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Section Heading
Number
1. Objective and Scope
2. References
3. Definitions
4. Principle
5 Validation, Verification, CCL indicative levels, monitoring and documentation
5.1 Background:
5.2 Physical validation
5.2.1 Physical validation process as flow
5.3 Equipment Cleaning validation monitoring & verification requirements
5.3.1. Background
5.3.2 Validation Process Flow
5.4 Product flushing for allergen removal
5.4.1 Validation Process Flow
5.4.2 Minimum verification
5.4.3 Minimum CCP monitoring
5.5 Indicative Levels
5.5.1 Background
5.5.2 Validation process flow

6. Sampling and Analytical Testing methods

6.1 Sampling
6.2 Food contact surface swabs
6.3 Final rinse waters from a CIP system
6.4 Environmental settle plates
6.5 Finished product, purge material or ingredient sampling
6.6 Allergen testing
6.7 Rapid tests used on site
6.8 Example of CCL Dilution Testing

7. Lab requirements

8. Rapid Testing Validation

9. References
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1. Objective & Scope

This document shall provide directions/guidance for developing and validating appropriate allergen
management programs through cleaning. The objective is to lay down technical information to guide
Suppliers and decision makers for program implementation.
Scope:
This document is recommended for all MDLZ Suppliers handling allergens. In scope
• Cleaning protocols
• Product Changeovers
• Verification & Monitoring
• Sampling and Test methods
Out of scope
• Allergen Labelling requirements
• Free-From Manual

2. References
• Mondelez Int. HACCP Standard
• Section 7.5 Allergen Management of the Supplier Quality expectations

3 Definitions

Allergen Cleaning Validation: Performed when product changeover from allergen containing and non-
allergen containing or different allergen containing product where cleaning is the control.
• One-off assessment with 3 consecutive runs.
• Systematic collection and evaluation of data
• Provides evidence if a line can be cleaned
• “Are we doing the right thing, and will it work?”
Allergen Cleaning Verification: Periodic checks to determine compliance with what was validated
• Are we doing what we planned to do?
Allergen Clean Monitoring: Done each time a clean is performed
• Are control measures operating as intended?
• “Has it worked every time?
Allergen Changeover: Where product containing allergens is manufactured on the same equipment as
products not containing those allergens, it is a requirement to demonstrate that the chosen
changeover/cleaning regime reduces the risk of cross contamination to an acceptable level.
Below Limit of Quantification (BLQ)/(<LOQ): Allergen not detected at limit of quantification of the test. This
is equivalent to not detected.
Cross Contact: also referred to as cross contamination or carryover. It describes situations when
allergens are present in foods unintentionally; for example, during manufacturing because of shared
equipment or processing lines that cannot be cleaned easily.
Cross Contact Labelling (CCL): also referred to as precautionary allergen labelling (PAL). These are label
statements describing the potential presence of unintentional allergens in food products.
ELISA (Enzyme-Linked ImmunoSorbent Assay):
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A method that uses antibodies to detect specific allergen proteins based on a color change. Quantitative
ELISA tests include a set of standards with different amounts of the allergen protein, against which unknowns
can be compared. Each ELISA kit will detect different allergen proteins, have different standard ranges,
different LOQs and different reporting units. Can be used for products, ingredients, surface swabs or rinse
waters. This is the Mondelēz method of choice for allergens.
Effective Validated Clean: Cleaning validation will be considered successful if all results from all samples
(surface swabs and next made product CCP Model 18; or flush / purge material and next made product CCP
Model 53) have tested negative (less than the Limit of Quantification <LOQ/BLQ) for the allergen of concern
on 3 consecutive runs.
Failed Validated Clean: Cleaning validation will be considered a failure when cleaning is not effective and
the results from any samples are not <LOQ/BLQ. Global sanitation must be consulted, and cleaning must
be optimized, and the validation repeated. If the validation cannot be improved and evidence provided that is
has not been successful, then Cross Contact Labelling (CCL) may be required. Contact global /regional
Supplier quality for advice, Food Safety may also be consulted if any product has been impacted.
FP: Finished product.
Indicative Level (IL): Target value in ppm for a specific allergenic protein that should not be exceeded with
a Mondelēz International product which is cross contact labeled for this allergen. The target values set take
clinical data into account and are safe for the majority of individuals being allergic to that specific protein. The
indicative level of an allergenic protein is an accepted internal maximum level for allergen cross contact at
Mondelēz International.
Limit of Detection (LOD): Lowest amount of analyte (protein) in a sample that can be detected.
Limit of Quantification (LOQ): The lowest amount of analyte (protein) in a sample that can be quantitatively
determined with suitable precision and accuracy.
Non-specific total protein tests: A simple, rapid test to detect total protein. Does not distinguish between
different allergen proteins or non-allergen proteins. Can be used for surface swabs or rinse waters only.
PCR (Polymerase Chain Reaction): A method to detect the DNA from a specific allergen. These tests are
only qualitative and cannot be used to measure allergen protein. Would be used if no suitable quantitative
ELISA test was available. Can be used for products, ingredients, surface swabs or rinse waters.

Physical validation: Physical validation is the first step in any allergen changeover validation (CCP/sPP).
The physical validation ensures that the current cleaning procedure is effective at removing visible traces of
allergen from the line. Only when the physical validation is satisfactory should the site proceed to analytical
validation.
Positive control: A finished product containing the allergen of interest, this sample is sent for analysis to
ensure that the chosen test can detect this allergen effectively.
Post-cleaning inspection: is the physical visual inspection of cleaning process effectiveness (following
cleaning).
Pre-operational inspection ensures that the processing line and production environment is ready for safe
food processing.
Qualitative ELISA test: A simple ELISA test to detect specific allergen proteins with a positive control (E.g.
Neogen Alert). Unknowns are compared to the control. Can be used for surface swabs or rinse water only.
Quality Clean: is defined as cleaning that will be the first part of the control step to changeover from an
allergen to a non-allergen or different allergen product. Per definition, a quality cleaning is a deep cleaning to
remove as much residue from product contact surfaces and adjacent areas where product can be
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contaminated, as possible. This type of cleaning is performed when there are inaccessible areas that cannot
be totally dismantled or cleaned by a CIP and cannot be guaranteed 100% residue free or when wet cleaning
cannot be performed e.g. chocolate production lines.
Rapid lateral flow device (RLFD): A simple, rapid qualitative test to detect a specific allergen protein. They
are either a device (e.g. Neogen Reveal 3D) or a strip format (eg. Romer Agrastrip). Can be used for surface
swabs or rinse waters only.
Spike Recovery Test: If a sample type has not been tested by a laboratory for the allergen in question
before, the laboratory must perform a spike recovery test. The laboratory may request the sample ingredients,
so they can assess whether they have tested a similar enough sample type before. If they have, this does
not need to be repeated but the site must record this evidence. If the laboratory needs to perform a spike
recovery test, they will add a known amount of allergen to the sample type, analyze it and “recover” the
allergen. Typical acceptable recovery is approximately 70 - 130%. This validation is used to identify any matrix
interferences with the method.
Threshold: the maximum amount of an allergenic protein that can be tolerated without triggering any adverse
reaction. An individual threshold is the maximum amount of an allergenic protein that can be tolerated by a
specific food-allergic individual. A population threshold is the maximum amount of an allergenic protein that
can be tolerated by the entire population (or a representative sub-population) of individuals with a specific
type of food allergy. Thresholds are often also referred to as NOAELs (no observed adverse effect levels) or
MTDs (maximum tolerated dose).
Target Allergen: When there are multiple allergens present on a line, cleaning validation does not need to
be done for all allergens. A target or marker allergen can be selected and used to collect evidence that the
cleaning has been effective. The decision will be based on which is present at the highest level and whether
there is a suitable quantitative ELISA test available. Global sanitation will be able to advise.
Visually Clean: No visual residue.

4. Principle
If it is possible to remove residual allergen from the line and avoid the need for CCL to maximize consumer
choice, this should always be the first consideration.
Production run length can vary across suppliers and type of business (from a batch in few hours to several
days of production). We should specify that validation of cleaning for allergens removal must be performed
using the worst-case scenario (highest allergens concentration and maximum production run length).

5.Validation, Verification, CCL indicative levels (Quality Clean), monitoring and documentation
5.1 Background:
A validation must be completed to demonstrate that the cleaning between allergen to non-allergen or to a
different allergen profile is effective. This procedure requires the physical validation of the cleaning and
pre-op inspection process and the analytical validation (based on the ELISA method).
A Re-Validation may be required in case of
1) Line /product transfer
2) New ingredient/New product/Reformulation
3) New supplier which may have impact on current allergen profile or labelling
4) Audit or HACCP reanalysis/ validation findings
5) Special situations
6) New line or New facility
7) After any major change has occurred which impact allergen cross contamination, for example
a. Installation of new equipment.
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b. Modifications to existing equipment/ process.

c. Change in validated cleaning method
Minimum verification must be performed annually or more frequently per local regulatory requirements.
The verification procedure requires a physical verification followed by the testing of finished product
produced after the allergen changeover clean.
The site must implement a monitoring plan as per the site HACCP or equivalent to verify that the
requirements identified during the validation process are strictly followed for each validated change over.
The validation process needs to reflect real production amount. If less amount than usual production is
produced product build up on the line would not reflect the reality and therefore it would negatively impact the
effectiveness and reliability of the validation process. This should be highlighted.
5.2 Physical validation
Physical validation is the first step in any allergen changeover validation. The physical validation ensures that
the current cleaning procedure is effective at removing allergens to a visually clean standard from the line
and the visually clean standard to be defined by the plant as part of changeover.Only when the physical
validation is satisfactory should the site proceed to analytical validation.
5.2.1 Physical validation process flow

Review site allergen assessment to identify the target

allergen for validation.
Note: Document cleaning criteria in the
Develop a flow diagram showing all equipment cleaning procedure needed to ensure
associated with the process used to manufacture the removal of allergens. Consider this as
product (HACCP process flow diagram). part of the sanitation cleaning protocol
needed for an effective allergen clean If
the equipment cannot be inspected
Identify/inspect the shared equipment & the equipment every time it is cleaned. The review of
that needs disassembly, special attention or difficult to the cleaning parameters must be
access areas. This guides the sampling points that included in the inspection form (i.e. CIP
need analytical validation. time/temperature, concentration of
chemicals, flushing material volume).
Using the flow diagram, prepare an inspection form or Testing of positive control sample must
update the existing inspection form. Update the current demonstrate that enough allergen can
cleaning procedure, post cleaning verification be detected using ELISA test.
checklist, HACCP check sheets, post cleaning check
sheets. Use digital pictures to supplement, if possible. Note : Spike recovery test
needs to be considered, as required

Clean the line after changeover as per

aligned/updated SOP. After an allergen changeover,
perform an inspection using the inspection form.
Note: Take positive control FG sample prior to
cleaning of the line.

If cleaning is No
satisfactory

Yes
Document and finalize the cleaning SOP.
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5.3 Equipment Cleaning validation, verification and monitoring requirements

5.3.1. Background
Applicable for changeovers where a single step cleaning can guarantee the removal of allergen hazards on
product contact surfaces, adjacent areas during allergen changeover and next made products. When
applying this model, all product contact surfaces must be inspected and be visually residue- free. Areas that
cannot be 100% inspected must be evaluated through another approved means, such as validated CIP
cleaning parameters/last rinse sample checks.

5.3.2 Validation Process Flow

Step 1: Physical Validation of the line

(Refer section 5.2)

Step 2: Proceed to swab sampling as per

the approved allergen testing for
quantitative ELISA.
Sampling should be performed as per
Section 6.

Step 3: Post swab sampling, proceed to

production of the product and collect FP
samples which do not contain the allergen
of concern. Hold 4 hrs* of production until Finished product sampling minimum
satisfactory analytical validation results requirement recommended
are available using ELISA method from 0 ,1,2,5,10,30 ,60 min+ Positive control (pre-clean
approved lab. sample containing allergen).

Step 4: Proceed to the next actions based

on section 5.4.3.

Step 5. Validation should be completed for

3 different consecutive batches/run
following the above procedure.
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5.4 Product flushing for allergen removal

5.4.1 Validation Process Flow

Step 1: Physical Validation of the line (section

5.2)
Proceed to quality clean + flushing the line
using flushing material.

Flush Sampling: Last flush samples shall

Step 2: Post satisfactory physical validation, be taken.
prepare allergen testing
13:00 – 14:30 Note: Evaluation of Flushing/production
volume during changeover shall be noted.

Step 3: Take the flushing mass sample to be Finished product sampling minimum
analyzed using ELISA method from approved requirement recommended
lab. 0 ,1,2,5, 10,30 ,60 min+ Positive control
(pre-clean sample containing allergen).

Step 4: Post sampling, proceed to production

of the product and collect FP samples which
do not contain allergen of concern. Hold 4 hrs*
production until satisfactory analytical
validation results are available.

Step 5: Review results – take improvement

action or proceed to Step 6 depending on
outcome

Step 6. Validation should be completed for 3

different consecutive batches/run/change over
following the above procedure.

It is preferable to simulate a changeover by cleaning as the line would normally be cleaned for the allergen
changeover; take the samples and resume production with a similar allergen profile or CCLed allergen
product.
If this is not possible, analyse the samples as soon as possible, and either wait for the test results before
resuming production or after allergen cleaning continue to the production with next product and place the
product on hold until the results are available. Placing 4hr production on hold is enough to flush the line. Basis
of 4hr production is strictly dependent on a comprehensive visual inspection (e.g. taking difficult to clean
areas into consideration) and no visible particles left on the line). Another alternative would be to clean the
line a second time and visually inspect.
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5.4.2 Minimum verification

Frequency - Minimum once in a year or more frequent as required by regulation.
Finished product testing for validated cleaning protocol against target allergen for one change over by ELISA
method from Accredited approved lab for 0 ,1,2,5,10,30 ,60 min.
Hold and release shall be applied (i.e. 4 hrs. of changeover production).

5.4.3 Minimum CCP monitoring

Monitoring & corrective action requirements should be defined for each allergen changeover and should be
documented as a part of site HACCP (should it be deemed a CCP).
5.5 Indicative Levels and Quality Clean
5.5.1 Background:
In the event that allergens cannot be cleaned from the line (confirmed by an assessment using the allergen
checklist) then the Supplier must ensure that the allergen carryover is below indicative levels.
Indicative levels have been set to protect those consumers who actively choose to ignore CCL on our
products. Published research indicates that up to 30% of allergic consumers voluntarily choose to ignore
products with CCL.
The scientific approach for setting indicative levels is based on dose distribution modelling obtained from
clinical feeding studies of food allergic consumers (Europe, ANZ and NA).
Indicative levels provided with this document are not a ‘stop’ / ‘go’ level for rejecting product (i.e. no hold &
release protocol needs to be followed). They should be understood as internal target levels.

5.5.2 Validation process flow:

Identify a target allergen for the study using a risk-based approach (i.e. allergen present at a highest level in
the product formula or which is intrinsically difficult to clean due to its physical properties (e.g. sticky). Rather
than validating all lines for all allergens this is done using a ‘risk-based approach’. In making this assessment
this also needs to consider the similarity of lines and associated equipment and its hygienic design status. In
cases where there are significant differences between lines and equipment then additional assessments will
need to be conducted.
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1. Target allergen and line to study identified on a

risk-based approach (highest level, most difficult
to remove). Consider sanitary design

Run the line with the target allergen product and

take a sample (positive control)

Perform the standard changeover sanitation

practices

Run the line with the CCL allergen product.

Take FP samples (approx. 200g of product) at
0, 1, 2, 5, 10, 30 and 60 min Site review changeover
practices and improve.
Repeat Indicative Level
Send samples to a accredited approved lab study
for ELISA test

Results are all Results are all Some / all results are
<LOQ <Indicative Level >Indicative Level

Check feasibility to remove the Maintain good practices. Re-assess

CCL and move to allergen Update HACCP quality protocol, amend,
cleaning. clean re-validate

Keep CCL. Maintain Remove CCL. Site

good practices. will perform
appropriate cleaning
validation
6.6.3 Decision Matrix

Minimum verification
Only repeated if a HACCP major change that requires reassessment.
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6. Sampling and Analytical Testing methods

6.1 Sampling
There are different types of sample that could be taken as part of an allergen testing program. These include
food contact surface swabs, final rinse water from a CIP system, environmental settle plates, flushing mass
and v finished products or ingredients.
6.2 Food contact surface swabs
Surface swabs are typically taken as part of the cleaning validation plan to establish if cleaned surfaces are
analytically free from allergen protein residue. The swabs are typically supplied as dry swabs with a separate
wetting buffer. These are either supplied by the external approved laboratory, or that laboratory will advise
where they can be purchased from. There will be separate buffers for each allergen being tested for. These
must be analyzed using a quantitative ELISA test. If no swabs are readily available, use a dry swab and wet
with RO (Reverse osmosis) water.
The details of where swab samples are taken from (and ideally a photo) must be recorded. Swab samples
must be taken using an aseptic technique – it is easy to contaminate them, so care must be taken.
1. Collect the required numbers of swabs and wetting buffers (picture 1).
2. Label the required number of swab transport tubes with indelible pen to preserve sample identity
(picture 2).
1. 2.

3. Estimate the swabbing area (approximately 10cm x 10cm). It must be visually clean.
Target the difficult to clean and reach areas for swabbing - rough, pitted, worn or welded surfaces.
4. Break the seal of the sterile swab transport tube and remove the swab (holding the lid which is
attached to the swab).
5. Wet the end of the swab by dipping into the wetting buffer (picture 3). Close the lid on the wetting
buffer.
6. Use the wetted swab to wipe the entire swabbing area, using side to side movements and revolving
the swab end on the surface (pictures 4 and 5).
Note: Ensure that pressure is placed on the swab end during this stage.
7. Repeat swabbing procedure in step 6, using movements at right angles in first swabbing (picture 6).
8. Return the swab to the transport tube &secure the cap. Do not add any extra wetting solution to tube.
9. Wipe the swabbed area with a clean, damp cloth to remove any swabbing solution residue.
10. Return the swabs to the approved lab for allergen testing.
11. Swabs can be stored in a fridge (2 to 8◦C) for up to 4 days prior to sending. If they need to be stored
for longer, they can be frozen.
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12. Reporting units for equipment swabs should be in µg/swab, or µg/1ml of wetting solution. They cannot
be converted into a ppm, % or mg/kg result.

3. 4. 5 6
. .

6.3 Final rinse waters from a CIP system

The final rinse water (rinsate) can be collected from a CIP system to establish if there is any allergen protein
present after the clean. Samples of the rinsate from each CIP objects covering all CIP loops must be collected
into clean containers without causing contamination. 50 – 100 ml is a sufficient sample size. These can be
stored in a fridge (2 to 8◦C) for up to 2 days prior to sending. If they need to be stored for longer, they can be
frozen.
6.4 Environmental settle plates
Environmental samples from settle plates can be used to establish the level of dusting. Plates should be
placed at locations where product is exposed to environmental dust. Settle plates should be left for the
maximum time that product could be exposed in normal production. The plates should then be swabbed
following the Food contact surface swabs procedure.
6.5 Finished product, purge material or ingredient sampling
Samples of finished products, purge material and ingredients will often be taken as part of an allergen testing
program. The minimum amount of sample should be approximately 200g per sample. All samples should be
taken into clean containers or bags that are clearly labelled without causing contamination.
Samples of finished product post cleaning will be taken to ensure that the allergen has not been carried over
to the next made product that does not contain it.
If the laboratory has not tested this sample type previously for the allergen in question, they must perform a
spike recovery test.
6.6 Allergen testing
Mondelēz does not approve specific testing kits for allergens. The method that is recommended is ELISA;
PCR testing would only be used in certain cases, if there was no reliable ELISA test available and there was
no other choice of target / marker allergen. Methods must be validated by the lab for the specific matrix.
Different ELISA test kits for the same allergen will have different LOQs and different standard ranges. They
may also target different allergen proteins. They may also have different reporting units (e.g. Total whole
peanut or peanut protein).
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6.7 Rapid tests used on site (Optional test)

There are several testing methods for allergens that could be used on site that do not involve the use of an
external laboratory. These include:
1. Rapid Lateral Flow Devices (RLFD) (e.g. Neogen Reveal, Romer Agrastrip or R-Biopharm)
2. Qualitative ELISA Tests (e.g. Neogen Alert).
3. Non-specific total protein tests (Should be only considered if neither of the above tests are available)
These three tests can only be used as an optional, additional test, after a clean, to demonstrate that the
cleaning has been effective. They do not replace the quantitative ELISA swabs and finished product
tests. The preferred method is RLFD as they do not require an internal QC testing lab. They must be validated
prior to use.

7.Lab requirements
Allergen validation shall be undertaken using industry best practice (i.e. post clean swabs & finished product
sampling, analysis conducted by a lab accredited to ISO17025 and repeated on three separate occasions).
Verification of the allergen cleaning shall be regularly verified (min. once per year). Carry over levels shall be
established by conducting sampling of finished product following the site standard product changeover
practices.

8.Rapid Testing Validation

Before being used, all rapid tests must be validated. These tests are simple and cannot replicate the
performance of the quantitative ELISA tests. Different rapid testing kits will have different sensitivities and
may not detect the allergen of concern at the same sensitivity on surfaces that have been in contact with
different matrices (e.g. A milk rapid test may detect milk well in liquid milk, but not very well in cheese or
yogurt). Therefore, it is critical that ALL rapid tests are validated prior to use.
This validation of a rapid test (RLFD, qualitative ELISA or non-specific protein test) involves two steps:
1. Selectivity – The rapid test must be validated to demonstrate that it can detect the allergen in the
form it is present in the sample type that is produced prior to the clean.
2. Sensitivity – The rapid test must be validated to demonstrate at what level the qualitative test
changes from a positive result to a negative result. This will provide an estimate of how sensitive the
rapid test is. Ideally, this should be close to the sensitivity of the quantitative ELISA used for the food
contact surface swab testing.
This validation should ideally be conducted by the manufacturer that produces the rapid test. This is the most
appropriate option as the manufacturer is the expert on their test kit. Most manufacturers of rapid tests
recommend this validation and will offer this service.
The next option is to ask the approved laboratory that is conducting the quantitative ELISA testing to validate
a rapid test. This validation can be conducted alongside the ELISA testing. This is a service that approved
labs may offer. The site will have to provide the sample and an estimate of the amount of allergen protein in
it (this could be through the specification).
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ELISA Results
Reported Result Interpretation
< 2.5 mg/kg almond The result shows that there is no allergen detected at the limit
of quantification (2.5 mg/kg)
12 mg/kg almond The result shows that 12 mg/kg of almond was detected.
Check the units – is its total almond or almond protein. There
will be an uncertainty (+/- % of result) associated with a
quantitative result. If the level is important (e.g. Indicative level
study), ask the lab what the uncertainty is.
>25 mg/kg almond The result shows that more almond was detected than the top
standard for the test. It could be 26 or 26,000 mg/kg. If the level
is important, ask the lab to do dilutions to bring the result into
range and quantify. (For more information refer to section
6.6.6)
Swab result reported as ppm Swab results should only be reported as ug/swab or ug/ ml
swab solution. There is no defined sample size, so they cannot
be converted to a ppm or %.

9. Scientific Basis
1. Park, Douglas L., 2005, Performance Test Method Multiple Laboratory Validation Study of ELISA-
Based Assays for the Detection of Peanuts in Food, Journal of AOAC International, Vol 88, No 1, p.p.
156 – 160
2. Jackson, Lauren S., Cleaning and Other Control Strategies to Prevent Allergen Cross-Contact in
Food-Processing Operations, Journal of Food Protection, Vol. 71, No. 2, pp. 445-458
3. For product that are not cross contact labelled, report validating the flushing method on file at the
plant.
4. FDE Guidance on Food Allergen Management for Food Manufacturers Jan 2013

Revision Log:

Revision Supersedes: Summary of Revision:

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