Dairy-based Ingredients: Regulatory Aspects 379- Well - rehearsed recall and traceability
procedures - Logical standard operating procedures
(SOPs) for processes, product formula-
tions, sanitation, and allergen control - Proactive glass and metal control programs
- Organized shipping, receiving, and storage
procedures and logistics
Although prerequisite programs may
impact HACCP, they are designed to ensure
wholesomeness and suitability of food for
human consumption. In contrast, HACCP
plans are narrower in scope and specifi c to
ensuring food safety. Prerequisite plans
should be in place and their effectiveness
assessed as HACCP plans are being designed
and implemented. All PP should be docu-
mented and regularly audited.
Food Additives and “ Generally
Recognized as Safe ”
Within the FDA, the Center for Food Safety
and Applied Nutrition ’ s (CFSAN) Offi ce of
Food Additive Safety is responsible for
reviewing safety information for food ingre-
dients and food packaging. The Food
Additives Amendment to the Federal Food,
Drug, and Cosmetic (FD & C)Act was enacted
in 1958. This act defi ned the term food addi-
tive and emphasized premarket approval for
new uses of food additives. The law estab-
lished the standard of review, the standard of
safety, and formal rule making procedures for
food additives. Substances excluded from the
defi nition of food additives are those that are
generally recognized among experts quali-
fi ed by scientifi c training and experience to
evaluate their safety as having been ade-
quately shown to be safe under the conditions
of their intended use. In other words, sub-
stances that are generally recognized as safe
(GRAS) under conditions of their intended
use are not food additives and do not require
premarket approval by FDA (Gaynor,
2005 - 06 ).Implementing HACCP
HACCP implementation is a systematic
exercise of identifying, evaluating, and
controlling food safety hazards based on
the following essential principles (FDA,
1997 ).
Principle 1: Conduct a hazard analysis.
Principle 2: Determine the critical control
points (CCPs).
Principle 3: Establish critical limits.
Principle 4: Establish monitoring proce-
dures.
Principle 5: Establish corrective actions.
Principle 6: Establish verifi cation proce-
dures.
Principle 7: Establish record - keeping and
documentation procedures.
Prerequisite programs (PPs) should be in
place to ensure successful HACCP imple-
mentation. CGMP, PMO, and the Food Code
are good guides for implementing PP.
According to the FDA, the important charac-
teristics of effective PPs are:
- Sanitary establishments and facilities with
linear product fl ow and logical traffi c pat-
terns that minimize cross contamination
from raw to processed products - A well - executed supplier assurance and
verifi cation program - Clear and regularly updated ingredient,
product, and packaging material specifi ca-
tions that refl ect known concerns - Sanitary processing equipment with pre-
ventive maintenance and regular calibra-
tion schedules - Written cleaning and sanitation procedures
with an aggressive verifi cation schedule - Adequate employee hygiene and train-
ing; look for problem areas and continu-
ously innovate to address this important
issue - Pest control and non - food chemical hazard
control