Specialized Nutrition

Infant and young children products
These products are specifically intended for infants (under 12 months old) and young children (1 to 3 years old).
These foods include:
- “Infant formulae”: food intended for use by infants during the first months of life and fully satisfying the nutritional requirements of such infants until the introduction of appropriate complementary feeding. In the event that breastfeeding is not possible, “infant formulae” are the only products that, on the advice of a paediatrician, can be used as substitutes, although the product labels must bear a statement declaring the superiority of breastfeeding.

- “Follow-on formulae”: food used by infants (from six months) when appropriate complementary feeding is introduced and constituting the principal liquid element in an infant’s progressively diversified diet.
Infant formulae and follow-on formulae, ruled by Directive 2006/141/EC, implemented with Decree Apr. 9th, 2009 no. 82. The new Delegated Regulation 2016/127 has applied from 22 February 2020, except in respect of infant formula and follow-on formula manufactured from protein hydrolysates, to which it shall apply from 22 February 2021.

- Baby foods also include “growing-up milks”, milk-based drinks for young children aged 1-3 years; notification of these products must be made to the Ministry of Health pursuant to EC Regulation 1925/2006.

- Cereal-based foods and baby foods for infants and young children are ruled by Directive 2006/125/EC, which codified Directive 96/5/EC (implemented with the current DPR 128/1999). These foods are intended to fulfil the particular requirements both of infants while they are being weaned, and of young children as a supplement to their diet and/or for their progressive adaptation to ordinary food. Infants have specific nutritional needs, both for their immature organs and organ systems, with consequent exposure to greater metabolic, biological and toxicological risks, and for nutrient requirements per pound of body weight, which are proportionally higher than at any other time in the life cycle and thereby increases the risk of exposure to contaminants, which is 25 times higher than that in adults.

For these reasons, the quantities of some substances in baby food products are regulated by specific regulations: to protect infants and children, the law sets maximum levels for certain contaminants in food products (EC Regulation 1881/2006), establishing the lowest maximum levels which are achievable through a strict selection of the raw materials used for the manufacturing of foods for infants and young children. Based on same considerations made for contaminants, the use of additives is also very strictly regulated at European level, and only permits a very limited number of additives at a low level compared to foods intended for the general population. EU Regulation 1129/2011 specifies the additives and maximum quantities that can be used in infant and young children products.

Consult the code of ethics

Foods for special medical purposes
“Foods for special medical purposes” are foods for specific groups pursuant to Regulation (EU) 609/2013 and are ruled by Regulation (EU) 2016/128, which complement Regulation (EU) no. 609/2013 as regards the specific compositional and information requirements for food for special medical purposes. Regulation (EU) 609/2013 defines FSMPs as “…. food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone.”
Ultimately, these products are intended for the dietary management of individuals who suffer from certain diseases, disorders or medical conditions that determine nutritional vulnerability, that is, the impossibility or severe difficulty of eating normal foods, including food supplements, to meet nutritional requirements.

Below are some examples of these products:

- A product administered with a nasogastric tube for feeding stroke patients who cannot swallow (nutritionally complete food - standard nutrient formulation) or patients who have undergone gastric or bowel resection.
- An amino acid-based formula intended for the dietary management of children suffering from maple syrup urine disease (MSUD) (nutritionally complete food - adapted to the disease). - A high vitamin A product for the dietary management of cystic fibrosis (nutritionally incomplete food - adapted to the disease).
- A product with a high glutamine content for the diet of patients with severe burns (nutritionally incomplete - adapted to the disease).

Consult the code of ethics

Food for people with a gluten intolerance / coeliac disease
The terms “gluten-free” and “very low gluten” in food labelling are ruled by Regulation (EU) 828/2014 as information provided on a voluntary basis pursuant to Article 36 of Regulation (EU) 1169/2011.

When a food is specifically formulated for people with coeliac disease to replace foods containing cereals that contain gluten, the information on the absence or reduced presence of gluten may be accompanied by the statements “specifically formulated for people intolerant to gluten” or “specifically formulated for coeliacs”.

For foods made with gluten-free ingredients that are not specifically formulated for coeliacs, without prejudice to Article 7 of Regulation (EU) 1169/2011, only the statement “gluten-free” is permitted as additional information, and may be accompanied by the statements “suitable for people intolerant to gluten” or “suitable for coeliacs”.

Foods for weight reduction
- Total diet replacements for weight control
EU Regulation 2017/1798 regards the specific compositional and information requirements for total diet replacement for weight control and shall apply from 27 October 2022. Until that date, in Italy VLCD products (Very Low Calorie Diet: <800 daily calories) remain classified as FSMPs. With the new Regulation, the European Commission has adopted specific requirements regarding the composition and information for these products, formulated specifically for obese or overweight adults in good health, as part of low-calorie diets aimed at reducing weight.

- Meal replacements for weight control (energy value between 200 and 250 calories).
These are normal foods governed by Regulation (EC) 1925/2006 on the addition of vitamins and minerals to foods. As regards the claims, Regulation (EU) 2016/1413 applies, which provides information on the energy value, fat content and composition, protein content and composition, vitamins and minerals. Notification of these products must be made to the Ministry of Health according to EC Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.

Sports foods
Sports foods are mainly normal products, possibly enriched, or food supplements, and can be classified in 4 categories:

- “Energy products”, which provide energy mainly through carbohydrates, fall within the scope of EC Regulation 1925/2006 due to the presence of vitamins.
- “Protein-amino acid supplements to maintain nitrogen balance” can fall under Directive 2002/46/EC on supplements or, in the case of energy and/or high-protein bars containing vitamins and minerals, under EC Regulation 1925/2006.
- “Products formulated to replenish fluid-sodium losses resulting from prolonged sweating”: in EU regulation 432/2012 these come under “carbohydrate-electrolyte solutions” with the relative authorised claim on the replacement of fluid-sodium losses.
- “Other specifically adapted products”, which come under different regulatory areas based on their composition.