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Calculating Margins of Safety (MoS) is at the core of cosmetic ingredient safety assessment. On paper, the principle appears simple: comparing a no-effect dose to an estimated exposure in order to verify that a sufficient safety margin exists. In practice, however, things are often far more complex. The calculation of a MoS relies on two major parameters: the Point of Departure (POD) the Systemic Exposure Dose (SED) Each of these parameters depends on assumptions, sometimes incomplete data, and ultimately on expert scientific judgment. 👉 As a result, the same substance may lead to different conclusions depending on: the selected data the exposure assumptions or the choices made regarding dermal absorption. For cosmetic ingredients, a MoS ≥ 100 is generally expected to conclude on safe use. The mathematical ratio itself is straightforward: MoS = PODsys / SED However, significant scientific complexity often lies behind this formula. Part 1: Point of Departure (POD) – Hazard Assessment The POD corresponds to the toxicological reference dose used as the starting point for risk assessment. 1.1 From NOAEL to PODsys Historically, the POD has most often been represented by the NOAEL (No Observed Adverse Effect Level), generally derived from repeated-dose toxicity studies, often conducted in rats. However, since most studies are performed by the oral route, the administered dose must be converted into a systemic dose in order to be comparable to cosmetic exposure. This is referred to as PODsys. This conversion notably takes oral bioavailability into account. In the absence of experimental data, the SCCS generally applies a default oral bioavailability of 50%. In some cases, when very low oral absorption has been demonstrated, a value of 10% may be considered. 1.2 The BMD Approach The SCCS increasingly favors the Benchmark Dose (BMD) approach. Unlike the NOAEL, which directly depends on the dose levels selected in the experimental study, the BMD approach uses the entire dose-response relationship to identify a dose associated with a predefined critical effect level. The associated lower confidence limit (BMDL) is generally retained as the Point of Departure because it incorporates statistical uncertainty. 👉 This approach often allows a more robust use of toxicological data. 1.3 Other Points Requiring Attention In practice, several elements may strongly influence the relevance of the selected POD. Study Reliability Not all available studies provide the same level of robustness. Scientific publications that do not follow OECD guidelines require a critical evaluation in order to assess their reliability and suitability. Adjustments and Extrapolations Certain adjustments may be necessary: correction for non-daily administration extrapolation from short-term studies read-across adjustments Data gaps Data gaps remain frequent in cosmetic safety assessment. In the absence of a NOAEL, some alternative approaches may be considered, but they require rigorous scientific justification. 👉 Read-across approaches, for example, should only be used following a structured assessment of the relevance of the selected analogue. Genotoxic TTC approaches and Cramer classes are only applicable to impurities or non-intentionally added compounds, and not to cosmetic ingredients themselves. Part 2: Systemic Exposure Dose (SED) – Use Assessment The Systemic Exposure Dose (SED) represents the amount of ingredient that actually reaches systemic circulation following cosmetic product application. Its estimation relies on several parameters: the amount of product applied the ingredient concentration frequency of use retention on the skin and dermal absorption. 👉 In practice, exposure assumptions directly influence the resulting Margins of Safety. Several reference datasets coexist, sometimes leading to significant differences depending on: the studied population the product category or real-life conditions of use. 2.1 Sources of Exposure Data Toxicologists rely on several major references to document cosmetic exposure. COLIPA Studies (Hall et al. 2007, 2011) These studies constitute the historical references for the main cosmetic product categories used by adults (face cream, deodorant, shampoo, etc.). They notably provide P90 exposure values widely used in safety assessments. LERCCo Data (2017; Gomez-Berrada et al. 2017/2018) These French studies provide particularly useful data for: children’s exposure real-life sunscreen use specific consumer usage habits. They notably help refine certain assumptions compared with generic SCCS default values. RIVM Tools (ConsExpo) ConsExpo probabilistic models are particularly useful for inhalation scenarios (sprays, powders). They notably help estimate the respirable fraction and refine exposure assessments. 2.2 Quantification of Dermal Absorption Dermal absorption is the key conversion factor between external exposure and the Systemic Exposure Dose (SED). 👉 It is also one of the parameters most frequently estimated, and therefore one of the main sources of uncertainty in Margin of Safety calculations. Experimental Values In vitro measurements on human skin according to OECD TG 428 currently constitute the reference approach. The SCCS also requires compliance with several methodological criteria (“basic criteria”, SCCS/1358/10) to ensure the quality and interpretation of results. For MoS calculations, the retained value generally corresponds to the mean plus one standard deviation (or two in cases of high variability). Default Values In the absence of experimental data, a conservative default value of 50% is generally applied for cosmetic ingredients. For impurities, the most conservative scenario (100%) is usually retained. Predictive Models Mathematical models (Potts & Guy, ten Berge, Ates, etc.) may also be used to estimate dermal absorption based on the physicochemical properties of the substance (molecular weight, logP, solubility, etc.). 👉 As with all models, these approaches have limitations and must be interpreted cautiously. 2.3 Waiving and Specific Cases In certain situations, the physicochemical properties of a substance may justify negligible systemic absorption, allowing adaptation of the toxicological data requirements for safety assessment. High Molecular Weight Polymers For certain high molecular weight polymers (e.g., MW > 1000 Da), insoluble and poorly bioavailable substances, dermal, and even oral, absorption may be considered negligible. In these situations, the assessment mainly focuses on: local effects (irritation, sensitization, etc.) impurities or potentially bioavailable residual monomers. 👉 Nevertheless, these situations require strong scientific justification, particularly regarding physicochemical properties and the actual composition of the material under assessment. Conclusion Margin of Safety calculations are often presented as simple mathematical ratios. In reality, they rely on a succession of scientific and regulatory decisions. The selection of toxicological data, exposure assumptions, and dermal absorption estimates can strongly influence the final conclusion. In practice, safety assessors combine: default data experimental results predictive models and sometimes structural analogues when scientifically justified. Exposure is now relatively well documented for many cosmetic product categories. In contrast, dermal absorption data remain frequently unavailable or estimated, often leading to conservative approaches. 👉 Harmonization of practices and traceability of assumptions are therefore essential to obtain robust and consistent Margins of Safety. In a context where data continuously evolve, structuring toxicological information is also becoming a major challenge for cosmetic safety assessors. Author: Clarisse Bavoux Reference: SCCS, Notes of Guidance 2023

The adoption of Directive (EU) 2024/3019 on urban wastewater treatment (UWWTD), published on 12 December 2024, introduces unprecedented requirements for the pharmaceutical industry. Integrated into the EU “Zero Pollution” Action Plan, this legislation imposes stringent management obligations for pharmaceutical residues, marking a transition from a means-based regulatory framework to one centred on performance obligations and direct financial accountability for pharmaceutical companies. 1. Quaternary Treatment: Removing Organic Micropollutants The directive’s key technical innovation lies in the mandatory implementation of quaternary treatment to remove micropollutants. Studies indicate that pharmaceutical residues account for approximately 59% of micropollutants detected in urban wastewater. Performance Requirements and Indicator Substances The directive establishes a minimum removal rate of 80% for a list of representative indicator substances. These molecules are classified according to their ease of treatment: Category Examples of Indicator Substances 1 : Very easy to treat Amisulpride, Carbamazepine, Citalopram, Clarithromycin, Diclofenac, Metoprolol, Venlafaxine 2 : Easy to remove Benzotriazole, Candesartan, Irbesartan, Mixture of 4- and 5-methylbenzotriazole To demonstrate compliance, wastewater treatment plants must monitor at least six substances, with twice as many Category 1 substances as Category 2 substances. 2. Extended Producer Responsibility (EPR): A Major Economic Challenge To finance these infrastructures, the directive applies the “polluter pays” principle through an Extended Producer Responsibility (EPR) scheme. From 31 December 2028 onwards, pharmaceutical companies will be required to cover at least 80% of the investment and operational costs associated with quaternary treatment and micropollutant monitoring. Diverging Financial Estimates The financial impact on the sector remains highly controversial: European Commission initial estimate: Approximately €130 million per year for France. (RE)SET study (Leem, FEBEA, GEMME): Estimates the annual burden at between €513 million and €633 million, i.e. four to five times higher than the Commission’s figures. Despite legal actions brought by industry federations challenging the allegedly disproportionate nature of the measure, the Court of Justice of the European Union (CJEU) dismissed these appeals in February 2026, ruling them inadmissible. 3. Exemption Strategies: The Importance of Biodegradability Article 9 of the directive defines two mechanisms allowing companies to be exempted from the EPR financial contribution: Volume threshold criterion: Placing less than 1 tonne per year on the EU market. Rapid biodegradability: Scientific demonstration that the substance is readily biodegradable in wastewater or does not generate persistent micropollutants at end of life. The European Commission must establish the detailed technical criteria for these exemptions by 31 December 2027 at the latest. For toxicologists, this highlights the importance of proactively characterising product portfolios to identify eligible substances. 4. Expanded Monitoring: PFAS and Microplastics Beyond pharmaceuticals, the directive strengthens environmental and public health monitoring obligations. The following are now mandatory: Monitoring of PFAS (per- and polyfluoroalkyl substances) in influents and effluents of wastewater treatment plants serving more than 10,000 population equivalent (p.e.). Monitoring of microplastics in sewage sludge, particularly where sludge is reused in agriculture. Epidemiological surveillance of pathogens such as SARS-CoV-2, influenza viruses, and antimicrobial resistance. 5. Implementation Timeline: The Countdown Has Begun The rollout of the directive’s obligations follows a phased approach extending to 2045. Deadline Major Milestone 31 July 2027 Deadline for transposition into French law 31 December 2027 Publication of biodegradability criteria and list of substances subject to EPR 31 December 2028 Operational launch of EPR financing scheme 2033 - 2045 Progressive commissioning of quaternary treatment in UWWTPs 2045 100% of concerned UWWTPs equipped Conclusion: Anticipating Change to Control Impact The 2024 UWWTD introduces a profound transformation of the pharmaceutical industry’s economic model by integrating the aquatic life-cycle costs of products into regulatory obligations. At CEHTRA, we support our partners in the toxicological assessment of their active substances to prepare exemption dossiers and navigate this new EPR framework. Author: Sophie SIMAR Looking to assess the impact of the revised UWWTD on your pharmaceutical portfolio? Contact Sophie Simar to discuss your regulatory strategy, biodegradability assessments, and EPR exemption opportunities.

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).

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. Revision of the UWWTD 2024: A Paradigm Shift for the Pharmaceutical Sector The adoption of Directive (EU) 2024/3019 on urban wastewater treatment (UWWTD), published on 12 December 2024, introduces unprecedented requirements for the pharmaceutical industry. Integrated into the EU “Zero Pollution” Action Plan, this legislation imposes stringent management obligations for pharmaceutical residues PHARMACEUTICAL CEHTRA at SETAC Europe 36: Poster Presentation on the “Rapidly Biodegradable” Criterion under the UWWTD CEHTRA is pleased to announce its participation in the SETAC Europe 36th Annual Meeting, taking place from May 19–21, 2026 in Maastricht. During the event, Floriane Demailly and Mylène Léger will present a scientific poster addressing the implementation challenges associated with the new “rapidly biodegradable” criterion introduced under the recast Urban Waste Water Treatment Directive (UWWTD). EVENTS (WEBINARS & CONFERENCES) Comprehensive Analysis of the Scope and Regulatory Framework for Substances of Directive (EU) 2020/2184 La Directive (UE) 2020/2184 introduit une réforme majeure de la sécurité sanitaire des eaux destinées à la consommation humaine. Son Article 11 est le pilier central des exigences minimales d’hygiène applicables aux matériaux en contact avec l’eau, visant à garantir que ces derniers ne compromettent pas la santé humaine, n'altèrent pas les propriétés organoleptiques de l'eau (notamment le goût, l’odeur ou la couleur) et ne favorisent pas la croissance microbienne. REGULATORY UPDATES 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

Learn about the EU Packaging and Packaging Waste Regulation (PPWR) and prepare your business for compliance. CEHTRA provides regulatory guidance and sustainability insights. PPWR - Packaging and Packaging Waste Regulation Supporting companies in understanding and complying with the EU Packaging and Packaging Waste Regulation (PPWR). Attend the Free PPWR Webinar What is the PPWR Regulation? The Packaging and Packaging Waste Regulation (PPWR) is a major regulatory initiative introduced by the European Union to reduce packaging waste and strengthen circular economy objectives. The regulation will introduce new obligations related to packaging design, recyclability, labelling, and waste reduction targets, affecting companies placing packaged products on the EU market. As the regulatory framework evolves, companies must anticipate these requirements to ensure compliance and adapt their packaging strategies accordingly. Contact our experts Why the PPWR Matters for Your Business The PPWR regulation will impact a wide range of industries placing packaged products on the European market. Companies may need to review: Packaging design and material choices Labelling and information requirements Responsibilities of economic operators Compliance timelines and regulatory obligations Waste reduction and recyclability targets Understanding these regulatory developments early is essential to anticipatepotential operational and compliance challenges. Who is concerned by the PPWR? The PPWR regulation applies to all companies placing packaged products on the EU market, including manufacturers, importers, distributors and brand owners across sectors such as cosmetics, food, pharmaceuticals and consumer goods. How CEHTRA Supports Your PPWR Compliance CEHTRA works alongside companies to translate regulatory requirements into practical compliance strategies. Our approach focuses on helping businesses: understand the regulatory framework anticipate operational impacts identify potential compliance gaps implement appropriate regulatory strategies By combining regulatory expertise and industry experience, CEHTRA helps companies prepare for upcoming packaging regulations and navigate complex compliance requirements. Discover all our packaging services Register for the Free PPWR Webinar: Understanding the Packaging and Packaging Waste Regulation Join our webinar dedicated to the Packaging and Packaging Waste Regulation (PPWR) and gain a clear overview of this new European regulation on packaging. Know more PPWR Webinar Objectives During this webinar, our experts will cover: the key provisions of the PPWR regulation the implementation timeline and deadlines the new obligations for companies impacts on packaging design and management the first steps to anticipate for regulatory compliance This session will help participants better understand the implications of the PPWR and identify the actions required to anticipate upcoming regulatory changes. Date: 18 June 2026 10:00 - 11:00 French Register to the webinar Date: 18 June 2026 14:00 - 15:00 English Register to the webinar Speaker Introduction Anaïs Coinet and Loriane De Franceschi support companies in understanding and implementing European packaging regulations (PPWR). They will share their expertise to anticipate legal obligations, optimize packaging design and strategy, and ensure compliance with PPWR requirements. Participants will gain practical guidance and concrete examples to prepare their packaging strategies in line with PPWR requirements. Preparing for the PPWR Regulation? Section À propos. Chaque site a une histoire et les utilisateurs veulent découvrir la vôtre. The upcoming Packaging and Packaging Waste Regulation (PPWR) will introduce new requirements affecting packaging design, labelling, and compliance responsibilities. CEHTRA experts can help you assess potential impacts and anticipate regulatory obligations. Contact us to discuss how we can support your PPWR compliance strategy. Request support

CEHTRA ensures the regulatory compliance of your packaging. Our experts can assist you with your declarations of conformity and with the risk assessment of your products. Our offer extends to laboratory testing, migration modeling and toxicological expertise. Packaging regulatory compliance and safety expertise for global markets Helping you ensure safe and compliant packaging, worldwide. Our services Request support Comprehensive regulatory services for safe and compliant packaging Packaging compliance with current regulations is no longer just a constraint; it has become a strategic level for performance, innovation and differentiation for all industrial players, regardless of their sector or position in the value chain. It now directly conditions the durability of products in the face of evolving regulatory requirements, as well as the growing expectations of the market and end customers. Our team of experts supports packaging manufacturers, suppliers and users in securing their regulatory compliance, while ensuring the long-term sustainability of their products in line with market requirements and customer expectations. Contact our experts Key regulatory services for packaging materials Ancre 1 Packaging regulatory watch Consumer safety: food contact, cosmetics, substances (SOC), REACH / CLP Environment: packaging regulations (PPWR, EPR, etc.) Geographical scope: Europe, USA, China Monitoring formats: monthly, standard or tailor-made Global PPWR / EPR compliance support Regulatory watch & country fact sheets: monthly monitoring and summary of requirements by country Customized dashboard: audit, deviations, and compliance roadmap Tailor-made training & webinars Expert support: dedicated ressource or ad hoc on PPWR / REP subjects Food Contact Packaging Compliance Supplier files: collection, drafting of questionnaires and certificate analysis Declarations of conformity: drafting and review of the DoC food contact (1935/2004/EC, 10/2011/EC, FDA, etc.) Migration & laboratory tests: test management (global/specific migration) and migration modeling Regulatory synthesis of requirements: summary by materials and geographical areas Cosmetic packaging compliance Supplier files: collection, questionnaires and certificate analysis Containment/Content Interactions: Substance Identification and Risk Assessment Exposure assessment: substance-by-substance analysis according to consumer use Tests & compatibility monitoring: laboratory management (Cosmetopack guidelines, adapted tests) Packaging Regulations Webinars and Training Staying up to date with packaging regulations is essential for companies that bring products to market. Our webinars and training courses enable professionals to understand key requirements, anticipate regulatory changes and ensure the compliance of their packaging. Led by regulatory experts, these sessions cover topics such as the regulation of food contact packaging and cosmetics, extended producer responsibility (EPR) and the enforcement of the PPWR Regulation (EU) 2025/40, offering practical advice for an effective compliance strategy. Free PPWR Webinar: Understanding the Packaging and Packaging Waste Regulation Know more Introduction to packaging regulations:understanding and implementing them Know more Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics Know more Looking for guidance on packaging compliance? Find it here. How can I ensure packaging safety and compliance with international regulations? Ensuring packaging safety starts with understanding global regulatory requirements. Our experts help review declarations of compliance, draft specifications, and monitor regulations across EU, USA, China, Switzerland, and Mercosur. By combining document assessment, supplier data collection, and risk evaluation, we provide practical guidance to keep your packaging materials safe and compliant worldwide. How can I ensure packaging safety for food contact materials? Ensuring the safety of food contact packaging requires compliance with specific regulations and careful material assessment. Our experts evaluate substances, perform risk assessments, and monitor interactions between packaging and food. We also guide you through documentation, declarations of compliance, and migration modeling to guarantee that your packaging is safe, compliant, and suitable for food applications. What does the new PPWR regulation mean for packaging compliance? The Packaging and Packaging Waste Regulation (PPWR) sets strict requirements for packaging design, recyclability, and material safety across the EU. Our experts help manufacturers and suppliers understand PPWR obligations, assess packaging safety, and implement compliant solutions. We provide guidance on restricted substances, documentation, and material selection to ensure your packaging meets regulatory requirements while supporting sustainability goals. Explore additional resources Can’t find your answer? Submit a request Enhance your regulatory strategy with our complementary services CEHTRA Training. Deepen your knowledge with our expertise. Digital Solutions. Your performance, our digital solutions. Simply Predict. In silico predictions: for faster, smarter decision-making. Flex + Your projects are moving forward. We provide the resources. Endocrine disruptors. The assessment of endocrine disruptors, with rigor and method. Haut de page