●use of reworks
●formulation errors
●incorrect labelingThe cause of a true food allergy is the pro-
tein in a food item, typically the primary
protein. These proteins are heat-stable and
are not eliminated by cooking or thermal
processing. When an allergenic individual
comes in contact with this protein, the body
has an immune-mediated response because
the protein is identified as a foreign sub-
stance that must be eliminated. A release of
histamine can cause symptoms that may
range from itchy skin or eyes to nausea or
difficulty breathing and potentially fatal
anaphylaxis.
Components of allergen control
Some states, independently or in coopera-
tion with the FDA, have initiated allergen
inspections and analysis of products selected
randomly from grocery stores with a result-
ant increase in product recalls. An allergen
control program should address:
Employee education. Employees must be
instructed about the handling of materials
that may contain allergens. Training may be
incorporated with the teaching of good
manufacturing practices. Training should be
documented through employee signature,
date, and materials covered.
Supplier monitoring. Product or ingredient
formulations, specification sheets, and cer-
tificates of analysis from suppliers of raw
materials should be obtained. Testing to ver-
ify the quantity of an allergen present can
determine essential precautions to be taken
during production. Verification that suppli-
ers have an ACP is needed.
Control steps. These precautions are nec-
essary for identified allergens in raw materi-
als if the manufactured products are not
produced on a separate line or complete wet
cleaning is not performed.
Cleaning. Allergen control through the
reduction of cross-contamination in a manu-
facturing plant may be enhanced through
the production of allergen-containing foods
as the last product on the production line fol-
lowed by a wet cleaning program. Since the
protein component within a food is responsi-
ble for the immunological symptoms of an
allergenic reaction in humans, complete
removal of these proteins is important.Opting
for the wet cleaning method necessitates
assessing the food items that are processed
with shared equipment.Each product may
contain a different allergen, requiring the
implementation of scheduling or cleaning
procedures. When cleaning operations
are not performed between allergen and
non-allergen-containing products, a parts-
per-million analysis is needed to establish the
safety of products that do not list allergens
on the label. A label declaration may be suf-
ficient for allergen control if all products
contain the same allergen.
Raw material storage. All raw materials
and foods that contain allergens should be
stored in an area that is secluded or removed
from nonallergenic materials. Incoming
palletized materials should be shrink-
wrapped to prevent cross-contamination
from potential leakage. Partially used bags
or other containers of allergen-containing
materials should be sealed and stored in seg-
regated areas. All materials that contain
allergens should be labeled accordingly with
a color-coded tag. Color-coding charts
should be placed in the production area,
especially above wall-mounted equipment
and near storage areas, for easy identifica-
tion by plant personnel. Allergen-containing
materials should be stored on the bottom
of racks or nearest to the floor to prevent
spillage on other items. Scoops and stor-
age containers should be dedicated for spe-
cific materials to maintain separation of
allergens.