Vojvodić Slađana, Kobiljski Dunja, Srđenović Čonić Branislava, Torović Ljilja
Department of Pharmacy, Faculty of Medicine, University of Novi Sad, Hajduk Veljkova 3, 21000 Novi Sad, Serbia.
Department of Industrial Engineering and Management, Faculty of Technical Sciences, University of Novi Sad, Trg Dositeja Obradovića 6, 21000 Novi Sad, Serbia.
Nutrients. 2025 May 2;17(9):1571. doi: 10.3390/nu17091571.
: Health and nutrition are increasingly important to people, which has increased the popularity of products promoted for their contribution to health, such as food supplements. : This study encompassed 87 herbal food supplements, assessing the compliance of health claims with regulatory requirements. The study was conducted in Serbia, a European country with a regulatory framework harmonized with the one in the EU; however, it requires the pre-market registration of supplements. : Health claims were listed on as many as 86.2% of the labels, but only 10.7% of them, all associated with vitamin and mineral ingredients, were compliant with the EU Register of authorized health claims. An additional 38.7% of supplements carried "on-hold" claims from the EFSA Register of questions for botanicals. The remaining ones (50.6%) comprised those attributed with strictly prohibited properties of disease prevention, treatment, or cure (9.3%), and those containing at least one botanical-related health claim out of the scope of the Register of questions. : The study unequivocally showed the worrying lack of adherence to regulations in the Serbian settings. Considering the importance of labelling for consumer protection and public health, the authors of this paper advocate for significant improvement in quality assurance of the registration process, tightening of market control, and an effective solution for on-hold claims on botanicals continuously used under transitional regulatory measures.
健康和营养对人们越来越重要,这使得那些宣传对健康有益的产品,如食品补充剂,越来越受欢迎。本研究涵盖了87种草药食品补充剂,评估了健康声称与监管要求的合规性。该研究在塞尔维亚进行,塞尔维亚是一个欧洲国家,其监管框架与欧盟的框架协调一致;然而,它要求补充剂进行上市前注册。多达86.2%的标签上列出了健康声称,但其中只有10.7%符合欧盟授权健康声称登记册的要求,且所有这些都与维生素和矿物质成分有关。另外38.7%的补充剂带有欧洲食品安全局植物药问题登记册中的“待决”声称。其余的(50.6%)包括那些具有严格禁止的疾病预防、治疗或治愈属性的声称(9.3%),以及那些包含至少一项超出问题登记册范围的与植物药相关的健康声称。该研究明确表明,塞尔维亚的情况令人担忧地缺乏对法规的遵守。考虑到标签对于消费者保护和公众健康的重要性,本文作者主张大幅改进注册过程的质量保证,加强市场监管,并为在过渡性监管措施下持续使用的植物药的待决声称找到有效解决方案。