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Know the procedure for food supplements notification in Italy: Know its regulations, its notification procedure and processing requirements.

Italy is one of the countries of the European Union that, as Belgium or France, has widely develop Food supplements regulations. What's more, not only has it developed it, but it constantly updates it.

Specifically, Italy has developed several Ministerial Guidelines (LGM), which contain provisions applicable to food supplements in aspects not harmonized at European level as provided for in article 5 of Legislative Decree 169/2004: "Supply of vitamins, minerals and other substances", and which fall into the following sections:

1. Vegetable substances (botanicals) and preparations.

2. Vitamins and minerals.

3. Probiotics and prebiotics.

4. Other substances with nutritional or physiological effect, other than botanical substances.

Regarding the use of plant extracts and preparations (so-called botanicals) in food supplements, it is currently regulated by the Ministerial Decree of August 10, 2018. This list is applicable only to plants/plant parts and their derivatives (for example, extracts or other preparations) with a history of significant food consumption before 1997. Otherwise, that is, substances, preparations and extracts obtained from plants but without a mentioned consumption history, are configured as novel foods according to Regulation (EU) 2015 /2283 and therefore cannot be used without prior authorization from the EU. This Ministerial guideline includes the plants and plant preparations that can be used in supplements marketed in the Italian market, establishing the part of the plant that can be used and establishing, in some cases, various safety warnings that must be incorporated into the labeling of the products.

Regarding vitamins and minerals, Italy sets maximum limits for vitamins and minerals, also establishing, as in the case of botanicals, certain safety warnings that must be indicated on the labeling of those products that contain the vitamins and/or minerals that are affected. In addition, Italy requires that the amount of vitamins and minerals used in food supplements reach at least 15% of their NRV (Nutrient Reference Value).

Regarding probiotics, this term is reserved for those microorganisms that are capable, once ingested in adequate quantities, of performing beneficial functions for the body. In this sense, by probiotic supplements, we refer to those products that contain, in sufficiently high quantities, live and active probiotic microorganisms, capable of reaching the intestine, multiplying and exerting a balancing action on the intestinal microflora through direct colonization. These are, therefore, products capable of promoting and improving the physiological balance functions of the body through a set of additional effects with respect to normal nutritional activities.

The definition of prebiotic is reserved for non-digestible substances of food origin that, taken in adequate quantities, selectively promote the growth and activity of one or more bacteria already present in the intestinal tract or taken together with the prebiotic. In this sense, the term food supplements with prebiotics refers to those products that contain adequate amounts of prebiotic molecules capable of promoting the development of bacterial groups useful to humans.

The Italian guide that regulates probiotics and prebiotics in food supplements available in the Italian market, includes specific provisions for these substances with a physiological effect and was updated by the Dietetics and Nutrition section of the Technical Committee on Nutrition and Animal Health in January 2018.

Italy has also developed a non-exhaustive list of other nutrients and other substances with nutritional or physiological effect that includes nutrients other than vitamins and minerals and other substances with nutritional or physiological effect permitted for use in food supplements. Where established, permitted intake limits with daily dosage and additional warnings are also indicated. It should be noted that for substances not included on the list, use is allowed if they have a significant history of consumption, such as to argue in favor of safety. Otherwise, it will be a novel food as regulated in Regulation (EU) 2015/2283 on novel foods.

Therefore, it turns out that the composition and labeling of a food supplement that wants to be marketed on the Italian market must respect and take into account the extensive applicable regulations, as well as take into account the legislative and regulatory developments regarding food supplements, in a manner that the food information provided to consumers complies with all of this.

Regarding the notification procedure for food supplements in Italy, it should be noted that it is an online procedure through a platform called NSIS, in which the operator must first request the access. Once these are available, the notification process can begin, in which it will be necessary to indicate all the relevant and detailed data related to the composition of the product, such as exhaustive information on plants (having to indicate both the botanical name as part of the plant used as a type of preparation), as well as the presence and content of certain active substances of interest in said food supplement; and other nutrients indicating their sources and quantities.

An important issue that must be taken into account in the notification procedure for food supplements in Italy is that a notification fee of 160.2 euros Will be required, with the peculiarity that in the case of a product that is present in several flavors will require the payment of a fee for each flavor, unless the only difference between the flavors lies only in the use of different aromas. For example, the same product that is presented in strawberry, cocoa and vanilla flavors where strawberry, cocoa or caramel is added depending on the flavor, will be considered as different products and will entail the payment of 3 different fees for notification.

It is therefore very important to be up to date with the legislative developments that affect the regulations on food supplements in Italy, and/or to have legal advice specialized in the composition and labeling revision  of food supplements, so that operators can develop formulas and labeling for their products that result in successful notification files that allow them to market safe products.

At LexSupplements Food Legal Consulting we are up to date and specialized in food regulations and the notification procedure for food supplements in Italy to guarantee that our clients develop safe formulas and correct labeling that comply with the legal regulations applicable to the food supplements they market.

We carry out the composition review, labeling review, and subsequent notification of placing on the market before the competent Health Authority of Italy (Ministero della Salute). We also carry out the revision and notification of food supplements in other EU countries such as Spain, Belgium, French, Germany, Ireland, Portugal or Malta. 

Do not hesitate to contact us if you need further information. 


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