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
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
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.