Handbook of Food Allergen Detection and Control

2nd Edition - March 1, 2025
Editor: Simon Flanagan
Language: English
Hardback ISBN:
9 7 8 - 0 - 1 2 - 8 2 1 7 3 3 - 7
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 9 8 4 1 6 - 4

Handbook of Food Allergen Detection and Control, Second Edition continues to be an essential resource of scientific and technical information in the food and analytical communiti… Read more

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Handbook of Food Allergen Detection and Control, Second Edition continues to be an essential resource of scientific and technical information in the food and analytical communities. This book provides information on current and emerging technologies for detecting and reducing allergens to improve allergen control overall. Written by experts in the field, it offers a wide scientific perspective on allergens and includes hot topics such as food allergen labeling and consumer perspectives on food allergen labels. Chapters are fully revised to include the latest information in the industry, including practical applications of new methods and control strategies. The book is useful for anyone in the food supply chain.

The book reviews current and emerging technologies for detecting and reducing allergens, as well as issues such as traceability, regulation, and consumer attitudes. Following an introductory chapter by a distinguished expert, Part One covers allergen management throughout the food chain. Part Two details current and emerging methods of allergen detection in food, with Part Three covering methods for reducing and eliminating allergens in food. Finally, Part Four focuses on the control and detection of individual food allergens and the risks each one presents in food manufacturing.

Title of Book
Cover image
Title page
Table of Contents
Copyright
Contributors
About the editor
Chapter 1. Introduction to food allergy
1.1 What is food allergy?
1.1.1 Non-IgE-mediated food allergy
1.1.2 Food intolerances
1.2 What is a food allergen?
1.2.1 Food allergens of public health importance
1.2.2 Food allergen cross-reactivity
1.2.3 Processing impact
1.3 Food allergy is a public health issue
1.4 Food allergen risk management
1.4.1 Food allergen risk management best practices
1.4.2 Cross-contamination risk management
1.4.3 Failures in food allergen risk management
1.5 Allergen risk communication
1.6 Determination of food allergen acceptable risk levels
1.7 The value of having food allergen data
1.8 Challenges and considerations in food allergen analysis
1.9 Conclusions
Part 1. Managing allergens in the food chain
Chapter 2. Traceability of allergenic foods in the food chain
2.1 Introduction
2.1.1 Definitions of traceability
2.1.2 Why good traceability practice is important
2.2 Legislation, standards, and guidance
2.2.1 Legislation
2.2.1.1 The European Union
2.2.1.2 The United Kingdom
2.2.1.3 The United States
2.2.1.4 Australia
2.2.2 Standards
2.2.2.1 BRC global standard for food safety issue 9
2.2.2.2 ISO 22005:2007
2.2.2.3 Codex principles for traceability/product tracing (CAC/GL 60-2006)
2.2.2.4 GS1 Traceability Standard
2.2.3 Guidance
2.2.3.1 EC guidance on regulation 178/2002 on general food law
2.2.3.2 FSA guidance notes for food business operators on food safety, traceability, product withdrawal, and recall
2.2.3.3 Japanese government handbook—Introduction of food traceability systems (guidelines for food traceability)
2.3 Traceability systems
2.3.1 Key system requirements
2.3.2 Building the traceability system
2.3.2.1 Team
2.3.2.2 Scope and limitations
2.3.2.3 Documents and records
2.3.2.4 Pilot evaluation
2.3.2.5 Training
2.3.2.6 Audit of the system
2.3.2.7 Review, maintenance, and record keeping
2.3.3 Relationship with site risk assessment process
2.3.4 Live incidents
2.3.5 When things go wrong with the system
2.3.6 Available traceability systems
2.3.6.1 Bespoke manual systems
2.3.6.2 Custom traceability software
2.3.7 Traceability software as part of a business-wide inventory system
2.4 Analytical methods used in traceability investigations
2.5 Conclusions
Chapter 3. Developing food allergen management thresholds
3.1 Introduction
3.2 Food allergy as a public health issue
3.2.1 Food allergy and food intolerance
3.2.2 Mechanisms of IgE-mediated food allergy
3.2.3 Symptoms of food allergy
3.2.4 Prevalence of food allergy
3.3 Allergen management thresholds: The keystone of quantitative risk assessment
3.3.1 Evolution and development of risk assessment for food allergens: An overview
3.3.2 Identifying the hazard
3.3.3 Characterizing the hazard
3.3.4 The voluntary incidental trace allergen labeling (VITAL) initiative and the elaboration of reference doses
3.3.5 The FAO/WHO Expert Consultation on risk assessment of food allergens (2020–23)
3.4 Application of food allergen management thresholds: Risk assessment approaches
3.4.1 Precautionary allergen labeling
3.4.2 Exemptions from mandatory allergen declaration
3.5 Conclusions
Chapter 4. Assessment and communication of allergen risks in the food chain
4.1 Introduction
4.2 Principles and methods
4.2.1 Application of hazard analysis and critical control points and risk assessment principles
4.2.2 Conventional food safety and hazard risk assessment
4.3 Allergen risk assessment and hazard characterization
4.3.1 Characterization of the risk from allergens (intentional/unintentional)
4.3.2 Role of GMP in allergen management
4.3.3 Supply chain risk assessment and the role of supplier quality assurance
4.3.4 Risk assessment—allergens as intentional ingredients
4.3.5 Allergens present in formulations/recipes
4.3.6 Allergens as unintentional ingredients (cross-contamination)
4.3.7 Assessment of probability of unintended allergen presence
4.3.8 Hazard characterization
4.3.8.1 Allergen protein concentration
4.3.8.2 Allergen potency and prevalence
4.3.8.3 Physical form of allergenic ingredients
4.3.8.4 Concentration of allergen likely to cross-contaminate
4.3.8.5 Quantitative allergen risk assessment
4.3.9 Assessment of control measures to minimize the risk of unintentional allergen presence
4.4 Risk communication
4.4.1 Labeling for intentional allergen presence
4.4.2 Labeling for unintentional allergen presence
4.5 Risk assessment to allergen control plan
4.6 Current research and future trends
4.7 Conclusions
Chapter 5. Consumer attitudes to allergens in foods∗
5.1 Introduction
5.2 Which consumers are avoiding foods and why?
5.3 What information do these consumers need?
5.4 Living with food allergy
5.5 Information from packaging
5.6 Challenges for consumers at different stages of life
5.6.1 Pregnancy
5.6.2 Weaning
5.6.3 Age 0–4
5.6.4 Age 5–11
5.6.5 Age 12 to adulthood
5.6.6 Leaving home and moving on
5.6.7 Travel and holidays
5.6.8 Self-catering
5.6.9 Eating catered food—Hotels, restaurants, and takeaways
5.6.10 Managing food allergy emergencies in remote places and abroad
5.6.11 Later life
5.6.12 Food allergy in the workplace
5.7 Summary of consumer needs
5.8 How can food suppliers ensure consumer confidence and trust?
5.8.1 Allergy advice boxes
5.8.2 Logos
5.8.3 Exemptions (and possible additions)
5.8.4 Thresholds
5.8.5 Analytical methods
5.8.6 Foods used in nonfood products
5.9 Conclusions and future trends
5.9.1 Changing consumer needs
5.9.2 New diagnoses
5.9.3 Tools to help consumers identify allergens in their own food
5.9.4 Meeting the market need in catering
5.9.5 The Food Information Regulation (1169/2011EC) (Regulation, 2011)
5.9.6 The market for “free from” foods
5.10 Sources of further information and advice
Chapter 6. Effective allergen management: A manufacturer's guide
6.1 The Marks and Spencer perspective
6.2 The M&S allergen journey
6.3 The M&S approach to allergen management
6.3.1 Eliminate
6.3.2 Minimize
6.3.3 Restrict
6.3.4 Manage
6.3.4.1 Allergen management risks
6.3.4.2 The M&S allergen risk assessment
6.4 Practical factory standards and controls
6.4.1 Raw material management
6.4.1.1 Delivery of raw materials
6.4.1.2 Storage of raw materials
6.4.1.3 Handling of raw materials
6.4.2 Manufacturing controls
6.4.2.1 Use of dedicated equipment
6.4.2.2 Cleaning
6.4.2.3 Cleaning validation
6.4.2.4 Cleaning verification
6.4.2.5 Testing
6.4.2.6 Emergency procedures
6.4.2.7 Personal hygiene
6.4.2.8 Training
6.4.3 Additional controls
6.4.3.1 Controls relating to nuts
6.4.3.2 Controls relating to “made without” or “free from” foods
6.5 The governance of allergen management
6.6 Industry challenges and future trends
6.7 Conclusion
Chapter 7. Effective allergen management
7.1 Allergen management as part of a wider food safety management program
7.2 Allergen risk assessments
7.2.1 Allergen identification
7.2.2 Identify cross-contact opportunities
7.2.3 Assess the likelihood of these opportunities occurring
7.2.4 Evaluate the level of risk associated with each of these opportunities
7.2.5 Are the control measures in place sufficient and effective?
7.2.6 Based on the risk assessment, is the communication to customers/consumers sufficient?
7.3 Management of allergens
7.3.1 People
7.3.1.1 Training
7.3.1.2 People movement
7.3.1.3 Standard operating procedures (SOPs)
7.3.2 Raw material management
7.3.2.1 Specification
7.3.2.2 Dedicated tools
7.3.2.3 Segregation
7.3.3 Process
7.3.3.1 Scheduling
7.3.3.2 Factory controls
7.3.3.3 Label control
7.3.4 Cleaning
7.3.4.1 Allergen cleaning validation and verification
7.3.5 Product development
7.4 When/when not to use precautionary allergen labeling
7.5 Common mistakes and when things go wrong
Part 2. Detecting allergens in food
Chapter 8. Sampling for food allergens
8.1 Allergen sampling and analysis
8.1.1 Introduction
8.2 Reasons to sample for food allergens and sampling plans
8.3 Approaches to sampling
8.3.1 Representative sampling
8.3.2 Selective sampling
8.3.3 Random sampling
8.3.4 Composite sampling
8.4 Sample types
8.4.1 Food samples: Raw materials, part-manufactured product, and finished product
8.4.2 Rinse water, wash water, and flushing materials
8.4.3 Settle plates
8.4.4 Environmental swabbing
8.5 Quality of the sample
8.6 Future trends
Chapter 9. Enzyme-linked immunosorbent assays (ELISAs) for detecting allergens in food∗
9.1 Introduction
9.2 Principles of an enzyme immunoassay
9.2.1 Sandwich ELISA format
9.2.2 Competitive ELISA format
9.3 Main components of ELISA
9.3.1 Extraction of allergens from food
9.3.2 Antibody
9.3.3 Antibody conjugate
9.3.4 Antigen
9.3.5 Calibrant
9.4 Detection issues relating to particular allergens: Egg, milk, nuts, prolamins, and glutelins
9.4.1 Egg
9.4.2 Milk
9.4.3 Nuts
9.4.4 Prolamins and glutelins
9.5 Validation, characteristical parameters of ELISA, and collaborative studies
9.5.1 Limit of detection and limit of quantitation
9.5.2 Recovery
9.5.3 Collaborative studies
9.5.4 Clinical validated reference samples (EuroPrevall)
9.6 Conclusions
Chapter 10. Lateral flow devices for detecting allergens in food
10.1 Introduction
10.2 Lateral flow devices
10.3 Development of a lateral flow device
10.3.1 Sample extraction
10.3.2 Sample/conjugate zone
10.3.3 Test zone
10.3.4 Reservoir/wick zone
10.4 Key considerations when using lateral flow devices
10.5 Future trends
10.6 Conclusions
Chapter 11. Optical thin-film biochips for detecting allergens in food
11.1 Introduction
11.2 Principles of optical thin-film biochips
11.2.1 Preparation of optical thin film biochips
11.2.2 Design and synthesis of specific primer pairs and probe
11.2.3 Biochips hybridization and assay protocol
11.3 Applications for detection of allergenic foods
11.4 Advantages and disadvantages of optical thin film biosensor chip assays
11.5 Future trends
11.6 Conclusions
Chapter 12. Polymerase chain reaction (PCR) methods for detecting allergens in foods∗
12.1 Introduction
12.2 Advantages of PCR for allergen detection
12.3 PCR principles and methods
12.3.1 General principle
12.3.2 Target sequence selection
12.3.3 DNA extraction and purification
12.3.4 Nucleic acid amplification techniques other than PCR
12.4 Multiallergen detection and quantification with PCR
12.4.1 Multiallergen detection with PCR
12.4.2 Allergen quantification with PCR
12.5 PCR performance characteristics
12.5.1 Sensitivity
12.5.2 Specificity
12.5.3 Accuracy
12.6 Conclusions and future trends
Chapter 13. IgE antibody-based analysis for detecting allergens in food
13.1 Introduction
13.2 General considerations
13.2.1 Food allergen extract and component calibrators
13.2.2 Human subject considerations
13.3 IgE antibody-based in vivo assay for food allergen potency assessment
13.3.1 In vivo assay methodology
13.3.2 Illustrative skin response
13.3.3 Quality control
13.3.4 Analytical sensitivity
13.3.5 Analytical specificity
13.3.6 Variability
13.3.7 Dynamic range
13.3.8 Strengths and limitations
13.4 IgE antibody-based in vitro assays for food allergen potency assessment
13.4.1 Cell-based IgE antibody in vitro assay for food allergen detection
13.4.2 Serological IgE antibody-based in vitro assay for food allergen detection
13.4.2.1 Allergosorbent
13.4.2.2 Human allergen-specific IgE antibody
13.4.2.3 Antihuman IgE detection reagent
13.4.2.4 Calibrators and controls
13.4.2.5 Assay design considerations
13.4.2.6 Data analysis
13.4.2.7 Quality control
13.5 Applications in the detection of peanuts
13.6 Allergosorbent competitive inhibition assay: Strengths and weaknesses
13.6.1 Strengths
13.6.2 Weaknesses
13.7 Future trends
Abbreviations
Chapter 14. Validation, standardization, and harmonization of analytical methods and test kits for detecting allergens in food
14.1 Introduction
14.2 Different methods for the detection of allergens in food
14.2.1 ELISA for the detection of allergen proteins
14.2.2 Rapid lateral flow devices for use in manufacturing environments
14.2.3 PCR for the detection of DNA from allergens
14.2.4 LC–MS/MS for the detection of peptides from allergens
14.3 Comparing the different methods
16.3.1 ELISA
16.3.2 RLFD
16.3.3 PCR
14.3.4 LC–MS/MS
14.4 Limitations of the different methods and how they can be overcome
16.4.1 ELISA
16.4.2 RLFD
16.4.3 PCR
14.4.4 LC–MS/MS
14.5 Importance of validation and good practices
14.5.1 Cross-reactivity
14.5.2 Matrix interference
14.5.3 In-house validation
14.6 Challenges of standardization and harmonization of analytical methods
14.6.1 Challenges of availability of reference materials
14.6.2 Challenge of the use of different antibodies and different calibrants
14.6.3 Challenge of different analytical targets
14.6.4 Collaborative studies
14.6.5 Steps to harmonize methods
14.7 Future trends
Part 3. Methods of reducing/eliminating allergens in food
Chapter 15. Sanitation and hygienic design as allergen control measures
15.1 Introduction
15.2 Hygienic design: Regulations and norms
15.3 Hygienic equipment design criteria
15.3.1 Separation
15.3.2 Construction materials
15.3.3 Cleanability and accessibility for cleaning
15.3.3.1 Accessibility
15.3.3.2 Cleanability
15.3.4 Smooth surfaces
15.3.5 Drainage
15.3.6 Hermetically sealed design
15.4 Hygienic building design
15.5 Putting the theory into practice—Assessing and implementing hygienic design
15.5.1 Hygienic design risk assessment
15.5.2 Failure mode effect analysis
15.5.3 Design reviews /stage gates
15.5.3.1 Hygienic design review checklists
15.6 Cleaning as an allergen control measure
15.6.1 Principles of cleaning
15.6.1.1 Product sensitivity
15.6.1.2 Equipment type and design
15.6.1.3 Soil characteristics
15.6.2 Cleaning methods
15.6.2.1 Wet cleaning
15.6.2.2 Dry cleaning
15.6.2.3 Flushing
15.7 Allergen cleaning: Validation, verification, and monitoring
15.7.1 Validation
15.7.2 Monitoring and verification
15.8 Food safety culture and training
Chapter 16. Assessing and managing allergenicity of genetically modified (GM) foods#
16.1 Introduction
16.2 Assessing the allergenicity of novel proteins
16.3 Key steps in allergenicity assessment
16.4 Environmental factors affecting allergenicity
16.5 Assessing the allergenicity of whole GM plants
16.6 Assessing the allergenicity of products from GM animals
16.7 Postmarket monitoring
16.8 Conclusion
Part 4. Control and detection of specific food allergens
Chapter 17. Milk as a food allergen
17.1 Introduction
17.2 Milk: Products and ingredients
17.2.1 Milk proteins
17.2.2 Milk products and ingredients
17.3 Milk allergy
17.3.1 Prevalence
17.3.2 Severity
17.3.3 Potency
17.3.4 Allergens
17.3.5 Non-IgE, mixed conditions
17.4 Regulation of milk as a priority food allergen
17.5 Milk detection and quantification
17.6 Allergen management challenges for milk
Chapter 18. Detection and control of eggs as a food allergen
18.1 Introduction
18.2 Egg allergy
18.3 Egg allergens
18.3.1 Allergens in egg white
18.3.1.1 Ovomucoid (Gal d 1)
18.3.1.2 Ovalbumin (Gal d 2)
18.3.1.3 Ovotransferrin (Gal d 3)
18.3.1.4 Lysozyme (Gal d 4)
18.3.1.5 Other egg white allergens
18.3.2 Allergens in egg yolk
18.3.2.1 Serum albumin (α-livetin, Gal d 5)
18.3.2.2 YGP42 (Gal d 6)
18.3.2.3 Other egg yolk allergens
18.4 Detection of egg allergens
18.5 Enzyme-linked immunosorbent assay
18.6 Other techniques: Western blots, lateral flow, and polymerase chain reaction devices
18.6.1 Western blots
18.6.2 Lateral flow
18.6.3 Polymerase chain reaction
18.7 Future trends
18.8 Conclusion
Chapter 19. Soybeans as a food allergen
19.1 Introduction
19.2 Key issues
19.3 Soybeans and their food uses
19.4 Composition and nutritional value of soybeans
19.5 Soybeans as a source of food ingredients
19.6 Basis for labeling priority for Soybean
19.7 Soybean allergy—Prevalence
19.8 Soybean allergy—Severity
19.9 Soybean allergy—Potency
19.10 Allergenicity of soy-based ingredients
19.11 Soybean allergens
19.11.1 Gly m 1 and Gly m 2
19.11.2 Gly m 3
19.11.3 Gly m 4
19.11.4 Gly m 5
19.11.5 Gly m 6
19.11.6 Gly m 8
19.11.7 Gly m 7
19.11.8 Kunitz soybean trypsin inhibitor
19.11.9 Gly m Bd 30K (P34)
19.11.10 Gly m Bd 28K
19.11.11 Soy oleosins
19.12 Detection of soy residues
19.12.1 PCR
19.12.2 ELISA
19.12.3 Lateral flow devices
19.12.4 Mass spectrometry
19.13 Control of soy protein residues in food manufacturing facilities
19.14 Effects of food processing unit operations on soy protein allergenicity
19.15 Future trends
19.16 Conclusions
Chapter 20. Gluten and wheat-related disorders
20.1 Introduction
20.2 Classification of wheat, rye, and barley proteins
20.3 Gluten
20.3.1 Gluten structure
20.3.2 Gluten as cause of wheat-related disorders
20.4 Wheat-related disorders
20.4.1 Celiac disease
20.4.1.1 Symptoms
20.4.1.2 Causes
20.4.1.3 Diagnosis and prevalence
20.4.1.4 Treatment
20.4.2 Nonceliac wheat sensitivity
20.4.3 Wheat allergy
20.4.3.1 Respiratory and skin allergy to wheat
20.4.3.2 Food allergy to wheat
20.4.3.3 Wheat-dependent exercise-induced anaphylaxis
20.4.4 Legislation
20.4.4.1 The European Union
20.4.4.2 America
20.4.4.3 Africa, Asia, Australia, and New Zealand
20.4.5 Gluten analysis
Chapter 21. Detection and control of fish, shellfish, and mollusks as food allergens#
21.1 Introduction
21.2 Classification of seafood and seafood protein characteristics
21.3 Seafood as allergens
21.4 Epidemiology of seafood allergy
21.5 Manifestations of seafood allergies
21.6 Management of seafood allergies
21.7 Summary and future trends
Chapter 22. Detection and control of mustard and sesame as food allergens#
22.1 Introduction
22.2 Mustard as an allergen
22.3 The major allergic proteins in mustard
22.4 Detection of mustard allergens and markers in food
22.4.1 Protein-based methods
22.4.2 DNA-based methods
22.5 Sesame as an allergen
22.6 The major allergic proteins in sesame
22.7 Detection of sesame allergens and markers in food
22.8 Future trends
Chapter 23. Mass spectrometry for analysis of food allergens
23.1 Introduction
23.2 MS and proteomics basics
23.2.1 The ion source
23.2.2 The mass analyzer
23.2.3 The detector
23.3 Proteomics workflows
23.3.1 Intact and top-down proteomics
23.3.2 Discovery and targeted proteomics
23.3.3 Discovery proteomics
23.4 Use of discovery data in identification of peptides and proteins
23.5 Targeted methods
23.5.1 SRM/MRM versus PRM
23.5.2 Target peptides
23.5.3 Product ions/transitions
23.6 Quantification
23.6.1 Stable-isotope labeled peptides as standards
23.6.2 Food calibrants
23.6.3 Calculation quantification approach
23.6.4 Using an external calibrant
23.6.5 Integrating multiple peptide quantities into a measure of allergenic food
23.7 Evaluating method performance
23.7.1 Specificity
23.7.2 Method performance factors
23.7.3 Detection capability
23.7.4 Recovery and precision
23.8 Challenges for MS method development and implementation
23.8.1 Sequence databases
23.8.2 Quantification: Conversion factors and calibration
23.8.3 Processing and matrix effects black box
23.8.4 Method transfer and collaborative validation studies
Index

Simon Flanagan

Simon Flanagan is an internationally acclaimed specialist in the field of food allergens. He is a biochemist by training and gained experience of working in a variety of sectors within the food industry before joining Reading Scientific Services Ltd (RSSL) in 2002. In his RSSL role Simon has worked with global blue-chip manufacturers, retailers and ingredient suppliers, as well as manufacturers of specialist dietary products to provide guidance on risk assessment, risk mitigation and management and analytical techniques for allergen detection in foods. Simon’s remit involved a broad scope of projects, from futureproofing corporate allergen policy through to independent expert site risk assessment and training programs and incident management.

Since 2005 Simon has been a key advisor to the Cadbury and more latterly Kraft / Mondelēz International on allergen control and responsible for developing policy, strategy and training. In 2016 Simon became an extended member of the Food Safety Team and is currently the Global Lead for Food Allergens and Food Allergy advising the business on both proactive allergen strategy and reactive lead for allergen incidents.

Simon is affiliated with numerous professional bodies, industry groups and technical committees (ILSI Europe, FDF, BRC, EFSA, FSA, FARRP, FAO/WHO) and has published numerous articles in peer reviewed journals. He was also principal editor for the ‘Handbook of Food Allergen Detection and Control’. He was presented with a technical leadership award in 2014 for contributions to food safety and a SOFHT industry award for the development of RSSL’s practical allergen workshops. He was also awarded ‘Food and Drink Scientist of the Year’ at the FDF awards in 2018.

Simon was one of the first to develop a practical methodology for quantitative allergen risk assessment (QRA), which is becoming widely accepted as industry best practice; QRA was recently recommended by The WHO/FAO Ad-Hoc expert group on Food Allergen Risk Assessment for the application of Precautionary Allergen Labelling.

Affiliations and expertise

Simon is a Research Fellow and food allergen subject matter expert for Mondelez International based in the UK.

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