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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

Careers in Regulatory Affairs, Toxicology & Chemical Safety Join CEHTRA, a leading regulatory affairs and toxicology consulting firm. Apply online easily through our application form – no CV upload required. Apply to CEHTRA Would you like to join a recognized consulting firm in regulatory affairs, toxicology and chemical risk assessment? CEHTRA regularly recruits scientific, regulatory and support profiles in France and internationally. Why join CEHTRA? For over 20 years, CEHTRA has been supporting industrial clients in sectors such as: Chemicals Cosmetics Biocides Pharmaceuticals Medical devices Food & feed What we offer: High-level scientific and regulatory projects Recognised European expertise A collaborative and people-focused environment Career development opportunities within a growing international group I am applying for the position of: First name* Last name* Phone* E‑mail* Curriculum Vitae* Import a file Cover Letter (optional) Import a file Apply Julien LEGHAIT "Working in a team with diverse points of view helps me to broaden my vision about things and allows me to take into account the elements that I wouldn’t have thought through otherwise."

Explore career opportunities at CEHTRA, including roles for ecotoxicologists, toxicologists, physico-chemical experts and regulatory consultants. Join our international team committed to chemical safety and apply today. Join our team at CEHTRA Explore exciting job opportunities at CEHTRA for toxicologists, ecotoxicologists, regulatory affairs experts, engineers, and more — across 10 key sectors including REACH, biocides, cosmetics, and beyond. Filter by sector Digital Marketing Marketing Digital Sales Digital Marketing Internship (Work-Study Program) Digital Marketing, Marketing Digital Work-study program, Alternance Paris, Lyon ASAP Apply Read more Sales Assistant M/F Customer Acquisition - Work-Study Program Sales Work-study program, Alternance, Bachelor's degree (Bac+3) Paris ASAP Apply Read more Careers at CEHTRA: What our team says Julien LEGHAIT "Working in a team with diverse points of view helps me to broaden my vision about things and allows me to take into account the elements that I wouldn’t have thought through otherwise."

Our experts assess the endocrine disrupting properties of your substances and their potential classification. Our optimized strategies and data compilation ensure compliance with regulatory requirements and anticipate future regulatory changes. Endocrine Disruptors (ED): Regulatory Assessment & Strategic Support Expert guidance on EU endocrine disruptor regulations, risk assessment, and strategic compliance solutions. Our services Request support Your partner for safety, compliance, and scientific evaluation of endocrine disruptors Since 2018, the evaluation of endocrine disruption (ED) potential has been a mandatory regulatory requirement for plant protection and biocidal products. In 2023, new hazard classes for ED were introduced under CLP (Regulation (EC) No 1272/2008). Further regulatory requirements are also expected in cosmetic, REACH, and pharmaceutical regulations. Our experts support you in anticipating these regulatory changes and ensuring the compliance of your substances and products across multiple markets. Contact our experts Key Services for Endocrine Disruptors Ancre 1 Critical review of existing data: Review of existing regulatory data Targeted bibliographic search according to ECHA-EFSA guidance Analysis of Toxcast data using our internal digital tool Data generation and tailored testing Tailored testing strategies aligned with OECD guidelines or most recognised protocols Monitoring and interpretation of ED-specific studies (in vitro / in vivo) In silico predictions and (Q)SAR screening Documentation & regulatory dossiers Preparation of ED-relevant sections for PPP and BPR Use of regulatory compliant formats (IUCLID, EFSA table…) Comprehensive documentation for internal strategic purpose or for regulatory submissions Expert statements & defence Independent scientific evaluation of ED properties and CLP classification Support during regulatory interactions with authorities Position papers defending ED assessment and classification Looking for guidance on Endocrine Disruptor assessment? Find it here. What is an endocrine disruptor (ED)? An Endocrine Disruptor (ED) is a substance or a mixture that alters one or more functions of the endocrine system and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations. Why is ED assessment required under EU regulations? Since 2018, ED assessment has been mandatory under the Plant Protection Products Regulation and Biocidal Products Regulation. In 2023, new hazard classes for endocrine disruptors were added to CLP Regulation. Updates to REACH Regulation, cosmetic and pharmaceutical legislations are expected to extend these requirements further — making ED evaluation essential for market access and compliance in the EU. Is there an official list of endocrine disruptors in the EU? There is currently no single, definitive EU list of all endocrine disruptors. However, several regulatory lists and databases identify or flag substances with suspected or proven ED properties: The ED assessment list published by European Chemicals Agency (ECHA) The list of approved and non-approved active substances under Plant Protection Products Regulation and Biocidal Products Regulation The Candidate List of Substances of Very High Concern (SVHC) under REACH Regulation In France, the Annex I of AGEC law lists substances identified as potential ED These lists are updated regularly, and companies should monitor them closely to anticipate regulatory impacts on their substances or products. CEHTRA has designed a digital tool to detect the presence of substances in those and many other lists of suspected or proven ED. Such data must be interpreted with caution and reviewed by an expert that CEHTRA can provide. Explore additional resources Can’t find your answer? Submit a request