Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-3-16 - PRODUCTION, PROCESSING, HANDLING OR DISTRIBUTION OF MILK, MILK PRODUCTS AND FROZEN DESSERTS › APPENDICES › Appendix O - VITAMIN FORTIFICATION OF FLUID MILK PRODUCTS

Current through Register Vol. 42, No. 9, June 28, 2024
PROCESS/METHODS OF VITAMIN ADDITION
Vitamin fortification can be accomplished by the addition of
				  vitamins at many different points in the processing system, preferably after
				  separation, including the pasteurizing vat, to the HTST constant-level tank, or
				  on a continuous basis into the pipeline after standardization and prior to
				  pasteurization in accordance with the manufacturer's recommendations. Both
				  batch addition and addition with metering pumps can be used. The batch
				  procedure requires accurate measurement of the volume of milk to be fortified,
				  accurate measurement of the vitamin concentrate, and proper mixing. When a
				  vitamin metering pump(s) is used with an HTST or HHST unit, the pump(s) shall
				  be installed so as to be activated only when the unit is in forward-flow. The
				  addition of vitamins shall be accomplished prior to pasteurization in
				  accordance with the manufacturer's recommendations.
The problem of under fortification is often related to the
				  point in the system where fortification takes place. Vitamins A and D are
				  fat-soluble and will gradually become more concentrated in the milk fat portion
				  of the milk. Both oil and water base vitamins are susceptible to this migration
				  problem.
If vitamins are added in the proper amount before separation
				  and standardization, and the product is separated and standardized, then the
				  low fat product will tend to be under fortified and the high fat product over
				  fortified. Water-soluble vitamin concentrates can minimize this problem if
				  vitamins are added before separation. Processors who use this procedure should
				  perform confirmatory assays to ensure proper fortification levels of each
				  product.
Many HTST systems are now being used with in-line fat
				  standardization, which also makes possible switching, without stopping, from
				  milk and milk products being fortified with vitamin D to those being fortified
				  with both A and D. These systems require metered injection of the proper
				  vitamins at a point after standardization and before pasteurization. Sanitary
				  positive-displacement pumps are available for this purpose.
There are two (2) types available:
1. The first is a piston type metering pump without valves.
				  It is equipped with a micrometer which allows accurate and reproducible amounts
				  of vitamins to be added based on the rate of product flow through the
				  system.
2. The other type is a peristaltic pump that offers precise
				  control. This precise control is possible since the volume can be controlled by
				  the tubing size and the pump speed. This system simplifies cleaning since only
				  the tube is in contact with the vitamin concentrates.
These pumps have a history of reproducibility and
				  reliability. All metering pumps should be designed to conform with these
				  rules.
The recommended injection point is after separation and prior
				  to homogenization. This allows the homogenization process to distribute the
				  vitamins throughout the milk. A check-valve is recommended to prevent milk from
				  contaminating the vitamin concentrate.
Separate pumps, tubing, and check-valves are recommended when
				  multiple types of vitamin concentrates are injected (refer to Figure
				  58).
Pumps should be calibrated based on the pasteurization system
				  flow rate. If flow rates change for different milk products, additional vitamin
				  pumps may be needed. Re-calibration of the metering pumps is not recommended
				  without verifying the accuracy. Routine calibration of metering pumps is
				  recommended. The following are recommended to achieve desired vitamin
				  fortification levels:
1. Management shall be committed to proper fortification and
				  concerned with both over and under levels.
2. Design the system correctly for proper addition in which
				  concentrate is added after standardization and before pasteurization.
3. Written procedures and training should be provided to all
				  employees responsible for vitamin fortification for each milk and milk product
				  to be fortified. These procedures should focus on milk or milk product start-up
				  and milk or milk product change-over.
4. Maintain accurate records of vitamins used and milk and
				  milk products produced, checked daily against theoretical use. Care should be
				  taken that adequate fortification of small run milk or milk products like skim
				  milk is not masked by much larger volumes of reduced fat 2 percent or other
				  partly skimmed milk products.
METERING PUMPS
Use an accurate, sanitary, positive-displacement metering
				  pump with a scheduled cleaning procedure after use. For batch addition, use
				  only accurate, calibrated measuring devices such as plastic graduated cylinders
				  or pipettes. Measuring devices should be sized to the amount of concentrate
				  added, i.e., if 8 mL is added, a 10 mL graduated cylinder would be appropriate.
				  Measuring devices should be rinsed with the milk or milk product being
				  fortified to ensure no residual concentrate is left. Use a check-valve on the
				  injection line to prevent milk or milk product from being pushed back into the
				  line. This depends on the pump displacement. Check the meter calibration
				  regularly, including both the pump and the tubing, by determining delivery rate
				  accuracy. Use only properly calibrated tubing for peristaltic pump systems and
				  replace the tubing regularly.
Storage vessels used for supplying vitamin concentrate to
				  metering pumps should be emptied on a regular basis. A regular systematic
				  cleaning and sanitizing schedule shall be maintained for these vessels, pumps,
				  and tubing. Vitamin concentrates should be stored and held in accordance with
				  the manufacturer's recommendations for maximum shelf life.
Vitamin metering pumps should be interwired with the flow
				  divert and recycle valves to prevent operation during divert and/or recycle
				  flows.
Analyze finished products regularly. Results should be
				  reported in International Units (I.U.)/Quart. Because of the sensitivity and
				  difficulty in performing these tests, it is necessary to procure the services
				  of a competent laboratory; one that is familiar with the handling and testing
				  of vitamin fortified dairy products.
Care shall be taken when reprocessing reclaimed product so
				  vitamin A and/or D levels do not exceed the label claims by more than 150
				  percent.
GOOD MANUFACTURING PRACTICES
Good manufacturing practices require that the vitamin A and D
				  levels be in compliance with 21 CFR 131.110 states: "(b)
				  Vitamin addition (Optional).
(1) If added, vitamin A shall be present in such quantity
				  that each quart of the food contains not less than 2000 I.U. thereof within
				  limits of good manufacturing practices.
(2) If added, vitamin D shall be present in such quantity
				  that each quart of the food contains 400 I.U. thereof within limits of good
				  manufacturing practice."
For the purpose of label claims, compliance for nutritional
				  labeling of food 21 CFR
				  101.9 applies and states:
(3) (i)
Class I.
Added nutrients in
				  fortified or fabricated foods.
(4) (i)
Class I
vitamins, mineral, protein,
				  dietary fiber, or potassium. The nutrient content of the composite is at least
				  equal to the value for that nutrient declared on the label.
Therefore, if added, the acceptable range for vitamins A and
				  D in the standardized milk products listed in
				  21 CFR,
				  131.110 Milk, 131.111 Acidified Milk, 131.112
				  Cultured Milk, 131.127 Nonfat Dry Milk Fortified with vitamins A and D (vitamin
				  addition not optional), 131.200 Yogurt, 131.203 Lowfat Yogurt, and 131. 206
				  Nonfat Yogurt are as follows:
*100-150 percent of label claims = (400 - 600 I.U. per quart
				  for vitamin D and 2000 - 3000 I.U. per quart for vitamin A)
*Within method variability
Fluid milk products found below 100 percent or above 150
				  percent of the required values or label claims should be resampled and the
				  cause of the problem determined.
Additionally,
				  21 CFR
				  130.10 - Requirements for foods named by use
				  of a nutrient content claim and a standardized term states: "That nutrients
				  must be added to the food to restore nutrient levels so that the product is not
				  nutritionally inferior to the standardized food for products which combine a
				  nutrient content claim, i.e., lowfat, non-fat, or reduced fat, with a
				  standardized term, i.e., milk, sour cream, eggnog." Therefore, vitamins A and D
				  shall be added to dairy products from which fat has been removed; such as,
				  reduced fat, lowfat, and nonfat dairy products, in an amount necessary to
				  replace the amount of these vitamins lost in the removal of fat.
TESTING METHODS
Test methods used for the detection of vitamins A and/or D
				  shall be acceptable to the FDA or other official methodologies that give
				  statistically equivalent results to the FDA methods. Vitamin analysis shall be
				  conducted in a laboratory accredited by the FDA and acceptable to the Health
				  Officer (refer to M-a-98, latest revision, for the specific milk and/or milk
				  products that have FDA validated and NCIMS accepted test methods for
				  vitamins).
TYPE OF CONCENTRATES AVAILABLE
A number of different types of concentrates are available.
				  All contain vitamin D and/or vitamin A palmitate with a carrier consisting of
				  any of the following: butter oil, corn oil, evaporated milk, non-fat dry milk,
				  polysorbate 80, propylene glycol, and glycerol monooleate. It is best to store
				  all concentrates under refrigeration unless manufacturer's directions indicate
				  otherwise. To achieve adequate dispersion, viscous concentrates should be
				  brought to room temperature before addition.
NEED FOR ADDITION
Vitamin A is fat-soluble. It will dissolve when mixed with
				  fat and will not dissolve in water. For this reason, vitamin A is found in
				  whole milk and to a lesser degree in low fat and absent in non-fat milk, unless
				  these products are fortified.
Vitamin D is the major regulator of calcium absorption in the
				  intestine. Fortification of fresh milk with vitamin D is acknowledged to have
				  virtually eliminated rickets in milk drinking children. Since normal levels of
				  vitamin D are necessary for optimal calcium absorption in children, it is also
				  known that these levels are required as one increases in age. It has been
				  associated with reducing the incidence of osteoporosis in premenopausal
				  women.
Vitamin A performs many functions. One is to enable the
				  retina of the eye to respond to dim light. Deficiency of vitamin A produces
				  night blindness. Vitamin A is also involved in the ability of the eye to
				  discern color.
Excessive levels of vitamins A and D in fluid milk can be a
				  potential threat to public health. Over fortification with levels of vitamin A
				  over 6,000 I.U. and vitamin D over 800 I.U. in fluid milk should be referred to
				  FDA for a health hazard review.
PROBLEMS INVOLVED WITH FORTIFICATION
Milk and milk products that contain a large proportion of fat
				  are relatively good dietary sources of vitamin A, but as is the case with other
				  natural foods, the vitamin D content of unfortified milk is quite low. As with
				  other milk components, vitamin A and D levels are affected by breed, season,
				  diet, lactation, and in the case of vitamin D, animal exposure to
				  sunlight.
In general, when lactating animals are transferred from
				  pasture to winter rations in the fall, a decline in the vitamin A and D levels
				  can be expected in the raw milk. This occurs slowly through the winter season
				  until the animals are once more on pasture in the spring. With the proper
				  selection of feed and diet concentrates, this effect can be kept to a minimum.
				  Natural levels of vitamin A range from 400 I.U. in winter to 1200 I.U. in
				  summer, and vitamin D, 5 I.U. in winter to 40 I.U. in summer. These are
				  approximate ranges to indicate possible seasonal variations. Because of
				  seasonal and other variations in natural vitamin levels, it is necessary to
				  monitor the level of fortification to assure that levels are within good
				  manufacturing practices. Vitamin concentrate potency degrades with time.
				  Concentrates should be stored in accordance with manufacturer's recommendation
				  to maintain label potency. Vitamin concentrate potency should be verified by
				  the vitamin supplier.
Vitamin D is very stable in homogenized whole milk and is not
				  affected by pasteurization or other processing procedures. Vitamin D in
				  fortified homogenized whole milk will remain constant with little or no loss of
				  vitamin potency during long periods of proper storage. No loss of vitamin D
				  will be experienced under normal shelf life periods.
Vitamins A and D fortified skim milk products are subject to
				  decreases in vitamin A, because the vitamin is no longer protected by fat as it
				  is in whole milk. In fluid skim or low fat milk, added vitamin A deteriorates
				  gradually during normal storage of the milk at 4.5°C (40°F) in the dark
				  but is destroyed rapidly when the milk is exposed to sunlight in transparent
				  glass bottles or translucent plastic containers. The photo destruction of added
				  vitamin A is dependent on the intensity and wave-length of light and the milk
				  source. The use of amber or brown glass bottles, pigmented plastic containers
				  formulated with specific light barriers and colored paper cartons retard this
				  destruction. Vitamin A losses in reduced fat milk 2 percent from five (5) dairy
				  plants ranged from 8 percent to 31 percent when they were exposed to 200
				  foot-candles (220 lux) of fluorescent light for twenty-four (24) hours in
				  opaque plastic containers. Use of pigmented containers or gold shields over
				  fluorescent tubes practically eliminated these losses.
Note: Figure 58 details a two (2) speed vitamin fortification
				  installation using two (2) pumps and two (2) vitamin concentrate sources. This
				  enables changing from different vitamin concentrates and different speed pumps
				  via the adjustment of three-way valves.
Recommendations:
1. Use a sanitary check-valve(s) to separate milklines from
				  vitamin concentrates.
2. All milk or milk product-contact surfaces should be of a
				  sanitary design, easily cleanable, and available for inspection.
Click to view
				  image
Figure 58. Vitamin
				  Fortification
Author:
G. M. Gallaspy, Jr.
Statutory Authority:
Code of Ala. 1975,
					 §§
											22-2-2,
					 22-20-7.