The Italian Ministry of Health has published a new guideline on the use of plants and their parts in food supplements to ensure the safety and protection of consumers. The reason for publishing a new guideline is the use of plant extracts and preparations with increasing concentrations of active ingredients, which are often not permitted in this form in food supplements.
The guideline contains important information for manufacturers who market dietary supplements containing botanicals. The principles for the use of authorized plant preparations are specified. In particular, the novel food issue of botanicals is addressed. Botanicals may only be used if the food business operator can prove the non-novel status through significant consumption history. It is also prescribed that the amount of active substances must be equal to the content that can be achieved by conventional methods. In addition, selectively extracted and purified compounds should not systematically be considered plant extracts. Their status should be reviewed according to the Novel Food Regulation.
Another important aspect concerns the principles for composition, safety, labeling, advertising, and self-monitoring. In particular, it is pointed out that EU-wide regulations must be complied with. The strict distinction between medicinal products and food supplements is pointed out. The use of medical claims, especially allusions to the prevention or treatment of diseases, is strictly prohibited.
If you have any questions about the plant extracts used or if you are unsure whether your product meets the requirements, please contact us and we will check the conformity of your food supplement or individual extracts.