[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR106.20]

[Page 184]
 
                        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.  106.20  Ingredient control.


    (a) Except as provided in Sec.  106.20(b), no analysis before use in 
manufacturing is needed for ingredients that are generally stable in 
shipping and storage, and that either are received under a supplier's 
guarantee or certification that the mixture has been analyzed as to 
nutrient composition or are labeled as having nutrient compositions 
complying with specifications in the U.S. Pharmacopeia, the National 
Formulary, the Food Chemicals Codex, or other similar recognized 
standards.
    (b) Unless each batch of finished product is analyzed as specified 
in Sec.  106.30(b)(1) before release of product for commercial or 
charitable distribution, the following shall apply:
    (1) When an ingredient is relied upon as a source of a nutrient(s) 
and when evidence indicates that such nutrient(s) in that ingredient is 
likely to be affected adversely by shipping or storage conditions, the 
manufacturer shall analyze that ingredient for each relied-upon nutrient 
that may be affected, using validated analytical methods.
    (2) Ingredients, including nutrient premixes, that are either 
without a supplier's guarantee or certification, or not labeled as 
complying with prescribed standards, shall be sampled and analyzed for 
each relied-upon nutrient by the manufacturer, except that ingredients 
used as a major source of protein or fat need not be analyzed for each 
relied-upon nutrient if the manufacturer has records to show that each 
relied-upon nutrient is present at a reasonably constant level. Nutrient 
premixes prepared by the infant formula manufacturer shall be sampled 
and analyzed for each relied-upon nutrient. Nutrient premixes which are 
received from suppliers shall be sampled and analyzed for each relied-
upon nutrient unless the supplier has sampled and analyzed each batch of 
premix for each relied-upon nutrient and has so certified in writing.