For Every Specific Requirement
President: Paolo CASONI - PERFETTI VAN MELLE S.p.A. Secretary: Anna PAONESSA
Throughout life, specialised nutrition provides protection and nutritional support when people need it most: when they are vulnerable or sick, or when they have special dietary needs that foods for general consumption cannot meet.
Specialised nutrition products help people eat properly while meeting to their specific needs, and are aimed at infants and young children, patients under medical supervision, overweight and obese consumers, people with gluten intolerance or coeliac disease and athletes.
90% of Europeans will use a specialised nutrition product at some point in their lives, and in many cases these foods will be their only source of nutrition:
- 70% of babies in Europe are fed infant formula before they are 6 months old: infant formulae are the only suitable alternative for infants whose mothers are unable, or unwilling, to breastfeed.
- 20 million people are at risk of malnutrition in the European Union, including 25% of hospital patients: Food for special medical purposes (FSMP) provides vital nutritional support to patients, from childhood to old age.
- About 25% of people try to maintain a healthy weight: special slimming and diet products help people lose and maintain weight safely, avoiding the dangers of extreme diets.
- About 5 million Europeans suffer from gluten intolerance or an autoimmune disease known as coeliac disease: specifically gluten free products help these people manage their condition and enjoy a wide range of foods that are an alternative to those that normally contain gluten.
- Sport is part of a healthy lifestyle and is practiced by millions of Europeans: sports foods provide professional and amateur athletes with the necessary nutrients before, during and after physical activity, in a form that is adapted to their needs and the time they eat it.
In 2021, foods for specialized nutrition totaled a turnover of 929.3 million euros with a + 2.7% on 2020. This includes food for special medical purposes, which totalled 172 million euros - up to -0.6% on the previous year, those for athletes and the so-called "slimming", with a total value of about 60 million euros, as well as gluten-free products specifically formulated for celiacs, which have come to represent a market of over 700 million that includes a wide range of products suitable to guarantee intolerant people or those suffering from an autoimmune disease known as celiac disease the possibility of eating properly and safely according to their specific needs. In substantial stability over 2020, the market for early childhood products reached a value of 292.8 million euros in 2021. These are products formulated to meet specific nutritional needs and that guarantee safety in a phase of high vulnerability, namely that of growth from the first months up to the first three years of life. In detail, milk saw the best performance on the basic segments, which with 75.5 million euros up 1.8% on 2020, is worth 26% of the sector. This is an incidence that is not surprising when we consider that infant formulas represent the only suitable alternative for babies whose mothers are unable or choose not to breastfeed and that in Europe 70% of babies before 6 months of age are fed with artificial milk.
CODES OF ETHICS
Infant and young children products
Code of Ethics for “Infant and young children products” (July 2021)
Foods for special medical purposes
Code of Ethics for “Foods for special medical purposes”
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Categories And Regulations
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 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.
A. MENARINI Industrie Farmaceutiche Riunite S.R.L. - Via Sette Santi 3 - 50131 Firenze (FI) - www.menarini.it;
A&D S.P.A. – GRUPPO ALIMENTARE E DIETETICO - Strada 2 Palazzo C1 - 20057 Assago-Mirafiori (MI) - www.matt.it;
ABBOTT S.R.L. - Viale Giorgio Ribotta 9 - 00144 Roma (RM) - www.it.abbott
ALFASIGMA S.P.A. - Via Ragazzi del '99 5 - 40133 Bologna (BO) - it.alfasigma.com
ALPIPAN S.R.L. - Via Provinciale Romana 18/D - Loc. Palandri - 55011 Altopascio (LU) - www.alpipan.com
APR APPLIED PHARMA RESEARCH - ITALY S.R.L. - Corso Vittorio Emanuele II 154 - 00186 Roma (RM)
B. BRAUN MILANO S.P.A. - Via Vincenzo da Seregno 14 - 20161 Milano (MI) - www.bbraun.it
DANONE NUTRICIA S.p.A. SOCIETÀ BENEFIT. - Via Farini 41 - 20159 Milano (MI) - www.nutricia.it
DIALCOS S.P.A. - Via Vittorio Veneto 27 - 35020 Due Carrare (PD) - www.dialcos.it
DIFA COOPER S.P.A. - Via Milano 160 - 21042 Caronno Pertusella (VA) - www.deutera.com
DIFASS INTERNATIONAL S.R.L. - Via Ausa 181 - Loc. Cerasolo - 47853 Coriano (RN) - www.difass.com;
DMF DIETETIC METABOLIC FOOD S.R.L. - Via Mazzini 13 - 20812 LIMBIATE (MB) - www.dmfmetabolic.it
DR. SCHÄR S.P.A. - Via Winkelau 5 - 39014 Postal (BZ) - www.drschaer.com/it
ENERVIT S.P.A. - Località Pian del Tivano - 22020 Zelbio (CO) - www.enervit.com
EUROSPITAL S.P.A. - Via Flavia 122 - 34147 Trieste (TS);
EUROVO S.R.L. - Via Mensa 3 - 48022 Lugo (RA) - www.eurovo.com
FARMACEUTICI DAMOR S.P.A. - Via Emilio Scaglione 27 - 80145 Napoli (NA) - www.farmadamor.it;
FARMACEUTICI PROCEMSA S.P.A. - Via Mentana 10 - 10042 Nichelino (TO) - www.procemsa.it
FARMO S.P.A. - Via Fetonte 12 - 20151 Milano (MI) - www.farmo.com
FINE FOODS NTM S.P.A. - Via Berlino 39 - Zingonia - 24040 verdellino (BG) - www.finefoods.it
FRESENIUS KABI ITALIA S.R.L. - Via Camagre 41 - 37063 Isola Della Scala (VR) - www.fresenius-kabi.com/it
GRUPPO LACTALIS ITALIA S.P.A. - Via Flavio Gioia 8 - 20149 Milano (MI) - www.gruppolactalisitalia.com
HALEON S.R.L. - Via Monte Rosa 91 - 20149 Milano (MI) - www.gsk.it;
HEINZ ITALIA S.P.A. - Via Cascina Belcasule 7 - 20141 Milano (MI) - www.heinz.it
HERBALIFE ITALIA S.P.A. - Via Idiomi 1/39 - 20090 Assago (MI) - www.herbalife.it
HUMANA ITALIA S.P.A. - Viale Liguria 22/A - 20143 Milano www.humana.it
LA CESENATE CONSERVE ALIMENTARI S.p.A. - Via Cervese 364 - 47521 Cesena (FC) - www.lacesenate.it
LARN S.R.L. - Via Fabbriche 18 - 15069 Serravalle Scrivia (AL) - www.larnsrl.it;
MONTEFARMACO OTC S.P.A. - Via IV Novembre 92 - 20021 Bollate (MI) - www.montefarmaco.com
NESTLÈ ITALIANA S.P.A. - Via del Mulino 6 - 20090 Assago (MI) - www.nestle.it
NT FOOD S.P.A. - Via della Galeotta Loc. Tei 6/C - 55011 Altopascio (LU) - www.ntfood.it
NUTRITION & SANTÈ S.P.A. - Largo Umberto Boccioni 1 - 21040 Origgio (VA) - www.nutritionetsante.com
PANIFICIO CREMONA ITALIA S.R.L. - Via della Repubblica 6-6° - Frazione Levata - 26044 Grontardo (CR) - www.panificiocremona.it
PANIFICIO ZORZI S.R.L. - Località Bra 1 - 37020 Brentino Belluno (VR) - www.panificiozorzi.com
PARMALAT S.P.A. - Via delle Nazioni Unite 4 - 43044 Collecchio (PR) - www.parmalat.it
PEDON S.P.A. - Via del Progresso 32 - 36064 Colceresa (VI) - www.pedon.it
PEPSICO BEVERAGES ITALIA S.R.L. - Via del Bosco Rinnovato, 8 - edificio U4 - 20057 Assago (MI) - www.pepsico.co.it
PERFETTI VAN MELLE S.P.A. - Via XXV Aprile 7 - 20020 Lainate MI - www.perfettivanmelle.com
PIAM FARMACEUTICI - Via Fieschi 8/7 - 16121 Genova (GE) - www.piamfarmaceutici.com
PROGE FARM S.R.L. - Largo Donegani 4 - 28100 Novara (NO) - www.progefarm.it
SIGMAR ITALIA S.P.A. - Via Sombreno 11 - 24011 Almè (BG)
SOCHIM INTERNATIONAL S.P.A. - Via Ghisolfa 86 - 20007 Cornaredo (MI) - www.sochim.it;
TRENTOFRUTTA S.P.A. - Via A. Degasperi 130 - 38100 Trento (TN) - www.trentofrutta.com/it
TRUFFINI & REGGÈ FARMACEUTICI S.R.L. - Via Oslavia 18 - 20134 Milano (MI) - www.truffini.it
VALSOIA S.P.A. - Via Ilio Barontini 16/5 - 40138 Bologna BO - www.valsoia.it
VIBAR NORD S.P.A. - Via Al Boscone 16 - Frazione Curcio - 23823 Colico (LC) - www.vibarnord.com