The Ministry of Health has introduced a new procedure for updating the National Register of Food Supplements, allowing companies to temporarily remove products that are no longer marketed from the Register through the so-called “freeze procedure”. The measure aims to make the Register more reliable and streamline monitoring activities. Companies operating in the sector must…
SAMe disulfate tosylate Novel Food has been classified in the European Union as a new food not yet authorized. The assessment specifically concerns S-adenosyl-L-methionine disulfate tosylate and stems from the lack of sufficient evidence to demonstrate significant food consumption in the EU before 15 May 1997. For companies that produce or market food supplements containing…
The substances under evaluation in food supplements are at the center of several European procedures. Fermented red yeast rice monacolins, berberine, hydroxycitric acid, hydroxyanthracene derivatives, alpha-lipoic acid and green tea catechins are subject to scientific assessments, regulatory procedures or possible new measures. For nutraceutical companies, monitoring these dossiers is essential: a safety assessment can lead…
A clinical study on patients with fatty liver disease reveals how the alkaloid acts on VEGF and blood pressure There’s a plant that researchers struggle to fit into a single category. It acts on blood sugar, on fats, on inflammation, and now it seems to be talking to blood vessels too. It’s called berberine, an…
Monacolins from fermented red rice could be banned in food supplements in the European Union. On 13 May 2026, the SCoPAAF approved a European Commission proposal aimed at banning their use. This is a significant update for manufacturers, distributors and companies in the nutraceutical sector. However, the ban is not yet definitively in force: the…
Regulatory update on red yeast rice monacolins in food supplements. The European Commission is evaluating a possible total ban, with transitional periods of 6 or 12 months. Analysis of timelines, regulatory implications, EFSA’s role and impact on nutraceutical companies. Red yeast rice monacolins are once again at the center of the European regulatory debate. In…
A crucial EU ruling (Case C-589/23) redefines the distinction between medical devices and medicinal products, clarifying when a substance—like D-mannose—exerts a pharmacological action under Directive 2001/83/EC The boundary between “medicinal product” and “medical device” is often subject to divergent interpretations in European markets, especially for so-called borderline products that do not clearly fall under one…
Thank You for Visiting Our Stand The participation of Gruppo Farmaimpresa at Vitafoods Europe 2025, held from May 20 to 22 at Fira Barcelona, has successfully come to an end. This event is one of the most important international gatherings for the nutraceutical industry, and we were proud to share our latest innovations in the…
Looking to simplify the market launch of medical devices, food supplements, and cosmetics? With Gruppo FarmaImpresa, it’s possible Having an innovative idea or a high-quality product is not enough for medical devices, food supplements, or cosmetics. To successfully reach the market, companies must navigate a complex and highly regulated path. In Europe, this process revolves…
How Amla Oil Extract Can Improve General Well-being Amla, also known as Indian gooseberry (Phyllanthus emblica), has been celebrated for centuries in traditional medicine for its numerous health benefits. Over time, scientific research has confirmed many of these benefits, making it a key ingredient in modern nutraceuticals. This small, tangy fruit is packed with vitamins,…