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Etichetta Alimenti

Label evaluation, notification process and other related services

The marketing of a food supplements in Italy is subject to a notification procedure at the Ministry of Health by a Food Business Operator (FBO), duly registered at the Competent Authority. The legislation on these products, regulated partly at European level and partly nationally, also provides for specific requirements for the composition and labelling.

The composition should comply with the general rule that only ingredients and substances with a history of significant consumption in the European Union, such as to ensure their safety, or that were previously authorised as novel foods, can be used in these products.

In particular, the composition of a food supplement can include nutrients such as vitamins and minerals, amino acids, other substances with a nutritional or physiological effect such as ialuronic acid or collagen, botanical extracts and preparations, prebiotics and probiotics, as well as additives.

Vitamins and minerals, and the relevant admitted forms that can be used, are defined by European regulations, while the admitted quantities are defined nationally.

In Italy, for ingredients of herbal origins (so called botanicals) and other nutritional substances, it is possible to refer to specific lists reporting warnings and/or indications to be stated in the label for each ingredient, as well as use restrictions and intake limitations. Moreover, for botanicals the information regarding the botanical name and the admitted parts of the plants is also included.

Additives than can be used in food supplements are also regulated by specific regulations attributing to each substance an E number acknowledged at European level.

Additives legislation also provides for a list of additives that are admitted for solid supplements and one for those in liquid form, reporting the maximum limits permitted as well as any restrictions or exceptions.

The labelling of food supplements should also comply with the regulations.

Without prejudice to the general legal requirements on food supplements providing for mandatory minimum information the labelling should also report the title «food supplement» or other synonyms as well as some specific wordings and warnings.

In addition, the label can include other optional information, such as nutritional and health indications regulated by the European Regulation (EC) no. 1924/2006, or the physiological effects provided for by the national lists.

The main services offered in this field are:

  • assistance for food supplements
  • assistance for Foods for Specific Group (FSG), including foods for special medical purposes
  • assistance for novel foods
  • assessment of the conformity to the labelling and composition regulations
  • assistance for health and nutritional claims
  • notification procedure at the Italian Ministry of Health
  • support in the notification procedures for the marketing in most EU countries and some extra-EU countries
  • preparation of a scientific rationale for supplements containing herbal preparations (botanicals)
  • assistance for the organic certification of food supplements
  • packaging graphic design