Allergen Management Procedure
Prerequisite
Program for Allergen Management
Distribution:
List of executives and other employees responsible for the implementation of the procedure.
4.1.1 XYZ Foods Inc. manufacture products with
known allergens. Few products contain milk, eggs, and wheat, where there is
specific attention on raw material requiring precise control. Nonetheless, the
canteen and staff may handle milk, egg, fish, crustaceans, peanuts, tree nuts,
meat, soya, sesame, etc., that contains allergenic substances unknowingly or
accidentally, where controls are put in place to prevent contamination.
4.1.2 The facility is nut-free, where staff and
agency workers (if used) must be notified during induction training to avoid
any allergen related nuts in their foods. The company does not manufacture
products carrying specific claims or produce products with organic claims and
does not use raw materials containing genetically modified material.
4.1.3 Intentional inclusion of allergenic
ingredients must be declared and labeled properly, and the cross-contact
allergens must be prevented through proper management controls.
4.2.1 The allergen management program must include
risk analysis, ensuring suppliers of materials and those raw materials,
ingredients, and processing aids, including food-grade lubricants that contain
allergens, must declare any allergenic substances in the materials they are
supplying, and identify the intentional and cross-contact allergens that could
occur, and the potential risk of occurrence.
4.2.2 The evaluation must be completed through a
detailed risk assessment, which accounts for raw material, interim product, and
finished product contamination risks at each stage within the XYZ's process and
the physical location.
4.2.3 The baseline risk assessment (gap analysis)
must be conducted to implement effective management controls and establish
alibi labeling requirements. The baseline data must be used to identify
potential cross-contacts or contamination risks.
4.2.4 The identified risks are further quantified,
allowing the established management controls to be further refined to
understand product cross-contamination risks in each production area and
develop a robust action plan to minimize risks wherever possible.
4.2.5 Collect reference information on the
identified risks in detail to examine the likelihoods of contamination and
quantities used to determine if alibi labeling for the allergen(s) of concern
is required or whether risks can be adequately managed.
4.2.6 The allergen management procedure must
include assessing workplace-related food allergens from locker rooms, vending
machines, lunchrooms, and visitors to determine the risk of cross-contact
allergens, where action can be taken to minimize or eliminate the risk.
4.2.7 The allergen management procedure has
included a register of allergens, which must be applied in the country of the
manufacturer and the country/s of destination, including changes in
legislation, as regulatory allergens change from time to time.
4.2.8 The list of regulatory allergens and
labeling laws specific to countries where the products are sold must be
declared and met during the receiving, processing, storage, and transportation.
4.2.9 The allergen management procedure has also
included a list of allergens accessible by relevant staff and operators and
areas, including canteens, locker rooms, and vending machines.
4.3.1 Allergen training must be provided to all
the employees, including essential awareness, consequences of unintentional
consumption of allergens, unintentional inclusion of trace amounts of
allergenic material in products (e.g., clothes, incorrect ingredient selection,
spillages, and inadequate cleaning), and the methods required to prevent
contamination.
4.3.2 The allergen management procedure must
include specific instructions for receiving staff on hazards associated with
allergens and how their control is incorporated into the food safety management
system to identify, handle, store, and segregate raw materials containing
allergens. Any materials known to contain allergens must be documented.
4.3.3 Provision must be made to clearly identify
and segregate foods that contain allergens, and segregation work instructions
must be implemented and continually monitored.
4.3.4 The procedure must also include instructions
for the receiving and operational staff on how to identify, store, and keep
separate non-allergenic materials.
4.3.5 The operators must identify all allergenic
ingredients at the receiving inspection and store them separately from
non-allergenic materials and materials containing different types of allergens.
Staff involved in receiving and storage must be fully aware of allergens'
presence and risk and the storage procedure.
4.3.6 Allergen-containing ingredients must be
clearly labeled with the allergenic substance's name and must be stored and
transported to avoid spillage or leakage onto other non-allergenic materials.
4.4.1 Cleaning and sanitation of product contact
surfaces between line changeovers must be effective, appropriate to the risk
and legal requirements. The treatment must be sufficient to remove all
potential targeted allergens from product contact surfaces, including aerosols
as appropriate, to prevent cross-contact, where allergenic material may be
intentionally or unintentionally present.
4.4.2 Separate handling and production equipment
must be provided where satisfactory line hygiene and clean-up or segregation
are impossible.
4.4.3 If allergenic material may be present,
product changeover procedures must be documented and implemented to eliminate
the risk of cross-contact.
4.4.4 If satisfactory cleaning cannot be
implemented, separate handling and production equipment is required.
4.4.5 Separate and isolated production equipment
must be provided to avoid cross-contact in a situation where the allergen risk
is greater (e.g., peanut protein can cause serious allergic reactions in minute
trace quantities), where processing equipment design does not permit adequate
cleaning. Care must also be taken to avoid cross-contact due to airflow,
transfer on tools or equipment, or staff movement from one line to the other.
4.4.6 The allergen preventive control plan must
document the hazards associated with storage, movement, and use of allergens in
the plant and how the specific hazards are controlled. Nonetheless, all
identified cross-contact and intentional allergens must be included in the
hazard control plan, and their controls identified. In an emergency or accident,
allergen controls may be identified as CCPs due to the risk to public health,
infringement of labeling regulations, and the potential for product recall.
Controls may include, but are not limited to:
- Specifications for ingredients and raw materials;
- Receipt and separate storage of raw materials and ingredients;
- Separate storage of work in progress and finished products;
- Scheduling of allergen-containing materials after non-allergen containing materials;
- Equipment design to avoid build-ups, bottlenecks and to allow for separation of highly allergenic materials;
- Control of rework;
- Allergen cleaning and sanitation procedures;
- Testing of products and equipment.
4.4.7 The effectiveness of validation and
verification of the cleaning and sanitation of specific areas and equipment in
which the allergens are used must be effectively implemented.
4.4.8 Cleaning and sanitation procedures on
processing lines that are producing allergenic and non-allergenic products must
be effectively operated and validated. Cleaning procedures must be effectively
documented, implemented, and validated to avoid cross-contact allergens
transferring across products.
4.4.9 The factory must ensure that all finished
products are correct to label concerning allergens, including labels that meet
the allergen labeling regulations in the country of manufacture and destination
country. Product changeover procedures must be controlled and supervised to
ensure that the correct product is on the correct label.
4.4.10 The acceptable validation testing methods must
use a test specific to the allergen being removed that requires a test method,
which uses an antigen (the given allergen) and an antibody specific to the
antigen.
4.4.11 Both the ELISA tests and lateral flow test
kits must be accepted as antigen and antibody tests for validation
activities. If the enzyme-linked
immuno-assay or ELISA method (either quantitative or qualitative) is used that
can be conducted in a laboratory or with test kits available for in-plant use
are both acceptable. However, other "acceptable" tests for validation
methods can be used, but the test must meet the "allergen-specific"
criteria or provide some other evidence that the validation is effective.
4.4.12 Annual re-validation must be conducted to
account for any changes that may have occurred. Still, any changes to the
production or process or any potential risk situation must conduct additional
validation activities. However, not all allergens have specific test kits
available, including some finfish and allergens modified by fermentation, heating,
or hydrolysis.
4.4.13 The procedures must be scientifically valid,
and any exclusions or exemptions must be thoroughly documented with a detailed
risk assessment. There must be a documented reassessment of the allergen
control program performed at least annually.
4.4.14 The purpose of a validated cleaning program is to confirm that the specifics of the cleaning process used are complete, effective, sufficient, and when implemented, will produce the same results every time.
4.4.15 Once a validated cleaning method has been
effectively implemented, the FST must verify that the validated procedures were
used each time. The verification must be documented after direct observation
during the sanitation process by a responsible person from the FST who has been
trained in the validated cleaning method.
4.4.16 The use of highly sensitive swabs is also an
acceptable verification method that tests for proteins. The use of these total
protein swabs or the ATP sensitive swabs must be calibrated with the validated
cleaning procedure by using them immediately after the validated method is used
and recording the allergen-specific test results and the protein or ATP swab
test.
4.4.17 The relative risk of allergen contamination
must be established considering the likelihood of an allergen contaminating
other materials and the quantity used in the area.
4.4.18 The corrective actions and additional
management procedures must be established to prevent allergens
cross-contamination in each area.
4.4.19 A list of actions must be prepared based on
allergen presence and the processing area, then color code areas based on the
potential risk identified. Use red for allergen presence and amber for
potential risk or cross-contact areas.
4.4.20 Adjust the color-coding of any perceived risks
on the allergens present by area and if the risk assessment has changed based
on the factory floor verification.
4.4.21 Protection measures must be established for
the risks identified through risk assessment to prevent allergen contamination
in each area.
4.4.22 Walkthrough audit must be conducted on each area and associated lines/ equipment in turn, preferably while typical production is running. Consideration must be given to the allergenic ingredients present in the area and what, if any, risks they pose to the product, which must be protected. If the area/ lines are used for multiple product groups/ types, the production plan must ensure that the verification includes the assessment during each production. A record must be kept on each walkthrough audit concerning perceived risk and action required.
4.4.23 Based on recipes or composition of materials,
for the materials present in the area containing a specific allergen, calculate
the percentage of the allergen within the material/recipe that is the highest
for the areas of concern.
4.4.24 Using reference tables, calculate the actual
percentage of allergenic protein within the material/ recipe with the highest %
of the allergen of concern.
4.4.25 This information can then be used to further refine
the action plan and form the basis for discussing appropriate alibi labeling
(or not) for own brand and customer branded products.
4.4.26 Decanted solid or powdered material must be
decanted into labeled lidded containers if required to be stored in the
containers. Scoops used and interim mixing containers must be cleaned after
use. Clean, dry containers, utensils, and scoops are obtained prior to
manufacturing a product containing different allergens to the previous product.
4.4.27 The red color PPE must be used while handling
allergen. Aprons and gloves must be disposed of immediately after use and hand
washed and sanitized before starting another product.
4.4.28 Dedicated equipment, e.g., trays/racks, must be
considered based on the risk assessment.
4.4.29 Products containing new allergens to the
facility must be carefully considered through both the HACCP and allergen risk
assessment before any product trials within the factory. Avoid introducing new
allergens wherever possible.
4.4.30 Any new product containing allergens must be considered against both the HACCP and allergen risk assessment prior to any product trials to establish if the allergen is new to the area/ equipment. Therefore additional management controls may be required.
4.4.31 Any products intended to carry free from
specific provenance or organic claims must be considered against both the HACCP
and allergen risk assessment before any product trials. Consideration must also
be given to additional accreditation requirements, production segregation and
fabrication changes, production planning, and further product testing.
4.4.32 Full hygiene and production cleaning methods
must be validated using post-cleaning hygiene ATP swabbing as per standard
hygiene procedure.
4.4.33 Additional verification test must be
considered in case of failure of the current methods or for the comparison
proposes.
4.4.34 Information in the form of self-audit questionnaires
and accreditation certificates must be held for each supplier.
4.4.35 Suppliers must provide specification documents
for all raw materials and interim products brought onto the facility. FSTL
examines the spec before taking delivery of new material, and the spec is filed
to signify acceptance of the information. Specs must include ingredients,
allergens, and potential allergen cross-contamination risks.
4.4.36 Technicians and contractors must wear
disposable overalls while completing work within the factory and storage areas.
Wherever possible, engineering works must take place outside of production
hours.
4.4.37 If engineering is required during production and in areas/ on equipment handling allergens, cleaned tools must be used, which are then cleaned and sanitized after contact with contaminated surfaces. Disposable overalls must always be removed after each engineering job is completed.
4.4.37 Site rules clearly state that nuts must not be
brought on-site, which must be strictly applied to prohibit
staff/visitors/contractors from carrying nuts, e.g., groundnuts, walnuts, etc.,
to the facility.
4.4.38 Staff canteen and food brought from home must
not contain nuts, and visitors have to confirm on a declaration that they are
not carrying nuts or products containing nuts.
4.4.39 Personnel is allowed to bring products to the
site that carry an alibi warning statement for other food allergens, e.g.,
'may contain fish/crustaceans' but not present as an intentional ingredient.
4.4.41 Equipment and the general environment within product packing must be subject to a documented clearance between product packing runs. A clean down of food contact surfaces and any environmental debris must be made and all packaging from the previous run cleared before the next run is permitted to commence. This clearance process must be verified and counter-signed on packing records before the next run commences.
4.4.42 For packaged products, a copy of the start and
end labels plus a sample of the first label from any reel change during packing
must be retained and attached to the packing record for the completed label
verification. A positive sign-off to verify that the label and printed
information is correct must be completed on the packing record.
5.0 References
5.1 Food safety procedure for
withdrawals/recalls – FSMS 02/FSP/08
6.0 Records
6.1 Food Allergen
Ingredient Analysis Form –
FSMS 04/PRP/14/F/01
6.2 Food Allergen Label
Verification List – FSMS 04/PRP/14/F/02
6.3 Production Line Food
Allergen Assessment Form – FSMS 04/PRP/14/F/03
6.4 Food Allergen Preventive Control Plan – FSMS 04/PRP/14/F/04
6.5 Food Allergen Risk Analysis – FSMS 04/PRP/14/CL/01
