Safety in Cosmetics and Cosmetovigilance, Current Regulations in Türkiye.

IF 1.8 Q3 PHARMACOLOGY & PHARMACY Turkish Journal of Pharmaceutical Sciences Pub Date : 2022-10-31 DOI:10.4274/tjps.galenos.2021.40697
İmran Altıokka, Melike Üner
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引用次数: 1

Abstract

Although it is considered that cosmetics do not have side effects, studies have revealed that a significant number of consumers experience side effects. Undesirable effects arising from the use of cosmetic products have created the need for a reporting and evaluation system, which is responsible for some restrictions on the use of cosmetics ingredients and putting into cosmetic regulation effect, called cosmetovigilance. However, the new cosmetovigilance concept needs some updates to become more effective for public health. For instance, side effects related to cosmetic use have been reported more frequently recently, but this rate is still quite low. Additionally, since the current cosmetic directive does not recognize cosmeceuticals as a distinct category from cosmetics, some products named cosmetic under the laws may affect the bottom layers of dermis and cause systemic side effects. Although the manufacturers must show safety assessments to the Turkish Pharmaceutical and Medical Device Agency to get a license, after launching they do not have post-vigilance reporting to the institution, which is another problem of the system. In this review, the current cosmetovigilance system in Türkiye was discussed and some hardships encountered were criticized regarding the implementation of the system. Additionally, scientific studies are conducted on cosmetic ingredients that can have side effects and contribute to the developing cosmetovigilance concept. Because of the study, the importance of the feedback of healthcare professionals in the cosmetovigilance system, the consultancy service to be given to the consumer and patient about the contents that should be considered. Besides, there is a need for new studies to indicate the adverse reaction incidence related to cosmetics in the Turkish market. Another outcome of this review article is to understand the importance of the new regulations regarding the increase in the new active ingredients in the cosmetic market.

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化妆品的安全与警惕,现行法规在日本。
虽然人们认为化妆品没有副作用,但研究表明,相当多的消费者会出现副作用。由于使用化妆品产生的不良影响,需要建立一个报告和评估系统,该系统负责对化妆品成分的使用进行一些限制并发挥化妆品监管作用,称为化妆品警惕。然而,新的化妆品警惕概念需要一些更新才能对公众健康更有效。例如,与化妆品使用有关的副作用最近被报道得越来越频繁,但这个比率仍然很低。此外,由于目前的化妆品指令没有将药妆品与化妆品区分开来,一些在法律下被命名为化妆品的产品可能会影响真皮层的底层,并导致全身副作用。尽管制造商必须向土耳其制药和医疗器械管理局(Turkish Pharmaceutical and Medical Device Agency)出示安全评估报告才能获得许可证,但在上市后,他们没有向该机构提交警戒后报告,这是该系统的另一个问题。本文对我国现行化妆品警戒制度进行了讨论,并对该制度实施过程中遇到的困难进行了批评。此外,对可能有副作用的化妆品成分进行了科学研究,并有助于发展化妆品警惕概念。由于该研究,医疗保健专业人员的反馈在化妆品警戒系统的重要性,咨询服务应给予消费者和患者有关的内容应考虑。此外,有必要进行新的研究,以表明土耳其市场上与化妆品有关的不良反应发生率。这篇综述文章的另一个结果是了解关于化妆品市场中新活性成分增加的新法规的重要性。
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来源期刊
CiteScore
3.60
自引率
5.90%
发文量
79
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