Following the discussions on mothers who decide to breastfeed and bottlefeed,
I thought about the need to educate our communities about the importance of
exclusive breastfeeding and the risks of infant formula.  Looking at the
various patents for infant formula at the US Patent Office, I think reading
them out loud or printing them may have some effect on people and their
perception of infant formula being without risk.  So in the spirit of the
season of gifts here is a gift for any and all to copy. This is patent #
6039985 called "Refrigeration-shelf-stable ultra-pasteruized or pasteurized
infant formula"--to view http://www.uspto.gov/patft/index.html then click on
blue number and type the number.  Happy New Year!  Valerie W. McClain, IBCLC

Refrigeration-shelf-stable ultra-pasteurized or pasteurized infant formula

BACKGROUND OF THE INVENTION

Infant formula is used as a supplement to or substitute for breast milk when
a mother cannot or does not want to breast feed her infant. Ideally, the
composition of the infant formula would be exactly the same as the
composition of human milk. Nonetheless, because infant formulas are typically
made with cow milk (and sometimes soy protein), on a molecular level, these
formulas are not the same as human milk. Nonetheless, infant formulas are
designed to mimic the formulation of human milk as much as possible.
Furthermore, infant formulas should contain nutrients as listed by the U.S.
Code of Federal Regulations, 21 CFR 107.100, 1998, as presented in Table 1.
The resultant infant formulas can be called "humanized milk", "simulated
human milk", "simulated mother milk", "simulated breast milk" and "infant
nutritional formula".

An infant formula which contains all the essential macronutrients and
micronutrients, have heretofore been available only in shelf-stable
sterilized products. Sterilized products are generally sold in hermetically
sealed containers such as cans and are intended to have a long room
temperature shelf-life. Table 2 lists several commercially available
shelf-stable sterilized infant formulas. Such formulas require expensive
processing steps which must be carefully controlled to properly remove
microorganisms and bacterial enzymes. As will be discussed further herein,
sterilization processes, due to the severity of the heat treatment can cause
undesirable physical, chemical, enzymatic and microbial changes which
deleteriously affect the final product.

Moreover, although such sterilized products are often marketed as
"ready-to-feed" (RTF), they are typically stored at room temperature, and
enzymatic reactions still occur, albeit slower, during room temperature
storage of sterilized products. Such reactions can result in a host of
undesirable defects, such as the destruction of vitamins which are necessary
to the integrity of the overall product. Since sterilized products are
designed to have up to one and a half (11/2) year of room temperature
shelf-life, such products will have a different actual content of degradable
micro nutrients (vitamins) in the early part of its shelf-life as compared to
the latter part. Thus, an infant will obtain a different and unknown amount
of vitamins depending on when the sterilized product is consumed.

To account for this degradative process during long-term shelf-life,
manufacturers of sterilized infant formulas often include up to 50% to 70%
more of a given vitamin than would normally be included to account for the
inherent degradation loss and to ensure the product is likely to contain at
least the labeled amount of nutrients at the end of its shelf-life. Such
large overdosing results in an imbalance in the taste of the product,
particularly if consumed in the early stages of its shelf-life. Moreover, the
cost factor of including such large overdoses is considerable. In addition to
the high cost of sterilization, and increased overdosing of vitamins,
sterilization processes require high cost packaging, such as in metal cans.

Like milk, liquid infant formulas (usually containing milk proteins and
sometimes soy protein) are heated for a variety of reasons, the main reasons
being: to remove potential pathogenic organisms and to increase shelf-life.
The major concerns about the resulting products of thermal process are safety
and quality. Like milk, heat-treated infant formulas should not be a public
health risk. They should have a good keeping quality, provide an intended
balance of nutrients, and be of desirable sensory characteristics, i.e.,
appearance, color, flavor, and mouth feel. When milk or infant formulas are
heated at a constant temperature, all their constituents and components will
be affected, but to different extents. Increasing the temperature will
accelerate reaction rates. But different reactions will be affected to
different extents. Physical, chemical, enzymatic and microbial changes will
depend principally upon the time-temperature conditions, but will also be
influenced by other factors, such as composition, pH, and oxygen content. The
wide range of reactions taking place when infant formulas are heated will
influence the safety and quality of the product. Upon heating of products at
higher temperatures for longer times, some undesirable changes can also take
place (e.g., decrease in pH, Maillard browning, cooked caramel flavor,
denaturation of whey proteins and interaction with casein). The changes that
take place during heating and subsequent storage, can affect the nutritional
value and sensory characteristics.

In thermal processing, the most important parameter is the level of microbial
inactivation achieved. For safety reasons, the minimum holding time
(residence time) should be considered for microbial inactivation, although
this will give an underestimate of the true level of microbial inactivation.

In terms of microbial quality and reducing spoilage rates, the emphasis is
toward that of prevention. One approach, now widely used, is that of Hazard
Analysis Critical Control Points (HACCP). Here the philosophy is to identify
where hazard may occur from raw materials, different processing stages,
packaging, or subsequent handling and storage. Critical control points are
then established. These are points in the production process where the hazard
can be effectively controlled. Loss of control permits the realization of the
potential hazard as an unacceptable food safety or spoilage risk.

The quality of raw materials (ingredients) also has a pronounced effect on
the quality of the final product. From the microbial point of view, the
ingredients must be free of serious pathogens, and have initial total
bacterial counts not more than 104 per gram. This reflects good hygiene in
production of the ingredients. It is also useful to monitor psychotropic
bacteria in raw ingredients (via direct assay of proteolytic enzymes) as they
are usually predominant among the microorganisms found in pasteurized
products.

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