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The safety of cosmetic products is generally assessed from the perspective of human health, considering endpoints such as skin irritation, skin sensitisation, systemic toxicity, and endocrine disruption. However, the environmental properties of cosmetic ingredients are becoming increasingly important in substance assessment processes and product development strategies, particularly when selecting formulation ingredients. This growing focus is driven by several converging factors: increasing consumer expectations; corporate sustainability (CSR/ESG) strategies; evolving environmental regulations; and the development of environmental impact assessment and scoring tools for cosmetic products. Despite this progress, several concepts are still frequently oversimplified or misunderstood. → A biodegradable substance is not necessarily harmless to aquatic organisms. → Likewise, some substances may become substances of concern well before any formal regulatory restriction is introduced. → Finally, the natural origin of an ingredient does not, by itself, guarantee a low environmental impact. The purpose of this article is to review the key concepts needed to understand how environmental properties can be integrated into the safety assessment of cosmetic ingredients. 1. Ecotoxicity and Environmental Fate: Two Complementary Pillars The environmental profile of a substance is primarily based on two major categories of information: ecotoxicity, which characterises its effects on living organisms; environmental fate, which describes how the substance behaves once released into the environment. Although complementary, these concepts address different scientific questions. Ecotoxicity Ecotoxicity aims to characterise the effects of a substance on organisms exposed under environmental conditions, including: aquatic organisms such as fish, algae and aquatic invertebrates; terrestrial organisms, including soil macroorganisms and microorganisms; and many other environmental species. Studies may investigate either short-term exposure (acute toxicity) or long-term exposure (chronic toxicity). The most commonly used endpoints include: EC50 and LC50 for acute toxicity; EC10 and NOEC for chronic toxicity. → These data are used to characterise the environmental hazard of a substance. Environmental fate Once released into the environment, a substance may partition between different environmental compartments (including water, soil, sediment and air) and undergo various transformation processes. Key parameters evaluated include: water solubility; volatility; degradation; biodegradability; mobility; bioaccumulation; adsorption to particles in water, sediment, soil, air and living organisms. → Environmental fate plays a major role in assessing: environmental exposure; long-range transport potential; persistence; the potential for accumulation in living organisms; and the overall environmental risk. Under cross-sector regulations such as REACH, as well as sector-specific legislation such as the Biocidal Products Regulation (BPR), ecotoxicity and environmental fate data are inseparable components of a comprehensive environmental assessment. Regulatory framework Requirements relating to environmental information are primarily established under: Regulation (EC) No 1907/2006 (REACH); Regulation (EC) No 1272/2008 (CLP); and the guidance documents published by the European Chemicals Agency (ECHA). By contrast, the European Cosmetics Regulation (EC) No 1223/2009 does not require a comprehensive environmental assessment of cosmetic ingredients before a cosmetic product is placed on the market. Nevertheless, other environmental regulations may indirectly affect ingredients used in cosmetic formulations. Some cosmetic ingredients are known to exhibit high toxicity to aquatic organisms. Frequently cited examples include BENZOPHENONE-3 and certain ethoxylated surfactants such as LAURETH-3. 2. Environmental Hazard Classifications under the CLP Regulation Ecotoxicological properties may lead to an environmental hazard classification under Regulation (EC) No 1272/2008 (CLP). The best-known environmental hazard classes are: Aquatic Acute; Aquatic Chronic. These classifications primarily consider: aquatic toxicity; biodegradability; bioaccumulation potential. Substances exhibiting very high toxicity to aquatic organisms may therefore be classified as: Aquatic Acute Category 1; Aquatic Chronic Category 1. Where appropriate, M-factors are assigned according to the lowest aquatic toxicity value, increasing the contribution of these substances when calculating the classification of mixtures. Today, however, environmental concerns extend well beyond aquatic toxicity alone. In 2023, several new environmental hazard classes were introduced under the CLP Regulation: Endocrine Disruptor for the Environment (ED ENV); Persistent, Bioaccumulative and Toxic (PBT); very Persistent and very Bioaccumulative (vPvB); Persistent, Mobile and Toxic (PMT); very Persistent and very Mobile (vPvM). These properties are now subject to close regulatory scrutiny because they help identify substances likely to cause long-term environmental impacts, often well before formal regulatory restrictions are adopted. Certain cyclic silicones, UV filters and fluorinated substances illustrate this growing trend towards proactive regulatory risk management. Bumetrizole, used as a UV filter, is another example of a substance identified as a concern because of its persistence and bioaccumulation potential and has been concluded to meet the vPvB criteria. Other cosmetic ingredients also illustrate concerns related to persistence and bioaccumulation. For example, C9-15 Fluoroalcohol Phosphate, which belongs to the PFAS family, is associated with the exceptional environmental persistence characteristic of fluorinated substances. Similarly, Octrizole (INCI: Octrizole), used as a UV absorber to protect cosmetic formulations from photodegradation, has also been identified as exhibiting concerning persistence and bioaccumulation properties and has been concluded to meet the vPvB criteria. These examples illustrate how PBT and vPvB criteria have become key drivers for regulatory anticipation and ingredient substitution strategies. → Today, these properties are major considerations when anticipating future regulatory developments and identifying potential substitution candidates. 3. Biodegradability: A Frequently Misunderstood Concept Biodegradability is probably the best-known environmental property among the general public. However, it is also one of the most frequently oversimplified. A biodegradable substance is not necessarily of low concern for the environment. Conversely, a substance exhibiting low immediate toxicity may still raise environmental concerns if it persists in the environment over extended periods. Biodegradability studies evaluate the ability of microorganisms to degrade a substance under standardized experimental conditions. Examples of cosmetic ingredients known to exhibit low biodegradability include: certain benzophenones, including BENZOPHENONE-1, BENZOPHENONE-2, BENZOPHENONE-6, and BENZOPHENONE-8; BHT; several modern UV filters; ETIDRONIC ACID (INCI: ETIDRONIC ACID); certain rosin-derived resins (INCI names including COLOPHONIUM, GLYCERYL ROSINATE, and HYDROGENATED ROSINATE); certain synthetic hydrocarbons. Biodegradability of mixtures For finished cosmetic products, biodegradability may be estimated based on the properties of the individual ingredients. However, this approach has several limitations: environmental data are not available for all ingredients; experimental test conditions do not always reflect real environmental conditions; interactions between ingredients may influence the biodegradation of the finished formulation. 4. How Environmental Regulations Influence Cosmetic Ingredients The European Cosmetics Regulation (EC) No 1223/2009 does not require a comprehensive environmental assessment before cosmetic products are placed on the market. However, several other regulatory frameworks may directly affect the ingredients used in cosmetic formulations, including: REACH; CLP; specific environmental restrictions. The well-known example of cyclic silicones The cyclic silicones: Cyclotetrasiloxane (D4); Cyclopentasiloxane (D5); Cyclohexasiloxane (D6), are probably the best-known example of the impact that environmental regulations can have on cosmetic ingredients. Their PBT and vPvB properties led to the introduction of restrictions under the REACH Regulation, with direct consequences for certain categories of cosmetic products, particularly rinse-off products. These restrictions were introduced through Commission Regulation (EU) 2018/35, amending Annex XVII to REACH. → Although these restrictions do not originate from the Cosmetics Regulation itself, they have a direct impact on the formulation of certain cosmetic products, especially rinse-off products. 5. Anticipating Rather Than Reacting: The Strategic Value of Environmental Data Environmental data are no longer used solely to demonstrate compliance with existing regulations. They have also become valuable decision-support tools for: formulators; cosmetic safety assessors; regulatory affairs professionals; sustainability (CSR/ESG) teams. The objective is to identify, as early as possible, substances that may become problematic in the future. Ingredients may therefore be excluded: because they are already subject to regulatory restrictions; to anticipate future regulatory developments; or as part of a voluntary environmental sustainability strategy. → Within this proactive approach, PBT, vPvB, and Endocrine Disruptor for the Environment (ED ENV) classifications are receiving increasing attention. Today, the COSMETICK database includes ecotoxicological and environmental profiles for more than 2,200 cosmetic ingredients. Among these, 140 have been identified as presenting a high to very high level of environmental concern. These include: several UV filters; certain parabens; various silicones; but also ingredients that are less commonly associated with environmental concerns, such as BAKUCHIOL, PROPYL GALLATE, and MENTHOXYPROPANEDIOL. This information helps companies prioritize substitution efforts while anticipating future regulatory developments. 6. Towards More Comprehensive Environmental Assessments The environmental assessment of a cosmetic product extends beyond the ecotoxicological profile of its ingredients. More comprehensive approaches are now being developed, incorporating factors such as: Life Cycle Assessment (LCA); carbon footprint; water consumption; packaging; environmental scoring of raw materials. Initiatives such as the Green Impact Index and EcoBeautyScore illustrate this shift towards multi-criteria environmental assessment. Within this broader context, ecotoxicological data represent an essential, although not exclusive, component of the overall environmental evaluation of cosmetic products. COSMETICK provides ecotoxicological and environmental property data for cosmetic ingredients, supporting Life Cycle Assessments (LCA) and other environmental impact assessment and scoring methodologies. 7. Data Gaps and Limitations of Environmental Assessments As in human toxicology, environmental data remain incomplete for many substances. The most common challenges include: the absence of biodegradability data; limited ecotoxicological information; methodological differences between studies; the need for read-across or other scientific extrapolations. These data gaps can make environmental assessments particularly challenging for: complex mixtures; certain naturally derived raw materials; substances that remain insufficiently characterized. Examples of widely used cosmetic ingredients for which environmental data remain limited include: POLYHYDROXYSTEARIC ACID; SACCHARIDE ISOMERATE; SCLEROTIUM GUM; ISONONYL ISONONANOATE. Managing these uncertainties has become one of the major challenges of modern environmental assessment. Conclusion The environmental impact of cosmetic ingredients depends on several complementary dimensions, including: ecotoxicity; biodegradability; persistence; bioaccumulation; regulatory status; and, increasingly, Life Cycle Assessment (LCA). → These properties are no longer used solely for hazard classification. They have become valuable tools for informed decision-making, responsible formulation, and proactive regulatory anticipation. As environmental requirements continue to evolve worldwide, the ability to organize, interpret, and exploit ecotoxicological data is becoming an essential capability for the cosmetics industry. Above all, one key message should be remembered: A biodegradable substance is not necessarily safe for the environment. Authors: Clarisse Bavoux & Cyril Durou

China is revising its rules on new chemical substance registration, with a draft revision of the Measures for the Environmental Management Registration of New Chemical Substances, commonly referred to as China REACH. The draft was released by China’s Ministry of Ecology and Environment on 11 June 2026 and was open for public comment until 12 July 2026. Once finalised, the revised measures are expected to replace MEE Order No. 12 of 2020. For companies placing substances or products on the Chinese market, the proposed changes could have a significant regulatory impact, especially where new chemical substances are involved. What is MEE Order No. 12? MEE Order No. 12 sets out the requirements for the environmental management registration of new chemical substances in China. A new chemical substance is generally understood as a substance that is not listed on China’s Inventory of Existing Chemical Substances, known as IECSC. Companies manufacturing, importing or placing products on the Chinese market may therefore need to assess whether substances used in their products fall within the scope of the registration requirements. Key proposed changes The draft revision introduces several important changes to the current registration framework. 1. Exclusion of overseas applicants One of the most impactful proposed changes concerns who can act as the registration applicant. Exclusion of Overseas Applicants: Overseas enterprises can no longer act as registration applicants. Only domestic Chinese producers or importers are eligible to apply. This means that foreign suppliers would no longer be able to act directly as registration applicants. Instead, they would need to rely on a Chinese manufacturer or importer to hold the registration. For companies exporting products or substances to China, this could have practical consequences for supply chain organisation, regulatory responsibility and market access planning. 2. Removal of several existing exemptions The draft revision also proposes the removal of several existing exemptions. According to the information currently available, the affected categories include pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, feed, fertilisers and related additives. Companies active in these sectors may therefore need to reassess whether they have additional obligations under China’s new chemical substance registration framework, even if their products are already subject to sector-specific regulations. This point is particularly important for companies that previously considered their products outside the scope of MEE Order No. 12 due to an existing product-category exemption. 3. Changes to registration categories The draft also proposes changes to the current registration procedures. Under the current system, Record Filing applies to certain lower-volume new chemical substances and eligible polymers. The draft revision would replace Record Filing with Simplified Registration. This means that substances that previously benefited from a lighter record filing process may become subject to an approval-based registration process. Companies currently relying on Record Filing should therefore review whether their substances may require a new registration as existing Record Fillings will need to be converted to registrations to remain valid. To retain access to the market, applicants should ensure that they have obtained a simplified registration certificate under the new measures by 31 December 2026. Why does this matter for companies doing business in China? The proposed changes could affect companies across several sectors, particularly those manufacturing, importing or supplying products containing new chemical substances to the Chinese market. The main points to monitor are: Companies may need to reassess whether their substances fall within the scope of China REACH. Foreign companies may need to work more closely with Chinese importers or producers, as overseas applicants would no longer be eligible to apply directly. Products previously covered by exemptions may need to be reviewed again. Substances currently managed through Record Filing may require Simplified Registration. These changes could affect regulatory timelines, responsibilities between suppliers and importers, and the ability to place certain products on the Chinese market. What should companies do now? Companies potentially affected by the draft revision should start by identifying whether they manufacture, import, export or supply products containing substances that may be considered new chemical substances in China. They should also review their current registration status, their use of existing exemptions, record filings and the role of their Chinese importers or local partners in the registration process. As the final version of the revised measures has not yet been published, companies should continue monitoring regulatory developments and prepare for possible changes to their compliance strategy. CEHTRA is following the situation CEHTRA is closely monitoring the revision of MEE Order No. 12 and its potential impact on companies doing business in China. For any questions on this topic, please contact Damien Guyomar

In pharmaceutical development, the preparation of CTD Tabulated Summaries is a critical component of regulatory submissions. These documents require scientific rigor, consistency, and accuracy, while also involving extensive data compilation, formatting, and verification activities. For internal teams, this process can become highly time-consuming and may divert valuable expert resources toward repetitive, low-value tasks. A Growing Need for Operational Efficiency Toxicology and regulatory affairs teams are facing increasing pressure due to: accelerated development timelines, growing volumes of data, complex regulatory expectations, and the need to focus expert resources on strategic activities. In this environment, optimizing document preparation has become an important lever for improving operational performance. CEHTRA’s Approach: Combining Expertise with Innovative Tools At CEHTRA, we have implemented new tools and optimized processes to streamline the preparation of CTD Tabulated Summaries while maintaining the highest scientific and regulatory standards. These solutions allow us to: automate parts of the document structuring and formatting process, improve data harmonization and consistency, reduce the risk of errors and inconsistencies, and accelerate delivery timelines. Importantly, these tools are designed to support, not replace, scientific expertise. By reducing manual and repetitive tasks, our toxicology experts can dedicate more time to scientific assessment, critical analysis, and strategic support for our clients. Reducing Low-Value Administrative Burden While Tabulated Summaries are essential for regulatory submissions, they should not unnecessarily consume internal resources that could otherwise contribute to innovation and decision-making. By outsourcing these activities to a specialized partner equipped with efficient tools and dedicated expertise, pharmaceutical companies can: save time, improve operational efficiency, secure regulatory timelines, and allow internal teams to focus on higher-value scientific priorities. A Modern Vision of Regulatory Support Digital transformation is progressively reshaping regulatory and toxicological practices across the pharmaceutical industry. At CEHTRA, we believe these innovations should ultimately serve one purpose: delivering greater scientific value to our clients. The combination of human expertise and modern tools enables the delivery of reliable, consistent, and high-quality CTD Tabulated Summaries within optimized timelines, without compromising scientific integrity. If you would like to discuss your CTD Tabulated Summary needs or explore ways to optimize your regulatory activities, the CEHTRA team would be pleased to support you. Author: Sophie SIMAR, Non-Clinical Toxicologist - Head of the Pharma Market

On 15 June 2026, Regulation (EU) 2026/1165 entered into force, amending the Biocidal Products Regulation (BPR) and extending data protection for certain active substance dossiers until 31 December 2030. The amendment addresses a long-standing concern arising from delays in the Review Programme for existing active substances and restores protection that had expired at the end of 2025. The full text of the Regulation is available on EUR-Lex and can be accessed here: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202601165. What Changed? Under the previous version of Article 95(5) of the BPR, data protection for many Review Programme dossiers expired on 31 December 2025. As a result, from 1 January 2026, alternative suppliers could rely on previously protected data when applying for inclusion on the Article 95 list without obtaining a Letter of Access (LoA) or sharing the costs incurred by the data owner. Regulation (EU) 2026/1165 changes this position by extending data protection until 31 December 2030 for active substance/product-type combinations for which an approval decision had not been adopted by 7 June 2018. The legislator considered that many of these dossiers required substantial additional data generation following the introduction of the endocrine disruptor criteria in 2018 and due to evolving regulatory requirements and guidance. The extension is intended to preserve incentives for data generation while recognising the significant delays in the completion of the Review Programme. Importantly, the extension applies to all data within the relevant dossiers rather than only to newly generated studies, providing a simpler and more predictable framework for both data owners and applicants. Impact on Article 95 Applications The practical consequence is that, from 15 June 2026, companies seeking inclusion on the Article 95 list can no longer freely rely on these dossiers. ECHA has confirmed that Article 95 applications making reference to an existing dossier without a Letter of Access will only be accepted where all applicable data protection periods have expired. In practice, applicants must ensure that: the relevant data is no longer protected under Article 60(2) of the BPR; and the data is no longer protected under Article 95(5), including the new extension introduced by Regulation (EU) 2026/1165. Where protection remains in place, applicants must obtain a Letter of Access or submit their own alternative dossier. ECHA has also clarified that renewal data may create additional protection obligations. Even where the original approval dossier is no longer protected, applicants may still require a Letter of Access to protected data generated in support of a renewal application. The January - June 2026 “Gap Period” One of the most interesting aspects of the amendment is how it deals with the period between 1 January and 15 June 2026. During this six-month period, the original Article 95(5) protection had expired, and the new Regulation had not yet entered into force. ECHA reported that more than 90 applications were processed during this interval, demonstrating the immediate practical impact of the temporary absence of data protection and the commercial interest in obtaining Article 95 listings. To address this situation, the legislator introduced an exception to the normal BPR principle that expired protection periods cannot restart. Article 60 was amended specifically to allow the affected data to become protected again. In addition, data owners may claim compensation from substance suppliers or product suppliers that benefited from the absence of protection and were included on the Article 95 list between 1 January and 15 June 2026. This compensation mechanism is likely to be closely monitored by industry, as it introduces a novel situation in which suppliers may face post-registration claims relating to access to data relied upon during the temporary lapse of protection. Looking Ahead The amendment provides greater certainty for companies that have invested in maintaining Review Programme dossiers and generating additional studies requested during the evaluation process. At the same time, it re-establishes the need for Article 95 applicants to carefully assess the protection status of the data on which they intend to rely. With ECHA now applying the revised rules and a broader evaluation of the BPR expected during 2026–2027, companies should review their Article 95 strategies, data access arrangements and ongoing applications to ensure continued compliance and avoid delays in market access. Author: Barbara Dhoop, Regulatory Affairs Manager - Biocides

On 27 November 2024, the European Union reached a landmark milestone with the adoption of Directive (EU) 2024/3019 on urban wastewater treatment. This text, which lays down minimum requirements for the collection, treatment and monitoring of urban wastewater, is the result of a comprehensive recast of the 1991 directive. However, it goes far beyond a mere technical update. It marks a structural shift designed to align wastewater management with the One Health approach, while also reducing greenhouse gas emissions, improving the sector’s energy balance and supporting the transition towards a circular economy. A systemic expansion of the scope of application The assessment of the previous regulatory framework showed that significant sources of pollution remained insufficiently addressed. According to the European Environment Agency’s 2018 report on European waters, small agglomerations exert significant pressure on 11% of the EU’s surface water bodies. To better tackle pollution at source and prevent untreated urban wastewater from being discharged into the environment, the new directive expands its obligations both territorially and technically. Inclusion of small agglomerations The compliance threshold for collection systems and secondary treatment of organic pollution has been lowered from 2,000 to 1,000 population equivalents (p.e.). Member States must ensure that agglomerations between 1,000 and 2,000 p.e. are equipped with collection systems by 31 December 2035, and that discharges from urban wastewater treatment plants serving these agglomerations comply with secondary treatment requirements by the same deadline. This measure aims to eliminate direct untreated discharges, particularly in rural and peri-urban areas. Integrated stormwater management One of the key pillars of the recast concerns urban runoff and storm water overflows. The directive requires integrated urban wastewater management plans to be established for all agglomerations of 100,000 p.e. and above by 31 December 2033, as well as for risk-prone agglomerations between 10,000 and 100,000 p.e. by 31 December 2039. These plans must prioritise green and blue infrastructure solutions wherever possible. The directive sets an indicative, non-binding objective that storm water overflows should represent no more than 2% of the annual collected urban wastewater load, calculated under dry-weather conditions. Importantly, before considering storage or treatment measures, integrated management plans must first assess preventive solutions aimed at avoiding the entry of unpolluted rainwater into collection systems, including natural water retention, rainwater harvesting and the expansion of green and blue urban spaces. Regulation of individual systems Where connection to a collection system is not technically feasible, would involve excessive cost, or would not provide environmental or public health benefits, individual systems such as septic tanks may be authorised by way of derogation. However, the directive now requires these systems to be designed, operated and maintained in a way that achieves the same level of environmental and human health protection as secondary and tertiary treatment. Member States must also register such systems and ensure regular inspections or controls based on a risk-based approach. Technological upgrading: tertiary and quaternary treatment The directive introduces a stricter treatment hierarchy to address both eutrophication and chemical contamination. Treatment level Main targets Implementation thresholds Final deadlines Secondary Organic matter: BOD5, COD Agglomerations of 1,000 p.e. 2035 Tertiary Nitrogen and phosphorus More than 150,000 p.e. (all discharges) / agglomerations of 10,000 p.e. and above discharging into eutrophication-sensitive areas 2039 / 2045 Quaternary Organic micropollutants More than 150,000 p.e. (all discharges) / agglomerations of 10,000 p.e. and above discharging into micropollutant-risk areas 2045 The technological leap of quaternary treatment Quaternary treatment is one of the flagship innovations of the recast directive. It is intended to reduce substances that may pollute water even at very low concentrations, including pharmaceutical residues and substances associated with cosmetic products. The treatment plants concerned will have to demonstrate an average removal rate of at least 80%, calculated on the basis of selected indicator substances. These indicators include complex molecules such as carbamazepine, diclofenac and venlafaxine. Extended Producer Responsibility Article 9 introduces the polluter-pays principle into the financing of wastewater treatment. The pharmaceutical and cosmetics industries are directly targeted because their residues are the primary source of the micropollutants detected in wastewater. Scope of financing By 31 December 2028, producers placing the relevant products on the EU market will be subject to extended producer responsibility. They will be required to cover at least 80% of the full costs of complying with quaternary treatment requirements, including both investment and operating costs, as well as the costs of monitoring micropollutants. Their financial contribution will be determined on the basis of the quantities and hazardousness, in urban wastewater, of the substances contained in the products they place on the market. Exemption criteria: the burden of proof A producer may be exempted where it can demonstrate that: the quantity of substances contained in the products it places on the EU market is below one tonne per year; or the substances contained in those products are “rapidly biodegradable” in wastewater or do not generate micropollutants in wastewater at the end of their life. The European Commission must adopt detailed criteria for the uniform application of the biodegradability and hazardousness exemption by 31 December 2027. For industry, anticipating these criteria will therefore be a major strategic issue, both from a compliance perspective and in terms of product formulation and portfolio management. Energy neutrality and circular economy The directive requires the urban wastewater sector to become an active contributor to the energy transition. Towards renewable-energy coverage The objective is to achieve energy neutrality for the urban wastewater treatment sector by 2045. This target applies, at national level, to urban wastewater treatment plants treating a load of 10,000 population equivalents (p.e.) and above, including their connected collecting systems. Mandatory energy audits will be required every four years for the relevant installations. The energy required to cover the sector’s needs must progressively come from renewable sources generated by or on behalf of wastewater treatment plant owners or operators, whether on-site or off-site, including biogas, solar and wind energy. Energy audits must cover both treatment plants and their associated collecting systems: by 31 December 2032 for installations above 100,000 p.e., and by 31 December 2033 for those between 10,000 and 100,000 p.e. Resource recovery The legislation also promotes the reuse of treated wastewater, particularly in water-stressed areas, provided that human health and environmental safety are ensured, notably in the case of agricultural irrigation. In parallel, phosphorus recovery from sewage sludge becomes a strategic priority. By encouraging nutrient recovery, the directive supports the circular economy and contributes to reducing the Union’s dependence on imported fertilisers. Governance, transparency and health srveillance The directive strengthens citizens’ rights and expands monitoring obligations. Health surveillance. The text institutionalises wastewater-based epidemiological surveillance, covering public health parameters such as SARS-CoV-2 and its variants, influenza viruses, poliovirus and emerging pathogens, as well as antimicrobial resistance (AMR). However, monitoring is not limited to epidemiological surveillance. It must also help detect the presence of microplastics, PFAS and metals in urban wastewater and sludge, thereby reinforcing a precautionary approach to emerging pollutants. Cost transparency. Agglomerations of more than 10,000 p.e. will have to provide households with clear information on the costs of measures implemented to protect public health and improve treatment performance. Access to sanitation. Member States must identify vulnerable and marginalised groups and improve their access to sanitation facilities, including in public spaces. Critical implementation milestones Date Regulatory milestone 1 January 2025 Official entry into force of the directive. 31 July 2027 Deadline for Member States to transpose the directive into national law. 31 December 2027 Publication by the Commission of EPR exemption criteria, including biodegradability criteria. 31 December 2028 Effective implementation of Extended Producer Responsibility schemes. 31 December 2030 First energy-neutrality milestone: renewable energy generation equivalent to 20% of annual energy use. Conclusion : Directive (EU) 2024/3019 is not merely a regulatory update; it represents a profound structural transformation that redefines urban wastewater management as a central pillar of public health protection and climate resilience within the European Union. By embedding the One Health approach and introducing fourth-generation treatment standards, the European legislator is placing Member States and economic operators on an unprecedented path towards higher environmental and operational performance. In this respect, the introduction of Extended Producer Responsibility (EPR) represents a major financial and operational challenge for the pharmaceutical and cosmetics industries. The 31 December 2028 deadline for the implementation of this regime requires companies to immediately reassess their market access strategies and to rigorously document the biodegradability of the substances they place on the market. At the same time, the objective of achieving energy neutrality by 2045 transforms wastewater treatment infrastructure into genuine renewable energy production and resource recovery units, including for critical resources such as phosphorus, thereby strengthening the European Union’s strategic autonomy. In this increasingly complex regulatory environment, anticipation will be key to compliance. The transposition period, ending on 31 July 2027, should be used by local authorities and industry stakeholders to assess their risks, structure their technical documentation and prepare for the forthcoming EPR exemption criteria expected by the end of 2027. Authors: Floriane Demailly & Loris Mistrulli

Fragrance diffusers, often perceived as wellness or decorative products, are becoming increasingly common in homes: reed diffusers, electric diffusers (plug-in, nebulisers, ultrasonic devices, etc.), sprays, stone diffusers, candles, and more. Their promise is simple: to create a pleasant and relaxing olfactory atmosphere. However, from a regulatory and safety perspective, these products are far from trivial. Whenever they contain a chemical mixture, whether of natural or synthetic origin, intended for release into indoor air, they raise a fundamental question: how can their chemical safety for consumers be ensured? Even when their function is exclusively fragrance-related, with no sanitising, antimicrobial, or repellent claims, these products may expose consumers to various chemical substances through inhalation, accidental dermal contact during refilling, or even accidental ingestion. For brands, the challenge is therefore not merely aesthetic or marketing-related. It is about demonstrating that the product placed on the market has been properly classified, labelled, and can be used safely under foreseeable conditions of use. Proper product qualification: a fragrance diffuser remains a chemical product In the case of a fragrance diffuser, the product should first and foremost be considered as chemical mixture, sometimes associated with a support or diffusion device. The fragrance formulation may contain solvents, fragrance compositions, essential oils, allergens, volatile organic compounds (VOCs), or substances presenting physicochemical, toxicological, or environmental hazards. The diffusion system itself, bottle, reeds, cap, refill, or electrical device, also plays a key role and influences the overall safety of the product. CLP: Classification, Labelling and Packaging of the fragrance mixture The CLP Regulation forms the European foundation for the classification, labelling, and packaging of hazardous substances and mixtures. It requires the hazards of a mixture to be determined before it is placed on the market. For a fragrance diffuser, this step is essential because it directly determines the information that must appear on the label: hazard pictograms, signal words, hazard statements, precautionary statements, supplier identification, and product identification. The Unique Formula Identifier (UFI) provides the link between the marketed product and the information submitted to Poison Centres. In the event of accidental exposure, it facilitates rapid identification of the mixture composition and supports appropriate medical advice. REACH and GPSR: from substance data to finished product safety The REACH Regulation is a key source of information for documenting the hazards and risks of substances used in fragrance diffusers. However, it operates on a substance-by-substance basis, and the extent of available data largely depends on manufacturing or import volumes. From one tonne per year per registrant, a substance subject to registration must be supported by a dossier containing minimum hazard information. From ten tonnes per year onwards, additional requirements apply, including a Chemical Safety Assessment (CSA) and, where certain hazard criteria are met under Article 14(4) of REACH, an exposure assessment and risk characterisation. For products intended for release into indoor air, this information can help determine whether anticipated consumer exposure remains compatible with available toxicological reference values. However, REACH alone does not always answer the question of finished product safety. Some substances may be used below registration thresholds, toxicological information may be limited, certain uses may be described too broadly, and available exposure scenarios may not accurately reflect the real conditions of use of a fragrance diffuser, such as diffusion duration, frequency of use, or exposure of sensitive populations. In such cases, the General Product Safety Regulation (GPSR) acts as a safety net. Since 13 December 2024, every consumer product must be safe under normal or reasonably foreseeable conditions of use (see our related article on the subject). For a fragrance diffuser, this assessment should be based on a comprehensive chemical safety approach applied to the finished product, taking into account both the hazards associated with the substances contained in the formulation and the exposure resulting from the product’s normal and reasonably foreseeable conditions of use (see our related article on the subject). The GPSR places responsibility on the economic operator placing the product on the market to demonstrate that the fragrance diffuser does not present an unacceptable chemical risk to consumers under normal and reasonably foreseeable conditions of use. The complex case of essential oils The relationship between REACH and GPSR is particularly important when a formulation contains essential oils. An essential oil is a complex natural substance composed of numerous constituents whose proportions may vary depending on plant species, geographical origin, cultivation conditions, extraction method, and plant part used. Essential oils are widely used in fragrance diffusers and are often marketed based on their natural origin. However, natural origin does not necessarily simplify toxicological assessment. On the contrary, it may make it significantly more complex. Its composition is not always fully characterised, and the frequent lack of toxicological data can make hazard and risk assessment particularly challenging. In this context, the GPSR plays a crucial role by requiring a broader assessment than that based solely on information available under REACH. It allows a more refined evaluation of the risks associated with the presence of essential oils in the finished product. When available information is limited, it becomes necessary to examine the composition of the essential oil more closely, identify relevant constituents, and assess the robustness of the toxicological reference values used for risk characterisation. This raises an important methodological question: should an essential oil be assessed as a whole substance, or should the assessment focus on its major constituents and identified substances of concern, even when present at low concentrations? The answer is critical when establishing a representative toxicological reference value. Failure to identify certain constituents and their associated hazards limits the overall representativeness of the available data. Furthermore, toxicological information is often insufficient, both for the essential oil itself and for some of its identified constituents. In the absence of fully established assessment methodologies for these complex natural substances, defining a robust and representative toxicological reference value may prove particularly challenging. How can the compliance and safety of a fragrance diffuser be ensured? Compliance should not be viewed solely through the lens of labelling requirements or the natural origin of ingredients. Rather, it requires a robust chemical safety strategy that combines the use of relevant data available under REACH with a finished-product risk assessment under the GPSR whenever necessary. This involves identifying the substances present in the product, evaluating their hazards, classifying the mixture correctly, fulfilling Poison Centre notification obligations where applicable, selecting appropriate toxicological reference values for the relevant exposure routes, documenting the intended conditions of use, and ensuring that any potential risks are adequately controlled through qualitative and/or quantitative risk assessment and suitable risk management measures. Author: Anna Chelle, Toxicologist and Chemical Risk Assessment & Safety service Manager

A product may contain a hazardous substance without necessarily presenting an unacceptable risk, provided that user exposure remains controlled. Conversely, an apparently low concentration is not always sufficient to guarantee safety. Everything depends on the substance’s toxicity, the way it is released, and the actual conditions of use. Chemical risk assessment therefore seeks to answer two complementary questions: what are the hazardous properties of the substances present, and how, and to what extent, can the user be exposed to them? A two-pillar approach Identifying the hazards of chemical substances present in a product Hazard assessment aims to identify the potential adverse effects of substances present in an article, mixture, or chemical product. It relies on all available information, including harmonized classifications or self-classifications under the CLP Regulation, Safety Data Sheets (SDS), experimental toxicological data, scientific literature, opinions issued by health agencies, and information from regulatory dossiers. Where sufficient data are available, this step leads to the selection or development of an appropriate toxicological reference value. This may be a Reference Dose (RfD), a Reference Concentration (RfC), or, where such values are unavailable, a toxicological point of departure such as a NOAEL/NOAEC (No Observed Adverse Effect Level/Concentration) or a LOAEL/LOAEC (Lowest Observed Adverse Effect Level/Concentration), to which uncertainty factors are applied. The selected reference value must always be consistent with the exposure route, exposure duration, and target population. For threshold effects, this reference corresponds to an exposure level below which no adverse health effects are expected under the assessed conditions. For non-threshold effects (such as carcinogenicity) or when available data are insufficient, the assessment must adopt a more precautionary approach and clearly document uncertainties. Estimating real-World user exposure to chemical substances Exposure assessment aims to determine the conditions under which users are actually exposed. It must cover both normal conditions of use and reasonably foreseeable conditions of use. Accidents, intentional misuse, or clearly unforeseeable behaviours require separate prevention, information, or risk management measures and should not be confused with the use scenario selected for concluding on product safety. The precautions provided on product labels or instructions for use are therefore directly linked to the assumptions used in the assessment. If users deviate from these conditions, product safety can no longer be guaranteed. Characterising chemical risk Risk characterisation consists of comparing estimated exposure with an appropriate toxicological reference value. Depending on the context, this comparison may take the form of a Risk Characterisation Ratio (RCR) or a Margin of Exposure (MOE). Risk does not depend solely on the presence of a hazardous substance. It also depends on substance concentration, the route of exposure, and the conditions under which the substance is released, inhaled, ingested, or handled. It is this combination of hazard and exposure that allows conclusions to be drawn regarding whether the risk is adequately controlled. Fragrance Diffusers: a practical example of chemical risk assessment A fragrance diffuser is a good example of a consumer product for which a pleasant fragrance can sometimes obscure the underlying chemical reality of the product. Whether it is a reed diffuser, nebuliser, electric diffuser, or liquid refill system, safety must be demonstrated based on the substances present, their mode of release, and the anticipated exposure of users. Verifying the applicable regulatory framework For companies formulating, importing, or marketing fragrance diffusers within the European Union, several regulatory checks are required: Verify the classification of the mixture and its substances under the CLP Regulation and ensure that labelling and packaging are consistent with this classification. Consider any applicable supplemental hazard statements, including those related to sensitising substances when regulatory thresholds are exceeded. Ensure that substances are registered under REACH where required, or covered by supply chain information when the company acts as a downstream user. Confirm that the intended use (“air freshener”, “air care product”, or “indoor air diffusion”) is covered by identified uses (Product Category PC3), Safety Data Sheets, and, where relevant, exposure scenarios provided by suppliers. Check restrictions applicable to substances contained in the mixture, including those listed under REACH Annex XVII, as well as any obligations relating to Substances of Very High Concern (SVHCs) or substances subject to authorisation. Maintain Safety Data Sheets and supplier information and make them available where required by regulation. Verify Poison Centre Notification obligations and UFI assignment requirements when the mixture is classified for physical or health hazards and intended for consumer or professional use. Determine whether product-specific regulatory obligations apply. These checks form the foundation of risk assessment. They help ensure composition control, data traceability, and accurate communication to users, while also determining whether an additional assessment is required to demonstrate compliance with the General Product Safety Regulation (GPSR). (See the GPSR blog post). Selecting appropriate toxicological reference values For fragrance diffusers, inhalation is generally the primary exposure route. Dermal exposure should also be considered when users handle refills, fill reservoirs, clean devices, or otherwise come into contact with the fragrance solution. For each relevant substance, it is therefore necessary to identify a toxicological reference value appropriate to the exposure route and expected duration of use, whether acute, repeated, or chronic. Where available data are limited, assessors must justify their choices, document uncertainties, and, where appropriate, adopt a conservative approach. Building a realistic exposure scenario for a fragrance product For fragrance diffusers, exposure is highly dependent on use conditions. Parameters that should be documented include: Type of diffuser (reed diffuser, electric plug-in diffuser, nebuliser, automatic spray system, refill, etc.) Quantity of product released and emission rate Concentration of substances within the mixture and their physicochemical properties, particularly volatility Emission duration, user presence time within the room, and frequency of use Room volume, air exchange rate, and ventilation conditions Potential handling activities such as installation, refilling, replacement of refills, and cleaning Potentially exposed populations, particularly children, pregnant women, and individuals with asthma or allergies, where relevant to the intended use A modelling tool such as ConsExpo, or an equivalent consumer exposure model, can be used to estimate exposure based on these parameters. The assumptions used should be realistic, sufficiently protective, and consistent with the instructions and precautions provided to consumers. Interpreting the results of a chemical risk assessment Where estimated exposure remains below the selected toxicological reference value, the risk may be considered adequately controlled under the assessed conditions. However, if exposure approaches or exceeds the selected reference value, or if available data do not allow a sufficiently robust conclusion, the formulation, mode of diffusion, or conditions of use should be reconsidered. From risk assessment to risk management: ormulation, Use Conditions, and Instructions for Use The objective of chemical risk assessment is not simply to produce a technical dossier. It should support practical decisions regarding product formulation, design, and consumer information. Several risk management measures may be implemented, including reducing the concentration of a substance, substituting an ingredient, modifying the emission rate, limiting recommended duration of use, discouraging use in specific rooms or situations, improving ventilation recommendations, strengthening labelling, or redesigning the device itself. Conclusion : demonstrating the chemical safety of the finished product A fragrance diffuser intended solely to provide fragrance remains a consumer chemical product. Its safety cannot be assumed based on a pleasant scent, an apparently low concentration, or the natural origin of its ingredients. Safety assessment must rely on a structured approach: identifying hazards, selecting appropriate toxicological reference values, characterising actual user exposure, and comparing these values with anticipated exposure levels. This scientific and regulatory approach makes it possible to determine whether risk is adequately controlled under normal and reasonably foreseeable conditions of use. Ultimately, regulatory compliance should not be viewed as a standalone administrative obligation, but rather as the extension of a fundamental objective: placing an enjoyable fragrance product on the market while demonstrating that it is safe for users under its intended conditions of use. Author: Anna Chelle, Toxicologist and Chemical Risk Assessment & Safety service Manager

Food supplements hold a unique position in the European Union (EU): they are neither medicines nor ordinary foods, but are intended to complement the daily diet. Their placement on the EU market is governed by a strict regulatory framework, combining harmonized European rules and national provisions, with a central goal: ensuring consumer safety. Definition of Food Supplements in the EU According to EU regulations, a food supplement differs from medicines by its nutritional or physiological effect and does not have a therapeutic action. It cannot treat, prevent, or cure diseases. The official EU definition is based on three cumulative criteria: Nature: concentrated source of vitamins, minerals, amino acids, or plant extracts with nutritional or physiological benefits. Purpose: to complement a normal diet without replacing it. Form: capsules, tablets, ampoules, sachets, or dropper bottles. This harmonized definition allows clear differentiation between dietary supplements, medicines, and conventional foods across the EU. European Rules Governing Food Supplements Several aspects of dietary supplement regulation are harmonized at the EU level: Lists of authorized vitamins and minerals; Labeling rules for dietary supplements, in line with general food labeling regulations; Nutrition and health claims, strictly regulated and scientifically validated; Novel ingredients, subject to the EU Novel Food Regulation and authorization procedures. These rules ensure safety, transparency, and compliance for dietary supplements throughout the EU. National Rules: Variations Across Member States Despite EU-wide harmonization, each Member State retains control over key aspects: Maximum doses of vitamins and minerals; Authorized or prohibited plants and usage conditions; Market placement procedures: notification or prior authorization; Monitoring of adverse effects, via nutrivigilance systems. Example: Garcinia cambogia was banned in France in April 2025 due to potential liver toxicity, but this national restriction does not automatically apply to other EU countries. Labeling and Health Claims: Ensuring Compliance Supplement labels must clearly indicate: The term "food supplement"; Full ingredient list; Recommended daily dose; Mandatory warnings such as “Keep out of reach of children”; Batch number and best-before date; Exact amounts of active substances (vitamins, minerals, plant extracts). All nutrition and health claims must be scientifically validated at the EU level. Any therapeutic or disease-related claims are prohibited. Manufacturers may include additional warnings to ensure consumer safety. Post-Market Surveillance and Nutrivigilance Safety monitoring continues after supplements are marketed. Some EU Member States, such as France, have had nutrivigilance systems in place since 2009 to: Record adverse effects; Analyze risk signals; Take rapid action in case of health risks, as illustrated by the temporary suspension of Garcinia cambogia. Conclusion: A Strict and Comprehensive Regulatory Framework The EU regulatory framework for dietary supplements, combining European and national rules, is among the most rigorous worldwide. From precise legal definitions, controlled composition, market authorization procedures, labeling requirements, validated health claims, to post-market monitoring, consumer safety is always the priority. Ensuring ingredient compliance, risk identification, and clear, legally compliant communication from early development stages is essential to secure the successful marketing of dietary supplements. Are you developing or marketing nutraceutical ingredients or dietary supplements?Ensure the safety and regulatory compliance of your products or ingredients by contacting our Food Expert, Marie Liamin. Author: Marie Liamin, Head of the Food Sector

In response to the public health and environmental challenges posed by endocrine disruptors (EDs), and following two previous national strategies on endocrine disruptors, the French government has unveiled its new roadmap for the next five years with a clear ambition: moving towards “zero exposure to endocrine disruptors”. The action plan (March 2026 version), currently under public consultation, is structured around six key actions aimed at better protecting citizens and strengthening the management of risks associated with endocrine-disrupting substances. Six Actions to Protect Citizens 1. Acting Closer to Communities The government plans to deploy “green prescriptions” (including organic food baskets for pregnant women) and support childcare facilities in creating healthier environments. 2. Educating, Informing and Raising Awareness The objective is to improve consumer information through clearer product labelling and awareness initiatives targeting young people from an early age, helping them make informed consumption choices. 3. Protecting the Most Exposed and Vulnerable Populations The strategy includes strengthening healthcare professionals’ training and expanding platforms dedicated to the early management of environmentally related infertility. 4. Regulating and Strengthening Controls Artificial intelligence could be used to better target inspections of imported products, particularly those intended for sensitive populations, such as toys, cosmetics and food products. 5. Monitoring the Impact of Endocrine Disruptors The plan aims to increase human biomonitoring activities as well as the monitoring of pollutants present in the environment. 6. Bringing Together Research and Expertise The creation of a dedicated research network on endocrine disruptors, together with a laboratory network, will help strengthen and standardise the identification of endocrine-disrupting substances. A Stronger Regulatory Framework France continues to position itself as a European leader in chemical risk management, notably through pioneering initiatives such as the PEPPER platform dedicated to the validation of testing methods. More specifically, four major regulatory priorities have been identified: Integrating endocrine disruptor considerations into the revision of key European regulations, including REACH, Cosmetics Regulation, Medical Devices Regulation, Ecodesign initiatives and the Plastics Treaty; Accelerating the identification of endocrine-disrupting substances and improving data sharing; Structuring and accelerating the validation of testing methods for endocrine disruptors through the PEPPER platform; Strengthening controls and monitoring of products, food and drinking water both within France and at its borders. The roadmap also includes: Establishing lists of endocrine-disrupting substances by use, which may be present in products, animal feed, foodstuffs and drinking water; Increasing controls on non-food products; Monitoring endocrine disruptors in human and animal food; Monitoring endocrine disruptors in water intended for human consumption. Anticipating Future Regulatory Developments In this context, the early identification of substances with endocrine-disrupting potential is becoming increasingly important for companies seeking to anticipate future regulatory developments. Early assessment can help identify potential concerns, better understand the regulatory status of substances and prepare for upcoming regulatory requirements. How CEHTRA Can Support You CEHTRA supports companies in identifying substances with endocrine-disrupting potential through innovative screening approaches, including: Regulatory status assessments; Literature reviews; QSAR predictions; Early identification of potential regulatory concerns. Would you like to assess the endocrine-disrupting potential of your substances or anticipate future regulatory developments? Our experts can support your evaluation and compliance strategy. For more information, please contact our expert, Julien Leghait.

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).

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

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). 📅 Poster presentation: Thursday, May 21, 2026🪧 Presentation ID: 7.02.P-Th299 The poster explores several scientific and regulatory questions linked to biodegradability assessment in urban wastewater systems, including: the interpretation of the “rapidly biodegradable” concept, the applicability of OECD biodegradability screening tests, the relevance of environmental fate modelling approaches, and the challenges linked to harmonized implementation across Europe. The work also discusses the connections between the UWWTD framework and existing European regulatory frameworks such as REACH and CLP. CEHTRA looks forward to exchanging with the scientific and regulatory community during the conference.

Directive (EU) 2020/2184 introduces a major reform of the public health protection framework for water intended for human consumption. Article 11 constitutes the central pillar of the minimum hygiene requirements applicable to materials in contact with water, with the aim of ensuring that such materials do not compromise human health, do not adversely affect the organoleptic properties of water (in particular its taste, odour or colour) and do not promote microbial growth. The technical and geographical scope The scope of Article 11 is defined very broadly in order to cover the entire supply chain, from water abstraction through to the final consumer. The Directive applies to materials used in new installations, as well as to those used in the repair or reconstruction of existing installations. It therefore covers all materials involved in the abstraction, treatment, storage and distribution of water up to the point of compliance, namely the user’s tap. Two major exclusions should, however, be highlighted. First, natural mineral waters and waters classified as medicinal products do not fall within this framework. Second, the substances covered by Article 12, such as treatment chemicals (including coagulants and disinfectants) and filter media (including ion-exchange resins, filtration membranes or sacrificial anodes) are not included in the positive lists of materials, or EUropean Positive Lists, managed by ECHA under Article 11. Typology of regulated substances and compositions The Directive distinguishes between substances according to the physico-chemical nature of the final material. Starting substances are any substances intentionally added for the production of organic materials, such as plastics, rubbers, silicones or adhesives, as well as to produce admixtures intended for cementitious materials. Organic cement constituents refer to the specific organic molecules used in the manufacture of cement-based materials, for example grinding aids or admixtures. Finally, the term compositions applies to metallic materials, enamels, ceramics and other inorganic materials. In this case, it is not an isolated substance that is included on the positive list, but rather the overall chemical formulation of the material. The hierarchy of technical functions (Level 1 and Level 2) ECHA requires applicants to define the technical function of their substance at two levels in order to structure the EUPL. Level 1 (Generic): This is the category of legal approval. For organic materials, the applicant must choose between: monomer or other reactant, additive, polymer production aid, polymerisation aid, or other. For cement, the functions include admixture, release agent or curing compound. This function will appear on the positive list and constitutes a condition of use. Level 2 (Specific): This level describes the precise role of the substance. For example, under “production aid”, one may find solvents, anti-foaming agents or surfactants. This level is crucial for the scientific risk assessment conducted by the Committee for Risk Assessment, RAC, as it makes it possible to anticipate the formation of reaction by-products. The status of additives and process aids A frequent source of confusion concerns substances used during manufacturing that are not necessarily intended to remain in the finished product. The Directive clarifies their status by adopting the intentionality of the addition as the main criterion. Additives: These are added in order to achieve a physical or chemical effect during processing or in the final material. Examples may include antioxidants, plasticisers or colourants. Since they are intended to be present in the finished product, they must be included on the EUPL. Aids to polymerisation: These substances are used to initiate or control the formation of the polymer structure, without themselves becoming structural units of that structure. Catalysts and initiators are typical examples. Although they may be absent from the final product, their intentional addition qualifies them as starting substances subject to approval. Polymer production aids: These, in turn, are used to provide an appropriate medium for manufacturing. They are not intended to exert an effect in the final material, but they nevertheless remain within the scope of application insofar as they are intentionally involved in the manufacturing process. The specific case of solvents and volatile agents Solvents used for evaporation during the processing are classified as polymer production aids. Whether they need to be included on the EUPL depends on the migration threshold rule of 0.1 µg/l. Accordingly, where a manufacturer can demonstrate that there is no possibility that the solvent, or its reaction products, may be present above 0.1 µg/l at the tap (that is, at the level of Ctap, i.e. the concentration at the tap) inclusion on the positive list is not mandatory for organic and cementitious materials. However, this exemption is subject to significant limitations. It cannot be relied upon where: the substance is a monomer or a main reactant; the substance has a toxicity profile that justifies a stricter limit, for example genotoxic substances; the substance is classified as CMR, categories 1A or 1B, as a category 1 endocrine disruptor, or has PBT, vPvB, PMT or vPvM properties. In such cases, inclusion is mandatory even where migration is negligible, and concentration restrictions in the final material apply, often below 0.1% or 0.02%. Impurities and Non-Intentionally Added Species (NIAS) Although Article 11 focuses primarily on intentionally added substances, the safety assessment must also cover impurities and non-intentionally added species, or NIAS. Impurities are intrinsic to the starting substance or to the composition. Any impurity present at more than 0.1% in the substance and at more than 0.02% in the final formulation must be identified. NIAS include products formed during processing, particularly under the effect of high temperatures, as well as products resulting from reactions or degradation, for example through hydrolysis upon contact with water. The applicant must use screening methods, such as GC-MS, in order to identify these substances in migration test waters. The complex case of UVCBs UVCBs, which include polymers, are subject to an adapted identification procedure. Due to their intrinsic variability, their identification cannot be based solely on chemical composition. In this specific case, the detailed description of the manufacturing process therefore becomes the central element of the dossier. The raw materials used, the reaction steps and the control parameters constitute essential information for characterising the substance. Unlike well-defined substances, no distinction is made between constituents and impurities for UVCBs. Governance: submission roles and data sharing Lead registrant and group submissions Unlike the REACH Regulation, the DWD does not impose either a lead registrant or a mandatory joint submission. Economic operators are nevertheless strongly encouraged to pool their efforts in order to submit a single application per substance and to avoid redundant testing. In this context, a group of operators may designate a single entity (for example a consortium or a consultant) to assume responsibility for the dossier. SIP and data sharing In order to collaborate effectively, operators must agree on a SIP, or Substance Identity Profile, which defines the boundaries of the substance, including the concentration limits and impurities covered by the common data. Data and cost sharing are governed exclusively by private agreements between the parties. ECHA has no legal basis to intervene or arbitrate in the event of a financial dispute. Furthermore, the use of a third-party representative may make it possible to protect the actual identity of an operator during public notification. Timeline and obligations of operators The transition to the harmonised European system imposes critical deadlines: 31 December 2026: The first EUPLs will apply from this date. National systems will cease to apply to new products. The 18-month rule: In order to renew an existing authorisation, the review dossier must be submitted to ECHA no later than 18 months before the expiry date of the approval for the substance. Notification of intention (NoI): This is mandatory within the 12 months preceding submission of the final dossier and is intended to facilitate collaboration between operators, including through consortia, in order to avoid redundant animal testing. Conclusion Directive (EU) 2020/2184 establishes a highly controlled environment in which the distinction between process substance and additive is gradually giving way to two decisive criteria: intentional addition and migration risk. Each molecule present in the manufacturing cycle, whether a volatile solvent or a catalyst, must be assessed in light of its potential residual Ctap. As from 2027, product compliance will depend on the presence of each starting substance on the EUPL. The management of migration and toxicity data is therefore becoming a major commercial and public health issue for the entire supply chain. Authors : Floriane Demailly & Loris Mistrulli

Information overload: a major challenge for chemical regulatory monitoring In today’s organisations, ensuring effective regulatory and toxicological monitoring of chemical substances has become a major challenge for regulatory teams, toxicologists, and R&D departments. Depending on markets, companies must track: sector-specific regulations (cosmetics, biocides, food…) cross-cutting frameworks (CLP, REACH, SVHC, restrictions, authorisations…) and external sources such as California Proposition 65, IARC classifications, inventories, and NGO lists Access to information is no longer the issue. Newsletters, databases, and professional associations continuously provide regulatory news and scientific updates. → The real challenge is now information overload. Regulatory professionals: managing large substance portfolios Regulatory professionals are responsible for monitoring the regulatory status of hundreds or even thousands of substances. This involves: product-level checks substance-level monitoring and transversal topics (PFAS, microplastics, CMRs, nanomaterials…) These activities often represent several days of work each month. Once the information is collected and filtered, teams still need to: assess impacts prioritise actions ensure compliance → But a key question remains: Can they be sure they are not missing a critical regulatory update? Or, conversely, spending time on information with no real impact? Toxicologists: between scientific monitoring and regulatory impact Toxicologists must maintain up-to-date toxicological risk assessments by continuously integrating new scientific data. They monitor: scientific opinions (EFSA, US EPA…) IARC monographs NTP and RIFM reports classification intentions (CLH, SVHC…) → The challenge is twofold: identifying relevant toxicological data without spending time on non-impactful information Some updates are minor. Others can significantly impact safety assessments and business decisions. → The key difficulty is to distinguish critical signals from background noise. R&D teams: anticipating without clear visibility R&D teams are directly impacted by this uncertainty. Internal “blacklists” of substances are sometimes implemented, but they quickly become outdated as scientific and regulatory knowledge evolves. → Key questions arise: Are these lists sufficient? Should certain substances be avoided proactively? How early should risks be anticipated? Without structured monitoring, decisions are made with uncertainty, potentially leading to late or costly reformulations. The real issue: non-targeted monitoring The problem is not a lack of information. → It is an excess of non-targeted information. Teams are forced to analyse data: unrelated to their substances without prioritisation without efficient filtering → The key question becomes: “Does this information actually concern my substances?” Without filtering based on substance portfolios and relevant regulatory and toxicological sources, monitoring becomes: time-consuming inefficient difficult to exploit The consequences of inefficient monitoring Poorly structured regulatory monitoring leads to: significant time loss difficulty prioritising actions delayed responses to regulatory changes → In the long term, this results in: operational stress reduced confidence in monitoring processes less secure decision-making Moving towards portfolio-focused regulatory intelligence To improve monitoring efficiency, two parameters must be clearly defined: the substance portfolio to monitor the relevant regulatory and toxicological sources → Combining these two dimensions enables: filtering out irrelevant information quickly identifying impactful changes significantly reducing information overload A structured approach to regulatory and toxicological monitoring portfolio-based monitoring approach allows organisations to: identify relevant regulatory and toxicological updates prioritise actions effectively optimise internal resources → This frees up time for what matters most: impact analysis and decision-making. In this context, digital tools such as CEHTRA WATCH support this approach by structuring regulatory intelligence, while remaining complementary to expert assessment. Author: Clarisse Bavoux

Webinar recap – CEHTRA PFAS remain a complex topic for industry stakeholders. Between rapidly evolving regulations, traceability challenges, and analytical limitations, compliance can no longer be reduced to a simple check. Compliance Is More Complex Than It Seems Being compliant with a single criterion does not mean being fully compliant.Thresholds (ppb / ppm) must be assessed globally, and a single exceedance can lead to non-compliance. In this context, a comprehensive approach is essential, especially as the regulatory framework continues to evolve rapidly. PFAS Traceability: A Major Challenge PFAS management heavily depends on the availability of data, which often remains limited. Today: Few clearly defined regulatory obligations Data that is difficult to obtain As a result, responsibility ultimately lies with manufacturers and industrial operators themselves. An Evolving and Uncertain Framework There is no simple answer when it comes to PFAS. The regulatory framework is still under development Technical and analytical uncertainties persist Decisions must be made despite these uncertainties Each situation must therefore be assessed on a case-by-case basis. Facing This Complexity PFAS require: regulatory expertise analytical capabilities agile support In this context, Flex+ provides flexible and operational support, tailored to both short-term needs and long-term challenges. Learn More Missed the webinar or want to go further?You can contact Stéphane Pierre or the CEHTRA teams directly. Flex+ is here to support you.

In August 2023, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) jointly published a landmark guidance document on the impact of water treatment processes on residues of active substances in water abstracted for drinking water production (EFSA Journal, doi: 10.2903/j.efsa.2023.8194). For companies placing biocidal products on the EU market, this guidance is not merely a technical update. Rather, it represents a fundamental shift in how regulatory dossiers must be constructed. Its applicability requirements have been formally agreed and have become mandatory as of 1 April 2026. What the Guidance Covers The 2023 ECHA/EFSA guidance establishes a tiered framework to assess how water treatment processes (such as chlorination, ozonation, or UV treatment, etc.) transform residues of active substances into potentially hazardous compounds known as treatment transformation products (tTPs). This matters because some tTPs, such as nitrosamines, can be significantly more toxic than the parent active substance from which they derive. The guidance applies to both plant protection products (PPPs) and biocidal products, but its implications are especially acute for the biocides sector, where products in areas such as drinking water treatment (Product Type 5), surface disinfection, and water used in food processing directly intersect with the water supply chain. The BPR Regulatory Context Under Regulation (EU) No 528/2012, no active substance may be approved, and no biocidal product may be authorized for market placement, without a rigorous demonstration that it does not pose unacceptable risks to human health, animals, or the environment. This explicitly includes risks arising via drinking water, either from direct use or from residues reaching water abstraction points. The 2023 guidance fills a critical gap that previously existed in BPR compliance. While earlier frameworks addressed disinfection by-products in limited contexts, they did not systematically assess what happens when biocide residues or their environmental metabolites enter a water treatment facility and undergo further chemical transformation. That gap is now closed and its closure has direct consequences for both active substance approval applications and product authorisation dossiers. When Does the Guidance Apply? The Agreed Applicability Rules The question of when exactly this guidance becomes mandatory generated significant debate among EU Member States' Competent Authorities (CAs) for biocidal products, which was formally resolved at the 104th CA meeting in June 2024 (CA-June24-Doc.7.2). The agreed conclusion is as follows: The guidance will NOT apply to: Active substance dossiers currently in the Review Programme. Given that the Review Programme has already been extended to December 2030, applying the new guidance to ongoing review submissions would induce delays to an already stretched schedule. The guidance WILL apply to: All other procedures both active substance approvals/renewals and biocidal product authorisations/renewals for which applications are submitted on or after 1 April 2026. Applications submitted before that date are not subject to the guidance. This approach deliberately aligns with the applicability framework agreed for the ECHA guidance on risks to bees from biocide use, and with the general CA practice on implementing new guidance documents in the biocides area. It also mirrors, in broad terms, the schedule adopted by the PAFF Committee (Standing Committee on Plants, Animals, Food and Feed) for plant protection products though with one important difference: unlike in the PPP area, the CA did not restrict product authorisation applications to only those products whose active substance was already assessed under this guidance. The rationale is that in the biocides sector, active substance approvals do not typically cover all the uses relevant at the product authorisation stage, meaning the guidance retains independent relevance for product-level dossiers regardless of how the AS was evaluated. It is also worth noting that applicants preparing submissions before 1 April 2026 are not prohibited from voluntarily applying the guidance. In fact, doing so proactively can help demonstrate compliance with the existing BPR requirement that residues must not cause unacceptable effects through drinking water. The Four-Step Assessment Framework The guidance introduces a structured, risk-proportionate methodology built around four sequential steps: Step 1 Exposure at the abstraction point: Using Predicted Environmental Concentrations (PEC), applicants must determine whether residue concentrations exceed 0.1 µg/L. If this threshold is breached, a full tTP formation assessment becomes mandatory. Step 2 Identification of treatment transformation products: Applicants must characterise which tTPs form during treatment processes. Any tTP detected above 0.075 µg/L triggers chemical identification and hazard characterisation. Step 3 Toxicity assessment: A tiered toxicological evaluation is applied to identified tTPs, starting with genotoxicity screening (Tier 1) and escalating to targeted experimental testing (Tier 3) where needed. Step 4 Risk characterisation for the consumer: If risk is considered acceptable based on the above, appropriate risk management and monitoring measures are defined. If not, the use may be refused for specific applications or the authorisation rejected entirely. What This Means for Industry For companies holding or seeking BPR-compliant authorisations, the practical implications are significant. Dossiers submitted from 1 April 2026 onwards must incorporate this framework, meaning that toxicological and environmental fate data packages must now extend well beyond the active substance itself to encompass its transformation products under realistic drinking water treatment conditions. Several structural challenges make this transition demanding. First, toxicological data on tTPs is often simply absent, forcing companies to rely on predictive in silico tools such as QSAR modelling and read-across approaches that regulators accept as a starting point but that frequently require subsequent experimental validation. Second, water treatment processes vary considerably across EU Member States, complicating the design of standardised simulation studies. Third, the costs and timelines involved in generating adequate tTP data can be prohibitive, particularly for SMEs. Coordination between active substance manufacturers and downstream biocidal product formulators is also critical. Data on tTPs generated by AS manufacturers must flow effectively to formulators who bear responsibility for full product dossier compliance. Without early, structured communication across the value chain, gaps in data availability will translate directly into delays or refusals at the authorisation stage. Proactive Compliance: Where to Start Companies should treat the April 2026 deadline not as a future concern but as an immediate operational priority. The recommended starting points are: Portfolio review: identify which active substances and product types have exposure pathways to drinking water abstraction areas. PEC screening: conduct preliminary PEC calculations to determine which products trigger the full tTP assessment. Supplier engagement: initiate dialogue with AS suppliers to understand what tTP data is already available and what studies remain outstanding. Data gap analysis: map missing toxicological and analytical data against the tiered requirements of the guidance, and commission studies accordingly. Conclusion The 2023 ECHA/EFSA guidance on water treatment transformation products is a regulatory milestone that reshapes what compliance looks like for the biocides industry. It operationalises existing BPR obligations, that authorised products must not endanger health via drinking water, with a data-driven methodology that leaves little room for ambiguity. For companies placing biocidal products on the EU market, the question is no longer whether to engage with this framework, but how quickly and systematically they can build it into their regulatory strategy. If you are a company looking for support in how to tackle this requirement, please don’t hesitate to contact our regulatory team Author: Barbara DHOOP References: EFSA Journal 2023, doi:10.2903/j.efsa.2023.8194; ECHA Guidance on Biocides Legislation (Vol. V); Regulation (EU) No 528/2012 (BPR); Directive (EU) 2020/2184 (Drinking Water Directive): https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.8194 https://circabc.europa.eu/ui/group/e947a950-8032-4df9-a3f0-f61eefd3d81b/library/0c904047-6742-4f85-9a1f-44d357dbc10f/details

Since 13 December 2024, the European consumer landscape has changed drastically with the application of Regulation (EU) 2023/988, better known by its acronym GPSR (General Product Safety Regulation). Less than a year later, an important milestone completed the framework: on 21 November 2025, application guidelines were published. They provide the long-awaited clarifications on the interpretation of the text and its operational requirements. GPSR: A Universal Safety Net for All Consumer Products The GPSR applies to all non-food consumer products, whether new, second-hand, repaired, or refurbished. Its strength lies in its transversal scope: it applies whenever there is no stricter specific provision in EU harmonization legislation. The goal is simple: no dangerous product should slip through the safety net, whether sold in physical stores or online. General Safety Obligation: Ensuring Safe Products on the Market The GPSR is abased on a general safety obligation: economic operators may only place safe products on the market. A safe product is defined as: "any product which, under normal or reasonably foreseeable conditions of use, including the actual duration of use, does not present any risk or only the minimum risks compatible with the product’s use, considered acceptable and consistent with a high level of protection of the health and safety of consumers." To achieve this, the regulation requires a rigorous methodological approach. Each manufacturer must now carry out an internal risk assessment before placing any product on the market. Risk is defined as "the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm." This assessment must be recorded in technical documentation, proportionate to the product's complexity, and retained for 10 years. Main Product Safety Assessment Criteria Under the GPSR Product characteristics: Design, composition, packaging, and instructions. Consumer categories: Special attention is given to vulnerable consumers (children, elderly, people with disabilities). Misleading appearance: Products mimicking foodstuff or particularly attractive to children (food imitations) are specifically targeted. New technologies: Cybersecurity, machine learning (AI) functions, and software updates are now integral to the safety assessment. Traceability and Notification: New GPSR Obligations for Manufacturers and Importers The GPSR modernizes market surveillance through two key platforms: Safety Gate: The former RAPEX system, renamed, for information exchange between authorities on dangerous products. Safety Business Gateway: A mandatory portal for companies. Any manufacturer or importer aware of a serious accident or a dangerous product on the market must notify through this single access point. For example, in 2025, 2,755 chemical and environmental alerts were reported across various consumer products. European Tools and Guidelines to Comply with the GPSR The GPSR relies on a set of guides and resources provided at the European level. They are a useful starting point to understand requirements and structure a compliance approach, but operational implementation often requires dedicated expertise, particularly when demonstrating and documenting risk levels robustly. SAGA: A First Qualitative Approach To support risk assessment, the Commission provides SAGA (Safety Gate Risk Assessment) via the Safety Gate ecosystem. This tool can provide a qualitative risk analysis which can be used as a first tiered approach (hazard, exposure, severity/probability) with models adapted to different product types. However, this approach alone is often insufficient when precise quantitative risk levels must be justified. Blue Guide and GPSR Guidelines for Businesses For the general implementation framework, operators can rely on the Blue Guide on the application of EU product rules. More specifically, on 21 November 2025, the Commission published dedicated guidelines: On the application of the general product safety regulation (GPSR) by businesses On the practical implementation of the Safety Business Gateway These texts aim to guide and harmonize practices while largely referencing existing EU standards, sector-specific requirements, and risk assessment methodologies already used at the EU level. Focus on Chemical Risks: Aligning With REACH When a product contains chemicals chemical component (substances, emissions, migration, skin contact, etc.), the dedicated risk assessment benefits from approaches consistent with REACH, including hazard characterization, exposure scenarios, risk characterization, and risk management measures. This is precisely the methodological foundation CEHTRA uses daily to produce robust, documented assessments aligned with European expectations, useful in a GPSR compliance approach. Conclusion: Ensure Your Products Comply with the GPSR The GPSR (EU Regulation 2023/988) strengthens consumer product safety in Europe and imposes strict obligations on manufacturers and importers for risk assessment, traceability, and notification. To ensure your products fully comply and protect consumers, it is essential to work with experts. Are you affected by this regulation? To determine whether your company is concerned, take our self-assessment GPSR quiz. You can also contact our team for personalized support and recommendations tailored to your regulatory context. Author: Anna Chelle, Product Safety Specialist Regulatory Sources and References Regulation (EU) 2023/988 (GPSR): https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32023R0988 Product Safety Legislation: https://ec.europa.eu/safety-gate/#/screen/pages/productSafetyLegislation Obligations for Businesses: https://ec.europa.eu/safety-gate/#/screen/pages/obligationsForBusinesses

The draft 24th Adaptation to Technical Progress (ATP) to the CLP Regulation (EC) No 1272/2008 proposes a significant number of new harmonised classifications that could affect chemical substance portfolios across several industrial sectors. Although the proposal has not yet been formally adopted, it already provides valuable regulatory news and scientific insights that companies can use to anticipate potential impacts on their substances and products. According to the current draft, 48 substances would receive new harmonised classifications, while 10 substances are proposed for reclassification. These updates are particularly relevant for companies involved in sectors such as coatings and adhesives, plastics and polymers, cosmetics and fragrances, and water treatment or biocides, where several of the substances included in the draft ATP are commonly used. As a result, manufacturers, importers, and downstream users may need to review the regulatory status of substances in their portfolios and assess implications for mixtures, labelling, and safety data sheets. One of the most notable aspects of the draft ATP is the number of high-concern hazard classes proposed. The draft includes four substances classified as Carcinogenicity Category 1A or 1B (among which [ethane-1,2- diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt , CAS n° 22036-77-7), thirty substances classified as Reproductive Toxicity Category 1A or 1B (among which bisphenol F, CAS n° 620-92-8, sodium bromide, CAS n° 7647-15-6, piperonal, CAS n° 120-57-0) , and four substances classified for Specific Target Organ Toxicity following repeated exposure (STOT RE 1) ( among which sodium bromide, CAS n° 7647-15-6, thymol, CAS n° 89-83-8,  fosthiazate, CAS n° 98886-44-3). In addition, among the proposed reclassifications, two substances would receive a STOT RE 1 classification, one substance would be reclassified for reproductive toxicity, and another would receive a classification as a respiratory sensitiser. It is important to emphasise that the current document is still a draft proposal, and therefore the classifications it contains are not yet final. Discussions within the CARACAL group and the remaining steps of the legislative process could still lead to modifications before the ATP is formally adopted. Once adopted, the usual ATP timeline would apply, beginning with publication in the Official Journal of the European Union, followed by entry into force approximately twenty days later, and a transition period of around 18 months. Even at this early stage, however, the draft ATP provides valuable input for regulatory monitoring and scientific watch activities , allowing companies to anticipate upcoming regulatory changes. Organisations can start by reviewing their substance portfolios to determine whether any of the substances included in the proposal are relevant to their products or supply chains. From there, companies should assess potential downstream impacts, such as changes to mixture classifications, labelling requirements, or safety documentation. In parallel, it is essential to continue monitoring developments, as draft ATPs may evolve before final adoption. Understanding CLP lists: from early signals to binding classifications Monitoring ATP updates requires understanding the different types of CLP-related lists that provide complementary regulatory information at different stages. Draft ATPs (under consultation) provide early visibility on proposed classifications based on RAC scientific opinions and represent forward-looking regulatory intelligence.  The Registry of CLH Intentions enables early identification of substances under evaluation, supporting proactive regulatory watch.  Adopted ATPs (not yet applicable) provide a transition phase before legal enforcement, allowing companies to anticipate compliance actions.  CLP Annex VI contains legally binding harmonised classifications that must be applied by industry. Together, these lists form a continuous regulatory monitoring framework , from early signal detection to legally binding obligations. For many companies, keeping track of developments such as ATP updates, new classifications, and other regulatory initiatives can be challenging, particularly when managing large portfolios of substances across multiple markets. This complexity has led to increased use of regulatory monitoring tools for chemicals and substance tracking solutions . Digital solutions can support organisations in monitoring regulatory lists, tracking toxicological updates, and identifying substances impacted by regulatory changes , enabling earlier and more informed decision-making. The CEHTRA WATCH platform supports companies in: tracking regulatory changes affecting their substances  monitoring toxicological data and scientific updates  identifying portfolio exposure to regulatory developments  By monitoring developments such as the draft 24th ATP and evaluating potential impacts ahead of time, companies can reduce regulatory uncertainty and ensure a smoother transition when new classifications become legally binding. Get in touch with our experts to assess the impact of these regulatory changes on your substance portfolio.

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

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.

Introduction 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. Chemically, PFAS can be divided into polymeric and non-polymeric substances . Polymeric PFAS include fluoropolymers, polymeric perfluoropolyethers and side-chain fluorinated polymers, while non-polymeric PFAS include polyfluoroalkyl and perfluoroalkyl substances. Among non-polymeric PFAS, perfluoroalkyl acids (PFAAs) are often further classified by chain length into long-chain, short-chain and ultrashort-chain PFAS. More than 16,000 PFAS substances  have been identified. These chemicals have been widely used in consumer and industrial applications because of their oil- and water-repellent properties , as well as their resistance to heat and chemical degradation. However, PFAS are highly persistent in the environment and may present toxicological concerns. As a result, regulatory authorities worldwide are introducing increasingly stringent restrictions and bans on PFAS uses, including in cosmetic products . PFAS in Cosmetic Products Technical functions in cosmetic formulations In cosmetic products, PFAS may perform several technical functions, including: hair and skin conditioning agents emulsifiers and stabilisers surfactants oil- and water-repellent agents Examples of PFAS substances reported in cosmetic formulations include: polytetrafluoroethylene (PTFE) perfluorononyl dimethicone trifluoroacetyl tripeptide-2 tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate perfluorohexylethyl triethoxysilane methyl perfluorobutyl ether methyl perfluoroisobutyl ether PFAS may enter cosmetic products either intentionally as formulation ingredients (this is a rare situation) or unintentionally as impurities or degradation products .   Occurrence of PFAS in cosmetics In the United States, 51 PFAS substances have been identified as intentionally added ingredients across 1,744 cosmetic product formulations . The most frequently affected product categories include: eye shadows eyeliners face powders foundations leave-on face and neck products Together, these categories represent approximately 56% of PFAS-containing cosmetics . In Europe, an analysis conducted by the Swedish Chemicals Agency (KEMI)  in 2021 reported that PFAS were most frequently detected in decorative cosmetics (3.7%). Lower occurrences were identified in: skin care products (0.78%) hair care products (0.65%) toiletries (0.27%) PFAS occurrence in perfumes and fragrances was almost negligible (0.03%). Overall, the market share of PFAS-containing cosmetic products remains relatively limited.   Increasing Global Regulation of PFAS Regulatory scrutiny of PFAS is increasing rapidly worldwide. Under the EU REACH Regulation , Germany, Denmark, the Netherlands, Norway and Sweden submitted a restriction proposal in 2023 targeting approximately 10,000 PFAS substances , including their use in cosmetics. Several countries have already introduced or proposed additional restrictions: United States:  at least eleven states have introduced bans on PFAS in cosmetics New Zealand:  ban on PFAS-containing cosmetics starting January 2028, with full removal by July 2028 Canada:  restrictions on long-chain PFCAs in cosmetics Republic of Korea:  prohibition of approximately 190 PFAS substances as cosmetic ingredients As regulatory pressure increases, many cosmetic manufacturers are already moving away from PFAS use . However, replacing PFAS often requires significant reformulation efforts, as direct drop-in alternatives are rarely available.   Toxicological and Environmental Concerns PFAS and their degradation products are extremely persistent  in the environment. Their removal from surface water, groundwater, soils and sediments is technically complex and often costly. PFAS have been detected in multiple environmental media, including: drinking water sources food crops wildlife remote geographical regions Human biomonitoring studies show that PFAS are widely detected in human populations , indicating widespread exposure.   Exposure to certain PFAS has been associated with several potential human health effects including increased cholesterol levels, effects on the immune system, thyroid hormone disruption, impacts on infant birth weight, and increased risk of certain cancers. Examples of health effects associated with PFAS exposure reported in the ECHA Annex XV restriction report (2023) are summarised below. Figure . Examples of health effects associated with PFAS exposure (ECHA Annex XV Restriction Report, 2023). Exposure Pathways in Cosmetic Products For cosmetic products, dermal exposure is generally the primary route of exposure. However, other exposure routes may occur depending on the type of cosmetic product: inhalation (e.g., powders or sprays) ocular exposure (e.g., eye makeup) incidental ingestion (e.g., lip products) Because cosmetics are frequently used daily, systemic exposure assessment remains a key element of cosmetic safety evaluation .   Toxicological Reference Values and Risk Assessment Several regulatory bodies have proposed approaches to assess PFAS exposure risks. In 2020, the European Food Safety Authority (EFSA)  concluded that immune system effects represent the most critical endpoint for PFAS risk assessment. EFSA established a group tolerable weekly intake (TWI)  of 4.4 ng/kg body weight per week  for combined exposure to four PFAS substances: PFOA PFNA PFHxS PFOS In 2021, the Dutch National Institute for Public Health and the Environment (RIVM)  proposed a risk assessment approach using relative potency factors (RPFs) , allowing exposure to multiple PFAS to be expressed as PFOA-equivalent concentrations. More recently, the U.S. Food and Drug Administration (FDA)  published a safety assessment of the 25 PFAS most frequently used in cosmetic products . The assessment concluded that: perfluorohexylethyl triethoxysilane  may raise safety concerns five PFAS substances (including PTFE and perfluorodecalin) present low safety concern  under intended conditions of use for 19 of the 25 substances , available data were insufficient to conduct a full safety assessment This highlights the importance of toxicological data availability and structured risk assessment methodologies .   PFAS and Cosmetic Safety Assessment The evaluation of PFAS in cosmetic products requires: access to reliable toxicological data exposure assessment identification of appropriate toxicological reference values calculation of the Margin of Safety (MOS)  when applicable These elements are essential for the preparation of the Cosmetic Product Safety Report (CPSR)  required under the European Cosmetic Regulation. Because PFAS data may be incomplete or evolving, toxicologists often rely on a weight-of-evidence approach , combining experimental studies, predictive tools and regulatory assessments.   Conclusion: Preparing for a Changing Regulatory Landscape PFAS have historically provided valuable technical properties in certain cosmetic formulations. However, increasing regulatory scrutiny, environmental persistence concerns and evolving toxicological knowledge are significantly reshaping the regulatory landscape. Cosmetic manufacturers should therefore: review their product portfolios evaluate supply chain disclosures identify potential PFAS ingredients or impurities anticipate reformulation needs Early strategic planning is likely to be more manageable than reactive reformulation once regulatory restrictions enter into force. Companies must also ensure that cosmetic safety assessments remain robust, transparent and well documented , particularly in the context of evolving PFAS regulations.   Toxicological Expertise for PFAS and Cosmetic Ingredients The safety assessment of PFAS and other complex cosmetic ingredients often requires a comprehensive evaluation of toxicological data , including the identification of relevant studies, the selection of appropriate Points of Departure, and the interpretation of regulatory and scientific literature. In many cases, available information may be fragmented across multiple sources, or important toxicological endpoints may require further evaluation through a structured toxicological profile . CEHTRA supports cosmetic manufacturers, ingredient suppliers and regulatory teams by preparing custom toxicological profiles and safety assessments  for cosmetic ingredients and impurities. These evaluations include: identification and analysis of relevant toxicological studies hazard characterisation across key toxicological endpoints selection and justification of Points of Departure support for Margin of Safety calculations documentation supporting Cosmetic Product Safety Reports (CPSR) These expert assessments help ensure that cosmetic ingredients are evaluated using robust and transparent methodologies aligned with current regulatory expectations . Supporting PFAS Safety Assessment with COSMETICK In addition to expert toxicological evaluations, CEHTRA has developed digital tools to support cosmetic safety assessment workflows. CEHTRA supports cosmetic industry companies in product safety evaluation and regulatory compliance  at European and global levels. This digital platform COSMETICK combines a toxicological database  and a cosmetic risk assessment tool , providing access to more than toxicological and ecotoxicological profiles for more than 4,000 substances , including over 100 PFAS substances . By structuring toxicological data and supporting risk assessment workflows, COSMETICK helps toxicologists prepare robust cosmetic safety assessments and CPSR documentation . Get expert support in assessing PFAS in your cosmetic products and ensure full compliance with evolving regulatory requirements. Authors: Clarisse Bavoux & Pramod Kumar References: FDA (2025), Per and Polyfluoroalkyl Substances (PFAS) in Cosmetics: https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics ECHA – Annex XV restriction: https://echa.europa.eu/fr/registry-of-restriction-intentions/-/dislist/details/0b0236e18663449b RIVM (2021), Mixture exposure to PFAS and relative potency factors https://www.rivm.nl/bibliotheek/rapporten/2018-0070.pdf Swedish Chemicals Agency (KEMI, 2021), PM 9/21: PFASs in Cosmetics EFSA (2020), Risk to human health related to the presence of perfluoroalkyl substances in food https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6223

The role of the PIF in placing products on the market In the European Union, a cosmetic product cannot be placed on the market without a complete file known as the Product Information File (PIF) . This is a legal requirement defined by Regulation (EC) No 1223/2009 . The PIF serves as regulatory proof that your product is safe, compliant, and scientifically substantiated before commercialization. It must be kept up to date and made available to authorities in the event of an inspection. At CEHTRA, we support brands at every stage of PIF preparation and compliance (toxicological assessment, safety report drafting, labeling, etc.) to ensure a smooth and compliant market entry.   What is the PIF? The PIF is a comprehensive technical dossier containing all necessary information about a cosmetic product: product identity, formulation, safety data, scientific evidence, regulatory compliance, etc. It has been mandatory since the implementation of the EU Cosmetic Regulation. It is the reference file demonstrating that all mandatory steps required by European regulation have been carried out before placing the product on the market.   Who is it mandatory for? The PIF is mandatory for every cosmetic product placed on the European Union market. This means that each variant (size, fragrance, specific formulation) must have its own PIF. Responsibility: The Responsible Person (RP) manufacturer, importer, or designated distributor,is legally required to compile and maintain the PIF.     When must it be created? The PIF must be established before placing the cosmetic product on the market. It ensures product safety, supports product efficacy when specific claims are made, and accurately describes the product to link the dossier content with the product available on the market. What does a PIF contain?  The PIF is a structured compilation of elements required by the EU Cosmetic Regulation: a) Detailed product description Trade name and product function Cosmetic category Intended use and target population Product reference number (unique identity linking all dossier data to the product)   b) Cosmetic Product Safety Report (CPSR)  Part A: safety data (ingredients, toxicology, concentrations) Part B: final safety assessment This report must be prepared by a qualified safety assessor and constitutes the scientific core of the dossier. c) Manufacturing information  Production method Compliance with Good Manufacturing Practices (GMP) d) Test data and evidence Results supporting claims (e.g., “moisturizing”, “anti-aging”) e) Animal testing information   List of animal tests conducted by the manufacturer or suppliers on the product or its ingredients, including those performed to meet third-country requirements     Additional CPSR content, the CPSR also includes: Qualitative and quantitative composition of the formula (chemical names, INCI, CAS/EINECS/ELINCS identifiers) Role and function of each substance Stability data Microbiological data   Shelf life and availability  European regulation requires that the PIF be kept for at least 10 years after the last batch has been placed on the market. It must also be made available to competent authorities within 72 hours in case of inspection.   Relationship with CPNP notification The PIF is linked to the product notification in the Cosmetic Product Notification Portal (CPNP), the European notification platform. Information from the PIF is used to complete this notification.   Why is a well-structured PIF essential? An incomplete, insufficient, or outdated PIF can lead to: Regulatory sanctions Temporary or permanent product withdrawal Loss of market trust Customs or international market access issues At CEHTRA, our expertise helps you anticipate these risks and build a robust, scientifically sound PIF.   Best practices for drafting a PIF  To ensure compliance: Use a clear and updateable structure Rely on recognized scientific sources for safety assessments Monitor regulatory changes (e.g., new ingredient restrictions) Update the PIF whenever there is a change in formulation, claims, or labeling Get expert support in preparing your PIF and ensure full compliance of your products with European regulations.

Endocrine disruption, Margin of Safety and toxicological data gaps in cosmetic safety assessment . During our recent COSMETICK webinar on cosmetic safety assessment, held on February 19, 2026, participants raised a number of insightful questions covering toxicological data gaps, Margin of Safety calculation, endocrine disruption, and modern non-animal approaches. These questions reflect many of the challenges currently faced by safety assessors working on cosmetic ingredients and formulations. COSMETICK is a digital platform combining a toxicological database  with a cosmetic risk assessment tool , designed to support cosmetic safety assessment workflows. Endocrine disruption: what data can toxicological databases provide? During the webinar, several participants asked whether endocrine disruption data are included in COSMETICK toxicological profiles. More broadly, toxicological databases play an important role in gathering and structuring scientific data used in cosmetic safety assessment. The regulatory classification of endocrine disruptors under the CLP Regulation is still relatively recent. As of March 2026, Annex VI contains only one substance classified as an endocrine disruptor, and only for environmental effects: propylparaben. However, toxicologists do not rely solely on harmonised classifications. When assessing potential endocrine activity, they review a range of scientific sources, including international databases and screening programmes such as SVHC listings, ED-related databases and initiatives like ToxCast. When building a toxicological profile, COSMETICK therefore screens these sources to identify potential signals. If a substance does not appear in dedicated endocrine disruption lists, this absence is documented. When relevant studies are available, they are summarised and referenced. Galaxolide Toxicological reference values and warnings within COSMETICK Galaxolide identification and CLP Annex VI classification within COSMETICK Importantly, many endocrine-related studies are mechanistic or screening studies and may not follow OECD Test Guidelines. While such studies may not be sufficient on their own to demonstrate endocrine disruption, they contribute to a weight-of-evidence evaluation  combining in silico, in vitro and in vivo data. In practice, endocrine-related data are often incomplete or heterogeneous. Toxicological profiles therefore provide a screening overview , highlighting potential signals and encouraging further evaluation when needed. From toxicological data to Margin of Safety Once the toxicological profile of an ingredient has been established, the next step for the toxicologist is to identify the Point of Departure (PoD)  used in risk assessment. In most cases, this value corresponds to a NOAEL , although a BMDL may also be used when available. Safety view for a formula within COSMETICK In cosmetic safety assessment, the selected PoD should reflect the most relevant adverse effect following repeated systemic exposure . Long-term exposure is particularly important in cosmetics, as some ingredients may be present in products used daily and sometimes across multiple products. For this reason, sub-chronic studies are generally preferred  when selecting the PoD. If such data are not available, a value may be derived from shorter-term studies or from a LOAEL through the application of adjustment factors. The aim is not simply to select the lowest value reported in the literature, but rather the value that best reflects the most relevant toxicological effect. The choice of PoD is often discussed among toxicologists. Applying a consistent methodology is therefore important to ensure that risk assessments remain transparent and reproducible . Once the PoD is defined, safety is evaluated using the Margin of Safety (MOS) , calculated as the ratio between the PoD and the Systemic Exposure Dose (SED) . According to the SCCS Notes of Guidance (2023), a MOS of 100  is generally considered sufficient for cosmetic ingredients. In some cases, additional factors or specific toxicokinetic data may justify adjustments to this value. These calculations ultimately support the preparation of the Cosmetic Product Safety Report (CPSR)  required under the European Cosmetic Regulation. Addressing data gaps in cosmetic safety assessment Data gaps are a common challenge in toxicological evaluation. One reason is that suppliers of cosmetic ingredients may have limited regulatory obligations regarding toxicological studies. In Europe, compliance with the REACH Regulation is required, but some studies are only mandatory at higher annual tonnage levels, such as micronucleus tests, certain reproductive toxicity studies or carcinogenicity studies. Other endpoints are not systematically covered by REACH requirements. For example, endocrine disruption data or phototoxicity studies may be needed for specific regulatory or safety considerations but are not always available. Another frequent gap concerns the identification of no-effect levels for local effects , such as skin irritation or skin sensitization. Yet these data are often important for cosmetic safety assessment. The first step is therefore a comprehensive review of the available toxicological information. When a data gap is confirmed, alternative approaches may be considered before generating new experimental data. These approaches may include in silico models, QSAR predictions or read-across strategies , which can provide useful indications at a screening level. In toxicological profiles, such predictions may help identify whether a missing dataset is likely to represent a low concern or whether it deserves further investigation. When it’s about impurities, safe levels can be identified through the Threshold of Toxicological Concern (TTC) concept. In practice, the final evaluation relies on a weight-of-evidence approach , combining available experimental data and predictive tools. Questions that reflect evolving safety assessment practices The questions raised during the COSMETICK webinar illustrate how cosmetic safety assessment continues to evolve. Toxicologists must not only access reliable toxicological data, but also interpret these data through transparent and reproducible methodologies. Selecting the appropriate Point of Departure, calculating the Margin of Safety and addressing data gaps remain central steps in the evaluation process. In practice, safety assessors increasingly rely on a combination of structured toxicological data, weight-of-evidence approaches and predictive tools. In this context, toxicological databases play an important role by organising scientific information and facilitating its interpretation. By structuring toxicological profiles and highlighting key parameters relevant to risk assessment, such tools can support toxicologists in navigating complex datasets while maintaining a scientifically robust evaluation process. In current regulatory practice, cosmetic safety assessment increasingly relies on structured toxicological databases and digital cosmetic risk assessment tools. Tools such as COSMETICK support toxicologists by providing structured toxicological profiles and facilitating cosmetic risk assessment workflows. Author : Clarisse Bavoux

Endocrine Disruptors: A Growing Need for Rapid Access to Information The identification of endocrine disruptors (EDs) has become a key challenge for many industries. With increasing regulatory requirements and the growing number of substance lists evaluated by authorities, obtaining a clear and rapid overview of a substance’s status has become increasingly complex. For regulatory, toxicology, and R&D teams, several recurring questions arise: Is a substance suspected of having endocrine-disrupting properties? Have competent authorities already evaluated it? Where can the relevant scientific and regulatory documentation be found quickly? How should this information be interpreted with regard to one’s own regulatory obligations? To facilitate access to this information, CEHTRA has developed ED Pedia , a digital tool dedicated to the structured consultation of data related to endocrine disruptors. ED Pedia: Rapid Access to Key Information ED Pedia enables anyone working with a chemical substance to quickly obtain an initial overview of its potential endocrine-disrupting properties. In particular, the tool allows users to: Instantly check whether a substance may present endocrine-disrupting properties Directly access the relevant associated documentation Download a PDF report summarizing the results Request support from CEHTRA experts when interpretation of the data is required ED Pedia does not replace a full scientific assessment, but it provides a structured entry point to guide the analysis .   How Does ED Pedia Work? ED Pedia is based on a search using the CAS number of a substance . The tool queries several lists originating from risk assessment programs that identify substances potentially presenting endocrine-disrupting properties, with different levels of concern. For each substance searched, ED Pedia indicates: Whether the substance is included in the identified lists In which lists it appears The associated level of concern, when available Access to the corresponding documentary sources This approach provides a consolidated overview without requiring manual consultation of multiple sources . Direct Access to Documentation and an Exportable Report For each search, ED Pedia allows users to: Access relevant references and documentation Quickly consult the available information Download a summary PDF report of the results This report can serve as internal documentation  or as a basis for more detailed regulatory analysis. Interpreting the Results: The Importance of Scientific Expertise The information available in ED Pedia is derived from public lists and existing evaluation programs. The results, particularly those originating from assessments by competent authorities, must be interpreted carefully and within their scientific and regulatory context. ED Pedia provides a structured synthesis, but the final interpretation depends on: the applicable regulatory framework the intended use of the substance the level of exposure the specific requirements of the concerned sector When necessary, users may contact CEHTRA experts  to obtain scientific support in interpreting the conclusions drawn from the generated report. A Digital Tool to Save Time During the Screening Phase The objective of ED Pedia is to facilitate the initial screening phase of substances  and improve access to available information. The tool helps to: Centralize information from multiple lists Accelerate documentary research Structure the initial analysis Quickly identify substances requiring further evaluation It therefore represents a practical operational support for teams dealing with endocrine disruption challenges. A Useful Tool for Several Industrial Sectors ED Pedia can be used by any stakeholder handling or assessing chemical substances, including in: the cosmetics industry biocides industrial chemicals food contact materials consumer products It is particularly relevant for: regulatory affairs managers toxicologists R&D teams product safety managers Check the endocrine disruption potential of a substance with ED Pedia or contact our expert Julien Leghait  for any questions regarding result interpretation or for a more in-depth assessment.

Since the sartans crisis in 2018, the detection of nitrosamines has highlighted systemic gaps in identifying contamination pathways across pharmaceutical supply chains. As impurities belonging to the “cohort of concern” following ICH M7 (R2) , nitrosamines present exceptionally high carcinogenic potency. Their mechanism of action relies on metabolic activation leading to the formation of adducts. If these lesions escape cellular repair systems, they can induce irreversible genetic mutations and carcinogenesis. With a TD50 typically below 1.5 mg/kg/day, this extreme toxicity prevents the application of the standard Threshold of Toxicological Concern (TTC) of 1,500 ng/day defined in ICH M7(R2). Acceptable Intake (AI) and carcinogenic potency assessment Patient safety is ensured through the establishment of an Acceptable Intake (AI), calculated for a theoretical excess cancer risk of 1 in 100,000 over a 70-year exposure. For compounds with sufficient data, the AI is derived through linear extrapolation from the most conservative TD50 values obtained in the most sensitive species. For NDSRIs (nitrosamines related to the active substance) lacking in vivo data, the CPCA (Carcinogenic Potency Categorisation Approach) recommended by the EMA is applied. This method classifies nitrosamines into five potency categories based on structural characteristics influencing metabolic activation. Alternatively, a negative Enhanced Ames Test (EAT) can justify the application of a limit of 1,500 ng/day. Sources and formation of nitrosamines   Control of these impurities requires a rigorous strategy. Nitrosamine formation generally results from the combination of amines with nitrosating agents under acidic conditions. Identified sources include: Contaminated or degraded solvents Nitrites present in excipients Risk management strategy Risk management follows three main steps: Proactive assessment Confirmatory testing Implementation of CAPA According to ICH M7, omission of specification may be considered if levels remain consistently ≤10% of the AI. Batch-by-batch control is required when levels are between 30% and 100% of the AI. When multiple nitrosamines are present, summation strategies must ensure that cumulative risk never exceeds the 1:100,000 threshold. Mitigation options Reformulation can be an effective mitigation strategy. The addition of nitrite scavengers or pH adjustment can slow nitrosation reactions. In some cases, these modifications may benefit from simplified procedures and avoid new bioequivalence studies. CEHTRA Expertise At CEHTRA, we mobilise our toxicology expertise and QSAR tools to support partners in the qualification of these impurities. This topic was presented during our latest webinar dedicated to nitrosamines and related regulatory expectations.Follow us to stay informed about upcoming webinars and publications.

Since 12 January 2026 , the European Union has reached a major milestone in the protection of public health and water resources. The transition period provided for under Directive (EU) 2020/2184 (recast Drinking Water Directive) has now ended. From now on, the systematic and harmonised monitoring of per- and polyfluoroalkyl substances (PFAS) is a legal obligation for all Member States.    1. A dual-threshold regulatory framework    The Directive now requires compliance with two distinct limit values, reflecting complementary monitoring objectives:  → “Sum of PFAS” (0.10 μg/L)   This parameter specifically targets 20 individual substances considered of concern. Listed in Annex III of the Directive, they include 10 perfluoroalkyl carboxylic acids (PFCAs) and 10 perfluoroalkyl sulfonic acids (PFSAs), with carbon chain lengths ranging from 4 to 13 atoms. The limit value is set at 100 ng/L for the sum of these compounds.  → “PFAS Total” (0.50 μg/L)   This parameter takes a much broader approach by covering all per- and polyfluoroalkyl substances . The limit value is set at 500 ng/L . The objective is to capture the total organofluorine load, including thousands of molecules not covered by the “Sum of PFAS”.  In accordance with Article 13(7) of the Directive, and following consultations with Member States, technical guidelines (C/2024/4910) have been published to define the analytical methods applicable to these two parameters.    2. Analytical control: requirements for the “Sum of PFAS”    The assessment of compounds under the “Sum of PFAS” relies on liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). The EN 17892:2024 standard, used as the reference analytical method, recommends two methodological approaches:  Part A (Direct injection): a rapid method in which unfiltered drinking water samples are injected directly into the LC-MS system.  Part B (SPE enrichment): this method involves solid-phase extraction (SPE) to concentrate the sample, providing higher sensitivity and lower quantification limits.    3. The technical challenge of “PFAS Total”    The comprehensive measurement of PFAS represents a major scientific challenge, as no single method can quantify all compounds in this chemically diverse group. Three approximation methods are currently validated by the Commission:  TOP assay (Total Oxidizable Precursors)    This method uses chemical oxidation to convert PFAS precursors into measurable perfluorocarboxylic acids. However, it may lead to underestimation, as some compounds (notably perfluorinated ethers) are not fully oxidised.  EOF-CIC (Extractable Organic Fluorine)    This method measures extractable organic fluorine via combustion and ion chromatography. The result, expressed in ng/L of fluorine, is converted into PFOA-equivalent using a conversion factor of 1.45 (thus, 345 ng/L F corresponds to 500 ng/L PFAS Total).  LC-HRMS (High-resolution mass spectrometry)    This non-targeted approach enables the detection of a much broader range of compounds. However, it remains semi-quantitative and requires a high level of expertise to interpret signals and minimise false positives.    4. The critical case of trifluoroacetic acid (TFA)     TFA is an ultra-short-chain PFAS (2 carbon atoms), characterised by high mobility, persistence, and strong hydrophilicity. It enters the water cycle through the degradation of pesticides, refrigerants, or industrial discharges. In many Member States, concentrations measured in untreated water frequently exceed the 0.50 μg/L threshold, thereby surpassing the parametric value for “PFAS Total”.  To address this issue, the Commission requires a four-step reporting protocol:  Measure [PFAS Total] using an approximation method.  Measure [TFA] specifically using a targeted analytical method compliant with the Directive.  Report three values: [PFAS Total] , [TFA] , and the difference [PFAS Total] – [TFA] .  If the result is negative, the measurement is considered inconclusive.    5. Performance criteria  To ensure measurement reliability, the Directive establishes several analytical requirements at the point of compliance:  Limits of quantification (LOQ)    The overall LOQ must be ≤ 30% of the parametric value , i.e. 30 ng/L for Sum of PFAS. However, the Commission recommends an individual LOQ of ≤ 1.5 ng/L for each of the 20 substances. For “PFAS Total”, the LOQ must be ≤ 150 ng/L.  For the most toxic compounds identified by EFSA (PFHxS, PFOA, PFOS, PFNA), even lower target limits are recommended.  Measurement uncertainty    The Directive sets a maximum expanded uncertainty of 50% at the parametric value level. In practice, European laboratories generally achieve better performance, with uncertainties ranging from 18% to 39% depending on the method used.  Validation of measurements    At ultra-trace levels (ng/L), environmental and laboratory conditions become limiting factors. Member States must ensure that analytical methods used for monitoring and compliance demonstration are validated in accordance with EN ISO/IEC 17025 or an equivalent internationally recognised standard.  Current limitations    Unlike the “Sum of PFAS”, methods for measuring “PFAS Total” are not yet fully harmonised at the European level. Available data on measurement uncertainty and LOQ remain limited, making it difficult to fully assess compliance with regulatory performance criteria for this global parameter.    6. Immediate actions in case of exceedance    The entry into force of these requirements means that any non-compliance must trigger immediate corrective actions to protect public health.  Water managers, under the supervision of national authorities, must:  Inform the public transparently about risks and precautionary measures.  Shut down wells or abstraction points where PFAS levels are excessive.  Implement specific treatment processes (activated carbon, ion exchange resins, or reverse osmosis) to remove contaminants.  Restrict water use if necessary until compliance is restored.    Conclusion  The implementation of these provisions is part of the “Zero Pollution” Action Plan . The new reporting framework now requires systematic transmission of data on exceedances and incidents to the Commission.  Beyond tap-level compliance, a comprehensive approach is required, including risk assessment from the abstraction area onwards. Anticipating pollution sources, combined with mastering complex analytical protocols (particularly for PFAS Total and TFA), is essential for ensuring sustainable and secure water resource management.    Authors: Floriane DEMAILLY & Loris MISTRULLI 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 24/02/2026).  Commission Notice C/2024/4910: Technical guidelines regarding methods of analysis for monitoring of per- and polyfluoroalkyl substances (PFAS) in water intended for human consumption, OJ C, C/2024/4910. Available on : http://data.europa.eu/eli/C/2024/4910/oj (accessed on 24/02/2026).

The recent amendment to the European Cosmetic Regulation significantly expands the list of fragrance allergens that must be declared on the INCI label (Regulation (EU) No 2023/1545 updating certain entries of Annex III of the EU Cosmetic Regulation).  In the original version of Regulation (EC) No 1223/2009, 26 allergens were subject to mandatory labelling. Two of them ,Lyral and Lilial, have since been prohibited. The new regulation adds 57 additional substances , bringing the total number of l abelled allergens to 81 . These include individual molecules as well as botanical extracts and essential oils that may induce skin allergy. Products already on the market containing these substances must be reviewed more closely, both to ensure correct labelling and to clarify potential risks.  The intrinsic risk of skin sensitisation of a product does not automatically change. However, if a substance was not previously identified, it may now need to be considered, particularly if the product claims to be “hypoallergenic” or suitable for “sensitive skin.”  Among the newly concerned substances are widely used cosmetic ingredients such as:  Vanillin   Benzaldehyde   Lavandin oil and extracts (Lavandula Hybrida Oil)   Peppermint oil (Mentha Piperita Oil)   Labelling is required when concentrations exceed:  0.001% in leave-on products   0.01% in rinse-off products   The regulatory deadlines are clearly defined:  Products placed on the market must comply by July 31, 2026   Products already on the market must comply by July 31, 2028   This regulatory development requires companies to conduct a systematic review of fragrance compositions, supplier data, and safety documentation.  However, labelling is only one part of the regulatory obligation.  Beyond Labelling: Annex I Requires a Complete Safety Assessment   Article 10 and Annex I: Mandatory Update of the Cosmetic Product Safety Report (CPSR) Article 10 of Regulation (EC) No 1223/2009 and Annex I require a complete safety assessment based on documented toxicological profiles and the calculation of the Margin of Safety (MOS) for each ingredient. Article 10(1)(c) specifies that the Safety Report (CPSR) must be updated whenever new relevant information becomes available.  A compliant cosmetic safety assessment requires :  The use of documented toxicological profiles   Evaluation of local effects (sensitisation, irritation, phototoxicity) and systemic effects, including identification of relevant concerns (critical warnings)  Calculation of the Systemic Exposure Dose (SED)   Determination of the Margin of Safety (MOS)   Integration of conclusions into the Cosmetic Product Safety Report (CPSR)  Margin of Safety (MOS): The Central Indicator in Cosmetic Risk Assessment The Margin of Safety (MOS) is the core regulatory indicator used to demonstrate ingredient safety within the CPSR framework.  It quantitatively expresses the relationship between hazard (NOAEL or relevant point of departure POD) and actual consumer exposure.  A product may comply with labelling thresholds while still requiring an in-depth evaluation. It is important to note that the 2012 SCCS opinion focused on skin sensitisation and did not address other potential toxicological endpoints.  Regulatory compliance therefore relies on a structured demonstration of the hazard × exposure assessment , not solely on verification of labelling thresholds.  Allergens requiring labeling (underscored) are identified based on their final concentration and the type of product. A margin of safety or margin of exposure is calculated each time it is possible.   Operational Impact: Recalculation of Margins of Safety and Update of the PIF   The transition from 24 to 81 labelled allergens significantly increases operational complexity:  Verification of fragrance compositions and botanical extracts  Recalculation of cumulative concentrations  Verification of the need to add allergens to the ingredient list  Confirmation of exposure scenarios  Reassessment of risks and recalculation of Margins of Safety  Update of the safety assessment through the CPSR and the Product Information File (PIF)   Any modification in concentration or formulation may directly impact the SED and consequently the MOS.  Traceability and reproducibility of calculations therefore become essential.  Toxicological Database and Digital Cosmetic Risk Assessment Tool In this context, the use of a structured toxicological database combined with a digital cosmetic risk assessment tool facilitates:  Harmonised access to toxicological profiles  Consistent calculation of SED and Margin of Safety  Generation of documentation compliant with Annex I  Consideration of the SCCS assessment methods and other international frameworks.  July 2026: A Regulatory Trigger for Systematic Risk Reassessment Therefore, Regulation (EU) No 2023/1545 updates the list of labelled allergens under Annex III of the EU Cosmetic Regulation and requires an update of the regulatory dossier.  The July 2026 deadline should be considered a regulatory trigger to:  To re-examine fragrance compositions and botanical extracts with regard to labelling requirements  To verify the Margins of Safety and confirm warnings or the absence of risk, and to update the CPSR accordingly The expansion of allergen labelling aims to enhance transparency.  However, consumer protection ultimately depends on the robustness of the cosmetic risk assessment and the scientific justification of safety through the Margin of Safety .  In regulatory practice, compliance does not merely consist of updating the INCI list.  It requires a continuously documented, traceable and scientifically substantiated assessment framework. These updates are therefore not simply an administrative revision of the ingredient list; they require regulatory and scientific expertise which, at least for Part B of the CPSR — covering the safety assessment — must be validated by a qualified safety assessor (toxicologist, pharmacist, etc.), as defined in Article 10 of the EU Cosmetic Regulation.  Would you like to ensure the safe assessment of allergens in your cosmetic formulas? Our experts can assist you in identifying allergens, conducting toxicological assessments, and ensuring your products comply with European and international requirements. To learn more about COSMETICK and our approach to cosmetic risk assessment, please contact: Clarisse Bavoux : Toxicologist, Deputy Chief Executive Officer in charge of digital solutions Florian Gautier : Cosmetics Market Leader References : Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards labelling of fragrance allergens in cosmetic products  https://eur-lex.europa.eu/eli/reg/2023/1545/oj/eng   Regulation (EU) (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products https://eur-lex.europa.eu/eli/reg/2009/1223/oj/eng   Scientific Committee on Consumer Safety SCCS, Opinion on Fragrance allergens in cosmetic products. SCCS/1459/11. 27 June 2012 https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_102.pdf    To comment on LinkedIn : https://www.linkedin.com/feed/update/urn:li:activity:7427743381092544512/

In December 2025, the European Commission published a targeted legislative proposal under its Food and Feed Safety Simplification Omnibus . One of its most relevant elements for the biocides sector is a proposed amendment to Regulation (EU) No 528/2012 (the Biocidal Products Regulation, or BPR), extending certain data protection periods for active substances still undergoing review. This initiative responds to long-standing concerns raised by industry and Member State authorities and has direct implications for companies supporting active substances, data owners, alternative suppliers, and product authorisation applicants. Background: Why This Amendment Was Needed Under the BPR, approval of biocidal active substances requires extensive scientific data demonstrating safety for human health, animal health, and the environment. These data packages are costly to generate and are therefore protected for a defined period to allow data owners to recover their investment. Article 95(5) of the BPR currently provides that data protection for certain existing active substance/product-type combinations expires on 31 December 2025 , regardless of whether the regulatory review has been completed. This “hard stop” was originally intended to balance fair compensation for data owners with increased market access and competition over time. However, the EU review programme for existing biocidal active substances, initiated more than two decades ago, has experienced significant and repeated delays. Completion is now scheduled for 31 December 2030 . Key drivers of these delays include limited resources in Member State authorities, evolving technical guidance, and, critically, the introduction of new scientific criteria for identifying endocrine-disrupting properties in 2018. These criteria triggered the need for additional, often expensive, studies well after original data submissions. As a result, many companies were required to generate new data without the prospect of adequate protection if the original 2025 cut-off remained unchanged. What the Commission Is Proposing The proposal seeks to realign data protection rules with the reality of the extended review programme. In practical terms, it would: Extend data protection until 31 December 2030 for all active substance/product-type combinations that were still under review on 7 June 2018 . Apply the extension to all data within the relevant dossiers , without distinguishing between older and newly generated studies, ensuring administrative simplicity and legal clarity. Introduce a derogation allowing protection to be reinstated even if it temporarily lapsed after 1 January 2026. Allow data owners to claim compensation  from substance or product suppliers that benefited from the absence of protection during the interim period. This results in a maximum protection period of approximately 11–12 years for data generated since 2018, broadly consistent with the standard data protection framework under the BPR. Balancing Innovation and Competition Stakeholder feedback highlighted diverging perspectives. Data owners and industry associations warned that allowing protection to expire amid regulatory delays would create free-rider risks, discourage investment in new studies (including vertebrate testing), and undermine supply security. Some Member State authorities supported extending protection at least for endocrine disruptor-related data. Conversely, alternative suppliers and SME representatives cautioned that prolonged protection could limit competition, increase costs, and complicate data-sharing negotiations. The Commission’s proposal reflects a compromise: it preserves incentives for data generation and regulatory compliance while maintaining the original objective of Article 95(5) to avoid disproportionate or perpetual exclusivity. What This Means for Companies For companies active in the biocides sector, the proposal provides: Greater legal certainty  for data owners who have invested in additional studies during a delayed review process. Continued relevance of letters of access and compensation negotiations  beyond 2025. Reduced risk of immediate, uncompensated data reuse by competitors. A clearer regulatory framework pending the broader evaluation of the BPR announced for 2026–2027. Next Steps The proposal will now be examined by the European Parliament and the Council under the legislative procedure. Until it enters into force, companies should carefully assess their data protection strategies, Article 95 positioning, and contractual arrangements. We will continue to monitor legislative developments closely and provide updates on timelines, implementation details, and strategic implications for substance suppliers and product authorisation holders. If you would like to discuss how this proposal may affect your portfolio or data protection strategy, please contact our regulatory team. Author: Barbara DHOOP Reference: Simplification Omnibus Package Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) No 528/2012 as regards the extension of certain data protection periods: https://food.ec.europa.eu/document/download/d8c35be0-ecc9-432b-a645-fd363681f5d3_en?filename=horiz_omnibus_reg_com-2025-1020-1-p1.pdf