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纳米载体作为化妆品行业的活性成分增效剂——欧美法规面临的挑战。

Nanocarriers as Active Ingredients Enhancers in the Cosmetic Industry-The European and North America Regulation Challenges.

机构信息

CEB-Center of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057 Braga, Portugal.

LABBELS-Associate Laboratory, Braga/Guimarães, 4710-057 Guimarães, Portugal.

出版信息

Molecules. 2022 Mar 3;27(5):1669. doi: 10.3390/molecules27051669.

Abstract

"Flawless skin is the most universally desired human feature" is an iconic statement by Desmond Morris. Skin indicates one´s health and is so important that it affects a person's emotional and psychological behavior, these facts having propelled the development of the cosmetics industry. It is estimated that in 2023, this industry will achieve more than 800 billion dollars. This boost is due to the development of new cosmetic formulations based on nanotechnology. Nanocarriers have been able to solve problems related to active ingredients regarding their solubility, poor stability, and release. Even though nanocarriers have evident benefits, they also present some problems related to the high cost, low shelf life, and toxicity. Regulation and legislation are two controversial topics regarding the use of nanotechnology in the field of cosmetics. In this area, the U.S. FDA has taken the lead and recommended several biosafety studies and post-market safety evaluations. The lack of a global definition that identifies nanomaterials as a cosmetic ingredient is a hindrance to the development of global legislation. In the EU, the legislation regarding the biosafety of nanomaterials in cosmetics is stricter. "The cost is not the only important issue, safety and the application of alternative testing methods for toxicity are of crucial importance as well".

摘要

德斯蒙德·莫里斯曾说过:“完美无瑕的肌肤是人类最渴望拥有的特征”。皮肤状况反映了一个人的健康状况,其重要性不言而喻,甚至会影响一个人的情绪和心理行为,正是这些因素推动了化妆品行业的发展。据估计,2023 年,该行业的销售额将超过 8000 亿美元。推动这一增长的原因是基于纳米技术的新型化妆品配方的发展。纳米载体能够解决与活性成分的溶解度、稳定性和释放相关的问题。尽管纳米载体具有明显的优势,但它们也存在一些问题,如成本高、保质期短和毒性。关于纳米技术在化妆品领域的应用,法规和立法是两个有争议的话题。在这一领域,美国食品和药物管理局(FDA)率先采取行动,建议进行多项生物安全研究和上市后安全性评估。缺乏将纳米材料定义为化妆品成分的全球标准,这阻碍了全球立法的发展。在欧盟,有关化妆品中纳米材料生物安全性的立法更加严格。“成本并不是唯一重要的问题,安全性和毒性替代测试方法的应用也至关重要”。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7acc/8911847/3e3c49ac8ad6/molecules-27-01669-g001.jpg

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