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image of Dermocosmetic Bioactive: Safety Assessment and Regulatory Challenges

Abstract

Introduction

The increasing demand for scientifically validated dermocosmetic products has led to the convergence of cosmetic and pharmaceutical functionalities, requiring robust safety and regulatory oversight. This review explores the global regulatory landscape and safety considerations for dermocosmetic bioactives, emphasizing emerging technologies such as nanotechnology and AI.

Methods

A comprehensive literature review was conducted using PubMed and Google Scholar. Regulatory frameworks from the EU, US, and India were compared, focusing on classification, approval processes, and safety assessments. Additionally, current and emerging testing methodologies, including in vitro, ex vivo, and AI-driven predictive toxicology, were evaluated.

Results

Significant disparities were identified in global regulatory frameworks, especially in defining and regulating cosmeceuticals. The EU mandates pre-market safety assessments and labeling, while the US adopts a more lenient approach unless therapeutic claims are made. India's evolving framework lacks clarity for cosmeceuticals, complicating market entry. Emerging tools like QSAR models, nanocarriers, and virtual clinical trials are underutilized due to limited regulatory acceptance.

Discussion

Harmonization of global regulations and integration of AI-based safety evaluation methods remain critical. The current lack of standardization in regulatory protocols delays innovation and increases development costs. Advances in nanotechnology and machine learning offer potential but require validation and alignment with international guidelines.

Conclusion

Regulatory reform, international harmonization, and adoption of advanced technologies are essential for ensuring the safety and efficacy of dermocosmetic bioactives. A unified approach will support innovation while maintaining consumer safety.

© 2025 Bentham Science Publishers
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2025-05-21
2025-11-06

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/content/journals/cds/10.2174/0115748863360706250508050957
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Dermocosmetic Bioactive: Safety Assessment and Regulatory Challenges
Bentham Science Publishers ; https://doi.org/10.2174/0115748863360706250508050957
/content/journals/cds/10.2174/0115748863360706250508050957
/content/journals/cds/10.2174/0115748863360706250508050957
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  • Article Type:     Review Article
Keywords: skincare ; nanotechnology ; cosmetic ; cosmeceuticals ; safety and efficacy assessment ; artificial intelligence ; Regulations ; predictive toxicology

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