Cosmetic Formulations from Natural Sources: Safety Considerations and Legislative Frameworks in the European Union

Cosmetics, Journal Year: 2024, Volume and Issue: 11(3), P. 72 - 72

Published: May 4, 2024

Consumer preferences, safety, and sustainability aspects of conventional cosmetic ingredients have contributed to an increase in the demand for natural products. Naturally derived active agents excipients may come into contact with various naturally occurring synthetic contaminants throughout supply chain, substantiating their safety is essential. This review examines legislative requirements applicable European Union (EU). Cosmetic include technical data based on ingredient profile, presence hazards risks associated intended conditions use. The hazard analysis includes screening microbial such as aerobic mesophilic bacteria, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans; chemical lead, cadmium, arsenic, mercury; toxins, allergens. toxicological assessment considers both local effects (such skin sensitisation, eye/skin irritation, photo-induced effects) systemic (including acute dermal toxicity, sub-acute sub-chronic mutagenicity carcinogenicity, reproductive toxicokinetics). EU prohibit use animal-based tests evaluation ingredients, paving way alternatives termed New Approach Methodologies (NAMs). validation NAMs critical wider usage, despite advancements, few been validated, particularly toxicity testing. evaluating complex further examined.

Language: Английский

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The Critical Role of Commercial Analytical Reference Standards in the Control of Chemical Risks: The Case of PFAS and Ways Forward

Environmental Health Perspectives, Journal Year: 2025, Volume and Issue: 133(1)

Published: Jan. 1, 2025

Various countries have instituted risk governance measures to control and minimize the risks of chemicals at national international levels. Activities typically include assessment based on a) hazard exposure assessments; b) setting limits production, use, emissions chemicals; c) enforcement regulations; d) monitoring effectiveness taken. These steps largely depend chemical analysis access pure reference standards. However, except for specific highly regulated categories chemicals, such standards often are not commercially available. This raises a critical question: Given widespread lack standards, is current approach governing adequate protect humans environment from harm? If not, what could be taken improve situation? We outline how hampered by produce required scientific evidence. also provide list recommendations controlling in absence use per- polyfluoroalkyl substances (PFASs), specifically C6O4 [perfluoro ([5-methoxy-1,3-dioxolan-4-yl]oxy) acetic acid], illustrate companies that can prevent argue very limited availability undermines ability scientists independent evidence needed and, thereby, prevents society protecting people against pollution its harms. Possible ways situation guaranteeing creating repository, redefining level confidence sufficient regulatory action, providing alternative options identification quantification when available, considering, no regulation class rather than individually. https://doi.org/10.1289/EHP12331.

Language: Английский

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Manganese dioxide nanostructures: Design, synthesis and conceptualization for developing innovative sensors in reporting environmental risk factors

Coordination Chemistry Reviews, Journal Year: 2023, Volume and Issue: 497, P. 215433 - 215433

Published: Sept. 18, 2023

Language: Английский

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Human biomonitoring and toxicokinetics as key building blocks for next generation risk assessment

Environment International, Journal Year: 2024, Volume and Issue: 184, P. 108474 - 108474

Published: Feb. 1, 2024

Human health risk assessment is historically built upon animal testing, often following Organisation for Economic Co-operation and Development (OECD) test guidelines exposure assessments. Using combinations of human relevant in vitro models, chemical analysis computational (in silico) approaches bring advantages compared to studies. These include a greater focus on the species molecular mechanisms kinetics, identification Adverse Outcome Pathways downstream Key Events as well possibility addressing susceptible populations additional endpoints. Much advancement progress made Next Generation Risk Assessment (NGRA) have been primarily focused new approach methodologies (NAMs) physiologically based kinetic (PBK) modelling without incorporating biomonitoring (HBM). The integration toxicokinetics (TK) PBK an essential component NGRA. models are describing quantitative terms TK processes with effective dose at expected target site. Furthermore, need amplified by increasing scientific regulatory interest aggregate cumulative interactions chemicals mixtures. Since HBM data strengthens reduces uncertainties assessment, here we elaborate integrated use TK, highlighting opportunities challenges limitations. Examples provided where TK/PBK can be used both hazard characterization shifting from external dose/response assays animal-free, internal exposure-based

Language: Английский

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Current and emerging issues in chemical food safety

Current Opinion in Food Science, Journal Year: 2025, Volume and Issue: unknown, P. 101284 - 101284

Published: Feb. 1, 2025

Language: Английский

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Exploring the use of Artificial Intelligence (AI) for extracting and integrating data obtained through New Approach Methodologies (NAMs) for chemical risk assessment

EFSA Supporting Publications, Journal Year: 2024, Volume and Issue: 21(1)

Published: Jan. 1, 2024

The future of risk assessment cannot neglect to consider the vast literature produced through application new approach methodologies (NAMs). This, however, constitutes a challenge for assessor, as availability data in this context is huge and heterogeneous both methods applied standardisation quality results. integration results generated from NAMs hence only feasible under some degree automation workflow, specifically searching, extracting integrating such "AOP-like" knowledge networks (AOP – Adverse Outcome Pathway). Artificial intelligence (AI) with its state-of-the-art tools one most promising sources support manual tasks among modern technologies. present paper illustrates exploration possible applications AI achieve goal. After introduction an evaluation framework quantitatively assess these methods, implementation six selected case studies selection dedicated workflow are presented. A qualitative survey which also incorporates experience gathered during study implementation, then Finally, recommendations formulated address main aspects identified that should, opinion authors, be pursued by EFSA SPIDO roadmaps. In summary, potentials tool could throughout workflow. Although many can supported (semi-)automation, showed subject matter experts need involved all steps.

Language: Английский

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Guidance on risk–benefit assessment of foods

EFSA Journal, Journal Year: 2024, Volume and Issue: 22(7)

Published: July 1, 2024

The EFSA Scientific Committee has updated its 2010 Guidance on risk-benefit assessment (RBA) of foods. update addresses methodological developments and regulatory needs. While it retains the stepwise RBA approach, provides additional methods for complex assessments, such as multiple chemical hazards all relevant health effects impacting different population subgroups. guidance includes approaches systematic identification, prioritisation selection hazardous beneficial food components. It also offers updates to characterising adverse effects, measures effect size dose-response modelling. expands options risks benefits, incorporating variability, uncertainty, severity categorisation ranking (beneficial or adverse) effects. impact types is assessed qualitatively quantitatively, depending problem formulation, scope question data availability. integration benefits often involves value-based judgements should ideally be performed with manager. Metrics Disability-Adjusted Life Years (DALYs) Quality-Adjusted (QALYs) can used. Additional are presented, probability and/or given severities their using weight functions. practical reporting results, interpreting outcomes communicating outcome an RBA, considering consumer perspectives responses advice.

Language: Английский

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Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment

Frontiers in Toxicology, Journal Year: 2024, Volume and Issue: 6

Published: April 5, 2024

The ICH S1B carcinogenicity global testing guideline has been recently revised with a novel addendum that describes comprehensive integrated Weight of Evidence (WoE) approach to determine the need for 2-year rat study. In present work, experts from different organizations have joined efforts standardize as much possible procedural framework integration evidence associated S1B(R1) WoE criteria. uses pragmatic consensus procedure hazard assessment facilitate transparent, consistent, and documented decision-making it discusses best-practices both organization studies presentation data in format suitable regulatory review. First, is acknowledged six factors described form an network within holistic used synergistically analyze explain safety signals. Second, proposed standardized builds upon considerations related primary sources evidence, mechanistic analysis, alternative methodologies investigative approaches, metabolites, reliability other acquired information. Each highlighting how they can contribute overall assessment. A suggested reporting summarize cross-integration also presented. This work notes even if study ultimately required, creating valuable understanding specific levels human carcinogenic risk better than identified previously bioassay alone.

Language: Английский

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Novel strategies for predicting allergenicity: development of a ranking method and screening tools to assess the allergy risk of innovative proteins

EFSA Supporting Publications, Journal Year: 2024, Volume and Issue: 21(6)

Published: June 1, 2024

Abstract To protect individuals who already have or are at risk of developing immune‐mediated adverse reactions to food, novel foods and genetically modified organisms (GMOs) undergo an allergenicity assessment. There shortcomings in this process that could be improved through use well‐defined clinically relevant allergen molecules with different allergenic potential. The objective project was develop strategies for predicting innovative/novel proteins address issue. We undertook a systematic review listed on Annex II the Food Information Consumers Regulation together additional known cause IgE‐mediated food allergies least one European region prevalence 0.5%. Around 750 in‐scope papers were quality assessed allow clinical relevance ranked. best characterised allergens identified peanut, hazelnut, cow's milk, fish crustacean shellfish data lacking from such as pecan, Macadamia, lupin melon. Furthermore, assessment silico tools prediction found that, whilst many able correctly predict allergenicity, none provide output linked relevance. Building these outcomes approach has been developed brings elements exposure assessment, combining silico, vitro, vivo methods. Tools risks cross‐reactive more mature only require refinement improve outputs inform process. However, mechanisms underlying development allergy not fully elucidated, remain matter ongoing research, de novo sensitisation is uncertain.

Language: Английский

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Towards a future regulatory framework for chemicals in the European Union – Chemicals 2.0

Regulatory Toxicology and Pharmacology, Journal Year: 2023, Volume and Issue: 142, P. 105431 - 105431

Published: June 12, 2023

The body of EU chemicals legislation has evolved since the 1960s, producing largest knowledge base on worldwide. Like any evolving system, however, it become increasingly diverse and complex, resulting in inefficiencies potential inconsistencies. In light Chemicals Strategy for Sustainability, is therefore timely reasonable to consider how aspects system could be simplified streamlined, without losing hard-earned benefits human health environment. this commentary, we propose a conceptual framework that basis 2.0 - future safety assessment management approach based application New Approach Methodologies (NAMs), mechanistic reasoning cost-benefit considerations. designed more efficient effective assessing chemicals, comply with goal completely replace animal testing, line Directive 2010/63/EU. We five design criteria define what should achieve. centered classification matrix which NAMs toxicodynamics toxicokinetics are used classify according their level concern. An important principle need ensure an equivalent, or higher, protection level.

Language: Английский

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