INFANT FORMULAE Vasilis Gatzios (Veterinarian MSc) Greek Food Safety Authority (EFET

Infant Formula Product intended for use by infants that simulates human milk or is suitable as a complete or partial substitute for human milk

“Closer than ever to breast milk..” “Just like breast milk...” “That milk make them even more clever..!!”

The Euro-Growth Study of milk feeding (Freeman, van't Hof, Haschke 2000) At the age of I month, 52% of the infants were exclusively breast fed and 26% were exclusively formula fed. At the age of 9 months, 18% of infants were fed only cow's milk. For 60% of European infants - a total of three million children - infant formula feeding starts before six months of age The study found high rates of breast-feeding: in Umea, Sweden, and in Athens, Greece low rates in Dublin, Ireland, in Toulouse, France, and in Glasgow, United Kingdom. The authors concluded that the use of cow's milk as the main milk drink before the age of 12 months is still common in certain European centres.

Infant formula and follow-on formula ‘infant formulae’ means foodstuffs intended for particular nutritional use by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding ‘follow-on formulae’ means foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants

Dir 2006/141 on Infant formula The principal purpose of the legislation is to contribute to the health of infants through mandatory and voluntary provisions, bearing in mind that the encouragement and protection of breast-feeding is an important aspect of health care.

Characteristics of human milk Double lactose and very less proteins than cow milk – need to add sweet flour Recognition of low concentration of protein in BM lead to the use of diluted cow milk Less mortality among infants But poor growth Totally different kind of proteins and amino acids – need to add plant products

Characteristics of human milk To increase caloric density of diluted cow milk, sugar or cereals were added Infants lived and grew Pediatrics became a medical specialty Mortality still remained high Little casein in human milk – infant formulas are based in whey even today Higher levels of sodium and phoshates of cow milk caused dehydration in infants – adding of potassium bicarbonate in 1867

The importance of vitamins was recognized Infant formulas became suitable vehicles Previously common vitamin-deficiency diseases such as scurvy and rickets became less prevalent 300 components (only 75 to infant formulas)

Four types of infant formula in European Union based on cow's milk protein with lactose as the sole carbohydrate based on cow's milk protein with other carbohydrates besides lactose based on soy bean protein isolate (lactose-free or not) based on partially hydrolysed (cleaved) protein (name HA) Cases with history of allergies

Dir 2006/141 on Infant formula Composition (compulsory and voluntary) Nutritional characteristics Safety (pesticides, contaminants, permitted substances, food additives) Microbiological quality (not a sterile product) Labelling

Labels should not discourage breastfeeding. Label should contain the statement "Breastmilk is the best food for your baby" or a similar statement as to the superiority of breastfeeding or breastmilk. Label should contain a statement that the product should only be used on advice of a independent health worker as to the need for its use and the proper method of use. The label shall have no pictures of infants and women nor any other picture or text which idealizes the use of infant formula. The terms "humanized", "maternalized" or other similar terms shall not be used.

Information shall appear on the label to the effect that infants should receive supplemental foods in addition to the formula, from an age that is appropriate for their specific growth and development needs, as advised by an independent health worker, and in any case from the age over six months. The products shall be labelled in such a way as to avoid any risk of confusion between infant formula, follow-up formula, and formula for special medical purposes. No nutrition and health claims shall be made regarding the dietary properties of the product.

Annexes to the Directive (1) Annex I – Essential composition of infant formula Annex II - Essential composition of follow-on formula Annex III – List of nutritional substances that are added Annex IV – Lists of nutrition & health claims permitted Annex V – List of indispensable and conditionally indispensable amino acids in breast milk.

Annexes to the Directive (2) Annex VI – Specification for the protein content and source and the processing for hydrolysates of whey proteins products Annex VII – Nutrition labelling Annex VIII – List of pesticides which shall not be used in agricultural production Annex IX – List of the specific maximum residue levels of pesticides

Composition (Annex I) Infant formulae and follow-on formulae must be manufactured in accordance with strict compositional rules. The sources of protein may only be cows’ milk or soya, however infant milk and follow- on milk may only be from cows’ milk protein. The use of any other protein source, such as goats’ milk, is therefore prohibited.

Proteins (1) Based on the concentrations of amino acids in mature human milk. The majority of infant formulas are based on highly modified cows’ (bovine) milk. Both the protein quantity and protein composition differ between bovine milk and human milk The total protein content of bovine milk is higher than that of mature human milk (3.3g/100ml vs. 1.3g/100ml respectively)

Nucleotides Substances that can be synthesised in the body from amino acids,basis of DNA Important metabolic regulators, involved in energy transfer Necessary to be taken by food during periods of rapid growth or in disease Much more in human milk than in cow milk Maximum 5 mg/100 kcal totally

Fat (1) Fats are also added to supply 50% of the energy in formula milks Usually vegetable oils are used. Also oils from fish and fungal sources The quantity of fat in cows’ milk and human milk is similar, but the component fatty acids are very different. Human milk is higher in unsaturated fats, particularly linoleic and α-linolenic acids. Also contains the long chain polyunsaturated fatty acids (LCPs) arachidonic acid, eicosapentaenoic acid and docosahexaenoic acid

Fat (2) Use of sesame seed oil and cotton seed oil is prohibited Trans fatty acid content shall not exceed 3% of total fat Long chain LCP no more than 1 – 2 % of total fat

Carbohydrate Lactose is found in most infant milks. Alternatively maltose and maltodextrine can be used for infant milks Infant formulas based on soy protein have maltose or glucose polymers added as a source of arbohydrate. Infant milk with glucose sugars is likely to contribute to higher levels of dental decay in infants (used only to hydrolysates protein formulas) Igredients containing gluten are prohibited

Standard Formulas Cow milk altered by Removing the butter fat Adding vegetable oils and carbohydrate Decreasing the protein Adding vitamins, minerals, and other nutrients such as amino acids, fatty acids, nucleotides Whey to casein ratio varies Major whey protein is β-lactoglobulin Major casein protein is bovine  -casein Amino acid profile varies Fatty acids are added

Soy Formulas Indications for use Milk protein intolerance (IGE mediated) Lactose intolerance (rare) Galactosemia Vegetarian diet Not appropriate for preterm infants < 1800 grams d/t risk of osteopenia and growth concerns Hereditary fructose intolerance (contains sucrose)

Protein Hydrolysates Hydrolyzed casein or whey protein Various fat blends All are lactose free

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