Regulation ((EU) 528/2012). The guidance has been adopted at BPC-45 meeting and published in January 2023. It provides a set of elements which can be used to assess the availability of suitable alternatives to substances meeting the exclusion criteria (Art.5(1)), and substances meeting the substitution criteria (Art. 10(1)), but not the exclusion criteria. It allows a flexible approach, tailored to the case and the entity performing the analysis of alternatives (i.e. an applicant or a MSCA). Applicants for CfS are advised to submit analysis of alternatives to MSCAs which are as comprehensive as possible, including a public version for publication, covering the different intended uses as part of their application. The submission of an AoA is not legally required but strongly recommended to support the comparative assessment at product authorisation stage as products containing a candidate for substitution will have to be subject to a comparative assessment by the receiving/evaluating competent authority at the time of authorisation and will only be authorised if there are no suitable alternatives (Art. 23(3)). Evaluating MSCAs also do not have a legal requirement to make an AoA per se in the active substance approval/renewal process but might be willing to make one themselves, e.g. as a complement to one submitted by an applicant. An analysis of alternatives is recognized to be very challenging due to numerous limiting factors such as limited and variable information on intended uses of biocidal products containing this active, limited information on number of uses, biocidal products and treated articles on the EU market, limited knowledge and expertise on the uses and potential active substance alternatives. Furthermore, approval of active substances according to different requirements and rules, different dossier types at different stages of the regulatory process also lead to uncertainties in the assessment of chemical alternatives. Despite these limitations, such analyses conducted by the applicants for CfS can provide a useful set of information for either the substance approval/renewal or for subsequent product comparative assessment. A good quality and sufficiently detailed analysis of alternatives provided by the applicant could lighten the workload for the more specific comparative assessments at product authorization stage. The information on alternatives collected at the stage of active substance approval/renewal can also be used by third parties willing to submit information on alternatives during the third parties’ consultations under Article 10(3). This guidance is mainly addressed to: The applicants to support their application for approval/renewal of a biocidal active substance which is meeting the exclusion or substitution criteria The MSCAs willing to perform an analysis of alternatives for active substances meeting the exclusion or substitution criteria (as a complement to one submitted by an applicant or for other reasons) It should be seen as a recommended non-mandatory framework guideline, providing advice on how to perform and structure an analysis of alternatives for active substances candidate for substitution. It is accompanied by a template which provides a structure for reporting this analysis. Applicants of such substances are advised to use this guidance and to submit an analysis of alternatives to their eCA as part of their application. A public version of this analysis is intended to be published on ECHA’s website. The guidance does not lead to clear-cut conclusions on the availability of suitable alternatives for the intended uses. This first version describes the desired content for AoA but not the content for the related aspects of the derogation criteria related to Art 5(2)(b)5 or Art 5(2)(c)6. For the latter criteria, the ECHA guidance on socioeconomic analysis may be mainly considered. Sources: Analysis of alternatives to biocidal active substances for applicants and authorities: a recommended framework guidance CA-Dec22 Doc.5.4.a AoA Guidance implementation Final.docx Template for analysis of alternatives ECHA guidance on socio-economic analysis

With the recent publication of the Packaging and Packaging Waste Regulation (PPWR) , Europe is entering a new chapter in circular packaging management , strengthening its commitment to sustainability  and the reduction of plastic waste . This regulation introduces key principles that will reshape the packaging industry: Recyclability of Packaging The PPWR requires packaging to be fully recyclable, meaning that all materials must be efficiently processed and reused. This is a major step toward a more circular and sustainable economy. Mandatory Recycled Content The regulation sets a minimum percentage of recycled content for plastic packaging from post-consumer waste. This encourages the use of recycled materials, reduces reliance on virgin resources, and boosts the recycling market. Waste Minimization PPWR aims to reduce packaging waste by promoting efficient, lightweight designs that use fewer materials while maintaining functionality. Harmonized Labeling and Sorting The regulation introduces Europe-wide harmonization of packaging labeling and sorting instructions. This makes it easier for consumers to sort packaging waste and allows businesses to comply with consistent guidelines, improving overall waste management. CEHTRA: Your Partner for PPWR Compliance At CEHTRA, we support companies in adapting to these new requirements. Our expertise helps you stay compliant with regulations while implementing sustainable and circular packaging solutions. Ready to ensure your packaging is fully compliant? Contact us today to get expert guidance from CEHTRA.

In March 2017, Annex VIII to the CLP Regulation  was introduced to harmonise the poison centre notification (PCN) process across EU Member States. This harmonised system became fully effective in January 2021  (extended from January 2020). Who is concerned? All importers and downstream users  placing hazardous mixtures  (classified for health and/or physical effects) on the EU market must provide specific information about their mixtures  to the centralised EU poison centre before placing them on the market. Key obligations To comply with Annex VIII, companies must: Register a Unique Formula Identifier (UFI) Include the UFI  on the label  for consumer and professional use Include the UFI  in Section 1.1 of the Safety Data Sheet (SDS)  for industrial use They must also submit a notification  via the ECHA harmonised submission portal , including: The full chemical composition  of the mixture Toxicological information  (SDS Section 11) The product category (according to the EU Product Categorisation System – EUPCS) The SDS and label  in the national language of the country where the product is placed on the market The UFI , a 16-character alphanumeric code that uniquely identifies the mixture and can be generated using ECHA’s UFI Generator Who holds the obligation? The obligation lies with the EU legal entity  (importer or downstream user).A non-EU supplier  cannot fulfil this requirement on behalf of the EU-based duty holder.However, a duty holder can entrust a third party , such as CEHTRA , to prepare and submit the PCN notification on their behalf. Compliance timeline Depending on the use of the mixture, the following deadlines apply: Hazardous mixtures for consumer and professional use:  from 1 January 2021 Hazardous mixtures for industrial use: from 1 January 2024 Existing mixtures already notified  under national systems: by 1 January 2025 How CEHTRA can support your PCN compliance CEHTRA provides a full range of regulatory support services to help you ensure compliance with Annex VIII requirements: Portfolio Review Screen your portfolio to identify mixtures that require PCN and determine notification deadlines. Safety Data Sheet and Label Review Perform a full compliance review of SDSs and labels to ensure they meet CLP and Annex VIII requirements. PCN Preparation and Submission Prepare and submit PCN notifications via the ECHA submission portal. UFI Generation Screen for full notification information and generate UFI codes for each mixture. Regulatory Advice Offer tailored regulatory advice on how best to fulfil your obligations under the CLP Regulation. With CEHTRA’s expertise, you can achieve and maintain full compliance with EU poison centre notification requirements efficiently and confidently.