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欧盟RAPEX系统及国家监测对纹身相关不良事件的监测。

Surveillance of tattoo-related adverse events by the EU RAPEX system and by national monitoring.

作者信息

Verdier Cécile

机构信息

Non-Clinical Assessor, Industrial Biology Engineer and Master Degree in Toxicology, Marines, France.

出版信息

Curr Probl Dermatol. 2015;48:210-7. doi: 10.1159/000369230. Epub 2015 Mar 26.

DOI:10.1159/000369230
PMID:25833647
Abstract

A resolution of the Council of Europe in 2008 (ResAP (2008)1) helped to define requirements and criteria for the safety of tattoos and permanent make-up in order to increase the level of consumer health protection for these products. Tattoo product usage is not without risk. These products are injected into the skin and may represent a risk to human health due to possible microbiological contamination and/or contamination by the presence of hazardous substances in the products. ResAP (2008) laid the foundation for the safety of tattoo products in Europe. This has generated awareness by European Member States and has encouraged them to adapt this resolution in their own law or to use it as a model to define their own regulation on tattoos. In order, to communicate on the hazard associated with these products between Member States and the European Commission, the European RAPEX system was created; this system will be further explained in this article. Finally, some Member States have created a specific vigilance system related to the adverse effects of tattoos. In this respect, a European national example will be presented.

摘要

2008年欧洲委员会的一项决议(ResAP (2008)1)有助于明确纹身和纹眉产品安全性的要求及标准,以提高对这些产品消费者健康的保护水平。纹身产品的使用并非毫无风险。这些产品被注入皮肤,由于可能存在的微生物污染和/或产品中有害物质的污染,可能对人体健康构成风险。ResAP (2008)为欧洲纹身产品的安全奠定了基础。这提高了欧洲成员国的认识,并鼓励它们将该决议纳入本国法律,或以此为范本制定本国的纹身监管规定。为了在成员国和欧盟委员会之间就这些产品所涉危害进行沟通,创建了欧洲RAPEX系统;本文将进一步介绍该系统。最后,一些成员国建立了与纹身不良反应相关的特定警戒系统。在这方面,将介绍一个欧洲国家的实例。

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