Food or edible material: processes – compositions – and products – Product with added vitamin or derivative thereof for...
Reexamination Certificate
2000-03-02
2001-02-27
Sayala, Chhaya D. (Department: 1761)
Food or edible material: processes, compositions, and products
Product with added vitamin or derivative thereof for...
C426S073000, C426S074000, C426S233000, C426S324000, C426S397000, C426S521000, C426S548000, C426S656000, C426S657000, C426S658000, C426S801000, C229S213000
Reexamination Certificate
active
06194009
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to refrigeration-shelf-stable ready-to-feed and concentrated infant formulas and products which are prepared using ultra-pasteurization or pasteurization processes.
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 governmental standards, for instance by the U.S. Code of Federal Regulations (21 CFR 107.100, 1998) as presented in Table 1A, or by responsible organizations as requested by governmental authorities, for instance by the Life Sciences Research Office (LSRO) of the American Society for Nutritional Sciences as presented in Table 1B. The resultant infant formulas are sometimes 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. 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 (1½) 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 heath 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 10
4
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.
Sterilization (Prior Art)
The currently practiced process for preparation of infant formulas is thermal sterilization. Table 2 shows that, at the present time, there are more than a dozen of these liquid infant formulas available in the market. Typically, these products are commercially sterile and offered in metal cans or heavy plastic containers and are stored at room temperature (i.e., they are shelf-stable). None of these infant formulas are prepared or offered as ultra-pasteurized or pasteurized product.
Sterilizing a product means exposing it to such powerful heat treatment that all microorganisms are killed. However, absolute sterility is not possible. The term “Commercial Sterility” is used instead. From the U.S. regulations point-of-view (21 CFR 113.3, 1998), “Commercial Sterility” of thermally processed food means the condition achieved—
1) By the application of heat which renders the food free of—
(a) Microorganisms capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution; and
(b) Viable microorganisms (including spores) of public health significance; or
2) By the control of water activity and the application of heat, which renders the food free of microorganisms capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution.
It is common practice in the commercial sterilization of low-acid foods (i.e., pH>4.5) to achieve at least a 12 decimal reduction for spores of
Clostridum botulinum
, because they are the most heat resistant of the major food poisoning organisms.
Two main methods are used for sterilizing liquid infant formulas: in-container sterilizatio
Hoffman & Baron LLP
Princeton Nutrition, LLC
Sayala Chhaya D.
LandOfFree
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