Introduction: a new framework for the “Zero Pollution” ambition Directive (EU) 2026/805 of 30 March 2026 constitutes a major revision of the European Union’s water legislation. By simultaneously amending the Water Framework Directive (2000/60/EC), the Groundwater Directive (2006/118/EC), and the Environmental Quality Standards Directive (2008/105/EC), the text aims to align the protection of water resources with the European Green Deal’s “zero pollution” ambition. The urgency of this reform is highlighted by findings from the European Environment Agency (EEA). According to Recital 3 of Directive (EU) 2026/805, which refers to the EEA’s 2024 report, Member States reported that, in 2021, approximately 40% of surface water bodies had achieved good or high ecological status, while 38% had achieved good chemical status. This situation is often obscured by historical contamination or by the emergence of new pollution issues. Revision of the assessment of chemical and ecological status The Directive introduces a fundamental change in the way water quality is assessed and classified. A. Integration of river basin-specific pollutants The most significant technical innovation is the transfer of river basin-specific pollutants into the definition of the “good chemical status” of surface waters. Previously, these pollutants were considered physicochemical quality elements supporting the assessment of ecological status. From now on, for a water body to achieve good chemical status, it must comply not only with the environmental quality standards (EQSs) established for Union priority substances, but also with the EQSs applicable to river basin-specific pollutants identified at national or regional level. Certain substances, such as alachlor, atrazine, and simazine, which no longer pose a widespread risk at Union level, have been moved from the list of priority substances to a register of harmonized EQSs for river basin-specific pollutants. B. New definition of status deterioration The Directive clarifies the concept of “deterioration of status”, drawing on the case law of the Court of Justice of the European Union. Any deterioration by at least one class of an individual quality element—whether biological, chemical, or hydromorphological—is now considered to constitute deterioration, even where it does not result in a reduction in the overall classification of the water body. C. Categorization of priority substances The revised Directive (EU) 2026/805 introduces a more targeted and proportionate approach to the management of priority substances in aquatic environments. As part of the review of the list of priority substances, the European Commission now classifies these substances into three distinct categories, each reflecting specific environmental concerns and triggering tailored regulatory obligations for Member States and industrial operators. D. Priority Hazardous Substances (PHS) These substances pose a particularly high risk to the aquatic environment and, in some cases, to human health. Their classification entails stringent measures aimed at reducing their presence in water bodies at the source. Member States are required to implement actions to cease or progressively eliminate discharges, emissions and losses of these substances. The Directive establishes an ambitious objective: the complete phase-out of releases no later than 20 years after the substance has been designated as a Priority Hazardous Substance at Union level. Newly classified PHS include Bisphenol A (BPA), reflecting increasing concerns regarding its ecotoxicological effects and endocrine-disrupting properties. For industrial operators, this classification may result in stricter emission controls, tighter permit conditions under environmental legislation, implementation of best available techniques (BAT), and, where feasible, substitution of hazardous substances by safer alternatives. Companies using or releasing PHS may also face increased monitoring and reporting obligations. E. Substances behaving as ubiquitous Persistent, Bioaccumulative and Toxic substances (uPBTs) These pollutants, such as mercury and certain polycyclic aromatic hydrocarbons (PAHs), are characterized by their widespread occurrence in the environment, often resulting from historical contamination or diffuse sources that are difficult to control. Recognising their ubiquitous nature, the Directive introduces specific provisions intended to optimise monitoring efforts. Where reliable statistical evidence demonstrates stable and representative occurrence, Member States may reduce monitoring frequency, with sampling potentially performed every three years. To ensure that these widespread contaminants do not mask progress achieved for other pollutants, Member States may also present supplementary maps showing the chemical status of water bodies both including and excluding uPBT substances. Although the focus is primarily on monitoring and assessment rather than additional restriction measures, industrial operators are still expected to minimise releases where technically and economically feasible and to demonstrate compliance with applicable emission limits and permit requirements. F. Substances that accumulate in sediments or biota Due to their physicochemical properties, these substances tend to accumulate preferentially in living organisms and/or sediments rather than remaining dissolved in the water column. Environmental assessment must therefore extend beyond water monitoring. The Directive requires Member States to apply Environmental Quality Standards (EQSs) established for biota and/or sediment matrices and to perform long-term trend monitoring to assess changes in concentration levels over time. Monitoring must generally be carried out at least annually unless an alternative scientifically justified approach is adopted. For industrial operators, this means that compliance cannot be assessed solely through concentration measured in water. Releases may contribute to the accumulation of substances in sediments or aquatic organisms even when water concentrations remain relatively low. Industries may therefore be required to implement additional emission reduction measures, provide supporting environmental monitoring data, and demonstrate that their activities do not contribute to increasing trends in sediment or biota concentrations. This category is particularly relevant for substances with bioaccumulative properties, as long-term environmental effects may occur despite relatively low concentrations in the water column. Updating pollutant lists and introducing new standards The Directive updates the lists of regulated substances in order to include several emerging pollutants or pollutants that were insufficiently covered by the existing framework. A. PFAS: Per- and Polyfluoroalkyl Substances A group-based approach is prioritised. For surface waters, an EQS is established for the sum of 25 PFAS, expressed as perfluorooctanoic acid (PFOA) equivalents. For groundwater, a standard is established for the sum of the 20 PFAS covered by the Drinking Water Directive, together with a strict limit of 0.0044 µg/L for the sum of the four PFAS considered to be of greatest concern: PFHxS, PFOS, PFOA, and PFNA. The Directive also pays particular attention to trifluoroacetic acid (TFA), due to its persistence, environmental prevalence, and multiple sources, including PFAS pesticides and fluorinated gases. For surface waters, TFA is currently included in the group of “25 PFAS” subject to an overall environmental quality standard, with a relative potency factor (RPF) of 0.002 compared with PFOA. For groundwater, although no strict individual limit has yet been established, the Commission is required to examine the establishment of a specific standard for TFA during the next legislative review. In the longer term, the Directive stipulates that the Commission should consider the establishment of a quality standard for TFA in surface waters in order to better reflect its specific risk independently of the broader PFAS group. For groundwater, the Commission should also consider establishing a quality standard for TFA, whether separate or as a part of a sum. B. Pesticides (PP + Biocides) Directive (EU) 2026/805 strengthens the protection of European water resources by establishing harmonized environmental quality standards (EQSs) for pesticides, including both plant protection products and biocidal products. It introduces stricter monitoring requirements for active substances, as well as their metabolites and degradation products, in groundwater and surface waters. For groundwater, the Directive maintains a limit of 0.1 μg/L for individual pesticides and 0.5 μg/L for the total concentration of pesticides. It also sets specific thresholds for non-relevant metabolites, with default values of 1 μg/L per substance and 5 μg/L for the total concentration. For surface waters, a new annual average EQS of 0.2 μg/L is established for the sum of priority pesticide substances, reflecting growing concern over the effects of chemical mixtures. Plant protection products and biocides may also be regulated as River Basin Specific Pollutants (RBSPs) through national or harmonized standards. The Directive further promotes the development of a mixture-based approach by requiring the Commission to assess the possibility of setting standards for groups of pesticides sharing the same mode of action. By May 2028, a harmonized EU list of relevant and non-relevant pesticide metabolites in groundwater will also be established, improving consistency in monitoring and risk assessment across Member States. Overall, the Directive strengthens pesticide management while placing continued emphasis on pollution prevention at source. C. Pharmaceuticals Several pharmaceutical substances are included in the regulatory annexes with specific quality standards. These notably include carbamazepine and diclofenac for surface waters, and carbamazepine, sulfamethoxazole, and primidone for groundwater. In order to address the cumulative risk from pharmaceuticals, the Commission should consider the setting of quality standards for the sum(s) of selected pharmaceuticals, potentially based on mode of action, at the next review. D. Bisphenol A (BPA) & Bisphenols Bisphenol A is now classified as a priority hazardous substance in surface waters. The Commission should review the listing of bisphenols in general at the next review and consider the establishment of an EQS for the totality of bisphenols (‘Bisphenols Total’) or at least for the sum of selected bisphenols (‘Sum of Bisphenols’), including at least Bisphenol-B and Bisphenol-S, supported by appropriate monitoring methods. E. Ubiquitous Persistent, Bioaccumulative and Toxic Substances — uPBTs Substances such as mercury and polycyclic aromatic hydrocarbons (PAHs) remain subject to strict monitoring. However, Member States may reduce monitoring intensity where a reliable statistical baseline demonstrates that concentrations remain stable. Beyond the substance-by-substance updates, the Directive strengthens the consideration of cumulative effects associated with pollutant mixtures. EFB methods For surface waters, an EQS is introduced for the sum of pesticides already listed as priority substances in order to better address cumulative risks. The Commission is also invited to consider, during future reviews, the establishment of standards for groups of substances sharing a common mode of action. This development is accompanied by the introduction of effect-based monitoring methods, allowing cumulative biological effects to be assessed beyond a strictly analytical approach. Such methods should notably be applied to oestrogenic substances as a complement to conventional monitoring methods. Vigilance mechanisms: watch lists Watch lists are an anticipatory tool intended to collect data on emerging pollutants for which the available knowledge remains insufficient. They help guide future reviews of regulated substance lists and prepare for the possible establishment of new environmental quality standards. For surface waters, the watch list may include up to ten substances or groups of substances. A similar mechanism is introduced for groundwater, although the groundwater watch list is limited to five substances. The inclusion of microplastics and antimicrobial resistance (AMR) indicators will become mandatory on both watch lists as soon as reliable and affordable monitoring methods are available. Member States must monitor each substance included on a watch list for a period of 24 months. The number of monitoring stations is strictly defined: For surface waters, the monitoring system is based on population and geographical area. It must include at least one monitoring station, with one additional station per million inhabitants and further stations depending on the surface area concerned. For groundwater, at least two monitoring stations are required, together with one additional station for every 45,000 km² of groundwater bodies. The role of ECHA A major institutional change is the transfer of scientific expertise to the European Chemicals Agency (ECHA). ECHA is now responsible for preparing the scientific reports required for the three-year review of watch lists and the six-year review of priority pollutant lists. ECHA therefore becomes a central and permanent source of scientific support for the Commission in identifying candidate substances, preparing scientific reports, and proposing environmental quality standards or threshold values. This centralisation is intended to ensure consistency between water legislation and other regulatory frameworks, including REACH, pesticide legislation, and veterinary medicinal product legislation. ECHA must also integrate data generated by innovative technologies, such as remote sensing and the Copernicus programme, into its assessments. Modernisation of reporting and digitalisation The Directive requires faster data transmission in order to enable more dynamic monitoring of water status. Member States must ensure the electronic transmission of data through the EEA’s Reportnet system, allowing automated reporting. The reporting frequency is increased: validated chemical data must be reported every two years, while biological data must be reported every three years. The framework also explicitly encourages the use of technological innovations, including artificial intelligence, Earth observation, and citizen science, to complement traditional monitoring networks. Liability and access to Justice The Directive strengthens citizens’ rights and the responsibilities of economic operators. Member States must guarantee access to justice in accordance with the Aarhus Convention, allowing members of the public concerned and environmental non-governmental organisations to challenge the legality of decisions or omissions associated with the implementation of the Directive. In addition, the Commission must publish, by 2029, a report assessing the feasibility of introducing an extended producer responsibility scheme. Such a mechanism could require producers to contribute to the costs of monitoring programmes for substances they place on the market. Specific provisions and exceptions The Directive establishes strict frameworks for certain projects and activities. In the short term, a project is not considered to constitute an infringement where its adverse impacts are no longer detectable after one year, or after three years for biological parameters, and provided that strict mitigation conditions are fulfilled. The transfer of water and sediments is permitted provided that it does not result in a net increase in the pollutant load, that all mitigation measures are implemented, and that drinking-water abstraction areas are protected by appropriate exclusion zones. Implementation deadlines and compliance roadmap The Directive provides for progressive implementation, with several key deadlines. These deadlines require the early identification of relevant substances, appropriate monitoring methods, and the actions needed to ensure compliance. Conclusion Directive (EU) 2026/805 represents a major development towards more integrated water management based on scientific rigor and digital transparency. In particular, it strengthens the assessment of chemical status by integrating pollutants specific to individual river basins and by expanding automated monitoring and reporting systems. For both public authorities and operators, the main challenges will involve integrating these new parameters into their compliance strategies and managing increasingly complex monitoring protocols, particularly for emerging substances such as PFAS, pharmaceutical residues, and microplastics. The centralization of data at European level and the strengthened role of specialized agencies will also increase the level of regulatory scrutiny and the frequency of controls. In this context, a proactive approach is becoming essential. The Directive confirms that the management of water quality can no longer rely solely on downstream monitoring. It must instead be supported by a better understanding of the substances placed on the market, their uses, their emissions, and their environmental fate. Our expertise should enable industrial operators to anticipate changes in environmental quality standards and the inclusion of new substances, thereby securing their regulatory compliance and placing their activities on a sustainable pathway. Authors: Flolriane DEMAILLY & Loris MISTRULLI

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

CEHTRAWATCH is a regulatory and toxicological monitoring platform for chemical substances. Stay ahead of CLP, SVHC, and global regulatory changes with automated, centralized monitoring. CEHTRAWATCH: regulatory & toxicological platform focused on your substances Designed by scientific and regulatory experts at CEHTRA, CEHTRAWATCH transforms regulatory monitoring into an automated, structured, and actionable system. Discover Book a demo Anticipate regulatory changes before they impact your substances Traditional regulatory monitoring is fragmented, manual, and time-consuming. CEHTRAWATCH replaces this complexity with a unified, automated system that continuously tracks global regulatory and toxicological sources. By focusing only on the substances that matter to your organization, the platform transforms raw regulatory data into clear, actionable intelligence for regulatory affairs, toxicology, R&D, and product stewardship teams. Book a demo Regulatory Monitoring Challenges and the Benefits of a Regulatory Intelligence Platform. Missed updates → compliance risk increases Traditional regulatory monitoring Manual tracking leads to delayed identification of regulatory changes, increasing the risk of non-compliance, reformulation delays, and uncertainty. CEHTRAWATCH Continuous automated monitoring ensures real-time detection of relevant regulatory and toxicological updates, reducing compliance risk and eliminating manual gaps. High operational costs → inefficient use of expert time Traditional regulatory monitoring Regulatory teams spend significant time on repetitive manual screening instead of focusing on strategic regulatory analysis and decision-making. CEHTRAWATCH Automation reduces monitoring time from hours to minutes, enabling teams to focus on higher-value regulatory intelligence and expertise. Limited anticipation → reactive compliance Traditional regulatory monitoring Without structured early signals, organizations often react too late to upcoming regulatory changes. CEHTRAWATCH Integrated regulatory intent tracking and early signals enable proactive anticipation of upcoming changes before implementation. Fragmented information → lack of global visibility Traditional regulatory monitoring Regulatory data is scattered across jurisdictions, internal teams, and multiple external sources, making consolidation difficult. CEHTRAWATCH A unified platform centralizes global regulatory and toxicological information into a single structured view. Unstructured collection → low operational usability Traditional regulatory monitoring Information is collected inconsistently, making it difficult to standardize, analyze, or integrate into workflows. CEHTRAWATCH Structured data transforms raw regulatory inputs into standardized, exportable insights (Excel-ready and integration-friendly). Information overload → low signal-to-noise ratio Traditional regulatory monitoring Teams are overwhelmed by irrelevant updates that do not concern their substance portfolio. CEHTRAWATCH Targeted alerts filter out noise and deliver only relevant updates tailored to your specific substance portfolio. How CEHTRAWATCH Works: Real-Time Chemical Regulatory Monitoring and Alerts 1. Upload your substance portfolio Import your substance list into the platform. 2. Automated analysis The system continuously cross-references your substances with global regulatory and toxicological updates. 3. Continuous monitoring Relevant changes are detected and filtered automatically. 4. Actionable alerts Receive only the insights that matter for regulatory decision-making. Book a demo Need help? Here are the answers to your questions. How does CEHTRAWATCH save time compared to manual regulatory monitoring? CEHTRAWATCH enables targeted regulatory and toxicological monitoring based on your substance portfolio. After importing your substance list, the platform automatically tracks their presence across multiple regulatory and toxicological lists. Relevant updates are identified and displayed in your dashboard or via alerts. Regulatory and toxicology teams no longer need to manually search multiple sources and can focus on impact analysis for their products and activities. How does CEHTRAWATCH help reduce compliance risks? Regulatory and toxicological changes can directly impact the use of substances. CEHTRAWATCH allows you to quickly identify whether a substance in your portfolio appears or evolves in a regulatory or toxicological list. Updates are integrated into the platform and changes between versions are highlighted. This targeted monitoring helps teams detect early changes that may affect compliance or risk assessment. Which regulatory and toxicological lists are monitored? CEHTRAWATCH monitors a wide range of regulatory and toxicological lists relevant to the chemical industry, including: European regulations (CLP, REACH, Cosmetics Regulation) SVHC and CLH intentions key national lists toxicological monographs (IARC, NTP…) toxicological reference values All updates are filtered based on your substance portfolio to ensure relevance. Does CEHTRAWATCH replace regulatory or toxicological expertise? No. CEHTRAWATCH does not replace human expertise. The platform facilitates the identification of relevant regulatory and toxicological changes, but impact assessment remains the responsibility of experts. It is designed as a complement to internal teams and CEHTRA consultants. Contact Book a demo

Request a CEHTRAWATCH demo and discover how the platform helps your teams monitor regulatory and toxicological updates for your substance portfolio. Book a CEHTRAWATCH demo Discover how CEHTRAWATCH can transform regulatory and toxicological monitoring into a structured, automated and actionable process tailored to your substance portfolio. Would you like to see how CEHTRAWATCH can support your regulatory, toxicology, R&D or product stewardship teams? Complete the form to request a personalised demo. Our experts will show you how the platform helps you monitor relevant regulatory and toxicological developments, identify changes affecting your substances and receive targeted alerts. Our team will contact you shortly to arrange the demonstration and better understand your regulatory monitoring needs. Your request will be handled with care and full confidentiality. Your contact details First name* Last name Company* Email* Phone Which sector(s) would you like to explore with CEHTRAWATCH? Autorisation REACH Biocides Chemical REACH Cosmetics Food Industrial hygiene Medical Devices Packaging Pharmaceutics Plant Protection Global chemicals notification Please select your preferred time slot for the demo (based on your local time): Morning (9:00 AM – 12:00 PM) Early afternoon (12:00 PM – 2:00 PM) Late afternoon (2:00 PM – 5:00 PM) Which days work best for you? Monday Tuesday Wednesday Thursday Friday Your needs in a few words Submit

CEHTRA provides regulatory, toxicology and risk assessment expertise for the chemical, biocides, PPP, cosmetics, pharma, food industries, ... Your partner in regulatory compliance and product safety Simplify your regulatory compliance with our expertise and innovative tools. Our sectors Contact us Nos programmes Recognized expertise in Regulatory Affairs and Risk Assessment For over 25 years, CEHTRA has been supporting chemical industry players across key strategic sectors. We assist manufacturers, formulators, distributors, and importers in areas including industrial chemicals (REACH), biocides (BPR), plant protection products (PPP), cosmetics, pharmaceuticals, and food products, including novel foods & supplements, as well as packaging, and other sectors related to health, environmental protection, and product safety. Thanks to our multidisciplinary expertise in toxicology, ecotoxicology, risk assessment and international regulations, we offer tailor-made solutions adapted to the specific requirements of each market, both within and outside Europe. Contact an Expert Our Areas of Expertise biocides Explore chemicals Explore cosmetics Explore food Explore packaging Explore pharmaceuticals Explore plant protection Explore all Explore Digital Solutions for Regulatory Affairs & Toxicology Your performance, our smart solutions. Focus on Directive (EU) 2026/805: Revision of Water Quality Standards and Monitoring Mechanisms Directive (EU) 2026/805 of 30 March 2026 constitutes a major revision of the European Union’s water legislation. By simultaneously amending the Water Framework Directive (2000/60/EC), the Groundwater Directive (2006/118/EC), and the Environmental Quality Standards Directive (2008/105/EC), the text aims to align the protection of water resources with the European Green Deal’s “zero pollution” ambition. TOXICOLOGY How to Integrate Environmental Properties into the Safety Assessment of Cosmetic Ingredients? 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. COSMETICS China’s MEE Order No. 12: Key Draft Changes to New Chemical Substance Registration 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. REGULATORY UPDATES 1 2 3 4 5 Need guidance? Speak with our specialists Select a sector:* First name:* Last name:* Company or Organization:* Email:* How can we help you? Submit