Nutrition And Health
An Inseparable Pair
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.
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.
Food supplements are foods – not medicines – and as such they are regulated and subject to all the same rules that are applicable to food products. They are concentrated sources of nutrients or other substances with a nutritional (e.g. vitamins, minerals, etc.) or physiological (e.g. plant extracts, probiotics, etc.) effect, the purpose of which is to supplement a normal diet and contribute to the body’s well-being. They are marketed in pre-dosed forms, i.e. designed to be taken in small measurable quantities to guarantee correct use and the safety of consumers. They usually are presented in the form of tablets, capsules, pills, chewing gum, sachets of powder, vials of liquid, various sized bottles, droppers and other similar forms of liquids and powders.
In terms of health and wellness, supplements are intended to integrate the diet and a correct lifestyle with substances capable of promoting health maintenance, in all stages of life. With the increasing elderly population and the rising costs of national health services, supplements are increasingly seen as a useful resource for improving the quality of life and helping to contain health costs.
Consult the code of ethics
In 2020, the food supplements market had to deal with the lockdown, recording a flattening of sales for physical exercises (-0.0%) after months even of passive, while for e-commerce - pharmacy and parapharmacy – an increase of sales (+ 87.5% in turnover, 260 million €) in terms of sell-out, with peaks evident above all in the weeks preceding the most critical periods - value at the end of the year of approximately 3.9 billion euros - with growth total turnover equal to + 3.2% and + 2.1% for pieces.
Focusing on the pharmacy, according to New Line Market Research data from 2019 to 2020, the context of supplements in the pharmacy channel recorded a certain stability with a + 0.3% in terms of turnover which corresponds to a decrease of -1.4% in terms of pieces and a total value of over 2.9 billion euros. Pharmacies with an overall channel trend with a turnover of -2.2% continue to represent the largest share of the value of the entire sector in absolute terms. The analysis at the category level shows schizophrenic dynamics, with the markets most linked to prevention and mental well-being in great growth (Vitamins + 48%, Immune functions + 70%, Night rest + 23% in turnover). On the other hand, mature markets such as Probiotics and Coughs suffer from the lower incidence of classic flu and the consequent lack of antibiotic treatment with a decrease in value of -9% and -28% respectively.
The research "Knowing and understanding the world of supplements at the time of the COVID-19 emergency" carried out by Kantar in 2021 (1000 interviews with supplement users), highlighted some traits of the world of supplement consumption at this particular time of health emergency.
The photograph shows how most supplement users have a predisposition to healthy lifestyles and a focus on maintaining or improving their psycho-physical well-being. Therefore, supplements do not replace a balanced diet and / or a healthy lifestyle but are instead a support or response to a specific need.
Proof of a conscious choice and often mediated by expert advice is the fact that the pharmacy - 61% buys habitually - and the parapharmacy - 33%, whether they are physical or online stores (buy at the Pharmacy / Parapharmacy website - 22 %), is the chosen place of purchase. Presence, competence and experience of the staff are the drivers of choice for this channel, while convenience, comfort and time savings guide the choice of e-commerce and the GDO channel.
The main components of food supplements are:
- Amino acids
- Essential fatty acids
- Probiotics / prebiotics
- Plants and plant extracts
Food supplements are regulated by Directive 2002/46/EC, implemented in Italy with Legislative Decree 169/2004, and by other national provisions issued by the Ministry of Health. Like all food products, supplements must also comply with European legislation on additives, contaminants, residues of pesticides and veterinary drugs, hygiene, novel food, claims and labelling. Please remember that:
- Food supplements cannot contain pharmacologically active substances.
- The following must appear on food supplement labels:
• The recommended daily dosage
• A warning not to exceed the doses
• Instructions that the product must be kept out of the reach of children
- Supplements, like all food products, cannot claim properties that prevent, treat or cure a human disease (Article 6 of Directive 2002/46/EC).
- Supplements are not intended as substitutes for a varied diet (Article 6 of Directive 2002/46/EC) and therefore must not bear statements that affirm, or imply that a balanced and varied diet is unable to provide a sufficient amount of nutrients (Article 7 of Directive 2002/46/EC).
- Food supplements, unlike other types of food products, are manufactured in factories specifically authorised by the Ministry of Health delegated to the Regions. The list of authorised factories is published on the Ministry website.
- The labels on food supplements must be notified to the Ministry of Health, which verifies the composition, dosages and instructions on the label.
- Supplements which have successfully concluded the notification procedure can be found in the Register published on the Ministry of Health’s website.
As far as efficacy is concerned, food supplements cannot in any way refer to properties that prevent, treat or cure a human disease, but only to nutritional or physiological effects or those which reduce risk factors. Food supplements have to comply with Regulation (EC) 1924/2006 on nutrition and health claims made on foods, which are authorised on the basis of an EFSA evaluation. For substances that have not yet been evaluated at European level, such as plants and plant extracts, the Ministry of Health has regulated their use and relevant health claims (see the portal http://www.salute.gov.it).
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O.T.I. S.R.L. OFFICINE TERAPIE INNOVATIVE - Tiburtina Valeria Km.69,300 - 67061 Carsoli (AQ)
OFTALPHARMA S.R.L. - Via Di Gonfienti 5/C/59 - 59100 Prato (PO)
OLCELLI FARMACEUTICI S.R.L. - Via San Damiano 24/A - 20833 Giussano (MB)
OMEGA PHARMA S.R.L. - Via Milano 129 - 22063 Cantù (CO)
OMIKRON ITALIA S.R.L. - Viale Bruno Buozzi 5 - 00197 Roma (RM)
OMNIA SALUTE & SERVIZI S.R.L. - Via Pietro Gobetti 2 - 63839 Servigliano (FM)
ORTIS S.A. - Hinter Der Heck 46 - 4750 Elsenborn (BE)
PALADIN PHARMA S.P.A. - Via Vincenzo Monti 12A - 10126 Torino (TO)
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
PASQUALI S.R.L. - Viale Belfiore 41 - 50144 Firenze (FI)
PEDIATRICA S.R.L. - Via Aurelio Nicolodi 28/A - 57121 Livorno (LI)
PEDON S.P.A. - Via del Progresso 32 - 36064 Colceresa (VI) - www.pedon.it
PENSA PHARMA S.P.A. - Ippolito Rossellini 12 Milano - 20124 Milano (MI)
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
PERRIGO ITALIA S.R.L. - Viale Dell'Arte 25 - 00144 Roma (RM)
PHARMA LINE - Via Agostino Bertani 2 - 20154 Milano (MI)
PHARMAELLE - Via Borgonuovo 10 - 40125 Bologna (BO)
PHARMALIFE RESEARCH S.R.L. - Via Casa Paradiso 2/A - 23846 Garbagnate Monastero (LC)
PHARMANUTRA S.P.A. - Via Delle Lenze 216/B - 56122 Pisa (PI)
PHARMAXIMA S.R.L. - Piazza Eleonora Duse 2 - 20122 Milano (MI) - www.pharmaxima.it
PHARMEXTRACTA S.P.A. - Via Natta 28 - 29010 Pontenure (PC)
PHOENIX S.R.L. - Via 2 Giugno 60/A1 - 20068 Peschiera Borromeo (MI)
PHYTO GARDA S.R.L. - Europa Unita 1A/4 - 37011 Bardolino (VR)
PHYTOITALIA S.R.L. - Abbadesse, 52 - 20100 Milano (MI)
PIAM FARMACEUTICI - Via Fieschi 8/7 - 16121 Genova (GE) - www.piamfarmaceutici.com
PIERPAOLI EXELYAS S.R.L. - Piazza Del Liberty 8 - 20121 Milano (MI)
PIERRE FABRE ITALIA S.P.A - Via Washington 70 - 20146 Milano (MI)
PIKDARE S.P.A. - Via Saldarini Catelli 10 - 22070 Casnate Con Bernate (CO)
PIZETA PHARMA S.P.A. - Via Roma Loc. Il Piano - 62039 Visso (MC)
POSTBIOTICA - Via Rita Levi Montalcini 2 - 20072 Pieve Emanuele (MI)
PRODECO PHARMA S.R.L. UNIPERSONALE - G. Toniolo 25/1 - 31033 Castelfranco Veneto (TV)
PROFESSIONAL DIETETICS S.P.A. - Via Ciro Menotti 1/A - 20129 Milano (MI)
PROGE FARM S.R.L. - Largo Donegani 4 - 28100 Novara (NO) - www.progefarm.it
PROGOODLIFE S.R.L. - Via Lorenzo Mascheroni 31 - 20145 Milano (MI)
PROTEIN S.A. - Corso Indipendenza 5 - 20129 Milano (MI)
R.E.F. REMISE EN FORME S.R.L. - Di Tor Sapienza 211 - 00155 Roma (RM)
RECORDATI S.P.A. - Via Civitali 1 - 20100 Milano (MI)
REVALFARMA S.R.L. - Via G.Chiarini 129 - 65126 Pescara (PE)
REVIVE S.R.L. - Via Borremei 6 - 20123 Milano (MI)
RIKREA S.R.L. - Via Sorda Sampieri C.da Zappulla Km.6 - 97015 Modica (RG)
RIVER PHARMA S.R.L. - Via Roma, 32 - 20077 Melegnano (MI)
S.I.I.T. S.R.L. - Via Ludovico Ariosto 50/60 - 20090 Trezzano Sul Naviglio (MI)
SAKURA ITALIA S.R.L. - Via Marziale Cerutti 90/C - 25017 Lonato Del Garda (BR)
SALIX S.R.L. - Viale Del Lavoro 14 - 36030 Monte Di Malo (VI)
SAN DEMETRIO S.R.L. - Strada Prov.Le 374, Km 5 - 73040 Specchia (LE)
SANITPHARMA S.R.L. - Viale Papiniano 44 - 20123 Milano (MI)
SANOFI-AVENTIS S.P.A. - Viale L. Bodio 37/B - 20158 Milano (MI) - www.sanofi.it
SCHWABE PHARMA ITALIA S.R.L. - Via Silvio Menestrina 1 - 39044 Egna (BZ)
SIFI S.P.A. - Ercole Patti 36 - 95025 Lavinaio - Aci S.Antonio (CT)
SIGMAR ITALIA S.P.A. - Via Sombreno 11 - 24011 Almè (BG)
SOCHIM INTERNATIONAL S.P.A. - Via Ghisolfa 86 - 20007 Cornaredo (MI)
SOFAR S.P.A. - Via Firenze 40 - 20060 Trezzano Rosa (MI)
SOLGAR ITALIA MULTINUTRIENT S.P.A. - Via Prima Strada 23/3 - 35129 Padova (PD)
STAR INDUSTRIALE S.P.A. - Via Matteotti 142 - 20864 Agrate Brianza (MB) - www.star.it
STARTINGLINE S.P.A. - Via El Alamein 11 - 20014 Nerviano (MI) - www.startingline.it
STEVE JONES S.R.L. - Via Alfieri 8 - 50019 Sesto Fiorentino (FI)
STUDIO 3 FARMA S.R.L. - Via Confin 62/A - 30020 Torre Di Mosto (VE)
SVEBA S.R.L. - Via Dell'Industria 369 - 22070 Cassina Rizzardi (CO)
T.PHARM - Via Consortile 3 3-5 - 03013 Ferentino (FR)
TECNIGEN S.R.L. - Via Galileo Galilei 40 - 20092 Cinisello Balsamo (MI)
TECNO-LIO S.R.L. - Riviera Berica 260 - 36100 Vicenza (VI)
TECNOSOFTGEL DIVISION OF TECNOCOSMESI S.P.A. - Strada Longa 809 29 - 26815 Massalengo (LO)
TEVA ITALIA S.R.L. - Piazzale Luigi Cadorna 4 - 20123 Milano (MI)
TRUFFINI & REGGÈ FARMACEUTICI S.R.L. - Via Oslavia 18 - 20134 Milano (MI) - www.truffini.it
U.G.A. NUTRACEUTICALS S.R.L. - Via Lodovico Pavoni 1 - 20900 Monza (MB)
URIACH ITALY S.R.L. - Centro Direz. Milanofiori Strada 1 - Pal. F6 - 20057 Assago (MI)
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
YAKULT ITALIA S.R.L. - Via Vincenzo Monti 51 - 20123 Milano (MI) - www.yakult.it
ZAMBON ITALIA S.R.L. - Via Lillo Del Duca 10 - 20091 Bresso (MI)
ZENTIVA ITALIA S.R.L. - Via P. Paleocapa 7 - 20121 Milano (MI)
ZETA FARMACEUTICI S.P.A. - Via Mentana, 38 - 36100 Vicenza (VI)