376 Chapter 15
Table 15.1. Resources for key provisions regulating dairy ingredients in the United States.
Provision Basis/agency recommendation
Standards of identity See Table 15.2
Food labeling 21 CFR: 1B: Part 101
Nutritional quality guidelines for foods 21 CFR: 1B: Part 104
Current good manufacturing practices in manufacturing,
packing, or handling food for human consumption21 CFR: 1B: Part 110
Pasteurized Milk Ordinance U.S. Department of Health and Human Services,
public health services, and U.S. Food and Drug
AdministrationSource: Patel, Oliver, Almeida and Vedamuthu, 2008 .Compiled from various sources.
Table 15.2. Resources for dairy ingredients stan-
dards of identity in the United States.
Product/process Legal Basis
Pasteurization 21 CFR 58.334
Whey 21 CFR 58.2601
Dry buttermilk and dry
buttermilk product21 CFR 58.2651
Defi nitions: cream,
pasteurized, and
ultra - pasteurized21 CFR 131.3Milk 21 CFR 131.110
Acidifi ed milk 21 CFR 131.111
Cultured milk 21 CFR 131.112
Concentrated milk 21 CFR 131.115
Sweetened condensed milk 21 CFR 131.120
Low - fat dry milk 21 CFR 131.123
Nonfat dry milk 21 CFR 131.125
Nonfat dry milk fortifi ed
with vitamins A and D21 CFR 131.127
Dry whole milk 21 CFR 131.147
Dry cream 21 CFR 131.149
Heavy cream 21 CFR 131.150
Light cream 21 CFR 131.155
Light whipping cream 21 CFR 131.157
Sour cream 21 CFR 131.160
Acidifi ed sour cream 21 CFR 131.162
Boiler water additives 21 CFR 173.310
Whey 21 CFR 184.1979
Concentrated whey 21 CFR 184.1979(2)
Dried or dry whey 21 CFR 184.1979(3)
Reduced lactose whey 21 CFR 184.1979a
Reduced minerals whey 21 CFR 184.1979b
Whey protein concentrate 21 CFR 184.1979cPatel, Oliver, Almeida, and Vedamuthu (2008). Based on
the Federal Food, Drug and Cosmetic Act, as amended.
Sec. 402 [342]
Adulterated Food and Sec. 403 [343] Misbranded Food.
Table 15.3. Resources on fundamental ele-
ments of GMP in the United States.
21 CFR Part 110 Focus area
Section 110.3 Defi nitions
Section 110.5 Current good manufacturing
practice
Section 110.10 Personnel
Section 110.19 Exclusions
Section 110.20 Plants and grounds
Section 110.35 Sanitary operations
Section 110.20 Sanitary facilities and controls
Section 110.40 Equipment and utensils
Section 110.80 Processes and controls
Section 110.93 Warehousing and distribution
Patel, Oliver, Almeida, and Vedamuthu (2008)ize and enhance the effectiveness and rele-
vance of current laws. An approach based on
risk analysis is the defi ning characteristic in
the revised version. According to the U.S.
Food and Drug Administration (FDA), mod-
ernized current GMP facilitate control of
food safety hazards for food manufacturers
by logical allocation of resources with
maximum impact on food safety. Improved
measures suggested in the amended regula-
tion are based on risk analysis and they have
been proven to signifi cantly reduce the risk
of foodborne hazards.
Salient aspects of current GMP are as
follows:- Risk - based approach requiring integration
of regulatory requirements with food safety
outcomes - Appropriate training
- Specifi c training emphasizing hygiene
and sanitation (personal as well as prem-
- Specifi c training emphasizing hygiene
to refl ect the needs of the 21st century.
Principles and essential elements of GMP are
depicted in Table 15.3.
A comprehensive revision of GMP is
ongoing as a continuous exercise to modern-