Transcript Infant formula legislation

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.
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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
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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
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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
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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 followon 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
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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
THANK YOU!!