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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.

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. PFAS in Cosmetic Products: Regulatory Trends and Safety Assessment Challenges Per- and polyfluoroalkyl substances (PFAS) are a large family of anthropogenic chemicals characterised by highly stable carbon–fluorine bonds. Structurally, PFAS typically contain at least one fully fluorinated methyl (CF₃-) or methylene (-CF₂-) carbon atom. DIGITAL SOLUTIONS Questions Toxicologists Asked About Cosmetic Safety Assessment – COSMETICK Webinar During our COSMETICK webinar on cosmetic safety assessment, toxicologists raised key questions on endocrine disruption, Margin of Safety (MOS), and toxicological data gaps. COSMETICS The PIF (Product Information File) for Cosmetics Rôle du PIF dans la mise sur le marché Dans l’Union Européenne, la mise sur le marché d’un produit cosmétique ne peut se faire sans un dossier complet que l’on appelle Product Information File (PIF) ou Dossier d’Information Produit (DIP) en français. Il s’agit d’une obligation légale définie par le Règlement (CE) n°1223/2009. COSMETICS 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

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. Regulatory news and experts insights. Stay updated with the latest developments, guidance, and resources in chemical regulations. All events Conferences Webinars Questions Toxicologists Asked About Cosmetic Safety Assessment – COSMETICK Webinar During our COSMETICK webinar on cosmetic safety assessment, toxicologists raised key questions on endocrine disruption, Margin of Safety (MOS), and toxicological data gaps. Mar 19 4 min read

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."