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Allergen Management in

Beverages – Introduction

1
Workshop Agenda

 What are Food Allergies?


 Pepsico Food Safety Policies
 HACCP & Allergen Codes of Practice
 Role of R&D In Allergen Management
 Allergen Management in Operations
 Risk Assessment of production lines
 Action Planning

2
Workshop Agenda

 What are Food Allergies?


 Pepsico Food Safety Policies
 HACCP & Allergen Codes of Practice
 Role of R&D In Allergen Management
 Allergen Management in Operations
 Risk Assessment of production lines
 Action Planning

3
Reactions to Food

Predictable Unpredictable

Occurs in anyone who


Occurs in some susceptible people
eats enough of the food.

1. Food Poisoning 2. Aversion


Toxic (dioxin,heavy metals) Psychological 3. Food
Microbiological (salmonella) intolerance based Hypersensitivity
Pharmacological (caffeine) upon dislike. Non-psychological
reaction to food.

Food Intolerance
Metabolic defect Food
(gluten)
Other abnormality Allergy
(lactose) Immune Reaction

4
Food Allergy Facts (1)

NO PROTEIN = NO ADVERSE REACTION!

What is a food allergen?


 Protein is the causative agent in food allergy
 The allergenic protein has active allergenic
sites or epitopes that interact with the body’s
immune system
 It can produce an immune system-mediated
adverse reaction in sensitive individuals,
sometimes fatal, when ingested/eaten
 Not usually destroyed by heating or
processing
5
Food Allergy Facts (2)

Food Allergens Stability

 Resistance to the digestive tract


 Resistance to proteolysis, hydrolysis and digestion
 Resistance to heat
– Peanut and egg allergens remain stable when heated
or boiled at 100 °C.
– Milk retains its allergenicity through condensation,
evaporation, and drying.
 Acid stable
– Peanut allergens are stable at pH 2.8

– Egg ovalbumin at pH 3.0.

6
7
Signs and symptoms of food allergy

 Hives, itching or eczema


 Swelling e.g. lips, face, tongue,
throat
 Wheezing, nasal congestion or
trouble breathing
 Abdominal pain, diarrhoea, nausea
Hives
or vomiting

Dermatitis Angioedema Swelling


8
Anaphylactic shock

 A generalised shock reaction with a severe


drop in blood pressure
 Constriction of airways, resulting in trouble
breathing
 Can have multiple organ failure
 Can be accompanied by any of the other
symptoms
 If not treated immediately…..

…can cause DEATH!!


9
Food Allergy Facts (1)

How common is food allergy?


 However, only around 1% of adults and 2 - 2.5% of children
world-wide have true food allergy
 Food allergy in children is most common up to 3 years old

Children with food allergy have a lower quality of life than


diabetic children (Avery et al; Pediatric Allergy and Immunology, 14(5), pp. 378-
382(5) 2003)

Note: The only therapeutic option available to treat food allergy


is avoidance of problem foodstuffs, and for the severely allergic
to carry adrenaline

10
Managing a food allergy (1)

Critical Risk Factors for Food Allergy Consumers:


• Accuracy of food label information

• Cross-contact of foods during preparation

• Awareness of catering staff

Therefore…
• High Risk - restaurant or takeaway food; party food
• Intermediate - patisserie and hand-made chocolates
• Low - labelled pre-packaged food (but may be
unhelpful)
• Lowest - fresh or home prepared food

11
Managing a food allergy (2)

Allergy Sufferers manage their allergies by:


 Avoiding allergenic food
 Diligent reading and research
 Label awareness and careful checking
 Brand loyalty = safety

Allergy sufferers rely on food manufacturers to


ensure that the food inside a pack matches the label
on the outside

Correct labelling - no cross-contamination


12
Workshop Agenda

 What are Food Allergies?


 Pepsico Food Safety Policies
 HACCP & Allergen Codes of Practice
 Role of R&D In Allergen Management
 Allergen Management in Operations
 What Allergens are in our Snacks in India
 Risk Assessment of production lines
 Action Planning

13
PepsiCo Global Food Safety Policies…

“No matter where we are, the safety and integrity of our


products is our single highest priority…. It’s our duty
as a responsible company. People buy our brands
because they know they can count on consistent quality
— every time. We follow very rigorous standards of safety
and quality. Our standards are equally rigorous in New
York, London and Beijing as they are wherever else we
operate. We stand behind each and every product we
sell.”
Indra Nooyi, CEO
PepsiCo
Annual Report

14
PepsiCo Global Food Safety Policies

This document and the


systems and processes it Applies to:
describes serve to ensure: PepsiCo
• The Implementation of the Franchises
Food Safety Policy Joint Ventures
• All PepsiCo divisions, Co-packers
franchises, co-packers and re- Re-packers
packers (warehouses and
distribution centres where
appropriate) shall maintain
compliance to these policy
requirements. Requirements:
• Products, processes and Company
systems conform to company, Customer
customer, consumer and Consumer
regulatory requirements Regulatory
15
PepsiCo Global Food Safety Policies

Applies to ALL PepsiCo products


16
PepsiCo Global Food Safety Policies

1. Organizational Responsibility
• HACCP
2. Critical Food Safety Elements • Low Acid
3. Regulatory Manufacturing
policies in place
4. Food Security
5. Design Quality
• Allergen
6. Manufacturing Management
• Crisis Management
7. Documentation & Records plan in place
8. Supply • Foreign Object
Controls and Devices
9. Auditing & Self Assessments • Master Sanitation
10. Corrective & Preventive Action Plan established and
documented
11. Training • GMP’s documented
12. Consumer & Customer Satisfaction and followed
• Pest Management
Programs in place

17
Workshop Agenda

 What are Food Allergies?


 Pepsico Food Safety Policies
 HACCP & Allergen Codes of Practice
 Role of R&D In Allergen Management
 Allergen Management in Operations
 Risk Assessment of production lines
 Action Planning

18
HACCP Code of Practice (COP)

To ensure that all products manufactured by PepsiCo


or for PepsiCo are safe and fit for consumption, the
PepsiCo Food Safety Policies delineates HACCP as a
Critical Food Safety Element, required across all
PepsiCo business units.
The Research and Development and commercialization
teams are responsible for ensuring that products and
processes meet regulatory requirements and are designed
to be safe for human consumption.
HACCP transfer documents - outlining all hazards
identified for new ingredients, new processes or new
finished products – must be provided prior to production
trials.
19
HACCP COP

• HACCP is required across all PepsiCo business units.


• Each operations site must have a documented and
approved HACCP plan for each process line, which
includes all types of product made.
• HACCP - based on Codex 7 Principles & 12
Implementation Steps
• The HACCP Plan must be audited for compliance,
revalidated on a routine basis, and must be current
for product and processes.
• Hazards - Biological, Physical & Chemical (which
includes Allergens)

Biological Physical Chemical

20
Allergen Code of Practice

ALLERGEN RISK MANAGEMENT POSITION


“PepsiCo aims to protect sensitive consumers
by providing safe foods with accurate and
informative labels. We apply appropriate
measures across our operations to avoid
cross-contamination, minimising
precautionary labelling. We ensure that we
follow local regulatory guidance, and apply
advisory statements for critical allergens in
the absence of regulatory requirements.”

21
Allergen Code of Practice

Requires:
• Application of control measures across
our operations to avoid cross-
contamination, minimising the use
precautionary labelling.
• Adherence to local regulatory guidance
• Application of advisory statements for
critical allergens in the absence of
regulatory requirements.

22
Allergen Code of Practice – “Big 8”

Pepsico Allergen List * List of “Treenuts”


Almond (Prunus dulcis, Amygdalus communis L.),
Peanut Hazelnut / Filbert nut (Corylus avellana)
Walnut (Juglans regia)
Tree nuts Butternut (Junglans cinerea)
Milk (All species) Cashew (Anacardium
Potential occidentale)
Allergen Exceptions
Pecan nutbleached,
• Refined, (Carya illinoiesis (Wangenh.) oils
and deodorized K.Koch)
Fish (All species) Brazil nut and
• Cultures (Bertholletia excelsa)
enzymes produced by
Shellfish (Crustacea Pistachio nut (Pistacia vera)
fermentation process
Macadamia / Queensland nut (Macadamia
and Molluscs) • Wheat derived glucose, glucose syrup,
ternifolia)
dextrose, dextrose
(Ginkgomonohydrate,
Egg (All species) Ginkgo nut
maltodextrin, andspp.)
biloba L.)
sugar alcohols.
Beech nut (Fagus
Soya Hickory nut (Carva spp.)
Wheat Shea nuts (Vitellaria paradoxa)
Indian nuts, Chestnuts and Chinquapin (Castanea
spp.)
Pine nuts (Pinus spp.)

23
Allergen Code of Practice

REQUIREMENTS:
Effective risk management of allergens can be achieved
through:
• Allergen hazard/Risk assessments,
• Using Supplier Specifications
• Risk Management
• Accurate and informative Consumer risk
communication.

24
Allergen Code of Practice

Risk Assessment
• Raw materials and their supply source, product recipe, and each
specific process platform within individual plant layouts.
• Risk from both intentional presence of allergens and likely
unintentional presence through cross-contamination, carried over
from raw materials and processes.
• Potential impact on manufacturing process and any need for on-pack
precautionary labelling.
Supply and Specifications
• Raw materials must have specifications with supplier declarations on
the intentional presence of critical allergens, and indicating any
likelihood of unintentional allergen cross-contamination.
• Supplier allergen risk assessment should be done as part of supplier
approval to demonstrate compliance with the PepsiCo Allergen
Management COP.

25
Allergen Code of Practice

Operations Allergen Risk Management Practices


• Introduction of new allergens to facilities should be
minimized, with an impact assessment carried out prior
to any such introduction.
• Competent cross-contamination controls for critical
allergens must be in place across operations.
• Control strategies - should include segregation (through
scheduling, sanitation, separation, dedicated equipment),
rework control, and right product right pack systems.
• A “visually clean” standard must be achieved as the aim
for sanitation (in view of the absence of globally accepted
critical limits).

26
Allergen Code of Practice

Risk Communication Practices


• Accurate and clear on-pack declarations of intentionally
present critical allergens are required for all products (including
trial product) - whether or not local regulatory requirements
exist.
• Allergen information should be provided within ingredient declarations.
• PepsiCo requires all relevant allergenic ingredients to be highlighted.
• Clear on-pack labelling is required to indicate any significant increase in
product allergen profile.
• Product labelling should comply with local regulations. In the absence of
local regulatory requirements, allergenic ingredients should be labelled
following the PepsiCo Allergen Management Code of Practice Annexes.

27
Allergen Code of Practice

Risk Communication Practices


• Additional precautionary labelling may be required,
dependent on HACCP-based risk assessments exist.

• Precautionary labelling is NOT a substitute for good


manufacturing practice (GMP), HACCP-based risk
management and optimal plant design.
May Contain:
Fish, Nuts, Peanuts,
Milk, Shellfish, Wheat,
Eggs, Soya, Mustard,
Sesame, Lupin, Strawberries,
Kiwi Fruit, Olives, Anchovies, Shrimp,
Crab, Yeast Extract, Anything!

28
Workshop Agenda

 What are Food Allergies?


 Pepsico Food Safety Policies
 HACCP & Allergen Codes of Practice
 Role of R&D In Allergen Management
 Allergen Management in Operations
 Risk Assessment of production lines
 Action Planning

29
R&D Overall Responsibility for Allergens

1. Identification of all potential allergens – Raw


Materials
2. If not a functional component :
• Do not design it in
• Design it out.
3. Avoid the introduction of an allergen into a facility
that did not already contain the allergen.
4. Total dedication and segregation (of lines where
possible) or equipment.
5. If risk is still present or not technically feasible,
use clear labelling of unavoidable allergens in
product or through supplementary advisory
statements. 30
R&D Responsibility – New Products (1)

• Potential allergens are identified in new ingredients -


(declared and undeclared allergens).
• If not functional for products, the use of ingredients
containing allergens are designed out.
• Facility portfolio assessment has been conducted to
minimize the introduction of an allergen into a facility
that did not already have the same allergens.
• Allergen hazard assessment has been conducted
before manufacturing line trials.

31
R&D Responsibility – New Products (2)

• Local legislation review has been conducted to


determine appropriate allergen labeling or appropriate
use of other advisory statements in absence of
regulatory requirements.
• Operational risk assessment has been conducted to
identify intentional and unintentional presence of
allergens and the requirements for accurate and
appropriate allergen labeling or advisory statements.
• The cost of allergen operational management
(cleaning, scheduling, manpower, and other resources)
has been considered prior to product launch.

HACCP Transfer Checklist

32
Workshop Agenda

 What are Food Allergies?


 Pepsico Food Safety Policies
 HACCP & Allergen Codes of Practice
 Role of R&D In Allergen Management
 Allergen Management in Operations
 Risk Assessment of production lines
 Action Planning

33
Allergen Management in Operations

Allergen Management is based


on

Segregation
Using:
• Labelling
• Distance
• Physical Barriers
• Cleaning
34
Allergen Management – Six Principles

Allergen management is based on segregation using


labelling, distance, physical barriers and cleaning.

1. Identify and label the allergens present in all raw materials


and finished products.
2. Complete a HACCP-based risk assessment of all process
lines to identify opportunities for cross-contamination.
3. Design/Modify process equipment to eliminate all potential
unintentional cross-contamination.
4. Use scheduling to group products with identical allergen
profiles to minimise changeover risks and cleaning.
5. Manage production and changeovers effectively, with
records to demonstrate due diligence checks were
completed.
6. Ensure the Allergen management system (HACCP) is
updated for all new ingredients, products and processes.

35
Allergen Management - Principle 1

1. Identify and label the allergens present in all


raw materials and finished products.
2. Complete a HACCP-based risk assessment of all process lines to
identify opportunities for cross-contamination.
3. Design/Modify process equipment to eliminate all potential
unintentional cross-contamination.
4. Use scheduling to group products with identical allergen profiles to
minimise changeover risks and cleaning.
5. Manage production and changeovers effectively, with records to
demonstrate due diligence checks were completed.
6. Ensure the Allergen management system (HACCP) is updated for all
new ingredients, products and processes.

36
Identifying Allergens in Ingredients

1. List ALL ingredients used in ALL products on


ALL lines
2. Get Allergen Information for ALL ingredients:
• Get quantities of allergenic protein present
3. Build the Allergen profile for each product: base
beverage, additions/concentrate and inclusions
4. Show the Allergen profile per product for each
line

37
Identifying Allergens in Ingredients

38
Identifying Allergens in Products

39
Allergen Management - Suppliers

• When selecting raw material/ingredient


suppliers, require your ingredient suppliers to
have a documented Allergen Control Plan.
• Require specifications/letters from suppliers
that guarantee the ingredients you purchase do
not contain undeclared allergens.
• Require suppliers to have validated sanitation
cleaning procedures in place to manage
Allergens.

40
Allergen Management - Suppliers

• Audit your suppliers on a regular basis to assess the


effectiveness of their Allergen Control Plan.
• Conduct a supplier survey which includes the following:
• The Allergen Control Plan of the supplier
• The range of allergenic products produced by the
supplier,
especially on shared equipment with ingredient for you
• The supplier’s allergen cleaning program and
protocols
• Allergen training records for supplier’s employees

41
Storage and labelling

42
Labelling Allergens in Operations

43
Labelling Allergens in Operations

44
Allergen Management - Principle 2

1. Identify and label the allergens present in all raw materials and
finished products.

2. Complete a HACCP-based risk assessment of


all process lines to identify opportunities for
cross-contamination.
3. Design/Modify process equipment to eliminate all potential
unintentional cross-contamination.
4. Use scheduling to group products with identical allergen profiles to
minimise changeover risks and cleaning.
5. Manage production and changeovers effectively, with records to
demonstrate due diligence checks were completed.
6. Ensure the Allergen management system (HACCP) is updated for all
new ingredients, products and processes.

45
HACCP – What are the Hazards

A HAZARD is... Three types of Hazards:

• Biological
Any property
which may cause
a product to be • Physical
unsafe for
consumption
• Chemical
ALLERGENS 46
Risk Assessment Model - Severity

RISK = Severity x Frequency


Severity if
controls Severity of affect if Hazard Occurs Multiplier
fail
Mild disappointment to the consumer. No medical treatment
Little
Damage
needed. May lead to a complaint, no business interruption. 1
Minor consequences.
Very minor medical treatment at home. Consumer disappointed
Damage
and likely to complain to the Company.
2
Serious Illness at home. May seek medical treatment. A disappointed
Damage consumer very likely to complain to a Regulatory Authority.
3
Very
Illness at home with medical treatment necessary. A very
Serious
disappointed consumer. Possible risk of prosecution.
4
Damage
Disaster Hospitalization required. Significant risk of proscecution. Media
Serious coverage. Intervention by ‘Crisis management team’. Damage to 5
Illness ‘branded ‘ image.
Catast- Death. Top level ‘crisis management’ Certain risk of
rophic proscecution. Destruction of ‘brand’
6
47
Assessing Allergen Risk

Size of Risk Source of Risk Degree of Risk


Wrong
Pack/label
RISK OF CONSUMER REACTIO N

Wrong Product

WHOLE PACK
Crossover/Spill

LIQUID/INCLUSIONS

Poor
Poor
Sanitation
Sanitation LIQUID

INCLUSIONS
AIRBORNE PARTICULATES/AEROSOLS

DOSE OF ALLERGEN

What opportunities are there for cross-contamination in a beverage system?

48
Risk of Contamination

Q. How much contamination can occur/has occurred ?

How much material each time? How often could the


contamination occur?
 Whole pack  Every pack
 Amount of liquid  1/hour
 Inclusions  1/shift
 After cleaning

Work out the total amount of allergenic protein that could be


ingested
• Based on a realistic level of consumption and worst case
contamination.
• Review Intended allergen profile and additions for
contaminating materials

49
GMPs, SCPs and CCPs – Allergen Control

Effective Allergen Changeover


CCP Cleaning

SCP Right Product/Right Pack(label)

• Prevention of Cross-contamination
GMP
• People Control
• Labelling
• Ingredient Control

50
Allergen Management - Principle 3

1. Identify and label the allergens present in all raw materials and
finished products.
2. Complete a HACCP-based risk assessment of all process lines to
identify opportunities for cross-contamination.

3. Design/Modify process equipment to eliminate


all potential unintentional cross-contamination.
4. Use scheduling to group products with identical allergen profiles to
minimise changeover risks and cleaning.
5. Manage all allergen changeovers effectively, with records to
demonstrate due diligence checks were completed.
6. Ensure the Allergen management system (HACCP) is updated for all
new ingredients, products and processes.

What sort of modifications could be made?


51
Equipment modification/design

Connectors used to prevent cross-contamination


52
Equipment modification/design

Plant design for correct flow through process without cross-contamination


53
Equipment modification/design

Can separate CIP circuits be used to prevent cross-contamination?


54
Allergen Management - Principle 4

1. Identify and label the allergens present in all raw materials and
finished products.
2. Complete a HACCP-based risk assessment of all process lines to
identify opportunities for cross-contamination.
3. Design/Modify process equipment to eliminate all potential
unintentional cross-contamination.

4. Use scheduling to group products with


identical allergen profiles to minimise
changeover risks and cleaning.
5. Manage production and changeovers effectively, with records to
demonstrate due diligence checks were completed.
6. Ensure the Allergen management system (HACCP) is updated for all
new ingredients, products and processes.

55
Basis for Allergen Scheduling

1. Start the production run with products


containing no allergens
2. Build up the schedule adding products with the
same allergen profile.
3. An allergen clean is required if a product does
NOT contain an allergen PRESENT in the
previous product.
4. This MUST take priority over colour and cross-
taint risk of products
5. Group products with the same allergen in the
base

56
Scheduling for Allergens - Beverage

Shellfish
Peanut

Wheat
Soya
nuts
Tree

Fish
Milk

Egg
Product
Orange Juice                
Orange juice with pulp              
Mango juice              
Milky Juice     MI        
Peanut Milk Pe    MI        
Allergen Clean
Soy drink - strawberry             So
Soy drink - vanilla             So
Allergen Clean
Orange juice

57
Scheduling for Allergens - Snacks

Shellfish
Peanut

Wheat
Soya
nuts
Tree

Fish
Milk

Egg
Product
Salt and vinegar                
Swiss Cheese     Mi          
Cheese and Onion     MI          
Cheese an Chilli     MI         Wh
Allergen Clean
BBQ Pe             Wh
Allergen Clean
Masala Magic             So Wh
Paprika             So Wh
Spicy Prawn       Fi     So Wh

58
Allergen Management - Principle 5

1. Identify and label the allergens present in all raw materials and
finished products.
2. Complete a HACCP-based risk assessment of all process lines to
identify opportunities for cross-contamination.
3. Design/Modify process equipment to eliminate all potential
unintentional cross-contamination.
4. Use scheduling to group products with identical allergen profiles to
minimise changeover risks and cleaning.

5. Manage production and changeovers


effectively, with records to demonstrate due
diligence checks were completed.
6. Ensure the Allergen management system (HACCP) is updated for all
new ingredients, products and processes.

59
Allergen Management during Production

Packaging handling:
• Use dedicated packaging lines whenever
possible
• Make the packaging material visually
distinctive.
Label handling:
• Control of similar labels for different products:
• Labels must be checked prior to start-up or
changeover.
• Monitoring: A label from each carton is visually
checked prior to use. This check must be
logged.
60
Packaging Visually distinctive?

61
Allergen Management during Production

Rework handling:
• Rework/holdover containers must be clearly labelled
(e.g. type and date) and segregated.
• Establish effective inventory controls.
• Rework usage will be clearly documented to assure
traceability.
• Develop rework/product matrix:

LIKE into LIKE


• Monitoring: The origin of rework is recorded on the
process sheet.

62
The life of a box of an ingredient...

• Delivered from Suppliers


• Checked & Accepted
• Stored
• Removed from Stores
• Used in Production
• Part Used Box
• Correctly Sealed
• Return To Stores
Procedure
• Checked & Accepted
63
Safe use of ingredients...

STORAGE USE RETURN TO STORE


Careful
I
contain returning
Milk
unused
t
h ea ingredients
W ou r
fl to the store
I
contain
Wheat Clear Identification

Clear Identification
Record
Keeping

ya
So
Original
Packaging
Segregation of retained with
Allergens Clear separation of
Ingredients
Ingredients in use
for
Traceability

64
Allergen Cleaning during Changeovers

Define cleaning procedures for all shared equipment:


• Define a validated cleaning procedure to avoid carryover.
• Select correct CIP cycle for Allergen products
• Develop a product sequencing/cleaning matrix.
• Monitoring: Review the equipment inspection log prior to start
up.
• Corrective action: Repeat cleaning when product residues are
visible.
• Documentation: Records must be reviewed on a monthly basis.
The sequencing/cleaning matrix must be reviewed anytime that
a new product is introduced.
Best Practice
• Avoid contamination of nearby lines:
• Use vacuum cleaning rather than air hoses (Dry Materials).
• Avoid use of High pressure hoses
• Use dedicated cleaning equipment. 65
Special Cleaning Equipment…

Brushes and scrapers specially made for Allergen cleaning

66
Allergen Cleaning during Changeovers

Redesign or reconfigure equipment to make cleaning


and inspection easier:
• Easily opened and inspected.
• Allergen contact surfaces should be accessible for
examination.
• Quick release fasteners should be used for removable covers.
• Avoid crossovers of conveyor belts or use shielding.

Develop an allergen spillage procedure:


• Define isolation areas.
• Place affected product on hold.
• Clean the cleaning equipment.
• All personnel affected must change overalls.
• Inspect to verify that all allergen containing product has been
removed.
67
Special CIP regime…Allergen 5-step

68
Allergen Cleaning – Verification/Validation

Validation:
• The equipment cleaning/flushing procedure must be validated
to demonstrate that it removes visible product residues from all
product contact surfaces.
• When the “visually clean” standard has been achieved it must
be validated using a Allergen Test Kit for the specific allergen
in the product.
• All cleaning procedures must be revalidated at least twice per
year

Verification (Inspection):
• All Allergen cleaning must meet the “visually clean” standard
• No visible trace of the previous product.
• Check all product contact surfaces and above open
product
• Completed for every Allergen clean 69
How Clean is “Clean”?

70
How Clean is “Clean”?

All filler valves should be checked

71
How Clean is “Clean”?

72
Guides

73
Allergen Changeover Inspection

1. INSPECT the line as ‘visually clean’


• Monitor during the cleaning process
• Thoroughly inspect all areas
• Reclean and re-inspect if needed
• Only PASS when completely satisfied
2. Check the product flow through to the
filler is set up correctly
3. Check the correct package/label is in
place

74
Allergen Champions

Part 1 - Theory - An introduction to


Allergens
Part 2 - Practical - inspection
techniques
Part 3 - Theory - Plant standards and White
controls Glove
Part 4 - Practical - Inspection sign off CERTIFIED
Part 5 - CERTIFICATION

75
Allergen – Protein Test Kits

Reveal Test kit for Total Milk Allergen - Neogen

Positive (more than 5 ppm)


sample can be interpreted
as soon as 2 lines are
visible (2-3 min).

Negative (less than 5 ppm)


sample should be
interpreted at 5 min. No
sample line and one
control line. (5-6 min.)

76
Allergen Management - Principle 6

1. Identify and label the allergens present in all raw materials and
finished products.
2. Complete a HACCP-based risk assessment of all process lines to
identify opportunities for cross-contamination.
3. Design/Modify process equipment to eliminate all potential
unintentional cross-contamination.
4. Use scheduling to group products with identical allergen profiles to
minimise changeover risks and cleaning.
5. Manage production and changeovers effectively, with records to
demonstrate due diligence checks were completed.
6. Ensure the Allergen management system
(HACCP) is updated for all new ingredients,
products and processes.

77
HACCP Transfer Checklist (HTC)
– When is it needed?

Before:
Any Significant changes • In-plant Trials
• First production

Product
Allergens
Higher Risk
Ingredients Anything new!

New Equipment,
Process Equipment Removal, Etc.

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Keeping Allergen Information up-to-date

HACCP Transfer Checklist:


Must Include:
• List of Allergens
• All potential Hazards/controls (+ additional requirements)

• Details of the Change:


• Products
• Brands
• Sites
• Supplier (if ingredient change)
• Material Safety Data Sheet
• Ingredient Specification
• Project Brief
• Product Description and intended use
• Risk Assessment
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Summary

Allergen management is based on segregation using


labelling, distance, physical barriers and cleaning.

1. Identify and label where allergens occur.


2. HACCP-based risk assessment of all process lines.
3. Modify process equipment to eliminate cross-
contamination.
4. Use scheduling to group products with identical
allergen profiles.
5. Manage all allergen changeovers effectively.
6. Ensure the Allergen management system (HACCP) is
kept up to date.

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Workshop Agenda

 Pepsico Food Safety Policies


 HACCP & Allergen Codes of Practice
 What are Food Allergies?
 Role of R&D In Allergen Management
 Allergen Management in Operations
 Risk Assessment of production lines
 Action Planning

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Allergen Risk Assessment – In-plant
1
Ingredients 1
• List Allergens
present in each raw
material
2
2
• Identify Allergens in
each product
• List product (and
allergen) mix on each
3 line
Production sequence

4
Cross-
• Identify Cross- 3
contamination
from one contamination Risks
• Modify equipment
line/product to
to prevent risk
another running at
the same time

Cross- • Assess line 4


contamination equipment
from one product cleanability
to the next on the • Visually Clean Std.
same line • Validation - Testing
Line 1 Line 2 83
Assessing Allergen Risk

Size of Risk Source of Risk Degree of Risk


Wrong
Pack/label
RISK OF CONSUMER REACTIO N

Wrong Product

WHOLE PACK
Crossover/Spill

LIQUID/INCLUSIONS

Poor
Poor
Sanitation
Sanitation LIQUID

INCLUSIONS
AIRBORNE PARTICULATES/AEROSOLS

DOSE OF ALLERGEN

84
Workshop Agenda

 Pepsico Food Safety Policies


 HACCP & Allergen Codes of Practice
 What are Food Allergies?
 Role of R&D In Allergen Management
 Allergen Management in Operations
 What Allergens are in our Snacks in India
 Risk Assessment of production lines
 Action Planning

85
Consumer Trust!

Or…

86
What Questions do you have…?

87

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