Italy just published a new Decree which includes a new list of botanicals allowed in food supplements. The Decree also includes guidelines that ensure compliance of botanicals in terms of quality and safety. This Decree will take effect on the 10th December 2018.
The use of botanicals in food supplements among Members States is already a complex business. With this decision from the Italian Ministry of Health, Italy becomes a stand-alone market for some food supplements containing botanicals. This decision might support innovation in this product category, but it will make it more difficult for Italian companies to enter other EU countries with certain botanicals in food supplements. Also, companies that want to bring botanical-containing products as food supplements that do not comply with the provisions of this decree into the Italian market will now have to provide proof of marketability in another EU country, as well as proof that these botanicals are not considered Novel Food according to Regulation (EU) 2015/2283.
The decree also contains guidance on a document each notifier of a herbal supplement has to provide to the Authority upon request. The document should contain data on the identification, preparation and stability of the herbal ingredient.
Outside Italy, food supplement manufacturers may want to follow the plant lists from France or Belgium when considering applying for Mutual Recognition with their products, as this may increase their chances to have their products approved in more EU markets.