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On 13 January 2026, the European Commission’s Joint Research Centre (JRC) published a new report: “JRC technical proposal on EU harmonised waste sorting labels under the packaging and packaging waste regulation”. ( Available here: JRC Publications Repository - JRC technical proposal on EU harmonised waste sorting labels under the packaging and packaging waste regulation ) More than just a design report The document is a technical blueprint to support the European Commission in developing future, harmonised packaging-sorting instructions, so consumers and producers encounter the same logic across Member States and packaging can circulate smoothly within the Single Market.  This timing is important because the Packaging and Packaging Waste Regulation (PPWR) applies from 12 August 2026, and the Commission is expected to use the JRC work as an input when preparing the secondary legislation on labelling. What the JRC report is proposing  At its core, the JRC proposes a harmonised system of consumer-facing labels for packaging and waste receptacles (bins), built to work across Europe’s very different collection and sorting systems.   The key idea is intuitive: matching labels so the label you see on packaging corresponds to what you should look for on the bin (and vice-versa).   The report serves as evidence-based input for the Commission services, especially DG Environment, to support the planned implementation measures of the PPWR (the JRC aims to inform the Commission’s implementing acts mentioned in the PPWR).  Built from behavioural evidence, not “designer taste”  One of the strongest signals in the report summary is the methodology behind it. The JRC says the proposal is grounded in:  extensive desk research  empirical evidence from citizen workshops, surveys, and experiments  expert stakeholder workshops and consultations   That matters, because sorting labels only work if they work in real kitchens, offices, and public spaces under time pressure, in different languages, and with varying levels of recycling knowledge. “Flexible, yet harmonised”: the balancing act  The JRC repeatedly frames the challenge as finding the sweet spot between EU-wide harmonisation and practical flexibility for Member States and real-world packaging constraints.   In practice, that balancing act shows up in three main design questions:  What should the label communicate?  The proposed “conceptual approach” focuses on informing consumers about material composition and providing clear sorting instructions, reinforced through matching labels on bins.   Determining the Appropriate Level of Label Granularity  A single “plastic” label offers simplicity but may be overly broad, especially in systems that differentiate between rigid and flexible plastics or where composite materials create confusion. According to the JRC summary, the proposed approach aims for a level of granularity that defines distinct labels based on both theoretical and practical considerations. External feedback on the JRC work indicates that early prototypes explored a range of material categories and subcategories. For instance, one industry analysis describes an initial prototype with eight material categories, including subcategories like “soft” vs “hard” plastics.  What should the label look like across 27 markets?  The visual approach aims to ensure the label both stands out and is understood across Member States, while allowing enough flexibility to work on-pack and on bins as you can see on the figure below.    However, even before the Commission locks anything in, the labelling conversation is already contentious. Several industry groups have publicly warned that heavy reliance on text and/or colour could recreate fragmentation because text triggers translation needs and can easily drift into national variants.   The JRC summary itself acknowledges the reality: the proposal includes compromises, identifies challenges, and flags future work needs given the complex interplay of regulatory requirements, stakeholder preferences, and practical limitations.  In other words, this is not presented as a final “perfect” answer, but as a structured, research-backed basis for the Commission to build on.  What this means for brands, retailers, and compliance teams  If you put packaged goods on the EU market, this is the moment to treat waste-sorting labels as a system change, not a minor artwork update. A few practical implications stand out:  Data discipline becomes design discipline. If labels need to reflect material composition reliably, internal packaging specifications (and component-level bills of materials) have to be clean, current, and auditable.  Space on-pack will be a constraint. Expect tension between information richness and small-format packaging realities especially if multiple components need instructions.  Consistency across SKUs will matter. Harmonisation is partly about consumer learning: the faster people recognise a label family, the better it performs.  Conclusion and next step  Under the PPWR, 12 August 2026 is a key milestone, as it is the date of general application of the Regulation and the deadline for the Commission to adopt implementing acts specifying harmonised labelling requirements. These implementing acts are adopted in 2026, while the harmonised labelling obligations take effect from 2028.  The bottom line: the JRC has now provided a concrete, evidence-backed proposal. For stakeholders, it’s crucial to begin reviewing the proposed direction now, as once the Commission’s act is adopted, the implementation timeline will accelerate rapidly.  CEHTRA supports you in implementing these regulations. Contact us today to learn more about how we can help you.  References  https://www.europen-packaging.eu/news/joint-industry-statement-on-wsl   JRC Publications Repository - JRC technical proposal on EU harmonised waste sorting labels under the packaging and packaging waste regulation   CEHTRA supports packaging stakeholders in anticipating and complying with the new PPWR requirements, particularly in terms of labeling and waste management. Author: Baptiste REVERDY

Institutional framework and protection objectives The sanitary safety of drinking water in the EU is primarily based on an increasing synergy between two legislative pillars: Directive (EU) 2020/2184 (Drinking Water Directive), which constitutes a revision of the pre-existing Directive 98/83/EC, and Regulation (EU) No 528/2012 (BPR). Although their scopes differ, they converge towards a common goal: the protection of human health. While the BPR governs the placing on the marketing and use of biocidal products (including drinking water treatment products), the Drinking Water Directive defines quality requirements at the tap through a risk management approach. In this interaction, four categories of actors are involved: Competent authorities and EU agencies : ECHA, EFSA, the European Commission and national authorities, responsible for governance and scientific arbitration. Industry and applicants : manufacturers of active substances (AS), formulators of biocidal products, and economic operators responsible for the compliance of files. Technical operators and suppliers : water suppliers and operators in the food sector ensuring treatment and distribution. Professionals and the general public : building professionals and end consumers, benefiting from safe water. The “dual key” principle The implementation of biocidal solutions in emissions integrated into the water cycle requires two-step validation validation to ensure consumer safety. The first key, defined by the Biocidal Products Regulation (BPR) , corresponds to the Authorization for Placing on the Market (AMM in French). This is the fundamental prerequisite for a biocidal product to be marketed. The BPR evaluates and validates the effectiveness of a disinfectant for a specific use and examines the intrinsic risks associated with this product, both for human health and the environment. The second key is determined by the Drinking Water Directive , which focuses on compliance of water at the tap. This step represents the validation of the performance of the biocidal product under real usage conditions. The objective is to ensure that an authorized biocide never leads to exceeding the water quality standards set. Technical requirements and evolution of chemical quality The guarantee of safe drinking water relies on the strict application of quantified health thresholds, on a rigorous framework for substances used in treatment to prevent any alteration of quality, and the implementation of a dynamic monitoring system to track the evolution of knowledge concerning new pollutants, as presented in various sections of Directive 2020/2184. Defined under article 12 , the use of chemical treatment agents and filtration media is subject to four imperatives: Human health: no direct or indirect compromise of health protection.  Organoleptic quality: maintenance the colour, odour and taste of water.  Microbiological stability: no unintended microbial proliferation.  Minimal contamination: strict limitation of residues to the level necessary for the intended use.  Contamination by by-products must be kept as low as possible. To address emerging pollutants, the directive introduces, in Article 13, an obligation for Member States to monitor water for chemical parameters and substances or compounds of concern identified in a watchlist ( Watch List ), such as PFAS, endocrine disruptors, or microplastics, whose parametric values will be specified in delegated acts by the European Commission. The parametric values used to assess water quality are defined by minimum requirements to be met, presented in Annex I of the directive, and cover microbiological, chemical and indicator parameters. Risk-based approach: from source to tap  The legislation requires a systemic analysis covering the entire supply chain (Article 7): Extraction (Art. 8) : assessment of environmental risks in abstraction areas. Treatment & distribution (Art. 9) : management of risks related to water treatment processes and the network.  Private installations (Art. 10) : monitoring of the internal distribution up to the tap. Joint ECHA/EFSA Guidance (2023) The 2023 joint ECHA/EFSA Guidance aims to harmonize the assessment of active substance (AS) residues and their transformation products in drinking water.  Starting from 1 April 2026 , this guidance became mandatory for all new submissions. It specifically includes consideration of environmental transformation products (eTPs), formed in the environment before entering the plant, and treatment transformation products (tTPs), formed during drinking water treatment processes through methods such as chlorination or ozonation. Some of these products, like nitrosamines, may be more toxic than the parent active substance. This regulatory evolution could have a significant impact on biocide manufacturers, potentially affecting them upstream of the active substance manufacturers, resulting in longer approval timelines for dossiers. Risk assessment methodology and critical alerts The assessment of residues and transformation products from the use of biocides (and plant protection products) is divided into four successive steps: Step 1: exposure assessment at the abstraction point via PEC (Predicted Environmental Concentrations). If PEC > 0.1 µg/L , a full assessment of tTP formation is triggered.  Step 2: detection of transformation products (tTPs) from water treatment process. A concentration > 0.075 µg/L triggers chemical identification and hazard assessment.  Step 3: toxicity assessment of formed products according to a tiered approach, from potential for genotoxicity (Tier 1) to targeted testing (Tier 3).  Step 4: risk characterization of the risk to the consumer . If exposure is acceptable, management and monitoring measures can be defined. Strategic impacts and industrial challenges  With the implementation of this regulatory framework, the biocides industry faces several structural obstacles that complicate its development and adaptation to regulatory requirements, with major strategic implications for the entire value chain. On a scientific and public health front , the lack of toxicological data concerning tTPs is a central challenge. In many cases, no experimental data is available regarding their genotoxicity or general toxicity. This gap forces industry players to rely on predictive approaches such as in silico models (QSAR, read-across). Although these tools provide an initial assessment, they generate significant uncertainties and frequently require subsequent experimental validation, impacting costs and timelines. This situation creates a strategic risk because the lack of robust data can delay or jeopardize authorization procedures. On the technical side , the complexity of evaluations is exacerbated by the lack of standardization of drinking water treatment processes at the European level. While the final water quality is regulated, treatment methods vary significantly depending on local contexts. Therefore, manufacturers must design specific experimental protocols, incorporating numerous parameters (raw water quality, pH, temperature, natural organic matter), making studies difficult to replicate and harmonize. The identification of tTPs is itself a major analytical challenge, requiring advanced technologies and non-targeted approaches capable of detecting compounds at extremely low concentrations. From an economic perspective , the costs associated with treatment simulation studies are considerable, making these analyses difficult for many companies, especially smaller ones, to access. Moreover, the time required to complete these studies is often incompatible with strict regulatory deadlines, creating tensions between legal requirements and operational capabilities within the industry. Coordination between the different actors in the value chain, especially between active substance (AS) manufacturers and biocide formulators, is also a critical issue. It is imperative to establish a smooth and efficient data-sharing process to ensure product compliance and safety throughout their life cycle. This cooperation would allow for better anticipation of risks and faster response to regulatory requirements. Finally, the regulatory consequences in case of uncertainty or identified risk are particularly structuring. In the absence of effective risk mitigation measures (RMM), non-compliance due to the presence of concerning tTPs can lead to the refusal of market authorization. Additionally, even if an active substance is approved, the identification of a toxic tTP in the formulated product may lead to rejection for a specific use. This situation places companies at high commercial risk and forces them to integrate tTP-related challenges early in their development, formulation, and marketing strategies. Strategic recommendations for operators  To ensure safe market access, operators must adopt a rigorous and proactive strategy: Review of product portfolio and associated active substances. To identify products that may pose a problem and implement appropriate solutions. In parallel, a thorough analysis of PECs must be conducted to verify if the critical threshold of 0.1 µg/L is exceeded. This step is crucial to ensure that products meet safety standards and do not present any risks to human health or the environment. Evaluate specific uses of products, particularly those that pose a risk to abstraction areas. Operators should engage in proactive and collaborative dialogue with active substance suppliers to improve availability of data on tTPs. Conclusion  According to the BPR, the conditions for granting authorization include ensuring that the biocidal product itself, or its residues, does not have an unacceptable immediate or delayed effect on human health and the environment, including vulnerable groups, or on animal health, directly or via drinking water, food, animal feed, air, or other indirect effects. The publication of the 2023 Joint Guidance ECHA/EFSA does fill a gap in recommendations for assessing effects via drinking water. However, the deadline of April 1, 2026, represents a breaking point: action must be taken now to anticipate the delays linked to technical studies. Authors : Floriane Demailly & Loris Mistrulli

In January 2026, the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods, and Food Allergens (NDA) endorsed a draft opinion on the safety of plant preparations containing berberine. This 195-page document, submitted for public consultation, represents a major step in the regulatory oversight of a widely used isoquinoline alkaloid in dietary supplements aimed at metabolic health (blood glucose, lipids, body weight) across Europe. This article provides a factual and structured reading of the draft, followed by an analysis of areas of uncertainty and levers available to industry stakeholders to actively engage in the regulatory dialogue before the final opinion. Context and Scope of the Assessment The request follows the 2019 opinion by ANSES, which identified concerns related to the consumption of plant-based supplements containing berberine: gastrointestinal disorders, hypoglycemia, hypotension, and drug interactions. The European Commission activated the procedure under Article 8(2) of Regulation (EC) No 1925/2006 and asked EFSA to address two key questions: Is there a link between consumption of the listed preparations and an adverse health effect? Can a safe daily intake be defined for the general population and vulnerable subgroups? The mandate covers thirteen species and specific plant parts: Berberis aquifolium , B. aristata , and B. vulgaris  (root, bark); Chelidonium majus (aerial parts); Coptis japonica , C. teeta , and C. trifolia (rhizomes); Coscinium fenestratum  (root, stem); Hydrastis canadensis (rhizome, root); Jateorhiza palmata  (root); Phellodendron amurense (bark); Thalictrum flavum  (root); and Tinospora sinensis  (root, stem, leaf). The assessment focuses on the preparations in their entirety, not on berberine alone. Three lines of evidence were integrated: data on isolated berberine, data on other protoberberine alkaloids present in these plants, and data specific to each plant preparation. Explicitly excluded are: benefit-risk analyses, medicinal products, and synthetic forms of berberine (covered under the Novel Food Regulation). EFSA Conclusions by Toxicological Endpoint Genotoxicity Berberine (isolated substance) EFSA concludes there is compelling evidence of in vitro genotoxicity for berberine. Gene mutations were observed in the HPRT test on murine cells and in the Ames test (S. typhimurium TA98), only without metabolic activation, suggesting a direct mutagenic potential. Clastogenic and/or aneugenic effects were reported in two in vitro  mammalian micronucleus tests. Identified mechanisms include DNA intercalation, inhibition of topoisomerases I and II, induction of single- and double-strand breaks, and oxidative DNA damage. Berberrubine, the main phase I metabolite, also inhibits topoisomerase II. In vivo  data remain inconclusive: a single mouse study did not confirm these effects, and the Panel emphasizes the need to verify genotoxicity at first-contact sites such as the gastrointestinal tract and liver. Other Protoberberines The Panel considers that other protoberberines present in plant preparations may share this genotoxic potential due to strong structural similarity with berberine. QSAR models predict mutagenicity for berberastine, columbamine, epiberberine, jatrorrhizine, palmatine, stephabine, and several others, while experimental data remain sparse and inconclusive, with only isolated signals for coptisine and palmatine. Chelidonium majus-specific Alkaloids Sanguinarine and chelerythrine, present in C. majus , pose genotoxic concerns independent of berberine, with evidence of chromosomal and DNA damage in vivo  for sanguinarine and QSAR predictions for chelerythrine. These non-protoberberine alkaloids constitute an additional concern. Carcinogenicity EFSA establishes evidence of carcinogenicity in rodents for H. canadensis  rhizome/root preparations. Two Tier 1 studies show an increased incidence of hepatocellular adenomas in male and female rats, with a positive trend in male mice. Consumption of these preparations therefore represents a carcinogenic risk for humans, even though the exact mechanism remains unclear. A genotoxic role of berberine or its metabolites is possible but not confirmed in vivo . For the other twelve evaluated species, no data are available. Hepatotoxicity Berberine (isolated substance) Hepatotoxicity cannot be established based on available studies. Ninety-day rat studies (156 mg/kg/day) and developmental toxicity studies showed no liver damage, with only two isolated cases of transaminase elevation reported in clinical trials. Berberrubine showed signs of hepatotoxicity in a 42-day rat study at 100 mg/kg/day. H. canadensis Tier 1 subchronic studies (90 days) identify the liver as the primary target organ, with rats being the most sensitive species. Increases in liver weight appear at the lowest tested dose (255-260 mg/kg/day), accompanied at higher doses by nearly generalized hepatocellular hypertrophy. These results, consistent with carcinogenicity data, indicate dose-dependent toxicity. EFSA notes that berberine is unlikely responsible, as hepatotoxicity occurs at doses far lower than those used for berberine alone. C. majus (aerial parts) Preparations of aerial parts are associated with 43 human cases of idiosyncratic hepatotoxicity, predominantly presenting with jaundice. Latency ranges from a few weeks to several months, making causality difficult to establish. This type of reaction is unpredictable, does not follow a dose-response relationship, and cannot be reliably reproduced in the laboratory. Developmental and Reproductive Toxicity Berberine showed signs of maternal and fetal toxicity in rats and mice, with a maternal NOAEL of 223 mg/kg/day in rats and a fetal NOAEL of 666 mg/kg/day in mice. These data are Tier 2 quality. For all plant preparations, information is almost nonexistent, and no reproductive toxicity studies are available, representing a critical data gap. Systemic Toxicity (Repeated Doses) No repeated-dose toxicity study compliant with OECD and GLP guidelines is available for berberine alone, preventing the establishment of a regulatory reference point. For most other species, general toxicity profiles are largely unknown. Available studies are Tier 2-3 quality and present limitations such as poorly described test material, a limited number of organs assessed, or incomplete reports. Drug Interactions Berberine inhibits CYP3A4 and possibly CYP2D6 and CYP2C9. H. canadensis  preparations also show inhibition of CYP3A and CYP2D6 and potential effects on intestinal influx transporters (OCTs), with (−)-β-hydrastine contributing significantly. Preparations containing berberine may therefore interact with many drugs, including anticoagulants, statins, antidiabetics, and antiarrhythmics. Gastrointestinal Effects Supplements containing berberine may cause constipation, diarrhea, nausea, or abdominal pain, the most systematically observed signal in clinical trials, at doses of 400-1500 mg/day. Hypoglycemia, Hypotension, Immunotoxicity Contrary to previous concerns, no evidence of hypoglycemia, hypotension, or immunotoxicity was found in available animal or human studies. NDA Panel Conclusion The Panel concludes: “The available data do not allow for the establishment of a safe intake for any of the plant preparations of the species included in the assessment.” This conclusion applies to all thirteen species and plant parts of the mandate. It is based on two determinants: established hazard signals ( in vitro  genotoxicity, H. canadensis  carcinogenicity, idiosyncratic hepatotoxicity of C. majus ) and a massive insufficiency of data for the majority of species. Grey Areas and Industry Levers Although the Panel’s conclusion is strict, a careful reading of the draft reveals an ecosystem of substantial scientific uncertainties, providing real space for dialogue and generation of complementary data. EFSA itself details in Section 6 a structured timeline (Steps 1-4) of information needed to move toward a more differentiated final opinion. Relevance of in vivo genotoxicity signals In vitro  genotoxicity of berberine is central to the Panel’s concern. However, the draft highlights a major methodological tension: berberine has low systemic bioavailability. Intestinal absorption is limited, intestinal metabolism predominates, and actual systemic exposure is low, with circulating forms mainly as phase II metabolites (glucuro- and sulfoconjugates). All genotoxicity evidence is based on in vitro  systems using free berberine at concentrations that may not reflect actual tissue exposure under real use conditions. EFSA explicitly states that negative in vivo  results will only be considered valid if target tissue exposure is demonstrated (toxicokinetic measurements in plasma and tissue homogenates). Robust tissue toxicokinetic data coupled with well-designed in vivo  studies could substantially alter the interpretation of genotoxic risk. Matrix effect: evaluating preparations, not berberine alone One of the draft’s key grey areas concerns the matrix effect of plant preparations. EFSA chose to evaluate whole preparations, not berberine alone. While scientifically justified, this creates complexity: the composition of a plant preparation is not limited to its marker alkaloid. Berberine content varies widely depending on botanical origin, plant part, developmental stage, harvest season, extraction process (solvent, temperature, drug/solvent ratio), and analytical method. Beyond berberine, most co-occurring protoberberines have not been systematically identified and quantified. The unidentified fraction complicates the assessment of mixture genotoxicity. For H. canadensis , the Panel explicitly notes that berberine is likely not responsible for observed hepatotoxicity and carcinogenicity, given the disproportion between equivalent berberine exposure (≈5 mg/kg/day in the hepatotoxic preparation) and doses of berberine alone without effect. Other plant constituents, including (-)-β-hydrastine and canadine, are suggested as potential contributors. In this context, complete and reproducible chemical characterization of preparations (full alkaloid profile, validated methods, botanical traceability) is the first step required by EFSA (Step 1) and a prerequisite for any regulatory argument. Non-transposability of data between species A major difficulty is the lack of data for most species, combined with the temptation to extrapolate from berberine or a better-documented species. The Panel explicitly resists automatic extrapolation, stating that study results for one preparation cannot automatically apply to another, even if berberine content is similar, due to distinct complete alkaloid profiles, differing unknown fractions, and variable component interactions. This is scientifically coherent but implies that each manufacturer wishing to maintain a species in their portfolio must generate or reference data specific to their preparation. Professional associations (such as EHPM, which has already submitted data in response to the data call) represent an important pooling lever. EFSA leaves a small door open: “The extent to which results can be extrapolated from one preparation to another will be evaluated based on the data provided and will be subject to expert judgment.”  Strong arguments on chemical profile comparability could be presented. Read-across for protoberberines Given the absence of experimental data for most protoberberines, the Panel allows for a read-across approach, conditional on applying EFSA SC 2025 guidance. This approach is considered applicable for mutagenicity (given convergent structural alerts and VEGA prediction reliability) but carries high uncertainty for chromosomal effects, due to VEGA model limitations for in vitro  and in vivo  MN. Experimental data on at least one other protoberberine family member (selected based on a worst-case criterion) are required to reduce uncertainty. A structured read-across argument supported by PBPK data (physiologically based pharmacokinetic modeling) and in vitro  MN data for a worst-case alkaloid could significantly reduce the evidence burden for the entire family. Public consultation as a dialogue space With the draft open to public consultation, the window for submitting comments and additional data is a direct lever. Industry stakeholders can: Submit comments on unclear methodological points (inter-preparation extrapolation criteria, exposure threshold for validating in vivo studies, worst-case definition for protoberberine read-across); Provide additional analytical data on the alkaloid profile of their preparations; Contribute to targeted toxicological studies, ideally through consortia via sector associations, for the species best represented in the European market. Conclusion EFSA’s draft opinion on berberine and plants containing it is a rigorous scientific assessment but suffers from considerable data asymmetry between species. While the in vitro  genotoxic signal and critical cases of H. canadensis  and C. majus  are legitimate and serious concerns, the inability to establish a safe intake for all thirteen species reflects more a data gap than unequivocal evidence of hazard. To meet regulatory requirements and support constructive dialogue with authorities, it is essential to provide reliable, well-targeted data, compliant with OECD and GLP standards, and supported by precise chemical characterization of preparations. Within this framework, CEHTRA assists industry by leveraging toxicology expertise to design and conduct rigorous, relevant, and actionable evaluation strategies, enhancing the scientific quality of dossiers and facilitating their assessment. Author: Marie LIAMIN References Draft Scientific Opinion on the safety of plant preparations containing berberine (EFSA-Q-2022-00803). EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA). 29 January 2026.

Stay up-to-date with regulatory and toxicological changes. CEHTRAWATCH is an online platform, verified by experts, no software installation needed. CEHTRA WATCH: regulatory and toxicological monitoring for chemical substances Stay compliant with real-time alerts and customized regulatory and toxicological tracking, substance by substance. Discover Book a demo Targeted monitoring based on your substance portfolio CEHTRA WATCH is a regulatory and toxicological monitoring tool for chemical substances, designed to track regulatory changes, regulatory lists (SVHC, CLP…) and scientific data impacting your substances. Monitor only the updates that matter to your substances and relevant lists, with a platform developed by CEHTRA’s regulatory and toxicological experts. → Save time for regulatory, toxicology and R&D teams → Quickly identify changes that may impact your business Explore the lists The challenge Regulatory and toxicological updates are numerous. But not all of them affect your substances. T eams must monitor regulatory news , scientific opinions and updates across multiple lists published by various authorities. The challenge is not only accessing information, but determining whether a change actually impacts your substance portfolio. CEHTRA WATCH enables both one-off screening and continuous monitoring of regulatory and toxicological changes. Regulatory and toxicological monitoring focused on your substances Unlike general regulatory monitoring tools, CEHTRA WATCH provides portfolio-based monitoring. With CEHTRA WATCH, you can instantly analyze a single substance or an entire portfolio: import your list of substances (CAS numbers or names) track their presence across regulatory and toxicological lists automatically receive notifications when your substances are impacted This allows you to avoid: manually monitoring multiple lists reviewing irrelevant information missing critical regulatory or toxicological updates Monitoring key regulatory and toxicological lists CEHTRA WATCH monitors updates across more than 130 regulatory and toxicological lists, focusing only on information relevant to your substance portfolio. The platform enables: SVHC monitoring (intentions and Candidate List) CLP classification tracking and CLH intentions monitoring of regulatory processes (Assessment of Regulatory Needs, CORAP…) monitoring of toxicological data and scientific publications (IARC, NTP, RIFM…) monitoring of toxicological reference values (ATSDR, ANSES, Prop 65…) Covered lists include European regulations (CLP, REACH, Cosmetics Regulation), as well as key national and international lists. All updates are automatically filtered based on your substance portfolio, ensuring that only relevant changes are highlighted. Significant time savings for regulatory and toxicology teams Instead of manually monitoring dozens of lists: CEHTRA WATCH identifies relevant regulatory and toxicological changes compares list versions over time alerts you directly when your substances are affected Teams can focus their expertise on impact assessment, rather than information gathering. A digital platform supported by CEHTRA expertise CEHTRA WATCH has been developed by CEHTRA’s scientific and regulatory experts. Updates integrated into the platform are selected and validated for industrial relevance. The platform complements the expertise of your internal teams and CEHTRA consultants by facilitating the identification of regulatory and toxicological changes. How CEHTRA WATCH works 1. Instant screening of a substance For a given substance, instantly access its presence across multiple regulatory and toxicological lists. → quick identification of existing classifications and statuses 2. Portfolio screening Upload a list of substances (CAS numbers or names) and obtain a consolidated view of their regulatory and toxicological status. → prioritization of substances to monitor 3. Continuous monitoring Receive notifications when your substances are impacted by regulatory or toxicological updates. → early detection of changes impacting your activities Need help? Here are the answers to your questions. How does CEHTRA WATCH save time compared to manual regulatory monitoring? CEHTRA WATCH enables targeted regulatory and toxicological monitoring based on your substance portfolio. After importing your substance list, the platform automatically tracks their presence across multiple regulatory and toxicological lists. Relevant updates are identified and displayed in your dashboard or via alerts. Regulatory and toxicology teams no longer need to manually search multiple sources and can focus on impact analysis for their products and activities. How does CEHTRA WATCH help reduce compliance risks? Regulatory and toxicological changes can directly impact the use of substances. CEHTRA WATCH allows you to quickly identify whether a substance in your portfolio appears or evolves in a regulatory or toxicological list. Updates are integrated into the platform and changes between versions are highlighted. This targeted monitoring helps teams detect early changes that may affect compliance or risk assessment. Which regulatory and toxicological lists are monitored? CEHTRA WATCH monitors a wide range of regulatory and toxicological lists relevant to the chemical industry, including: • European regulations (CLP, REACH, Cosmetics Regulation) • SVHC and CLH intentions • key national lists • toxicological monographs (IARC, NTP…) • toxicological reference values All updates are filtered based on your substance portfolio to ensure relevance. Does CEHTRA WATCH replace regulatory or toxicological expertise? No. CEHTRA WATCH does not replace human expertise. The platform facilitates the identification of relevant regulatory and toxicological changes, but impact assessment remains the responsibility of experts. It is designed as a complement to internal teams and CEHTRA consultants. Contact Book a demo

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. Regulatory Convergence between the Drinking Water Directive (EU 2020/2184) and the Biocidal Products Regulation (BPR) The sanitary safety of drinking water in the EU is primarily based on an increasing synergy between two legislative pillars: Directive (EU) 2020/2184 (Drinking Water Directive), which constitutes a revision of the pre-existing Directive 98/83/EC, and Regulation (EU) No 528/2012 (BPR). TOXICOLOGY EFSA opinion on berberine, protoberberines, and plants containing these substances : understanding the draft to engage in the dialogue. In January 2026, the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods, and Food Allergens (NDA) endorsed a draft opinion on the safety of plant preparations containing berberine. FOOD PFAS in Cosmetic Products: Regulatory Trends and Safety Assessment Challenges Per- and polyfluoroalkyl substances (PFAS) are a large family of anthropogenic chemicals characterised by highly stable carbon–fluorine bonds. Structurally, PFAS typically contain at least one fully fluorinated methyl (CF₃-) or methylene (-CF₂-) carbon atom. DIGITAL SOLUTIONS 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 A digital solution dedicated to cosmetic risk assessment, integrating structured cosmetic toxicological profiles, the calculation of Margins of Safety (MOS) , and the preparation of Cosmetic Product Safety Reports (CPSR) to ensure regulatory compliance for cosmetics. Discover Book a demo Simplify your cosmetic regulatory 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 (CPSR) supported by reliable toxicological profiles. COSMETICK is a toxicological database dedicated to cosmetics, combined with a digital cosmetic safety assessment tool. It provides access to structured cosmetic toxicological profiles, enables exposure assessment, supports the calculation of Margins of Safety (MOS), and generates structured documentation to support the preparation of the Cosmetic Product Safety Report (CPSR) in accordance with the EU Cosmetic Regulation. Developed by regulatory toxicologists, COSMETICK supports cosmetic regulatory compliance through a clear and traceable hazard × exposure methodology. 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 A dedicated toxicological database for cosmetics: comprehensive toxicological and ecotoxicological profiles Characterisation of toxicological effects based on structured bibliographic review by endpoint Identification of no-effect levels (NOAELs and reference values) relevant for Margin of Safety (MOS) calculation Integration of key data required for cosmetic safety assessment and CPSR preparation Visual warning system using colour-coded indicators for rapid and structured interpretation For cosmetic formula safety assessment: Margin of Safety (MOS) calculation and CPSR preparation Simplified formula input with product type selection (leave-on / rinse-off) Automated calculation of Margins of Safety (MOS) based on exposure assessment and toxicological profiles Clear regulatory decision-support interface (MOS values, warnings, alerts) Export of a structured pre-filled document to facilitate preparation of the Cosmetic Product Safety Report (CPSR) A dynamic platform supporting cosmetic regulatory compliance Customisation of cosmetic toxicological profiles according to your assessment needs Online submission of new profile requests in just a few clicks Regular updates of the toxicological database Continuous integration of regulatory developments impacting ingredient safety Monthly newsletter dedicated to cosmetic safety and regulatory compliance updates View all features Why users rely on COSMETICK 🧪 Data Reliable profiles ⚖️ Decision Consistent assessments ⚡ Efficiency Faster workflows Select the formula that fits your requirements. Access to toxicological profiles Eco-toxicological profiles Customization with confidential data Export toxicological profiles and assessment reports (pre-CPSR) Updates & regulatory newsletter Advanced Details Basic Details They trust us. Need help? Here are the answers to your questions. What are the different COSMETICK licences available? COSMETICK offers two licence levels designed for professionals involved in cosmetic safety assessment and cosmetic regulatory compliance: BASIC Licence Provides access to the COSMETICKtoxicological database, including structured cosmetic toxicological profiles required for CPSR preparation. ADVANCED Licence Provides full platform access, including the toxicological database, formula evaluation features, automatedMargin of Safety (MOS)calculation, and structured documentation to support CPSR preparation. Each licence is available under two access models: • Unlimited access – suitable for teams conducting regular safety assessments • On-demand access – flexible solution for occasional toxicological evaluations Need guidance selecting the most appropriate solution for your cosmetic risk assessment needs? Contact us at cosmetick@cehtra.com.(mailto:cosmetick@cehtra.com) What if an ingredient is not available in the COSMETICK toxicological database? If a cosmetic toxicological profile is not available in the COSMETICK toxicological database, you may submit a request directly via the online form. Each request is reviewed by regulatory toxicologists to ensure that the newly developed profile meets scientific and regulatory standards applicable to cosmetic safety assessment and CPSR preparation. Once validated, the profile is added to the toxicological database. You can track the progress of your request online and will receive an email notification when it becomes available. Does COSMETICK generate a Cosmetic Safety Report (CSR) and safety margins? COSMETICK produces a structured pre-assessment containing the key elements required for preparation of the Cosmetic Product Safety Report (CPSR), in accordance with Annex I of Regulation (EC) No 1223/2009. This pre-assessment includes: • Exposure assessment based on the product formulation • Calculation of the Margin of Safety (MOS) for each ingredient • Evaluation of impurities, including CMR substances (carcinogenic, mutagenic or reprotoxic) • Identification of relevant toxicological warnings • Justification of skin tolerance • Integration of user-specific data (test results, specifications, supplier information) The generated document supports preparation of Part B of the CPSR, which must be reviewed and validated by a qualified safety assessor in accordance with Article 10 of the EU Cosmetic Regulation. Contact Book a demo