[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR106.30]

[Page 186-187]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 106--INFANT FORMULA QUALITY CONTROL PROCEDURES--Table of Contents
 
 Subpart B--Quality Control Procedures for Assuring Nutrient Content of 
                             Infant Formulas
 
Sec. 106.30  Finished product evaluation.

    (a) The manufacturer shall establish criteria for sampling and 
testing to ensure that each batch of infant formula meets the nutrient 
requirements of section 412(g) of the act or of regulations promulgated 
under section 412(a)(2) of the act before release of product for 
commercial or charitable distribution.
    (b)(1) Immediate analysis. Before release of product for commercial 
or charitable distribution, the manufacturer shall analyze 
representative samples of each batch of finished product for:
    (i) Specific nutrient(s) to assess process degradation; and
    (ii) All nutrients not previously analyzed for by the manufacturers, 
unless each in-process batch is analyzed for nutrients as specified in 
Sec. 106.25(b) and the ingredients are analyzed as specified in 
Sec. 106.20(b). No analyses are needed for linoleic acid, vitamin D, 
vitamin K, choline, inositol, and biotin; and for nutrients that are 
added as a part of a nutrient premix analyzed by the manufacturer or 
having a supplier's guarantee or certification and for which an 
indicator nutrient(s) was analyzed by the manufacturer.
    (2) Periodic analysis. The manufacturer shall sample at least one 
newly processed finished product batch every 3 months and shall analyze 
representative samples for all nutrients except those that the 
manufacturers measured in the immediate analysis of that product batch.
    (3) Stability analysis. Using representative samples collected from 
finished product batches, the manufacturer shall conduct stability 
analysis for selected nutrients with sufficient frequency to 
substantiate the maintenance of nutrient content throughout the shelf 
life of the product.
    (c) The manufacturer shall evaluate new formulations and the effect 
of changes in ingredients or processing conditions that could affect the 
level of nutrients by means of a testing program designed to confirm 
uniformity of batches and to determine the effects of such changes. The 
following shall apply:
    (1) A minor change is a minor reduction in nutrient levels, a minor 
increase in levels of nutrients that are subject to maximum limits 
established under section 412(g) of the act or in regulations 
established under section 412(a)(2) of the act, or any other change 
where experience or theory would not predict a possible significant 
adverse impact on nutrient levels or nutrient availability. After a 
minor change the manufacturer shall analyze representative samples for 
all nutrients so changed and those possibly affected by the change.
    (2) A major change is any new formulation, or any change of 
ingredients or processes where experience or theory would predict a 
possible significant adverse impact on levels of nutrients or 
availability of nutrients. After a major change the manufacturer shall 
analyze representative samples for osmolality, all nutrients, and the 
biological quality of the protein. A protein biological quality analysis 
is not necessary for a formulation change that is not expected to have 
an adverse effect on the biological quality of the protein. Vitamin D 
shall be determined by the rat bioassay method as prescribed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists'' (AOAC), 13th Ed. (1980), sections 43.195-43.208, ``Vitamin D 
(30)--Official Final Action,'' which is incorporated by reference. 
Copies are available from the Association of Official Analytical 
Chemists International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2504, or available for inspection at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC. Before release of the product for commercial or 
charitable distribution, the manufacturer shall have completed all 
appropriate analyses except that shipment of the product need not be 
delayed until results of the vitamin D bioassay and, if required, a 
protein biological quality bioassay are complete, provided such 
bioassays have been initiated, and if another analysis for the vitamin D 
has been run and the protein content has

[[Page 187]]

been determined by a suitable method. The biological quality of the 
protein shall be determined by an appropriate modification of the AOAC 
bioassay method of analysis. The manufacturer shall analyze additional 
samples from the same batch for vitamin D, by any suitable method, and 
for the biological quality of the protein. The manufacturer shall 
perform such analyses at least annually for a period not to exceed the 
expected shelf life of the product.
    (d) A simple adjustment in the level of an ingredient to accommodate 
inconsistencies in processing is considered to be neither a minor nor a 
major change.

[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 
63 FR 14035, Mar. 24, 1998]